Presentation on theme: "Pharmacovigilance Shanthi Pal, M.Pharmacy, PhD"— Presentation transcript:
1 Pharmacovigilance Shanthi Pal, M.Pharmacy, PhD Quality Assurance and Safety of MedicinesWHO
2 Learning objectivesParticipants will be aware of what pharmacovigilance isParticipants will learn why safety monitoring is importantParticipants will learn what WHO is doing in pharmacovigilanceParticipants will learn what they could do in pharmacovigilance
3 Medicine SafetyTo undergo treatment you have to be very healthy, because apart from your sickness you have to withstand the medicine.Molière
5 PharmacovigilanceThe 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 problemsdetection of increases in frequencyidentification of risk factorsquantifying riskspreventing patients from being affected unnecessarilyRational 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 usedThere is a high risk of misuse of drugsDiseasePopulationDrugHealth care systemMore 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 illnessThe epidemiology of prevalent disease
23 PHP Education Environmental modifications Nutrition intervention Lifestyle and behavioural changesMass free distribution of drugs
24 LOCAL COORDINATOR FOR HEALTH PROGRAMMES PHP ORGANIZATIONINTERNATIONALOthersSPONSORSWHOOTHERSFilariasisHIV/AIDSLEVELTuberculosisMalariaV a c c i n e sPUBLICHEALTH PROGRAMMESMALARIAMALARIANATIONALPROGRAMME MANAGERSLOCAL COORDINATOR FOR HEALTH PROGRAMMESHEALTH WORKERSLOCALPATIENTS
25 What about the risk / effectiveness of drugs used? PHP monitoringIncidence and prevalence of the diseaseMorbidity and mortality ratesNumber of patients treatedNumber of drug units deliveredWhat about the risk / effectiveness of drugs used?
27 New Challenges in PHPs Adherence Mass treatment regimens Nutritional aspectsUnlabelled and off-labelled indications(pregnant or breast feeding woman, small children, elderly people)Drug resistancesNew drugsCo-morbiditiesAdherence
29 ItalianCohortMain reasons of discontinuation of first HAART regimen within st year: ICONAICONANaiveAntiretroviralMonforte et al. AIDS 1999
30 NATIONAL PUBLIC HEALTH PROGRAMMES HIV / AIDSFilariasisTuberculosisMalariaV a c c i n e sWHO-PV(UMC)WHOPROGRAMMESEXISTING SYSTEMSHIV/AIDSFilariasisTuberculosisMalariaPV CoordinatorNational PV centreVaccinesNATIONAL PUBLIC HEALTH PROGRAMMESHealth workersHealth workersPATIENTSPATIENTS
31 Urgent need for synergistic collaboration PHPopportunity to implement PV activitiesOffer a cohort of patients under controlled conditions to be monitored for safety over a period of timePVdetect, evaluate, and prevent adverse eventspromote rational use of drugs in mass treatment programmesEvaluate the impact of the programmesimprove acceptability of the programme
32 WHO-PV (UMC) PATIENTS PATIENTS Health workers INTEGRATING P.H.P AND PV FUNCTIONAL AND STRUCTURAL RELATIONSHIPT r a c h o m a t i sF i l a r i a s i sT u b e r c u l o s i sM a l a r i aV a c c i n e sWHO-PV(UMC)WHO ADVISORYCOMMITTEEW.H.OPROGRAMMESDRUG REGULATORY AUTHORITYExpert Safety ReviewPanelT r a c h o m a t i sF i l a r i a s i sT u b e r c u l o s i sM a l a r i aPV CoordinatorNational PV centreV a c c i n e sNATIONAL PUBLIC HEALTH PROGRAMMESDISTRICT INVESTIGATION TEAMPATIENTSPATIENTSHealth workers
33 PV and PHP Synergy Strengthen spontaneous reporting systems Establish active surveillance component in public health programmesHIV/AIDSMalariaLymphatic filariasisWork with the WHO Collaborating Centre for International Drug Monitoring (the Uppsala Monitoring Centre)
34 Malaria Collaboration Joint training courseJoint reviews of specific antimalarialsArtemesinin derivativesChlorproguanil-dapsoneAmodiaquine-artesunateJoint initiatives for collaboration with pharmaceutical industry – Novartis Agreement
35 Collaboration with HIV/AIDS Workshop in Pretoria 2004Action plan developed by ACSoMP 2005Joint training course planned for April 2006
36 Collaboration with TDR Chlorproguanil-dapsone exampleJoint 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 "Dying from a disease is sometimes unavoidable. But, dying from an adverse drug reaction is unacceptable".Dr Vladimir LepakhinGeneva 2005
38 Procurement and Supply Management Plan 2.6 Ensuring rational use of medicinesIs 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.