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Essential medicines

Gavin Steel – National Department of Health. Essential medicines. Policy - Section 27 of the Constitution. (1) Everyone has the right to have access to – (a) health care services, including reproductive health care;

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Essential medicines

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  1. Gavin Steel – National Department of Health Essential medicines

  2. Policy - Section 27 of the Constitution (1) Everyone has the right to have access to – (a) health care services, including reproductive health care; (2) The state must take reasonable legislative and other measures, within its available resources, to achieve the progressive realisation of each of these rights. (3) No one may be refused emergency medical treatment.” Presenter logo to come here

  3. Policy – National drug Policy (1) • The goal of the National Drug Policy is to ensure an adequate and reliable supply of • safe, • cost-effective drugs • of acceptable quality • to all citizens of South Africa and the rational use of drugs by prescribers, dispensers and consumers.

  4. Policy – National drug Policy (2) Chapter 5. Drug selection • The selection of drugs on the National Essential Drugs List will be based on the following criteria:  • must meet the health needs of the majority of the population • sufficient proven scientific data must be available regarding the effectiveness of any such product • products should have a substantial safety and risk benefit ratio

  5. Essential Medicines List • Divided into 3 categories: • Primary Heath care • Hospital care • Adult • Paediatrics • Tertiary and quaternary care • Primary and hospital care are Standard Treatment Guideline (STG) based and tertiary is a pure formulary system.

  6. Essential Medicines List (2) Current status Note the list is: • Generic (INN) based. • Does not specify formulations and the pack size. • Makes use of 64 therapeutic classes

  7. Essential Medicines List (3)

  8. Selection of Essential Medicines • Quality • Registered medicines. • Safety • Clinical trial data • Pharmacovigilance data • Effectiveness {not efficacy} • Evidence based medicine approach • Cost • Market analysis • Pharmacoeconomics

  9. Process • Three year review cycle • Call up notice for comments. • Expert committee reviews STGs: • Chapters sent for comment. • Peer review of evidence based submissions. • Publication: • STG Book and cell phone application. • Formulary • Medicines review

  10. Process (2) • Peer review is a critical component: • Technical subcommittees • National Essential Medicines List Committee • National Department of Health Programmes. • Universities. • Provincial PTCs. • Clinical societies. • Medical schemes.

  11. Process (3) • Medicines • Identified as an integral component of the STG • Technical medicine report • Background, quality of the evidence, effectiveness, safety. • Once effectiveness and safety have been established cost is considered. • Pharmacoeconomic review • Market intelligence to establish input costs. • Generic preferred due to competition • Modelling as required. • Evidence and costs and reviewed from a practice perspective and recommendation is made.

  12. Process (4) • Value of an evidenced based medicine approach • Transparency • Contributes toward the management of conflict of interest • Decisions based on a holistic perspective of the evidence as opposed to the most recent trial • Conflict resolution • Increased “buy in” on the ground. • Promotes effectiveness as opposed to efficacy based decisions • Remember Decision = Evidence + values • Reviews can therefore be translated into formularies at the Provincial or Medical Scheme level.

  13. Medical Schemes and the EML • Provision has been made for inclusion of medical scheme experts on the technical sub committees. • Medical schemes included in peer review. • EML serves as the basis for formularies with schemes. • Training at medical schools is EML based so the medicines are know to all professionals. • NHI contracted Prescribers will be able to integrate between systems.

  14. Coalition of Leadership • Pharmaceutical industry’s marketing machinery is based on Key opinion Leaders (KoLs). • Discordance between the public and private sector leads to disorder and we end up at the mercy of the clam pharmaceutical marketing machinery. • Participation in the EML is a logical coalition of leadership.

  15. Important Medicines Policy Directions for medical Schemes. • Recent government gazette on market inducements by the pharmaceutical industry. • This neutralises the competitive advantage. • CCMDD – Central Chronic Medicines Dispensing and Distribution program. • Supply chain reforms. • Direct deliveries. • Cross docking. • Track and trace.

  16. THANK YOU

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