Posted by Faye Marks, Solicitor
New measures recommended to avoid potentially fatal overdoses of commonly prescribed rheumatoid arthritis drug
In August 2019 the European Medicines Agency (EMA) recommended new measures to prevent serious and potentially fatal errors with the dosing of methotrexate, a chemotherapy drug used to treat cancer and autoimmune diseases such as rheumatoid arthritis, psoriasis and Crohn’s disease. Methotrexate is an effective medicine for these conditions, however it can also be highly toxic.
In the treatment of inflammatory conditions, methotrexate must be administered just once a week, rather than on a daily basis. A daily dose, if prolonged, can lead to serious and even fatal immune system failure.
Unfortunately, mistakes happen during prescribing, dispensing and administration of methotrexate because medical professionals, pharmacists and patients themselves are not used to seeing oral medications being prescribed on a weekly basis and assume that the drug should be administered daily.
How will the new measures help?
The new measures recommended by the EMA include restricting the medical professionals who can prescribe methotrexate to those with specific expertise, making warnings on the packaging more prominent and providing educational materials for patients and healthcare professionals.
To help patients follow the once-weekly dosing, the EMA recommends that methotrexate should be provided in smaller blister packs, which better match weekly doses, rather than large bottles or tubs of tablets. It is also recommended that a patient card emphasising the weekly dosing schedule should be provided to patients.
The current situation with methotrexate
As clinical negligence lawyers we often see the same mistakes being made over and over again. Indeed, concerns over potentially fatal dosing errors of methotrexate are not a recent phenomena.
In 2004 the now defunct National Patient Safety Agency (NPSA), which was then responsible for identifying and reducing risks to patients receiving NHS care, issued an alert regarding the dangers of methotrexate tablet being administered in a daily basis in non-cancerous indications. The warning came after 25 deaths and 26 incidents of serious harm in the preceding decade. In some of these cases, even once the error had been identified, patients died due to ongoing deterioration after methotrexate withdrawal.
Despite this stark warning, the NPSA had to repeat their advice again, only two years later in 2006, as patients were still receiving dangerously high doses. Like the EMA, one of the NSPA’s recommendations was for specific warning on the labels and patient information leaflets and for manufacturers to move from packs of 100 loose tablets to reduced pack sizes of 16 or 24 tablets.
Following the recommendations the Medicines and Healthcare products Regulatory Agency (MHRA), which is the government agency responsible for ensuring that medicines and medical devices work and are acceptably safe, did ensure that the appropriate warnings about weekly dosing appeared on the patient information leaflets in the UK. However, neither the NPSA or the MHRA had the power to compel manufacturers to change their pack sizes. Packs of methotrexate tablets in tubs of 100 are still readily available today and mistakes are still happening.
Methotrexate dosing errors are regarded by the NHS as “Never Events”, serious incidents which should always be avoidable. According to the latest provisional report of Never Events occurring between April and July this year, one such methotrexate incident occurred in England during this five month period alone.
It is alarming that despite all of the warnings, such errors with this powerful drug are still occurring. But what is the answer? The EMA’s recommendations will hopefully go a long way in minimising the risks of methotrexate dosing errors. However, the European Commission has yet to issue a final legally binding decision, which will then be legally binding in all member states.
In reality, it is unlikely that a binding decision will be made in the near future and before a potential no-deal Brexit on 31 October. If the EMA’s recommendations are not to become legally binding in the UK, then it is my view that new legislation will be required to compel drug manufacturer to implement measures to minimise the risk of potentially fatal errors.
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