Knowledge Level and Perceptions of Pharmacists and Prescribers Regarding Boxed Warnings

Background: Black box warnings indicating harmful or potentially fatal adverse events are required by the Food and Drug Administration on certain drugs and chemical entities; however it is unclear if prescribing and dispensing habits are impacted by these warnings. This study investigates the knowledge and perceptions of prescribers and pharmacists regarding black box warnings.

Methods: A cross-sectional survey of self-reported behavior related to black box warnings was administered to prescribers and pharmacists across North Carolina between October 2010 and January 2011.

Results: A total of 867 pharmacists and prescribers completed the survey, including 715 pharmacists and 152 prescribers. Of the respondents, 54% were female and 92% described their ethnicity as Caucasian. Overall, pharmacists reported a greater change in behavior than did prescribers in relation to the presence of a boxed warning (P < .01). Pharmacists also demonstrated a significantly greater overall knowledge of boxed warnings compared to prescribers (P < .01). No differences in reported behavior or knowledge were observed between prescribers and pharmacists based on demographic factors.

Limitations: Solicitation through professional association mailing lists resulting in low response rates may impact findings.

Conclusion: Overall knowledge on information pertaining to boxed warnings was lacking. Impact in clinical practice due to the lack of understanding regarding boxed warnings may put patients at increased risk. To improve the overall knowledge of black boxed warnings, the FDA should adopt develop a publicly available central repository for all black box warnings. Curricula in schools of medicine and pharmacy as well as professional continuing education should include a focus on boxed warnings.