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Pharmacovigilance

Pharmacovigilance. Shanthi Pal, M.Pharmacy, PhD Quality Assurance and Safety of Medicines WHO. Learning objectives. Participants will be aware of what pharmacovigilance is Participants will learn why safety monitoring is important

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Pharmacovigilance

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

  2. 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 • Participants will learn what they could do in pharmacovigilance

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

  4. Pharmacovigilance What IS this?

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

  6. 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

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

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

  9. Why Pharmacovigilance? Adverse Drug Reactions are among the top ten causes of mortality (Lazarou J. et al., 1998)

  10. Why Pharmacovigilance? The percentage of hospital admissions due to drug related events in some countries is about or more than 10%. (Bhalla et al, 2003; Imbs et al, 1999)

  11. Why Pharmacovigilance? Economic impact Drug related morbidity and mortality expenses exceeded US$ 177.4 billion in the USA in 2000 (Ernst & Grizzle, 2001)

  12. WHO Programme for International Drug Monitoring WHO HQ WHO Collaborating Centre, Uppsala National Centres

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

  14. Technical support to countries • Training courses on pharmacovigilance (Regional Training Courses, biennial course by UMC and HQ) • Annual Meeting of Pharmacovigilance Centres

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

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

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

  18. Public Health or community health Science and art of preventing disease, prolonging life and promoting health and efficiency through organized community efforts.

  19. Public Health Programmes • Specific to each country (developed or developing) • Dependent on: The specific burden of illness The epidemiology of prevalent disease

  20. DEVELOPING COUNTRIES • Endemic and/or epidemic diseases Tuberculosis, Leprosy, HIV/AIDS, STD Malaria, Schistosomiasis, Amoebiasis, Leishmaniasis, Trachoma, Lymphatic filariasis, Onchocerciasis, • High morbidity and mortality rates

  21. PHP • Education • Environmental modifications • Nutrition intervention • Lifestyle and behavioural changes • Mass free distribution of drugs

  22. PHP ORGANIZATION I NTERNATIONAL Others SPONSORS WHO OTHERS Filariasis HIV/AIDS LEVEL Tuberculosis Malaria V a c c i n e s MALARIA PUBLIC HEALTH PROGRAMMES MALARIA NATIONAL PROGRAMME MANAGERS LOCAL COORDINATOR FOR HEALTH PROGRAMMES HEALTH WORKERS LOCAL PATIENTS

  23. PHP monitoring • Incidence and prevalence of the disease • Morbidity and mortality rates • Number of patients treated • Number of drug units delivered What about the risk / effectiveness of drugs used?

  24. PHP guidelines (WHO, National) Inadequate (no) reference to: • ADRs • Pharmacovigilance • Reporting

  25. New Challenges in PHPs • Mass treatment regimens • Nutritional aspects • Unlabelled and off-labelled indications (pregnant or breast feeding woman, small children, elderly people) • Drug resistances • New drugs • Co-morbidities • Adherence

  26. Eroding confidence in the malaria programme

  27. Italian Cohort Main reasons of discontinuation of first HAART regimen within 1st year: ICONA I C O N A Naive Antiretroviral Monforte et al. AIDS 1999

  28. HIV / AIDS Filariasis Tuberculosis Malaria V a c c i n e s WHO-PV (UMC) WHO PROGRAMMES EXISTING SYSTEMS HIV/AIDS Filariasis Tuberculosis Malaria PV Coordinator National PV centre Vaccines NATIONAL PUBLIC HEALTH PROGRAMMES Health workers Health workers PATIENTS PATIENTS

  29. 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

  30. 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

  31. PV and PHP Synergy • 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)

  32. Malaria Collaboration • Joint training course • Joint reviews of specific antimalarials • Artemesinin derivatives • Chlorproguanil-dapsone • Amodiaquine-artesunate • Joint initiatives for collaboration with pharmaceutical industry – Novartis Agreement

  33. Collaboration with HIV/AIDS • Workshop in Pretoria 2004 • Action plan developed by ACSoMP 2005 • Joint training course planned for April 2006

  34. Collaboration with TDR • Chlorproguanil-dapsone example • Joint initiatives on post-marketing surveillance studies (Phase 4 clinical trials) • Joint initiatives on development of pregnancy registers for antimalarials and antrietrovirals

  35. "Dying from a disease is sometimes unavoidable. But, dying from an adverse drug reaction is unacceptable". Dr Vladimir Lepakhin Geneva 2005

  36. 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.

  37. Thank You Merci beaucoup !

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