Advocating for the Inclusion of Allergen Statements on Medication Labeling

Abstract

As defined by the Society for Technical Communication (n.d.), the job of a technical communicator is to: “communicate about technical or specialized topics; communicate by using technology; and/or provide instructions about how to do something.” Though technical communication is frequently associated with software and engineering, it has important applications for other disciplines, including the medical field. In this thesis, allergen statements on a medical document are critiqued from a technical communication, and further usability, viewpoint. Allergen statements are primarily associated with food products and are rarely found on pharmaceutical labeling. However, pharmaceuticals, although they include medication (the API), they also include “filler” materials made from food products, including incendiary foods like lactose, wheat, and soy. The lack of an allergen statement on pharmaceuticals may endanger food sensitive individuals, like those with food allergies, celiac, or food intolerances. The following thesis provides a brief review of research done on allergen statements and incendiary foods in pharmaceuticals; results from a usability test conducted based on principles of technical communication, like comprehension and readability; an analysis and discussion of those results; and recommendations for the FDA and pharmaceutical manufacturers. Based on a literature review and the results from this usability test, it is highly recommended that the FDA require pharmaceutical companies to include an allergen statement somewhere on their product. This statement should include brief details on where cross-contamination could occur and be accessible to consumers, not just healthcare professionals.