Michael Barry

Dear Coroner, Re: Regulation 28 Report to Prevent Future Deaths – Michael Paul Barry who died on 2 September 2023.

Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 12 June 2025 concerning the death of Michael Paul Barry on 2 September 2023. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Michael’s family and loved ones. NHS England is keen to assure the family and yourself that the concerns raised about Michael’s care have been listened to and reflected upon.

Your Report raises the concern that there is ‘no specialist commissioned service available for GPs to which they might refer their patients to manage reduction of their of intake of prescribed dependency-forming medications’. This is in contrast to the available commissioned services for patients dependent on illicit drugs and/or alcohol.

National role NHS England remains aware of this important issue and has worked at a national level to provide guidance and support across the NHS. In particular, NHS England is responsible for providing oversight of the management and use of controlled drugs, including opioids such as codeine. NHS England’s Controlled Drugs Accountable Officers (CDAOs) undertake this role within each geographical region across England. They provide assurance that all healthcare organisations, including GP practices and pharmacies, adopt a safe practice for appropriate clinical use, prescribing, storage, destruction and monitoring of controlled drugs. CDAOs facilitate the routes to share concerns, report incidents and take remedial action, as well as highlighting good practice. This is shared with wider partners such as Integrated Care Boards (ICBs) and the Police through the Controlled Drugs Local Intelligence Networks (CD LINs). Details of all CDAOs in England are held on a national register, which is owned and published by the Care Quality Commission (CQC): www.cqc.org.uk/content/controlled-drugs-accountable-officers.

Co-National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG

29 July 2025

Framework for prescribed dependency-forming medications In March 2023, NHS England published ‘Optimising personalised care for adults prescribed medicines associated with dependence or withdrawal symptoms: Framework for action for ICBs and primary care’. This Framework was developed for action with and for ICBs and primary care in response to a Public Health England (PHE) review and recommendations (2019) and NHS England’s subsequent analysis of the data up to 2020/21. NHS England’s Framework was prepared in collaboration with organisations including the Department of Health and Social Care (DHSC), CQC, National Institute for Health and Care Excellence (NICE) and the Medicines and Healthcare products Regulatory Agency (MHRA). A range of stakeholders were consulted during the process, including patients with lived experience and groups representing them, charities and voluntary sector organisations involved in the provision of services in this area, clinical experts and Royal Colleges. The Framework includes five actions, resources and case studies to help healthcare systems develop plans that can support people who are taking medicines associated with dependence and withdrawal symptoms including opioids by:
• Optimising personalised care for adults who are prescribed medicines associated with dependence or withdrawal symptoms.
• Informing ICB improvement and delivery plans, when commissioning services, and developing local policies that offer alternatives to medicines in the first place and/or support patients experiencing prescribed drugs dependence or withdrawal.
• Adopting a whole system approach and pathways involving multiple interventions, to improve care for people prescribed medicines associated with dependence and withdrawal symptoms. Additionally, NICE has published guidelines on:
• Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain (including guidance on pharmacological management and the use of opioids for chronic primary pain).
• Medicines associated with dependence or withdrawal symptoms: safe prescribing and withdrawal management for adults. Overprescribing guidance The National overprescribing review report was published in September 2021 and it evaluated the extent, causes and consequences of overprescribing and made 20 recommendations to address it. NHS England and partner organisations have been implementing the review’s recommendations over the past 3 years, aiming to achieve long term sustainable reductions to overprescribing via delivery of systemic and cultural improvements within the NHS.

A number of interventions are being delivered by NHS England to address and reduce overprescribing including:
• Publication of the National medicines optimisation opportunities for the NHS in 2024/25, which includes an opportunity for chronic non-cancer pain management without opioids. ICBs have been encouraged to select opportunities for delivery.
• Support for delivering Structured Medication Reviews (SMR).
• A national programme to offer non-pharmacological alternatives such as social prescribing, as well as funding for social prescribers through the Additional Roles Reimbursement Scheme (ARRS).  Social prescribing is demonstrated to support patients in addressing wider determinants of health which may be an underlying or contributory factor to the inappropriate use of medication. Other developments The NHS Medicines Safety Improvement Programme (which forms a key part of the NHS Patient Safety Strategy) is also delivering a focused programme of work relating to the improved care of people with chronic pain and a reduction in the use of prescribed opioids. The programme has been in place since January 2021. The national programme is supporting Integrated Care Systems to learn from, adapt and adopt effective practice using a whole-system improvement approach. In 2022/23, 18 Integrated Care Systems received intensive support to develop and implement improvements in care, with a further 15 participating in shared learning events. Specialist commissioned service The commissioning of services to support people with chronic pain (including services to support people to safely withdraw from prescribed medicines that may cause dependence and withdrawal) now lies with ICBs as a delegated specialised service. NHS England expects ICBs to commission appropriate services to meet the needs of the population that each ICB geographically covers. This includes taking due regard of the above national commissioning and clinical guidance. A multi-disciplinary team (MDT) approach is needed with input from, for example, pain specialists, dependence services, mental health services and peer support groups. I note that your Report has also been addressed to Mid and South Essex ICB and trust that they will be able to respond further on this issue. I would also like to provide further assurances on the national NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed by the Regulation 28 Working Group, comprising Regional Medical Directors, and other clinical and quality colleagues from across the regions. This ensures that key learnings and insights around events, such as the sad death of Michael, are shared across the NHS at both a national and regional level and helps us to pay close attention to any emerging trends that may require further review and action.

