January 29, 2014
OTC Liquid Medications Generally Follow Voluntary Recommendations to Reduce Dosing Errors

Atlanta—The government’s effort to reduce dosing errors with liquid OTC products for children has had the desired effect: Voluntary recommendations on methods to reduce dosing errors with orally ingested OTC liquid medications are generally being followed by manufacturers, according to researchers from the CDC.

Even more could be done, however, according to their report, published recently in the journal Pediatrics.

Background in the article discusses how FDA guidance was finalized in 2011 to identify and prioritize specific improvements to dosing directions and devices for liquid pediatric analgesics/antipyretics and cough, cold, and allergy medications.

For the study, recommendations were categorized as top-tier or low-tier, based on potential to directly address dosing errors. Dosing directions and accompanying dosing devices for adherence to recommendations were assessed by two independent reviewers.

Researchers found that, of 68 products, 91% of dosing directions and 62% of dosing devices adhered to all top-tier recommendations; 57% of products adhered to every top-tier recommendation, and 93% adhered to all or all but one.

A dosing device, a dosing cup or oral syringe, was included with all products, according to the study.

The authors also note that no dosing directions used atypical volumetric units (e.g. drams), and no devices used volumetric units that did not appear in dosing directions.

Six products, however, used trailing zeros or failed to use leading zeros with decimal doses. Overall, product adherence to low-tier recommendations ranged from 26% to 91%.

The final sample included 100% of analgesic/antipyretic national brands and 98.6% of cough, cold, and allergy solutions during the study period, all sold by food, drug, and mass merchandiser stores. Of the 68 products, 81% were cough, cold, and allergy medications, and 88% were marketed as infants’ or children’s products. Of the 55 cough, cold, and allergy medications, nine (16%) were homeopathic products.

“Products adhered to most recommendations in the final FDA guidance and Consumer Healthcare Products Association guideline, suggesting that these voluntary initiatives promote adherence to recommendations,” the authors write. “Improving adherence to recommendations should be prioritized based on potential to reduce harm.”

The authors note that “additional opportunities for standardization include design and marking of dosing devices and promotion of milliliter as the standard unit for dosing orally ingested liquid medications” and called for ongoing evaluation and continued improvement of labels and devices for OTC liquid medications.

U.S. Pharmacist Social Connect