A Survey of Adverse Event Reporting Practices Among US Healthcare Professionals

Stella Stergiopoulos (), Carrie A. Brown, Thomas Felix, Gustavo Grampp and Kenneth A. Getz
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Stella Stergiopoulos: Tufts Medical School
Carrie A. Brown: Tufts Medical School
Thomas Felix: Amgen Inc.
Gustavo Grampp: Amgen Inc.
Kenneth A. Getz: Tufts Medical School

Drug Safety, 2016, vol. 39, issue 11, No 6, 1117-1127

Abstract: Abstract Introduction The under-reporting of adverse drug events (ADEs) is an international health concern. A number of studies have assessed the root causes but, to our knowledge, little information exists relating under-reporting to practices and systems used for the recording and tracking of drug‐related adverse event observations in ambulatory settings, institutional settings, and retail pharmacies. Objectives Our objective was to explore the process for reporting ADEs in US hospitals, ambulatory settings, and retail pharmacies; to explore gaps and inconsistencies in the reporting process; and to identify the causes of under-reporting ADEs in these settings. Methods The Tufts Center for the Study of Drug Development (Tufts CSDD) interviewed 11 thought leaders and conducted a survey between May and August 2014 among US-based healthcare providers (HCPs) in diverse settings to assess their experiences with, and processes for, reporting ADEs. Results A total of 123 individuals completed the survey (42 % were pharmacists; 27 % were nurses; 15 % were physicians; and 16 % were classified as ‘other’). HCPs indicated that the main reasons for under-reporting were difficulty in determining the cause of the ADE, given that most patients receive multiple therapies simultaneously (66 % of respondents); that HCPs lack sufficient time to report ADEs (63 % of respondents); poor integration of ADE-reporting systems (53 % of respondents); and uncertainty about reporting procedures (52 % of respondents). Discussion The results of this pilot study identify that key factors contributing to the under-reporting of ADEs relate to a lack of standardized process, a lack of training and education, and a lack of integrated health information technologies.

Date: 2016
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DOI: 10.1007/s40264-016-0455-4

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