Wide Variation Found in OTC Pediatric Drug Directions

Dosing directions, measuring devices found inconsistent prior to '09 FDA guidelines

TUESDAY, Nov. 30 (HealthDay News) -- When the U.S. Food and Drug Administration released guidelines recommending more consistency and clarity in over-the-counter (OTC) drug dosing directives in November 2009, top-selling pediatric OTC liquid drugs included extremely inconsistent and variable directions and measuring devices, according to a study published online Nov. 30 in the Journal of the American Medical Association.

H. Shonna Yin, M.D., of the New York University School of Medicine and Bellevue Hospital Center in New York City, and colleagues evaluated the prevalence of inconsistent dosing directions and measuring devices among 200 top-selling pediatric oral liquid OTC medications during the 52 weeks ending Oct. 30, 2009.

The investigators found that measuring devices were packaged with 148 of 200 products. However, inconsistencies between the medication's dosing directions and markings on the device were found in 146 of the 148 products (98.6 percent). In terms of units of measurement, milliliter was used in 143 products (71.5 percent), teaspoon in 155 products (77.5 percent), and tablespoon in 37 products (18.5 percent). Of products that included an abbreviation, 163 did not define at least one abbreviation. A nonstandard abbreviate for milliliter -- not mL -- was found with 97 products.

"Yin and colleagues offer three recommendations for improving current product labeling: ensure a standardized measuring device is present with all liquid medication packaging, ensure consistency between the label dosing instructions and the markings on the measuring device, and choose standard measurement units and abbreviations," writes the author of an accompanying editorial. "The third suggestion raises an important consideration for the FDA and the pharmaceutical industry. Can the FDA and industry agree on using one type of unit across all liquid medications and measurement devices?"

Several study authors and the author of the editorial disclosed financial relationships with pharmaceutical and/or medical device companies.

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