University Health Board
Action Planned
The Health Board reported the death to the Medicines and Healthcare products Regulatory Agency (MHRA). A project proposal is in development by the Mental Health Clinical Board, Pharmacy and Information Technology to develop an interface between PARIS and PMS to improve the transfer of information. (AI summary)
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Dear Dr Richards Regulation 28 report Mr Christopher Summerhayes Thank you for your letter, dated 27 August 2019, following the inquest into Mr Summerhayes death_ have reviewed the points you have raised within the Regulation 28 report which relates to the very sad death of Mr Summerhayes. response has been informed by colleagues within the Clinical Diagnostics and Therapeutics, Primary Care and Intermediate Care and Mental Health Clinical Boards_ am grateful to you for agreeing an extension to respond to you whilst information was gathered to support our response. recognise that this will have been a difficult for Mr Summerhayes family and would wish to offer my sincere condolences on behalf of the University Hospital Board (UHB): For ease of reference, will respond to each of the matters of concern you have raised in turn: An adverse event report should be filed with the Medicines and Healthcare products Regulatory Agency in respect of Clozapine and the death of Mr Summerhayes. can confirm that the matter has been reported to the Medicines and Healthcare products Regulatory Agency (MHRA): Bard Icchyd Pntyspol Caerdrdd a"t Fro YW cnw Onelthtecol Dwyrdd Icchyd Ulcol Prtyspal Cacrdrdd or Fro Cardll and Vale Unlvcrilty Health Gaard Lhc operationai abme Cardlfi and Vale Untvertny Loca Heblth Boam 51541149 Cothwt Bwod ohtntedt * Grmttto neu Sutlntd Sehawn brddwn }1 GKethnbu cNJn Gch Ouwt Ieth M Fvod pohabu I Gymtted Yn OTu unrhyw Oad Bourd Helonad cotTloondeno Meh Enabin; Wa Ondln UneI 74 communce' You couan {anutyr Ccorroontent Welth wuna bud [0 outy My time
am able to advise that there is requirement for patients Clozapine to be registered with a service to monitor the medicine during the course of their treatment with it. Additionally, when patient who is taking Clozapine dies Or ceases to take it, the manufacturer supplying the medication must be informed. The monitoring service currently in place for Cardiff and Vale University Health Board is via the Zaponex Treatment Access System (ZTAS) which is provided by the medicine's manufacturer that we currently use, called Leyden Delta. The necessary information was shared at the time via ZTAS. Where more than 5 medications are prescribed the drugs be examined by an associate physician or pharmacist for adverse interactions, either alone or in combination, which give rise to medical conditions which themselves predict hospitalisation and shorten longevity. Consideration would be for automatic referral to an individual qualified to assess i) drug-drug interactions; ii) the risks posed to the specific patient taking into account age, conditions suffered, lifestyle and the length of time the drug has been prescribed; iii) dosing levels to be 'signed off by the qualified individual; iv) all prescribing parties and the patient to be advised of the assessment outcome. The UHB has Medicines Code in place and this was updated in
2018. It contains a section on medicines reconciliation. It sets out the responsibilities of various healthcare professionals in this process_ including doctors, the pharmacy team and other prescribers. The Pharmacy Directorate has system in place of dedicated pharmacists aligned to clinical directorates and Clinical Boards to provide a source of support and expertise in medicines management. A specialist mental health pharmacist supports prescribing in in-patient mental health settings. The Primary Care and Intermediate Care Clinical Board has a Medicines Management and Prescribing Team who support related issues in primary care settings. Guidance from the National Institute of Health and Care Excellence (NICE) for assessing physical health of patients on Clozapine is available on their website (wnice orguk) and monitoring arrangements are in place in line with this in the UHB. The AlI Wales Medicines Strategy Group has produced number of guidance documents to promote polypharmacy reviews_ These documents can be viewed on their website which is WWWaWmsgorg Polypharmacy reviews are actively promoted to healthcare professionals by the Pharmacy Directorate in secondary care and the Medicines Management and Prescribing Team in primary care_ Brmd Iechyd Pafysgol Caerdydd ar Fr yw enm Awernredol Bwyrdd Iechyd Llcol Pnifyigol Cacrdydd a'r Fro Cardif and Vale Unrverslny Healih Board the opcrallonal aame Cardlll and Vale Unlveriity Local Health Board o1548449 Cmutt Bxrdd chebiaain yn Gymreen Reu 8441n50 SOnokn brddwnYa cynimbu cy tah Oawi Eblh: m frdd gahobu M Gpmrtea Cu unit Tha Bocm Wekonyi comnipondence Wulsh = Enaltn W Ienln m3 #r cottumchi chaten [41pucoa Conolpondanca #dm Wn bud ta oelty taking Our 04
