13-Bejing II 07 WHO(revised).pptVIP

The WHO International Programme for Medicines Safety WHO Drug Monitoring ProgrammeFounding Members 1968 WHO International Drug Monitoring Programme October 2006 Flow of information Department of Medicines Policy and Standards Quality Assurance and Safety of Medicines (QSM) Pharmacovigilance in HQ Exchange of Information Policies, guidelines, normative activities Country support Collaborations within WHO and outside Capacity in low-income countries still inadequate Capacity building : multi regional, multi lingual trainings, regional centres of excellence in PV Local evidence for the need of pharmacovigilance Economics of it: facts and figures for political commitment Draft protocol developed for baseline data WHO Collaborating Centrethe Uppsala Monitoring Centre established as a foundation 1978 based on agreement Sweden - WHO international administrative board WHO Headquarters responsible for policy self financing UMC activities Cumulative reporting to WHO database Top ten contributors to WHO database Staff medical director pharmacists biomedical scientists IT specialists sales and marketing administrative total approx 50 persons Functions Signal detection Identification of previously unknown drug reactions Signal detection at the UMC Eur J Clin Pharmacol 1998;54:315-321 A combination of Automated quantitative data mining, using Bayesian statistics and a neural network architecture (Information Component – ‘IC value’) ‘Triage’ Human assessment Review Panel National Centres UMC staff SSRI Neonatal convulsions or neonatal withdrawal syndrome IC interpretation IC = 0 : Combination reported as often as expected relative to the background IC 0 : Combination reported more frequently than expected IC025 0 : Also the lower value of the 95% confidence interval is higher than expected from the background Combinations database - example Advantages of computerized signal generation Necessary for huge databases Automatic, no time loss Objective,