Master of Medicine in Clinical Pharmacology

This qualification serves as a basis for formal credentialing of medical practitioners as specialists in clinical pharmacologists. The aim of the qualification is to set the standards to ensure that the local and regional needs of this speciality are met. As this is a newly registered qualification it is intended that this qualification can set standards for such a qualification nationally. Clinical pharmacologists should play a role at all levels of the health system. As well as providing specialist knowledge on the use of any drug and monitoring a laboratory service, they can manage rational drug use qualifications and be instrumental in implementing the Essential Drug Qualification at any level. A clinical pharmacologist should be able to conduct community-based research and be central to any health facility's cost containment qualifications and drug utilisation review. There is a particular need for people with thee skills at primary and secondary health care levels.

The resulting learner will have the following core skills

• A strong knowledge of the basic pharmacology of medicines (including pharmacokinetics, pharmacodynamics and principles of drug action, toxicology).
• An ability to apply that knowledge rationally and safely in a clinical context.
• Competency in research methodology, statistics and evaluation of data.
• An understanding of the scientific basis of drug development, which will include regulatory issues.
• Skills in drug utilisation review (from primary care to specialist level).
• To develop leadership skills and the capacity to teach others in these fields.

The learner will have the public interest at heart, and be committed to supporting rational, safe and cost effective drug use by all health care professions.

Entry Requirements

The minimum entry requirement for this qualification is

• Bachelor of Medicine and Bachelor of Surgery, Level 8, 480 Credits.

a)

1. Be able to describe and explain the influence of Pharmacodynamics on treatment outcome.
2. Be able to describe and explain the influence of Pharmacokinetics on treatment outcome.
3. Be able to guide and interpret therapeutic drug monitoring.
4. Be able to communicate how drugs are to be used rationally in the prevention and management of disease.
5. Be able to contribute critically to Medical Audit of self and peers.
6. Be able to contribute critically to Clinical meetings.
7. Be able to describe, explain, and quantify the risks associated with individual drugs and drug combinations.
8. Be able to conduct a critical appraisal of relevant medical literature.
9. Be able to provide effective management of a project.
10. Be able to describe, justify and implement the ethical principles required in the conducting of Research.
11. Be able to design, conduct and report on an ethical, relevant and Clinical trial.
12. Be able to contribute to the promotion of rational drug use.
13. Be able to describe, explain, quantify and prioritise the effects of medicines on individuals, communities and societies (Pharmacy-epidemiology and pharmacoeconomics).

• Be able to describe and explain the influence of receptors, agonists and antagonists, structure - activity relationship, and the dose response curve on the effect of treatment on individual and community health outcomes.
• Be able to critically evaluate the validity and public health implications of pharmacodynamics studies.
• Be able to describe and explain the factors which may influence drug absorption and disposition, metabolism and excretion, and to interpret basic mathematical models which describe these.
• Able to explain inter-individual variability on the basis of the above, including the effects of disease.
• Able to design, implement and report on a pharmacokinetic study.
• Be able to interpret service laboratory results.
• Able to describe the indications and sampling times for therapeutic monitoring to guide clinicians cost effective use of both routine and non-routine therapeutic drug monitoring.
• Be able to effectively communicate current knowledge of therapeutics, drug safety, and toxicology to under learner medical, nursing and pharmacy learners, and to post learners undergoing continuing professional development, in the form of one-to one, small group facilitation and large group presentations.
• Be able to facilitate problem-based, interdisciplinary small group tutorials.
• Be able to participate actively in daily peer review/medical audit meetings (of both the public and private sectors drug utilisation).
• Be able to participate actively in regular clinical meetings (including infectious disease, immune suppressant, medical Intensive Care Unit (ICU) pharmacology ward rounds, and medical social ward rounds).
• Be able to describe and explain mechanisms, detection, management and causality assessment of adverse events.
• Be able to compare the risks and benefits of drugs at an individual and societal level, taking risk factors, drug interactions and co-morbid disease into account.
• Be able to succinctly present strengths and limitations of publications, with particular emphasis on the validity, generalisability and relevance of findings.
• Be able to thoroughly review literature pertinent to research project.
• Be able to develop necessary leadership skills, budgetary, personnel management (and, if required disciplinary procedure) to effectively manage a training or research project.
• Be able to drafting at least one successful submission (addressing ethical requirements of study design and informed and voluntary consent) to the institution's Research and Ethics Committee.
• Be able to critically review at least two proposals submitted to the institution's Ethics and Research Committee.
• Be able to design, conduct, analyse and report on at least one clinical trial as principal investigator. Be familiar with the process by which outcomes and sample sizes are selected, how to reduce bias, and how to interpret regression and correlation, probability and significance analyses.
• Be able to describe and explain the process of development and implementation of prescribing policies, treatment guidelines. Be able to compile and sub-edit sections of the South African Medicines Formulary. Be able to provide technical support to the national essential drugs qualification through critical, evidenced based review of treatment guidelines.
• Be able to understand terminology, principles, methodology and interpretation of drug efficacy and drug safety in populations, drug utilisation reviews, and cost minimisation, cost effectiveness, cost benefit, and cost utility analyses.

Integrated Assessment

Assessment and evaluation

1. Structured and regular peer assessment and review of basic and clinical pharmacological skills. This will be done throughout the qualification by means of in-house presentations.
2. A thesis on the chosen topic presented in the final year of study.
3. External assessor to assess skills and knowledge and evaluate thesis.
4. A monitoring committee, including external consultants, will regularly evaluate the Master of Medicine (qualification).

Thesis/dissertation

• The registrar must be involved in and contribute significantly to at least one of the following areas during the Master of Medicine. This topic will be the basis for a thesis completed in the last year of the qualification. They will be expected to provide teaching on this topic to their peers:
• Drug regulation and policy (Drugs and therapeutics committees, Essential Drugs Qualifications, Medicines Control Council, principles of drug development);
• Pharmaco-epidemiology (theory and research project);
• Pharmaco-economics (theory and research project);
• Improving the rational use of drugs at any level of the health care system;
• Pharmacovigilance and adverse drug event monitoring (including causality assessment);
• Attachment to a decentralised health service (provincial or district hospital, provincial pharmacist hospital).