Measuring Devices for Over-the-Counter Medicines Invite Confusion, Put Children at Risk

New research by RWJF Physician Faculty Scholar H. Shonna Yin establishes baseline for evaluating industry compliance with new FDA guidelines.

    • February 16, 2011

Nearly 5,700 children end up in hospital emergency rooms every year after overdosing on over-the-counter medications given them by their caregivers, according to the Centers for Disease Control and Prevention (CDC). New research by H. Shonna Yin, M.D., M.S., of the 2012 class of Robert Wood Johnson Foundation (RWJF) Physician Faculty Scholars, suggests that one potential cause of these emergency visits is that the dosing instructions and measuring devices that come with pediatric over-the-counter medications invite confusion.

Yin is an assistant professor of pediatrics at the New York University School of Medicine, and her research focuses on developing and evaluating strategies to improve parent understanding of medication instructions, including examining how to address the ways medication information is presented to families. “My interest in this issue really grew out of my experiences as a pediatric resident working in a public hospital in New York City,” she says. “I saw how often parents became confused by medication instructions, and how this was a likely contributor to treatment failures and unnecessary visits to the hospital.” She notes that many studies have found that doctors, nurses and pharmacists sometimes provide incomplete or confusing instructions about medications, and that the written information provided to families is typically geared toward a reading level too advanced for the average American.

Her most recent study, conducted with colleagues from New York University, Northwestern University, the University of Miami (Florida) and Emory University, and published in the December 15, 2010 issue of the Journal of the American Medical Association (JAMA), studied top-selling pediatric oral liquid medications available without a prescription. Researchers examined 200 products, representing 99 percent of the U.S. market for analgesic, cough/cold, allergy and gastrointestinal over-the-counter oral liquid medications for children younger than 12 years old. They checked each product to see if a measuring device, like an oral syringe, dropper, or cup was included, and whether the dosage markings on the devices matched up with the dosage instructions on the product label.

The researchers were surprised by the results. “We suspected that we might find quite a few problems,” Yin says, “but we did not expect that almost all of the products that included a measuring device would have one or more inconsistencies.”

In fact, 98.6 percent of the products that came with a measuring device had some type of inconsistency between the dosing directions listed on the product label and the markings on the accompanying device. Nearly a quarter of the dosing devices were missing a marking for one or more doses listed in the label instructions.

The opposite problem turned up as well: More than three-quarters of the dosing devices had superfluous markings that did not correspond to doses listed on the label—a potential contributor to parent confusion. In addition, about 1 in 20 products used atypical units of measure such as “cc” or drams, for example, which are terms some parents might find difficult to understand.

In their JAMA article, Yin and her colleagues describe the stakes, writing,

The risks posed by confusing or inconsistent dosing directions on pediatric over-the-counter medication packaging and measuring devices may vary depending on the nature of the discordant 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 over-the-counter medications…. In addition, one in three U.S. adults and at least one in four U.S. parents have limited health literacy; an even greater percentage have poor numeracy…. Studies report that 40 to 60 percent of parents make errors when administering medications to their children, with caregivers who have low health literacy at greatest risk.

Yin and her colleagues intended for their study to provide baseline data about the extent of the problem, initiating it shortly after the Food and Drug Administration (FDA) issued voluntary guidelines recommending greater consistency in dosing directions and accompanying measuring devices for liquid medications. Those guidelines were a response to numerous reports of overdoses among children, attributed at least in part to labeling and devices that were confusing and inconsistent. A follow-up study is planned to gauge industry compliance with the FDA guidelines in the upcoming year, as part of the CDC’s PROTECT Initiative—a public-private collaboration of federal agencies, professional organizations, manufacturers, consumer advocacy groups and academic partners working together to address the problem of medication overdoses in children.

Yin notes that the necessary changes may require some investment from industry. “One reason the dosages devices may not match up with instructions is that companies may use the same instruments for multiple products,” presumably to save on manufacturing costs. Indeed, she is concerned that FDA’s voluntary guidance will not solve the problem and that federal regulations may be necessary.

She recognizes, however, that manufacturers of over-the-counter medications have shown a strong interest in addressing the problem, and making the needed changes. “The Consumer Healthcare Products Association, the organization that represents manufacturers of over-the-counter products, has been working with the CDC as part of the PROTECT initiative over the past few years,” she said. “They have agreed to make changes to their product packaging, and have said that they will cooperate with a reassessment of products over the upcoming year.”

In the meantime, she says parents and other caregivers should “pay careful attention to labels and devices when giving over-the-counter medications to children to make sure that the dose recommended for their child on the label matches up with device markings.“ Yin adds, “If no measuring device is included in the packaging, parents should find a standard measuring device to use, like an oral syringe or dropper, rather than a kitchen spoon.”

Yin’s co-authors on the JAMA article include Ruth Parker, M.D., an alumna of the RWJF Clinical Scholars program (1986) and Lee M. Sanders, M.D., M.P.H., an alumnus of the Generalist Physician Faculty Scholars program (1999).

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