Off-label Prescribing Continues in Children

Laura Putre

December 15, 2014

Off-label medications continue to be prescribed by general practitioners to children in significant numbers, despite campaigns to discourage the practice, a new study finds.

Possible adverse reactions make prescribing drugs for unapproved uses in children problematic, noted the study, which was published online December 15 in Pediatrics.

However, unlike previous studies, the new study does not find that off-label prescribing increases the risk for adverse reactions.

Aurore Palmaro, MSc, from the Université de Toulouse, France, and colleagues collected data from 2313 children, seen at 46 general practices in southwestern France between March and July 2011.

Physicians who participated in the study prescribed at least one medication for a total of 1960 children (84.7%). Of the children who received prescriptions, 37.6% received off-label prescriptions and 6.7% received prescriptions for unlicensed drugs.

Among children with adverse reactions, the most frequent were fever (30.4%; n = 7), diarrhea (21.7%; n = 5), and erythema (skin reaction) (21.7%; n = 5). None were serious enough to require hospitalization.

To discourage the use of off-label prescribing, regulations introduced in Europe in 2007 provide incentives to develop pediatric-specific drugs and also study medications' effects on children specifically. However, many drugs often prescribed off-label are not addressed in the 2007 regulation.

Earlier research, published in 2002, found that pediatric off-label prescribing was widespread (42%) and had a significant link to adverse drug reactions in children.

The 2002 study looked at pediatricians' prescribing habits. The new study looks at general practitioners' (GPs') habits, as pediatricians are becoming less common in France.

The 2002 study found that GPs as a group had different prescribing practices than pediatricians. The GPs wrote more pediatric prescriptions for antibiotics, expectorants, corticosteroids, and digestive motility and anti-inflammatory drugs than pediatricians.

GPs in the current study most often prescribed nasal decongestants, H1 antihistamines, and corticosteroids for off-label uses. In addition, they most often prescribed lower-than-recommended dosages for cold medications, ibuprofen, helicidine, and rifamycin. GPs most frequently prescribed higher-than-recommended dosages for the nasal decongestant tuaminoheptane, an organic compound used to treat intestinal spasms called phloroglucinol (not in general use in the United States), and the antibiotic amoxicillin.

Researchers classified the off-label prescribing into nine categories, including prescribing a drug withdrawn from the market, not following the age/administration/dosage recommendations, using a drug that is contraindicated, using a drug for different indications, giving a drug by the wrong route of administration, prescribing it for a higher or lower dose than recommended, and inadvisable coprescribing.

The authors call for more research into the reasons for off-label prescribing. "[I]t is generally believed that off-label prescribing is prompted by the unavailability of pediatric formulations," they write.

They also observe that off-label drugs are often prescribed for conditions that are closely related to conditions that fall within approved use. This may indicate a lack of options for pediatric prescribers.

The authors have disclosed no relevant financial relationships.

Pediatrics. Published online December 15, 2014. Abstract


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