REVIEW OF NON-PHYSICIAN PRESCRIBING and ...

Ontario College of PharmacistsSubmission to theHealth Professions RegulatoryAdvisory CouncilonNon-Physician Prescribing andAdministration of Drugsunder the Regulated HealthProfessions ActNovember 2008

Health Professions Regulatory Advisory Council Submission“Non-Physician Prescribing and Use of Drugs” - PharmacyIntroductionThe Ontario College of Pharmacists (the College) as the licensing and regulatory bodyfor Pharmacy in Ontario is pleased to respond to the Health Professions RegulatoryAdvisory Council (HPRAC)’s Applicant Questionnaire respecting the Review of Non-Physician Prescribing and Use of Drugs as it relates to the pharmacists’ practice inOntario.Our submission, and the contents therein, very much builds on the College’s previoussubmission respecting the Scope of Practice for Pharmacy review which was submittedto HPRAC last June. For this review respecting non physician prescribing and use ofdrugs, the College focuses on the actual activities that we propose pharmacists must beable to do to fully realize their roles in Medication Therapy Management (MTM).Medication therapy management, or “MTM” as it is referred to within North America, isthe term that best describes the cognitive role that pharmacists play before making thedecision to dispense a drug and while monitoring ongoing drug therapy. The rolereaches far beyond dispensing as pharmacists must first gather information from thepatient or agent or the prescriber to determine whether the prescribed drug isappropriate based on the patient’s medication and relevant history. Once a diagnosishas been made, pharmacists can play a key role in partnership with physicians andother prescribers to ensure that the right drug is prescribed or that, where no drug isprescribed, the patient understands why. Many pharmacists promote health andwellness in their practice settings by hosting clinics on smoking cessation, fluprevention and infection control, healthy weight and exercise, and women’s healthissues. Monitoring patient compliance and effectiveness of medication therapy is a keycomponent of medication therapy management. All of this should be reflected in thescope of practice.In day-to-day practice pharmacists are called upon to perform acts that are consideredto be part of two additional controlled acts “administering a substance by injection orinhalation” and “performing a procedure on a tissue below the dermis” which are notcurrently authorized to the profession of pharmacy. Specifically, because pharmacistsare expected to provide information and education to patients or their agents whenproviding drugs, health care aids and devices, pharmacists will:• pierce a patient’s finger with a lancet to obtain blood for the purpose ofdemonstrating the proper use of a glucose monitoring device• administer insulin by injection for demonstration purposes when teaching newdiabetic patients or their agents how to properly do so• administer a substance by inhalation when providing education respecting theproper use of inhalers and inhalant devices.The following activities are those that pharmacists currently are called upon to do as adaily and routine part of current practice but legally only with the express consent of aprescriber, or through the use of delegation, medical directives, or professionaljudgement. As family physicians are increasingly unavailable for consultation in atimely manner, we are seeking the authority for pharmacists to be permitted to do thefollowing without further authorization from a prescriber:1

• adapt an existing prescription to facilitate patient compliance, such aschanging the dosage form (e.g. from a capsule or tablet to an oral liquidformulation for patients who have difficulty swallowing); changing thedosage regimen (e.g. from one tablet twice a day to two tablets once a dayto facilitate compliance); changing the dosage form to one reimbursable bythe patient's third party drug benefit plan (e.g. capsule to tablet); and whenthe prescribed dose or dosage form is not commercially available (e.g. 50 mgonly comes in 52.5 mg)• authorize further extension of a prescription where there are no existingrefills for continuity of care• provide Schedule II and III drugs as a prescription for minor ailments whererequired for reimbursement under drug plans• adjust dosage of medication in response to monitoring (e.g. lab tests).• administer drugs, including through injection and inhalation, for patienteducationPharmacists will be expected to communicate these prescription changes to the familyphysician, nurse practitioner, and other health professionals in a timely manner, inorder to ensure that other members of the patient's health care team are informed ofchanges in the patient's medication therapy.Further, the College is aware that plans are already underway to implement significantenhancements to the undergraduate pharmacy education programs both at theUniversity of Toronto and the University of Waterloo. The new programs will graduatenew pharmacists from a robust, enhanced curriculum who are ready to practice in anexpanded role - starting in 2014 these pharmacists graduating with Clinical Doctorate inPharmacy (Pharm.D) degrees will expect to practice in an expanded role that willinclude among other activities administering drugs by injection for both emergency androutine purposes, and initiating drug therapy in collaborative practice environmentsunder certain conditions. Accordingly, the College strongly supports an HPRACrecommendation that would provide us the flexibility to create an extended class ofpharmacist practitioner when appropriate to accommodate the changing education andtraining of these new pharmacists so they are able to fully utilize their knowledge, skillsand abilities in optimizing patient care and meeting the changing health care needs inOntario.Permitting Ontario pharmacists to adapt, modify and extend prescriptions under certainconditions will bring Ontario into line with what pharmacists are already or soon will bedoing in other jurisdictions across Canada. Permitting pharmacists to pierce the dermisand administer drugs by injection or inhalation for patient education will allow them tohave a greater role in medication therapy management. The Colleges proposalscontained within this submission are based on the fundamental belief that allpharmacists in Ontario today possess the knowledge, skills and ability to adapt, modifyand extend prescriptions under certain conditions. The College believes that itsproposals are solidly supported by the unique body of knowledge that pharmacistspossess respecting the use, monitoring and management of drugs.Note: References have been included in our previous submission on Scope of Practicefor Pharmacy and are available upon request.2

Tom Magyarody, Executive DirectorOntario Dental Association----------------------------------------------------Tel: ---------------------Email:--------------------------------Barb LeBlanc, Executive Director, Health Policy DepartmentOntario Medical Association----------------------------------------------------Tel: ---------------------Email:-------------------Dennis Darby, Chief Executive OfficerOntario Pharmacists' Association----------------------------------------------------Tel: ---------------------Email:-------------------Doris Grinspun, Executive DirectorRegistered Nurses' Association of Ontario----------------------------------------------------Tel: ---------------------Email:-------------------EMPLOYER ASSOCIATIONSDean Miller, PresidentOntario Chain Drugstore Associationc/o Director of Pharmacy for OntarioShoppers Drug Mart----------------------------------------------------Tel: ---------------------Email:-------------------Heather Stewart, Hospital ConsultantOntario Hospital Association----------------------------------------------------Tel: ---------------------Email:-------------------5

FACULTIES / SCHOOLS OF PHARMACY IN ONTARIOWayne Hindmarsh, DeanLeslie Dan Faculty of PharmacyUniversity of Toronto----------------------------------------------------Tel: ---------------------Email:-------------------Jake Thiessen, DirectorSchool of PharmacyUniversity of Waterloo----------------------------------------------------Tel: ---------------------Email:-------------------ONTARIO MINISTRY OF HEALTH AND LONG-TERM CAREBrent Fraser, DirectorDrug Program ServicesOntario Ministry of Health and Long-Term Care-----------------------------------------------------------------------------Tel: ---------------------Email:-------------------Angie Wong, Senior Manager (Acting)Pharmaceutical Services Coordination UnitOntario Ministry of Health and Long-Term Care----------------------------------------------------Tel: ---------------------Email:-------------------Tim Blakley, Manager (Acting)Legislative and Special Projects UnitOntario Ministry of Health and Long-Term Care----------------------------------------------------Tel: ---------------------Email:-------------------6

Frank Schmidt, ManagerHealth Human Resources Program Policy UnitOntario Ministry of Health and Long-Term Care----------------------------------------------------Tel: ---------------------Email:-------------------PHARMACIST REGULATORY BODIES IN OTHER PARTS OF CANADAGreg Eberhart, RegistrarAlberta College of Pharmacists----------------------------------------------------Tel: ---------------------Email:-------------------Marshall Moleschi, RegistrarCollege of Pharmacists of British Columbia----------------------------------------------------Tel: ---------------------Email:-------------------Ron Guse, RegistrarManitoba Pharmaceutical Association----------------------------------------------------Tel: ---------------------Email:-------------------Bill Veniot, RegistrarNew Brunswick Pharmaceutical Society----------------------------------------------------Tel: ---------------------Email:-------------------Donald Rowe, Secretary-RegistrarNewfoundland and Labrador Pharmacy Board----------------------------------------------------Tel: ---------------------Email:-------------------7

Jeannette Hall, RegistrarNorthwest Territories Regulatory AuthorityDepartment of Health and Social ServicesGovernment of the Northwest Territories---------------------------------------------------------------------------------------Tel: ---------------------Email:---------------------------------Susan Wedlake, RegistrarNova Scotia College of Pharmacists----------------------------------------------------Tel: ---------------------Email:-------------------Manon Lambert, Sécretaire géneraleOrdre des pharmaciens du Québec----------------------------------------------------Tel: ---------------------Email:-------------------Neila Auld, RegistrarPrince Edward Island Pharmacy Board----------------------------------------------------Tel: ---------------------Email:-------------------Ray Joubert, RegistrarSaskatchewan College of Pharmacists----------------------------------------------------Tel: ---------------------Email:------------------------------------Fiona Charbonneau, RegistrarYukon Consumer ServicesDepartment of Community ServicesGovernment of the Yukon----------------------------------------------------Tel: ---------------------Email:-------------------8

PHARMACIST PROFESSIONAL ASSOCIATIONS IN CANADAKeith Stewart, Chief Executive OfficerAlberta Pharmacists' Association----------------------------------------------------Tel: ---------------------Email:-------------------Linda Vaillant, Directrice généraleAssociation des pharmaciens des établissements de santé du Québec----------------------------------------------------Tel: ---------------------Email:-------------------Normand Cadieux, Directeur généralAssociation québécoise des pharmaciens propriétaires----------------------------------------------------Tel: ---------------------Email:-------------------Marnie Mitchell, Chief Executive OfficersBritish Columbia Pharmacy Association----------------------------------------------------Tel: ---------------------Email:-------------------Scott Ransome, Executive DirectorManitoba Society of Pharmacists----------------------------------------------------Tel: ---------------------Email:-------------------Paul Blanchard, Executive DirectorNew Brunswick Pharmacists' Association Inc.----------------------------------------------------Tel: ---------------------Email:-------------------George Skinner, Executive DirectorPharmacists' Association of Newfoundland and Labrador----------------------------------------------------Tel: ---------------------Email:-------------------9

Brett Filson, Executive DirectorPharmacists' Association of Saskatchewan----------------------------------------------------Tel: ---------------------Email:-------------------Larry Shipp, Executive DirectorPharmacy Association of Nova Scotia----------------------------------------------------Tel: ---------------------Email:-------------------Laura Beattie, PresidentPharmacy Society of the Yukon--------------------------Tel: ---------------------Email:-------------------Erin Farrell MackenziePrince Edward Island Pharmacists Association----------------------------------------------------Tel: ---------------------Email:-------------------NATIONAL PHARMACY ORGANIZATIONSFrank Abbott, Executive DirectorAssociation of Deans of Pharmacy of Canada----------------------------------------------------Tel: ---------------------Email:-------------------Nadine Saby, President & CEOCanadian Association of Chain Drug Stores----------------------------------------------------Tel: ---------------------Email:-------------------Tim Fleming, PresidentCanadian Association of Pharmacy Technicians----------------------------------------------------Email:-------------------10

Linda Dresser, PresidentCanadian College of Clinical PharmacyDepartment of PharmacyNorth York General Hospital----------------------------------------------------Tel: ---------------------Email:-------------------David Hill, Executive DirectorCanadian Council for Accreditation of Pharmacy Programs----------------------------------------------------Tel: ---------------------Email:-------------------Arthur Whetstone, Executive DirectorCanadian Council on Continuing Education in Pharmacy----------------------------------------------------Tel: ---------------------Email:-------------------Jeff Poston, Executive DirectorCanadian Pharmacists Association----------------------------------------------------Tel: ---------------------Email:-------------------Bev Berekoff, Administrative OfficerCanadian Society for Pharmaceutical Sciences----------------------------------------------------Tel: ---------------------Email:-------------------Sandra Leung, PresidentCanadian Society of Consultant PharmacistsCommunity Care Services, Capital Health----------------------------------------------------Tel: ---------------------Email:-------------------Myrella Roy, Executive DirectorCanadian Society of Hospital Pharmacists----------------------------------------------------Tel: ---------------------Email:-------------------11

Marita Tonkin, PresidentOntario BranchCanadian Society of Hospital Pharmacists----------------------------------------------------Tel: ---------------------Email:-------------------Carole Bouchard, Executive DirectorNational Association of Pharmacy Regulatory Authorities----------------------------------------------------Tel: ---------------------Email:-------------------John Pugsley, Registrar-TreasurerThe Pharmacy Examining Board of Canada----------------------------------------------------Tel: ---------------------Email:-------------------NATIONAL HEALTH PROFESSIONAL ASSOCIATIONSWilliam Tholl, Secretary General, CEOCanadian Medical Association------------------------------------------------------------------------------Tel: ---------------------Email:-------------------Lucille Auffrey, Chief Executive OfficerCanadian Nurses Association----------------------------------------------------Tel: ---------------------Email:-------------------PRIVATE SECTOR DRUG PLANSIrene Klatt, President and CEOCanadian Life and Health Insurance Association----------------------------------------------------Tel: ---------------------Email:-------------------12

PHARMACEUTICAL INDUSTRYRussell Williams, PresidentCanada’s Research-Based Pharmaceutical Companies----------------------------------------------------Tel: ---------------------Email:-------------------Jim Keon, PresidentCanadian Generic Pharmaceutical Association----------------------------------------------------Tel: ---------------------Email:-------------------David Skinner, PresidentNDMAC----------------------------------------------------Tel: ---------------------Email:-------------------INTERNATIONAL PHARMACIST /PHARMACY ORGANIZATIONS:Yves Gariepy, Chair, Administration, Pharmacy SectionInternational Pharmaceutical Federation------------------------------------------------------------------------------Tel: ---------------------Email:-------------------John Gans, Executive DirectorAmerican Pharmacists Association----------------------------------------------------Tel: ---------------------Email:-------------------Henri R. ManasseCEO / Executive Vice PresidentAmerican Society of Health-System Pharmacists----------------------------------------------------Tel: ---------------------Email:-------------------13

Carmen Catizone, Executive DirectorNational Association of Boards of Pharmacy----------------------------------------------------Tel: ---------------------Email:-------------------Peter Wilson, Head of Post Registration DivisionRoyal Pharmaceutical Society of Great Britain----------------------------------------------------Tel: ---------------------Email:-------------------Registered Nurses' Association of Ontario----------------------------------------------------Tel: ---------------------Email:-------------------CURRENT AUTHORIZED ACTS AND REGULATIONS9. Do current authorized acts and regulations reflect best practices for theprescribing or administration of drugs in the course of practice of membersof your profession?No. It is this College’s view that the current authorized acts for Pharmacy, (set outunder s.4, Pharmacy Act) do not fully reflect best practices today. The currentauthorized acts are:In the course of engaging in the practice of pharmacy, a member is authorized, subjectto the terms, conditions and limitations imposed on his or her certificate of registration,to dispense, sell or compound a drug, or supervise the part of a pharmacy where drugsare kept.The authorized acts of “selling, compounding and dispensing a drug” involve bothtechnical and cognitive components, and pharmacists are expected to competentlyperform both. While “selling and dispensing” imply a focus that is on the product, bestpractices in pharmacy today focus on the patient and demonstrate the pharmacist’sunique role in promotion health and wellness, and monitoring and managing thepatient’s medication therapy. With extensive education and training in such areas asmedicinal, physical, biological, and pharmaceutical chemistry, anatomy, physiology,biopharmaceutics and pharmacokinetics, therapeutics, pharmacology and pathology,pharmacists have a unique body of knowledge and an expertise that no other healthprofessional has respecting drugs, their actions, interactions and effects. Whilepharmacists continue to oversee and ensure that safe and effective drug distributionsystems are in place, pharmacists today are called upon to use their expertise to fullyrealize their roles in medication therapy management.Medication therapy management, or “MTM” as it is referred to within North America,best describes the cognitive role of pharmacists in making the decision to dispense a14

drug while monitoring ongoing drug therapy. The role reaches far beyond dispensing aspharmacists must first gather information from the patient or agent or the prescriber todetermine whether the prescribed drug is appropriate based on the patient’s medicationand relevant history. When a diagnosis has been made, and before a drug is prescribed,pharmacists can play a key role in partnership with physicians and other prescribers toensure that the right drug is prescribed or that, where no drug is prescribed, thepatient understands why. Many pharmacists promote health and wellness in theirpractice settings by hosting clinics on smoking cessation, flu prevention and infectioncontrol, healthy weight and exercise, and women’s health issues. Monitoring patientcompliance and effectiveness of medication therapy is a key component of medicationtherapy management.Activities falling within a pharmacist’s role in Medication Therapy Management include:• adapting an existing prescription to facilitate patient compliance, such aschanging the dosage form (e.g. from a capsule or tablet to an oral liquidformulation for patients who have difficulty swallowing); changing the dosageregimen (e.g. from one tablet twice a day to two tablets once a day to facilitatecompliance); changing the dosage form to one reimbursable by the patient'sthird party drug benefit plan; and when the prescribed dose or dosage form isnot commercially available (e.g. 50 mg only comes in 52.5 mg)• authorizing further extension of a prescription where there are no existing refillsfor continuity of care• providing Schedule II and III drugs as a prescription where required forreimbursement under drug plans• adjusting dosage of medication in response to monitoring (e.g. lab tests)Pharmacists are also, by virtue of their scope of practice, expected to provideinformation and education to patients or their agents when providing drugs, health careaids and devices. Accordingly, in day-to-day practice pharmacists are called upon toperform the acts of “administering a substance by injection or inhalation” and“performing a procedure on a tissue below the dermis” - acts which are not currentlyauthorized to the profession of pharmacy as described below:• pierce a patient’s finger with a lancet to obtain blood for the purpose ofdemonstrating the proper use of a glucose monitoring device• administer insulin by injection for demonstration purposes when teaching newdiabetic patients or their agents how to properly do so• administer a substance by inhalation when providing education respecting theproper use of inhalers and inhalant devices.Pharmacists perform controlled acts other than dispensing, selling, and compoundingdrugs, currently through delegation, medical directives, professional judgment or theexceptions provided under S29 (1) of the Regulated Health Professions Act. In all otherprovinces, pharmacists are or will be permitted to prescribe or adapt prescriptions, andto provide refills of medications already prescribed. This College has not pursued thecontrolled act of prescribing but considers that permitting pharmacists to legally adapt,modify and extend prescriptions without further authorization from a prescriber underspecified conditions falls squarely within the pharmacist’s scope and abilities as expertsin medication management and would bring Ontario pharmacists into line with whatprescribing pharmacists may do across Canada. Without doubt, pharmacists possess15

the knowledge, skills, ability and judgment required to safely adapt a dosage form,dosing regimen, or dose strength to facilitate drug coverage and to authorizeprescription extensions for continuing therapy. College Council acknowledged that theseactivities are called prescribing in other jurisdictions such as Alberta, Saskatchewan,Manitoba and the Atlantic provinces.The College further acknowledges the need for all stakeholders to clearly understandthat those pharmacists permitted to “prescribe” in other jurisdictions only do so once adiagnosis has already been made by another health care professional authorized todiagnose. While the terminology of prescribing is used in other jurisdictions to describeactivities that fall within a pharmacist’s scope, the perception may exist amongst thepublic and other health professions that prescribing must follow differential diagnosisanactivity that currently does not fall within the realm of pharmacy training andpractice. This College is recommending pharmacists be permitted to adapt, modify, orextend prescriptions on the basis that these activities fall within the cognitive aspects ofthe controlled act of dispensing and are already thus within the realm of thepharmacists scope of practice. Should HPRAC consider that granting pharmacists inOntario the ability to adapt or alter a dosage form, dosing regimen or dose strengthand to authorize prescription extensions for continuation of care is more appropriatelydone through prescribing-subject to the terms and conditions cited above, the Councilof the Ontario College of Pharmacists would strongly support such a recommendation.PROPOSED CHANGES TO AUTHORIZED ACTS AND REGULATIONS10. Please describe in detail any proposed changes to current authorized actsand regulations that would reflect best practices for:a) prescribing * of drugs by members of your profession, orb) administration of drugs by members of your profession.To reflect and support best practices today the College seeks the following:a. That, to fully realize their role in Medication Therapy Management pharmacistsbe permitted to adapt, modify or extend an existing prescription subject toterms, conditions and limitations as described in question 9. Should it bedeemed appropriate that pharmacists have the authority to “prescribe”, subjectto terms, conditions and limitations in order to fully optimize their role inMedication Therapy Management, this College would strongly support such arecommendation.Permitting pharmacists to legally adapt, modify and extend prescriptions under specificconditions would bring Ontario into line with what prescribing pharmacists are able todo in other Canadian jurisdictions and falls squarely within the pharmacists scope andabilities as experts in medication management. Without doubt, pharmacists possess theknowledge, skills, ability and judgment required to safely adapt a dosage form, dosingregimen, or dose strength as appropriate and to authorize prescription extensions ofmaintenance medication for continuing care purposes. College Council acknowledgedthat these activities are called prescribing in other jurisdictions such as Alberta,Saskatchewan, Manitoba and the Atlantic provinces and acknowledges the need for allstakeholders to clearly understand that those pharmacists permitted to “prescribe” inother jurisdictions generally do so once a diagnosis has already been made by another16

health care professional authorized to diagnose. This College had recommended“dispensing without further authorization from a prescriber subject to terms andconditions” over “prescribing” on the premise that these activities fall within thecognitive aspects of the controlled act of dispensing and are thus already within therealm of the pharmacists scope of practice. While the terminology of prescribing is usedin other jurisdictions to describe activities that fall within a pharmacist’s scope, theperception often exists amongst the public and other health professions that prescribingmust follow differential diagnosis- an activity that currently does not fall within therealm of pharmacy training and practice.Notwithstanding, should HPRAC consider that granting pharmacists in Ontario theability to adapt or alter a dosage form, dosing regimen or dose strength and toauthorize prescription extensions for continuation of care is more appropriately donethrough “prescribing” than “dispensing”-subject to the terms and conditions citedabove, the Council of the Ontario College of Pharmacists would strongly support such arecommendation. The College would further support the legislative and regulatorychanges that are necessary to give effect to these proposals.b. The addition of the two controlled acts of “administering a substance by injectionor inhalation” and “performing a procedure on a tissue below the dermis” subjectto certain terms and conditions.The proposed change to the Authorized Acts is as follows:S.4 of the Pharmacy Act would read:In the course of engaging in the practice of pharmacy, a member is authorized,subject to the terms, conditions and limitations imposed on his or her certificateof registration to dispense, sell or compound a drug; to supervise the part of apharmacy where such drugs are kept; to administer a substance byinjection or inhalation and to perform a procedure on tissue below thedermis.Pharmacists when educating patients or their agents to use monitoring devices (e.g.blood glucose monitoring) often use a lancing device to obtain a small amount of bloodfrom the patient so that the patient may learn how to use the lancing device and testtheir blood. This involves the controlled act of performing a procedure on tissue belowthe dermis.Pharmacists when educating patients or their agents through the actual demonstrationor administration of a drug through injection (e.g. insulin) or through inhalation (e.g.asthma therapy), perform the controlled act of administering a substance by injectionor inhalation.Pharmacists also administer by injection, flu shots and other vaccines in emergencysituations. Including this controlled act within the scope of practice, would ensurepharmacists would be trained and use the skill routinely, rather than performing it onlyin emergencies.11. Why are these changes necessary? What regulatory or clinical practicepurposes would be served by such changes? How would they advancepatient care and patient safety?17

The College believes that these proposals- which will enable pharmacists to fully realizetheir role in promotion of health and wellness and medication therapy management willalso support this government’s strategic priorities to reduce wait times in EmergencyRooms and to increase public access to necessary health care services. Numerousfamilies in Ontario today are without family physicians, a reality which has resulted inpharmacists and other health care providers assuming more expanded roles to help fillexisting care gaps in Ontario.Pharmacists are not trying to replace physicians, nurses or any other health careprofessionals. Pharmacists do want to maximize their unique body of knowledge thatallows them to play a key role in triaging and treating minor ailments and in MedicationTherapy Management working in collaboration with physicians and other health careprofessionals. As Dr. Joshua Tepper recently noted in a presentation to health careprofessions - new expectations, capabilities and roles are being demanded of our healthcare work force.There are a number of key activities that pharmacists perform as a daily and routinepart of current practice but currently may only legally do so with the express consent ofa prescriber, or through the use of delegation, medical directives, or professionaljudgment. As family physicians are increasingly unavailable for consultation in a timelymanner, requiring pharmacists to first seek and obtain the authorization of a prescriberto be able to fully perform their expected role in medication therapy management isboth unnecessary, impractical and may result in undue delays in treatment for thepatient. Using the pharmacist to the full extent of their extensive training and educationcan help to address care gaps, reduce the burdens of family practitioners so that thepatients requiring more care can access them, reduce the need to attend at ERs toobtain refill authority for continuing care prescriptions, reduce the morbidities andhospital admissions associated with adverse drug reactions in the elderly and allpatients, and increase patient compliance by adapting or modifying the dose or dosageform of a prescribed drug in appropriate circumstances.Accordingly, the College is seeking the authority for pharmacists to be permitted toadapt, modify or extend prescriptions without further authorization from a prescriber.We expect pharmacists will communicate prescription changes to the family physician,nurse practitioner, and other health professionals in a timely manner, in order to ensurethat other members of the patient's health care team are informed of changes in thepatient's medication therapy.18

a. Gaps in professional services and Patient SafetyStudies have repeatedly shown that Canadians receive less than optimal drug therapyand disease management, resulting in poor health outcomes and preventablehospitalizations. These may be attributed to poor access to health professionals andmay be improved by interdisciplinary health care teams and closer monitoring ofpatients, especially those with chronic conditions. Pharmacists, because of theirexpertise, accessibility, and frequent contact with patients getting prescriptionsdispensed, can facilitate improved patient care.Some of these gaps in service were identified in the report of the Ontario Health QualityCouncil. The Council found in surveys, that 92 percent of people in Ontario said theyhave a family physician, but only 86 percent of immigrants who have lived here lessthan five years have a family physician. Only 10 percent of Ontario family physiciansare taking new patients, down from 40 percent seven years ago. Only 39 percent ofOntarians who need to see their doctor can do so that day or the day after.The Council estimated that about 8,000 lives could be saved annually, and the qualityof life improved for many more people, if there was better delivery of regular care andmonitoring that prevents people with chronic disease from becoming more severely ill.The Council also reported that people with coronary artery disease are only getting twothirdsof the right drugs and tests — and women get much less care than men. TheCouncil found that three-quarters of patients were recommended aspirin; about twothirdswere recommended beta-blockers and a similar proportion, statins. In theory, allpatients with coronary artery disease should at least be considered for each of thesethree treatments. But just one in three is considered for all three drugs.The Council recommended that people get a second opinion on their prescriptionsthrough the MedsCheck program in which all Ontarians who take three or moreprescription medications for chronic conditions can receive a free one-on-one review oftheir medications from a pharmacist, once per year. A follow-up MedsCheck is alsocovered if the person has been recently discharged from hospital and needs to havemedication changes double-checked.Patient safetyMedications have been a key concern in patient safety, not only from the perspective ofadverse events and interactions with other drugs, but also in accurate communicationamong health professionals about a patient's medication therapy as they receiveservices in different health sectors.In comparing patterns of potentially inappropriate drug therapy prescribing incommunity-dwelling older adults and nursing home residents in Ontario in 2001,researchers found that nursing home residents were close to half as likely to bedispensed a potentially inappropriate drug therapy as community-dwelling older adults.Clinical pharmacist services, which are mandated in the nursing home setting, werethought to be responsible for these differences.In long term care facilities, research found that the overall rate of adverse drug eventswas 9.8 per 100 resident-months; 42% of these adverse events were preventable.Errors associated with preventable events occurred most often at the stages of ordering19

and monitoring. Residents taking antipsychotic agents, anticoagulants, diuretics, andantiepileptics were at increased risk of a preventable adverse event.Recognition of the expertise of the pharmacist in medication management and their rolein promoting health, preventing and treating diseases, dysfunctions and disordersintroduces little or no new risk to patients because, in many cases, pharmacists alreadyperform these duties. Patient safety will increase as more proactive involvement ofpharmacists in medication therapy management and other medication-related activitieshave been found to reduce medication-related problems.With the expanded scope of practice, pharmacists will be able to facilitate bettermedication therapy management, including more regular care and monitoring,especially as patients come to pharmacies to get their refills of chronic medications.Many other jurisdictions, across Canada and around the world have taken steps topermit pharmacists to fully engage in the activities required to optimize their roles inmedication therapy management. In all other provinces pharmacists are or will bepermitted to prescribe or adapt prescriptions, and to provide refills of medicationsalready prescribed to ensure continuing care.Pharmacists routinely provide information and education to patients or their agents onthe use of monitoring devices (e.g. blood glucose monitoring) and use a lancing deviceto obtain a small amount of blood from the patient so that the patient may learn how touse the lancing device and test their blood. This involves the controlled act ofperforming a procedure on tissue below the dermis.Pharmacists routinely educating patients or their agents through the actualdemonstration or administration of a drug through injection (e.g. insulin) or throughinhalation (e.g. asthma therapy), perform the controlled act of administering asubstance by injection or inhalationPharmacists also administer by injection, flu shots and other vaccines in emergencysituations. Including this controlled act within the scope of practice, would ensurepharmacists would be trained and use the skill routinely, rather than performing it onlyin emergencies.12. Are the proposed changes considered part of current routine practice ofthe profession, and authorized to members by medical directives, orders ordelegation? Please describe. If authorized by medical directives, orders ordelegation, is this approach inadequate or insufficient? Please explain.Yes, the proposed changes will permit pharmacists to perform acts that are consideredpart of current, routine practice but which currently can only be done throughdelegation, medical directives, professional judgment or the exceptions provided underS29 (1) of the Regulated Health Professions Act.The College does not consider it appropriate that pharmacists today may only performcertain activities under delegation or medical directives. Because family physicians areincreasingly unavailable for consultation in a timely manner, requiring pharmacists tofirst seek and obtain the authorization of a prescriber to be able to fully perform theirexpected role in medication therapy management and pharmacy practice isunnecessary, impractical and may result in undue delays in treatment for the patient.Many other jurisdictions, across Canada and around the world have taken steps to20

permit pharmacists to fully engage in the activities required to optimize their roles inmedication therapy management. In other provinces pharmacists are or will bepermitted to prescribe or adapt prescriptions, and to provide refills of medicationsalready prescribed to ensure continuing care. Pharmacists in many jurisdictions are alsopermitted to independently prick a finger, and administer certain substances byinjection.The College is seeking the authority for pharmacists to be permitted to do the followingwithout further authorization from a prescriber*.• adapt an existing prescription to facilitate patient compliance, such aschanging the dosage form (e.g. from a capsule or tablet to an oral liquidformulation for patients who have difficulty swallowing); changing thedosage regimen (e.g. from one tablet twice a day to two tablets once a dayto facilitate compliance); changing the dosage form to one reimbursable bythe patient's third party drug benefit plan (e.g. capsule to tablet); and whenthe prescribed dose or dosage form is not commercially available (e.g. 50mg only comes in 52.5 mg)• authorize further extension of a prescription where there are no existingrefills for continuity of care• provide Schedule II and III drugs as a prescription where required forreimbursement under drug plans• adjust dosage of medication in response to monitoring (e.g. lab tests).• administer drugs, including through injection and inhalation, (for patienteducation and information)• perform a procedure below the dermis (for patient information andeducation, and in emergency situations)*We will expect pharmacists to communicate their actions to the family physician,nurse practitioner, or other primary care health professionals in a timely manner, inorder to ensure that other members of the patient's health care team are informed ofactions taken on their patients’ behalf.13. Would the proposed changes result in an enhanced or changed scope ofpractice for the profession?This College’s previous submission to HPRAC and the contents therein, supported anamended scope of practice statement that more accurately reflects what pharmacistsdo today. Within the College, there are currently three classes of registrants -registered pharmacy students, interns and pharmacists. All practice within the samescope of practice but are subject to the terms and conditions placed on the certificatesof registration of a respective class. The scope of pharmacy practice has evolved ratherthan changed over the past thirty years from a prescription-focused model to a patientcentredpharmaceutical care approach. For example, in the 1960’s pharmacists wereprohibited by law from putting the name of the drug on the prescription label and werestrongly discouraged from speaking to patients about their prescriptions, yet today it isan expected standard of practice that pharmacists provide both information andeducation to their patients or agents respecting the use of drugs, health care aids anddevices.While pharmacists were once the only persons in a dispensary able to dispenseprescriptions, the technical functions of dispensing have gradually been assumed bypharmacy assistant personnel freeing up pharmacists to focus on their areas of21

expertise. With extensive education and training in such areas as medicinal, physical,biological, and pharmaceutical chemistry, anatomy, physiology, biopharmaceutics andpharmacokinetics, therapeutics, pharmacology and pathology, pharmacists have aunique body of knowledge and an expertise that no other health professional hasrespecting drugs, their actions, interactions and effects. While pharmacists continue tooversee and ensure that safe and effective drug distribution systems are in place,pharmacists today are called upon to use their expertise to fully realize their roles inmedication therapy management.Medication therapy management, or “MTM” as it is referred to within North America, isthe term that best describes the cognitive role that pharmacists play before making thedecision to dispense a drug and while monitoring ongoing drug therapy. The rolereaches far beyond dispensing as pharmacists must first gather information from thepatient or agent or the prescriber to determine whether the prescribed drug isappropriate based on the patient’s medication and relevant history. After a diagnosishas been made, pharmacists can play a key role in partnership with physicians andother prescribers to ensure that the right drug is prescribed or that, where no drug isprescribed, the patient understands why. Many pharmacists promote health andwellness in their practice settings by hosting clinics on smoking cessation, fluprevention and infection control, healthy weight and exercise, and women’s healthissues. Monitoring patient compliance and effectiveness of medication therapy is a keycomponent of medication therapy management. All of this should be reflected in thescope of practice.Accordingly, we have proposed that the existing scope of practice for pharmacy simplybe amended through the addition of two phrases which more accurately reflectpharmacist practice today. The added phrases are in bold:The practice of pharmacy is the promotion of health, prevention and treatmentof diseases, dysfunction and disorders through medication and non-medicationtherapy; the monitoring and management of medication therapy; the custody,compounding and the dispensing of drugs; the provision of health care aids anddevices and information related to their use.14. Please describe in detail any changes or additions that would be requiredto the controlled acts that are now authorized to the profession and what, ifany, limitations or conditions should be attached to the authorized act.The proposed change to the Authorized Acts (in bold) are as follows:S.4 of the Pharmacy Act would read:In the course of engaging in the practice of pharmacy, a member is authorized,subject to the terms, conditions and limitations imposed on his or her certificateof registration to dispense, sell or compound a drug; to supervise the part of apharmacy where such drugs are kept; to administer a substance byinjection or inhalation and to perform a procedure on tissue below thedermis.1) Dispensing without further authorization/PrescribingWhile other jurisdictions have made the decision to seek the right for pharmacists toprescribe, the College has sought an expansion of authority to permit “dispensingwithout further authorization from a prescriber subject to terms and conditions” on the22

asis that this falls within the cognitive aspects of the controlled act of dispensing andis already thus within the realm of the pharmacists scope of practice. However, shouldHPRAC consider that granting pharmacists in Ontario the ability to adapt or alter adosage form, dosing regimen or dose strength and to authorize prescription extensionsfor continuation of care is more appropriately done through prescribing subject to theterms and conditions cited above, the Council of the Ontario College of Pharmacistswould strongly support such a recommendation.Limitations and ConditionsThe following activities would occur within the pharmacist’s medication therapymanagement role, in a collaborative relationship with a patient’s prescriber or primarycare physician. After a diagnosis has been made and in most instances, where amedication has already been prescribed:• adapting an existing prescription under the following conditions:‣ to facilitate patient compliance, such as changing the dosage form (e.g. froma capsule or tablet to an oral liquid formulation for patients who havedifficulty swallowing);‣ changing the dosage regimen (e.g. from one tablet twice a day to two tabletsonce a day to facilitate compliance);‣ changing the dosage form to one reimbursable by the patient's third partydrug benefit plan; and when the prescribed dose or dosage form is notcommercially available (e.g. 50 mg only comes in 52.5 mg)• authorizing further extension of a prescription where there are no existing refillsfor continuity of care in circumstances such as described in the PAPE agreement(see page 57)• providing Schedule II and III drugs as a prescription where required forreimbursement under drug plans• adjusting dosage of medication in response to monitoring (e.g. lab tests)2) Administering a substance by injection or inhalation (not currentlyauthorized)The College proposes that pharmacists be permitted, in the course of engaging in theirrole as provider of information and education to patients in the course of practicingpharmacy to:• Perform a procedure on tissue below the dermis• Administer a substance by injection or inhalationLimitations and ConditionsThe College is recommending that pharmacists be granted the above two controlledacts subject to terms, conditions and limitations relating to the pharmacist’s role inproviding education to the public. To allow for greater flexibility and to accommodatefuture evolution of the scope of practice for pharmacists, the College respectfullyrecommends that any terms, conditions and limitations necessary to protect the publiccould be placed in standards of practice rather than in legislation. Including suchconditions and limitations to the practice standard means that a member not practisingin accordance with the standard would appropriately face a professional misconductreview.23

We would expect to adopt and/or adapt existing practice standards already in use inother Canadian jurisdictions where pharmacists are currently able to prescribe and assuch are realizing their full role in medication management therapy.15. (a) Has the profession submitted a request to the Ministry of Health andLong-Term Care for changes or additions to the list of drugs that areincluded in the regulation under the profession-specific act? If yes, pleaseattach copies of the submissions, and indicate when the request was made.(b) Are there additions or changes, since the submission was made, thatHPRAC should now consider? Please describe in detail.(c) If a formal submission has not been made at this time, what are theexact changes you now propose to current legislation and regulations?No formal requests have been made in addition to the Ontario College of Pharmacists’submission to HPRAC respecting the Scope of Practice Review for Pharmacy, submittedJune 19, 2008 (as attached, for reference and information). In our previous submission,we did not address the use of or the need for a list of drugs to be included in theregulation under the Pharmacy Act.The College does not believe pharmacists should be restricted to a list of drugs. Theprofession of pharmacy has expertise in drug therapy management, and limiting themto a certain list of drugs would limit their ability to impact patient care. In fact, as thepharmacist is often collaborating with prescribers who have specialty areas of expertise,the value of the pharmacist lies in being able to manage a patient’s overall drugtherapy.RISK OF HARM16. What additional risk of harm to the patient or client might result from theproposed changes? How would your profession manage this risk?Recognition of the expertise of the pharmacist in medication management and their rolein promoting health, preventing and treating diseases, dysfunctions and disordersintroduces little or no new risk to patients because, in many cases, pharmacists alreadyperform these duties. Patient safety will increase as more proactive involvement ofpharmacists in medication therapy management and other medication-related activitieshave been found to reduce medication-related problems.Medications have been a key concern in patient safety, not only from the perspective ofadverse events and interactions with other drugs, but also in accurate communicationamong health professionals about a patient's medication therapy as they receiveservices in different health sectors. The College anticipates strengthening existingstandards of practice relating to documentation and communication with other healthcare providers to optimize patient care.In comparing patterns of potentially inappropriate drug therapy prescribing incommunity-dwelling older adults and nursing home residents in Ontario in 2001,researchers found that nursing home residents were close to half as likely to bedispensed a potentially inappropriate drug therapy as community-dwelling older adults.24

