Tuesday, 10 July 2018

Yellow Card Confusion

Earlier this year Jim Shannon MP asked a parliamentary question about the Yellow Card system. The reply he got indicated that harms from the psychosocial therapies of CBT and GET could not be reported via the Yellow Card system.

Click on image to enlarge
Thus it seemed that there was no means by which data on the harms, caused by these therapies, could be officially reported.  With no reports of harm being collated, it might therefore appear that these therapies are harmless.

Patients however have been reporting harms, and patient surveys from various charities have collated details of those harms.  Yet these reports are not seen as official, and so CBT and GET are still widely reported as "safe", and not causing harm.

This is a problem. I wrote a blogpost  about the issue in February this year:
Yellow Cards & Psycho-Social Therapies

In June, the Countess of Mar asked another couple of questions, relating to the reporting of harms from psychiatric and psychological therapies, and in the latest answer we are told that the Yellow Card system can indeed be used for reporting harms from psychological treatments!




This is now a very confusing situation.  With the current review of NICE guidelines for the treatment of  "ME/CFS" coming up, it is most important that harms from the current therapies are officially recorded.

The Yellow Card website has a space to submit questions.  So I asked them the following:

There seems to be some confusion over the Yellow card system.  

On 13th March 2018 Jim Shannon asked a parliamentary question (Medical Treatments: Safety: Written question - 132337) about reporting harms from the psychosocial interventions of Cognitive Behavioural Therapy (CBT) and  Graded Exercise Therapy (GET) and was told that: 

"As cognitive behaviour therapy and graded exercise therapy are both non-pharmaceutical or medical device treatments, they do not fall under the remit of the MHRA or the Yellow Card Scheme. Therefore, any harms associated with them would not be reported to the Yellow Card Scheme."

Yet a more recent question asked on 20th June 2018, by the Countess of Mar  (Medical Treatments: Side Effects: Written question - HL8829) indicates that the Yellow card system can in fact be used to report harms from such therapies.  

"The Yellow Card Scheme includes a facility to report suspected adverse incidents associated with products used in psychological treatments."

Please can you let me know which of these of these answers is correct, and also under which heading harms from CBT and GET should be reported?


Today's Yellow Card Headings

The medical establishment cannot just assume no harms have occurred if there has been no attempt made to collate them.  Once the correct reporting channels are clarified, I think it is important that patients ask their GPs to use these channels to feed back on the outcomes of CBT and GET as applied to ME.

Thank you to both Jim Shannon MP and the Countess of Mar for following up on these issues.

Edit 11.30pm - After online discussions with other ME advocates, there are some concerns that the most recent response referring to "products used in psychological treatments" applies only to the items used in therapy (whatever they may be) rather than the therapies themselves.  Thus we may be no further forward with the issue of how to officially report harms from CBT & GET! 

Links:

Question by Jim Shannon MP:
https://www.parliament.uk/business/publications/written-questions-answers-statements/written-question/Commons/2018-03-13/132337/

Questions by the Countess of Mar:
https://www.parliament.uk/business/publications/written-questions-answers-statements/written-question/Lords/2018-06-05/HL8366/
https://www.parliament.uk/business/publications/written-questions-answers-statements/written-question/Lords/2018-06-20/HL8829/

Yellow Card website:
https://yellowcard.mhra.gov.uk/


2 comments:

  1. Excellent questions all. Another way we are screwed by the system. Hope you get official answers.

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    Replies
    1. Answers should be interesting. (See Edit just added re wording of the most recent response.)

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