The European Medicines Agency (EMA) has started a review of the risk of dosing errors with methotrexate medicines, prompted by continued reports of overdose.
When used for inflammatory diseases, such as arthritis and psoriasis, methotrexate is taken once a week, whereas for some types of cancer, the dose is higher and the medicine is used more frequently. Mistakes have led to some people incorrectly receiving a dose every day instead of every week. As a result, people have received too much of the medicine, with serious consequences in some cases.
The risk of dosing errors with methotrexate has been recognised for many years and several measures are already in place in some countries to reduce this risk, including the use of visual reminders on the medicine packs. However, a recent assessment found that serious adverse events related to overdose, including fatalities, are still occurring. The Spanish medicines regulator, AEMPS, therefore asked EMA to further investigate the reasons why dosing errors continue to occur in order to identify measures to prevent them (under Article 31 of Directive 2001/83/EC).
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) are now examining the available evidence in order to recommend whether further measures are needed to minimise the risk of dosing errors. A meeting at the EMA about this will take place on Tuesday 26 February 2019, with patients attending to represent the broader community. Therefore, we wanted to gather people’s experiences about potential risk of dosing errors with methotrexate to be able to present at this meeting. There are several patients attending; including myself, on behalf of The International Foundation for Autoimmune and Autoinflammatory Arthritis (IFAA).
Your responses are anonymous, and will be used by Simon and IFAA to:
- Inform the EMA’s PRAC about people’s experiences with methotrexate dosing errors; and
- Provide general summaries of methotrexate dosing errors, which may be published by IFAA.
This survey has been developed by Simon Stones, Patient Advocate and Consultant, in partnership with Tiffany Westrich-Robertson from The International Foundation for Autoimmune and Autoinflammatory Arthritis (IFAA). The EMA has not been involved in this process.