who medicines strategy - libdoc.who.int - World Health Organization

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WHO MEDICINES STRATEGY 2004-2007 | 102EO 6.4Post-marketing surveillance ofmedicines safety maintained andstrengthened through the ongoingdevelopment of pharmacovigilancecentres and their involvement ininternational adverse drug reactionmonitoring systemsFigure 24: WHO Programme for InternationalDrug MonitoringWHOHQ>>>>WHOCOLLABORATINGCENTREUPPSALARationaleNATIONALCENTRES>The aims of pharmacovigilance are to promotepatient care and patient safety in relation to theuse of medicines, especially with regard to theprevention of unintended harm from the use ofmedicines; to improve public health and safetyin relation to the use of medicines through theprovision of reliable, balanced informationresulting in more rational use of medicines; andto contribute to the assessment of the risk-benefitprofile of medicines, thus encouraging safer andmore effective use of medicines. Through effortsto promote pharmacovigilance WHO seeks toensure that all medicines in all Member States aresubject to monitoring for adverse reactions.ProgressThe WHO Programme for International DrugMonitoring is comprised of three parts, eachof which is integrally linked and has a role inadverse drug reaction monitoring.The Programme has issued several guidelines onadverse drug reaction monitoring in the Safetyof Medicines series. These include: Guidelinesfor setting up and running a PharmacovigilanceCentre; The Importance of Pharmacovigilance;and A guide to detecting and reporting adversedrug reactions. The Programme has also runtraining courses on pharmacovigilance, includinga course in 2003 held jointly with Roll BackMalaria to monitor the introduction of newantimalarials in five African countries. TheProgramme network has expanded to include 72countries and the global database has increasedto over 3 million reports of adverse events fromthe participating countries.
COMPONENTS OF THE STRATEGY | 103Challenges remainingThe biggest challenge in adverse drug reactionmonitoring is under-reporting by healthprofessionals. There is an urgent need to raiseawareness among all interested parties of theimportance of monitoring medicines. Morecountries need to establish the process elementsof an Adverse Drug Reaction Centre (ADR)and consequent involvement in internationalmonitoring. The established ADR centres needto improve reporting, both qualitatively andquantitively. The scope of pharmacovigilancecontinues to broaden as the array of medicinalproducts grows. It includes the use of herbal andtraditional medicines, blood products, biologicals,and vaccines. A more recent and urgent challengehas arisen with the launch by WHO of the ‘3 by5’ initiative aimed at providing ARVs for 3 millionpeople by 2005. These new drugs are beingintroduced into populations where there is littleinfrastructure to monitor their use.Meeting the challenges 2004-2007Over the next four years WHO will:> promote pharmacovigilance through activitiesand Annual Meetings of the National Centresparticipating in the International DrugMonitoring Programme.> collaborate with existing pharmacovigilancecentres for capacity building in countriescurrently not included in the Programme.> maintain normative activities, including theannual meetings of the Advisory Committeeon the Safety of Medicinal Products and theproduction of guidelines in the Safety ofMedicines series. Forthcoming publicationsinclude: Pharmacovigilance and PublicHealth and the Safety Monitoring of Herbalmedicines.> increase efforts to provide training inpharmacovigilance.OUTCOME INDICATORS1999 2003 2007#REPORTING % TARGET#REPORTING % TARGETNo. of countries monitoring adverse drug reactions 56/191 29% 35% 72/192 38% 45%
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