Improving the quality of adverse drug reaction reporting by 4th-year medical students

Curtis J. Rosebraugh, Yi Tsong, Feng Zhou, Min Chen, Ann Corken Mackey, Charlene Flowers, Denise Toyer, David A. Flockhart, Peter K. Honig

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

Purpose. Evaluate whether a 15-minute lecture intervention will improve adverse drug reaction reporting quality on standard MedWatch forms. Methods. Seventy-eight 4th-year medical students were randomized to intervention 'Group-A' or non-intervention 'Group-B' on the first day of a required five-day clinical pharmacology rotation. Group-A participants attended a 15-minute lecture on completing a MedWatch form with quality information considered by the Food and Drug Administration as critical to adequate adverse drug reaction reporting. Group-B participants did not attend this lecture. Both groups then watched a standardized patient interview of a recognizable adverse drug reaction and completed MedWatch forms. Four Safety Evaluators from the Food and Drug Administration (FDA) rated student responses in a blinded fashion for the primary efficacy variable of Overall Impression and six informational domins using a standardized data quality analysis form that was developed within the Office of Postmarketing Drug Risk Assessment of the FDA. Results. Seventy-eight MedWatch forms were evaluated (Group-A = 40, Group-B = 38). Overall MedWatch information quality scores for the intervention group were significantly higher than the non-intervention group (p < 0.004). Conclusions. As little as a 15-minute intervention can significantly improve the quality of adverse drug reaction reporting by 4th-year medical students. Academic medical centers should consider incorporating adverse drug reaction reporting curriculum into the clinical training of medical students.

Original languageEnglish
Pages (from-to)97-101
Number of pages5
JournalPharmacoepidemiology and Drug Safety
Volume12
Issue number2
DOIs
StatePublished - Mar 2003

Fingerprint

Drug-Related Side Effects and Adverse Reactions
Medical Students
United States Food and Drug Administration
Clinical Pharmacology
Curriculum
Interviews
Students
Safety
Pharmaceutical Preparations

Keywords

  • Adverse drug reaction
  • Adverse drug reaction reporting
  • Food and drug administration
  • MedWatch
  • Standardize patient

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

Rosebraugh, C. J., Tsong, Y., Zhou, F., Chen, M., Mackey, A. C., Flowers, C., ... Honig, P. K. (2003). Improving the quality of adverse drug reaction reporting by 4th-year medical students. Pharmacoepidemiology and Drug Safety, 12(2), 97-101. https://doi.org/10.1002/pds.797

Improving the quality of adverse drug reaction reporting by 4th-year medical students. / Rosebraugh, Curtis J.; Tsong, Yi; Zhou, Feng; Chen, Min; Mackey, Ann Corken; Flowers, Charlene; Toyer, Denise; Flockhart, David A.; Honig, Peter K.

In: Pharmacoepidemiology and Drug Safety, Vol. 12, No. 2, 03.2003, p. 97-101.

Research output: Contribution to journalArticle

Rosebraugh, CJ, Tsong, Y, Zhou, F, Chen, M, Mackey, AC, Flowers, C, Toyer, D, Flockhart, DA & Honig, PK 2003, 'Improving the quality of adverse drug reaction reporting by 4th-year medical students', Pharmacoepidemiology and Drug Safety, vol. 12, no. 2, pp. 97-101. https://doi.org/10.1002/pds.797
Rosebraugh, Curtis J. ; Tsong, Yi ; Zhou, Feng ; Chen, Min ; Mackey, Ann Corken ; Flowers, Charlene ; Toyer, Denise ; Flockhart, David A. ; Honig, Peter K. / Improving the quality of adverse drug reaction reporting by 4th-year medical students. In: Pharmacoepidemiology and Drug Safety. 2003 ; Vol. 12, No. 2. pp. 97-101.
@article{58fb68f5d82c4501be8d1dae47942e73,
title = "Improving the quality of adverse drug reaction reporting by 4th-year medical students",
abstract = "Purpose. Evaluate whether a 15-minute lecture intervention will improve adverse drug reaction reporting quality on standard MedWatch forms. Methods. Seventy-eight 4th-year medical students were randomized to intervention 'Group-A' or non-intervention 'Group-B' on the first day of a required five-day clinical pharmacology rotation. Group-A participants attended a 15-minute lecture on completing a MedWatch form with quality information considered by the Food and Drug Administration as critical to adequate adverse drug reaction reporting. Group-B participants did not attend this lecture. Both groups then watched a standardized patient interview of a recognizable adverse drug reaction and completed MedWatch forms. Four Safety Evaluators from the Food and Drug Administration (FDA) rated student responses in a blinded fashion for the primary efficacy variable of Overall Impression and six informational domins using a standardized data quality analysis form that was developed within the Office of Postmarketing Drug Risk Assessment of the FDA. Results. Seventy-eight MedWatch forms were evaluated (Group-A = 40, Group-B = 38). Overall MedWatch information quality scores for the intervention group were significantly higher than the non-intervention group (p < 0.004). Conclusions. As little as a 15-minute intervention can significantly improve the quality of adverse drug reaction reporting by 4th-year medical students. Academic medical centers should consider incorporating adverse drug reaction reporting curriculum into the clinical training of medical students.",
keywords = "Adverse drug reaction, Adverse drug reaction reporting, Food and drug administration, MedWatch, Standardize patient",
author = "Rosebraugh, {Curtis J.} and Yi Tsong and Feng Zhou and Min Chen and Mackey, {Ann Corken} and Charlene Flowers and Denise Toyer and Flockhart, {David A.} and Honig, {Peter K.}",
year = "2003",
month = "3",
doi = "10.1002/pds.797",
language = "English",
volume = "12",
pages = "97--101",
journal = "Pharmacoepidemiology and Drug Safety",
issn = "1053-8569",
publisher = "John Wiley and Sons Ltd",
number = "2",

