Inside Under the microscope: New standards for registered pharmacies 6 Return to registration 3 Pharmacy technicians who s on the register?

October 2012 Issue 7 Upholding standards and public trust in pharmacy Inside Under the microscope: New standards for registered pharmacies 6 Return to registration 3 Pharmacy technicians who s on the register? 10 www.pharmacyregulation.org

Contents From the chair 2 Registrant update 3 - What do you do? 3 - Returning to the register 3 - Progress on renewals 3 - Revalidation stakeholder event 4 - Sharing exam questions 4 Around Great Britain - Working with the Scottish Parliament 5 - Responding to Welsh consultation 5 - Introducing Health Education England 5 Standards for registered pharmacies - The new standards explained 6 - Next steps 7 - Supply of Pharmacy medicines 8 - Extemporaneous preparation of methadone 8 - A new inspection model for pharmacy 9 Pharmacy technicians Who s on the register? 10 Letters 11 Fitness to practise - Determinations 12 - Learning 13 Regula+e is the registrant bulletin of the General Pharmaceutical Council. It is sent to all registrants (at the time of posting) and pre-registration trainees. At times we may approach external organisations or individuals to submit an article or opinion on a topical issue. All articles and letters commissioned, written or submitted are subject to editorial control and may not be printed in full or with reference back to source. If you would like to contact the editor or submit a letter or comment to Regula+e please contact us at: regulate@pharmacyregulation.org The Editor, Regula+e General Pharmaceutical Council 129 Lambeth Road London SE1 7BT General Pharmaceutical Council 2011 From the chair In a significant development for both pharmacy and pharmacy regulation, we have launched new standards for registered pharmacies which focus on the role of pharmacy owners and superintendents in supporting professionalism and achieving results for patients. These new standards are separate and distinct from the standards which we expect individual pharmacy professionals to meet and against which we assess their fitness to practise. And they will be accompanied by a new inspection model and robust enforcement powers. These new standards focus on the decisions taken by pharmacy owners and superintendents to achieve results for patients, including how they encourage and support the pharmacy professionals who work for them to live up to their professional responsibilities. They embody our commitment to supporting and encouraging professionalism in pharmacy. We firmly believe that the professionalism of pharmacists and pharmacy technicians offers the best protection for patients. These standards recognise that owners and superintendents play a key role in creating the conditions that allow professionalism to flourish. A copy of the new standards is enclosed with this issue of Regula+e and I would encourage you to read and make yourselves familiar with them. We won t have full powers to enforce them before October 2013, but when we do, we will be able to issue improvement notices, to impose conditions on owners and, in extreme circumstances, to close pharmacies. So, the next 12 months offer a key opportunity to make the transition to the new standards and to be able to demonstrate that pharmacy owners are meeting them. The responsibility for meeting the standards sits with pharmacy owners and superintendents. You can find out more on page 6. We are designing a new way of inspecting pharmacies so we can check that the new standards are being followed. We are very committed to involving patients and members of the public, as well as pharmacy professionals and owners, in the design of this new inspection system. We have set up sounding boards in England, Scotland and Wales made up of owners and pharmacy professionals to support the development of a framework for inspection decisions. Read more on page 9. We are also working with patients and members of the public to raise awareness of the new standards and how they can use them, and to involve them, as well as pharmacy professionals, in the development of public reporting of inspections. You can read more about the new standards at: www.pharmacyregulation.org/standards /standards-registered-pharmacies Earlier in the year, Regula+te reported on pharmacists on the register in this issue we look for the first time at an analysis of one of the most recent health professions to be statutorily registered - pharmacy technicians. Go to page 10 to find out more. Can I encourage you to continue to send your thoughts and ideas to us at regulate@pharmacyregulation.org Bob Nicholls Chair 2 Regula+e: October 2012 Issue 7

