Herefordshire and Worcestershire NHS Trust
Action Taken
The Trust asserts that existing Clozapine Treatment Guidelines and a standard operating procedure are in place and address the concerns. They have re-issued both documents to mental health clinical staff and will undertake follow-up actions to ensure awareness and compliance. (AI summary)
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Dear Deborah Lakin, Re: Regulation 28 response – Jack Horace Burton Thank you for forwarding on your Regulation 28 report, the concerns that you raised have been noted and I respond to your matters of concern as below:-
1. There were inconsistent accounts provided to me by two Consultant Psychiatrists, about the relevance in reduction in smoking, rather than cessation of smoking, attributable to there being no guidance available to doctors on this issue. Herefordshire and Worcestershire Health and Care Trust have Clozapine Treatment Guidelines in date and available on the Trust Intranet site. This guidance was authored by , Chief Pharmacist and Juliet Shepherd, Lead Pharmacist, Mental Health, Herefordshire. The guidance was ratified in February 2022 and has had regular review with a current review date of February 2029. Please find the document attached. The guidelines make clear reference to the impact of both smoking cessation and reduction. “Smoking Cessation. The aromatic hydrocarbons in tobacco smoke induce the enzyme CYP1A2 – which reduces plasma clozapine levels. Therefore, a person who smokes tobacco regularly may need a higher dose of clozapine than someone who does not smoke tobacco. If a patient reduces their level of smoking tobacco the level of clozapine available in their body will rise. This change can be dramatic and potentially result in overdose or toxic plasma levels of clozapine.”
[Page 2] The Trust would also like to point out there is clear national guidance available on this issue in the link below: Managing specific interactions with smoking – NHS SPS - Specialist Pharmacy Service – The first stop for professional medicines advice
2. The evidence revealed that there is no guidance on any standardised practice available to practitioners relating to asking questions and recording answers given when discussing possible symptoms of side effects of the medication. Practitioners can therefore make no record if no information is provided, which does not indicate whether questions were asked. Herefordshire and Worcestershire Health and Care Trust have a standard operating procedure, Community Mental Health Team’s Clozapine Clinic Guidance and Promotion of Health & Wellbeing,thisdocument is in date and available on the Trust intranet. Please find the document attached. As documented within the standard operating procedure it is standard practice for Trust practitioners to monitor for any side effects of Clozapine, and this is completed by using the Glasgow Antipsychotic Side-effect Scale (GASS). The outputs from this are then recorded with the patient electronic health record and followed up as clinically indicated. In further response to the concerns raised by the Coroner, the Trust has re-issued both documents to the mental health clinical workforce. Follow-up actions will be undertaken to ensure that both newly appointed and existing staff are aware of, and comply with, the guidelines.
1. There were inconsistent accounts provided to me by two Consultant Psychiatrists, about the relevance in reduction in smoking, rather than cessation of smoking, attributable to there being no guidance available to doctors on this issue. Herefordshire and Worcestershire Health and Care Trust have Clozapine Treatment Guidelines in date and available on the Trust Intranet site. This guidance was authored by , Chief Pharmacist and Juliet Shepherd, Lead Pharmacist, Mental Health, Herefordshire. The guidance was ratified in February 2022 and has had regular review with a current review date of February 2029. Please find the document attached. The guidelines make clear reference to the impact of both smoking cessation and reduction. “Smoking Cessation. The aromatic hydrocarbons in tobacco smoke induce the enzyme CYP1A2 – which reduces plasma clozapine levels. Therefore, a person who smokes tobacco regularly may need a higher dose of clozapine than someone who does not smoke tobacco. If a patient reduces their level of smoking tobacco the level of clozapine available in their body will rise. This change can be dramatic and potentially result in overdose or toxic plasma levels of clozapine.”
[Page 2] The Trust would also like to point out there is clear national guidance available on this issue in the link below: Managing specific interactions with smoking – NHS SPS - Specialist Pharmacy Service – The first stop for professional medicines advice
2. The evidence revealed that there is no guidance on any standardised practice available to practitioners relating to asking questions and recording answers given when discussing possible symptoms of side effects of the medication. Practitioners can therefore make no record if no information is provided, which does not indicate whether questions were asked. Herefordshire and Worcestershire Health and Care Trust have a standard operating procedure, Community Mental Health Team’s Clozapine Clinic Guidance and Promotion of Health & Wellbeing,thisdocument is in date and available on the Trust intranet. Please find the document attached. As documented within the standard operating procedure it is standard practice for Trust practitioners to monitor for any side effects of Clozapine, and this is completed by using the Glasgow Antipsychotic Side-effect Scale (GASS). The outputs from this are then recorded with the patient electronic health record and followed up as clinically indicated. In further response to the concerns raised by the Coroner, the Trust has re-issued both documents to the mental health clinical workforce. Follow-up actions will be undertaken to ensure that both newly appointed and existing staff are aware of, and comply with, the guidelines.