title: Adverse drug reactions in neonates: could we be documenting more?
abstract: Neonates are vulnerable to adverse drug reactions but reports of these events are relatively infrequent. Reporting can be increased by adapting a number of standard techniques to the unique features of neonatal care and pathology. However, clinicians and parents will be reluctant to report information about harms in the absence of mechanisms to ensure that reports affect clinical practice. Improved reporting will depend on education and cultural change that are informed by research about pharmacovigilance in neonatal settings. The efficient use of neonatal adverse drug reaction reports will require harmonization of terminology and interoperable databases.
authors.affiliation: Department of Women's and Children's Health, University of Liverpool, Alder Hey Children's Hospital, Eaton Road, Liverpool, L12 2AP, UK.
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Hawcutt
authors.forename: Olya
authors.initials: O
authors.lastname: O'Connor
authors.forename: Mark A
authors.initials: MA
authors.lastname: Turner
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000818:Animals; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D006801:Humans; D007231:Infant, Newborn; D060735:Pharmacovigilance; D009626:Terminology as Topic
keywords: adverse drug reaction; neonates; pharmacovigilance; spontaneous reporting scheme