The Pharmaceutical Journal
Vol 271 No 7256 p3
5 July 2003

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Patients to have new role in improving methotrexate safety, says NPSA

Patients are to play a greater part in preventing medication errors involving methotrexate as part of a package of measures announced by the National Patient Safety Agency on 4 July.

The announcement follows concerns over the safety of the drug. Over a 10-year period, the NPSA identified 25 patient deaths and 26 cases of serious harm linked to the use of oral methotrexate in a community setting in England. Key problems included patients not being informed about how to take the drug, particularly taking it on a weekly rather than daily basis, and unclear packaging.

Wendy Harris, senior pharmacist at the NPSA, told The Journal: "The NPSA is not here to produce guidelines. Our job is to deliver practical, simple solutions."

Among the new measures is a treatment diary that provides patients with information such as the "dos and don'ts" of treatment, symptoms to look for, monitoring results and a records of appointments.

A group of patients, carers and professionals received the diary this week. "Their job is to comment on the design and information content of the diary," she explained. "Then prototypes will be made up and tested later this year." How patients and professionals use the diary will be assessed, along with monitoring for any adverse incidents. An example of use would be a patient taking methotrexate who consults a pharmacist about a sore throat. If the pharmacist does not know the patient then the diary would be useful to alert them to the fact that the sore throat might be a sign of methotrexate toxicity.

To tackle the issue of packaging, the NPSA is working with the three pharmaceutical companies that manufacture methotrexate in the UK. Together, they hope to develop new packaging designs and patient information to improve safety of the drug.

A study assessing patients' needs in packaging is about to start. One need worth considering is manual dexterity. Many patients who take methotrexate have rheumatoid arthritis and find opening foil blister packs and child-resistant containers difficult. Some might tip the tablets into another container, losing the original instructions, Ms Harris explained. She added: "The pack needs to stand out on the shelf and be easily identifiable by patients."

Finally, the NPSA hopes to adapt IT systems in general practices and community pharmacies to try to reduce human error. Such an error might be hitting the "daily" key by accident, commented Ms Harris. The new IT system should include flagging mechanisms and default settings to try to prevent these types of error.

"By January next year we hope to have the patient diary and IT solutions in place to roll out," she said. The packaging initiative might take a bit longer because of applying for licences for redesigned packaging, clearing old stock and so on. The NPSA will be providing pharmacists with training about the new solutions at the time of national launch.