the SAPC website (http://www.sapc.za.org/B_Regs_Search. asp) only mentions ... categories of registered persons: pharmacy students, pharmacist interns ...
Forum SA Association of Hospital and Institutional Pharmacists
Training for clinical pharmacists: plat du jour or smörgåsbord? Andy Gray and Fatima Suleman, Discipline of Pharmaceutical Sciences, University of KwaZulu-Natal
a “Submit evidence to the registrar that he or she has obtained at least a Master’s degree in the speciality that he or she desires to register at a university in the Republic, or has obtained an equivalent postgraduate qualification in the speciality he or she desires to register, and that the subject contents and standard of such qualification and the institution where the qualification was obtained are acceptable to the Council.
Here are some extracts from a query that was recently submitted by a colleague: “I have always been involved with clinical work, especially within X, and have constantly been on the lookout for clinical pharmacist registrations that are utilised worldwide. Recently, I came across SAPC specialist pharmacist registration. Who qualifies for this? Who may apply? What does the registration mean?”
b Submit evidence to the registrar that for a period of at least two years after obtaining the qualification referred to in paragraph a, he or she was directly and personally involved in the delivery of a pharmaceutical service in the speciality he wishes to register at an institution that is acceptable to the Council.
“I have been involved in development of ward rounds and clinical pharmacy (clinical governance and antibiotic stewardship).Would I perhaps qualify as a specialist pharmacist?”
c Be registered as a pharmacist with the Council during the period of service referred to in paragraph b.
The response to the first query was to point to the specialist registers that already exist for pharmacists, and that are managed by the South African Pharmacy Council (SAPC). Finding out about them is not easy. The new search facility on the SAPC website (http://www.sapc.za.org/B_Regs_Search. asp) only mentions registers for registered persons, pharmacies (Y numbers), providers (R and U numbers), training sites, assessors and moderators, inspections and tutors. It lists the following categories of registered persons: pharmacy students, pharmacist interns, community service pharmacists, pharmacists, specialist pharmacists, authorised pharmacist prescribers, and pharmacist’s assistants (basic, learner basic, learner post-basic and post-basic), as well as pharmaceutical sales representatives. The statistics page provides some details on how many specialist pharmacists have been registered. The number is just 13, in category “unknown”, i.e. not assigned to community, institutional, manufacturing, or wholesale practice settings.
d Pay the prescribed fees to the Council.” If a pharmacist’s application was refused, he or she could request an examination in terms of Section 28(4) of the Pharmacy Act (Act 53 of 1974), which would consist of “ a written paper of two hours, an oral examination of one hour, and a practical examination of four hours, to ascertain whether such person (non-compliance with the prescribed requirement notwithstanding), is competent to practise in the speciality for which he or she desires registration”. In terms of Regulation 5, two additional issues were regulated: • A pharmacist may only practise in only one speciality, and shall limit his or her practice to that speciality, provided that a pharmacist may, with the prior consent of the Council, also conduct a general pharmacy practice. • A pharmacist may, notwithstanding the provisions of the subregulation above, have more than one speciality entered opposite his name in the register.
The available existing specialities for pharmacists are outlined in the regulations relating to the registration of the specialities of pharmacists (http://www.mm3admin. co.za/documents/docmanager/0C43CA52-121E-4F58-B8F681F656F2FD17/00011755.pdf). This is an old document, having been published in April 1994, and designates just two specialities, namely clinical pharmacokinetics and radio-pharmacy.
The first of these is important. It is a general principle in medical specialist registration that a specialist must restrict his or her practice to that speciality only, and may not practise as a generalist. The equivalent ethical rule, stipulated by the Health Professions Council of South Africa (HPCSA), (http://discover. sabinet.co.za/webx/access/netlaw/Health%20Professions%2023. htm#reg14) states that a “medical practitioner or a dentist who holds registration as a specialist in terms of the Act, shall:
In order to obtain registration on one of the two registers, an applicant would need to:
In the case of a speciality, confine his or her practice to the speciality or related specialities in which he or she is registered, and in the
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Forum case of a subspeciality, confine his or her practice mainly to the subspeciality in which he or she is registered. • The retention of his or her registration as a specialist in the relevant speciality, related specialities or subspeciality, shall be contingent on whether or not he or she so confines his or her practice. However, the HPCSA’s requirements for entry to a specialist register are very different. In essence, they require proof of having completed at least four years’ training as a registrar in a “hospital, department, or facility accredited by the board for specialist education and training”, as well as having completed a “specialist qualification in the relevant speciality in medicine”. That qualification is either a Fellowship examination conducted by the College of Medicine, or a Master of Medicine degree awarded by an accredited university.
