New nationwide solutions to prevent deaths linked to methotrexate UK

The National Patient Safety Agency (NPSA) has alerted the NHS to the risks associated with the use of the drug oral methotrexate, and issued a three-pronged solution to combat risks associated with the drug.


Oral methotrexate tablets are taken by thousands of people in the UK, normally for the treatment of moderate to severe rheumatoid arthritis and severe psoriasis. It is a safe and effective medication if taken at the right frequency and in the right dose and with appropriate monitoring.


However, 25 patient deaths and 26 cases of serious harm linked to the use of oral methotrexate outside hospitals were identified by NPSA in a study of the use of the drug in England over a 10 year period. The key underlying factors that put patients at risk include patients having insufficient information about how the drug should be taken - normally weekly, and not daily; confusion between different tablet strengths; lack of clear messages on packaging; mistakes in prescribing; and variations in patient monitoring and treatment reviews.


The NPSA's work involved a unique collaboration with the pharmaceutical industry, and health professionals, patient groups, and medical and pharmaceutical software suppliers to develop three practical national solutions:


-- Prescribing support IT systems and pharmacy dispensing IT systems are being adapted to design-out opportunities for human error in prescribing using default settings incorporating warnings and prompts about methotrexate. Changes to prescribing software programmes are already underway and should be completed by November 2004.


-- NPSA has provided core information that should be communicated to patients both prior to commencing treatment with methotrexate tablets, and during treatment. Pre-treatment patient information leaflets and patient held monitoring and dosage records should now be provided to all patients taking the drug. Sample leaflets and guidance about the layout will be sent out with the alert notice.


-- In an unprecedented collaboration with the pharmaceutical industry, the three UK manufacturers or license holders of methotrexate, Pfizer, Goldshield (currently Wyeth) and Mayne Pharma, are working with the NPSA to develop safer, patient-friendly packaging.


The companies which produce the 10mg tablet have already changed the shape of this tablet to help clinicians and patients distinguish it from the 2.5mg tablet, and have recalled all previously round shaped tablets in order to prevent any further confusion. The Chief Medical Officer, Sir Liam Donaldson said: "Whilst the vast majority of NHS care is safe, errors do occur.


And as this work so clearly demonstrates, in most cases these are not isolated events, but can be traced to weaknesses in systems and processes. By tackling this problem at a number of levels, we can protect staff and patients from common pitfalls that although minor in themselves, can have tragic consequences. In this country we are helping to lead an international initiative championing patient safety and putting it right at the centre of all health care being delivered today.















This latest initiative is about a real problem that has cost lives in the past. We have learned and further learning will save lives in the future." Wendy Harris, Senior Pharmacist at the NPSA, said: "Oral Methotrexate is a safe and effective drug if taken at the right frequency of dose and with appropriate monitoring, but all too easily in the past mistakes have been made, sometimes with fatal consequences.


"We've had to tackle this complex problem at a number of levels, and have combined forces with industry, and involved patients, clinicians and pharmacists who have given us invaluable feedback about making treatment safer.


"All the evidence tells us that these solutions will help to reduce the risk for those taking oral Methotrexate and ultimately save lives". Neil Betteridge, Director of Public Affairs at Arthritis Care, said: "Eighty percent of people who take oral Methotrexate are patients who have moderate to severe arthritis. The effectiveness of the drug is not in question and has improved the quality of life for some people with arthritis. However, it is essential that patients have an understanding of all the risks around the drugs that they are taking, particularly in relation to dosage and frequency. We believe that the patient information the NPSA has developed will be crucial in helping people with arthritis to take oral Methotrexate safely and effectively".


There are 13,000 medicines currently licensed for use in the UK. Oral methotrexate is one of only six medicines that should be taken weekly - the others are: Chloroquine, alendronic acid 70mg, mefloquine, mebenazole and piperazine. Methotrexate is also used in the treatment of neoplastic disease such as leukaemia, however, for these conditions it is used within hospital settings only. Errors with administering oral methotrexate were highlighted as a priority in the Chief Pharmaceutical Officer's report "Building a Safer NHS for Patients - Improving Medication Safety".