Parental misinterpretations of over-the-counter pediatric cough and cold medication labels.
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.
Lokker
Nicole
N
Department of Pharmacy, University of Wisconsin Hospital and Clinics, Madison, Wisconsin, USA.
Sanders
Lee
L
Perrin
Eliana M
EM
Kumar
Disha
D
Finkle
Joanne
J
Franco
Vivian
V
Choi
Leena
L
Johnston
Philip E
PE
Rothman
Russell L
RL
D000328:Adult; D000367:Age Factors; D000996:Antitussive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003139:Common Cold / Q000188:drug therapy*; D032882:Comprehension; D003371:Cough / Q000188:drug therapy*; D003657:Decision Making; D004348:Drug Labeling; D064420:Drug-Related Side Effects and Adverse Reactions; D004522:Educational Status; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006306:Health Surveys; D006633:Histamine Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007223:Infant; D008297:Male; D008433:Mathematics; D008508:Medication Errors; D014663:Nasal Decongestants / Q000008:administration & dosage* / Q000009:adverse effects; D004366:Nonprescription Drugs / Q000008:administration & dosage* / Q000009:adverse effects; D016017:Odds Ratio; D010290:Parents; D012017:Referral and Consultation; D014481:United States; D055815:Young Adult
D000996:Antitussive Agents; D006633:Histamine Antagonists; D014663:Nasal Decongestants; D004366:Nonprescription Drugs