Ensuring continuing fitness to practice in the pharmacy workforce: Understanding the challenges of revalidation

Research in Social and Administrative Pharmacy 9 (2013) 199–214

Review Article

Ensuring continuing fitness to practice in the pharmacy workforce: Understanding the challenges of revalidation Ellen Ingrid Schafheutle, M.Sc., M.Res., Ph.D., M.R.Pharm.S.*, Karen Hassell, B.Sc. (Hons.), Dip.M.R.S., Cert., M.A.(Econ.), Ph.D., Peter R. Noyce, C.B.E., Ph.D., F.R.Pharm.S. School of Pharmacy and Pharmaceutical Sciences, The University of Manchester, Stopford Building, Oxford Road, Manchester, M13 9PT, UK

Abstract Background: Revalidation is about assuring that health practitioners remain up to date and fit to practice, and demonstrating that they continue to meet the requirements of their professional regulator. Objectives: To critically discuss issues that need to be considered when designing a system of revalidation for pharmacy professionals. Although providing international context, the article focuses in particular on Great Britain (GB), where both pharmacists (Phs) and pharmacy technicians (PTs) are regulated. Methods: Following a brief historical overview, the article draws on emerging evidence in context. Results: Revalidation may involve discrete periodic assessment or a continuous process of assessment against clearly identified standards. The evolving scope of pharmacy practice involves increasingly clinical roles and also practitioners in nonpatient-facing roles. The potential risk to patients and the public may require consideration. Although revalidation, or systems for recertification/relicensure, exist in numerous jurisdictions, most center on the collection of continuing education credits; continuous professional development and reflective practice are increasingly found. Revalidation may involve assessment of other sources, such as appraisals or monitoring visits. Existing revalidation systems are coordinated centrally, but particularly in larger jurisdictions, like GB, where approximately 67,000 pharmacy professionals are regulated, some responsibility may need to be devolved. This would require engagement with employers and contracting organizations to ensure suitability and consistency. Existing systems, such as company appraisals, are unfit for the assessment of fitness to practice owing to a focus on organizational/business targets. Certain groups of pharmacy professionals may pose particular challenges, such as self-employed locums, pharmacy owners, those working in different sectors, or returning after a break. Conclusions: To ensure proportionality, it must be considered whether the same standards and/or sources of evidence should apply to all pharmacy professionals, either dependent on whether they are patient facing, their scope of practice, or whether Phs and PTs should be treated differently. Ó 2013 Elsevier Inc. All rights reserved. Keywords: Revalidation; Appraisals; Performance assessment; Performance monitoring; Standards; Registration; Certification; Regulation; Fitness to practice; Recertification; Competence assessment; Continuing education; Continuing professional development; Pharmacists; Pharmacy technicians; Regulation; Pharmacy owners

* Corresponding author. Tel.: þ44 161 275 7493; fax: þ44 161 275 2416. E-mail address: [email protected] (E.I. Schafheutle). 1551-7411/$ - see front matter Ó 2013 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.sapharm.2012.08.007

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Introduction The purpose of health professional regulation is to safeguard patients and the public, and ensure/assure that the regulated professionals are competent to deliver defined aspects of healthcare safely and effectively.1 Pharmacists (Phs) have traditionally been seen as persons who are professionally qualified (and licensed/registered) to prepare, sell, or dispense drugs and compounds. This is still reflected in most general and medical dictionary definitions, but some have begun to include Phs’ broadening scope of practice into more clinical roles, including advice to patients and healthcare professionals, as well as more independent practice, such as prescribing medications.2 It is recognized that the scope of practice has and continues to change for many healthcare professions, so pharmacy is no exception.3 Advances in technology, newly emerging drugs, and advances in evidence-based treatments all contribute to a need for all healthcare professionals to be competent to provide the services within their scope of practice. The need for Phs to maintain currency and relevance of competence has been universally recognized. Those who regulate health professional licensure or registration (ie, State Boards in the United States, Provincial Colleges in Canada, and healthcare regulators in the United Kingdomdbrought together under the Council for Healthcare Regulatory Excellence4), recognize the importance of not only setting initial entry requirements for practitioners but also to ensure that they remain competent throughout their practice careers. As a first step, this has involved the implementation of a relicensure requirement by many pharmacy regulators to undertake continuing education (CE). At its most basic level, relicensure requires the attendance at certified training events (or undertaking of accredited distance or online learning), often counted by the number of CE “clock hours” or credits. This continues to be the sole requirement in most U.S. State Boards, and it was a requirement in the United Kingdom until 2004. However, there is a lack of research evidence to demonstrate that participation in CE solely has any impact on competence, particularly practice outcomes, and didactic delivery appears least effective.5–7 This led to the introduction of continuing professional development (CPD), which a

