Adverse Drug Events in Ambulatory Care: A Cross-Sectional Study

Joseph M. Plasek (), Mary G. Amato, Abigail Salem, Dinah Foer, Stuart Lipsitz, Gretchen Purcell Jackson, David W. Bates and Li Zhou ()
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Joseph M. Plasek: Brigham and Women’s Hospital
Mary G. Amato: Brigham and Women’s Hospital
Abigail Salem: Brigham and Women’s Hospital
Dinah Foer: Brigham and Women’s Hospital
Stuart Lipsitz: Brigham and Women’s Hospital
Gretchen Purcell Jackson: IBM Watson Health
David W. Bates: Brigham and Women’s Hospital
Li Zhou: Brigham and Women’s Hospital

Drug Safety, 2025, vol. 48, issue 4, No 4, 363-374

Abstract: Abstract Background Adverse drug events (ADEs) are understudied in the ambulatory care setting. We aim to estimate the prevalence and characteristics of ADEs in outpatient care using electronic health records (EHRs). Methods This cross-sectional study included EHR data for patients who had an outpatient encounter at an academic medical center from 1 October 2018 through 31 December 2019. We developed a stratified sampling strategy based on a comprehensive set of 994 ADE-related International Classification of Disease (ICD-10) codes to identify clinical encounters and notes likely to contain ADEs. Within each ICD-10 likelihood group, clinical notes were randomly sampled and annotated for present or possible ADE-drug relationships and severity. The overall estimated population prevalence of ADEs presenting in the outpatient setting was calculated. The generalizability of the findings was assessed by comparing ICD-10 code frequencies against a large commercial database. Results The study included 3126 notes (unique patient encounters) from 2882 unique patients. Of these, 1383 patient encounters (44.2%) had a present or possible ADE documented (6308 mentions). Of the 6038 ADEs mentioned, 14.1% were hypersensitivity reactions, 1.1% were life-threatening, 22.4% were serious, and 60.4% were significant. Main causal agents included anti-infectives (19.3%), central nervous system agents (12.8%), and cardiovascular agents (11.5%). The overall prevalence of present ADEs mentioned in the clinical notes was estimated to be 1.97 per 100 patient encounters (or 2.52 per 100 patient encounters when possible ADEs are included). Conclusions This study identified the overall population prevalence per encounter of ADEs in the outpatient population by leveraging ICD-10 codes and investigating ADEs documented in clinical notes. Understanding the ADE characteristics in a large corpus of outpatient documentation advances pharmacovigilance knowledge, enhancing the detection, monitoring, and prevention of ADEs in ambulatory care.

Date: 2025
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DOI: 10.1007/s40264-024-01501-w

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