The study, authored by five researchers from across the country, including the Miller School’s Lee Sanders, M.D., M.P.H., associate professor of pediatrics, was released online today because of its public health importance.
“As of now, we only have voluntary guidelines for dosing and measuring devices, so it’s time to demand the appropriate federal agencies establish more enforceable standards,’’ Sanders said. “My colleagues and I often get called in the middle of the night by well-meaning parents who do not understand the labels. Often the doses and units on the dosing device do not match the label. That sort of inconsistency is inexcusable.’’
Sanders and colleagues in New York, Atlanta and Chicago set out to determine the prevalence of inconsistent dosing directions and measuring devices among popular pediatric over-the-counter (OTC) medications at the time the U.S. Food and Drug Administration (FDA) released new voluntary guidelines to industry groups responsible for manufacturing, marketing, or distributing OTC liquid medications, particularly those intended for children.
Released in November 2009, the FDA 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.
The researchers analyzed 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 in the one-year period ending October 30, 2009. They found a standardized measuring device was provided for 148 products, or 74 percent, and nearly all of them (98.6 percent) contained one or more inconsistencies between the labeled directions and the accompanying device, with respect to doses listed or marked on the device, or text used for unit of measurement. Almost a quarter of products (24.3 percent) lacked necessary markings.
“Among the measuring devices, 81.1 percent included one or more superfluous markings,’’ the authors wrote. “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 researchers also found that across all products, milliliter (143 products or 71.5 percent) and teaspoon (155 products or 77.5 percent) were the most frequently used units of measurement. Tablespoon was used in 37 products (18.5 percent). 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 one abbreviation.
The study authors make recommendations in three critical areas. They said a standardized measuring device should be included with all nonprescription liquid products; within each product, consistency should be ensured between the labeled dosing directions and markings on the associated measuring device; and across products, measurement units, abbreviations, and numeric formats should be standardized.
“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 discordant labeling, yet the potential for harm is substantial,’’ the authors wrote. “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.’’
The researchers also noted that the 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.”
In addition to Sanders, the study authors include H. Shonna Yin, M.D., M.S., of New York University School of Medicine; Michael S. Wolf, Ph.D., M.P.H., of the Feinberg School of Medicine, Northwestern University; Benard P. Dreyer, M.D., of New York University School of Medicine; and Ruth M. Parker, M.D., of Emory University School of Medicine.
To read the study please visit the JAMA website.