introduces self-reflection into a self-directed, cyclical process of reflection (on learning needs, strengths, and weaknesses), planning, action, and evaluation.8 This is recognized by the American Council for Pharmacy Education, which acknowledges the lifelong and systematic nature of CPD as a self-directed and outcomes-focused approach to learning and professional development.9 Although most U.S. State Boards of Pharmacy continue to rely on mandatory CE (hours or credits) to meet the requirements for maintenance of their Phs’ licences, the State Board of Pharmacy in North Carolina now includes a CPD approach.9 This followed the pilot of a CPD program in 5 states during 2006-2007.10 Several countries, including Great Britain (GB; United Kingdoma), Canada, Australia, New Zealand (NZ), and Singapore, have also incorporated the principles of CPD into their CE.8,9,11–14 In GB, CPD and its recording began as an optional requirement for pharmacy professionals in 2005, but became mandatory in 2009, and legally binding in 2010. Currently, maintenance of registration requires the submission of 9 satisfactory CPD records annually, which reflects the scope of self-declared practice. CPD records can be called for inspection, and noncompliance with the above-mentioned regulatory requirements can lead to fitness to practice proceedings. CPD as a practice is thus firmly established. There is an established and growing body of research evidence to describe pharmacy professionals’ involvement in CE and CPD and the impact this has on practice.15–19 However, although the undertaking of accredited CE and/or CPD supports practitioner currency, competence, and performance, it does not guarantee satisfactory performance in practice.20 Indeed, it is recommended that a CPD system should be based on outcome measurement rather than a process, such as collection of points or numbers of hours and so on.21 Some authors use the terms “competence” and “performance” interchangeably, but Rethans et al.20 make a useful distinction. Whilst competence is about what a practitioner is “capable of doing,” performance is about what they “actually do in practice.” The term “fitness to practice” takes this one step further, as it not only combines competence and performance but also takes into account practitioners’ conduct and health. Thus,

The United Kingdom comprises England, Scotland, Wales, and Northern Ireland (NI), whereas NI is not part of GB.

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a practitioner (pharmacy professional) is fit to practice if “they can demonstrate the skills, knowledge, character, and health required to do their job safely and effectively.”22 But how can a practitioner demonstrate or “prove” their fitness to practice? This is what revalidation is about. It has been defined (in the United Kingdom) as the process by which healthcare professionals periodically prove that they remain up to date and fit to practice.21 Revalidation brings with it a paradigm shift away from self-regulation and professional autonomy and a “softer” touch on regulation, to increasing policy intervention and public scrutiny. Revalidation is largely evidence based, requiring assessment and performance review mechanisms involving the monitoring and appraisal of individual practitioners. This article considers how this could be operationalized and what issues would need to be considered when designing a system of revalidation for pharmacy professionals. The article begins with an overview of the historical context, which has brought about this shift in professional regulation, with a particular focus on developments in the United Kingdom. The article then draws in particular on a number of joint studies undertaken to inform a system for revalidation and its implementation in UK pharmacy,23–26 and qualitative work and a survey of pharmacy professionals, which preceded the introduction of revalidation.27 The article further contextualizes these with previously published research, taking account of the current policy situation. Relevant articles were identified through Scopus, using the search terms “revalidation,” “(re)certification,” “(re)licensure,” and “regulation,” and by scanning lists of references and later articles, which Scopus identified as citing the article in question. This article goes on to discuss issues, which arise, some of them specific to (UK) pharmacy, and how they could be taken forward by policy makers and regulators dealing with the future design and implementation of revalidation in pharmacy. This article thus does not aim to present either a comprehensive or a systematic review of all the literature, but to provide a critical discussion of key issues and challenges, which b

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need to be considered when designing a revalidation system for pharmacy. The evolution and context of revalidation in UK The introduction of the concept of revalidation in the United Kingdom is largely owing to the occurrence of health professional misdemeanors, which led to significant patient harm. Two cases, above all, achieved a particularly high public profile.28–30 Following what became to be known as “the Bristol Inquiry,”28 the notion of a patient-centred healthcare service committed to continuous improvement was reinforced. A new culture within the National Health Service (NHS)b, creating a 3-way partnership of respect, honesty, and openness, was promulgated. This was taken forward through the implementation of clinical governance, a vehicle through which the quality of patient care within a healthcare system was to be continuously improved.31 This combined high standards of care with transparent responsibility and accountability for those standards, but did so without imposing any particular structure or system. The impetus for the introduction of revalidation as a requirement for all healthcare practitioners in the United Kingdom to retain the right to practice followed the case of the family physician Dr Harold Shipman who is thought to have killed more than 200 of his patients over his course of practice of more than 20 years.29,30 Dame Janet Smith, Chair of the “Shipman Inquiry,” in her fifth report, highlighted not only the need for systems for raising concerns and handling complaints against doctors but also made recommendations for the revalidation of doctors. She explained the purpose of revalidation as ensuring “that health professionals remain up to date and continue to demonstrate that they continue to meet the requirements of their professional regulator.”29 Her recommendations shaped further developments in medical, and later also in nonmedical, revalidation. In 2006, 2 government-commissioned reviews on revalidation were published. The Donaldson review32 covered the revalidation of doctors, which had first been considered in the late

