Literature DB >> 26553279

Recognition and Knowledge of Medications with Black Box Warnings Among Pediatricians and Emergency Physicians.

Craig Geoffrey Smollin1, Jonathan Fu2, Ross Levin2.   

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.

Keywords:  Adverse drug reactions; Black box warnings; FDA

Mesh:

Year:  2016        PMID: 26553279      PMCID: PMC4880604          DOI: 10.1007/s13181-015-0519-3

Source DB:  PubMed          Journal:  J Med Toxicol        ISSN: 1556-9039


  5 in total

1.  Pharmacy students' knowledge of black box warnings.

Authors:  Karen E Moeller; Theresa I Shireman; Joyce Generali; Sally Rigler; Angela Mayorga
Journal:  Am J Pharm Educ       Date:  2010-02-10       Impact factor: 2.047

2.  Boxed warning inconsistencies between drug information resources and the prescribing information.

Authors:  Christine M Cheng; Carrie Fu; B Joseph Guglielmo; Andrew D Auerbach
Journal:  Am J Health Syst Pharm       Date:  2011-09-01       Impact factor: 2.637

3.  Trends in boxed warnings and withdrawals for novel therapeutic drugs, 1996 through 2012.

Authors:  Christine M Cheng; Jaekyu Shin; B Joseph Guglielmo
Journal:  JAMA Intern Med       Date:  2014-10       Impact factor: 21.873

4.  Adherence to black box warnings for prescription medications in outpatients.

Authors:  Karen E Lasser; Diane L Seger; D Tony Yu; Andrew S Karson; Julie M Fiskio; Andrew C Seger; Nidhi R Shah; Tejal K Gandhi; Jeffrey M Rothschild; David W Bates
Journal:  Arch Intern Med       Date:  2006-02-13

5.  Prospective Assessment of Inpatient Boxed Warning Prescriber Adherence.

Authors:  Megan A Kloet; Brian R Lohr; Pamela L Smithburger; Amy L Seybert; Sandra L Kane-Gill
Journal:  J Patient Saf       Date:  2017-03       Impact factor: 2.844

  5 in total
  2 in total

1.  Assessment of Knowledge Regarding Safety Profile, Use, and Boxed Warnings of Fluoroquinolones Among Healthcare Professionals in Saudi Arabia: A Potential Implication for Drug Regulatory Authorities.

Authors:  Tauqeer Hussain Mallhi; Abdullah Salah Alanazi; Yusra Habib Khan; Nasser Hadal Alotaibi; Muhammad Salman; Abdulaziz Ibrahim Alzarea; Salah-Ud-Din Khan; Nabil K Alruwaili; Alaa Salah Alenazi; Ahmed D Alatawi; Zafar Iqbal; Muhammad Hammad Butt; Muhammad Shahid Iqbal
Journal:  Front Med (Lausanne)       Date:  2022-04-29

Review 2.  Risk Evaluation and Mitigation Strategies (REMSs): Are They Improving Drug Safety? A Critical Review of REMSs Requiring Elements to Assure Safe Use (ETASU).

Authors:  Pol F Boudes
Journal:  Drugs R D       Date:  2017-06
  2 in total

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