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A Survey of Adverse Event Reporting Practices Among US Healthcare Professionals

Author

Listed:
  • 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)

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.

Suggested Citation

  • Stella Stergiopoulos & Carrie A. Brown & Thomas Felix & Gustavo Grampp & Kenneth A. Getz, 2016. "A Survey of Adverse Event Reporting Practices Among US Healthcare Professionals," Drug Safety, Springer, vol. 39(11), pages 1117-1127, November.
    • Handle: RePEc:spr:drugsa:v:39:y:2016:i:11:d:10.1007_s40264-016-0455-4
    DOI: 10.1007/s40264-016-0455-4
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    References listed on IDEAS

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    1. Kevin Klein & Joep H. G. Scholl & Niels S. Vermeer & André W. Broekmans & Eugène P. Puijenbroek & Marie L. Bruin & Pieter Stolk, 2016. "Traceability of Biologics in The Netherlands: An Analysis of Information-Recording Systems in Clinical Practice and Spontaneous ADR Reports," Drug Safety, Springer, vol. 39(2), pages 185-192, February.
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    Cited by:

    1. Karen Smith & Su Golder & Abeed Sarker & Yoon Loke & Karen O’Connor & Graciela Gonzalez-Hernandez, 2018. "Methods to Compare Adverse Events in Twitter to FAERS, Drug Information Databases, and Systematic Reviews: Proof of Concept with Adalimumab," Drug Safety, Springer, vol. 41(12), pages 1397-1410, December.
    2. Solomon Shiferaw Nadew & Kidanemariam G/Michael Beyene & Solomon Worku Beza, 2020. "Adverse drug reaction reporting practice and associated factors among medical doctors in government hospitals in Addis Ababa, Ethiopia," PLOS ONE, Public Library of Science, vol. 15(1), pages 1-19, January.
    3. Patricia García-Abeijon & Catarina Costa & Margarita Taracido & Maria Teresa Herdeiro & Carla Torre & Adolfo Figueiras, 2023. "Factors Associated with Underreporting of Adverse Drug Reactions by Health Care Professionals: A Systematic Review Update," Drug Safety, Springer, vol. 46(7), pages 625-636, July.
    4. Alaa M. Abu Alrub & Yasser Sami Amer & Maher Abdelraheim Titi & Aisha Charmaine A. May & Farheen Shaikh & Maram M. Baksh & Fadi El‐Jardali, 2022. "Barriers and enablers in implementing an electronic incident reporting system in a teaching hospital: A case study from Saudi Arabia," International Journal of Health Planning and Management, Wiley Blackwell, vol. 37(2), pages 854-872, March.

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