Autori: De Bie S, Coloma PM, Ferrajolo C, Verhamme KM, Trifirò G, Schuemie MJ, Straus SM, Gini R, Herings R, Mazzaglia G, Picelli G, Ghirardi A, Pedersen L, Stricker BH, van der Lei J, Sturkenboom MC; on behalf of the EU-ADR consortium.
Rivista: Br J Clin Pharmacol. Feb 2015
AbstractAIM
Electronic healthcare records (EHR)-based surveillance systems are increasingly being developed to support early detection of safety signals. It is unknown what the power of such a system is for surveillance among children and adolescents. In this paper we provide estimates of the number and classes of drugs, and incidence rates (IRs) of events, that can be monitored in children and adolescents (0-18 years).
METHODS
Data were obtained from seven population-based EHR databases in Denmark, Italy, and the Netherlands during the period 1996-2010. We estimated the number of drugs for which specific adverse events can be monitored as a function of actual drug use, minimally detectable relative risk (RR), and IRs for 10 events.
RESULTS
The population comprised 4,838,146 individuals (25,575,132 person years (PYs)), who were prescribed 2,170 drugs (1,610,631 PYs drug-exposure). Half of the total drug-exposure in PYs was covered by only 18 drugs (0.8%). For a relatively frequent event like upper gastrointestinal bleeding there were 39 drugs for which an association with a RR ≥ 4, if present, can be investigated; the corresponding number of drugs was 8 for a rare event like anaphylactic shock.
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