Dear Ms Mutch, Response to Regulation 28 Report into the death of Louise Danielle Rosendale Thank you for your letter and for sharing with us the findings from the recent inquest, along with the matters of concern outlined in the Regulation 28 Report. We would like to begin by expressing our sincere condolences to the family and loved ones of Ms Rosendale. We recognise that this has been an extremely difficult and distressing time, and we are deeply sorry for their loss. As a practice, we fully acknowledge the emotional impact that events such as these can have on those affected. We welcome the opportunity to reflect on the circumstances of this case and to respond constructively. We have carefully considered the issues raised in the Prevention of Future Deaths report, particularly those relating to the prescribing and administration of opiates. As part of our commitment to learning and improvement, we have undertaken a review of our current practices and will provide additional education and guidance to our staff to reinforce safe prescribing, monitoring, and administration of these medications. We are making changes which are relevant to addressing the concerns. Background
1. Regulation 28 Report into the death of Louise Danielle Rosendale A1

132 Flixton Road Urmston Manchester M41 5BG Tel 0161 748 2021

Email: flixtonroad.mc@nhs.net Our Response To each of the matters of concern are provided as follows: - Concern - Prescribed Opiates The inquest heard that Ms Louise Rosendale had been prescribed opiates for many years despite the risks associated with long term opiate prescribing. The evidence before the inquest was that there had been very limited attempts to review the long-term prescribing of opiates to her. Response to Concern Ms Rosendale (our patient) had passed away, the review by the coroner noted that there was historic high use of opioids. Ms Rosendale was taking 120mg of Morphine via tablet form and taking oramorph also. Ms Rosendale had been taking historically high doses of opioids before becoming a patient at Flixton Road Medical Centre, due to symptoms of severe abdominal pain and had seen general surgeons and gastroenterologist who confirmed the high dose opioid use to control Ms Rosendale’s pain. Ms Rosendale was taking 120mg of oral morphine through tablets and liquid morphine when required. Ms Rosendale’s patient history stated there were several admissions to casualty with severe pain. Ms Rosendale transferred to Flixton Road Medical Centre in December 2019 following the closure of her previous GP practice, along with the doctors who had been caring for her. She continued to be seen regularly for general health reviews throughout 2020. In May 2021, she had a medication review with her regular GP, which included management of her mental health condition and medications prescribed by the mental health team. Ms Rosendale was reviewed in the gastroenterology clinic in March 2022, where a continued diagnosis of pancreatitis was made. Despite ongoing severe pain, no changes were made to her opioid medication. At this time, she was also under haematology for chronic anaemia and cardiology for arrhythmias; all involved specialists were aware of her medications and raised no concerns. In June 2022, a GP medication review confirmed the continuation of high-dose opioid treatment as per gastroenterology advice. Ms Rosendale reported that only by taking oral morphine sulfate (120mg daily) and Oramorph as needed, did she gain some relief. The risks of high-dose opioid use were discussed. In September 2022, the Primary Care Network pharmacist switched her medication to Zomorph. A follow- up review in October 2022 resulted in no further changes. That same month, she attended Wythenshawe Hospital with severe abdominal pain. A CT scan showed no acute changes, and she was treated with additional opioids. A referral to gastroenterology was made. A2

132 Flixton Road Urmston Manchester M41 5BG Tel 0161 748 2021

Email: flixtonroad.mc@nhs.net In March 2023, the medicines management team reviewed her prescription after she reported a lost bottle of Oramorph, later confirmed to have been mistakenly discarded by her father. She was seen in August 2023 for ENT concerns and diagnosed with a deviated septum. Blood tests showed no abnormalities. In September 2023, she attended her annual health check with the nurse. In November 2023, Ms Rosendale sustained a fractured clavicle after a fall and received treatment. She was reviewed by a GP in March 2024 for concerns about low B12, and blood tests were ordered. In July 2024, the practice pharmacist conducted a medication review. Ms Rosendale later reported misplacing some Zomorph; the amount was calculated and replaced. A follow-up consultation reinforced the importance of adhering to the prescribed dose. Ms Rosendale stated her father assisted with her medication. She was advised not to take additional opioids beyond the prescription. She was offered a face-to-face appointment on 18 September 2024, but did not respond. On 20 September, she contacted the surgery regarding ankle swelling and was seen the same day. Flixton Road Medical Practice was notified of Ms Rosendale’s death on the 25th of September 24. The cause of death was respiratory infection, but the pathologist noted the high levels of opioids in the patient postmortem results. There was also codeine which was not prescribed by the practice and the combination of both medications added to the respiratory depression. As part of the practice’s commitment to continuous learning and patient safety, a comprehensive review of opioid prescribing was undertaken. This included a revision of the opioid prescribing policy in line with current clinical guidelines, alongside the introduction of mandatory training for all prescribers to support safer opioid use. An audit of high-risk prescribing was completed to identify areas for improvement and ensure appropriate monitoring. Electronic safety alerts within the prescribing system were optimised to support clinical decision-making at the point of care. Structured medication reviews were reinforced as a routine part of ongoing care, particularly for patients on long-term or high-dose opioids. In addition, a standardised communication protocol was developed to ensure consistent, clear, and timely documentation and coordination between clinical teams involved in patient care. These actions aim to strengthen prescribing safety, enhance patient outcomes, and support a culture of continuous quality improvement. To ensure that the learning from this case is fully embedded across our practice, we have developed an action plan to address the concerns raised, which is enclosed with this response. Key elements of our learning dissemination include publication on our internal learning platform (TeamNet), briefing sessions with the clinical team, and structured reflection during team meetings. A3