Current proposals In a submission in March 2009 to the National Department of Health’s ministerial task team, the SAPC included proposals for three categories of specialist pharmacists: clinical pharmacists, public health pharmacists, and industrial pharmacists. In the clinical pharmacist category, a number of sub-specialities were identified: oncology, pharmacokinetics, paediatrics, radiopharmacy, veterinary pharmacy, and antiretroviral therapy. A scope of practice for clinical pharmacists was proposed: “In addition to the acts and services which form part of the scope of practice of the pharmacist, as prescribed in terms of Section 35A of the Pharmacy Act 53 of 1974, a pharmacist registered in the category clinical pharmacist may: • Provide advanced clinical services to a variety of specialities, including general medicine and surgery.
In this light, the SAPC’s requirements seem overly restrictive in one sense (only a Masters or other post-graduate qualification: presumably a PharmD or equivalent), but permissive in another (only two years’ experience, but not in a formal registrarship).
• Provide a leading pharmaceutical role in clinical protocol and guideline development.
Why the need for a clinical pharmacist registration?
• Develop, implement, evaluate, and provide strategic leadership for clinical pharmacy services.
In terms of evidence, a review published in 2008 stated that: “Many studies have shown that clinical pharmacists can effectively identify and prevent clinically significant drug-related problems, and that physicians acknowledge and act on the clinical pharmacist’s suggestions for interventions to the drug-related problems”.1 At a practical level in South Africa, the need for specialist registration in the category “clinical pharmacy” is required in order to implement the occupation-specific dispensation (OSD) negotiated in the relevant bargaining chambers, and applicable to the public sector. In addition to the supervisory ranks created, the OSD provided for ranks of “pharmaceutical policy specialists” and “clinical pharmacists”. However, the annexure to the final document (dated 14 July 2010) included this caveat in relation to the clinical pharmacist posts: “Codes for this post and the grades are created on the PERSAL system, but these are not activated yet. The Department of Health will inform departments when these codes are to be activated”. The original graphic explaining the OSD included this note: “Clinical pharmacist: new work level (category). No translation to this level with implementation. Posts are to be created once the Council has introduced a register for this category. The post is to be filled through the normal recruitment process (open competition)”. Therefore, no progress can be made until the SAPC has created a register for clinical pharmacists. However, is the envisaged process going to be enabling, or overly restrictive? Will there be appropriate recognition of prior learning? Will there be just one route to registration, or an appropriate menu of options? And, will the register be acceptable to other employers, and in particular to private hospitals?
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• Lead a clinical audit of medicine use. • Act as a leading pharmaceutical partner within a multiprofessional healthcare team.
• Undertake pharmaceutical risk management. • Provide education and training relating to clinical pharmacy.” However, no details of the educational path to registration were provided. In fact, in this document, far more attention was paid to the training of primary care drug therapy pharmacists (authorised prescribers). These proposals were followed up with the publication of draft regulations for comment (Board Notice 122, Government Gazette 34428, 1 July 2011), outlining the changes that would be made to enable the registration of authorised pharmacist prescribers. No further (visible) progress seems to have been made in respect of clinical pharmacists.
Learning from elsewhere Some useful lessons can be learned from other countries and their systems. In the USA, a useful three-part definition of clinical pharmacy has been provided by the American College of Clinical Pharmacy:2 “Clinical pharmacy is a health science discipline, in which pharmacists provide patient care that optimises medication therapy, and promotes health, wellness, and disease prevention. The practice of clinical pharmacy embraces the philosophy of pharmaceutical care. It blends a caring orientation with specialised therapeutic knowledge, experience and judgment, for the purpose of ensuring optimal patient outcomes. As a discipline, clinical pharmacy also has an obligation to contribute to the generation of new knowledge that advances health and quality of life. Clinical pharmacists care for patients in all healthcare settings. They possess in-depth knowledge of medications integrated with a foundational understanding of the biomedical, pharmaceutical,
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Forum socio-behavioural, and clinical sciences. To achieve desired therapeutic goals, the clinical pharmacist applies evidencebased therapeutic guidelines, evolving sciences, emerging technologies, and relevant legal, ethical, social, cultural, economic, and professional principles. In accordance, clinical pharmacists assume responsibility and accountability for managing medication therapy in direct patient care settings, whether practising independently, or in consultation or collaboration with other healthcare professionals. Clinical pharmacist researchers generate, disseminate, and apply new knowledge that contributes to improved health and quality of life.
standards. As the BPS’s website explains: “Once a specialty area has been recognised, a specialty council of content experts works with the BPS and its highly qualified psychometric consultants to develop a bank of test items. Each council is composed of six pharmacists practising in the specialty area, along with three outside pharmacists. In addition, BPS routinely solicits questions from practitioners working in the field, ensuring a democratic examination with real-life relevance. Certification examinations, consisting of 200 multiple-choice questions, are administered annually at designated sites throughout the USA and other countries. To ensure that knowledge and skills are maintained at the specialty level, each BPS pharmacist must recertify every seven years”.
