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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