Dangerous Inconsistencies Found in Dosing Directions for Children's Medications, Study Says
An examination of 200 of the top-selling over-the-counter (OTC) cough/cold, allergy, analgesic and gastrointestinal liquid medications for children reports a high level of variability and inconsistencies in medication labeling and measuring devices, according to a study released online today by JAMA.
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. In fact, analgesics, cough/cold medications, antihistamines and gastrointestinal drugs account for more than a quarter of medications administered to children, with liquid formulations typically used for young children, the authors report.
In November 2009, the U.S. Food and Drug Administration released new voluntary guidelines to industry groups responsible for manufacturing, marketing or distributing OTC liquid medications -- particularly those intended for use by children. These guidelines were developed in response to numerous reports of unintentional overdoses attributed, in part, to liquid medications with inconsistent or confusing labels and measuring devices, the authors report.
With this in mind, the goal of the new study was to determine the prevalence of inconsistent dosing directions and measuring devices among 200 top-selling pediatric liquid OTC medications. The medications sampled represent 99 percent of the U.S. market of OTC analgesic, cough/cold, allergy and gastrointestinal oral liquid products with dosing information for children younger than 12.
Out of the 200 medications examined, 148 products (74 percent) included a standardized measuring device. But nearly all of these devices (98.6 percent) contained one or more inconsistencies between the directions on the label and the device with regard to doses listed or marked on the device or text used for the unit of measurement, the authors report.
"Among the measuring devices, 81.1 percent included one 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.
Adding to concern is the fact that one in three U.S. adults and at least one in four U.S. parents have limited health literacy and an even greater percentage have poor mathematical literacy, according to the study. The researchers say previous studies show 40 to 60 percent of parents make errors when administering medications to their children.
According to the authors, the study points to problems in three critical areas: A standardized measuring device should be included with all OTC liquid products; within each product, consistency should be ensured between the labeled dosing directions and markings on the included measuring device; and, across products, measurement units, abbreviations and numeric formats should be standardized.
"Supporting consumer comprehension by providing clear, consistent and standardized information increases the likelihood that consumers can safely and effectively use OTC medications," the authors conclude.
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