Registrant update What do you do? There have been some big changes in pharmacy in recent years, including the introduction of compulsory statutory registration of pharmacy technicians. To better understand the impact of these changes, and to be able to consider the implications of any future changes, we will be conducting a survey of all 70,000 pharmacists and pharmacy technicians on the register. This will be the first all-registrant survey the GPhC has conducted. Preliminary research has confirmed much of the anecdotal feedback we have received about some particular challenges and issues within the pharmacy team: the need to enhance understanding of the pharmacy workforce: the roles, activities and sectors pharmacy technicians in particular are working in, and the job roles of support staff how best to support professionalism both in the new registrant group and in pharmacy as a whole team-based issues including the development of clinical governance in a community pharmacy setting the need to develop leadership and management skills at all levels The results will help us to identify issues we need to respond to, but also to work with pharmacy organisations who may be better placed to respond on some issues. We hope to be in a position to issue the survey in the new year and to publish the results in spring 2013, and will publicise updates on our website www.pharmacyregulation.org and in future issues of Regula+e. To read the background paper, Enhancing understanding of issues within the pharmacy team, and our plans to commission a survey, go to: www.pharmacyregulation.org/aboutus/who-we-are/gphc-council/councilmeetings/13-september-2012-0 Returning to the register We have updated our policy for pharmacy professionals applying to return to the register. If it has been more than 12 months since your last entry on the GPhC register and you want to re-register, you will need to submit a portfolio of evidence which demonstrates your current level of competence against the GPhC s Standards of conduct, ethics and performance - the core standards for all registrants. Guidance on completing a return to registration application and providing evidence of current competence can be found on our website at: www.pharmacyregulation.org/sites/ default/files/portfolio%20guidance% 20Sept%202012.pdf Your portfolio will then be assessed by two external evaluators who will make a recommendation to the registrar as to whether registration should be granted. If necessary, additional professional requirements may be imposed either before or after re-registration. If you are unhappy about decisions made about your application, you can make an appeal to the GPhC s appeals committee. Duncan Rudkin, GPhC chief executive and registrar, said: We have updated this policy to make sure we have a consistent approach to registration. One of the key ways we protect patients and people who use pharmacy services is by registering competent professionals to practise pharmacy. We have a robust and fair way of checking that their knowledge is up to date and that they are fit to practise. You can find out more about returning to the register at: www.pharmacyregulation.org/ registration/registering-pharmacist/ previous-registration-rpsgb Progress on renewals For the majority of registrants and pharmacy premises, the deadline for renewing your registration is 31 October. If you were planning to pay by direct debit, you have missed the 25 September cut off point for making this arrangement. If this is the case, you should have received an email from us explaining that we have suspended your direct debit and that you will need to complete your registration renewal using another method of payment. To find out how to complete you registration renewal, go to: www.pharmacyregulation.org/ renewal Upholding standards and public trust in pharmacy 3

Registrant update Revalidation stakeholder event We are committed to revalidation in pharmacy and earlier this year our governing council agreed a set of principles to underpin our work in this area. We have included specific objectives about revalidation in our current Corporate Plan to agree and develop a model of revalidation to further enhance the assurance of continuing fitness to practise. Implementation plans for this model will be finalised in 2015 and will include the timing and arrangements for the introduction of revalidation itself. To support these objectives, we hosted a stakeholder event in the summer to introduce delegates from the pharmacy profession and representative bodies, as well as other healthcare regulators, to these revalidation principles, which you can find at: www.pharmacyregulation.org/ education/revalidation The event also provided the opportunity to discuss key aspects of the principles to support further thinking and development. Key areas of feedback from participants showed the need for: open and transparent development of revalidation, and for co-creation of regulation with the profession, involving patients and public, and taking into consideration lessons learnt from related developments including medical revalidation incremental development and implementation, drawing on relevant existing systems and supported by effective testing and piloting regular communication of key messages on revalidation to promote awareness and future thinking access to effective services and support to enable registrants to meet revalidation requirements, underpinned by clear roles and responsibilities on revalidation for different organisations. We received positive feedback from delegates, which has provided us with valuable insights into key considerations for different areas of the pharmacy profession, and will help to inform future scoping and development of what revalidation may need to cover. We will provide regular updates as our work on revalidation develops. We welcome questions and comments, which can be sent to: revalidation@pharmacyregulation.org Sharing exam questions: a warning We would like to remind pre registration trainees not to share assessment questions, after it was discovered that some questions had been shared after the 28 September assessment. Sharing questions is a breach of the registration assessment regulations, specifically: 4.9 Question papers and individual questions are the property of the GPhC. Removing papers or questions from an assessment hall constitutes serious misconduct. If this is proven, it will result in a candidate being failed. Questions may not be copied into reference sources during the open book paper, they may not be distributed by email or text message, or posted on social networking sites. This list is not exhaustive. The GPhC owns the copyright to the questions in its registration assessment and that is one of the reasons we do not allow them to be reproduced. But more importantly, sharing questions could undermine the fairness and integrity of future exams, which would be bad for patients and for the profession. 4 Regula+e: October 2012 Issue 7

