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Frequency of adverse drug reactions in hospitalized patients: a systematic review and meta-analysis†
Version of Record online: 4 JUL 2012
Copyright © 2012 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 21, Issue 11, pages 1139–1154, November 2012
How to Cite
Miguel, A., Azevedo, L. F., Araújo, M. and Pereira, A. C. (2012), Frequency of adverse drug reactions in hospitalized patients: a systematic review and meta-analysis. Pharmacoepidem. Drug Safe., 21: 1139–1154. doi: 10.1002/pds.3309
- Issue online: 29 OCT 2012
- Version of Record online: 4 JUL 2012
- Manuscript Accepted: 30 MAY 2012
- Manuscript Revised: 29 MAY 2012
- Manuscript Received: 11 JAN 2012
- adverse drug reactions;
- systematic review;
To perform a comprehensive systematic review of prospective studies about frequency of adverse drug reactions (ADRs) occurring during hospitalization (ADRIn), including a thorough study quality assessment, meta-analysis and heterogeneity evaluation.
Systematic review of several databases: Pubmed, EMBASE, CINAHL, Cochrane, ISI, International Pharmaceutical Abstracts, Scirus, NHS economic, and others, as well as manual search. Inclusion criteria were: prospective studies (assessing all patients before discharge, by a specialized team, at least once a week); with data about ADRs occurring during hospitalization, using WHO's or similar definition of ADR. Two independent reviewers assessed eligibility criteria, extracted data, and evaluated risk of bias.
From 4139 studies initially found, 22 were included. Meta-analysis indicate that ADRs may occur in 16.88% (CI95%: 13.56,20.21%) of patients during hospitalization; however, this estimate has to be viewed with caution because there was significant heterogeneity (I2 = 99%). The most significant moderators of heterogeneity were risk of bias, population, ward, and methodology for ADR identification. Low risk of bias studies adjusted for population (pediatric versus adult) had I2 = 0%.
These data are useful as a broad characterization of in-hospital ADRs and their frequency. However, due to heterogeneity, our estimates are crude indicators. The wide variation in methodologies was one of the most important moderators of heterogeneity (even among studies using intensive monitoring). We suggest criteria to standardize methodologies and reduce the risk of bias. Copyright © 2012 John Wiley & Sons, Ltd.