Clinical pharmacist services, which are mandated in the nursing home setting, werethought to be responsible for these differences.In long term care facilities, research found that the overall rate of adverse drug eventswas 9.8 per 100 resident-months; 42% of these adverse events were preventable.Errors associated with preventable events occurred most often at the stages of orderingand monitoring. Residents taking antipsychotic agents, anticoagulants, diuretics, andantiepileptics were at increased risk of a preventable adverse event.EDUCATION AND CONTINUING COMPETENCY17. How does your profession require demonstration of competencies forpharmacotherapy?The following information setting out the context and nature of prescribing andeducational preparation of pharmacists has been prepared by the Leslie Dan Faculty ofPharmacy, University of Toronto. However, the Faculty of Pharmacy at the University ofWaterloo also follows the same Canadian accreditation standards for pharmacyprograms.The role and importance of medications within the health care system continues togrow. With advances in pharmaceutical research, conditions that (in the past) mayhave been managed using surgical or other means are now increasingly managed usingmedications. Advances in pharmacotherapy have been significant, and the result hasbeen more cost-effective and efficient health care delivery, particularly in the context ofchronic disease management.With this increased reliance upon medications as a primary modality of management ofmedical conditions, there has also been a commensurate increase in issues andproblems related to their use. Baker et al. (2004) have identified patient safety issuesrelated to improper prescribing or use of medications in Canada, and the burden thisplaces on individuals, caregivers, and the health care system as a whole. While thetrend towards increasing reliance upon medications is likely to continue, a clearobjective for the health care system must be to ensure these medications are used assafely, effectively, and efficiently as possible. Thus, those given the responsibility forprescribing of medications must be well prepared for the task, accountable foroutcomes, and able to effectively manage this important responsibility.The Nature of Prescribing:The activity of “prescribing” is actually a variety of different, context-specific tasks.Many activities are technically prescribing, but require different competencies, skills,and levels of education.There are at least five distinct and different circumstances that are “prescribing”:a) Diagnosing a medical condition and prescribing a medication for its treatmentIn this activity, an individual will apply knowledge related to pathophysiology toundertake a differential diagnosis. The activity of diagnosis is a complex observationaland problem solving process requiring foundational knowledge in a variety of differentbiomedical disciplines. Once a diagnosis has been reached, a prescription can be25

determined based upon patient-specific factors such as medical history, medicationhistory, allergies/tolerances, prescribing protocols, etc. This activity of prescribingrequires an understanding of pharmacology and pharmacotherapeutics to ensure themost appropriate agent is selected for a particular diagnosis. This sort of diagnosisprescriptionactivity is most commonly seen in medical practice, but is now alsoavailable under specific circumstances to nurse practitioners and others.b) Prescribing in response to a diagnosis that has already been made by anotherpractitionerIn this type of prescribing one clinician will use the diagnostic work of another clinicianto select the most appropriate pharmacotherapeutic agent in a particular circumstancefor a specific patient. As such, while a knowledge of pathophysiology is important forcontextualizing a patient’s condition, core knowledge related to pharmacology andpharmacotherapeutics is more relevant. Identifying the most appropriate agent for aspecific condition requires sophisticated comparative analysis of multiple availableoptions. Prescribing based on another practitioner’s diagnosis also requires considerableinterprofessional collaboration and trust, but also provides opportunities to leverageand optimize individual practitioners unique strengths.c) Changing an existing prescription based on a diagnosisIn this type of prescribing, a diagnosis and prescription have already been made.However, in some cases, the specific prescription may not necessarily be the mostappropriate for the patient’s specific circumstances. Modifications to existingprescriptions are currently considered a type of prescribing and are most frequentlyundertaken for the following reasons:i) Errors in prescriptionA core function of pharmacy practice today involves thorough evaluation of all newprescriptions to ensure there are no drug-drug or other types of interactions, noallergies or intolerances that may affect the patient, and to ensure dosing, duration,route of administration and other elements are correct. Obvious prescribing errorstechnically require new prescriptions in order to be dispensed correctly (even if theerror is obvious). Under current regulations, pharmacists cannot correct such obviouserrors without first receiving a new prescription from a prescriber, resulting insignificant inefficiencies in health care delivery.ii) Therapeutic AppropriatenessOptimizing medication therapy is a complex and important task. A key aspect ofoptimization involves ensuring the most therapeutically appropriate agent is selectedfrom a range of available options. Making this selection requires sophisticatedcomparative understanding of pharmacologic differences between individual drugswithin a specific therapeutic category and/or understanding of how drugs in differenttherapeutic categories can be effective in specific circumstances. Cost-effectivenesscalculations are also made to ensure the most economic (but still safe, effective, andefficient) is utilized.d) Continuing/renewing as prescribed, a previously prescribedmedication based on a previous diagnosisChronic management of medical conditions is an increasingly important aspect of healthcare. In such situations, patients are often placed on long-term drug therapy that will26

equire periodic re-evaluation to ensure the specific medication/dose are stillappropriate. Safe and effective renewal of prescriptions requires an understanding ofpathophysiology and disease progression, as well as application of pharmacotherapeuticknowledge. The issue of prescription renewals is particularly sensitive. Many patientscomplain about the difficulty they encounter trying to renew chronic medications.Practitioners also recognize the inefficiencies that result when the individual at the pointof dispensing is not able to exercise professional judgment regarding renewal of chronicmedications.e) Adjusting doses of previously prescribed medicationsIn most cases, prescribing requires on-going monitoring and follow-up. Initial dosesthat are prescribed may require adjustment based on patient response. While the mostappropriate drug may be utilized, the most appropriate dose of that drug may requiresome time to finalize. Adjusting does of medications based on clinical response ofpatients requires understanding of both pathophysiology and pharmacotherapeutics. Insome cases (for example medications with a narrow therapeutic index such as warfarinor lithium), close monitoring of blood levels and other laboratory tests are required tocorrectly adjust doses. Optimizing use of these drugs requires close attention andvigilance, as well as clear communication between practitioners and patients.In addition to (a) and (e) above, it is important to note that pharmacists are already ininvolved in a type of “prescribing” behaviour associated with recommendations for useof Schedule 2 (behind-the-counter) medications. Drugs in this schedule are notavailable for self-selection by patients, and do not require a prescription. They do,however require assessment by and consultation with a pharmacist to ensure safe andeffective use. The clinical skills used by pharmacists in their work with patientsrequiring Schedule 2 medications is, in essence a form of assessment/diagnosisfollowed by recommendation/prescription of a medication.Educational Requirements for Safe and Effective Prescribing:Recognizing that prescribing is not a single act but a variety of different tasks based onspecific contexts and circumstances, it is important to realize that differentcompetencies and educational preparation is required and appropriate for each type ofactivity.Prescribing at all levels is cognitively complex, relying upon application of scientificknowledge within a clinical context. Integration of concepts from a variety of scientificdisciplines (pharmcotherapeutics, pathophysiology, etc.) must be coupled with effectiveproblem-identification and problem-solving skills. The ability to theorize and drawinferences from basic scientific knowledge to anticipate and prevent or respond topotential problems associated with medication use is also required.Traditionally, most prescribers have learned this craft through modeling and mentoringat the bedside, with limited formal academic preparation rooted in scientific disciplines.During this process, most prescribers-in-training assume greater, independentresponsibility over time before they are able to take on fully independent prescribingresponsibilities.Safe and effective prescribing requires a scientific foundation. Core pharmaceuticalscientific courses (such as medicinal chemistry, pharmaceutical analysis, pharmacology,and physical chemistry) provide students with an understanding of the physical-27

chemical properties of medications and provides a basis for predicting how these drugswill be absorbed, distributed, metabolized, and excreted from the system, as well asthe ways in which these medications may interact with or affect other drugs, laboratorytests or even food.Safe and effective prescribing requires clinical application. To some extent, classroombasedpharmacotherapeutics coursework can provide a context for applying scientificknowledge within a paper-case environment. Such coursework examines the way inwhich drug use is optimized, and should lay the foundation for real-world learning andapplication in a clinical setting.Ideally, learning to prescribe is a continuum, beginning with basic biomedical andpharmaceutical sciences course work, moving towards pharmacotherapeutics basedcoursework, then culminating in application in a clinical setting under mentorship orsupervision. Consistent assessment is required to ensure knowledge and skills aredeveloping appropriately, and that competency requirements are achieved as expected.Finally, soft-skills related to interprofessional collaboration, interpersonalcommunication, history-taking, conflict resolution, patient education, and ethicaldecision making is required to ensure information is gathered and interpretedappropriately and that effective patient-centered education is provided. Once again,academic/theoretical coursework complemented by the use of clinical simulations, inservicelearning, and consistent competency-based assessment/evaluation is requiredto ensure integration of knowledge and skills has occurred to facilitate effectiveapplication within a clinical context.Educational Preparation of Pharmacists in Ontario:Pharmacy education in Ontario has been university-based for over 50 years. As such,professional education is closely linked to research in the field. Professional education inpharmacy is therefore built upon a solid foundation of evidence and science.Currently, students require a minimum of 5 post-secondary years of education tocomplete the BScPhm degree. Completion of this degree is but one requirement forlicensure as a pharmacist; other requirements include in-service training (internships),completion of national board examinations (including a 16-station objective structuredclinical examination involving standardized patient interviews, as well as 2-day casebasedmultiple choice test of clinical knowledge), and relevant jurisprudenceexaminations.Currently, students may be admitted to the professional program after a minimum ofone year of general arts and science coursework. Due to intense competition foradmission to the program, students typically have 3+ years of arts and science coursesprior to entry in the program. At the University of Toronto, for 240 available positions,there are routinely more than 1500 applicants each year.Once admitted to the program, students undertake a rigorous, science-basedprofessional program balancing coursework in biomedical, pharmaceutical,social/administrative, and clinical sciences. Early years tend to focus on biomedical andpharmaceutical coursework (e.g. anatomy, physiology, pathophysiology,pharmacology). Later years tend to focus on application of this scientific knowledge in a28

classroom-based hypothetical clinical context. Throughout the program, there arecourses focusing on the behavioural and social-administrative sciences, to providestudents with an understanding of the health care system, its context, and how patientsperceive wellness, illness, and medication taking.Currently, consolidation of didactic learning occurs during a 16-week experientialclinical training block in the final semester of the 4th year of the program. During thisperiod, students are placed in two clinical rotations (one in hospital, one in communitypractice) under the supervision of a trained preceptor. The preceptor provides teachingand learning opportunities, but is also responsible for assessing the student’s readinessto practice in a clinical, patient-centred environment. Following completion of thedegree, but before registration as a pharmacist, licensing examinations and a minimum12-week internship period is required.Educational programs in pharmacy are accredited by the Canadian Council forAccreditation of Pharmacy Programs (CCAPP), an arms-length organization chargedwith development of standards for pharmaceutical education. Periodic accreditationincluding site visits by external accreditors is required to ensure curricula are meetingstandards and expectations as outlined by CCAPP.Adequacy of academic preparation to enable prescribing by pharmacists:Graduates of CCAPP accredited pharmacy programs are expected to possess theknowledge and skills necessary to support collaborative patient-centred care.Pharmacy education has, for over a decade, focused on preparation of practitioners ableto optimize medication therapy of patients. To this end, of the types of prescribingdiscussed previously, graduates should be able to:a) prescribe in response to a diagnosis that has already been madeb) change a pre-existing prescription based on an existing diagnosis(to address an error or to optimize pharmacotherapeutic effectiveness)c) continue/renew an existing prescriptiond) adjust doses of a previously prescribed prescriptionAs can be seen, all these forms of prescribing involve collaboration with other healthcare providers and reliance upon another practitioner’s diagnosis. Providing studentswith the knowledge and skills required to make informed pharmacotherapeuticdecisions as part of a collaborative team is the goal of pharmacy education.Independent diagnosis/prescribing is not currently an objective of pharmacy educationand consequently teaching and assessment are not aimed at this outcome. Instead,curriculum and evaluation are focused on fostering interprofessional collaboration thatleverages pharmacists’ clinical knowledge and skills to allow them to contributeoptimally to patient care. The four prescribing acts described above are part of thisobjective.Unfortunately, the current reality of practice means that, while these skills are taughtand assessed in the didactic part of the program, they are not modeled or evaluatedduring clinical rotations. Since most pharmacists today do not perform (a) - (d) as partof their daily clinical work, student pharmacists are deprived a significant learningopportunity to observe experienced practitioners undertake these tasks. Thus, while(based on a review of accreditation standards and curricular documents) it isreasonable to expect that graduates of accredited programs ought to be able toperform these types of prescribing, the reality is that none of these types of prescribing29

is currently practiced clinically and consequently neither formally taught nor assessedduring clinical/experiential rotations. Thus, there is no specific evidence that graduatescan and do perform these prescribing activities, despite accreditation standardssuggesting they have adequate educational preparation to do so. Regulatory changewill be required to allow these prescribing activities to become commonplace inpractice. When this happens, modeling, mentorship and evaluation of thesecompetencies in practice (rather than simply in the classroom) can then occur, as canresearch to determine impact of pharmacist prescribing on practice-related outcomes.Currently, pharmacy students are not taught how to diagnose illnesses or administermedications. The University of Toronto is in the process of developing a revised, entrylevelPharm D curriculum to update the BScPhm. This curriculum will include academicmaterial that will, in the future, bring pharmacists closer to the diagnosis/prescribingrole as well as physical assessment skills to support medication administration. Ifapproved by the government, the new entry-level Pharm D program should providegraduates with the knowledge and skills necessary to contribute even more effectivelyto collaborative patient-centred care.Conclusions:Safe and effective prescribing is a cornerstone of the health care system in Ontario.The knowledge, skills, and competencies required for safe and effective prescribing arecomplex; prescribing is not a single activity but instead a group of related tasks. Thecurrent educational preparation of pharmacists, linked to external accreditationstandards, prepares students for a variety of collaborative, patient-centred prescribingactivities.18. Please provide pharmacotherapy course content in the current educationalcurriculum and demonstrate how it ensures the minimum qualifications forthe prescribing or administration of drugs by members of your profession.The pharmacotherapy course content within the pharmacy curriculum which supportsprescribing or administration of drugs by the profession of pharmacy includes thefollowing:Physiology 200YMicrobiology 232YPathophysiology and Clinical Biochemistry 330YPharmacology I and II - 231H and 331HPharmcokinetics 324YToxicology 345HTherapeutics (Pharmaceutical Care) II and III – 321Y and 421YCourse outlines for the above can be found by accessing the following link:http://pharmacy.utoronto.ca/undergrad/curric/detail.jspIn addition each pharmacy student in the final year of the program completes 16 weeksof structured practice experience in both institutional and community settings. Thesecourses are designed to provide students with a variety of opportunities to apply theknowledge, skills and professional values/behaviors gained through faculty-basedlearning. Students are assigned to pharmacists, designated as ‘Teaching Associates”,and undertake a number of formalized activities to meet specific learning objectives.30

As outlined in question 17, this course content is designed to have students meet theCanadian Council for Accreditation of Pharmacy Programs (CCAPP) competencies ofinitiating a prescription once a diagnosis is made, adjusting doses of medication,renewing and continuing therapy and adapting prescriptions. Ability to practice theseskills in the work environment is currently limited as pharmacists do not have authorityto perform limited prescribing, except under a medical directive. The curriculum doesnot currently provide for administration of drugs by injection or prescribing includingdiagnosis. These skills would be included in an enhanced program such as a doctor ofpharmacy program.19. Does the health professional college require continuing education andtraining for members to ensure competency in the prescribing oradministration of drugs? Please be specific and provide documentation tothe extent possible. Please describe how the college ensures its memberskeep pace with advancements in pharmacotherapy, pharmacology andpatient safety.OCP does not currently require continuing education and training for members toensure competency in the prescribing or administration of drugs as these are notcurrently included in our controlled acts or scope of practice. However, many membersof the profession have taken advanced training and are working under medicaldirectives within collaborative practices, where they are performing these controlledacts. Those pharmacists are expected to maintain their knowledge and skills in theseareas if agreeing to take on a medical directive. As well, in daily practice, pharmacistsare called upon to adapt, modify or extend prescriptions. This is currently done with aphone call to the prescriber for authorization, or, if the prescriber is not available,through professional judgement acting in the best interest of the patient. Pharmacistscurrently have the education and training, and possess these competencies, but do nothave legal authority to provide these services to patients.The College has an extensive program of quality assurance to ensure that memberskeep pace with advancements in pharmacotherapy, pharmacology and patient safety.Each member is expected to keep a learning portfolio of their continuous professionaldevelopment, and OCP provides members with up to date information on qualityprograms in these areas. An on-line CPD portal allows each member to keep an on-linerecord of their learning, and to submit it to the College upon request. In addition, eachpharmacist is expected to complete a self-assessment every 5 years, both assessingthemselves on practice standards, as well as completing a clinical exam. Four timesper year, pharmacists are randomly selected to undergo a practice review at the collegewhere they undergo a peer review of their communication and patient care skills withstandardized patients, and a multiple choice exam of their clinical knowledge. TheQuality Assurance program does not currently include assessments relating toprescribing and administering drugs, but can be readily adapted to do so, shouldpharmacists be given these controlled acts.20. Please indicate what college documents are available to members on theprescribing or administration of drugs, including relevant standards ofpractice, rules and guidelines. Are these documents current? Please includethe documents with the submission.There are currently no specific documents available to members on the prescribing oradministration of drugs as pharmacists do not have authority to perform thesecontrolled acts. However, our colleagues in Alberta, British Columbia and New31

Brunswick have been establishing practice standards and guidelines as they implementprescribing in their provinces, and the College will be able to adopt much of the workthat has already been done in this area in other provinces.The College does have standards of practice for current controlled acts and scope,which are updated regularly. The current standards could be readily updated shouldpharmacists in Ontario be granted the authority of pharmacists in other provinces.21. Please describe current competencies, education and training of membersof the profession to perform any of the proposed changes.A comprehensive overview of the education and training that currently supportspharmacists adapting, modifying and extending prescriptions to fully realize their rolesin Medication Therapy Management is provided by the Leslie L. Dan Faculty ofPharmacy, University of Toronto and in lieu of repeating material, we respectfully referyou to the information provided in Question 17, page 25.A comparative analysis of education of pharmacy and medical students was alsorecently conducted by Dr David Hill, Executive Director, Canadian Council forAccreditation of Pharmacy Programs (CCAPP) in response to a request from Alberta, BCand New Brunswick for assistance in demonstrating the necessary levels of educationand training needed to support an expanded role for pharmacists in those provinces.Dr Hill expressed the opinion that pharmacy students at the time of receipt of their BSPdegree have more drug/therapeutics knowledge than medical students (at the time ofreceipt of their MD degree) as follows: “I based that comment on a comparison of theacademic program curriculum requirements set by the accrediting agencies forpharmacy schools and medical schools. For pharmacy schools, CCAPP accreditationstandards (2006) re drug/therapeutic knowledge are as follows:CCAPP Guideline 9.2The pharmaceutical sciences should be of such depth, scope, timeliness, quality,sequence, and emphasis to provide foundation for and support to the intellectual andclinical objectives of the professional program in pharmacy. The pharmaceuticalsciences should provide the basis for understanding the use of medicines in maintaininghealth and treating disease. Content should include medicinal chemistry, pharmacology,toxicology, pharmaceutics (encompassing the physical/chemical principles of dosageforms and drug delivery systems), biopharmaceutics, pharmacokinetics andpharmaceutical biotechnology.CCAPP Guideline 9.4Content should include clinical pharmacokinetics, collaborative drug therapymanagement, complementary and alternative medicines, compounding, diagnostic andpoint-of-care testing, disease state management, dispensing and prescriptionprocessing, drug abuse and dependency, drug information including drug literatureevaluation, drugs in pregnancy, emergency first care, evidence based decision making,geriatrics, health promotion and disease prevention, immunization, informationtechnology practice support tools, medication administration, nutrition, pediatrics,patient assessment and outcomes monitoring, patient and professionalcommunications, patient records and documentation of care, pharmacy law and32

egulatory issues, pharmacotherapeutics, physical assessment, prescriptive authority,and self care/non-prescription drug use.For medical schools: LCME ED-11For the MD degree program in Canada, LCME standards for curriculum content in themedical schools (std ED-11) state only that the content must include "...thosedisciplines that have been traditionally titled anatomy, biochemistry, genetics,physiology, microbiology and immunology, pathology, pharmacology and therapeutics(my emphasis),and preventive medicine.That is all the LCME standards require re drug/therapeutics content inCanadian medical school programs.The difference between pharmacy student knowledge and medical student knowledge isnarrowed by the time physicians become registered by the added education from the 2year medical residency requirement (although the gap could be widened again with theintroduction of the PharmD curriculum as the first professional degree in pharmacy).Certainly, the one year hospital pharmacy residencies and a first professional degreePharmD curriculum would give pharmacists (at least those going into hospital practice)very comparable training to physicians.Dr. Hill concluded his comments with the opinion that given access to the sameinformation about a patient that a physician has (e.g. diagnosis, history, treatmentgoals, concomitant diseases, etc.), “there is no doubt in my mind that the universityprograms in Canada for pharmacy prepare entry to practice pharmacists who would beequally (if not more so) competent in the skill of prescribing drugs and managing drugtherapy as medical students at graduation”.22. Do all members of the profession have the competencies to perform anyproposed activity related to the prescribing and/or administration of drugs?It is the College’s view that all members of the profession currently have thecompetencies to adapt an existing prescription, to continue/renew an existingprescription or to adjust does of a previously prescribed prescription. Many pharmacistsare already called upon to adapt, renew or adjust prescriptions in the patient’s bestinterest on an emergency basis. Others are working under medical directives to providethese services.All members currently have the competencies to pierce the dermis with a lancet inorder to test blood and to administer a drug by inhalation or injection for education andinformation purposes. All pharmacists do not necessarily have the competencies toadminister routine drugs by injection. This is currently done under a medical directive.Whether done under a directive or independently, pharmacists are expected to be ableto demonstrate their competence in all aspects of their practice.In addition, the College notes that curricula changes at the two schools of pharmacy inOntario will yield graduates with the necessary knowledge skills, and ability to performroutine injections and to initiate therapy. Accordingly, the College proposes theflexibility be built into HPRAC’s recommendations to accommodate the changingeducation and training of pharmacy students.33

As with Alberta and BC pharmacists, it would be necessary to orient members to thenew controlled acts and to outline their responsibilities and accountabilities.23. What effect would the proposed change in the prescribing oradministration of drugs have on members of your profession who are alreadyin practice?a) What additional competencies, education and training would be required forall (or some additional) members of the profession to perform anyproposed activity?b) How will the members become current with the changes, and how will theircompetency be assessed?c) What quality improvement or quality measurement programs do you havein place and what additional programs would be put into place?d) What educational bridging programs will be necessary for currentmembers?Pharmacists across Ontario welcomed the recent announcement that the Minister ofHealth and Long Term Care may recognize prescribing by pharmacists.The proposed change in scope recognizes activities that pharmacists have already beendoing, currently through delegation, medical directives, S29 (1) of the RHPA, andprofessional judgment and we believe that pharmacists in Ontario will readily acceptand embrace the proposed changes. Pharmacists will want to know and mustunderstand the terms and conditions under which they would be permitted to adapt,modify and extend prescriptions and administer drugs by injection or inhalation. TheCollege will develop a communication and education plan for all members respectingthe changes in the scope of practice and the conditions under which they will apply.Pharmacists are currently assessed both through the College’s inspection process whichexamines operational and cognitive aspects of the practice setting, and through theQuality Assurance program. Both of these have evolved in concert with the evolvingstandards of practice for pharmacists and operational standards for pharmacies.The College provides two primary tools to assist pharmacists with their continuingprofessional development. The Self-Assessment Survey assists in identifying strengthsand learning needs. The Learning Portfolio assists in developing learning goals,education action plans and documenting learning activities. All pharmacists in Part A ofthe Register are subject to random selection for the College's Practice Review process.Part A refers to pharmacists who are engaging in direct patient care, and maintainingthe minimum practice requirements (600 hours of practice within Canada every threeyears). The Quality Assurance Practice Review consists of two phases. Every year, 20%of members in Part A of the Register will be selected to take part in Phase I of thepractice review process. This means that approximately 2000 pharmacists will beselected to participate each year, and every pharmacist in Part A will be selected toparticipate in Phase I once every five years. Candidates who are selected for Phase Iare required to complete the Self-Assessment Survey and Summary of ContinuingEducation Activities and submit them to the College within eight weeks. Approximately240 pharmacists per year are selected for Phase II of the Practice Review, which is thePeer Review, a clinical knowledge and practice-based assessment lasting approximatelysix hours. Peer Reviews are held quarterly in Toronto at the Ontario College ofPharmacists. Phase II of the Practice Review is an assessment based on a nationalmodel competency document developed by the National Association of Pharmacy34

Regulatory Authorities (NAPRA). This competency document was reviewed and updatedin 2007.Pharmacists must maintain their competency through ongoing professionaldevelopment activities. There are numerous continuing education programs availablethrough Continuing Education at the University of Toronto, the Ontario PharmacistsAssociation and other educational providers (e.g. certified diabetic educators, asthma).These will be revised to include the expanded scope of practice including medicationcounselling and medication therapy management.With respect to educational bridging, it is again noted that the proposed change inscope recognizes activities that pharmacists have already been doing, currently throughdelegation, medical directives, S29 (1) of the RHPA, and professional judgement. TheCollege does not consider that educational bridging programs will be required forpharmacists to work within the new scope but as always, will encourage anypharmacists wishing to do so to seek out and participate in the many educationalprograms offered by the Ontario Pharmacists Association and the Faculty in order toenhance their own skills.As previously noted, plans are underway to implement significant enhancements to theundergraduate pharmacy education programs both at the University of Toronto andUniversity of Waterloo. The new programs will graduate pharmacists from a morerobust, enhanced curriculum who are ready to and will expect to practice in anexpanded role. In 2014 pharmacists will graduate from the University of Toronto withClinical Doctorates in Pharmacy (Pharm D) degrees prepared to practice in an expandedrole that may include among other activities administering drugs by injection for moreroutine purposes and initiating drug therapy in collaborative practice environmentsunder certain conditions. In concert with the new Pharm D program, the University ofToronto, Faculty of Pharmacy will offer an educational bridging program to Bachelor ofScience degree pharmacists wishing to upgrade their knowledge, skills and ability to thePharm D level. The College strongly recommends regulatory amendments that wouldallow us the flexibility to establish an extended class of pharmacist practitioner at thattime and expects that the educational bridging program offered through the Universityof Toronto would be a requirement for moving from the BSc to the Pharm D level.PUBLIC INTEREST24. Describe how the proposed changes are in the public interest. Pleaseconsider and describe the influence of any of the following factors or otherrelevant matters:a) Patient safety,b) Epidemiological trends in illness and disease,c) Access to care and coordination of care,d) Wait times for health care services,e) Best practices of the profession,f) Promotion of collaborative practice, andg) Professional competencies not currently recognized.Granting pharmacists the ability to perform these new acts in a legislatively recognizedmanner, will enable all pharmacists to fully realize their role as experts in medicationtherapy management. No other profession possesses the unique body of knowledge35

that pharmacists have or the extensive education and training respecting drugs andhow they work. While all pharmacists possess the necessary knowledge, skills andability to work in this expanded role, there are many who as noted, are reluctant to doanything outside of the current authorized acts, whether through delegation, medicaldirectives, or through the use of professional judgment. There is little question thatoptimizing the role of the pharmacist can help fill the current gaps in our health caresystem with respect to access. Enabling the pharmacist to be the primary care providerfor minor ailments for example would increase patient access to necessary care andalso help alleviate the burden of family practitioners who cannot now accommodate allof the patients seeking consultations for prescription authorizations or complaints of aminor nature.The proposed changes to the scope of practice of pharmacy will benefit the public by:• Reducing patient's disruption in drug therapy and improving continuity of patientcare (e.g. extensions for ongoing drug therapy, correction of minor prescriptionproblems)• Improving safety through pharmacist reconciling medication and providingseamless care as patients receive care in different health care sectors• Optimizing patient health outcomes by pharmacists identifying, resolving, andpreventing actual and potential medication-related problems; initiating ormodifying drug therapy; and monitoring and evaluating response to drugtherapy, in a collaborative framework with physicians and other health careproviders, especially in collaborative health teams in hospitals, long term carefacilities, family health teams, community health centres, and home care• Increasing the public's convenient access to necessary health care services (e.g.family physicians, walk-in clinics, emergency departments) as the pharmacistwill be reducing the workload of other health care professionals related to refills,minor ailments, and medication therapy management• Increasing the public's access to home care services and long term care facilitiesas pharmacists will be proactively involved in optimizing medication therapy thusproactively reducing the drug-related problems that often result in the publicneeding home care services or being institutionalized• Facilitating the management of chronic and recurrent diseases and conditions• Improving the effectiveness of drug therapy (e.g. improved therapeutic andhealth outcomes) primarily due to improved accessibility to the pharmacist’sexpertise• Increasing the public's safety by minimizing risks and reducing drug errors andother drug-related problems) due to a more proactive pharmacist role (e.g.helping ensure drugs prescribed appropriately initially) rather than a reactiverole (e.g. resolving the drug related problem after it has occurred); decreasedadverse drug reactions and drug-drug interactions• Facilitating the education and training of patients to use their drugs properly(e.g. demonstration of injecting and inhaling drugs) and to self-monitor (e.g.blood glucose monitoring)• Facilitating and supporting patient self-care by assessing symptoms, providingadvice on the management of minor ailments and the use of medications, andreferring patients to other health care providers, where appropriate• Providing education and interventions to prevent disease and disability, therebypromoting healthy lifestyles.• Facilitating the identification of Ontarians with significant risk factors forconditions or diseases (e.g. through screening clinics, health promotion36

programs) and then referring them to physicians and other health careprofessionalsThe medical and pharmaceutical literature contains thousands of articles documentingthe effectiveness of pharmacists at optimizing drug therapy, improving healthoutcomes, and developing innovative and collaborative programs with other health careproviders. McLean reviewed over 500 articles that demonstrated the pharmacist’s valuein achieving health outcomes (i.e. better disease control; decreased drug-relatedproblems, including decreased adverse drug reactions, decreased administrationproblems, increased compliance, better dosing, decreased inappropriate consumption ofdrugs; increased quality of life; decreased use/need of health services, includingdecreased hospital admissions and length of stay; decreased mortality); humanisticoutcomes (i.e. increased quality of life, increased patient satisfaction) or economicoutcomes (i.e. decreased drug costs, decreased use of health services; decreased costof morbidity/complications).a. Gaps in professional services and Patient SafetyStudies have repeatedly shown that Canadians receive less than optimal drug therapyand disease management, resulting in poor health outcomes and preventablehospitalizations. These may be attributed to poor access to health professionals andmay be improved by interdisciplinary health care teams and closer monitoring ofpatients, especially those with chronic conditions. Pharmacists, because of theirexpertise, accessibility, and frequent contact with patients getting prescriptionsdispensed, can facilitate improved patient care.Some of these gaps in service were identified in the report of the Ontario Health QualityCouncil. The Council found in surveys, that 92 percent of people in Ontario said theyhave a family physician, but only 86 percent of immigrants who have lived here lessthan five years have a family physician. Only 10 percent of Ontario family physiciansare taking new patients, down from 40 percent seven years ago. Only 39 percent ofOntarians who need to see their doctor can do so that day or the day after.The Council estimated that about 8,000 lives could be saved annually, and the qualityof life improved for many more people, if there was better delivery of regular care andmonitoring that prevents people with chronic disease from becoming more severely ill.The Council also reported that people with coronary artery disease are only getting twothirdsof the right drugs and tests — and women get much less care than men. TheCouncil found that three-quarters of patients were recommended aspirin; about twothirdswere recommended beta-blockers and a similar proportion, statins. In theory, allpatients with coronary artery disease should at least be considered for each of thesethree treatments. But just one in three is considered for all three drugs.The Council recommended that people get a second opinion on their prescriptionsthrough the MedsCheck program in which all Ontarians who take three or moreprescription medications for chronic conditions can receive a free one-on-one review oftheir medications from a pharmacist, once per year. A follow-up MedsCheck is alsocovered if the person has been recently discharged from hospital and needs to havemedication changes double-checked.37

Patient SafetyMedications have been a key concern in patient safety, not only from the perspective ofadverse events and interactions with other drugs, but also in accurate communicationamong health professionals about a patient's medication therapy as they receiveservices in different health sectors.In comparing patterns of potentially inappropriate drug therapy prescribing incommunity-dwelling older adults and nursing home residents in Ontario in 2001,researchers found that nursing home residents were close to half as likely to bedispensed a potentially inappropriate drug therapy as community-dwelling older adults.Clinical pharmacist services, which are mandated in the nursing home setting, werethought to be responsible for these differences.In long term care facilities, research found that the overall rate of adverse drug eventswas 9.8 per 100 resident-months; 42% of these adverse events were preventable.Errors associated with preventable events occurred most often at the stages of orderingand monitoring. Residents taking antipsychotic agents, anticoagulants, diuretics, andantiepileptics were at increased risk of a preventable adverse event.Recognition of the expertise of the pharmacist in medication management and their rolein promoting health, preventing and treating diseases, dysfunctions and disordersintroduces little or no new risk to patients because, in many cases, pharmacists alreadyperform these duties. Patient safety will increase as more proactive involvement ofpharmacists in medication therapy management and other medication-related activitieshave been found to reduce medication-related problems.With the expanded scope of practice, pharmacists will be able to facilitate bettermedication therapy management, including more regular care and monitoring,especially when patients come to pharmacies to get their refills of chronic medications.b. Epidemiological trends in illness and diseaseCanadians are living longer. One in three people in Ontario has a chronic disease, suchas heart disease, emphysema, diabetes and arthritis. Eighty percent of Canadians whoare older than 65 have some form of chronic disease and of those, about 70 percentsuffer two or more. According to the World Health Organization, an estimated 89percent of all deaths in Canada are caused by chronic disease. WHO research puts thecost of medical treatment for chronic diseases, and the lost productivity they cause, at$80 billion annually in Canada. The 33% of Canadians with one or more of sevenchronic health conditions uses approximately 51% of general practitioner consultations,55% of specialist consultations, 67% of nursing consultations, and 72% of nights spentin a hospital.The expanded scope of practice will enable pharmacists to focus on medication therapymanagement for these chronic diseases. By permitting pharmacists to change dosagesand order laboratory tests, pharmacists can provide anticoagulation services andmonitor patients on drugs such as warfarin. Pharmacists will also be involved in morescreening programs to identify people with increased risk factors to develop chronicdiseases and then provide information on how to prevent or manage the diseases. The38

screening programs can also help detect these diseases sooner, hence facilitatingearlier treatment and management, thus improving health outcomes. Pharmacistdirectedcare has been found to significantly reduce the risk of all-cause hospitalizationsand hospitalizations for heart failure, but was associated with a non-significantreduction in mortality. Pharmacist collaborative care resulted in greater reductions inheart failure hospitalization rates compared to pharmacist-directed care.c. Access to and Coordination of Care/ increased public awareness of availableservicesA study of the supply and utilization of general practitioner and family physician(GP/FP) services in Ontario, found the use of their services, as measured by the percapita visit rate, declined from 1993/94 to 2001/02. Most of this decline was the resultof a large drop in utilization among children and young adults. There was a slight shiftin care to pediatricians, but this accounted for only 6% of the decrease in GP/FP visits.Visits to the emergency department by children and young adults also fell during the1990s. It appeared that young Ontarians were simply visiting GP/FPs less. Onepossibility is that decreased physician supply may lead to increased wait times suchthat an otherwise healthy adult or child with a minor acute self-limiting condition maybe less likely to seek care. The proportion of the population with no GP/FP visits in ayear rose from 21.4% to 24.6%. One possible explanation for this trend is that anincreasing number of Ontarians cannot find a family doctor, but the 2001 StatisticsCanada Health Services Access Survey suggests that only 5.7% of Ontarians report nothaving a family physician, and only one-half of these individuals stated that it wasbecause they could not contact one. One explanation was that more patients areengaging in self-care for minor conditions.This study also found that one-third to one-quarter of all GP/FP visits were of probablelow acuity. This indicated opportunities for delegation to other health professionals andto increase patient education on how to self-manage some of these low acuityconditions. A very slight decrease in probable low acuity visits was observed, possibilitydue to patients who are more knowledgeable than before and thus visit GP/FPs lessoften for minor complaints. Another possibility is that because physician supply isdecreasing, such patients may elect not to see their physician if there are longerqueues.The public is more interested in self-care and taking an active role in the managementof their health. They actively research through computer websites to find informationabout their illnesses and treatment options. They question their physicians and otherhealth care professionals about their findings.Pharmacists, with their new scope of practice, can help patients by managing theirminor ailments and help them with self-treatment and increasing self-management oftheir chronic diseases. There are over 11,000 pharmacists accessible to the publicthroughout the province, through all hospitals and in 3,600 pharmacies. Pharmacies arelocated in communities in which there is limited access to physicians and other healthcare services. Therefore pharmacists can increase the public's access to health servicesby managing minor ailments and other medication therapists. This would allowphysicians to focus on their diagnostic skills and more complex cases.39

d. Wait times for health care servicesThe Ontario Health Quality Council reported that only 39 percent of Ontarians who needto see their doctor can do so that day or the day after. Having pharmacists be able totreat minor ailments, renew prescriptions, and adjust dosages will provide continuingcare for many patients until they are able to see their physician.The concern about waiting times in emergency departments have resulted in theOntario government taking numerous coordinated steps to reduce wait times andimprove patient satisfaction. A major factor causing long emergency room wait times isthe high number of alternate level of care (ALC) patients occupying acute care hospitalbeds, making it difficult to admit patients from the emergency room to the hospital.More than 18 per cent of patients who are currently in a hospital bed in Ontario are inneed of an alternate level of care. A study at Vancouver General Hospital found thatmore than 1 in 9 emergency department visits are due to drug-related adverse events.Of these, 68 per cent were considered to be preventable. The most common reasonsfor drug-related visits were adverse drug reactions (39.3%), nonadherence (27.9%)and use of the wrong or suboptimal drug (11.5%). The probability of admission wassignificantly higher among patients who had a drug related visit than among thosewhose visit was not drug-related. Among those admitted, the median length of staywas longer – 8 v. 5.5 days. The findings suggested that the highest rate of drug-relatedvisits occurred during the night (midnight to 0759h). This may reflect differences in thepatient population that visits the emergency department overnight and lack of access toother health care resources at that time of day. Pharmacists’ interventions can reducemedication errors by 66 per cent in an emergency department. With an expanded scopeof practice, pharmacists can assist by proactively intervening to facilitate bettermedication therapy and hence help avoid emergency visits and hospitalizations. Thereare some pharmacists who work in emergency departments, but their potentialcontributions are not readily recognized by other health professionals.Access to other health services, such as long term care beds, also can be facilitated bythe expanded scope of practice of pharmacists. Pharmacists will help improve thehealth outcomes of patients, especially through better medication management ofchronic conditions, thus helping maintain Ontario residents in their homes longer.e. Best Practices include Wellness and Health PromotionPharmacists are very active in wellness and health promotion. Studies have found thattrained community pharmacists, providing a counseling and record keeping supportprogram for their customers, may have a positive effect on smoking cessation rates.Pharmacists have assisted in government-lead initiatives to increase flu immunizationsby hosting flu vaccine clinics, to provide education on smoking cessation, and havedistributed testing kits to detect colorectal cancers.Pharmacies often host clinics that involve providing information and may involveconsultation appointments. These clinics may include other health care professionalssuch as nurses, dietitians, and personal trainers. Some examples are:• Heart Health -- cholesterol screening / management; lipid panel screen; bloodpressure reading; Framingham Risk Assessment; assessment of currentmedications; body mass index calculation; nutritional assessment; physicalactivity assessment; discussion about risk factors (modifiable and nonmodifiable)and suggestions to reduce risks; recommendations onpharmacotherapy and lifestyle modifications.40

• Osteoporosis -- bone density scan; review of risk factors (modifiable and nonmodifiable);customize individual plan for lifestyle (i.e., calcium intake andsuggestion for implementing weight bearing exercises).• Asthma -- puffer instruction; peak flow meter training; recommendations foractions patient may need to take (i.e., discussing with physician medicationchanges, identification of potential triggers and how to avoid and decrease thelikelihood of an asthma attack)• Diabetes -- blood glucose monitoring; lifestyle assessment; medicationassessment.• Men’s Health -- discussion of erectile dysfunction and treatment options• Smoking Cessation -- assessment of smoking habits, lifestyle changes, andtreatment options• Women’s Health -- hormonal replacement therapy counseling; menopausalsymptom reduction – lifestyle modifications and natural remedies.• Influenza Vaccination Clinic• Pain Management -- discussion of symptoms and disease state (e.g. arthritis,chronic back pain), assessment of current medications.• Weight Loss and Nutrition Consultations• Anticoagulation Management Clinics• Travel Clinic -- discussion about destination and potential problems; travelsafety precautions, needed vaccinesThe expanded scope of practice will empower pharmacists to provide more of thesewellness and health promotion initiatives. The public will benefit from more access tothese services, including education, being identified earlier with risk factors or thedisease or condition being screened, and hence earlier treatment.f. Promotion of Collaborative PracticePharmacists work within inter-professional teams, especially in institutional settings andin primary care teams. In 1996, a joint statement was developed by the CanadianPharmacists Association and the Canadian Medical Association to include the goal ofdrug therapy, strategies for collaboration to optimize drug therapy and physicians’ andpharmacists’ responsibilities in drug therapy. The statement recognizes the importanceof patients, pharmacists and physicians working in close collaboration and partnershipto achieve optimal outcomes from drug therapy. In 2003, the Canadian MedicalAssociation, the Canadian Nurses Association and the Canadian Pharmacists Associationdeveloped the Joint Statement on Scopes of Practice. The statement states:In order to support interdisciplinary approaches to patient care and good healthoutcomes, physicians, nurses and pharmacists engage in collaborative andcooperative practice with other health care providers who are qualified andappropriately trained and who use, wherever possible, an evidence basedapproach. Good communication is essential to collaboration and cooperation.In a 2007 survey of Canadian pharmacists, increasing numbers reported that theywould like to formally collaborate with physicians, i.e. 81% of Canadian pharmacists, upfrom 66% in 2005. Twenty-one per cent of Ontario pharmacists reported that theycurrently collaborate. All pharmacists collaborate to various degrees with physiciansand other health care providers every day in their routine practice. Ontario respondentsto a Canadian survey supported the idea of community pharmacists being members ofteams. Support for this position was slightly higher among respondents who werealready members of teams. Pharmacists on teams were more likely to agree their41

training and skills were sufficient to participate, and to report good relations withphysicians. Pharmacists on teams were more likely to agree there was moreopportunity to meet and get to know other health disciplines, and to see teamwork aspart of their role. They were also more likely to agree physicians wanted their input,and less likely to see other disciplines as being too protective of their professional turf.Pharmacists on teams did not differ from those not on teams in rating lack of time, badpast experiences with teamwork, financial reimbursement or proximity to other healthcare workers as barriers to being a member of a community-based primary care team.An enhanced scope of pharmacy practice will contribute to inter-professional healthcare delivery.Pharmacists have always worked in collaboration with other health professionals, inboth the community and institutional settings. Pharmacists provide a safety net for thepublic on medication issues by providing prescription checks on dosage amounts andchoices of drug therapy. Pharmacists working in hospitals, long term care and otherinstitutional settings work in collaborative health teams environment where theirexpertise in medication management directly impacts on the patients. Pharmacistsroutinely review the patient’s health history and medications, access laboratory andother diagnostic information in order to make recommendations to physicians on thebest medication therapy option for the patient.Documenting and record keeping are key parts of the pharmacist’s current practice.With the expanded scope, pharmacists will communicate, in a timely manner, theirmedication management activities and other pertinent information to physicians, nursepractitioners and other health care professionals involved with their patients.Examples of Collaborative InitiativesThe College developed with the College of Physicians and Surgeons of Ontario and otherstakeholders authorizing mechanisms based on delegation and medical directives. TheCollege, the Ontario Medical Association, the College of Physicians and Surgeons ofOntario, and the Ontario Pharmacists Association have agreed to conditions underwhich a pharmacist may authorize and dispense an extension of a prescription whenthe prescribing physician is unavailable to provide refill authorization. (See PAPEagreement, page 57)A consultation session on the Pharmacists Scope of Practice Review was held on May 9,2008. Representatives from the College of Physicians and Surgeons of Ontario, theCollege of Nurses of Ontario, the Royal College of Dental Surgeons of Ontario, theOntario College of Family Physicians, the Ontario Dental Association, the OntarioMedical Association, the Nurse Practitioners Association and the Registered NursesAssociation of Ontario indicated support for the greater use of the expertise ofpharmacists in medication management, especially in collaboration with them. Therewas no consensus on whether pharmacists should be recognized for additionalcontrolled acts or if pharmacists should continue performing the controlled acts underdelegation, medical directives, Section 29(1) of the RHPA, and professional judgment.42

