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  • Title: Impact of implementing alerts about medication black-box warnings in electronic health records.
    Author: Yu DT, Seger DL, Lasser KE, Karson AS, Fiskio JM, Seger AC, Bates DW.
    Journal: Pharmacoepidemiol Drug Saf; 2011 Feb; 20(2):192-202. PubMed ID: 21254291.
    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.
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