Around Great Britain Working with the Scottish Parliament As part of our work monitoring policy and political decision-making bodies, our director for Scotland, Lynsey Cleland, recently attended meetings of the mental health and health inequalities cross party groups (CPGs) at the Scottish Parliament. Lynsey said: Attending these meetings provided a valuable opportunity to develop relationships with patient representative groups, other regulators, health policy makers and key political decision makers. This is particularly important as new and innovative models of delivering pharmacy services are being discussed via a number of review processes. Responding to Welsh consultation We have submitted a formal response to the first stage of the Welsh Government s consultation on new draft regulations governing the provision of NHS pharmaceutical services in Wales. Our director for Wales, Darren Hughes, said: Our response sets out how our new standards for registered pharmacies can support the draft regulations, and how the development of our new inspection model will help to ensure that potential risks are prioritised for investigation. Our response can be found at: www.pharmacyregulation.org/getinvolved/consultations/our-responsesconsultations To find out more about the consultation, which closes on 22 November 2012, visit: www.wales.gov.uk/docs/dhss/ consultation/120830item3en.pdf Introducing Health Education England Our chair, Bob Nicholls, has written to Sir Keith Pearson, chair of Health Education England (HEE), to express our interest in working collaboratively with the new national leadership body for education, training and development of the health workforce, including pharmacy. The letter also highlighted the need to make sure that quality assurance structures for the NHS, including those of HEE, work effectively alongside those of the professional regulators. A small group of professional regulators, coordinated by Mr Nicholls, has been brought together to support both formal and informal working with HEE, which began operating in shadow form on 28 June 2012. The GPhC is responsible for defining the education and training requirements for pharmacists and pharmacy technicians, including accrediting courses and approving qualifications for pharmacists and pharmacy technicians. To find out more about how we accredit, approve and assure education and training in pharmacy, visit: www.pharmacyregulation.org/ education/approval-courses Upholding standards and public trust in pharmacy 5

Standards for registered pharmacies Our new approach to regulating pharmacies Chief executive and registrar Duncan Rudkin describes the aims of the new standards for registered pharmacies You may be familiar with the GPhC as the body which registers pharmacy professionals pharmacists and pharmacy technicians. We also have powers to regulate pharmacies, in recognition of the fact that the decisions that pharmacy owners and superintendents make have a powerful influence on safety, quality and the standard of services that patients and the public receive. The new standards for registered pharmacies are a once-in-a-generation change in pharmacy regulation focusing on the responsibility of pharmacy owners and superintendents to create the conditions that allow professionalism to flourish and deliver results for patients. They move away from a rules-based approach which describes what people have to do, to an approach which describes what pharmacies need to achieve. The new standards are distinct and separate from the standards that registered pharmacy professionals have to meet. Responsibility for meeting these new standards lies with owners and superintendents. What is really important is what is being achieved for patients, not that something has been ticked off a list. The new standards focus on what it is that results from the partnership between a pharmacy professional and those who provide the environment in which that professional operates. The new standards set out what the GPhC expects of pharmacy owners and superintendents (when the owner is a company); they also embody the GPhC s belief that the professionalism of pharmacists and pharmacy technicians offers the best protection for patients. There s a focus on professionalism running through all we do. Owners and superintendents need to create the environment and conditions in which professionals can behave professionally. This means having the authority and wherewithal to be able to exercise their professional responsibility, as well as enabling pharmacy professionals who work for them to embrace and live up to the professional responsibilities they have taken on. Pharmacy owners and superintendents share the same set of responsibilities for meeting the standards. As the standards say, a corporate owner does not avoid responsibility by employing a superintendent. All pharmacy professionals should make themselves familiar with the new standards, including those in a responsible pharmacists role. However, the standards are clear that responsibility for meeting the new standards lies with pharmacy owners and superintendents. The GPhC does not expect to have a full range of powers to enforce these standards before October 2013, at the earliest. This gives pharmacy owners, superintendents, pharmacists and pharmacy technicians 12 months, at least, to become familiar with the new standards and to be able to demonstrate that they are being met. Five principles We have grouped the standards under five principles, each of which is equally important: Principle 1: the governance arrangements safeguard the health, safety and wellbeing of patients and the public Principle 2: staff are empowered and competent to safeguard the health, safety and wellbeing of patients and the public Principle 3: the environment and condition of the premises from which pharmacy services are provided, and any associated premises, safeguard the health, safety and wellbeing of patients and the public Principle 4: the way in which pharmacy services, including the management of medicines and medical devices, are delivered safeguards the health, safety and wellbeing of patients and the public Principle 5: the equipment and facilities used in the provision of pharmacy services safeguard the health, safety and wellbeing of patients and the public 6 Regula+e: October 2012 Issue 7

Standards for registered pharmacies Next steps We handed out over 400 copies of the new standards at the Pharmacy Show publishingthestandards: a hard copy is available in this issue of Regula+e and copies can be downloaded from: www.pharmacyregulation.org/sites/ default/files/standards%20for%20re gistered%20pharmacies%20septemb er%202012.pdf developingguidance:we are developing three pieces of guidance to support the new standards (internet pharmacy; preparing medicines under Section 10; and the supply of Pharmacy medicines in the community) designinganewinspectionmodel: read more on page 9 developinginspectionreports: we will work with pharmacy and patients and the public to design the approach and format of public reporting of inspections enforcingthestandards:the new standards need to be put into Rules (a form of legislation) which need to be consulted on, then approved and laid before Parliament. Only then will we have full powers to enforce the standards. This is not expected to happen before October 2013. You can find out more about the new standards and our plans to work with the pharmacy profession over the next 12 months (before the standards are fully operational) at: www.pharmacyregulation.org/standards/ standards-registered-pharmacies Or you can ring our customer services team on 020 3365 3400. Upholding standards and public trust in pharmacy 7

