OTC Pediatric Liquid Medications: Recommendations for Dosing Directions

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, GeorgiaMedicalResearch.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%.

MedicalResearch.com: Were any of the findings unexpected?

Dr. Budnitz: It was notable that the most common unit used in dosing directions and on dosing devices was milliliter (mL), with 74% of assessed products using mL alone or in combination with teaspoons.  Dosing and measuring liquid medicines in metric units (mL) rather than “spoons” (teaspoons and tablespoons) discourages use of household spoons (which are not calibrated dosing devices) and aligns with standards used in inpatient settings.

MedicalResearch.com:  What should clinicians and patients take away from your report?

Dr. Budnitz:

Messages for Clinicians:

To prevent errors related to confusion around units, clinicians are encouraged to use mL when recommending liquid medication dosing for OTC medicines as well as for prescription medicines.

To help ensure accurate dosing, clinicians should encourage patients and caregivers to use the included dosing devices, not household spoons to measure doses.

Messages for Patients/Caregivers:

Patients and caregivers should always read the dosing directions and the measuring scales on dosing devices carefully.  Pay particular attention to the units to avoid giving 5 teaspoons when the directions recommend 5 mL. Pay particular attention to decimals to avoid giving 25 mL if directions recommend 2.5 mL.

Patients and caregivers should not use kitchen spoons for dosing medicines, but should use the dosing devices included with the medicines.  If a measuring device is misplaced, ask your pharmacist as they can recommend an appropriate device (often for free or at low cost).

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Dr. Budnitz: Findings from this study suggest that the voluntary FDA guidance and CHPA guideline encouraged adherence to recommendations for dosing directions and devices for many brand name liquid OTC products.  Further improvement efforts should prioritize potential multi-fold dosing errors.

Generic OTC products as well as prescription products dispensed from retail pharmacies were not assessed, but future studies might assess these in the future.

Finally, it may be appropriate to review and revise recommendations judged to be low tier and less likely to result in clinically significant dosing errors and to clarify recommendations that required interpretation by study investigators.

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

Daniel S. Budnitz, Maribeth C. Lovegrove, and Kathleen O. Rose

Pediatrics peds.2013-2362; published ahead of print January 6, 2014, doi:10.1542/peds.2013-2362