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56-520: The Health and Social Care Act 2008 and the subsequent Pharmacy Order 2010 allowed for regulatory functions of the RPSGB to be transferred to the new pharmacy regulator, the GPhC. The GPhC is therefore responsible for the update and maintenance of the registers of pharmacists, pharmacy technicians, pharmacy premises and pharmacy training premises. These registers can be accessed electronically by any member of

112-497: A 12-month period between Oct 2021 and Sep 2022. 86% (17,894) of the 20,924 closures were reported by six of the largest pharmacy chains (Lloyds, Boots, Well, Tesco, Rowlands and ASDA) despite these chains accounting for only 36% (4,134) of the 11,600 registered pharmacies in England. In September 2022, the GPhC issued a statement, saying that pharmacy closures “may raise concerns for patient safety, particularly if people cannot access

168-564: A false statement in relation to their CPD. The GPhC is governed by a fourteen-member GPhC Council, with equal numbers of lay and registrant members, which is independent from the government, the professionals it regulates and any other interest groups. The GPhC state that to reinforce this independence, all members of the GPhC Council, including the chair, are appointed by the Privy Council , rather than elected. The first chair of

224-643: A period of 24 years. The distinction between revalidation and CFtP is therefore an important one, which should be recognised if healthcare regulators are to be able to claim they have genuinely learned from past events, including the Shipman Inquiry. The GPhC’s “revalidation” programme does not meet the definitions put forward by the Professional Standards Authority, the Department of Health and Social Care, and others. That

280-456: A reflective account, in which the individual considers his/her own practice; and a peer discussion. This does not amount to revalidation because it does not involve a formal assessment by another person that the registrant is meeting regulatory requirements, in order for the registrant to re-register. Such formal assessment is a feature of the GMC and NMC revalidation programmes, which were, at the time

336-471: A register of pharmacy premises, registered pharmacy owners, sanctions that it has issued against either, or a hearings schedule in respect of sanctions it may issue in respect of either. A Freedom of Information request submitted by The Pharmacists’ Defence Association in late 2017 found that although the GPhC had issued over 3,500 sanctions against individual registrants (rising to 4,111 by mid 2018), i.e. pharmacists and pharmacy technicians, it had never issued

392-405: A role in investigating them, it did not explain what purpose this would serve. The GPhC stated that some closures may be appropriate if necessary in the interests of patient safety. However, many closures are avoidable; they may occur, for example, due to a failure by a pharmacy owner to ensure enough staff are available to open the pharmacy. Between 2010 and 2021 there was a substantial increase in

448-609: A single sanction for a breach of pharmacy premises standards since its inception in 2010. This was despite the fact that there were 995 occasions in the two financial years preceding the FOI request where the GPhC had identified serious issues that it wanted rectifying, where its standards hadn't been met. The Freedom of Information request also identified that the GPhC had never: A further Freedom of Information request submitted by The Pharmacists’ Defence Association in mid-2018 revealed that whilst carrying out routine inspections of pharmacies,

504-427: Is discovered on its own courses. Pharmacists and pharmacy technicians are required to provide evidence annually to the GPhC that they have maintained their fitness to practise. Prior to 30 March 2018, the process of ongoing learning – evidence of which had had to be provided to the GPhC since its inception in 2010 – had been referred to as "Continuing Professional Development" (CPD). For three years from 2014 to 2017,

560-472: Is not, according to the GPhC's statutory role set out in The Pharmacy Order 2010, meant to be the concern of the GPhC. According to the GPhC's statement, the cessation of inspections would improve the provision of safe and effective care; this implies that its conduct of inspections would in fact reduce the safe and effective care provided to patients. As part of its role as a premises regulator,

616-520: Is responsible for the regulation of 61,137 pharmacists and 24,928 pharmacy technicians as at July 2022. In 2016/17, the Pharmacists' Defence Association conducted a survey of its members, in which one of the questions asked was "Do you have confidence that the working environments in the pharmacy, set by your main employer, are satisfactorily regulated by the GPhC/PSNI in such a way as to support