Standards for registered pharmacies Supply of Pharmacy P medicines In light of recent discussion about the supply of P medicines, we would like to be absolutely clear about the position now a blanket prohibition on the self selection of P medicines remains in place until at least October 2013. The law says that any supply of P medicines must be supervised by a pharmacist, and the law is not changing in this regard. Our new standards for registered pharmacies will continue to insist that medicines are stored and supplied safely, and place a clear responsibility on owners and superintendents to make sure that pharmacy services are managed and delivered safely and effectively. This includes making sure that medicines are safeguarded from unauthorised access and supplied safely. Before self selection can be considered as an option, a number of activities need to happen which include putting additional safeguards in place. These safeguards are: that the GPhC must have its full range of enforcement powers in place, that compliance guidance has been developed and agreed, and that we would need to be notified in advance of any intention to enable self selection. Supply of extemporaneously prepared of methadone Methadone which has been prepared extemporaneously has been supplied as a matter of custom and practice for some time. Following a number of court decisions, we have clarified that the GPhC does not consider that supplying extemporaneously prepared methadone, as an alternative to an available licensed version, is compatible with the law. The interim standards for registered premises, which the new standards replace, referred to a requirement to ensure compliance with medicines legislation, including the requirement to supply products with a marketing authorisation where such products exist in a suitable form and are available, in preference to unlicensed products or food supplements. Although the new standards do not make reference to this requirement, our governing council has confirmed that the need to comply with the law in this area remains. Duncan Rudkin, GPhC Chief Executive and Registrar, said: Patient care is our number one priority. We will work with pharmacies over the next 12 months, until our full enforcement powers are in place, to understand the scale of what is required to bring all pharmacies into compliance with the law. We plan to work with relevant representative bodies, trade organisations and NHS organisations in helping them to do so. We want to reassure patients that there is no reason for pharmacies to interrupt supplies of medicines given our proposed timetable for seeking compliance with the new standards. 8 Regula+e: October 2012 Issue 7

Standards for registered pharmacies A new inspection model for pharmacy The new standards will be accompanied by a new way of inspecting pharmacies to make sure that they, as well as other mandatory standards, are being followed. Our preference is always to work with pharmacy to focus on securing compliance with our standards but we need to be clear that when these new standards are fully enforceable, we will have powers to issue improvement notices, to impose conditions and to close pharmacies. We will be moving away from a onesize-fits-all approach to one that better manages risks to patients. We remain committed to involving pharmacy professionals and patients and the public in the design of the new system. And there will be an extensive testing phase of the new inspection model before it is rolled out in full. We are developing a relationship management approach designed to strengthen the dialogue between the GPhC and pharmacy owners and superintendents, and to improve accountability. Where there is a corporate owner, we propose to identify how standards are being met corporately and to compare what we have been told with what is happening in individual pharmacies. We have listened to consultation feedback from pharmacy professionals, particularly with regard to the consistency of decision making by our inspectors. To prepare for this new approach, we are developing a framework to support inspection decisions. This framework will be publicly available and will describe the sorts of evidence we will be looking for, and list outcome indicators against the standards. We will also be publicly reporting on the findings of our inspections, and will be working with both pharmacy, and patients and members of the public, on developing an approach and format for those inspection reports. Sounding boards We have recruited registrants to sounding boards to support the development of the inspection decisions framework with separate sounding boards in England, Scotland and Wales. We sent invitations seeking expressions of interest to more than 10,000 pharmacy professionals, as well as advertising in a number of publications and websites. There was a high level of interest in this work and we received 126 formal expressions of interest. We have processed these and notified the successful 36 applicants at the end of September. The first meetings of each sounding board will be held shortly. Cardiff 23 October Edinburgh 25 October London 5 November Upholding standards and public trust in pharmacy 9

