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Vol 274 No 7354 p761-762
18 June 2005

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Agenda for 2005

Why the profession of pharmacy must engage in a debate about revalidation

In this article, Gill Hawksworth, who was president of the Royal Pharmaceutical Society from 2003–04), gives her personal view that revalidation of practising pharmacists is inevitable and that members of the Society must prepares themselves for that future

Agenda series


In the post Kennedy era, following the Bristol inquiry, it became evident that Dame Janet Smith’s inquiry into the Shipman case would produce far-reaching recommendations for all health professionals. The fourth Shipman Report is clear that the practice of health care and the use of Controlled Drugs need to change radically. The fifth report criticised the General Medical Council revalidation procedures and this resulted in the Chief Medical Officer instituting a review of the effective revalidation of doctors and the role of the GMC. This will have implications for other health care professionals through the Foster Review.

The terms of reference of the Foster Review are to put in place comprehensive and consistent measures to ensure all professionals treating patients remain fit to practise. There is a need to strengthen fitness-to-practise procedures, ensure effective continuing professional development, develop appraisal and progress towards regular revalidation where appropriate, ensure effective regulation of new roles where there is patient contact and look at any changes needed to the role, structure, functions and number of regulators.

The report of the Royal Pharmaceutical Society’s Shipman Working Group stated, in its response to the fifth Shipman report, that “periodic revalidation should be seen as a positive assessment as to whether the practitioner is currently fit to practise, rather than a negative assessment on the basis that nothing adverse is known about them”, ie, revalidation goes further than CPD. Revalidation is important from both the public interest and employers’ perspective. In most cases the “employer” for pharmacists is the NHS, directly in the managed sector or as an independent contractor to the NHS. However, pharmacists working elsewhere, such as in the private sector and prison pharmacy, would also be included.

Lessons can be learnt from other industries that have developed various models which give assurances to the public by raising continuing standards and filtering out incompetence. For example the lessons from aviation include the fact that revalidation is completely accepted within this industry and this comes with an admission factor. Pilots are licensed to fly (practise) every six months and there is an element of observation in the revalidation process every 12 months. Revalidation is carried out by people respected within the industry. There is a mandatory reporting system that makes whistle-blowing easier (as a legal requirement). There is, however, a cost in the loss of personnel. Teams are assessed by performance on the job, which brings in the trust factor, and there are losses each year due to health issues.

Further lessons can be learnt from the medical profession. It is assumed that the public’s expectation is that registration is conditional on revalidation throughout the doctor’s practising life and that this includes assessment of practice, ie, what one actually does, rather than just the knowledge and skills of what one could do.

So what are the medical profession’s revalidation proposals, why are there problems and what are the alternative approaches that might be considered? Furthermore, what are the potential implications for pharmacy?

Its proposed model for revalidation is a set of appraisal-based procedures, operated locally and overseen by the GMC. The purpose is to secure the evaluation of a medical practitioner’s fitness to practise as a condition of continuing to hold a licence to practise. There is no assessment involved; revalidation in medicine is about fitness to practise, not unfitness to practise. It is intended to be a demonstration of fitness to practise now, not just the assumption that possession of a primary medical qualification leads to the award of a licence to practise.

Factors to be taken into account in revalidation include patient and public involvement, clear standards, rigorous quality assurance and detailed scrutiny when local systems are not fit for purpose or do not exist. There appears to be an acknowledged problem around who accredits GPs and local accreditation of GPs, which is not uniform. There needs to be a clear purpose to revalidation: good revalidation should reward excellence and not have the simple purpose of detecting the 5 per cent below grade.

What can pharmacy learn from this? There are many questions to be answered, such as what CPD is and what it is not. What is revalidation and its purpose in pharmacy? Why might revalidation be different for different pharmacists?

First let us consider the role of appraisal as a measure of current competence or performance. It will only be useful if it assesses whether performance is satisfactory, identifies attitudes, values or behaviour problems and highlights skills and knowledge that need to be enhanced. A more formal performance assessment may be triggered around any concerns and this may be a contractual requirement. It may go beyond solely addressing individual development or working as part of a team and it may be appropriate to introduce measures such as a validation process with periodic endorsement by a supervisor or mentor. The purpose of revalidation is that renewing registration assures fitness to practise, which for health professionals must secure and maintain public trust and confidence in professionalism. This can be done in a number of ways, such as a common set of minimum standards, competency to do a particular job and being fit for purpose.

There is a public expectation, endorsed by the fifth Shipman report, that revalidation should be an effective indicator of a professional’s competence. This means information supplied by the practitioner alone without an assessment carried out by or on behalf of a regulator will not suffice. Revalidation may or may not include information provided by an accredited employer, such as an NHS appraisal, but the process of revalidation should include, if necessary, remedial action and a managed exit from the register. There should be a link to the regulator functions with fitness-to-practise procedures. These should include rapidly addressing serious concerns and recurrent themes of misconduct, including dishonesty and abuse, to protect the public. There is, therefore, an element of conduct, not necessarily deficiency of knowledge or performance. A major change in culture is required right from the first admission to a school of pharmacy that there is not a job for life by right. However, there needs to be a balance between stifling innovation, which improves patient care, and regulation.

It is clear that pharmacists in clinical practice will need to be assessed to confirm fitness to practise on such competencies as communication skills and application of medicines use reviews, although a different format would be expected for an academic. The assessment may need to include where relevant a practical assessment or in some cases, where this is impractical, portfolio assessment. Consider what are the competencies required normally for a pharmacist, informed by the core knowledge and skills framework of the Society. How do competencies fit into revalidation? Should health and suitability be considered? What else needs to be considered? Are there any conditions that question suitability? Is the CPD record adequate and does it take into account recent career changes and any specialties within the sphere of practice? Can different jobs be easily assessed? How will they be assessed and by whom? Which options for assessment will be best and what are the practicalities? Critically, what are the resource implications and who will pay?

These are just some of the issues to be considered and resolved as pharmacy prepares itself for the future. If we want to be a step ahead, we must first catch up with what is expected of us so far. CPD, and getting it right is the first stage of preparation for the next step — revalidation. There is at the moment an unknown timetable but the clock is ticking.

At a recent Chiltern regional meeting, following the presentation of this information on revalidation, there was the first attempt to facilitate a discussion on the subject with a group of pharmacists in an open meeting. The following feedback was useful to the debate that the profession must now undertake in order to gather the views and concerns of the membership:

· There was a concern about assessment against core competencies and those attached to any specialism, for example hospital pharmacists who work as community locums

· There is a need to consider how core competencies fit into the sector the pharmacist is working in and how they can be revalidated

· There will be specialist areas where all core skills are not relevant and there will also be core skills that will be needed by everyone

· Some areas of practice bring into question the need to be a practising pharmacist if core competencies are not relevant; therefore, linked to the questions on the fee declaration form there needs to be clarity about where being a pharmacist does add value

· With regard to a portfolio pharmacist, the question was raised of annotation of the register which at the moment only records the qualification not the competency of, for example, a prescriber

· It became clear that on, admission to pharmacy university courses, both undergraduate and postgraduate, potential students would need to realise the commitment to life-long learning and the additional CPD requirement in specialist areas with respect to future revalidation

The implications of revalidation, as the next step following continuing professional development, are obvious and the Foster review ensures that it will not go away. To develop an acceptable framework for revalidation is a major piece of work for the Royal Pharmaceutical Society.

The members of the Society will want their say.

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