2005 Edition Report on Drug Administration Procedure & Practices ...

ForewordMedication safety and provision of quality care to patients are the first and foremost priority in thedelivery of medical services of the Hospital Authority. Towards this aim, the Hospital Authority hasfor years been maintaining a close watch on the high risk areas of the drug administration systemwhich may require improvement or change in practices. In 2000, the <strong>Report</strong> on DrugAdministration Procedures and Practices was published. Since then, the 2000 <strong>Report</strong> has beenvalued as an indispensable piece of guidance for the medical, pharmacy and nursing staff in theHospital Authority.However, with the passage of time, the advancement in new technology leading to more complextreatment protocols and the increasing public demand for high quality services, new issues and newpotential risk areas continue to emerge in the drug administration process. Thus, in 2004/<strong>2005</strong>,medication incident has become one of the priority areas in the annual plan of the RiskManagement Committee. A working group was appointed by the Risk Management Committee toreview commonly occurred medication incidents in the Hospital Authority and to makerecommendations for improving patient safety. As a step forward, the working group was alsogiven the task by the Drug Utilization Review Committee to review the 2000 report founding on thespirit and principle of the recommendations.The essential theme of the recommendations is to nurture a culture of high quality patient care withzero medication incidents as the ultimate goal of all personnel involved in the drug administrationprocess. Medication incidents do occur for a variety of reasons and at almost every stage of the drugadministration process. With the increasing complexity in treatment protocols, the possibility andfrequency of the occurrence of medication incidents will correspondingly increase. Maximumawareness of each health and medical professionals involved in the drug administration processwould be one of the important factors to reduce medication incidents. Standardisation of proceduresand their strict compliance will also help to minimize medication incidents. Risk management thuscalls for the highest vigilance of every one of us.With the above in mind, the Working group had carried out a comprehensive revision of the 2000<strong>Report</strong>. The revised guidance will help to make medicine safer for all the patients.Dr. W L CheungChairman, Drug Utilization Review Committee1

Executive SummaryIn 2000, the <strong>Report</strong> on Drug Administration Procedures and Practices was published. A set ofrecommended practices and requirements were drawn up with respect to all the then identified riskareas in the drug administration process. The 2000 <strong>Report</strong> has already laid a good foundation forsafe medication.In mid 2004, a working group comprising of medical, pharmacy and nursing staff from differentclusters was set up with two objectives. The first one is to identify gaps between the recommendedprocedures and the actual practices and to make recommendations for improvement. The secondobjective is to review and update the 2000 <strong>Report</strong>. The <strong>2005</strong> <strong>Report</strong> on Drug AdministrationProcedures and Practices is thus an updated version of the 2000 <strong>Report</strong>.To maintain easy reference, the <strong>2005</strong> <strong>Report</strong> adopts substantially the same format and layout of the2000 <strong>Report</strong>.Chapter 1 outlines the composition, terms of reference and objectives of the working group.Chapter 2 provides an overview of the progress on the implementation of the recommendations ofthe 2000 <strong>Report</strong>.Chapter 3 identifies those areas where improvements are needed in the drug administration process.Satellite Pharmacy model and the Cluster Pharmacy model which have been operating for sometime in certain hospitals are included in addition to the conventional In-patient model for in-patientdrug administration review.Chapter 4 consolidates the updated recommendations on the different procedures and practices inthe drug administration process. The recommendations on certain high risks areas have beenemphasized and strengthened. The high risk areas are, for example drug allergy, electronicprescribing on discharge prescription, drug repackaging and drug replenishment. New evolvingareas such as management of drug samples, handling of specific drug groups, hazardous chemicals,resuscitation medications and Chinese Medicine are also included.Chapter 5 sets out various Quality Assurance Programmes regarding Drug Therapy Administrationwith specific highlights on the implementation of the Advanced Incidents <strong>Report</strong>ing System (AIRS).2

Chapter 6 summarizes the specific recommendations in order to facilitate a speedy reference onvarious major tasks for priority implementation.As with the 2000 report, it is recommended that clusters’ and hospitals’ DTC should use this newreport as a framework to review their local practices, to promulgate and disseminate therecommended practices extensively and effectively to all staff concerned, and to carry out auditprogrammes on staff adherence to the recommended practices.Lastly, members of the Working Group would like to express their gratitude to all the hospital staffand professionals who had provided invaluable feedbacks and constructive proposals. It is only withthe collaborative efforts of the multidisciplinary team that this <strong>Report</strong> can be successfully published.3

TABLE OF CONTENTSReferenceParagraphsForewordExecutive SummaryAbbreviationsChapter 1 The Working GroupMembership of the Working Group 1.1Terms of Reference 1.2-1.3Objectives 1.4Chapter 2 The Progress <strong>Report</strong>Progress <strong>Report</strong> of HA Hospitals based on the 10 Recommendations of the<strong>Report</strong> on Drug Administration Procedures & Practices (2000 <strong>Edition</strong>) 2.1Chapter 3 Areas for Improvement in the Existing DrugAdministration ProceduresFlow Chart of Existing In-patient Drug Administration ProcedureExisting In-patient Drug Administration ProcedurePrescription PracticesPharmacy Drug Supply SystemDelivery of DrugsStorage of DrugsAdministration of Drugs in the Wards<strong>Report</strong>ing of Medication Incidents & Adverse Drug ReactionsDisposal / Return of DrugsChapter 4 Recommended Practices and RequirementsPrescription Practices / Procedures 4.3-4.50Pharmacy Drug Supply System 4.51-4.79Delivery / Storage Of Drugs 4.80-4.92Drug Administration Procedures In The Wards 4.93-4.127Handling Requirements For Specific Drugs 4.128-4.135Information Technology In Patient Care 4.136-4.137Quality Assurance Programmes 4.138-4.140Chapter 5 Quality Assurance ProgrammesMedication Incident <strong>Report</strong>ing Programme 5.1-5.5Adverse Drug Reactions <strong>Report</strong>ing Programme 5.6-5.8Quality Complaint on Pharmaceutical Items 5.9-5.11Drug Recall 5.12-5.154

Chapter 6Conclusions and RecommendationsTeam Approach to the Promulgation, Dissemination and Implementationof Procedural Guidelines6.1-6.7Recommended Development ProgrammesStandardization on Medication Administration Processes 6.8Information Technology in Patient Care 6.9-6.11Medication Incident <strong>Report</strong>ing Programme 6.12Adverse Drug Reactions <strong>Report</strong>ing Programme 6.13Implementation of MAR, CARS, & Barcode Topping Up Systems 6.1424 hours or Extended Pharmacy Service 6.15Aseptic Dispensing Services 6.16Clinical Pharmacy Service 6.17Continuing Education 6.18-6.19Audit Programme 6.20-6.21List of ReferenceAppendicesAppendix 1Appendix 2Appendix 3aAppendix 3bAppendix 4Appendix 5Appendix 6Appendix 7Appendix 8Appendix 9Appendix 10Appendix 11Appendix 12Appendix 13Appendix 14Appendix 15Appendix 16Appendix 17IV Fluid and Drug Additives Administration FormInsulin Administration MAR FormsLists of HA-wide Approved / Standard Abbreviations in Prescribing“Do Not Use Abbreviations”Schedule for the Administration of “tds” DrugsMechanism for the Management of Drug Samples in the HAHA Guideline on Safe Management of Potassium Chloride IV SolutionsSupply of Antidotes and Detoxifying Agents in HA HospitalsGuideline for Supply of Medication for Patients during Inter-Hospital TransferSamples of the Line LabelsGuidelines on the use of Three-way / Four-way StopcocksGuidelines on Patient Self Medication for General PatientsGuidelines on Patient Self Medication for Psychiatric In-patientGuidelines on the Disposal of Pharmaceutical Chemical WasteGuidelines on the Handling of Dangerous Drugs in HA HospitalsMedication Incident <strong>Report</strong>ing ProgrammeAdverse Drug Reaction <strong>Report</strong>ing ProgrammeProcedure for Quality Complaints on Pharmaceutical ItemsUpdated in Oct 08 5

AbbreviationsThe abbreviations used in this book are listed in the table below for your easy reference.ADR Adverse Drug Reactions HCE Hospital Chief ExecutiveA&E Accident and Emergency ICP Intra-cranial PressureAIRSAdvanced Incidents <strong>Report</strong>ingSystemITInformation TechnologyCARSComputerized Automatic RefillSystemIVIntravenousCCE Cluster Chief Executive KCl Potassium ChlorideCDDH Corporate Drug Dispensing History LKSSC Li Ka Shing Specialist ClinicCE Chief Executive MAR Medication Administration RecordCIVASCentralized Intravenous AdmixtureServiceMIMedication IncidentCM Chinese Medicine MIRP Medication Incident <strong>Report</strong>ingProgrammeCMS Clinical Management System MOE Medication Order EntryCOS Chief of Service MOEMET Medication Order Entry MajorEnhancement TaskCPO Chief Pharmacist’s Office NCR No Carbon Required Multi-partCarbonless PaperCSC Clinical Service Coordinator PMH Princess Margaret HospitalCVP Central Venous Pressure PMS Pharmacy Management SystemD Director PMS-OP Pharmacy Management System –Out-patientDM Department Manager PYNEH Pamela Youde Nethersole EasternHospitalDTC Drug and Therapeutics Committee QMH Queen Mary HospitalDURC Drug Utilization Review Committee SOPD Specialist Out-patient DepartmentEDS Express Dispensing System TKOH Tseung Kwan OGM(N) General Manager (Nursing) TMH Tuen Mun HospitalGOPD General Out-patient Department TPN Total Parenteral NutritionHA Hospital Authority YOOPD Yan Oi Out-patient DepartmentHAHOHospital Authority Head Office6

CHAPTER ONETHE WORKING GROUPMEMBERSHIP OF THE WORKING GROUP1.1 The Working Group was appointed to review and update the contents of the <strong>Report</strong> onDrug Administration Procedures and Practices in Public Hospitals (2000 edition). All thesafety issues associated with the whole process of drug administration would be reviewed.Its membership was selected from the three professional groups involved namely, doctors,nurses and pharmacists from the institutions under Hospital Authority.The composition of the working group is as follows:Convenor:Mr Pak Wai LEEMembers:Dr S Y AUDr Eric CHANMs C C CHENGMs Sau Chu CHIANGMr Dalton CHONGMs Pauline CHUMr William CHUIMs Betty KUDr C B LAWMs Anna LEEDr Benjamin LEEDr Petty LEEMr Michael LINGDr Siu Fai LUIMr William POONDr Cheung San TJIUDr Tak Cheung WONGMr Alan WONGDr Loretta YAMSecretary:Ms Teresa NGANChief Pharmacist, HAHOService Director (Community Care), NTWC / Consultant(Geriatrics), TMHExecutive Manager (Nursing), HAHODepartment Operation Manager (Medicine & Geriatrics), KWHSenior Pharmacist (Pharmacy Practice Management), HAHOManager (Nursing)2, HAHOCluster Coordinator, NTWC (PHARM)HKWC Chief of Pharmacy Service / QMHPHA DMDepartment Operation Manager 5, Team (3,5,7), KCHConsultant (Medicine & Geriatrics), PMHSenior Pharmacist (Professional & Clinical ServicesDevelopment), HAHODepartment Manager (Pharmacy), PWHPharmacist, (Professional & Clinical Services Development),HAHODepartment Manager (Pharmacy), KWHCluster Co-ordinator (Pharmacy), NTEC / Service Director(RM&QA), PWH / Co-ordinator (Clinical Services), PWH /Consultant (Medicine), PWHSenior Nursing Officer (Central Nursing Division), UCHResident (Surgery), UCHChief of Service (Medicine), TKOHGeneral Manager (Nursing), QMH/TYH/SYPCSC(Medicine), HKEC / Clinical Coordinator 4, PYNEH / Chiefof Service (Medicine), PYNEHExecutive Partner (CPO), HAHO7

TERMS OF REFERENCE1.2 To identify gaps between the recommended procedures and actual practices and torecommend guidelines for improvement.1.3 To review and update the <strong>Report</strong> on Drug Administration Procedures and Practices inPublic Hospitals.OBJECTIVES1.4 The following objectives were laid down to guide the deliberation of the Working Group:(a) Patient SafetyThe Working Group regards patient safety as the single most important objective in theentire process of drug administration. The latter is composed of the prescribing, dispensingand administration processes. It requires that a continuous effort is made by all the threeprofessional groups, namely doctors, nurses and pharmacists and this must be coordinated.Procedural guidelines should be drawn up and enforced to maximize patient safety, facilitiesand equipment must be optimized to minimize medication error.(b) Professional StandardsIn an endeavour to devise policies to optimize patient safety, the Working Group acceptsthat there are professional standards relevant to the medical, pharmacy and nursing gradesthat should be considered. Taking into account their different roles, these professionalstandards must be coordinated and incorporated into procedures and practices, so thatmedical, pharmacy and nursing staff can discharge their duties smoothly and effectively.(c) Optimizing the Utilization of ResourcesConsiderations must also be given to optimize the systems used for drug administrationprocedure within the institutions. Procedures must be streamlined to utilize better theresources available, whether it be manpower, drugs or facilities.8

CHAPTER TWOTHE PROGRESS REPORT2.1 Progress <strong>Report</strong> of HA Hospitals based on the 10 Recommendations of the <strong>Report</strong> onDrug Administration Procedures & Practices (2000 <strong>Edition</strong>)No. Recommendations Current Status (December 2004)IIIIIIIVVHAHO should encourage thepromulgation, dissemination &implementation of therecommended practices &procedural guidelines in the2000 <strong>Report</strong> on DrugAdministration Procedures andPractices in Public HospitalHospitals DTC should adopt theprocedural guidelines andpromulgate them at the localhospital level. Following theiradoption the DTC shouldcommence the continuousreview of staff adherence tothese guidelines.Hospital should follow theCentral list of HA-wideapproved/standard abbreviationsin prescribing.Hospitals should review theModel Intravenous (IV) Fluid &Drug Additives AdministrationForm. They should reassesstheir existing hospital IV drugadministration forms and makeany modifications necessary.Hospitals should seek tooptimize turnaround times andprevent any possible tamperingor losses during the process ofdrug delivery to wards.• A presentation had been made to all HCE in the HCE RoundtableMeeting in January 2000.• A briefing session of the <strong>Report</strong> had been held for all DTCchairpersons and representatives from pharmacy and nursingsections in April 2000.• Pocket version of the Drug Administration Procedures andPractices was published and distributed to all medical, pharmacyand nursing staff in 2000.• Hospitals are required to report the level of compliance to therecommendations of the <strong>Report</strong> on Drug AdministrationProcedures and Practices (2000) as stipulated in HA Annual PlanSection 3 Standard 29 (Medication Use). <strong>Report</strong>s should besupported by DTC minutes and evidence of relevant auditprogrammes / documents.• A central “List of HA-wide Approved / Standard Abbreviationsin Prescribing” consisted of standard abbreviations for drugnames, routes of administration, drug administration frequenciesand dosages was drawn up and included in both the standard andpocket versions of the <strong>Report</strong>.• A model “IV Fluid and Drug Additives Administration Form”was recommended to the Hospital DTCs for appropriatemodification of their hospital IV drug administration form.• Various designs of drug receptacles to be used for drug deliveryhad been sourced and recommended to the hospital pharmacies.• Hospital pharmacies were recommended to review their drugtransportation process and rectify deficiencies which couldpossibly result in misappropriation or tampering of drugs.VIHospitals should prioritize theirresources for the purpose ofensuring the safe drug use,improving the efficiency of drugdistribution systems and thequality of patient care.• Round-the-clock pharmacy service was introduced in QMH,PMH and TMH in Oct 2001.• Clinical Pharmacy Service was introduced as an on-goinginitiative in various hospitals at the ward level of nephrology unit,critical care unit, paediatrics unit, oncology unit etc, and satellitepharmacies were established in PYNEH, PMH, TKOH and TMH.• Clustering of the aseptic dispensing services, in-patient drug9

No. Recommendations Current Status (December 2004)VI (continued) distribution and drug procurement was developed along the lineof the cluster development plan to improve the efficiency of thedrug distribution systems.• The current IT system was continuously updated to facilitate drugadministration processes in patient care: -‣ Individual patient dispensing for in-patients including CARS,non-CARS and Aseptic Dispensing (TPN dispensing,Cytotoxic dispensing and CIVAS)‣ Ward stock processes including barcode topping up system‣ Discharge / Out-patient dispensing (GOPD, SOPD, Staff,A&E ) including PMS-OP, MOE system, EDS, RefillPrescription, Pre-pack Label and MOEMET‣ Computer-linked automated dispensing system, namely BakerCell Dispensing System (introduced in various hospitalpharmacies) and Robotic Prescription Dispensing System(introduced in LKSSC and YOOPD in Mar 2002)‣ With the introduction of the CDDH in PMS & CMS in 1996and 1999 respectively, patient’s medication dispensing historycan be made readily available in PMS and CMS.VIIMedical, nursing and pharmacystaff should keep abreast of thefast changes in the field ofmedicine, drug therapy &related technology, to enablethem to be competent inproviding a professional service.VIII Hospitals should comply withthe Medication Incident<strong>Report</strong>ing Programme (MIRP)with the aim ofminimizing/preventing theoccurrence of medicationincidents.• On-going education in the form of seminars, lectures andworkshops has been organized, and various drug informationleaflets have been produced by HAHO and local hospitals.• Drug bulletins such as Drug Education Bulletin and New ProductBulletin are published on an on-going basis; and DrugInformation Leaflets on Asthma, Cardiovascular Disease,Diabetes, Parkinson’s Disease and Renal Disease have beenpublished by the HAHO.• MIRP Bulletins are published on an on-going basis at half-yearlyinterval by the HAHO, and 19 bulletins have been published atpresent.• “Insulin Administration / Blood Glucose Monitoring Form” and“Intravenous Insulin Administration Form” were recommendedby the insulin working group convened by HAHO to the hospitalDTCs with the aim of minimizing medication incidents.• Electronic reporting of medication incidents through AIRS isbeing implemented in phases since 2002.IXXA standard reportingmechanism/format to beestablished to collectinformation on Adverse DrugReactions (ADR) fromhospitals.Individual hospitals to set upaudit programmes to monitorstaff adherence to the variousguidelines.• The ADR <strong>Report</strong>ing Programme was established andimplemented in October 2001.• Hospitals are required to report the level of compliance to therecommendations of the <strong>Report</strong> on Drug AdministrationProcedures and Practices (2000) as stipulated in HA Annual PlanSection 3 Standard 29 (Medication Use) supported by DTCminutes and evidence of relevant audit programmes / documents.• Compliance of hospitals to the <strong>Report</strong> will be monitoredperiodically in the Service Management Meeting (Pharmacy).10

CHAPTER THREEAREAS FOR IMPROVEMENT IN THE EXISTING DRUG ADMINISTRATION PROCEDUREFlow Chart of Existing In-patient Drug Administration ProcedurePrescriber initiates the drug orderPrescriber writes the drug orderNurse reviews the drug orderSatellite Pharmacy ModelNONurse screens all the drug orders and decides which one to be sent downto pharmacy for drug supplyDrug orders that bypass thepharmacy vetting systemDrug orders that go through the pharmacy vetting systemClinical Pharmacist reviewsthe drug order in wardNurse prepares drugs (e.g.ward stock, clinical trialmedications & patient’s“brought in” drugs) in theward to administer to patientsClusterPharmacy ModelDrugs delivered to thewards of other hospitalsPharmacy reviews the drug orderOrders verified correct by pharmacyDrugs prepared &supplied by pharmacyDrugs delivered to the wardsAutomatic CARSrefills until“off”MAR sent/faxed to Pharmacyby nurseOrders verifiedcorrect by clinicalPharmacistDrugs prepared &dispensed directlyinto the drug trolleyby pharmacy staff ofSatellite PharmacyDrugs stored in thewards of other hospitalsDrugs stored in the wardsDrugs stored in the drug trolleysNurse prepares drugs to administer to patientsNurse identifies the patient in the wardNurse administers drugs to patient in the wardNurse records drug administration in the wardThe monitoring & reporting of the patients’ responses to medicationsNurse disposes or returns ward drugs to pharmacy11

