Master of Medicine in Clinical Pharmacology

Purpose

This qualification aims to develop General Practitioners to become medical specialists in Clinical Pharmacology. These specialists will possess specialised knowledge and competence to contribute to the science and practice of Clinical Pharmacology. Graduates of the Master of Medicine (MMed) (Clinical Pharmacology) will be able to register with the College of Medicine (CMSA) of the Health Professions Council of South Africa (HPCSA) as specialist in Clinical Pharmacology. The programme intends to deliver graduates that will demonstrate a systematic understanding of in-depth knowledge, and a critical awareness of current problems and new insights at the forefront of Clinical Pharmacology and research and its related area of professional practice.

On completion of this programme, graduates will be able to

• Fulfil the role of a specialist Clinical Pharmacologist in the medical and academic communities, and in society at large.
• Register and practise as specialist Clinical Pharmacologists in terms of the Medical, Dental and Supplementary Health Services Act.

Rationale

Although Clinical Pharmacology is a well-known speciality world-wide, existing for more than 50 years in countries such as in Europe and United States of America (USA), but also practiced in South Africa for over 30 years, it was only recently that it was approved as a recognised clinical speciality in South Africa which makes South Africa the first African country to approve Clinical Pharmacology as speciality. This milestone occurred concurrently with the World Health Organization (WHO)'s publication of a position paper entitled 'Clinical Pharmacology in health care, teaching and research', which explains the benefits of Clinical Pharmacologists to decision-makers. Clinical Pharmacologists are medical practitioners trained in 'the scientific discipline that involves all aspects of the relationship between drugs and humans'.

The need for Clinical Pharmacologists worldwide springs from several factors which also apply to South Africa. There has been an enormous increase in the number of therapeutic products and formulations. Unfortunately, this expanding therapeutic armamentarium has been associated with an increased incidence of adverse drug reactions, drug interactions, drug resistance, drug overdose and medical errors. Because the increasing cost of new drugs is a major concern, insight into pharmaco-economic evaluation of new interventions is of critical importance. The population of patients with special dosing requirements is expanding-to mention but a few: it includes those at the extremes of age, with co-morbid conditions, and those who are pregnant. There have been calls for increased clinical research in South Africa that is largely focused on the robust evaluation of therapeutic interventions, and addressing health needs of the local population. Therefore, there is an urgent need for skilled Clinical Pharmacologists to undertake the training and research and offer their services to ensure rational use of drugs in humans.

Currently, the Health Professions Council of South Africa (HPCSA) accepts both the Master of Medicine (MMed) (Clinical Pharmacology) and the FCClin. Pharm qualifications for specialist registration. Currently, the universities offering the MMed training Degree in Clinical Pharmacology are the University of Cape Town (UCT), SUN and Sefako Makgatho Health Sciences University (SMU). The training involves student interaction and/or rotation in several specialities or disciplines, all of which are available at the university health training facilities in the Free State. In our case, the Academic Health Complex in Bloemfontein, which comprises of Universitas, Pelonomi and National Hospitals, is providing health care services from primary to tertiary level. As such, a well-organised working relationship and collaboration between the University of Free State (UFS), Academic Complex in Bloemfontein, and Kimberley Hospital Complex can provide an excellent training environment for registrars in Clinical Pharmacology.

There are too few specialists in this field and an increasing interest of medical doctors to specialise in this field. There is a growing demand in academia, the public sector, the private sector, drug regulatory agencies and industry for suitably trained scientists who are skilled in Clinical Pharmacology. The MMed (Clinical Pharmacology) would therefore cater for both needs for the country as a whole and also for Africa in general, since Clinical Pharmacologists in Africa are few in number.

This qualification will provide an essential step in the training of medical graduates in Clinical Pharmacology and will address an obvious need. The target group will include suitably qualified Bachelor of Medicine and Bachelor of Surgery (MB,ChB), or equivalent, graduates and will also appeal to students from African countries. The programme will address the needs of a variety of stakeholders, including the national and provincial Departments of Health (especially those involved in teaching and training activities). Given the critical shortage of Clinical Pharmacologists nationally, the health services of the country will eventually benefit from the programme.

Recognition of Prior Learning (RPL)

Strict admission requirements will be applied in this programme and therefore no RPL for access will be allowed. However, exemption from components or modules, fully or partially, on the basis of comparable training and experience gained at another institution could be granted by the University of the Free State (UFS); according to its Credit Accumulation and Transfer (CAT) and RPL policy. The maximum admissible period of exemption is 12 months. RPL will be applied according to the policy of the UFS and will be done in consultation with the particular Head of Department Pharmacology, the Head of the School of Medicine and appropriate structures within the Faculty of Health Sciences.

Entry Requirements

The minimum requirements for admission into this Master's Degree are

• Bachelor of Medicine and Bachelor of Surgery (MB,ChB) Degree at Level 8, or an equivalent qualification.
• The student must be fully registered as a medical practitioner with the Health Professions Council of South Africa (HPCSA) for independent practice in terms of the Health Professional Act, Act 56 of 1974.
• Students should have at least 2 years of related medical experience.

