The role of electronic healthcare record databases in paediatric drug safety surveillance: a retrospective cohort study.

ABSTRACT:

Aim

Electronic healthcare record (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 in

SUBMITTER: de Bie S 

PROVIDER: S-EPMC4541978 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature