Pharmacovigilance

1. 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 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. 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 Urgent need for synergistic collaboration

16. 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 Monitoring WHO HQ 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 • Guidelines • 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 Monitoring WHO HQ 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 Monitoring WHO HQ WHO Collaborating Centre, Uppsala National Centres

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

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.