Department of Health and Social Care
Central Government
Action Planned
The Department of Health and Social Care plans to publish a White Paper in early 2020 responding to the Independent Review of the Mental Health Act and will consult publicly on proposals to amend the Act. (AI summary)
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From Nadine Dorries MP Parliamentary Under Secretary of State for Mental Health, Department Suicide Prevention and Patient Safety of Health & Social Care 39 Victoria Street London SW1H OEU 020 7210 4850 Your Reference: 8813 Our Reference: PFD-1193673 Mrs Maria Eileen Voisin HM Senior Coroner; Avon HM Coroner's Court The Courthouse Old Weston Road Bourton BS48 1UL 23 January 2020 NNS Vs ~o. Thank you for your correspondence of 10 October 2019 to Matt Hancock about the death of Abdeslam Benelghazi: am replying as Minister with responsibility for mental health services and patient safety and am grateful for the additional time in which to do s0_ Firstly, would Iike to say how very saddened was to of the circumstances of Mr Benelghazi's death and extend my deepest sympathies to his family and loved ones We must do all we can to learn from regrettable incidents such as these, especially when they involve vulnerable individuals detained under the Mental Health Act, to ensure the safety of health services and prevent future deaths_ am clear that the Avon and Wiltshire Mental Health Partnership NHS Trust must take forward the learning from this inquest in order to avoid another such tragic death In considering the concerns in your report, Departmental officials sought the advice of the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE): In relation to the prescribing of methadone beyond the normal limits and continuing administration of clonazepam; a drug known to be associated with an increased risk of death when taken with opioids, am advised as follows The increased risk of respiratory depression, coma and death when benzodiazepines and opioids are used together is known and changes to the product information highlighting these risks was recommended following an EU review in 2018. Wording for inclusion in the product information for both benzodiazepines and opioid medicines was published that year Flax read the
The MHRA has reviewed all licences for clonazepam and methadone noted that not all marketing authorisation holders (MAH) have applied the appropriate amendments The MHRA is therefore contacting the MAH holders to request updates to the product information and the outstanding changes are expected to be implemented within three to six months_ In reviewing the product information for methadone, the MHRA has noted that several products contain information regarding respiratory depression and state that due to the slow accumulation of methadone in the tissues, respiratory depression may not be fully apparent for a week or two_ The MHRA agrees that this important information should be included in all methadone products and has committed to working with MAH holders to update the product information within the timeframe above_ In addition, the MHRA will remind healthcare professionals of the risks of respiratory depression when benzodiazepines and opioids are co-prescribed via an article in its Safety Update early this year: The MHRA has added this case to its Yellow Card database (reference number ADR
24445672): The Yellow Card Scheme is the UK system for collecting and monitoring information on suspected adverse reactions (ADRs). The purpose of the Scheme, run by the MHRA, is to provide an early warning that the safety of a product may require further investigation_ As with all safety concerns, the MHRA will keep this particular issue under review and will update product information further if necessary_ Prescribing decisions are made by clinicians who are responsible for taking into consideration the dosage of medication prescribed and the combination of medicines administered. Prior to offering treatment, healthcare professionals are expected to carefully consider information on the likely benefits of a treatment and balance these against possible adverse side effects, interactions and contraindications before making decisions appropriate to the circumstances of the individual (in consultation with them, andlor their families and carerslguardian) Sources of information include the British National Formulary (BNF2) and, as already mentioned, a drug's summary of product characteristics (SmPCs). SmPCs contain information regarding the administration of medicines, and issues such as adverse side effects, contraindications and special warnings. SmPCs are available on the electronic httos Jlwhma eulfileadminldateien/Human_MedicinesICMD hAdvice_from_CMDhICMDh_3722018_Revo02 201
8.pdf bttps Ilbnfnice orgukl?utm_sourcezevidence_bnf_redirect&utm_medium-(other)&utm_campaignzold_site_redirect and Drug drug
