Title:New Ways of Detecting ADRs in Neonates and Children
Volume: 21
Issue: 39
Author(s): Ricardo Jimenez, Anne Smith and Bruce Carleton
Affiliation:
Keywords:
Adverse drug reactions, paediatrics, drug safety, children.
Abstract: Severe adverse drug reactions (ADRs) cause 5-7% of all hospital admissions, an estimated 2,000,000
severe reactions, and over 100,000 deaths each year in the USA. A recent systematic review indicated that the
overall incidence of ADRs was 11% in hospitalized children and 1% in outpatients. Detecting ADRs in neonates
and children is challenging, particularly because there are fewer clinical trials involving children than adults and
drug use in children is common without a labeled indication. Ontogeny and significant physiological changes
related to age have an impact on metabolic drug clearance and pharmacodynamics in children compared to adults,
as well as on drug action. A variety of strategies have been developed for the identification and further evaluation
of ADRs, starting from case reports and advancing into more structured methodologies, such as active surveillance,
for accumulating the necessary information. While each approach has merit, a comprehensive surveillance
approach with different methods is required to monitor drug safety in the post-market period. Among the methods that have shown value
in neonates and children are anecdotal reporting, voluntary organized reporting, prescription event monitoring, pharmacoepidemiology
using administrative databases, and active surveillance. There is an urgent need to improve the evaluation of paediatric drug safety in the
pre- and post-market phases of drug evaluation in order to better predict in whom serious harm may occur and better ensure the safe use
of drugs for neonates and children.