Thank you for bringing these important patient safety issues to my attention and please do not hesitate to contact me should you need any further information.

Dear Mr Horstead,

Thank you for the Regulation 28 report of 12th June 2025 sent to the Department of Health and Social Care about the death of Michael Paul Barry. I am replying as the Minister with responsibility for prescribing.

I would like to take this opportunity to say how saddened I was to read of the circumstances of Mr Barry’s death, and I offer my sincere condolences to their family and loved ones. The circumstances your report describes are concerning and I am grateful to you for bringing these matters to my attention.

Your report raises concerns over the lack of specialist commissioned services available to GPs for onward referral of patients requiring assistance with management of dependency- forming medicines. Specifically, a lack of services focused on reducing intake of prescribed dependency-forming medications and those offering specialist advice. Your report also highlights that the reduction or cessation of prescriptions for dependency- forming medications needs to be very carefully managed, due to the risk of withdrawal symptoms. Reduction and cessation of such medications requires specialist input and training to maximise the prospects of success and to avoid potentially fatal consequences. In preparing this response, my officials have made enquiries with NHS England and the Medicines and Healthcare products Regulatory Agency (MHRA) to ensure that your concerns have been adequately addressed.

First, regarding the lack of specialist commissioned services available to GPs, NHS England has advised that the Prescribed Opioid Dependence Local Enhanced Service referenced in your report has been a locally proposed initiative that was not commissioned nationally. Therefore, whilst I do understand your concerns on this matter, NHS England is not able to comment on this specific service.

NHS England has said that the Essex Partnership University NHS Foundation Trust (the Trust) recognises the growing concern around dependence on prescribed medication, particularly following the COVID-19 pandemic, during which access to elective procedures and chronic pain management services was disrupted. The Trust agrees that the safe reduction or cessation of these medications requires clinical expertise and coordinated care planning to reduce the risk of harm, including the potential for serious withdrawal effects and, in some cases, avoidable deaths. At present, however, the Trust is not commissioned to provide a specialist service for a stand-alone prescription medication dependency service that would allow direct referral from GPs solely for tapering and withdrawal management of these medicines. I would like to take this opportunity to detail what initiatives are in place by key organisations to address the wider areas of concern raised by your report. I have detailed these below. NHS England The Government commissioned a review into the use of medication and overprescribing. The outcome of this work, titled the National overprescribing review report, was published in September 2021. The report evaluated the extent, causes and consequences of overprescribing and made 20 recommendations to address it. NHS England and partner organisations have been implementing the review’s recommendations over the past 3 years, aiming to achieve long term sustainable reductions to overprescribing via delivery of systemic and cultural improvements within the NHS. A number of interventions are being delivered by NHS England to address and reduce overprescribing including:
• Publication of the National medicines optimisation opportunities for the NHS in 2024/25, which includes an opportunity on chronic non-cancer pain management without opioids. ICBs have been encouraged to select opportunities for delivery.
• Support for delivering Structured Medication Reviews (SMR).
• A national programme to offer non-pharmacological alternatives such as social prescribing, as well as funding for social prescribers through the ARRS.  Social prescribing is demonstrated to support patients address wider determinants of health which may be an underlying or contributory factor to the inappropriate use of medication. The NHS Medicines Safety Improvement Programme (which forms a key part of the NHS Patient Safety Strategy) is also delivering a focussed programme of work relating to the improved care of people with chronic pain and a reduction in the use of prescribed opioids. The programme has been in place since January 2021. The national programme is supporting Integrated Care Systems to learn from, adapt and adopt effective practice using a whole-system improvement approach. In March 2023, NHS England published ‘Optimising personalised care for adults prescribed medicines associated with dependence or withdrawal symptoms: Framework for action for