The College of Nurses of Ontario (CNO) wrote a letter to provide the College with CNO'sinitial feedback to the May 2008 consultation. Extracts from this letter include:Additional Controlled ActsWe do not believe that the exception provisions listed in section 29 of theRegulated Health Professions Act are meant to be used to provide a regulatedhealth profession with broad and routine access to controlled acts. It is CNO'srecommendation that OCP seek legal access to the controlled acts; this approachis transparent, provides clarity to pharmacists and to other health carepractitioners and protects the public - as it facilitates role clarity and OCP'sability to govern its members with respect to the performance of these acts.CNO's interpretation of OCP's proposal is that pharmacists would not beinitiating prescriptions, but they would alter prescriptions initiated by anauthorized prescriber. This could include changes as straightforward assubstitutions or, under specific circumstances, authorizing refills or adjustingdoses. CNO appreciates that OCP envisions that these activities would occurwithin a collaborative context and would require enhanced communicationbetween the pharmacist and other health care providers.We understand that there has been some groundwork on the issue ofauthorizing refills between the medical and pharmacy communities with thePAPE (Pharmacist Authorization of Prescription Extensions) agreement. Werecommend that OCP begin this dialogue with other prescribers.OCP proposes that pharmacists be authorized to order and receive laboratorytests to monitor drug therapy and adjust dosages in certain conditions. CNOrecommends that OCP develop these conditions in consultation with otherproviders of the health care team, specifically prescribers. We would alsoemphasize that our support is contingent upon appropriate two-waycommunication between the pharmacist and other health providers.Overall, we believe that this type of expanded role for pharmacists would workbest in a system that is integrated and would be most appropriate in settingswhere pharmacists are directly involved as part of the larger health care team.This provides direct access to the client's health record and the otherprofessionals involved in medication therapy. These types of settings includehospitals, Family Health Teams and Community Health Centres. We view theabsence of an integrated electronic health record as a key barrier toimplementing these initiatives in the community (i.e. retail) pharmacy sector.Minor Ailment ManagementCNO understands this to be a role that in many ways pharmacists are alreadyfilling in Ontario. It is CNO's interpretation that the pharmacist in this situationwould not be dispensing prescription drugs, but rather would recommend anddispense either schedule II or III drugs.We are supportive of such an initiative that would make better use ofpharmacists' competencies and understand that OCP's position is that thisinitiative would require pharmacists to communicate their interventions to theclient's physician. CNO requests that this concept be expanded to requirepharmacists to also communicate with other primary care providers, specifically43

nurse practitioners. There are currently over 700 nurse practitioners providingprimary care services to people across the province - and this number isgrowing. Increasingly, pharmacists are going to come across clients who receivetheir primary health care from a nurse practitioner.Should OCP be proposing that this initiative involve pharmacists dispensingprescription drugs, CNO would interpret the activity as initiating a prescriptionand would therefore suggest the need for additional consultation.g. Professional competencies not currently recognizedThe public and other health professionals often do not recognize the many servicespharmacists can provide. Official recognition of these in the expanded scope of practicewill facilitate integration of pharmacists into more programs, services and initiatives.Physicians often think that pharmacists can already adapt prescriptions by changingformulations (e.g. changing tablets/capsules to oral liquid for patients who havedifficulties swallowing; changing the dosage strength / formulation if prescribed one notcommercially available or not covered by patient’s drug plan) and that pharmacists canprovide interim supplies. Physicians become frustrated when contacted by pharmaciststo obtain authorization to do the above. This confusion can delay the patient gettingtheir prescription filled quickly when physicians aren’t able to return, in a timelymanner, phone calls from pharmacists requesting prescription changes.The publicity surrounding the expanded scope of practice will help educate the publicabout the many services they can expect to receive from pharmacists.25. How would the proposed change affect other health professions? Thepublic? Describe the effect the proposed change in the prescribing and/oradministration of drugs might have on:a) Health human resources,b) Enhancement of quality of services,c) Access to services,d) Service efficiency,e) Interprofessional care delivery, andf) Other impacts.PharmacistsSignificant time is required by pharmacists and technicians to ensure prior authorizationis obtained for prescription changes and obtaining refills. Anecdotal reports fromAlberta, where pharmacists have been able to independently adapt prescriptions andprescribe in emergencies since April 2007, indicate that their expanded scope ofpractice has significantly decreased time involved in trying to contact physicians tochange prescriptions and to obtain refills, thus offsetting the additional time requiredfor increased documentation and communicating prescribing decisions to the patient’sfamily physician and other health professionals.The appropriate management of the pharmacist as a high priority health humanresource is undergoing significant studies. In 2005, eight leading national pharmacyorganizations partnered together to carry out a human resources study of pharmacistsand pharmacy technicians, now known as Moving Forward: Pharmacy Human Resourcesfor the Future. This study was funded by the Foreign Credential Recognition Program of44

Human Resources and Social Development Canada and managed by the CanadianPharmacists Association. The multi-pronged research program examined factorscontributing to pharmacy human resources challenges in Canada, and has developed aseries of pharmacy human resources planning recommendations to ensure a strongpharmacy workforce prepared to meet the future health care needs of Canadians. Thisinitiative complements another collaborative initiative known as the Blueprint forPharmacy. The Blueprint has developed a vision, mission, and strategic action plan forthe pharmacy profession in Canada to strengthen its alignment with the health careneeds of Canadians and to respond to the stresses on the health care system. It isbased on the enhanced roles pharmacists and pharmacy technicians including drugtherapy management, public health outreach, prescribing and monitoring authority,self-care patient support and dispensing leadership.Hence, pharmacists throughout Canada are working to ensure the availability ofpharmacists for expanded scopes of practice.PhysiciansMany physicians have found the interventions of pharmacists useful and areaccustomed to working with pharmacists, especially in hospitals and long term carefacilities. Studies have found physicians develop a very positive attitude to pharmacistinterventions after working with pharmacists in primary care models. Physicians willbenefit from pharmacists being integrated more fully into the health system and asmembers of collaborative health teams. They will get increased support frompharmacists in helping to manage medication therapy by:• improving communication among health care providers• providing information on the review and modification of all medicationtherapies a patient is taking (prescription, non-prescription, herbals, etc.) forpatients receiving medication therapy management• improving continuity of care/seamless care as patients move between healthsectors.Physicians' workload will be reduced related to pharmacists• authorizing dosage / formulation changes and refills• treating minor injuries, illnesses, and self-limiting conditions• extending prescriptions• managing of chronic and recurrent diseases and conditions• decreasing interruptions outside of physician regular practice hours,associated with requests for authorization of prescriptions.Physicians will also be able to reallocate their time to see new patients and otherpatients who require their expertiseNurses/Nurse PractitionersNurses and nurse practitioners also are accustomed to working with pharmacists,especially in hospitals and long term care facilities. They rely on the pharmacist'sexpertise on medications and medication therapies and will benefit from pharmacistsbeing integrated more fully into the health system and as members of collaborativehealth teams. They will get increased support from pharmacists in helping to managemedication therapy by:45

• improving communication among health care providers• providing information on the review and modification of all medicationtherapies a patient is taking (prescription, non-prescription, herbals, etc.) forpatients receiving medication therapy management• improving continuity of care / seamless care as patients move betweenhealth sectors.• managing of chronic and recurrent diseases and conditionsOther Health Care ProfessionalsOther health care professionals (e.g. dietitians, physiotherapists, and respiratorytherapists) will benefit from greater access to pharmacists as members of interprofessionalteams and their expertise in medication therapy management.PublicThe public impact and benefits of the expanded scope of practice for pharmacists hasbeen discussed in Question 24.a. Health human resources issuesThere are shortages of many health professionals, including physicians, nurses, nursepractitioners and pharmacists. Having pharmacists more involved in medication therapymanagement and in treating minor ailments, will relieve the workload of these otherhealth professionals, allowing them to focus on their unique areas of expertise. This willmake them more accessible to the public.In addition, pharmacy technicians will soon be regulated and assuming responsibility forthe technical elements of dispensing, thereby freeing up the pharmacist to providemore patient focused care.b. Enhancement of quality of services;By allowing pharmacists to manage medication therapies and order laboratory tests,there will be decreased delays in needed changes to medication dosages and hencebetter monitoring. By allowing pharmacists to adapt prescriptions and provide suppliesto continue therapy, delays or disruptions in therapy will be reduced.Proactive involvement of pharmacists will help reduce preventable drug-relatedproblems and adverse events.c. Access to services;The public can experience difficulty in accessing health services in all areas of theprovince, including cities. In more remote or rural areas, pharmacies may be readilyaccessible while physicians may only be accessible on certain days. In allcircumstances, pharmacists provide required services to their patients as necessary,often through delegation and frequently through the use of their professional judgment.The expanded scope will improve access to the pharmacist services and hence to otherhealth professionals in these areas, who can reallocate their time to patients and morecomplex cases as the pharmacists provide medication therapy management and treatminor ailments.46

Patients will save time, transportation costs, and time away from work due to fewervisits to the physician or emergency department for refills and the treatment of minorillnesses. They will also benefit from improved medication therapy and better healthoutcomes.Pharmacists will start providing and charging for more comprehensive consultations onmedication therapy management. There may be additional charges to the public forthese depending upon whether the government and private sector drug plans coverthese fees.The expanded scope of practice would provide increased access to the pharmacist'sexpertise by the public and to other health care professionals. It would also increasethe public's access to health and wellness programs and to other health professionalsand services that would have time freed up by pharmacists more integrated into thehealth system. We believe that using pharmacists to the full extent of their scope ofpractice, especially in assessing and treating minor ailments* (*see 25g page 48) canboth improve public access to necessary health care services and decrease overall coststo the health care system.d. Service efficiency;The health system will be able to more effectively use health care providers andresources and provide residents of Ontario with better access to medication therapymanagement, such as:• provide more flexibility in designing programs to make better use of health careproviders according to their qualifications, skills and training• facilitate the greater use of pharmacists to manage medication therapy inhospitals, long term care facilities, family health teams, primary care,community health centres, home care, outpatient, outreach, and communitybased programs• reduce the workload of physicians, nurses, and other health professionalsrelated to medication therapy permitting reallocation of their time to patientswho require their expertise• improving continuity of care / seamless care as patient moves between healthsectors• facilitate the incorporation of pharmacists into primary care treatment groupsand disease management programse. Inter-professional care delivery;Pharmacists work within inter-professional teams, especially in institutional settings andin primary care teams. The majority of the 150 family health teams in Ontario includepharmacists. In a 2007 survey, increasing numbers of Canadian pharmacists reportedthat they would like to formally collaborate with physicians, i.e. 81% up from 66% in2005. Twenty-one per cent of Ontario pharmacists reported that they currentlycollaborate.f. Economic issues and Other Impacts;Total drug spending in Canada is estimated to have reached $26.9 billion in 2007. Forthe last decade, drugs have represented the second-largest component of healthspending, after hospitals. This represents an estimated annual growth rate of 7.2%, an47

increase of approximately $2 billion over 2006. Spending on prescribed drugs continuesto grow faster than spending on non-prescribed drugs and is estimated to have reached84% of the total drug bill in 2007. Total drug spending in Ontario is estimated to havereached $11.3 billion in 2007. This represents 17.6% of total health expenditure, abovethe Canadian average of 16.8%. The per capita spending on drugs by the public sectoris forecast to have been $341 in Ontario, above the Canadian average of $327.Prescribed drug expenditure per capita financed by the private sector is expected tohave been $391, again higher than the Canadian average of $356.In addition to their beneficial therapeutic effects, drugs are a significant cause of illness,disability and death. Inappropriate prescribing is estimated to cause at least 1.1% to3.1% of hospitalizations, and at least 1.1% to 4% of physician visits. In 1997, aconservative estimate of these costs was $0.84 billion to $2.56 billion in Canada eachyear. The estimated cost of misuse, underuse, and overuse of medications ranges from$2 billion to $9 billion per year. Between 1995 and 2000, costs associated with adversedrug-related events rose from US$76.6 billion to over US$177.4 billion.In a recent Canadian study, 24% of patients were admitted to a hospital’s internalmedicine service for medication-related causes, and over 70% of these admissionswere deemed preventable. A study at Vancouver General Hospital found that morethan 1 in 9 emergency department visits are due to drug-related adverse events. Ofthese, 68% were considered to be preventable. The most common reasons for drugrelatedvisits were adverse drug reactions (39.3%), nonadherence (27.9%) and use ofthe wrong or suboptimal drug (11.5%). The probability of admission was significantlyhigher among patients who had a drug-related visit than among those whose visit wasnot drug-related. Among those admitted, the median length of stay was longer – 8 v.5.5 days. The findings suggested that the highest rate of drug-related visits occurredduring the night (midnight to 0759h). This may reflect differences in the patientpopulation that visits the emergency department overnight and lack of access to otherhealth care resources at that time of day.Adverse events after hospital discharge have been reported as 23% of patientsexperiencing an adverse event within 30 days; 50% of these adverse events weredeemed preventable and 72% were due to medications. Preventable drug relatedmorbidity in Canadians aged 65 or older has been estimated at $11.9 billion in 2000,with admissions to long-term care facilities being the largest component of costs(61.3%) and hospital admissions being second. This model captured only costs to apublic payer, and did not include costs (direct or indirect) to private sector payers,including the seniors and their families.Expanding the scope of pharmacists will empower them to become more proactivelyinvolved throughout the health system and help reduce these preventable adverseevents and help optimize medication therapy.g) Treatment of Minor Ailments: A Key InitiativeOne significant area involves the assessment and treatment of minor ailments. Asnoted earlier, a study of the supply and utilization of GP/FP services in Ontario, foundthat one-third to one-quarter of all GP/FP visits were of probable low acuity. The publicroutinely seek out pharmacists as their primary source of advice and care for numerousminor ailments and because pharmacists are easily seen without appointments theyhave long been recognized as the most accessible health care professionals. Throughthe expanded scope of practice and government recognition and support, more patients48

can be encouraged to use their pharmacist as the first line health professional for theassessment and treatment of minor ailments.Such programs have existed in the United Kingdom since the early 2000s, first as pilotsand then as core services. These minor ailments schemes enable patients who areexempt from prescription charges to receive treatment for common illnesses free ofcharge direct from a community pharmacy. The minor ailments and drug benefits varywith the jurisdiction. The ailments can include acne, allergies, athlete's foot, back pain,bites, burns, colds, simple viral infections (e.g. cold sores), colic, conjunctivitis,constipation, contact dermatitis, cough, cystitis, diaper rash, diarrhea, dyspepsia,earache, ear wax, eczema, fever, hemorrhoids, hayfever, headaches, head lice,indigestion, mouth ulcers, nasal congestion, oral thrush, scabies, sore throat, strains,teething, threadworms, urinary tract infections, vaginal thrush and warts. While theproducts prescribed under this scheme generally are not prescription-requiring by law,they may require a prescription in order for the patient to obtain drug coverage by theNHS. It relieves pressure in primary care by discouraging patients from seeingphysicians for minor ailments. In April 2006, minor ailments schemes became one ofthe four core services in the community pharmacy contract, meaning that it would beoffered by every community pharmacy in Scotland. In England, the governmentrecently proposed that minor ailments schemes be commissioned from communitypharmacies in every primary care trust. As of March 2007, only 24% of all pharmaciesheld such contracts.Preliminary data, (available on request), included in the appendices, demonstratesincreased access by the public to necessary health services for minor ailments,increased access to physicians by patients who are more seriously ill, and overall costsavings to the NHS. IMS Health analysed anonymized patient records from its databaseof 210 general practices across the UK, covering four million patient records and 190million prescriptions. Data from 500,000 UK patients who had consulted their GP abouta minor ailment suggested that, in 2006–07, 51.4 million GP consultations a year weresolely for minor ailments. Estimated at eight minutes per consultation, this represents18 per cent of GPs’ workload or an hour a day for each GP. The total cost to the NHS ofthese consultations is £1.8bn and 80 per cent of this (£1.5bn) is attributable to the costof GPs’ time. In addition, 10 minor ailments are responsible for 75 per cent of the costof minor ailments consultations and 85 per cent of the cost of prescriptions for minorailments.These are:• back pain• indigestion• dermatitis• nasal congestion• constipation• migraine• acne• cough• sprains and strains• headache49

A minor ailments program was used by the Canadian Forces. If their members did nothave access to a base pharmacy, the member had to consult a physician to get aprescription to get an over-the-counter drug covered. The pilot project was tested inseveral Canadian locations, including London, Ontario. The Canadian Forces membercould get the over-the-counter drug directly from these pharmacies and the pharmacywould bill the Canadian Forces. The researchers found the provision of these drugs bypharmacists to be cost-effective and convenient. They found that the membersinteracted with the pharmacists to obtain optimal treatment of the ailments and thatfew members required follow-up with a physician to treat the ailments.Implementation of such a program in Ontario would more fully utilize the training andexpertise of the pharmacist, but could also be expected to increase the public’s accessto health services involving minor ailments and free up family physicians to see moreseriously ill patients. The overall costs to the health care system would decreaseproportionately with decreased “first line” visits to physician offices, walk-in clinics andemergency rooms for minor ailments.26. Are members of your profession in favour of the proposed changes? Pleasedescribe any consultation process and the response achieved.Yes, the members are in favor of these proposed changes. Many pharmacists havedeveloped their practices over the years through the use of medical directives toinclude these proposed changes thus indicating their support for legislative recognition.In concert with our consultations over the past ten years respecting the regulation ofpharmacy technicians, the College has consulted widely with the membership regardingthe scope of practice for pharmacists to gain solid understanding of what pharmacistsare currently doing in their day-to-day practice and what the comfort level is amongmembers respecting their scope. The consultations mainly have taken place during theCollege’s bi-annual face to face district meetings and through informal surveys. Thelong standing position of this College to not actively pursue prescribing rights forpharmacists was taken based on feedback from the majority of pharmacists who wereconcerned that prescribing traditionally follows the process of conducting a differentialdiagnosis and the acknowledgement that they were not trained to diagnose. We learnedhowever, that members feel on the whole extremely comfortable in medication therapymanagement and embrace the ability to adapt or alter existing prescriptions to ensurepatient compliance, to extend authorizations of prescriptions for continuing care, toadjust dosages based on laboratory results, to administer substances by injection orinhalation in the course of educating their patients about their therapy, etc. This isconsistent with what is considered pharmacist prescribing in other Canadianjurisdictions. We believe that pharmacists in Ontario support and embrace being able toadapt, modify and extend prescriptions without authorization of a prescriber subject tothe above conditions.Ontario pharmacists have participated in the consultations on the Pharmacy HumanResources for the Future Research Program and on the Blueprint for Pharmacy(website: www.pharmacists.ca/blueprint). Both of these initiatives support expandedscopes for pharmacists. These include:• Drug Therapy Management: Pharmacists will spend more time managing drugtherapy in collaboration with patients, physicians, and other health providers• Public Health Outreach: Pharmacists will play a more prominent role in healthpromotion, disease prevention, and chronic disease management50

• Prescribing and Monitoring Authority: Pharmacists will have greater responsibilityand authority for making prescribing decisions (including initiating and modifyingdrug therapy) and monitoring drug therapy outcomes (including ordering andperforming tests) in collaboration with other health providers• Self-Care Patient Support: Pharmacists will continue to be accessible and availableto support patient self-care.Pharmacists responding to the consultations expressed broad support for theseexpanded roles. They recognized the increased workload and liability and noted therewould also be an increase in job satisfaction. The following are actual commentsprovided to HPRAC over the summer of 2008:My ability to perform to my full potential is limited by regulations that have not kept upwith the pharmacist’s expanding role in patient care and education. For example, aspart of current practice, patients and caregivers expect me to pierce a patient’s fingerto demonstrate how to use a lancing device for blood sugar monitoring, administermedication such as insulin to demonstrate proper technique, and administer medicationwhen teaching patients how to use inhalers.I think we play a valuable role everyday in the health of all Ontarians and couldcontribute even more by having expanded privileges. Furthermore, by having expandedroles, healthcare costs would be lowered while health outcomes improved so there areadvantages on many fronts.Pharmacists are willing and able to play an important role in making Ontario’s healthcare system more efficient and effective. To make the most of our accessibility andexpertise as pharmacists, our scope of practice needs to expand so we have greaterresponsibility for prescribing decisions, and the tools we need to monitor drug therapyoutcomes, to better meet the needs of Ontarians now and in the future.The expansion of pharmacists’ role to include ordering laboratory tests (INR) anadjusting doses of chronic medications (warfarin) under a set protocol, andreimbursement for these services would enable us to care for more patients. Thesepatients would be provided with safer, more effective warfarin therapy which woulddecrease the incidence of both DVT’s and warfarin related bleeding. Also, physicianswould have assistance in the care of their warfarin patients.Many of the day to day tasks for the pharmacist are “hampered” by the need of apharmacist to contact a physician for authorization to make changes to a prescriptionwhich may have been incorrectly written or needing a change such as switching from acapsule dose to a liquid dose for a child or an adult having difficulty swallowing. Theseare common prescription changes that a pharmacist is quite capable of making andshould not require the authorization of a physician to do. Many of our patients can waitdays for their medication before an authorization is sent from a physician. In our area,many physicians do not take calls from pharmacist so we must fax over request for ourchanges and then wait for a reply. This is very frustrating for both the patient and thepharmacists, causing a delay in delivery of appropriate and needed medication,especially in the case of antibiotics.Over recent years many research initiatives (SMART, IMPACT) have been completedproviding new knowledge on how pharmacists can be integrated into primary care withother health care professionals including physicians, nurse practitioners, dietitians andothers to use their medication related expertise synergistically to aim to optimize the51

health related outcomes of patients from their medications. This practice puts thepharmacist at the point of prescribing such that the best possible medication should beprescribed to the patient. Improved training initiatives (Structured practical experienceprogram – U of T, Faculty of Pharmacy) for community pharmacy based pharmacistshave provided a renewed focus on the patient as opposed to product.To make the most of our accessibility and expertise as pharmacists, our scope ofpractice needs to expand so we have greater responsibility for prescribing decisions,and the tools we need to monitor drug therapy outcomes, to better meet the needs ofOntarians now and in the future. With the shortage of family physicians currently in theprovince of Ontario, the need for an expanded scope of practice for pharmacists isurgent to relieve the demand on the health care system.I believe that pharmacist have the aptitude and knowledge to expand our role toinclude limited prescribing (including initiating patient therapy based on physiciandiagnosis and lab results) and adjusting prescription medication dosage based on labresults.Many limitations in current legislation “tie” the hands of the pharmacist in their effortsto provide optimal patient care.Collaborating regularly with the physician in my community I have come to believe thatexpanding the role of pharmacists is the next logical step to improve patient-centredcare and allow the most effective use of time, skills and knowledge of our communityhealthcare providers.We are more than capable of handling these added responsibilities. These are notgroundbreaking proposals. Other countries such as the UK, Australia, and otherjurisdictions in Canada have even further than this. It is time pharmacists in thisprovince be allowed to practice what they were all educated and trained for.Having to call the doctor for medication adjustments is merely a delay in therapy, and itis unnecessary as pharmacists are the drug experts and are in the best position tomake changes to drug formulations, continue therapy (i.e. authorize refills) whilepatients are waiting for another doctors appointment, teach/administerinhalation/injectable drugs, or adjust medication doses/forms based on laboratorytests/responses. Physicians are busy and get annoyed with unnecessary phone calls –plus, their expertise lies in diagnosing the problems, whereas pharmacists’ expertise ismedication management and monitoring. I think the above changes would enhancepatient care by minimizing delays in therapy, plus it would make use of the skillspharmacist already have. It is a more efficient use of the healthcare system.52

PRESCRIBING: DRUG REGULATIONS UNDER PROFESSIONAL ACTS27. Please describe challenges faced by members of the profession as a resultof listing specific drugs in regulation schedules made under the professionspecificact.Because the College’s proposal does not contemplate pharmacists providingprescriptions for prescription-requiring or Schedule l drugs, we are not recommendingthe creation of a list of drugs embedded in regulation. Indeed, the province of Alberta,which permits all pharmacists to adapt or continue all schedule l drugs that have beenoriginally prescribed by a prescriber, did not support the establishment of a drug list.Listing or defining specific drugs in regulation schedule(s) under the Pharmacy Actwould pose significant challenges to the profession by potentially hampering thepharmacists’ ability to optimize the care of their patients in a timely manner. Theexisting process required in Ontario to currently effect regulatory amendments orchange is unnecessarily time consuming, onerous and inefficient. We would beconcerned that the list would not adapt fast enough to keep pace with changing andemerging drug therapies that continue to come onto market and be prescribed.Prescribing pharmacists in Alberta can prescribe any Schedule 1 drug. Even thoughsome of the pharmacists that are prescribers may practice in specialty areas, drugs arenot restricted to that specialty. Pharmacists are trained to be experts in medicationtherapy management. Even those pharmacists working in specialty areas find that theiroverall expertise in pharmacotherapy is valuable. Medical specialists in an area will bevery familiar with the drugs they use regularly. However, part of the value of apharmacist is that they can manage overall drug therapy.In the same way that pharmacists in Alberta are expected to demonstrate collaborativerelationships and practices that support prescribing with documentation and follow-upwith any drug they prescribe, prescribing pharmacists in Ontario would also beexpected to use their professional judgment – just like any other prescribers.The Ontario College of Pharmacists would similarly expect pharmacists to exercise theirprofessional judgement when adapting, modifying or authorizing a refill for anyprescribed drug(s). To fully realize their roles in Medication Therapy Management,pharmacists will be called upon to adapt, modify, adjust doses and extend prescriptionsfor numerous drugs. The College expects pharmacists to exercise sound professionaljudgment when making appropriate decisions and recommendations and does notsupport the creation of a defined list of drugs or categories. It is our view that such alist will not afford the flexibility necessary to accommodate changing drug therapies ortreatment modalities as they emerge and could ultimately limit the desired benefits tothe public.28. If classes of drugs, rather than a list of specific drugs, were included in theproposed regulations, please describe how this would impact the membersof the profession and the college. What, if any, additional education andtraining, competency review, or updates to clinical guidelines or standardsof practice would be required?The Ontario College of Pharmacists is not supportive of establishing a list of specificdrugs or classes of drugs for pharmacists.53

The College’s proposals contemplate that all pharmacists in practice today have theknowledge, skills, ability and judgment to optimize patient care through medicationtherapy management. Pharmacists are expected to be familiar with clinical guidelinesregarding the areas in which they practice. Creating a specific or defined list of drugswould severely restrict the ability of pharmacists in practice to optimize their patients’drug therapy and care.Further, we consider a list to be inconsistent with the principles of self regulation whichrecognize individual accountability to practice within the scope of their knowledge,ability and expertise. The ongoing challenges associated with effecting regulatorychange(s) will also pose potential barriers to prompt care as new therapies come ontothe market and are prescribed.The College supports all pharmacists being permitted to adapt and modify prescriptionsfor any Schedule I, II, or III drugs prescribed and to extend prescriptions for Schedule Imaintenance drugs prescribed for chronic care. The College acknowledges that,pursuant to federal legislation, the adapting, modifying or extending of all prescriptionsfor narcotic or controlled substances will continue to be done in collaborative practicethrough delegation or medical directives.29. If classes of drugs, rather than a list of specific drugs were included in theregulation, what conditions should be attached, if any, to the classes?Should the broad purpose, indications, or some other reference be specified(e.g. for pain relief in labour; for smoking cessation; for treatment ofsexually transmitted diseases; in emergency; refill). Please comment indetail.30. If classes of drugs, rather than a list of specific drugs were included in theregulation, how would you classify the drugs for your profession? Are therecircumstances where a drug class would not be appropriate in a regulationschedule for the profession? Are there situations where a combination ofclass and list of specific drugs would better respond to the competencies ofthe profession?31. If applicable, please describe in general your profession’s experience withrequests for changes to drug regulations, including specifics of therequests made, regulation changes that followed, if possible the timerequired for changes to regulations, and what, if any, proposed changeswere, or were not, approved by government.As alluded to previously, it is our experience that the current process required to giveeffect to proposed regulatory changes or amendments is time consuming, onerous andfraught with ongoing delays and frustrations. As an example, the College initiallysubmitted regulatory amendments under the Drug and Pharmacies Regulation Act(DPRA) to government in 1995-in the past twelve years that the proposals have beenwith government, emerging issues in the practice of the profession have resulted inCollege Council adding to or further revising the initial proposals. To date we havebeen unable to attract the necessary attention or political interest/will to give effect tothese regulations which will greatly assist the College in more effectively regulatingpharmacy practice in Ontario in the public interest.54

COLLABORATION32. Do members of your profession practice in a collaborative or teamenvironment where a change in drug regulations or legislation wouldcontribute to multidisciplinary health care delivery? How would relationsbetween professionals working in a team be impacted?What additional standards would be required (e.g., record-keeping, referralprotocols)? Please describe any consultation process, agreements or otherarrangements that have occurred with other professions.On May 9, 2008, consultation focus groups were held at the College respecting thissubmission and while no representatives of other professions opposed the notion ofpharmacists fully realizing their role as experts with a unique body of knowledge inmedication therapy, there was less support from the medical profession representativesfor pharmacists initiating a prescription. The notion of pharmacists dispensing withoutfurther authorization subject to terms and conditions seemed less problematic, perhapsbecause of the recent changes in institutional settings and in primary care teams. In1996, a joint statement was developed by the Canadian Pharmacists Association andthe Canadian Medical Association to include the goal of drug therapy, strategies forcollaboration to optimize drug therapy and physicians’ and pharmacists’ responsibilitiesin drug therapy. The statement recognizes the importance of patients, pharmacists andphysicians working in close collaboration and partnership to achieve optimal outcomesfrom drug therapy. In 2003, the Canadian Medical Association, the Canadian NursesAssociation and the Canadian Pharmacists Association developed the Joint Statementon Scopes of Practice. The statement states:In order to support interdisciplinary approaches to patient care and good healthoutcomes, physicians, nurses and pharmacists engage in collaborative andcooperative practice with other health care providers who are qualified andappropriately trained and who use, wherever possible, an evidence basedapproach. Good communication is essential to collaboration and cooperation.In a 2007 survey of Canadian pharmacists, increasing numbers reported that theywould like to formally collaborate with physicians, i.e. 81% of Canadian pharmacists, upfrom 66% in 2005. Twenty-one per cent of Ontario pharmacists reported that theycurrently collaborate. All pharmacists collaborate to various degrees with physicians andother health care providers every day in their routine practice. Ontario respondents to aCanadian survey supported the idea of community pharmacists being members ofteams. Support for this position was slightly higher among respondents who werealready members of teams. Pharmacists on teams were more likely to agree theirtraining and skills were sufficient to participate, and to report good relations withphysicians. Pharmacists on teams were more likely to agree there was moreopportunity to meet and get to know other health disciplines, and to see teamwork aspart of their role. They were also more likely to agree physicians wanted their input,and less likely to see other disciplines as being too protective of their professional turf.Pharmacists on teams did not differ from those not on teams in rating lack of time, badpast experiences with teamwork, financial reimbursement or proximity to other healthcare workers as barriers to being a member of a community-based primary care team.An enhanced scope of pharmacy practice will contribute to inter-professional healthcare delivery.55

Pharmacists have always worked in collaboration with other health professionals, inboth the community and institutional settings. Pharmacists provide a safety net for thepublic on medication issues by providing prescription checks on dosage amounts andchoices of drug therapy. Pharmacists working in hospitals, long term care and otherinstitutional settings work in collaborative health teams environment where theirexpertise in medication management directly impacts on the patients. Pharmacistsroutinely review the patient’s health history and medications, access laboratory andother diagnostic information in order to make recommendations to physicians on thebest medication therapy option for the patient.The College developed with the College of Physicians and Surgeons of Ontario and otherstakeholders authorizing mechanisms based on delegation and medical directives. TheCollege, the Ontario Medical Association, the College of Physicians and Surgeons ofOntario, and the Ontario Pharmacists Association have agreed to conditions underwhich a pharmacist may authorize and dispense an extension of a prescription whenthe prescribing physician is unavailable to provide refill authorization.-----------------------------------------------------------------------------------------PHARMACIST AUTHORIZATION OF PRESCRIPTION EXTENSIONS (PAPE) AGREEMENTJanuary 2008The following agreement provides conditions under which a pharmacist may provideauthorization of a prescription extension to a patient where an urgent need for patientdrug therapy management exists and the prescribing physician is unavailable to providerefill authorization.This Agreement assumes the following principles:1. Pharmacist authorization of prescription extensions cannot and does not take theplace of ongoing medical care.2. Each request for a pharmacist authorization of prescription extensions must bejudged on the individual nature of the patient’s need/history and professionaljudgment exercised accordingly.3. The pharmacist assumes the responsibility for the extended refill.A pharmacist may authorize a prescription extension where the following conditions aremet:1. The pharmacist must be reasonably satisfied that the prescriber, if available,would in all likelihood, provide the authorization.2. The medication to be extended has been prescribed to the patient for a chronicor long term condition (generally for at least a year or longer).3. The patient shall have an established, stable history (no recent changes todosages or drug therapy) with that medication.4. The prescription to be extended shall be with that particular pharmacy and thepatient shall be within the care of the pharmacy.5. Narcotic or controlled substances shall NOT be authorized for extension withinthe confines of this agreement.6. The pharmacist may authorize a prescription extension once only. Furtherrequests for extensions must be handled by the patient’s physician or originalprescriber or an on-call physician.7. The amount of medication provided must not exceed the previous amount filled,or three months, whichever is lesser.56

8. The pharmacist shall assign a new prescription number to the prescriptionextended under this agreement (PAPE) and shall record on the prescription theRx number of the original prescription. The original prescriber shall be listed asthe prescriber on the extended prescription. The pharmacist shall be recorded asauthorizing the extension.9. The PAPE shall be documented on the patient record in such a manner as toensure the prescription will not be “extended” a second time.10. The PAPE shall be reported in written format within one week to the originalprescriber and to the patient’s primary care physician (if different from theprescriber). A copy is to be kept in the pharmacy.11. A prescriber retains the right to indicate “no extension” on a prescription;however this does not preclude the pharmacist from exercising professionaljudgment in an emergency situation.Support/endorsement for this policy is being actively sought from the Council of theOntario College of Pharmacists, as well as from:The Ontario Pharmacists Association,The Ontario Medical Association, andThe College of Physicians and Surgeons of Ontario--------------------------------------------------------------------------------------------------Documentation and record keeping are a key part of pharmacy practice and the Collegedoes not contemplate that requiring pharmacists to maintain more fulsome recordsrespecting the medication management provided to their patients will be problematic.The College has already communicated the need for pharmacists to not only documenttheir actions taken on behalf of a patient but also to communicate their actions to thepatient’s primary health care provider in a timely manner. The College currentlyconducts routine inspections of all pharmacies in Ontario to ensure that operationalstandards and record keeping requirements are appropriate and would anticipate that amore comprehensive examination of documented actions will be incorporated into theroutine inspection processes.With respect to referral protocols, the College has already adopted much of the workalready done in other jurisdictions- such as Alberta and the UK where pharmacists arealready prescribing to various degrees. An excellent referral tree has been developedin the UK for triage of minor ailments and the College expects to build on the excellentwork already done to date.OTHER JURISDICTIONS33. Describe any obligations or agreements on trade and mobility that may beaffected by the proposed changes for the profession. What are your plansto address any trade/mobility issues?The change in scope of practice will bring Ontario in line with pharmacy practice inother provinces. The legal acknowledgement and recognition of the pharmacists role inmedication therapy management is in keeping with what pharmacists across Canadaare already doing in many instances and working towards in others. As all pharmacistsare able to do all of the proposed actions, it is not expected that the proposed scope ofpractice change will in any way affect the mutual recognition agreement for Pharmacyin Canada.57

34. (a) What is the experience in other Canadian jurisdictions?The scope of practice of pharmacy varies significantly among the provinces, reflectingthe differences in health professional legislation, i.e. exclusive scope of practice vs.controlled acts. At minimum, it includes compounding, preparing, dispensing, andselling drugs. Activities that may be controlled or restricted in one jurisdiction may notbe addressed in others. For example, diagnosis is not a restricted activity in Alberta. Insome provinces, the practice of pharmacy is defined or described outside of the mainAct governing pharmacy. Tables 1 and 2 summarize decision-making authorityregarding prescriptions and Table 3, other aspects of the scope of practice, excludingcompounding, preparing, dispensing, and selling drugs.There are various definitions or interpretations of the term prescribe. Some provinceslimit its use to ordering prescription status drugs while other provinces considerpharmacists to prescribe if they provide Schedule II and III drugs to a patient without aprescription from a regulated prescriber. There are different interpretations as towhether prescribing activity includes diagnosis or if it can be performed separately fromthe person who makes the diagnosis. For example, in Alberta diagnosis is not arestricted activity. So pharmacists may assess patients when they prescribe for minorailments while they use a diagnosis from a physician or other diagnostician for chronicdiseases and more complex situations. For the purpose of this section, the terminology"decision-making authority regarding prescriptions" will be used.Pharmacists Prescribing / Decision-Making Authority Regarding Prescriptionsin CanadaPharmacists have been dependently making decisions regarding prescriptions in Canadafor decades, especially those pharmacists in institutional practice where they haveworked under delegation and protocols to therapeutically substitute and change dosesand drugs according to patient’s responses and laboratory and other diagnostic testresults.The Controlled Drugs and Substances Act restricts the prescribing of specified drugs(e.g. narcotics, controlled drugs, barbiturates, anabolic steroids, benzodiazepines) tophysicians, dentists and veterinarians. 1, 2,3 This federal Act takes precedence overprovincial legislation.Legislatively, in the community, pharmacy prescribing began with emergencycontraceptives. British Columbia, Quebec and Saskatchewan enacted legislativechanges in 2000, 2001 and 2003, respectively. 4 Manitoba implemented continued careprescriptions in July 2002. Alberta pharmacists started independently prescribing inApril 2007. 51 The Controlled Drugs and Substances Act permits the development of regulations to recognizeother prescribers. The New Classes of Practitioners Regulation has been developed to permitmidwives, nurse practitioners, and doctors of podiatric medicine as practitioners under this Act, ifthey are recognized as prescribers under provincial legislation.2 Podiatrists with prescribing authority under provincial legislation can prescribe benzodiazepines.3 Some products with small amounts of codeine per dose are exempted and can be sold without aprescription. Some provinces have included these products for pharmacist prescribing, primarilyto facilitate reimbursement from third party payors.4 In May 2008, Plan B for emergency contraception was changed to a Schedule III drug.5 Yuksel N, Eberhart G, Bungard TJ. Prescribing by pharmacists in Alberta. Am J Health-SystemPharm. 2008;65:2126-32.58

In all provinces, pharmacists must limit their prescribing to areas in which they arecompetent, must have enough information about the patient, and must communicate tophysicians and other health professionals their prescribing decision within a timelymanner. Pharmacists are not obliged to prescribe, they have the choice to do so,depending on the circumstances.As shown in Tables 1 and 2, all provinces have, or are pursuing, decision-makingauthority regarding prescriptions for pharmacists. All provinces have, or are pursuingrenewals or continuity of care. Most provinces are pursuing dependent authority, inwhich delegation or collaboration is required from a physician or another authorizedprescriber. The information was obtained from a survey of provincial regulatory bodiesin June 2008, and updated in November 2008. The regulatory bodies were asked if theyhad plans to pursue other types of prescribing and controlled acts. Their responses areas follows:BC:pharmacist initiated prescriptions under parameters similar to Alberta's existingframework; injecting vaccinesAB: will work with other provincial regulatory bodies to seek changes to federallegislation that will permit pharmacists to prescribe narcotics and controlledsubstances. A precursor to such discussion will be to define the necessaryaccountability and security measures as they relate to the pharmacists role inprescribing and dispensing.• Will pursue ordering of laboratory tests; however this should not require achange in legislation.NB:will pursue some program type initiatives such as smoking cessation and someadditional prescribing authority similar to Alberta.NS: are currently working with the College of Physicians and Surgeons onAgreements that would allow pharmacists to adjust doses of various types ofdrugs based upon point-of-care test results (e.g. warfarin based upon INRs,insulin based upon glucose and certain medications based upon creatininelevels).• will pursue administering vaccines and emergency prescribing.59

Table 1: Summary of Pharmacist Prescribing / Decision-Making AuthorityRegarding Prescriptions in CanadaProvBCABSKMBONSummaryIn 2000, legislation permitted pharmacists to prescribe emergency contraception.Effective January 1, 2009, pharmacists will be able to adapt existing prescriptions tooptimize the therapeutic outcome of treatment for patient (e.g., changing dose,formulation or regimen of a new prescription; renewal of a prescription for continuityof care, including an emergency supply; making a therapeutic drug substitutionwithin the same therapeutic class for a new prescription). The pharmacist is requiredto address seven fundamental elements.In April 2007, pharmacists could independently prescribe Schedule 1 drugs. Allpharmacists can adapt existing prescriptions and prescribe in emergency situations,when immediate treatment is required, but another prescriber is not accessible.Adapting a prescription includes changing the formulation, dosage, regimen;therapeutic substitutions; and providing extensions of the prescription. About 7,000prescriptions are written monthly by pharmacists for beneficiaries of the governmentdrug programs, representing about 0.6% of the prescriptions. These were primarilyfor chronic diseases, e.g. thyroid, statins, insulins, oral diabetic therapies,antihypertensives, anticoagulants, and asthma drugs. 6 Pharmacists who have beenevaluated and granted additional prescribing authorization may initiate, modify, andmanage drug therapy for acute and chronic conditions. As of October 2008, 30pharmacists have been granted additional prescribing authorization. Applications arereceived and reviewed on a monthly basis by the Alberta College of Pharmacists.A policy statement and supporting guidelines are under development to establish theregulatory framework that would permit pharmacist prescribing interdependently.This involves mutual recognition of competencies by the health care team but is notsynonymous with delegation or transfer of function. The proposed implementation isearly 2009.In July 2002, Manitoba implemented continued care prescriptions. The newPharmaceutical Act was passed in December 2006, but will not be proclaimed untilregulations are developed, approved by pharmacists and government. The Act allowspharmacists to prescribe and administer drugs, order tests and interpret patientadministered automated tests. Prescribing authority in the draft regulations allowsfor adapting prescriptions, continued care prescriptions, prescribing for third partycoverage and in declared emergencies. Other activities, like dosage adjustments, willbe permitted through Council approved practice directions. Pharmacists withExtended Practice qualifications would have enhanced prescribing authority withintheir scope of practice.Pharmacists may perform certain authorized acts through the use of delegation ormedical directives, permitted under the Regulated Health Professions Act, and underprofessional judgment.6 Bacovsky RA. Prescribing Pharmacists in Alberta: Understanding the Conditions and Implicationsof Their Expanded Role in Drug Therapy. IMS Health Canada White Paper. November 2007.60

Prov SummaryQC In 2001, pharmacists could independently prescribe emergency contraceptives.The Pharmacy Act allows pharmacists to initiate or adjust medication therapy,according to direction/prescription from a physician, making use, where applicable,of appropriate laboratory analyses. For example, a physician may write aprescription to allow one or many pharmacists to initiate a medication therapy, or toadjust a medication therapy, to an individual patient, or a group of patients. Whenthe prescription targets only one patient, it is referred to as an individualprescription; when it targets a group of patients and/or pharmacists, it is referred toas a collective prescription.NB Pharmacists can renew an existing prescription for 30 days (except fornarcotic/controlled substances). Effective October 30, 2008, pharmacists can adaptprescriptions and prescribe in emergencies.NS Pharmacists can extend prescription for up to 30 days (continued care). Regulationsare being developed for medication management activities, including therapeuticsubstitution and to prescribe in an emergency.PE On May 22, 2008, the Pharmacy Act was amended to change the definition of“practise of pharmacy” to include the prescription of drugs. Regulations to furtherdefine scope of prescribing activities are expected to be available by the end of2008.NL Parameters around “continuing care” prescriptions (similar to that NB and NS) havebeen agreed to in principle by representatives of the NL Pharmacy Board, College ofPhysicians and Surgeons, Medical Association and Association of RegisteredNurses. Discussions are underway on how to implement (e.g., may be through achange in the Pharmacy Act, a change in Regulations, or agreed upon protocol).Sources: Canadian Pharmacists Association. Summary: Provincial Pharmacy Statusregarding Pharmacist Prescribing Authority. May 2008.Responses from pharmacy regulatory bodies. November 2008.61

Table 2: Pharmacist Decision-Making Authority Regarding Prescriptions inCanadaBC*AB* SK* MB* ON*C ON *P QC* NB NS*PE*NL*Adapting a prescription written by a prescriber-- altering the formulation I I P-D P PJ P-I D I P No P-- altering the dosage / I I* P-D-R P PJ/D P-I D I P No Pregimen-- therapeutic substitution I I P-D-R P-D-R D* D* D I P* No No-- continuing therapyI I P-D PJ PJ P-I D I I P Pinterim supply-- continuing therapymaintenanceI I * P-D P-D D P-I D I I* P PPharmacist initiates prescription (Schedule I drugs; excluding narcotics and controlled drugs)-- drugs in emergency I I P-D PJ No No I - I P P PsituationsI -EC P-IEC-- minor ailments No I-R P-D P-I-R No No D No No No No-- drugs for lifestyle / No I-R P-D-R P-I-R No No D No No No Nohealth promotion-- chronic diseases /conditionsNo I-R P-D P-I-R D D D No No No NoPharmacist prescription for Schedule II/III drugs recognized for reimbursement#Extends existingI I P-D P No P-I D I I P PprescriptionInitiates prescription No I P-D P No P-I D I I P NoNote: For Ontario, the current status (ON C) and the proposed scope (ON P) areprovided* See additional information section for each province/territory (starts on followingpage)# Public and private sector drug plans decide what they will reimburse for theirbeneficiaries, including the drug products and what type of prescriber has written theprescriptionsD: Pharmacists can dependently make decisions regarding prescriptions, i.e. authoritydelegated from physician or other independent prescriber or authority from agreementbetween pharmacy and regulatory body for physicians or other independent prescribersEC Emergency contraceptionI: Pharmacists can independently make decisions regarding prescriptionsI-R: Independent prescribing restricted to designated pharmacists (e.g. Alberta model)No No activity permitted or proposedP: Proposed: regulations / standards / policies under developmentP-D: Proposed: regulations / standards / policies under development for pharmacists todependently make decisions regarding prescriptionsP-D-R: Proposed: regulations / standards / policies under development for certain pharmacists todependently make decisions regarding prescriptions (i.e. activity restricted to designatedpharmacists or to certain directives)P-I-R: Proposed: regulations / standards / policies under development for certain pharmacists toindependently make decisions regarding prescriptions; activity will be restricted todesignated pharmacistsPJ: Permitted under professional judgment62

