E-DRUG: UMC SIGNAL document: increased transparency and openness
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One aim of the WHO Programme for International Drug Monitoring is the early identification of international drug safety problems not identified in clinical trials, known as signals. These signals are published in the Uppsala Monitoring Centre's SIGNAL document, and represent varying levels of suspicions derived from examination of the data in the WHO Global Individual Case Safety Reports (ICSR) database - also known as VigiBase(tm) - which contains over 7 million such reports. After receiving a signal, National regulatory authorities may consider possible action, for instance further evaluation of source data, or a study for the testing of a hypothesis.
Wider audience
In 2011 the WHO Advisory Committee on the Safety of Medicinal Products (ACSoMP) recommended that SIGNAL articles be made public. A first step in making UMC signals publicly available, and reach a wider audience, will be taken in early 2012 when for the first time they will be included in WHO Pharmaceuticals Newsletter (WHO-PN). The WHO-PN is issued every second month and currently contains sections on Regulatory matters, Safety of medicines and Features. Publishing UMC signals on an unrestricted basis means a fourth section - Signals - will be added. Currently 450 professionals receive the restricted SIGNAL document, mainly staff at national pharmacovigilance centres. As there are more than 4,000 subscribers to WHO-PN (also freely accessible from the WHO website), a wider audience will receive this information.
UMC role
The Uppsala Monitoring Centre is the field name of the WHO Collaborating Centre for International Drug Monitoring. One of our core functions is to screen and analyse international adverse drug reaction (ADR) data with the aim of finding drug safety signals as early as possible.
UMC receives summary reports of suspected adverse reactions to medicines from over 100 national pharmacovigilance centres in countries participating in the WHO Programme for International Drug Monitoring. The reports are collated in a single global database, VigiBase TM, which is managed by the UMC.
Quarterly analysis of VigiBase data is performed with the aim of finding drug safety signals. Drug-ADR combinations considered to be signals are circulated in the SIGNAL Document. A signal from the UMC is to be seen as a hypothesis together with data and arguments; it is not only uncertain but also preliminary in nature and its significance may change substantially over time when more data are gathered.
Method of production
The current procedure gives the opportunity for relevant pharmaceutical companies to read and comment on SIGNAL texts, prior to publishing. Articles will continue to be circulated to National Pharmacovigilance Centres prior to publishing in the WHO Pharmaceuticals Newsletter.
Sten Olsson
Chief WHO Programme Officer
Uppsala Monitoring Centre
WHO Collaborating Centre for International Drug Monitoring
Box 1051, SE-751 40 Uppsala, Sweden
Tel: +46 (0)18656060, Fax: +46 (0)18656088
www.who-umc.org
Sten Olsson <Sten.Olsson@who-umc.org>