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CDC Study Strongly Underscores Progress Made by Industry Voluntary Labeling Guidelines

Tue, 01/07/2014 - 8:10am

WASHINGTON--(BUSINESS WIRE)--Jan 6, 2014--The Consumer Healthcare Products Association (CHPA) says the makers of over-the-counter (OTC) pediatric liquid medications have made significant progress in carrying out voluntary efforts to promote safe use through standardized dosing directions and dosing devices, as underscored by the results of a Centers for Disease Control and Prevention (CDC) study released today in “Pediatrics.”

In 2009, CHPA members approved voluntary labeling guidelines for all pediatric liquid medications in an effort to reduce the potential for dosing errors. Following reports of unintentional overdoses in 2011, the U.S. Food and Drug Administration (FDA) finalized similar recommendations for standardizing labeling and dosing devices included with OTC liquid medications.

Today’s “Pediatrics” article, “Adherence to Label and Device Recommendations for Over-the-Counter Pediatric Liquid Medications,” discusses the results of a study conducted by the Centers for Disease Control and Prevention (CDC) to assess recommendation adherence for national brand name orally ingested OTC liquid pediatric analgesics/antipyretics and cough, cold, and allergy medications available after the FDA guidance was finalized. The report found high levels of adherence to most recommendations provided in the final FDA Guidance as well as the CHPA guideline.

“This report shows that our industry is making great progress, and it demonstrates our commitment to proactively working to empower consumers to safely use our products in order to reduce treatment errors in children,” said Barbara Kochanowski, CHPA’s vice president, Regulatory & Scientific Affairs. “Hand in hand with our efforts to improve labeling is our commitment to educating parents about the importance of safe medicine storage. Accidental, unsupervised medicine ingestions are the leading cause of emergency department visits related to medication exposure, and reminding parents to store all medicines out of the reach and sight of young children is a top CHPA priority.”

Top-tier recommendations from the 2011 FDA Voluntary Guidance and 2009 CHPA Voluntary Guidance include the following:
•Dosing devices should be included with all products
•Atypical units should not be used (eg, drams, dropperfuls)
•Teaspoon and tablespoon units should not be used together
•Trailing zeros should not be used (to avoid 10-fold dosing errors)
•Leading zeros should be used before decimal doses <1 (to avoid 10-fold dosing errors)
•Small font should be used with numerals in fractions (to avoid interpreting “1/2” as “1 or 2”)
•Dosing devices should not bear extraneous or unnecessary volumetric units
•Dosing devices should not be significantly larger than the largest doses in the directions
•Dosing devices should provide markings that can readily measure doses in the directions

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