Inconsistent Measuring Devices, Dosing in Kids' Medications
Parents are told to make sure they use the special measuring spoons or other dosing devices that come with their child’s medicine. But a new study indicates that parents may not always be able to trust those measuring devices, and that the dosing instructions may be faulty as well.
Most popular kids’ medications have confusing directions
More than 700 over-the-counter (OTC) products in liquid form to treat colds/flu, pain, cough, allergies, and gastrointestinal problems are on the market for children, a dizzying selection for any parent. The investigators in a new study, which will be published in the December 15 issue of the Journal of the American Medical Association, evaluated the 200 top-selling liquid medications for children, which represented 99 percent of the US market share for these products.
The study was conducted following the release of the Food and Drug Administration’s (FDA’s) voluntary guidelines to the pharmaceutical industry regarding OTC liquid medications, especially those for children. The guidelines were prepared because there have been concerns about inconsistent or confusing measuring devices (e.g., calibrated cups, syringes, droppers, spoons) and dosing instructions on these medications.
Under direction of H. Shonna Yin, MD, MS, of the New York University School of Medicine and Bellevue Hospital Center, a team of researchers analyzed the 200 OTC products for children younger than 12 years. Of these medications, 74 percent (148 items) had a standardized measuring device, and of these, 98.6 percent included at least one inconsistency between the device and the labeled directions.
A closer inspection of the measuring devices showed that 81.1 percent had at least one “superfluous” marking, and that “the text used for units of measurement was inconsistent between the product’s label and enclosed device in 89 percent of products,” inconsistencies parents could well find confusing and which could result in improper dosing of their children.
Investigators also noted other inconsistencies with the measurement devices and dosing information, including the use of nonstandard units of measurement in 5.5 percent of products, a nonstandard abbreviation for milliliter in 97 products, and the omission of at least one abbreviation in 163 cases.
Considering that more than 50 percent of children in the United States take at least one medication during a given week and that more than half of these are OTC drugs, a great number of children could be harmed by this lack of consistency and clarity.
In an editorial that accompanies the study in JAMA, Darren A. DeWalt, MD, MPH, of the University of North Carolina at Chapel Hill, noted that “the most elegant and efficient medical therapies will fail if patients or caregivers cannot adequately and accurately administer the therapy.” Inconsistencies in measuring devices for children’s liquid medications and in the dosing instructions led the study’s authors to note that “additional regulatory oversight may be needed to ensure practices that best support safe and effective use of OTC medications.”
DeWalt DA. JAMA 2010; 304(23): doi: 10.1001/jama.2010.1844
Yin HS et a. JAMA 2010; 304(23): doi: 10.1001/jama.2010.1797