Existing In-patient Drug Administration Procedure3.1 The existing drug administration procedure consists of a number of sequential actionscarried out by doctors, nurses and pharmacists. The ideal sequence should be the doctorinitiates and writes drug order, the pharmacist reviews the order and supplies the drugs,the nurse administers the drugs to the patient.3.2 The following flow chart indicates the sequential steps of the existing in-patient drugadministration process, from ordering, through dispensing to administration. Each step hasits own unique opportunities for error. Most of the steps are critical control points, whereunchecked errors at those points can lead to a chain of errors.Prescriber initiates the drug orderPrescriber writes the drug orderPrescriber initiates the drug orderExisting Problems:• Patient information such as medical history,patient biodata & drug history includingdrug allergy, is needed in initiating a drugorder and might not be readily available.• Drug information might not be easilyavailable at the time when it is needed.Prescriber writes the drug orderExisting Problems:• Illegible handwriting.• Use of non-standard drug nameabbreviations.• Dose of medication is not in exact dosage.• Unclear abbreviations for time of drugadministration, e.g. q.d. & q.i.d.• Use of non-standard abbreviations for theroute of administration.• Intravenous drug order not available forpharmacy for vetting.• Different interpretation of “start date” onthe drug order.12

Existing In-patient Drug Administration Procedure (continued)Nurse reviews the drug orderNurse screens all the drugorders and decides whichone to be sent down topharmacy for drug supply(i) Drug ordersthat gothroughthe pharmacyvetting system(ii) Drug orders thatbypass the pharmacyvetting systemNurse reviews the drug orderNurses will be responsible for reviewing thedrug order and dispensing when ward stocksare prescribed. In some cases of IndividualPatient Dispensing, for reasons of quickaccess, nurses might administer drugs fromovernight ward stocks or belonging toanother patient to patients before theirindividual medications are dispensed. This isundesirable as the following problems mightoccur. Ideally there should be a balancebetween the pharmacy and nursing staffinvolvement in the process of reviewingdrug orders. Counterchecking is moreimportant and should be practised whereverpossible.Nurse prepares drug orders in the wardThis includes the drug orders for ward stock,clinical trial medications & patient’s “broughtin” drugs.Existing Problems:• Some medications may be administered topatients directly in wards prior to ordervetting by the pharmacy.• Nurses may not be familiar with the use &administration of certain drugs.• Upon order receipts, pharmacies do not inputthe orders into the patients’ profiles.• It is sometimes impossible to identifymedications brought in by patients.Existing Problems:• The nurse needs to interpret accuratelythe new order after it has been writtenso that the correct drug can be given.• Might not be aware of any inherentproblems in the prescription order, e.g.potential drug interactions, adverse drugreactions.• Illegible orders can be misinterpreted orpresumed to be the wrong drug.• Verbal orders can be misheard ormisinterpreted.13

Existing In-patient Drug Administration Procedure (continued)Nurse sends the drug order topharmacy for drug supplyPharmacy reviews the drugorderNurse sends the drug order to pharmacy fordrug supplyThe MAR forms are used in all the HA hospitals.The MARs are transmitted either by fax or NCRto the pharmacy for dispensing. This practicecan reduce the chances of transcribing error andthe workload of the nursing staff.Existing Problems:• Time-lag between drug orders by ward andmedication supplies from pharmacy mayrender the use of “unused” stocks in wards inurgent situations.• Transcribing errors still exist owing to theillegibility of the original order andmisinterpretation during transcribing onto thenew MAR forms.Pharmacy reviews the drug orderExisting Problems:• The complete drug profile for each patientnot being available to the pharmacy forchecking of any potential druginteractions.• The pharmacist might not have all thenecessary information, such as druginformation & patient informationincluding diagnosis available whenreviewing the order.• Not every order can be checked bypharmacist due to resource & manpowerconstraints.Satellite Pharmacy ModelThe clinical pharmacist reviews the drugorders in wards soon after prescribing or withthe prescriber during the ward rounds. Thedrugs will be dispensed by the pharmacystaff of the satellite pharmacy directly intothe drug trolleys in wards.14

Existing In-patient Drug Administration Procedure (continued)Order verified correct bypharmacyDrugs prepared andsupplied by pharmacyYesNoIllegible/ambiguous/problematic drug ordersExisting Problems:• It is possible for an illegible/ambiguous orderto be misinterpreted or presumed to beanother drug.• Extra time or effort will be needed inconfirming the order.Drugs prepared & supplied by pharmacyThere are 2 methods of drug supply frompharmacy, which are Individual PatientDispensing and Ward Stock Supply. Wardstock are still needed due to the lack of a 24hours pharmacy service:Existing Problems:i) Individual Patient DispensingDispensing errors arise from :• Similar drug item codes• Similar drug names & sound-alikedrug names• Look-alike packages of drug items• Wrong dose calculation• Wrong information on labels• Non-compliance with the doublecheck systemii) Ward Stocks• Larger variety of ward stocks holding,pooling & transferring of ward stock andimproper rotation of ward stock may stillexist in those wards without the wardtopping-up system.• Prescriptions for ward stock items are notsent to pharmacy, thus the drug profiles ofpatients compiled by pharmacy areincomplete.• Pharmacy does not have the opportunityto verify these prescriptions and cannotmonitor the actual consumption of noncontrolledward stocks.• Nurses are not specifically trained todispense drugs.15

Existing In-patient Drug Administration Procedure (continued)Drugs delivered to the wardswithin the same hospital andof other hospitalsMost of the drugs are delivered to wards in properly locked receptacles except for the delivery bysatellite pharmacy where drugs dispensed are placed directly into the drug trolley in ward.Drugs delivered to the wards within the same hospital (except for Satellite Pharmacymodel )Existing Problems:• Physical constraints, e.g. insufficient locked receptacles for the transportation of drugs.• Locked receptacles are not absolutely safe and secure if plastic seals of no numberidentificationare used to lock the receptacles, tampering of seals is possible.Drugs delivered to the wards of the other hospitals (Cluster Pharmacy model)Some hospitals may provide in-patients drug dispensing service to other hospitals within the samecluster. The drugs will be dispensed against the MARs faxed from the receiving-hospital to thedispensing-hospital. The drugs will then be delivered to / picked up by the inter-hospital porterteam.Existing Problems:• Inadvertent dispensing for drugs prescribed outside the hospital formulary of the receivinghospitalis possible.• In the receiving-hospital, a larger variety and higher stock level may be required in wards andthe emergency drug cupboards for urgent requirement.• Longer duration of drug supply may be required as daily delivery service may not beavailable and this may increase the drug returns and drug wastage.• If more than one receiving-hospital is served, drugs may be placed in the wrong receptaclesand transported to the wrong hospitals resulting in treatment delay or medication incidents.16

Existing In-patient Drug Administration Procedure (continued)Drugs stored in the wardsNurse prepares drugs toadminister to patientsDrugs stored in the wardsExisting Problems:• Inadequate storage cupboards or storagespace for drugs.• Drugs may be stored in a disorganisedmanner or at inappropriate locations e.g.refrigerated items are not being refrigeratedand items not required refrigeration are beingrefrigerated.• Domestic refrigerators without any lockingdevice or without an adequate temperaturecontrolling function are used for the storageof drugs.• Other non-pharmaceutical items (e.g. bloodsamples, food) may be stored with the drugsand that will create a contamination hazard.• Unused pre-diluted / reconstitutedmedications may not be discarded and keptfor future use.Nurse prepares drugs to administer topatientsExisting Problems:• Different hospitals have differentpractices regarding the level of nursingpersonnel involved in drug administration.• Non-compliance with the guidelinesregarding drug administration practice.• Some of the medications are not suppliedin the most ready-to-administer form, forexample, injectable drugs. Their dosecalculation & reconstitution are morelikely to generate errors. The workload ofnurses and their lack of familiarity withcertain drugs can also give rise tomedication errors.17

Existing In-patient Drug Administration Procedure (continued)Nurse identifies the patientin the wardNurse administers drugs tothe patient in the wardNurse identifies the patient in the wardExisting Problems :• No requirement for patients to wear identitybracelets in some hospitals.• Wrong patient gum labels on the MAR.Nurse administers drugs to the patient inthe wardExisting Problems:Medications errors often arise from:• Non-compliance with the standardpractice guidelines, especially the 3checks and 5 rights.Each route has its own risk, especially theparenteral route :• Injectable drugs are not supplied in themost ready-to-administer form.• Technical factors can also cause errorsincluding equipment malfunction or pumpfailure.18

Existing In-patient Drug Administration Procedure (continued)Nurse records drugadministration in the wardThe monitoring & reporting ofthe patients’ responses tomedicationsNurse records drugs administration in thewardUnder the existing practices, there are twogroups of patients regarding medicationadministration.The first group of patients participate in theself-administration programme, and can selfadministertheir own drugs. The other group ofpatients will take their medications under thesupervision of the nursing staff.Existing Problems:• For the second group of patients, nursesmay not wait to confirm that the medicationhas been consumed by the patient in somebusy wards. Unattended drugs left on apatient’s over-bed table may lead to theomission of doses or drugs being consumedby the wrong patient.• The medications for a particular patientmay be charted in more than one place andmultiple records can potentially lead toconfusion and errors.• Nurses may not be aware of thediscontinued medications on the MAR andmay continue to administer to patients.• Medications may not be administeredaccording to the recommended time /intervals of administration.The monitoring & reporting of patients’responses to medicationsAdverse Drug Reaction (ADR) <strong>Report</strong>ingThere is a standard procedure or mechanism torecord clinically significant ADR in HAhospitals.Existing Problems:• Some ADR may not be reported.Medication Incident (MI) <strong>Report</strong>ingThere is a standard procedure or mechanism toreport MI in HA hospitals. <strong>Report</strong>ing of MI byelectronic means via the AIRS will be rolledout in phrases to more hospitals of the HA.Existing Problems:• Some medication incidents such as nearmisscases may not be reported.• Those medication errors which have beenrectified before drug administration areunder reported in some hospitals. These‘near-miss’ cases can actually be used foreducational purposes.• Insufficient follow-up action & educationfollowing medication incidents.19

Existing In-patient Drug Administration Procedure (continued)Nurse disposes or returns warddrugs to pharmacyNurse disposes or returns ward drugs topharmacySome dispensed drugs are unused due to thedischarge or death of patients or other reasons forthe discontinuation of treatment. These left-overneeded to be returned to pharmacy or disposed ofin other ways.Existing Problems:• Over-prescribing, frequent changes in drugtherapies and inefficient drug distributionsystems have all contributed to the hugeamounts of ward drugs returned for disposal.This has created much unnecessary and costlydrug wastage.• A lot of manpower and time are used insorting out the returned drugs.• Unused drugs might be pooled together inwards to form ‘unofficial’ ward stocks.• Refrigerated drugs are left in roomtemperature for a certain period of time priorto returning to pharmacy render the drugsinappropriate for reuse.20

CHAPTER FOURRECOMMENDED PRACTICES AND REQUIREMENTS4.1 Based on the problem areas detailed in the preceding chapter and considering the overallobjective of ensuring quality patient care, the Working Group has come up with thefollowing sets of recommended practices and requirements to prevent medication errors andencourage the economical use of drugs.4.2 The Working Group recognised that there are different constraints in the various institutionsand has accordingly incorporated certain flexibilities into these recommended practices andrequirements. Individual institutions should therefore be able to use this document as aframework to draw up/review their existing guidelines.(A) RECOMMENDATIONS ON PRESCRIPTION PRACTICES / PROCEDURES4.3 The Medication Administration Record (MAR), commonly called the Drug Chart, should berecognised as the official document for the entire in-patient drug administration process. Assuch, it should be the ONLY document on which doctors prescribe, for which the pharmacystaff dispense drugs, and according to which the nurses administer drugs. The onlyexception is when computerised order entry arrangement has obviated the need for a paperMAR.Design of the MAR4.4 The MAR should be designed so as to facilitate prescribing by doctors, administration bynurses and dispensing by pharmacy staff. The following are regarded as essentialinformation to be provided in the design of any MAR :(a)Personal detailsInformation on personal details should include name, HKID no., sex, age (or in the case ofneonates, the date of birth, body weight in kg and the identity of the mother), drug allergy,hospital identification number, and preferably the diagnosis of the patient. Beforeprescribing, doctors MUST ensure that the MARs have already been labelled with thecorrect patient’s information.(b)Drug allergyThe drug or any substance that the patient is or becomes allergic to MUST be recorded inthe appropriate areas of the drug orders and patient’s medical records. Doctors should verifyand amend the drug allergy information where appropriate. Patients without drug allergymust be recorded as “NIL” or “No Known Drug Allergy (NKDA)”. Prior to the prescribingof medications, drug allergy records of the patients must be re-checked by the doctors.21

Standard Intravenous Fluid and Drug Additives Administration Form4.5 The administration of intravenous infusion and drug additives has been found to beassociated with serious medication errors, therefore its prescription order and administrationshould be documented as part of the MAR. A model “IV Fluid and Drug AdditivesAdministration Form” has been recommended to hospitals’ DTCs for appropriatemodification for their local use (refer to Appendix 1). The IV form should be madeavailable to doctors, nurses and pharmacists and allow the pharmacist to review and verifythe safety of the intravenous drug order, to check the accuracy of the dose calculation aswell as the dilution and infusion rate of the intravenous infusion before administration. Inorder to minimize the occurrence of medication incidents, the prescribers should reviewintravenous prescription orders on a daily basis.4.6 The prescription order and administration of the other routes of parenteral administrationsuch as intramuscular injection, subcutaneous injection, have already been documented andincluded in the normal MAR.Standard Insulin Administration MAR Form4.7 It has been shown that insulin administration is one of the most frequently reportedmedications incidents in the HA. To ensure patient safety and to safeguard againstmedication incidents in the utilization of insulin in the HA, two structured MAR forms,namely “Insulin Administration / Blood Glucose Monitoring Form” and “IntravenousInsulin Administration Form (DKI or IV insulin pump)” which serve as the templates forprescribing, dispensing and administration of insulin have been recommended to hospitals’DTCs for appropriate modification for their local use (refer to Appendix 2).Legibility4.8 The MAR is the official document detailing the drug treatment for the patient. It is essentialfor doctors to prescribe in a clear and legible manner so as to be understood by all personnelhandling the MAR. Illegible or doubtful prescriptions should always be verified with theprescriber.4.9 Clear and legible prescriptions are an essential requirement of good clinical practice. Thisshould be strongly emphasised in all hospital drug administration guidelines. In addition, anumber of other measures should be considered :-(a)(b)Doctors should be required to write FIRMLY on the MAR with indelible ink, e.g.using a black ball pen.A regular feedback mechanism should be established, in order to enhance theawareness of prescribers to the problem of illegibility.Start Date4.10 This should be included to record the date on which a drug treatment is to commence.22

Drug Name4.11 There should be a hospital Formulary available. This Formulary should be regularly updatedand be easily accessed by medical & nursing staff. This Formulary should list the approvednames, i.e. the generic names and the dosage formulations of the drugs in stock. The habit ofusing trade names for drugs should be discouraged particularly when generics are beingdispensed.4.12 Prescriptions should be made in the most appropriate conventional form and dosage of drugs,as according to the hospital Formulary.4.13 All drugs should be prescribed by their approved name and should preferably be printed infull in BLOCK LETTERS. It is essential that all entries made on the MAR are complete andlegible. Only approved abbreviations should be accepted.4.14 A list of standard, HA-wide approved drug name and frequency abbreviations has beenestablished. Doctors should either prescribe in full text or adhere to this list ofabbreviations (refer to Appendix 3).4.15 A ‘Hospital Authority Drug Formulary’ has been drawn up. The professional staff can referto this list for cross reference and information.Dosage4.16 The dose of medications should be prescribed using the METRIC system. Also dosageshould be expressed in terms of the active ingredients and NOT, for example, the number oftablets or volume of liquid, except in the case of compound preparations.4.17 Dosage abbreviations and decimal points should be avoided. eg. 0.5g should be expressed as500 mg. To avoid any confusion with milligram (mg), Microgram should be written in fullinstead of mcg or μg. Units should be written in full instead of i.u.4.18 It is recommended that standardized dosing and dilution methods for a list of commonlyused IV medications should be devised and endorsed by the hospitals’ DTC. Doctors shouldprescribe the IV medications by their standardized dilution concentrations and choice ofdiluents in normal circumstances.Routes of Administration4.19 A list of unambiguous, standard abbreviations should be drawn up. Doctors should eitherprescribe in full text or adhere to this list of standard abbreviation in prescribing the route ofadministration (refer to Appendix 3). In case of doubt, the staff member who is responsiblefor the drug administration must verify with the prescriber the abbreviations used.Times of Administration4.20 Times of administration schedule should be clearly given. As an alternative, this can be preprintedon the MAR for regular medications. Doctors should need only to select theappropriate times on the chart. This will save the doctors’ time in stating the frequency of23

administration in full. If abbreviations are to be used, prescribers should adhere to the list ofstandard abbreviations of time for drug administration listed in Appendix 3. For drugadministering on a three times daily basis, ‘Schedule for the Administration of “tds” Drugs’in Appendix 4 may be referred to.4.21 For once ONLY medications, the date and time of administration should be specified. For‘as required’ medications, they should include the reasons for treatment, the maximumfrequency of administration and/or the times of administration if appropriate. For onceDAILY medications, it is recommended that the full text ‘daily’ should be used but NOT‘q.d.’ and the time of administration should also be specified.Valid Period4.22 When it is anticipated that a certain medication is to be given for a defined period, thisshould be clearly stated. Automatic ‘stop’ arrangements for a normal course of treatmentshould be agreed beforehand for certain groups of medication, e.g. antibiotics. Continueduse after such agreed period should then be subject to physician’s review.Signature4.23 The doctor must put their identification code or full name in block letters together with theirauthorised signature on all the prescriptions. The prescribing physicians’ most updatedspecimen signatures should be made available for reference by nursing and pharmacy stafffor checking purposes.Transcription of Drug Order4.24 A copy of the MAR in the doctor’s original handwriting should be sent to the pharmacy inorder to avoid transcribing errors. This can be done, for example, by using the NCR paper orby fax. In future this process would be replaced by a computerised order entry system.Alterations to a prescription4.25 No prescription item should be altered in part. Changes in a prescription order shouldinvolve the complete cancellation of the existing prescription item and the writing of a newone to avoid any ambiguity and consequent administration errors.Discontinuing and cancelling a prescription4.26 Prescriptions should be reviewed regularly by doctor. Medications should be cancelled ordiscontinued by drawing a diagonal line through the drug name and/or a slanted double-lineacross the administration section corresponding to the “discontinued” medication on theMAR in order to minimize the risk of continuous administration. Cancellations anddiscontinuations of instructions must be signed and dated.24

Electronic prescribing (Medication Order Entry -- MOE)4.27 Discharge and home leave prescriptions can be prescribed through the Medication OrderEntry (MOE) system. While electronic prescriptions improve legibility and remove theambiguity of orders, this should be developed in the in-patient section (In-patient MOE).Verbal Orders4.28 Only in emergency and approved circumstances may a verbal order be given if the doctor isunable to attend personally. The instruction may only be accepted by an Enrolled orRegistered nurse who must immediately record the instruction in the patient’s MAR andannotate it a ‘verbal order’.4.29 After the instruction has been written, it must be READ BACK to the doctor checking thepatient’s identity, drug name, dosage, frequency and method of administration. It is theresponsibility of the doctor giving the verbal order to ensure the correct interpretation of theverbal order.4.30 The nurse receiving the message must, after following the normal checking procedure,administer the drug and personally give both verbal and written instructions to the nursestaking over from him/her.4.31 A verbal order must be confirmed in writing by the doctor concerned as soon as possibleand within 24 hours at the latest [refer to Pharmacy & Poisons Regulations, Cap. 138A,Section 23(4)].4.32 Dangerous Drugs should not be ordered through verbal orders (refer to Dangerous DrugsRegulations, Cap. 134A, Section 3).Patient’s Own Medications4.33 Patients should always be asked if they have brought any medications into hospital withthem. To prevent unauthorised self-administration, brought-in medications should be takeninto safe custody by the nursing staff and shown to the doctor and/or pharmacist.4.34 The patient’s own medications should not normally be administered in hospital unless theyhave been positively identified, specifically prescribed by the doctor and when supplies arenot immediately available from hospital sources. The general practice of allowing patientsto continue their own brought-in medications without verification should not be encouraged.(Identification of medications currently used in the HA may be searched by the TabletIdentifier on HA intranet http://cpointra/tabident.php;Registered Pharmaceutical in Hong Kong may be searched on the website of Department ofHealth http://www.info.gov.hk/pharmser/Reg_ir/download_pharm.html)4.35 The protocol / logistics for identification, prescribing and administration of brought-inmedications to patients should be endorsed by the hospitals’ DTC.25

