Study Finds Kids’ Liquid Medications Are “˜Inconsistent’
According to a study, there have been high levels of variability and inconsistencies regarding children’s liquid medication labeling and measuring devices.Â
The study, which will appear in the December 15 issue of JAMA, examined 200 of the top-selling cough/cold, allergy, analgesic and gastrointestinal over-the-counter liquid medications for children.
"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," according to a recent press release.
Dr. H. Shonna Yin of the New York University School of Medicine and Bellevue Hospital Center conducted the study with colleagues in order to determine the prevalence of inconsistent dosing directions and measuring devices among 200 top-selling pediatric oral liquid OTC medications.Â
Of the 148 products studied, 98.6 percent contained one or more inconsistencies between the labeled directions and the accompanying device with respect to doses listed or marketed on the device.
About a quarter of the products lacked the necessary markings.
"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," the authors write.
The team also found that all the products should have a standardized way of measuring units, as well have consistency between the labeled dosing directions and markings on the associated measuring device.
The researchers said that when dosing instructions and devices match, and standard abbreviations are used, parents will be less confused and better able to give the proper dose of medication to their child.
"Devices often have extra markings on them that are not listed on the label, which can be distracting and lead to confusion," says Dr. Yin. "Furthermore, some devices are missing doses that are recommended on the label, making the task of dosing more difficult."
They said that over half of U.S. children are exposed to one or more medications in a given week, and more than half of these are OTC medications.
The authors wrote that this study provides baseline data for assessing the degree and pace of industry conformity with the guidelines.
"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."
"There are very straightforward things that can be done to help parents dose OTC medications correctly," said co-author Benard P. Dreyer, MD, professor of pediatrics at NYU School of Medicine, and president-elect of the Academic Pediatric Association. "Making sure that all products follow these guidelines will help parents use OTC medicines more safely and effectively."
—
On the Net: