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ContentsFrom the chief executiveand registrar 2Registrant update- Renewals and removals 3- Our new guidance 3- Our view on singledispensing errors 4- Can you help find them? 4Around the UK- Meet our Director for Wales 5- Closer to Northern Ireland 5First steps to revalidation 6Registered pharmaciesconsultation 8Being proportionate- Changing the order? 10Obtaining consent 12- Physical examinationsLetters 13Fitness to Practise- Determinations 14- Learning 16Regula+e is the registrant bulletin of theGeneral Pharmaceutical Council.It is sent to all registrants (at the time ofposting) and pre-registration trainees. Attimes we may approach externalorganisations or individuals to submit anarticle or opinion on a topical issue. Allarticles and letters commissioned, writtenor submitted are subject to editorial controland may not be printed in full or withreference back to source.If you would like to contact the editor orsubmit a letter or comment to Regula+eplease contact us at:regulate@pharmacyregulation.orgThe Editor, Regula+eGeneral Pharmaceutical Council129 Lambeth Road | London | SE1 7BTGeneral Pharmaceutical Council ©2012From the chiefexecutive andregistrar2012 is shaping up to be a busy andchallenging year and this, our thirdedition of Regula+e, seeks to give you aflavour of why that is.First, can I welcome more than 20,000pharmacy technicians to our register.Having a statutory register for pharmacytechnicians is a milestone in pharmacy.Our new registrants join around 1.2million registered health professionalsworking across the UK in 30 differenthealth professions.This edition of Regula+e has arrivedwith copies of our new guidancedocuments covering consent, maintainingclear sexual boundaries, and raisingconcerns. A copy of our confidentialityguidance is available on our websitewww.pharmacyregulation.org/standards/guidance and a printedcopy will be sent with the next editionof Regula+e.We have been pleased by your responseto the “taking a view” process on thiswork. Can I thank everyone who tookthe time to send us your comments,which we have used to shape this work.We look forward to hearing what youthink of the final products.As Regula+e lands on your doorstep,we are launching our formalconsultation on registered pharmacies.This is an important piece of work and asignificant step forward for us as thepharmacy regulator. You may know usbest as the organisation which registersyou as a pharmacist or pharmacytechnician. Now we are setting out ourvision for the regulation of pharmacies -how pharmacy services are managedand delivered in Great Britain. We havehad interim standards covering thisarea up to now.Our new approach is based on two keyideas - the outcomes we think are rightto protect patients and the public, andan approach to regulation we think isproportionate and seeks not to hinderthe development of high-quality andinnovative practice. You can read moreabout our proposals on page 8. Can Iencourage you to respond in whateverway you would like. The consultationruns until 7 May.Another key area of work this year isrevalidation. The GPhC Council hasrecently taken a decision to moveforward and design a model forrevalidation, which will requirepharmacists and pharmacy techniciansto demonstrate their fitness to practiseon an ongoing basis. We haven’t yet seta timetable for the introduction ofrevalidation. Before we do, we are keento work with you and further developour ideas. We want to start by asking foryour help to refine the seven principleswe have set out to underpin this work.You can read more on page 5.I hope you continue to find Regula+teuseful and can I encourage you to shareyour thoughts with us atregulate@pharmacyregulation.orgDuncan RudkinChief executive and registrarregulate@pharmacyregulation.org2 Regula+e: February 2012 | Issue 3

Registrant updateRenewalsand removalsA total of 2.5 per cent of registrantswere removed from the register on31 December 2011 for non renewal oftheir registration. These included:• 1037 pharmacists• 158 pharmacy technicians• 34 pharmacy premisesWe have since received applicationsfor restoration from at least 152pharmacists and 10 pharmacytechnicians. We are processing allapplications for restoration as a matterof priority.Restoration costs a total of £486 forpharmacists, £297 for pharmacytechnicians and £789 for premises ifremoval has been for non renewal, whileregistration costs £267 for pharmacists,£120 for pharmacy technicians and £221for premises to renew.We list the pharmacists, pharmacytechnicians and premises that have beenremoved from the register athttp://www.pharmacyregulation.org/registration/renewing-yourregistration/removalsIt may be the case that registration hasbeen restored since we published thatinformation so it is worth searching theregister for the most up-to-dateinformation.The GPhC operates what is known as arolling register, which is a requirement ofthe Pharmacy Order. This is thelegislation which sets out our role andpowers. A rolling register means thatyour registration runs from the date youentered the register and must berenewed by that date every year.Only registrants who transferredfrom the previous regulator’s registercontinue to have a 31 Decemberexpiry date.For all registrants, the renewal deadlineis two months before your registrationexpiry date. Your renewal date is shownclearly on your renewal notice and youcan call us on 0203 365 3400 if you haveany queries.For more information about renewing your registration go tohttp://www.pharmacyregulation.org/registration/renewing-your-registrationOur newguidanceYou will have received copies of ournew pieces of guidance with thisedition of Regula+e. This workexpands on key areas of ourstandards of ethics, conduct andperformance and covers:• consent• maintaining clear sexualboundaries• raising concernsThe fourth piece of guidance coveringconfidentiality is available, with theother three, on our website atwww.pharmacyregulation.org/standards/guidance and a printedcopy will be sent with the nextedition of Regula+e.In the second half of last year weasked for your commentson this work. While this was not aformal consultation, we were pleasedthat many of you looked at the draftguidance on our website or on socialmedia sites, and chose to submitviews and comments.Guidance onconsentGuidance onmaintaining aining clearsexual boundariesThank you for taking the time torespond. We have taken all thefeedback into account in shapingthe final products, and you havealso provided us with ideas aboutfurther guidance, which we areconsidering.February 2012February 2012February 2012Guidance onraising concernsUpholding standards and public trust in pharmacy 3

