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Gluten in medications — GPhC CRA MCQ

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ModerateGI TherapeuticsGluten in medicationsGPhC CRA

A 30-year-old woman with coeliac disease asks the pharmacist whether she needs to check that her medications are gluten-free. What is the most accurate advice?

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Correct answer: ASome medications may contain starch derived from wheat but the gluten content is generally considered clinically insignificant; specific concerns should be checked with the manufacturer

Some pharmaceutical excipients contain wheat starch, but regulatory guidance and Coeliac UK confirm that the level of gluten in medicines is generally well below the threshold that would cause harm (20 parts per million). The risk is considered clinically negligible in the vast majority of cases. However, if a patient has specific concerns, the pharmacist can check with the manufacturer or consult the PIL/SmPC for excipient information. There is no blanket requirement to avoid specific dosage forms.

Reference: BNF Guidance; Coeliac UK; MHRA