EMA recommends new measures to avoid dosing errors with methotrexate
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- Only doctors with expertise in using methotrexate-containing medicines to prescribe them.
- Healthcare professionals to ensure that patients or carers are able to follow the once-weekly dosing schedule.
- To avoid confusion, recommendations to split the dose should be deleted from the product information for the tablet formulation.
- Packaging for all methotrexate-containing medicines for once-weekly use to include a prominent reminder of how the medicine should be used.
- Patient card emphasising the weekly dosing for inflammatory diseases to be provided with oral medicines.
- Healthcare professionals to be provided with educational materials for oral medicines and to counsel patients accordingly.
- Tablets to be available in blister packs instead of bottles (or tubes) in order to help patients follow the once-weekly dosing.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.
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