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672-563: Is to achieve improved consistency, with the strategic relationship manager holding three formalised structured meetings with the Superintendent Pharmacist and his/her team each year to review corporate documents and processes. This will facilitate other inspectors’ reviews of individual premises to confirm ongoing compliance with company policies and procedures." The GPhC listed its powers to regulate corporate bodies, effected through its committees, thus: In September 2022,

728-595: Is unclear what action the GPhC has taken on this matter since that time.” It is not clear whether the GPhC took any action to investigate following the PDA report. Buttercups Training, whose chairman at the time was also the Chairman of the GPhC's Audit and Risk Committee, responded to the PDA report, saying among other things that “cheating is a part of the human condition”. However, it said it has robust systems to detect cheating and will respond swiftly and decisively where it

784-828: The Second Johnson ministry to mandate that care home staff be required as a condition of employment to maintain COVID-19 vaccination status. On 13 July the House of Lords had poignant questions for Nadhim Zahawi MP, at the time the Minister for Business and Industry and also the Minister for COVID Vaccine Deployment at the DHSC . It was unclear to certain members of the Secondary Legislation Scrutiny Committee just why and on what basis

840-810: The GPhC Council was Bob Nicholls CBE , a lay member with extensive experience in the National Health Service , who has previously been a lay member of the General Medical Council , among other regulatory appointments. The current chair is Nigel Clarke, a lay member with experience of the General Osteopathic Council and chairing the Future Professional Body for Pharmacy and then the Transitional Committee, which created

896-581: The GPhC and to be able to practise as pharmacists. It is taken by those who have completed their university studies and gained an MPharm degree, and completed a year of pre-registration training. Health and Social Care Act 2008 The Health and Social Care Act 2008 (c 14) is an Act of the Parliament of the United Kingdom . The Act was created on 11 March 2009 with the following regulated activities: The Care Quality Commission has

952-413: The GPhC appoints strategic relationship managers to chain pharmacies with more than 50 pharmacies. The GPhC has not provided any information about this role in the public domain, such as how it contributes to pharmacy inspection results or why it treats multiple pharmacies differently. It appears that some of the inspection outcome is predetermined as a desktop exercise at a head office level before visiting

1008-464: The GPhC developed proposals to change the requirements upon pharmacists and pharmacy technicians as a Continuing Fitness to Practise “CFtP” programme. The GPhC decided to change the name to “revalidation” around three weeks before the launch of the public "consultation" on the proposed change, whilst the Head of Continuing Fitness to Practise was on leave, and after its CFtP advisory group - which had advised

1064-492: The GPhC during the programme - had been disbanded. The Head of CFtP, on learning of the change on return from leave, implored the GPhC to reconsider, and revert to calling the process "CFtP". During the meetings of the CFtP advisory group, the Head of CFtP at the GPhC spoke in favour of calling the process, simply, “CPD”. The requirements under the framework include submitting four CPD records each year (two of which must be planned);

1120-433: The GPhC had issued 667 ‘poor’ ratings between 1 November 2013 and 24 June 2018. A poor rating signified that: The PDA juxtaposed this finding against the finding from its earlier FOI request that the GPhC had never issued any sanctions for premises breaches. The GPhC keeps a "bank of acceptable tolerances" to help it decide what pharmacy inspection rating to give. It refused to disclose it, saying that it would prejudice

1176-638: The GPhC introduced the change, the only two revalidation programmes among healthcare regulators regulated by the Professional Standards Authority . Formal assessment by another person was the basis of revalidation as recommended in the Shipman report, in which actual revalidation has many of its roots. The Shipman report was a landmark report in UK healthcare into a doctor who is estimated to have murdered at least 215 of his patients over

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1232-422: The GPhC must have the following committees; The Pharmacy Order 2010 requires not only that the GPhC sets acceptable standards of continuing professional development (CPD), but that it ensures that all registrants meet those required standards, and that there are processes in place for various remedial measures, including removal of a registrant from the register if they either fail to meet these standards, or make

