OVERVIEW OF THE ZIMBABWE NATIONAL MEDICINES POLICY Dr C E Ndhlovu, M Med Sci, FRCP Chairperson, NMTPAC Deputy Dean, UZCHS National workshop, Jan 22-23, 2014 Outline of presentation • Discuss the specific objectives of the ZNMP • Discuss achievements and highlight challenges 1. Availability • Aim to have 100% availability of the V items • At primary care level throughout the nation • VEN classification to prioritize procurement of medicines • CBAS classification • Level of use of medicines • C medicines - primary health care (clinic) level and should be available at all levels of care. • B medicines - district hospital level or secondary and higher levels of care. • A medicines are prescribed at provincial or central hospital levels. • S medicines -specialist only medicines can be used by specialist physicians only in settings adequate diagnostic and laboratory monitoring facilities. 2. Legislation and Regulation of Medicines and Medical Supplies • Through MCAZ, DPS, NMTPAC & relevant stakeholders • Use of registered or authorized medicines only • “SAFEQUAR” • Regular reviews and updates of policies/guidelines • TRIPS compliance(2003) • Parallel importation allowed • Compulsory licensing to promote local production • “Bolar provisions” in place 3. Medicine Selection • Adoption of the “essential medicines concept” • Adoption of primary health approach since 1980 • Use of standard treatment guidelines • PEDLIZ (1980) • Now at EDLIZ (6th edition/2011) • ART guidelines Principles of the Essential Medicines Concept • Majority of health problems • treated with a small number of medicines • Health professionals in practice use few medicines • fewer medicines can be used more rationally • Procurement & distribution • more efficient with fewer medicines • Patients can be better informed when fewer medicines are used 4. Generic Medicines • Register, procure, prescribe and dispense “generics” • Promote local production of generic medicines 5. Assuring quality , safety and efficacy of medicines • Mainly MCAZ functions: • Medicines must be “registered” or “authorized” • Review and maintain the register • E.g. remove “unsafe” medicines • Monitor adverse medicines events via Pharmacovigilance and Clinical Trials(PVCT) Committee 6. Production of Medicines within Zimbabwe • Promote production of essential medicines • Promote production of cost-effective medicines • Using current Good Manufacturing Practice(GMP) 7. Information, Advertising and Promotion • Provide accurate, unbiased, evidence based medicine information • For healthcare workers and the general public • Watch out for “unethical” medicine promotion 8. Rational use of medicines • Promotion of rational or appropriate prescribing, dispensing and use of medicines • For both public and private sectors • Promote training in RUM at pre-service and in-service levels • Monitor RUM through data collection/ regular surveys 9. Medicines Supply- procurement, distribution and storage • Medicine Management cycle What is NatPharm’s role? “ the government will support the status and viability of the procurement agency and will provide sufficient financial basis for its operations” 10. Other Objectives • 10. Economic Strategies • 11. Organization, management and coordination of the ZNMP • 12. Development of Human Resources • 13. Operational and Technical research • 14. The National Medicine and Therapeutics Policy Advisory Committee (NMTPAC) • Setting up of HMTC • 15. National, Regional and International Collaboration Final objective • 16. Trade and Public Health • Need to balance IPR and the public health good • to ensure/enhance access to essential medicines • for public health purposes • Allow parallel importation • Compulsory licensing • Allow exploitation of the “Bolar provisions” Has Zimbabwe addressed equity? • Equity issues arise at least 3 levels • international level • Zim became TRIPS compliant in 2003: • compulsory licensing through the Ministry of Health • parallel importation of patented products • Bolar provisions • national level • registration of all medicines insisting on generic labelling of medicines • adoption of essential medicines concept • training in AMU at pre-graduate and post-graduate levels • and community level?? • Use of medicines appropriately ConclusionsNice to look at ! But how useful are they to us?
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