FAO: Medicines and Healthcare products Regulatory Agency

Clozapine is the only medication approved for treatment resistant schizophrenia and yet there have been few improvements in prescribing over the last 30 years, impacting thousands of lives in the UK and worldwide. The guidelines for administering clozapine are outdated and inadequate, despite current research and evidence for improvement they remain unchanged, this urgently needs to be addressed. 

We are a group of parents/ carers in the UK who have loved ones currently taking clozapine. Through lived experience we know that clozapine is the only antipsychotic medication that has helped our loved ones and given hope for any meaningful recovery. We have consulted parents, patients, pharmacists, MP’s and clinicians.

Everyone with a Serious Mental Illness should have the right to be able to start and continue clozapine. Stopping someone from taking clozapine due to a low white blood count, is like a diabetic being prevented from having insulin, or a cancer patient prevented from taking cancer treatment medication.  Continuous clozapine treatment in schizophrenia is associated with a significant lower long term all cause mortality rate compared to other antipsychotics and an 86% reduction in suicide attempts.

There are life improving changes that can be made now from research carried out and therefore it is a travesty to all who suffer that they have not been implemented.  With enough support far more radical approaches could be used to save and improve the lives of people living with SMI, in the long-term saving the country a substantial amount of money.

We are requesting immediate change of the following:

• Threshold for RED result to be lowered in line with USA: Lower the ANC from less than 1·5 × 10./L to less than 1·0 × 10./L and cease platelet and white cell counts.
• Do not allow abrupt cessation of clozapine unless absolutely proven that the count is due to clozapine.
• Update the guidelines/legals for all clinicians, to allow the rights of patients to continue clozapine. It should be the patient's choice. In many cases this leads to a lifetime of unrecoverable psychosis.
• Reduce the frequency of blood monitoring to every 3 months, after 6 months on clozapine. Blood monitoring needs a radical overhaul as it is one of the main blockers for many patients starting clozapine. Fingerstick testing (MyCare/ Athelas device) should be made available at the very least.
• Revision of the current guidelines and views for ‘therapeutic levels’ and ‘target maintenance doses’
• Allow readily available access to supplies of clozapine to avoid unnecessary stoppages. 

Then followed, by a full review of clozapine guidelines and its use as per our 12-point list below.

Our loved ones are subjected to unnecessary monthly blood tests to obtain clozapine, the only medication that helps them. They are then at risk of having their medication stopped if they get a red ANC result. We cannot allow the unnecessary suffering, fatalities, and unrecoverable catastrophic effects of having clozapine abruptly stopped continue. The outdated product label, inadequate guidelines and the stigma attached to its use needs to change.

The research has been carried out; it needs to be urgently implemented.

We implore those that can make the changes to do so with immediate effect.

Karen and Melanie

Clozapine Support Group UK

Clozapine is the only medication approved for treatment resistant schizophrenia, improvements in its use are severely lacking.

THIS NEEDS TO CHANGE, are you with us?

Our Core Aims:

• Clozapine should be offered to everyone who does not respond to standard antipsychotics.
• Clozapine should be prescribed in a manner which MAXIMISES its effectiveness and tolerability to achieve a ‘Meaningful Recovery’.
• Clozapine should not be stopped unnecessarily.
• Monitoring requirements need to be amended to help more people start and continue with Clozapine. 

Items to be Addresses for Improving the use of Clozapine in the UK:

1. Dr Laitmans protocol to be urgently peer reviewed within the UK so psychiatrists can use his methods rather than disregard them. His methods are proven to work, they give people the chance of having a ‘Meaningful Recovery’. Please see link to protocol: Dr Laitmans Protocol
   • To include the use of all named adjunct medications in his protocol, to not only help with positive symptoms, but the negative symptoms as well.
   • Slower titration of clozapine.
   • Regular therapeutic drug monitoring.
   • For clozapine to be used to its ‘FULL potential’ before adding another antipsychotic
2. Implement Dr Laitmans EASE model to mental health teams in the UK 
   • Early introduction of clozapine in the course of the illness
   • Assertive monitoring and interventions for side effects
   • Slow titration and optimum dosing informed by therapeutic drug concentrations
   • Engagement and support of patients AND their careers.  See link to EASE model: EASE Model
3. Lower the ANC from less than 1·5 × 10./L to less than 1·0 × 10./L and cease platelet and white cell counts as per FDA guidelines and research conducted by Prof. David Taylor and Colleagues at SLAM, link to research article
4. End the process of clozapine being stopped and discontinued for a red ANC.  All other possible explainable causes to be examined before stopping.  See Maudsley Guidelines and research conducted by Prof. David Taylor and Colleagues at SLAM, link to research article 
   • If immediate stopping of clozapine is required, where a patient is known to be treatment resistant (other than clozapine) allow the reintroduction of clozapine as soon as a green result is provided. In the case where it is not possible to reintroduce immediately then a backup antipsychotic with appropriate anticholinergic medication to reduce/avert serious withdrawal psychosis. This should be initiated under medical supervision and potentially an inpatient setting.  
   • Patients should not just be left unmedicated, abruptly stopping clozapine in individuals with schizophrenia and psychotic disorders causes tormenting rebound psychosis and withdrawal effects, this is cruel and in most cases unnecessary.
   • End the UK requirement for a manufacturer off-licence agreement to be able to restart clozapine after a red ANC.
   • Training on use of high levels of depakote and other drug interactions that can cause low white blood count.  Rather than stopping clozapine abruptly, be proactive and stop/reduce the other drugs.
   • Fully explore all possible reasons for occurrence of NMS before stopping clozapine
5. Reduce the frequency of clozapine blood monitoring tests as per research conducted by Prof. David Taylor and Colleagues at SLAM, link to research article.
   • After the use of clozapine for 6 months, blood test frequency to be reduce to three monthly, this has been introduced at SLAM, why are other Trusts not following?
   • There is also evidence for ending monitoring after the first 6 –12 months of treatment.
6. Make available the MyCare finger stick device, this needs to be available to all clozapine users in the UK.  It is available at SLAM, why are other Trusts not using it? 
7. Allow for an emergency supply of clozapine to be held.
   • The clozapine product label provides recommendations for ANC ranges and testing frequency but does not declare ANY restrictions on dispensed quantities or instructions to ration pills.
   • Clozapine prescription to be available via local pharmacists as per any other antipsychotic.
8. Revision of the current guidelines and views for ‘therapeutic levels’ and ‘target maintenance doses’, there is significant evidence that people often need higher levels, more than currently stated, we know everyone metabolises clozapine differently.
   • Clozapine is limited by side effects, treat the side effects aggressively so clozapine is tolerated and can be used effectively.  
   • End the arbitrary cutoffs many psychiatrists follow.  There is not an absolute level of clozapine that is associated with either efficacy or toxicity.
   • Make full use to the Myogene Clozapine Test by Prof. David Taylor, see link The Clozapine Test.  It is available at SLAM, why are other Trusts not using it?  See research article by Prof. David Taylor and Colleagues at SLAM.
9. At present, there is no established or consistent approach to the training of clozapine medicine management in the UK.  There should be one updated guide on the use of clozapine for all NHS Trusts to follow.  
   • Mental Health teams to receive full training on the new guidance, management and use of clozapine for treatment of positive and negative symptoms, along with how to manage side effects.  Aiming for a full ‘Meaningful Recovery’ NOT ‘part recovery’.
   • End the stigma and negative perception of clozapine and stop ‘clozaphobia’ it should be used as a first medication, not a last resort. 
   • Focus on the benefits of clozapine, which massively out way the small risks. 
10. We need a dedicated clozapine clinic and helpline.  There is nothing currently in place for carers and clozapine users to seek advice and help when needed
    • Often psychiatrists do not know enough, and we have had to reach out to Dr Laitman from Team Daniel USA for advice on his Saturday zoom meetings, which he holds for free and for anyone to join worldwide.  
    • TREAT is available in London, this needs to be UK wide.
11. Educate mental health teams and carers on anosognosia.  Someone suffering from anosognosia is not able to make the correct choices on medications when they do not have the insight to understand they are unwell, they will make the wrong decisions.  We are shocked by the lack of information given to carers about anosognosia in the UK.  
    • Full training needed on Dr Xavier Amador LEAP method (Listen, Empathise, Agree, Partner) a vital evidence-based communication programme designed to help build a relationship with someone who is unable to understand they are unwell, with the goal of helping them accept treatment.  Please see link for LEAP: LEAP Method
    • Stop leaving patients untreated due to lack of insight or refusing treatment.  Anosognosia is part of their illness.  Stop telling us ‘We can’t do anything unless they are a danger to themselves of others’ or ‘we can’t do anything unless they want to engage with services’.  This is not good enough.
    • Treat sooner to prevent the illness developing and further damage to the brain, also to prevent suicides, hospitalisation, and imprisonment.  The mental health act is not protecting people, it is preventing them from receiving the help they urgently need.
    • Use CTO’s more often to encourage patients to continue with medication.
12. FINALLY – FOR FAMILIES AND CARERS TO ACTUALLY BE INCLUDED AND LISTENED TO, DESPITE THE TRIANGLE OF CARE THIS IS STILL NOT HAPPENING.  WE ARE BEING EXCLUDED AND IGNORED WHEN WE ARE THE ‘EXPERTS’ OF OUR LO’S WE KNOW THEM BEST.

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You are also welcome to join our facebook group for updates:  Clozapine Support Group UK