P3.F105: Evaluating the safety of pediatric over the counter liquid medications with a focus on product labeling and presence of pharmaceutical excipients and preservatives

Background: Dosing errors associated with over the counter (OTC) pediatric liquid medications present a patient safety and public health concern. The U.S. Food and Drug Administration (FDA) and Consumer Healthcare Products Association (CHPA) provide guidelines for industry on optimal labeling for dosing directions and dosing devices for pediatric liquid medications. There is a lack of recent evidence evaluating adherence to label and device recommendations and presence of pharmaceutical preservatives or excipients in these products. The objectives of this study were to evaluate the adherence of OTC pediatric liquid medications to FDA and CHPA recommendations and to investigate the presence of potentially harmful pharmaceutical excipients and preservatives.

Methods: We investigated brand and generic OTC pediatric liquid products from CVS, Walgreens, and Walmart pharmacies and collected data on dosing devices, packaging labels, and excipients. FDA and CHPA guidelines for optimal labeling of dosing directions and devices were used when reviewing product labels. Previous literature has categorized recommendations as top or low tier based on dosing error potential. Adherence to top and low tier recommendations and presence of excipients was documented. Data was analyzed using descriptive statistics.

Results: Seventy-three medications were investigated (40 generic and 33 brands), of which 65% (26/40) generic products and 63.6% (21/33) brand products had information available on product labeling. Of those, 18/26 (69.2%) generic products and 11/21(52.4%) of brand-name products adhered to top-tier recommendations. Non-adherence to top-tier recommendations was 8/26 (30.8%) of generics and 10/21 (47.6%) of brands. All generic products and 19/21 (90.5%) brand-name products adhered to low-tier recommendations. Non-adherence issues identified included the dosing device being larger than the largest dose in the directions, mixing teaspoon and tablespoon units, trailing zeros, and failing to define abbreviations. Pharmaceutical preservatives or excipients most found in OTC pediatric liquid medications were sodium benzoate (55/73, 75.34%), parabens (17/73, 23.28%), polyethylene glycol (9/73, 12.32%), polysorbate 80 (9/73, 12.32%), and sorbitol (44/73, 60.27%).

Conclusion: Non-adherence to FDA and CHPA top-tier recommendations for labeling of dosing directions and devices was present in 30.8% of generic and 47.6% of brand products available for review in this study. Compared to brand products, generics were more adherent to top-tier and low-tier recommendations. This study highlights the need for increased adherence to FDA and CHPA recommendations for OTC pediatric liquid medications. Alternatives for parabens and other concerning excipients found in these products should be further investigated.