Richard Lux, Simone Bergner, Karin Holz, Simone Wärntges
Studies with small, specified populations are carried out prior to drug authorisation. Following market launch, use and effects of a product need to be observed in large populations including such vulnerable groups as (pregnant) women, children, elderly people. The aim of the project is to increase drug (therapy) safety by considering the following aspects: 1) exact ascertainment of the incidence of undesired drug effects, 2) detection of delayed and/or unusual drug effects, 3) evaluation of effects of co-medication, 4) assessment of consequences of overdosing, 5) proof of superiority or inferiority compared with standard therapy.
Internal and external data bases are linked and evaluated in the light of the project aims. The results obtained using pharmacoepidemiological methods are part of the pharmacovigilance data set. They shall be the basis of evidence based regulatory risk reduction measures taken for the benefit of drug (therapy) safety.
1. Strom BL, Kimmel SE, Hennessy S (Hrsg) (2012) Pharmacoepidemiology, 5. Aufl. Wiley, Chichester