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Drug Saf. 2016 Nov;39(11):1117-1127.

A Survey of Adverse Event Reporting Practices Among US Healthcare Professionals.

Author information

1
Tufts Center for the Study of Drug Development, Tufts Medical School, 75 Kneeland Street, Ste 1100, Boston, MA, 02111, USA. stella.stergiopoulos@tufts.edu.
2
Tufts Center for the Study of Drug Development, Tufts Medical School, 75 Kneeland Street, Ste 1100, Boston, MA, 02111, USA.
3
Amgen Inc., Washington, DC, USA.
4
Amgen Inc., Thousand Oaks, CA, USA.

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.

PMID:
27638657
PMCID:
PMC5045838
DOI:
10.1007/s40264-016-0455-4
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

Compliance with Ethical Standards Declaration of conflicting interests Gustavo Grampp and Thomas Felix are employed by Amgen Inc., own stock, and/or hold stock options in Amgen, Inc., and have provided expert testimony on behalf of Amgen Inc. in support of legislation in US states that allows for automatic substitution of FDA-approved interchangeable biologic products with provisions to communicate and record biologic product dispensed. Gustavo Grampp and Thomas Felix have no conflicts of interest that are directly relevant to the content of the study. Carrie A. Brown, Kenneth A. Getz, and Stella Stergiopoulos have no conflicts of interest that are directly relevant to the content of this study. Carrie A. Brown was employed at Tufts University at the time the study was conducted and is now affiliated with Boston University. Funding This study was funded by a non-restricted grant from Amgen.

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