Evaluation of Consistency in Dosing Directions and Measuring Devices for Pediatric Nonprescription Liquid Medications, December 15, 2010, Yin et al. 304 (23): 2595 — JAMA

Original Contribution
JAMA. 2010;304(23):2595-2602. Published online November 30, 2010. doi: 10.1001/jama.2010.1797
Evaluation of Consistency in Dosing Directions and Measuring Devices for Pediatric Nonprescription Liquid Medications

1. H. Shonna Yin, MD, MS;
2. Michael S. Wolf, PhD, MPH, MA;
3. Benard P. Dreyer, MD;
4. Lee M. Sanders, MD, MPH;
5. Ruth M. Parker, MD

[+] Author Affiliations

1. Author Affiliations: Department of Pediatrics, New York University School of Medicine and Bellevue Hospital Center, New York, New York (Drs Yin and Dreyer); Health Literacy and Learning Program, Center for Communication in Healthcare, Division of General Internal Medicine, and Institute for Healthcare Studies, Feinberg School of Medicine, Northwestern University, Chicago, Illinois (Dr Wolf); Department of Pediatrics, Miller School of Medicine, University of Miami, Miami, Florida (Dr Sanders); and Department of Medicine, Emory University School of Medicine, Atlanta, Georgia (Dr Parker).

Abstract

Context
In response to reports of unintentional drug overdoses among children given over-the-counter (OTC) liquid medications, in November 2009 the US Food and Drug Administration (FDA) released new voluntary industry guidelines that recommend greater consistency and clarity in OTC medication dosing directions and their accompanying measuring devices.

Objective
To determine the prevalence of inconsistent dosing directions and measuring devices among popular pediatric OTC medications at the time the FDA's guidance was released.

Design and Setting
Descriptive study of 200 top-selling pediatric oral liquid OTC medications during the 52 weeks ending October 30, 2009. Sample represents 99% of the US market of analgesic, cough/cold, allergy, and gastrointestinal OTC oral liquid products with dosing information for children younger than 12 years.

Main Outcome Measures
Inclusion of measuring device, within-product inconsistency between dosing directions on the bottle's label and dose markings on enclosed measuring device, across-product use of nonstandard units and abbreviations, and presence of abbreviation definitions.

Results
Measuring devices were packaged with 148 of 200 products (74.0%). Within this subset of 148 products, inconsistencies between the medication's dosing directions and markings on the device were found in 146 cases (98.6%). These included missing markings (n = 36, 24.3%) and superfluous markings (n = 120, 81.1%). Across all products, 11 (5.5%) used atypical units of measurement (eg, drams, cc) for doses listed. Milliliter, teaspoon, and tablespoon units were used for doses in 143 (71.5%), 155 (77.5%), and 37 (18.5%) products, respectively. A nonstandard abbreviation for milliliter (not mL) was used by 97 products. Of the products that included an abbreviation, 163 did not define at least 1 abbreviation.

Conclusion
At the time the FDA released its new guidance, top-selling pediatric OTC liquid medications contained highly variable and inconsistent dosing directions and measuring devices.

* KEYWORDS: ADMINISTRATION, ORAL,
* CAREGIVERS,
* CHILDREN'S HEALTH,
* DRUG LABELING,
* NONPRESCRIPTION DRUGS,
* OVERDOSE,
* PARENTS,
* PATIENT SAFETY,
* UNITED STATES FOOD AND DRUG ADMINISTRATION.

Evaluation of Consistency in Dosing Directions and Measuring Devices for Pediatric Nonprescription Liquid Medications, December 15, 2010, Yin et al. 304 (23): 2595 — JAMA