Participants will be aware of what pharmacovigilance is
Participants will learn why safety monitoring is important
Participants will learn what WHO is doing in pharmacovigilance
Participants will learn what they could do in pharmacovigilance
Medicine Safety
To undergo treatment you have to be very healthy, because apart from your sickness you have to withstand the medicine.
Molière
Pharmacovigilance
What IS this?
Pharmacovigilance
The science and activities relating to the detection, evaluation, understanding and prevention of adverse drug reactions or any other drug-related problems
Pharmacovigilance Major Aims
early detection of unknown safety problems
detection of increases in frequency
identification of risk factors
quantifying risks
preventing patients from being affected unnecessarily
Rational and Safe use of Medicines
Why Pharmacovigilance?
Pre-marketing safety data
Animal Experiments: Relevant?
Clinical Trials: Complete?
Why Pharmacovigilance?
Post Marketing Topics
Unexpected adverse reactions
Interactions
Risk factors
Quality of life
Long-term efficacy
Cost assessment
Why Pharmacovigilance?
Adverse Drug Reactions are among the top ten causes of mortality
(Lazarou J. et al., 1998)
Why Pharmacovigilance?
The percentage of hospital admissions due to drug related events in some countries is about or more than 10%.
(Bhalla et al, 2003; Imbs et al, 1999)
Why Pharmacovigilance?
Economic impact
Drug related morbidity and mortality expenses exceeded US$ 177.4 billion in the USA in 2000
(Ernst & Grizzle, 2001)
WHO Programme for International Drug Monitoring
WHO Programme for International Drug Monitoring (HQ)
Policy
Exchange of Information
Technical support to countries
Advisory Committee on Safety of Medicinal Products
Technical support to countries
Training courses on pharmacovigilance (Regional Training Courses, biennial course by UMC and HQ)
Annual Meeting of Pharmacovigilance Centres
WHO Collaborating Centre (Uppsala Monitoring Centre)
ADR database
No of reports: more than 3.5 million
Each year increase ~160,000 / year
WHO Collaborating Centre (Uppsala Monitoring Centre)
ADR Reports
Analysis
Output
Feedback to National Centres
Signal documents
Why Pharmacovigilance for Procurement and Management Supply Plans?
It is not always the product that determines drug safety but how it is used
There is a high risk of misuse of drugs
Disease
Population
Drug
Health care system
More than 50% of ADRs are preventable
Public Health or community health
Science and art of preventing disease, prolonging life and promoting health and efficiency through organized community efforts.
Public Health Programmes
Specific to each country (developed or developing)
What about the risk / effectiveness of drugs used?
PHP guidelines (WHO, National)
Inadequate (no) reference to:
ADRs
Pharmacovigilance
Reporting
New Challenges in PHPs
Mass treatment regimens
Nutritional aspects
Unlabelled and off-labelled indications
(pregnant or breast feeding woman, small children, elderly people)
Drug resistances
New drugs
Co-morbidities
Adherence
Main reasons of discontinuation of first HAART regimen within 1st year: ICONA
Urgent need for synergistic collaboration
PHP
opportunity to implement PV activities
Offer a cohort of patients under controlled conditions to be monitored for safety over a period of time
PV and PHP Synergy
Strengthen spontaneous reporting systems
Establish active surveillance component in public health programmes
HIV/AIDS
Malaria
Lymphatic filariasis
Work with the WHO Collaborating Centre for International Drug Monitoring (the Uppsala Monitoring Centre)
Malaria Collaboration
Joint training course
Joint reviews of specific antimalarials
Artemesinin derivatives
Chlorproguanil-dapsone
Amodiaquine-artesunate
Joint initiatives for collaboration with pharmaceutical industry – Novartis Agreement
Collaboration with HIV/AIDS
Workshop in Pretoria 2004
Action plan developed by ACSoMP 2005
Joint training course planned for April 2006
Collaboration with TDR
Chlorproguanil-dapsone example
Joint initiatives on post-marketing surveillance studies (Phase 4 clinical trials)
Joint initiatives on development of pregnancy registers for antimalarials and antrietrovirals
"Dying from a disease is sometimes unavoidable. But, dying from an adverse drug reaction is unacceptable".
Dr Vladimir Lepakhin
Geneva 2005
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.