4.36 If the patient’s own medications are to be administered in hospital, the prescription orderand administration of brought-in medications should then be recorded in the patient’s MARand the MAR should be sent / faxed to the pharmacy for order vetting and computer input.4.37 These medications should be returned to patients on discharge with a clear indication as towhether they are to be continued / discontinued.Drug Samples4.38 Drug samples should include not only new drugs but also post-marketing drugs which arenew to that hospital. In 2002, a mechanism for the management of drug samples in the HAhas been endorsed by the DURC (refer to Appendix 5). The hospital DTC or an equivalentcommittee should establish policies and procedures to approve, control and monitor the useof drug samples in the hospitals and their affiliated clinics.4.39 As with all medications, the drug samples approved for use must be dispensed by thepharmacy. This will enable HAHO to keep an updated record of all the drug samples usedin the HA.4.40 The standards, drug recalling and incidents reporting mechanisms applicable to medicationsuse in the hospitals should apply to drug samples.4.41 The introduction of drug samples to the Hospital Formulary should follow the normal newdrug application procedures as established by the hospital DTCs.4.42 Patients should be fully informed that drug samples are prescribed to them for trial only overa definite period.Clinical Trial Medications4.43 Individual hospitals should draw up their own protocols regarding the supply, storage,preparation and distribution of clinical trial medications. Appropriate details regarding suchclinical trial medications should be supplied to the pharmacy before the commencement ofthe clinical trial.Record of all Medications4.44 All medications including routine drugs, clinical trial medications, brought-in drugs, drugsample, intravenous fluid, insulin and TPN should be prescribed properly and theiradministration recorded accordingly.Chinese Medicines (CM)4.45 The use of CM in the HA hospitals should follow the guiding principles of the “HospitalAuthority Guidelines on Interface Issues between Chinese Medicine and ConventionalWestern Medicine” (refer to Clinical Manuals / Guidelines of Chinese Medicine on HAintranet).26

4.46 When the use of CM is permitted to be given to the patients treated in the HA hospitals,either under research protocols or authorized by the doctors, the details of CM prescribed bythe CM practitioners should be properly recorded in the patients’ medical records.4.47 In any case, the use of CM should be indicated by the doctors on the MARs as “ChineseMedicines”. The MARs should be sent / faxed to the Pharmacy for computer entry so that itwill be indicated in the patient’s profile that “Chinese Medicines” are being used. Theadministration of CM should be properly recorded as with the practices for otherconventional medications.Nurse-initiated Medications4.48 In order to facilitate effective patient care, under the authority of appropriate writtenprotocols approved by Hospital DTC, qualified nurses may be allowed to initiate certainmedications on their own. Individual hospitals may consider and approve a list of nurseinitiatedmedications. Such protocols should specify the rank of nurses allowed to initiatemedication on the approved list and specify limits on the number of doses, dosages to begiven. Medications initiated by nurses should be checked and countersigned by a doctorwithin :(a) 48 hours in the case of non-poisons,(b) 24 hours in the case of poisons (i.e. controlled medicines which are under theclassification of Schedule I to III in the Pharmacy and Poisons Ordinance.)Discharge Medications4.49 Doctors should prescribe all the medications that the patients are currently taking and notjust those required for discharge. However, when the supplies of certain medications are notrequired, they should be clearly indicated in the MOE with the action status (dispense inclinic / purchase by patient / keep record only). When the manual discharge prescriptionsare made, the action status used in the MOE should be written on the prescriptions.4.50 Particular care should be taken when patients are taking two or more similar drugs or thesame drugs in different dosage forms. The possibility and consequences of drugs beingprescribed previously or subsequently at outpatient clinics should be considered.(B) RECOMMENDATIONS ON PHARMACY DRUG SUPPLY SYSTEMPharmacy Drug Supply System4.51 The Pharmacy drug supply system should be designed so as to facilitate drug distribution, toestablish a complete drug profile for each patient and to minimise the amount of ward drugreturn. All in-patient prescriptions should go through the pharmacy vetting system whichacted as a safe guard before the drugs administered to the patients. All drug orders receivedby the pharmacy must be input into the system in order to maintain a complete patient’smedication profile.4.52 The Computerised Automatic Refill System (CARS) is one of the drug supply systemscurrently being used in HA hospitals. This system facilitates the drug distribution process27

and generates a complete drug profile for each patient. It is a medication refill systemdesigned to save nursing time. The refill duration should be decided locally with the aim ofminimising the amount of ward drug return and drug wastage.Individual Patient Dispensing4.53 The majority of inpatient medications should be supplied on an individual patient basis bythe pharmacy. Individual patient dispensing enables the pharmacist to verify the safety andappropriateness of each prescription order and to detect and deal with any potentialproblems such as drug interactions and drug allergies before supplying medications to wards.The correct dispensing of medications is the professional responsibility and duty of thepharmacy staff.Involvement of Pharmacists in the Drug Administration Process4.54 Pharmacists should take an active role in the drug administration process which is anintegral part of patient care. This should be achieved through having a Clinical PharmacyService at the ward level. All information available including that contained within thepatients’ notes as well as that obtained on ward rounds and by direct communication withthe doctor and patient should be used by the clinical pharmacists to offer advice to doctorsand nurses on appropriate medications and potential medication-related problems.4.55 Pharmacists should ensure that medications are used rationally, cost-effectively and in theirproper therapeutic context. Verification by the prescribing doctors must be made shouldthere be ambiguity or doubt in the appropriateness of the drug orders.Clinical Pharmacy Service4.56 A Clinical Pharmacy Service involves the practice of pharmacy in a multidisciplinaryhealthcare team with the objective of achieving the best possible quality use of medicationsand thus providing optimal patient care. The service includes medication history taking,drug supply, drug therapy monitoring, drug information, discharge patient counselling andpharmacokinetic interventions. The Clinical Pharmacist-run Compliance and Refill Clinicshave been set up, as part of the clinical pharmacy service initiatives, in many specialistclinics of the hospitals.4.57 A Satellite Pharmacy Service is a mode of operation in the Clinical Pharmacy Service. It hasalready been implemented in PMH, PYNEH, TKOH and TMH with satisfactory results. TheSatellite Pharmacy is in close proximity to the wards. It enhances the involvement of theclinical pharmacy service and the efficiency of the in-patient pharmacy service. It optimisesthe drug distribution system and minimises the amount of ward drug supply. This results inreduced ward drug return and unnecessary drug wastage. Nurse dispensing duties arereduced and more nursing time can be given to patient care. It also allows a unit dosedispensing system to be practised.Preparation of Drugs4.58 Pharmacists are recommended to supply drugs in the most appropriate form or the mostready-to-administer form in order to minimise errors. Therefore, the provision of TPN,28

cytotoxic and central intravenous admixture services by pharmacy would improve qualityand safety. In addition, a number of issues have been considered :(a)(b)(c)Limiting the choices of available drugs in pharmacy and the dose concentration orstrength for each drug would help to reduce the chances of errors.Complete, updated information on the reconstitution, dilution and compatibility ofintravenous drugs should be supplied by pharmacy to the nurses on the wards foreducational and cross-checking purposes. 1Doctors who have prescribed unconventional strengths or forms of a drug should becontacted by a pharmacist in order to discuss for modifying the prescription.Accuracy in Dispensing4.59 Proper in-house checking procedures should be built into the dispensing system in thepharmacy. The pharmacy staff must remain alert in the process of data entry, as similar drugcodes often give rise to medication errors. It is important to recognise that the merechecking of the label against the content is not sufficient. Reference should always be madeto the ORIGINAL prescription in checking the end product of the dispensing process for thecorrectness of the drugs and any possible undesirable interactions amongst them. The doublecheck system should be practised whenever possible.4.60 For high risk drug items e.g. digoxin, or those known to be associated with seriousmedication errors, all steps in the dispensing process especially the calculation of dose,should be checked independently by another member of the pharmacy staff, preferably apharmacist.4.61 Every prescription order and all dispensed medications should preferably be checked by apharmacist, for detecting and dealing with any potential medication errors and potentialproblems such as contraindicated drug, drug interactions. Any necessary clarification in aprescription order must be resolved with a doctor before the medication is dispensed andadministered to the patient.Labelling of Dispensed Medications4.62 The labelling of dispensed medications allows for the positive identification of the drug andthe patient to whom the drug is supplied. Proper labelling should be provided on alldispensed medications in compliance with the requirements of the Hong Kong MedicalCouncil and the Pharmacy and Poisons Board. The list of requirements for the labelling ofmedications is as follows :(a) Name of patient(b) Date of dispensing(c) Trade name or pharmacological name of the drug 2(d) Dosage per unit1 Cross-checking is defined as checking the correctness of the information or a calculation by a different personwhile double-checking is defined as checking the correctness twice by the same person or by a different person.2 In HA, this will be in the form of approved pharmacological name or when unavoidable, trade name of the medication(i.e. in the case of compound preparation). Exemption might be made for approved research when patients have giventheir fully informed consent, the drug name might not be included.29

(e) Method and dosage of administration(f) Precautions where applicableAll of the above labelling requirements are applicable to the dispensing of medications forout-patients. In the case of in-patient medications, such as Individual Patient Dispensing andWard Stock, appropriate labelling should be used.Containers of Dispensed Medications4.63 All medications should be supplied in clean, safe and appropriate containers.Manufactures’ Original Packaging and Labelling4.64 In order to reduce errors that could arise from inappropriate packaging and labelling of themanufactures’ original products, users’ immediate feedback to the CPO on the issues isdeemed necessary. This will facilitate the CPO in future products selection, advisingvendors on improvement and liaising with the Department of Health on the regulatorycontrol on packaging and labelling of pharmaceutical products.Re-packaging of Medications from the Manufacturers’ Original Containers4.65 Re-packaging of medications refers to re-packaging and re-labelling of commonly used drugproducts from the manufacturers’ original packages to suitable and convenient quantities fordispensing and drug distribution.4.66 The process of re-packaging must be supervised and checked by authorized personnel in thepharmacy and proper in-house rules should be in place to safeguard the procedures.4.67 The process of re-packaging should be performed in a suitable demarcated area in thepharmacy with appropriate lighting and minimal distraction.4.68 The re-packaged unit should be properly labelled with clear identification of the drug, aretraceable batch reference and any other relevant information to fit on the label as far aspossible.4.69 Proper records of re-packaged drugs should be kept in case of any future recall.Drug Replenishment4.70 Drug replenishment includes replenishment to the drug shelf and automated dispensingmachines should be performed and counterchecked by well-trained dispensing staff. Properrecording and checking mechanisms should be in place to facilitate the replenishment andrecall of drugs.4.71 Replenishment of stocks should follow the “First In, First Out” principle to ensure properstocks rotation. The stocks should be placed in the correct locations against the shelves’labels clearly marked with the proper drug names, strengths and dosage form etc in anorderly and tidy manner.30

4.72 Special precautions should be taken in situations such as replenishment of re-packed drugs,drugs from the ward return and medications not picked up by patients, etc.Pharmacy Service Hours4.73 In order to improve the quality of services, round-the-clock pharmacy services wereintroduced in QMH, PMH and TMH in October 2001. The 24 hours pharmacy serviceshould be further rolled-out to all acute general hospitals when resources are available.Ward Stock Supplies4.74 To maintain the continuity of drug supplies outside pharmacy service hours and for variousother operational reasons, ward stocks will still be required to facilitate the process of supplyand administration of medications to patients. In order to maintain a proper ward stocksystem, the following points should be considered :(a) The reasons for keeping ward stocks must be well established. The items included in theward stock list must be appropriate to the practice/activity of each individualspecialty/unit.(b) Particular caution should be exercised regarding the drug items that have commonlybeen involved in potential medication errors, such as concentrated forms of drug itemsthat required dilution into larger volume, e.g. concentrated KCl injection (refer toAppendix 6). These drug items should not be kept as ward stock in general care areas.All ward stock items must be supplied in appropriate labelled containers.(c) The range of ward stocks and the quantity kept for each item should be minimised. Theward stock item level should be updated periodically.(d) A list of ward stock items should be maintained and periodically reviewed. Anyunnecessary items should be deleted. The addition of any item to the list must beexamined critically.(e) Pharmacy staff should be actively involved and responsible for the whole process ofward stock management e.g. by using a bar-code topping up system.(f) In the absence of barcode topping up system due to resource constraints, the “two bottlesystem” should be employed. This will help the nursing staff monitor the levels of wardstocks more easily.Emergency Drug Supplies outside Pharmacy Service Hours4.75 When a 24 hours pharmacy service is not feasible, access to a limited supply of medicationsfrom the Night Cabinet should be available to doctors or nursing staff for use in initiatingurgent medication orders. For the “Cluster Pharmacy Model”, an effective and efficientward stock replenishment system and special arrangement for ad hoc / urgent requirementsmust be in place.31

4.76 A small quantity of the drug items should be kept in the night cabinet which is kept lockedwhen not in use. The drug items to be kept in the night cabinet, should be chosen with safetyin mind. The container for each item should be labelled with the drug’s name, strength,quantity, expiry date and retraceable lot number.4.77 Where an emergency drug supply is made and a prescription is to be provided later, amedication order must be made at the time of emergency drug supply. Such medicationorder should be verified by the pharmacy staff and the drug item replenished within 24 hours.Supply of Antidotes and Detoxifying Agents in HA hospitals4.78 Certain antidotes and detoxifying agents are stocked by some HA hospitals (refer toAppendix 7). Clinical departments should check with their hospital pharmacies for the mostupdated version of the list. Arrangement should be made through the hospital pharmacy ifany of these agents are required.Supply of Medications for Patients during Inter-hospital Transfer4.79 The continuity of drug supply must be considered as the top priority regarding the supply ofmedications for patients during inter-hospital transfers. The medications should be properlylabelled. The detailed HAHO guidelines are shown in Appendix 8.(C) RECOMMENDATIONS ON THE DELIVERY / STORAGE OF DRUGSDelivery of Drugs4.80 Delivery of drugs includes the drugs delivered to within and outside (Cluster PharmacyModel) the hospitals. Hospitals should continue to improve their existing facilities fortransportation of drugs to prevent possible misappropriation or tampering by the use oflocked receptacles. Plastic seals with control number printed on each seal or combinationlocks can be used.4.81 For the “Cluster Pharmacy Model”, designated personnel to handle the drug delivery / pickupare recommended. Use of different coloured / colour-coding receptacles for differenthospitals should help to minimize the chances of mix-up of drugs delivery between hospitals.4.82 Separate receptacles should be used for refrigerated items and cytotoxic drugs. Auxiliarysigns to accompany items that require special handling instruction, such as “drugs requiredrefrigeration” and “CHEMOTHERAPY — HANDLE WITH CARE, DISPOSE OFPROPERLY”, in both English and Chinese should be made available.Storage of Drugs4.83 All drugs must be stored under suitable conditions, appropriate to the nature and stability ofthe drug concerned. They must be protected from contamination, sunlight, atmosphericmoisture and adverse temperatures, kept in safe custody with locks.32

4.84 To prevent mixing up medications for different patients, it is essential that drug trolleys withseparate receptacles for keeping the individual patients’ medications should be used on thewards.4.85 Ward drug cupboards and drug trolleys have to be kept locked when not in use and to bekept out of reach of patients.4.86 DD should be kept under lock and key in a designated drug cabinet and the key should bekept by the nurse in-charge at all times.4.87 Some medicinal products require storage at a low temperature. Pharmacy and ward staffshould check the labelling on the product for the appropriate storage requirements.Pharmaceutical refrigerators, wherever possible, should be used for the proper storage ofdrugs in wards and in pharmacy. It should be equipped with a maximum/minimumthermometer. The temperature should be checked regularly and should be in the range of2°C to 8°C. The refrigerators used for storing medications, should be used solely for thispurpose4.88 It is important that medicinal products for external use be stored separately from the drugitems that are for internal use. Medicinal products for external use e.g. liquid antiseptics,have to be stored in a SAFE place and labelled with the warning “For external use only”.Inspection of Storage and Records of Drugs4.89 The designated registered pharmacist(s) or medical practitioner(s) should inspect the storageconditions of poisons in places, such as pharmacies and wards, where poisons are requiredto be stored at regular intervals of time not exceeding three months in accordance with therequirements as stipulated in the Pharmacy & Poisons Regulations, Cap. 138A, Section24(5).4.90 The person(s) appointed by the medical officer in charge of the hospitals / clinics shouldexamine the storage, supplies and stocks of the DD in the hospitals / clinics at least once inevery month in accordance with the requirements as stipulated in the Dangerous DrugsOrdinance, Cap. 134, Section 23(5).Storage of Dangerous Goods (DG)4.91 Dangerous Goods (DG) should be stored at designated places in the clearly labelledchemical storage cabinets. Only minimum amount should be kept at the place of workaccording to OSH recommendation. For details, end-users should refer to (1) Factories andIndustrial Undertakings (fire precautions in notifiable workplaces) Regulation, Cap. 59V,Section 9 for storage of inflammable substances and (2) Dangerous Goods General from theFire Services Department.Storage of Medical Gas Cylinders/Containers4.92 The storage of medical gas cylinders must comply with the provisions of the DangerousGoods (General) Regulations. For details, end-users should refer to the Medical Gas SystemOperation Manual on cpo.home of HA intranet.33

(D) RECOMMENDATIONS ON DRUG ADMINISTRATION PROCEDURES IN THEWARDSNo medications should be administered to a patient if a drug order is unclear or when there isdoubt in the appropriateness and safety of the patients.Level of Nursing Personnel involved in Drug Administration4.93 Under normal circumstances, a Registered Nurse is competent to administer medications onhis/her own. However, it is advisable to have a second person counter check the processespecially in situations where skill, experience and familiarity with the clinical conditionsare required to ensure safe practice, such as with paediatric medication, intravenousinjections, dangerous drugs, cytotoxic drugs and drugs added to infusion fluids. In any case,nurses should exercise care to double check themselves and not to rely solely on others withregard to the checking process.4.94 Enrolled Nurses should work within their qualification and training. In normalcircumstances, they can administer medications, when delegated this duty by RegisteredNurses. In the case of the extended and expanded role of the Enrolled Nurse, an enablingcourse or clear guidelines should be provided.4.95 Nurse learners who have undergone training in medication administration and are deemed tobe competent, may administer medications under the supervision of qualified nurses.Order and Receipt of Drug Supplies from the Pharmacy4.96 All drugs orders should be sent (e.g. by fax or by NCR) to the pharmacies for vettingirrespective of whether the supplies of drugs are required. Prior to sending of the drugorders, authorized nurses should screen the information on the orders to ensure the correctpatient’s label has been affixed and all important information for drug dispensing andadministration have been clearly written.4.97 All “discontinued” medications on the MAR should be faxed to the pharmacy as soon aspossible so that unnecessary re-dispensing of discontinued drugs can be avoided. In thecases of urgent / uncertain situations, the pharmacy department should be called to confirmthe receipt of the drug orders.4.98 All drugs delivered to wards must by checked by the authorized nursing staff as soon as theyare received. Drugs with special storage instructions such as refrigerated items must be putin the refrigerator promptly. The patient’s name on each of the drug label and the name andcondition of each of the drug dispensed must be checked for accuracy and acceptabilitybefore putting them into the drug trolleys.34