Additional InformationBC: Implementation January 1, 2009AB:SK:MB:ON:Pharmacists approved by the Alberta College of Pharmacists have additionalprescribing authorization. Unless a pharmacist has additional prescribingauthorization, the pharmacist can only alter a dosage for a new prescription, nota renewed prescription, and the adjustment must be needed because of thepatient's age, weight, or organ function or that the prescribed dosage is notcommercially available. A pharmacist with additional prescribing authorizationcan provide ongoing continuing maintenance therapy, while the regularpharmacist can only provide interim supplies or a refill based on thecircumstances.Proposed implementation early 2009. The Saskatchewan College of Pharmacistssupports interdependent pharmacist prescribing in collaborative practiceenvironments. Interdependent prescribing is a working relationship betweenanother prescriber and a pharmacist where each professional relies upon oneanother's skills to manage the pharmacotherapy needs of their patients in acollaborative environment. All prescribing decisions performed by the pharmacistare communicated to the other prescriber. For the provincial comparison chart,the response has been categorized as “dependant”, because it depends uponmutual recognition. This should not be interpreted in any way as beingsynonymous with delegation, or transfer of function, or other related process.The Saskatchewan College of Pharmacists supports pharmacistsprescribing under two levels of authority: 7Level 1 - recognizes the basic level of knowledge, skills and training that allpharmacists have; additional training is not required; and includes:a. continuing therapy - interim supplies and maintenance therapyb. drugs in emergency circumstances (previously prescribed medication)c. incomplete or inaccurate prescriptionsd. refills of medications during physician absence (with limitations)e. medications for self caref. exempted codeine productsg. non-prescription drugs (to obtain third party coverage)h. seamless care.Level 2 - pharmacists with advanced training and credentials; includes:a. provision of oral contraception and lifestyle and health promotionb. collaborative prescribing agreements, therapeutic substitution, andaltering dosage and/or dosage regimen.The Pharmaceutical Act was passed on December 4, 2006, permittingpharmacists to prescribe certain drugs and to order diagnostic tests. Regulationsare being developed.Ontario permits pharmacists to make decisions regarding a prescription under amedical directive by physicians to pharmacists within a collaborative practicemodel. The model templates are at www.medicaldirectives-delegation.com.• Pharmacists in institutions can therapeutically substitute drugs in accordancewith hospital / facility policies7 Saskatchewan College of Pharmacists. Position Statement on Enhanced Authority for thePharmacist to Prescribe Drugs in Collaborative Practice Environments. September 2008.www.napra.ca/pdfs/provinces/sk/Pharmacist_Prescribing_Final_Sept08.pdf.63

QC:Other than emergency contraceptives, all other activities related to prescribinginvolve action related to an individual or collective prescription. The word“prescription” in this context, means a direction given to a professional by aphysician, a dentist or another professional authorized by law, specifying themedications, treatments, examinations or other forms of care to be provided toa person or a group of persons, the circumstances in which they may beprovided and the possible contraindications. In practice, a prescription of thistype:- Can be written by a single physician or a group of physicians;- May target one patient or a group of patients;- May target one or a number of professionals, from one or more than onegroup of professionals- May target or a number or clinical situationsThe terms individual or collective prescriptions refer to the following:• if a prescription is written by one physician, targets one patient, and will onlybe entrusted to one pharmacist, it is an individual prescription.• if a prescription is written by a number of physicians and/or targets a groupof patients and/or targets more than one professional, it is deemed acollective prescriptionThe collective prescription contains information on:• A name or title: ex. collective script for the adjustment of warfarintherapy;• The professional (s) targeted, for example: pharmacists practising in thecity of X ;• The group of patients targeted , for example: patients under treatmentfor atrial fibrillation with warfarin and under the care of doctors at theheart clinic of x hospital;• The circumstances under which the use of this prescription is allowed forthe targeted professionals ( could be a duration of use before a visit tothe physician);• The circumstances under which the use of this prescription would not beallowed (contra-indications related to other diseases, age, etc…);• A description of what the targeted professional is expected to do inaccordance with the collective script;• Treatment guidelines (medication adjustment for example) whenappropriate;• Communications guidelines between the prescriber and the targetedprofessionals.NS:Continuing care prescriptions are permitted through an agreement between theNS College of Pharmacists and the College of Physicians and Surgeons of NS. Itauthorizes pharmacists to prescribe continued therapy independently from theoriginal prescriber. The pharmacist’s name goes on the prescription and label asthe prescriber and the pharmacist is 100% accountable for the extension oftherapy. Regulations are being prepared to authorize medication managementactivities, including therapeutic substitution.• Pharmacists in institutions can therapeutically substitute drugs in accordancewith hospital / facility policies.64

Table 3: Provincial Comparison of Scopes of Practice for Pharmacy(Excluding compounding, preparing, dispensing and selling drugs;decision-making authority regarding prescriptions described in Table 1)Activity BC AB SK MB ON QC NB NS PE NLDiagnosing / communicating a No NA No No No No No No No NodiagnosisAdministering a substance/drug by No Yes No Yes P No Yes P NC NCinjectionR* RAdministering a substance/drug by Yes Yes No P P No Yes NC NC NCinhalationPerforming a procedure on tissue No Yes Yes P P Yes Yes NC NC NCbelow the dermis (e.g. pricking theskin)**Ordering a laboratory or diagnostic Yes Yes No P-D P Yes Yes NC NC NCtest**Interpreting a laboratory ordiagnostic testYes Yes Yes*P-D P Yes*Yes NC NC NCUsing or interpreting point-of-caremonitoring / testing devices orself-monitoring devicesUsing or interpreting screeningtestsYes*YesYes*P P Yes*Yes NC NC NCYes Yes Yes P-D P Yes Yes NC NC NC**NS does not have health profession legislation that defines controlled or restricted activities.NL legislation does not specifically address these activities.NA: Not applicableNC: Not a controlled activity. There is no provincial legislative authority, but pharmacists mayperform the activity as part of patient education and/or therapy monitoring, and may be relatedto the environment in which they practice (e.g. interpreting/ordering laboratory or diagnostictests as part of medication management activities in institutional care or collaborative practices)Yes: Pharmacists can perform activityYes-R: Pharmacists can perform activity, but restricted to pharmacists being certifiedNo: Controlled / restricted activity; pharmacists can not perform activityP: Proposed* See additional information belowAdditional Information:BC: When interpreting tests (e.g. screening; laboratory/diagnostic; patient selfmonitoring),a pharmacist cannot convey a diagnosis.AB: Pharmacists must complete a training program that is approved by the council ofthe Alberta College of Pharmacists prior to administering drugs by injection.Pharmacists may inject drugs subcutaneously and intramuscularly. They cannotadminister drugs intravenously or intrathecally.Ordering a laboratory or diagnostic test is not an activity that is regulated inAlberta. Provincial laboratories are accredited by the College of Physicians andSurgeons of Alberta, and laboratories are operated by regional healthauthorities. Now that there is greater experience with pharmacists usinglaboratory information, the Alberta College of Pharmacists is proceeding toaddress the ordering of laboratory information.SK: The "*" activities are limited to the practice of pharmaceutical careQC: Pharmacists can order a laboratory or diagnostic test under an individual orcollective prescription. Pharmacists can interpret tests and use point-of-care orscreening tests within their scope of practice, i.e. when adjusting medicationtherapy but not for diagnosis purposes65

NB:Does not have health profession legislation that defines controlled or restrictedactivities. The Pharmacy Act will allow ordering and interpreting tests andadministration, however, this piece will not be enabled until a later date.66

34(b). What is the experience in other International jurisdictions?The scope of practice of pharmacy varies significantly around the world, reflecting thedifferences in health professional legislation, i.e. exclusive scope of practice vs.controlled acts. At minimum, it includes compounding, preparing, dispensing, andselling drugs. Administering, including injecting drugs may not be restricted activities inmany jurisdictions. The discussion here will focus on prescribing drugs.There are many types of prescribing models for pharmacists internationally. They varyfrom independent models to dependent models based on protocols, adherence toformularies, and collaboration with physicians. Many countries have long permittedpharmacists in institutional settings to prescribe in these dependent models. Manycountries, such as Canada and the United Kingdom, restrict some non-prescriptiondrugs to distribution after consultation with a pharmacist. These are Schedule II drugsin Canada. The United States is currently considering implementing such a schedule.The United Kingdom has recognized both dependent and independent prescribingmodels for pharmacists. Collaborative prescribing models started in the US in the1970s. Most states in the US now recognize collaborative prescribing and permit theirpharmacists to administer drugs and immunizations. These two jurisdictions aredescribed below.United KingdomThe United Kingdom has recognized pharmacists as supplementary (i.e. dependent)prescribers and independent prescribers. The first supplementary pharmacist registeredin 2005. Pharmacists as independent prescribers were recognized in May 2006, with thefirst pharmacist being registered in January 2007. The registration of its pharmacists inthese categories is limited. Of about 40,000 practising pharmacists registered with theRoyal Pharmaceutical Society of Great Britain, but only 1,417 were registeredsupplementary prescribers and 534 were registered independent prescribers. One areathat is increasingly utilizing the expanded scope of pharmacists is in the treatment ofminor ailments.Independent PrescribersWhile a pharmacist independent prescriber can prescribe any medicine (excludingControlled Drugs at present) for any condition, it is not anticipated that pharmacists willbe consulted by and prescribe for all patients who need treatment with medicines.Some pharmacist independent prescribers will have a role in prescribing for patientswho present with minor ailments or a defined range of self-limiting conditions. Otherpharmacist independent prescribers will specialise in the management of patients withidentified clinical conditions. As independent prescribers they will be able to work asautonomous practitioners making prescribing decisions based on their assessment ofthe patient’s condition and their judgment of the most appropriate medication regime.In addition to the management of the presenting condition, the pharmacist can respondto the signs and symptoms of an additional clinical problem and make a professionaldecision on whether to treat the patient or refer to another practitioner.67

All pharmacist independent prescribers, whether prescribing for self-limiting conditionsor managing a specified disease, will be providing a professional service that is withintheir professional competence and agreed with a health organisation that hasresponsibility for the health services provided to the patient. In return the healthservice organisation will provide the funding for the service. It is the arrangement withthe health service organisation that defines the scope of the pharmacist’s prescribingpractice.Pharmacist independent prescribing is different from pharmacist supplementaryprescribing in the degree of autonomy and clinical responsibility exercised by thepharmacist in their prescribing practice. If circumstances dictate or if the pharmacistchooses, a pharmacist independent prescriber can work as a supplementary prescriber.Supplementary PrescribersSupplementary prescribing is a voluntary prescribing partnership between a medicalpractitioner (independent prescriber) who establishes the diagnosis and initiatestreatment, a pharmacist (supplementary prescriber) who monitors the patient andprescribes further supplies of medication and the patient who agrees to thesupplementary prescribing arrangement. For each patient, the framework forsupplementary prescribing is set out in an individual clinical management plan whichcontains details of the patient, their condition, treatment with medicines and when thepatient should be referred back to the independent prescriber. Unlike pharmacistindependent prescribing, a supplementary prescriber can only prescribe within thelimitations of the clinical management plan and cannot prescribe for conditions that arenot included in the clinical management plan.A recent review of supplementary prescribing found that pharmacists were positiveabout supplementary prescribing but the medical profession was more critical andlacked awareness/ understanding. Supplementary prescribing was identified in manyclinical settings but implementation barriers included funding problems, delays inpracticing and obtaining prescription pads, encumbering clinical management plans andaccess to records. It was found that the development of independent prescribing andthe apathy of the medical profession represented significant threats to the success ofthis the supplementary prescribing initiative.Use of Pharmacists - Minor Ailments SchemesMinor Ailments Schemes were piloted in the United Kingdom in the early 2000s. Theseminor ailments schemes enable patients who are exempt from prescription charges toreceive treatment for common illnesses free of charge direct from a communitypharmacy. The minor ailments and drug benefits vary with the jurisdiction. Theailments can include acne, allergies, athlete's foot, back pain, bites, burns, colds,simple viral infections (e.g. cold sores), colic, conjunctivitis, constipation, contactdermatitis, cough, cystitis, diaper rash, diarrhea, dyspepsia, earache, ear wax, eczema,fever, hemorrhoids, hayfever, headaches, head lice, indigestion, mouth ulcers, nasalcongestion, oral thrush, scabies, sore throat, strains, teething, threadworms, urinarytract infections. vaginal thrush, and warts. While the products prescribed under thisscheme generally are not prescription-requiring by law, they may require a prescription68

in order for the patient to obtain drug coverage by the NHS. It relieves pressure inprimary care by discouraging patients from seeing physicians for minor ailments. InApril 2006, minor ailments schemes became one of the four core services in thecommunity pharmacy contract, meaning that it would be offered by every communitypharmacy in Scotland. In England, the government recently proposed that minorailments schemes be commissioned from community pharmacies in every primary caretrust.Preliminary data, included in the appendices, demonstrates increased access by thepublic to necessary health services for minor ailments, increased access to physiciansby patients who are more seriously ill, and overall cost savings to the NHS. IMS Healthanalysed anonymized patient records from its database of 210 general practices acrossthe UK, covering four million patient records and 190 million prescriptions. Data from500,000 UK patients who had consulted their GP about a minor ailment suggested that,in 2006–07, 51.4 million GP consultations a year were solely for minor ailments.Estimated at eight minutes per consultation, this represents 18 per cent of GPs’workload or an hour a day for each GP. The total cost to the NHS of these consultationsis £1.8bn and 80 per cent of this (£1.5bn) is attributable to the cost of GPs’ time. Inaddition, 10 minor ailments are responsible for 75 per cent of the cost of minorailments consultations and 85 per cent of the cost of prescriptions for minor ailments.These are:• back pain• indigestion• dermatitis• nasal congestion• constipation• migraine• acne• cough• sprains and strains• headacheTherefore, such a service could help reduce pressures on surgeries and free up time forGPs and their staff to treat people with more complex needs. Analysis so far indicatesthat the cost of medicines supplied by pharmacies for minor ailments may be less thanthe cost of medicines prescribed by GPs, and that introduction of such a scheme canboth meet people’s requirements and be cost-efficient.The Department of Health released a White Paper that describes future NHSpharmaceutical services:• become ‘healthy living’ centres – promoting health and helping more people to takecare of themselves;• offer NHS treatment for many minor ailments (e.g. coughs, colds, stomachproblems) for people who do not need to go to their local GP;• provide specific support for people who are starting out on a new course oftreatment for long term conditions such as high blood pressure or high cholesterol;• offer screening for those at risk of vascular disease;• use new technologies to expand choice and improve care in hospitals and thecommunity, with a greater focus on research; and• be commissioned based on the range and quality of services they deliver.The White Paper outlines roles for pharmacists at three levels:• supported self care – where people monitor their own conditions with periodicsupport and advice;• disease management – supporting people on multiple, complex medicines regimes;and69

• case management – working alongside other primary care providers supporting highrisk patients.United StatesCollaborative prescribing models started in the US in the 1970s. Most states (42 of 50)now recognize collaborative prescribing. Forty-two states do permit their pharmacists toadminister drugs and forty-three permit pharmacists to administer immunizations. Inthe majority of states, many restrictions apply, including training requirements,limitations to practice environment (e.g. hospitals only), restricted to designatedpatient groups, and to designated drugs or vaccines.Table 3: US State Pharmacy Laws on Collaborative Practice and Administering Drugsand ImmunizationsStateChange Drug Therapyunder CollaborativePracticePharmacists MayAdminister DrugsPharmacists MayAdministerImmunizationsAlabama No Yes YesAlaska Yes Yes Yes *Arizona Yes Yes * Yes *Arkansas Yes Yes * Yes *California Yes Yes YesColorado Yes Yes YesConnecticut Yes * Yes * Yes *Delaware No Yes YesD.C. No No NoFlorida Yes * No NoGeorgia Yes Yes YesHawaii Yes Yes * Yes *Idaho Yes Yes YesIllinois No No Yes *Indiana Yes * Yes * Yes *Iowa Yes Yes * Yes *Kansas Yes * Yes * Yes *Kentucky Yes Yes * YesLouisiana Yes Yes YesMaine Yes * No NoMaryland Yes No * Yes *Massachusetts No Yes * Yes *Michigan Yes Yes Yes *Minnesota Yes Yes * Yes *Mississippi Yes Yes YesMissouri Yes Yes YesMontana Yes Yes Yes *Nebraska Yes Yes YesNevada Yes * Yes * YesNew Hampshire Yes * No NoNew Jersey Yes Yes YesNew Mexico Yes * Yes YesNew York No No NoNorth Carolina Yes Yes * YesNorth Dakota Yes Yes Yes *Ohio Yes * Yes * Yes *70

StateChange Drug Therapyunder CollaborativePracticePharmacists MayAdminister DrugsPharmacists MayAdministerImmunizationsOklahoma Yes * Yes Yes *Oregon Yes * Yes * YesPennsylvania Yes * Yes YesRhode Island Yes * Yes Yes *South Carolina No Yes YesSouth Dakota Yes Yes YesTennessee Yes Yes YesTexas Yes Yes * YesUtah Yes Yes * Yes *Vermont Yes Yes YesVirginia Yes Yes * YesWashington Yes Yes Yes *West Virginia No * No Not addressedWisconsin Yes * Yes * Yes *Wyoming Yes Yes * Yes ** Restrictions apply (e.g. special training, certain drugs / vaccines; patient groups)COSTS AND BENEFITS35. What are the potential costs and benefits to the public and the profession ofthe proposed changes? Please consider and describe the economic impact,costs and benefits to:a) patients,b) broader health care service delivery system,c) educational sector,d) regulatory sector, ande) the profession Costs/Benefitsa) Patients,Patients will save time, transportation costs, and time away from work due to fewervisits to the physician or emergency department for refills and the treatment of minorillnesses. They will also benefit from improved medication therapy and better healthoutcomes. The costs to patients and third party payors could decrease, especially whenpharmacists use less expensive drugs as first line therapies. Pharmacists will startproviding and charging for more comprehensive consultations on medication therapymanagement. There may be additional charges to the public for these depending uponwhether the government and private sector drug plans cover these fees.b) broader health care service delivery system,The Ministry of Health and Long Term Care has identified Ontario’s two most importanthealth care priorities over the next four years as reducing wait times with a specialfocus on emergency departments and improving access to quality family health care.The expanded scope of practice for pharmacists is consistent with and complementaryto these priorities. The high number of drug-related visits to emergency departmentscan be reduced through proactive involvement of pharmacists in medication therapymanagement and by managing minor illnesses.71

The health system will be able to more effectively use health care providers andresources and provide residents of Ontario with better access to medication therapymanagement, such as:• provide more flexibility in designing programs to make better use of health careproviders according to their qualifications, skills and training• facilitate the greater use of pharmacists to manage medication therapy inhospitals, long term care facilities, family health teams, primary care,community health centres, home care, outpatient, outreach, and communitybased programs• reduce the workload of physicians, nurses, and other health professionalsworkload related to medication therapy permitting reallocation of their time topatients who require their expertise• improving continuity of care / seamless care as patient moves between healthsectors• facilitate the incorporation of pharmacists into primary care treatment groupsand disease management programsThere also will be increased efficiencies in the health system resulting from pharmacistsparticipating in screening clinics to identify patients with illnesses and conditions andsignificant risk factors.Studies have shown that when pharmacists have a more active role in drug therapy,the health care system saves money. Studies have shown that preventable drugrelatedproblems are a significant expense to the system, financially and in inefficientuse of resources.- Benefits and costs associated with wait times,The potential impact of pharmacists improving access to physicians, nurse practitioners,other health care practitioners, emergency departments, other health services and longterm care beds has been discussed in Question 25. This has been shown in theliterature to result from their proactive role in medication therapy management andpreventing preventable drug-related problems.c) educational sector,Plans are already underway to implement enhanced education and training within thepharmacy curricula both at the University of Toronto and the University of Waterloo.Their cost implications are expected to relate to the enhanced experiential training builtinto the curricula and the benefits will lie in the graduation of pharmacists withenhanced training prepared to take on even more of an expanded role in pharmacyincluding, but not limited to, initiating certain therapies.d) regulatory sectorThere are no substantial costs estimated for regulatory sector involvement. The Collegeexpects its regular reviews of existing standards of practice, continuing competencyprocesses, and routine pharmacy inspections will give rise to a number of changesnecessary to reflect and accommodate this new scope of practice. Costs associated withthe development of new processes will ultimately benefit the public, other professionsand pharmacists by facilitation of models of inter-professional collaboration and care.72

ADDITIONAL INFORMATION36. Is there any other relevant information that HPRAC should consider whenreviewing your submission?The fact that the current legislation restricts certain acts only to certain professions wasnot an issue twenty years ago but, today, this limits pharmacists from fully realizingtheir role in medication therapy management. The reality of pharmacy practice today isthat some of the controlled acts not previously authorized to pharmacists are nowincorporated into the day-to-day practice of pharmacists in both hospital andcommunity practice settings. The need to teach patients how to self-administer drugsthrough inhalation and injection and to self-monitor their diseases with devices thatanalyze small amounts of blood obtained through the use of lancets is a commonlyaccepted practice standard for pharmacy practice across Canada. Pharmacists have theeducation and training to do this. The need for pharmacists to adapt prescriptions byproviding interim supplies and refills, to change dosage formulations to facilitatecompliance, or to change the dosage strength or formulation to a product commerciallyavailable has increased in tandem with the public’s increasing difficulty in accessing afamily physician for routine appointments or to seek authorization for the prescriptionrefill or change. Permitting pharmacists to practice within clear legislative authorityrather than relying on S.29(1) of the RHPA and professional judgment more clearlyestablishes the pharmacist’s direct accountability for his / her safe practice. It alsoclarifies the pharmacist’s direct accountability to members of the public and to otherhealth professionals.Pharmacists routinely assess patients who come to them in community pharmacies forhealth advice for minor ailments. Pharmacists recommend medication and nonmedicationtherapy. If the optimal therapy is a Schedule II or III drug, and is a benefitunder the patient's drug plan, the patient must then see an authorized prescriber for aprescription. This also pertains to a patient requiring further supplies of a Schedule II orIII drug that the patient has received previously under a prescription from anauthorized prescriber. Private and public sector drug plans decide which drugs arebenefits. These third party payors also can determine the types of practitioners (e.g.physicians, dentists, nurse practitioners, midwives) that they will accept as prescribersfor prescriptions they will reimburse. In Alberta, when pharmacists gained prescribingauthority, all drug plans recognized prescriptions written by pharmacists forreimbursement, including prescriptions for Schedule II and III drugs. If changes to thelegislation permitted pharmacists to adapt, modify, and extend prescriptions withoutfurther authorization, it is anticipated that drug plans in Ontario would be consistentwith Alberta in recognizing this dispensing for reimbursement purposes. Hence, thepublic could obtain their medications in a more timely and cost-efficient manner,without further use of the health system by seeing family physicians, using walk-inclinics or emergency departments.Some pharmacists provide controlled acts under medical directives. While concernsrespecting accountability and liability are often barriers, the reality is that when afamily physician retires, dies, or re-locates to another community, pharmacists whohave competently been performing delegated activities as a part of their practice, areleft without the ability to gain an authorization mechanism to provide or continue thecare their patients require, except under professional judgment or Section 29(1) of theRHPA. This is of special concern in isolated and under-serviced areas where there maynot be another health professional to perform the controlled act or delegate to thepharmacist in a timely manner.73

In the institutional sector, the need for all physicians to sign medical directives is alsovery difficult to achieve administratively and in a timely manner. Recognition of thesecontrolled acts for pharmacists would greatly facilitate the integration of pharmacistsinto health care teams, and provide them with the flexibility to address patient needs ina more timely and cost efficient fashion.Changes to the Public Hospitals Act will allow recognition of orders for treatment anddiagnostic tests given by pharmacists, thus facilitating monitoring of therapy andtherapy changes in a more timely manner, as currently a practitioner who is recognizedunder this Act must do the ordering or co-sign the pharmacist's order. Changes to theHealth Insurance Act will permit payment to employers for services provided toinpatients under the pharmacist’s authority and for pharmacists to be included inprograms and services. Changes to the Laboratory Specimen and Collection CentreLicensing Act and its regulations will recognize tests ordered by pharmacists to beprocessed by the laboratories and specimen collection centres (e.g. INR tests foranticoagulation monitoring). This recognition will facilitate pharmacists being able tofunction more fully in medication therapy management and thus facilitating greaterintegration into health care teams.Pharmacists can be reluctant to do more than what is stated in legislation. The publicrelies on pharmacists to provide health information and access to drugs when they cannot access their physician or the health system in a timely manner. This is particularlyimportant in times of emergencies. An analysis of pharmacist practice in Torontoduring the severe acute respiratory syndrome (SARS) outbreak in 2003 and theelectrical system failure in the Eastern Seaboard of North America in August 2004,found that during times of crisis, pharmacies become frontline health care facilities andthere was an increased reliance on pharmacists’ experience, expertise and professionaljudgment. During the SARS outbreak the health care system literally was suspendedfor many patients. During the blackout, pharmacists did not have access to theircomputers and the patient’s medication records. So they often had to dispenseprescriptions without knowing the status of the patient’s prescription (i.e. remainingrefills) or if the patient had a prescription (e.g. urgent need for an inhaler for a personwho appeared to have breathing difficulties due to asthma). They did so by gatheringinformation from the patients or their agents and by applying their knowledge, skillsand judgment in an appropriate way. The researchers found that for many pharmacists,especially younger pharmacists, this created significant coping challenges. Thepharmacists were very concerned about rules and the law and were worried thatperforming acts not traditionally authorized for pharmacy could result in disciplinaryproceedings or prosecution.Consultations and anecdotal reports also reveal that other health professionals are notsure what pharmacists can or can not do and under what circumstances. Manyphysicians and other prescribers are unaware that pharmacists must dispense aprescription as written and must receive authorization from the prescriber for evenminor prescription changes (e.g. substituting tablets or capsules for a patient who hasdifficulty swallowing) or to provide interim supplies for continuity of therapy, when thepatient has difficulty seeing their family physician in a timely manner. Many healthprofessionals think of the stereotype of pharmacists as compounders and dispensers ofmedications rather than as medication therapy experts with extensive training andexpertise. The current scope of practice in the legislation reinforces these limitedperceptions of pharmacists, hence contributing to their underutilization in medicationtherapy management.74

Other Legislation Requiring ChangesManaging medication therapy involves knowing which drugs require monitoring throughlaboratory tests and subsequent dosage adjustment depending on the test results. Inexisting models involving professional collaboration and care, pharmacists orderbloodwork for patients whose medications require ongoing blood monitoring and adjustdosages of chronic medications depending on the results (e.g. INR clinics, renal clinics).The College would strongly support pharmacists in both community and hospitalpractice settings being able to initiate orders for laboratory testing within the ambit ofmedication therapy management and collaborative practice.The Laboratory Specimen and Collection Centre Licensing Act and its regulationsrequire changes to Section 9(1) of Regulation 682 and Sections 2(b) and (5) ofRegulation 683 to include pharmacists as health professionals who can order laboratorytests. These tests would be for the purpose of medication monitoring and management.Regulation 965 of the Public Hospitals Act needs to permit pharmacists variousauthorities with respect to treating inpatients, including the recognition of orders fortreatment or diagnostic tests given by pharmacists.Regulation 522 under the Health Insurance Act needs changes to recognize pharmacistservices to permit payment to employers for services provided to inpatients under thepharmacist’s authority and for pharmacists to be included under other services andprograms. Without this recognition, services and programs funded under the HealthInsurance Act may exclude pharmacists due to payment concerns.Attachment:Health Professions Regulatory Advisory Council Submission - Scope of Practice ofPharmacy – June 19, 2008C:\Documents and Settings\ltodd\hprac-nppquestionnairefinal-OCP response doc Version 8.doc75

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008Page iHealth Professions Regulatory Advisory Council SubmissionScope of Practice of PharmacyIntroduction and Executive Summary“If pharmaceuticals are a key cost driver in the system, isn’t it simply commonsense to make better use of those who are experts in pharmaceuticals? To taptheir knowledge, use their skills and bring their expertise to bear in creating amore rational system of drug therapy? Leaving pharmacists on the sidelines islike having Wayne Gretzky on your team – and benching him. It makes nosense and it must change.”Roy RomanowCanadian Pharmacists Association Conference, May 13, 2002The Ontario College of Pharmacists (the College) as the licensing and regulatory body forPharmacy in Ontario is pleased to respond to the Health Professions Regulatory AdvisoryCouncil (HPRAC)’s Applicant Questionnaire respecting the scope of practice review forPharmacy.Our submission, and the contents therein, support an amended scope of practice statementthat more accurately reflects what pharmacists do today. Within the College, there arecurrently three classes of registrants - registered pharmacy students, interns andpharmacists. All practice within the same scope of practice subject to any terms andconditions placed on the certificates of registration of a respective class. The scope ofpharmacy practice has evolved rather than changed over the past thirty years from aprescription-focused model to a patient-centred pharmaceutical care approach. While in the1960’s pharmacists were prohibited by law from putting the name of the drug on theprescription label and were strongly discouraged from speaking to patients about theirprescriptions, today it is an expected standard of practice that pharmacists provide bothinformation and education to their patients or agents respecting the use of drugs, healthcare aids and devices. While pharmacists were once the only persons in a dispensary able todispense prescriptions, the technical functions of dispensing have gradually been assumedby pharmacy assistant personnel freeing up pharmacists to focus on their areas ofexpertise. With extensive education and training in such areas as medicinal, physical,biological, and pharmaceutical chemistry, anatomy, physiology, biopharmaceutics andpharmacokinetics, therapeutics, pharmacology and pathology, pharmacists have a uniquebody of knowledge and an expertise that no other health professional has respecting drugs,their actions, interactions and effects. While pharmacists continue to oversee and ensurethat safe and effective drug distribution systems are in place, pharmacists today are calledupon to use their expertise to fully realize their roles in medication therapy management.Pharmacists today no longer “count and pour, lick and stick” - they don’t want to, and theydon’t have to. There are pharmacy technicians who will be regulated by 2010 and aretrained to safely and effectively perform the technical aspects of compounding anddispensing drugs. Today this is done under the direct supervision of a pharmacist butregulated technicians will be able to assume certain aspects of dispensing independently. Itis a long standing position of the College that the authorized acts of “selling, compoundingand dispensing a drug” involve both technical and cognitive components, and pharmacistsare expected to competently perform both.Medication therapy management, or “MTM” as it is referred to within North America, is theterm that best describes the cognitive role that pharmacists play before making the decision

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008Page iito dispense a drug and while monitoring ongoing drug therapy. The role reaches far beyonddispensing as pharmacists must first gather information from the patient or agent or theprescriber to determine whether the prescribed drug is appropriate based on the patient’smedication and relevant history. Once a diagnosis has been made, and before a drug isprescribed, pharmacists can play a key role in partnership with physicians and otherprescribers to ensure that the right drug is prescribed or that, where no drug is prescribed,the patient understands why. Many pharmacists promote health and wellness in theirpractice settings by hosting clinics on smoking cessation, flu prevention and infectioncontrol, healthy weight and exercise, and women’s health issues. Monitoring patientcompliance and effectiveness of medication therapy is a key component of medicationtherapy management. All of this should be reflected in the scope of practice.Accordingly, we are proposing that the existing scope of practice for pharmacy simply beamended through the addition of two phrases which we believe more accurately reflectpharmacist practice today. The added phrases are in bold:The practice of pharmacy is the promotion of health, prevention and treatment ofdiseases, dysfunction and disorders through medication and non-medicationtherapy; the monitoring and management of medication therapy; the custody,compounding and the dispensing of drugs; the provision of health care aids and devicesand information related to their use.In day-to-day practice pharmacists are called upon to perform acts that are considered tobe part of two controlled acts “administering a substance by injection or inhalation” and“performing a procedure on a tissue below the dermis” which are not currently authorized tothe profession of pharmacy. Specifically, because pharmacists are expected to provideinformation and education to patients or their agents when providing drugs, health care aidsand devices, pharmacists will:• pierce a patient’s finger with a lancet to obtain blood for the purpose ofdemonstrating the proper use of a glucose monitoring device• administer insulin by injection for demonstration purposes when teaching newdiabetic patients or their agents how to properly do so• administer a substance by inhalation when providing education respecting the properuse of inhalers and inhalant devices.Therefore, the College asks HPRAC to consider recommending that pharmacists have thecontrolled acts of “administering a substance by injection or inhalation” and “performing aprocedure on a tissue below the dermis” subject to certain terms and conditions relating tothe pharmacist’s role in providing information and education to the public. This would allowpharmacists to do what they are trained and expected to do within their scope of practice ina manner that allows clarity and transparency to pharmacists, other health carepractitioners, and the public. Although this section was never intended as a means tocircumvent the controlled acts model, an alternative is to rely on the exemptions providedwithin s.29 (1)(e) of the Regulated Health Professions Act which provides exemption topersons performing “administering a substance by injection or inhalation” if done in thecourse of:(e) assisting a person with his or her routine activities of living and the act is acontrolled act set out in paragraph 5 or 6, subsection 27.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008Page iiiPharmacists are not trying to replace physicians, nurses or any other health careprofessionals. But pharmacists do seek the recognition and authority to fully perform theirrole in medication therapy management. The following is a list of the key activities thatpharmacists are currently autonomously and within their scope of practice, engaged in on adaily basis:• compound, prepare, dispense, and sell drugs• supervise and manage the part of a pharmacy where drugs are kept and other drugdistribution systems to maintain public safety and drug system security• assist and advise patients and other health care providers by contributing uniquedrug and non-drug therapy knowledge on drug and non-drug selection and use,• monitor responses and outcomes to drug therapy and collaborate with physiciansand other health care providers respecting their patient’s care• provide information and education to patients respecting the use, administration oftheir drugs, health care aids and devices• where, in the patient’s best interest, and where, in the professional judgement of thepharmacist, it is appropriate to do so, provide an emergency supply of prescribedmedication(s), injections of flu shots or other vaccinations (i.e. SARS, pandemic)• assess patients seeking advice for minor ailments and recommend appropriatetreatment and follow up• promote health and wellness through advice on smoking cessation, diet and otherlifestyle matters, drug and non-drug therapy, and host, in participation with otherprofessionals, educational and screening clinics• conduct or administer drug and other health-related programs,• conduct or collaborate in drug-related research.The following activities are those that pharmacists do as a daily and routine part of currentpractice but legally only with the express consent of a prescriber, or through the use ofdelegation, medical directives, or professional judgement. As family physicians areincreasingly unavailable for consultation in a timely manner, we are seeking the authorityfor pharmacists to be permitted to do the following without further authorization from aprescriber. Pharmacists will communicate these prescription changes to the familyphysician, nurse practitioner, and other health professionals in a timely manner, in order toensure that other members of the patient's health care team are informed of changes in thepatient's medication therapy. We consider pharmacists to currently possess the knowledge,skills and abilities within their scope of practice to:• dispense a prescription without further authorization from a prescriber under certaincircumstances, including:• adapting an existing prescription to facilitate patient compliance, such aschanging the dosage form (e.g. from a capsule or tablet to an oral liquidformulation for patients who have difficulty swallowing); changing the dosageregimen (e.g. from one tablet twice a day to two tablets once a day to facilitatecompliance); changing the dosage form to one reimbursable by the patient's thirdparty drug benefit plan (e.g. capsule to tablet); and when the prescribed dose ordosage form is not commercially available (e.g. 50 mg only comes in 52.5 mg)• authorizing further extension of a prescription where there are no existing refillsfor continuity of care• providing Schedule II and III drugs as a prescription where required forreimbursement under drug plans• adjusting dosage of medication in response to monitoring (e.g. lab tests).• administer drugs, including through injection and inhalation, for patient education

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008Page ivMany other jurisdictions, across Canada and around the world have taken steps to permitpharmacists to fully engage in the activities required to optimize their roles in medicationtherapy management. In all other provinces, once a diagnosis has been made pharmacistsare or will be permitted to prescribe or adapt prescriptions, and to provide refills ofmedications already prescribed. This College has not pursued the controlled act ofprescribing for pharmacists and within the timeframe allocated for this submission, was notable to undertake the extensive consultation with members and other stakeholders requiredto change this position. Permitting pharmacists to legally dispense a prescription withoutfurther authorization from a prescriber under specific conditions as set out above wouldbring Ontario into line with what prescribing pharmacists are able to do in other Canadianjurisdictions and falls squarely within the pharmacists scope and abilities as experts inmedication management. Without doubt, pharmacists possess the knowledge, skills, abilityand judgement required to safely adapt a dosage form, dosing regimen, or dose strength tofacilitate drug coverage and to authorize prescription extensions for continuing therapy.College Council acknowledged that these activities are called prescribing in otherjurisdictions such as Alberta, Saskatchewan, Manitoba and the Atlantic provinces. TheCollege further acknowledges the need for all stakeholders to clearly understand that thosepharmacists permitted to “prescribe” in other jurisdictions only do so once a diagnosis hasalready been made by another health care professional authorized to diagnose. This Collegeis recommending “dispensing without further authorization from a prescriber subject toterms and conditions” over “prescribing” on the basis that these activities fall within thecognitive aspects of the controlled act of dispensing and are already thus within the realm ofthe pharmacists scope of practice. The College is aware that while the terminology ofprescribing is used in other jurisdictions to describe activities that fall within a pharmacist’sscope, the perception exists amongst the public and other health professions thatprescribing must follow differential diagnosis- an activity that currently does not fall withinthe realm of pharmacy training and practice. Should HPRAC consider that grantingpharmacists in Ontario the ability to adapt or alter a dosage form, dosing regimen or dosestrength and to authorize prescription extensions for continuation of care is moreappropriately done through prescribing than dispensing-subject to the terms and conditionscited above, the Council of the Ontario College of Pharmacists would support such arecommendation as long as it is clear that such activity would occur within the pharmacistsmedication therapy management role and only after a diagnosis has been made. TheCollege supports the legislative and regulatory changes that are necessary to give effect tothese proposals.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 1Health Professions Regulatory Advisory Council SubmissionScope of Practice of PharmacyThe Ontario College of Pharmacists (the College) is pleased to provide the followingresponse to the Health Professions Regulatory Advisory Council (HPRAC)’s “Applicant’sQuestionnaire” respecting the scope of practice review for pharmacists. While we havesummarized the key components of the College’s position in the rather comprehensiveIntroduction and Executive Summary attached to this document, many of the same pointsmay be reiterated in our attempt to fully respond to the questions posed below.Our proposals are intended to:• reflect current practice, education and competencies of pharmacists,• increase patient access to timely health services,• increase efficiencies within the system and enhance cost-effectiveness by decreasingduplication, and• clarify and enhance pharmacist accountability.Profession InformationApplicant’s Questionnaire1) Does your current scope of practice accurately reflect your profession’scurrent activities, functions, roles and responsibilities?No. The scope of pharmacy practice has not changed for many years but what pharmacistsactually do within their scope has evolved. As the technical aspects of the dispensingfunction have been gradually but steadily assumed by pharmacy assistant personnel, andthe education and training of pharmacists have become more extensive, the pharmacist’spractice has evolved from a product-centred model to a patient-centred pharmaceutical caremodel. Currently the scope of practice for pharmacy as set out in S.3 of the Pharmacy Actis:The practice of pharmacy is the custody, compounding and dispensing of drugs, theprovision of non-prescription drugs, health care aids and devices and the provision ofinformation related to drug use.The authorized acts for Pharmacy under S.4 are:In the course of engaging in the practice of pharmacy, a member is authorized, subjectto the terms, conditions and limitations imposed on his or her certificate of registration,to dispense, sell or compound a drug or supervise the part of a pharmacy where drugsare kept.It is our view that the current scope of practice and authorized acts do not adequatelyreflect or accommodate pharmacist practice today which is focused to a lesser degree ondispensing of a drug and to a greater degree on the cognitive aspects of medication therapymanagement. Currently any activities performed by pharmacists outside the existingauthorized acts are performed through the use of delegation or medical directives,professional judgement or under S.29(1) of the Regulated Health Professions Act (RHPA)which provides exceptions to permit persons to perform controlled acts when rendering first

