Quantitative analysis of caregiver comprehension of children's over-the-counter cough and cold medication dosing instructions
Gaynor, Melissa Robyn
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The Food and Drug Administration maintains the authority to regulate the labeling of children’s over-the-counter cough and cold medications. FDA’s primary interests in this area are to protect children from incidences of adverse events due to over-dosing and to ensure that medications are administered correctly so that the patient may receive the proper therapeutic dose. Labeling is only effective if it can be accurately interpreted and followed by caregivers. Published literature and a qualitative pilot study completed in 2010 suggest that caregivers are dissatisfied with the current dosing instructions of children’s over-the-counter cough and cold medications. The purpose of this study is to quantitatively examine the findings of previously completed research and to determine the effect of caregiver functional health literacy on their ability to accurately interpret product labeling. Recommendations to enhance FDA’s regulations by modifying current product labeling requirements are made.