Presentation on theme: "World Health Organization"— Presentation transcript:
1 World Health Organization 28 March 2017Challenges for the WHO Programme for International Drug MonitoringShanthi Pal Quality Assurance and Safety of MedicinesCecilia BiriellReports, Analysis and Country Support
3 RiskNo medicinal product is entirely or absolutely safe for all people, in all places, at all times.We must always live with some measure of uncertainty.
4 What is Pharmacovigilance? World Health OrganizationWhat is Pharmacovigilance?28 March 2017WHO definition:The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.This applies throughout the life-cycle of a medicine equally to the pre-approval stage as to the post-approval.ADR monitoring – Medicines safety – Drug Monitoring
5 What is the scope of pharmacovigilance? improve patient care and safety in relation to the use of medicines, and all medical and paramedical interventions,improve public health and safety in relation to the use of medicines,contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use, andpromote understanding, education and clinical training in pharmacovigilance and its effective communication to the public
6 Why pharmacovigilance? Humanitarian concernsHippocrates admonitionat least do not harmEconomical concernsPV is needed to: 1. prevent unnecessary suffering 2. save money for other important thingsA child with Stevens-Johnson syndrome (SJS) from an antiviral drug. SJS is a life-threatening condition affecting the skin in which cell death causes the epidermis to separate from the dermis. The syndrome is thought to be a hypersensitivity complex affecting the skin and the mucous membranes. Although the majority of cases are idiopathic, the main class of known causes is medications, followed by infections and (rarely) cancers. Important for doctors to be able to recognize it in order to immediately stop the drug.
7 Examples of product recalls due to toxicity MedicineYearExamples of serious and unexpected adverse events leading to withdrawalThalidomide1965PhocomeliaPractolol1975Sclerosing peritonitisClioquinol1970Subacute nephropathyBenoxaprofen1982Nephrotoxicity, cholestatic jaundiceTerfenadine1997Torsade de pointesRofecoxib2004Cardiovascular effectsSibutramine2010Anxiety, depression, movement disorders
8 Studies of ADR related deaths UK:It has been suggested that ADRs may cause 5700 deaths per year in UKPirmohamed et al, 2004US:ADRs were 4th-6th commonest cause of death in the US in 1994Lazarou et al, 1998Sweden:ADRs were 7th commonest cause of death in Sweden in 2001Jönsson et al, 2010
9 World Health Organization 28 March 2017125 Patients24 Patients experienced ADRs (19%)59% were avoidableIntro 2
10 Cost of ADRs in the US?Cost of drug related morbidity and mortality exceeded $177.4 billion in 2000Ernst FR & Grizzle AJ, 2001: J American Pharm. AssocADR related cost to the country exceeds the cost of the medications themselves
11 Pharmacovigilance in WHO HQ Exchange of InformationPolicies, guidelines, normative activitiesCountry supportCollaborationsFund raising
12 WHO HQ Pharmacovigilance staff Dr Shanthi Pal, Acting ManagerMedicines Saftey, QSM+ 3 support staff
13 1. Exchange of Information National Information OfficersPublications(WHO Pharm Newsletter, Restricted Pharm List, Drug Alerts, WHO Drug Information)International Conference of Drug Regulatory Authorities (ICDRA)
14 2. Policies, Guidelines and Normative Activities The Importance of Pharmacovigilance (2002)Safety Reporting - A guide to detecting and reporting adverse drug reactions (2002)Policy perspectives on medicines (Pharmacovigilance) 2004Safety monitoring of herbal medicines (2004)Pharmacovigilance in Public HealthAdvisory Committee for the Safe Use of Medicinal Products (ACSoMP)
15 3. Country supportTraining courses on pharmacovigilance (Regional Training Courses, biennial course by UMC and HQ)Address specific / stated needs: kava, ARVs, antimalarials….Annual Meeting of Pharmacovigilance Centres
16 4. Collaborations & Partnerships within WHO Over a 100 million people targeted for either diethylcarbamazine citrate (DEC) plus albendazole or ivermectin plus albendazole.MalariaHIV/AIDSLeprosyLymphatic FilariasisLeishmaniasisChagasPatient SafetyPoisons and Chemicals SafetyTraditional MedicinesVaccines
17 5. Resource Mobilisation Gates foundationEuropean CommissionGlobal FundOthersHuman resources:WHO Consultants Network for Pharmacovigilance (PV) in Africa (PvSF – Pharmacovigilance Sans Frontières)
18 WHO International Pharmcovigilance Programme Full and Associate Members At the moment there are 94 full member countries and 28 associate member countries. To become an associate member country, the government of a country needs to send an official application to the WHO HQ in Geneva. To become a full member the country also needs to send at least 20 ADR reports in a correct format. Less member countries in Africa but a major increase recently.November 2010, 102 member countries
19 Uppsala Monitoring Centre (UMC) WHO Collaborating Centre for International Drug Monitoring the operational centre of the WHO PV Programmeestablished as a foundation 1978based on agreement Sweden - WHOinternational administrative boardWHO Headquarters responsible for policyself financed
20 UMC main tasks - summary Collect and analyse ICSRs worldwideCommunicate potential drug safety issuesActively support and provide trainingDevelop the science of pharmacovigilance
21 WHO Programme for International Drug Monitoring UMC-A WHO-CCAccraUMCWHO-CCUppsalaWHO-HQGenevaNationalCentresMedicalpracticesPharmacompanies(Make doctors understand how their activity is connected to the WHO and that their contribution is critical. We are unable to do anything if they don’t produce any ADR reports in the first place.)
