Tuesday, July 16, 2019

European drug regulatory authority proposes new recommendations to prevent dosing errors with methotrexate

Pharmacovigilance Risk Assessment Committee (PRAC), the safety committee of European Medicines Agency (EMA) has recommended new measures to avoid dosing errors with methotrexate that have led to some patients incorrectly taking methotrexate-containing medicines.

Methotrexate is used to treat both inflammatory diseases and cancer. When used as an anti-inflammatory in the treatment of diseases such as arthritis and psoriasis, it is taken once a week. For the treatment of some types of cancer, a much higher dosage is needed and the medicine is taken more frequently.

The proposed measures to prevent dosing errors with methotrexate are:

·         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 emphasizing 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

The PRAC recommendations will now be sent to the Committee for Medicinal Products for Human Use (CHMP), which will adopt an opinion.

(Source: EMA, July 12, 2019)

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA

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