Transcript Pharmacovigilance Dr

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)
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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
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Public Health Programmes
 What?
 How?
 Benefit risk assessment?
 ADR reporting, PV?
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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
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Eroding confidence in the malaria programme
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Italian
Cohort
I
C O
N A
Naive
Antiretroviral
Main reasons of discontinuation
of first HAART regimen within
1st year: ICONA
Toxicity
Failure
Non-adherence
Other
Continued
Monforte et al. AIDS 1999
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Trachomatis
Filariasis
Tuberculosis
Malaria
Vaccines
INTEGRATING P.H.P AND PV
FUNCTIONAL AND STRUCTURAL RELATIONSHIP
W.H.O
PROGRAMMES
WHO ADVISORY
COMMITTEE
WHO-PV
(UMC)
DRUG REGULATORY
AUTHORITY
Trachomatis
Filariasis
Tuberculosis
Malaria
Vaccines
NATIONAL PUBLIC
HEALTH
PROGRAMMES
Expert Safety Review
Panel
PV Coordinator
National PV centre
DISTRICT
INVESTIGATION
TEAM
PATIENTS
PATIENTS
Health workers
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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.
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"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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