Impact of implementing alerts about medication black-box warnings in electronic health records.
BACKGROUND
The Food and Drug Administration issues black-box warnings (BBWs) regarding medications with serious risks, yet physician adherence to the warnings is low.


METHODS
We evaluated the impact of delivering BBW-based alerts about drug-drug, drug-disease, and drug-laboratory interactions for prescription medications in outpatients in an electronic health record with clinical decision support. We compared the frequency of non-adherence to all BBWs about drug-drug, drug-disease, and drug-laboratory interactions for 30 drugs/drug classes, and by individual drugs/drug groups with BBWs between the pre- and post-intervention periods. We used multivariate analysis to identify independent risk factors for non-adherence to BBWs.


RESULTS
There was a slightly higher frequency of non-adherence to BBWs after the intervention (4.8% vs. 5.1%, p=0.045). In multivariate analyses, after adjustment for patient and provider characteristics and site of care, medications prescribed during the pre-intervention period were less likely to violate BBWs compared to those prescribed during the post-intervention period (OR 0.67, 95% CI, 0.47-0.96). However, black-box warning violations did decrease after the intervention for BBWs about drug-drug interactions (6.1% vs. 1.8%, p<0.0001) and drug-pregnancy interactions (5.1% vs. 3.6%, p=0.01).


CONCLUSIONS
Ambulatory care computerized order entry with prescribing alerts about BBWs did not improve clinicians' overall adherence to BBWs, though it did improve adherence for specific clinically important subcategories.
Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02120, USA.
Donghui Tony
DT
Yu
Diane L
DL
Seger
Karen E
KE
Lasser
Andrew S
AS
Karson
Julie M
JM
Fiskio
Andrew C
AC
Seger
David W
DW
Bates
D000293:Adolescent; D000328:Adult; D000368:Aged; D000553:Ambulatory Care; D001900:Boston; D016009:Chi-Square Distribution; D003257:Consumer Product Safety; D020000:Decision Support Systems, Clinical; D004346:Drug Information Services; D004347:Drug Interactions; D004348:Drug Labeling; D004360:Drug Therapy, Computer-Assisted; D064420:Drug-Related Side Effects and Adverse Reactions; D057286:Electronic Health Records; D005260:Female; D019983:Guideline Adherence; D006801:Humans; D016015:Logistic Models; D008297:Male; D050316:Medical Order Entry Systems; D008508:Medication Errors / Q000517:prevention & control*; D008875:Middle Aged; D016017:Odds Ratio; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians'; D018570:Risk Assessment; D012307:Risk Factors; D014481:United States; D014486:United States Food and Drug Administration; D055815:Young Adult