The NHS is the comprehensive, publicly funded healthcare system of the United Kingdom. It provides acute and long-term care at primary, secondary, and tertiary tiers, as well as emergency care. Secondary and tertiary care is provided by directly employed NHS staff, for example, hospital pharmacists. Primary care is provided by NHS contractors (eg, general medical practitioners and community pharmacists) on national terms and conditions.27

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1990s,33 and made relatively specific recommendations for the introduction of revalidation for UK doctors.32 The introduction of medical revalidation is underpinned by a strong evidence base, and full implementation is planned for December 2012,34 but this may slip to 2013.35 Meanwhile, Forster reviewed the regulation of nonmedical healthcare professionals, including pharmacy.36 Publication of the Government White Paper “Trust, Assurance, and SafetydThe Regulation of Health Professionals in the 21st Century”37 followed in 2007. It sought to ensure that health professionals do not pose a risk to patients, and maintain the confidence and trust of patients and the public; it also outlined a pathway of reform for the regulation of all healthcare professionals within the United Kingdom. Two key issues covered in the White Paper had particular consequences for pharmacy: first, it highlighted the need for professional regulators to be independent and impartial in their actions. This led to the separation of the Royal Pharmaceutical Society (RPS) of GB’s combined regulatory and professional leadership functions. Since 2010, the General Pharmaceutical Council (GPhC) has been the new independent regulator for pharmacy professionals, that is, Phs and pharmacy technicians (PTs), and the RPS is now the professional body for Phs in GB (ie, England, Scotland, and Wales).38,39 Unique within UK healthcare professional regulation, Phs in NI remain separately regulated by the Pharmaceutical Society of Northern Ireland (PSNI),40 which so far has retained its dual regulatory and membership functions. Second, all healthcare regulators, including the GPhC and PSNI, were charged with setting standards not only for admission to but also remaining on the professional register.37 They were thus tasked with putting arrangements for revalidation in place, through which all registrants would be required to periodically demonstrate that they are up to date and fit to practice. Professional standards for revalidation Professional standards are those standards that registrants will have to meet to maintain their registration, or in other words, those against which they will be assessed to be revalidated. These need to be contemporary standards,41 that is, “those which demonstrate that a practitioner is up to date in their specialty to be fit to practice within a contemporary healthcare setting,” and

this is seen as the fundamental standard necessary for public protection.29 These standards are crucial, as they will determine the types of evidence the regulator will require so that they can make an assessment of whether a registrant meets these standards or not. Uniquely in pharmacy, the Ontario College of Pharmacy has had Standards of Practice in place since January 2003,42 replaced by new Model Standards of Practice in January 2010.43 They cover 4 domains: “expertise in medications and medication use,” “collaboration,” “safety and quality,” and “professionalism and ethics” and have built on the practice standards of other healthcare professions, in particular good medical practice (GMP).44 However, a crucial difference exists between pharmacy in Ontario and the United Kingdom. In Ontario, the register of Phs is split into part A (for Phs active in direct patient care) and part B (for those who are active in nondirect patient care).45 The above-mentioned assessment criteria only apply to part A registrants, whereas in the United Kingdom, revalidation is likely to apply to all pharmacy professionals, regardless of whether they practice in a patient-facing role/sector or not.46 Revalidation developments and implementation in the medical profession are considerably more advanced than in pharmacy in the United Kingdom. The framework they have developed for appraisal and assessment47 is based on GMP,44 the General Medical Council’s (GMC) core ethical guidance for doctors. It sets out the principles and values on which good practice is founded, and it informs the education, training, and practice of all doctors in the United Kingdom.47 The framework is organized under the domains “knowledge;” “skills and performance;” “safety and quality;” “communication, partnership, and teamwork;” and “maintaining trust.” A number of attributes, generic standards, and possible sources of evidence are then listed under each domain. The generic standards, which contain an explicit link to individual items in GMP, have subsections that apply to all doctors, those which specifically apply to doctors with management, teaching or research roles, and doctors with clinical roles. The only relevant UK pharmacy standards currently in existence are the Standards of Conduct, Ethics, and Performance48 in GB (previously the Code of Ethics for Pharmacists and Pharmacy Technicians49), the Code of Ethics in NI,50 and the performance standards applied during preregistration training (before full Ph registration).51

