Study: Packaging for OTC Products Hard for Parents to Understand
By Salynn Boyles
WebMD Health News
Reviewed by Laura J. Martin, MD
Nov. 30, 2010 -- Dosing instructions for over-the-counter liquid medicines used by kids are often confusing, inconsistent, and hard for parents to follow, a new study shows.
Researchers examined the packaging of 200 best-selling liquid cough and cold, allergy, pain, and GI products marketed for children following the publication of voluntary packaging guidelines by the FDA in 2009.
Those guidelines called for over-the-counter liquid medicines to include a measuring device to help with dosing. Federal officials also said directions on the devices and medicine labeling should be consistent, with the same abbreviations and units of measurement.
The new report, published online Tuesday in the Journal of the American Medical Association, illustrates the extent of the problem with over-the-counter pediatric liquid medicine packaging.
Among the major findings:
- One-in-four liquid drugs examined did not contain a dosing device, such as a cup, dropper, or syringe.
- Just about all of those that did (99%) had markings on the enclosed device that were inconsistent with the label instructions. Some of these inconsistencies were small, but others made correct dosing very difficult, the researcher noted.
- More than half the medicines did not use standard abbreviations for terms such as teaspoon or milliliter.
"It is really important that parents understand product instructions so that they are able to give medications correctly," NYU assistant professor of pediatric medicine and study researcher Shonna Yin, MD, tells WebMD. "We should be helping by providing them with clear and straightforward dosing instructions and devices."
In a news release, study co-author Ruth Parker, MD, of Atlanta's Emory University School of Medicine expressed doubt that the FDA's voluntary guidelines were sufficient for addressing the problem.
"The current guidance does not contain a timeline for compliance or specify consequences for non-compliance," she notes. "Standards and regulatory oversight will likely be needed to ensure that all products contain label information and dosing device markings that match and are understandable and useful."
More than half of children in the U.S. take one or more medications every week, and more than half of these are over-the-counter drugs, the researchers note.
Darren A. DeWalt, MD, MPH, of the University of North Carolina, Chapel Hill, says it defies logic that pharmaceutical companies spend hundreds of millions of dollars developing new drugs -- including determining the appropriate dosage to give -- and then fail to provide clear dosing instructions for them.
DeWalt, whose research focuses on how well patients understand doctors' instructions and the impact on medical care, says the fault does not lie with the product labelers alone.
"At every level, including the clinic and the pharmacy, we are not doing a very good job of helping parents understand what they need to know when they give these medications at home," he tells WebMD.
Teaspoon, Tablespoon Confusion
DeWalt says one of the biggest areas of confusion involves teaspoon and tablespoon dosing recommendations.
He says people often confuse the two and use tablespoons, which are typically three times the size of teaspoons, when instructions call for teaspoons.
"This happens all the time," he says. "Most of the time there is no real harm. But if it happens with, say, Tylenol several times a day for several days, there could be issues with liver toxicity. Or if it happens with Benadryl that can knock a child out."
Devices for delivering medicines often have extra markings that are not necessary for following label directions.
In the newly published analysis, four out of five measuring devices included these superfluous markings.
And some products included units of measurement that hardly anyone understands, such as "drams" and "cubic centimeters."
"I couldn't tell you what a dram is, and it's a safe bet that very few people can," DeWalt says.
In an editorial published with the study, DeWalt recommended that milliliters be adopted as the standard unit for delivering liquid medications.
Yin says if this happens, efforts to educate the public and health care providers about this unit of measure will be needed.
"This is not a term many parents understand," she says. "And doctors, nurses, and pharmacists will need to use this term. There has to be a united front, or it will just add to the confusion."
Consumer Healthcare Products Association Responds
In a statement released Tuesday afternoon, the trade association representing the over-the-counter drug industry says it is working with federal officials and others to simplify dosing for consumers.
"The OTC medicine industry takes very seriously its responsibility to help parents and caregivers safely and correctly administer OTC pediatric medicines to children," the Consumer Healthcare Products Association (CHPA) statement reads.
Last November, the CHPA approved dosing guidelines for liquid drugs that also called for the inclusion of appropriate dosing devices in over-the-counter liquid medications. The group also recommends the adoption of milliliters as the preferred unit for dosing with the abbreviation to read "mL."
"CHPA's voluntary guidelines, supported by the American Association of Poison Control Centers, were developed as part of a public-private partnership, called the PROTECT Initiative, with the CDC and other stakeholders," the statement reads.
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