Details:

Alternative Title:
Pediatrics
Personal Author:
Budnitz, Daniel S. ; Lovegrove, Maribeth C. ; Rose, Kathleen O.
Budnitz, Daniel S. ; Lovegrove, Maribeth C. ; Rose, Kathleen O. Less -
Description:
Objective

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.

Methods

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.

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 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%.

Conclusion

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.


Subject:
[+]
Administration, Oral
Child
Drug Labeling
Humans
Infant
Medication Adherence
Medication Errors
Nonprescription Drugs

Source:
Pediatrics. 133(2):e283-e290
Pubmed ID:
24394683
Pubmed Central ID:
PMC4651167
Document Type:
Journal Article
Funding:
CC999999/Intramural CDC HHS/United States
Name as Subject:
United States. Food and Drug Administration.
Place as Subject:
United States
Collection(s):
CDC Public Access
Main Document Checksum:
[+]
urn:sha256:b45349671a9756ff4da8857d10e6d0fc6960eec42d88c1fe1675dd6d07abcd7c
File Type:

Supporting Files

• 	NIHMS732355-supplement-Supplemental_Appendix.pdf	pdf
  	nihms732355.nxml	xml
  	nihms732355f1.gif	gif
  	nihms732355f1.jpg	jpeg

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