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The GPhC has recommended that their Standards of Conduct, Ethics, and Performance48 should be built on for revalidation but acknowledge that this may require an updated version, similar to that developed by the GMC, the UK regulator of doctors.46 The scope of revalidation of the pharmacy profession in GB (ie, England, Scotland, and Wales) Since 2005, the pharmacy regulator (now the GPhC) not only regulates Phs but also PTs. Their registration was voluntary during a transitional period and became mandatory from July 1, 2011. The PTs are thus as much regulated pharmacy professionals as Phs are, something that isd although commonly called fordnot the case in most other countries.52,53 (Indeed, there is no registration of PTs in NI.) Currently, there are approximately 46,500 Phs and 20,500 PTs registered with the GPhC.54,55 Furthermore (and this is no different in many other countries, including the United States), Phs and PTs work in a whole variety of different sectors. Most of them work in patient-facing sectors, that is, in hospitals (Phs: 21.4% and PTs: 21.2%) or community pharmacies (Phs: 71.0% and PTs: 67.4%).56,57 Approximately 7-10% of Phs (and 4% of PTs) work in nonpatient-facing sectors.57,58 They can be found in the pharmaceutical industry, academia (in pharmacy teaching and research), as well as various professional or regulatory organisations, such as the RPS, the GPhC, and the Medicines and Healthcare products Regulatory Agencydequivalent of the Food and Drug Administration in the United States. A substantial number also work in NHS health organizations and commission primary care, including community pharmacy, services. Such variability in practice and sectors of pharmacy is captured because the definition of a Ph or PT practitioner used by the GPhC is very broad. It is not simply limited to the dispensing and supply of medicines and covers roles in patient- and nonpatient-facing sectors: “A person practices as a pharmacist or a pharmacy technician if, whilst acting in the capacity of or purporting to be a pharmacist or a pharmacy technician, that person undertakes any work or gives any advice in relation to the preparation, assembly, dispensing, sale, supply or use of medicines, the science of medicines, the practice of pharmacy or the provision of healthcare” (section 3.2).39

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Principles for revalidation In November 2008, the Department of Health (DH) published principles for nonmedical revalidation.21 This DH report was a pivotal publication, as it outlined the high level principles that would guide the development of models of revalidation for nonmedical professionals. Their aim was to identify practical steps that would support the development of an implementation strategy. By this point in time, the focus was clearly on developing an implementation strategy. In developing their revalidation principles, the DH took account of the 5 principles for good regulation, which had been developed previously.59 These principles are that regulation should be transparent, accountable, proportionate, consistent, and targeted where action is needed. Revalidation principles were then grouped under these headings and are listed in Table 1.

Collecting the evidence for revalidation The White Paper “Trust, Assurance and Safety”37 provided guidance for groups of registrants in different nonmedical employment or practice settings. For employees of NHS organizations, such as hospitals, the recommendation was that evidence to support revalidation should be provided as part of the normal staff management and clinical governance systems. Here, employers would then provide revalidation recommendations to the professional regulators. For those who provide services commissioned by the NHS, like community pharmacies, but are not in NHS ownership, it was proposed that the revalidation processes could be carried out either under the supervision of the NHS commissioning organization or the regulatory body, or as a collaboration between the 2 bodies. The survey by Potter et al.27 in early 2009 provides some useful insights into the views of registrants on the evidence, which they felt should feed into a revalidation process and assessment. Most registrants agreed that CPD should form part of the evidence submitted for revalidation.27 Besides strong agreement with CPD relevant to one’s practice feeding into revalidation, fitness to practice appraisals (ie, those focusing on an individual’s ability to perform as a pharmacy professional rather than on financial or performance targets) also gained good support, particularly by PTs. Feedback from peers and colleagues and observation of counseling skills in practice gained

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Table 1 Nonmedical principles for revalidation21 Principle

Theme

Summary description

Transparent Principle 1

Consistency

Models should be consistent with the better regulation executive’s 5 principles of good regulation The regulatory body for each profession should set out the contemporary professional standards, which registrants will have to meet to maintain registration Where revalidation processes highlight performance concerns, there should be scope for remediation of the professional but measures to secure public safety must remain paramount

Principle 2

Professional standards

Principle 3

Remediation

Accountable Principle 4 Principle 5

Patient and public involvement CPD

Principle 6

Quality assurance

Consistent Principle 7

Equality

Principle 8

Integration

Principle 9

UK-wide

Proportional and targeted Principle 10 Demonstrating benefits Principle 11

Information

Principle 12

Incremental introduction

A successful revalidation process must have the confidence of the public that it is appropriate, relevant, and fit for purpose This is the process by which individual registrants keep themselves up to date to maintain the highest standards of professional practice Quality assurance mechanisms must be built into revalidation processes Equality and diversity considerations must be evident in the development of systems and processes for revalidation Clinical governance frameworks yield information on professionals’ performance and practice. Where appropriate, effective connections need to be made between them and the system of revalidation Revalidation arrangements should be consistent in outcome across the United Kingdom The structures and processes of revalidation should be effective in confirming fitness to practice The nature of the information required by each regulatory body will be based on their risk profiling of their registrant groups The introduction of revalidation should be incremental

significantly higher support from PTs than Phs. Both groups also agreed with the use of a portfolio of written evidence of good practice, but were less inclined toward feedback from patients contributing to revalidation. Finally, both groups agreed that revalidation should be an ongoing, continuous process as opposed to a comprehensive assessment event. Interestingly, although Phs felt that they should be revalidated every 5 years, most PTs felt that the revalidation should occur more frequently.

