An examination of 200 of the top-selling cough/cold, allergy, analgesic and gastrointestinal liquid medications sold over-the-counter (OTC) for children found high levels of variability and inconsistencies with labeling and measuring devices, according to a study that will appear in the December 15 issue of JAMA. The study is being released early online because of its public health importance.
The FDA guidelines
“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 background information in the article.
What the study involved
H. Shonna Yin, M.D., of the New York University School of Medicine and Bellevue Hospital Center led a study to determine the prevalence of inconsistent dosing directions and measuring devices among 200 top-selling pediatric oral liquid OTC medications at the time the FDA’s guidelines were released. The one-year study ended October 2009. The study represents 99 percent of the U.S. market of analgesic, cough/cold, allergy, and gastrointestinal OTC oral liquid products with dosing information for children younger than 12 years.
What the study revealed
The analysis showed that measuring devices were included in only 74 percent of the medications, and nearly all (98.6 percent) contained 1 or more inconsistencies between the labeled directions and the accompanying device. Almost a quarter of products (24.3 percent) lacked necessary markings.
Some had unnecessary, potentially confusing markings. The text used for units of measurement was inconsistent between the product’s label and the enclosed device in 89 percent of products. Five percent of the products used nonstandard units of measurement, such as drams, cubic centimeters, or fluid ounces.
Major problems in critical areas
This study identifies problems in three critical areas:
- A standardized measuring device should be included with all nonprescription liquid products;
- Within each product, consistency should be ensured between the labeled dosing directions
- Markings on the measuring devices across products—including measurement units, abbreviations, and numeric formats—should be standardized.
Does it really matter?
The risks posed by confusing or inconsistent dosing directions on pediatric OTC medication packaging and measuring devices may vary depending on the nature of the contradictory labeling, yet the potential for harm is substantial. More than 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.
Is this the canary in the mine?
This study suggests that the “degree and pace of the industry” to conform to the guidelines should be addressed. At this time, the FDA’s guidelines are voluntary, and companies have no legal obligation to follow them.
“Clinicians’ familiarity with most of these measuring units may lead them to overlook the tremendous variation within and across products and opportunities for dosing errors. [We] frequently forget about transferring responsibility to patients who are not comfortable with several different types of measurements,” said Dr. Darren DeWalt, M.D., University of North Carolina at Chapel Hill. “The most elegant and efficient medical therapies will fail if patients or caregivers cannot adequately and accurately administer the therapy.”
Take heed and be mindful when administering OTC liquid medications to your children.
Source: American Medical Association (AMA)