Codeine prescribing practices before and after the 2017 FDA warning at an academic health system

In April of 2017, the U.S. Food and Drug Administration (FDA) issued a boxed warning contraindicating codeine use in all patients younger than 12 years of age.

The purpose of this study was to describe changes in codeine prescribing practices across a broad range of professions and specialties before and after the boxed warning and identify opportunities for optimization of a health system-wide response to changes in evidence-based practice recommendations.

Patients younger than 12 years of age with codeine-containing products prescribed between February 2017 and April 2018 at a single health system were included. Patient demographics, provider specialty, and prescription indication were collected by retrospective chart review. For categorical variables, frequency and percentage were calculated; for continuous variables, means with standard deviations or medians with interquartile ranges were calculated.

Codeine prescriptions for patients younger than 12 years of age declined after the boxed warning issued by the FDA. Some provider specialties reacted promptly whereas others took longer to change their practice. Temporally, the largest decreases in prescribing centered around the month after the FDA communication release in April 2017 and the later implementation of electronic health record (EHR) alerts in June 2017.

Given the persistence of codeine prescribing even after EHR soft-stop alerts were implemented, future pharmacy informatic responses to changes in evidence-based practice recommendations could be optimized using hard-stop alerts for high-impact recommendations. Studies comparing combination codeine products and other opioid medications for chronic pain in pediatric patients would be helpful to characterize the true level of risk in this population.