Certain complex medicines are subject to formal shared care arrangements to ensure that roles and responsibilities are clearly defined. The Primary Care and Intermediate Care team established Medicines Management Incentive Scheme with GPs to ensure that medicines prescribed across care settings are added to the GP record SO there is complete medicines record for patients on the GP systems. The driver for this project was to promote patient safety but it has seen cost-benefits. Education is provided to staff within GP practices who are then required to identify their local process to ensure that a patient's medication history is accurately updated prospectively. Practices have also been asked to retrospectively add certain complex medicines to the GP systems t0 ensure are clearly recorded. To de-prescribe where appropriate rather than accruing an increasing list of daily medications whereby further protectant medications are required to be prescribed with the risk of medication induced hospital admissions and risk to life: Principles for de-prescribing are embedded within the aforementioned documents available regarding polypharmacy reviews at WWWawmsg org The Primary Care and Intermediate Care team has also developed criteria to stop various medicines in a number of patient pathways of care. The criteria are designed to guide healthcare professionals in de-prescribing processes. An example of where this may be used is in relation to analgesia that has been subject to long-term use_ Where there are two or more prescribing organisations (primary and secondary care) drug monitoring should be undertaken as mandated; by the responsible parties; and the information promptly shared with all prescribers and their patients. Prescribing in relation to Clozapine is undertaken as mandated. The process is in place via ZTAS as outlined previously: The Primary Care and Intermediate Care Clinical Board maintains list of over 300 patients who are currently prescribed Clozapine within the UHB. The team actively checks systems in GP surgeries to monitor the records of all patients who are known to have Clozapine prescribed in secondary care to ensure an interface with primary care. The Medicines Management Incentive Scheme that referred t0 earlier was designed to ensure there is an accurate record of patient's medication within the GP's records and all practices in the Cardiff and Vale UHB area are currently participating in this Scheme. Bwrdd [echyd Pritvtool Caerdydd &'r Fto yr enw Owcithredol Dwyrdd Iechyd Ucal Pntysqa: Cacrdydd 4" Fro Cardlfl and Vale Unlverilty Health Board Ine opcrailona nome Cardilf and Vale Un vcftICY Local Healh Board 01541449 Coturtt Owod chabioeth }n Ghnne? nau 5041n68 Scmutn brosltnyn GMtthnou _ dmtkh dut th Mtod pohatu Gymrm moru unhrw The Boad rukewtt contponhn Walch Enouah Wa mlente mEm ma communcda Ca chocen lerqurte Coreapondane Wdth deoy they 0 Drd Bed t
A project proposal is in development by Mental Health Clinical Board, Pharmacy and Information Technology to develop an interface between PARIS (patient management and information software in use in Mental Health and community services) and PMS (patient management system) to improve the transfer of information The project aims to improve the interface between these systems and introduce Medicines Transcribing and e-Discharge to mental health wards with use of the Welsh Clinical Portal. Your findings at Mr Summerhayes inquest are of relevance to all Clinical Boards in the UHB: A copy of your Regulation 28 report and my response will be shared with the Clinical Boards and Medication Safety Executive Group. The Patient Safety and Quality Department will include the learning from Mr Summerhayes sad death in a forthcoming newsletter: hope that the information setout in this letter provides you with the assurance that the Health Board has fully considered the issues raised as consequence of Mr Summerhayes death, and taken appropriate action in response
am able to advise that there is requirement for patients Clozapine to be registered with a service to monitor the medicine during the course of their treatment with it. Additionally, when patient who is taking Clozapine dies Or ceases to take it, the manufacturer supplying the medication must be informed. The monitoring service currently in place for Cardiff and Vale University Health Board is via the Zaponex Treatment Access System (ZTAS) which is provided by the medicine's manufacturer that we currently use, called Leyden Delta. The necessary information was shared at the time via ZTAS. Where more than 5 medications are prescribed the drugs be examined by an associate physician or pharmacist for adverse interactions, either alone or in combination, which give rise to medical conditions which themselves predict hospitalisation and shorten longevity. Consideration would be for automatic referral to an individual qualified to assess i) drug-drug interactions; ii) the risks posed to the specific patient taking into account age, conditions suffered, lifestyle and the length of time the drug has been prescribed; iii) dosing levels to be 'signed off by the qualified individual; iv) all prescribing parties and the patient to be advised of the assessment outcome. The UHB has Medicines Code in place and this was updated in
