Examination of pharmacists’ intention to report serious adverse drug events (ADEs) to the FDA using the theory of planned behavior

Gavaza, Paul; Brown, Carolyn M.; Lawson, Kenneth A.; Rascati, Karen L.; Wilson, James P.; Steinhardt, M

doi:10.1016/j.sapharm.2010.09.001

Cited by 60 publications

(71 citation statements)

References 69 publications

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“…This finding concurs with Gavaza and colleagues who found that Texas pharmacists had a strong positive intent to report serious ADEs to the FDA. 7 This finding is encouraging and may result in more reports from students if these intentions are translated into behavior. Behavioral intention and its antecedents are important predictors of ADE reporting behavior among pharmacists, other factors being equal.…”

Section: Discussionmentioning

confidence: 80%

“…Behavioral intention and its antecedents are important predictors of ADE reporting behavior among pharmacists, other factors being equal. 7 Pharmacy students have mostly positive attitude toward reporting serious ADEs to the FDA. Students believed that ADE reporting was valuable, good, and beneficial.…”

Section: Discussionmentioning

confidence: 99%

“…6,7,26 The survey instrument had 58 items designed to measure the respondents' intention, attitude, knowledge of ADE reporting, and demographic data.…”

Section: Methodsmentioning

confidence: 99%

“…1 Underreporting of ADEs, including serious or severe ADEs to spontaneous reporting systems by healthcare professionals is common. [5][6][7] Failure to report ADEs is influenced by many factors, such as lack of time, indifference, malpractice litigation concerns, lack of motivation, lack of economic incentive, complacency, lack of knowledge on ADE reporting requirements, and negative attitudes. 5,6,8,9 In addition, reluctance to send reports based on mere suspicion of ADEs, lack of confidence in recognizing adverse drug reactions, misconceptions about ADE reporting, and difficulty in accessing means of reporting (eg, forms) [10][11][12][13][14][15][16] also affect the reporting of ADEs.…”

Section: Introductionmentioning

confidence: 99%

“…20 Intention is in turn shaped by attitudes toward the behavior, social norms, and perceived control over the behavior. The theory of planned behavior has been used successfully to predict behaviors of pharmacists 7,21,22 and other healthcare professionals. [23][24][25] Thus, the theory of planned behavior provides a promising framework for predicting pharmacy students' intention and behaviors and was used as the guiding theoretical framework in the current study.…”

Section: Introductionmentioning

confidence: 99%

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Pharmacy Students’ Attitudes Toward Reporting Serious Adverse Drug Events

Gavaza

Bui

2012

American Journal of Pharmaceutical Education

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Objectives. To determine pharmacy students' attitude toward and knowledge of reporting serious adverse drug events (ADEs) to the Food and Drug Administration (FDA). Method. A 58-item survey questionnaire constructed to measure respondents' intention to report ADEs (3 items), attitude toward reporting ADEs (20 items), knowledge of ADE reporting (9 items), and demographic data was administered to all third-year (final-year) pharmacy students at the Appalachian College of Pharmacy.Results. The majority of the 58 students who responded (91% response rate) intended (84%) and planned (85.3%) to report serious ADEs when they encounter them. Most respondents had favorable attitudes toward reporting serious ADEs to the FDA; respondents believed that reporting serious ADEs was valuable (5.6 6 1.5, mean 6 SD), good (3.0 6 1.7), and beneficial (5.7 6 1.5). Many students also believed that ADE reporting resulted in increased risk of malpractice, compromised relationships with physicians, broken trust with patients, disruption of the normal workflow, and was time consuming. Many students had inadequate knowledge on reporting ADEs. Conclusion. Although pharmacy students had strong intentions and favorable attitudes toward ADE reporting, they had inadequate knowledge of how to report serious ADEs.

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Section: Discussionmentioning

confidence: 80%

Section: Discussionmentioning

confidence: 99%

“…6,7,26 The survey instrument had 58 items designed to measure the respondents' intention, attitude, knowledge of ADE reporting, and demographic data.…”

Section: Methodsmentioning

confidence: 99%