Presentation on theme: "Pharmacovigilance Shanthi Pal, M.Pharmacy, PhD Quality Assurance and Safety of Medicines WHO."— Presentation transcript:
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
5 The science and activities relating to the detection, evaluation, understanding and prevention of adverse drug reactions or any other drug-related problems Pharmacovigilance
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
19 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
20 Public Health or community health Science and art of preventing disease, prolonging life and promoting health and efficiency through organized community efforts.
21 Public Health Programmes Specific to each country (developed or developing) Dependent on: The specific burden of illness The epidemiology of prevalent disease
22 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
23 PHP Education Environmental modifications Nutrition intervention Lifestyle and behavioural changes Mass free distribution of drugs
24 PHP ORGANIZATION LEVE L I N T E R N A TI O N A L NATIONALNATIONAL LOCALLOCAL SPONSORS WHO OTHERS MALARIAMALARIA PROGRAMME MANAGERS HEALTH WORKERS PATIENTS V a c c i n e s Malaria Tuberculosis HIV/AIDS Filariasis MALARIAMALARIA PUBLIC HEALTH PROGRAMMES LOCAL COORDINATOR FOR HEALTH PROGRAMMES Others
25 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?
27 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
29 Main reasons of discontinuation of first HAART regimen within 1st year: ICONA ICO N A Italian Cohort Naive Antiretroviral Monforte et al. AIDS 1999
30 EXISTING SYSTEMS WHO PROGRAMMES WHO PROGRAMMES V a c c i n e s Malaria Tuberculosis Filariasis HIV / AIDS WHO-PV (UMC) PV Coordinator National PV centre PATIENTS NATIONAL PUBLIC HEALTH PROGRAMMES Vaccines Malaria Tuberculosis Filariasis HIV/AIDS Health workers PATIENTS
31 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
32 Expert Safety Review Panel INTEGRATING P.H.P AND PV FUNCTIONAL AND STRUCTURAL RELATIONSHIP W.H.O PROGRAMMES W.H.O PROGRAMMES V a c c i n e s M a l a r i a T u b e r c u l o s i s F i l a r i a s i s T r a c h o m a t i s WHO ADVISORY COMMITTEE WHO-PV (UMC) PV Coordinator National PV centre Health workers NATIONAL PUBLIC HEALTH PROGRAMMES V a c c i n e s M a l a r i a T u b e r c u l o s i s F i l a r i a s i s T r a c h o m a t i s DISTRICT INVESTIGATION TEAM DRUG REGULATORY AUTHORITY PATIENTS
33 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) PV and PHP Synergy
34 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
35 Collaboration with HIV/AIDS Workshop in Pretoria 2004 Action plan developed by ACSoMP 2005 Joint training course planned for April 2006
36 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
37 "Dying from a disease is sometimes unavoidable. But, dying from an adverse drug reaction is unacceptable". - Dr Vladimir Lepakhin Geneva 2005
38 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.