SAQA

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SOUTH AFRICAN QUALIFICATIONS AUTHORITY

REGISTERED QUALIFICATION:

Master of Medicine in Clinical Pharmacology

SAQA QUAL ID	QUALIFICATION TITLE
111452	Master of Medicine in Clinical Pharmacology
ORIGINATOR
Sefako Makgatho Health Sciences University
PRIMARY OR DELEGATED QUALITY ASSURANCE FUNCTIONARY			NQF SUB-FRAMEWORK
CHE - Council on Higher Education			HEQSF - Higher Education Qualifications Sub-framework
QUALIFICATION TYPE	FIELD		SUBFIELD
Master's Degree	Field 09 - Health Sciences and Social Services		Curative Health
ABET BAND	MINIMUM CREDITS	PRE-2009 NQF LEVEL	NQF LEVEL	QUAL CLASS
Undefined	180	Not Applicable	NQF Level 09	Regular-Provider-ELOAC
REGISTRATION STATUS		SAQA DECISION NUMBER	REGISTRATION START DATE	REGISTRATION END DATE
Registered		EXCO 0733/25	2024-06-30	2027-06-30
LAST DATE FOR ENROLMENT		LAST DATE FOR ACHIEVEMENT
2028-06-30		2031-06-30

In all of the tables in this document, both the pre-2009 NQF Level and the NQF Level is shown. In the text (purpose statements, qualification rules, etc), any references to NQF Levels are to the pre-2009 levels unless specifically stated otherwise.

This qualification does not replace any other qualification and is not replaced by any other qualification.

PURPOSE AND RATIONALE OF THE QUALIFICATION

Purpose:
The primary purpose of Master of Medicine in Clinical Pharmacology qualification is to educate and train qualifying learners who can contribute to the development of knowledge such that they are prepared for specialised professional employment. This professional Master of Medicine in Clinical Pharmacology fulfils the requirements for professional registration or recognition and includes appropriate forms of work-integrated learning.

Successful completion of the professional qualification will enable learners to acquire a high level of theoretical engagement and intellectual independence as well as be able to demonstrate the ability to relate knowledge to the resolution of complex problems in professional practice.

The purpose of the qualification is to produce qualifying learners with specialist training in clinical pharmacology, who may be registered at the level of a specialist with the Health Professions Council of South Africa (HPCSA). The qualification will produce qualifying learners with expertise in research, which includes the ability to evaluate and implement research findings in the clinical pharmacology specialisation and the ability to guide junior candidates if the qualifying learner is in an educational setting, thus increasing a cadre of clinical pharmacologists required in the country. The qualification will provide an essential step in the training of medical qualifying learners in clinical pharmacology and will address an obvious need.

Upon completion of the qualification, the qualification will enable learners to:

Deal with complex issues both systematically and creatively.

Design and critically appraise analytical writing.

Make sound judgements using data and information at their disposal and communicate their conclusions clearly to specialist and non-specialist audiences.

Demonstrate self-direction and originality in tackling and solving problems.

Act autonomously in planning and implementing tasks with a professional orientation.

Continue to advance their knowledge, understanding and skills relevant to a particular profession.

Rationale:
The Master of Medicine in Clinical Pharmacology is a professional four-year qualification pegged at NQF Level 9 aligns with the requirements of the Higher Education Qualifications Sub-Framework (HEQSF) (2013). Clinical pharmacology is a new medical specialty in South Africa.
There are too few specialists in this field and thus there is 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.

There is an urgent need in South Africa for skilled clinical pharmacologists to undertake training and research and offer their services to ensure rational use of drugs. The qualification would therefore cater for both needs for the country as a whole and for Africa in general, since there are a few clinical pharmacologists in Africa. This qualification contributes to the drive to revitalise clinical research in a developing country like South Africa to enhance health care at all levels by providing specialist knowledge and competencies in clinical pharmacology and promoting good policymaking.

The need for Clinical Pharmacologists specialists originates from recent developments in health sciences and healthcare practice. 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 also of critical importance. Patients with special dosing requirements is expanding to 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.

