Black Box Warning Contraindicated Comedications: Concordance Among Three Major Drug Interaction Screening Programs
- 1 January 2010
- journal article
- Published by SAGE Publications in Annals of Pharmacotherapy
- Vol. 44 (1), 28-34
- https://doi.org/10.1345/aph.1m475
Abstract
BACKGROUND Black box warnings represent the strongest safety warning that the Food and Drug Administration can issue for a marketed prescription drug. Some black box warnings recommend against coadministration of specific medications due to an increased risk for serious, perhaps life-threatening, effects. OBJECTIVE To determine the level of agreement in presence, clinical severity scores level of documentation ratings, and alert content among 3 leading drug interaction screening programs with regard to contraindicated comedications that are mentioned in black box warnings. METHODS We reviewed the prescribing information for currently marketed prescription drugs with a black box warning that mentioned a contraindicated drug combination. We selected the drug interaction databases Facts & Comparisons 4.0, MICROMEDEX DRUG-REAX, and Lexi-Comp Lexi-Interact to evaluate the interactions. Discrepancies in the inclusion of interactions and level of agreement in clinical severity scores and level of documentation ratings for each interaction were assessed, using descriptive statistics, Spearman's correlation coefficient, Kendall-Stuart Ö-c, and Cronbach's α. RESULTS We identified 11 drugs with black box warnings that contained information on 59 unique contraindicated drug combinations, only 68% of which were covered by any source. Lexi-Comp detected the most interactions (n = 29) and DRUG-REAX the least (n = 18). Only 3 drug combinations were detected and rated as contraindicated or potentially life-threatening in all 3 databases. The severity scores and level of documentation ratings varied widely. CONCLUSIONS There are discrepancies among major drug interaction screening programs in the inclusion, severity, and level of documentation of contraindicated drug combinations mentioned in black box warnings. Further studies could explore the implications of these inconsistencies, particularly with regard to the integration of black box warning information in clinical practice. Clinicians should consult multiple drug resources to maximize the potential for detecting a potentially severe drug interaction.Keywords
This publication has 18 references indexed in Scilit:
- New drugs and dosage formsAmerican Journal of Health-System Pharmacy, 2008
- Clinical Decision Support Tools: Performance of Personal Digital Assistant versus Online Drug Information DatabasesPharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, 2007
- Spillover Effects on Treatment of Adult Depression in Primary Care After FDA Advisory on Risk of Pediatric Suicidality With SSRIsAmerican Journal of Psychiatry, 2007
- Decline in Treatment of Pediatric Depression After FDA Advisory on Risk of Suicidality With SSRIsAmerican Journal of Psychiatry, 2007
- FDA drug prescribing warnings: is the black box half empty or half full?Pharmacoepidemiology and Drug Safety, 2005
- Evaluation of Drug Interaction Software to Identify Alerts for Transplant MedicationsAnnals of Pharmacotherapy, 2005
- Current status of pharmacist-operated drug information centers in the United StatesAmerican Journal of Health-System Pharmacy, 2004
- Timing of New Black Box Warnings and Withdrawals for Prescription MedicationsJAMA, 2002
- What is coefficient alpha? An examination of theory and applications.Journal of Applied Psychology, 1993
- Ordinal Measures of AssociationJournal of the American Statistical Association, 1958