The Pharmaceutical Journal
Vol 276 No 7399 p541-542
6 May 2006

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Fitness to practise procedures examined

In this article, Christopher Dunn looks at the implications for pharmacists of new fitness-to-practise procedures

Before April 2005, quality assurance of pharmacists was largely the remit of the Royal Pharmaceutical Society. Its authority comes from Section 7 of the Pharmacy Act 1954, which established the Statutory Committee “to supervise the functions and activities of registered pharmacists, including power to remove names from the Register and inspect premises”. Section 8 required the committee to consider, “any convictions received by, or allegations of misconduct made against, a pharmacist or a person applying for registration with the Society”. The committee has the powers to reprimand, admonish or remove pharmacists from the Register, and also to adjourn on terms such as an undertaking by a pharmacist to comply with conditions. The committee can also disqualify a company, and direct the removal of that company’s premises from the Register. Appeals by pharmacists against action taken by the committee to remove them from the Register (there is no appeal against a reprimand) can only be made to the High Court under Section 10 of the Pharmacy Act 1954.

PCTs and fitness to practise

Now, however, In addition to considerations based largely around actions by the Society, Section 46 of the NHS Act 1977 gives local primary care organisations (currently primary care trusts) the authority to hear “service” complaints against pharmacists and to withhold NHS payments, report them to the Society, etc. The Health and Social Care Act 2001 amended the NHS Act 1977 to enable regulations to be made that require health care professionals (including pharmacists) to make fitness-to-practice declarations to PCTs (Section 20). Various sections in the Act that apply to health care professionals seeking to practise within a local area require the PCT with varying degrees of discretion to:

· Examine practitioners’ enhanced criminal record certificates (Section 19)

· Prepare and publish lists of all professionals approved to practise in its area (Section 24) — only practitioners on PCT lists will be able to practise

· Make a decision to include a professional in its lists only subject to conditions (Section 21)

· Ensure professionals make full declarations of any financial or other interests they may have in relevant matters (Section 23)

· Suspend or disqualify practitioners from PCT lists according to established criteria (Section 25)

The NHS (Pharmaceutical Services) Regulations SI 2005/641 came into force on 1 April 2005 and implemented the above requirements for “providers” of pharmaceutical services — sole traders, bodies corporate and limited liability partnerships. These groups of “providers” had to supply all the necessary information to their “home” PCTs by 3 October 2005. The home PCT is defined as that in which the registered office of the body corporate is located in England, and it is deemed the responsibility of this PCT to notify all other PCTs in which the body corporate has registered pharmacies.

In general, the conditions that determine whether or not a body corporate can be included in PCT professional lists are broadly similar to those that determine the corporations’ removal: colleagues are referred to the Regulations for the essential detail on the “provider” lists. Regulations that will determine entry to and exclusion from lists of “performers” (ie, individual pharmacists) who “assist in the provision of pharmaceutical services” are expected to be implemented in spring 2006 and will probably include similar conditions to those for “provider” lists except:

· The concept of a home PCT will not apply — filing of information by an individual pharmacist with one PCT will allow that pharmacist to work in any PCT area

· “Providers” were required to make fitness-to-practise declarations with reference only to the provision of essential services of the new community pharmacy contract; “performers” are expected to make fitness-to-practise declarations for all three tiers of the contract thus giving PCTs the authority to determine if applicants are suitable to provide all levels of service

· The PCT will have the authority to remove a “performer” from its list if the pharmacist has not worked in the PCT’s area during the previous year

What does it all mean in practise? It means that a pharmacy company or an individual pharmacist who wants to practise within the area of a PCT must file a fitness-to-practise declaration with that office and allow it to check the information provided.

In addition to the requirement for pharmacists to file, essentially, a full curriculum vitae, they are under a “duty” to provide a range of information whether an existing practitioner or a new applicant. For “providers”, this information is outlined in Schedule 1, Part 4, Paragraphs 29 and 30 of the Regulations and includes where the applicant:

· Has a criminal conviction in the UK

· Has accepted a police caution in the UK

· Has, in summary proceedings in Scotland in respect of an offence, been the subject of an order discharging that person absolutely even without proceeding to a conviction

· Has, in Scotland, accepted a fixed penalty as an alternative to prosecution

· Has been convicted anywhere else of an offence that would also be a criminal offence in England and Wales

· Is subject to proceedings that might lead to a conviction

· Is, or has been where the outcome was adverse, subject to any investigation into his or her professional conduct associated with past or present employment

· Is subject to an investigation by the NHS Counter Fraud and Security Management Service

· Is subject to any investigation of any PCT or equivalent that has or might result in removal from a professional list

In addition, applicants must provide the names of two professional referees and give “consent” to the local PCT to request any information of any former employer or licensing or regulatory body in the UK or anywhere else about a current investigation or of an investigation with an adverse outcome.

The PCT (probably through the formation of a trained panel of lay and professional people) is required to check all the information and to take up the references. If these are satisfactory, the applicant is added to the relevant “provider” or “performer” list. If they are unsatisfactory, the PCT must refuse admission under some circumstances (eg, if the applicant has been found guilty of murder, sentenced to a term of imprisonment greater than six months, etc) or can consider discretionary refusal, conditional inclusion, or deferment (pending, for example, the result of a criminal or professional investigation). In respect of pharmacists already on a list who are found guilty of some criminal or professional offence, the PCT can consider contingent removal, suspension or disqualification.