Register analysis Pharmacy technicians who s on the register? We have completed the first analysis of pharmacy technicians, using a snapshot of the register in July 2012, a year after mandatory registration for this group came into effect in July 2011. The main findings include: 21,361 pharmacy technicians on the register, as at 31 July 2012 of those, almost two-thirds (65%) joined prior to July 2011 90.2% of registered pharmacy technicians were female smaller proportions of male pharmacy technicians are registered in Scotland and Wales compared to England the mean age of registered pharmacy technicians is 41.4 years. Female pharmacy technicians are on average older than male pharmacy technicians at 41.9 years versus 36.4 years the majority of pharmacy technicians have a registered address in England (83.2%) the majority of registered pharmacy technicians are of white ethnic origin (89.5%) the largest non-white group of pharmacy technicians are Asian (7.6%) by country, registered addresses for pharmacy technicians are 17,772 (83.2%) in England, 1,985 (9.3%) in Scotland and 1,454 (6.8%) in Wales Fig 3: Age range Pharmacists 40 36 32 28 24 20 16 12 8 4 23.7 30.4 0 29 years 30-39 Fig 4: Ethnic origin Pharmacists White 61.3% Chinese 3.7% 22 40-49 17 50-59 6.8 60 Asian 26.9% Black 5.4% Mixed and other 2.8% Fig 2: Gender split Percentages Pharmacy technicians Pharmacy technicians 100 90 80 70 60 50 40 30 20 10 0 40 36 32 28 24 20 16 12 8 4 40.6 Male pharmacists 15.5 28.7 59.4 0 29 years 30-39 White 89.5% Chinese 0.1% Female pharmacists 31.6 40-49 9.8 Male pharmacy technicians 20.9 50-59 90.2 Female pharmacy technicians 3.3 60 Asian 7.6% Black 1.8% Mixed and other 1.0% Steve Acres, President of the Association of Pharmacy Technicians UK (APTUK), said: This analysis of the pharmacy technician register is an important step in understanding more about the demographics of our new profession. We strongly support further analysis to gain a greater understanding as this will help determine future regulatory and professional development opportunities. As a result of this analysis we have been able to compare the information we have for both pharmacists and pharmacy technicians on the register (although the data for pharmacists is from 2011 and the data for pharmacy technicians is from 2012.) 10 Regula+e: October 2012 Issue 7

Upholding standards and public trust in pharmacy 11 Letters DearEditor, Iverymuchenjoyedtherecent SeptembereditionofRegula+e.In particular,ifoundthestatisticalanalysis regardingthejuneregistration assessmenttobebothinformativeand interesting.itwashearteningtoseethe highestpassratesince2002. Astheprofession scharity,pharmacist Supportassistspharmacistsandtheir families,studentsandformer pharmacistsaswellaspre-registration trainees(whomadeup24%ofour enquirieslastyear). Thecharityiskeentoensurethatour servicesmeettheneedsofourtarget audience.weareawarethatpharmacy canbeauniquelystressfulprofession. Wewouldthereforeliketoinviteall readerstoparticipateinabriefonline surveytoassistthecharityinthe developmentofstressspecificservices. Youcanparticipatebycompletingthis importantsurveyat www.surveymonkey.com/s/pharmacist SupportSurvey whichcanalsobe accessedfromourwebsiteat www.pharmacistsupport.org. Thesurveyisanonymous. Thisisyouropportunitytoshapefuture supportservicesforyou,yourfamily, andyourcolleagues.pleasetakefive minutesoutofyourdaytohelpusto helpyou. YoursFaithfully, DianeLeicester CharityManager PharmacistSupport DearEditor, Iamwritinginresponsetothelettersof RichardLeeandSteveAcresinthelast twoissuesofregula+e,toinformyour readersaboutsomelearningthathas beendevelopedbythecentrefor PharmacyPostgraduateEducation (CPPE),specificallytosupportpharmacy technicians. AtCPPEwerecognisedthatformany pharmacytechnicians,therouteto becomingapharmacyprofessionalwas somewhatunplanned.whilstthose studyingnowwillbeaimingfor registrationwiththegphc,formany peoplefurtherintotheircareer,thiswas notalwaysthecase.thishasleadto differentlevelsofunderstandingabout exactlywhatitmeanstobeapharmacy professionalandabouttheimportance ofcpd. InconjunctionwiththeAssociationof PharmacyTechniciansUK(APTUK)we havelaunchedaninteractivepdfon Professionalism.Developedbyateam ofpharmacytechniciansfromallsectors ofpracticeitexploresprofessionalism throughaseriesofethicaldilemmas andcasestudies,signpostingto Regula+eforfurtherlearning opportunities.thebenefitoftheipdf formatisthatindividualscanlearn onlineathome,ortheycanprintoffa copyandlearninagroupwithother pharmacytechnicians,toshareideas andbestpractice. Thisprogrammeisavailablefreetoall GPhCregistrantsat www.cppe.ac.uk/professsionalism Forthosewhowouldlikesupportwith theircpdrecordingwearealsorunning aseriesofworkshopsthroughout EnglandfromnowuntilApril2013. Placescanbebookedviaourwebsite. Ifanypharmacytechniciansarenotyet registeredwithcppe,theprocessisfree andsimple,justgothecppewebsite www.cppe.ac.ukandenteryourgphc numberontheregistrationpage. KarenWraggMRPharmS RegionalManager CentreforPharmacyPostgraduate Education DearEditor, Recently,IattendedaGPhCeventfor stakeholderstodiscuss/sharesome thoughtsontheoutcomeofthe consultationonregisteredpharmacies, andthegphc snewstandardsfor registeredpharmacies.ithoughtiwould writetoyouwiththespecificaimof encouragingpharmacytechniciansfrom everysectortoreadandunderstandthe informationpublishedonthegphc websiteaboutthisimportanttopic. Muchofthediscussionhasbeenabout professionalism and,asanew profession,manypharmacytechnicians arestillcomingtotermswiththisnewfoundstatus. Theacidtestofhowotherregistered healthcareprofessionalsregard pharmacytechnicianswillverymuch dependontheattitudeandbehaviour oftheprofession that seachand everyregisteredpharmacytechnician ieyouandme!partofbeinga professionalisbeingawareofthe importantthingsgoingoninthe professionalenvironment,hence,my encouragementtoreadtheavailable informationonthegphcwebsite. PharmacyTechniciansshouldalsoknow thataptukarealwaysaware,and involvedinprofessionaldevelopments onbehalfofourmembers.please contactusifyouhavefurtherqueries. SteveAcres President AssociationofPharmacyTechnicians(UK)

