NPSA reinforces oral methotrexate dangers

Asignificant minority of organisations have yet to implement the actions set out in the Agency’s original alert on oral methotrexate, published in July 2004. The NPSA’s new alert, Improving compliance with oral methotrexate guidelines, tells NHS organisations to ensure that all actions described in the original alert are completed; and give patients the core patient information leaflet and monitoring document which have been reviewed in collaboration with the British Society for Rheumatology (BSR) and the British Association of Dermatologists (BAD).

Oral methotrexate is used to treat some types of rheumatic disease such as rheumatoid arthritis, as well as severe psoriasis, and bowel diseases such as Crohn’s disease. It is a well-established and effective medication if taken at the right dose, at the right frequency and with appropriate monitoring. Very occasionally, however, problems with taking the medication can cause serious harm and even death.

In his 2004 annual report, the chief medical officer (England) Professor Sir Liam Donaldson, cited the NPSA’s original oral methotrexate guidance as an example of how NHS organisations had been slow to comply with alerts. Feedback from the Department of Health’s Safety Alert Broadcast System (SABS) indicates that 18% of NHS organisations (104 out of 569) have still not fully implemented the actions set out in the NPSA’s original patient safety alert. Since July 2004 the NPSA has received, via its National Reporting and Learning System (NRLS), 165 reports of patient safety incidents involving oral methotrexate.

Fourteen of these incidents occurred before the launch of the original patient safety alert in July 2004. The remaining 151, however, occurred after the alert had been issued. It is possible – although the NPSA has not received sufficient detailed information to confirm it – that some incidents could have been prevented if advice issued to the NHS had been followed.

The NPSA’s medical director, Professor Sir John Lilleyman said: “Methotrexate is a well-established and vital part of treatment for many conditions, and incidents relating to it are very rare.

“As our reporting system shows, however, patients are still being harmed and in some cases this medication is still not being taken or monitored properly.

“Progress has been made since the original alert was issued in July 2004; however incidents may have been prevented if action had been taken. The NPSA’s aim is to protect patients and staff from the consequences of simple but potentially fatal mistakes and the steps we are urging the NHS to take will help to do that.”