Medicines Compendium website? which contains up-to-date, easily accessible information about medicines licensed for use in the UK The NICE website hosts the BNF, which is a joint publication of the British Medical Association and the Royal Pharmaceutical Society: The BNF provides prescribers_ pharmacists, and other healthcare professionals with up-to-date information about the selection, prescribing, dispensing and administration of medicines. A further source of advice is the General Medical Council's prescribing guidance4 In addition, healthcare professionals are expected to take account of NICE guidelines that offer advice on clinical care based on evidence of best practice. In 2014, NICE published Psychosis and schizophrenia in adults: prevention and management (CG1785) , that includes recommendations on when to offer psychotic medication and how to initiate and monitor its use_ NICE published technology appraisal guidance Methadone and buprenorphine for the management of opioid dependence (TA1146_ in 2007, that recommends the treatments as options for maintenance therapy in the management of opioid dependence and highlights the potential risks, including of respiratory depression and interactions with other drugs. There are also NICE guidelines that make recommendations on the use of clonazepam? and gabapentin8. In summary, a healthcare professional is expected to consider the patient's circumstances and the possible benefits and risks before making an informed decision about what treatment might be appropriate for them. In relation to the finding by the inquest jury of a failure to adequately monitor Mr Benelghazi and to identify signs of over sedation, the General Medical Councils (GMC) Good practice in prescribing and managing medicines and devices9 , is clear that prescribers must make sure that suitable arrangements are in place for monitoring, follow- up and review_ taking into account the patients' needs and any risk arising from the medicines. This is particularly important where the medicines prescribed have potentially serious or common side effects_ The Nursing and Midwifery Council (NMC) is responsible for the standards of education of undergraduate nurses and works to ensure that registered nurses have the knowledge and skills need to deliver high-quality, safe care on a consistent basis. The NMC's Future hltpsllmedicines org uklemc https JlWgmc-Ukorglethical-guidancelethical-quidance-for-doctorslprescribing-and-managing-medicines-and: devices https IWWnice_org Uklguidancelcg178/chapterlt-Recommendationstlfirst-episode-psychosis-2 https Iwwnice_org uklguidancelta114 httpsIMWnice_org uklquidancelcg137 https Inico org uklquidance/cg173 https ILwWgmc-ukorglelhical-quidancelethical-quidance-for-doctorslprescribing-and-managing-medicines-and- devices/reviewng-medicines they
Nurse: Standards of proficiency for registered nursesto specifies the knowledge and skills that registered nurses must demonstrate when caring for people of all ages and across all care settings. It is expected that a registered nurse should be able to demonstrate the knowledge and ability to respond proactively and promptly to signs of deterioration or distress in mental, physical, cognitive and behavioural health and use this knowledge to make sound clinical decisions and contribute to a comprehensive clinical plan that is compliant with the employer's policy on monitoring and observing patients In response to changes to the National Early Warning Score (NEWS) parameters"1, Health Education England (HEE) is working in partnership with NHS England and NHS Improvement and others, to support learning needs for the health and care workforce_ Learning resources have either been developed, are in development or are being planned for staff working in secondary care, primary care, ambulance settings and mental health settings. The resources consist of a number of case studies covering presentations common to particular care settings In response to your report; HEE advises that it will ensure the development of a specific case study to cover opioid use and over sedation when it develops the early warning score learning resource for mental health settings. am further advised that HEE is providing education and training opportunities for mental health practitioners through the development of related competency frameworks and teaching initiatives. HEE is working with health system stakeholders , subject matter experts and people with lived experience, to develop guidance, endorsed by the Royal Pharmaceutical Society, that sets out additional guidance, support, resources and learning materials specifically related to prescribing in mental health: On medicine safety more generally, the Government is committed to supporting the work of the Medicine Safety Improvement Programme12, led by NHS England and NHS Improvement; which aims to increase safety across the medication pathway: The programme will bring together a variety of projects to support medicine safety, from improvements to technology and the roll out of electronic prescribing, to improved training for health and care professionals in the safe use of medicines The Government recognises the need to modernise the Mental Health Act 1983 to ensure it