Registrant updateOur viewon singledispensingerrorsWe have consistently made clear our viewthat single dispensing errors, withoutother significant aggravating factors,would not amount to a fitness to practiseconcern. We have therefore welcomedthe recent initiative to address concernsabout the risk of prosecution when aninadvertent dispensing error is made.The Medicines and Healthcare productsRegulatory Agency (MHRA) hasannounced that it will work on aprogramme of activities to address theseconcerns. We were at the meeting heldby the MHRA, four UK HealthDepartments and Chief Pharmacists,Pharmaceutical Society of NorthernIreland (PSNI) and other interestedparties, to discuss this programme.The MHRA has indicated it intends toconduct a review of sanctions andpenalties in medicines legislation. Themeeting was also told that theGovernment has been considering anoption currently available to them toamend the Health and Social Care Billwhich is being considered by Parliamentat this time. The amendment wouldenable anyone at risk of prosecutionunder section 67 of the Medicines Act tomount a defence that they had exercisedall due diligence to avoid committingsuch an offence.GPhC Chief Executive, Duncan Rudkin said:“We welcome the commitment of theGovernment to legislate at the earliestopportunity and the MHRA’s plans for awider review of the nature and extent ofsanctions and penalties in this area.“As the pharmacy regulator, we want toencourage a culture of openness amongpharmacy professionals wheneveradverse incidents occur. Providingfurther reassurance and clarification inrelation to the extent of criminal liabilityis one of the key ways that we canimprove practice and protect the public.“Anything that acts as a disincentive tothe disclosure of adverse incidents,including dispensing errors, isdetrimental to public safety. This is whywe have made clear that singledispensing errors would not in our viewconstitute a fitness to practise concern,if there was not a wider pattern of errorsor significant aggravating factors.”Can you helpfind them?We are seeking your help to findindividuals who have put their careerson hold and have not yet completedtheir pre-registration training. This isparticularly the case for anyone whoentered training on or before noon on12 November 2010. They mustcomplete their education and trainingand apply to register by noon on20 December 2013.Our records indicate that there is agroup of over 400 individuals in thesecircumstances.Despite repeated attempts, we havenot been able to contact everyone inthis group and would appreciate yourhelp in raising awareness of the needto finish their training if they intendto seek registration.The key is whether someone enteredpre-registration training before orafter the 2010 date.The GPhC introduced a registrationtime limit (eight years) to ensurethat the learning that traineepharmacists carry through intopractice is up to date.Anyone who entered pre-registrationtraining after the 2010 date has eightyears to complete their registrationas a pharmacist. This gives traineesan additional three years beyondthe length of time of an MPharmdegree and year of pre-registrationtraining and the RegistrationAssessment.4 Regula+e: February 2012 | Issue 3

Around the UKNew directorfor WalesWe are delighted to welcomeDarren Hughes as our first directorfor Wales.Darren joins us from the GeneralMedical Council (GMC), where he hasbeen acting head of office in Wales.He has worked for the GMC in Walessince 2006. Before that Darren workedfor the Countryside Alliance in a rangeof roles, including as campaignsco-ordinator in Wales.Darren said: “I’m really looking forwardto working with the GPhC to raise theprofile of Welsh affairs. The healthcaredelivery structures in Wales areincreasingly diverging from those inother parts of the UK and I want to helpensure that the Council is regulating in away that reflects the needs of patients,the public and the pharmacyprofessions in Wales."Recent reforms in the NHS mean thatpharmacists are playing a bigger role inimproving the well-being of people inWales. I’ll also be working to helpAssembly Members, patients, educationproviders and other key partners tobetter understand the role andregulatory scope of the GPhC in Wales.”Darren Hughes, new director for WalesCloser to Northern IrelandA consistent approach to the principles that underpin pharmacy regulationacross the United Kingdom became a reality when we signed a Memorandumof Understanding (MOU) with the Pharmaceutical Society of Northern Ireland(PSNI), which has responsibility for regulating pharmacy in Northern Ireland.Both the PSNI and the GPhC believe this consistency is important in maintainingpublic confidence in the pharmacy profession and in helping pharmacists topractise safely and consistently wherever they choose within the UK.GPhC chief executive and registrar, Duncan Rudkin, said: “We are delightedto have signed this Memorandum. We already had a strong friendship withPSNI and this cements that bond. Of course this is not just a token of ourfriendship but a practical agreement and a guide to how we want tocollaborate in the future.”“This new agreement provides us with an opportunity to reassure patients andthe public that both regulators are working together to maintain standards on aUK-wide basis.”PSNI chief executive Trevor Patterson, said: “With increasing divergence indevolved healthcare systems there are real challenges to regulation inmaintaining consistency whilst recognising and accommodating differences.”“This MOU is a very welcome practical example of organisations workingtogether in an open and practical manner to deliver their shared objectives.Since its inception we have enjoyed an excellent relationship with GPhC andI look forward to further joint working in the future.”Upholding standards and public trust in pharmacy 5