22 Number of members of the WHO International Drug Monitoring Programme The increase of new member countries There was a turning-point in After that the trend is a steady increase.
23 Strengths Weaknesses Global PV network National Centres MeetingsOnly available global database of ADRsOver 40 years track record in medicine safetyPublic health approachNo hidden agendasWeaknessesInadequate representation in AfricaOnly Spontaneous reportingno denominator datapoor quality reportsLittle or no budgetPHPs: Vertical approach
24 Duplication of efforts Opportunities Threats Donor interest in PV New partnersMalaria, HIV AIDS, neglected diseasesurgent PV needsinvesting in new methodsThreatsLucrative businessLack of harmonizationDuplication ofefforts
25 Challenges to Pharmacovigilance An analysis of pharmacovigilance activities in 55 low- and middle-income countriesSten Olssona, Shanthi Palb, Andy Stergachisc, Mary CouperaDrug Safety 2009/2010(a: WHO CC, Uppsala; b: WHO QSM; c: UWa)
28 WHO - UMC relationships HIV/AIDSWHOClassifi-cationsVaccinesafetyOtherTropicalDiseasesMalariaPatientSafetyAllianceMedicinesPolicy andStandardsUMC
29 3 tiers-approach for WHO Maintain as the cheapest, easiest, most sustainable methodAs beforeSpontaneous reportingRegional trainings – WHO and UMCCountry support – WHO, UMC and UMC-AMore than before- Active surveillanceTools - CEMFlow for Cohort Event MonitoringHandbooksNigeria, Tanzania, Ghana – Cohort Event Monitoring in Public Health Programmes
30 Support, guidelines & technical resources Expecting the Worst - Crisis Management Support, guidelines & technical resourcesWhy do pharmacovigilance and how to do it. A critical examination of the strengths and weaknesses of present systems of safety monitoring, in order to increase their impact, and an overview of the challenges facing pharmacovigilance in the future. Guidelines for setting up (establishing) and running a Pharmacovigilance Centre.Readings for the TBS:The importance of pharmacovigilanceSafety of MedicinesThe Safety of Medicines in public health programmesPromoting Safety of Medicines for ChildrenExpecting the worst
31 3 tiers-approach for WHO As never beforeIndicatorsMinimum requirements for a Functional National PV SystemFundraisingEuropeAid; UNITAID, GFATM, PEPFAR; FP7 etcCentres of excellenceGhana – WHO Collaborating Centre for Advocacy and training in PVMorocco – training for francophone countriesDeveloping networksPV Consultants Network for AfricaGlobal Network for ADR reporting in prequalified vaccinesNational Centres meeting in Ghana
32 Activities the last few months Ghana, MayPV conference arranged by West African Health OrganizationMorocco, JuneTraining course for francophone countriesTogo, OctoberPV Consultants Network for AfricaGhana, NovemberStakeholders meeting, Donors and WHOActivities in other parts of the world:Training course in Singapore for Asian countriesUMC country visits in eastern European countriesRestart of PV in IndiaComing – training course in Mexico
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