Background and Importance The use of excipients containing gluten in medicines can be a problem for celiac patients, especially for those with chronic pathologies. Based on this, current spanish legislation requires pharmaceutical laboratories to declare excipients containing gluten and those that may contain gluten.
Aim and Objectives To evaluate the presence of unsafe excipients for celiacs patients in medicines and the quality of the information regarding gluten content for patients and prescriptors; as well as to create an application that facilitates prescription by professionals.
Material and Methods A database in a table format was created to determine the percentage of pharmaceutical presentations with excipients that may contain gluten. Data collected was: active ingredients, therapeutic group, type of excipient, and marketing status. This data was obtained from the prescription Nomenclator tables (source: Agencia Española del Medicamento y Productos Sanitarios). With this database, an application was created to find out which presentations may contain these excipients and what alternatives are available on the market.
Results 41319 presentations were recorded, of which 19957 were commercialised. The database revealed that 8% of the presentations commercialised included excipients that may contain gluten. Of these, 93.05% corresponded to carboxymethyl starch and sodium carboxymethyl starch, of which it is difficult to know the source of the starch and its possible gluten content. Moreover, 1.836% contained wheat starch, which can have variable amount of gluten. The information found in the data sheets was variable and, in some cases, insufficient to acknowledge the real risk.
With this data, an application has been created in which it is possible to search by active ingredient or therapeutic group, providing specialties that contain excipients with gluten or its derivatives, as well as therapeutic alternatives suitable for celiac patients. In addition, this application warns of the presence of lactose.
Conclusion and Relevance Carboxymethyl starch and sodium carboxymethyl starch are the most used excipients that may contain gluten and there is a great difficulty in finding reliable information about their origin. This situation makes prescription difficult and shows the need for tools that allow quick and easy access to data, guiding towards a safer prescription for celiac patients.
Conflict of Interest No conflict of interest