132 Flixton Road Urmston Manchester M41 5BG Tel 0161 748 2021

Email: flixtonroad.mc@nhs.net On reflection, several areas have been identified where care could have been improved. Earlier identification of risks associated with long-term high-dose opioid use may have prompted more timely interventions. Greater patient involvement in decision-making could have supported shared understanding and safer management plans. There was limited external input from specialist services in reviewing ongoing opioid prescribing, and an absence of a formal monitoring framework meant that risk mitigation strategies were not consistently applied. Resource constraints also impacted the ability to implement more proactive, structured reviews. Opportunities were missed for more proactive monitoring of opioid use, supported by a clear and structured communication protocol across the clinical team. Additionally, ongoing training in opioid safety and polypharmacy was not embedded consistently across the team. Structured medication reviews should have been undertaken more frequently and in a multidisciplinary context. These findings have guided recent improvements aimed at enhancing clinical practice and ensuring safer patient care. A more robust process for prescribing high-dose opioids has now been introduced to ensure greater clinical oversight and patient safety. This includes a clear prescribing protocol that outlines thresholds for escalation, mandatory documentation of clinical rationale, and multidisciplinary involvement in decision- making. All high-dose opioid prescriptions are now subject to regular structured medication reviews, with clearly defined intervals and oversight by both GPs and clinical pharmacists. Electronic prescribing systems have been updated to include enhanced safety alerts, specifically highlighting high opioid use, with a safety message now embedded in our EMIS clinical system to prompt prescribers at key decision points. Additionally, any new initiation or dose escalation of high-level opioids requires a documented risk-benefit discussion with the patient, including exploration of alternative pain management strategies. This process is supported by ongoing staff training in opioid safety and polypharmacy and monitored through regular audits to ensure compliance and continuous improvement. We have included the following documents for your consideration with our response.
1. Investigation Action Plan
2. Regulation 28 – Response Final
3. Review of Opioids Treatment for non-Palliative Patients
4. Teamnet Page Opioids and Pain Management
5. Opioids Prescribing Protocol
6. SEA
7. Audit A4

132 Flixton Road Urmston Manchester M41 5BG Tel 0161 748 2021

Email: flixtonroad.mc@nhs.net In addition, we will share the key findings and learning points with our Primary Care Network (PCN) colleagues and across other practices within the Trafford area to support wider system learning and reinforce safe practice in the prescribing and management of opiates. To ensure the effectiveness of the actions taken and to support continuous improvement, we will implement follow-up audits to monitor compliance with revised protocols and safety measures related to opiate prescribing. The audit results and learning will be reviewed at our practice meeting, where we will strive to ensure all new processes are acknowledged and embedded by all the clinical team. Thank you once again for providing the practice with the copy of the regulation 28 report for our attention and remedial action.

Dear Ms. Mutch Re: Regulation 28 Report to Prevent Future Deaths - Louise Danielle Rosendale Thank you for your Regulation 28 Report dated 30 April 2025 regarding the sad death of Louise Danielle Rosendale. On behalf of NHS Greater Manchester Integrated Care (NHS GM), We would like to begin by offering our sincere condolences to Ms. Rosendale’s family for their loss. Thank you for highlighting your concerns during the inquest which concluded on the 17 March 2025. On behalf of NHS GM, we apologise that you have had to bring these matters of concern to our attention. We recognise it is very important to ensure we make the necessary improvements to the quality and safety of future services. During the inquest you identified the following cause for concern: Louise Rosendale had been prescribed opiates for many years despite the risks associated with long term opiate prescribing. The evidence before the inquest was that there had been very limited attempts to review the long-term prescribing of opiates to her. The inquest was told that she had been identified as a patient on a long-term opiate prescription in 2022. The next action had been a pharmacy review in July 2024. There was no evidence of long-term detailed planning or oversight of these patients within the practice. NHS GM has undertaken an investigation into the cause for concern. As the GP practice responsible for Ms. Rosendale’s care, Flixton Road Medical Centre has provided a comprehensive response, and I understand that their response has been shared directly with you. The practice has shared their response with NHS GM, and I have included this and the associated documentation at Appendix 1 to this letter.