1288-484: The GPhC or anyone else. If the records are deemed unsatisfactory, he/she could be given two further chances to put this right. Having a framework which is capable of robust early detection of deficient practice was a key expectation of the GMC’s revalidation framework following the Shipman Inquiry. The GPhC asserted that the change from CFtP to "revalidation" was made due to concerns over the negative connotations associated with

1344-468: The GPhC’s governing council explored a means of implementing a framework for assuring continuing fitness to practise. The meeting papers stated: “The terms ‘revalidation’ and ‘continuing fitness to practise’ are subtly different. In the GPhC’s view ‘revalidation’ implies a fixed point assessment whereas ‘continuing fitness to practise’ suggests a review of practice viewed on a continuum. The latter better describes

1400-476: The Human Rights Act 1998. The challenge was ultimately not successful, but the judgement has been called into question. The GPhC's social media guidance (“Demonstrating Professionalism Online”) – which asks pharmacists not to get involved in “negative, unconstructive discussions”, has not as yet been subject to legal challenge on the grounds of human rights. However, action taken against a pharmacist on

1456-468: The Pharmacy Order 2010 makes provisions which would allow the GPhC to set standards relating to pharmacy closures. The standards can relate, for example, to: Article 7(3) of the Pharmacy Order 2010 does not limit the contents of the standards that the GPhC must set under Article 7(1). The GPhC’s Standards for Registered Pharmacies, in the table below, are relevant to pharmacy closures. The GPhC

1512-511: The Professional Standards Authority launched a report in Parliament on improving patient safety. Noting the GPhC’s powers to regulate pharmacy owners and pharmacy premises, the PSA stated: “The GPhC has more modern legislation, established under the Pharmacy Order 2010… the GPhC can issue improvement notices or conditions, or ultimately, disqualify a pharmacy owner and remove all their premises from

1568-528: The UK… since 2011, an extensive set of responses to assessment questions appears to have been developing, all of which are publicly visible and indexed on online search engines. This means that trainee pharmacy technicians completing the distance learning courses can find answers to these questions and could potentially plagiarise them word-for-word to help them pass their assessments, without having conducted their own research or developing their own understanding. Some of

1624-538: The basis that he/she was involved in a negative and/or unconstructive discussion (which ostensibly includes, for example, talking to someone who was complaining about the weather) has the potential to engage human rights issues in relation to freedom of expression. In July 2018, The Pharmacists’ Defence Association reported on “potential cheating, collusion or plagiarism among trainee pharmacy technicians”. It stated that: “A small number of online distance learning courses are undertaken by many trainee pharmacy technicians in

1680-435: The best interests of both patients and registrants. However, the regulation of ‘high street’ providers of healthcare is complex and piecemeal, and may not be fit for purpose.” In 2018, a Freedom of Information request revealed that 5,878 temporary pharmacy closures occurred in England in a 12-month period in 2016-17. In November 2022, a Freedom of Information request revealed that 20,924 temporary closures occurred in England in

1736-494: The committee goes on to say: “We found the response of the Department of Health and Social Care … to these concerns, as set out in the Explanatory Memorandum, unconvincing.” In 2017, the GPhC renamed its “Standards of Conduct, Ethics and Performance”, which set standards for pharmacists registered with the GPhC, to “Standards for Pharmacy Professionals”. At the same time, it changed the standards, and set out for

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1792-523: The consultation exercise on the grounds that they may reduce patient safety, particularly provisions allowing Superintendent Pharmacists to cover more than one firm and Responsible Pharmacists to cover more than one pharmacy or to operate remotely. We also note significant levels of distrust from the profession that the regulator, the General Pharmaceutical Council … would be able to set standards and rules appropriately. Worryingly,

1848-401: The council had decided to retain the name “because of its relative ease of understanding and they felt we needed to do more to explain the type of assurance that it provided to the public”. There is no record in the minutes of the council’s meeting of 12 October 2017 of this being discussed, though revalidation was discussed. Calling the process, inaccurately, "revalidation", could have at least

1904-446: The education and training of pharmacists and pharmacy technicians. The GPhC also sets requirements for the education and training of pharmacy support staff. As such, there was an apparent conflict of interests in holding this role. As well as regulating pharmacists and pharmacy technicians as individuals, the GPhC is also the regulator of pharmacies across Great Britain. It carries out inspections of pharmacy premises. It does not publish

