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

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:

Lord O'Shaughnessy answered:

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?

 

I've just sent a message on the Yellow Card Scheme website saying

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.

 

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.

 

This is contradictory to the earlier reply to question asked by Jim Shannon. Which is it then? https://www.parliament.uk/business/...s/written-question/Commons/2018-03-13/132337/



Edit to add screen shot of earlier question

 

The Yellow Card scheme has a contact form for asking questions, if anyone wants to take this on:

https://yellowcard.mhra.gov.uk/contact-us/

 

Okay I’ll ask now.

 

See my post up-thread where I ask for confirmation on which category to use for CBT and GET.

 

I think we may need a blue card system.

 

More seriously, it looks to me as if O'Shaughnessy didn't know what he was taking about. Somebody needs to ask what the mechanism is for reporting harms from therapies if it is NOT yellow card.

 

Blue cardy?

 

Okay. I've asked a question on the site, and also dumped all my thoughts into a blog post

http://sallyjustme.blogspot.com/2018/07/yellow-card-confusion.html

 

Can people from abroad use this, too? (I guess not.)

 

No - I understand it to be UK specific

 

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.

 

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: