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Critically Ill Kids Often Get Drugs Off-Label

NEW ORLEANS  –  The majority of drugs used in the pediatric intensive care unit (PICU) are used in an off-label manner, exposing patients to medications that may not have been adequately studied in children, a single-center study showed.

Of 335 different drugs used in a PICU over a 5-month period, 75% were used off-label at least once, according to Susan Sorenson, PharmD, of Primary Children’s Medical Center in Salt Lake City.

And nearly all of the patients (96%) received a drug off-label at least once, she reported at the American Academy of Pediatrics meeting here.

Although there have been some legislative steps taken in recent years to improve drug labeling for pediatric indications, including the FDA Modernization Act (FDAMA) of 1997 and the Best Pharmaceuticals for Children Act (BPCA) of 2002, “there’s still some work to do,” Sorenson said.

She and her colleagues examined off-label medication use in the 32-bed PICU at their center prospectively from October 2002 to February 2003. Pharmacists recorded the indications for all medications used.

A drug was considered to have been used off-label when it was prescribed for a patient whose age was not listed on the label, when no pharmacokinetic data were listed for the patient’s age, or when the drug was used for an indication that was not approved by the FDA.

The analysis included 490 patients, with a median age of 2 years (range 4 days to 17 years).

There were 6,823 drug orders for 335 different drugs during the study period.

The medications most likely to be used off-label based on drug orders were morphine (268), ondansetron (144), metoclopramide (141), dopamine (130), and fentanyl (127).

The researchers looked at which of the 40 drugs with the highest number of f-label medication orders during the study have had labeling changes since the passage of the BPCA in 2002, and found that only 14 have had labeling changes and 19 still lack safety and efficacy information for a pediatric population.

Sorenson said that it is important to have studies of these drugs in a pediatric population in order to provide guidance to clinicians.

“I know at our hospital, and I’m sure it’s the same in other hospitals, as soon as a drug receives a pediatric label if it’s comparable to what we’re using, we’ll switch to that drug just because safety and efficacy has been shown,” Sorenson said.

Because most of the drugs used in the study are off-patent, however, it will be difficult to find funding to perform such expensive studies, she said.

The BPCA may help increase drug studies in the pediatric population.

According to an FDA spokesperson, “the Pediatric Exclusivity incentive, originally created in FDAMA and reauthorized in BPCA, allows companies to qualify for an additional 6 months of marketing exclusivity if they complete the studies in children as specified in a Written Request issued by the FDA. If a product is off-patent, the FDA can refer the Written Request to the NIH to award grants so that third parties can conduct the needed studies.”

Source: Med Page Today at[email protected]&mu_id=

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