Fitness to practise determinations Fitness to practise determinations If a fitness to practise committee determines that a registrant s fitness to practise is impaired, the committee may impose a sanction that is proportionate to the conduct that has been found proven. This may include, for example, issuing a warning, placing conditions on the individual s registration, suspension of registration or, in the most serious cases, erasing the individual from the register so that they can no longer practice. The matters listed here include the registrant s registration number, date of determination and the sanction. Determinations of the facts and additional information about the hearings can be found on our website at www.pharmacyregulation.org/search/ search_decisions Uppal,SahajdeepSingh,2048669 Determination date 2 July 2012 Removal from the register Khan,AfzaalMohammed,2048899 Determination date 1 August 2012 Suspension for 6 months Watson,Eleisha,2060846 Determination date 3 August 2012 Suspension for 3 months Tugnet,AnilKumar,2041042 Determination date 8 August 2012 Removal from the Register Jamil,MohammedKhalil,2064873 Determination date 31 August 2012 Warning given You are warned as to your future conduct in that you must ensure that you maintain proper professional boundaries in the relationships you have with colleagues, patients, the public and other individuals that you come into contact with in the course of your professional practice, that your behaviour, conversation and demeanour towards others is correct and appropriate at all times, that you are conscious of and take care to allow appropriate space to colleagues and others, and that you avoid physical contact with them. Parsons,WilliamJohn,2020046 Determination date 10 September 2012 12 month suspension imposed on registration to be reviewed before the end of the period Leal,PorsotamRam,2036918 Determination date 10 September 2012 Removal from the register Sweatland,Cherise,5014131 Determination date 12 September Suspension for six months Vadhera,Nevin,2048902 Determination date 14 September 2012 Review hearing in respect of 12 month suspension previously imposed on registration. Direction that the suspension will be extended for a further 3 months, with a review before the end of that period Odedra,Rakesh,2044570 Determination date 21 September 2012 Removal from the register Kanani,MohamedRajabali,2034555 Determination date 24 September 2012 Suspension for three months Jones,BerylWyn,2038222 Determination date 27 September 2012 Suspension for 12 months Smith,MatthewJonathan,2052446 Determination date 2 October 2012 Review hearing in respect of previous suspension Interim orders: Davies,RogerLlewelyn,2011875 Determination date 9 August 2012 Review hearing. Suspension previously imposed on registration to remain in force Humphreys,Jon,5027177 Determination date 20 August 2012 Suspension for 18 months, to be reviewed in 6 months Logan,Chris,2054337 Determination date 23 August 2012 Suspension for 18 months, to be reviewed in 6 months Thakker,Sunil,2026324 Determination date 31 August 2012 Review hearing. Suspension previously imposed on registration to remain in force Mabbott,FraserAdam,2076546 Determination date 2 September 2012 Suspension for 18 months, to be reviewed in 6 months Khan,AnwarUlhaq,2035895 Determination date 4 September 2012 Conditions imposed on registration Kirby-Smith,Alex,2066259 Determination date 7 September 2012 Review hearing. Suspension previously imposed on registration to remain in force Rocco,Ferdinando,2044719 Determination date 21 September 2012 Suspension for 18 months PleasechecktheGPhCregisterforwarningsforindividualregistrants. 12 Regula+e: October 2012 Issue 7