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 2aid or temporary assistance in an emergency S.29(1)(a) and assisting a person with his orher routine activities of living S.29(1)(e). On a daily basis, pharmacists are called upon touse their professional judgement to take action that is in the best interest of the patient. 1Health Promotion and WellnessThe current scope of practice of pharmacy does not acknowledge the pharmacist’s key rolein the promotion of health, prevention and treatment of diseases, dysfunction and disordersthrough medication and non-medication therapy. The public routinely seek out pharmacistsas their primary source of advice and care for numerous minor ailments and becausepharmacists are easily seen without appointments they have long been recognized as themost accessible health care professionals. In 1990, the Lowy Report cited pharmacists asunder-utilized professionals and the advantages of expanding the role of the pharmacist. 2 Incollaboration with nurses and other professionals, pharmacists routinely host screeningclinics, flu shot clinics and educational days on various topics respecting health and wellnesspromotion, such as smoking cessation. Many pharmacists offer screening clinics forcholesterol and diabetes management, and consultation/information services respectinghormone replacement, menopause and aging, and maternal and child health. The Ontariogovernment has been a leader in recognizing and reimbursing pharmacists for their role incolorectal screening and the MedsCheck program.Accessible Health Care ProfessionalsWhile pharmacists are not currently trained in differential diagnoses or formally trained inprescribing, it must be recognized that in the area of minor ailments and non-prescriptionmedications and self-care, pharmacists are both competent and capable in assessing theirpatients and recommending the best options. These recommendations may includemedications, other therapies, lifestyle changes, or a referral to physicians or other healthprofessionals. This constitutes a considerable part of a pharmacist’s daily practice. InEngland, Ireland, Scotland and Wales, the National Health Service (NHS) has implemented,with the support of physicians, pharmacists and the public, the Minor Ailments Schemewhich reimburses pharmacists for their role in first line assessments of a number ofidentified minor ailments. (See Appendix 1.) In certain instances pharmacists may prescribemedications for their patients within the Minor Ailments Scheme. The minor ailments anddrug benefits vary with the jurisdiction. While the products prescribed under this schemegenerally are not prescription-requiring by law, they may require a prescription in order forthe patient to obtain drug coverage by the NHS. Preliminary data, included in theattachments, demonstrates increased access by the public to necessary health services forminor ailments, increased access to physicians by patients who are more seriously ill, andoverall cost savings to the NHS. Implementation of such a scheme in Ontario would morefully utilize the training and expertise of the pharmacist, but could also be expected toincrease the public’s access to health services involving minor ailments and free up familyphysicians to see more seriously ill patients. It could also improve access to walk-in clinicsand emergency rooms as patients also use these services for minor ailments.1 Professional judgement involves four key areas:1. taking actions that are in the best interest of the patient, including the patient having an active rolein the decision-making process as well as understanding all the options and choices that are availableto him/her;2. having knowledge and expertise to make the judgement;3. making decision that pharmacist peers would consider reasonable given the circumstances; and4. documenting all relevant actions including what happened and why, names of the professionals withwhom you conferred and when, and all outcomes.2 Lowy F, Jordan M, Moulton R, et al. Prescriptions for Health: Report of the Pharmaceutical Inquiry ofOntario. Toronto: Ministry of Health. Ontario; 1990.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 3Pharmacists currently host screening and flu shot clinics in their pharmacies and provideinformation on many diseases and health issues. The College does not consider pharmacistswho assess a patient for a minor ailment or condition and then recommend a drug (e.g.Schedule II or III) to be communicating a diagnosis. The College considers that suchactivities fall clearly within the pharmacist’s role and expertise in medication therapymanagement and constitute the cognitive components of dispensing and selling drugs.Patient EducationIt is an expected standard of practice that all pharmacists educate patients or their agentsrespecting prescribed medications and how to use accompanying health care aids anddevices and non-prescription therapies. This frequently entails teaching patients or theiragents how, through demonstration, to administer a drug by injection and inhalation andhow to use self-monitoring devices by using lancets to obtain blood samples. While theseactivities, which we consider fall within the College’s interpretation of the existing scope ofpractice, are currently performed either through delegation/medical directives (which arenot practical in community pharmacy practice) or using the exemption permitted under S.29(1) (a) and (e) of the RHPA, pharmacists are trained to, and routinely do prick the skin todemonstrate the proper use of glucose monitoring devices, administer a substance byinjection when educating patients how to self-inject their insulin, and/or administer asubstance by inhalation when educating a patient or their agent on the properadministration of a drug using an inhalant device. Many pharmacists have sought outtraining on their own, and the two schools of Pharmacy in Ontario will incorporate trainingpharmacy students on administering injections in anticipation of a pandemic.The College strongly supports pharmacists being able to perform certain parts of thesecontrolled acts (administering a substance by injection or inhalation; performing aprocedure on tissue below the dermis…..) subject to terms and conditions limiting theseactivities to the pharmacist’s role in patient education and medication therapy management.Use of Professional JudgementPharmacists routinely are called upon to extend or modify prescriptions, and to refill part ofa prescription without further authorization from a prescriber where prior authorization fromthe patient’s physician in a timely manner is not available or when patients cannot get atimely appointment with their physician. 3 In other jurisdictions, such as the UK, Alberta andNew Brunswick, this is considered to be performing the controlled act of prescribing adrug. Almost daily, pharmacists will be called upon to alter or adapt an existing prescriptionwhere it is clearly in the patient’s interest to do so. For example, switching a dosage form tofacilitate compliance (e.g. providing an oral liquid formulation when a patient cannotswallow the tablets or capsules that have been prescribed); changing the prescribed drug toa strength or dosage form that is commercially available when they cannot get priorauthorization from the original prescriber; authorizing the refilling of part or all of aprescription where patients are unable to see a physician or he/she is not available toprovide approval. This year, the College in collaboration with the College of Physicians andSurgeons of Ontario, the Ontario Medical Association, and the Ontario PharmacistsAssociation agreed to conditions under which a pharmacist may authorize and dispense anextension of a prescription for continuing care when the prescribing physician is unavailable3 The Ontario Health Quality Council reported that only 39 percent of Ontarians who need to see theirdoctor can do so that day or the day after. Ontario Health Quality Council. 2008 Report on Ontario’sHealth System. 2008:www.ohqc.ca.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 4to provide refill authorization. 4 The PAPE (Pharmacist Authorization of PrescriptionExtensions) has been approved by the Councils of these four organizations and a regulatoryamendment to the Drug and Pharmacies Regulation Act, is needed to give effect to thisagreement at the point of care. Currently pharmacists provide limited refill authority fortheir patients in situations where they are called upon to exercise professional judgement.2) If the answer to question #1 is no, then please answer the remainingquestions (only those that apply) as thoroughly as possible:2. Name the profession for which a change in scope of practice is being sought,and the professional Act that would require amendmentProfession: PharmacyProfessional Act: Pharmacy Act 1991 and regulations under the Pharmacy Act (Regulation202/94)Drug and Pharmacies Regulation Act and regulations under the Drug and PharmaciesRegulation Act3. Describe the change in scope of practice being soughtThe College is proposing the existing scope of practice statement be amended through theaddition of two phrases which we consider more accurately reflect pharmacy practice today.The suggested amendment, in bold, for the new scope of practice for pharmacy is:The practice of pharmacy is the promotion of health, prevention andtreatment of diseases, dysfunction and disorders through medication andnon-medication therapy; the monitoring and management of medicationtherapy; the custody, compounding, and the dispensing of drugs; the provision ofhealth care aids and devices and information related to their use.Under this scope, pharmacists:• compound, prepare, dispense, and sell drugs• supervise and manage the part of a pharmacy where drugs are kept and other drugdistribution systems to maintain public safety and drug system security• dispense a prescription without further authorization from a prescriber undercertain circumstances, 5 including:• adapting an existing prescription to facilitate patient compliance, such aschanging the dosage form (e.g. from a capsule or tablet to an oral liquidformulation for patients who have difficulty swallowing); changing thedosage regimen (e.g. from one tablet twice a day to two tablets once aday to facilitate compliance); changing the dosage form to onereimbursable by the patient's third party drug benefit plan (e.g. capsule4 Ontario College of Pharmacists, Ontario Pharmacists Association, Ontario Medical Association, Collegeof Physicians and Surgeons of Ontario. Pharmacist Authorization of Prescription Extensions (PAPE)Agreement. Draft. January 2008. (See Appendix 2E.)5 These activities currently are done through use of delegation, medical directive or professionaljudgement.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 5to tablet); and when the prescribed dose or dosage form is notcommercially available (e.g. 50 mg only comes in 52.5 mg)• authorizing further extension of a prescription where there are noexisting refills for continuity of care• providing Schedule II and III drugs as a prescription where required forreimbursement under drug plans• adjusting dosage of medication in response to monitoring (e.g. lab tests)• assist and advise patients and other health care providers by contributing unique drugand non-drug therapy knowledge on drug and non-drug selection and use,• monitor responses and outcomes to drug therapy and collaborate with physicians andother health care providers respecting their patient’s care• provide information and education to patients respecting the use, administration of theirdrugs, health care aids and devices• administer drugs, including through injection and inhalation for patienteducation• assess patients seeking advice for minor ailments and recommend appropriatetreatment and follow up• promote health and wellness through advice on smoking cessation, diet and otherlifestyle matters, drug and non-drug therapy, and host, in participation with otherprofessionals, educational and screening clinics• provide, dispense and administer drug therapy in an emergency, including administeringdrugs through injection and inhalation• conduct or administer drug and other health-related programs,• conduct or collaborate in drug-related research.The activities included under dispensing without further authorization are a key part of theday-to-day practice of a pharmacist. The College considers that pharmacists possess theknowledge, skills and ability to perform them safely. Pharmacists will communicate theseprescription changes to the family physician, nurse practitioner, and other healthprofessionals in a timely manner, in order to ensure that other members of the patient'shealth care team are informed of changes in the patient's medication therapy. Accordinglywe are seeking the legal authority for pharmacists to be permitted to do these activitieswithout further authorization from a prescriber.4. Name of the College/association/group making the request, or sponsoring theproposal for change, if applicableOntario College of Pharmacists5. Address/website/e-mailAddress: 483 Huron St, Toronto, ON M5R 2R4Website: www.ocpinfo.comE-mail: info@ocpinfo.com6. Telephone and fax numbersTelephone: 416-962-4861; toll free 1-800-220-1921Fax: 416-847-8283

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 67. Contact person (including day telephone numbers)Deanna L Williams, RegistrarOntario College of PharmacistsDirect Telephone: 416-847-8240 1-800-220-1921 ext2408. List other professions, organizations or individuals who could provide relevantinformation applicable to the proposed change in scope of practice of yourprofession. Please provide contact names, addresses and contact numbers wherepossible.PROFESSIONAL REGULATORY BODIES IN ONTARIOKathy Wilkie, RegistrarCollege of Medical Laboratory Technologists of Ontario36 Toronto Street, Suite 950Toronto, ON M5C 2C5Tel: 416-861-9605Email: kwilkie@cmlto.comAnne Coghlan, Executive DirectorCollege of Nurses of Ontario101 Davenport RoadToronto, ON M5R 3P1Tel: 416-928-0900 ext. 7525Email: acoghlan@cnomail.orgRocco Gerace, RegistrarCollege of Physicians & Surgeons of Ontario80 College St.Toronto, ON M5G 2E2Tel: 416-967-2603Email: rgerace@cpso.on.caIrwin Fefergrad, RegistrarRoyal College of Dental Surgeons of Ontario6 Crescent RoadToronto, ON M4W 1T1Tel: 416-961-6555Email ifefergrad@rcdso.orgPROFESSIONAL ASSOCIATIONS IN ONTARIOBen Shenouda, PresidentIndependent Pharmacists Association of Ontario5720 Timberlea Blvd., Suite 201Mississauga, ON L4W4W2Tel: 905-625-1476Email: bens@ipoassociation.com

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 7Pamela Pogue, PresidentNurse Practitioners’ Association of OntarioThe Trillium Health Centre#500 - 90 Burnhamthorpe Rd. WestMississauga ON L5B 3C3Tel: 905-848-7580 ext. 2556Email: ppogue@thc.on.caJan Kasperski, Chief Executive OfficerOntario College of Family Physicians357 Bay Street, Mezzanine LevelToronto, ON M5H 2T7Tel: 416-867-9646Email: jk_ocfp@cfpc.caTom Magyarody, Executive DirectorOntario Dental Association4 New StreetToronto, ON M5R 1P6Tel: 416-922-3900Email: c/o his assistant Fran: fchaschowy@oda.on.caBarb LeBlanc, Executive Director, Health Policy DepartmentOntario Medical Association525 University Ave, Suite 200Toronto, ON M5G 2K7Tel: 416-599-2580Email: barb_leblanc@oma.orgDennis Darby, Chief Executive OfficerOntario Pharmacists' Association375 University Avenue, Suite 800Toronto, ON M5G 2J5Tel: 416-441-0788 ext. 4242E-mail: ddarby@opatoday.comDoris Grinspun, Executive DirectorRegistered Nurses' Association of Ontario158 Pearl St.Toronto ON M5H 1L3Tel: 416-408-5600Email: dgrinspun@rnao.org

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 8EMPLOYER ASSOCIATIONSDean Miller, PresidentOntario Chain Drugstore Associationc/o Director of Pharmacy for OntarioShoppers Drug Mart243 Consumers RdToronto, ON M2J 4W8Tel: 416-493-1220Email: dmiller@shoppersdrugmart.caHeather Stewart, Hospital ConsultantOntario Hospital Association2800 – 200 Front Street WestToronto, ON M5V 3L1Tel: 416-205-1382Email: hstewart@oha.comFACULTIES / SCHOOLS OF PHARMACY IN ONTARIOWayne Hindmarsh, DeanLeslie Dan Faculty of PharmacyUniversity of Toronto144 College StreetToronto, ON M5S 3M2Tel: 416-978-2880Email: wayne.hindmarsh@utoronto.caJake Thiessen, DirectorSchool of PharmacyUniversity of Waterloo200 University Avenue WestWaterloo, ON N2L 3G1Tel: 519-888-4848E-mail: director@pharmacy.uwaterloo.caONTARIO MINISTRY OF HEALTH AND LONG-TERM CAREBrent Fraser, DirectorDrug Program ServicesOntario Ministry of Health and Long-Term CareHepburn Block, 9th Floor80 Grosvenor StreetToronto, ON M7A 1R3Tel : 416-327-8315Email: brent.fraser@ontario.ca

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 9Angie Wong, Senior Manager (Acting)Pharmaceutical Services Coordination UnitOntario Ministry of Health and Long-Term Care3rd Floor - 5700 Yonge StreetToronto, ON M2M 4K5Tel: 416-327-8878Email: angie.wong@ontario.caTim Blakley, Manager (Acting)Legislative and Special Projects UnitOntario Ministry of Health and Long-Term Care12th Floor - 56 Wellesley Street WestToronto, ON M5S 2S3Tel: 416-326-6000Email: Tim.Blakley@ontario.caFrank Schmidt, ManagerHealth Human Resources Program Policy UnitOntario Ministry of Health and Long-Term Care12th Floor - 56 Wellesley Street WestToronto, ON M5S 2S3Tel: 416-326-0224Email: Frank.Schmidt@ontario.caPHARMACIST REGULATORY BODIES IN OTHER PARTS OF CANADAGreg Eberhart, RegistrarAlberta College of Pharmacists1200 - 10303 Jasper AvenueEdmonton, AB T5J 3N6Tel: 780-990-0321E-mail: greg.eberhart@pharmacists.ab.caMarshall Moleschi, RegistrarCollege of Pharmacists of British Columbia200-1765 West 8th AvenueVancouver, BC V6J 5C6Tel: 604-733-2440E-mail: marshall.moleschi@bcpharamcists.orgRon Guse, RegistrarManitoba Pharmaceutical Association187 St. Mary's RoadWinnipeg, MB R2H 1J2Tel: 204-233-1411E-mail: rguse@mpha.mb.caBill Veniot, RegistrarNew Brunswick Pharmaceutical Society373 Urquhart Avenue, Unit BMoncton, NB E1H 2R4Tel: 506-857-8957E-mail: bill.venoit@nbpharmacists.ca

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 10Donald Rowe, Secretary-RegistrarNewfoundland and Labrador Pharmacy BoardApothecary Hall, 488 Water StreetSt. John's, NL A1E 1B3Tel: 709-753-5877E-mail: drowe@nlpb.caJeannette Hall, RegistrarNorthwest Territories Regulatory AuthorityDepartment of Health and Social ServicesGovernment of the Northwest TerritoriesCentre Square Tower, 8th FloorP.O. Box 1320Inuvik, NT X1A 2L9Tel: 867-920-8058E-mail: professional_licensing@gov.nt.ca or jeannette_hall@gov.nt.caSusan Wedlake, RegistrarNova Scotia College of Pharmacists1464 Dresden RowHalifax, NS B3J 3T5Tel: 902-422-8528E-mail: swedlake@nspharmacists.caManon Lambert, Sécretaire géneraleOrdre des pharmaciens du Québec266, rue Notre-Dame Ouest, Bureau 301Montréal, QC H2Y 1T6Tel: 514-284-9588E-mail: mlambert@opq.orgNeila Auld, RegistrarPrince Edward Island Pharmacy Board7-20424 Trans Canada Highway, Box 89Crapaud, PE C0A 1J0Tel: 902-658-2780E-mail: peipharm@pei.aibn.comRay Joubert, RegistrarSaskatchewan College of Pharmacists700 - 4010 Pasqua StreetRegina, SK S4S 7B9Tel: 306-584-2292E-mail: info@saskpharm.ca or ray.joubert@saskpharm.ca

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 11Fiona Charbonneau, RegistrarYukon Consumer ServicesDepartment of Community ServicesGovernment of the YukonP.O. Box 2703, C-5Whitehorse, YT Y1A 2C6Tel: 867-667-5111E-mail: consumer@gov.yk.caPHARMACIST PROFESSIONAL ASSOCIATIONS IN CANADAKeith Stewart, Chief Executive OfficerAlberta Pharmacists' Association1800-10303 Jasper Avenue NWEdmonton, AB T5J 3N6Tel: 780-990-0326E-mail: rxa@rxa.orgLinda Vaillant, Directrice généraleAssociation des pharmaciens des établissements de santé du Québec4050 rue Molson, Bureau 320Montréal, QC H1Y 3N1Tel: 514-286-0776E-mail: info@apesquebec.orgNormand Cadieux, Directeur généralAssociation québécoise des pharmaciens propriétaires4378, avenue Pierre-de-CoubertinMontréal, QC H1V 1A6Tel: 514-254-0676E-mail: pharm@aqpp.qc.caMarnie Mitchell, Chief Executive OfficersBritish Columbia Pharmacy Association1530 - 1200 West 73rd AvenueVancouver, BC V6P 6G5Tel: 604-261-2092E-mail: info@bcpharmacy.caScott Ransome, Executive DirectorManitoba Society of Pharmacists202-90 Garry StreetWinnipeg, MB R3C 4H1Tel: 204-956-6680E-mail: info@msp.mb.caPaul Blanchard, Executive DirectorNew Brunswick Pharmacists' Association Inc.410-212 Queen StreetFredericton, NB E3B 1A8Tel: 506-459-6008E-mail: nbpa@nbnet.nb.ca

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 12George Skinner, Executive DirectorPharmacists' Association of Newfoundland and Labrador702 Water StreetSt. John's, NL A1E 1C1Tel: 709-753-7881E-mail: email@panl.netBrett Filson, Executive DirectorPharmacists' Association of Saskatchewan202 - 2629 29th AvenueRegina, SK S4S 2N9Tel: 306-359-7277E-mail: brett.filson@rbsp.caLarry Shipp, Executive DirectorPharmacy Association of Nova Scotia1470 Dresden RowHalifax, NS B3J 3T5Tel: 902-422-9583E-mail: pans@pans.ns.caLaura Beattie, PresidentPharmacy Society of the YukonPO Box 31828Whitehorse, YTTel: 867-668-3927Erin Farrell MackenziePrince Edward Island Pharmacists Association13 Stratford Road, Box 24042Stratford, PE C1B 2V5Tel: 902-367-7080E-mail: peipharm@hotmail.comNATIONAL PHARMACY ORGANIZATIONSFrank Abbott, Executive DirectorAssociation of Deans of Pharmacy of Canada3919 West 13th AvenueVancouver, BC V6R 2T1Tel: 604-222-0221E-mail: fabbott@telus.netNadine Saby, President & CEOCanadian Association of Chain Drug Stores301 – 45 Sheppard Avenue EastToronto, ON M2N 5W9Tel: 416-226-9100E-mail: nsaby@cacds.com

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 13Tim Fleming, PresidentCanadian Association of Pharmacy TechniciansP.O. Box 1271 Station FToronto, Ontario M4Y 2V8E-mail: prez@capt.caLinda Dresser, PresidentCanadian College of Clinical PharmacyDepartment of PharmacyNorth York General Hospital4001 Leslie StreetToronto, ON M2K 1E1Tel: 416-756-6000 ext 3282E-mail: linda.dresser@utoronto.caDavid Hill, Executive DirectorCanadian Council for Accreditation of Pharmacy Programs200-1765 West 8th AvenueVancouver, BC V6J 5C6Tel: 604-676-4230E-mail: dhillccapp@shaw.caArthur Whetstone, Executive DirectorCanadian Council on Continuing Education in Pharmacy102 - 4010 Pasqua StreetRegina, SK S4S 7B9Tel: 306-545-7790E-mail: info@cccep.caJeff Poston, Executive DirectorCanadian Pharmacists Association1785 Alta Vista DriveOttawa, ON K1G 3Y6Tel: 613-523-7877E-mail: jposton@pharmacists.caBev Berekoff, Administrative OfficerCanadian Society for Pharmaceutical Sciences3126 Dentistry/Pharmacy CentreUniversity of AlbertaEdmonton, AB T6G 2N8Tel: 780-492-0950E-mail: csps@cspscanada.orgSandra Leung, PresidentCanadian Society of Consultant PharmacistsCommunity Care Services, Capital Health406 - 10216 124th StreetEdmonton, AB T5N 4A3Tel: 780-735-3315E-mail: sleung@cha.ab.ca

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 14Myrella Roy, Executive DirectorCanadian Society of Hospital Pharmacists30 Concourse Gate, Unit 3Ottawa, ON K2E 7V7Tel: 613-736-9733E-mail: mroy@cshp.caMarita Tonkin, PresidentOntario BranchCanadian Society of Hospital Pharmacists3 - 30 Concourse GateOttawa, ON K2E 7V7Tel: 905-521-2100 ext. 42569Email: tonkimar@hhsc.caJim Dunsdon, Interim Executive DirectorNational Association of Pharmacy Regulatory Authorities750 - 220 Laurier Avenue WestOttawa, Ontario K1P 5Z9Tel: 613-569-9658E-mail: info@napra.caJohn Pugsley, Registrar-TreasurerThe Pharmacy Examining Board of Canada717 Church StreetToronto, ON M4W 2M4Tel: 416-979-2431E-mail: jpugsley@pebc.caNATIONAL HEALTH PROFESSIONAL ASSOCIATIONSWilliam Tholl, Secretary General, CEOCanadian Medical Association1867 Alta Vista DriveOttawa, ON K1G 3Y6Toll free: 888 855-2555;Tel: 613-731-8610, ext. 2307;Email : (to assistant) chantal.nadeau@cma.caLucille Auffrey, Chief Executive OfficerCanadian Nurses Association50 DrivewayOttawa ON K2P 1E2Telephone: 613-237-2133 or 1-800-361-8404Email: executiveoffice@cna-aiic.ca

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 15PRIVATE SECTOR DRUG PLANSIrene Klatt, President and CEOCanadian Life and Health Insurance AssociationQueen Street East, Suite 1700Toronto, ON M5C 2X9Tel: 416-777-2221E-mail: iklatt@clhla.caPHARMACEUTICAL INDUSTRYRussell Williams, PresidentCanada’s Research-Based Pharmaceutical Companies1220 – 55 Metcalfe StreetOttawa, ON K1P 6L5Tel: 613-236-0455E-mail: rwilliams@canadapharma.orgJim Keon, PresidentCanadian Generic Pharmaceutical Association409-4120 Yonge StreetToronto, ON M2P 2B8Tel: 416-223-2333E-mail: jim@canadiangenerics.caDavid Skinner, PresidentNDMAC406-1111 Prince of Wales DriveOttawa, ON K2C 3T2Tel: 613-723-0777E-mail: david.skinner@ndmac.caINTERNATIONAL PHARMACIST /PHARMACY ORGANIZATIONS:Yves Gariepy, Chair, Administration, Pharmacy SectionInternational Pharmaceutical FederationPO Box 842002508 AE The HagueThe NetherlandsTel: +31-70-302 19 70E-mail: fip@fip.orgJohn Gans, Executive DirectorAmerican Pharmacists Association1100 15th Street NW, Suite 400Washington, DC 20005-1707 USATel: 202-628-4410E-mail: feedback@pharmacist.com

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 16Henri R. ManasseCEO / Executive Vice PresidentAmerican Society of Health-System Pharmacists7272 Wisconsin AvenueBethesda, MD 20814 USATel: 866-279-0681Email: custserv@ashp.orgCarmen Catizone, Executive DirectorNational Association of Boards of Pharmacy1600 Feehanville DriveMount Prospect, IL 60056 USATel: 847-391-4406E-mail: exec-office@nabp.netPeter Wilson, Head of Post Registration DivisionRoyal Pharmaceutical Society of Great Britain1 Lambeth High StreetLondon, England SE1 7JNTel: +44 0207 572 2380E-mail: peter.wilson@rpsgb.orgFOR ASSOCIATIONS9. Names and positions of the directors and officersNot applicable10. Length of time the association has existed as a representative organization forthe professionNot applicable11. List name(s) of any provincial, national or international association(s) for thisprofession with which your association is affiliated or who have an interest in thisapplication. Please provide contact names, addresses and contact numbers wherepossible.Not applicableDETAILS OF THE PROPOSALLegislative Changes12. What are the exact changes that you propose to the profession’s scope ofpractice (scope of practice statement, controlled acts, title protection, harmclause, regulations, exemptions or exceptions that may apply to the profession,standards of practice, guidelines, policies and by-laws developed by the College,other legislation that may apply to the profession, and other relevant matters)?How are these proposed changes related to the profession and its current scope ofpractice?

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 17Scope of PracticeThe proposed change to the Scope of Practice statement for Pharmacy is as follows:S.3 of the Pharmacy Act would read:The practice of pharmacy is the promotion of health, prevention and treatment ofdiseases, dysfunction and disorders through medication and non-medication therapy;the monitoring and management of medication therapy; the custody, compounding,and the dispensing of drugs; the provision of health care aids and devices; andinformation related to their use.Controlled ActsThe proposed change to the Authorized Acts is as follows:S.4 of the Pharmacy Act would read:In the course of engaging in the practice of pharmacy, a member is authorized,subject to the terms, conditions and limitations imposed on his or her certificate ofregistration to dispense, sell or compound a drug; to supervise the part of apharmacy where such drugs are kept; to administer a substance by injection orinhalation and to perform a procedure on tissue below the dermis.Pharmacists perform controlled acts other than dispensing, selling, and compounding drugs,currently through delegation, medical directives, professional judgement or the exceptionsprovided under S29 (1) of the Regulated Health Professions Act. In all other provinces, oncea diagnosis has been made pharmacists are or will be permitted to prescribe or adaptprescriptions, and to provide refills of medications already prescribed. This College has notpursued the controlled act of prescribing for pharmacists and within the timeframe allocatedfor this submission, was not able to undertake the extensive consultation with members andother stakeholders required to change this position. Permitting pharmacists to legallydispense a prescription without further authorization from a prescriber under specificconditions as set out above would bring Ontario into line with what prescribing pharmacistsare able to do in other Canadian jurisdictions and falls squarely within the pharmacistsscope and abilities as experts in medication management. Without doubt, pharmacistspossess the knowledge, skills, ability and judgement required to safely adapt a dosageform, dosing regimen, or dose strength to facilitate drug coverage and to authorizeprescription extensions for continuing therapy. College Council acknowledged that theseactivities are called prescribing in other jurisdictions such as Alberta, Saskatchewan,Manitoba and the Atlantic provinces. The College further acknowledges the need for allstakeholders to clearly understand that those pharmacists permitted to “prescribe” in otherjurisdictions only do so once a diagnosis has already been made by another health careprofessional authorized to diagnose. This College is recommending “dispensing withoutfurther authorization from a prescriber subject to terms and conditions” over “prescribing”on the basis that these activities fall within the cognitive aspects of the controlled act ofdispensing and are already thus within the realm of the pharmacists scope of practice. TheCollege is aware that while the terminology of prescribing is used in other jurisdictions todescribe activities that fall within a pharmacist’s scope, the perception exists amongst thepublic and other health professions that prescribing must follow differential diagnosis- anactivity that currently does not fall within the realm of pharmacy training and practice.Should HPRAC consider that granting pharmacists in Ontario the ability to adapt or alter adosage form, dosing regimen or dose strength and to authorize prescription extensions forcontinuation of care is more appropriately done through prescribing than dispensingsubjectto the terms and conditions cited above, the Council of the Ontario College of

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 18Pharmacists would support such a recommendation as long as it is clear that such activitywould occur within the pharmacists medication therapy management role and only after adiagnosis has been made.We consider most of these activities to fall within a pharmacist’s ability to dispense aprescription without the further authorization of a prescriber under certain circumstances:• adapting an existing prescription to facilitate patient compliance, such as changingthe dosage form (e.g. from a capsule or tablet to an oral liquid formulation forpatients who have difficulty swallowing); changing the dosage regimen (e.g. fromone tablet twice a day to two tablets once a day to facilitate compliance); changingthe dosage form to one reimbursable by the patient's third party drug benefit plan;and when the prescribed dose or dosage form is not commercially available (e.g. 50mg only comes in 52.5 mg)• authorizing further extension of a prescription where there are no existing refills forcontinuity of care• providing Schedule II and III drugs as a prescription where required forreimbursement under drug plans• adjusting dosage of medication in response to monitoring (e.g. lab tests)The College proposes that pharmacists be permitted, in the course of engaging in their roleas provider of information and education to patients in the course of practicing pharmacyto:• Perform a procedure on tissue below the dermis• Administer a substance by injection or inhalationPharmacists when educating patients or their agents to use monitoring devices (e.g. bloodglucose monitoring) often use a lancing device to obtain a small amount of blood from thepatient so that the patient may learn how to use the lancing device and test their blood.This involves the controlled act of performing a procedure on tissue below the dermis.Pharmacists when educating patients or their agents through the actual demonstration oradministration of a drug through injection (e.g. insulin) or through inhalation (e.g. asthmatherapy), perform the controlled act of administering a substance by injection or inhalationPharmacists also administer by injection, flu shots and other vaccines in emergencysituations. Including this controlled act within the scope of practice, would ensurepharmacists would be trained and use the skill routinely, rather than performing it only inemergencies.The College asks HPRAC to consider recommending that pharmacists be granted the abovetwo controlled acts subject to terms, conditions and limitations relating to the pharmacist’srole in providing education to the public. The Council of the College also supports HPRAC toconsider recommending that pharmacists be permitted to dispense without furtherauthorization or prescribe under the conditions identified previously. The Collegerecommends that any terms, conditions and limitations necessary to protect the public beplaced in standards of practice rather than in legislation. We would expect to adopt existingpractice standards developed and in use in other Canadian jurisdictions where pharmacistsare currently able to prescribe and as such are realizing their full role in medicationmanagement therapy. Including such conditions and limitations to the practice standardmeans that a member not practising in accordance with the standard would appropriatelyface a professional misconduct review.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 19Other Legislation Requiring ChangesManaging medication therapy involves knowing which drugs require monitoring throughlaboratory tests and subsequent dosage adjustment depending on the test results. Inexisting models involving professional collaboration and care, pharmacists order bloodworkfor patients whose medications require ongoing blood monitoring and adjust dosages ofchronic medications depending on the results (e.g. INR clinics, renal clinics). The Collegewould strongly support pharmacists in both community and hospital practice settings beingable to initiate orders for laboratory testing within the ambit of medication therapymanagement and collaborative practice.The Laboratory Specimen and Collection Centre Licensing Act and its regulations requirechanges to Section 9(1) of Regulation 682 and Sections 2(b) and (5) of Regulation 683 toinclude pharmacists as health professionals who can order laboratory tests. These testswould be for the purpose of medication monitoring and management.Regulation 965 of the Public Hospitals Act needs to permit pharmacists various authoritieswith respect to treating inpatients, including the recognition of orders for treatment ordiagnostic tests given by pharmacists.Regulation 522 under the Health Insurance Act needs changes to recognize pharmacistservices to permit payment to employers for services provided to inpatients under thepharmacist’s authority and for pharmacists to be included under other services andprograms. Without this recognition, services and programs funded under the HealthInsurance Act may exclude pharmacists due to payment concerns.13. How does current legislation (profession-specific and/or other) prevent orlimit members of the profession from performing to the full extent of the proposedscope of practice?The fact that the current legislation restricts certain acts only to certain professions was notan issue twenty years ago but, today, this limits pharmacists from fully realizing their role inmedication therapy management. The reality of pharmacy practice today is that some of thecontrolled acts not previously authorized to pharmacists are now incorporated into the dayto-daypractice of pharmacists in both hospital and community practice settings. The needto teach patients how to self-administer drugs through inhalation and injection and to selfmonitortheir diseases with devices that analyze small amounts of blood obtained throughthe use of lancets is a commonly accepted practice standard for pharmacy practice acrossCanada. Pharmacists have the education and training to do this. The need for pharmaciststo adapt prescriptions by providing interim supplies and refills, to change dosageformulations to facilitate compliance, or to change the dosage strength or formulation to aproduct commercially available has increased in tandem with the public’s increasingdifficulty in accessing a family physician for routine appointments or to seek authorizationfor the prescription refill or change. Permitting pharmacists to practice within clearlegislative authority rather than relying on S.29(1) of the RHPA and professional judgmentmore clearly establishes the pharmacist’s direct accountability for his / her safe practice. Italso clarifies the pharmacist’s direct accountability to members of the public and to otherhealth professionals.Pharmacists routinely assess patients who come to them in community pharmacies forhealth advice for minor ailments. Pharmacists recommend medication and non-medicationtherapy. If the optimal therapy is a Schedule II or III drug, and is a benefit under the

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 20patient's drug plan, the patient must then see an authorized prescriber for a prescription.This also pertains to a patient requiring further supplies of a Schedule II or III drug that thepatient has received previously under a prescription from an authorized prescriber. Privateand public sector drug plans decide which drugs are benefits. These third party payors alsocan determine the types of practitioners (e.g. physicians, dentists, nurse practitioners,midwives) that they will accept as prescribers for prescriptions they will reimburse. InAlberta, when pharmacists gained prescribing authority, all drug plans recognizedprescriptions written by pharmacists for reimbursement, including prescriptions for ScheduleII and III drugs. If changes to the legislation permitted pharmacists to dispense withoutfurther authorization, it is anticipated that drug plans in Ontario would be consistent withAlberta in recognizing this dispensing for reimbursement purposes. Hence, the public couldobtain their medications in a more timely manner, without further use of the health systemby seeing family physicians, using walk-in clinics or emergency departments.Some pharmacists provide controlled acts under medical directives. While concernsrespecting accountability and liability are often barriers, the reality is that when a familyphysician retires, dies, or re-locates to another community, pharmacists who havecompetently been performing delegated activities as a part of their practice, are left withoutthe ability to gain an authorization mechanism to provide or continue the care their patientsrequire, except under professional judgment or Section 29(1) of the RHPA. This is of specialconcern in isolated and under-serviced areas where there may not be another healthprofessional to perform the controlled act or delegate to the pharmacist in a timely manner.In the institutional sector, the need for all physicians to sign medical directives is also verydifficult to achieve administratively and in a timely manner. Recognition of these controlledacts for pharmacists would greatly facilitate the integration of pharmacists into health careteams, and provide them with the flexibility to address patient needs in a more timelyfashion.Changes to the Public Hospitals Act will allow recognition of orders for treatment anddiagnostic tests given by pharmacists, thus facilitating monitoring of therapy and therapychanges in a more timely manner, as currently a practitioner who is recognized under thisAct must do the ordering or co-sign the pharmacist's order. Changes to the HealthInsurance Act will permit payment to employers for services provided to inpatients underthe pharmacist’s authority and for pharmacists to be included in programs and services.Changes to the Laboratory Specimen and Collection Centre Licensing Act and its regulationswill allow pharmacists to have tests ordered by pharmacists processed by the laboratoriesand specimen collection centres (e.g. INR tests for anticoagulation monitoring). Thisrecognition will facilitate pharmacists being able to function more fully in medication therapymanagement and thus facilitating greater integration into health care teams.Pharmacists can be very reluctant to do more than what is stated in legislation. The publicrelies on pharmacists to provide health information and access to drugs when they can notaccess their physician or the health system in a timely manner. This is particularlyimportant in times of emergencies. An analysis of pharmacist practice in Toronto during thesevere acute respiratory syndrome (SARS) outbreak in 2003 and the electrical systemfailure in the Eastern Seaboard of North America in August 2004, found that during times ofcrisis, pharmacies become frontline health care facilities and there was an increased relianceon pharmacists’ experience, expertise and professional judgment. During the SARSoutbreak the health care system literally was suspended for many patients. During theblackout, pharmacists did not have access to their computers and the patient’s medicationrecords. So they often had to dispense prescriptions without knowing the status of thepatient’s prescription (i.e. remaining refills) or if the patient had a prescription (e.g. urgent