In South Africa, clinical pharmacology is represented by the College of Clinical Pharmacologists (CCP) within the Colleges of Medicine of South Africa (CMSA). The application for the qualification Clinical Pharmacology (Clin Pharm) offered by the College of Clinical Pharmacologists has been approved by the Health Professions Council of South Africa (HPCSA) Postgraduate Education and Training Subcommittee, the Medical and Dental Professions Board and Council. Formal registration of the specialty training in clinical pharmacology by the Department of Pharmacology and Therapeutics was approved by the HPCSA.

LEARNING ASSUMED TO BE IN PLACE AND RECOGNITION OF PRIOR LEARNING

Recognition of Prior Learning (RPL):
The institution has a well-established policy that deals with RPL. Possible exemption, for a maximum period of 2 years (50% of the time), based on comparable training and experience gained at another recognized academic institution could be granted, subject to the following conditions:

The periods of training must have occurred within at most two years before registering for the MMed in Clinical Pharmacology

Sufficient experience must be proven using a logbook, portfolio and certification by the Head of the Department of Clinical Pharmacology where the experience was gained.

The above information must be evaluated by the Head of the Department of Clinical Pharmacology of the institution and approved as equivalent. With the consent of the Head of the Department and the Executive Committee (MEDEX) of the School of Medicine.

Entry Requirements:
The minimum entry requirement for this qualification is:

Bachelor of Medicine and Surgery, NQF Level 8.

Be registered with the Health Professions Council of South Africa as a medical practitioner with paid-up annual fees.

Be appointed to a Registrar's post recognised by the HPCSA. This post must be occupied for the full duration of registration as required under these rules.

RECOGNISE PREVIOUS LEARNING?

QUALIFICATION RULES

This qualification consists of the following compulsory modules at National Qualifications Framework Level 9 totalling 720. Credits.

Compulsory Modules, 720 Credits:

Principles of Clinical Pharmacology, 180 Credits.

Applied Clinical Pharmacology, 360 Credits.

Mini Dissertation: Clinical Pharmacology, 180 Credits.

EXIT LEVEL OUTCOMES

1. Implement the drug policy.
2. Manage individual patients and health of communities/special risk populations.
3. Acquire new medicines information and critically evaluate its quality and utility.
4. Function as an effective team member in the broader context of health care.
5. Play an active role in training other health care workers.
6. Engage in research.

ASSOCIATED ASSESSMENT CRITERIA

Associated Assessment Criteria for Exit Level Outcome 1:

Apply rational drug selection principles for formulary and standard treatment guidelines development 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, pharmaco-economics and pharmaco-epidemiology.

Provide guidance regarding key regulatory legislation (e.g. for drug regulation, dispensing, unregistered medicines and clinical trials).

Advise or assist other professionals where necessary on drug policy.

Associated assessment criteria for Exit Level Outcome 2:

Select appropriate, safe, effective, and cost-effective therapeutic regimens for patients presenting at different levels of healthcare.

Apply the principles and practice of prescribing in special risk groups of patients, e.g. children, elderly, obesity, malnutrition, pregnancy, lactation, renal failure, hepatic failure and porphyria.

Diagnose and manage of cases of suspected poisoning and overdose.

Detect and manage of drug interactions.

Use appropriate therapeutic drug monitoring.

Manage, report and evaluate appropriate adverse events/adverse drug reactions and failed therapy.

Participate in treatment selection for individual patients as a member of multidisciplinary team.

Provide guidance on medico-legal aspects of drug use, substance abuse and prescriptions.

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, clinical relevance locally and utility of medicines information.

Associated assessment criteria for Exit Level Outcome 4:

Treat all healthcare workers (including traditional, alternative and complementary practitioners) 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 as needed.

Maintain high ethical and professional standards.

Associated assessment criteria for Exit Level Outcome 5:

Regularly participate in academic undergraduate and Postgraduate 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 of drug therapy this may include preclinical research, as clinical pharmacology is a bridging discipline between basic and clinical sciences.

Integrated Assessment:
To ensure that all the qualification's Exit Level Outcomes are met, an integrated assessment approach is used throughout the training which includes continuous assessment and a comprehensive final examination by internal and external specialist clinicians.

The composition of logbooks, portfolios, and summative assessments in the form of written papers, oral examinations, and clinical assessments are included. Assessments ensure integration of all learning requirements to ensure that learners exit with specialised knowledge in the field of Clinical Pharmacology.

