Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Close this folderAccess to drugs and vaccines II
View the documentTwenty-five years of essential medicines: progress and agenda for regulators
View the documentEssential drugs list: South African experience
View the documentThe role of government and essential drugs - Indonesian experience
View the documentThailand’s experience in access to medicines
View the documentCurrent vaccine shortages in the United States of America
View the documentExpanding access to essential medicines and vaccines: lessons learnt in Brazil
View the documentRecommendations
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover

Essential drugs list: South African experience

Ms Malebona Precious Matsoso, South Africa

South Africa did not have a national drug policy prior to 1994. Following the introduction of the new democratic process, a drug policy was developed and used as a basis for the national health policy. South Africa has now integrated a number of services that were fragmented, has embarked on a special drug programme with the assistance of WHO, and has amended legislation in order to improve drug accessibility.

Before 1994, the procurement list for the public sector had about 2600 items, and involved a lot of duplication. Therefore, an essential drugs programme is being developed to:

• ensure the availability and accessibility of essential medicines to all citizens;
• guarantee the safety, efficacy and quality of all medicines;
• encourage good prescribing and dispensing practices; and
• promote the rational use of medicines by health professionals and patients.

The working principles underlying the essential drugs list are to:

• identify the most common health problems, their severity and prevalence;

• develop treatment guidelines, based on best available clinical evidence, clinical experience and best practice models;

• ensure quality, efficacy and safety of medicines;

• promote the use of generic names;

• ensure applicability by amending legislative provisions;

• promote the use of single pharmaceutical agents; and

• carry out regular updates.

We have encountered some difficulties in the consultation process, especially from specialists in cardiology and psychiatry. However, we have had good cooperation with the nursing profession, medical practitioners, and also family medicine practitioners. In addition, we have held several workshops with a number of stakeholders to promote the concept. Draft guidelines and essential drugs list were disseminated to 250 institutions for comment and eventually specific inputs from 57 specialists and consultants were received.

The development of the essential drugs programme has reduced the number of items on the procurement list from 2600 to about 1000.

This significant reduction applies just to the public sector. The private sector has developed its own formularies. The medical practice groups, managed care organizations and private health insurers have embarked on formulary development.

There have been a number of impact studies in South Africa. Baseline studies were conducted in nine provinces using 13 indicators adapted from WHO. The results showed that 84.6% of key medicines were available in most of the clinics. However, this still needs to be improved, and similar studies should be done at hospital level.

Access to antiretroviral drugs remains a major challenge in South Africa. There is an urgent need for the standardization of clinical guidelines, development of decision-trees on safety, and fast-track training of clinicians. Also, an infrastructure for monitoring resistance should be set up and massive resources should be redirected.

In conclusion, there are several interventions that could further improve the selection and quality of drugs. First, for the selection of drugs, the essential drugs list should be regularly updated, and provincial therapeutics committees should be established or strengthened. Updated and locally relevant information on efficacy and safety of antiretroviral drugs should be disseminated. For the quality of drugs, results of quality control tests should be used as the basis of prequalification of suppliers in adjudicating tenders. Law enforcement, particularly within the developing country context, should be strengthened in order to combat counterfeit drugs.

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