Adherence to Label and Device Recommendations for Over-the-Counter Pediatric Liquid Medications

OBJECTIVE: To reduce dosing errors when administering orally ingested over-the-counter liquid medications, the US Food and Drug Administration (FDA) and the Consumer Healthcare Products Association released voluntary recommendations for dosing directions and dosing devices. This study assessed recommendation adherence for national brand name orally ingested over-the-counter liquid pediatric analgesics/antipyretics and cough, cold, and allergy medications available after the FDA guidance was finalized in 2011 to identify and prioritize specific improvements to dosing directions and devices. METHODS: Recommendations were categorized as top tier or low tier based on potential to directly address ≥3-fold dosing errors. Two independent reviewers assessed dosing directions and accompanying dosing devices for adherence to recommendations. RESULTS: 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 was included with all products. No dosing directions used atypical volumetric units (eg, drams), and no devices used volumetric units that did not appear in dosing directions. Six products used trailing zeros or failed to use leading zeros with decimal doses; eight did not use small font for fractions. Product adherence to low tier recommendations ranged from 26% to 91%. CONCLUSIONS: 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. Improving adherence to recommendations should be prioritized based on potential to reduce harm.