Prevalence of adverse drug reactions in the primary care setting: A systematic review and meta-analysis

Widya N. Insani, Cate Whittlesea, Hassan Alwafi, Kenneth K.C. Man, Sarah Chapman, Li Wei

Research output: Contribution to journalReview articlepeer-review

44 Citations (SciVal)


Background Adverse drug reactions (ADRs) represent a major cause of iatrogenic morbidity and mortality in patient care. While a substantial body of work has been undertaken to characterise ADRs in the hospital setting, the overall burden of ADRs in the primary care remains unclear. Objectives To investigate the prevalence of ADRs in the primary care setting and factors affecting the heterogeneity of the estimates. Methods Studies were identified through searching of Medline, Embase, CINAHL and IPA databases. We included observational studies that reported information on the prevalence of ADRs in patients receiving primary care. Disease and treatment specific studies were excluded. Quality of the included studies were assessed using Smyth ADRs adapted scale. A random-effects model was used to calculate the pooled estimate. Potential source of heterogeneity, including age groups, ADRs definitions, ADRs detection methods, study setting, quality of the studies, and sample size, were investigated using sub-group analysis and meta-regression. Results Thirty-three studies with a total study population of 1,568,164 individuals were included. The pooled prevalence of ADRs in the primary care setting was 8.32% (95% CI, 7.82, 8.83). The percentage of preventable ADRs ranged from 12.35–37.96%, with the pooled estimate of 22.96% (95% CI, 7.82, 38.09). Cardiovascular system drugs were the most commonly implicated medication class. Methods of ADRs detection, age group, setting, and sample size contributed significantly to the heterogeneity of the estimates. Conclusion ADRs constitute a significant health problem in the primary care setting. Further research should focus on examining whether ADRs affect subsequent clinical outcomes, particularly in high-risk therapeutic areas. This information may better inform strategies to reduce the burden of ADRs in the primary care setting.

Original languageEnglish
Article numbere0252161
JournalPLoS ONE
Issue number5 (May)
Publication statusPublished - 26 May 2021

Bibliographical note

Funding Information:
WNI is funded by a scholarship from Indonesia Endowment Fund for Education (LPDP No. 201908223215121), Ministry of Finance, Republic of Indonesia. This funding body had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Publisher Copyright:
© 2021 Insani et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Copyright 2021 Elsevier B.V., All rights reserved.

ASJC Scopus subject areas

  • General


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