This qualification comprises compulsory modules at Level 9 totalling 480 Credits

• Basic Science of Clinical Pharmacology, 124 Credits.
• Applied Clinical Pharmacology, 280 Credits.
• Research Project in Clinical Pharmacology, 64 Credits.
• Research Methodology, 12 Credits.

1. Advise on the management of patients.
2. Advise on drug policy.
3. Acquire new medicines' information and critically evaluate its quality and utility.
4. Function as an effective team member in the broad context of health care.
5. Play an active role in training other health care workers.
6. Engage in research.

Associated Assessment Criteria for Exit Level Outcome 1

• Select appropriate, safe, effective, and cost-effective therapeutic regimens for different levels of care.
• Apply principles and practice of prescribing in special risk groups of patients, children, elderly, pregnancy, lactation, renal failure, hepatic failure and porphyria
• Assist with the diagnosis and management of cases of suspected poisoning and overdose
• Detect and manage of drug interactions
• Use appropriate of therapeutic drug monitoring
• Appropriately manage, report, and evaluate on adverse drug reactions
• Participate in treatment selection for individual patients as a member of multidisciplinary team
• Advise on medico-legal aspects of drug use, drug abuse and prescriptions

Associated Assessment Criteria for Exit Level Outcome 2

• Assist with rational principles of formulary development and standard treatment guidelines for different levels of care.
• Critically evaluate the risks and benefits of all drugs, particularly new drugs and new information on available drugs, by applying the principles of evidence-based medicine and pharmaco-epidemiology.
• Provide guidance regarding key regulatory legislation (e.g. for drug regulation, dispensing, unregistered medicines and clinical trials).
• Apply basic principles of pharmaco-economics to drug selection, and the development of treatment guidelines and formularies.

Associated Assessment Criteria for Exit Level Outcome 3

• Access information using electronic and traditional methods.
• Engage in continuing professional development activities.
• Critically appraise the quality, relevance and utility of medicines information.

Associated Assessment Criteria for Exit Level Outcome 4

• Treat all health care workers with respect.
• Recognise the roles other health care workers play and consult appropriately.
• Effectively communicate with health care workers in verbal and written format.
• Provide leadership when called upon to do so.
• Maintain high ethical standards.

Associated Assessment Criteria for Exit Level Outcome 5

• Regularly participate in academic undergraduate teaching activities and continuing professional development programmes.
• Regularly participate in academic meetings.
• Communicate health-related information effectively to colleagues.

Associated Assessment Criteria for Exit Level Outcome 6

• Design, conduct, analyse and report on studies involving all aspects of drug therapy that includes pre-clinical research.

Integrated Assessment

Assessment is strictly followed according to the regulations as stipulated by The Colleges of Medicine of South Africa (CMSA) and the University of the Free State (UFS) assessment policy and will consist of:

Part I examination within 15 months of enrolment-consists of

• 2 written papers of 3 hours each (50% pass).
• 3 monthly evaluation of progress.
• 3 monthly self-evaluation of progress.
• Portfolio.

Part II examination after completion of 3 years full-time post-internship training as a registrar/clinical assistant in either of the following combinations: (a) All 3 years in a teaching hospital department of pharmacology or 2 years in a teaching hospital department of Pharmacology plus one year as a registrar in a satellite clinical teaching department (25% of clinical pharmacology training must be in clinical care) (exceptions for part-time training are provided in the CMSA regulations). The examination consists of:

• Written: Two written papers on the principles and practice of clinical pharmacology and therapeutics (3 hours each).
• Objective Structured Clinical Examination: This includes clinical slides, interpretation of laboratory results, and short case-histories
• Oral examination: Candidates will be assessed on their ability to apply the principles of Clinical Pharmacology and therapeutics to complex clinical and policy-making scenarios.

In order to pass the examination, candidates must obtain

• 50% or more for Part I of the examination (2 written papers).
• 50% or more for each component of Part II of the examination.
• 50% or more for the combined mark from the two written papers.
• 50% or more for the OSCE.
• 50% or more for the oral examination in Part II of the examination.

The three components of Part II of the examination will be weighted as follows

• Two written papers will contribute 50% to the final mark (25% for each paper).
• The OSCE will contribute 20% to the final mark.
• Oral examination will contribute 30% to the final mark.

Furthermore, the candidates will be assessed by

• 3 monthly evaluation of progress.
• 3 monthly self-evaluation of progress.
• Portfolio.

Research Methodology module

• Written examination testing core competencies on completion of the theoretical module.

Assessment of research project

• Initial research protocol must be presented to and approved of by the Head of Department, and Research Committees as well as the relevant Faculty Committee.
• The progress will be monitored by the supervisor(s) of that specific project.
• The completed research project will be assessed according to university guidelines with internal and external assessment as prescribed.
• The student will give an oral presentation on completion of the research project.
• The research mini-dissertation must be completed before part II of the CMSA examination.