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

2. Objectives To discuss the need for pharmacovigilance
To present WHO’s role in promoting pharmacovigilance

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

4. Pharmacovigilance
What IS this?

5. Vigilance Vigilare = to watch alert watchfulness
forbearance of sleep; wakefulness
watchfulness in respect of danger; care; caution; circumspection
the process of paying close and continuous attention

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

7. 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

8. Why Pharmacovigilance?

9. Why Pharmacovigilance?
Post-marketing Topics
Unexpected adverse reactions
Interactions
Dependence
Long-term efficacy, Resistance
Risk factors
Quality (Counterfeit)
Cost assessment

10. Why Pharmacovigilance?
Adverse Drug Reactions are the 4th to 6th largest cause of mortality in the USA
(Lazarou J. et al., 1998)

11. Why Pharmacovigilance?
The percentage of hospital admissions
due to drug related events in some countries is about or more than 10%.
UK Study : 10.1 % (Bhalla et al, 2003)
French study : 10.3 % prevalence of ADRs (Imbs et al, 1999)

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

13. Some Examples Medicine ADR Thalidomide Congenital malformations
Amidopyrine
Agranulocytosis
Clioquinol
Myeloneuropathy (SMON)
Statins
Rhabdomyolyis
Oral Contraceptives
Thromboembolism

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

16. Exchange of Information
WHO Pharmaceuticals Newsletter
WHO Drug Alerts
WHO Drug Information
WHO Restricted Pharmaceuticals List
(Vigimed - electronic exchange)
(Uppsala Reports)
(Signal)

17. Technical support to countries
Technical guidelines on all aspects of pharmacovigilance
(Several publications and documents)
Training courses on pharmacovigilance
(Regional Training Courses, biennial course by UMC and HQ)

18. Training courses for Public Health Programmes
Introducing Pharmacovigilance into Malaria Programmes- Zambia 2003
Introducing Pharmacovigilance into HIV/AIDS Programmes – South Africa 2004

20. WHO Collaborating Centre (Uppsala Monitoring Centre)
ADR database
No of reports: more than 3 million
Each year increase ~250,000 / year
Top 5 reporting countries
USA
United Kingdom
Germany
Australia
Canada

21. WHO Collaborating Centre (Uppsala Monitoring Centre)
ADR Reports
Analysis
Data mining (BCPNN)
Output
Feedback to National Centres
Signal documents
Ad hoc research results

22. Address broader safety concerns Integrate work throughout WHO
Future challenges
Raise awareness
Monitor all medicines
Address broader safety concerns
Integrate work throughout WHO
Improve training activities

23. In conclusion ….
The work of WHO in the area of safety monitoring of medicines is necessary if we are to achieve the mission of EDM:
Medicines should be Available, Affordable, Safe and Properly used.

24. Thank you
' A blue fly, if it clings to the tail of a thoroughbred horse, can travel ten thousand miles '.