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Parental misinterpretations of over-the-counter pediatric cough and cold medication labels
Nicole Lokker1, Lee Sanders, Eliana M Perrin
1Department of Pharmacy, University of Wisconsin Hospital and Clinics, Madison, Wisconsin, USA.
Insights
Many parents misunderstand over-the-counter (OTC) cold medicine labels, leading to potential harm. Labeling and lower numeracy skills contribute to misinterpretation of age indications for infant cold medications.
Area of Science:
- Pediatrics
- Public Health
- Pharmacology
Background:
- Concerns regarding the safety and efficacy of OTC cold medications have prompted regulatory action.
- The US Food and Drug Administration (FDA) issued a advisory against using OTC cold medications in children under 2 years of age.
Purpose of the Study:
- To assess caregiver comprehension of age indications on OTC cold medication labels.
- To identify factors influencing caregiver understanding of these labels.
Main Methods:
- 182 caregivers of infants (≤1 year old) were recruited from three clinics.
- Participants completed questionnaires on OTC cold medication use and underwent literacy and numeracy assessments.
- Caregivers were asked about the appropriateness of using "infant" labeled cold medicines in children under 2 years.
Main Results:
- 86% of caregivers believed "infant" labeled cold medicines were appropriate for children under 2.
- Over 50% would administer these products to a 13-month-old with cold symptoms.
- Labeling cues (e.g., "infant" text, graphics) and lower numeracy skills influenced inappropriate interpretations.
Conclusions:
- Widespread misunderstanding of OTC cold medication age indications exists among caregivers.
- Label design and poor numeracy skills contribute to misinterpretation, potentially leading to unsafe medication use.
- Revisions to OTC labeling by the FDA and manufacturers are recommended to improve comprehension and child safety.
Objective:
Concerns about the safety and efficacy of over-the-counter cold medications have led to a recent US Food and Drug Administration public health advisory against their use in children <2 years of age. Our goal was to examine caregiver understanding of the age indication of over-the-counter cold medication labels and identify factors, associated with caregiver understanding.
Methods:
Caregivers of infant children (< or =1 year old) were recruited from clinics at 3 institutions. Questions were administered regarding the use of 4 previously common "infant" over-the-counter cold and cough medicines labeled to consult a physician if used in children <2 years of age. Literacy and numeracy skills were assessed with validated instruments.
Results:
A total of 182 caregivers were recruited; 87% were the infants' mothers. Mean education level was 12.5 years, and 99% had adequate literacy skills, but only 17% had >9th-grade numeracy skills. When examining the front of the product label, 86% of the time parents thought these products were appropriate for use in children <2 years of age. More than 50% of the time, parents stated they would give these over-the-counter products to a 13-month-old child with cold symptoms. Common factors that influenced parental decisions included label saying "infant," graphics (eg, infants, teddy bears, droppers), and dosing directions. Caregivers were influenced by the dosing directions only 47% of the time. Caregivers with lower numeracy skills were more likely to provide inappropriate reasons for giving an over-the-counter medication.
Conclusions:
Misunderstanding of over-the-counter cold products is common and could result in harm if medications are given inappropriately. Label language and graphics seem to influence inappropriate interpretation of over-the-counter product age indications. Poorer parental numeracy skills may increase the misinterpretation of these products. Opportunities exist for the Food and Drug Administration and manufacturers to revise existing labels to improve parental comprehension and enhance child safety.
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