Appraisals Use in medical revalidation Annual appraisals will be a cornerstone of revalidation for doctors in the United Kingdom and these will build on existing structures, where appraisals have been defined as: “.a professional

process of constructive dialogue in which the doctor being appraised has a formal structured opportunity to reflect on their work and to consider how their effectiveness might be improved.”60 Other sources of evidence will also feed into a 5-yearly revalidation cycle, including CPD as well as peer and patient feedback (where relevant).34 Multisource feedback (MSF), also called 360degree assessment, is an established approach to assessing professional attitudes and behaviors in the workplace.61 Here, a number of colleagues (peers) act as assessors of an individual and record their assessment on a proforma, which is fed back to the individual.62 It has been shown that such assessments can be practical, valid, and reliable.61 Besides feedback from peers, patients will also feed into the process of medical revalidation. Colleague and patient questionnaires have been developed63–66 and are being evaluated with encouraging findings.67–71 However, concerns have

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been raised around, for example, confidentiality,72–74 and whether MSF, and indeed revalidation, could effectively identify doctors in difficulty.74–76 Pharmacy registrants in patient-facing roles Community pharmacies, where the largest proportion of Phs (71%)56 and PTs (67%) practice,58 are commercial enterprises. They range from independent ownership (managed by an owner Ph), to increasing numbers of medium- and large-sized national pharmacy chains, and supermarkets,77 each with a superintendent Ph who oversees the pharmaceutical operations within the business. Superintendents (and owners) hold overall responsibility for setting out the standards and policies for the provision of pharmacy services by their organizations, and adherence to pharmacy and medicines legislation.78 Each community pharmacy throughout its opening hours also has a designated “Responsible Pharmacist,” who takes responsibility at any particular time for the safe and effective running of that pharmacy.79,80 The research evidence on the current use of appraisals and other potential sources of revalidation evidence,24,25 as well as the views of pharmacy professionals themselves,27 shed some light on the variation within community pharmacy. Although independent community pharmacies (usually under individual Ph ownership) have been declining over the recent years, they still make up a considerable proportion of the community pharmacy sector.77 Although about half of independent pharmacies had appraisals in place for PTs, none had any formal appraisal system for Phs; and none of the Ph owners themselves were subject to appraisals.24 In the national chains (particularly the larger ones), the use of appraisals of employees was widespread and regular (usually annually).24 Although they tended to have some key features in common (identification of learning and development needs, review of current objectives, and setting of new ones), “performance” was mainly focused on business targets, whereas clinical and professional competence (or performance)20 was noticeably absent from appraisals. A view seemed to be held by some that clinical and professional competence were the responsibility of the individual practitioner and a review of these was not seen as a management responsibility.24 As noted earlier, a review of CPD is part of medical revalidation. However, the only pharmacy

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sector where a review of CPD featured in appraisals was in NHS organizations, particularly in acute hospitals.23 Here, the Knowledge and Skills Framework, a competency framework for NHS nonmedical staff,81 underpinned appraisals. Indeed, when surveyed about the potential usefulness of appraisals for revalidation, most hospital respondents thought that their current appraisal system was adaptable for revalidation.23 Pharmacy professionals who were employed by the NHSdin contrast to their community pharmacy peersdfelt collection of evidence for revalidation could be relatively easily incorporated into their existing routine appraisals.

Self-employed practitioners Although a considerable number of Phs are employed by community pharmacy organizations, many work as (self-employed) locums.56,57,82 They have very varied work patterns, ranging from working full time to working in only occasional sessions. Some work regularly for the same company(ies), others have various, sometimes ad hoc, arrangements.83 It is also not uncommon for (locum and employed) Phs to work in more than 1 sector (eg, community and hospital or primary care, or community/hospital and academia), also referred to as portfolio working.57 Evidence suggests that these registrants are sometimes employed by 1 organization (in 1 sector), while practicing in a selfemployed capacity in other organization(s) or sector(s). In these situations, it seems that pharmacy professionals may fall under the management structures and appraisals of their employer, but not those of the other sector(s), so that only performance in 1 sector may be captured during an appraisal.26 Interviews with community pharmacy employers and locum agencies have confirmed that normally there are no arrangements for appraising locum Phs.24 Although conduct and/or performance concerns may sometimes be raised, there is no formal system to address or share these concerns, unless they are so serious that they warrant referral to the regulator. Furthermore, the regulator does not hold up-to-date information on sector(s) of practice or whether pharmacy professionals are employed or work as locums. The only information on which Phs work as locums dates back to the last national census of registered Phs in 2008.57

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Revalidation of registrants who are not in active clinical practice As mentioned earlier, approximately 10% of Phs (and 4% of PTs) work in nonpatient-facing sectors,57,58 such as the pharmaceutical industry; academia (teaching and/or research); and service commissioning, policy, and regulation. Requirements for revalidation may be different for these sectors. The research on the potential relevance of appraisals for revalidation purposes in these sectors showed that appraisal content was commonly not specific to pharmacy, to being a pharmacy professional or related to fitness to practice.26 In academia, the review of “performance” focused on teaching and research (covering scholarly activities such as curriculum/ module design, student engagement and satisfaction, securing research funding, and writing publications). In the pharmaceutical industry, appraisals had a business focus and, in that respect, had many parallels with appraisals in community pharmacy.

