title: Recognition and Knowledge of Medications with Black Box Warnings Among Pediatricians and Emergency Physicians.
abstract: "Boxed warnings" (BW), sometimes referred to as "black box warnings," are the most serious level of warning provided by the Food and Drug Administration (FDA). We aimed to assess physician awareness and knowledge of BW, and to gain a better understanding of where physicians obtain information about serious adverse drug reactions for commonly prescribed medications. A cross-sectional survey instrument was administered to emergency medicine (EM) and pediatrician (Peds) attending and resident physicians. The main outcome measures were physician performance in identifying medications with and without black box warnings and the content of the warnings. The survey response rate was 81/198 (41 %). Respondents correctly identified medications with BW only 36.3 % of the time, but were able to correctly identify medications without such warnings 83.8 % of the time. Attending physicians were better able to identify medications with or without BW when compared with residents (p < 0.05). Among residents, there was a statistically significant increase in the ability to identify medications with or without BW with increasing year of training (p < 0.01). Correct identification of the content of BW was low in both groups (13.3 %). Only 19/50 (37 %) EM physicians and 16/31 (52 %) Peds reported that they consider BW when prescribing medications. 23/81 (29 %) respondents indicated that they did not stay current or had no method of staying current with black box information. EM and Peds attending and resident physicians at a single institution had limited ability to identify medications containing BW or the content of such warnings. A significant number reported that they did not stay current or had no consistent method for staying current with BW.
authors.affiliation: Department of Emergency Medicine, University of California San Francisco, 1001 Potrero Ave, SFGH 5, 1E21, Box 1377, San Francisco, CA, 94143, USA. craig.smollin@emergency.ucsf.edu.
authors.forename: Craig Geoffrey
authors.initials: CG
authors.lastname: Smollin
authors.affiliation: Department of Emergency Medicine, University of California San Francisco, 1001 Potrero Ave, SFGH 5, 1E21, Box 1377, San Francisco, CA, 94143, USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Fu
authors.affiliation: Department of Emergency Medicine, University of California San Francisco, 1001 Potrero Ave, SFGH 5, 1E21, Box 1377, San Francisco, CA, 94143, USA.
authors.forename: Ross
authors.initials: R
authors.lastname: Levin
mesh_terms: D000046:Academic Medical Centers; D022126:Access to Information; D000328:Adult; D001291:Attitude of Health Personnel; D003430:Cross-Sectional Studies; D004346:Drug Information Services; D004348:Drug Labeling; D004502:Education, Medical, Continuing; D034742:Electronic Mail; D004636:Emergency Service, Hospital; D019538:Health Care Surveys; D006801:Humans; D007396:Internship and Residency; D008505:Medical Staff, Hospital; D000072143:Pediatricians / Q000193:education; D010865:Pilot Projects; D010818:Practice Patterns, Physicians'; D011361:Professional Competence; D012495:San Francisco; D000073819:Self-Directed Learning as Topic; D000078329:Workforce
keywords: Adverse drug reactions; Black box warnings; FDA