Study: Misunderstanding of OTC cold product directions common
ELK GROVE VILLAGE, Ill. A study published Tuesday on the journal Pediatrics’ Web site determined that misunderstanding of dosage directions for pediatric over-the-counter cold products is common and could result in harm if medications are not given appropriately.
Researchers, however, used “old” kids cough-cold labeling as part of the study — labeling that advises parents to “consult a physician” in children under the age of 2. Today, kids' cough-cold medicines advise parents to “not use” any cough-cold product in children under the age of 2; the industry voluntarily removed all products carrying the previous label recommendation from store shelves in fall 2007. And in January 2008, the Food and Drug Administration made it official — no kids' cough-cold product could be marketed to children under the age of 2.
“While this study focuses on products that are not available, it does shine light on an issue that is still very germane,” commented Heinz Schneider, VP science and medical affairs, Consumer Healthcare Products Association. “In contrast to the artificial scenario created by the study authors who asked a small cohort of caregivers to look only at the front of product packages to determine appropriate use, the makers of OTC medicines want to remind parents to read the entire label before giving any medicine to a child. There is no substitute for reading and following the OTC Drug Facts label. The label provides specific dosing instructions, including when to contact a doctor for more information.”
Researchers interviewed 182 caregivers of infants of less than 1 year in age; 87% were the infants’ mother, the mean education level was 12.5 years and 99% had adequate literacy skills, though only 17% had greater than 9th-grade mathematical skills.
When examining the front of the product label, 86% of the time parents thought these products were appropriate for use in children less than 2 years of age. More than 50% of the time, parents stated they would give these OTC products to a 13-month-old child with cold symptoms. Caregivers were influenced by the dosing directions only 47% of the time.