PEDIATRICS Vol. 123 No. 6 June 2009, pp. 1464-1471 (doi:10.1542/peds.2008-0854)
ARTICLE |
Parental Misinterpretations of Over-the-Counter Pediatric Cough and Cold Medication Labels
a Department of Pharmacy, University of Wisconsin Hospital and Clinics, Madison, Wisconsin
b Department of Pediatrics, University of Miami, Miami, Florida
c Department of Pediatrics, University of North Carolina, Chapel Hill, North Carolina
d Center for Health Services Research
e Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee
f School of Pharmacy, Belmont University, Nashville, Tennessee
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 (
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.
Key Words: nonprescription drugs • literacy • safety
Abbreviations: OTC—over-the-counter • CDC—Centers for Disease Control and Prevention • FDA—Food and Drug Administration • STOFHLA—Shortened Test of Functional Health Literacy in Adults • WRAT-3—Wide Range Achievement Test 3 • GEE—generalized estimating equations • aOR—adjusted odds ratio • CI—confidence interval • Qn—question n
Accepted Oct 2, 2008.
CiteULike 
Connotea 
Del.icio.us 
Digg 
Facebook 
Reddit 
Technorati 
Twitter What's this?
This article has been cited by other articles:
|
|
 |
|
  L. M. Sanders, J. S. Shaw, G. Guez, C. Baur, and R. Rudd Health Literacy and Child Health Promotion: Implications for Research, Clinical Care, and Public Policy Pediatrics, November 1, 2009; 124(Supplement_3): S306 - S314. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. L. Rothman, H. S. Yin, S. Mulvaney, J. P. T. Co, C. Homer, and C. Lannon Health Literacy and Quality: Focus on Chronic Illness Care and Patient Safety Pediatrics, November 1, 2009; 124(Supplement_3): S315 - S326. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 C. Kemp Parents often misinterpret OTC medication labels AAP News, August 1, 2009; 30(8): 2 - 2. [Full Text] [PDF]
|
|
