UK: The Yellow Card Scheme has been confirmed as the route to report 'adverse incidents' from GET and CBT (or has it?)

Surprisingly, they seem to be against 'unprofessional' conduct, of the RCP, presumably this means they consider it unprofessional not to address questions in due time. I have no idea how they feel about the conduct of actual psychiatrists, possibly because I was unable to finish the article, but I doubt it based on what I read.
 
Keela Too said:
It’s not opening for me @adambeyoncelowe but guess it is the same as reply I got just now.

Agree it is strange no one wants to collate these harms officially.
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Interesting that they recommend complaining to the NHS trust where the therapist is based - and that there would, as you say, be no national collation of results. It would just look as though the individual therapist was at fault, rather than anything inherently wrong with the therapy.

I wonder what our next step should be in relation to this?
 
Sasha said:
Interesting that they recommend complaining to the NHS trust where the therapist is based - and that there would, as you say, be no national collation of results. It would just look as though the individual therapist was at fault, rather than anything inherently wrong with the therapy.

I wonder what our next step should be in relation to this?
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Jim Shannon MP asked a question on my behalf a few days ago. But he asked Jeremy Hunt. He may need to redirect it to the new man now. Hectic
 
Here is the question I asked him to ask..

"How exactly should harms from the therapies of Cognitive Behavioural Therapy and Graded Exercise Therapy be reported, in order to ensure there is an adequate recording of those harms? Patients are concerned that these therapies are assumed to be harmless simply because no mechanism for reporting the harm they cause officially exists."
 
Keela Too said:
Here is the question I asked him to ask..

"How exactly should harms from the therapies of Cognitive Behavioural Therapy and Graded Exercise Therapy be reported, in order to ensure there is an adequate recording of those harms? Patients are concerned that these therapies are assumed to be harmless simply because no mechanism for reporting the harm they cause officially exists."
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Do you think he should make his question a bit more specific so as not to be fobbed off by being told what you've just learned? That is, he could be told that patients should report it to the NHS trust in question - job done?

Maybe something like:

"How exactly should harms from the therapies of Cognitive Behavioural Therapy and Graded Exercise Therapy be reported, in order to ensure there is an adequate recording of those harms at a national level? Patients are concerned that these therapies are assumed to be harmless simply because no obvious, let alone national mechanism for reporting the harm they cause officially exists, in contrast to the Yellow Card scheme for drugs and medical devices."​
 
The question was created a while back and emailed to JS as a suggestion. He then decided to ask it. As you say @Sasha I might have worded it slightly differently in light of recent developments.

Edit to add - I’ll try ringing on Monday to see what is happening with the question.
 
Andy said:
With the draft revised NICE guidelines talking clearly about harms from GET and CBT, is it worth trying to get a system in place for reporting of those types of harm now?
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I assume it's out of scope for NICE but given a well-documented history of harm, this is necessary to make sure that deviations from guidelines are not the norm, working informally from hidden NHS guidelines instead.

Question is how does that process work? It's pretty clear that such a system would be a death blow to the BPS/MUS/FND ideology, it simply cannot withstand scrutiny. Big task, but necessary. Lots of people have a lot to lose both ways, but one side has all the power while the other does all the losing.
 
The current scheme is run by the MHRA. I suspect it could take time to negotiate and agree all the details for a new category of harm – at least as long as the NICE guideline review? – but it's definitely worth pursuing. All those poor BPS practitioners will still need to earn a living if the NICE ME guideline largely forces them out of our field!

This is the current reporting page, showing the categories for the Yellow Card Scheme:

Yellow Card.jpg
 
Kitty said:
The current scheme is run by the MHRA. I suspect it could take time to negotiate and agree all the details for a new category of harm – at least as long as the NICE guideline review? – but it's definitely worth pursuing. All those poor BPS practitioners will still need to earn a living if the NICE ME guideline largely forces them out of our field!

This is the current reporting page, showing the categories for the Yellow Card Scheme:

View attachment 12512
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Yeah, patients have made multiple attempts to report harms via the existing system and been turned away every time (as far as I'm aware). It would need the MHRA to take the evidence that NICE now takes seriously on board and create a new category.
 
