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.

Prevalence of antihypertensive, antidiabetic, and dyslipidemic prescription medication use among children and adolescents.

OBJECTIVE: To document trends in the use of prescription medications indicated for types 1 and 2 diabetes mellitus, hypertension, and dyslipidemia among children and adolescents. DESIGN: Serial, cross-sectional study. SETTING: Age-eligible children and adolescents with prescription drug benefits managed by CVS Caremark, a pharmacy benefits manager. PARTICIPANTS: Commercially insured US children and adolescents aged 6 to 18 years. Population size varied by month from approximately 5.3 million to 6 million individuals. MAIN OUTCOME MEASURE: Monthly prevalence of prescription drug use, measured from September 1, 2004, through June 30, 2007. RESULTS: The 1-month prevalence of antihypertensive, dyslipidemic, or oral antidiabetic medication or insulin use increased 15.2% from 3.3 per 1000 youths in November 2004 to 3.8 per 1000 youths in June 2007. The 16- to 18-year-olds had the highest prevalence overall, but the greatest rate of increase was found among 6- to 11-year-olds: 18.7% for girls and 17.3% for boys. Among antihypertensive medications, beta-blockers had the highest prevalence (1.5 per 1000 youths), followed by angiotensin-converting enzyme inhibitors, diuretics, calcium channel blockers, and angiotensin II receptor blockers. For 6- to 11-year-olds, angiotensin-converting enzyme inhibitor use increased 27.7% among girls and 25.2% among boys. Dyslipidemia therapy, which was dominated by statin use, declined 22.9%. CONCLUSIONS: The increasing use of oral antidiabetic and antihypertensive pharmacotherapy among children and adolescents, especially in the younger age group, indicates either an increased awareness of treatment needs or increased incidence of cardiovascular risk factors typically associated with adult populations. The decrease in treatment of dyslipidemia may reflect the ongoing controversy regarding statin use.