2018. It contains a section on medicines reconciliation. It sets out the responsibilities of various healthcare professionals in this process_ including doctors, the pharmacy team and other prescribers. The Pharmacy Directorate has system in place of dedicated pharmacists aligned to clinical directorates and Clinical Boards to provide a source of support and expertise in medicines management. A specialist mental health pharmacist supports prescribing in in-patient mental health settings. The Primary Care and Intermediate Care Clinical Board has a Medicines Management and Prescribing Team who support related issues in primary care settings. Guidance from the National Institute of Health and Care Excellence (NICE) for assessing physical health of patients on Clozapine is available on their website (wnice orguk) and monitoring arrangements are in place in line with this in the UHB. The AlI Wales Medicines Strategy Group has produced number of guidance documents to promote polypharmacy reviews_ These documents can be viewed on their website which is WWWaWmsgorg Polypharmacy reviews are actively promoted to healthcare professionals by the Pharmacy Directorate in secondary care and the Medicines Management and Prescribing Team in primary care_ Brmd Iechyd Pafysgol Caerdydd ar Fr yw enm Awernredol Bwyrdd Iechyd Llcol Pnifyigol Cacrdydd a'r Fro Cardif and Vale Unrverslny Healih Board the opcrallonal aame Cardlll and Vale Unlveriity Local Health Board o1548449 Cmutt Bxrdd chebiaain yn Gymreen Reu 8441n50 SOnokn brddwnYa cynimbu cy tah Oawi Eblh: m frdd gahobu M Gpmrtea Cu unit Tha Bocm Wekonyi comnipondence Wulsh = Enaltn W Ienln m3 #r cottumchi chaten [41pucoa Conolpondanca #dm Wn bud ta oelty taking Our 04
Certain complex medicines are subject to formal shared care arrangements to ensure that roles and responsibilities are clearly defined. The Primary Care and Intermediate Care team established Medicines Management Incentive Scheme with GPs to ensure that medicines prescribed across care settings are added to the GP record SO there is complete medicines record for patients on the GP systems. The driver for this project was to promote patient safety but it has seen cost-benefits. Education is provided to staff within GP practices who are then required to identify their local process to ensure that a patient's medication history is accurately updated prospectively. Practices have also been asked to retrospectively add certain complex medicines to the GP systems t0 ensure are clearly recorded. To de-prescribe where appropriate rather than accruing an increasing list of daily medications whereby further protectant medications are required to be prescribed with the risk of medication induced hospital admissions and risk to life: Principles for de-prescribing are embedded within the aforementioned documents available regarding polypharmacy reviews at WWWawmsg org The Primary Care and Intermediate Care team has also developed criteria to stop various medicines in a number of patient pathways of care. The criteria are designed to guide healthcare professionals in de-prescribing processes. An example of where this may be used is in relation to analgesia that has been subject to long-term use_ Where there are two or more prescribing organisations (primary and secondary care) drug monitoring should be undertaken as mandated; by the responsible parties; and the information promptly shared with all prescribers and their patients. Prescribing in relation to Clozapine is undertaken as mandated. The process is in place via ZTAS as outlined previously: The Primary Care and Intermediate Care Clinical Board maintains list of over 300 patients who are currently prescribed Clozapine within the UHB. The team actively checks systems in GP surgeries to monitor the records of all patients who are known to have Clozapine prescribed in secondary care to ensure an interface with primary care. The Medicines Management Incentive Scheme that referred t0 earlier was designed to ensure there is an accurate record of patient's medication within the GP's records and all practices in the Cardiff and Vale UHB area are currently participating in this Scheme. Bwrdd [echyd Pritvtool Caerdydd &'r Fto yr enw Owcithredol Dwyrdd Iechyd Ucal Pntysqa: Cacrdydd 4" Fro Cardlfl and Vale Unlverilty Health Board Ine opcrailona nome Cardilf and Vale Un vcftICY Local Healh Board 01541449 Coturtt Owod chabioeth }n Ghnne? nau 5041n68 Scmutn brosltnyn GMtthnou _ dmtkh dut th Mtod pohatu Gymrm moru unhrw The Boad rukewtt contponhn Walch Enouah Wa mlente mEm ma communcda Ca chocen lerqurte Coreapondane Wdth deoy they 0 Drd Bed t
A project proposal is in development by Mental Health Clinical Board, Pharmacy and Information Technology to develop an interface between PARIS (patient management and information software in use in Mental Health and community services) and PMS (patient management system) to improve the transfer of information The project aims to improve the interface between these systems and introduce Medicines Transcribing and e-Discharge to mental health wards with use of the Welsh Clinical Portal. Your findings at Mr Summerhayes inquest are of relevance to all Clinical Boards in the UHB: A copy of your Regulation 28 report and my response will be shared with the Clinical Boards and Medication Safety Executive Group. The Patient Safety and Quality Department will include the learning from Mr Summerhayes sad death in a forthcoming newsletter: hope that the information setout in this letter provides you with the assurance that the Health Board has fully considered the issues raised as consequence of Mr Summerhayes death, and taken appropriate action in response