If "effective" isn't sufficient and "safe" isn't certain, what is your responsibility when prescribing?

February 1, 2006

How to balance providing effective treatments for your patients and the need to protect them from undesirable side effects of drugs

What is the appropriate balance to strike when you weigh the desire to provide effective treatments for your patients against the need to protect them from the undesirable side effects of drugs? How much risk is acceptable? And how should a concern about risk influence your prescribing practices and the decisions of regulatory agencies?

Although many drugs that we prescribe for our patients haven't been subjected to clinical studies of efficacy in persons younger than 18 or 21 years, two articles in this issue discuss pharmaceuticals that, in fact, have been shown effective in adolescents:

The black box warning applied to all antidepressant medications since 2004 challenges physicians to accept responsibility for close monitoring of therapy when they prescribe an SSRI, or other type of antidepressant, for a young patient who suffers depression. Considering the importance of depression as a prelude to suicide, and recognizing that suicide remains the third leading cause of death among teenagers in the United States, it is critical that the black box warning not discourage prescribing of antidepressants when such therapy is warranted. Peter R. Ferren, MD, author of the article on antidepressant prescribing, outlines a practical mechanism for monitoring treatment in partnership with the services of a mental health professional. His article reminds us that, despite the recognition of potential risk and an admonition to monitor carefully to keep our patients safe, it is important that we keep the scales tipped in favor of effective treatment.

Dr. McMillan, editor-in-chief of Contemporary Pediatrics, is professor of pediatrics, vice chair for pediatric education, and director of the pediatric residency training program, Johns Hopkins University School of Medicine, Baltimore.