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Adverse Drug Events in Ambulatory Care: A Cross-Sectional Study
Joseph M Plasek1,2,3, Mary G Amato4,5, Abigail Salem4,5,6
1Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA. jplasek@mgb.org.
Drug Safety
|December 2, 2024
Summary
Adverse drug events (ADEs) occurred in 44.2% of outpatient encounters, with anti-infectives and CNS agents being common causes. This research enhances pharmacovigilance by detailing ADE prevalence and characteristics in ambulatory care.
Area of Science:
- Pharmacovigilance
- Health Informatics
- Clinical Pharmacology
Background:
- Adverse drug events (ADEs) are significantly understudied in ambulatory care settings.
- Electronic Health Records (EHRs) offer a valuable resource for investigating ADEs in outpatient populations.
- Understanding ADE prevalence is crucial for improving patient safety in non-hospital settings.
Purpose of the Study:
- To estimate the prevalence and characterize Adverse Drug Events (ADEs) in the outpatient setting.
- To leverage Electronic Health Records (EHRs) for comprehensive ADE analysis.
- To inform pharmacovigilance strategies for ambulatory care.
Main Methods:
- A cross-sectional study utilizing EHR data from an academic medical center (October 2018 - December 2019).
- A stratified sampling strategy using 994 International Classification of Disease (ICD-10) codes related to ADEs.
- Random sampling and annotation of clinical notes to identify ADEs, their causal agents, and severity.
Main Results:
- Out of 3126 analyzed notes, 44.2% documented present or possible ADEs, totaling 6308 mentions.
- Hypersensitivity reactions (14.1%) and significant ADEs (60.4%) were most common.
- Estimated prevalence was 1.97 per 100 encounters (2.52 per 100 including possible ADEs), with anti-infectives and CNS agents as primary causal agents.
Conclusions:
- This study quantifies ADE prevalence in outpatient settings using ICD-10 codes and clinical notes.
- Findings advance pharmacovigilance by detailing ADE characteristics in ambulatory care.
- Improved detection, monitoring, and prevention of ADEs in outpatient settings are facilitated by this research.
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