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

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Adverse drug event (ADE) reporting by pharmacists is an indispensable part of the drug safety system. U.S. pharmacists may submit reports of serious ADEs that they encounter to the Food and Drug Administration (FDA) through MedWatch. However, underreporting of serious ADEs is a common problem. Little is known about pharmacists’ decision making with respect to ADE reporting.


This study explored the utility of the theory of planned behavior (TPB) model in predicting Texas pharmacists’ intention to report serious ADEs to the FDA.


Data were collected from practicing Texas pharmacists using a mail questionnaire. A total of 1500 surveys were mailed, and 377 usable responses were obtained for a response rate of 26.4%.


A majority (70.2%) of the 377 respondents were white/Caucasian, and 52.9% were male. Overall, pharmacists intended to report serious ADEs (mean=15.87±4.22; possible range: 3-21), had a positive attitude toward reporting (mean=4.62±4.92; possible range: −15 to +15), perceived that important others wanted them to report (subjective norm [SN] score=5.65±2.99; possible range: −9 to +9), and believed that they had control over their reporting behavior (perceived behavioral control [PBC] score=3.54±2.69; possible/actual range: −6 to +6). Attitude (β=0.221, P<.001) and SN (β=0.438, P<.001) significantly predicted intent; however, PBC (β=0.028, P>.05) did not. Attitude, SN, and PBC together accounted for 34.0% of the variance in intention to report serious ADEs (P<.001). The addition of past reporting behavior (P=.021) and perceived moral obligation (P<.001) significantly increased the variance in intention explained by the TPB model.


Pharmacists showed a strong positive intent to report serious ADEs to the FDA. Strategies to increase pharmacists’ intentions to report serious ADEs should focus on helping them see the value of reporting and altering their perception of social pressure toward reporting. The TPB may have utility in predicting ADE-reporting behavior.

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