RevalidationFirst stepsto revalidationWe have taken the decision to introducerevalidation, which will requirepharmacists and pharmacy techniciansto demonstrate their fitness to practiseon an ongoing basis.The GPhC Council has recently agreedboth a draft definition of revalidationand a draft set of principles.We have defined revalidation as:“The process by whichassurance of continuingfitness to practise of registrantsis provided and in a waywhich is aimed primarily atsupporting and enhancingprofessional practice.”We have also agreed seven draftprinciples (see box). Further workis planned to test and refine the draftprinciples, and we would welcomeyour comments, which can be sent torevalidation@pharmacyregulation.orgGPhC Chief Executive, Duncan Rudkin, said:"This is a significant step forward inthat we have set out what we wantto achieve from this process. This isnot a souped-up version of CPD andnor are we interested in a one sizefits all approach; some abstractassessment of knowledge and skills.What we want to develop are differentapproaches depending on your areaof practice.6 Regula+e: February 2012 | Issue 3

Revalidation"A key focus for us will be to minimisethe need to create new systems andprocesses as far as possible. Revalidationshould prompt pharmacy to ask itselfhow it can provide us with the evidencewe need rather than us taking an overlyprescriptive approach."The work to date has been developedby our Revalidation Task and FinishGroup, which has been chaired byDr Peter Wilson, and includedSarah Brown, Judy Worthington,Professor Soraya Dhillon, Gordon Dykesand Tina Funnell. All sit on the GPhCCouncil. The group developed this workhaving met with a range of stakeholdersand looked at key evidence.The group looked at the challenges facedin other health professions which hadsought to introduce revalidation, notingthat it had taken over 12 years for medicalrevalidation to reach the point of piloting.They heard from other regulatory bodieshow difficulties over defining the issue andexplaining the purpose of revalidation hadundermined attempts to introduce it.Having reviewed the evidence, thegroup found that the arguments forthe introduction of revalidation werestill compelling:• to maintain public confidence in thepharmacy professions. Opinionpolling has repeatedly shown that thepublic believe health professionalsare already subject to regular reviewsor assessments of fitness to practice• evidence from the Bristol InquiryReport showed that competence didnot always grow with experience andcould diminish over time, and thatthere was no system in place to spotwaning competence, to support thoseprofessionals or to protect patients• as the independent pharmacyregulator, the GPhC has a duty toassure fitness to practise ofregistrants from the point theycome onto the register. The BristolInquiry underlined that waiting forthings to go wrong did not protectpatients adequately, and that therewas evidence of sub-optimalperformance within the medicalprofession. Our Task and FinishGroup thought that althoughevidence of sub-optimal performancewas limited in pharmacy, the situationwas unlikely to be very different fromother professions• despite seeking a more flexible,tailored and flexible approach torevalidation, the government stillexpects the health professionalregulators to provide evidence on thissubject and a clear direction of travel.No timetable has yet been set for theintroduction Draft principles: of revalidation. TheWe arekeen to work with you we developcontinuing assurance ofour ideas, and we expect thisfitness to practise ofdevelopment work to span at leasttwo pharmacists years. and pharmacytechnicians1. The focus should beassurance of continuingfitness to practise andnot a fixed pointassessment2. The model should beconsistent with thegeneric principles agreedby the Non MedicalRevalidation WorkingGroup3. The model will need toconsider more than onesource of information4. Some form ofassessment will berequired and will needto be made againsta standard5. That standard should bebased on the standardsof conduct, ethics andperformance whichapply to all registrants6. The model must takefull account of thestructure of thepharmacy workforce7. Any model would needto be appropriatelycosted and subject totesting, includingpilotingUpholding standards and public trust in pharmacy 7

Registered pharmaciesOur visionfor registeredpharmaciesModernising pharmacyregulation:A consultation on the draft standards for registered pharmaciesOn 8 February, we launched aformal consultation on our visionfor a safe system of managing anddelivering pharmacy services inGreat Britain. Included in this workare new draft standards for registeredpharmacies. The consultation runsto 7 May.The way pharmacy care and servicesare organised in England, Scotland andWales is changing. Pharmacists andpharmacy technicians have knowledgeand skills which can help to promote,protect and improve the health ofindividuals and the public. Thisenhanced role - and the good that itdoes - goes way beyond dispensingmedicines on prescription.This greater scope for doing goodbrings with it the potential for newrisks. We believe it’s our role, as thepharmacy regulator, to ensure that thepublic is properly protected so thatthey can safely benefit frompharmacy services in the way thateveryone wants.Our main concern is what matters topatients and the public so our focus inthis consultation is on what the systemfor managing and delivering pharmacyservices achieves for them.Our consultation proposals seek to:• describe the outcomes of safe andeffective practice that we think shouldbe achieved• make clear who is responsible andwhat they are responsible for• enable pharmacy professionals totake decisions in the best interests oftheir patients rather than against adetailed step by step rule book fromthe regulatorWe have recognised that it is not enoughfor us to publish standards for registeredpharmacies alone. We want to be clearabout which premises we believe mustbe registered with us and must adhereto our standards. We have also set outthe approach we plan to take to securingcompliance with the standards and howwe will manage non-compliance.8 Regula+e: February 2012 | Issue 3

