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

Filetype[PDF-1.50 MB]

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      To reduce dosing errors when administering orally-ingested over-the-counter (OTC) liquid medications, the US Food and Drug Administration (FDA) and the Consumer Healthcare Products Association (CHPA) released voluntary recommendations for dosing directions and dosing devices. This study assessed 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 in 2011 in order to identify and prioritize specific improvements to dosing directions and dosing devices.


      Recommendations were categorized as top tier or low tier based on potential to directly address ≥3-fold dosing errors. Labeled dosing directions and accompanying dosing devices were assessed by 2 independent reviewers for adherence to specific recommendations.


      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 was included with all products. 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 used trailing zeros or failed to use leading zeros with decimal doses and 8 did not use small font for fractions. Product adherence to low tier recommendations ranged from 26% to 91%.


      Products adhered to most recommendations in the final FDA Guidance and CHPA Guideline suggesting that these voluntary initiatives promote adherence to recommendations. Improving adherence to recommendations should be prioritized based on potential to reduce harm.

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