1. Pharmacovigilance Shanthi Pal, M.Pharmacy, PhD
Quality Assurance and Safety of Medicines
WHO

2. Learning objectives
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

3. Medicine Safety
To undergo treatment you have to be very healthy, because apart from your sickness you have to withstand the medicine.
Molière

4. Pharmacovigilance
What IS this?

5. Pharmacovigilance
The science and activities relating to the detection, evaluation, understanding and prevention of adverse drug reactions or any other drug-related problems

6. 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

7. Why Pharmacovigilance?
Pre-marketing safety data
Animal Experiments: Relevant?
Clinical Trials: Complete?

8. Why Pharmacovigilance?
Post Marketing Topics
Unexpected adverse reactions
Interactions
Risk factors
Quality of life
Long-term efficacy
Cost assessment

9. Why Pharmacovigilance?
Adverse Drug Reactions are among the top ten causes of mortality
(Lazarou J. et al., 1998)

10. 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)

11. Why Pharmacovigilance?
Economic impact
Drug related morbidity and mortality expenses exceeded US$ billion in the USA in 2000
(Ernst & Grizzle, 2001)

12. WHO Programme for International Drug MonitoringHQ
WHO
Collaborating
Centre, Uppsala
National
Centres

13. WHO Programme for International Drug Monitoring (HQ)
Policy
Exchange of Information
Technical support to countries
Advisory Committee on Safety of Medicinal Products

15. Technical support to countries
Training courses on pharmacovigilance (Regional Training Courses, biennial course by UMC and HQ)
Annual Meeting of Pharmacovigilance Centres

16. WHO Collaborating Centre (Uppsala Monitoring Centre)
ADR database
No of reports: more than 3.5 million
Each year increase ~160,000 / year

17. WHO Collaborating Centre (Uppsala Monitoring Centre)
ADR Reports
Analysis
Output
Feedback to National Centres
Signal documents

19. 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

20. Public Health or community health
Science and art of preventing disease, prolonging life and promoting health and efficiency through organized community efforts.

21. Public Health Programmes
Specific to each country (developed or developing)
Dependent on:
The specific burden of illness
The epidemiology of prevalent disease

22. DEVELOPING COUNTRIES Endemic and/or epidemic diseases
Tuberculosis, Leprosy, HIV/AIDS, STD
Malaria, Schistosomiasis, Amoebiasis, Leishmaniasis, Trachoma, Lymphatic filariasis, Onchocerciasis,
High morbidity and mortality rates

23. PHP Education Environmental modifications Nutrition intervention
Lifestyle and behavioural changes
Mass free distribution of drugs

24. LOCAL COORDINATOR FOR HEALTH PROGRAMMES
PHP ORGANIZATION I
NTERNATIONAL
Others
SPONSORS
WHO
OTHERS
Filariasis
HIV/AIDS
LEVEL
Tuberculosis
Malaria
V a c c i n e s
PUBLIC
HEALTH PROGRAMMES
MALARIA
MALARIA
NATIONAL
PROGRAMME MANAGERS
LOCAL COORDINATOR FOR HEALTH PROGRAMMES
HEALTH WORKERS
LOCAL
PATIENTS

25. What about the risk / effectiveness of drugs used?
PHP monitoring
Incidence and prevalence of the disease
Morbidity and mortality rates
Number of patients treated
Number of drug units delivered
What about the risk / effectiveness of drugs used?

26. PHP guidelines (WHO, National)
Inadequate (no) reference to:
ADRs
Pharmacovigilance
Reporting

27. New Challenges in PHPs Adherence 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

28. Eroding confidence in the malaria programme

29. 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

30. NATIONAL PUBLIC HEALTH PROGRAMMES
HIV / AIDS
Filariasis
Tuberculosis
Malaria
V a c c i n e s
WHO-PV
(UMC)
WHO
PROGRAMMES
EXISTING SYSTEMS
HIV/AIDS
Filariasis
Tuberculosis
Malaria
PV Coordinator
National PV centre
Vaccines
NATIONAL PUBLIC HEALTH PROGRAMMES
Health workers
Health workers
PATIENTS
PATIENTS

31. 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
detect, evaluate, and prevent adverse events
promote rational use of drugs in mass treatment programmes
Evaluate the impact of the programmes
improve acceptability of the programme

32. 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

33. 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)

34. 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

35. Collaboration with HIV/AIDS
Workshop in Pretoria 2004
Action plan developed by ACSoMP 2005
Joint training course planned for April 2006

36. 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

37. "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

38. 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.

39. Thank You
Merci beaucoup !