Prevention of Future Deaths reports · 2022
Regulation 28 report to prevent future deaths, reference 2022-0176, written 15 Jun 2022. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 15 Jun 2022 |
|---|---|
| Reference | 2022-0176 |
| Deceased | Marjorie Walker |
| Coroner | Alison Mutch |
| Coroner area | Manchester South |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths · Alcohol, drug and medication related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1) Secretary of State for Health and Social Care; 2) Greater Manchester Health and Social Care Partnership 1 CORONER I am Alison Mutch, Senior Coroner, for the Coroner Area of Greater Manchester South 2 CORONER’S LEGAL POWERS I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013 3 INVESTIGATION and INQUEST On 28th May 2020 I commenced an investigation into the death of Marjorie Walker. The inquest concluded on the 3rd March 2022 and the conclusion was one of: Narrative: Died from a combination of natural causes contributed to by a toxic level of prescribed medication given in hospital and neglect. The medical cause of death was: 1a) Combined effects of gabapentin, morphine, buprenorphine on a background of congestive cardiac failure, chronic renal failure, chronic obstructive pulmonary disease, bronchopneumonia, cerebrovascular disease and hyperkalaemia 4 CIRCUMSTANCES OF THE DEATH Marjorie Walker had a significant number of co-morbidities. She was on pain relief in the community including Fentanyl and liquid Morphine (for breakthrough pain). She had reacted poorly to an increase in opioid based pain relief in the community. She was admitted to Tameside General Hospital with a significantly raised INR. Whilst an inpatient she was prescribed Gabapentin 2020 she was transferred to the Stamford Unit. Whilst on the unit she had a series of falls. The second fall necessitated her going to the Emergency Department at Tameside General Hospital. Tests there indicated she had an acute kidney injury in addition to chronic kidney disease. She returned to the Stamford Unit and then back on 22nd May 2020 to Tameside General Hospital due to a further raised INR. The Gabapentin continued On 18th May 1 to be given at the previous dosage because it was not recognised by any of the treating clinicians or the hospital pharmacy review that it needed to be reduced because of her reduced kidney function. The increased risk of toxicity was not recognised. On 22nd May 2020 at the Stamford Unit her Fentanyl patch was changed to a Buprenorphine patch. Her Morphine Sulphate oral prescription was not changed to reflect the amendment in the amount of opioid being delivered through the patch. That she was on too high a dose was not recognised by the clinicians on the Stamford Unit, the clinicians on her return to Tameside General Hospital or at the hospital pharmacy review at Tameside General Hospital. Her raised potassium level on 26th May 2020 was not acted on for reasons that were unclear. On 27th May 2020 she was found unresponsive in her bed at Tameside General Hospital. CPR was not given because a DNA CPR was in place. The DNA CPR had not been completed in accordance with the Trust's protocol. Post Mortem examination included toxicology. The toxicologist found that Gabapentin was present at an above therapeutic level and at a level that is encountered in fatalities. Morphine and Buprenorphine that she was prescribed were also found. 5 CORONER’S CONCERNS During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths will occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows. – 1. The inquest heard evidence that despite the consequences for a patient of a DNA CPR it had not been completed in accordance with protocols. The inquest heard evidence that the importance of well documented and correctly completed paperwork in relation to DNA CPR was important in all cases but particularly in relation to vulnerable members of the community such as Mrs Walker; 2. Mrs Walker had lived with significant chronic pain for many years. Evidence was heard that she would have benefited from an appointment with a pain clinic for specialist input and the risks around pain medication could have been reduced with specialist input. The inquest heard that there were significant delays in accessing specialist pain clinics due to demand and capacity issues across the NHS; 3. Mrs Walker was prescribed Gabapentin as part of helping her to manage her chronic pain. The evidence was that the use of pain medication such as Gabapentin carried risk particularly in relation to a patient with underlying kidney issues. The inquest was told that a lack of understanding and recognition of monitoring kidney function including clearance results by health professionals including pharmacists and doctors alongside prescribing created a risk of overdose particularly of vulnerable patients. The inquest was told that the risk would be reduced by greater ease of access to results, more robust checking and education. 2 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe you have the power to take such action. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 10th August 2022. I, the coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the timetable for action. Otherwise you must explain why no action is proposed. 8 COPIES and PUBLICATION I have sent a copy of my report to the Chief Coroner and to the following on behalf of the family; Interested Persons namely 1) 2) Tameside General Hospital, who may find it useful or of interest. I am also under a duty to send the Chief Coroner a copy of your response. The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a copy of this report to any person who he believes may find it useful or of interest. You may make representations to me, the coroner, at the time of your response, about the release or the publication of your response by the Chief Coroner. 9 Alison Mutch OBE HM Senior Coroner 15.06.22 3
2 responses published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
From Neil O’Brien MP Parliamentary Under Secretary of State for Primary Care and Public Health 39 Victoria Street London SW1H 0EU Ms Alison Mutch Senior Coroner Manchester South 1 Mount Tabor Street Stockport SK1 3AG Dear Ms Mutch, 23 January 2023 Thank you for your letter of 15 June 2022 about the death of Mrs Marjorie Walker. I am replying as Minister with responsibility for Primary Care and Public Health at the Department of Health and Social Care. Firstly, I would like to offer my sincere condolences to the family of Mrs Walker. I was very saddened to read the circumstances of her death and I am grateful to you for bringing these matters to my attention. In preparing this response, Departmental officials have made enquiries with NHS England, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Care Quality Commission (CQC). Regarding your concern about significant delays to access specialist pain clinics, the pandemic has put enormous pressures on the NHS with elective waiting lists growing to over 7 million patients, but we remain committed to ensuring people get the right care at the right time. That is why we are delivering record staffing numbers, and putting in record levels of funding, to help the NHS recover and transform services. Having virtually met our target to eliminate long waits of two years or more for elective procedures in July 2022, our next ambition is to eliminate waits of eighteen months or more by April 2023. To support this elective recovery, the government plans to spend more than £8 billion from 2022- 23 to 2024-25, in addition to the £2 billion Elective Recovery Fund and £700 million Targeted Investment Fund already made available to systems last financial year, to help drive up and protect elective activity. Taken together, this funding could deliver the equivalent of around nine million more checks and procedures and will mean the NHS in England can aim to deliver around 30% more elective activity by 2024-25 than before the pandemic. A significant part of this funding will be invested in staff, both in terms of capacity and skills. However, the Department has also committed to a £5.9 billion investment in capital for new beds, equipment and technology. The Department will also continue to work closely with NHS England to deliver the ‘Delivery Plan for Tackling the COVID-19 Backlog of Elective Care’, providing the necessary support and challenge to make sure it benefits patients and delivers value for money. Turning specifically to pain clinics, it is within the remit of Integrated Care Boards (ICBs) to commission services within their geographical area and NHS England expects ICBs to commission appropriate services to meet the needs of the population they serve, including services that can support people with chronic pain. NHS England is only responsible for the commissioning of highly specialist pain services in line with a published service specification.1 There are currently eight adult NHS England specialist pain providers and access to these will depend on meeting the eligibility criteria. Your other concern addressed a lack of understanding and recognition of monitoring kidney function, including clearance of test results by pharmacists and doctors alongside prescribing, that created a risk of overdose particularly in vulnerable patients. You may wish to know that the NHS Medicines Safety Improvement Programme, which forms a key part of the NHS Patient Safety Strategy, has launched a focussed programme of work relating to the improved care of people with chronic pain and a reduction in the use of prescribed opioids.2 The programme has been in place since January 2021 and is supporting Integrated Care Systems to learn from, adapt and adopt effective practice using a whole-system improvement approach. As of 2022/23, 18 Integrated Care Systems are receiving intensive support to develop and implement improvements in care and a further 15 are participating in shared learning events. In addition, the National Overprescribing Review report evaluated the extent, causes and consequences of overprescribing and made 20 recommendations to address it.3 Led