Fitness to practise learning Fitness to practise learning We receive concerns about pharmacy professionals from a wide variety of sources. Some of the concerns fall below our threshold criteria and so do not get referred on to our investigating committee or fitness to practise committee. Cases are only referred to these committees where there is reason to believe that the registrant s fitness to practise may be impaired. We are keen to share learning from a variety of cases to improve practice and for registrants to better understand how we deal with these matters. We would like to highlight these cases as good examples of why it is important that all pharmacists and pharmacy technicians are familiar with our standards of conduct ethics and performance and our guidance on raising concerns. We would also encourage all members of the pharmacy team to familiarise themselves with our new standards for registered pharmacies. Staff should feel empowered to raise concerns if they feel that the pharmacy professionals with whom they work are not acting appropriately and that their actions could result in risks to patients or public safety. Every pharmacy should have a policy on raising concerns or whistle blowing which staff should be familiar with. More information on how to raise a concern and where to go for more advice can be found in our raising concerns guidance which is available on our website at: www.pharmacyregulation.org/sites/defa ult/files/gphc%20guidance%20on%20rai sing%20concerns.pdf The following cases emphasise the importance of raising concerns. Operating a pharmacy without a responsible pharmacist appointed The fitness to practise committee heard that a superintendent pharmacist had allowed prescription-only medicines to be dispensed without a responsible pharmacist present, and that there were over 100 occasions in an 18-month period where a responsible pharmacist may not have been present at the pharmacy. This case was brought to our attention by a pre-registration trainee and a pharmacist who worked in one of the premises in question. The superintendent pharmacist and his wife, who was not a registered pharmacy professional, were co directors of two rural pharmacies. There was a considerable distance between the two premises. Simultaneous inspection visits were made to both pharmacies on 9 February 2011. In the first pharmacy, the superintendent s wife explained that a locum pharmacist, who should have been working at that time, had phoned to say that she was not able to come in. The inspector spoke to the locum who said that she had not been booked to work that day and consequently had not phoned to say that she would not be able to come in. The superintendent could not produce any rotas or other documents which showed that the locum had been booked to work on 9 February. The responsible pharmacist record for the previous 18 months showed that in this period, on 14 occasions the superintendent was recorded as the responsible pharmacist for both pharmacies at the same time. On around 13 occasions, the superintendent was recorded as the responsible pharmacist for one of the pharmacies when he was teaching at a nearby university. On 73 occasions, there was no record in the responsible pharmacist book at either pharmacy. Upholding standards and public trust in pharmacy 13

Fitness to practise learning A pre registration trainee at one of the pharmacies explained that she had seen prescription-only medicines being supplied without a pharmacist present. During the inspection visit, the inspector looked at the till roll for the morning of the 9 February and found that a prescription-only medicine had been supplied. Drivers, who collected dispensed medication (including controlled drugs) for delivery to local care homes, explained that they thought that the superintendent s wife was a pharmacist. They often collected medicines and other products when only she and other assistants were working at the pharmacy. The superintendent claimed that he had run into staffing difficulties after a pre-registration pharmacist qualified and then left, and that he found it difficult to find locum cover. He wanted to make sure that patients had access to a pharmacy in a rural setting. During the inspection of one of the pharmacies, the inspector also found stock of dressings and appliances which had been returned from nursing homes. Some of the items had the remains of old dispensing labels from other pharmacies. Other pharmacy staff explained that the superintendent had told them that it was ok to reuse medicines and dressings. One member of staff had often been asked to place patient-returned medicines on the dispensing shelves for reuse. She had also been asked to sort through patientreturned medicines to find expensive items that could be reused. The fitness to practise committee was not convinced that the superintendent s motivations were simply to provide a pharmacy service under difficult staffing conditions, and concluded that at some point, the superintendent made a conscious decision to run two pharmacies without providing full locum pharmacist cover. The driving factors were self interest and greed. The committee found that although no patients were harmed, the pharmacy management failures that the registrant was directly involved in were endemic and systematic, with a significant risk of recurrence. The superintendent s name was removed from the register. Dishonest dispensing practice The fitness to practise committee heard a case involving a superintendent pharmacist who instructed staff he employed to carry out dishonest and dangerous dispensing practices, and to discredit another pharmacist who had informed the local PCT of what was occurring in the pharmacy. A locum pharmacist working at the pharmacy in March 2009 noticed some boxes of co-codamol capsules on the dispensary shelf, which had an expiry date of the previous October. She asked the dispenser about the expired medication, who explained that although she had taken all the out-ofdate stock off the shelves, the superintendent had put it back, telling the dispenser that it was fine to use. The dispenser said that she had put the out-of-date stock into bags, and that some of these medicines had been used to fill dossette boxes. The dispenser didn t agree with the practice and had refused to handle anything to do with the dossette boxes. The locum pharmacist also noticed that generic products were being substituted for branded medicine, where the prescription specified the branded product. On one occasion, she was asked to check a dossette containing Oxybutynin, where the corresponding prescription specified the branded product. She refused to check it, and left a note explaining that she could not carry out the check as it didn t contain the product ordered. In January 2009, a relative of a patient who had died returned some of the patient s unused medicines, which included controlled drugs. A preregistration trainee at the pharmacy was told by the superintendent that these medicines could be reused, and was asked to remove the labels. The superintendent then put a box of the medicine in the controlled drugs cabinet. Although there was no evidence that these particular drugs were redispensed, the committee found that it was clear that the superintendent pharmacist intended them to be available for dispensing by storing them with other controlled drugs. The locum pharmacist made a statement to the primary care trust (PCT) about her experiences at the pharmacy. When the superintendent was notified of the PCT s concerns, he approached both the dispenser and the pre-registration trainee individually and asked them to say that the pharmacist s statement was a lie. The committee was confident that both the locum pharmacist and the pre-registration trainee were professional and credible witnesses. Consequently, they found that dishonesty was an integral part of the registrant s management of his pharmaceutical practice. There was no evidence that the superintendent pharmacist demonstrated any insight into his actions, and so he posed a continuing risk to patients and the public if he continued to practise pharmacy. The superintendent s name was removed from the register. 14 Regula+e: October 2012 Issue 7