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 21need for an inhaler for a person who appeared to have breathing difficulties due to asthma).They did so by gathering information from the patients or their agents and by applying theirknowledge, skills and judgement in an appropriate way. The researchers found that formany pharmacists, especially younger pharmacists, this created significant copingchallenges. The pharmacists were very concerned about rules and the law and were worriedthat performing acts not traditionally authorized for pharmacy could result in disciplinaryproceedings or prosecution. 6Consultations and anecdotal reports also reveal that other health professionals are not surewhat pharmacists can or can not do and under what circumstances. Many physicians andother prescribers are unaware that pharmacists must dispense a prescription as written andmust receive authorization from the prescriber for even minor prescription changes (e.g.substituting tablets or capsules for a patient who has difficulty swallowing) or to provideinterim supplies for continuity of therapy, when the patient has difficulty seeing their familyphysician in a timely manner. Many health professionals think of the stereotype ofpharmacists as compounders and dispensers of medications rather than as medicationtherapy experts with extensive training and expertise. The current scope of practice in thelegislation reinforces these limited perceptions of pharmacists, hence contributing to theirunderutilization in medication therapy management.Collaboration14. Do members of your profession practice in a collaborative or teamenvironment where a change in scope of practice and the recognition of existing ornew competencies will contribute to multidisciplinary health care delivery? Pleasedescribe any consultation process that has occurred with other professions.Pharmacists work within inter-professional teams, especially in institutional settings and inprimary care teams. 7,8,9,10 In 1996, a joint statement was developed by the CanadianPharmacists Association and the Canadian Medical Association to include the goal of drugtherapy, strategies for collaboration to optimize drug therapy and physicians’ andpharmacists’ responsibilities in drug therapy. The statement recognizes the importance ofpatients, pharmacists and physicians working in close collaboration and partnership toachieve optimal outcomes from drug therapy. 11 In 2003, the Canadian Medical Association,6 Austin Z, Martin JC, Gregory PA. Pharmacy practice in times of civil crisis: The experience of SARSand the blackout in Ontario, Canada. Research in Social & Administrative Pharmacy: 2007. 3(3):320-35.7 Howard M, Trim K, Woodward C, Dolovich L, et al. Collaboration between community pharmacistsand family physicians: lessons learned from the Seniors Medication Assessment Research Trial.Journal of the American Pharmacists Association: 2003;43(5):566-72.8 Dolovich L, Kaczorowski J, Howard M, et al. for the IMPACT team. Cardiovascularoutcomes of a pharmaceutical care program integrated into family practices (abstract). CanJ Clin Pharmacol 2007;14(2):e116.9 Dolovich L, Kaczorowski J, Sellors C, et al. on behalf of the IMPACT team. Integration of apharmaceutical care program into family practices: Drug-therapy problems identified andrecommendations made by participating pharmacists (abstract). Can J Clin Pharmacol2007;14(2):e164.10 Farrell B, Woodend K, Pottie K, et al. Collaborative working relationships between family physiciansand pharmacists: changes over time as pharmacists integrated into family practice. Can J ClinPharmacol 2006; 13(2):e217.11 Canadian Medical Association and the Canadian Pharmacists Association Joint Statement.Approaches to Enhancing the Quality of Drug Therapy. 1996. www.pharmacist.ca.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 22the Canadian Nurses Association and the Canadian Pharmacists Association developed theJoint Statement on Scopes of Practice. 12 The statement states:In order to support interdisciplinary approaches to patient care and good healthoutcomes, physicians, nurses and pharmacists engage in collaborative andcooperative practice with other health care providers who are qualified andappropriately trained and who use, wherever possible, an evidence based approach.Good communication is essential to collaboration and cooperation.In a 2007 survey of Canadian pharmacists, increasing numbers reported that they wouldlike to formally collaborate with physicians, i.e. 81% of Canadian pharmacists, up from 66%in 2005. Twenty-one per cent of Ontario pharmacists reported that they currentlycollaborate. 13 All pharmacists collaborate to various degrees with physicians and otherhealth care providers every day in their routine practice. Ontario respondents to a Canadiansurvey supported the idea of community pharmacists being members of teams. 14 Supportfor this position was slightly higher among respondents who were already members ofteams. Pharmacists on teams were more likely to agree their training and skills weresufficient to participate, and to report good relations with physicians. Pharmacists on teamswere more likely to agree there was more opportunity to meet and get to know other healthdisciplines, and to see teamwork as part of their role. They were also more likely to agreephysicians wanted their input, and less likely to see other disciplines as being too protectiveof their professional turf. Pharmacists on teams did not differ from those not on teams inrating lack of time, bad past experiences with teamwork, financial reimbursement orproximity to other health care workers as barriers to being a member of a community-basedprimary care team. An enhanced scope of pharmacy practice will contribute to interprofessionalhealth care delivery.The College developed with the College of Physicians and Surgeons of Ontario and otherstakeholders authorizing mechanisms based on delegation and medical directives. TheCollege, the Ontario Medical Association, the College of Physicians and Surgeons of Ontario,and the Ontario Pharmacists Association have agreed to conditions under which apharmacist may authorize and dispense an extension of a prescription when the prescribingphysician is unavailable to provide refill authorization. 15 (See Appendix 2E.)A consultation session on the Pharmacists Scope of Practice Review was held on May 9,2008. Representatives from the College of Physicians and Surgeons of Ontario, the Collegeof Nurses of Ontario, the Royal College of Dental Surgeons of Ontario, the Ontario College ofFamily Physicians, the Ontario Dental Association, the Ontario Medical Association, theNurse Practitioners Association and the Registered Nurses Association of Ontario indicatedsupport for the greater use of the expertise of pharmacists in medication management,especially in collaboration with them. There was no consensus on whether pharmacistsshould be recognized for additional controlled acts or if pharmacists should continueperforming the controlled acts under delegation, medical directives, Section 29(1) of theRHPA, and professional judgement.12 Canadian Medical Association, Canadian Nurses Association, Canadian Pharmacists Association.Joint Statement on Scopes of Practice. March 2003. www.cma.ca.13 2007 Trends and Insights, prepared for Rogers Media:www.mckesson.ca/documents/Trends_2007.pdf.14 Dobson RT, Henry CJ, Taylor JG, et al. Interprofessional health care teams: attitudes andenvironmental factors associated with participation by community pharmacists. Journal ofInterprofessional Care. 2006;20(2):119-32.15 Ontario College of Pharmacists, Ontario Pharmacists Association, Ontario Medical Association,College of Physicians and Surgeons of Ontario. Pharmacist Authorization of Prescription Extensions(PAPE) Agreement. Draft. January 2008.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 23The College of Nurses of Ontario (CNO) wrote a letter to provide the College with CNO'sinitial feedback to the May 2008 consultation. 16 Extracts from this letter include:Additional Controlled ActsWe do not believe that the exception provisions listed in section 29 of the RegulatedHealth Professions Act are meant to be used to provide a regulated health professionwith broad and routine access to controlled acts. It is CNO's recommendation thatOCP seek legal access to the controlled acts; this approach is transparent, providesclarity to pharmacists and to other health care practitioners and protects the public -as it facilitates role clarity and OCP's ability to govern its members with respect tothe performance of these acts.Dispensing Without Authorization - Medication Therapy ManagementCNO's interpretation of OCP's proposal is that pharmacists would not be initiatingprescriptions, but they would alter prescriptions initiated by an authorized prescriber.This could include changes as straightforward as substitutions or, under specificcircumstances, authorizing refills or adjusting doses. CNO appreciates that OCPenvisions that these activities would occur within a collaborative context and wouldrequire enhanced communication between the pharmacist and other health careproviders.We understand that there has been some groundwork on the issue of authorizingrefills between the medical and pharmacy communities with the PAPE (PharmacistAuthorization of Prescription Extensions) agreement. We recommend that OCP beginthis dialogue with other prescribers.OCP proposes that pharmacists be authorized to order and receive laboratory tests tomonitor drug therapy and adjust dosages in certain conditions. CNO recommendsthat OCP develop these conditions in consultation with other providers of the healthcare team, specifically prescribers. We would also emphasize that our support iscontingent upon appropriate two-way communication between the pharmacist andother health providers.Overall, we believe that this type of expanded role for pharmacists would work bestin a system that is integrated and would be most appropriate in settings wherepharmacists are directly involved as part of the larger health care team. Thisprovides direct access to the client's health record and the other professionalsinvolved in medication therapy. These types of settings include hospitals, FamilyHealth Teams and Community Health Centres. We view the absence of an integratedelectronic health record as a key barrier to implementing these initiatives in thecommunity (i.e. retail) pharmacy sector.Minor Ailment ManagementCNO understands this to be a role that in many ways pharmacists are already fillingin Ontario. It is CNO's interpretation that the pharmacist in this situation would notbe dispensing prescription drugs, but rather would recommend and dispense eitherschedule II or III drugs.16 Campbell HM, Director, Practice & Policy, Ontario College of Nurses. May 27, 2008. Letter to AnneResnick, Director, Professional Practice, Ontario College of Pharmacists.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 24We are supportive of such an initiative that would make better use of pharmacists'competencies and understand that OCP's position is that this initiative would requirepharmacists to communicate their interventions to the client's physician. CNOrequests that this concept be expanded to require pharmacists to also communicatewith other primary care providers, specifically nurse practitioners. There arecurrently over 700 nurse practitioners providing primary care services to peopleacross the province - and this number is growing. Increasingly, pharmacists aregoing to come across clients who receive their primary health care from a nursepractitioner.Should OCP be proposing that this initiative involve pharmacists dispensingprescription drugs, CNO would interpret the activity as initiating a prescription andwould therefore suggest the need for additional consultation.Public Interest15. Describe how the proposed changes to the scope of practice of the professionare in the public interest. Please consider and describe the influence of any of thefollowing factors:The proposed change in scope of practice will reflect what pharmacists are doing. Permittingpharmacists to do so, in a legislatively recognized manner, will enable all pharmacists tofully realize their role as experts in medication therapy management. No other professionpossesses the unique body of knowledge that pharmacists have or the extensive educationand training respecting drugs and how they work. While all pharmacists possess thenecessary knowledge, skills and ability to work in this expanded role, there are many whoas noted, are reluctant to do anything outside of the current authorized acts, whetherthrough delegation, medical directives, or through the use of professional judgement. Thereis little question that optimizing the role of the pharmacist can help fill the current gaps inour health care system with respect to access. Enabling the pharmacist to be the primarycare provider for minor ailments for example would increase patient access to necessarycare and also help alleviate the burden of family practitioners who cannot nowaccommodate all of the patients seeking consultations for prescription authorizations orcomplaints of a minor nature.The proposed changes to the scope of practice of pharmacy will benefit the public by:• Reducing patient's disruption in drug therapy and improving continuity of patientcare (e.g. extensions for ongoing drug therapy, correction of minor prescriptionproblems)• Improving safety through pharmacist reconciling medication and providing seamlesscare as patients receive care in different health care sectors 17• Optimizing patient health outcomes by pharmacists identifying, resolving, andpreventing actual and potential medication-related problems; initiating or modifyingdrug therapy; and monitoring and evaluating response to drug therapy, in acollaborative framework with physicians and other health care providers, especiallyin collaborative health teams in hospitals, long term care facilities, family healthteams, community health centres, and home care17Nickerson A. MacKinnon NJ. Roberts N. Saulnier L. Drug-therapy problems,inconsistencies and omissions identified during a medication reconciliation and seamlesscare service. Healthcare Quarterly. 8 Spec No:65-72, 2005.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 25• Increasing the public's convenient access to necessary health care services (e.g.family physicians, walk-in clinics, emergency departments) as the pharmacist will bereducing the workload of other health care professionals related to refills, minorailments, and medication therapy management• Increasing the public's access to home care services and long term care facilities aspharmacists will be proactively involved in optimizing medication therapy thusproactively reducing the drug-related problems that often result in the public needinghome care services or being institutionalized• Facilitating the management of chronic and recurrent diseases and conditions• Improving the effectiveness of drug therapy (e.g. improved therapeutic and healthoutcomes) primarily due to improved accessibility to the pharmacist’s expertise• Increasing the public's safety by minimizing risks and reducing drug errors and otherdrug-related problems) due to a more proactive pharmacist role (e.g. helping ensuredrugs prescribed appropriately initially) rather than a reactive role (e.g. resolving thedrug related problem after it has occurred); decreased adverse drug reactions anddrug-drug interactions• Facilitating the education and training of patients to use their drugs properly (e.g.demonstration of injecting and inhaling drugs) and to self-monitor (e.g. bloodglucose monitoring)• Facilitating and supporting patient self-care by assessing symptoms, providing adviceon the management of minor ailments and the use of medications, and referringpatients to other health care providers, where appropriate• Providing education and interventions to prevent disease and disability, therebypromoting healthy lifestyles.• Facilitating the identification of Ontarians with significant risk factors for conditions ordiseases (e.g. through screening clinics, health promotion programs) and thenreferring them to physicians and other health care professionals 18The medical and pharmaceutical literature contains thousands of articles documenting theeffectiveness of pharmacists at optimizing drug therapy, improving health outcomes, anddeveloping innovative and collaborative programs with other health care providers. 19McLean 20 reviewed over 500 articles that demonstrated the pharmacist’s value in achievinghealth outcomes (i.e. better disease control; decreased drug-related problems, includingdecreased adverse drug reactions, decreased administration problems, increasedcompliance, better dosing, decreased inappropriate consumption of drugs; increased qualityof life; decreased use/need of health services, including decreased hospital admissions andlength of stay; decreased mortality); humanistic outcomes (i.e. increased quality of life,increased patient satisfaction) or economic outcomes (i.e. decreased drug costs, decreaseduse of health services; decreased cost of morbidity / complications).18 Tsuyuki RT, Olson KL, Dubyk AM, et al. Effect of community pharmacist intervention on cholesterollevels in patients with high risk of cardiovascular events: The second Study of Cardiovascular RiskIntervention by Pharmacists (SCRIP-plus). Am J Med 2004;116:130-3.19 Bacovsky RA. Pharmacists Prescribing in Alberta: An Examination of the Literature andPharmacist Practices. Prepared for the Alberta College of Pharmacists. June 2003:www.pharmacists.ab.ca.20McLean W. Pharmaceutical care evaluated: the value of your services. Canadian PharmaceuticalJournal 1998;131(4):34-40.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 26a. Gaps in professional servicesStudies have repeatedly shown that Canadians receive less than optimal drug therapy anddisease management, resulting in poor health outcomes and preventable hospitalizations.These may be attributed to poor access to health professionals and may be improved byinterdisciplinary health care teams and closer monitoring of patients, especially those withchronic conditions. Pharmacists, because of their expertise, accessibility, and frequentcontact with patients getting prescriptions dispensed, can facilitate improved patient care.Some of these gaps in service were identified in the report of the Ontario Health QualityCouncil. 21 The Council found in surveys, that 92 percent of people in Ontario said they havea family physician, but only 86 percent of immigrants who have lived here less than fiveyears have a family physician. Only 10 percent of Ontario family physicians are taking newpatients, down from 40 percent seven years ago. Only 39 percent of Ontarians who need tosee their doctor can do so that day or the day after.The Council estimated that about 8,000 lives could be saved annually, and the quality of lifeimproved for many more people, if there was better delivery of regular care and monitoringthat prevents people with chronic disease from becoming more severely ill.The Council also reported that people with coronary artery disease are only getting twothirdsof the right drugs and tests — and women get much less care than men. The Councilfound that three-quarters of patients were recommended aspirin; about two-thirds wererecommended beta-blockers and a similar proportion, statins. In theory, all patients withcoronary artery disease should at least be considered for each of these three treatments.But just one in three is considered for all three drugs.The Council recommended that people get a second opinion on their prescriptions throughthe MedsCheck program in which all Ontarians who take three or more prescriptionmedications for chronic conditions can receive a free one-on-one review of their medicationsfrom a pharmacist, once per year. A follow-up MedsCheck is also covered if the person hasbeen recently discharged from hospital and needs to have medication changes doublechecked.22With the expanded scope of practice, pharmacists will be able to facilitate better medicationtherapy management, including more regular care and monitoring, especially when patientscome to pharmacies to get their refills of chronic medications.b. Epidemiological trends in illness and diseaseCanadians are living longer. One in three people in Ontario has a chronic disease, such asheart disease, emphysema, diabetes and arthritis. Eighty percent of Canadians who are olderthan 65 have some form of chronic disease and of those, about 70 percent suffer two ormore. 23 According to the World Health Organization, an estimated 89 percent of all deathsin Canada are caused by chronic disease. 24 WHO research puts the cost of medical21 Ontario Health Quality Council. 2008 Report on Ontario’s Health System. 2008:www.ohqc.ca.22 Medchecks website: www.medchecks.ca.23 Gilmour H & Park J. Dependency, chronic conditions, and pain in seniors. Health Reports.2005:supplement1:21-31:www.statcan.ca/english/freepub/82-003-SIE/2005000/pdf/82-003-SIE20050007443.pdf.24 World Health Organization. Innovative Care for Chronic Conditions: Building Blocks for Action.Geneva 2002.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 27treatment for chronic diseases, and the lost productivity they cause, at $80 billion annuallyin Canada. 25 The 33% of Canadians with one or more of seven chronic health conditionsuses approximately 51% of general practitioner consultations, 55% of specialistconsultations, 67% of nursing consultations, and 72% of nights spent in a hospital. 26The expanded scope of practice will enable pharmacists to focus on medication therapymanagement for these chronic diseases. 27 , 28 By permitting pharmacists to change dosagesand order laboratory tests, pharmacists can provide anticoagulation services and monitorpatients on drugs such as warfarin. 29,30 Pharmacists will also be involved in more screeningprograms to identify people with increased risk factors to develop chronic diseases and thenprovide information on how to prevent or manage the diseases. The screening programs canalso help detect these diseases sooner, hence facilitating earlier treatment andmanagement, thus improving health outcomes. 31 Pharmacist-directed care has been foundto significantly reduce the risk of all-cause hospitalizations and hospitalizations for heartfailure, but was associated with a non-significant reduction in mortality. Pharmacistcollaborative care resulted in greater reductions in heart failure hospitalization ratescompared to pharmacist-directed care. 32c. Changing public need for services and increased public awareness of availableservicesA study of the supply and utilization of general practitioner and family physician (GP/FP)services in Ontario, found the use of their services, as measured by the per capita visit rate,declined from 1993/94 to 2001/02. 33 Most of this decline was the result of a large drop inutilization among children and young adults. There was a slight shift in care to pediatricians,but this accounted for only 6% of the decrease in GP/FP visits. Visits to the emergencydepartment by children and young adults also fell during the 1990s. It appeared that youngOntarians were simply visiting GP/FPs less. One possibility is that decreased physiciansupply may lead to increased wait times such that an otherwise healthy adult or child with aminor acute self-limiting condition may be less likely to seek care. The proportion of thepopulation with no GP/FP visits in a year rose from 21.4% to 24.6%. One possibleexplanation for this trend is that an increasing number of Ontarians cannot find a familydoctor, but the 2001 Statistics Canada Health Services Access Survey suggests that only25 World Health Organization. Primary Health Care: A Framework for Future Strategic Directions. 2003.26 Health Council of Canada. 2007. Population Patterns of Chronic Health Conditions in Canada: A DataSupplement to Why Health Care Renewal Matters: Learning from Canadians with Chronic HealthConditions. Toronto: Health Council. www.healthcouncilcanada.ca.27 Diamond SA, Chapman KR. The Impact of a nationally coordinated pharmacy-based asthmaeducation intervention. Can Respir J. 2001, Jul-Aug; 8(4):261-5.28 McLean W, Gillis J, Waller R. The BC Community Pharmacy Asthma Study: A study of clinical,economic and holistic outcomes influenced by an asthma care protocol provided by specially trainedcommunity pharmacists in British Columbia. Can Respiratory J. 2003; 10:195-202.29 Bungard TJ, Archer SL, Hamilton P, et al. Bringing the benefits of anticoagulation managementservices to the community. Can Pharm J 2006;139(2):58-64.30 Lalonde L. Martineau J. Blais N. et al. Is long-term pharmacist-managed anticoagulation serviceefficient? A pragmatic randomized controlled trial. Submitted Thrombosis Research(August 2007).31 Chambers LW, Kaczorowski J, Dolovich L. et al. A community-based program for cardiovascularhealth awareness. Canadian Journal of Public Health. 2005;96(4):294-8.32 Koshman SL, Charrois TL, Simpson SH, et al. Pharmacist care of patients with heart failure: asystematic review of randomized trials. Arch Intern Med 2008;168:687-94.33 Chan BTB, Schultz SE. Supply and Utilization of General Practitioner and Family Physician Servicesin Ontario. ICES Investigative Report. Toronto: Institute for Clinical Evaluative Sciences. 2005.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 285.7% of Ontarians report not having a family physician, and only one-half of theseindividuals stated that it was because they could not contact one. One explanation was thatmore patients are engaging in self-care for minor conditions.This study also found that one-third to one-quarter of all GP/FP visits were of probable lowacuity. This indicated opportunities for delegation to other health professionals and toincrease patient education on how to self-manage some of these low acuity conditions. Avery slight decrease in probable low acuity visits was observed, possibility due to patientswho are more knowledgeable than before and thus visit GP/FPs less often for minorcomplaints. Another possibility is that because physician supply is decreasing, such patientsmay elect not to see their physician if there are longer queues.The public is more interested in self-care and taking an active role in the management oftheir health. They actively research through computer websites to find information abouttheir illnesses and treatment options. They question their physicians and other health careprofessionals about their findings.Pharmacists, with their new scope of practice, can help patients by managing their minorailments and help them with self-treatment and increasing self-management of their chronicdiseases.d. Waiting times for health care servicesThe Ontario Health Quality Council reported that only 39 percent of Ontarians who need tosee their doctor can do so that day or the day after. 34 Having pharmacists be able to treatminor ailments, renew prescriptions, and adjust dosages will provide continuing care formany patients until they are able to see their physician.The concern about waiting times in emergency departments have resulted in the Ontariogovernment taking numerous coordinated steps to reduce wait times and improve patientsatisfaction. 35 A major factor causing long emergency room wait times is the high number ofalternate level of care (ALC) patients occupying acute care hospital beds, making it difficultto admit patients from the emergency room to the hospital. More than 18 per cent ofpatients who are currently in a hospital bed in Ontario are in need of an alternate level ofcare. A study at Vancouver General Hospital found that more than 1 in 9 emergencydepartment visits are due to drug-related adverse events. Of these, 68 per cent wereconsidered to be preventable. The most common reasons for drug-related visits wereadverse drug reactions (39.3%), nonadherence (27.9%) and use of the wrong orsuboptimal drug (11.5%). The probability of admission was significantly higher amongpatients who had a drug related visit than among those whose visit was not drug-related.Among those admitted, the median length of stay was longer – 8 v. 5.5 days. The findingssuggested that the highest rate of drug-related visits occurred during the night (midnight to0759h). This may reflect differences in the patient population that visits the emergencydepartment overnight and lack of access to other health care resources at that time ofday. 36 Pharmacists’ interventions can reduce medication errors by 66 per cent in an34 Ontario Health Quality Council. 2008 Report on Ontario’s Health System. 2008:www.ohqc.ca.35 Government of Ontario. News Release. Ontario Tackles ER Waits With $109 Million Investment.May 30, 200836 Zed PJ, Abu-Laban RB, Balen RM, et al. Incidence, severity and preventability of medication-relatedvisits to the emergency department: a prospective study. CMAJ 2008;178 1563-1569.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 29emergency department. 37 With an expanded scope of practice, pharmacists can assist byproactively intervening to facilitate better medication therapy and hence help avoidemergency visits and hospitalizations. There are some pharmacists who work in emergencydepartments, but their potential contributions are not readily recognized by other healthprofessionals. 38Access to other health services, such as long term care beds, also can be facilitated by theexpanded scope of practice of pharmacists. Pharmacists will help improve the healthoutcomes of patients, especially through better medication management of chronicconditions, thus helping maintain Ontario residents in their homes longer.e. Geographic variation in availability and diversity of health care providers acrossthe provinceThe availability of physicians varies greatly across the province, in both primary care andspecialists. A study of physician services in rural and northern Ontario found that there issignificant variation in physicians among rural communities at both the individualcommunity and District Health Council (DHC) area levels. There are also variations inphysician type, number and demographics, with communities in the southern DHC areasshowing increasing turnover, decreasing physician to population ratios and an agingworkforce. 39 International medical graduates (IMGs) are an important source of specialistsin rural areas, but not so for family physicians.There are over 11,000 pharmacists accessible to the public throughout the province,through all hospitals and in 3,600 pharmacies. Pharmacies are located in communities inwhich there is limited access to physicians and other health care services. Thereforepharmacists can increase the public's access to health services by managing minor ailmentsand other medication therapists. This would allow physicians to focus on their diagnosticskills and more complex cases.f. Changing technologyAdvances in drug formulation design have resulted in increasing numbers of drugs beingadministered through injection or inhalation. Advances in parenteral therapy administrationdevices and techniques and changes in health care delivery have resulted in more patientsfinishing their drug therapy infusions at home. The new scope of practice will facilitatepharmacists in educating patients about these therapies and how to administer themproperly.Advances in technology for self-monitoring of diseases and conditions often require smallamounts of blood obtained by using a lancet. In addition to blood glucose monitoring, otherhome devices are being developed, such as INR for patients on warfarin. The new scope ofpractice will facilitate pharmacists in educating patients about using these devicesaccurately.37 Brown JN, Barnes CL, Beasley B, et al. Effect of pharmacists on medication errors in an emergencydepartment. Am J Health Syst Pharm 2008;65(4):330-3.38 Rowland M. A day in the life of an emergency department pharmacist. May 2008.39 Tepper JD, Schultz SE, Rothwell DM, et al. Physician Services in Rural and Northern Ontario. ICESInvestigative Report. Toronto: Institute for Clinical Evaluative Sciences. 2005.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 30Advances in technology allow more types of disease screening in a pharmacy setting (e.g.osteoporosis) thus helping Ontarians detect these diseases earlier, change lifestyles toimprove their health outcomes, and obtain treatment earlier.Biomonitoring and genomic forecasting will help health professionals, including pharmaciststo identify Ontarians at risk for disease and tailor therapies accordingly.Electronic health records, under development in Ontario, will enable pharmacists, especiallythose in community practice, to access health information of their patients and thus providebetter medication management. Pharmacists will be able to order tests to monitor patients’response to medication therapy, and receive the results in a timely manner. Patient portalsto electronic health records will allow patients to see their records and support selfmanagementinitiatives. Electronic health records will also facilitate electronic prescribing,thus improving patient safety by reducing drug errors due to misreading of hand writtenprescriptions.g. Demographic trendsThe population of Ontario is projected to grow by 30 per cent, or 3.8 million, from anestimated 12.69 million on July 1, 2006, to 16.49 million on July 1, 2031. Over this period,net migration is estimated to account for 74 per cent of total population growth, primarilythrough immigration. The median age of Ontario’s population is projected to rise to 43years in 2031 from 38 years in 2006. The median age for women climbs from 39 to 43years, and the median age for men increases from 37 to 42 years. The population age 65and over more than doubles from 1.6 million, or 12.9 per cent of the population, in 2006 to3.5 million, or 21.4 per cent, in 2031. The population aged 75 and over will also more thandouble, increasing from 776,000, or 6.1 per cent of the population, in 2006 to 1.6 million,or 9.7 per cent, in 2031. The growth in seniors’ share of the population will accelerate after2011 as baby boomers begin to turn age 65. The life expectancies at birth for 2031 remainat 82.6 years for males and 85.0 years for females. 40An older population has more chronic health conditions and uses more health services.Pharmacists will be able to provide medication therapy management for these chronicconditions. With pharmacists helping treat minor ailments, the time of physicians can bereallocated to serving this older population.h. Promotion of collaborative scopes of practicePharmacists have always worked in collaboration with other health professionals, in both thecommunity and institutional settings. Pharmacists provide a safety net for the public onmedication issues by providing prescription checks on dosage amounts and choices of drugtherapy. Pharmacists working in hospitals, long term care and other institutional settingswork in collaborative health teams environment where their expertise in medicationmanagement directly impacts on the patients. Pharmacists routinely review the patient’shealth history and medications, access laboratory and other diagnostic information in orderto make recommendations to physicians on the best medication therapy option for thepatient.40 Ontario Ministry of Finance. (2007). Ontario Population Projections Update: 2006-2031. Availableat:http://www.fin.gov.on.ca/english/economy/demographics/projections/2007.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 31Documenting and record keeping are key parts of the pharmacist’s current scope. With theexpanded scope, pharmacists will communicate, in a timely manner, their medicationmanagement activities and other pertinent information to physicians, nurse practitionersand other health care professionals involved with their patients.i. Patient safetyMedications have been a key concern in patient safety, not only from the perspective ofadverse events and interactions with other drugs, but also in accurate communicationamong health professionals about a patient's medication therapy as they receive services indifferent health sectors.In comparing patterns of potentially inappropriate drug therapy prescribing in communitydwellingolder adults and nursing home residents in Ontario in 2001, researchers found thatnursing home residents were close to half as likely to be dispensed a potentiallyinappropriate drug therapy as community-dwelling older adults. Clinical pharmacist services,which are mandated in the nursing home setting, were thought to be responsible for thesedifferences. 41In long term care facilities, research found that the overall rate of adverse drug events was9.8 per 100 resident-months; 42% of these adverse events were preventable. 42 Errorsassociated with preventable events occurred most often at the stages of ordering andmonitoring. Residents taking antipsychotic agents, anticoagulants, diuretics, andantiepileptics were at increased risk of a preventable adverse event.Recognition of the expertise of the pharmacist in medication management and their role inpromoting health, preventing and treating diseases, dysfunctions and disorders introduceslittle or no new risk to patients because, in many cases, pharmacists already perform theseduties. Patient safety will increase as more proactive involvement of pharmacists inmedication therapy management and other medication-related activities have been found toreduce medication-related problems.j. Wellness and health promotionPharmacists are very active in wellness and health promotion. Studies have found thattrained community pharmacists, providing a counselling and record keeping supportprogram for their customers, may have a positive effect on smoking cessation rates. 43Pharmacists have assisted in government-lead initiatives to increase flu immunizations byhosting flu vaccine clinics, to provide education on smoking cessation, 44 and havedistributed testing kits to detect colorectal cancers.41 Lane CJ, Bronskill SE, Sykora K. et al. Potentially inappropriate prescribing in Ontario communitydwellingolder adults and nursing home residents. Journal of the American Geriatrics Society.2004;52(6):861-6.42 Gurwitz J, Field T, Judge J, et al. The incidence of adverse drug events in two largeacademic long-term care facilities. Am J Med 2005;118(3):251-258.43 Sinclair HK, Bond CM, Stead LF. Community pharmacy personnel interventions for smokingcessation. Cochrane Database of Systematic Reviews. 1, 2008.44 Ontario Ministry of Health Promotion. News Release. April 5, 2007. Ontario Pharmacists’ Associationand the Centre for Addiction and Mental Health announce new phase of the STOP Study – offering5,000 Ontarians free medication to quit smoking.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 32Pharmacies often host clinics that involve providing information and may involveconsultation appointments. These clinics may include other health care professionals suchas nurses, dietitians, and personal trainers. 45 Some examples are:• Heart Health -- cholesterol screening / management; lipid panel screen; bloodpressure reading; Framingham Risk Assessment; assessment of currentmedications; body mass index calculation; nutritional assessment; physical activityassessment; discussion about risk factors (modifiable and non-modifiable) andsuggestions to reduce risks; recommendations on pharmacotherapy and lifestylemodifications.• Osteoporosis -- bone density scan; review of risk factors (modifiable and nonmodifiable);customize individual plan for lifestyle (i.e., calcium intake andsuggestion for implementing weight bearing exercises).• Asthma -- puffer instruction; peak flow meter training; recommendations for actionspatient may need to take (i.e., discussing with physician medication changes,identification of potential triggers and how to avoid and decrease the likelihood of anasthma attack)• Diabetes -- blood glucose monitoring; lifestyle assessment; medication assessment.• Men’s Health -- discussion of erectile dysfunction and treatment options• Smoking Cessation -- assessment of smoking habits, lifestyle changes, andtreatment options• Women’s Health -- hormonal replacement therapy counseling; menopausal symptomreduction – lifestyle modifications and natural remedies.• Influenza Vaccination Clinic• Pain Management -- discussion of symptoms and disease state (e.g. arthritis, chronicback pain), assessment of current medications.• Weight Loss and Nutrition Consultations• Anticoagulation Management Clinics• Travel Clinic -- discussion about destination and potential problems; travel safetyprecautions, needed vaccinesThe expanded scope of practice will empower pharmacists to provide more of these wellnessand health promotion initiatives. The public will benefit from more access to these services,including education, being identified earlier with risk factors or the disease or conditionbeing screened, and hence earlier treatment.k. Health human resources issuesThere are shortages of many health professionals, including physicians, nurses, nursepractitioners and pharmacists. Having pharmacists more involved in medication therapymanagement and in treating minor ailments, will relieve the workload of these other healthprofessionals, allowing them to focus on their unique areas of expertise. This will makethem more accessible to the public.In addition, pharmacy technicians will soon be regulated and assuming responsibility for thetechnical elements of dispensing, thereby freeing up the pharmacist to provide more patientfocussed care.45 Pharmacists Association of Alberta. Fact Sheet on Pharmacist Clinical Services. 2003.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 33l. Professional competencies not currently recognizedThe public and other health professionals often do not recognize the many servicespharmacists can provide. Official recognition of these in the expanded scope of practice willfacilitate integration of pharmacists into more programs, services and initiatives.Physicians often think that pharmacists can already adapt prescriptions by changingformulations (e.g. changing tablets/capsules to oral liquid for patients who have difficultiesswallowing; changing the dosage strength / formulation if prescribed one not commerciallyavailable or not covered by patient’s drug plan) and that pharmacists can provide interimsupplies. Physicians become frustrated when contacted by pharmacists to obtainauthorization to do the above. This confusion can delay the patient getting their prescriptionfilled quickly when physicians aren’t able to return, in a timely manner, phone calls frompharmacists requesting prescription changes.The publicity surrounding the expanded scope of practice will help educate the public aboutthe many services they can expect to receive from pharmacists.m. Access to services in remote, rural or under serviced areasThe public can experience difficulty in accessing health services in all areas of the province,including cities. In more remote or rural areas, pharmacies may be readily accessible whilephysicians may only be accessible on certain days. In all circumstances, pharmacistsprovide required services to their patients as necessary, often through delegation andfrequently through the use of their professional judgement.The expanded scope will improve access to the pharmacist services and hence to otherhealth professionals in these areas, who can reallocate their time to patients and morecomplex cases as the pharmacists provide medication therapy management and treat minorailments.16. How would this proposed change in scope of practice affect the public’s accessto health professions of choice?This proposed change in scope of practice will increase the public’s access to the medicationtherapy expertise of pharmacists in institutions and in the community sector. Sincepharmacists will be able to assess and treat more minor illnesses and conditions, providerefills, and provide medication therapy management, other health professions will be moreaccessible.17. How would the proposed change in scope of practice affect current membersof the profession? Of other health professions? Of the public? Describe the effectthe proposed change in scope of practice might have on:a. Practitioner availability;PharmacistsSignificant time is required by pharmacists and technicians to ensure prior authorization isobtained for prescription changes and obtaining refills. Anecdotal reports from Alberta,where pharmacists have been able to independently adapt prescriptions and prescribe inemergencies since April 2007, indicate that their expanded scope of practice has

