@article{7046, author = {Donghui Tony Yu and Diane L. Seger and Karen E. Lasser and Andrew Karson and Julie M. Fiskio and Andrew C. Seger and David W. Bates}, title = {Impact of implementing alerts about medication black-box warnings in electronic health records.}, abstract = {

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.

}, year = {2011}, journal = {Pharmacoepidemiol Drug Saf}, volume = {20}, pages = {192-202}, month = {02/2011}, issn = {1099-1557}, doi = {10.1002/pds.2088}, language = {eng}, }