Putting Pediatric Off Label Prescribing on the Map: A Study to Understand which Children, Medications and Physicians are Involved in Prescribing Drugs for Unapproved Uses
Abstract
Background: Prescribing medications for an indication or age outside of the terms of U.S. Food and Drug Administration (FDA) approval is called off label prescribing. In children, off label prescribing has resulted in drug disasters and increased adverse events and has been the subject of recent legislation promoting medication study. Off label prescribing appears to be a very common pediatric practice; nonetheless, the pharmacoepidemiology of off label prescribing has not been systematically studied and could inform approaches to interventions.Methods: The National Ambulatory Medical Care Surveys (NAMCS), a nationally representative population based sample of U.S. outpatient medical visits collected by the Centers for Disease Control and Prevention (CDC) were utilized over a four year period (2001 2004). We evaluated an estimated 312 million prescription visits by children 0-17 years old (based on a sample of 7901 prescription visits). FDA approved age and indication were compared to the to the child's age and diagnoses. Descriptive and regression analyses were used to determine epidemiological characteristics and predictors of: (1) pediatric off label prescribing in general, (2) prescribing to infants and toddlers (0-3 yrs; n=81 million visits) and (3) off label prescribing for age versus off label prescribing for indication. Results: Sixty two percent of U.S. outpatient pediatric prescription visits included off label prescribing, with 25% (95% CI: 23%, 27%) including off…
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