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 34significantly decreased time involved in trying to contact physicians to change prescriptionsand to obtain refills, thus offsetting the additional time required for increaseddocumentation and communicating prescribing decisions to the patient’s family physicianand other health professionals.The appropriate management of the pharmacist as a high priority health human resource isundergoing significant studies. In 2005, eight leading national pharmacy organizationspartnered together to carry out a human resources study of pharmacists and pharmacytechnicians, now known as Moving Forward: Pharmacy Human Resources for the Future.This study was funded by the Foreign Credential Recognition Program of Human Resourcesand Social Development Canada and managed by the Canadian Pharmacists Association.The multi-pronged research program examined factors contributing to pharmacy humanresources challenges in Canada, and has developed a series of pharmacy human resourcesplanning recommendations to ensure a strong pharmacy workforce prepared to meet thefuture health care needs of Canadians. 46 This initiative complements another collaborativeinitiative known as the Blueprint for Pharmacy. 47 The Blueprint has developed a vision,mission, and strategic action plan for the pharmacy profession in Canada to strengthen itsalignment with the health care needs of Canadians and to respond to the stresses on thehealth care system. It is based on the enhanced roles pharmacists and pharmacytechnicians including drug therapy management, public health outreach, prescribing andmonitoring authority, self-care patient support and dispensing leadership.Hence, pharmacists throughout Canada are working to ensure the availability ofpharmacists for expanded scopes of practice.PhysiciansMany physicians have found the interventions of pharmacists useful and are accustomed toworking with pharmacists, especially in hospitals and long term care facilities. Studies havefound physicians develop a very positive attitude to pharmacist interventions after workingwith pharmacists in primary care models. Physicians will benefit from pharmacists beingintegrated more fully into the health system and as members of collaborative health teams.They will get increased support from pharmacists in helping to manage medication therapyby• improving communication among health care providers• providing information on the review and modification of all medication therapies apatient is taking (prescription, non-prescription, herbals, etc.) for patientsreceiving medication therapy management• improving continuity of care/seamless care as patients move between healthsectors.Physicians' workload will be reduced related to pharmacists• authorizing dosage / formulation changes and refills• treating minor injuries, illnesses, and self-limiting conditions• extending prescriptions• managing of chronic and recurrent diseases and conditions• decreasing interruptions outside of physician regular practice hours, associatedwith requests for authorization of prescriptions.46 Ascentum Inc. Integrated Key Findings from the Moving Forward: Pharmacy Human Resources forthe Future Research Program. Synthesis Report. May 2008. www.pharmacyhr.ca.47 Task Force on a Blueprint for Pharmacy. Blueprint for pharmacy: the vision for pharmacy. Ottawa(ON): Canadian Pharmacists Association; 2008. www.pharmacists.ca.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 35Physicians will also be able to reallocate their time to see new patients and other patientswho require their expertiseNurses / Nurse PractitionersNurses and nurse practitioners also are accustomed to working with pharmacists, especiallyin hospitals and long term care facilities. They rely on the pharmacist's expertise onmedications and medication therapies and will benefit from pharmacists being integratedmore fully into the health system and as members of collaborative health teams. They willget increased support from pharmacists in helping to manage medication therapy by• improving communication among health care providers• providing information on the review and modification of all medication therapies apatient is taking (prescription, non-prescription, herbals, etc.) for patientsreceiving medication therapy management• improving continuity of care / seamless care as patients move between healthsectors.• managing of chronic and recurrent diseases and conditionsOther Health Care ProfessionalsOther health care professionals (e.g. dietitians, physiotherapists, and respiratory therapists)will benefit from greater access to pharmacists as members of inter-professional teams andtheir expertise in medication therapy management.PublicThe public impact and benefits of the expanded scope of practice for pharmacists has beendiscussed in Question 15.b. Education and training programs, including continuing education;The proposed change in scope would have a minimal impact on education and trainingprograms as pharmacists are educated to perform these activities, except for injectingdrugs. Education and training programs will be revised to include the expanded scopes ofpractice. More will be offered on medication therapy management and training in injectingdrugs.In a 2007 survey of Canadian pharmacists, 49% of Ontario pharmacists reported that theywere most likely to provide special pharmaceutical care services, beyond the day-to-daycounseling about prescriptions. This was the highest percentage in Canada. These servicesinclude medication management, drug utilization review, diabetes-related care, and drugtherapy management for seniors, smoking cessation and hypertension management. 48c. Enhancement of quality of services;By allowing pharmacists to manage medication therapies and order laboratory tests, therewill be decreased delays in needed changes to medication dosages and hence better482007 Trends and Insights, prepared for Rogers Media:www.mckesson.ca/documents/Trends_2007.pdf.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 36monitoring. By allowing pharmacists to adapt prescriptions and provide supplies to continuetherapy, delays or disruptions in therapy will be reduced.Proactive involvement of pharmacists will help reduce preventable drug-related problemsand adverse events.d. Costs to patients or clients;Patients will save time, transportation costs, and time away from work due to fewer visits tothe physician or emergency department for refills and the treatment of minor illnesses.They will also benefit from improved medication therapy and better health outcomes.Pharmacists will start providing and charging for more comprehensive consultations onmedication therapy management. There may be additional charges to the public for thesedepending upon whether the government and private sector drug plans cover these fees.e. [Cost Effective] Access to Services;The expanded scope of practice would provide increased access to the pharmacist'sexpertise by the public and to other health care professionals. It would also increase thepublic's access to health and wellness programs and to other health professionals andservices who would have time freed up by pharmacists more integrated into the healthsystem. We believe that using pharmacists to the full extent of their scope of practice,especially in assessing and treating minor ailments can both improve public access tonecessary health care services and decrease overall costs to the health care system.Treatment of Minor AilmentsOne significant area involves the assessment and treatment of minor ailments. As notedearlier, a study of the supply and utilization of GP/FP services in Ontario, found that onethirdto one-quarter of all GP/FP visits were of probable low acuity. 49 The public routinelyseek out pharmacists as their primary source of advice and care for numerous minorailments and because pharmacists are easily seen without appointments they have longbeen recognized as the most accessible health care professionals. Through the expandedscope of practice and government recognition and support, more patients can beencouraged to use their pharmacist as the first line health professional for the assessmentand treatment of minor ailments.Such programs have existed in the United Kingdom since the early 2000s, first as pilots andthen as core services. These minor ailments schemes enable patients who are exempt fromprescription charges to receive treatment for common illnesses free of charge direct from acommunity pharmacy. The minor ailments and drug benefits vary with the jurisdiction. Theailments can include acne, allergies, athlete's foot, back pain, bites, burns, colds, simpleviral infections (e.g. cold sores), colic, conjunctivitis, constipation, contact dermatitis,cough, cystitis, diaper rash, diarrhea, dyspepsia, earache, ear wax, eczema, fever,hemorrhoids, hayfever, headaches, head lice, indigestion, mouth ulcers, nasal congestion,oral thrush, scabies, sore throat, strains, teething, threadworms, urinary tract infections.vaginal thrust, and warts. While the products prescribed under this scheme generally arenot prescription-requiring by law, they may require a prescription in order for the patient toobtain drug coverage by the NHS. It relieves pressure in primary care by discouraging49 Chan BTB, Schultz SE. Supply and Utilization of General Practitioner and Family Physician Servicesin Ontario. ICES Investigative Report. Toronto: Institute for Clinical Evaluative Sciences. 2005.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 37patients from seeing physicians for minor ailments. In April 2006, minor ailments schemesbecame one of the four core services in the community pharmacy contract, meaning that itwould be offered by every community pharmacy in Scotland. 50 In England, the governmentrecently proposed that minor ailments schemes be commissioned from communitypharmacies in every primary care trust. 51 As of March 2007, only 24% of all pharmaciesheld such contracts. (See Appendix 1.)Preliminary data, included in the appendices, demonstrates increased access by the publicto necessary health services for minor ailments, increased access to physicians by patientswho are more seriously ill, and overall cost savings to the NHS. IMS Health analysedanonymized patient records from its database of 210 general practices across the UK,covering four million patient records and 190 million prescriptions. 52 Data from 500,000 UKpatients who had consulted their GP about a minor ailment suggested that, in 2006–07,51.4 million GP consultations a year were solely for minor ailments.Estimated at eight minutes per consultation, this represents 18 per cent of GPs’ workload oran hour a day for each GP. The total cost to the NHS of these consultations is £1.8bn and80 per cent of this (£1.5bn) is attributable to the cost of GPs’ time. In addition, 10 minorailments are responsible for 75 per cent of the cost of minor ailments consultations and 85per cent of the cost of prescriptions for minor ailments. These are:• back pain• indigestion• dermatitis• nasal congestion• constipation• migraine• acne• cough• sprains and strains• headacheA minor ailments program was used by the Canadian Forces. 53 If their members did nothave access to a base pharmacy, the member had to consult a physician to get aprescription to get an over-the-counter drug covered. The pilot project was tested inseveral Canadian locations, including London, Ontario. The Canadian Forces member couldget the over-the-counter drug directly from these pharmacies and the pharmacy would billthe Canadian Forces. The researchers found the provision of these drugs by pharmacists tobe cost-effective and convenient. They found that the members interacted with thepharmacists to obtain optimal treatment of the ailments and that few members requiredfollow-up with a physician to treat the ailments.Implementation of such a scheme in Ontario would more fully utilize the training andexpertise of the pharmacist, but could also be expected to increase the public’s access tohealth services involving minor ailments and free up family physicians to see more seriouslyill patients. The overall costs to the health care system would decrease proportionately with50 Bellingham C. How to manage a minor ailment service. Pharmaceutical Journal 2005;275:694.51 Department of Health. Pharmacy in England: Building on strengths – delivering the future, April2008.52 Moberly, T. Making the case for a pharmacy-based minor ailments scheme for England.Pharmaceutical Journal 2008:280:111.53 Vaillancourt R, Trottier M, Gervais A, et al. Provision of non-prescription medications to CanadianForces members through civilian pharmacies: interim results of a pilot project CanadianPharmaceutical Journal 2002;135(9):36-37.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 38decreased “first line” visits to physician offices, walk-in clinics and emergency rooms forminor ailments.f. Service efficiency;The health system will be able to more effectively use health care providers and resourcesand provide residents of Ontario with better access to medication therapy management,such as:• provide more flexibility in designing programs to make better use of health careproviders according to their qualifications, skills and training• facilitate the greater use of pharmacists to manage medication therapy in hospitals,long term care facilities, family health teams, primary care, community healthcentres, home care, outpatient, outreach, and community based programs• reduce the workload of physicians, nurses, and other health professionals related tomedication therapy permitting reallocation of their time to patients who require theirexpertise• improving continuity of care / seamless care as patient moves between healthsectors• facilitate the incorporation of pharmacists into primary care treatment groups anddisease management programsg. Inter-professional care delivery;Pharmacists work within inter-professional teams, especially in institutional settings and inprimary care teams. 54,55,56,57 The majority of the 150 family health teams in Ontario includepharmacists. In a 2207 survey, increasing numbers of Canadian pharmacists reported thatthey would like to formally collaborate with physicians, i.e. 81% up from 66% in 2005.Twenty-one per cent of Ontario pharmacists reported that they currently collaborate. 5854 Howard M, Trim K, Woodward C, Dolovich L, et al. Collaboration between community pharmacistsand family physicians: lessons learned from the Seniors Medication Assessment Research Trial.Journal of the American Pharmacists Association: 2003;43(5):566-72.55 Dolovich L, Kaczorowski J, Howard M, et al. for the IMPACT team. Cardiovascularoutcomes of a pharmaceutical care program integrated into family practices (abstract). CanJ Clin Pharmacol 2007;14(2):e116.56 Dolovich L, Kaczorowski J, Sellors C, et al. on behalf of the IMPACT team. Integration of apharmaceutical care program into family practices: Drug-therapy problems identified andrecommendations made by participating pharmacists (abstract). Can J Clin Pharmacol2007;14(2):e164.57 Farrell B, Woodend K, Pottie K, et al. Collaborative working relationships between family physiciansand pharmacists: changes over time as pharmacists integrated into family practice. Can J ClinPharmacol 2006; 13(2):e217.58 2007 Trends and Insights, prepared for Rogers Media:www.mckesson.ca/documents/Trends_2007.pdf.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 39h. Economic issues; andTotal drug spending in Canada is estimated to have reached $26.9 billion in 2007. 59 For thelast decade, drugs have represented the second-largest component of health spending,after hospitals. This represents an estimated annual growth rate of 7.2%, an increase ofapproximately $2 billion over 2006. Spending on prescribed drugs continues to grow fasterthan spending on non-prescribed drugs and is estimated to have reached 84% of the totaldrug bill in 2007. Total drug spending in Ontario is estimated to have reached $11.3 billionin 2007. This represents 17.6% of total health expenditure, above the Canadian average of16.8%. The per capita spending on drugs by the public sector is forecast to have been $341in Ontario, above the Canadian average of $327. Prescribed drug expenditure per capitafinanced by the private sector is expected to have been $391, again higher than theCanadian average of $356.In addition to their beneficial therapeutic effects, drugs are a significant cause of illness,disability and death. Inappropriate prescribing is estimated to cause at least 1.1% to 3.1%of hospitalizations, and at least 1.1% to 4% of physician visits. In 1997, a conservativeestimate of these costs was $0.84 billion to $2.56 billion in Canada each year. 60 Theestimated cost of misuse, underuse, and overuse of medications ranges from $2 billion to$9 billion per year. 61 Between 1995 and 2000, costs associated with adverse drug-relatedevents rose from US$76.6 billion to over US$177.4 billion. 62 , 63In a recent Canadian study, 24% of patients were admitted to a hospital’s internal medicineservice for medication-related causes, and over 70% of these admissions were deemedpreventable. 64 A study at Vancouver General Hospital found that more than 1 in 9emergency department visits are due to drug-related adverse events. Of these, 68% wereconsidered to be preventable. The most common reasons for drug-related visits wereadverse drug reactions (39.3%), nonadherence (27.9%) and use of the wrong orsuboptimal drug (11.5%). The probability of admission was significantly higher amongpatients who had a drug-related visit than among those whose visit was not drug-related.Among those admitted, the median length of stay was longer – 8 v. 5.5 days. The findingssuggested that the highest rate of drug-related visits occurred during the night (midnight to0759h). This may reflect differences in the patient population that visits the emergencydepartment overnight and lack of access to other health care resources at that time ofday. 65Adverse events after hospital discharge have been reported as 23% of patients experiencingan adverse event within 30 days; 50% of these adverse events were deemed preventable59 Canadian Institute for Health Information, Drug Expenditure in Canada, 1985 to 2007(Ottawa: CIHI, 2008).60Coambs RB, Jensen P, et al. A Preliminary Review of the Causes of Inappropriate Prescribing and itsCosts in Canada. Toronto: Health Promotion Research. February 1997.61 Romanow RJ, chair. Building on values: the future of health care in Canada — final report.Saskatoon (SK): Commission on the Future of Health Care in Canada; 2002:194.62 Johnson JA, Bootman JL. Drug-related morbidity and mortality: a cost of illness model. Arch InternMed 1995;155:1949-56.63 Ernst FR, Grizzle AJ. Drug-related morbidity and mortality: updating the cost-of illness model. J AmPharm Assoc 2001;41:192-9.64 Samoy LJ, Zed OH, Wilbur K, et al. Drug-related hospitalizations in a tertiary care internal medicineservice of a Canadian hospital: a prospective study. Pharmacotherapy 2006;6:1578-86.65 Zed PJ, Abu-Laban RB, Balen RM, et al. Incidence, severity and preventability of medication-relatedvisits to the emergency department: a prospective study. CMAJ 2008;178 1563-1569.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 40and 72% were due to medications. 66 Preventable drug related morbidity in Canadians aged65 or older has been estimated at $11.9 billion in 2000, with admissions to long-term carefacilities being the largest component of costs (61.3%) and hospital admissions beingsecond. 67 This model captured only costs to a public payer, and did not include costs (director indirect) to private sector payers, including the seniors and their families.Expanding the scope of pharmacists will empower them to become more proactivelyinvolved throughout the health system and help reduce these preventable adverse eventsand help optimize medication therapy.i. Other impacts.By expanding their scope, pharmacists will be better prepared to act in times ofemergencies to help patients with their medication issues and to inject immunizations asthey will be more familiar with injecting drugs when they educate patients on how to do so.18. Are members of your profession in favour of this change in scope of practice?Please describe any consultation process and the response achieved.Yes, the members are in favor of this change in scope of practice. Many pharmacists havedeveloped their practices over the years and have participated in medical directives toinclude this proposed scope of practice thus indicating their support for legislativerecognition.In concert with our consultations over the past ten years respecting the regulation ofpharmacy technicians, the College has consulted widely with the membership regarding thescope of practice for pharmacists to gain solid understanding of what pharmacists arecurrently doing in their day-to-day practice and what the comfort level is among membersrespecting their scope. The consultations mainly have taken place during the College’s biannualface to face district meetings and through informal surveys. The long standingposition of this College to not actively pursue prescribing rights for pharmacists was takenbased on feedback from the majority of pharmacists who were concerned that prescribingtraditionally follows the process of conducting a differential diagnosis and theacknowledgement that they were not trained to diagnose. We learned however, thatmembers feel on the whole extremely comfortable in medication therapy management andembrace the ability to adapt or alter existing prescriptions to ensure patient compliance, toextend authorizations of prescriptions for continuing care, to adjust dosages based onlaboratory results, to administer substances by injection or inhalation in the course ofeducating their patients about their therapy, etc. This is consistent with what is consideredpharmacist prescribing in other Canadian jurisdictions. We believe that pharmacists inOntario support and embrace being able to “dispense a prescription without authorization ofa prescriber” subject to the above conditions and as well as the autonomy to perform othercontrolled acts so that they can provide the necessary patient education within their scopeof practice.66 Forster AJ, Clark HD, Menard A, et al. Adverse events among medicalpatients after discharge from hospital. CMAJ 2004; 170:345-9.67 MacKinnon NJ, Kidney T. Preventable Drug-Related Morbidity in Older Adults: a Canadian Cost-of-Illness Model. Presentation. Canadian Pharmacists Association Annual Conference. Winnipeg,Manitoba May 14, 2002.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 41Ontario pharmacists have participated in the consultations on the Pharmacy HumanResources for the Future Research Program and on the Blueprint for Pharmacy. 68 (SeeAppendix 3.) Both of these initiatives support expanded scopes for pharmacists. Theseinclude: 69• Drug Therapy Management: Pharmacists will spend more time managing drug therapy incollaboration with patients, physicians, and other health providers• Public Health Outreach: Pharmacists will play a more prominent role in healthpromotion, disease prevention, and chronic disease management• Prescribing and Monitoring Authority: Pharmacists will have greater responsibility andauthority for making prescribing decisions (including initiating and modifying drugtherapy) and monitoring drug therapy outcomes (including ordering and performingtests) in collaboration with other health providers• Self-Care Patient Support: Pharmacists will continue to be accessible and available tosupport patient self-care.Pharmacists responding to the consultations expressed broad support for these expandedroles. They recognized the increased workload and liability and noted there would also be anincrease in job satisfaction.19. Describe any consultative process with other professions that might beimpacted by these proposed changes.The most recent consultative process respecting the scope for pharmacy occurred in the fallof 2007 resulting in the joint development and approval of the PAPE agreement which wouldpermit pharmacists to extend the authorization of prescriptions for continuing care. On May9, 2008, consultation focus groups were held at the College respecting this submission andwhile no representatives of other professions opposed the notion of pharmacists fullyrealizing their role as experts with a unique body of knowledge in medication therapy, therewas less support from the medical profession representatives for pharmacists initiating aprescription. The notion of pharmacists dispensing without further authorization subject toterms and conditions seemed less problematic, perhaps because of the recent processinvolving PAPE. Other professions in attendance, nurses, nurse practitioners appearedsupportive.As mentioned in Question 14, the College of Nurses of Ontario has indicated its support forthe College’s pursuit of an expanded scope.Risk of Harm20. How will the risk of harm to the patient or client be affected by the proposedchange in scope of practice?Medications have been a key concern in patient safety, not only from the perspective ofadverse events and interactions with other drugs, but also in accurate communicationamong health professionals about a patient's medication therapy as they receive services in68 Task Force on a Blueprint for Pharmacy. Blueprint for pharmacy: the vision for pharmacy. Ottawa(ON): Canadian Pharmacists Association; 2008. www.pharmacists.ca.69 Ascentum Inc. Integrated Key Findings from the Moving Forward: Pharmacy Human Resources forthe Future Research Program. Synthesis Report. May 2008. www.pharmacyhr.ca.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 42different health sectors. As discussed in Question 15(i), the recognition of the expertise ofthe pharmacist in medication management and their role in promoting health, preventingand treating diseases, dysfunctions and disorders introduces little or no new risk to patientsbecause, in many cases, pharmacists already perform these duties. Patient safety willincrease as more proactive involvement of pharmacists in medication therapy managementand other medication-related activities have been found to reduce medication-relatedproblems. 70,7121. What other regulated and unregulated professions are currently providing carewith the competencies proposed as an expansion to your scope of practice? Bywhat means are they performing it? (under delegation, supervision or on theirown initiative?)Physicians, dentists, nurses with extended practice can perform all of these additionalactivities on their own initiative. Medical radiation technologists, midwifery (within scope),registered nurses (general class), registered practical nurses, respiratory therapists,advanced care paramedics, critical care paramedics can administer substances by injectionor inhalation if authorized under order or regulation. 7222. Specify the circumstances (if any) under which a member of the professionshould be required to refer a patient/client to another health professional, bothcurrently and in the context of the proposed change in scope of practice.Pharmacists routinely assess and triage each patient as required, especially in thecommunity setting and refer patients to a physician or another appropriate health careprofessional (e.g. dietitian, physiotherapist). If the pharmacist has the competencies andappropriate information to recommend drug therapy for minor self-limiting or self diagnosedconditions, he or she may recommend the therapy to the patient or to their primary careprovider. Alternatively, if a Schedule I drug is a better choice, the pharmacist will suggestthe patient see their family physician. If the pharmacist suspects there is an urgent needfor medical advice, the pharmacist will suggest the patient seek medical advice as soon aspossible.23. If this proposal is in relation to a current supervisory relationship with anotherregulated health profession, please explain why this relationship is no longer inthe public interest. Please describe the profession’s need for independence/autonomy in practice.When a family physician retires, dies, or re-locates to another community, pharmacists whohave competently been performing delegated activities as a part of their practice, are leftwithout the ability to gain an authorization mechanism to provide or continue the care theirpatients require, except under professional judgment or Section 29(1) of the RHPA. This isof special concern in isolated and under-serviced areas where there may not be anotherhealth professional to perform the controlled act or delegate to the pharmacist in a timelymanner.70 Lane CJ, Bronskill SE, Sykora K. et al. Potentially inappropriate prescribing in Ontario communitydwellingolder adults and nursing home residents. Journal of the American Geriatrics Society.2004;52(6):861-6.71 Gurwitz J, Field T, Judge J, et al. The incidence of adverse drug events in two largeacademic long-term care facilities. Am J Med 2005;118(3):251-258.72 Ontario Health Plan for an Influenza Pandemic. July 2007.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 43In the institutional sector, the need for all physicians to sign medical directives is also verydifficult to achieve administratively. Recognition of these controlled acts for pharmacistswould greatly facilitate the integration of pharmacists into health care teams.24. Does the proposed change in scope of practice require the creation of a newcontrolled act or an extension of or change to an existing controlled act? Does itrequire delegation or authority to perform an existing controlled act or subset ofan existing controlled act?The College strongly supports pharmacists being able to perform the new controlled acts ofadministering a substance by injection or inhalation and performing a procedure on tissuebelow the dermis. This would require a change to Section 4 of the Pharmacy Act.Changes are needed to extend the conditions under which a pharmacist can dispensewithout further authorization.25. If the proposed change in scope of practice involves an additional controlledact being authorized to the profession, specify the circumstances (if any) underwhich a member of the profession should be permitted to delegate that act. Inaddition, please describe any consultation process that has occurred with otherregulatory bodies that have authority to perform and delegate this controlled act.Pharmacists should perform the controlled acts of administering a substance by injection orinhalation and performing a procedure on tissue below the dermis subject to terms andconditions limiting these activities to the pharmacist’s role in patient education andmedication therapy management.The pharmacist should be permitted to delegate these acts to an employee who is not aregulated health professional, such as pharmacy technician, who may be involved in patienteducation and in training patients to use self-monitoring devices. The College has developeda policy, with six principles regarding the use of medical directives and delegation bypharmacists. 73 In order to delegate or to accept delegation, pharmacists must ensure that:1. The procedure being directed or delegated is clinically appropriate and in thepatient’s best interest;2. The delegator (authorizer) and the delegate (implementer) have the competency(knowledge, skills and judgment) to perform the acts or tasks;3. Patients have consented to receive care by the delegate, under the directive ordelegation;4. There is a process for documentation of the care provided and for communication ofthe care to the authorizer;5. Re-delegation of the delegated act(s) is not permitted;6. The above considerations are documented in a readily retrievable format which alsoincludes:a) A process for regular review of the directive or delegation;b) The signatures of all authorizers and implementers on the directive or delegation.A consultation session on the Pharmacists Scope of Practice Review was held on May 9,2008. Representatives from the College of Physicians and Surgeons of Ontario, the Collegeof Nurses of Ontario, the Royal College of Dental Surgeons of Ontario, the Ontario College ofFamily Physicians, the Ontario Dental Association, the Ontario Medical Association, the73 Ontario College of Pharmacists. Policy on Directives and Delegation Approved. PharmacyConnection. May/June 2007:8.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 44Nurse Practitioners Association and the Registered Nurses Association of Ontario indicatedsupport for the greater use of the expertise of pharmacists in medication management,especially in collaboration with them. There was no consensus on whether pharmacistsshould be recognized for additional controlled acts or if pharmacists should continueperforming the controlled acts under delegation, medical directives, Section 29(1) of theRHPA, and professional judgement.The College of Nurses of Ontario (CNO) wrote a letter to provide the College with CNO'sinitial feedback to the May 2008 consultation. 74 (See Question 14.) Extracts from this letterinclude:Additional Controlled ActsWe do not believe that the exception provisions listed in section 29 of the RegulatedHealth Professions Act are meant to be used to provide a regulated health professionwith broad and routine access to controlled acts. It is CNO's recommendation thatOCP seek legal access to the controlled acts; this approach is transparent, providesclarity to pharmacists and to other health care practitioners and protects the public -as it facilitates role clarity and OCP's ability to govern its members with respect tothe performance of these acts.Competencies / Educational requirements for practice26. Are the entry-to-practise (didactic and clinical) education and trainingrequirements of the profession sufficient to support the proposed change in scopeof practice? What methods are used to determine this sufficiency? What additionalqualifications might be necessary?The proposed changes to the scope of practice apply to pharmacists on Part A of theregister. These are pharmacists who are engaging in direct patient care and maintaining theminimum practice requirements (600 hours of practice within Canada every three years).Pharmacists in their university programs are trained to assess prescriptions forappropriateness so have the competency to adapt prescriptions and provide refills. They aretrained to educate patients on their medications, including how to administer them byinjection and inhalation. Pharmacists are trained how to use and interpret patient selfmonitoringdevices such as blood glucose monitors.Question 28 provides details about the College's measures to ensure competency of itsmembers.27. Do members of the profession currently have the competencies to perform theproposed scope of practice? Does this extend to some or all members of theprofession?All pharmacists have the competency to adapt prescriptions and provide refills, to educatepatients on administering their drugs through injection and inhalation, to prick the skin forobtaining a blood sample for monitoring blood glucose, as pharmacists routinely do theseactivities.74 Campbell HM, Director, Practice & Policy, Ontario College of Nurses. May 27, 2008. Letter to AnneResnick, Director, Professional Practice, Ontario College of Pharmacists.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 4528. What effect will the proposed change in scope of practice have on members ofyour profession who are already in practice? How will they be made current withthe changes, and how will their competency be assessed? What qualityimprovement/quality measurement programs should or will be put into place?What educational bridging programs will be necessary for current members topractise with the proposed scope?Pharmacists across Ontario welcomed the recent announcement that the Minister of Healthand Long Term Care may recognize prescribing by pharmacists.The proposed change in scope recognizes activities that pharmacists have already beendoing, currently through delegation, medical directives, S29 (1) of the RHPA, andprofessional judgement.The College will develop a communication and education plan for members respecting thechange in the scope of practice and the conditions.Pharmacists are currently assessed both through the College’s inspection process whichexamines operational and cognitive aspects of the practice setting, and through the QualityAssurance program. Both of these have evolved in concert with the evolving standards ofpractice for pharmacists and operational standards for pharmacies.The College provides two primary tools to assist pharmacists with their continuingprofessional development. The Self-Assessment Survey assists in identifying strengths andlearning needs. The Learning Portfolio assists in developing learning goals, education actionplans and documenting learning activities. All pharmacists in Part A of the Register aresubject to random selection for the College's Practice Review process. Part A refers topharmacists who are engaging in direct patient care, and maintaining the minimum practicerequirements (600 hours of practice within Canada every three years). The QualityAssurance Practice Review consists of two phases. Every year, 20% of members in Part A ofthe Register will be selected to take part in Phase I of the practice review process. Thismeans that approximately 2000 pharmacists will be selected to participate each year, andevery pharmacist in Part A will be selected to participate in Phase I once every five years.Candidates who are selected for Phase I are required to complete the Self-AssessmentSurvey and Summary of Continuing Education Activities and submit them to the Collegewithin eight weeks. Approximately 240 pharmacists per year are selected for Phase II ofthe Practice Review, which is the Peer Review, a clinical knowledge and practice-basedassessment lasting approximately six hours. Peer Reviews are held quarterly in Toronto atthe Ontario College of Pharmacists. Phase II of the Practice Review is an assessment basedon a national model competency document developed by the National Association ofPharmacy Regulatory Authorities (NAPRA). This competency document was reviewed andupdated in 2007.Pharmacists must maintain their competency through ongoing professional developmentactivities. There are numerous continuing education programs available through ContinuingEducation at the University of Toronto, the Ontario Pharmacists Association and othereducational providers (e.g. certified diabetic educators, asthma). These will be revised toinclude the expanded scope of practice including medication counselling and medicationtherapy management.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 4629. How should the College ensure that members maintain competence in thisarea? How should the College evaluate the membership’s competence in this area?What additional demands might be put on the profession?The College expects all pharmacists to maintain an acceptable level of competence andfurther that pharmacists will not practice to a level where they lack the ability or confidenceto safely do so. Only practicing pharmacists who are in Part A of the College’s register mayprovide direct patient care and accordingly are subject to the provisions and expectationsrespecting continuing competence. Pharmacists who are not practicing are not subject toprovisions of the Quality Assurance program and as such, elect into Part B of the Register.As pharmacy technicians become regulated in 2010, and are permitted to take on moreindependent technical roles within the drug distribution system, pharmacists will be betterpositioned to focus on the cognitive aspects of medication therapy management includedwithin the scope.30. Describe any obligations or agreements on trade and mobility that may beaffected by the proposed change in scope of practice for the profession. What areyour plans to address any trade/mobility issues?The change in scope of practice will bring Ontario in line with pharmacy practice in otherprovinces. The legal acknowledgement and recognition of the pharmacists role in medicationtherapy management is in keeping with what pharmacists across Canada are already doingin many instances and working towards in others. As all pharmacists are able to do all of theproposed actions, it is not expected that the proposed scope of practice change will in anyway affect the mutual recognition agreement for Pharmacy in Canada.Public education31. How do you propose to educate or advise the public of this change in scope ofpractice?The public members on the College’s Council were very supportive of the proposed changes.Many of the public already think pharmacists already do these activities because they haveexperienced them when pharmacist’s exercised professional judgment. The College willdevelop a communication and education plan for the public to help them understand whatpharmacists can do, what pharmacists can not do, and what the public should expect fromtheir pharmacist.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 47Other jurisdictions32. What is the experience in other Canadian jurisdictions? Please provide copiesof relevant statutes and regulations.The scope of practice of pharmacy varies significantly among the provinces, reflecting thedifferences in health professional legislation, i.e. exclusive scope of practice vs. controlledacts. At minimum, it includes compounding, preparing, dispensing, and selling drugs.Activities that may be controlled or restricted in one jurisdiction may not be addressed inothers. For example, diagnosis is not a restricted activity in Alberta. In some provinces, thepractice of pharmacy is defined or described outside of the main Act governing pharmacy.Tables 1 and 2 summarize decision-making authority regarding prescriptions and Table 3,other aspects of the scope of practice, excluding compounding, preparing, dispensing, andselling drugs. Appendix 2 contains the sections of relevant provincial legislation andagreements.There are various definitions or interpretations of the term prescribe. Some provinces limitits use to ordering prescription status drugs while other provinces consider pharmacists toprescribe if they provide Schedule II and III drugs to a patient without a prescription from aregulated prescriber. There are different interpretations as to whether prescribing activityincludes diagnosis or if it can be performed separately from the person who makes thediagnosis. For example, in Alberta diagnosis is not a restricted activity. So pharmacists mayassess patients when they prescribe for minor ailments while they use a diagnosis from aphysician or other diagnostician for chronic diseases and more complex situations. For thepurpose of this section, the terminology "decision-making authority regarding prescriptions"will be used.Pharmacists Prescribing / Decision-Making Authority Regarding Prescriptions inCanadaPharmacists have been dependently making decisions regarding prescriptions in Canada fordecades, especially those pharmacists in institutional practice where they have workedunder delegation and protocols to therapeutically substitute and change doses and drugsaccording to patient’s responses and laboratory and other diagnostic test results.The Controlled Drugs and Substances Act restricts the prescribing of specified drugs (e.g.narcotics, controlled drugs, barbiturates, anabolic steroids, benzodiazepines) to physicians,dentists and veterinarians. 75,76 This federal Act takes precedence over provincial legislation.Legislatively, in the community, pharmacy prescribing began with emergencycontraceptives. British Columbia, Quebec and Saskatchewan enacted legislative changes in2000, 2001 and 2003, respectively. 77 Manitoba implemented continued care prescriptions inJuly 2002. Alberta pharmacists started independently prescribing in April 2007.In all provinces, pharmacists must limit their prescribing to areas in which they arecompetent, must have enough information about the patient, and must communicate to75 The Controlled Drugs and Substances Act permits the development of regulations to recognize otherprescribers. The New Classes of Practitioners Regulation has been developed to permit midwives,nurse practitioners, and doctors of podiatric medicine as practitioners under this Act, if they arerecognized as prescribers under provincial legislation.76 Podiatrists with prescribing authority under provincial legislation can prescribe benzodiazepines.77 In May 2008, Plan B for emergency contraception was changed to a Schedule III drug.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 48physicians and other health professionals their prescribing decision within a timely manner.Pharmacists are not obliged to prescribe, they have the choice to do so, depending on thecircumstances.As shown in Tables 1 and 2, all provinces have, or are pursuing, decision-making authorityregarding prescriptions for pharmacists. All provinces are pursuing renewals or continuity ofcare. Most provinces are pursuing dependent authority, in which delegation or collaborationis required from a physician or another authorized prescriber. The information was obtainedfrom a survey of provincial regulatory bodies in June 2008. The regulatory bodies wereasked if they had plans to pursue other types of prescribing and controlled acts. Theirresponses are as follows:BC:pharmacist initiated prescriptions under parameters similar to Alberta's existingframework; injecting vaccinesAB: will work with other provincial regulatory bodies to seek changes to federallegislation that will permit pharmacists to prescribe narcotics and controlledsubstances. A precursor to such discussion will be to define the necessaryaccountability and security measures as they relate to the pharmacists role inprescribing and dispensing.• Will pursue ordering of laboratory tests; however this should not require a change inlegislation.NB:will pursue some program type initiatives such as smoking cessation and someadditional prescribing authority similar to Alberta.NS: are currently working with the College of Physicians and Surgeons on Agreementsthat would allow pharmacists to adjust doses of various types of drugs based uponpoint-of-care test results (e.g. warfarin based upon INRs, insulin based upon glucoseand certain medications based upon creatinine levels).• will pursue administering vaccines and emergency prescribing.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 49Table 1: Summary of Pharmacist Prescribing / Decision-Making AuthorityRegarding Prescriptions in CanadaProvBCABSKMBONSummaryIn 2000, legislation permitted pharmacists to prescribe emergency contraception.In Fall, 2008, pharmacists who have completed a two hour orientation to theCollege’s Medication Management Protocol will be able to adapt existing prescriptionsto optimize the therapeutic outcome of treatment for patient (e.g., changing dose,formulation or regimen of a new prescription; renewal of a prescription for continuityof care, including an emergency supply; making a therapeutic drug substitutionwithin the same therapeutic class for a new prescription). Pharmacist is required toaddress seven fundamental elements.In April 2007, pharmacists could independently prescribe Schedule 1 drugs. Allpharmacists who have completed an orientation to new practice standards can adaptexisting prescriptions and prescribe in emergency situations, when immediatetreatment is required, but another prescriber is not accessible. The orientation ismandatory for pharmacists by July 1, 2008. Adapting a prescription includeschanging the formulation, dosage, regimen; therapeutic substitutions, and providingextensions of the prescription. About 7,000 prescriptions are written monthly bypharmacists for beneficiaries of the government drug programs, representing about0.6% of the prescriptions. These were primarily for chronic diseases, e.g. thyroid,statins, insulins, oral diabetic therapies, antihypertensives, anticoagulants, andasthma drugs. 78Pharmacists who have been evaluated and granted additional prescribingauthorization may initiate, modify, and manage drug therapy for acute and chronicconditions. After a pilot to test the application and review process, 15 pharmacistswere so recognized in December 2007. The application process was opened to allpharmacists and the next group of applicants is being assessed.A policy statement and supporting guidelines are under development to establish theregulatory framework that would permit pharmacist prescribing interdependently.This involves mutual recognition of competencies by the health care team but is notsynonymous with delegation or transfer of function. The proposed implementation isFall 2008.In July 2002, Manitoba implemented continued care prescriptions. The newPharmaceutical Act was passed in December 2006, but will not be proclaimed untilregulations are developed, approved by pharmacists and government. The Act allowspharmacists to prescribe and administer drugs, order tests and interpret patientadministered automated tests. Prescribing authority in the draft regulations allowsfor adapting prescriptions, continued care prescriptions, prescribing for third partycoverage and in declared emergencies. Other activities, like dosage adjustments, willbe permitted through Council approved practice directions. Pharmacists withExtended Practice qualifications would have enhanced prescribing authority withintheir scope of practice.Pharmacists may perform certain authorized acts through the use of delegation ormedical directives, permitted under the Regulated Health Professions Act, and underprofessional judgement.78 Bacovsky RA. Prescribing Pharmacists in Alberta: Understanding the Conditions and Implications ofTheir Expanded Role in Drug Therapy. IMS Health Canada White Paper. November 2007.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 50Prov SummaryQC In 2001, pharmacists could independently prescribe emergency contraceptives.The Pharmacy Act allows pharmacists to initiate or adjust medication therapy,according to direction/prescription from a physician, making use, where applicable,of appropriate laboratory analyses. For example, a physician may write aprescription to allow one or many pharmacists to initiate a medication therapy, or toadjust a medication therapy, to an individual patient, or a group of patients. Whenthe prescription targets only one patient, it is referred to as an individualprescription; when it targets a group of patients and/or pharmacists, it is referred toas a collective prescription.NB Pharmacists can renew an existing prescription for 30 days (except fornarcotic/controlled substances). On October 30, 2008, pending the approval ofregulations, pharmacists will be able to adapt prescriptions, prescribe in emergenciesand initiate prescriptions for minor ailments.NS Pharmacists can extend prescription for up to 30 days (continued care). Discussionsare ongoing for optimizing a pharmacist’s authority through collaboration utilizingthe Pharmacy Act’s “Conditional Authority” enabling regulation.PE On May 22, 2008, the Pharmacy Act was amended to change the definition of“practise of pharmacy” to include the prescription of drugs. Regulations are to bedrafted to further define scope of prescribing activities.NL Parameters around “continuing care” prescriptions (similar to that NB and NS) havebeen agreed to in principle by representatives of the NL Pharmacy Board, College ofPhysicians and Surgeons, Medical Association and Association of RegisteredNurses. Discussions are underway on how to implement (e.g., may be through achange in the Pharmacy Act, a change in Regulations, or agreed upon protocol).Sources: Canadian Pharmacists Association. Summary: Provincial Pharmacy Statusregarding Pharmacist Prescribing Authority. May 2008.Responses from pharmacy regulatory bodies to survey. June 2008.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 51Table 2: Pharmacist Decision-Making Authority Regarding Prescriptions in Canada(As of June 17, 2008, responses had not been received from PE and NL)BC* AB* SK* MB* ON* ON * QC* NB NSC PAdapting a prescription written by a prescriber-- altering the formulation P-I I P-D P PJ P-I D I P-- altering the dosage /P-I I* P-D-R P PJ/D P-I D I Pregimen-- therapeutic substitution P-I I P-D-R P-D-R D* D* D I D*-- continuing therapy interim I I P-D PJ PJ P-I D I Isupply-- continuing therapymaintenanceP-I I* P-D P-D D P-I D I IPharmacist initiates prescription (Schedule I drugs; excluding narcotics and controlleddrugs)-- drugs in emergencyI I P-D PJ No No I - I PsituationsI -EC P-IEC-- minor ailments No I-R P-D P-I-R No No D I No-- drugs for lifestyle / health No I-R P-D-R P-I-R No No D No Nopromotion-- chronic diseases / conditions No I-R P-D P-I-R D D D No NoPharmacist prescription for Schedule II/III drugs recognized for reimbursement#Extends existing prescription P-I I P-D P No P-I D I IInitiates prescription No I P-D P No P-I D I INote: For Ontario, the current status (ON C) and the proposed scope (ON P) are provided* See additional information section for each province/territory (starts on following page)# Public and private sector drug plans decide what they will reimburse for theirbeneficiaries, including the drug products and what type of prescriber has written theprescriptionsD: Pharmacists can dependently make decisions regarding prescriptions, i.e. authority delegatedfrom physician or other independent prescriber or authority from agreement between pharmacyand regulatory body for physicians or other independent prescribersEC Emergency contraceptionI: Pharmacists can independently make decisions regarding prescriptionsI-R: Independent prescribing restricted to designated pharmacists (e.g. Alberta model)No No activity permitted or proposedP: Proposed: regulations / standards / policies under developmentP-D: Proposed: regulations / standards / policies under development for pharmacists to dependentlymake decisions regarding prescriptionsP-D-R: Proposed: regulations / standards / policies under development for certain pharmacists todependently make decisions regarding prescriptions (i.e. activity restricted to designatedpharmacists or to certain directives)P-I-R: Proposed: regulations / standards / policies under development for certain pharmacists toindependently make decisions regarding prescriptions; activity will be restricted to designatedpharmacistsPJ: Permitted under professional judgment

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 52Additional InformationBC: Proposed implementation Fall 2008.• All active / practising pharmacists will be required to complete a two hourorientation prior to being able to prescribe.AB:SK:MB:ON:QC:Some pharmacists have additional prescribing authorization. Unless a pharmacisthas additional prescribing authorization, the pharmacist can only alter a dosage for anew prescription, not a renewed prescription, and the adjustment must be neededbecause of the patient's age, weight, or organ function or that the prescribed dosageis not commercially available. A pharmacist with additional prescribing authorizationcan only provide ongoing continuing maintenance therapy, while the regularpharmacist can only provide interim supplies or a refill based on the circumstances.Proposed implementation Fall 2008. The Saskatchewan College of Pharmacists isproposing “Interdependent Prescriptive Authority in Collaborative PracticeEnvironments” where all members of the health care team rely upon one another’sexpertise to maximize the benefits of drug therapy. This requires mutual recognitionof competencies and allows the pharmacist to prescribe according to thosecompetencies. Where all pharmacists have these competencies, they may prescribewithout further training, other than orientation to the prescribing process. Mutualrecognition will arise from agreements between the respective professionalorganizations. Where some pharmacists possess added competencies due toadvanced training, such as certification as a disease state educator, they mayprescribe under a collaborative practice agreement. This is a different form of mutualrecognition that arises from agreements at the individual practitioner level. Thus, forthe comparison chart, the response has been categorized as “dependant”, because itdepends upon mutual recognition. This should not be interpreted in any way asbeing synonymous with delegation, or transfer of function, or other related process.The Pharmaceutical Act was passed on December 4, 2006, permitting pharmacists toprescribe certain drugs and to order diagnostic tests. Regulations are beingdeveloped.Ontario permits pharmacists to make decisions regarding a prescription under amedical directive by physicians to pharmacists within a collaborative practice model.The model templates are at www.medicaldirectives-delegation.com.• Pharmacists in institutions can therapeutically substitute drugs in accordance withhospital / facility policiesOther than emergency contraceptives, all other activities related to prescribinginvolve action related to an individual or collective prescription. The word“prescription” in this context, means a direction given to a professional by aphysician, a dentist or another professional authorized by law, specifying themedications, treatments, examinations or other forms of care to be provided to aperson or a group of persons, the circumstances in which they may be provided andthe possible contraindications. In practice, a prescription of this type:- Can be written by a single physician or a group of physicians;- May target one patient or a group of patients;- May target one or a number of professionals, from one or more than one group ofprofessionals- May target or a number or clinical situationsThe terms individual or collective prescriptions refer to the following:

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 53• if a prescription is written by one physician, targets one patient, and will only beentrusted to one pharmacist, it is an individual prescription.• if a prescription is written by a number of physicians and/or targets a group ofpatients and/or targets more than one professional, it is deemed a collectiveprescriptionThe collective prescription contains information on:• A name or title: ex. collective script for the adjustment of warfarin therapy;• The professional (s) targeted, for example: pharmacists practising in the cityof X ;• The group of patients targeted , for example: patients under treatment foratrial fibrillation with warfarin and under the care of doctors at the heart clinicof x hospital;• The circumstances under which the use of this prescription is allowed for thetargeted professionals ( could be a duration of use before a visit to thephysician);• The circumstances under which the use of this prescription would not beallowed (contra-indications related to other diseases, age, etc…);• A description of what the targeted professional is expected to do inaccordance with the collective script;• Treatment guidelines (medication adjustment for example) when appropriate;• Communications guidelines between the prescriber and the targetedprofessionals.NB:NS:Responses based on approved legislation, effective October 30, 2008, pendingapproval of the RegulationsContinuing care prescriptions are permitted through an agreement between the NSCollege of Pharmacists and the College of Physicians and Surgeons of NS. Itauthorizes pharmacists to prescribe continued therapy independently from theoriginal prescriber. The pharmacist’s name goes on the prescription and label as theprescriber and the pharmacist is 100% accountable for the extension of therapy.• Pharmacists in institutions can therapeutically substitute drugs in accordance withhospital / facility policies

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 54Table 3: Provincial Comparison of Scopes of Practice for Pharmacy(Excluding compounding, preparing, dispensing and selling drugs;decision-making authority regarding prescriptions described in Table 1)Activity BC AB SK MB ON QC NB*Diagnosing / communicating a No NA No No No NodiagnosisAdministering a substance/drug by No Yes No Yes P No YesinjectionR* RAdministering a substance/drug by Yes Yes No P P NoinhalationPerforming a procedure on tissue No Yes Yes P P Yes Yesbelow the dermis (e.g. pricking the**skin)Ordering a laboratory or diagnostic Yes Yes No P-D P Yes Yestest**Interpreting a laboratory orYes Yes Yes P-D P Yes Yesdiagnostic test**Using or interpreting point-of-caremonitoring / testing devices orself-monitoring devicesUsing or interpreting screeningtestsYes*YesYes*P P Yes*Yes Yes Yes P-D P Yes Yes**#Note: As of June 17, 2008, responses had not been received from PE and NLNS does not have health profession legislation that defines controlled or restricted activities.NA: Not applicable; not a controlled activityYes: Pharmacists can perform activityYes-R: Pharmacists can perform activity, but restricted to pharmacists being certifiedNo: Controlled / restricted activity; pharmacists can not perform activityP: Proposed* See additional information belowAdditional Information:BC: When interpreting tests (e.g. screening; laboratory/diagnostic; patient selfmonitoring),a pharmacist cannot convey a diagnosis.AB: Pharmacists must complete a training program that is approved by the council of theAlberta College of Pharmacists prior to administering drugs by injection. Pharmacistsmay inject drugs subcutaneously and intramuscularly. They cannot administer drugsintravenously or intrathecally.• Ordering a laboratory or diagnostic test is not an activity that is regulated inAlberta. Provincial laboratories are accredited by the College of Physicians andSurgeons of Alberta, and laboratories are operated by regional health authorities.Once there is greater experience with pharmacists using laboratory information,the Alberta College of Pharmacists will proceed to address the ordering oflaboratory information.SK: The "*" activities are limited to the practice of pharmaceutical careQC: Pharmacists can order a laboratory or diagnostic test under an individual or collectiveprescription. Pharmacists can interpret tests and use point-of-care or screening testswithin their scope of practice, i.e. when adjusting medication therapy but not fordiagnosis purposesNB: Does not have health profession legislation that defines controlled or restrictedactivities. The Pharmacy Act will allow ordering and interpreting tests andadministration, however, this piece will not be enabled until a later date.YesNS#PE#NL#

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 5533. What is the experience in other International jurisdictions?The scope of practice of pharmacy varies significantly around the world, reflecting thedifferences in health professional legislation, i.e. exclusive scope of practice vs. controlledacts. At minimum, it includes compounding, preparing, dispensing, and selling drugs.Administering, including injecting drugs may not be restricted activities in manyjurisdictions. The discussion here will focus on prescribing drugs.There are many types of prescribing models for pharmacists internationally. They vary fromindependent models to dependent models based on protocols, adherence to formularies,and collaboration with physicians. 79 Many countries have long permitted pharmacists ininstitutional settings to prescribe in these dependent models. Many countries, such asCanada and the United Kingdom, restrict some non-prescription drugs to distribution afterconsultation with a pharmacist. These are Schedule II drugs in Canada. The United States iscurrently considering implementing such a schedule.The United Kingdom has recognized both dependent and independent prescribing models forpharmacists. Collaborative prescribing models started in the US in the 1970s. Most states inthe US now recognize collaborative prescribing and permit their pharmacists to administerdrugs and immunizations. These two jurisdictions are described below.United KingdomThe United Kingdom has recognized pharmacists as supplementary (i.e. dependent)prescribers and independent prescribers. The first supplementary pharmacist registered in2005. Pharmacists as independent prescribers were recognized in May 2006, with the firstpharmacist being registered in January 2007. The registration of its pharmacists in thesecategories is limited. Of about 40,000 practising pharmacists registered with the RoyalPharmaceutical Society of Great Britain, but only 1,417 were registered supplementaryprescribers and 534 were registered independent prescribers. 80 One area that isincreasingly utilizing the expanded scope of pharmacists is in the treatment of minorailments.Independent Prescribers 81While a pharmacist independent prescriber can prescribe any medicine (excluding ControlledDrugs at present) for any condition, it is not anticipated that pharmacists will be consultedby and prescribe for all patients who need treatment with medicines. Some pharmacistindependent prescribers will have a role in prescribing for patients who present with minorailments or a defined range of self-limiting conditions. Other pharmacist independentprescribers will specialise in the management of patients with identified clinical conditions.As independent prescribers they will be able to work as autonomous practitioners makingprescribing decisions based on their assessment of the patient’s condition and theirjudgement of the most appropriate medication regime. In addition to the management ofthe presenting condition, the pharmacist can respond to the signs and symptoms of anadditional clinical problem and make a professional decision on whether to treat the patientor refer to another practitioner.79 Emmerton L, Marriott J, Bessell T, et al. Pharmacists and Prescribing Rights: Review ofInternational Developments. J Pharm Pharmaceut Sci 2005;8(2):217-225.80 Registration, Royal Pharmaceutical Society of Great Britain. June 6, 2008.81 Royal Pharmaceutical Society of Great Britain. Pharmacist Prescribing.www.rpsgb.org/worldofpharmacy/currentdevelopmentsinpharmacy/pharmacistprescribing/index.html

