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

Andy

Andy

Retired committee member
I decided to make a new thread from this post in the UK House of Lords/ House of Commons Questions thread.

The Countess Of Mar asked the following question:
To ask Her Majesty's Government, further to the Written Answer by Lord O'Shaughnessy on 19 June (HL8366), what means are available for reporting and recording adverse health events resulting from non-pharmacological treatments such as graded exercise therapy or cognitive behavioural therapy on a similar basis to those for reporting adverse events to pharmacological treatments through the Medicines and Healthcare Products Regulatory Agency's Yellow Card Scheme.
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Lord O'Shaughnessy answered:
The Yellow Card Scheme includes a facility to report suspected adverse incidents associated with products used in psychological treatments. In addition, in guideline development, when reviewing the evidence relating to interventions, the National Institute for Health and Care Excellence’s guideline development committees will take into account any adverse outcomes that are reported, alongside the clinical and cost-effectiveness.

Patients are able to raise concerns about such treatments directly with a healthcare professional, by raising a concern with the healthcare provider or by making a complaint.
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https://www.parliament.uk/business/...nts/written-question/Lords/2018-06-20/HL8829/

ME Research have posted about this question, http://www.meresearch.org.uk/news/cbt-get-parliamentary-question/, providing a bit of background information about the Yellow Card Scheme.

Link to the Yellow Card Scheme website, https://yellowcard.mhra.gov.uk/

Given that this now gives a confirmed route to report incidents with GET, CBT and any other treatment, should the patient community make a push for (genuine) reports to be made?
 
Andy said:
Given that this now gives a confirmed route to report incidents with GET, CBT and any other treatment, should the patient community make a push for (genuine) reports to be made?
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absolutely

the form isnt properly set up to do it but if people try to use it and contact MHRA with questions/complaints they will have to adapt it.

the pressure has forced this change - it is important that the scheme is now used for reports about GET/CBT otherwise it will become another way of just bouncing the issue of harm saying "well if people have incidents they can report them and we arent getting reports"
 
I've just sent a message on the Yellow Card Scheme website saying
Please can you confirm which is the appropriate category to use if I want to report an adverse incident from either Graded Exercise Therapy or Cognitive Behavioural Therapy.
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Knowing how large firms and national/local government can be, it wouldn't surprise me if any report that didn't use the right category was just ignored, so it would be good if I could get confirmation direct from them.
 
Is there a clearer indication that the scheme actually applies to therapist-delivered treatments elsewhere in the text? The reply mentions 'products used in psychological treatments. That to me sounds like drugs used during the use of treatment for psychological conditions and perhaps treatments involving a therapist but it is not very clear what 'product' means here.

Yellow cards are mostly ignored anyway but at least they may be lying around if someone raises a question about an adverse event needing auditing.

I think it would be very helpful if this does indeed mean you ca do a yellow card for CBT or GET. It may set an important precedent for issues on a much larger scale.
 
Jonathan Edwards said:
Is there a clearer indication that the scheme actually applies to therapist-delivered treatments elsewhere in the text? The reply mentions 'products used in psychological treatments. That to me sounds like drugs used during the use of treatment for psychological conditions and perhaps treatments involving a therapist but it is not very clear what 'product' means here.

Yellow cards are mostly ignored anyway but at least they may be lying around if someone raises a question about an adverse event needing auditing.

I think it would be very helpful if this does indeed mean you ca do a yellow card for CBT or GET. It may set an important precedent for issues on a much larger scale.
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I took it to mean that you should use the 'products' category instead, as there isn't one for behavioural treatments. I may have misunderstood.
 
Whatever way you look at it, the answers given to Jim Shannon and the Countess of Mar are contradictory. I have put screen shots in my blog post (http://sallyjustme.blogspot.com/2018/07/yellow-card-confusion.html) and also the question I asked on the site. It follows on from my Feb post about Yellow Cards.

Basically it's all as clear as mud. And if it's difficult or confusing to report harms, then GPs are unlikely to do so. Which means basically they are not checking for harms in any serious way. That is a problem, considering the volume of harm reports in patient surveys, forums and social media.

Still looks to me like they don't want to know about the harm that may be caused!
 
It seems that the difference is whether the 'therapies' use 'products':

"cognitive behaviour therapy and graded exercise therapy are both non-pharmaceutical or medical device treatments"

and

"The Yellow Card Scheme includes a facility to report suspected adverse incidents associated with products used in psychological treatments."
 
We have a similar parallel 'yellow' adverse reactions reporting system in veterinary medicine but my understanding of it is that it is meant to hold the manufacturers of pharmaceuticals and products to account.

I hope this system can be used to report harms because it feels like it could be a game changer.
 
MeSci said:
It seems that the difference is whether the 'therapies' use 'products':

"cognitive behaviour therapy and graded exercise therapy are both non-pharmaceutical or medical device treatments"

and

"The Yellow Card Scheme includes a facility to report suspected adverse incidents associated with products used in psychological treatments."
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And this could then be used to nullify any "harms" reported via the system. I think you are right. CBT/GET harms can still not be reported via the Yellow Card system.

As @Jonathan Edwards says:
Jonathan Edwards said:
Somebody needs to ask what the mechanism is for reporting harms from therapies if it is NOT yellow card.
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