Safety of Prescribing Off-Label Drugs for Noncritical Ill Children: A Cross-Sectional Study.

Abstract

“Off-label” (OL) refers to the use of a drug for indications and/or conditions different from those for which it was licensed.1 However, off-label drug use (OLDU) is not necessarily incorrect. The Food and Drug Administration stated that “Good medical practice and the best interests of the patient require that physicians use legally available drugs ... according to their best knowledge and judgment.”2 Prescribing OL drugs is a common practice. Because of limited pharmacologic research in children, it is more frequent in pediatric care,3 particularly in hospitalized children.4 Adverse drug reactions (ADRs)5 occur with OLDU at frequencies between 23% and 60%, depending on the type of drug and the group of patients considered6; however, information on this topic is limited, particularly in pediatrics, and in many cases the detection of ADRs is based on different definitions and methodologies.7,8 A standardized procedure for searching ADRs can achieve more accurate results.9 There is an urgent need to better understand OLDU, particularly in Latin America, where economic, social, and cultural reasons may guide different drug choices from developed countries and possibly tip the balance toward more OL prescribing in pediatrics. We estimate the prevalence of OLDU and of ADRs in hospitalized children. This was a cross-sectional study that included patients aged <18 years, hospitalized at a pediatric tertiary care hospital, during 2017. We include one whole year to avoid epidemiological bias related to different cause of hospitalization in children across the year (ie, respiratory infection …