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
Date
02/10/2012Pubmed ID
22316142DOI
10.1517/14740338.2012.650165Scopus ID
2-s2.0-84857387094 (requires institutional sign-in at Scopus site) 7 CitationsAbstract
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 MLAuthor
Zachary Smith DO Associate Professor in the Medicine department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
Adverse Drug Reaction Reporting SystemsAttitude of Health Personnel
Awareness
Data Collection
Drug-Related Side Effects and Adverse Reactions
Health Knowledge, Attitudes, Practice
Humans
Nurse Practitioners
Pharmacovigilance
Physician Assistants
Professional Role
United States
United States Food and Drug Administration
Volition
