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Pharmacovigilance What? (2.6) Ensure ADR monitoring (Spontaneous reporting/Cohort studies) Who? Healthcare workers How? WHO International Drug Monitoring.

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Presentation on theme: "Pharmacovigilance What? (2.6) Ensure ADR monitoring (Spontaneous reporting/Cohort studies) Who? Healthcare workers How? WHO International Drug Monitoring."— Presentation transcript:

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 Pharmacovigilance Dr 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 st year: ICONA I C O N A Naive Antiretroviral Monforte et al. AIDS 1999

7 WHO-PV (UMC) PATIENTS PATIENTS Health workers 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
"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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