Author Interviews, Pediatrics / 17.01.2014
OTC Pediatric Liquid Medications: Recommendations for Dosing Directions
MedicalResearch.com Interview with:
Dr. Daniel S. Budnitz MD MPH CAPT, USPHS
Division of Healthcare Quality Promotion
Director of the Centers for Disease Control and Prevention’s Medication Safety Program
Atlanta, Georgia
MedicalResearch.com: What are the main findings of the study?
Dr. Budnitz: To reduce dosing errors when administering orally ingested over-the-counter (OTC) liquid medications, especially among children, the US Food and Drug Administration (FDA) released and the Consumer Healthcare Products Association (CHPA) released recommendations for how to display dosing directions and markings on dosing devices.
This study assessed recommendation adherence for national brand name orally ingested OTC liquid pediatric analgesics/antipyretics and cough, cold, and allergy products available after the FDA guidance was finalized in 2011. To identify and prioritize specific areas for improvement, recommendations were categorized as ‘top tier’ (potential to address ≥3-fold errors) or ‘low tier’ (intended to improve clarity and consistency).
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 (e.g., oral syringe, dosing cup). 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; eight did not use small font for fractions. Appropriate use of zeros and decimals is important to avoid 10-fold overdoses; using small font for fractions (½ vs. 1/2) helps avoid potential 4-fold errors if 1/2 interpreted as 1 or 2. Product adherence to low tier recommendations ranged from 26% to 91%.
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