Within the system of health care, clinical pharmacists are experts in the therapeutic use of medications. They routinely provide medication therapy evaluations and recommendations to patients and healthcare professionals. Clinical pharmacists are a primary source of scientifically valid information and advice regarding the safe, appropriate, and cost-effective use of medications.”
The guide to candidates in 2011 (http://www.bpsweb.org/pdfs/ CandidatesGuide.pdf) suggests the following ways to prepare for the examination: • “Residency or other formal training
The same group has also outlined the competencies of clinical pharmacists, as provided through the basic qualification (PharmD), and two year-long residency programmes (PGY1 and PGY2), focusing on their clinical problem solving, judgment, and decision making; communication and education; medical information evaluation and management; management of patient populations and therapeutic knowledge.3
• The study of journal articles, textbooks, or other publications related to the content outline • Continuing education programmes and courses in specialised pharmacy practice • Study groups and examination preparation courses • Reviewing sample test questions printed in this guide, or on the BPS website”.
While there are recognisable, apparent differences in the training of pharmacists in the USA and South Africa, such as the nature and duration of the initial qualification, some lessons can be learned from the use of residency programmes (akin to registrarships), and the role of the Board of Pharmaceutical Specialties (http://www. bpsweb.org/).
Interestingly, certification by the BPS is open to foreign-registered pharmacists who do not practise in the USA. The only requirement is a pass in the 200-question multiple-choice examination. There is also an African structure from which South Africa could benefit from some ideas, namely The West African Postgraduate College of Pharmacists (WAPCP), a specialised agency of the West African Health Organisation (WAHO).
This document noted that “doctor of pharmacy degree programmes provide broad, but relatively superficial coverage of disease states, pharmacotherapy, and general therapeutic principles”, and that “entry-level pharmacy graduates usually gain some clinical pharmacy practice experience during their educational programmes. This experience prepares them for entry into the profession, but not as fully competent clinical pharmacists”. Accordingly, “graduates of PGY1 residency programmes are minimally competent to provide general clinical services, e.g. patient counselling and routine drug monitoring, but are not often prepared to independently assume responsibility for the more complex decision making involved in drug therapy selection and drug therapy management. The PGY2 programmes allow residents to develop more in-depth knowledge and skills by working in specialised or differentiated areas of practice. Focusing on specific patient care populations, e.g. critical care, oncology, and paediatrics, allows graduates of PGY2 programmes to enter practice as entry-level clinical pharmacists”.
A way forward? While there seems to be some progress in respect of the authorised pharmacist prescriber, the same cannot yet be said about the specialist clinical pharmacist. Significant resources are available about the necessary competencies for specialist clinical pharmacists. In planning a way forward, we should guard against anything that is overly restrictive, that prescribes only a single route to registration (the plat du jour approach), and seek the greatest flexibility, with appropriate recognition of prior learning and varying routes to a clear demonstration of competency (the smörgåsbord approach). In summary, the SAPC needs to work with the universities, and also with professional associations, employers, medical schemes, and selected partners from outside the country.
However, while many USA employers now insist on clinical pharmacists having completed a residency programme, credentialing with the Board of Pharmaceutical Specialties (BPS) is based on a competency assessment, and not necessarily completion of a residency. This is a voluntary process, managed by an independent structure, created more than 30 years ago by the American Pharmacy Association, and based on peer-developed
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References 1. Viktil KK, Blix HS. The impact of clinical pharmacists on drug-related problems and clinical outcomes. Basic Clin Pharmacol Toxicol. 2008;102(3):275-280. 2. The definition of clinical pharmacy. American College of Clinical Pharmacy. Pharmacotherapy. 2008;28(6):816-817. 3. American College of Clinical Pharmacy, Burke JM, Miller WA, et al. Clinical pharmacist competencies. Pharmacotherapy. 2008;28(6):806-815.
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