How can parents prevent unintentionally overdosing their child if pediatric OTC medication labeling and measuring devices are inconsistent? According to an article published in JAMA (Journal of the American Medical Association) and written by researchers from New York University School of Medicine and Bellevue Hospital Center, a study of the 200 best-selling childhood medications, including analgesics, gastrointestinal medicines, as well as those for coughs and colds and allergies had “high levels of variability and inconsistencies” in their labeling and measuring devices.

The authors wrote:

    “In November 2009, the U.S. Food and Drug Administration (FDA) released new voluntary guidelines to industry groups responsible for manufacturing, marketing, or distributing over-the-counter (OTC) liquid medications, particularly those intended for use by children. These guidelines were developed in response to numerous reports of unintentional overdoses that were attributed, in part, to products with inconsistent or confusing labels and measuring devices.”

H. Shonna Yin, M.D., M.S., and team set out to find out how similar or different dosing directions and measuring devices were among the countries 200 highest selling liquid OTC medications for children when the FDA’s guidelines were issued.

The study lasted between October 2008 and October 2009. The scientists say these 200 products represent 99% of the American market for analgesic, gastrointestinal, cough/cold, and allergy OTC oral liquid products with dosing data for children aged less than 12 years.

They found that:

  • 74% (148) products had a standardized measuring device.
  • 98% of the products with a standardized measuring device had at least 1 inconsistency between the labeled instructions and the device accompanying it regarding the dosages marked or listed on the device, or text used for unit measurement.
  • 24.3% of them did not have the necessary markings to help measure out the right dosage.

The researchers wrote:

    “Among the measuring devices, 81.1 percent included 1 or more superfluous markings. The text used for units of measurement was inconsistent between the product’s label and the enclosed device in 89 percent of products. A total of 11 products (5.5 percent) used nonstandard units of measurement, such as drams, cubic centimeters, or fluid ounces, as part of the doses listed.”

71.5% of the products used milliliter dosaging and 77.5% referred to a teaspoon measurement. 18.5% used the term “tablespoon”. The standard abbreviation for milliliter is “mL” – 97 products used another form of abbreviation.

Of all the labels that had abbreviations in them, 163 did not define at least one of them.

The authors say they identified three problem areas that need to be addressed:

  • All OTC liquid products should use a standardized measuring device
  • Manufacturers should make sure their labeled dosing instructions are consistent with the markings on the measuring device within the same product
  • The following should all be standardized – measurement units, numeric formats, and abbreviations

The authors inform that over half of all American children are exposed to at least one medication in any given week – over half of these are OTC medications. If adults are at risk of getting the dosage wrong because of inconsistencies within the industry, and often within the product itself, there is a greater danger of harm for the child.

The authors wrote:

    “At this time, the FDA’s guidelines are voluntary, and companies have no legal obligation to follow them. Subsequent systematic product analyses may therefore be helpful to monitor progress, including assessing whether additional regulatory oversight may be needed to ensure practices that best support safe and effective use of OTC medications.”

Darren A. DeWalt, M.D., M.P.H., of the University of North Carolina at Chapel Hill, wrotes:

    “Clinicians’ education in and familiarity with most of these measuring units may lead them to overlook the tremendous variation within and across products and opportunities for dosing errors. But that is just the point: health care providers, including pharmaceutical companies, frequently forget about transferring responsibility to patients who are not comfortable with several different types of measurements,” writes Dr. DeWalt. “The most elegant and efficient medical therapies will fail if patients or caregivers cannot adequately and accurately administer the therapy.”

“Evaluation of Consistency in Dosing Directions and Measuring Devices for Pediatric Nonprescription Liquid Medications”
H. Shonna Yin, MD, MS; Michael S. Wolf, PhD, MPH, MA; Benard P. Dreyer, MD; Lee M. Sanders, MD, MPH; Ruth M. Parker, MD
JAMA. Published online November 30, 2010. doi:10.1001/jama.2010.1797

Written by Christian Nordqvist