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Pharmacovigilance

Pharmacovigilance. What? (2.6) Ensure ADR monitoring (Spontaneous reporting/Cohort studies) Who? Healthcare workers How? WHO International Drug Monitoring Programme Partners: WHO, WHO CC, Countries NPC (79) Here: Ghana, South Africa, Tanzania, Zambia Others: HQ and Country offices

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Pharmacovigilance

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  1. Pharmacovigilance • What? (2.6) Ensure ADR monitoring (Spontaneous reporting/Cohort studies) • Who? Healthcare workers • How? WHO International Drug Monitoring Programme Partners: WHO, WHO CC, Countries NPC (79) • Here: Ghana, South Africa, Tanzania, Zambia • Others: HQ and Country offices • Beyond PSM: An entry point for pharmacovigilance (Access to Global ADR Data of 3.5 million reports, causality experts, forecasting resistance, treatment guidelines)

  2. PharmacovigilanceDr Shanthi Pal, Quality Assurance and Safety of Medicines, WHO To undergo treatment you have to be very healthy, because apart from your sickness you have to withstand the medicine. Molière

  3. Public Health Programmes • What? • How? • Benefit risk assessment? • ADR reporting, PV?

  4. PV in PHP: Why? 5 Ds (Diagnosis, diseases, drug, diet, DRA) It is not always the product that determines drug safety but how it is used

  5. Eroding confidence in the malaria programme

  6. Italian Cohort Main reasons of discontinuation of first HAART regimen within 1st year: ICONA I C O N A Naive Antiretroviral Monforte et al. AIDS 1999

  7. INTEGRATING P.H.P AND PV FUNCTIONAL AND STRUCTURAL RELATIONSHIP T r a c h o m a t i s F i l a r i a s i s T u b e r c u l o s i s M a l a r i a V a c c i n e s WHO-PV (UMC) WHO ADVISORY COMMITTEE W.H.O PROGRAMMES DRUG REGULATORY AUTHORITY Expert Safety Review Panel T r a c h o m a t i s F i l a r i a s i s T u b e r c u l o s i s M a l a r i a PV Coordinator National PV centre V a c c i n e s NATIONAL PUBLIC HEALTH PROGRAMMES DISTRICT INVESTIGATION TEAM PATIENTS PATIENTS Health workers

  8. Procurement and Supply Management Plan 2.6 Ensuring rational use of medicines Is there a system for monitoring adverse drug reactions and drug resistance? If yes, describe briefly how the system works. If no, describe plans to establish a system.

  9. "Dying from a disease is sometimes unavoidable. But, dying from an adverse drug reaction is unacceptable". Dr Vladimir Lepakhin Geneva 2005

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