Pediatric medication information may not reach physicians

AORN Journal,  Feb, 2007  

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Many research findings regarding medication safety, dosing, and efficacy in pediatric populations may not be reaching the medical community or the physicians who prescribe medications to children, according to a Sept 12, 2006, news release from Duke University Medical Center News, Durham, NC. Children have different physiologies than adults, so medications that are safe and effective in adult populations may be ineffective, may require different doses, or may be harmful in pediatric populations. Results of studies on medication use in children, however, may not be widely disseminated beyond mandated changes to label information.

Researchers examined medications that had undergone pediatric trials and determined how often the results of such studies were published in peer-reviewed, scientific journals. Publishing results of research studies in such journals is often cited as one of the most effective ways to communicate information to the medical community. The researchers found that of the 253 studies on medication use in children, 100 resulted in a key labeling change (ie, a significant finding related to dose, safety, or efficacy that is different for children than for adults). Of those studies, however, only 37 were published in peer-reviewed journals. When studies resulted in a key labeling change,

* only 49% were published in peer-reviewed journals if there was a dosing change,

* only 43% were published if there was a change to safety information, and

* only 38% were published if the medication was found to be ineffective in children.

In addition, researchers found that 54% of studies that resulted in a "positive" labeling change (ie, a medication's safety and efficacy in children was established) were published, compared to only 36% of studies that resulted in a "negative" labeling change (ie, the medication was ineffective in children or was associated with a worse outcome than a comparison therapy).

Study Finds Safety Test Results on Children's Drugs Not Always Reaching Physicians [news release]. Durham, NC: Duke University Medical Center News; September 12, 2006. Available at: http://www.dukemednews.duke.edu/news/article.php?id=9864. Accessed November 9, 2006.

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