Fitness to practise learning Stealing from the pharmacy The fitness to practise committee heard a case where a pharmacist left with 540 of prescription-only medicines from the pharmacy where he had just completed a locum shift. A trainee dispenser who was working with him noticed that during his shift, he had put together two large pharmacy bags which he placed close to his personal belongings and away from the area where prescriptions were usually made up. She thought that the pharmacist was behaving suspiciously, and pretended to accidentally knock the bags over to see what was inside. When she saw that they contained unlabelled medication, she was concerned as she could see no reason why the drugs should be there. The trainee dispenser initially thought about alerting security but she was not sure they would understand the need for the medication to be labelled, so she called the pharmacy manager and told him about her concerns. The pharmacy manager arranged for the pharmacist to be stopped and searched after locking up and leaving the pharmacy. The pharmacist was found to be carrying two bags containing unlabelled prescription medicine and Nicorette products, which had not been paid for. He was taken back to the pharmacy to be asked about the drugs he was carrying and whilst there, he picked up two prescriptions from the dispensing counter and put them in his bag. The pharmacist admitted that he did not have permission to take the drugs but said that they were urgently needed for members of his family. He said that he had private prescriptions to cover the medicines although he did not show any to the staff present. He had not paid for the drugs because he had been alone in the pharmacy, and it was against company policy to serve himself on the till. He was intending to complete the labelling and pay for the drugs the following day when the pharmacy manager would be in the store. He denied that he was acting dishonestly. The next day, the pharmacist returned to the pharmacy without the private prescriptions he had mentioned, and was dismissed from his locum shift. The matter was also referred to the police and when interviewed two weeks later, the pharmacist showed them two private prescriptions issued by his brother, a consultant orthopaedic surgeon. However, when copies of these were shown to the store staff who stopped the pharmacist, they confirmed that these were not the prescriptions that they had seen the pharmacist pick up from the dispensing counter. The pharmacy manager confirmed that two identifiable NHS prescriptions were missing and that the drugs listed on these did not correspond to those taken by the pharmacist. The committee heard that one of the drugs the pharmacist had taken was Keppra, an anti-epileptic drug, which he claimed was for his father. After initially indicating that his father suffered from epilepsy, he later confirmed that this wasn t the case. The pharmacist also took 100 Erythrocin tablets, which he initially explained were for an uncle, in a text message to the pharmacy manager. He later claimed these were urgently needed for his father. The committee felt that his account was a carefully considered attempt to try to create a story that exonerated him, and could not be reconciled with the facts. They were satisfied that he was attempting to steal drugs from the pharmacy, and that he took two NHS prescriptions in an attempt to pretend that these covered the medicines that he had tried to take. We also contacted the General Medical Council (GMC) at the beginning of our Fitness to Practise process to alert them to the consultant orthopaedic surgeon s involvement in the case. These cases highlight the following important key points: Keypoints acting with honesty and integrity is a fundamental part of being a pharmacy professional pharmacy professionals have a professional responsibility to raise concerns about individuals, actions or circumstances that could compromise patient safety all pharmacists and pharmacy technicians should be familiar with our standards and our guidance on raising concerns and should refer to this guidance and apply it if they have concerns all members of the pharmacy team should familiarise themselves with our standards for registered pharmacies and with their organisation s policy on raising concerns You can find out more about the role of the investigating committee at: www.pharmacyregulation.org/raising-concerns/hearings/committees/investigating-committee And about the fitness to practise committee at www.pharmacyregulation.org/raising-concerns/hearings/committees/fitness-practise-committee Our threshold criteria can be found at: www.pharmacyregulation.org/sites/default/files/the%20threshold%20criteria.pdf Upholding standards and public trust in pharmacy 15

Check that a pharmacy professional is registered: www.pharmacyregulation.org/registers CopiesofRegula+eareavailabletodownloadfrom ourwebsitewww.pharmacyregulation.org/publications Wewelcomefeedbackandcommentson thispublicationwhichcanbesentto regulate@pharmacyregulation.org General Pharmaceutical Council 129 Lambeth Road London SE1 7BT Telephone: 020 3365 3400 Email: info@pharmacyregulation.org Designed and produced by Tangerine UK