Off-label medications prescribed to nearly all pediatric intensive care patients

October 21, 2012

"Off label" drugs are medications that have not been tested for safety or efficacy for a specific patient age or condition. New research presented Oct. 21 at the American Academy of Pediatrics (AAP) National Conference and Exhibition in New Orleans found that off-label treatments were ordered for 96 percent of all pediatric patients, and 100 percent of patients ages 13-17, in the intensive care unit of an urban children's hospital.

In "Off-Label in the Unit," researchers collected data on all patients admitted to the 32-bed pediatric (PICU) at Primary Children's Medical Center (PCMC) in from October 2002 to February 2003, including age, diagnosis, medications ordered and indication for each medication ordered. Each drug was assessed for whether it was used in an on-label or off-label manner.

Off-label use was declared when a drug was prescribed for a patient whose age was not listed on the package label, no pharmacokinetic (PK) data was listed in the package insert, and/or if the drug was used for a non-FDA approved indication.

A total of 335 drugs were prescribed in 492 from birth to age 17. Ninety-six percent of patients received at least one off-label drug. Off-label prescribing occurs in almost every patient in the PICU.

"Treatment with off-label medications is the rule rather than the exception in the PICU," said study author Susan Sorenson, a doctor of pharmacy.

"Numerous problems emanate from the lack of drug data in children, including uncertainty about whether a drug is effective in children for a particular disease, questions about the side effect profile, and lack of dosing information," said Dr. Sorenson.

"It is very difficult when you stand at the bedside and want to treat a sick child with a drug and you don't know if the dose or drug you have chosen or recommended will harm the child or help the child. Everyone does the best they can to find suggested doses and do the right thing, however, it is better medicine to dose or recommend doses based on evidence.

"This study is attempting to determine the drugs that are used most frequently in our sickest patient population that do not carry dosing information, with the intent that studies of dosing, safety, and efficacy will be carried out on those drugs," said Dr. Sorenson. "More studies need to be conducted so that prescribing in our youngest and sickest patients can be done based on evidence."

Explore further: Off-label drug use common, but patients may not know they're taking them, study finds

Related Stories

Off-label drug use common, but patients may not know they're taking them, study finds

August 6, 2012
Many people have probably heard of off-label drug use, but they may not know when that applies to prescriptions they are taking, a Mayo Clinic analysis found. Off-label drug use occurs when a physician prescribes medication ...

Research suggests off-label prescribing of medications is common

April 16, 2012
A study evaluating off-label prescribing of medications in a primary care network in Canada suggests the practice is common, although it varies by medication, patient and physician characteristics, according to a report published ...

Reducing off-label use of antipsychotic medications may save money

May 15, 2012
Reducing the non-FDA-approved use of antipsychotic drugs may be a way to save money while having little effect on patient care, according to a Penn State College of Medicine study.

Recommended for you

Data revealed under FOI shows benefits of multiple sclerosis drug currently blocked by regulators

August 17, 2017
A drug that is blocked by the EU regulatory system has now been found to improve the quality of life of people with multiple sclerosis (MS), according to a study by Queen Mary University of London (QMUL).

Opioids overused in migraine treatment, regardless of race, study finds

August 17, 2017
African-Americans are more likely to experience debilitating migraine headaches than whites, but a new study probing the issue found no evidence of racial disparities in treatment practices.

Finding better ways to reduce serious drug side effects

August 14, 2017
Many of the medicines we depend on to treat disease—and even to save our lives—pose potentially serious risks along with their benefits. Data from the U.S. Centers for Disease Control and Prevention indicate that about ...

Ultrasound-triggered liposomes for on-demand, local anesthesia

August 10, 2017
Researchers at Boston Children's Hospital have found a new way to non-invasively relieve pain at local sites in the body; such systems could one day improve pain management by replacing addictive opioids and short-lasting ...

Independent pharmacies and online coupons help patients save money on drugs

August 8, 2017
Uninsured patients or those with limited prescription drug coverage can save significant money by buying their drugs at independent pharmacies instead of big box, grocery or chain drug stores and by using discount coupons, ...

New study generates more accurate estimates of state opioid and heroin fatalities

August 7, 2017
Although opioid and heroin deaths have been rising dramatically in the U.S., the magnitude of the epidemic varies from state to state, as does the relative proportion of opioid vs heroin poisonings. Further complicating the ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.