1. Dr Mary Couper Quality Assurance and Safety of Medicines WHO
Pharmacovigilance
Dr Mary Couper
Quality Assurance and Safety of Medicines
WHO

2. 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.

3. 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

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

5. Pharmacovigilance
What IS this?

6. 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

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

8. 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

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

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

11. Why pharmacovigilance? Factors influencing change
Toxicity (adverse drug reactions)
Lack of patient adherence

12. HIV Clinic 2005 31 December 2005 Re: Mr Joseph Bloggs R/
Prescription
Dr A. Who
31 December 2005
Re: Mr Joseph Bloggs  R/
1)     abacavir + lamivudine + zidovudine 1 BD
2)       atenolol 100 mg/d
3)      acetylsalicylic acid 150mg/d
4)      simvastatin 10 mg/d
 5) bezafibrate 200 mg/d
6) metformin 500 mg/d
7) fluoxetine 50 mg/d
8) sildenafil

13. Why Pharmacovigilance for Procurement and Management Supply Plans?
It is not always the product that determines drug safety but how it is used
More than 50% of ADRs are preventable
there is a high risk of misuse of drugs
Disease
Population
Drug
Health care system

14. Populations Mass treatment regimens,
Low standard of living and education,
Cultural specificities,
not always suffering from the diseases
unlabelled and off labelled indications
(pregnant or breast feeding woman, small children, elderly people),
Drug and disease interactions.

15. 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

16. 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

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

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

19. Exchange of Information
WHO Pharmaceuticals Newsletter
WHO Drug Alerts
WHO Drug Information
WHO Restricted Pharmaceuticals List
International Conference of Drug Regulatory Authorities (ICDRA)

21. 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
Advisory Committee on the Safety of Medicines (ACSOMP)

22. Country Support 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)

23. 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)

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

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

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

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

29. National centres China India Indonesia Philippines Sri Lanka Thailand
Vietnam
Associate members:
Nepal
Pakistan

30. Procurement and Supply Management Plan
2.6 Ensuring rational use of medicines
There should be a system for monitoring adverse drug reactions and drug resistance. Describe briefly how the system works.