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

Discussion in 'Psychosomatic news - ME/CFS and Long Covid' started by Andy, Jul 10, 2018.

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  1. Andy

    Andy Committee Member

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    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?
     
    Andy, Jul 10, 2018
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  2. NelliePledge

    NelliePledge Moderator Staff Member

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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"
     
    NelliePledge, Jul 10, 2018
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  3. Andy

    Andy Committee Member

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    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.
     
    Andy, Jul 10, 2018
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  4. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

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    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, Jul 10, 2018
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  5. adambeyoncelowe

    adambeyoncelowe Senior Member (Voting Rights)

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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.
     
    adambeyoncelowe, Jul 10, 2018
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  6. Keela Too

    Keela Too Senior Member (Voting Rights)

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    Keela Too, Jul 10, 2018
    #6
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  7. Sasha

    Sasha Senior Member (Voting Rights)

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    Sasha, Jul 10, 2018
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  8. Keela Too

    Keela Too Senior Member (Voting Rights)

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    Keela Too, Jul 10, 2018
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  9. Andy

    Andy Committee Member

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    See my post up-thread where I ask for confirmation on which category to use for CBT and GET.
     
    Andy, Jul 10, 2018
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  10. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

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    I think we may need a blue card system.
     
    Jonathan Edwards, Jul 10, 2018
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  11. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

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    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.
     
    Jonathan Edwards, Jul 10, 2018
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  12. Keela Too

    Keela Too Senior Member (Voting Rights)

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    Blue cardy?
     
    Keela Too, Jul 10, 2018
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  13. Keela Too

    Keela Too Senior Member (Voting Rights)

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    Keela Too, Jul 10, 2018
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  14. Inara

    Inara Senior Member (Voting Rights)

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    Can people from abroad use this, too? (I guess not.)
     
    Inara, Jul 10, 2018
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  15. Keela Too

    Keela Too Senior Member (Voting Rights)

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    No - I understand it to be UK specific
     
    Keela Too, Jul 10, 2018
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  16. Trish

    Trish Moderator Staff Member

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    Maybe the person writing the answer misunderstood the question and assumed that Graded Exercise Therapy involved using equipment like exercise bikes or treadmills.
     
    Trish, Jul 10, 2018
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  17. Keela Too

    Keela Too Senior Member (Voting Rights)

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    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!
     
    Keela Too, Jul 10, 2018
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  18. MeSci

    MeSci Senior Member (Voting Rights)

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    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."
     
    MeSci, Jul 10, 2018
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  19. SallyC

    SallyC Senior Member (Voting Rights)

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    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.
     
    SallyC, Jul 10, 2018
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  20. Keela Too

    Keela Too Senior Member (Voting Rights)

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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:
     
    Keela Too, Jul 10, 2018
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