Role of contracting body, employer, and individual registrant in revalidation The above discussion has highlighted the diversity of pharmacy practitioners and their employment arrangements, and the focus of any performance management systems or appraisals. This has shown that some pharmacy professionals, particularly Phs, do not fall under any management structures and are also not appraised. For many others, particularly those who were in management positions themselves, or those not working in traditional patient-facing sectors, appraisals were often not pharmacy specific and commonly did not have any clinical or professional performance criteria, which would have any relevance for fitness to practice and revalidation. If appraisals were to become a key component in the revalidation of pharmacy professionals, it will be important to work closely with pharmacy employers, so that efficient, mutually beneficial, and workable systems can be designed and implemented. From a survey of Phs and PTs, it appears that there is little clarity or agreement on who should be making a revalidation assessment.27 Many Phs and PTs were undecided whether an assessment should be conducted by an assessor employed by their main employer, directly by an assessor from the pharmacy regulator, by a senior

pharmacy professional based at local level, or a combination.

Other sources of evidence: inspection and contract monitoring visits in community pharmacy Besides the use of appraisals and CPD, there are other sources of evidence, which could feed into a system of revalidation. Two existing structures, which are very specific to pharmacy in GB, are visits that are undertaken to registered pharmacies. The agencies involved are the GPhC’s own inspectorate and NHS staff who monitor NHS services commissioned from community pharmacies. Inspections focused on the compliance with legal requirements by the registered pharmacies, whereas monitoring visits focused on compliance with NHS pharmaceutical contractual arrangements and service specifications by individual community pharmacies.25 So, a key difference between appraisals and visits was that although appraisals were focused on individual practitioners, inspection and monitoring visits were concerned with the operation of pharmacies and service standards. The focus of visits in pharmacies (rather than individual practitioners) was seen as having important implications for their potential relevance and usefulness for revalidation. There may, or may not, be a continuing association between an individual practitioner and an individual pharmacy. At the particular time of a visit, a pharmacy could be under the responsibility of a Ph who generally worked elsewhere, for example a locum. In contrast, evidence gathered during inspections or visits may, for example, be valuable for independent pharmacy owners (12.3% of community Ph posts),57 where other sources of evidence may be limited.24,25 In 2004, “primary medical performers lists” were introduced for any doctor (including locums) who wants to provide general medical services for NHS patients in England.84 Some performance measures are required to be entered and retained on this list, such as criminal records checks and clinical references. The NHS service commissioners can refuse to admit a doctor onto their performers’ list or remove them from it at a later stage. Such a performers list does not currently exist for pharmacy professionals wanting to provide pharmaceutical services to NHS patients, but foundations for a possible introduction have

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been laid in the Health and Social Care Act 2012.85 These may provide a framework for recording as well as sharing concerns and could potentially feed into revalidation.

Embracing the principles of revalidation Recognizing remediation as part of revalidation emphasizes the importance of formative assessment. The latter encompasses both formal and informal procedures, which are supportive, focus on improvement, and typically involve qualitative (and detailed) feedback (rather than quantitative pass/fail scores). The DH revalidation principles21 note that appraisals should be both formative and summative, and in medicine this ethos is evident in the assertion that revalidation should continue to encourage practitioners to reflect on their practice, identify areas of improvement, and demonstrate fitness to practice.34 This addresses, to some extent, the concerns voiced in studies in pharmacy,24–26 as well as by authors in medicine,86–88 about a potential conflict between the formative nature of an appraisal or a visit, and the summative nature of an assessment. Indeed, both appraisals and also inspection visits were generally seen as formative and supportive, and there was a strong feeling across sectors that these 2 purposes should be kept separate. In fact, there was a feeling that using appraisals for summative revalidation purposes would undermine their formative (supportive and developmental) underpinning, and registrants’ willingness to be open and honest. Although a (summative) revalidation assessment would be concerned with the scoring of practice or performance (against set standards/ criteria), remediation follows the identification of substandard performance and is concerned with correcting (remedying) this. Making and recognizing remediation as an essential part of performance management in general, and in revalidation in particular, is an important step to realize a revalidation system that is a supportive and developmental process.21 This will ensure that practitioners with performance concerns are appropriately supported and recognize that revalidation assessments will need to work alongside other mechanisms. In studies about appraisals and inspection/monitoring visits in pharmacy, there was agreement among respondents that poor performance was more likely, and also more appropriately, identified through other means and

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opportunities.24–26 If performance concerns had arisen, the view generally was that these should not be left until appraisals, but should be dealt with immediately. Equally, with regards to visits, it was felt that poor performance was more likely to be identified through complaints (which in some cases lead on to an investigation) rather than routine visits. This confers well with other evidence about how poor performance is currently identified in Phs.89 At this point, it may be worth noting that revalidation is about setting minimum standards, commensurate with ensuring fitness to practice. However, these should be seen as minimum standards rather than aspiration goals, as leading-edge practice will always be above minimum standards.

