Off-Label Utilization of Antihypertensive Medications in Children

Objective: To examine off-label use and costs of antihypertensive drugs in children by using a national sample of prescription claims. Methods: We conducted a cross-sectional study using the 2002 Medstat MarketScan Database, a national sample of outpatient prescription claims of children ≤18 years old enrolled in private, employer-sponsored health plans. Our main outcomes were off-label use of antihypertensive drugs by patient age and costs of antihypertensives calculated as mean cost per child per 30-day fill. Results: One half of the index antihypertensive prescription claims were off label, based on minimum age criteria. Boys were more likely (56%) than girls (46%) to be prescribed off-label antihypertensives (P < .001). Children aged ≥12 years were more likely to be prescribed off-label antihypertensives (53%) compared with children aged ≤5 (46%) and 6-11 years (42%; P < .001). Off-label use varied significantly by class of antihypertensive drugs (P < .001). Overall, off-label antihypertensives were significantly more expensive than on-label antihypertensives. Conclusions: Despite availability of often less expensive on-label alternatives for the same class of antihypertensive drugs, off-label antihypertensive drugs were prescribed frequently in children. These findings underscore the potential clinical and economic implications of common off-label prescribing, for children, their parents, physicians, and payers.