The Principle of Three checks and Five RightsCheck patient’s identity according to the patient identification guidelines.4.99 In drug administration, the principle of “three checks and five rights” should always beobserved. These include :-(a) Careful checking BEFORE taking the medication out from thecontainer,…………(first check)(b) Careful checking AFTER removing the medication from thecontainer,………………(second check)(c)(d)(e)(f)(g)(h)Final checking of the medication against the container before disposal/putting itaway………………...(third check)Right patientRight drugRight doseRight routeRight time4.100 To ensure the practice of three checks and five rights, the related checking procedures aredescribed below :(a)(b)(c)(d)(e)(f)READ the prescription. Ascertain which drug is due to be given. If the prescriptionis illegible, the nurse must refer back to the prescriber to have the prescription rewritten.Nurses should refer to the MAR for the administration of drugs. Transcription of thedrug order onto a separate work sheet should be avoided. The MAR for long staypatients in convalescent hospitals should be appropriately designed. It should beused as the record of administration of drugs to patients.Check the identity of the patient according to the patient identification guidelines.Check the patient’s name and that the name of the drug corresponds with theprescription. It is very important that the RIGHT patient and drug are positivelyidentified.Check the patient’s drug allergy.Check the name, strength, and expiry date of the drug (where available), the dose tobe given and route and time of administration, and that the drug order is still valid.35

(g)Caution should be exercised in the calculation of dose. For high risk drug items, allwork especially the calculation of dose should be checked independently by anothernursing staff member.4.101 Should nurses have any doubt during the course of the procedure, they should withhold drugadministration until verification by the prescribing doctor or, exceptionally, by anotherRegistered Nurse.Administration of Intravenous Medications4.102 As injectable drugs can be associated with very serious medication errors, special cautionmust be exercised in the administration of intravenous drugs.4.103 Administration guidelines for parenteral drugs which provides information on the dilutionand administration of injectable drugs that are commonly used in the HA is available in thepharmacy and on cpo.home of HA intranet. Nurses should always make reference to theguidelines and in the case of any uncertainty about the information provided, nurses shouldrefer to the product inserts or contact the pharmacy department of their hospitals.4.104 When a high risk intravenous medication is prescribed, the prescription order must beindependently checked by 2 nurses to ensure that the order has been correctly interpretedand that the drug, dose calculations, preparations, route & mode of administration areaccurate.4.105 Extreme care should be exercised with those intravenous drugs which can never be given bybolus but only by infusion. In such cases, the dose calculation should preferably be done bya pharmacist. However, pre-defined charts for dilutions and protocols for standardizedinfusion rates should be used when intravenous infusions are to be prepared by nurses in thewards.4.106 The bolus of IV dangerous drugs should preferably be administered by a doctor.4.107 The administration of IV fluids and drug additives should always be documented. The IVchart together with the date, time and the amount of drug to be given should be signed.4.108 Syringes containing drugs should be properly identified in order to prevent any mix-up ofmedications. In no circumstances should any unidentified drugs be given to patients andthey MUST BE discarded immediately when found.4.109 Patients who simultaneously have an IV line and other types of non-IV tubing in place, areat risk of a potential mix-up in the lines. It is important that the tubing lines are traced backcarefully to the site of insertion before drugs or feeds are administered. It should have accessline label if it is more than one line. (refer to Samples of the Line Labels in Appendix 9)4.110 Nursing staff using medication administration devices such as infusion pumps, shouldunderstand their operation and the risks of error that might occur with the use of suchdevices. Double checking should be practised when setting up infusion pumps for infusinghigh risk drugs. Limiting the types of infusion pump available to a minimum would alsohelp to reduce the chances of error.36

4.111 Three-way (red and blue) and four-way stopcocks (blue only) are predominantly used forthe administration of intravenous solutions and intermittent injection of drugs. A uniformcolour-code for stopcocks has been adopted to facilitate line identification with blue colourdenoting venous line and the red colour denoting arterial line or intra-cranial pressureline. Since simultaneous dual access may be required for venous access only, Four-waystopcock would only be available in blue colour. The guidelines on the use of three-wayand four-way stopcock are shown in Appendix 10.Record of Administration4.112 The MAR should be used as the record of the administration of drugs to patients. This willeliminate any error inherent in other transcribed reference. The supervising RegisteredNurse and nurse learner administering the drugs should sign the MAR.4.113 The date, time of administration and signature should be entered immediately AFTER thedrug has been given and CONSUMED by the patient.Recording and <strong>Report</strong>ing4.114 Whenever a patient refuses or vomits back a drug, the matter should be recorded on thepatient’s MAR. Other reasons leading to an omission in drug administration should also berecorded, e.g. patient was fasting, drug unavailable. If a dangerous drug has to be discardedbecause it has been spoilt or rejected by a patient, the event should be reported to Nurse inchargeand entry made in the appropriate ledger. The doctors concerned should always beinformed.4.115 As part of the ongoing process (not solely at the times of administration of medications) theeffects and side-effects of the treatment experienced by the patient or observed by nursesshould be recorded and reported.Self-medication Programme4.116 Patients are encouraged and trained to self-administer their own drugs as part of theirrehabilitation programme.4.117 Individual hospitals should establish protocols for carrying out this programme. Suchprotocols should specify the selected patient group, the required physical & mentalconditions of the patient, maturity, level of consciousness and educational background.Nurses may refer to Appendix 11 for Guidelines on Patient Self Medication for GeneralPatients and Appendix 12 for Guidelines on Patient Self Medication for Psychiatric Inpatient.For specific procedure such as patient controlled analgesia, ‘Nursing Standards forPatient Care’ formulated by the Nursing Section of HAHO should be referred to.4.118 Pharmacist should provide patient education and counselling on the use of drugs.Appropriate supervision by the nursing staff must be provided and the assessment of thepatient should be documented.37

The Supply of Ward Stocks4.119 Ward stocks should be stored in an orderly manner. The practice of the rotation of stockshould be observed. Any changes in requirements e.g. stock levels, should be referred to thepharmacy for appropriate action.Pooling of Drugs4.120 Pooling, transferring, repackaging and relabelling of ward stocks should be avoided.4.121 Drugs supplied to the ward whether as ward stocks or on an individual patient basis shouldnot be pooled together. Neither should unused medications be pooled together to form‘unofficial’ ward stocks.Relabelling4.122 Labels originally provided by the pharmacy should NOT be altered or amended. In caseswhere labels are inadvertently destroyed or soiled, the container with its contents should bereturned to pharmacy for relabelling.Dispensing outside Pharmacy Service Hours4.123 For the dispensing of A&E and other prescriptions outside pharmacy service hours, the localpolicy of individual hospital should be followed. Dispensing of ward stock medications bydoctors or nurses for home leave and on discharge is not recommended. When this isunavoidable, the medication dispensed should still be clearly labelled and comply with therequirement of the Hong Kong Medical Council and the Pharmacy and Poisons Board.The list of Requirements for the Labelling of Medications is as follows:(a) Name of patient(b) Date of dispensing(c) Trade name or pharmacological name of the drug (refer to Para. 4.62c)(d) Dosage per unit(e) Method and dosage of administration(f) Precautions where applicableBorrowing of Drugs4.124 Borrowing drugs from another patient’s supply or from other wards should be restricted toexceptional circumstances.Method of Drug Return / Disposal4.125 In order to minimise the amount of ward drugs returned, it is important to optimiseprescribing and drug distribution. This would reduce much unnecessary drug wastage andassociated costs. Unused drugs left over by patients because of discontinuation of treatment38

or their discharge or death, should be returned to the pharmacy. Local policies regardingward drug returns and disposal should be followed and any other required documentationcompleted.4.126 Substances prepared for administration and subsequently not used in the treatment of thepatient concerned, must be disposed of immediately. Procedures for handling of unusedrefrigerated drugs should be established. In the case of DD, this must be recorded in theledger book by both nurses involved.4.127 Antibiotics, dangerous drugs, poisons, other pharmaceutical products and cytotoxic drugs inbulk or significant residue volume 3 in container (e.g. unused or partially used drugs inampoules or syringes) are classified as Pharmaceutical Chemical Waste and should bedisposed according to the Chemical Waste Disposal Regulation. Each hospital unit shouldfollow the guidelines set up by Environmental Protection Department for disposal asstipulated in Appendix 13.(E) RECOMMENDATIONS ON HANDLING REQUIREMENTS FOR SPECIFIC DRUGSDangerous Drugs4.128 The guidelines on the handling of DD in HA hospitals was revised in April 1998. For details,Appendix 14 should be referred to.Cytotoxic Drugs4.129 Cytotoxic Drugs have both anti-cancer activity and the potential to damage normal tissues.Thus they must be handled with extreme care. Individual hospital should draw up localpolicies with regard to their handling and disposal procedures. (refer to the HA SafetyManual on Cytotoxic Drugs Safety)Hazardous Chemicals4.130 Each hospital should establish a Comprehensive Chemical Safety Programme to ensure allhazardous chemicals used in the hospital are properly managed to minimize the riskinvolved. The principles and guidelines established must comply with the OccupationalSafety and Health Ordinance (OSHO) and Subsidiary Regulations. (refer to the HA SafetyManual on Chemical Safety, Material Data Safety Sheet, reference fact sheets and theupdated version of ChemWatch)High Risk Drugs4.131 Particular caution should be exercised regarding the high risk drugs that have been involvedin potential or serious medication errors, e.g. digoxin, concentrated KCl injection. Thesedrug items should not be kept as ward stock in general care areas.3 Significant residue volume means more than 3% volume of container holding the cytotoxic drugs. Ampoules orsyringes holding less than 3% volume of cytotoxic drugs in containers can be placed in sharp boxes and disposed asGroup I Clinical Waste.39

Medications used in Resuscitation4.132 Standard lists of resuscitation medications meeting the national and international trend ofevidence based approaches in different patient groups should be defined. Pharmacologicalmanagement plans for safe and precise medication administration in different situationsshould be formulated by the hospital DTC and followed strictly in CPR.4.133 The medications used in resuscitation are stocked in the emergency trolley and emergencykit(E-kit):-(a) Medications in emergency trolleyThe medications in the emergency trolleys must be specific and consistent within the samespecialty of the cluster / hospital and they must be stored in areas with easy accessibility.The conditions and expiry dates of the medications should be checked periodically andrecords kept of such check.(b) Medications in emergency-kit (E-kit)i. All E-kits should be prepared in the pharmacy. The contents of the E-kit should beproperly labelled, concentrations of the medications standardized and layout of the E-kit consistent within the same cluster / hospital / specialty.ii.A mechanism should be in place in the pharmacy for medication replenishment andreplacement/exchange of the E-kit. Once the security lock/seal is broken, the E-kitshould be returned to the pharmacy department as soon as possible to exchange for anew one with lock/seal. A proper record should be kept in the pharmacy to monitor theexpiry dates of the medications and the location of the E-kit.4.134 Clinical staff must be well-acquainted with the medications used in CPR in terms of theirindications, dosages, units, routes of administration and other special considerations4.135 All medications ordered and administered should be documented in the MAR / resuscitationforms as soon as possible or within 24 hours of the CPR process whichever is the earlier.All orders on the MAR / resuscitation forms should be signed by the clinicians making theorders and administration signed by the nurses giving the medications.(F) INFORMATION TECHNOLOGY IN PATIENT CARE4.136 The improvement made in clinical practice, for example, in the areas of pharmacy service,through the use of information technology system, has been successfully demonstrated.This is evident in the implementation of PMS through system functions, such as thedispensing modules, the CARS, the CDDH, the Bar code Ward Stock Topping Up and theMOE etc. All these systems have significantly enhanced the efficiency of the dailypharmacy operations and have facilitated the process of drug distribution.4.137 It is noted that there is also the use and development of the CMS in the HA to support theclinical care of the patients for use by clinicians and the related parties. This systemrequires active and collaborative participation from clinicians, pharmacists and nursing staff.It can be used to review and reform operational procedures. Not only will this facilitate40

operational requirement but also it will help meeting the clinical needs of users for betterquality patient care.(G) QUALITY ASSURANCE PROGRAMMES4.138 The purpose of quality assurance programmes is to ensure that every drug reaching thepatients is safe, effective and is of quality standard. A number of corporate programmeshave been developed to facilitate the continuous quality assurance of medication use in thehospitals.4.139 These programmes include Medication Incident <strong>Report</strong>ing Programme, Adverse DrugReactions <strong>Report</strong>ing Programme, Quality Complaints on Pharmaceutical Items and DrugRecall.4.140 All medical, pharmacy and nursing staff involved in prescribing, dispensing andadministration of drugs should adhere to the reporting guidelines and procedures asstipulated in each programme for continuous quality assurance. Details of each of theprogrammes are provided in Chapter Five.41

CHAPTER FIVEQUALITY ASSURANCE PROGRAMMESMedication Incident <strong>Report</strong>ing Programme5.1 Medication incidents including “near-miss” cases in HA hospitals should be reported locallyin each hospital using standardised forms. The reporting is on a voluntary basis. Any staffmember encountering a medication incident should be encouraged to make a report,irrespective of whether patients have been involved (refer to Appendix 15).5.2 Completed reports are directed to the hospital DTC or its equivalent which monitors andidentifies the underlying causes for each incident and recommends appropriate preventive orremedial measures to the HCE. The Committee should also report quarterly statistical dataas well as the details of cases of severity index 1-6 to the HAHO using the standardisedreturn forms.5.3 The HAHO will monitor the overall trend of medication incidents and consider appropriatecorporate-wide measures. Apart from this, HAHO also issues MIRP bulletins at half yearlyintervals to HA staff for educational purposes and to the lay press for public accountability.5.4 At the hospital level, each hospital unit is recommended to establish a quality assurance/riskmanagement mechanism. In such mechanism, medication errors would be reviewed andappropriate recommendations and educational programmes would be organized to alert andeducate front-line staff.5.5 <strong>Report</strong>ing of MI by electronic means via the AIRS is being piloted in certain HA hospitalsand will continue to be rolled out to more hospitals of the HA. The value-added factors inAIRS would be the enhanced tools of analysis to assist management in probing root causesof incidents. The promulgation of safety concept and development of learning culturethrough a systematic reporting and reviewing process would be the ultimate goal of the newsystem.Adverse Drug Reactions <strong>Report</strong>ing Programme5.6 The World Health Organisation defines an Adverse Drug Reaction as “any response to adrug which is noxious and unintended, and which occurs at doses normally used in man forprophylaxis, diagnosis or therapy of disease or for the modification of physiologicalfunctions.”5.7 Doctors, nurses and pharmacists must be alert to the potential for or presence of ADR. Astandard procedure to record and report clinically significant ADRs has been established(refer to Appendix 16).5.8 These reports should be reviewed and evaluated on a regular basis, so that any necessaryactions including intervention, documentation, prevention and the provision of educationalfeedback to prescribers and other health care professionals can be done to maximise thesafety of drug use.42

Quality Complaints on Pharmaceutical Items5.9 A quality complaint regarding a pharmaceutical item is defined as concern that is raised ondiscrepancies in efficacy, appearance, packaging, possible contamination or any othercircumstances observed that may jeopardize or cause reasonable doubt on the routine andintended utilization of that item.5.10 In order to provide safe and effective pharmaceutical items to all patients, the qualitycomplaints should be handled in a systematic manner. The procedure must be complied withand all cases of quality complaints must be reported by using the standard report form. Fordetailed procedure, Appendix 17 should be referred to.5.11 Whenever an alert with batch suspension is issued, immediate action must be taken toquarantine all affected batches in all stores both within and outside pharmacy in the hospital.Close liaison with nursing staff should be maintained in order that the situation is fullyunderstood by all parties concerned. All subsequent recommendations including productsuspension, replacement, withdrawal or recall should be executed immediately and to allward levels.Drug Recall5.12 Pharmacists must comply immediately with any warning or recall about defective medicines.A drug recall system must be maintained so that all problematic batches can be traced andretrieved in order to protect patients from any harmful effects due to defective medicines.5.13 All drugs should preferably be kept in their original containers with their unique lot/batchnumber. If it is necessary for drugs to be transferred to another container, such as pre-packs,the retraceable lot/batch number should be marked on the label of the drug item.5.14 When a drug recall is activated, pharmacy must notify all parties concerned immediately,such as the unit head and nurse-in-charge, of the product to be recalled, the reason for itsrecall and the batch number involved.5.15 All affected stock must be quarantined pending further instructions.43

CHAPTER SIXCONCLUSIONS AND RECOMMENDATIONSThis report attempts to address the very important issues of patient safety, system efficiency andquality improvement related to the in-patient drug administration process, which includes drugprescribing, dispensing and administration. The majority of activities related to the assessment ofthe in-patient drug administration process are driven by HAHO but promulgated and implementedin the individual hospitals. In order to achieve the objectives of this report, effective teamwork isessential particularly in the promulgation, dissemination and implementation of the proceduralguidelines and recommended practices to all HA hospitals.Team Approach to the Promulgation, Dissemination and Implementation ofProcedural Guidelines6.16.2It is recommended that a team approach involving the HAHO, individual hospitals’top management such as the CCE / HCE, COS and the professional front-line staff,should be used in the promulgation, dissemination and implementation of theprocedural guidelines in this report.Doctors, nurses and pharmacists have different but integrated roles to play in the wholeprocess of drug administration. They should work together as a team with an ultimateaim of providing quality patient care. Such team work is particularly important inHospital DTC, Department Quality Assurance Programme/Risk ManagementForums and Review Panels on medication incidents.The Mechanism of the Team Approach to the Promulgation, Dissemination andImplementation of Procedural Guidelines6.3 The following flow chart illustrates an example of the mechanism of the team approachand provides a structural accountability framework for the effective promulgation,dissemination and implementation of the procedural guidelines in hospitals.44

LEVELSHAHOCE / DTOOLS & MECHANISMDURCCCE /HCEDTCGM (N)COS /CSCDM (Pharmacy)NursingstaffMedicalstaffPharmacystaffTEAM WORK6.4 The commitment and support from the HAHO and the top management of the individualhospitals are very important. In order to disseminate the procedural guidelines effectively,hospitals should prioritize their resources for the purpose of conducting more trainingworkshops, seminars and forums and train-the-trainer workshops for all staff concernedand especially front-line staff.6.5 Individual hospitals’ DTC should include doctors, nurses and pharmacists. They shouldadopt the procedural guidelines and enhance their roles and responsibilities tocoordinate the various professionals in the promulgation, dissemination andenforcement of guidelines, to monitor and review cases of medication errors, and toaudit staff adherence to these guidelines.6.6 The drug administration guidelines are to be widely distributed and easily accessed byevery doctor, nurse and pharmacist. Wherever necessary, relevant parts of theguidelines should be extracted for use and reference by the relevant staff groups.6.7 The establishment of a mechanism for effective communication between management andfront-line staff should be encouraged. Regular feedback should be obtained from thevarious professional groups, so that problems can be identified and effectiverecommendations/corrective measures made.45

To achieve these objectives, the following range of development programmesare recommended to be implemented in all HA hospitals.Standardization on Medication Administration Processes6.8The working party has acknowledged the importance of standardization of medicationprocesses in establishing uniformity in practice to prevent medication incidents. Anumber of areas have been identified and recommended as priority areas for suchstandardization.It is strongly recommended that standardization should be implemented at theappropriate level such as specialty, hospital, cluster or HA-wide. These include thestandardization of• MAR forms (cluster)• Times of administration of medications (HA)• Dosing and dilution methods of IV solutions (hospital / cluster)• Medications used in resuscitation (specialty / hospital / cluster)Information Technology in Patient Care6.9 The introduction and extensive use of information technology in the areas of prescribingand pharmacy service have had a positive impact on existing practices. The importance ofinformation technology in patient care has already been discussed in paragraph F ofchapter four.6.10 Successful application of the various information technology systems, e.g. PMS, theCARS, the CDDH, the Bar-code Ward Stock Topping Up has brought significantimprovement in the pharmacy service. It facilitates putting many principles of the drugadministration procedures discussed in this <strong>Report</strong> into practice and provides impetus forfurther development. The systems should be extended to more HA hospitals.6.11Use of the MOE module for discharge-patients and out-patients in the CMS improvesclinicians’ access to patients’ drug information and the prescribing process. Furtherenhancement of the medication order entry functions and integration with the pharmacysystems should be developed to improve the utilisation of the systems and to providedecision support to clinicians in drug prescribing and dispensing.It is recommended that feasibility study should be conducted on the development ofin-patient MOE. Robust mechanisms to prevent the prescribing of potentiallyharmful medications to patients with known allergy must be established.46