1960-478: The exercise of its functions. The GPhC's inappropriate approach to pharmacy premises regulation worsened in 2023 when it announced that it would conduct fewer routine inspections of pharmacies "to ensure we support pharmacies during these challenging times to provide safe and effective care to patients". The GPhC has no role in "supporting pharmacies" and would be less likely to detect problems if it wasn't conducting inspections; whether or not "challenging times" exist

2016-651: The first time expressly that “The standards need to be met at all times, not only during working hours.” Two pharmacists, Pitt and Tyas , who were employees of the Pharmacists’ Defence Association, initiated judicial review proceedings on the basis that – they alleged - the new standards would infringe their human rights set out in Articles 8, 10 and 11 of the European Convention on Human Rights, as given effect in UK law through Sch. 1 to

2072-595: The following effects: The GPhC Exam or GPhC Registration Assessment exam was set by the Royal Pharmaceutical Society of Great Britain, but since September 2010 has been the responsibility of the GPhC. The examination takes place on two occasions each year: the summer (the last Friday in June) and the autumn (the last Friday in September). Candidates are required to pass it in order to register with

2128-456: The framework does not amount to revalidation was acknowledged by the GPhC and other pharmacy stakeholders at a CFtP advisory group meeting on 11 October 2017. The advisory group requested that the GPhC’s governing council be asked, at its meeting the following day, to change the name of the framework from “revalidation” to an alternative which accurately reflects its nature. The advisory group was subsequently informed by email on 1 November 2017 that

2184-457: The medicines and other pharmacy services many rely on”. However, it claimed that “as a regulator” it does not have a role in authorising when pharmacies open, investigating pharmacy closures, or monitoring opening hours. It encouraged the public and pharmacists to report concerns to the NHS. It also said that closures could be reported to the GPhC, but in the context of its statement that it doesn’t have

2240-416: The number of pharmacists relative to the number of registered pharmacies. This holds true when the increased number of pharmacists working in primary care, is taken into account. The GPhC has a legal function, under Article 3 of The Pharmacy Order 2010, to set and promote standards for the safe and effective practice of pharmacy at registered pharmacies. As regards the contents of the standards, Article 7 of

2296-489: The pharmacy, irrespective of how it is applied in practice. An internal document from a large pharmacy multiple stated: "The GPhC is mindful that community pharmacy multiples are different from independent pharmacies in that their policies and procedures are developed centrally and much of the decision-making cannot be made at local level. Therefore, the GPhC has appointed a designated Strategic relationship manager to all multiples with more than 50 pharmacies. The purpose of this

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2352-407: The process did not amount to revalidation was repeatedly conveyed by the GPhC to the CFtP advisory group. It was also noted in the "CFtP Interim Evaluation Report" produced for the GPhC by Solutions for Public Health that the GPhC's framework did not amount to revalidation, but this explanation was removed and was not present in the final report published publicly by the GPhC. The GPhC did not advise of

2408-405: The prospectus for the reformed Royal Pharmaceutical Society Nigel Clarke, GPhC Chairman from 2014–2022, was previously a partner of GJW, the firm Boots used for its public affairs and lobbying, between 1993 and 1998 and onwards. He was part of Prime Minister David Cameron 's business trade delegation to India in 2013, the year before his appointment to the healthcare regulator in 2014. Clarke

2464-555: The public online at the GPhC's website. In addition the GPhC states that the Health and Social Care Act 2008 has sufficient provisions to allow for the transfer of regulatory powers from the Pharmaceutical Society of Northern Ireland to the GPhC in the future, subject to approval of Northern Ireland Ministers. The principal functions of the GPhC, as stated within Pharmacy Order 2010 are: Furthermore, under statute,

2520-474: The register.” It also observed that “The GPhC’s inspection and enforcement powers are unique among the healthcare professional regulators. They give it significant scope to influence a number of areas including governance, risk management and safe staffing.” The PSA then noted that regulation by the GPhC may not be fit for purpose: “We are seeing large corporate chains accused of ‘hard sell’ tactics, and other questionable practices, that seem to prioritise profit over

