01 October 2019
The European Medicines Agency (EMA) recently published new recommendations affecting the marketing authorisation (MA) of medicinal products containing methotrexate.
The new measures, applicable in all EU member states, are intended to reduce dosing errors, include restricting who can prescribe these medicines, making warnings on the packaging more prominent, and providing educational materials for patients and healthcare professionals. You can view more information here.
The new product information updates stipulate that only physicians with expertise in using methotrexate medicines should prescribe them. We are aware that this is causing some concern to our members and may be interpreted as excluding physician associates and nurse practitioners from prescribing methotrexate.
We understand from the Medicines and Healthcare products Regulatory Agency (MHRA) that some methotrexate products in the UK already include this wording, so these new measures are viewed as a harmonisation in the statutory product information across all products rather than an introduction of new advice.
The MHRA has taken the position that the new measures are not intended to change who can currently prescribe methotrexate in the UK. There have also been questions about what would constitute expertise in using methotrexate medicines. The MHRA’s position is that this condition is met if prescribers are aware of the benefits and risks of methotrexate treatment and have the necessary professional competence to prescribe it safely.
Our advice is that healthcare professionals who currently prescribe methotrexate should continue to do so as long as they are supported in their practice by a relevant qualification and appropriate policies and procedures at Trust or Board level.
We also ask members to make us aware of any problems or concerns caused by these recommendations on policy@rheumatology.org.uk.