Medication Incident <strong>Report</strong>ing Programme6.12One of the most important methods for preventing medication errors is for individual, unitor hospital to learn from the mistakes and problems that have already been encountered.It is recommended that each hospital should strengthen their mechanism for thereview of all medication errors and make appropriate recommendations orcorrective measures. Information on medication incidents should be discussed andpresented in the form of workshops and lectures for educational purposes.Electronic reporting through AIRS should be pursued.Adverse Drug Reaction <strong>Report</strong>ing Programme6.13HA has developed a comprehensive, ongoing programme for reporting, monitoring,reviewing and evaluating adverse drug reactions.It is important that each hospital should strengthen their mechanism to collectinformation on ADRs for analysis on a regular basis. Educational feedback shouldbe provided to the prescribers and other health care professionals.Implementation of MAR, CARS & Bar-code Topping Up Systems6.14MAR, CARS and Bar-code Topping Up systems are systems implemented by individualhospitals’ pharmacy department and have made a great impact on the drug administrationprocedure and have enhanced the drug distribution process. The importance of thesesystems has already been discussed in paragraphs 4.51, 4.52 & 4.74 (e). All these systemsare important components in the process of eliminating medication errors during drugadministration.It is highly recommended that these systems be implemented comprehensively in allHA hospitals in the absence of any better alternative at present.47

24 hours or Extended Pharmacy Service6.15The working party has acknowledged the need to provide a 24-hour or at least an extendedpharmacy service in acute general hospitals. A number of problems were identified in thein-patient drug administration procedure arising from the limitations in pharmacy servicehours.It is strongly recommended that a 24 hours or at least an extended pharmacy servicebe introduced in acute general hospitals when manpower and other resources areavailable.Aseptic Dispensing Services6.16Pharmacies are recommended to prepare and dispense medications in the most ready-toadministerform in order to minimize the opportunities for errors. Aseptic dispensingservices, such as TPN, cytotoxic and central intravenous admixture services, arerecognized as important pharmacy services to improve efficiency and accuracy throughstandardization and specialization.It is recommended that the provision of Aseptic Dispensing Services by thepharmacy be extended to or through clustering of service by the acute generalhospitals.Clinical Pharmacy Service6.17The importance of the Clinical Pharmacy Service and the benefits of Satellite PharmacyServices and Compliance and Refill Clinics have already been discussed in paragraphs4.54, 4.55, 4.56 and 4.57. A Clinical Pharmacy Service can undertake risk managementstudies, improve safety and quality as well as reducing the chances for medication errorsand enhancing a multi-disciplinary approach.It is recommended that priority be given to establishing Clinical Pharmacy Servicesin acute hospitals.48

Continuing Education6.18 In order to keep abreast of the fast changes in the field of medicine, drug therapy andrelated technology, doctors, nurses and pharmacy staff including pharmacists anddispensers must receive continuing education and training to enable them to be competentin providing professional services.6.19Information on drug therapy, methods of administration and the use of intravenousadministration devices, should be made available to all personnel in order to maintaintheir standard of knowledge.It is recommended that continuing education in the form of seminars, workshops andlectures should be organized. Information leaflets, drug bulletins and on-line druginformation, for example via the intranet should be prepared for dissemination toall staff concerned, especially the front-line staff on a regular basis.Audit Programme6.20 The Working Group recommended that local feedback systems should be set up toincrease staff awareness of the risk areas in drug administration procedures and anaudit programme should be established in all hospitals to monitor staff adherence tothese guidelines.6.21 At the corporate level, the HAHO will facilitate the adoption of these guidelines andcontinuously monitor and review their implementation.49

List of Reference1. Medicines, Ethics and Practice, A Guide for Pharmacists 1998, Royal PharmaceuticalSociety of Great Britain.2. Practice Standards of ASHP, American Society of Health System Pharmacists.3. Practice Standards and Definitions, The Society of Hospital Pharmacists of Australia 1996.4. Guidelines on Hospital Pharmacy Practice, Second <strong>Edition</strong> 1997, Society of HospitalPharmacists of Hong Kong.5. Good Dispensing Practice Manual 1998, Department of Health.6. Reducing Adverse Drug Events 1998, Lucian L. Leape, Andrea Kabcenell, Donald M.Berwick, Jane Rosessner, Institute For Healthcare Improvement.7. Medication Incidents, The Australian Journal of Hospital Pharmacy Vol 29, No 1 1999,Vol 28, No 2, 4, 5, 6, 1998.8. ISMP Medication Safety Alert, Institute for Safe Medication Practices , Vol 2, issue 231997, Vol 3, issue 2, 3, 5, 8, 14, 18, 19, 20, 1998.9. Medication Incidents <strong>Report</strong>ing Programme Bulletin, Hospital Authority, No. 1 - 1010. Hong Kong Government, Dangerous Drugs Regulations, Dangerous Drugs Ordinance,Pharmacy and Poisons Ordinance, Cap. 134, 138.11. U.K.C.C. Standards for the Administration of Medicines, U.K.C.C., London, 1992.12. Patient Self-administration of Medicine: A Review of the Literature, Collingsworth S., etal, International Journal of Nursing Studies, Vol. 34, No. 4, pp. 256-269, 1997.13. Nursing Standards for Patient Care, Nursing Section, Hospital Authority, Hong Kong.14. Foundations of Nursing, Christensen BL. & Kockrow EO, St. Louis, Mosby, 1995.15. Clinical Nursing Skills: Nursing Process Model Basic to Advanced Skills, Smith SF., &Duell DJ., Norwalk, Appleton & Lange, 1992.16. Basic Nursing: A Psychophysiologic Approach, Sorensen & Luckmann’s, Philadelphia,W.B. Saunders, 1994.17. Fundamentals of Nursing : Human health and function (2 nd ed.), Craven, R.F. & Himle, C.J.(1996), Philadelphia : Lippincott,18. Clinical Skills in Nursing Practice (2 nd ed.), Earnest, V.V. (1993), Philadelphia: Lippincott.50

APPENDICESAppendix 1Appendix 2Appendix 3Appendix 4Appendix 5Appendix 6Appendix 7Appendix 8Appendix 9Appendix 10Appendix 11Appendix 12Appendix 13Appendix 14Appendix 15Appendix 16Appendix 17IV Fluid and Drug Additives Administration FormInsulin Administration MAR FormsLists of HA-wide Approved / Standard Abbreviations in PrescribingSchedule for the Administration of “tds” DrugsMechanism for the Management of Drug Samples in the HAHA Guideline on Safe Management of Potassium Chloride IV SolutionsSupply of Antidotes and Detoxifying Agents in HA HospitalsGuideline for Supply of Medication for Patients during Inter-Hospital TransferSamples of the Line LabelsGuidelines on the use of Three-way / Four-way StopcocksGuidelines on Patient Self Medication for General PatientsGuidelines on Patient Self Medication for Psychiatric In-patientGuidelines on the Disposal of Pharmaceutical Chemical WasteGuidelines on the Handling of Dangerous Drugs in HA HospitalsMedication Incident <strong>Report</strong>ing ProgrammeAdverse Drug Reaction <strong>Report</strong>ing ProgrammeProcedure for Quality Complaints on Pharmaceutical ItemsUpdated in Apr 08

Appendix 1IV Fluid and Drug Additives Administration Form

Hospital Authority Hospital No. : ID No. :Hospital Name : ( )Intravenous Fluid And Drug Additive Administration Form Date of Birth : Age/Sex :All IV infusions must be written by the prescribers and reviewed on a daily basis Ward : Bed No. : Dept :Known Drug Sensitivity/Allergy :Weight : Kg Height :Diagnosis :IV Fluid Prescription Record of AdministrationLine C/P Date/time IV fluid Volume Drug Additives Infusion rate Dr. sign. TimestartGivenbyCheckedbyVolume infusedPharmacy useC = central P = peripheralHAHO Aug 001

Appendix 2Insulin Administration MAR Forms

Sensitivity:Prescription/ routewith Doctors’ signature & codeInsulin Administration /Test strip glucoseMonitoring FormHosp # ______________ ID # _____________________Name __________________________________________Sex _____ Age ____ CName ______________________(For Doctors / Nurses Use)Ward____ Bed ____ Dept ______________________H’stix glucose DatePage #monitoring Freq.Date Time Urine H’stix Treatment Given Check Given Remarksketone-ed by byOnOffOnOffOnOffOnOffDate Time Prescription/ route Dr. CheckedbyStat Dose Prescription (Please record under “Remarks”)Givenby.Date Time Prescription/ route Dr. CheckedbyGivenby• PRN insulin should be given before meal • Avoid frequent use of sliding scale which can lead to fluctuating blood glucose control• Capillary blood glucose should be done before or 2-hour post meal or when patient is symptomaticHAHO Apr 021

Intravenous InsulinAdministration Form(DKI or IV insulin pump)Drug allergy ________________Interval of test strip glucose monitoringDate/Time orderedIntervalHospital No: ____________ ID No. _______________Name _________________________________________Sex ______ Age_____ Chinese name_______________Ward______ Bed_____ Department________________Date/TimeDr’s prescriptionInsulin prescriptionDr Sig.TimeBlood glucosemmol/LUrine ketoneIV Insulin PumpInsulin(Units/hr)CheckedbyGivenbyTimestartNurse RecordDextrose Potassium Insulin (DKI) regimenIV fluidInsulin K +OtherTimeadded addedIV fluid Vol (ml)end(units) (mmol) additivesIV fluidinfused(ml)CheckedbyGiven byRemarksInsulin pumpTimeChecked byPrepared byHAHO Apr 022

Appendix 3aLists of HA-wide Approved/StandardAbbreviations in Prescribing

Lists of HA-wide Approved / Standard Abbreviations in PrescribingPrescribers should either prescribe in full text or adhere to the following lists of approvedAbbreviations:1) Standard Drug Name AbbreviationsDRUGAcetomenaphthoneAdenosine TriphosphateAdrenocorticotrophic HormoneAdsorbed Diphtheria & Tetanus VaccineAdsorbed Diphtheria, Tetanus & Pertussis VaccineAlpha Tocopheryl AcetateAlpha Tocopheryl NicotinateAscorbic AcidBacillus Calmette Guerin VaccineABBREVIATIONVit. KATPACTHDTDTPVit. EVit. EVit. CBCG VaccineCalcium Carbonate CaCO 3Calcium Chloride CaCl 2CarmustineBCNUCisplatinCDDPCyanocobalamin Vit. B 12CytarabineAra-CDesmopressinDDAVPErgocalciferol, Calciferol Vit. D 2ErythropoietinEPOEtoposideVP-16Ferrous Sulphate FeSO 4FilgrastimG-CSFFluorouracil5-FUGlyceryl TrinitrateGTN, TNGHepatitis B Immune GlobulinHBIGIsoniazidINAHLomustineCCNUMagnesium Chloride MgCl 2Magnesium Sulphate MgSO 4Measles/Mumps/Rubella VaccineMMR VaccineMercaptopurine6-MPMethotrexateMTXMolgramostimGM-CSFPhenoxymethylpencillinPencillin VPhytomenadioneVit. K lPotassium ChlorideKClPotassium IodideKIPotassium Permanganate KMnO 4PropylthiouracilPTUProstaglandin E 2 PGE 2Pyridoxine Hydrochloride Vit. B 6Riboflavine Vit. B 2Sodium Bicarbonate NaHCO 3Sodium ChlorideNaCl1

DRUGTeniposideABBREVIATIONVM-26Thiamine Vit. B 1Thyrotrophin-releasing hormoneTRHThyroxine T 4Liothyronine Sodium T 3Zinc OxideZnOReference :1. Martinadale, The Extra Pharmacopoeia, 34 th edition, The Royal Pharmaceutical Society ofGreat Britain.2. American Hospital Formulary Service (AHFS) Drug Information 2002, Authority of the Boardof Directors of the American Society of Health-System Pharmacists3. Medline Plus® (Medical Dictionary – The US National Library of Medicine and the NationalInstitutes of Health)HA-wide Approved Local Drug Name AbbreviationsDRUGBalance Salt SolutionDihydrocodeine TartrateExpectorant StimulantABBREVIATIONBSSDF118MESHydrocortisone 1% & Clioquinol 3% H 1 V 3MultivitaminMVVitamin B ComplexVit.B Co2) Standard Abbreviations for the Route of AdministrationABBREVIATIONI.D.I.M.I.V.I.P.N.G.P.O.P.R.P.V.S.C.S.L.EXPLANATIONIntradermalIntramuscularIntravenousFor intravenous injection, whether it is bolus, slow IV orinfusion should be specified.IntraperitonealNasogastricPer oralPer rectumPer vaginaSubcutaneousSublingual2

3) Standard Abbreviation for Drug Administration FrequencyINSTRUCTION LATIN ABBREVIATIONonce dailyonce dailytwice a day bis die b.d.twice a day bis in die b.i.d.three times daily ter die sumendus t.d.s.three times daily ter in die t.i.d. 1four times daily quater in die q.i.d. 2four times daily quater die sumendus q.d.s.at bedtime hora somni h.s.at night nocte noct.every night omni nocte o.n.every morning omni mane o.m.before noon ante meridiem a.m.afternoon post meridiem p.m.when required pro re nata p.r.n.used as directed more dicto utendus m.d.u.immediately statim stat.alternate alternus alt.before food ante cibum a.c.after food post cibum p.c._______________________1 t.i.d. is preferable to be used in prescription2 q.i.d. is preferable to be used in prescription because q.d.s. is easily mistaken with q.d.4) Standard Abbreviations for Dosage FormsDOSAGE FORM LATIN ABBREVIATIONScapsule capsula cap.drops guttae gtt.for the eye oculo ocul.irrigation irrigatio irrig.mixture mistura mist.ointment unguentum ung.pessary pessus pess..powder pulvis pulv.suppository suppositorium supp.syrup syrupus syr.tablet tabletta tab.tincture tinctura tinct.Reference : Pharmaceutical Handbook, The Pharmaceutical PressPharmaceutical Practice, D.M. Collect, M.E. AultonThe Chief Pharmacist’s Office is responsible for coordinating the procedures involved in the addition of drugabbreviation. Any request for addition of drug abbreviation should be made through the hospital pharmacy.HAHO 2000(revised in Jan 05)3

Appendix 3b“Do Not Use Abbreviations”Updated in Oct 2008

“Do Not Use Abbreviations”Do Not Use Use Instead Potential Problemu or U (unit) units Misinterpreted for ‘0’ (zero) or ‘4’ (four)iu or IU (International unit) units Misinterpreted for IV (intravenous) or ‘10’ (ten)q.d., qd, Q.D., QD (daily) daily Misinterpreted as qid (four times daily)q.o.d, qod,Q.O.D., QOD (every other day)on alternate daysMisinterpreted as qd (daily) orqid (four times daily)mcg, µg microgram Misinterpreted for mg (milligrams)Reference1. Joint Commission. “Do Not Use” List2. ISMP’s List of Error-Prone Abbreviations, Symbols, and Dose Designations. 2006.

Appendix 4Schedule for the Administration of “tds” Drugs

NMS/C Paper 31/2Schedule for the Administration of “tds” DrugsBackgroundThe administration time of tds drugs in hospitals was raised as an issue following arecent incident. Although it was recognised that tds regime cannot be at an 8 hourly interval evenunder normal circumstances. The administration schedule for tds drug regimen was found to beunevenly distributed and in some cases the interval between administration can be as long as 15hours between.2. This issue has been raised at the 30 th Nursing Management Sub-committee Meeting.It was recognised that hospital routine and patient’s activities of daily would need to be taken intoaccount in the scheduling of a more evenly distributed drug administration regime for tds drug. Areview of existing practices in selected hospitals was conducted in consultation with nursemanagers.Principle of Drug Administering Schedule for tds Regimen3. The review indicated that it is not possible to restrict to one single drugadministration time for tds drug in all hospitals given the differences in ward routine and patientmeal time. The following two schedules for tds drugs have been recommended in consultation withChief Pharmacist’s Office :• 8 am 12N 8 pm• 7:30am 11:30am 7:30pmRecommendation4. It is recommended hospitals should adopt one of the tds drug administrationschedules in paragraph 3.Nursing SectionHAHOAugust 20001

Appendix 5Mechanism for the Management of Drug Samples in the HA

Mechanism for the Management of Drug Samples in the HA________________________________________________________________________________Background1. Drug samples are offered freely by the pharmaceutical companies for doctors’ trial use inhospitals and clinics. This has always been the practice, and certainly not one that is uniqueto Hong Kong. Although there exists a well established and accountable system for thewhole administration process for all medications in HA institutions, drug samples are notsubjected to the same extent of control. Moreover, the number of drug samples kept in eachhospital is also substantial. A rough estimate of over 100 different drug samples are stockedin major acute hospitals in the HA, with approximately 11,000 to 12,000 dispensingtransactions for each major hospital in the year 2000-2001 alone.Advantages of using drug samples2. The provision of drug samples offers certain benefits for the HA. First, althoughpharmaceutical companies provide drug samples as a means of introducing new products todoctors and patients, and may try to change their utilization behaviour in due course, drugsamples provide doctors and patients with an opportunity to obtain first hand experiencewith newly released drugs which are otherwise available only on properly conductedclinical trials. Second, patients who have previously failed all other therapeutic choices onthe existing drug formulary or those who are suitable may benefit from the new drugtherapy. Third, by prescribing free drug samples, doctors may help to contain departmentaldrug budgets.Problem with using drug samples3. However, liberal distribution of free drug samples within the institutions is not withoutproblem. Being new drugs, information regarding these drug samples is often very limited.Doctors usually prescribe based on information supplied by pharmaceutical representatives,and not necessarily on the best scientific evidence available in the medical literature. Indeviating from clinical guidelines that are derived from best evidence, it is possible thatdrug samples may not be the most beneficial therapeutic choice for patients, bearing inmind the risk of undetermined efficacy (relative to established therapy) or unknown adverseeffects associated with their use. For the introduction of new pharmaceuticals, (andlikewise, for the introduction of new technologies), a well-founded system is alreadyavailable in the HA. The central Drug Advisory Committee has been serving this particularrole since 1996, by evaluation the cost-effectiveness of new pharmaceuticals based onscientific evidence, through a panel of experts from different medical disciplines with arotating membership. Free drug samples, being prescribed as non-formulary drugs,however, fall outside this system, and may not have been subjected to any formal evaluationbefore being widely used within the HA. HA normally provides coverage to all staff onliability arising from patients treatment including drug therapy and medical proceduresconducted within the organisation. However, since drug samples are used without a formalevaluation process, it is not certain whether HA would be able to provide the same extent ofprofessional indemnity coverage should any medication incidents or adverse effects that areassociated with the drug sample occur.1