The research component forms an integral part of the qualification in that a problem within the research focus of the division is studied in more detail. Learners will produce a mini-dissertation and a publishable article for assessment by internal and external examiners as per the institution assessment policy.

The Colleges of Medicine of South Africa (CMSA) examination will constitute the summative assessment. The learners will have to do part I of the examination within 15 months to 2 years and complete Part II at 3 to 4 years as a registered learner for the Master of Medicine (MMed) in Clinical Pharmacology.

This Professional Master's Degree qualification focuses on practising clinical work and research. It has a structured learning, and assessment programme which consists of regular formative evaluation throughout the training period with the use of a Portfolio of Learning as required by the College of Clinical Pharmacology of South Africa. The facilitation of the qualification is carried out in a work-integrated learning approach, as well as scheduled academic activities such as journal presentation, topical discussions and seminars as well as clinic-pathologic discussions often held with other clinical departments. Learners will receive their professional training whilst performing these services albeit under the supervision of senior academic staff. Learners will attend clinics in all Divisions of the institution to learn to diagnose and manage clinical problems and to provide clinical pharmacology advice on drug treatment.

INTERNATIONAL COMPARABILITY

The speciality Clinical Pharmacology was recently approved in South Africa (SA), the first country in Africa to do so (Government Gazette No. 35612, 22 August 2012). This milestone occurred concurrently with the World Health Organisation (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' (S Afr Med J 2013; 103(3):150-15). Similar qualification exists in Europe, United Kingdom (UK) and United States of America (USA).

In the UK, Clinical pharmacologists make a vital contribution to the health of patients and the wealth of the NHS, providing unparalleled generalist and specialist expertise across the breadth of its services.

Significant progress has been made in improving the UK's academic expertise in clinical pharmacology through the Medical Research Council's and the Welcome Trust's initiatives, and in improving prescribing practice through the British Pharmacological Society's collaborative project with MSC Assessment: The Prescribing Safety Assessment.

CPT is the only medical specialty focusing on the safe, effective, and economic use of medicines. It is a diverse and wide-ranging discipline that plays an essential role across multiple areas of the NHS, contributing to its organisational objectives and, most importantly, improving patient outcomes and experiences.

Clinical pharmacologists make a particularly valuable contribution to the NHS in areas including:

Providing specialist and generalist patient care in hospitals (including paediatrics) and other settings, using their expertise in the use of medicines to improve outcomes and prevent avoidable harm.

Leading clinical toxicology services and the National Poisons Information Service.

Advising on all aspects of medicines policy and management including regulation, health economic assessments, prescribing guidance, and formulary management in order to optimise the clinical and cost-effective use of medicines - for every �1 of investment, clinical pharmacology has delivered savings of �10 to the NHS.

Providing education and training for undergraduates and postgraduates to ensure doctors have the appropriate skills to prescribe safely and effectively.

Working with industry and supporting the UK's life sciences sector to enhance the development of innovative new medicines and improve the use of current medicines.

Bringing innovation to the NHS through experimental medicine by designing early phase clinical trials, establishing NHS clinical research facilities, and providing overarching clinical support.

ARTICULATION OPTIONS

This qualification allows possibilities for both horizontal and vertical articulation.

Horizontal Articulation:

Master of Clinical Pharmacy, NQF Level 9.

Vertical Articulation:

Doctor of Philosophy (PhD) qualification, NQF Level 10.

Diagonal Articulation:
There is no diagonal articulation for this qualification.

MODERATION OPTIONS

N/A

CRITERIA FOR THE REGISTRATION OF ASSESSORS

N/A

NOTES

N/A

LEARNING PROGRAMMES RECORDED AGAINST THIS QUALIFICATION:

NONE

PROVIDERS CURRENTLY ACCREDITED TO OFFER THIS QUALIFICATION:

This information shows the current accreditations (i.e. those not past their accreditation end dates), and is the most complete record available to SAQA as of today. Some Primary or Delegated Quality Assurance Functionaries have a lag in their recording systems for provider accreditation, in turn leading to a lag in notifying SAQA of all the providers that they have accredited to offer qualifications and unit standards, as well as any extensions to accreditation end dates. The relevant Primary or Delegated Quality Assurance Functionary should be notified if a record appears to be missing from here.

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