New EU measures to avoid potentially fatal dosing errors with methotrexate

[Fred]

The European Medicines Agency (EMA) have set out new measures to avoid fatal dosing errors with methotrexate.

*The UK have said they will mirror the EMA advice.

Information for patients:

• If you are taking methotrexate for rheumatoid arthritis, psoriasis or Crohn’s disease, you must take it just once a week.
  
• Take your methotrexate medicine on the same day every week.
  
• Follow the instructions on the packaging of your methotrexate medicine.
  
• You will receive a patient card with your methotrexate tablets (or oral liquid). Read it carefully because it tells you how to take your medicine.
  
• Show your patient card to any new healthcare professional who treats you so that they know that you take your methotrexate medicine once a week.
  
• See your doctor at once if you get a sore throat, fever, mouth ulcers, diarrhoea, vomiting, skin rashes, bleeding or unusual weakness. These can be signs of taking too much methotrexate.
  
• Always attend your scheduled clinic visits and blood test appointments. They are important for making sure that your methotrexate medicine is working and that it is not causing any concern.
  
• If you are not sure about how to take your methotrexate medicine or you have any questions about it, talk to your doctor or pharmacist.
  

Information for healthcare professionals:

• Methotrexate for inflammatory conditions is intended for use just once a week. Serious side effects including fatalities have occurred when methotrexate is taken more often.
  
• Only physicians with expertise in using methotrexate medicines should prescribe them.
  
• Healthcare professionals who prescribe or dispense methotrexate for inflammatory conditions should:
  • read the educational materials for oral methotrexate medicines;
    
  • ensure that they are familiar with the latest changes to the summaries of product characteristics for methotrexate medicines used for inflammatory conditions;
    
  • give clear instructions to the patient (or carer) about once-weekly dosing;
    
  • check carefully that the patient (or carer) understands that the medicine must be used once a week, and do this each time a new prescription is issued or the medicine is dispensed;
    
  • decide together with the patient (or carer) on which day of the week the patient uses methotrexate;
    
  • counsel the patient (or carer) about signs of methotrexate overdose and give instructions to promptly seek medical advice in case of suspected overdose.
    

Source: ema.europa.eu and gov.uk

Methotrexate

[jiml]

I'm pleased to see that the uk are also going to issue the same advice, as methotrexate taken too often can cause serious problems, I'm not a fan of it but do understand that many get relief from it. It wasn't for me though .

[Fred]

I'm pleased to see that the uk are also going to issue the same advice,

Makes sense to mirror the EU till they get settled .................................................... hopefully one day.

[Sheila]

I imagine that it would be quite similar in Canada?

[Caroline]

I imagine that it would be quite similar in Canada?

Yes, the effect of the medication does not differ from the location..

These are extra guidelines, to prevent that people take too high doses and that medical professionals prescribe too high doses. I can also imagine that those kinds of mistakes happen over the whole of the world.

[D Foster]

I looked at the information that I got from the NHS when I went on to MTX and it was substantially more comprehensive than the information from the EU.
I also have a great deal of information regarding folic acid and taking MTX which doesn't appear to be covered at all.

[JohnB]

I looked at the information that I got from the NHS when I went on to MTX and it was substantially more comprehensive than the information from the EU.
I also have a great deal of information regarding folic acid and taking MTX which doesn't appear to be covered at all.

Interesting they haven't mentioned anything about regular monitoring of the the patients blood. When I went on it there were a couple of cases where patients had died from liver failure where it had been prescribed by a GP and they failed to follow up with blood monitoring.

[D Foster]

I looked at the information that I got from the NHS when I went on to MTX and it was substantially more comprehensive than the information from the EU.
I also have a great deal of information regarding folic acid and taking MTX which doesn't appear to be covered at all.

Interesting they haven't mentioned anything about regular monitoring of the the patients blood. When I went on it there were a couple of cases where patients had died from liver failure where it had been prescribed by a GP and they failed to follow up with blood monitoring.

It does in the information that I got which was a good few years ago now.

[Fred]

Just to point out this thread is about "new measures to avoid fatal dosing errors" it's an addition to the normal recommendations of use, and you are reading it wrong.

They do recommend regular blood tests and the use of folic acid when prescribing methotrexate. If you read the first post again you will see the UK have said they will mirror the EMA advice of this additional information.

[D Foster]

Just to point out this thread is about "new measures to avoid fatal dosing errors" it's an addition to the normal recommendations of use, and you are reading it wrong.

They do recommend regular blood tests and the use of folic acid when prescribing methotrexate. If you read the first post again you will see the UK have said they will mirror the EMA advice of this additional information.

I couldn't find that, mmm I see Fred.