General Pharmaceutical Council

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.[8][9] 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.[10] Clarke 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)[11][12] and also a council member (2014-2020).[13][14][15][16]

The chairman of the GPhC's audit and risk committee, Digby Emson was (from 2008 onwards, and ongoing as at July 2022) [17][18] 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.[19][20][21] The GPhC's regulatory duties include setting standards for and accrediting the education and training of pharmacists and pharmacy technicians.[22] The GPhC also sets requirements for the education and training of pharmacy support staff.[23] As such, there was an apparent conflict of interests in holding this role.

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 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.[24]

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, the GPhC had issued 667 ‘poor’ ratings between 1 November 2013 and 24 June 2018. A poor rating signified that:

[25]

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 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 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.[26]

As part of its role as a premises regulator, the GPhC appoints strategic relationship managers[27] 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 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 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."[28]

The GPhC listed its powers to regulate corporate bodies, effected through its committees, thus:[29][30]

• The committee has the power under Section 80 of the Medicines Act 1968 to deal with ‘disqualification allegations’ made against a corporate body that carries on a retail pharmacy business. The committee may direct that:
  • a corporate body should be disqualified for the purposes of Part IV of the Medicines Act 1968
  • a ‘representative’ of the corporate body should be disqualified as being a representative for the purposes of Part IV of the Medicines Act 1968
  • the registrar should remove from the register of premises some or all of the premises at which the corporate body carries on retail pharmacy
  • the registrar should remove from the register of premises, for a limited time, some or all of the premises at which the corporate body carries on retail pharmacy

In September 2022, 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 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 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.”[31]

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.[32] In November 2022, a Freedom of Information request revealed that 20,924 temporary closures occurred in England in 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.[33][34][35][36]

In September 2022, the GPhC issued a statement, saying that pharmacy closures “may raise concerns for patient safety, particularly if people cannot access 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 a role in investigating them, it did not explain what purpose this would serve.[37]

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 the number of pharmacists relative to the number of registered pharmacies. [38] This holds true when the increased number of pharmacists working in primary care,[39][40] 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 the Pharmacy Order 2010 makes provisions which would allow the GPhC to set standards relating to pharmacy closures.[41] The standards can relate, for example, to:

• pharmacy governance arrangements, including arrangements for managing and monitoring the safe and effective provision of pharmacy services
• the working environment at and the condition of registered pharmacies; the patient and public experience of pharmacy services provided
• arrangements for ensuring staff of the retail pharmacy business are properly held accountable for the health, safety and well-being of patients to whom pharmacy services are provided

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.

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 the safe provision of pharmacy services to patients?". Of the 1,492 responses received, 72.7% said "No" or that they were unsure.[43]

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 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, 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.”[44]

For three years from 2014 to 2017, 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 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”.[49][50]

The requirements under the framework include submitting four CPD records each year (two of which must be planned); 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 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 a period of 24 years.[51] 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.[50][52][49][53][54][55][56][57][58][59][60][61][62]

That 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 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 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 the term “fitness to practise”. This reasoning is implausible and likely dishonest (a behaviour which the GPhC says damages public confidence and undermines integrity). [63] 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 the use of this term. The term "fitness to practise" is used repeatedly on its website and in its policies.[64][65] It is also a term referred to extensively in The Pharmacy Order 2010, the act of legislation which gives the GPhC its powers.[66] It is also used repeatedly in the GPhC’s “revalidation framework” document.[67]

The framework does not meet the GPhC’s own definition of revalidation. At a meeting in November 2013, 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 the thinking outlined in this proposal, so that term will be used from now on.”[68]

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 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.”[69] 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 was called ‘revalidation’. We have decided not to use this term anymore because it was not well understood.”[70] 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 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.”[71]

That 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 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.[72][73]

Calling the process, inaccurately, "revalidation", could have at least the following effects:[49][50]

• It creates the impression that the GPhC's approach to regulation, as a whole, is more robust than it is.
• The GPhC misleads the public and others as to the nature of the process, and that the assurance in respect of public protection is greater than the process actually affords. This occurs each time that it uses the term, including through its continued use.
• In order to register, registrants must submit a false declaration each year, that they have undertaken revalidation, when in fact they have not.
• In using the term, pharmacy organisations and registrants join the GPhC, unwittingly or otherwise, in misleading the public and others as to the nature of the process.
• It may de-professionalize the pharmacy profession. If it is accepted that pharmacists can “revalidate” annually simply by creating six records with very little chance that they will be reviewed by anyone, let alone the GPhC, then it can be argued that little public safety assurance is required in the regulation of pharmacists. As such, pharmacists pose little risk to the public, and the role is straightforward.
• Reduced confidence in revalidation frameworks provided by other regulators, if public perception of the meaning of revalidation alters to accommodate the GPhC's lower standards.
• It may suggest that the regulatory practise of pharmacists and pharmacy technicians is more advanced than it is in reality, misleading the public as to the confidence it can have in one or both groups. This may then be used to advance government policy objectives in respect of the use of the groups (or one group instead of another) in the health service.

