The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has issued new recommendations aimed at reducing the risk of methotrexate dosing errors that have led to some patients incorrectly receiving methotrexate-containing medicines daily instead of weekly for inflammatory diseases.
The PRAC has now recommended that only doctors with expertise in using methotrexate-containing medicines should be permitted to prescribe the products, and healthcare professionals must ensure that patients and 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 and packaging for all methotrexate-containing medicines for once-weekly use must include a prominent reminder of how the medicine should be used. It is also recommended that a patient card emphasising the weekly dosing schedule for inflammatory diseases should be provided with oral medicines.
PRAC recommends that healthcare professionals are provided with educational materials for oral medicines and how to counsel patients accordingly.
It also calls for tablets to be available in blister packs instead of bottles or tubes in order to help patients follow the once-weekly dosing.
The recommendations will now be forwarded to the Committee for Medicinal Products for Human Use (CHMP), which will adopt an opinion.