PRAC April 2018 - Risk of dosing errors with methotrexate and unmet medical need for hydroxyethyl-starch (HES) solutions for infusion

During its meeting of April 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a review of the risk of dosing errors with methotrexate medicines. The PRAC decided to further consider unmet medical need for hydroxyethyl-starch (HES) solutions for infusion and will discuss its recommendation at its May 2018 meeting.

Risk of dosing errors with methotrexate

The PRAC has started a review of the risk of dosing errors with methotrexate medicines, used to treat cancers such as acute lymphoblastic leukaemia and various inflammatory conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis and psoriatic arthritis.

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 patients incorrectly receiving a dose every day instead of every week. As a result, patients 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 European 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.

The PRAC will now examine the available evidence and recommend whether further measures are needed to minimise the risk of dosing errors. The PRAC will also take into account the work of bodies specialising in patient safety.

In Belgium, medicinal products containing methotrexate are available under the following commercial names : EMTHEXATE, LEDERTREXATE, METHOTREXATE ACCORD HEALTHCARE, METOJECT.

More information is available on the EMA website.

Unmet medical need for hydroxyethyl-starch (HES) solutions for infusion

Following the PRAC recommendation in January 2018 to suspend the marketing authorisations for HES solutions for infusion across the European Union, the European Commission has requested that the committee further consider any possible unmet medical need that could result from the suspension, as well as the feasibility and likely effectiveness of additional risk minimisation measures.

The PRAC is now looking at these specific aspects and will discuss its recommendation at its May 2018 meeting. The PRAC’s revised recommendation will then be sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a final position.

In Belgium, medicinal products containing hydroxyethyl-starch are available under the following commercial names : TETRASPAN, VENOHES, VOLULYTE and VOLUVEN.

More information is available on the EMA website.

Last updated on
22/05/2018