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Pharmacovigilance (PV) in Zambia

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Pharmacovigilance (PV) in Zambia

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  1. Pharmacovigilance (PV) in Zambia Pretoria –September 2004 Presented by Dr Albert Mwango Mrs Bernice Mwale

  2. Background • Zambia has a population of 10.9 million (2004) • 1 (One) million Zambians are HIV positive (2003) • 44,942 Reported AIDS cases (2001) • 140,000 require ARVs (2003) • 12,000 are on ARVs both in the public and private sector (August 2004)

  3. Stavudine Zidovudine Didanosine Lamivudine Abacavir Fifty (50) different ARV preparations are registered for use in Zambia Efavirenz Nevirapine Indinavir FDCs Syrups, tablets & capsules No injectables Antiretroviral Drugs in Use in Public Health Facilities

  4. Treatment guidelines • Treatment Guidelines as outlined by WHO for low resource settings • Recommended First Line Agents (public health facilities) • Stavudine or Zidovudine + Lamivudine + Nevirapine or Efavirenz • Second Line Agents • Eg. Didanosine + Abacavir + Indinavir (Comprehensive guidelines can be made available)

  5. Current situation of Pharmacovigilance in Zambia (1) • Pharmaceutical regulatory authority (P&PB) Legislation • Medicines regulation • Product registration • Pharmaceutical inspections • Post marketing surveillance capability inadequate

  6. Current situation of Pharmacovigilance in Zambia (2) • No drug information service for public and private sector • Few functional Drugs & Therapeutic Committees (in hospitals)

  7. Current situation of Pharmacovigilance in Zambia (3) • ADR reporting for anti-malarials is pathfinder for PV for all drugs in Zambia • System to pick up on • ADRs • quality problems • Treatment failures • Counterfeit products • Product presentation problems

  8. PV System Progress Made • ADR forms, protocols and systems developed • ADR reporting orientation in 28 (areas of Coartem use) out of 72 districts in Zambia • Creating awareness for reporting ADRs for all drugs

  9. Future Plans • Learn from WHO course • Stimulate culture of reporting and continue training of Health professionals in PV • Ultimately incorporate into national health information system • All drugs (ARVs, Anti-TB, etc)

  10. THE END Thank you and Greetings from Zambia