is used in a fair and just way and that people are not detained any more than is necessary. We want to make sure that people subject to the Act receive better care, that they have a much greater say in that care and that are treated with the dignity and respect deserve_ We will publish a White Paper in early 2020 , which will set out the Government's response to Sir Simon Wessely' s Independent Review of the Mental Health Act. We will consult publicly on our proposals and will bring forward Bill to amend the Act when Parliamentary time allows_ 10 https IlwWnmoorg uklglobalassetslsitedocuments/education-standardslfuture-nurse-proficiencies pdf https Ilwwwrcplondon acuklprojectsloutputsInational-early-warning-score-news-2 https Ilimprovement nhs uk/resources/national-medicines-safety-programmel they they
Finally, have asked Departmental officials to bring the matters of concern in your report to the attention of NHS England and NHS Improvement, the Care Quality Commission and the Healthcare Safety Investigation Branch. hope this response is helpful. Thank you for bringing these concerns to my attention. Iy~S, MoM NADINE DORRIES
The MHRA has reviewed all licences for clonazepam and methadone noted that not all marketing authorisation holders (MAH) have applied the appropriate amendments The MHRA is therefore contacting the MAH holders to request updates to the product information and the outstanding changes are expected to be implemented within three to six months_ In reviewing the product information for methadone, the MHRA has noted that several products contain information regarding respiratory depression and state that due to the slow accumulation of methadone in the tissues, respiratory depression may not be fully apparent for a week or two_ The MHRA agrees that this important information should be included in all methadone products and has committed to working with MAH holders to update the product information within the timeframe above_ In addition, the MHRA will remind healthcare professionals of the risks of respiratory depression when benzodiazepines and opioids are co-prescribed via an article in its Safety Update early this year: The MHRA has added this case to its Yellow Card database (reference number ADR
24445672): The Yellow Card Scheme is the UK system for collecting and monitoring information on suspected adverse reactions (ADRs). The purpose of the Scheme, run by the MHRA, is to provide an early warning that the safety of a product may require further investigation_ As with all safety concerns, the MHRA will keep this particular issue under review and will update product information further if necessary_ Prescribing decisions are made by clinicians who are responsible for taking into consideration the dosage of medication prescribed and the combination of medicines administered. Prior to offering treatment, healthcare professionals are expected to carefully consider information on the likely benefits of a treatment and balance these against possible adverse side effects, interactions and contraindications before making decisions appropriate to the circumstances of the individual (in consultation with them, andlor their families and carerslguardian) Sources of information include the British National Formulary (BNF2) and, as already mentioned, a drug's summary of product characteristics (SmPCs). SmPCs contain information regarding the administration of medicines, and issues such as adverse side effects, contraindications and special warnings. SmPCs are available on the electronic httos Jlwhma eulfileadminldateien/Human_MedicinesICMD hAdvice_from_CMDhICMDh_3722018_Revo02 201
8.pdf bttps Ilbnfnice orgukl?utm_sourcezevidence_bnf_redirect&utm_medium-(other)&utm_campaignzold_site_redirect and Drug drug
Medicines Compendium website? which contains up-to-date, easily accessible information about medicines licensed for use in the UK The NICE website hosts the BNF, which is a joint publication of the British Medical Association and the Royal Pharmaceutical Society: The BNF provides prescribers_ pharmacists, and other healthcare professionals with up-to-date information about the selection, prescribing, dispensing and administration of medicines. A further source of advice is the General Medical Council's prescribing guidance4 In addition, healthcare professionals are expected to take account of NICE guidelines that offer advice on clinical care based on evidence of best practice. In 2014, NICE published Psychosis and schizophrenia in adults: prevention and management (CG1785) , that includes recommendations on when to offer psychotic medication and how to initiate and monitor its use_ NICE published technology appraisal guidance Methadone and buprenorphine for the management of opioid dependence (TA1146_ in 2007, that recommends the treatments as options for maintenance therapy in the management of opioid dependence and highlights the potential risks, including of respiratory depression and interactions with other drugs. There are also NICE guidelines that make recommendations on the use of