Registered pharmaciesOur consultation brings togetherthese three key elements - registrationrequirements, draft standards, andour approach to compliance andenforcement.You can find a copy of theconsultation document atwww.registeredpharmacies.orgOnce the formal period for feedbackhas finished, we will consider all theresponses and produce a reportsummarising what you told us. Thisreport on feedback will be availableon our website and we will makecopies available to those whoparticipated in the consultation.In terms of next steps, there willbe a significant period of time setaside for those who will be accountablefor upholding the standards tofamiliarise themselves with both thefinal set of agreed standards, as well assubsequent guidance and policiesfrom the GPhC.We are asking a series ofquestions about our proposalsand would welcomeyour responses.The easiest way to let us know your views is to go to our dedicated websitewww.registeredpharmacies.orgYou can download copies of the consultation document and the questionnaire,or fill in our questionnaire or just the questions you are interested in, online.If you want to produce your own response, you can email that to:consultations@pharmacyregulation.orgIf you would like a hard copy of the consultation document and/orquestionnaire, you can:phone: 0203 365 3506email: consultations@pharmacyregulation.orgwrite to:Registered Pharmacies Consultationc/o Communications DepartmentGeneral Pharmaceutical Council129 Lambeth RoadLondon SE1 7BTOther formatsThere is a Welsh Language version of this consultation document available atwww.registeredpharmacies.orgYou can request an alternative format by emailing us atconsultations@pharmacyregulation.org or calling us on 020 3365 3506.We will be publishing more information about the consultation on ourwebsite, here in Regula+e, and in our e-bulletin, Upda+te. You can also followthe progress of the consultation on social media sites like Twitter, LinkedInand Facebook.We will be hosting a number of meetings and events over theconsultation period - you can find our calendar of events atwww.registeredpharmacies.org/eventsIf you would like us to attend a meeting or event to talk about these proposals,please contact us at consultations@pharmacyregulation.org or call us on020 3365 3506.We will bring copies of the consultation document and questionnaire tomeetings and events.Upholding standards and public trust in pharmacy 9

Being proportionateChangingthe order?We have recommended a series ofchanges to the Pharmacy Orderin advance of the Law Commission'sreview of the legislative framework forhealth professions regulation. ThePharmacy Order is the piece oflegislation which sets out the role andpowers of the GPhC.The government announced last year thatit intended to simplify the existinglegislative framework and develop a draftBill for consultation. The LawCommission's review is part of thatprocess. We have developed ourrecommendations so we are best placedto influence the design andimplementation of any new legislativeframework. Our recommendations havebeen agreed by the GPhC Council.They include:• enabling us to require evidence ofEnglish language co mpetence fromEuropean Economic Area (EEA)applicants for registration• removing the detail which specifiesregistration periods and expiry dates.We would like to have the flexibility todeal with length of registration periodsand expiry dates by way of rules,which we would consult on beforethey were finalised• increasing the flexibility and efficiencyof the initial stages of the fitness topractise process by allowing greateruse of administrative decision-makingby the registrar in less serious cases,and enhancing the scope of theCouncil's powers to issue criteria toguide referrals to and by theinvestigating committee• enabling us to work in a more joinedupway with other regulators andauthorities, like the police, by requiringthird parties to provide informationabout people applying for registration.We have experienced difficulties insome cases in obtaining necessaryinformation• removing the requirements to specifyin rules the intervals at whichinspectors may conduct routineinspections and the circumstances forspecial inspections and other visits.This is so we can continue to develop arisk-based and proportionate approachto regulation.Government would be required toconsult on any changes to the PharmacyOrder.10 Regula+e: February 2012 | Issue 3

Being proportionateGPhC Chief Executive, Duncan Rudkin said:“Our approach needs to be flexible enoughto respond to the changing pharmacycontext and to allow for innovation, whilesupporting high-quality practice. We arecommitted to regulating in a proportionateand outcomes-focused way.”The Law Commission is thestatutory independent bodycreated by the Law CommissionsAct 1965 to keep the law underreview and to recommendreform where it is needed.The aim of the Commission is toensure that the law is fair,modern, simple and as costeffective as possible.The Commission has beenreferred the project onRegulation of HealthcareProfessions by the Department ofHealth. The Commission aims toopen the consultation in springthis year.You can read more about thework of the Commission athttp://www.justice.gov.uk/lawcommissionUpholding standards and public trust in pharmacy 11

