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Pharmacovigilance

Pharmacovigilance. Shanthi Pal, M.Pharm, PhD Quality Assurance and Safety of Medicines WHO. Medicine Safety. To undergo treatment you have to be very healthy, because apart from your sickness you have to stand the medicine. Molière. Pharmacovigilance. What IS this?. Pharmacovigilance.

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Pharmacovigilance

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  1. 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$ 177.4 billion in the USA in 2000 (Ernst & Grizzle, 2001)

  11. Some Examples

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

  13. WHO Programme for International Drug Monitoring WHO HQ 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

  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) • www.who.int/medicines/edmtopics.shtml

  19. 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 • Expert Advisory Committee

  20. 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)

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

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

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

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

  25. 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.

  26. Backstage … Gaynor, Laura,Lisa

  27. Thank You Merci beaucoup !

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