ICBs and primary care’. This framework includes five actions, resources and case studies to help systems develop plans that can support people who are taking medicines associated with dependence and withdrawal symptoms, including opioids, by:
• Optimising personalised care for adults prescribed medicines associated with dependence or withdrawal symptoms.
• Informing ICB improvement and delivery plans, when commissioning services and developing local policies that offer alternatives to medicines in the first place and/or support patients experiencing prescribed drugs dependence or withdrawal.
• Ensuring a whole system approach and pathways involving multiple interventions, to improve care for people prescribed medicines associated with dependence and withdrawal symptoms. Across 2022 and 2023, 18 Integrated Care Systems received intensive support to develop and implement improvements in care and a further 15 participated in shared learning events. Commissioning of services to support people with chronic pain (including services to support people to safely withdraw from prescribed medicines that may cause dependence and withdrawal) now lies with Integrated Care Boards (ICBs). NHS England expects ICBs to commission appropriate services to meet the needs of the population that the ICB geographically covers. This includes taking due regard to any of the above national commissioning or clinical guidance. Controlled Drugs Accountable Officers and Controlled Drugs Local Intelligence Networks In light of the information provided by NHS England, I hope you will find it helpful if I explain the safeguards currently in place to ensure that healthcare organisations adopt safe practice in this area. NHS England has a clear responsibility in providing systems oversight for the management and use of controlled drugs, including opioids such as codeine. I am aware that NHS England’s Controlled Drugs Accountable Officers (CDAOs) undertake this role within each geographical region across England. They provide assurance that all healthcare organisations, including GP practices and pharmacies, adopt a safe practice for appropriate clinical use, prescribing, storage, destruction and monitoring of controlled drugs. CDAOs facilitate the routes to share concerns, report incidents, and take remedial action as well as highlighting good practice. This is shared with wider partners such as Integrated Care Boards and the police through the Controlled Drugs Local Intelligence Networks (CD LINs). Details of all CDAOs in England are held on a national register, which is owned and published by the Care Quality Commission: www.cqc.org.uk/content/controlled-drugs- accountable-officers. National Institute for Health and Care Excellence As you may already be aware, the National Institute for Health and Care Excellence (NICE) is the independent body responsible for developing evidence-based guidance for the NHS

and is responsible for developing guidance in line with established methods and processes. NICE guidelines are based on a thorough assessment of the available evidence and are developed through a rigorous process, that includes extensive engagement with stakeholders and expert input throughout the guideline development process. NICE has published guidelines on the assessment and management of chronic primary pain and the safe prescribing and withdrawal management of medicines associated with dependence of withdrawal symptoms. These guidelines can be found here:
• Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain
• Medicines associated with dependence or withdrawal symptoms: safe prescribing and withdrawal management for adults. NICE guidelines describe best practice and the government expects NHS commissioners to take them into account in designing services that meet the needs of their local populations. It is however important to note that NICE guidelines are not mandatory and do not override a clinician’s responsibility to make decisions appropriate to the individual needs of their patients.

Commission for Human Medicines As with any patient dependent on an opioid medicine, cessation of treatment should be undertaken slowly under the supervision of a healthcare professional to prevent the potential from withdrawal reactions. In 2020, following a review of addiction and dependence to opioids by the Opioid Expert Working Group of the Commission for Human Medicines, consistent warnings were added to product information to include this guidance. In addition, MHRA published a Drug Safety Update article for healthcare professionals and a leaflet which healthcare professionals are encouraged to give to patients. The MHRA continues to review the safety and access to codeine and will take regulatory action if considered appropriate. Managing co-occurring substance use and mental health As you mentioned in your report, Mr Barry had a long-standing history of mental health problems and illicit drug and alcohol misuse. Therefore, I hope you will find it helpful if I explain the actions being taken more broadly for those with substance use and mental health needs. Following a recommendation from Dame Carol Black’s independent review of drugs in 2020, the Department has been developing a comprehensive action plan to set out a path to improving service provision for those with co-occurring substance use and mental health needs. NHS England and the Department have worked with subject matter experts, including people with lived experience, academics, clinicians, and service providers in creating this plan. The plan is aimed to be as inclusive as possible and is built on the principles of ‘Everyone’s job’ and ‘No wrong door’. The first principle, ‘Everyone’s job’, states that commissioners and providers of mental health and alcohol and drug treatment services have

a joint responsibility to meet the needs of people with co-occurring conditions by working together to treat those with mental health conditions as well as substance use conditions. The second principle, ‘No wrong door’, states that providers in alcohol and drug treatment, mental health and other services have an open-door policy for individuals with co-occurring conditions and make every contact count. Treatment for co-occurring conditions is available through every contact point and services should be working together seamlessly to meet needs. I hope this response is helpful. Thank you for bringing these concerns to my attention.