clonazepam? and gabapentin8. In summary, a healthcare professional is expected to consider the patient's circumstances and the possible benefits and risks before making an informed decision about what treatment might be appropriate for them. In relation to the finding by the inquest jury of a failure to adequately monitor Mr Benelghazi and to identify signs of over sedation, the General Medical Councils (GMC) Good practice in prescribing and managing medicines and devices9 , is clear that prescribers must make sure that suitable arrangements are in place for monitoring, follow- up and review_ taking into account the patients' needs and any risk arising from the medicines. This is particularly important where the medicines prescribed have potentially serious or common side effects_ The Nursing and Midwifery Council (NMC) is responsible for the standards of education of undergraduate nurses and works to ensure that registered nurses have the knowledge and skills need to deliver high-quality, safe care on a consistent basis. The NMC's Future hltpsllmedicines org uklemc https JlWgmc-Ukorglethical-guidancelethical-quidance-for-doctorslprescribing-and-managing-medicines-and: devices https IWWnice_org Uklguidancelcg178/chapterlt-Recommendationstlfirst-episode-psychosis-2 https Iwwnice_org uklguidancelta114 httpsIMWnice_org uklquidancelcg137 https Inico org uklquidance/cg173 https ILwWgmc-ukorglelhical-quidancelethical-quidance-for-doctorslprescribing-and-managing-medicines-and- devices/reviewng-medicines they
Nurse: Standards of proficiency for registered nursesto specifies the knowledge and skills that registered nurses must demonstrate when caring for people of all ages and across all care settings. It is expected that a registered nurse should be able to demonstrate the knowledge and ability to respond proactively and promptly to signs of deterioration or distress in mental, physical, cognitive and behavioural health and use this knowledge to make sound clinical decisions and contribute to a comprehensive clinical plan that is compliant with the employer's policy on monitoring and observing patients In response to changes to the National Early Warning Score (NEWS) parameters"1, Health Education England (HEE) is working in partnership with NHS England and NHS Improvement and others, to support learning needs for the health and care workforce_ Learning resources have either been developed, are in development or are being planned for staff working in secondary care, primary care, ambulance settings and mental health settings. The resources consist of a number of case studies covering presentations common to particular care settings In response to your report; HEE advises that it will ensure the development of a specific case study to cover opioid use and over sedation when it develops the early warning score learning resource for mental health settings. am further advised that HEE is providing education and training opportunities for mental health practitioners through the development of related competency frameworks and teaching initiatives. HEE is working with health system stakeholders , subject matter experts and people with lived experience, to develop guidance, endorsed by the Royal Pharmaceutical Society, that sets out additional guidance, support, resources and learning materials specifically related to prescribing in mental health: On medicine safety more generally, the Government is committed to supporting the work of the Medicine Safety Improvement Programme12, led by NHS England and NHS Improvement; which aims to increase safety across the medication pathway: The programme will bring together a variety of projects to support medicine safety, from improvements to technology and the roll out of electronic prescribing, to improved training for health and care professionals in the safe use of medicines The Government recognises the need to modernise the Mental Health Act 1983 to ensure it is used in a fair and just way and that people are not detained any more than is necessary. We want to make sure that people subject to the Act receive better care, that they have a much greater say in that care and that are treated with the dignity and respect deserve_ We will publish a White Paper in early 2020 , which will set out the Government's response to Sir Simon Wessely' s Independent Review of the Mental Health Act. We will consult publicly on our proposals and will bring forward Bill to amend the Act when Parliamentary time allows_ 10 https IlwWnmoorg uklglobalassetslsitedocuments/education-standardslfuture-nurse-proficiencies pdf https Ilwwwrcplondon acuklprojectsloutputsInational-early-warning-score-news-2 https Ilimprovement nhs uk/resources/national-medicines-safety-programmel they they
Finally, have asked Departmental officials to bring the matters of concern in your report to the attention of NHS England and NHS Improvement, the Care Quality Commission and the Healthcare Safety Investigation Branch. hope this response is helpful. Thank you for bringing these concerns to my attention. Iy~S, MoM NADINE DORRIES