Prescriber compliance with black box warnings in older adult patients.
BACKGROUND
Patients prescribed medications with US Food and Drug Administration-issued black box warnings (BBWs) warrant additional vigilance by prescribers because these drugs can cause serious adverse drug events. Seniors are at greater risk for adverse drug events due to increased medication burden and greater health vulnerability.


OBJECTIVE
To improve our understanding of the prescribing and patient-monitoring practices of physicians prescribing medications with a BBW to patients age >or=65 years in an ambulatory care setting.


METHODS
A retrospective cohort study of administrative pharmacy and medical claims identified 58,190 patients age >or=65 years in the Horizon Blue Cross Blue Shield of New Jersey beneficiary population with >or=1 claim for >or=1 of the 8 targeted medications between January 1, 2005, and December 31, 2005. Medications included carbamazepine, amiodarone, ketoconazole, loop diuretics, methotrexate, cyclosporine, metformin and combinations, and cilostazol. Patients were followed 12 months from the index prescription date to evaluate prescriber compliance with BBWs using operationalized definitions of compliance.


RESULTS
Patients prescribed drugs with a drug-laboratory warning had lower rates of prescriber BBW compliance (0.7%-24.9%) than patients prescribed drugs with a drug-disease warning (84.7%-90.2%).


CONCLUSIONS
Administrative claims analysis identified low rates of prescriber compliance with BBWs in managing patients age >or=65 years. Claims analysis may be a cost-effective strategy to monitor prescriber compliance with BBWs in older patients at higher risk.
Ricci
Judith R
JR
CVS Caremark, Hunt Valley, MD, USA.
Coulen
Charmaine
C
Berger
Jan E
JE
Moore
Marsha C
MC
McQueen
Angela
A
Jan
Saira A
SA
D000368:Aged; D015331:Cohort Studies; D004348:Drug Labeling; D011307:Drug Prescriptions / Q000706:statistics & numerical data*; D006801:Humans; D007345:Insurance Claim Review; D004364:Pharmaceutical Preparations; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D012189:Retrospective Studies; D014481:United States; D014486:United States Food and Drug Administration
D004364:Pharmaceutical Preparations