Private & Confidential Ms Alison Mutch Senior Coroner for the area of Manchester South Coroner's Court 1 Mount Tabor Street Stockport SK1 3AG A6

4th Floor, Piccadilly Place, Manchester M1 3BN Tel: 0161 6257791 www.gmintegratedcare.org.uk NHS GM (Trafford locality) Medicines Optimisation team have reviewed your report and the cause for concern and have provided information on the expectation of care for patients prescribed opioids, work underway in the locality to reduce harm from opioids and plans for improvements in the future. GP practice expectation regarding review of patients prescribed opioids. Since October 2020, there has been a requirement, as part of the PCN Direct Enhanced Service (DES) contract, for GP practices to proactively identify and prioritise for structured medication review (SMR) patients using one or more potentially addictive medications from the following groups: opioids; gabapentinoids; benzodiazepines; and z-drugs. However, the PCN DES also states that the number of SMRs that a PCN is required to offer will be determined and limited by their clinical pharmacist capacity. Work undertaken in the NHS GM Trafford Locality The Trafford locality Medicines Optimisation Team have undertaken several actions with the aim of reducing harm from opioids. One of the pharmacists in the team leads on opioid risk reduction and pain management, collaborating with colleagues to share good practice and implement strategies for opioid risk reduction. This includes:
• Taking part, along with a pharmacy technician from the Trafford team, in the Medicines Safety Improvement Programme (MedSIP) breakthrough series collaborative which aims to implement a whole system approach to high-risk opioid prescribing. This has resulted in sharing of good practice and closer working with other secondary and primary care colleagues across Greater Manchester.
• Representing the Trafford Locality at the Greater Manchester Pain Collaborative which brings together stakeholders to identify and develop solutions to the challenges of prescribing pain medicines across Greater Manchester.
• Attending the local hospital trust’s Opioid Safety Group to facilitate primary and secondary care colleagues working together to reduce the harm from opioids. One of the current areas of work for this group is the implementation of the GM Communication Standards for Opioids at Discharge.
• Attendance at trust-led case-based discussions regarding opioid prescribing to gain a better understanding of the challenges faced in secondary care and how these impact on primary care
• Working with colleagues from Manchester University to investigate and implement use of the new Safety Medication (SMASH) dashboard indicator which identifies patients prescribed opioids within 30 days of discharge from hospital. The aim of the indicator is to facilitate identification and review of patients to prevent harm from long term opioid use.
• Collaboration with a colleague from another locality to produce a communication for primary care to highlight the risks from opioids used in chronic pain, encourage review of these patients and signpost to resources available on the Greater Manchester Pain Management Resources Hub.
• Discussion at regular meetings held with PCN clinical pharmacists to highlight the need to identify and prioritise patients prescribed opioids for structured medication reviews and ensuring they are aware of resources available to facilitate review, including the Greater Manchester Pain Management Resources Hub. A7

4th Floor, Piccadilly Place, Manchester M1 3BN Tel: 0161 6257791 www.gmintegratedcare.org.uk
• Attendance at the Regional CD Local Intelligence Network meetings to ensure awareness of and learning from issues/incidents in other areas and share good practice. As well as continuing with the work detailed above, the following actions are planned in Trafford locality this year:
• Work with GP practices to increase use of the safety medication (SMASH) dashboard, including the new opioid indicator.
• Review by a pharmacy technician and pharmacist from the team of patients flagged by the SMASH opioid indicator and identify improvements that can be made to primary care review processes as well as feeding back, via the trust Opioid Safety Group, potential improvements to secondary care processes.
• Work with colleagues in other GM localities to produce and implement standards for primary care review of patients discharged on opioids.
• Provide data to GP Practices regarding their opioid prescribing, including high dose opioids, and ensure they are aware of resources available to facilitate review of patients.
• Increase awareness, and ensure information is readily accessible to GP practice clinicians, regarding local services available to support the review of patients on opioids, including pain clinic referral pathways and non-pharmacological support for pain management.
• Collaborate with colleagues from other GM localities and secondary care pain clinics to explore the potential for multidisciplinary team review of complex patients on high dose opioids in primary care. NHS GM works in partnership across all locality Medicines Management teams and all learning is shared through the ICB for GM wide system learning. I hope that this responses assures you that NHS GM has responded to your report and will take positive steps to share learning. If you have any questions about this responses, please contact me. Best wishes A8