Quality assurance Quality assurance is concerned with ensuring consistency in standards and processes used by peers, employers, or others engaged in assessing fitness to practice. One issue when ensuring consistency will be about who should be responsible for the judgment of a registrant’s fitness to practice. If the employer was to take on a role in this, appropriate governance arrangements would need to be in place to ensure that a final decision on an individual’s revalidation is an independent one, which follows clearly set criteria from the regulator. Another consideration will be about what the requirements would need to be of any person making revalidation assessments or judgements. The importance of, for example, appraisals being undertaken by pharmacy professionals with good sector and also role understanding has already been highlighted.24–27 However, pharmacy professionals’ line managers were not always pharmacy professionals themselves. Although those working in direct patient contact, for example, Phs working in individual community pharmacies, were commonly (but not always) appraised by a Ph, those working higher up the management structures were usually line managed and appraised by non-Phs. The same applied in the nonpatientfacing sectors, academia or industry. Conversely, external agencies, such as those currently undertaking inspection and monitoring visits, were unsure whether they had sufficiently close understanding of pharmacy professionals’ areas of work and roles. For those registrants who work

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across areas or sectors, a revalidation assessment would need to cover all areasdas an individual Ph’s or PT’s CPD records need to reflectdand an assessor(s) would need a good understanding of all sectors involved. To ensure consistency in the determination of fitness to practice, and be able to review all relevant evidence, a revalidation assessor needs to be appropriately trained and accredited, to assess appropriately professional and clinical competence. Furthermore, mechanisms are needed to ensure that revalidation outcomes are consistent nationally in outcome.

Risk Regulation needs to be proportional and targeted.41 Risk profiling of registrants could address the question of whether certain subsections of the profession may require different levels of revalidation assessment that is more frequent, intensive, or targeted. Risk profiling To address/inform the potential risk posed by practitioners, or groups of practitioners, to patients and the public, both UK pharmacy regulators (GPhC and PSNI) commissioned research on risk associated with contemporary pharmacy practice.90,91 However, it seems that evidence to inform risk profiling, or even what is actually meant by risk in pharmacy practice, is scarce.92 Phipps et al.92 described pharmacy as a “sociotechnical” activity, and that potential indicators of risk in pharmacy practice may include both Phs themselves, but also work systems and tasks. In other words, a more complex task or activity, if underpinned by appropriate training, experience, and contextual support, does not necessarily carry a higher risk. However, risks posed by unsafe working systems, increasing workloads, and an increasingly target-driven culture in community pharmacy, and so on need to be recognized as impacting on performance93 and therefore need to be taken account of in a revalidation system in pharmacy. Most risk research has focused on tasks and systems as opposed to “risky practitioners,” which would be relevant to revalidation. Nevertheless, some evidence is available, which suggests that certain demographic characteristics, such as age, gender, or sector, are related to an increased likelihood of performance and fitness to practice

concerns.93–95 Furthermore, there is some evidence that original registration in another country had an impact on practitioners’ performance, where not only practice in a different language but also within different cultural norms play a role.96,97 Another way of risk profiling for revalidation is to look not at Ph demographics/characteristics, but at the likely risk of the roles or tasks they fulfill (more of a task-focused risk approach). It raises the question whether groups who undertake advanced (or specialist) practice should have additional revalidation requirements placed on them. A starting point in GB pharmacy practice may be to look at advanced practice, which requires additional training and accreditation, and/or carries a separate annotation on the regulatory register. At present, the latter only applies to Phs with supplementary and independent prescribing rights.98 Others with expanded scopes of practice may be recognized by employers or commissioners, but not by the regulator, as areas of advanced or specialist practice. Interestingly, this is similar in the United States, where State Boards (regulators) have not extended their control to the regulation of advanced and specialist practice. Instead, the Board of Pharmacy Specialties, an autonomous division of the American Pharmacists’ Association, has become a postlicensure certification agency and has gained national recognition for this.99

Conclusion This article has set contemporary evidence informing the design and implementation of a system of revalidation in pharmacy in context. This raises pivotal issues for the operationalization of revalidation in the pharmacy workforce. Revalidation, risk, and patient/public protection Policymakers designing and implementing a system of revalidation will need to consider whether the profession ought to be subdivided into certain groups and/or sectors, possibly based on whether they may carry more (or less) risk for patients and the public. The first consideration, and one that may be relatively peculiar to GB, is whether Phs and PTs should attract the same level of revalidation. Although both are regulated by the GPhC and have the same requirement for complying with the Standards for Conduct, Ethics, and Performance48 and the submission of 9 CPD records annually, PTs are defined as

