Master of Medicine in Clinical Pharmacology

Purpose

The important role of Clinical Pharmacology in appropriate patient care, drug policy, drug development and regulatory affairs has been recognised internationally. The proposed 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 (MBChB) graduates and will also appeal to students from other African countries.

The primary goal of the qualification is to improve patient care, directly or indirectly, by developing better medicines and promoting the safer and more effective usage of drugs. The qualification will focus on ensuring that students acquire knowledge about medications used for particular illnesses, their side effects, how they work and which patients should or should not have them prescribed. The focus will also help to produce healthcare professionals equipped with knowledge, skills and attitudes to achieve affordable, accessible and optimal health for all African communities.

Formal registration of the specialty training in Clinical Pharmacology by the Division of Pharmacology (Stellenbosch University) is pending with the Health Professions Council of South Africa (HPCSA).

In summary, the qualification will provide an essential step in the training of medical specialists in Clinical Pharmacology and address an obvious need following the formal recognition of this medical specialty in South Africa.

Rationale

The introduction of Clinical Pharmacology ushers in a new medical specialty. There are too few specialists in this field and an increasing interest of medical doctors to specialise in this field is observed. 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 Master of Medicine in Clinical Pharmacology would therefore cater for both the needs for the country as a whole and also for Africa in general, since there is a limited number of Clinical Pharmacologists in all of Africa.

The qualification 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 qualification. Clinics need to be attended by the students in all Divisions of the Department of Medicine to learn to diagnose and manage clinical problems and to provide clinical pharmacology advice on drug treatment.

The Master of Medicine: Clinical Pharmacology offers focused training which integrates basic and clinical sciences, and equips students with the essential skills required to function effectively as Clinical Pharmacologists. Students will acquire core skills, enabling an appreciation of how to apply Clinical Pharmacological, regulatory and ethical principles to the optimisation of therapeutic practice and clinical research.

Students are expected to be able to read and critically evaluate academic texts in English and communicate information and their own ideas orally and in written texts that are grammatically correct, well structured, clear and concise, using accepted standards of medical science and academic writing at NQF Level 8.

Recognition of Prior Learning

The University of Stellenbosch has a Recognition of Prior Learning policy in place. Due to the nature of the qualification, the admission criteria for the Master of Medicine in Clinical Pharmacology programme comprise a Bachelor of Medicine and Bachelor of Surgery (MBChB) or equivalent degree. Other students will therefore not be admitted into this qualification.

The qualification will conform to the University criteria for Assessment and Recognition of Prior Learning (ARPL). Because of the low number of students entering this qualification, the criteria can be applied on an individual basis to acknowledge prior learning.

Access to the Qualification

The standard admission criteria for a Master of Medicine Degree at the University of Stellenbosch apply. To be considered students should have:

• A Professional Medical Degree (MBChB) at NQF Level 8.
• Registration with the HPCSA as Medical Practitioner.
• At least 2 years of medical experience.

The Master of Medicine: Clinical Pharmacology consists of four compulsory modules at NQF Level 9 that total 480 Credits.

Modules

• Principles of Clinical Pharmacology, 80 Credits.
• Applied Clinical Pharmacology, 270 Credits.
• Research Assignment in Clinical Pharmacology, 120 Credits.
• Research Methodology, 10 Credits.

1. Apply theoretical knowledge, practical ability and interpersonal skills as a specialist in clinical pharmacology.
2. Function as an ethical, effective team member in the broad context of health care.
3. Demonstrate thorough and systematic knowledge of the safety and efficacy of drugs and their clinical use.
4. Evaluate and practically apply new knowledge, understanding and skills to the field of clinical pharmacology in South Africa.
5. Demonstrate broad knowledge of current state-of-the-art developments in medicine in general.
6. Conduct a research project in the field of Clinical Pharmacology.
7. Provide advice to health care providers (physicians, drug and therapeutics committees and others), regarding the appropriate and cost-effective use of drugs.
8. Apply an ethical, mature and responsible approach as an independent medical practitioner.

Critical Cross-Field Outcomes

This qualification addresses all the Critical Cross-Field Outcomes.

Associated Assessment Criteria for Exit Level Outcome 1

• Make responsible and independent decisions through application of basic and advanced scientific methods.
• Identify complex problems and solve problems through critical and innovative thinking.
• Engage in continuing professional development activities.
• Develop a capacity for self-reflection and critical appraisal.

Associated Assessment Criteria for Exit Level Outcome 2

• Work as part of a team and add value to the larger group, not only through collaboration but also by cooperation and self-initiated actions.
• Respect the rights and values of others and treat everyone with dignity.
• Maintain integrity and honesty in professional practice.

Associated Assessment Criteria for Exit Level Outcome 3

• Select appropriate, safe, effective, and cost-effective therapeutic regimens for different levels of care.
• Assess new drugs and new information on existing drugs.
• Practice prescribing in special risk groups of patients such as children, the elderly, pregnant women, lactating mothers, and conditions such as renal failure, hepatic failure and porphyria.

Associated Assessment Criteria for Exit Level Outcome 4

• Detail the Medico-Legal aspects of medicines in South Africa.
• Produce an overview of the South African public health system.
• Explain the epidemiology of common diseases in South Africa.

Associated Assessment Criteria for Exit Level Outcome 5

• Explain the pre-clinical and early clinical phases of drug development.
• Provide guidance regarding key regulatory legislation, including that for drug regulation, dispensing, unregistered medicines and clinical trials.
• Manage, report, and evaluate adverse drug reactions.
• Participate in treatment selection for individual patients as a member of the multidisciplinary healthcare team.
• Apply the basic principles of pharmaco-economics to drug selection and the development of treatment guidelines and formularies.

Associated Assessment Criteria for Exit Level Outcome 6

• Design, conduct, analyse and report on studies involving all aspects of drug therapy.
• Compile a literature review and critically appraise publications in a given therapeutic area.
• Decide on the most appropriate methodologies to address the research question(s).
• Draw logical, evidence-based conclusions from analysed data.
• Present and defend the outcomes of the research project in an acceptable, scientific format.

Associated Assessment Criteria for Exit Level Outcome 7

• Explain the importance of the variability of drug response (pharmacogenetics and pharmacogenomics).
• Explain principles and managing, (and, where possible, preventing common causes of poisoning and overdose.
• Assist with the diagnosis and management of cases of suspected poisoning and overdose.
• Detect and manage drug interactions.

Associated Assessment Criteria for Exit Level Outcome 8

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

Integrated Assessment

All internal and external assessment and moderation takes place in accordance with the institutional policy document. Internal assessment will be conducted in line with the University of Stellenbosch policy on assessment practices. An external examiner who has been approved for this purpose by the Senate of the Stellenbosch University will perform the final written and practical moderation and assessment. Programme coordinators are responsible to ensure that assessment practices are explicit, valid and reliable and in line with the quality assurance policy of learning and teaching programmes.