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Dabigatran monitored dosage system — GPhC CRA MCQ

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HardDispensing and SupplyDabigatran monitored dosage systemGPhC CRA

A care home requests that dabigatran capsules be removed from original packaging and placed into a monitored dosage system for four weeks. The patient has AF and eGFR 55mL/min/1.73m2. What is the legal classification/requirement?

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Correct answer: CCheck stability guidance and avoid repackaging if the product must remain in original packaging.

Some medicines, including dabigatran capsules, have important packaging requirements related to moisture protection. Repackaging into an MDS may compromise stability and safety unless reliable product-specific guidance supports it. Capsules should not be opened because exposure can alter drug delivery and bleeding risk.

Reference: BNF; SmPC; MEP