OTC Medication Labels Can Be Confusing to Parents
< May 27, 2009 > -- A new study has found that medication labels on children's over-the-counter (OTC) cold medicine can be confusing to parents.
According to the study's lead researcher, Dr. Russell Rothman, an assistant professor of internal medicine and pediatrics at Vanderbilt University Medical Center in Nashville, Tenn, language that is easy to read with clearer graphics is necessary to guide the selection and safe use of the medications,
"The age indications of over-the-counter pediatric cold and cough products are difficult for caregivers to understand," Dr. Rothman says. "These misinterpretations may pose significant hazards to child safety."
In 2007, drug makers removed several OTC cold and cough medications from supermarkets and/or drugstores in cooperation with the US Food and Drug Administration (FDA) recommendation - do not use OTC cough and cold medications in children younger than two years old. In regards to products that remained on store shelves, pharmaceutical companies changed the medication labels to reflect this recommendation as well.
Research Study and Conclusion
In this study, Dr. Rothman and his research team decided to evaluate how well parents understood information printed on medications labels of OTC cold medicines. The target population was parents with children four years old and greater. This population was selected because OTC products remained on the market specifically for this age group.
Researchers evaluated 182 parents as they read medication labels from four different OTC cold and cough medicines. These labels were taken from OTC products removed from the market earlier, because they had been labeled for "infant" use.
Each label advised consumers to contact a physician prior to using the medication in children who were two years old. According to study findings, about 86 percent of the time, parents thought that these OTC cough and cold medications could be given to children younger than two. In addition, dosing instructions were not read or clearly understood.
Over 50 percent of the time, parents admitted giving these medications to children younger than two years old with cold symptoms, even though the label instructed them to consult a physician first. Parents stated that pictures of infants, teddy bears and droppers, and the word "infant" on labels influenced their decision.
Study findings also indicated that parents with poor math skills were more likely to give incorrect or inappropriate answers.
"Instructions on over-the-counter cough and cold medicines can be difficult to understand, and this can potentially lead to misuse and threats to child safety," Dr. Rothman says. "Labeling needs further improvements to aid parental understanding."
Some manufacturers may have recently changed labels on OTC medications, but "the changes made vary from product to product, and it is not uniform," Dr. Rothman adds.
"Manufacturers and the FDA should continue to work together to further improve current OTC labels," Dr. Rothman says. "This includes removing misleading graphics, using more uniform, plain language, improving the display of quantitative information and simplifying the Drug Facts Panel component of the label. Any warnings about use - related to age and other factors - need to be more prominently displayed using simple, uniform language with large, bold print that is easy to read and identify on the package."
Future Debates Regarding OTC Medication
Another concern besides labeling, according to Dr. Rothman, is whether the OTC products work and should be used in children.
Dr. Rothman feels there is limited data to support how well the medicines work in children younger than 6. "Parents should be cautious about using over-the-counter cold and cough medicines, particularly medicines that contain combinations of products," he says. "They should read packaging carefully and discuss with their doctor or other health-care providers before use."
Dr. Rothman feels that the research study highlighted important concerns about parental understanding of all OTC products and identified potential harms to children of all ages, not just those younger than two.
"We applaud the pharmaceutical industry's recent announcement to add warnings on these products for children less than four years old," Dr. Rothman says. "However, if over-the-counter cold and cough products marketed for children are to remain on the market, significant changes are necessary to make product packaging and labeling more clearly understandable by all caregivers. A single warning statement is unlikely to be sufficient."
Dr. Rothman adds that he hopes the study's findings "will be of use to the FDA as it continues to deliberate how better to inform the public about the appropriateness of over-the-counter medications."
Always consult your child's physician for more information.
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Over-The-Counter Medicines for Infants and Children