Medical College of Wisconsin
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Suboptimal reporting of adverse medical events to the FDA Adverse Events Reporting System by nurse practitioners and physician assistants. Expert Opin Drug Saf 2012 Mar;11(2):177-83



Pubmed ID




Scopus ID

2-s2.0-84857387094   7 Citations


OBJECTIVES: The Adverse Events Reporting System (AERS) of the FDA is used to identify toxicities of drugs that are on the market. Nurse practitioners (NP) and physician assistants (PA), having an increasing role in the delivery of medical care, are also needed to participate in post-marketing pharmacovigilance. This study was performed to assess awareness and use of the AERS in voluntary reporting of drug toxicities by NPs and PAs.

METHODS: A cluster sample survey was issued at the Principles of Gastroenterology for the Nurse Practitioner and Physician Assistant course in August 2010. The survey assessed familiarity with the AERS, the number of adverse events seen and the frequency of reports sent to the AERS. NP and PA responses were compared using the two-tailed Fisher's exact.

RESULTS: Of the 92 respondents, 67 (72%) were NPs and 24 (26%) PAs. Of the 50 (54%) respondents that reported being familiar with the AERS system, 20 (40%) incorrectly identified the methods to report using the AERS. Overall reporting of adverse events was low, particularly in respondents seeing 5-12 adverse events per year.

CONCLUSION: The study suggests that improved education regarding the importance of using AERS for pharmacovigilance is suggested for NPs and PAs. Due to the small size of the study, these data should be viewed as preliminary, pending a larger confirmatory study.

Author List

Ehrenpreis ED, Sifuentes H, Ehrenpreis JE, Smith ZL, Marshall ML


Zachary Smith DO Associate Professor in the Medicine department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adverse Drug Reaction Reporting Systems
Attitude of Health Personnel
Data Collection
Drug-Related Side Effects and Adverse Reactions
Health Knowledge, Attitudes, Practice
Nurse Practitioners
Physician Assistants
Professional Role
United States
United States Food and Drug Administration