Patient Safety and Quality

Label changes, manufacturer's warning letter did not reduce use of propofol for conscious sedation in children

A new study reveals that the use of the anesthetic propofol for moderate conscious sedation (MCS) in pediatric patients increased threefold from 2001 to 2007, despite an early 2001 cautionary change in the drug's label and a letter to physicians from the manufacturer. Drug labels are often complex, with information about recommended dosing, contraindications, and black box warnings. In 2001, the label for propofol (a rapid-onset, short-duration sedative hypnotic) was changed to describe increased mortality with propofol use in a clinical trial involving patients in pediatric intensive care units (ICUs, 9 percent mortality vs. 4 percent for a standard sedative). Shortly after the label change, the manufacturer sent out a letter to physicians noting that propofol "is currently not approved for sedation in pediatric ICU patients in the U.S."
Despite these warnings, discharges for moderate conscious sedation using propofol dropped from 12 percent in 2001 to 9 percent in 2003, but then rose to 33 percent by the end of 2007. After adjusting for multiple variables, the odds of receiving propofol for moderate conscious sedation in 2007 was 3.32 times greater than in 2001. A higher frequency of propofol use was seen among pediatric patients who were Hispanic or white, 5–9 years old, insured through a public payer such as Medicaid, had an extended hospital stay, or whose attending physician specialized in critical care or gastroenterology.
The findings were based on analysis of the Premier Perspective Comparative Hospital Database, an all-payer database with data from more than 400 hospitals nationally. The researchers did a trend analysis of data on inpatient pediatric discharges from January 2001 through December 2007. Their study was funded in part by the Agency for Healthcare Research and Quality (HS16957) to the Center for Education and Research on Therapeutics (CERT) on Pediatric Therapeutics at Cincinnati Hospital Children's Medical Center.
For more information on the CERTs program, visit http://www.certs.hhs.gov.
More details are in "Impact of drug label changes on propofol use in pediatrics for moderate conscious sedation," by Pamela C. Heaton, Ph.D., Joseph Schuchter, M.P.H., Carole M. Lannon, M.D., M.P.H., and others in Clinical Therapeutics 33(7), pp. 886-895, 2011.

— DIL