Obtaining consentPhysicalexaminationsA recent Fitness to Practise case hasraised the issue of pharmacistsundertaking physical examinationsOur standards of conduct, ethics andperformance emphasise thatpharmacists must recognise the limits oftheir professional competence andpractise only in those areas in whichthey are competent to do so.Physical examinations of patients cansometimes be useful in making adiagnosis, but pharmacists should onlyundertake them when they have theappropriate skills and training for thattype of physical examination.It is also vital to gain explicit consentfrom the patient for examinations –our new guidance on consent is helpfulin understanding what you need to thinkabout when obtaining consent.Students and trainees are likely toreceive some limited training in physicalexaminations. Pharmacists may go on todevelop further skills, depending on thenature of their practice and continuingprofessional development.We asked you aboutRegula+e...We know that you are busy people so thank you to everyone who took twominutes to take part in our online feedback survey.The results are in – 70% of you said that Regula+e is useful, quite usefulor very useful. And you made some great suggestions about how we canimprove the magazine.Over 80% of you said you would like more on learning scenarios andFtP cases. We have our regular learning section on page 16 and we will belaunching a new online learning tool soon. Keep an eye on our websitewww.pharmacyregulation.orgYou may want to tell us more, or maybe didn’t get a chance to take partin the first survey. You still can by going to www.pharmacyregulation.org/regulate-feedbackWe took your survey responses and mapped how often key words appeared.As the word cloud shows, the word you raised most often was learning.12 Regula+e: February 2012 | Issue 3

LettersDear editor,May I start this letter by saying howmuch I am enjoying having regularcommunication from the GPhC. I findreading Regula+e very interesting andcongratulate you on its production.I am a pharmacy technician in a largemultiple and have worked for thecompany for over 28 years. I have saton the Welsh Pharmacy Board and wasalso a member of PRLOG – a groupthat was formed to oversee theestablishment of the GPhC. I am also anactive member of the Association ofPharmacy Technicians UK (APTUK),not only as its national continuingprofessional development (CPD) officer,but also the chairperson of the Cardifflocal branch.It has been a very exciting time inpharmacy over the last few yearsand I have been proud to be a memberof an evolving profession. I haveenjoyed being involved in theestablishment of the GPhC and partof the sometimes very lively debateson various issues.One of the main fears of mandatoryregulation for pharmacy technicianswas how they would cope with beinga regulated professional, and theresponsibilities that came with that.I have to say that all of the pharmacytechnicians that I have spoken to,whether it be at a national or locallevel, have embraced regulation withopen arms and are proud to berecognised as healthcare professionals.They are enjoying the opportunityto record their ongoing learning asCPD entries and don’t seem to befazed by it!I look forward to receiving futureeditions of Regula+e and readingarticles relevant to pharmacytechnicians and how we as a pharmacyprofession can work efficiently togetherensuring that we are delivering thesafest services to ourpatients/customers.Fiona Price, ACT, Boots, CardiffCPD officer, APTUKDear Fiona,Thanks for letting us know your thoughtson Regula+e.We are delighted to welcome pharmacytechnicians to the register. We havetaken on board not just your feedbackbut the many calls and emails we havereceived asking for more informationabout the role of pharmacy technicians.We will be responding in an upcomingedition of Regula+e.We hope you and colleagues willcontinue to let us know how we aredoing and how regulation cancomplement your work to deliver safeservices for patients and the public.Editor.Upholding standards and public trust in pharmacy 13

Fitness to Practise - determinationsFitness toPractise –determinationsShould a fitness to practise committeedetermine that a registrant’s fitness topractise is impaired, the committee mayimpose a sanction that is proportionate tothe conduct that has been found proven.This may include, for example, issuing awarning, placing conditions on theindividual’s registration, suspension ofregistration or, in the most serious cases,erasing the individual from the register sothat they can no longer practise.The matters listed here include theregistrant’s registration number, date ofdetermination and the sanction.Determinations of the facts and additionalinformation about the hearings can befound on our website athttp://www.pharmacyregulation.org/search/search_decisionsLumby, Andrew, 2066939Determination date 10 NovemberWarning recorded on the register inrelation to “submitting work colleaguesto sexual harassment”; conditionimposed that he attend and completean equality and diversity educationand training course no later than16 March 2012Gaskell, Michelle Julie, 5000650Determination date 24 November 2011Warning that in her future practice, shestrictly observes the requirements ofPrinciple 6 of the Code of Ethics and theprovisions of the Medicines Act 1968Adisi, Albertina, 5003399Determination date 24 November 2011Conditions imposed on registrationAtkinson, James Jamieson, 2024671Determination date 25 November 2011The registrant was erased from theregisterGhafoor, Asif, 2058709Determination date 1 December 2011Warning that “when conducting any kindof examination of a patient, Mr Ghafoormust have regard to Principles 3.9 and 6.5of the Code of Ethics, which require himto take special care when dealing withvulnerable individuals, and to adhere toaccepted standards of professionalconduct. Those standards includerecognising the limits of his professionalcompetence and practising only in thoseareas in which he is competent to do so”Damji, Sameed Abdulkarim, 2069571Determination date 7 December 2011Warning that he must not put himself in aposition in the future whereby he is atrisk of contravening the provisions of theMisuse of Drugs Act 197114 Regula+e: February 2012 | Issue 3