by NHS England, a cross-organisational implementation programme brings together lead organisations, along with partners from across the health system, to implement the review’s recommendations. The programme aims to achieve long term sustainable reductions to overprescribing via delivery of systemic and cultural improvements within the NHS. One of the key deliverables of the programme is a national resource to help practices improve the consistency of repeat prescribing processes and supported by appropriate training. Additionally, as part of the Dependence and Withdrawal Forming Prescribed Medicines Implementation programme, the National Institute for Health and care Excellence (NICE) has published guidance on Chronic pain assessment and management.4 Further to this, the MHRA monitors the safety of medicines and endeavours to ensure that up-to- date information on the benefits and risks of a medicine is available for healthcare professionals and patients. The Summary of Product Characteristics (SmPC) for a medicine provides information for healthcare professionals (HCPs) about the medicine, including warnings and precautions of use in higher risk situations. Gabapentin is a controlled medicine under the Misuse of Drugs Regulations 2012 and is regularly reviewed for signals of adverse effects to be included in the SmPC. The current SmPC for gabapentin contains detailed guidance on the administration of gabapentin in patients with compromised renal function and / or those on haemodialysis. The MHRA also published a Drug Safety Update article in 2019, concerning prescribing medicines in renal impairment.5 Also in 2019, the MHRA sought advice from the Opioids Expert Working Group (EWG) of the Commission on Human Medicines on the risks of dependence to opioids in the treatment of non- cancer pain. The review included an examination of worldwide clinical guidance on dose recommendations where risks exceed benefits, and the available evidence on conversion factors and calculations for the different opioids into morphine equivalent values. The EWG concluded that available values are not precise as they can be influenced by the individual patient past experience of opioid use as a patient can develop tolerance to their opioid medicine. The issue of tolerance has been reflected in the SmPC. The MHRA worked closely with the Faculty of Pain and the issues of tolerance and dose calculation has been highlighted in the Opioids Aware pages. 1 https://www.england.nhs.uk/publication/adult-highly-specialist-pain-management-services/ 2 https://www.england.nhs.uk/patient-safety/patient-safety-improvement-programmes/#MedSIP 3 https://www.gov.uk/government/publications/national-overprescribing-review-report 4 https://www.nice.org.uk/guidance/NG193 5 Drug Safety Update volume 13, issue 3: October 2019: 3. The British National Formulary and the Opioids Aware pages provide approximate conversion values to enable calculation of an appropriate dose to be used with a recommendation that a lower dose be used when switching between opioids. The MHRA also issued a Drug Safety Update article for pregabalin, which is similar to gabapentin in its mechanism of action and side effects. The article highlights a European review of all reports of severe respiratory depression thought to be associated with pregabalin alone. Therefore, healthcare professionals were advised to consider dose adjustments in patients at a higher risk of respiratory depression, such as those with compromised respiratory function or renal impairment.6 Finally, the MHRA continue to monitor the benefits and risks of gabapentin and opioid medicines and will take further prompt regulatory action when needed to ensure that product information is clear and consistent. I hope this response is helpful. Thank you for bringing these concerns to my attention. NEIL O'BRIEN 6 Drug Safety Update volume 14, issue 7: February 2021: 2
Date: 9th August 2022 Ms A Mutch HM Senior Coroner Coroner’s Court 1 Mount Tabor Street Stockport SK1 3AG Dear Ms Mutch Re: Regulation 28 Report to Prevent Future Deaths – Marjorie Walker 27/05/20 Thank you for your Regulation 28 Report dated 15/06/22 concerning the sad death of Marjorie Walker on 27/05/20. On behalf of NHS Greater Manchester Integrated Care (NHS GM), I would like to begin by offering our sincere condolences to Ms Walkers family for their loss. Thank you for highlighting your concerns during Ms Walkers Inquest which concluded on 3 March 2022. On behalf of NHS GM, I apologise that you have had to bring these matters of concern to our attention but it is also very important to ensure we make the necessary improvements to the quality and safety of future services. The inquest concluded that Marjorie’s death was a result of 1a) Combined effects of gabapentin, morphine, buprenorphine on a background of congestive cardiac failure, chronic renal failure, chronic obstructive pulmonary disease, bronchopneumonia, cerebrovascular disease and hyperkalaemia. Following the inquest, you raised concerns in your Regulation 28 Report to NHS GM that there