General Pharmaceutical Council

The General Pharmaceutical Council (GPhC) is the body responsible for the independent regulation of the pharmacy profession within England, Scotland and Wales, responsible for the regulation of pharmacists, pharmacy technicians and pharmacy premises. It was created, along with the Royal Pharmaceutical Society, in September 2010 when the previous body responsible for regulation, the Royal Pharmaceutical Society of Great Britain, was split so that representative and regulatory functions of the pharmacy profession could be separated.

Statutory

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 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:

• to establish and maintain a register of pharmacists, pharmacy technicians and premises at which a retail pharmacy business is;
• to set and promote standards for the safe and effective practice of pharmacy at registered pharmacies;
• to set standards to which registrants must demonstrate that their fitness to practise is not impaired;
• to promote the safe and effective practice of pharmacy by registrants;
• to set standards and requirements in respect of the education, training, acquisition of experience and continuing professional development that it is necessary for pharmacists and pharmacy technicians to achieve to be entered in the Register or to receive an annotation in the Register and to maintain competence; and
• to ensure the continued fitness to practise of registrants.

Furthermore, under statute, the GPhC must have the following committees;

• Investigating Committee (considers allegations that a registrant's fitness to practise is impaired, and can refer to the Fitness to Practise Committee for a full inquiry);
• Fitness to Practise Committee (makes decisions in cases where a registrant's fitness to practise may be impaired, for reasons concerning their conduct, professional performance or health); and
• Appeals Committee (considers appeals of decisions relating to applications for registration and registration status).

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 a false statement in relation to their CPD.

Governance

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 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 the prospectus for the reformed Royal Pharmaceutical Society

Interests of Members of the Governing 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. 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 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).

Whilst 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 the education and training of pharmacists and pharmacy technicians. The GPhC also sets requirements for the education and training of pharmacy support staff.

Regulation of pharmacy premises

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.

Failures in premises regulation

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.

The Freedom of Information request also identified that the GPhC had never:

• Fulfilled its legal obligation to set Standards for Registered Pharmacies in rules
• Issued an improvement notice to a pharmacy owner under its powers
• Brought a fitness to practise case against a registrant for a failure to comply with its Standards for Registered Pharmacies
• Established a category in its fitness to practise database for recording allegations which relate to compliance with its Standards for Registered Pharmacies
• Disqualified, removed, or sought to disqualify or remove, a pharmacy from the register (article 14 of the Pharmacy Order 2010 – failure to comply with an improvement notice, which could lead to a fine)
• Sought or obtained a conviction against a pharmacy owner under articles 12 or 14 of the Pharmacy Order 2010 (failing to assist or obstructing an inspector, providing false or misleading information to an inspector, failing to produce a document or record to an inspector when requested to do so or failure to comply with an improvement notice)

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:

• The GPhC has "major concerns about patient safety… that require immediate improvement"
• The pharmacy is "likely to present an unacceptable risk of harm to patients and the public. This means the risk is likely to occur and/or will have moderate to high impact."

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.

Relationships with pharmacy chains

As part of its role as a premises regulator, 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 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."

Human rights legal challenge to its professional standards

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 the first time expressly 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 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 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.

Potential cheating/collusion/plagiarism on pharmacy technician training courses

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 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 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.” It also stated that “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 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 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 is discovered on its own courses.

Pharmacist Registration Assessment

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 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.

In explaining the importance of the pharmacist registration assessment, the GPhC said: "It is a national standard... if you talk to the public and you talk to patients, that is something that genuinely matters - that they can be reassured that all of the good work that goes on in schools of pharmacy and in pre-registration training has at the end a moment where we can say, as a national regulator, that a standard has been met. There are very few objective ways of doing it, but an examination is one of those... There has been an exam since 1993... we've thought about it long and hard and we've concluded that an examination as a national standard to demonstrate to the public that a standard has been met is really quite crucial... It is fair. Everybody gets the same one. You cannot say that your examination was harder than somebody else's, or easier, and that's again something that is genuinely reassuring. There are so many assessments over the course of four years in a school of pharmacy, it's quite hard to compare them. We're comfortable with the fact that the learning outcomes are met across the nations but it's very hard to say that at any one moment - because it's not true - that everybody had the same assessment, and this is the only moment currently where that is the case. That's an important reassurance for the public. The other signoff in pre-registration is a tutor signoff. And those of you who know anything about assessment will know that a one-to-one signoff is one of the less reliable forms of assessment. It's quite rich because there's a lot of interaction involved, you know the person well, but that in itself can cloud your judgement, so on the scale of reliability and validity, it might be quite valid but it's not necessarily that reliable. That's why as a general principle you never use one kind of assessment in a high-stakes year of training, so that's another reason it's there. And there is another aspect that we cannot ignore. Despite the best efforts of schools of pharmacy and pre-registration training, there are individuals who get to the exam and fail it dismally... who get zero in calculations, for example, or 30% or 20%. So clearly there is a need for that final backstop for those individuals who for whatever reason have made it that far. So there is a genuine public protection reason for having the exam, so that's our rationale for keeping it."

Potential collusion / failure of integrity of the pharmacist registration exam in March 2021

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. 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". 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, 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."

July 2021 pharmacist registration assessment

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. Those who were successful in the application could join the register from 1 August 2020.

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. 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. 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, and in all likelihood had already done so. 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 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 - was 25 out of 40 questions (62.5%). 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.

Potential collusion / failure of integrity of the pharmacist registration exam in June 2022

The GPhC's organisation of the June 2022 pharmacist registration exam led to protests outside of its offices on 13 July 2022 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. 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 accountable and 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 the GPhC's own assessment) a crucial measure to protect the public, the GPhC decided to allow provisional registration, subject to eligibility criteria, for those who were severely impacted by its own 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).

Oversight of health and social care regulators

The Professional Standards Authority for Health and Social Care (PSA), is an independent body accountable to the UK Parliament, which promotes the health and wellbeing of the public and oversees the nine UK healthcare regulators, including General Pharmaceutical Council. It reviews the GPhC's performance annually, but has no power to compel it to do anything.

See also

• Association of Pharmacy Technicians UK
• Pharmaceutical industry in the United Kingdom
• List of pharmacy organisations in the United Kingdom
• List of schools of pharmacy in the United Kingdom
• British National Formulary
• The Pharmacy Practice Research Trust

External links

• Official Website