Gluten in pharmaceutical products: a scoping review

Abstract

Background Celiac disease (CD) is one of the most common gluten-related disorders. Although the only effective treatment is a strict gluten-free diet, doubts remain as to whether healthcare professionals take this restriction into consideration when prescribing and dispensing medicines to susceptible patients. This scoping review aimed to find out the current evidence for initiatives that either describe the gluten content of medicines or intend to raise awareness about the risk of prescribing and dispensing gluten-containing medicines in patients with CD and other gluten-related disorders. Methods A scoping review was conducted using three search strategies in PubMed/MEDLINE, TripDatabase and Web of Science in April 2021, following the PRISMA extension for scoping reviews (PRISMA-ScR). References from included articles were also examined. Two researchers screened the articles and results were classified according to their main characteristics and outcomes, which were grouped according to the PCC (Population, Concept and Context) framework. The initiatives described were classified into three targeted processes related to gluten-containing medicines: prescription, dispensation and both prescription and dispensation. Results We identified a total of 3146 records. After the elimination of duplicates, 3062 articles remained and ultimately 13 full texts were included in the narrative synthesis. Most studies were conducted in the US, followed by Canada and Australia, which each published one article. Most strategies were focused on increasing health professional’s knowledge of gluten-containing/gluten-free medications (n = 8), which were basically based on database development from manufacturer data. A wide variability between countries on provided information and labelling of gluten-containing medicines was found. Conclusion Initiatives regarding the presence of gluten in medicines, including, among others, support for prescribers, the definition of the role of pharmacists, and patients’ adherence problems due to incomplete labelling of the medicines, have been continuously developed and adapted to the different needs of patients. However, information is still scarce, and some aspects have not yet been considered, such as effectiveness for the practical use of solutions to support healthcare professionals.

Gluten‐free diet for pediatric patients with coeliac disease: A position paper from the ESPGHAN gastroenterology committee, special interest group in coeliac disease

“…There is scarce data on the actual content of gluten in medical drugs. Most likely, the amounts are minimal considered the low amounts of wheat starch used in medical drugs resulting in a low daily dose of gluten 80,81 . Therefore, almost all medical drugs are considered to be safe.…”

Disponibilidad de analgésicos y antibióticos libres de gluten para uso odontológico en farmacias del Área Metropolitana de Asunción

“…Una de las preocupaciones más frecuentemente expresadas por los pacientes afectados por EC hace referencia a la carencia de la información acerca de la presencia de gluten en los medicamentos de venta libre en las farmacias (26) , por lo que sería recomendado incluir en la legislación la obligatoriedad de declarar la ausencia o presencia de excipientes que puedan causar reacciones adversas a los pacientes y que esta declaración esté presente en la ficha técnica, el prospecto y el etiquetado de los medicamentos incluyendo también las trazas de sustancias originadas en los procesos de fabricación de los principios activos que puedan ser origen de reacciones nocivas, con la finalidad de permitir un acceso rápido y preciso a los medicamentos.…”