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Exposed or not exposed? Exploring exposure classification in studies using administrative data to investigate outcomes following medication use during pregnancy

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Abstract

Purpose

The aim of this systematic review was to examine and compare differences in the way medication exposures are classified in studies using linked administrative data to investigate outcomes following medication use during pregnancy. This was undertaken with a focus on studies investigating specific neonatal outcomes following prenatal exposure to selective serotonin reuptake inhibitors (SSRIs).

Methods

We searched Medline and Embase to identify studies that used linked administrative data to investigate specific neonatal outcomes (congenital malformations, birth weight, gestational age) following prenatal exposure to SSRIs.

Results

Key factors such as dose, duration and timing of exposure were inconsistently addressed in the studies identified. In addition, there was a great deal of variability in the way medication exposures were classified and how women who stop taking their medication before or during early pregnancy are handled in analyses. Furthermore, there are issues in assuming how and when women who receive a dispensing for a medication actually take it during pregnancy. This creates a great deal of uncertainty around medication exposure during pregnancy in studies using linked administrative data, potentially resulting in biased risk estimates.

Conclusions

There is a need for greater focus on determining the most effective and accurate way of using linked administrative data to investigate outcomes following medication use during pregnancy in an effort to minimise potential biases.

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Acknowledgments

JLM was supported by a Heart Foundation South Australian Cardiovascular Research Network Fellowship (CR10A4988).

Conflict of interest

The authors declare that they have no conflict of interest

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Authors and Affiliations

  1. 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, SA, 5001, Australia

    Luke E. Grzeskowiak & Andrew L. Gilbert

  2. Early Origins of Adult Health Research Group, School of Pharmacy and Medical Sciences, Sansom Institute for Health Research, University of South Australia, Adelaide, SA, Australia

    Janna L. Morrison

Authors
  1. Luke E. Grzeskowiak
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  2. Andrew L. Gilbert
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  3. Janna L. Morrison
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Corresponding author

Correspondence to Luke E. Grzeskowiak.

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Grzeskowiak, L.E., Gilbert, A.L. & Morrison, J.L. Exposed or not exposed? Exploring exposure classification in studies using administrative data to investigate outcomes following medication use during pregnancy. Eur J Clin Pharmacol 68, 459–467 (2012). https://doi.org/10.1007/s00228-011-1154-9

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  • DOI: https://doi.org/10.1007/s00228-011-1154-9

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