title: Methodological challenges in using routinely collected health data to investigate long-term effects of medication use during pregnancy.
abstract: To date, the investigation of teratogenic effects of medications has largely focused on physical alterations present at birth (i.e. malformations) as opposed to functional alterations (i.e. neurodevelopment, metabolic function) that may not be apparent at birth but could influence an individual's health and risk of disease in later life. The use of routinely collected health data represents one approach to better identifying, quantifying, and understanding the long-term risks or benefits of medication use during pregnancy. As such, the objective of this review was to identify and explore opportunities and challenges associated with using routinely collected health data to examine long-term effects of medication use during pregnancy. Drawing on published research several key methodological issues associated with their use in investigating long-term outcomes are reviewed. While significant opportunities exist to make greater use of routinely collected health data, there are a number of key challenges. Identified challenges relate to aspects of study design and analysis, and include obtaining access to data, the ability to match records across datasets and over long periods of time, how medication exposures are ascertained and classified, issues around loss to follow-up how outcomes are ascertained and classified, and the careful interpretation of results in light of study and data limitations. Understanding key challenges associated with using routinely collected health data to investigate long-term effects of medication use during pregnancy is essential in supporting their appropriate use and interpretation, which will contribute to improving the quality of research undertaken and ensure the reliability of results obtained.
authors.affiliation: Quality Use of Medicines and Pharmacy Research Centre, School of Pharmacy and Medical Sciences, Sansom Institute for Health Research, University of South Australia, GPO Box 2471, Adelaide, South Australia 5001, Australia.
authors.forename: Luke E
authors.initials: LE
authors.lastname: Grzeskowiak
authors.affiliation: Professor, Quality Use of Medicines and Pharmacy Research Centre, School of Pharmacy and Medical Sciences, Sansom Institute for Health Research, University of South Australia, Adelaide, South Australia, Australia.
authors.forename: Andrew L
authors.initials: AL
authors.lastname: Gilbert
authors.affiliation: Heart Foundation South Australian Cardiovascular Network Fellow, Early Origins of Adult Health Research Group, School of Pharmacy and Medical Sciences, Sansom Institute for Health Research, University of South Australia, Adelaide, South Australia, Australia.
authors.forename: Janna L
authors.initials: JL
authors.lastname: Morrison
keywords: data linkage; medication; pharmacovigilance; pregnancy; teratogen
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