9 of 10 pediatric patients are prescribed off-label drugs

in intensive care units

A joint research team of researchers from the Department of Pharmacy at Seoul National University Hospital, Seoul National University College of Medicine, and Gachon University’s College of Pharmacy published a report

Over 9 out of 10 patients admitted to the pediatric intensive care unit (PICU) at university hospitals were found to have been prescribed drugs off-label.

 

The joint research team of the Department of Pharmacy at Seoul National University Hospital, Seoul National University College of Medicine, and Gachon University’s College of Pharmacy studied the 6,183 medications that were prescribed to 502 patients admitted to the pediatric intensive care unit (PICU) at the Seoul National University Hospital for 1 year from July 2019 (median age 1.7 years).

 

The results were released on the 15th, and published in a recent issue of the international pharmaceutical journal, Saudi Pharmaceutical Journal.

 

Off-label medications are drugs that were approved by the Ministry of Food and Drug Safety but are being used for an indication, age, or dose that is not listed in the approved label for the drug.

 

Drugs are mainly used off-label in children, pregnant women, elderly patients, patients with rare diseases, and cancer patients for whom separate clinical trials had not been conducted during the approval process.

 

The report showed that pediatric patients in the PICU received a median of 12 drugs per patient, 9 of which were off-label prescriptions.

 

99.6% of the 500 patients received one or more off-label prescriptions during their time in the PICU.

 

In other words, most drugs that are prescribed to severe pediatric patients were being prescribed at the doctor’s discretion based on their adult indications and doses.

 

The drugs that were most often used off-label were sedatives, followed by digestives, antibacterial, then cardiovascular-related drugs.

 

By category, the labeling changes were most often made on the dose (67.8%), followed by age (50.1%), then indication(31.5%).

 

During the study period, 67 adverse drug reactions were identified in 5.4% (27 patients) of the patients from off-label use.

 

The research team estimated that the incidence of moderate or severe adverse drug reactions from off-label drug use was 69.0%, much higher than the 38.9% that arise from on-label drug use.