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 56All pharmacist independent prescribers, whether prescribing for self-limiting conditions ormanaging a specified disease, will be providing a professional service that is within theirprofessional competence and agreed with a health organisation that has responsibility forthe health services provided to the patient. In return the health service organisation willprovide the funding for the service. It is the arrangement with the health serviceorganisation that defines the scope of the pharmacist’s prescribing practice.Pharmacist independent prescribing is different from pharmacist supplementary prescribingin the degree of autonomy and clinical responsibility exercised by the pharmacist in theirprescribing practice. If circumstances dictate or if the pharmacist chooses, a pharmacistindependent prescriber can work as a supplementary prescriber.Supplementary PrescribersSupplementary prescribing is a voluntary prescribing partnership between a medicalpractitioner (independent prescriber) who establishes the diagnosis and initiates treatment,a pharmacist (supplementary prescriber) who monitors the patient and prescribes furthersupplies of medication and the patient who agrees to the supplementary prescribingarrangement. For each patient, the framework for supplementary prescribing is set out in anindividual clinical management plan which contains details of the patient, their condition,treatment with medicines and when the patient should be referred back to the independentprescriber. Unlike pharmacist independent prescribing, a supplementary prescriber can onlyprescribe within the limitations of the clinical management plan and cannot prescribe forconditions that are not included in the clinical management plan. 82A recent review of supplementary prescribing found that pharmacists were positive aboutsupplementary prescribing but the medical profession were more critical and lackedawareness/ understanding. Supplementary prescribing was identified in many clinicalsettings but implementation barriers included funding problems, delays in practicing andobtaining prescription pads, encumbering clinical management plans and access to records.It was found that the development of independent prescribing and the apathy of the medicalprofession represented significant threats to the success of this the supplementaryprescribing initiative. 83Use of Pharmacists - Minor Ailments SchemesMinor Ailments Schemes were piloted in the United Kingdom in the early 2000s. Theseminor ailments schemes enable patients who are exempt from prescription charges toreceive treatment for common illnesses free of charge direct from a community pharmacy.The minor ailments and drug benefits vary with the jurisdiction. The ailments can includeacne, allergies, athlete's foot, back pain, bites, burns, colds, simple viral infections (e.g.cold sores), colic, conjunctivitis, constipation, contact dermatitis, cough, cystitis, diaperrash, diarrhea, dyspepsia, earache, ear wax, eczema, fever, hemorrhoids, hayfever,headaches, head lice, indigestion, mouth ulcers, nasal congestion, oral thrush, scabies, sorethroat, strains, teething, threadworms, urinary tract infections. vaginal thrust, and warts.While the products prescribed under this scheme generally are not prescription-requiring bylaw, they may require a prescription in order for the patient to obtain drug coverage by the82 Royal Pharmaceutical Society of Great Britain. Pharmacist Prescribing.www.rpsgb.org/worldofpharmacy/currentdevelopmentsinpharmacy/pharmacistprescribing/index.html83 Cooper RJ, Anderson C, Avery T, et al. Nurse and pharmacist supplementary prescribing in the UK—A thematic review of the literature. Health Policy 2008(85): 277–292.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 57NHS. It relieves pressure in primary care by discouraging patients from seeing physiciansfor minor ailments. In April 2006, minor ailments schemes became one of the four coreservices in the community pharmacy contract, meaning that it would be offered by everycommunity pharmacy in Scotland. 84 In England, the government recently proposed thatminor ailments schemes be commissioned from community pharmacies in every primarycare trust. 85 As of March 2007, only 24% of all pharmacies held such contracts. (SeeAppendix 1.)Preliminary data, included in the appendices, demonstrates increased access by the publicto necessary health services for minor ailments, increased access to physicians by patientswho are more seriously ill, and overall cost savings to the NHS. IMS Health analysedanonymized patient records from its database of 210 general practices across the UK,covering four million patient records and 190 million prescriptions. 86 Data from 500,000 UKpatients who had consulted their GP about a minor ailment suggested that, in 2006–07,51.4 million GP consultations a year were solely for minor ailments.Estimated at eight minutes per consultation, this represents 18 per cent of GPs’ workload oran hour a day for each GP. The total cost to the NHS of these consultations is £1.8bn and80 per cent of this (£1.5bn) is attributable to the cost of GPs’ time. In addition, 10 minorailments are responsible for 75 per cent of the cost of minor ailments consultations and 85per cent of the cost of prescriptions for minor ailments. These are:• back pain• indigestion• dermatitis• nasal congestion• constipation• migraine• acne• cough• sprains and strains• headacheTherefore, such a service could help reduce pressures on surgeries and free up time for GPsand their staff to treat people with more complex needs. Analysis so far indicates that thecost of medicines supplied by pharmacies for minor ailments may be less than the cost ofmedicines prescribed by GPs, and that introduction of such a scheme can both meetpeople’s requirements and be cost-efficient.The Department of Health released a White Paper that describes future NHS pharmaceuticalservices:• become ‘healthy living’ centres – promoting health and helping more people to take careof themselves;• offer NHS treatment for many minor ailments (e.g. coughs, colds, stomach problems)for people who do not need to go to their local GP;• provide specific support for people who are starting out on a new course of treatment forlong term conditions such as high blood pressure or high cholesterol;• offer screening for those at risk of vascular disease;84 Bellingham C. How to manage a minor ailment service. Pharmaceutical Journal 2005;275:694.85 Department of Health. Pharmacy in England: Building on strengths – delivering the future, April2008.86 Moberly, T. Making the case for a pharmacy-based minor ailments scheme for England.Pharmaceutical Journal 2008:280:111.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 58• use new technologies to expand choice and improve care in hospitals and thecommunity, with a greater focus on research; and• be commissioned based on the range and quality of services they deliver. 87The White Paper outlines roles for pharmacists at three levels:• supported self care – where people monitor their own conditions with periodic supportand advice;• disease management – supporting people on multiple, complex medicines regimes; and• case management – working alongside other primary care providers supporting high riskpatients.United StatesCollaborative prescribing models started in the US in the 1970s. Most states (42 of 50) nowrecognize collaborative prescribing. Forty-two states do permit their pharmacists toadminister drugs and forty-three permit pharmacists to administer immunizations. In themajority of states, many restrictions apply, including training requirements, limitations topractice environment (e.g. hospitals only), restricted to designated patient groups, and todesignated drugs or vaccines.Table 3: US State Pharmacy Laws on Collaborative Practice and Administering Drugs andImmunizations 88StateChange Drug Therapyunder CollaborativePracticePharmacists MayAdminister DrugsPharmacists MayAdministerImmunizationsAlabama No Yes YesAlaska Yes Yes Yes *Arizona Yes Yes * Yes *Arkansas Yes Yes * Yes *California Yes Yes YesColorado Yes Yes YesConnecticut Yes * Yes * Yes *Delaware No Yes YesD.C. No No NoFlorida Yes * No NoGeorgia Yes Yes YesHawaii Yes Yes * Yes *Idaho Yes Yes YesIllinois No No Yes *Indiana Yes * Yes * Yes *Iowa Yes Yes * Yes *Kansas Yes * Yes * Yes *Kentucky Yes Yes * YesLouisiana Yes Yes YesMaine Yes * No NoMaryland Yes No * Yes *Massachusetts No Yes * Yes *Michigan Yes Yes Yes *87 Department of Health. Pharmacy in England: Building on strengths – delivering thefuture, April 2008.88 National Association of Boards of Pharmacy. Survey of Pharmacy Law. 2008.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 59StateChange Drug Therapyunder CollaborativePracticePharmacists MayAdminister DrugsPharmacists MayAdministerImmunizationsMinnesota Yes Yes * Yes *Mississippi Yes Yes YesMissouri Yes Yes YesMontana Yes Yes Yes *Nebraska Yes Yes YesNevada Yes * Yes * YesNew Hampshire Yes * No NoNew Jersey Yes Yes YesNew Mexico Yes * Yes YesNew York No No NoNorth Carolina Yes Yes * YesNorth Dakota Yes Yes Yes *Ohio Yes * Yes * Yes *Oklahoma Yes * Yes Yes *Oregon Yes * Yes * YesPennsylvania Yes * Yes YesRhode Island Yes * Yes Yes *South Carolina No Yes YesSouth Dakota Yes Yes YesTennessee Yes Yes YesTexas Yes Yes * YesUtah Yes Yes * Yes *Vermont Yes Yes YesVirginia Yes Yes * YesWashington Yes Yes Yes *West Virginia No * No Not addressedWisconsin Yes * Yes * Yes *Wyoming Yes Yes * Yes ** Restrictions apply (e.g. special training, certain drugs / vaccines; patient groups)Costs/Benefits34. What are the potential costs and benefits to the public and the profession inallowing this change in scope of practice? Please consider and describe the impactof any of the following economic factors:1. Direct patient benefits/costs;Patients will save time, transportation costs, and time away from work due to fewer visits tothe physician or emergency department for refills and the treatment of minor illnesses.They will also benefit from improved medication therapy and better health outcomes. Thecosts to patients and third party payors could decrease, especially when pharmacists useless expensive drugs as first line therapies. Pharmacists will start providing and charging formore comprehensive consultations on medication therapy management. There may beadditional charges to the public for these depending upon whether the government andprivate sector drug plans cover these fees.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 602. Benefits and costs to the broader health care service delivery system;The Ministry of Health and Long Term Care has identified Ontario’s two most importanthealth care priorities over the next four years as reducing wait times with a special focus onemergency departments and improving access to quality family health care. The expandedscope of practice for pharmacists is consistent with and complementary to these priorities.The high number of drug-related visits to emergency departments can be reduced throughproactive involvement of pharmacists in medication therapy management and by managingminor illnesses.The health system will be able to more effectively use health care providers and resourcesand provide residents of Ontario with better access to medication therapy management,such as:• provide more flexibility in designing programs to make better use of health careproviders according to their qualifications, skills and training• facilitate the greater use of pharmacists to manage medication therapy in hospitals,long term care facilities, family health teams, primary care, community healthcentres, home care, outpatient, outreach, and community based programs• reduce the workload of physicians, nurses, and other health professionals workloadrelated to medication therapy permitting reallocation of their time to patients whorequire their expertise• improving continuity of care / seamless care as patient moves between healthsectors• facilitate the incorporation of pharmacists into primary care treatment groups anddisease management programsThere also will be increased efficiencies in the health system resulting from pharmacistsparticipating in screening clinics to identify patients with illnesses and conditions andsignificant risk factors.Studies have shown that when pharmacists have a more active role in drug therapy, thehealth care system saves money. Studies have shown that preventable drug-relatedproblems are a significant expense to the system, financially and in inefficient use ofresources.3. Benefits and costs associated with wait times;The potential impact of pharmacists improving access to physicians, nurse practitioners,other health care practitioners, emergency departments, other health services and longterm care beds has been discussed in Question 15(d). This has been shown in the literatureto result from their proactive role in medication therapy management and preventingpreventable drug-related problems.4. Workload, training and development costs;There are no substantial costs estimated for workload, training and development.Continuing education programs are constantly being revised to reflect current therapies andevolving practice standards.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 615. Costs associated with educational and regulatory sector involvement.There are no substantial costs estimated for educational and regulatory sector involvement.35. Is there any other relevant information that HPRAC should consider whenreviewing your proposal for a change in scope of practice?Pharmacists have been working toward the recognition of an expanded scope of practicethrough their evolving practice and through initiatives at the provincial level (e.g. theCollege, the Ontario Pharmacists Association, Ontario Branch of the Canadian Society ofHospital Pharmacists) and nationally (e.g. the Canadian Pharmacists Association, theCanadian Society of Hospital Pharmacists) and the two national collaborative initiatives(i.e. Moving Forward: Pharmacy Human Resources for the Future Research Program, theBlueprint for Pharmacy). The regulation of pharmacy technicians is also underway, whichwill provide pharmacists with the time to devote their expertise into these expanded roles.As mentioned earlier, in all other provinces, once a diagnosis has been made pharmacistsare or will be permitted to prescribe or adapt prescriptions, and to provide refills ofmedications already prescribed. This College has not pursued the controlled act ofprescribing for pharmacists and within the timeframe allocated for this submission, was notable to undertake the extensive consultation with members and other stakeholders requiredto change this position. Permitting pharmacists to legally dispense a prescription withoutfurther authorization from a prescriber under specific conditions as set out above wouldbring Ontario into line with what prescribing pharmacists are able to do in other Canadianjurisdictions and falls squarely within the pharmacists scope and abilities as experts inmedication management. Without doubt, pharmacists possess the knowledge, skills, abilityand judgement required to safely adapt a dosage form, dosing regimen, or dose strength tofacilitate drug coverage and to authorize prescription extensions for continuing therapy.College Council acknowledged that these activities are called prescribing in otherjurisdictions such as Alberta, Saskatchewan, Manitoba and the Atlantic provinces. TheCollege further acknowledges the need for all stakeholders to clearly understand that thosepharmacists permitted to “prescribe” in other jurisdictions only do so once a diagnosis hasalready been made by another health care professional authorized to diagnose. This Collegeis recommending “dispensing without further authorization from a prescriber subject toterms and conditions” over “prescribing” on the basis that these activities fall within thecognitive aspects of the controlled act of dispensing and are already thus within the realm ofthe pharmacists scope of practice. The College is aware that while the terminology ofprescribing is used in other jurisdictions to describe activities that fall within a pharmacist’sscope, the perception exists amongst the public and other health professions thatprescribing must follow differential diagnosis- an activity that currently does not fall withinthe realm of pharmacy training and practice. Should HPRAC consider that grantingpharmacists in Ontario the ability to adapt or alter a dosage form, dosing regimen or dosestrength and to authorize prescription extensions for continuation of care is moreappropriately done through prescribing than dispensing-subject to the terms and conditionscited above, the Council of the Ontario College of Pharmacists would support such arecommendation as long as it is clear that such activity would occur within the pharmacistsmedication therapy management role and only after a diagnosis has been made.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Page 62Appendices:1.0 International Pharmacy Experience2.0 Provincial Pharmacy LegislationAppendix 2A: British ColumbiaAppendix 2B: AlbertaAppendix 2C: SaskatchewanAppendix 2D: ManitobaAppendix 2E: OntarioAppendix 2F: QuebecAppendix 2G: New BrunswickAppendix 2H: Nova ScotiaAppendix 2I: Prince Edward IslandAppendix 2J: Newfoundland and Labrador3.0 Blueprint for Pharmacy

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 1: 1Appendix 1: Information on Pharmacy Practice in the UKBetter Management of Minor Ailments: Using the Pharmacist, June 2003.http://www.rpsgb.org/pdfs/bettmanminail.pdfNHS Lothian. Minor Ailments Formulary 2006. For use in community pharmacy. October2006: www.ljf.scot.nhs.uk/maf/MAF_Oct2006.pdf

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 1APPENDIX 2: Provincial Inter-jurisdictional Review: Scope of Practice of PharmacyAPPENDIX 2A: British ColumbiaThe scope of practice of pharmacy is defined in the Pharmacists, Pharmacy Operations andDrug Scheduling Act and further described in the Framework of Professional Practice.Professional Policy Practice - 58 permits pharmacists to prescribe.Pharmacists, Pharmacy Operations and Drug Scheduling ActDefinitions"dispense" includes the preparation and sale of a drug or device referred to in a prescriptionand taking steps to ensure the pharmaceutical and therapeutic suitability of a drug or devicefor its intended use and taking steps to ensure its proper use;"practice of pharmacy" includes the practice of and responsibility for(a) interpretation and evaluation of prescriptions,(b) compounding, dispensing and added labelling of drugs and devices,(c) monitoring drug therapy,(d) identification, assessment and recommendations necessary to resolve or prevent drugrelated problems in patients,(e) advising persons of the therapeutic values, content and hazards of drugs and devices,(f) safe storage of drugs and devices,(g) maintenance of proper records, including patient records, for drugs and devices,(h) services, duties and transactions necessary to the management, operation and controlof a pharmacy or to provide pharmacy services in a hospital, facility or care centre, and(i) sale of drugs by pharmacists;

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 2Framework of Professional Practice (March 2006)ComponentsPurpose“The primary purpose of the profession of pharmacy is to help people achieve theirdesired health outcomes. Pharmacists do this by providing current, rational, safeand cost-effective pharmaceutical services, information, and products, incollaboration with clients and others in the health care community.”Pharmacists who contributed to a functional analysis process that describes why theprofession of pharmacy exists, developed this purpose statement. Much like a missionstatement, the purpose statement is fundamental to understanding the Framework ofProfessional Practice. It is the starting point for each component and it relates to everyonewho contributes to the profession.RolesThe work of today’s pharmacists goes far beyond the public’s general notion of ‘dispensing’drugs. It is both more complex and more related to promoting health and wellness thanmost people realize. As health care professionals, we are key members of our clients’ healthcare teams.To maintain good standards of pharmacy practice, and meet the standards described in thisFramework of Professional Practice, B.C. pharmacists identified five key roles that requiredirect pharmacist involvement or supervision.1. Provide pharmaceutical care2. Produce and distribute drug preparations and products3. Contribute to the effective operation of the pharmacy4. Maintain professional development and contribute to the professional developmentof others5. Contribute to the effectiveness of the health care systemFunctionsIn order to fulfill the five Roles of the Framework of Professional Practice, pharmacists areresponsible for a wide range of Functions in their daily practice. No one pharmacist isresponsible for all of the Roles and Functions described in the Framework of ProfessionalPractice. Some Functions are more relevant to pharmacists actively involved in directpatient care, while others are more relevant to pharmacists engaged in research,management, education or consulting.Each Function describes a broad area for which pharmacists have responsibility. Making surethese Functions are performed well and consistently within each practice setting is essentialto the fulfillment of each Role.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 3Activities and Indicators of good practiceEach Activity describes a component of a Function. Activities describe the day-to-day workpharmacists (or their colleagues) do to achieve each Function. Following each Activity is alist of Indicators of good practice. Each Indicator is a description of good pharmacy practice.The Indicators for any one Activity may not be the only possible ones. They are the onesthat B.C. pharmacists say are most critical to good performance. These indicators answerthe question, “How do I know an activity is being performed well?”Knowledge and skills specificationsThe final section of the Framework of Professional Practice specifies Knowledge and SkillsSpecifications. It is the fundamental knowledge and skills that pharmacists possess thatenable them to perform the Roles, Functions and Activities described in the Framework ofProfessional Practice. To do this, pharmacists draw on their expertise, usually in the form ofknowledge, skills and abilities unique to each pharmacist.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 4RolesRole 1 Provide pharmaceutical carePharmaceutical care is a primary responsibility of the pharmacist, although shared withphysicians and other health care providers. Pharmacists may provide this service directly topatients or their caregivers; or they may manage/supervise or teach/train others to providethis care. Thus the ‘client’ may vary depending on the specific responsibility pharmacistshave in this role.Role 2 Produce and distribute drug preparations and productsDrug distribution is a primary technical responsibility, often performed by pharmacytechnicians under direction or supervision of the pharmacist. The pharmacist is legallyresponsible for all functions in this role, so they must be able to perform these functions inorder to train or supervise others, even if they do not perform the functions directly.Role 3 Contribute to the effective operation of the pharmacyAll pharmacists, regardless of their responsibility, contribute directly or indirectly to thisrole. For example: they contribute by helping to maintain the effectiveness and efficiency ofthe workplace; supervising others; ensuring adequate staffing; and/or ensuring qualityproducts and services are provided to meet client needs.Role 4 Maintain professional development and contribute to the professionaldevelopment of othersProfessional development is a continuous process in the changing profession of pharmacy.As pharmacy practice evolves, pharmacists need to keep current and knowledgeable, andsupport others. They can do this through professional development, continuing education;workplace interaction and problem-solving.Role 5 Contribute to the effectiveness of the health care systemAs members of the health care community, pharmacists contribute to the health care teamby identifying ways to improve overall health outcomes. Pharmacists do this by promotinghealth and wellness in the community; improving working relationships; investigatingemerging therapies; and sharing new information to benefit their clients.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 5College of Pharmacists of British ColumbiaProfessional Practice Policy: Medication Management PPP-58Protocol for medication management (adapting a prescription)This professional practice policy enables pharmacists to maximize their full educational andprofessional competencies by providing authorization to adapt existing prescriptions. Thispolicy is not mandatory and the decision whether to adapt a prescription is at the discretionof the individual pharmacist.To guide decisions with respect to adapting a prescription, where a specific hospital boardorCollege of Pharmacists of BC council- approved protocol does not exist, the pharmacistmust refer to all applicable legislation and standards. This includes, but is not limited to, thePharmacist, Pharmacy Operations and Drug Scheduling Act and related Bylaws, the HealthCare (Consent) and Care Facility (Admission) Act, the Framework of Professional Practice,the Code of Ethics and Professional Practice Policies. This specific policy (PPP#58) does notapply to narcotic and controlled drugs and cancer chemotherapy agents.The Framework of Professional Practice (FPP) is the standards of pharmacy practice inBritish Columbia. In adapting a prescription the pharmacist must follow the FPP Role 1Provide pharmaceutical care. Role 1 elements include:• Function A – Assess the client’s health status and needs• Function B – Develop a care plan with the client• Function C – Support the client to implement the care plan• Function D – Support and monitor the client’s progress with the care plan• Function E – Document findings, follow-ups recommendations, information provided andclient’s outcomesIn addition to the FPP, PPP#58 outlines that a pharmacist may dispense a drug contrary tothe terms of a prescription (adapt a prescription) if the action is intended to optimize thetherapeutic outcome of treatment with the prescribed drug and meets all of the followingelements of a protocol to adapt a prescription:1. Individual competencea. Pharmacist has appropriate knowledge and understanding of the condition and thedrug being dispensed in order to adapt the prescription.2. Appropriate informationa. Pharmacist has sufficient information about the specific client’s health status toensure that adapting the prescription will maintain or enhance the effectiveness ofthe drug therapy and will not put the client at increased risk.3. Prescriptiona. Pharmacist has a prescription that is current, authentic, and appropriate.4. Appropriatenessa. Pharmacist determines whether adapting the prescription is appropriate in thecircumstances.5. Informed consenta. Pharmacist must obtain the informed consent of the client or client’srepresentative before undertaking any adapting activity.6. Documentationa. Pharmacist must document in the client’s record any adaptation of theprescription, the rationale for the decision, and any appropriate follow-up plan.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 67. Notification of other health professionalsa. Pharmacist must notify the original prescriber (and the general practitioner ifappropriate) as soon as reasonably possible (preferably within 24 hours ofdispensing) and this must be recorded in the client’s record or directly on theprescription hard copy.Benefits of professional practice policyThe benefits to clients are to:a) Optimize drug therapy leading to improved client health outcomesa. Better therapeutic responses.b. Reduced drug errors.c. Fewer adverse drug reactions/interactions.b) Have an effective and efficient health care systema. Minimize delays in initiating and changing drug therapy.b. Make the best use of human resources in the health care system.c) Expand the opportunities to identify people with significant risk factors.d) Encourage collaboration among health care providers.Note: PPP#58 is not a stand-alone document and must be read with the orientation manualcurrently under development. For a pharmacist to use PPP#58 they will be required tocomplete an orientation to PPP#58, details of which are also under development.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 7Appendix 2B: AlbertaThe scope of practice of pharmacy is described in Schedule 19 of the Health Professions Actand section 16 of the Pharmacists Profession Regulation.Health Professions Act Schedule 19 Profession of PharmacistsPractice3 In their practice, pharmacists promote health and prevent and treat diseases, dysfunctionand disorders through proper drug therapy and non-drug decisions and, in relation to that,do one or more of the following:(a) assist and advise clients, patients and other health care providers by contributingunique drug and nondrug therapy knowledge on drug and nondrug selection and use,(b) monitor responses and outcomes to drug therapy,(c) compound, prepare and dispense drugs,(d) provide non-prescription drugs, blood products, parenteral nutrition, health care aidsand devices,(e) supervise and manage drug distribution systems to maintain public safety and drugsystem security,(f) educate clients, patients and regulated members of the Alberta College ofPharmacists and of other colleges in matters described in this section,(g) conduct or collaborate in drug-related research,(h) conduct or administer drug and other health-related programs, and(i) provide restricted activities authorized by the regulations.Pharmacists Profession RegulationRestricted ActivitiesClinical pharmacists16(1) A clinical pharmacist is authorized to perform, within the practice of pharmacy and inaccordance with the Pharmacists' Standards of Practice, the following restricted activities:(a) to dispense, compound, provide for selling or sell a Schedule 1 drug or Schedule 2drug;(b) to administer a vaccine or parenteral nutrition;(c) to compound blood products;(d) to insert or remove instruments, devices or fingers(i) beyond the anal verge, and(ii) beyond the labia majora;(e) to prescribe a Schedule 1 drug for the purpose of adapting an existing prescription;(f) to prescribe blood products for the purpose of adapting an existing prescription;(g) to prescribe a Schedule 1 drug if(i) it is not reasonably possible for the patient to see a health professional to obtainthe prescription, and(ii) there is an immediate need for drug therapy;(h) to prescribe blood products if(i) it is not reasonably possible for the patient to see a health professional to obtainthe prescription, and(ii) there is an immediate need for blood products.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 8(2) In subsection (1), "adapting an existing prescription" means(a) altering the dosage, formulation or regimen for a Schedule 1 drug that has beenprescribed for a patient;(b) substituting another drug for a prescribed Schedule 1 drug if the substituted drugis expected to deliver a therapeutic effect that is similar to the therapeutic effect ofthe prescribed drug;(c) substituting a generic drug for the prescribed drug;(d) renewing a prescription to dispense a Schedule 1 drug or blood product to ensurecontinuity of care.(3) Subject to subsection (4), a clinical pharmacist is authorized to perform, within thepractice of pharmacy and in accordance with the Pharmacists' Standards of Practice, therestricted activities of prescribing a Schedule 1 drug and prescribing blood products if theclinical pharmacist(a) has provided evidence satisfactory to the Registrar of having successfullycompleted the Council requirements to prescribe Schedule 1 drugs and bloodproducts, and(b) has received notification from the Registrar that the authorization is indicated onthe clinical register.(4) A clinical pharmacist authorized under subsection (3) may prescribe a Schedule 1 drugor blood products only if the clinical pharmacist(a) has determined that a Schedule 1 drug or blood products are appropriate for thepatient through an assessment of the patient,(b) has received a recommendation that the patient receive drug therapy from ahealth professional who is authorized to prescribe a Schedule 1 drug or bloodproducts, or(c) has determined in consultation with or has determined in conjunction with ahealth professional that a Schedule 1 drug or blood products are appropriate for thepatient.(5) A clinical pharmacist is authorized to perform, within the practice of pharmacy and inaccordance with the Pharmacists' Standards of Practice, the restricted activity ofadministering anything by an invasive procedure on body tissue below the dermis or themucous membrane for the purpose of administering subcutaneous or intramuscularinjections if the clinical pharmacist(a) has provided evidence satisfactory to the Registrar of having successfullycompleted the Council requirements for the administration of injections, and(b) has received notification from the Registrar that the authorization is indicated onthe clinical register.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 9Additional InformationAll pharmacists who have completed an orientation program developed and delivered by theAlberta College of Pharmacists can prescribe for the purpose of “adapting prescriptions” andfor the purpose of meeting emergency needs (defined in standards).Pharmacists wishing “additional prescribing privileges” as contemplated in s16(3&4) of thePharmacists Profession Regulation, must make application to the registrar, and demonstratetheir competency to prescribe for the purposes outlined in the section. Candidates mustsubmit a portfolio that provides documentation capable of demonstrating their competenceto prescribe. The portfolio requires three types of information:• Personal information outlining education, training, experience, practice relationships,and how the candidate intends to incorporate prescribing privileges within their practice.• Three comprehensive care plans for three patients that the pharmacist has co-managedthe drug therapy needs of.• Two letters of collaboration from other regulated health professionals, one of whommust have prescribing authority.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 10Appendix 2C: SaskatchewanThe scope of practice of pharmacy is provided under an exclusive scope description insection 23(1) of the Saskatchewan Pharmacy Act. It is further described in the Standards ofPractice.The following permits pharmacists to prescribe:Section 14(2)(i.1) of the Saskatchewan Pharmacy Act.Section 9.1 of the Drug Schedules Regulations athttp://www.napra.ca/pdfs/provinces/sk/the_drug_schedules_regs_1997-2006.pdfSection 14.13.10.2 of the bylaws athttp://www.napra.ca/pdfs/provinces/sk/Bylaws-Drug-Schedules-I-II-III-March2008_v2.pdfsupplemented by the guidelines athttp://www.napra.org/docs/0/203/262/269.aspThe Saskatchewan Pharmacy Act 196623(1) No person other than a licensed pharmacist or intern practising under thesupervision of a licensed pharmacist, may prepare, compound, dispense or selldrugs in Saskatchewan.14(2) Subject to this Act, regulatory bylaws may be made pursuant to section 13 for thefollowing purposes:(i.1) governing the prescribing and dispensing of drugs by members;Drug Schedules RegulationsPrescription privileges – pharmacists9.1 A licensed pharmacist may, subject to the terms, conditions and restrictions in his orher licence, prescribe any drug listed in Schedule I that is an oral contraceptive if, in thecircumstances, the provision of a sufficient quantity of the drug for emergencycontraception is required to meet the patient’s needs.Bylaws14.13.10.2 Upon having received training as approved by Council, a pharmacist mayprescribe and sell a Schedule I drug to a member of the public, in the absence of aprescription from a medical practitioner, when under emergency or urgent circumstancesthe pharmacist deems it to be in the best interests of the patient to provide a reasonablequantity of an oral contraceptive sufficient to meet the patient’s needs and a diagnosis orassessment by a practitioner for emergency contraception is not required, as the pharmacistis able to assess the patient’s needs for emergency contraception.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 11Standards of PracticeTHE ROLE OF THE PHARMACISTThe contemporary role of the pharmacist is defined as drug use control. To fulfil this role,the pharmacist must perform three major functions.Control FunctionEnsuring prescription drugs and non-prescription drugs are correctly stored and distributedto minimize drug misuse and drug abuse. This function includes the pharmacist’s traditionalactivities of compounding and dispensing which ensures the provision of the correct drug.However, it also requires that appropriate nonprescribed drug(s) be provided for thecondition(s) being treated.Education FunctionEnsuring the patient gets maximum benefit from prescription and non-prescription drugs byproviding the appropriate information for the patient to understand the use, precautions,common side effects, and storage requirements of the medication.Consultant FunctionProviding information on drug products and therapy to the physician and other members ofthe health care team.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 12Appendix 2D: ManitobaThe definition of the practice of pharmacy is contained in the Pharmaceutical Act. The Actwas passed December 4, 2006, and will be enacted once the regulations have beenapproved by the membership of the Manitoba Pharmaceutical Association. The draftregulations contain information on prescribing, administering drugs, and ordering andinterpreting diagnostic tests.The Pharmaceutical ActPRACTICE OF PHARMACYPractice of pharmacy2(1) The practice of pharmacy consists of the following practices:(a) the compounding, dispensing, and retail sale of drugs;(b) monitoring drug therapy and advising on the contents, therapeutic values andhazards of drugs;(c) advising on the use, calibration, effectiveness and hazards of devices used inconnection with drugs or to monitor health status;(d) identifying and assessing drug-related problems, and making recommendations toprevent or resolve them;(e) the practices set out in subsection (2), when performed by a member who meets thequalifications and any restrictions or conditions set out in the regulations.Included practices2(2) A member who meets the qualifications set out in the regulations may, subject to anyrestrictions or conditions set out in the regulations, engage in any of the following practicesin the course of practising pharmacy:(a) prescribe drugs that are designated in the regulations for the purpose of this clause;(b) administer drugs that are designated in the regulations for the purpose of thisclause;(c) interpret patient-administered automated tests that are designated in theregulations;(d) order and receive reports of screening and diagnostic tests that are designated in theregulations.Drug to be dispensed only by prescription2(3) A member may dispense a drug only pursuant to a prescription and in accordance withthis Act, the standards of practice, the code of ethics, and any relevant practice direction.Exclusive right to practise3(1) Subject to subsection (2), no person other than a member shall engage in the practiceof pharmacy.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 13Draft Regulations (December 7, 2007)Practice of Pharmacy13(1) The practice of pharmacy includes:(a) the supervision of monitoring drug therapy and advising on the contents, therapeuticvalues and hazards of drugs;(b) the provision of information and training to identify and assess drug relatedproblems and making recommendations to prevent or resolve them; or,(c) the responsibility that the practice of pharmacy by other members is done incompliance with the Act.PART 12 – PRESCRIBING BY MEMBERSPrescribing by members86(1) Subject to this part, any member may prescribe the following:(a) a drug listed on schedule 2 of the manual;(b) a drug listed on schedule 3 of the manual;(c) a drug which is not listed in the manual, but has been issued a drug identificationnumber or natural health product number under the Food and Drugs Act (Canada); and(d) a medical device approved by Health Canada.Prescribing by extended practice pharmacists86(2) Subject to this part, a member who is an extended practice pharmacist mayprescribe a drug listed on schedule 1 of the manual, within the scope of his or her specialty.Prescribing by clinical assistant specialist86(3) In addition to the requirements of this part, a member who qualifies as a clinicalassistant specialist must prescribe a drug only in accordance with the requirements of TheMedical Act and regulations applicable to clinical assistants.Prescribing in emergency86(4) Notwithstanding subsection (2), where the minister gives council written notice thata public health emergency exists in all or part of the province, council may approvemembers to prescribe drugs listed on schedule 1 of the manual, under any conditionsdeemed appropriate by council, until the state of emergency is lifted.Criteria for prescribing87 A member may only prescribe where:(a) the member has made a reasonable inquiry to assess whether the drug will be safeand effective in the circumstances of the patient, including:(i) the patient’s symptoms;(ii) the patient’s medical history or information;(iii) the patient’s allergies;(iv) other medications the patient may be taking; and(v) any other inquires reasonably necessary in the circumstances.(b) the member has assessed the patient in person, in compliance with the standards ofpractice or practice directions;(c) the drug is prescribed in a circumstance which is within the member’s usual scope ofpractice or specialty;(d) the member has complied with any policies or rules related to prescribing at thepharmacy at which the member practices;(e) the member has complied with any applicable practice directions;(f) the member has determined that the prescription is reasonably necessary ordesirable to treat the patient;

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 14(g) except where the prescription is being issued for an in-patient of a facility under theHealth Services Insurance Act, the member has discussed with the patient, or his or heragent, reasonable and available therapeutic options and costs.(h) the device is needed to meet the care needs of the patient.Controlled substances88 This Part is subject to the restrictions set out in the Controlled Drugs andSubstances Act (Canada) and the regulations thereunder.Continued care prescriptions90(1) Subject to this section, a member may authorize an additional refill of a prescription,beyond those authorized by the original practitioner issuing the prescription, where:(a) the patient has a continuing need or chronic condition;(b) the prescribing practitioner or extended practice pharmacist has died or retiredwithin the previous six months or has not responded to an inquiry for refill authorizationand it would be onerous or impossible for the patient to contact or attend with theoriginal practitioner issuing the prescription in a timely manner;(c) the history of the patient with the subject drug has not changed;(d) the patient advises that they have not recently experienced any adverse drugreactions to the subject drug;(e) the prescription was previously filled at the same pharmacy; and(f) the member complies with any applicable practice directions.Requirements for continued care prescriptions90(2) Where a member authorizes a refill under subsection (1), the member must(a) promptly notify the original practitioner who issued the prescription, subject to theirdeath or retirement described in section 90(1)b;(b) enter the refill into DPIN; and(c) keep the records required by part 8 of this regulation.Restrictions on continued care prescriptions90(3) A member must not authorize a refill under subsection (1):(a) where the refill quantity is in excess of the original prescribed refill amount;(b) where the drug falls under the Controlled Drugs and Substances Act(Canada) unless it is issued in compliance with sections 88 and 90(1) of the regulations;(c) where the drug is a benzodiazepine, unless:(i) the drug is used to manage a convulsive disorder; or(ii) there is a serious risk of seizure due to sudden withdrawal;(d) where the patient appears to be using continuing care refills to avoid obtainingongoing medical care.PART 13 – ADMINISTRATION OF DRUGSAdministration of drugs by members91(1) Any member or intern may administer a drug listed in the manual or has been issueda drug identification number or natural health product number under the Food and DrugsAct (Canada) to a patient:(a) orally, including sublingual and buccal;(b) topically, including ophthalmic, otic and intranasal; or(c) via inhalation.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 15Certification in drug administration91(2) Council may establish a training program to certify members in other methods ofdrug administration that includes enhanced safety measures and emergency resuscitation,and specify the frequency by which the certification must be renewed.Use of titles91(3) No person may represent that they are certified in drug administration unless theyhold current certification under subsection (2).Advanced drug administration91(4) A member who has current certification in drug administration, or under training anddirect supervision as described in section 91(2), may administer a drug:(a) through intradermal injection;(b) through subcutaneous injection;(c) through intramuscular injection; or(d) intravenously through an established central or peripheral venous access device.Administration by clinical assistant specialist91(5) Notwithstanding anything in this section, a member who is a clinical assistantspecialist may administer a drug in accordance with the requirements of The Medical Actand regulations applicable to clinical assistants.PART 14 – TEST INTERPRETATIONInterpretation of tests by members93 Any member may interpret and advise the patient of the results and implications of anypatient administered automated tests.Test interpretation record94(1) A member who interprets and makes a recommendation to a patient regarding apatient administered test must make and retain a record in the pharmacy of:(a) the name of the patient;(b) the address of the patient;(c) the nature of the test interpreted;(d) the results of the test;(e) the nature of the advice given to the patient;(f) the name of the member interpreting the test; and(g) the date of the test.PART 15 – ORDERING AND RECEIPT OF TEST REPORTSOrdering tests by members95(1) Any member may, upon approval from the patient's practitioner, order and receivecopies of a screening or diagnostic test.Ordering tests by members in hospital95(2) Any member in a pharmacy with a hospital pharmacy licence, may, in accordancewith hospital policy, order and receive a screening or diagnostic test for a person who is anin-patient of a hospital designated under The Health Services Insurance Act.Ordering tests by extended practice pharmacist95(3) In addition to the tests referred to in subsections (1) and (2), a member who is anextended practice pharmacist may order and receive the results of screening and diagnostictests which are within the scope of the member’s specialty.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 16Results to be made available95(4) A member who orders and receives the results of a screening or diagnostic test,under this section, that;(a) reveals medical issues requiring attention, or,(b) the member is not able to interpret must promptly forward the results to a healthprofessional responsible for the patient's care for the interpretation of the results afterwhich the member may advise the patient when delegated the authority to do so.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 17Appendix 2E: OntarioThe scope of practice for pharmacy is set out in the Pharmacy Act. Pharmacists can extendprescriptions in accordance to the PAPE agreement.Pharmacy Act S3:The practice of pharmacy is the custody, compounding and dispensing of drugs, theprovision of non-prescription drugs, health care aids and devices and the provision ofinformation related to drug use.The authorized acts for Pharmacy under S.4 are:In the course of engaging in the practice of pharmacy, a member is authorized, subjectto the terms, conditions and limitations imposed on his or her certificate of registration,to dispense, sell or compound a drug or supervise the part of a pharmacy where drugsare kept.PHARMACIST AUTHORIZATION OF PRESCRIPTION EXTENSIONS (PAPE) AGREEMENTDraft: January 2008The following agreement provides conditions under which a pharmacist may provideauthorization of a prescription extension to a patient where an urgent need for patient drugtherapy management exists and the prescribing physician is unavailable to provide refillauthorization.This Agreement assumes the following principles:1. Pharmacist authorization of prescription extensions cannot and does not take theplace of ongoing medical care.2. Each request for a pharmacist authorization of prescription extensions must bejudged on the individual nature of the patient’s need/history and professionaljudgment exercised accordingly.3. The pharmacist assumes the responsibility for the extended refill.A pharmacist may authorize a prescription extension where the following conditions aremet:1. The pharmacist must be reasonably satisfied that the prescriber, if available, wouldin all likelihood, provide the authorization.2. The medication to be extended has been prescribed to the patient for a chronic orlong term condition (generally for at least a year or longer).3. The patient shall have an established, stable history (no recent changes to dosagesor drug therapy) with that medication.4. The prescription to be extended shall be with that particular pharmacy and thepatient shall be within the care of the pharmacy.5. Narcotic or controlled substances shall NOT be authorized for extension within theconfines of this agreement.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 186. The pharmacist may authorize a prescription extension once only. Further requestsfor extensions must be handled by the patient’s physician or original prescriber or anon-call physician.7. The amount of medication provided must not exceed the previous amount filled, orthree months, whichever is lesser.8. The pharmacist shall assign a new prescription number to the prescription extendedunder this agreement (PAPE) and shall record on the prescription the Rx number ofthe original prescription. The original prescriber shall be listed as the prescriber onthe extended prescription. The pharmacist shall be recorded as authorizing theextension.9. The PAPE shall be documented on the patient record in such a manner as to ensurethe prescription will not be “extended” a second time.10. The PAPE shall be reported in written format within one week to the originalprescriber and to the patient’s primary care physician (if different from theprescriber). A copy is to be kept in the pharmacy.11. A prescriber retains the right to indicate “no extension” on a prescription; howeverthis does not preclude the pharmacist from exercising professional judgment in anemergency situation.Support/endorsement for this policy is being actively sought from the Council of the OntarioCollege of Pharmacists, as well as from:The Ontario Pharmacists Association,The Ontario Medical Association, andThe College of Physicians and Surgeons of Ontario

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 19Appendix 2F: QuebecThe practice of pharmacy is defined in section 17 of the Pharmacy Act.Pharmacy ActPRACTICE OF PHARMACYPharmacy practice.17. The practice of pharmacy consists in determining and ensuring the proper use ofmedications, particularly to identify and prevent pharmacotherapeutic problems, and inpreparing, storing and delivering medications in order to maintain or restore health.Reserved activities.The following activities in the practice of pharmacy are reserved to pharmacists:1) Issuing a pharmaceutical opinion;2) Preparing medications;3) Selling medications, in accordance with the regulation under section 37.1;4) Supervising medication therapy;5) Initiating or adjusting medication therapy, according to a prescription, making use,where applicable, of appropriate laboratory analyses;6) Prescribing and personally dispensing emergency oral contraception medication provideda training certificate has been issued to the pharmacist by the Order pursuant to aregulation under paragraph o of section 94 of the Professional Code (chapter C-26).1973, c. 51, s. 17; 1990, c. 75, s. 4; 2002, c. 33, s. 22.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 20Appendix 2G: New BrunswickThe practice of pharmacy is defined in the Pharmacy Act.Pharmacy ActPRACTICE OF PHARMACY5.1(1) The practice of pharmacy promotes health, the prevention and treatment ofdiseases, dysfunction and disorders through proper drug therapy and non-drug therapy,including, but not limited to, the following actions:(a) assist and advise clients, and other health care providers by contributing unique drugand non-drug therapy knowledge on drug and non-drug selection and use;(b) monitor responses and outcomes to drug therapy;(c) compound, prepare, dispense and administer drugs;(d) provide non-prescription drugs, blood products, parenteral nutrition, health care aidsand devices;(e) supervise and manage drug distribution systems to maintain public safety and drugsystem security;(f) educate clients, and members of the Society in matters described in this section;(g) conduct or collaborate in drug-related research;(h) conduct or administer drug and other health related programs;(i) advise and support other pharmacists in the provision of pharmacy services;(j) direct the client to consult with other health care providers when appropriate;(k) the practices set out in subsection (2), when performed by a member who meets thequalifications and any restrictions or conditions set out in the regulations.5.1(2) A member who meets the qualifications set out in the regulations may, subject toany restrictions or conditions set out in the regulations, engage in any of the followingpractices in the course of practicing pharmacy:(a) prescribe drugs and treatments that are designated in the regulations for thepurpose of this section;(b) administer drugs that are designated in the regulations for the purpose of thissection;(c) interpret client-administered automated tests that are designated in the regulations;(d) order and receive reports of screening and diagnostic tests that are designated in theregulations.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 21Appendix 2H: Nova ScotiaThe practice of pharmacy is defined in the Pharmacy Act. S.80(2)d of the Pharmacy Actpermits the Governor in Council to make regulations respecting the circumstances underwhich a licensed pharmacist may prescribe drugs.Pharmacy Act(r) "practice of pharmacy" means the practice of pharmacy as described in this Act andincludes professional services provided by a pharmacist related to the use, dispensing,compounding or distribution of drugs to or for the public and the responsibility for taking allreasonable steps to ensure pharmaceutical and therapeutic appropriateness of the therapy;(2) The practice of pharmacy includes the practice of and responsibility for(a) the interpretation and evaluation of prescriptions;(b) the provision of information respecting drug and non-drug therapy;(c) the compounding, dispensing and added labeling of drugs and devices;(d) taking all reasonable steps to ensure pharmaceutical and therapeuticappropriateness of a drug therapy;(e) monitoring drug therapy;(f) the identification, assessment and recommendations necessary to resolve or preventproblems in patients related to drugs;(g) counselling persons respecting the therapeutic values, content, hazards, side effectsand proper use and storage of drugs and devices;(h) the safe storage of drugs and devices;(i) the maintenance of proper records for drugs and devices, including patient records;(j) services, duties and transactions necessary to the management, operation andcontrol of pharmacies;(k) the sale of drugs and devices; and(l) other professional services authorized by law.PROFESSIONAL RESPONSIBILITY25 (1) The primary responsibility of a pharmacist is the provision of optimal patient care.(2) The practice of pharmacy includes the practice of and responsibility for(a) the interpretation and evaluation of prescriptions;(b) the provision of information respecting drug and non-drug therapy;(c) the compounding, dispensing and added labeling of drugs and devices;(d) taking all reasonable steps to ensure pharmaceutical and therapeuticappropriateness of a drug therapy;(e) monitoring drug therapy;(f) the identification, assessment and recommendations necessary to resolve or preventproblems in patients related to drugs;(g) counselling persons respecting the therapeutic values, content, hazards, side effectsand proper use and storage of drugs and devices;(h) the safe storage of drugs and devices;(i) the maintenance of proper records for drugs and devices, including patient records;(j) services, duties and transactions necessary to the management, operation andcontrol of pharmacies;(k) the sale of drugs and devices; and(l) other professional services authorized by law.(3) Every pharmacist shall ensure that each patient has sufficient information and advicefor the proper use of the drug or device dispensed.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 2280(2) The Governor in Council may make regulations respecting(a) those provisions of this Act that apply to hospital pharmacies;(b) the regulation of hospital pharmacies;(c) the regulation of the practice of pharmacy in a hospital;(d) the circumstances under which a licensed pharmacist may prescribe drugs.(3) In any regulation passed pursuant to this Section, the Council or the Governor inCouncil may adopt by reference, in whole or in part, any schedule, code, specification,examination, standard or formulary, and may also provide that it is adopted as amendedfrom time to time, except such amendments as are expressly disallowed by the Council orthe Governor in Council, as the case may be.Regulation 24 of the Regulations Respecting Qualifications and Professional Accountability,provides the following:Conditional authority24 (1) In this Section, "conditional authority" means the authority for a pharmacist tolawfully carry out medical activities, services or functions under the conditions set out in awritten agreement between the College and the College of Physicians and Surgeons of NovaScotia.(2) The College may enter into a written agreement with the College of Physicians andSurgeons of Nova Scotia that authorizes a pharmacist to carry out medical services,activities or functions and that has as its underlying objectives, improved access to healthcare by the public and achieving the best health care results for the public.(3) An agreement entered into under this Section must(a) prescribe the conditions under which the conditional authority may be exercised,including any education or certification that may be advisable or required by apharmacist before a pharmacist can perform any medical activities, services or functionsunder the conditional authority;(b) confirm the professional responsibility and accountability of a pharmacist whoperforms any medical activities, services or functions under the conditional authority;and(c) be filed with the Minister of Health.(4) An agreement entered into under subsection (2) must not authorize a pharmacist toprescribe narcotic or controlled drugs and a pharmacist is prohibited from prescribingnarcotic or controlled drugs under a conditional authority.(5) A medical activity, service or function that a pharmacist carries out under a conditionalauthority is deemed to be practising pharmacy in accordance with the Act and theregulations made under the Act.(6) For the purposes of Section 44 of the Medical Act, a medical activity, service or functionthat a pharmacist carries out under a conditional authority is deemed to not be a violation ofthe Medical Act or the regulations made under the Medical Act.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 23Appendix 2I: Prince Edward IslandThe practice of pharmacy is defined in the Pharmacy Act.Pharmacy Act (including amendments May 22, 2008)(o.1) “practice of pharmacy” means(i) manufacturing, compounding or otherwise preparing a drug, including packaging,repackaging or labelling,(ii) dispensing a drug,(iii) giving expert instruction or advice on the use of or appropriateness of a drug, theperformance of which skill, in the opinion of the Board, requires specialist knowledgeand judgment concerning the properties of drugs; or(iv) giving a prescription for a drug.(p) “prescription” means a direction for the preparation and dispensing of a drug that isgiven by(i) a person authorized by the law of any province or territory to practise as a physician,dentist or veterinarian,(ii) a person authorized to do so by the Minister under section 14.1; or(iii) a pharmacist.7(2) The functions of the Board are to...(g) prescribe conditions and restrictions on the authority of pharmacists to giveprescriptions.

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 2: 24Appendix 2J: Newfoundland and LabradorThe practice of pharmacy is defined in the Pharmacy Act.Pharmacy Actpractice of pharmacy means(i) having responsibility for preparing, distributing and controlling drugs in a pharmacy,(ii) compounding a prescription,(iii) dispensing a drug,(iv) selling a drug by retail,(v) disseminating information on the safe and effective use of a drug when dispensing orselling a drug, or(vi) subdividing or breaking up a manufacturer's original package of a drug for the purposeof repackaging the drug in larger or smaller quantities for redistribution, and includesteaching, consulting or advising in the areas of pharmaceutical services, education, policy orresearch by a person registered under this Act;

HPRAC Submission: Scope of Practice of Pharmacy: June 19, 2008 Appendix 3: 1Appendix 3: Blueprint for PharmacyTask Force on a Blueprint for Pharmacy. Blueprint for pharmacy: the vision for pharmacy. Ottawa(ON): Canadian Pharmacists Association; 2008. www.pharmacists.ca.O:\dwilliams\HPRAC submission re Pharmacy Scope of Practice - June 19, 2008.doc