4. As with all medications, there should be an efficient and effective mechanism for recallingdrug samples when circumstances require. Different hospitals may have different practicesin the record keeping of drug samples, and, to date, there is still an absence of a quick andeffective way for retrieving the medication records for drug samples and recalling themfrom patients. For instance, cerivastatin (Lipobay®) was withdrawn globally in August2001 due to the occurrence of a fatal adverse effect of rhabdomyolysis and myopathy whenit was co-prescribed with fibrates. Although cerivastatin was not yet listed in the HA drugformulary at the time, it was being used as a drug sample in many HA hospitals. The globalwithdrawal necessitated an urgent recall from the hospitals. However, being a nonformularydrug, cerivastatin was not coded in the same way as other formulary drugs in theHA computerized pharmaceutical system. The recall had to be conducted by a manualsearch through each individual dispensing record under the Corporate Drug DispensingHistory (CDDH) system, which had proved to be an inaccurate and lengthy process.Mishandling of these situations could even result in delayed actions and seriousconsequences.5. The provision of free drug samples poses another problem of managing patients’expectation. When the drug samples are no longer free, doctors will face the dilemma ofeither continue prescribing the new drug, which in many cases are more expensive than thecurrent ones, or to change back to their usual preferred drugs. However, once the medicalconditions of the patients are stabilised with the drug sample, it would be difficult toconvince them that their therapy would be discontinued or changed to an alternative, unlessthe situation has been clearly explained to them prior to commencement of the drug sample.HA Drug Sample Policy6. In view of the above discussed issues associated with the handling of drug samples, it isimportant that a formal mechanism should exist for the control of drug samples in the HA.The JCAHO (Joint Commission on Accreditation of Healthcare Organisations) providesstandards for medication use in hospitals and institutions in the US. The JCAHO standardrequires that there should be a policy and procedure related to the control of drug samplesthroughout the institution. In addition, all other standards applicable to medication useapply to drug samples to the same extent as they apply to regular prescription medicationsdispensed by the hospital pharmacy.7. Proposed mechanism for the management of drug samples in the HA :7.1 There should be a system (defined by policy and procedure) for the control,accountability and security of all drug samples throughout the hospital and affiliatedclinics. The hospital Drug & Therapeutics Committee (DTC) (or an equivalentcommittee) would be a suitable body for overseeing the system.7.2 Only registered drugs should be used as drug samples.7.3 Hospitals are not required to introduce drug samples as formulary drugs beforeallowing for trial use in their institutions.7.4 Request for the use of drug samples by an individual doctor within the hospital willbe submitted through the COS to the hospital DTC for record. The COS will decideon and be accountable for all the drug samples used within his/her department. Eachrequest will clearly indicate the following details :7.4.1 indications for the use of drug sample; whether it is the only treatment optionor an alternative treatment option with claimed benefits over existingformulary drugs2

Action7.4.2 types of patients to be treated7.4.3 estimated number of patients to be treated7.4.4 duration of treatment for each patient7.4.5 total trial period7.5 Patients should be fully informed that the drug samples prescribed for them are fortrial use over a definite period only. The efficacy and safety of the drug sampleswould require further evaluation. HA could not commit to provide these drugsamples on a long-term basis. An information pamphlet for patients receiving drugsamples will be designed by HAHO and issued to hospitals for future distribution.7.6 Hospital DTC will inform HAHO (via CPO) of the use of drug sample in itsinstitutions. This will enable HAHO to keep an updated record of all the drugsample used in the HA, and facilitate appropriate action to be taken promptly if anyurgent situation such as recall or medication incidents should occur.7.7 Hospital DTC is responsible for the monitoring of the progress of the use of drugsamples in its institutions. If hospital DTC and the CPO have been notified of theuse of the drug sample, and that it is prescribed according to hospital guidelines, HAshould be able to cover liability associated with its use as with other formularydrugs.7.8 All drug samples must be stored by the pharmacy according to the manufacturer’sspecifications and prevailing law and regulation.7.9 Drug samples should be labeled and dispensed according to the same standardisedmethod that the hospital uses for non-sample medications i.e. dispensed throughhospital pharmacy.7.10 Documentation requirements for drug samples should be the same as for other nonsamplemedications ordered and dispensed by the hospital i.e. written records forordering and administering in hospitals should be kept on the MAR, and on MOE orprescriptions for out-patients. Computerised records should be kept on the CDDH(Corporate Drug Dispensing History) system and should be easily retrieved whenrequired.7.11 The recall mechanism for drug samples should be efficient and effective, and shouldfollow the same procedure that exists for other formulary drugs in the HA. Inaddition to the computerized records, a manual record may be kept by the hospitalpharmacy if such record keeping facilitates the recall procedures and is convenientto update.7.12 As with other medications, it is expected that significant medication errors andsignificant adverse drug reactions that occur with sample drugs are identified,reported and reviewed according to the same procedures for other drugs listed in theHA i.e. using the same MIRP and ADR reporting systems and indicating that thedrugs implicated are drug samples.8. All hospitals are advised to observe the recommendations outlined above in para 7 and todevise a hospital drug sample policy accordingly. These should be forwarded to HAHO forrecord.HAHO Feb 023

Appendix 6HA Guideline on Safe Management ofPotassium Chloride IV SolutionsUpdated in Apr 08

HA Guideline on Safe Management of Potassium Chloride IV SolutionsSubject Officers:Prepared By:Approved By:Chief Manager (Q&RM)Chief PharmacistFirst Issue Date: Dec 1998Reviewed Date: May 2007Effective Date: 1 July 2007File No:HAHO Medication Safety CommitteeCentral Committee on Quality and Risk ManagementDrug Utilisation Review CommitteeMSC/0011. BackgroundIntravenous potassium chloride is indicated in the treatment of potassium deficiency stateswhen oral replacement is clinically inappropriate. Concentrated potassium chloride (14.9%)IV solution has potential risks to cause serious harm to patients, and can be fatal if giveninappropriately. This guideline is the revised version of the previous “Handling and StorageGuidelines of Potassium Chloride Injection” issued in 1998 which has been included in theDrug Administration Procedures & Practices in Public Hospitals <strong>2005</strong> edition. It aims tointroduce procedures for the safety controls of potassium chloride IV solutions, to limit andensure safe use of concentrated potassium chloride in clinical areas.2. SupplyA. Concentrated potassium chloride injection (MUST BE DILUTED before use)• Potassium chloride 14.9% (20mmol) in 10ml ampouleB. Pre-mixed Concentrated potassium chloride minibags (For use only with a calibratedinfusion device) for exceptional circumstances e.g. acute correctionIn 100ml preparations• Potassium chloride 10mmol (10mEq) in 100ml water for injection (New)• Potassium chloride 20mmol (20mEq) in 100ml water for injection (New)C. Pre-mixed potassium chloride solutions (Ready to Use)- should be used whenever possibleIn 500ml preparations• Potassium chloride 10mmol in 500ml D5 (5% Dextrose)• Potassium chloride 10mmol in 500ml NS (0.9% Sodium Chloride)• Potassium chloride 10mmol in 500ml ½:½ (0.45% Sodium Chloride:2.5% Dextrose)• Potassium chloride 20mmol in 500ml D5 (5% Dextrose)• Potassium chloride 20mmol in 500ml NS (0.9% Sodium Chloride)• Potassium chloride 20mmol in 500ml ½:½ (0.45% Sodium Chloride:2.5% Dextrose)In 1L preparation• Potassium chloride 20mmol in 1L NS (0.9% Sodium Chloride)Page 1/3

2.1 Concentrated potassium chloride injectionCritical care units• Supply of concentrated potassium chloride injection as floor stock should onlybe limited within these critical care areas, ICU, CCU or equivalent.General wards• No floor stock of concentrated potassium chloride injection is allowed ingeneral wards (1,2) .• Supplies of concentrated potassium chloride injection to general wards mustbe made on individual patient basis with a completed MAR order sent topharmacy (preferably including required concentration, diluent, volume ofinfusion and infusion rate) and checked by pharmacists.• All unused concentrated potassium chloride injections obtained on individualpatient basis with MAR have to be returned to pharmacy immediately upondiscontinuation of treatment.• After pharmacy hours, concentrated potassium chloride injection can beobtained in emergency cupboard if necessary.Supply from Pharmacy• Supplies of concentrated potassium chloride injection to wards in sealed bagwith distinctive warning label and physically separated from othermedications.2.2 Pre-mixed Concentrated potassium chloride minibags and Pre-mixed potassiumchloride solutionsAll wards (Both critical care units and general wards included)• Both pre-mixed minibags and solutions could be supplied as floor stock andreplenished by pharmacy similar to other ward stock items.3. Storage3.1 Concentrated potassium chloride injectionAll wards (Both critical care units and general wards included)• All concentrated potassium chloride injection, including those issued forindividual patient in general wards or as floor stock in critical care units, mustbe stored in DESIGNATED and LOCKED cupboard which must bePHYSICALLY SEPARATED from other similarly packaged frequently useddiluents e.g. ampoules of 0.9% sodium chloride and water for injection.1Under very exceptional circumstances, the respective COS should (i) apply with justifications to CCE via DTC forstocking concentrated potassium chloride solution in areas other than critical care areas and Paediatrics, (ii) beresponsible for the establishment of a safe management system similar to that of Dangerous Drugs.2Exception is granted for Paediatrics pending further review and sourcing of suitable pre-mixed potassiumchloride infusion for use in PaediatricsPage 2/3

3.2 Pre-mixed Concentrated pre-mixed potassium chloride minibags and Pre-mixedpotassium chloride solutionsAll wards (Both critical care units and general wards included)• Storage requirements for pre-diluted potassium chloride solutions are thesame as other ward stock IV solutions, which should be clearly segregatedaway from one another, aiming to prevent any mix-up among differentward stock IV solutions.4. Administration of Potassium Chloride Injection4.1 Concentrated potassium chloride injection(a) Concentrated potassium chloride MUST BE DILUTED before use.(b) For dilution of concentrated potassium chloride, it is recommended to invert themixed infusion bag several times to avoid accumulation of the drug.(c) COUNTER-CHECK during the retrieval for correct product, dosage dilutions, mixingand labeling during the preparation and before administration of the product isessential. Staff should remain alert and be aware of the potential danger ofincorrect use.4.2 Pre-mixed Concentrated Pre-mixed potassium chloride minibags(a) For use only with a CALIBRATED INFUSION DEVICE for exceptionalcircumstances e.g. acute correction(b) COUNTER-CHECK during the retrieval for correct product and before administrationof the product is essential. Staff should remain alert and be aware of the potentialdanger of incorrect use.4.3 Other recommendations(a) A rate controlled infusion pump should be used if the infusion rate of potassiumchloride is faster than 10mmol/hr.(b) Concentration higher than 40mmol/L (i.e. 4 mmol per 100ml) of potassium mustbe used with extreme caution. Infusion flow rate and infused volume must always beclosely monitored and regulated for this high dose therapy.(c) Patients should be monitored for signs and symptoms of hyperkalaemia during andafter infusion.(d) In cases where a patient complains of severe pain at injection site, the prescribershould immediately be notified to consider adjustment of the infusion rate or theconcentration of potassium chloride content.The Drugs and Therapeutics Committee (or equivalent) of individual hospital should formulateits policy on the dosage range and preferred diluents applicable to the clinical needs of itspatients. Staff education and training on the risks associated with concentrated potassiumchloride would be pivotal for improved patient safety.Page 3/3

Appendix 7Supply of Antidotes and Detoxifying Agents in HA hospitals

複 本 Antidotes and emeg drug list to hosp revised 28 April 08 Page 1 of 6 PagesAntidotes and Emergency Drug List April 2008LEVEL § ANTIDOTES & DETOXIFYING AGENT UNIT AHNH CMC KWH NDH PMH POH PWH PYNEH QEH QMH RHTSK SJH TKO TMH UCH YCH HKPIC ※A. SPECIFIC ANTIDOTES & ANTAGONISTSI 1a Acetylcysteine Inj. 2g/10ml ACET14 amp YI 1b Acetylcysteine Infusion 200mg/ml x 25ml ACET38 Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y YIII 2 Acetamide Inj 0.5gm/ml x 5ml ACET42 50 Y Y 50 50 50 225II 3 Calcium Disodium Versenate Inj 200mg/ml x 5ml CALC39 amp 23 6 7* 36 18 6 0 6 6 1I 4 Bromocriptine tab 2.5mg BROM07 tab Y Y Y Y Y Y Y Y Y Y Y Y Y YII 5a Calcium Folinate Inj. 15mg/2ml (Leucovorin Ca) CALC23 amp 5 5 180 250 263 105b 100mg(base) (Leucoverin Ca) CALC24 400 1095c 300mg(base)(Leucoverin Ca) CALC32 394 175 400 270 411 10 15d 30mg (Base)(Leucoverin Ca) CALC55 654 214I 6 Desferrioxamine Mesylate Inj. 500mg DESF01 vial Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y YI 7a Digitalis Antidote Inj. DIG101 amp Y Y 6 Y Y7b Digoxin immune Fab (Ovion) Inj 40mg DIGO07 Y 10 6 10 (CCU) Y Y 10 Y 10I 8 Dimercaprol Inj. 50mg/ml 2ml DIME09 amp Y Y Y Y Y Y Y Y Y Y Y Y Y YI 9 Dimercaptopropone Sod Sulphonate Inj 125mg/2ml (China) (DMPS) DIME22 amp Y Y Y Y* Y Y Y Y Y Y Y Y* Y Y Y Y 60010 Disodium Edetate (Sod Edetate) Inj. 1% SODI96 ampI 11 Flumazenil Inj. 0.1mg/ml 5ml FLUM02 amp Y Y Y Y Y Y Y Y Y Y Y Y* Y Y Y Y12a Folinic Acid 15mg tab FOLI09 tab Y12b Folinic Acid 15mg cap FOLI02 cap Y Y Y Y Y Y YIII 13 Fomepizole 1gm/ml x 1.5ml Δ FOME01 vial 4I 14 Glucagon (HCl) Inj. 1mg GLUC37 vial Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y YIII 15 Hydroxocobalamin Inj 2.5gmHYDR53 vial Y Y* 2 2 2 4* 2 2416 Mesna Inj. 100mg/ml x 4ml MESN04 amp Y Y Y 0 Y Y Y Y Y Y Y Y YIII 17 Methionine tab 250mg Δ METH76 tab Y 40 120 40I 18 Methylene Blue Inj 1% 5ml METH24 amp Y Y Y Y Y Y Y Y Y Y Y* Y Y Y YI 19 Naloxone HCL Inj. 0.4mg/ml NALO02 amp Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y YI 20 Penicillamine Tab. 250mg PENI04 tab Y Y Y Y Y Y Y Y Y Y Y Y Y Y YI 21a Phytomenadione Inj.10mg/ml PHYT04 amp Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y21b Phytomenadione tab 5mg PHYT05 Y Y Y 50 Y Y 50 Y YI 22 Pralidoxime Iodide Inj. 500mg/20ml PRAL02 amp Y Y Y Y Y Y Y Y Y Y Y Y Y YI 23 Pralidoxime Chloride Inj. 250mg per ml x 2ml PRAL04 amp Y Y Y Y Y Y Y Y 130 Y Y Y Y YI 24 Protamine Sulphate Inj. 50mg/5ml PROT12 vial Y Y Y Y Y Y Y Y Y Y Y Y Y Y YI 25 Sodium Nitrite Inj. 3% 10ml SODI51 amp Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y YI 26 Sodium Thiosulphate Inj. 25% 50ml SODI48 vial Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y YIII 27 Succimer (DMSA) cap 100mg Δ SUCC05 cap Y28 Ethanol 95% & 70% for external use YI 29 Alcohol Absolute Injection 5ml ALCO11 ampI 30 Alcohol Dehydrated Injection 20ml ALCO17 vial Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Pending orderII 31a Levocarnitine Injection 0.2G/ml 5ml LEVO10 amp 2 Y 30 10 10 28 0 10 21 1II 31b Levocarnitine Solution 0.3gm/ml x 20ml LEVO06 bot 197 198 Y Y Y 24 16B. DRUGS FOR POISONING OR OVERDOSE32a Charcoal Activated Powder 1000gm CHAR03 gram Y32b Activated Susp. 50G/300ml CHAR02 bot Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y32c Tablet 300mg CHAR01 tab Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y33 Cholestyramine 4G/Bag CHOL04 bag Y Y Y Y Y Y Y Y Y Y Y Y Y Y34 Fuller's Earth 60G/ Box FULL01 gram Y Y Y Y35 Ipecacuanha Syr(Emetic) APF (Note 1) IPEC03 ml Y* Y Y Y Y Y Y36a Polystyrene Sulphonate Calcium POLY07 gram Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y36b Powder (Resonium ) Sodium POLY08 Y Y Y Y Y Y Y Y Y Y Y Y Y Y YI 36c Polyethylene glycol ELE (Klean-prep) 68.8gm per pack POLY19 pack Y Y Y Y Y Y Y Y YC. SYMPTOMATIC TREATMENT IN DRUG POISONING37 Acetic Acid Soln. 5% ACET22 ml Y Y Y Y Y Y Y Y Y Y Y Y38a Adrenaline Inj 1:1000 amp ADRE01 amp Y Y Y Yamp(no antimicrobial agent) ADRE12 amp Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y38b vial ADRE02 vial Y Y Y# Y Y Y Y Y Y

複 本 Antidotes and emeg drug list to hosp revised 28 April 08 Page 2 of 6 PagesAntidotes and Emergency Drug List April 2008LEVEL § ANTIDOTES & DETOXIFYING AGENT UNIT AHNH CMC KWH NDH PMH POH PWH PYNEH QEH QMH RHTSK SJH TKO TMH UCH YCH HKPIC ※39 Metaraminol Tartrate Aramine Inj. 10mg/ml x 1ml META04 ampI 40a Atropine Sulphate Inj. 0.6mg ATRO01 amp Y Y Y Y Y Y Y Y Y Y40b Atropine Sulphate Inj. 1.2mg ATRO03 amp Y Y Y Y Y41 Cardioplegia Inj 20ml CARD03 amp YI 42 Dantrolene Inj 1mg/ml 20ml DANT01 vial Y Y Y Y Y Y Y Y Y Y Y** Y Y Y Y43a Dopamine Inj. 50mg/5ml DOPA01 amp43b 200mg/5ml DOPA02 vial Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y44 Edrophonium Chloride Inj.10mg/ ml EDRO01 amp Y Y Y Y Y Y Y Y Y Y Y 0 Y Y Y Y45 Isoprenaline Inj. 1mg/5ml ISOP12 amp Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y46a Lignocaine Inj. 1% 50ml (1% 20ml for FH) LIGN02 vial Y Y Y Y Y Y Y Y Y Y Y Y Y46b 1% 5ml LIGN53 amp Y Y Y Y Y Y Y Y Y46c 1.5% 50ml LIGN03 vial47 Neostigmine 2.5mg/ml luer-fit NEOS06 vial Y Y Y Y Y Y Y Y Y Y Y Y Y Y YI 48 Pyridoxine Inj. (preservative free) 100mg/ml x 1ml PYRI13 amp Y Y Y Y Y Y Y Y Y* Y Y Y YI 49a Pyridoxine Inj. 50mg/ml 2ml PYRI14 amp Y 10049b Pyridoxine HCl (No preservative) Inj 100mg/ml x 10ml PYRI15 YD. SNAKE ANTIVENENE SERAIII 50 Agkistrodon Actus 2000u/amp,China AGKI02 amp 4 2 2 8 8 8II 51 Agkistrodon halys 6000u/amp,China AGKI03 amp 2 4 2 2 4 4 4 4 6 4 1II 52 Bungarus Multicinctus antivenin Inj 10000u/amp BUNG02 amp 2 2 2 8 2 4 5 5 2 4 4 2III 53 Cobra Antivenene 0.6mg/ml,Thailand COBR01 vial 2 2 5* 6 8 8 454 Green Pit Viper 0.6mg/ml, Thailand GREE01 vial 4 4 8 3* 10 4 4 6 1255 King Cobra Antivene 1mg/ml, Thailand KING01 vial 10* 6 8 8 3 3III 56 Krait Banded 0.6mg/ml Thailand KRAI01 vial 2 4 2 7 5* 5 5 10 2 7 5 2II 57 Naja Naja 1000u/amp, China NAJA01 amp 2 4 2 8 2 4 4 4 2 8 4III 58 Russells Viper 0.64mg/ml Thailand RUSS01 vial 2 4 2 4 4 20 20 6 12 6III 59 Tiger Snake Antivenene Inj 3000u, Australia TIGE01 vial 1 1 1 4 4 6E. RADIATION EMERGENCY60 Aluminium Hydroxide Suspension 6% ALUM03 bot Y Y Y Y Y Y Y Y YI 61a Calcium Gluconate Inj. 10% x 10ml CALC16 vial Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y YI 61b Calcium Chloride Dihydrate Inj 10% x 10ml CALC08 Y Y Y Y Y Y Y Y YII 62 CaNa 2 EDTA (see item 2) CALC39 vial 6 7* 29 9 9 6 6 6 1I 63 Desferrioxamine (see item 5) DESF01 vial Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y YI 64 Dimercaprol Inj 50mg/ml x 2ml (see item 7) DIME09 amp Y Y Y Y Y Y Y Y Y Y Y Y Y65a DTPA - Diethylenetriamine Calcium salts CALC38 vial Ypenta-acetic acid inj. Zinc salts ZINC15 vial Y66 Ipecac. Syrup (see item 33) IPEC03 bot Y* Y Y Y Y Y Y67a Magnesium Sulphate Soln. 49.3% X 5ML MAGN11 amp67b MAGN13 amp Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y YI 68a Penicillamine (see also item 20) PENI04 tab Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y68b Potassium iodide tab 130mg POTA63 tab Y Y Y Y Y YIII 69ΔPrussian Blue (Potassium Ferric Ferrocyanide) 500mgPRUS01 cap 120 150 150 310I 70 Sodium Bicarbonate Inj. 8.4% X 100ML SODI07 vial Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y YF. IMMUNOGLOBULINS & ANTITOXINS71 Anti-D(RHO)Immunoglobulin Inj. 300mcg ANTI01 vial Y Y Y Y Y Y Y Y Y Y Y Y72 Anti- hepatitis B 2ml ANTI19 vial73 Antirabies Immunoglobulin Inj. 150iu/ml 2ml ANTI07 vial Y Y Y Y Y Y Y Y Y Y* Y Y YIII 74 Botulism Trivalent Antitoxin Δ BOTU04 vial 2 2 3 275 Botulism Type A Toxin Inj 100u BOTU03 vial Y Y Y Y Y Y Y Y Y Y Y 176 Diphtheria Antitoxin 10000u DIPH08 vial Y Y Y Y77a Hepatitis B Vaccine Inj. 20mcg/ml x 1ml (Engerix) HEPA12 vial Y Y Y Y Y Y Y Y Y Y Y* Y Y Y Y77b Hepatitis B Immunoglobulin Inj. 109u/0.5ml HEPA36 vial77c Hepatitis B Immunoglobulin Inj. 220u/1ml HEPA38 vial Y Y Y Y Y Y* Y Y77d Hepatitis B Inj prefilled Syringe 110 iu/0.5ml HEPA39 Y Y Y Y Y Y Y Y77e Hepatitis B Immunoglobulin Inj 220u/1ml HEPA40 vial Y Y Y Y

