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

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

3. Pharmacovigilance
What IS this?

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

5. 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

6. Why Pharmacovigilance?

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

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

9. 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)

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

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

12. Pilot project of ten countries
Australia, Canada, Denmark, Germany, Ireland, Netherlands, New Zealand, Sweden, United Kingdom, USA

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

14. Safety
saves
Mary
Caroline
Shanthi

15. Pharmacovigilance in WHO
Exchange of Information
Policies, guidelines, normative activities
Country support
Collaborations
9/16/2018

16. Exchange of Information
24th WHA (1971)
Resolution WHA 24.56
Need for a system of collection and dissemination of information on results of safety and effectiveness trials of new drugs and on their registration in the countries, for possible use of data by health authorities of countries importing these drugs

17. Exchange of Information
INTERNATIONAL INFORMATION
SYSTEM
National Information Officers
(WHO Liaison Officers)
WHO Pharmaceuticals Newsletter
WHO Restricted List Updates

18. Exchange of Information
Ad hoc “Drug Alerts”
WHO Drug Information
International Conference of Drug Regulatory Authorities (ICDRA)
9/16/2018

19. Policies, Guidelines and Normative Activities
The Importance of Pharmacovigilance (2002)
Safety Reporting - A guide to detecting and reporting adverse drug reactions (2002)
Pharmacovigilance in public health
Safety monitoring of herbal medicines
Expert Advisory Committee
9/16/2018

21. Country Support Strengthen spontaneous reporting systems
Establish active surveillance component in public health programmes
Work with the WHO Collaborating Centre for International Drug Monitoring (the Uppsala Monitoring Centre)
Ongoing Regional projects:
“Implementation and Development of Pharmacovigilance in Newly Independent States of Eastern Europe”, since 2000
(National pharmacovigilance systems established in all 8 participating countries)
9/16/2018

22. Partnerships within WHO
Malaria
HIV/AIDS
Patient Safety
Leprosy (UK Thalidomide)
Poisons and Chemicals Safety
Traditional Medicines

23. Challenges Awareness and Advocacy Public Health Programmes
Geriatrics (Access improves longevity !!)
Paediatrics (Learning from SSRIs)
DTC advertising and Internet sales
Pregnancy
Patient Safety

24. Challenges Patient Safety Pregnancy
Fast Track & High Through-put Products
Counterfeit Drugs

25. Solutions Guidelines and Standards: PV in
HIV/AIDS, Malaria, Paediatrics….
Global Alliance for Patient Safety
Electronic discussion groups
Advocacy material
Training Tools
Databases

26. 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.

27. Backstage …
Gaynor, Laura, Lisa

28. Thank You
Merci beaucoup !