The PCT has three grounds on which to consider the suspension or disqualification of a pharmacist (Section 49F of the Health and Social Care Act 2001):

· Where “continued inclusion … in the list would be prejudicial to the efficiency of the service” — the so-called “efficiency” case (Subsection 2)

· Where “(a) the person … has … by an act of omission caused … detriment to any health scheme by securing … any financial benefit, and (b) knew that he … was not entitled to the benefit” — the “fraud” case (Subsection 3)

· Where “the person concerned is unsuitable to be included in the list” — the “unsuitability” case (Subsection 4)

Because of the newness of these Regulations, no pharmacist has yet been penalised under them. However, where other health professionals have been subject to these arrangements, “fraud” has been relatively easy to define and to punish. It must be a fraud in connection with the NHS rather than simple dishonesty in other aspects of the pharmacist’s life. Cases of lack of “efficiency” or “unsuitability” tend to merge into one another (although the sanctions that can be imposed are different in some respects). For example, indecent behaviour by a pharmacist might impair the efficiency of the service being provided as well as make the pharmacist unsuitable to practise.

Currently, the sanctions imposed on a health care professional are determined on a case-by-case basis, but the CHRE (PJ, 9 July 2005, p37) is developing a template to outline appropriate penalties for: serious departure from professional standards; doing serious harm; abuse of position; sexual offences including child pornography; violent offences; dishonesty; and a persistent lack of insight into the seriousness of actions.

Any action a PCT may take against a “provider” or “performer” has to be based on “natural justice” and there is guidance on what the Department of Health considers as “good practice”:

· The PCT panel should appoint a named executive of the board who has formal responsibilities for taking decisions

· Likewise, the PCT should appoint an investigating officer who, while presenting the case to the PCT, should not be involved in the actual decision to penalise the pharmacist, and the practitioner should be allowed to present his or her case with legal representation allowed in some circumstances

· The practitioner should be allowed to make his or her own representations

· The panel could rely on a Memorandum of Conviction from a criminal court, or reports from a professional body, an NHS body, the CFSMS, or from individuals

· Any hearing of the panel should be in private and within 28 days of receiving any representations from the practitioner

· The PCT panel can consider whatever it wishes — ie, there appear to be no limits on the information and evidence that can be taken into account in reaching a decision

· There are strict time limits on who should be notified in writing of the decision — the affected practitioner (within 28 days and providing the practitioner the opportunity to seek a review); the Family Health Services Appeal Authority on whether or not an appeal is lodged; and various “interested” bodies (eg, the Society) within seven days of the decision being finally confirmed

Acting on behalf of the Secretary of State, the FHSAA can be considered as the final arbiter in any sanction imposed on a practitioner: it can confirm or overturn a decision made by a PCT and has power to impose the ultimate professional sanction in the imposition of a national disqualification of a pharmacist or other health care professional. It is perhaps not unreasonable to assume that some of these questions of interpretation of the statutory provisions will require determination by the High Court.

The result of all these old and new Regulations is that pharmacists can be disciplined by their professional body (the Society) and, if the penalty is “unduly lenient”, be referred to the High Court for further consideration up to and including being struck off the professional register. Separately, or even in addition to any sanction imposed by the Society or referral by the CHRE to the High Court, the PCT in whose area the pharmacist practises can impose sanctions that could prevent the pharmacist practising in that particular PCT area or even nationally. And, if those restrictions are insufficient, the complainant has the civil and criminal courts to fall back on.

Conclusions

So will these new Regulations result in pharmacists being more responsible (legally and professionally) and providing a better service to patients? There is no clear answer. It is perhaps unfortunate that the UK Government and various professional bodies have reacted to the actions of few high-profile, tragic and unforgivable circumstances to introduce a range of sanctions that, on the one hand, could be used against diligent pharmacists who may make a well-publicised error in a high-pressure environment. On the other hand, the Government promotes the concept of a “blame-free” environment in which errors occur through system failures rather than deficiencies of individuals.

One consequence of these Regulations as they are implemented for “providers” and are anticipated for “performers” — together with increasing professional requirements for continuing professional development and substantial increases in the annual retention fee to remain on the Society’s Register — is that a significant proportion of elderly pharmacists (on whom the large companies have heavily relied in order to continue to provide a community pharmacy service) are likely to voluntarily withdraw from the “active” Register meaning that they can no longer practise.

To a degree, this reduction in pharmacist numbers will eventually be countered by graduates from several new UK schools of pharmacy whose students will register in two or three years’ time. But with all these new Regulations (of which fitness-to-practise is but a part) the newly qualified graduates will find a profession probably much more heavily regulated than at any time in its past. And the pharmacies in which they work will be subject to “entry” by the PCT (to monitor compliance with the essential and, where appropriate, advanced services), by patient representative groups, and, under the Health Bill currently going through parliament, by the police (to assess compliance with Controlled Drugs Regulations).

Acknowledgements Encouragement, comments and suggestions received from Martin Dunn, Graham Hopkins, and Mark Mildred are gratefully acknowledged.