複 本 Antidotes and emeg drug list to hosp revised 28 April 08 Page 3 of 6 PagesAntidotes and Emergency Drug List April 2008LEVEL § ANTIDOTES & DETOXIFYING AGENT UNIT AHNH CMC KWH NDH PMH POH PWH PYNEH QEH QMH RHTSK SJH TKO TMH UCH YCH HKPIC ※77f Hepatitis B Immunoglobulin im injection 220 iu/ml x 5ml HEPA43 Y Y Y Y Y Y Y Y Y Y78 Immunoglobulin(Human) IV Inj 3G NORM15 vial Y Y Y Y Y Y Y Y Y Y Y Y Y Y79 Rabies Vac. (Inactivated) Inj. 2.5iu RABI01 vial Y Y Y Y Y Y Y Y Y Y Y Y* Y Y Y Y80 Tetanus Adsorbed Vaccine Inj. 5ml TETA03 vial Y Y Y Y Y Y Y Y Y Y Y Y* Y Y Y Y81 Tetanus immuno Globulin, human prefilled syringe 250iu TETA10 syringe Y Y Y Y Y Y Y Y Y Y Y* Y YII 82 Stone Fish Anti-venom 2000u STON01 vial 1*+1 2 2 2 2 1II 83 Phentolamine Methanesulphonate Inj. 10mg/ml 1ml PHEN21 amp 8 5 20 8 14 25 29 21 8 22 16 11 6II 84 Octreotide Acetate Inj. 0.1mg/ml 1ml OCTR01 amp 20 138 638 20 28 129 319 189 189 402 745 923 99II 85 Octreotide Acetate 1ml Inj. 0.05mg/ml OCTR02 amp 21 666 21 36 139 139 60 50I 86 Physostigmine Salicylate Inj 1mg/ml x 2ml PHYS03 amp Y Y Y Y Y Y Y Y Y Y Y Y Y YI 87 Cyprohepatadine HCl 4mg/tab CYPR01 tab Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y88 Silymarine tab 70mg YKEYS§ : Levels of antidotes stock with reference to memo (Ref: HA820/130/4/7/3) issued by DD(PS) on 9 May 2006. Level I Items (in blue)- HA Acute Hospital Level;Level II Items (in green) - HA Cluster Level; Level III Items (inred) - HA Central Level.※ : Hong Kong Poison Information Centre (tel: 26351111 from 9am to 9pm OR tel: 35134125 from 9pm to 9am daΔ : For the use of Level III antidotes, prior consultation with the Hong Kong Poison Information Centre (HKPIC) is strongly advi*: Stocked in A&E and not in Pharmacy**: Stocked in OT only#: Stocked in ICU and not in Pharmacy^: Stocked only in Emergency Cupboard in 2nd Floor and not in Pharmacy(1): In ICU and not in PharmacyNote 1: Ipecacuanha Syr. Emetic (A.P.F.) = Ipeca. Liq. Extract 0.6ml/10ml = 12mg (total alkaloids)/10ml or BPItems deleted from the table:Agkistordon Actus Thailand (Agki 01)Amyl Nitrite vitrillae (Amyl 01)Anti-hepatitis B Immunoglobulin syringe 100iu/0.5ml(Anti23)Barium sulphate (Bari 01)Bungarus Multicinctus 8000u/amp (Bung01)Dimercaptopropone Sod Sulphonate Inj 50mg/ml x 5ml (Germany) (Dime21)Gas gangrene antitoxin (Gas 01)Hepatitis B Immunoglobulin Inj 200u/ml x 2ml (Hepa35)Hydrochloric Acid Dilute Inf 0.15N x 500ml (Hydr 34)Ipecacuanha Paed Mixt 14mg/10ml (=Ipeca Liq Extract 0.7ml/10ml=14mg total alkaloids/10ml)Isoprenaline inj 0.2mg/ml x 10ml (Isop 06)Malayan Pit Viper Antivene 2mg/ml (Mala04)Metaraminol Tartrate Inj 10mg/ml x 1 ml (meta04)Neostigmine metasulphite inj 12.5mg/5ml (Neos 05)Neostigmine metasulphite inj 1mg/mll (Neos 07)Nikethamide inj 25% x 1.5ml (Nike 01)Penicillamine cap 250mg (Peni 02)Pralidoxime chloride inj 50mg per ml x 10ml (Pral03)Protamine sulphate inj 10mg/ml x 10ml (Prot 02)Pyridoxine Inj 100mg/ml x 10ml (Pyri05)Sodium Bicarbonate + 0.01% EDTA Infusion 1.26% x 500ml (Sodi10)Sodium Calcium Edetate Inj 200mg/ml x 5ml (Sodi 10)

Appendix 8Guidelines for Supply of Medication for Patientsduring Inter-Hospital Transfer

GUIDELINES FOR SUPPLY OF MEIDCATIONFOR PATIENTS DURING INTER-HOSPITAL TRANSFERBackgroundThere is currently no laid-down policies in the HA on the supply of medications forpatients during inter-hospital transfers. Individual discharge or recipient hospitals may or may nothave any agreed arrangements regarding the issue or acquisition of medications for these patients.observed.In a survey conducted by CPO, several problems relating to such transfers have been1. Disruption of supply of medication occurs if a non-formulary drug of the recipient hospitalhas been prescribed and is not issued by the discharging hospital upon transfer.2. Disruption of supply of medication if the patient transfer is made after Pharmacy openinghours when no drugs accompany the patient upon transfer.3. Medications issued directly from ward of discharging hospital to ward of recipient hospitaldo not have proper labeling may be in violation of legal requirements.4. If only items within the Drug Formulary of the recipient hospital are allowed to beprescribed upon transfer-out, doctors of the originating hospital must be very familiar withthe Formulary of the recipient hospital in order to avoid disruption of supply of medicinedue to non-formulary items being prescribed.Issues to be consideredWhen drawing up the Inter-Hospital Transfer Policy, the patient’s benefit must beconsidered as the top priority. Continuity of supply of medication must be ensured when workingout details for the procedures for inter-hospital transfer. The operation of the transfer proceduremust be practicable and the financial implications, if any, must be worked out between thedischarging and recipient hospitals.Recommendations1. To simplify the procedure, it is recommended that each inter-hospital transfer can beviewed as a discharged case for the hospital transferring out the patient, and an admissioncase for the recipient hospital. It is a shared responsibility for both the discharge andrecipient hospital to ensure the continuity of supply of medicine for the patient.2. A 5-working days’* discharge medication order covering all the patient’s currentmedication profile should be written up and sent to the pharmacy of the discharginghospital for dispensing. The 5-working day’s medication supply would allow ample timefor the pharmacy of the recipient hospital to make arrangement for the continued supplyof drugs. For antibiotics or certain rarely used items, the discharge hospital may considerto prescribe the full course*. If non-formulary drugs have been prescribed, there shouldalso be sufficient time for the pharmacy to contact the case medical officer for1

substitution with other drugs in accordance with the prescribing policies of the recipienthospital. If consensus is reached between the case medical officer and the Pharmacy thatno substitution can be made, urgent arrangement must be made to acquire medication inorder to ensure continued supply.3. Sample code can be used for inputting dispensing information for the non-formulary itemprescribed until the item code for the new item can be downloaded from CPO.4. Mechanism for stocking or acquiring the non-formulary item should be according to theindividual hospital’s operation procedures.5. Financial issues must be worked out between the discharge and recipient hospitals.Pharmacies of recipient hospitals finding difficulties in maintaining the continuity ofsupply of medications due to financial implications should bring their problems forwardto the Hospital Drugs and Therapeutics Committee or any concerning committee fordiscussion and formulation of appropriate actions. Financial data relating to interhospitaltransfer dispensing activities will be available from the PHS for monitoring andanalytical purposes. HCE’s of both discharging and recipient hospitals must haveconsensus on the procedures and financial arrangement for inter-hospital transfer.WorkflowArrangement for the supply of patient’s medication during inter-hospital transfershould be according to the following procedure.* Or otherwise agreed between the discharge and recipient hospitals2

A) Discharging hospital1. Use an appropriate prescription form to write up a discharge medication order for aduration of 5 working days*. The transfer status of the patient should preferably beclearly indicated on the prescription.2. The prescriber should write up the discharge medication order as soon as the decision fortransfer has been made. The prescription should then be promptly sent to the Pharmacyfor dispensing to enable the medication to be dispensed by the Pharmacy in time toaccompany the patient to recipient hospital. This way, medicines having proper labelingcan always be ensured.3. After confirming that the contents of the prescription is complete and appropriate, thepharmacy of the discharging hospital faxes the prescription to the pharmacy of therecipient hospital*.4. The pharmacy dispenses the prescription with labeling that complies with the legalrequirement.5. The patient is transferred to the recipient hospital together with the transfer-outmedication dispensed by the pharmacy.B) Recipient hospital1. After receiving the faxed prescription from the pharmacy of the discharging hospital, thepharmacy of the recipient hospital should check the availability of the medicationprescribed*. Necessary action should be taken if non-formulary items are involved.2. The recipient ward sends a copy of the MAR or the discharge medication summary to thepharmacy for information and necessary action.3. If a non-formulary item has been prescribed, use sample code to input dispensinginformation until the new item code can be downloaded from CPO.4. If the non-formulary item is to be used on a one-off basis, suspend the item code after thetreatment course has been completed.5. The recipient hospital may also consider to review its formulary to include commonlyprescribed non-formulary items by the discharge hospital.* Or otherwise agreed between the discharge and recipient hospitalsHAHO Jan 993

Appendix 9Samples of the Line Labels

Samples of the Line LabelsColourYellowGreenPurpleBrownBlueRedHAHO Feb 991

Appendix 10Guidelines on the use of Three-way / Four-way Stopcocks

GUIDELINES ON THE USE OF THREE-WAY / FOUR-WAY STOPCOCKS1. Three-way and Four-way stopcocks are predominantly used for the administration ofinfusion solutions and intermittent injection of drugs.2. The tap of the Three-way stopcock can be turned 180°, and that of the Four-way stopcockcan be turned 360°. Simultaneous dual access to the connected line can only be achievedwith Four-way stopcock, as described below :All ports open fortwo simultaneousinfusions or for oneinfusion with“simultaneous”injectionOnly “side port” openfor infusion, injectionor CVP-measurementOnly “main port”for one infusionAccessMain Port onlySide Port onlySimultaneousClose3-way4-way3. It is intended that the colour-code of stopcocks should be uniformed to facilitate lineidentification, in such a way that the blue colour denotes venous line and the red colourdenotes arterial line or intra-cranial pressure line. Since simultaneous dual access may berequired for venous access only, Four-way stopcock would solely be available in theblue colour.4. Stopcocks should not be used on other connections other than those specified.5. If other versions of stopcocks are required through local purchases, the guideline oncolour-code should always be followed.HAHO DEC 97(revised in FEB 05)1

Appendix 11Guidelines on Patient Self Medicationfor General Patients

ApprovedCOC(N) Paper 2/2000Guidelines on Patient Self Medication(For General Patients)IntroductionThe purpose of this paper is to introduce the guidelines on the implementation ofpatient self medication.Background2. Patient self-medication has been introduced in UCH for post-partum women andpatients with chronic renal failure since 1998. With positive results in drug compliance, medicationknowledge of patients, staff job satisfaction and cost saving presented at the OBEM(N) in August1998, hospitals were encouraged to implement this practice.3. To facilitate the implementation of patient self-medication in hospitals, COC(N) hasdecided to establish guidelines to carrying out this program in collaboration with ChiefPharmacist’s Office. A task group was then formed in May 1999 to develop the guidelines.Definition4. Patient self-medication program is a program in which patients are educated andgiven the responsibility to manage and take their prescribed medication when in hospital ordischarged home.Objectives5. The objectives of the guidelines are :5.1 To heighten/maximise patient’s self-care ability5.2 To enhance patient’s drug knowledge and proper handling of medications5.3 To improve medication complianceCriteria for Selection6. The selective criteria of patients are :6.1 Willingness to participate in self-medication program6.2 Ability to perform self-care, comprehensive with sound mind6.3 Ability to communicate and understand medication instructions6.4 Undisturbed by mental symptoms6.5 No detectable suicidal tendency6.6 Stabilised medication regime6.7 Inclination to seek information in pursuit of better health1

Operational Guidelines7. The operational guidelines include the followings :7.1 Preparation of patients7.1.1 Obtain consent form patient (either verbal or written)7.1.2 Educate patient to ensure(a) Understanding on effects, side-effects, missing dose and specialprecautions of drugs, proper method and time schedule inadministering(b) Bringing of updated “prescription” upon admission(c) Proper storage of medications(d) Proper documentations of self-medication record7.1.3 Provide training program to elderly patients with multiplemedications if required7.2 Preparation of medications- Individualised packing of medication for each patients- Provision of relevant information on medication regime for patientsupon admission7.3 Supervision of patients- Nurses are responsible to supervise individual patients, monitorpatients’- Compliance and observe for adverse drug reactions throughout theprogram7.4 Handling of non-compliance- Investigate the causes of non-compliance- Record any unfavourable medication incidence- Re-educate the patient on the proper way of drug administration- Re-assess the patient’s ability in self-medication7.5 Monitoring and evaluation- Monitor the process, compliance, unfavourable incidence and problemsencountered- Evaluate the outcomes, such as : drug compliance, patient satisfaction,staff satisfaction, cost saving etc.Responsibility of the hospital8. Though self-medication can foster a feeling of independence and control in thepatient, the hospital is responsible to provide professional support whenever necessary. Thehospital should have a mechanism in place to ensure that the operational guidelines are adhered to.It is important that the right patient receives the right medication with the right dosage, through theright route and at the right time.Nursing SectionHAHOApril, 2000(further revised in August 2000)2

Appendix 12Guidelines on Patient Self Medicationfor Psychiatric In-patient

COC(N) Paper 12/2004Approved by COC(N) at56 th Meeting held on 3 June 04Guidelines on Patient Self Medication(For Psychiatric In-Patients)IntroductionThe purpose of this paper is to introduce the guidelines on the implementation ofself-medication programme for psychiatric in-patients.Background2. Medication non-compliance is the major factor, which leads to relapse and accountsfor most psychiatric re-hospitalization. With the increased awareness of patient’s right, medicationeducation will enable the psychiatric patients to acquire knowledge on medication, to makeinformed choices and promote their commitment in the treatment plan.3. The self-medication programme has been implemented in Psychiatric in-patientservice as part of the rehabilitation training. It aims at enhancing the patients’ knowledge on drugclassification, the expected therapeutic effect / side effect and the proper storage of the drugs. Italso enforces the patients’ understanding on the importance of medication compliance and havingthe medication taken by self accurately.4. To standardize the practice among clusters, COC(N) decided to establish guidelinesto carrying out this programme for Psychiatric in-patients with input from Chief Pharmacist’sOffice.Definition5. Patient self-medication programme is a programme in which patients are educatedand given the responsibility to manage and to take their prescribed medication when in hospital ordischarged home.Objectives6. The objectives of the guidelines are :6.1 To heighten/maximize patient’s self-care ability6.2 To enhance patient’s drug knowledge and proper handling of medications6.3 To improve medication compliance6.4 To promote patient’s commitment in the treatment plan1

Operational guidelines7. Operational guidelines on implementation of the programme for individualpsychiatric hospital / psychiatric unit should be in place. The guidelines should be endorsed bylocal hospital Drug Committee and include the followings :7.1 Selective criteria of patients are : Scope of patient selection e.g. patient with history of non compliance Participation of the health care team in patient selection Mode of obtaining consent and its documentation7.2 Supply and storage of the medicationMechanism in place to state Agreement with the Pharmacy of individual hospital/ unit for the drug supplypolicy, provision of the individualized packing of medication, procedures inrequesting / revising / returning of drugs for self-medication etc. Appropriateness of the medication storage place in respect of patients’ safetyand accessibility and local hospital / unit structure Appropriateness of DD storage in respect of the Dangerous Drug Act7.3 Training and monitoring Availability of the training kits and assessment tools e.g. content of eachtraining session Personnel involved in the training and their responsibilities e.g. medical officer,nurse or pharmacist Protocol for stepping up and stepping down the training for individual patient Documentation of patients’ knowledge assessment and suitability for thepractical part after the theory sessions Documentation of patients’ self-medication practice and it should be in linewith the local hospital / unit policy on AOM e.g. to keep patient’s selfadministration form together with the MAR Level of supervision and mechanism in ensuring patients’ medicationcompliance in different stages of self-medication e.g. issuing of medicationreminder card for forgetful patients2

7.4 Evaluation Record and report the positive indicators e.g. successful rate of early discharge,patient’s level of drug knowledge, patient satisfaction etc. Record and report the negative indicators e.g. medication incidents (MIRP),adverse drug reaction (ADR) & medication incident (MIRP) due to noncompliance, failure cases and other unfavorable incidents Outcome evaluation by studying the indicatorsResponsibility of the Hospital8. Self-medication is a part of the rehabilitation training that carries out in the hospital /unit for psychiatric patients. Apart from following the guidelines of individual hospital / unit inimplementing the programme, patients’ safety in taking their medications in this aspect is utmostimportant. It is the responsibility of the hospital to establish a control mechanism to monitor theprocess and to diminish the risk in implementing the programme.COC(N)June 20043