During the COVID-19 lockdown, graduates (who had passed the MPharm exam and completed a year of pre-registration training) were allowed to practice as "provisionally registered pharmacists" from the 1st of August 2020, without sitting a registration exam to verify their competence or fitness to practise.[75] 2600 candidates, including many provisionally registered pharmacists, sat exams on either the 17th or 18 March 2021, in order to register with the GPhC as pharmacists. Following the assessment on the 18th of March, there were reports on social media that many questions on the 18th of March sitting were the same as those which appeared on the 17th. Some candidates who sat the exam on the 17th had reportedly shared what questions were on the exam with some of those sitting it on the 18th, in chat groups used by candidates. The reports included that at least 30 questions were similar, "both papers were nearly identical", the "majority" of questions were the same and "at least 50% of the questions came back". The GPhC responded, stating "There have been some concerns raised by candidates that the papers for each sitting were the same or very similar, and that this could have an impact on which candidates pass the assessment." It stated that "the majority of questions were different, with some questions appearing similar but having appropriately different answers" but acknowledged that "a number of questions were the same".[76] The GPhC has not stated that it will conduct any investigation into the reports, or that it will discount the questions that were repeated on the 18th. It appears that all candidates who sat the exam on the 18th were eligible to register as pharmacists, without any investigation or corrective action taking place.

A Freedom of Information request was submitted for the number of questions which appeared on both exams. The GPhC initially refused to provide the information. However, following a decision from the Information Commissioner's Office relating to the request, it stated: "We held a computer-based registration assessment on the 17 March 2021 and again on the 18 March 2021. On each day, there was a 40-question part 1 paper and a 120-question part 2 paper and the papers were different. In total, 14 identical questions were used in both part 1 papers and 62 identical questions were used in both part 2 papers."[77]

Provisional registration as a pharmacist was introduced as a temporary measure in response to the COVID-19 pandemic. It was secured through an application process, and was open to those who had completed their University studies in pharmacy, and pre-registration training year. Those who joined the provisional register had not sat a registration assessment beforehand. Only those who intended to practise as pharmacists needed to apply.[78] Those who were successful in the application could join the register from 1 August 2020.[79]

In the pharmacist registration assessment of July 2021, 2625 candidates sat the assessment for the first time, of which 259 were provisionally registered pharmacists. 2189 candidates passed it, of which 172 were provisionally registered pharmacists.[80] The results were announced on 9 September 2021. Therefore, 66.4% of those who were provisionally registered pharmacists, and 85.2% of those who were not, passed the exam. The assessment in July was the second opportunity for provisionally registered pharmacists to sit the assessment, the first opportunity having been provided in March 2021.[81] Provisionally registered pharmacists did not have to sit the assessment in March 2021; the numbers referred to above are only those who sat it for the first time in July 2021.

The results of the July 2021 assessment raise the question as to why those who had spent time in practice as pharmacists - which in some cases may have been almost 1 year at the point of sitting the assessment - would be less likely to pass the exam than those who had not previously practised as pharmacists.

It also raises the issue that 33.6% of the provisionally-registered cohort who sat the assessment - those who failed it - had been allowed to practise as pharmacists. This was before sitting an assessment which showed that by the GPhC's ordinary standards for entry onto the register, they would not have been fit to do so, since the ordinary requirement is that the person has passed the registration assessment. It is not clear what effect this had on public safety and protection. The GPhC has not said whether it has checked for or observed any trends in terms of concerns raised to it in respect of the provisionally-registered cohort, and it does not have oversight of or monitor dispensing errors or other pharmacy incidents.

A further issue is that the pass mark for the calculations part of the exam - paper one [82] - was 25 out of 40 questions (62.5%).[83] If the questions had been set at a level at which it was expected that candidates would be able to do them, this raises the question as to whether a 62.5% pass rate for this part of the assessment is sufficient; should the extent of the assurance provided to the public by the assessment be that pharmacists may only be able to get calculations right at least 62.5% of the time?

These issues were not mentioned by the GPhC when it announced the assessment results.

The GPhC's organisation of the June 2022 pharmacist registration exam led to protests outside of its offices on 13 July 2022 [84] and a petition alleging "systematic failure in properly regulating the GPHC exam", which had attracted more than 1,500 signatures as at 14 July 2022.

The exam was held on 29 June 2022, and resulted in the GPhC issuing a formal statement on the same date apologising for the delayed start at 5 out of 113 test centres.[85] However, further issues emerged from student accounts in the days immediately following the assessment. These included reports that students were at test centres for 14 hours, including 8 hours without food; were made to end the test 30 mins early because the centre ‘had to close the building’; candidates being able to use phones with a delayed exam start; loud, distracting noise in some test centres; some trainees being able to look at others' screens during the exam; invigilators not checking calculators for the calculations part of the exam; some candidates being allowed to use a scientific calculator; some questions being almost a page long to read with 3 minutes per question not being enough time; candidates whispering in the exam with no action taken by invigilators; and technical issues whilst attempting the exam with the software used.

The GPhC is responsible for how it chooses to conduct the assessment, and the measures it puts in place to ensure it is properly conducted. Despite the exam being (in its own assessment) a crucial measure to protect the public,[74] the GPhC decided to allow provisional registration, subject to eligibility criteria, for those who were severely impacted by its shortcomings in ensuring the proper conduct and management of the assessment, and who as a result did not pass the exam. Reflecting its anger at its own shortcomings, it issued a formal statement saying that "We share the sense of anger that many have expressed about the severe delays that some candidates sitting the registration assessment have experienced." The decision was made in part to "going a long way to allaying candidates’ concerns about employment and income" (matters which are not part of its regulatory objective of protecting the public).[85][86]