}

TY - JOUR

T1 - Improving the quality of adverse drug reaction reporting by 4th-year medical students

AU - Rosebraugh, Curtis J.

AU - Tsong, Yi

AU - Zhou, Feng

AU - Chen, Min

AU - Mackey, Ann Corken

AU - Flowers, Charlene

AU - Toyer, Denise

AU - Flockhart, David A.

AU - Honig, Peter K.

PY - 2003/3

Y1 - 2003/3

N2 - Purpose. Evaluate whether a 15-minute lecture intervention will improve adverse drug reaction reporting quality on standard MedWatch forms. Methods. Seventy-eight 4th-year medical students were randomized to intervention 'Group-A' or non-intervention 'Group-B' on the first day of a required five-day clinical pharmacology rotation. Group-A participants attended a 15-minute lecture on completing a MedWatch form with quality information considered by the Food and Drug Administration as critical to adequate adverse drug reaction reporting. Group-B participants did not attend this lecture. Both groups then watched a standardized patient interview of a recognizable adverse drug reaction and completed MedWatch forms. Four Safety Evaluators from the Food and Drug Administration (FDA) rated student responses in a blinded fashion for the primary efficacy variable of Overall Impression and six informational domins using a standardized data quality analysis form that was developed within the Office of Postmarketing Drug Risk Assessment of the FDA. Results. Seventy-eight MedWatch forms were evaluated (Group-A = 40, Group-B = 38). Overall MedWatch information quality scores for the intervention group were significantly higher than the non-intervention group (p < 0.004). Conclusions. As little as a 15-minute intervention can significantly improve the quality of adverse drug reaction reporting by 4th-year medical students. Academic medical centers should consider incorporating adverse drug reaction reporting curriculum into the clinical training of medical students.

AB - Purpose. Evaluate whether a 15-minute lecture intervention will improve adverse drug reaction reporting quality on standard MedWatch forms. Methods. Seventy-eight 4th-year medical students were randomized to intervention 'Group-A' or non-intervention 'Group-B' on the first day of a required five-day clinical pharmacology rotation. Group-A participants attended a 15-minute lecture on completing a MedWatch form with quality information considered by the Food and Drug Administration as critical to adequate adverse drug reaction reporting. Group-B participants did not attend this lecture. Both groups then watched a standardized patient interview of a recognizable adverse drug reaction and completed MedWatch forms. Four Safety Evaluators from the Food and Drug Administration (FDA) rated student responses in a blinded fashion for the primary efficacy variable of Overall Impression and six informational domins using a standardized data quality analysis form that was developed within the Office of Postmarketing Drug Risk Assessment of the FDA. Results. Seventy-eight MedWatch forms were evaluated (Group-A = 40, Group-B = 38). Overall MedWatch information quality scores for the intervention group were significantly higher than the non-intervention group (p < 0.004). Conclusions. As little as a 15-minute intervention can significantly improve the quality of adverse drug reaction reporting by 4th-year medical students. Academic medical centers should consider incorporating adverse drug reaction reporting curriculum into the clinical training of medical students.

KW - Adverse drug reaction

KW - Adverse drug reaction reporting

KW - Food and drug administration

KW - MedWatch

KW - Standardize patient

UR - http://www.scopus.com/inward/record.url?scp=0037337821&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0037337821&partnerID=8YFLogxK

U2 - 10.1002/pds.797

DO - 10.1002/pds.797

M3 - Article

VL - 12

SP - 97

EP - 101

JO - Pharmacoepidemiology and Drug Safety

JF - Pharmacoepidemiology and Drug Safety

SN - 1053-8569

IS - 2

ER -