Fitness to Practise - determinationsRosa, Rute Sofia Brito Leanardo Silva,2062636Determination date 8 December 2011Suspension for one monthAdodra, Sumir, 2048903Determination date 12 December 2011Warning that “membership of yourchosen profession as a pharmacist carrieswith it significant responsibilities in termsof both personal and professionalbehaviour. This is rightly expected, bothby the public and by your pharmaceuticalcolleagues. Your full adherence to theprofessional and ethical expectations ofthe code of conduct must be uppermostin your mind at all times. More severeconsequences will undoubtedly resultfrom any further breaches of the code”Virdi, Bhupinder Singh, 2034628Determination date 13 December 2011Suspension for 12 months. Thecommittee also directed that hisregistration should be suspendedimmediately until the substantivesuspension is imposed, or pending theoutcome of any appealDunkley, Robert Ian, 2018660Determination date 13 December 2011Imposition of conditions on hisemployment for two years, to bereviewed in 12 monthsSheridan, Orla Sarah, 2058723Determination date 14 December 2011Conditions placed on registration for twoyears without the need for a reviewHussain, Sajid, 2052862Determination date 15 December 2011Warning that “any repetition of the kindof behaviour that led to his conviction willplace him in jeopardy of either suspensionfrom practice or removal from theregister. That warning will be recorded inthe register for the next five years”Hussain, Mozimmal, 2050358Determination date 19 December 2011Warning that “membership of yourchosen profession as a pharmacist carrieswith it significant responsibilities in termsof both personal and professionalbehaviour. This is rightly expected both bythe public and by your pharmaceuticalcolleagues. Your full adherence to boththe law as well the professional andethical expectations of the Code ofConduct must be uppermost in your mindat all times. More severe consequenceswill undoubtedly result from any furthercriminal code or breaches of the Code”Hutchinson, David Reginald, 2018724Determination date 20 December 2011Warning placed on the register for fiveyears “as to the complete unacceptabilityof violence of any sort in any situation”Omar, Riaz Ahamed Abdul Satar, 2036323Determination date 22 December 2011Decision to extend the suspension for aperiod of three months, and order thatthere be a further review before thatperiod expiresKondrasova, Juliya, 2060480Determination date 5 January 2012Suspension for 12 months, to followa previous suspension of six monthsUnadkat, Amit Vinod, 2054198Determination date 5 January 2012Conditions to remain in force for thesix months remaining of theconditional orderPatel, Nirav Harshad, 2060771Determination date 18 January 2012Suspension for nine months, witha review before the end of thesuspension periodTyler, Abigail Eloise Henderson, 2063688Determination date 19 January 2012Suspension for six monthsMelville, Jennifer Elizabeth, 2055865Determination date 20 January 2012Condition imposed that the registrantundertakes regular hair tests for thedetection of cocaine and amphetaminesfor a two year period. The results of suchtests should be promptly forwarded tothe Council and the costs of such tests areto be borne by the registrant. Thecondition will be reviewed at the end ofthe two yearsAlvarez-Rementaria, Maria Del RosarioFerrero, 2057434Determination date 23 JanuarySuspension for six monthsUpholding standards and public trust in pharmacy 15

Fitness to practise – learningFitness topractise –learningWe receive concernsabout pharmacyprofessionals froma wide variety ofsources. Some of theconcerns fall belowour threshold criteriaand so do not getreferred on to ourinvestigatingcommittee or fitnessto practise committee.Cases are onlyreferred to thesecommittees wherethere is reason tobelieve that theregistrant’s fitness topractise may beimpaired. We are keento share learning froma variety of cases toimprove practice andfor registrants tobetter understand howwe deal with thesematters.Making false claimsfor MURsA complaint was received from asuperintendent pharmacist that apharmacist had made false statementsover a period of several months abouthis completion of Medicine Use Reviews(MURs) and that these statements hadresulted in false claims for NHS paymentby his employer.According to the complaint, thepharmacist had reported on his keyperformance indicator that he hadcompleted 103 MURs from the period1 January 2010 to 6 April 2010 - 95 ofwhich had been claimed for from theNHS. The pharmacist later admitted thathe had completed only 15 MURs.As part of our investigation, thepharmacist was written to for anexplanation of the complaint. In hisresponse, he admitted that he knew theMUR claims were false but that he hadnot intended to defraud anyone, nor hadhe personally benefitted financially fromthe false claims. He had intended tocomplete the MURs later in the year buthad felt under pressure over this period.He claimed that the pharmacy had lost anumber of staff who had not beenreplaced and that he was worried thathe would lose his job.The matter was considered by theinvestigating committee and itconcluded that the case did not need tobe referred to the fitness to practisecommittee. The committee decided thatit was appropriate and proportionate,taking into account all of thecircumstances of the case, to issue thepharmacist with a letter of warning.The committee asked that a letter bewritten to the pharmacist’s employer atthe time the false claims were made,requesting them to review theirpractices to ensure that pharmacists didnot feel under such pressure tocomplete MURs.Learning points• you must always act with honestyand integrity• you must make sure that yourprofessional judgement is notaffected by having to achievetargets set in the course of youremployment• if you feel under undue pressureto meet certain targets that havebeen set for you, you should raisethis with your manager orsuperintendent pharmacistFor a schedule of fitness to practisehearings, please visit our website,www.pharmacyregulation.org/raising-concerns/hearings/hearing-schedule16 Regula+e: February 2012 | Issue 3