Having pondered on this, I think that the, hopefully initial, route to go might be to set up our own system to record harms.

Even if the new guideline is implemented with no changes at all, we all know that it is likely that some practitioners will seek to continue 'treating' ME patients as they have done in the past. So harms will continue to be caused, and if we can have a system that enabled more detailed recording of them then an occasional survey, it might provide enough evidence to force an official system being established.

It would obviously need the support and involvement of some or all of the charities - I think this would be an important next step following the publishing of the new guideline.

ETA: change "to" to "the" so that my last sentence now makes sense.
 
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Andy said:
Having pondered on this, I think that the, hopefully initial, route to go might be to set up our own system to record harms.
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It would obviously need to support and involvement of some or all of the charities - I think this would be an important next step following the publishing of the new guideline.
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Good idea and much needed. Discussed the continuing problem of GET being ‘prescribed’ relatively recently with Nicola C-B of @PhysiosforME

 
Agree this is an excellent point @Andy. I think it makes sense to show it can be done.

And I feel that MHRA are unlikely to do anything about reporting of harms from physical or psychological therapy ‘merely’ for ME as that would set some kind of precedent opening them up to massive numbers of potential reports from people being treated for many conditions. Which would be quite a whale of a change for them.
 
Kitty said:
The current scheme is run by the MHRA. I suspect it could take time to negotiate and agree all the details for a new category of harm – at least as long as the NICE guideline review? – but it's definitely worth pursuing. All those poor BPS practitioners will still need to earn a living if the NICE ME guideline largely forces them out of our field!

This is the current reporting page, showing the categories for the Yellow Card Scheme:

View attachment 12512
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Technically the whole thing already falls under "falsified medical advice" but the problem with failure is that if it's popular enough failure isn't acknowledged as failure.

It's hard to deal with a system that harbors irrational beliefs. This clearly falls under falsified advice, no questions there. And yet it's not enough for advice to be falsified, people have to accept it. Bit of a major fundamental issue dealing with reality here.
 
Sasha said:
Do you think he should make his question a bit more specific so as not to be fobbed off by being told what you've just learned? That is, he could be told that patients should report it to the NHS trust in question - job done?

Maybe something like:

"How exactly should harms from the therapies of Cognitive Behavioural Therapy and Graded Exercise Therapy be reported, in order to ensure there is an adequate recording of those harms at a national level? Patients are concerned that these therapies are assumed to be harmless simply because no obvious, let alone national mechanism for reporting the harm they cause officially exists, in contrast to the Yellow Card scheme for drugs and medical devices."​
Click to expand...

Andy said:
Yeah, patients have made multiple attempts to report harms via the existing system and been turned away every time (as far as I'm aware). It would need the MHRA to take the evidence that NICE now takes seriously on board and create a new category.
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Thought I should add Sally Callow’s #ShakeItUp Campaign details in here, because she continues to work on this.

See the ‘Updates’ section of the petition, where she details replies received or thoughts on the next steps
eg July 2022 - not connecting with Rt Hon Steve Barclay yet, when the post of Secretary of State to the DHSC (Dept of Health & Social Care) may be changing yet again, in September, when a new cabinet is formed by the new leader of the Conservative party.

https://www.change.org/p/department...non-pharmaceutical-treatment-harms/u/30731538

The DHSC and NHS England believe that no mechanism is required because NICE Guidelines say GET/(and ‘the wrong sort of’) CBT is not to be used.

Except we all know that they are still used, under numerous different names.

Plus, if a person is diagnosed with MUS/FND then the Guideline on ME/CFS can be ignored :banghead:


We are still being sent around in circles.

The new NICE Guidelines advise that all problems (harms) should be reported - under ‘Your Responsibility’:

https://www.nice.org.uk/guidance/ng206 :

“All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.”

But MRHA have absolutely no method of recording harms caused by non-pharmaceutical or non-mechanical treatments


This is likely to need to go all the way to an Inquiry (in the same way as Baroness Cumberlege’s investigations for The Independent Medicines and Medical Devices Safety Review
https://www.immdsreview.org.uk/Report.html )
 
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