2576-403: The registrant’s fitness to practise. The report confirms the GPhC’s continued commitment at that point not to develop a revalidation model (which it had earlier said implies a fixed-point assessment): “The GPhC’s direction of travel is to move away from a process of a fixed point assessment for assurance… Given the PSA guidance on the CFtP model being proportionate to risk, this makes sense.” That

2632-464: The responsibilities to ensure service providers are providing quality care when carrying on the regulated activities. The Act makes further substantial revisions and repeals to the Public Health (Control of Disease) Act 1984 , by section 129, and Schedule 11. These have the effect of repealing, and replacing most of the provisions of Part 2 of the 1984 Act. In summer 2021, it was proposed by

2688-621: The safe provision of pharmacy services to patients?". Of the 1,492 responses received, 72.7% said "No" or that they were unsure. In 2022, during the parliamentary process of examining the Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022, comments from the Secondary Legislation Scrutiny Committee were noted which related to professional distrust in the GPhC. It was noted that "several proposals were not popular with respondents to

2744-473: The significance of the change in name, in its public consultation. The above details were not included in the consultation documents and were not shared by the GPhC with the wider audience at its engagement event in London on 16 May 2017. The GPhC checks the records of 1 in 40 registrants each year. This means that a registrant could go through his/her career of many years without having his/her records checked by

2800-451: The suggested responses to exam questions indicate what grading was obtained for that response. Communication also appears to occur through private messaging. As at 22 March 2018, the threads identified had been viewed a combined total 61,483 times... GPhC-commissioned research, published in 2014, included comments relating to the potential for cheating, collusion and plagiarism on pharmacy technicians’ initial education and training courses... It

2856-399: The term “fitness to practise”. This reasoning is implausible and likely dishonest (a behaviour which the GPhC says damages public confidence and undermines integrity). The GPhC has not renamed its Fitness to Practise Committee or Fitness to Practise declarations; stopped requiring registrants to complete a “fitness to practise” declaration annually; or taken any other discernible steps to avoid

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2912-430: The thinking outlined in this proposal, so that term will be used from now on.” In 2014, a page was created on the GPhC’s website explaining why it was looking to implement a CFtP framework and not revalidation. On that page, under the heading “What happened to revalidation?”, it stated: “We have been working on the introduction of new arrangements for assuring continuing fitness to practise for some time, and initially this

2968-471: The use of this term. The term "fitness to practise" is used repeatedly on its website and in its policies. It is also a term referred to extensively in The Pharmacy Order 2010, the act of legislation which gives the GPhC its powers. It is also used repeatedly in the GPhC’s “revalidation framework” document. The framework does not meet the GPhC’s own definition of revalidation. At a meeting in November 2013,

3024-591: Was also the business partner of Digby Emson, a former Boots superintendent, who was the chairman of the GPhC's audit and risk committee (circa 2017-2020) and also a council member (2014-2020). The chairman of the GPhC's audit and risk committee, Digby Emson was (from 2008 onwards, and ongoing as at July 2022) the chairman of Buttercups, an organisation that sells training courses for pre-registration pharmacists, and training courses and apprenticeships for pharmacy technicians and pharmacy support staff. The GPhC's regulatory duties include setting standards for and accrediting

3080-417: Was called ‘revalidation’. We have decided not to use the word ‘revalidation’ anymore because it has a very specific meaning relating to a particular method of assuring continuing fitness to practise.” As at 5 February 2017, this had been changed to “We have been working on the introduction of new arrangements for further assuring standards for safe and effective pharmacy practice for some time, and initially this

3136-558: Was called ‘revalidation’. We have decided not to use this term anymore because it was not well understood.” The webpage has since been removed from the GPhC’s website. In the version of the evaluation report of the CFtP pilot published on the GPhC’s website in February 2017, it explains that the General Medical Council (GMC) and Nursing and Midwifery Council (NMC) revalidation models include a fixed-point assessment of

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