Magazine article Drug Topics

Pediatric Medication Errors Signal Need for Labeling

Magazine article Drug Topics

Pediatric Medication Errors Signal Need for Labeling

Article excerpt

Because pediatric medication errors are common, a greater effort toward finding ways to avoid them is needed, according to a report issued recently from the United States Pharmacopeial Convention, Rockville, Md.

The most common errors relate to overdosing, said USP, which gathers information about prescription errors on an ongoing basis.

Although many pediatric medication errors are the fault of a variety of health professionals, the problem is exacerbated by the lack of pediatric labeling on drug packaging. USP cited a Food & Drug Administration survey conducted in 1988, which found that most medications commonly prescribed for children are not approved by the agency for pediatric use. In addition, the survey found, only 30% of the pediatric drugs available have labeling indicating FDA approval for use in children. The agency has not conducted a similar survey since then, according to FDA and other sources.

"Until now, pediatricians have used compendia for their prescribing behaviors, which is the standard practice," as opposed to relying on FDA-approved drug labeling, said Thomas Copman, assistant v.p.-biotechnology and biologics, Pharmaceutical Manufacturers Association.

To address the lack of pediatric labeling on drug packaging, the FDA proposed on Oct. 27 last year to require pharmaceutical manufacturers to begin adding pediatric-related information to the labeling for their drugs.

As of the first week in May, no further action had been taken on the proposal, an FDA source said. But the proposal is alive, according to PMA's Copman. …

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