DC Metro Area Medical Malpractice Law Blog

According to a recent study by the Pediatric Health Information Systems Research Group, almost 80% of hospitalized children receive drugs that have been tested and approved only for adults.  The study revealed that the drugs most frequently used off-label for children were painkillers, nutrients and gastrointestinal agents. Children were more likely to receive off-label drugs if they underwent surgery, were older than 28 days and had more severe illnesses.  Least likely drugs to be used in this manner were anti-cancer drugs.

 "Using drugs that have been insufficiently studied in children has contributed to adverse outcomes, which have been documented in the medical literature," said Samir Shah of The Children's Hospital of Philadelphia. "We hope that by better defining the magnitude of off-label drug use, our study may help encourage greater cooperation among industry, academia, and government in carrying out studies to better protect children."

The study focused on patient records from 31 major U.S. children's hospitals for the year 2004 and involved 90 drugs that were either frequently administered to children or had been recommended for further pediatric study by the Food and Drug Administration.

Researchers in the Pediatric Health Information Systems Research Group, representing various medical centers, analyzed patient records from 31 major U.S. children's hospitals for the entire year of 2004. At least one drug was used off-label in 79 percent of the more than 355,000 children requiring hospitalization. Off-label use accounted for $270 million, some 40 percent, of the total dollars spent on children's medication in the study, which appears in the March issue of the Archives of Pediatrics and Adolescent Medicine.

Although off-label prescribing is relatively common among adult patients, it has long been recognized that many of the drugs used in pediatrics have never been tested in children. In recent years, federal regulations providing financial incentives to pharmaceutical companies have helped increase the number of drugs tested and approved for children. However, said Dr. Shah, "there was little information on the extent of off-label use among children, the types of drugs used off-label, and the characteristics of hospitalized children receiving those drugs."

All previous studies of off-label drug use in hospitalized children were performed outside the United States and were often limited to specific conditions or other restrictions. The current study focused on 90 drugs that were either administered frequently to children or were recommended for further pediatric study by the FDA.

Senior study author Anthony Slonim noted that, once the FDA approves a drug for use, physicians may legally prescribe it for different conditions and patients in other age groups. The practice is called prescribing "off-label."

The study was published in the March issue of the Archives of Pediatrics and Adolescent Medicine.