is a risk future deaths will occur unless action is taken. I hope the response below demonstrates to you and Ms Walker’s family that NHS GM has taken the concerns you have raised seriously and will learn from this as a whole system. This letter addresses the issues that fall within the remit of NHSGM and how we can share the learning from this case. Completion of DNACPR documentation Following the trust’s own investigation, the findings were presented to the Surgical PASQAF and Grand Round. This is a learning forum attended by all clinical staff across all divisions of the organisation. Electronic white boards have been introduced in all patient areas which assist in improving oversight of patient needs, flow and bed capacity and highlighting concerns through a control centre. Patient safety information including falls risk, nutritional needs and medical conditions can also be highlighted using the boards. DNACPR status is included within the options available for staff. Using the DNACPR feature allows clinical teams to identify where one is in place or where one may be required. This is discussed within safety huddles in each clinical area at the start of each shift. These statuses can be updated at any time supporting early identification of patients admitted who may not have had such decisions made in the community, or whose condition may have changed necessi tating consideration of this. A trust-wide DNACPR audit took place in February and March 2022 with actions identified around 4th Floor, Piccadilly Place, Manchester M1 3BN Tel: 0161 6257791 www.gmintegratedcare.org.uk DNACPR discussion and completion of appropriate documentation. The findings were presented to the Trust Deteriorating Patient Group and Mortality Steering Group. A medical lead has been appointed to support the identified actions and strengthen the overall process. This has included reviewing the e - learning modules which support DNACPR training. This training will be made available to all medical staff and the specialist palliative care nursing team. Access to specialist pain clinics Provision of pain management services are within the standard contract. This is agreed at a national level with no specification for this area. A contracted plan is agreed at the start of each financial year to include activity for patients who require inpatient care, clinical interventions on a day case basis and specialist management and review in outpatient clinics. Patients who have two or more long term conditions (including COPD and heart failure), are eligible for referral to the Trust Extensive Care Team. This is a specialist team for patients with long term conditions focused on living independently, managing their condition to avoid hospital admission, which may have also identified that specialist advice relating to pain management may have been beneficial. Within Tameside there is a single commissioning function for health and social care. There are strong links between the five neighborhoods or primary care networks and the trust. The trust is currently discussing how best to share the learning from this inquest with GP partners, including facilitated discussion about best practice and available services. Understanding of risks associated with gabapentin usage In response to the missed opportunities to appreciate the dose of morphine and gabapentin in relation to the reduced kidney function, the trust completed a baseline analgesic dosing audit in 2021. A re -audit was undertaken following the introduction of new medication charts in December 2021. The audit was reviewed by the Medicines Safety Group and Pharmacy Governance and further learning identified and actioned. A Pharmacy Safe Bulletin has been distributed to Multidisciplinar y Teams. A presentation was also provided to the Trust wide Grand Round. Actions taken or being taken to share learning across Greater Manchester. 1. Learning to be presented/shared with the Greater Manchester System Quality Group. This meeting is attended by commissioners, including commissioners of specialist services, regulators, Healthwatch and NICE. 2. Shared learning from this and similar cases at Greater Manchester and borough level will be cascaded to professionals through relevant governance and learning forums. In conclusion, key learning points and recommendations will be monitored to ensure they are embedded within practice. NHS GM is committed to improving outcomes for the population of Greater Manchester. I hope this response demonstrates to you and Ms Walkers’ family that NHS GM has taken the concerns you have raised seriously and is committed to work together as a system including our service users, carers and families to improve the care provided. 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. 4th Floor, Piccadilly Place, Manchester M1 3BN Tel: 0161 6257791 www.gmintegratedcare.org.uk Yours sincerely Interim Chief Nurse GM Integrated Care 4th Floor, Piccadilly Place, Manchester M1 3BN Tel: 0161 6257791 www.gmintegratedcare.org.uk
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