Appendix 13Guidelines on the Disposal of Pharmaceutical Chemical Wastes

DISPOSAL OF HOSPITAL PHARMACEUTICAL CHEMCIAL WASTES1. Scope of Service1.1. The service covers the collection and disposal of the following categories ofunwanted materials;a. Antibiotics (as defined in Antibiotics Ordinance, Cap. 137);b. Dangerous Drugs (as defined in Dangerous Drugs Ordinance, Cap. 134);c. Poisons (as defined in Pharmacy and Poisons Ordinance, Cap. 138);d. Other pharmaceutical products and medicines, not elsewhere specified.2. Containers & Labels2.1 Solidsa. Wide mouth screw open top 20 Litre HDPE pails will be provided byEnviropace for collection of : (i) tablets, capsules with and without packing,and other totally solid materials, (ii) vials and ampoules containing liquids orslurries not exceeding 50ml each.b. Wastes should be filled to occupy maximum 70% of the volume of the pails(i.e. maximum 14 litres/pail). Liquid content in each container should notexceed 500 ml in total. A Liquid Waste Tracking Label (See Appendix 1)will be attached to the pail at time of despatching. The slip is to be updatedeach time when liquid waste is disposed into the pail.c. Please refer to Appendix IIA for the design of the solid pharmaceutical wastecontainer label.2.2 Liquids3. Collection Plana. Closed top screw cap 20 litre HDPE pail will be provided for collection ofwastes other than those described in Item 2.1 above, e.g. bottles containingmore than 50ml of liquid.b. All wastes should be decanted from original packing into the collection pail.In case there are reactions during decanting, stop the process and report toEnviropace, Miss Dandy Wong at 2434 6450. Instructions on handling andsafety precautions would be provided.c. Please refer to Appendix IIB for the design of the liquid pharmaceuticalwaste container label.d. Emptied containers properly rinsed with water are not considered aschemical wastes and can be discarded as ordinary refuse.3.1 One open top container for solids and one closed top container for liquids will bedispatched to each hospital, upon their request, for pharmaceutical wastes.Additional containers will be provided on a case by case basis.1

3.2 Collection of pharmaceutical wastes will be scheduled at time of collection ofother chemical wastes from hospitals.3.3 The Chemical Waste Service Co-ordinator appointed by each hospital, should takecharge of co-ordination of this service.4. Documentation of Part A Chemical Waste4.1 On disposal of materials categorized under Item 1.1a to 1.1c above, wasteproducers are required by law to notify EPD prior to disposal using Form EPD-132. In such case Enviropace would arrange collection service only upon receiptof copy of EPD’s Part A Waste disposal directions on Form EPD-131 specifyingthe CWTF as the designated disposal point.4.2 A Part A Waste Verification Label (Appendix III) will be attached to eachcontainer at time of dispatching. If the container contains Part A waste at time ofcollection, a packing list must accompany the container. If the container does notcontain any Part A waste, the Chemical Waste Service Co-ordinator or anappropriate designated person in charge shall sign next to the confirmationstatement to verify (Appendix III).4.3 Form EPD-132 should be sent to :Environmental Protection DeptWaste & Waster Management Group25/F, Southorn Centre130 Hennessy RoadWan ChaiHong KongEnquiry Hotline : 2835 1082Fax : 2305 0453[Appendix I, IIA, IIB, III are not included]HAHO Sept 95(revised in Jan 05)2

Appendix 14Guidelines on the Handling ofDangerous Drugs in HA Hospitals

REVISED GUIDELINES ON THE HANDLING OFDANGEROUS DRUGS IN HA HOSPITALSProcess Authorised Staff Particulars(1) Issuance of a signedorder for the procurement ofDD from pharmacy.Ward Manager (WM) i/c;Nurse Specialist (NS) i/c;Nursing Officer (NO) i/c;Registered Nurse (RN) i/c;Enrolled Nurse (EN) (If no registerednursing staff are on-duty)Each ward to supply a list of authorizednursing staff with specimen signatures topharmacy.For practical purpose, the list should bekept small and up-dated regularly.The nursing staff issuing the signed ordershould sign and indicate her title andname clearly for verification bypharmacy staff(2) Delivery of DD to/fromwardsAs advised by the Department of Heath,the pharmacist i/c or an authorizednursing staff can appoint a designatedhospital staff acting as his/her agent forthe collection, delivery andtransportation of DD to/from wardsLockable receptacles should be used inthe transportation of DD.(3) DD records and stocks inwardsA DD register will be kept in each wardto record DD transactions.Copies of the signed order issued shouldalso be kept for the statutory 2 years.Pharmacist should inspect the DDregister and stocks in the wards monthly.Any irregularity should be rectifiedimmediately. Any irregularity thatcannot be rectified have to be reported tothe Director of Health as required underthe Dangerous Drug Ordinance.(4) Disposal of DD records The expired register and the signedorders in the wards can be disposed ofonly with the approval of the pharmacisti/c in accordance with agreed procedureswith hospitals.For administrative convenience, thepharmacist i/c will be appointed as theperson approving of the disposal.Pharmacy would work out the agreedprocedure with the nursing staff.(5) Transfer of DD from 1ward to another foremergency use after officehours when pharmacy isclosed.The designated WM, NS, RN i/c of thehospital at after-office hours should beinformed and approved of such transfer.The ‘recipient’ ward should send aqualified nurse or a student nurse to the‘donor’ ward for the collection of the DDand the MAR of the patient should bepresented. The qualified nurse in the‘donor’ ward should record the patientparticulars in its DD register.The pharmacist should be informed ofthe incident and to review the optimalward stock level.It is not necessary for the ‘recipient’ward to record the quantity of DDreceived in its register becausetechnically, the DD is only administeredto its patient and not stocked.(6) Retrieval of DD fromlocked DD cupboard inwardsWM, NS, NO and designated RN andEN who are performing the duty of thesister i/c.Should exercise 3C 5R principle.Advisable to have a second person tocountercheck.(7) Administration of DD topatients in accordance todoctors’ prescriptions ordirections in the bed cards orcase sheets.Any qualified nurse which include:Registered Nurse (General);Registered Nurse (Psychiatric);Enrolled Nurse (General);Enrolled Nurse (Psychiatric);Registered Midwife;Nurse Learner under supervision.Should exercise 3C 5R principle.Advisable to have a second person tocountercheck.7ddguide5 HAHO 17 April 981

Appendix 15Medication Incident <strong>Report</strong>ing Programme

QUALITY ASSURANCE IN DRUG THERAPYHOSPITAL AUTHORITY MEDICATION INCIDENTS REPROTING PROGRAMMEPurpose1. This memo announces the setting up of the Hospital Authority’s Medication Incidents<strong>Report</strong>ing Programme and its implementation.Background2. The goal of any drug therapy is the achievement of defined and desired therapeuticoutcomes with minimal side effects and “risks” to the patients. “Risks” in the course ofdrug therapy may arise because of “adverse reaction” to drug appropriately prescribed andproperly administered. Alternatively, patient may suffer from medication errors which arepreventable through effective systems controls and implementation of sound proceduralguidelines.3. In the course of reviewing the drug delivery systems in public hospitals, the “WorkingParty on Drug Administration Procedures and Practices” has considered in detail, thecausation and prevention of medication errors, and the principles involved in the settingup and operation of any monitoring mechanism on medication errors.4. The feasibility of having a Medication Incidents <strong>Report</strong>ing Mechanism for HospitalAuthority has since been discussed at the HA’s Central Drug and TherapeuticsCommittee. Further and more intensive discussion by professional staff in Hospitals havealso been promoted by the publication of Hospital Authority Drug Education BulletinIssue No. 4 and the organisation of a series of 3 seminars on the subject in October 1993.Medication incidents reporting5. It is certainly important to take proactive measures to prevent medication errors byimproving procedural guidelines, staff education and system support. It is equallyimportant that we can learn retroactively through errors that have been committed. In thisregard, there are sound support from overseas experience, for a medication incidentsreporting mechanism to be in place in all in-patient health care facilities so thatmedication incidents could be identified and documented and their causes studied in orderto develop systems that minimize recurrence. A variety of different reporting mechanismsare being used overseas in health care facilities. They may differ in the definition of casesto be reported, the reporting format, details of inquisition and the approach taken to dealwith the staff and patients involved.6. It is held however, that any effective incident reporting system should stress the qualityassurance and constructive aspect of the process and avoid a punitive or disciplinaryapproach. In this regard, the Hospital Authority already have appropriate procedures inplace to deal with serious cases of medication error which warrant medical-legalconsiderations. Immediate assistance could be solicited from the Legal Liaison Officersat HAHO in accordance with HAHO General Administration Circular No. 2/92.7. Recognizing the need and benefit of medication incidents reporting and monitoring, anumber of HA Hospitals have already set up their own reporting systems within the lastyear.1

Hospital Authority Medication Incident <strong>Report</strong>ing Progamme (MIRP)8. With more than 1 1 / 2 years’ period of discussion since the idea was first recommended bythe Working Party on Drug Administration Procedure and Practices, and positivedevelopments in a number of HA Hospitals, it is time for an overall Medication Incident<strong>Report</strong>ing Programme (MIRP) to be set up for the Hospital Authority. The MIRP willcomprise the local <strong>Report</strong>ing Programme at each HA Institution and an overall monitoringand supporting function at the HAHO. Hospitals which already have a MIRP set up alongthe lines described below would continue to operate the programme whilst all otherHospitals are requested to set up their MIRP by 1 April 1994. The mode of operations ofthe MIRP are set out as follows:(a)(b)(c)(d)(e)(f)(g)(h)(i)Hospital staff are required to report all Medication Incidents (MI) irrespective ofwhether patients have been involved.Any staff coming to knowledge of a Medication Incident (MI) could report. Inparticular, managers responsible for operational units e.g. COS, DOM, WM, DM,should report.The reports are to be made on a standard proforma. A sample of such proforma isat Appendix I. Hospitals already with MIRP could retain their forms and otherhospitals could adapt the sample form at Appendix I for their own use.The identity of the staff involved in the Incident and the patient are NOTREQUIRED to be reported.The incidents reports are to be directed to the Hospital Drug Committee orequivalent mechanism. A panel consisting of at least one doctor, one pharmacistand one nurse will be appointed by the Hospital Drug Committee to review allreported cases in conjunction with the respective managers on a periodic basis.The Hospital Drug Committee will identify the underlying causes of each incidentand recommend appropriate preventive on remedial measures to the HCE.Hospital Drug Committee will also report the statistical data and anyrecommended action to the HAHO using the proforma at Appendix II.Documents related to these quality assurance activities are to be separately andsecurely filed by the Committee. This include the incidents reports which shouldNOT be filed into the patients medical record.These quality assurance related procedures should not interfere with any necessarycorrective and supportive therapy to the patient.Medication errors resulting in injury to the patient should be reported to theHAHO Legal Liaison Officer in parallel and handled separately according to HAGeneral Admin Circular No 2/92.Continuous Review and Follow-up action9. Whilst Hospitals will take appropriate remedial / preventive actions regarding problemsunveiled by reviewing medication incidents occurring locally, HAHO would monitor theoverall trend of medication incidents and consider appropriate global measures againstmajor or service wide problems and to support the Hospitals in this area.[Appendix I & II are not included] HAHO Feb 942

Appendix 16Adverse Drug Reaction <strong>Report</strong>ing Programme

QUALITY ASSURANCE IN DRUG THERAPYHOSPITAL AUTHORITY ADVERSE DRUG REACTION REPORTING PROGRAMMEPurpose1. This memo announces the setting up of the Hospital Authority’s Adverse DrugReaction Programme and its implementation.Background2. As unexpected or undesirable effect may arise during the course of drug therapy,appropriate quality assurance system for medication use should be in place to identifythe causation and prevent the occurrence of these events.3. Currently, central quality assurance programs regarding medication incidents andpharmaceutical product quality are in place at the Hospital Authority. The MedicationIncident <strong>Report</strong>ing Program (MIRP), initiated by the Drug Utilization ReviewCommittee (DURC), was set up to identify opportunities for quality improvement andto assist health professionals in reducing and avoiding medication errors. As for themonitoring of the quality of pharmaceutical products, there are central proceduralguidelines for the reporting and the handling of quality complaints set forth by theChief Pharmacist’s Office.Adverse Drug Reaction reporting4. It is well aware that adverse drug reaction (ADR) may cause unnecessary physicianvisits, hospital admissions, and increased length of hospital stay. Local study showedthat 4.4% of acute admissions to a general ward were due to adverse drug reactions.To reduce these unnecessary admissions or hospitalization, it is thus important toidentify those ADRs which may be avoidable.5. Many overseas countries have a national ADR reporting system in place, whichcollects ADR reports from health care professionals for the purpose of assessing thesafety of the marketed drugs. Although the reporting of ADR is voluntary, manyhospitals have set up internal reporting programs to further improve the quality of carein their institutions. The ADR reports collected in the hospitals are forwarded to theirrespective agency for central review.6. Currently there is no systematic ADR reporting program in HA. A few hospitals arecollecting their own ADR reports without any inter-hospital communications orsharing of the reports. In order to unify the ADR reporting systems and to encouragemore active reporting throughout the HA, a centralized reporting system is considereddesirable.7. The potential problem of setting up a separate ADR reporting program in parallel tothe existing MIRP had been thoroughly considered and a pilot exercise had beenconducted in OLMH and QMH from October 2000 to March 2001. Taking referencefrom the pilot exercise and overseas experience it is now proposed that the HA ADRreporting program would be set up as from 1 January 2002.1

Hospital Authority Adverse Drug Reaction (ADR) <strong>Report</strong>ing Programme8. The ADRs would be reported via a similar mechanism (See Fig.1) as the medicationincidents and the mode of operation are set out as follows :a) A local reporting program set up at each HA institution.b) Suspected ADRs will be reported on a standard form, filled by a doctor or apharmacist. A sample of the form is attached in Appendix I.c) The reports are directed to the ADR sub-committee of the hospital’s Drug &Therapeutic Committee -• Each ADR report is evaluated and given a causality rating.• Educational feedback will be provided to the prescribers and otherhealth care professionals.• The completed ADR reports are to be forwarded to the CPO on aquarterly basis.d) The CPO would analyse the overall trend of the ADRs and take appropriatemeasures to enhance safety in medications.9. As recommended in the 2000 <strong>Edition</strong> of the “<strong>Report</strong> on Drug AdministrationProcedures and Practices”, a standard reporting mechanism/format should beestablished to collect information on ADRs from the hospitals for analysis on a regularbasis. Doctors, pharmacists and nurses should be alert to the potential occurrence ofADR.[Appendix I is not included] HAHO Oct 012

Fig. 1: ADR voluntary reporting system in HALevel I : Hospital – Local reporting programDoctors / Pharmacists(<strong>Report</strong>ers)SuspectedADRSADR sub-committee(Reviewers)EducationalFeedbackEvaluate & rate all ADRsbased on the algorithmsDrug & Therapeutic CommitteeLevel II :HAHOEducationalFeedbackCompleted ADR<strong>Report</strong>sCPO / HAHO• Central Data analysis• Notify frontline health professional• Alert Dept of Health &/ Manufacturer• Consider withholding the useHAHO Oct 013

Appendix 17Procedure for Quality Complaints on Pharmaceutical Items

PROCEUDRE FOR QUALITY COMPLAINTSONPHARMACEUTICAL ITEMSIntroductionA quality complaint of a pharmaceutical item is defined as concern that is raised ondiscrepancies in efficacy, appearance, packaging, possible contamination or any othercircumstances observed that may jeopardise or cause reasonable doubt on the routine and intendedutilization of that item.This procedure and the standard “Pharmaceutical Product Quality Complaint <strong>Report</strong>Form” are designed to provide a standardised and comprehensive mean for reporting and recordingquality complaints of pharmaceutical items. The report form will also be used as a base forcommunications and correspondences. E-mail should not be used as a mean to report complaint.The report form must be used for all cases of quality complaints. The followingguidelines should be observed in order to proceed and handle such complaints in a systematicmanner. Apart from the head of pharmacy, a co-ordinator should also be nominated to receive andhandle quality complaint promptly. The co-ordinator should be made known and updated to boththe Chief Pharmacist’s Office and all departments within your hospital as a one stop contact oncomplaint matters. The Pharmacist (Procurement) or his delegate Chief Dispenser (Procurement)will be the co-ordinator of complaint at Chief Pharmacist’s Office.Whenever an alert with batch suspension is issued, immediate action must be takento quarantine all affected batches in all stores both within and outside pharmacy. Close liaisionwith nursing staff should be maintained in order the situation is fully understood by all partiesconcerned. All subsequent recommendation including product suspension, replacement,withdrawal or recall should be executed immediately and to all ward levels.Possible ActionsClass IRemoval of all traceable quantity of a product within your hospital.Class IIRetrieval of all affected batches within your hospital and hold in quarantine pendingfurther follow up actions.Class IIIGeneral alert to all users where specific guidelines or procedures needed to befollowed for safety reason.Class IVThe affected batch is released for use.Class VNo immediate action but will keep in view of the development.1

Part I Pharmacy Department1. Receiving the Complaint1.1 The co-ordinator or his delegate must attend to the complaint immediately.1.2 Identify the item concerned, the particular manufacturer in question and record thebatch.1.3 Note and understand the nature, when and how the complaint is identified.1.4 Note the originating Department/Ward, name and rank of the complainant.1.5 Inform the head of pharmacy about the complaint.2. Immediate Action2.1 The head of pharmacy and the co-ordinator must first assess and understand thesituation, collect the complaint sample and decide what actions to be taken.2.2 Start a case file on the complaint.2.3 Alert all pharmacy staff of the situation.2.4 In case where the batch is suspended from use, consolidate the affected batch withinyour hospital and hold in quarantine.2.5 Complete the “Pharmaceutical Product Quality Complaint <strong>Report</strong> Form”. Allrequired details and any immediate actions taken must be documented.2.6 Notify either Pharmacist or Chief Dispenser of the Procurement Section bytelephone before forwarding the completed report form by fax to the ProcurementSection of Chief Pharmacist’s Office.2.7 Make urgent arrangement to despatch the relevant complaint sample and two unitsof the circulating stock of the same batch to Chief Pharmacist’s Office.2.8 Follow-up with the officer previously notified if acknowledgement of complaint byreturn fax is not received.3. Follow-up Action3.1 Continue to monitor the progress of the complaint and follow up with ChiefPharmacist’s Office where necessary.3.2 Inform Chief Pharmacist’s Office on any subsequent actions taken within yourhospital where appropriate.3.3 Observe the recommended action or outcome from Chief Pharmacist’s Office.3.4 Inform and follow-up with the concerned department/ward/personnel on theoutcome of complaint and the progress of any recommended actions.3.5 <strong>Report</strong> to Chief Pharmacist’s Office when recommended action is completed.2

Part II Procurement Section, CPO1. Receiving the Complaint1.1 The officer receiving the call must ensure the complaint form is received afterbeing notified by the institution initiating the complaint.1.2 The officer receive the complaint must acknowledge the complaint by return fax tothe initiating institution immediately.1.3 The Pharmacist (Procurement) or his delegate must follow up with the initiatinginstitution to ensure full understanding of the nature of the complaint and receiptof relevant samples where appropriate.1.4 Open case file which must be endorsed by Senior Pharmacist (Procurement) andcirculate within the procurement section.1.5 The report form must be used to document and communicate with relevant partiesby fax on all the activities taken throughout the entire exercise.2. Immediate Action2.1 The Pharmacist (Procurement) will assess the situation and seek endorsement fromSenior Pharmacist (Procurement) on the course of actions to be taken.2.2 Organise, arrange and document all evaluation testing on both the complaintsample and circulating stock respectively.2.3 Inform users, supplier, the Department of Health, the Government SuppliesDepartment and HA Central Procurement Unit if necessary on all actions taken asappropriate.2.4 Evaluate the situation and make necessary arrangement to ensure continuity ofsupply of the affected item if necessary.2.5 All actions and steps taken are properly documented on the report form.3. Follow-up Action3.1 Follow up on the progress of investigation by supplier/manufacturer.3.2 Validate the outcome of the any investigation by independent testing or consultexpert opinion where necessary.3.3 Assess the validity, accept or reject the submitted explanation and proposedimprovements to be implemented by the supplier/manufacturer.3.4 Inform users, supplier, the Department of Health, the Government SuppliesDepartment and HA Central Procurement Unit if necessary on any proposedactions or recommendation as appropriate.3.5 All actions and steps taken are properly documented on the report form.HAHO Aug 963