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working under the supervision of a Ph who holds overall responsibility.100 For Phs, the earlier-mentioned example of a register split into practitioners with and without patient-facing care in Ontario makes intuitive sense. However, not only patient-facing Phs are likely to have a potential important impact on patient and public safety. The more generic parts of research and teaching activity of, for example, academic Phs, are likely to be managed and governed through other systems,101,102 but the elements specific to pharmacy (fitness to practice and revalidation) may not be covered.26 Nevertheless, these registrants teach future Phs, thus potentially having indirect impact on patient care, through their education of relatively large numbers of students. Another issue is that of movement between sectors. In Ontario, for example, movement from practice in “nondirect patient care” (part B) to becoming active in direct patient care (part A) would necessitate compliance with certain additional requirements.45 Despite there not appearing to be large movement between sectors, such sector movement does occur in GB.57 Moving between sectors, and reentering pharmacy practice after a career break, have various patterns and reasons,103 but it is clear that such movements require careful management and support. Equally, temporary migration to another country and subsequent return may need to be considered,104,105 particularly as those pharmacy professionals not intending to practice in GB can no longer retain registration with the GPhC.39 Another approach that may be worth considering is one proposed by the U.S. Institute of Medicine (p. 217),106 who suggest a system of staged or graduated licensure, which would be based on a professional’s demonstrated ability to perform certain functions or on a certain level of practice. This is similar to licensure used for pilots in the United States, who first obtain a private, single-engine license, then progressively add further qualifications to obtain a commercial license, and then accumulate flying hours and experience to qualify for an air transport license. In addition to this, pilots are recertified (revalidated) at regular intervals throughout their flying careers.106 What would/could a revalidation model in pharmacy look like? Although the development of revalidation is firmly embedded in UK policy, comparable

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considerations and developments are underway in many other countries. Most are still based on CE, but CPD and reflective practice are increasingly embedded. This enables a move from mere competency to performance (and fitness to practice) assessment. What type of revalidation model will be most effective and suited to a particular context will depend on many factors. The review and assessment of CE or CPD for revalidation purposes, or pure competence assessments, could be organized centrally and commonly by the regulator. The process of collecting (and assessing) multiple types/sources of evidence, such as appraisals, 360-degree feedback, and so on, introduces a level of complexity. Also important is whether revalidation is a single event or a continuous process. The size of the task will further depend on the number of pharmacy professionals controlled by a single (national or State) regulator. Assuming a 5-yearly revalidation cycle, this would mean that some 180 Phs and 80 PTs would need to be revalidated on an average every week in GB. This may require some functions to be devolved to a more local level, and if this is the case, this needs to be supported by an appropriate infrastructure. It seems that most revalidation systems currently in existence (eg, Canada, NZ, and Singapore13,14,45) are centralized and do indeed serve much smaller Ph populations than those present in GB. The original model proposed for the revalidation of the GB pharmacy workforce was a decentralized (or devolved) model, which would require engagement and infrastructure. The research commissioned by the pharmacy regulator at that time, to inform the design of such a devolved system, has provided a unique opportunity to explore the feasibility and challenges of operating a devolved system of revalidation, and these are summarized below. Other than for NHS employees (ie, most hospital Phs), it appears unlikely that it will be feasible to adapt existing arrangements, such as appraisals, GPhC inspections, or contract monitoring for the revalidation of pharmacy professionals.23–26 It is further unlikely that a bespoke national infrastructure will be established for Phs, as has been created through the network of “local” Responsible Officers for ensuring the fitness to practice of medical practitioners.34 A further challenge is posed in devising a system of revalidation for portfolio and locum Phs, Ph managers, and Ph owners that matches the scope and robustness of revalidation for other patient-facing

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Phs. To enable this, the regulator would need to hold sufficient information on the register to ensure that they know which pharmacy professionals fall into these various groups. In any devolved revalidation system, a new and significant contribution of employers for ensuring the fitness to practice of their employee Phs would be required.24 Against this, GB pharmacy professionals, and in particular Phs, were almost evenly split on whether they would or would not want their employer involved in assessments for revalidation.27 Engaging employers in the revalidation of their Ph employees appears to pose considerable challenges. They are not currently orientated toward participation in revalidation, or ensuring the fitness to practice of their Ph and PT employees, which they see primarily as the responsibility of the individual practitioner and the regulator.24 Large employers of Phs and PTs would need to develop revalidation infrastructure, including training of appraisers/assessors and quality assurance systems to ensure consistency and independence. Smaller employers would probably need to access appraisal/assessor expertise through, for instance, contractual or cooperative arrangements. Under new arrangements for commissioning health professional training in the United Kingdom, employers will become involved in commissioning of training (and assessment) of pharmacy professionals before registration.107 They will thus become more accustomed to taking a share of the responsibility for the fitness to practice of their professional staff. At present, although some pharmacy employers and managers have experience of providing preregistration training, most do not. The new GB pharmacy regulator, the GPhC, having the benefit of research to inform them,23–26 are now reconsidering revalidation and have started by publishing some high-level principles for consultation.108 They have also further finessed the definition of revalidation in pharmacy to: “the process by which assurance of continuing fitness to practice of registrants is provided and in a way that is aimed primarily at supporting and enhancing professional practice,”108 thus firmly linking summative and formative assessment with remediation. The GPhC still has to decide whether it will provide different routes to revalidation to accommodate different practitioner circumstances and preferences, and whether options for revalidation of PTs will parallel those of Phs.

Acknowledgments The authors would like to thank the editor and 3 reviewers for their constructive and detailed comments, which have helped them to clarify and internationalize this article.

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