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Editorials

Pharmacotherapy for Pediatric Cardiovascular Diseases

The Role of Off-Label Drug Use in the 21st Century

John C. Ring, MD

From the Office of Policy Research and Development, American Heart Association—National Center, Washington, DC.

Correspondence to John C. Ring, MD, American Heart Association—National Center, 1150 Connecticut Ave, NW, Suite 300, Washington, DC 20036. E-mail john.ring@heart.org

Key Words: pediatrics • pharmacology • drug research • evidence-based drug therapy

An extract of the first 250 words of the full text is provided, because this article has no abstract.

Rigorous scientific investigation is the foundation for many of the remarkable advances in medical care that have occurred over the course of the last century. Patients with cardiovascular diseases, in particular, have received considerable benefit from such research, especially that which pertains to drugs and medical devices. Infants and children, however, have not benefited proportionately from this great increase in knowledge, due to several factors: the economic return on investment is often insufficient for industry to justify the commitment of substantial resources to meet the opportunity cost of a relatively small patient population; the research capacity for pediatrics has been limited; and child patients have been considered ethically unsuitable subjects for study. As a result, drug therapy of many sorts in pediatric patients has been guided too often by theory or extrapolation from practice with adults and by expert experience and good intentions rather than by evidence obtained through clinical trials. To this day, most pediatric pharmacotherapy is based on the off-label use of drugs.¹ This must change.

Article see p 74

Pasquali et al,² writing in this issue of Circulation: Cardiovascular Quality and Outcomes, report the experience of off-label drug use in patients 18 years old and younger who have congenital and acquired heart disease severe enough to require hospitalization. Using the Pediatric Health Information System database, they identified potential study subjects through International Classification of Diseases, Ninth Revision codes pertinent for congenital and acquired cardiovascular diseases; both diagnostic and procedural codes were screened, and only infants with . . . [Full Text of this Article]

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Off-Label Use of Cardiovascular Medications in Children Hospitalized With Congenital and Acquired Heart Disease

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Circ Cardiovasc Qual Outcomes 2008 1: 74-83. [Abstract] [Full Text] [PDF]