Drug Administration via Enteral Feeding Tubes: A Landscape Analysis of Information in Drug Product Labeling.

Oral drug products are sometimes administered via enteral feeding tubes in populations with temporary or long-term swallowing disorders or difficulties. Health care providers require product-specific information regarding appropriate administration of drug products through enteral tubes to avoid occlusion of tubes and ensure the safe and effective use of the drug products. In this review, the enteral tube-related information in drug product labeling is characterized to better understand how such information is conveyed to health care professionals to help inform their clinical decision-making. The review identified 71 unique drug products with labeling related to administration via enteral feeding tube. Of those, 85% discussed the type of feeding tube and 46% discussed enteral tube size. Only 14% discussed the tubing material and 8% discussed timing of enteral feeds as it relates to dosing. The effect of enteral tube administration on the pharmacokinetics of the drug was only included in 18% of the drug product labeling. The high variability in the type and extent of enteral tube-related information in the drug product labeling suggests that innovative strategies are needed to help inform optimal use of drug products administered using this method. The few labeling that discuss feeding tube administration raises broader questions of if, and how, these data should be more consistently studied and included in labeling. Collaborative efforts from multiple stakeholders including drug developers and regulators can effectuate improvements in this area.