Fitness to practise – learningHandling patientreturnedmedicinesA GPhC inspector received informationthat a pharmacist had dispensed a boxof five Levemir FlexPens where two ofthe items were date expired and one ofthose two had the plunger depressed,showing that approximately 125 units ofinsulin had been used.The patient, who had been prescribedinsulin for the first time, had noticedthat two of the pens had expired. Sheinformed her diabetes nurse when shewent for her insulin-initiationappointment. The diabetes nurseinformed the GP who prepared anincident report which was sent to thelocal Primary Care Trust.An inspector visited the pharmacist, whowas the responsible pharmacist at thepharmacy when the medicine wasdispensed. He admitted that he wasresponsible for the assembly of theprescription, and said the final accuracycheck had been undertaken by anaccredited checking assistant.The pharmacist told the inspector thathe had employed three students toassist in the shop. None of them hadbeen trained in dealing with patientreturnedmedication and nor had theycompleted an accredited medicinescounter assistant course.The pharmacist explained to theinspector that he believed one of thestudents had accepted some patientreturnedinsulin pens which had beenplaced in a tote box from a wholesaler.When the pharmacist had asked why theinsulin pens were loose in the tote box,he was told that the packaging of theinsulin pens had been damaged. Heassumed the damaged box had just beenreceived from the wholesaler and thepens removed from their packaging, sohe put them in the fridge. The inspectorspoke to the three students but none ofthem could remember the incident.When the pharmacist went to dispensethe prescription for the five LevemirFlexpens, he went to the fridge and sawthe five loose pens. He put these in adispensing box and labelled them for thepatient. He did not check the expiry dateand neither did the accredited checkingassistant.The inspector examined the shelves inthe dispensary and the waste bins andfound no further evidence of patientreturnedmedication being re-dispensed.The whole dispensary, including thefridge, had been date-checked andrecords were available to support this.The inspector gave the pharmacist arange of advice, including theimportance of checking each element ofa prescription, how to undertake thefinal accuracy check, good practicearound managing expiry dates, and theneed to pay particular attention toinfrequently purchased and oftenexpensive items of stock, e.g. LevemirFlexpens. The inspector alsorecommended that he review thepharmacy’s procedure for acceptingpatient-returned medicines. Thepharmacist was asked to amend thepharmacy’s Standard OperatingProcedures (SOPs) to reflect theserecommendations and that all staffshould re-read and re-sign the SOPS.The matter was considered by theinvestigating committee who concludedthat the case did not need to be referredto the fitness to practise committee.This was on the basis that thepharmacist had co-operated with theinvestigation, had accepted all of theInspector’s advice, and that onsubsequent inspection no evidence ofpatient-returned medication being redispensedwas found.The committee decided to issue a letterof warning, emphasising the importanceof staff training regarding patientreturnedmedicines.Learning points• all staff should be trained andcompetent for their roles and allactivities that they carry out, evenwhen they are students orworking part-time• always remember to check that amedicine or medical device is indate before you supply it to apatient• medicines to be disposed ofmust be kept separate from allother stockUpholding standards and public trust in pharmacy 17

Fitness to practise – learningInappropriate useof loyalty cardsAllegations of misconduct were receivedabout a pharmacist who used her TescoClubcard to obtain points to which shewas not entitled.The pharmacist was alleged to haveaccrued points belonging to customerswho did not present a Clubcard whilepurchasing goods on 55 occasions,and used a promotional voucher togain additional points on a further43 occasions.The matter was heard by the fitness topractise committee, who found theallegations proved. The pharmacist thenadmitted that her fitness to practisewas impaired.In their determination of facts, thecommittee said the pharmacist had usedher own Clubcard to obtain pointsearned on purchases made by customerswho either did not have Clubcards or didnot wish to use them. She had also useda ‘50-extra points’ voucher, which shehad acquired from an in-storepromotion, to obtain the 50-extra pointswhen she swiped her own Clubcard onother people’s purchases. Terms andconditions applied to the promotionstipulating that the voucher could onlybe used once. The pharmacist had usedthis voucher on 43 occasions. The totalpoints wrongly transferred to her cardwere 2518, which amounted to £25.18.The fitness to practise committeesuspended the pharmacist for onemonth. They found that the misconductinvolved dishonesty and also amountedto an abuse of trust. On each occasionshe had been the only pharmacist onduty; her conduct had been not onlyrepetitive but systematic; and there hadbeen no explanation of the use of thevoucher on 43 occasions.The committee concluded that there hadbeen a lack of insight. The pharmacisthad adopted a stance from the start thatshe did not realise what she was doingwas wrong and had sought to blame, insome measure, her employer for failingto instruct her about what she could useher loyalty card for. The committee saidthat if the pharmacist was in doubt, sheshould have sought advice.The committee took into account thatthe pharmacist had “never been introuble before” and had not ultimatelybenefitted from the conduct, nor hadthere been any harm to patients nor lossto her employer.The committee did not consider thatthere was a measurable risk of anyrepetition or recurrence of this typeof conduct.Learning points• inappropriate use of loyaltycards, irrespective of themonetary value gained, isdishonest• you must always be honest andtrustworthy in your professionalpractice and you must takeresponsibility for your ownactionsRefusing to sellmedicationA complaint was received that apharmacist had refused to sell a memberof the public a box of Day & Night Nursecapsules and a box of Night Nursecapsules at the same time. According tothe complainant, the pharmacist hadsaid that the levels of pseudoephedrinein both boxes of capsules exceeded thelegal limit, which the pharmacist thoughtwas 480 milligrams. When challenged bythe member of the public, thepharmacist had acknowledged that theNight Nurse capsules did not containpseudoephedrine.The pharmacist had still expressed anunwillingness to sell both boxes ofcapsules and asserted that it was herright as a pharmacist to refuse a salethat she thought was unsafe orinappropriate.The complainant also queried theinformation provided about the legalrestriction on the sale ofpseudoephedrine.This matter was considered by ourinvestigations and case managementteam, together with the inspectionsteam, who determined that the mattersraised did not call into question thepharmacist’s fitness to practise, and nofurther action was required. Thecomplainant was advised thatpharmacists can use their professionaljudgement in determining whetheror not to sell or supply a medicineto a patient.Even though it is not unlawful to sell abox of Day and Night Nurse capsules anda box of Night Nurse capsules in onetransaction, the pharmacist can refuseto sell any medicine if they think that itis unsafe or inappropriate to do so.18 Regula+e: February 2012 | Issue 3

Fitness to practise – learningLearning points• you must be satisfied that anymedicine you sell or supply issafe and appropriate for thepatient• if you do not think it isappropriate to sell a particularmedicine to a patient ormember of the public then youshould fully explain your reasonsto them• make sure that your knowledgeis up to date about themedicines that you supplySelf administrationof medicinesAn allegation was received that apharmacy technician had taken twocapsules of a prescription-only medicine(POM) from the pharmacy withouthaving a prescription, and selfadministeredthat medicine.The matter was referred directly tothe fitness to practise committee.The pharmacy technician admittedthe allegation.The committee heard that the pharmacytechnician took two Mucodyne capsuleswithout consent. She had been sufferingfrom an infection which she decided totreat with a “concoction” made with thecontent of Mucodyne capsules andsome linctus.Mucodyne products are all POMs. Thepharmacy technician had been told bythe pharmacist that she could not takethe capsules from pharmacy stock andwould need a prescription. However,on two occasions during the day, shemade herself a “concoction” from thecapsules taken from pharmacy stock.She did not have permission fromanyone in the pharmacy.The pharmacy technician laterobtained a prescription for Mucodynesyrup from her GP and then told thepharmacist what she had done withthe capsules.The committee found that the pharmacytechnician had been dishonest and hadbreached section 58(2)(a) of theMedicines Act 1968 by obtaining thePOM which could only be suppliedagainst a legally valid prescription froman appropriate practitioner (unlessotherwise legally allowed, for examplesupply against a patient group direction).In determining the sanction, thecommittee said that her conduct hadonly come to light as a result of heradmission and she had not sought,at any stage, to deny making thatadmission. She had acceptedresponsibility that what she haddone was wrong.The committee said that misconduct ofthis kind had a wide range of gravity –from taking controlled drugs“surreptitiously and habitually” at oneend of the range, to the other end andthe sort of conduct involved here. It wasa single incident; the medicine was notaddictive nor a sensation-inducing drug;it was taken for a genuine medicalcondition; and it was medicine thepharmacy technician needed, asdemonstrated by the prescription shehad subsequently obtained.The committee determined that thepharmacy technician should be issuedwith a warning, emphasising that in herfuture practice as a pharmacytechnician, she must strictly observe therequirements of Principle 6 of thestandards of conduct, ethics andperformance and the provisions of theMedicines Act 1968.Learning points• you must not abuse your positionof trust as a pharmacyprofessional and the responsibilitythat you have been given• you must not self medicate fromthe dispensary stock, if you needa POM for a genuine medicalcondition you should get a legallyvalid prescriptionYou can find out more about the role of the investigating committee at:http://www.pharmacyregulation.org/raising-concerns/hearings/committees/investigating-committeeAnd about the fitness to practise committee at:http://www.pharmacyregulation.org/raising-concerns/hearings/committees/fitness-practise-committee*Our threshold criteria can be found at:http://www.pharmacyregulation.org/sites/default/files/The%20threshold%20criteria.pdfUpholding standards and public trust in pharmacy 19

Check that a pharmacy professional is registered:http://www.pharmacyregulation.org/theregister/index.aspxCopies of Regula+e are available to download fromour website www.pharmacyregulation.org/publicationsWe welcome feedback and comments onthis publication which can be sent toregulate@pharmacyregulation.orgGeneral Pharmaceutical Council129 Lambeth Road | London | SE1 7BTTelephone: 020 3365 3400Email: info@pharmacyregulation.orgDesigned and produced by Tangerine UK