Dear Sir response to the Regulation 28 Report to Prevent Future Deaths Inquest touching upon the death of Mrs Amanda Kramer I write with reference to your Regulation 28 Report to Prevent Future Deaths, dated 11 September 2023, issued further to the Inquest touching upon the death of Mrs Amanda Kramer (‘the Regulation 28 Report’). On behalf of the Practice (‘the Practice’), I would like to extend my deepest condolences to Mrs Kramer’s family. I would like to reassure them that the Practice has taken the Coroner’s findings seriously and has taken steps to address any deficiencies, which are set out in this response. The Coroner’s concerns ‘1. Zopiclone is a drug licenced for the treatment of short-term insomnia. The risks associated with the drug are first, that it is a central nervous system depressant and second, that patients prescribed the drug can form a dependency upon it.
2. Mrs Kramer was prescribed Zopiclone for 18 years.
3. Despite the deceased being under the care of both a GP and a secondary care mental health trust prior to her death. No clear evidence emerged in this inquest that

anyone had reviewed Mrs Kramer’s use of this drug even when Mrs Kramer has demonstrated a pattern of high-risk behaviour by deliberately overdoing on prescribed medication.’ The Practice’s response To address the Coroner’s concerns, the Practice has taken the following steps:
1. All patients being prescribed with Zopiclone or Zolpidem have been identified via an audit, enclosed with this response as Exhibit 1; the Practice is in the process of reviewing their medication – the progress of this can be demonstrated in the re-audit, undertaken in October 2023 (Exhibit 2). The goal is for each patient to have a plan in place to reduce and eventually stop the medication or change it to a safer alternative. Notification letters of these actions and patient leaflets will be sent to all patients on Zopiclone and Zolpidem. The completed plans have been coded onto the patients’ notes on the EMIS computer system for both healthcare professionals and administrators to be aware of the care plan and not deviate from it. Patient alert system notification has also been put in place for all these patients as an identification for other healthcare providers both in the out of hours service and hospital trusts.
2. Where possible, all patients on Zopiclone or Zolpidem will have a medication review every 4 weeks; such review will focus on reducing the regimen of their medication, depending on withdrawal symptoms, level of risk and support structure.
3. All prescriptions of Zopiclone and Zolpidem have been reviewed to ensure they are acute, rather than repeat prescriptions; this will be a policy for new requests as well. This will also provide opportunities for more frequent reviews and discussion on how the withdrawal plan is being achieved with the patient. All quantities on prescription are reduced to a maximum 2-week supply.
4. The dosage instructions now state on the prescription that the medication is to be used on a ‘as required’ basis, not regularly; and to reduce the dosage down and stop when appropriate, so to remind the patient and the community pharmacist of the withdrawal plan. All local community pharmacists have been informed of the Practice’s plan and the shared goal of reducing these prescriptions and to work with the Practice to achieve it.
5. For the patients who are under a shared care arrangement, the Practice will implement a joint care policy with their secondary care provider.

6. The Practice has prepared a new policy for prescribing Zopiclone and Zolpidem under shared care arrangements – this is enclosed with this response as Exhibit 3. The audit (Exhibit 1) and re-audit (Exhibit 2) demonstrate that these changes have been already implemented at the Practice; a total of 69 patients on either Zopiclone or Zolpidem have had their medications stopped as of 19 October 2023, the date the re-audit was completed, compared to 18 patients who were stopped following the first audit in March
2023. I trust that that this response provides reassurance that the Practice has taken action to address the matters raised by the Coroner. Should any further information be required, please do not hesitate to contact me.

Dear Sir Re: Inquest touching upon the death of Amanda Kramer I refer to your Regulation 28 report, dated 11 September 2023, detailing your concerns about the risk of future deaths in light of the findings of this Inquest. I should like to extend my sincere condolences to the family of Mrs Amanda Kramer. This must have been an extremely difficult time and I hope that my response provides them, and you, with assurances that the North East London Foundation Trust (NELFT) is taking action to address the issues set out in your report. I note that your concerns are as follows:
1. Zopiclone is a drug licenced for the treatment of short-term insomnia. The risks associated with the drug are first, that it is a central nervous system depressant and second, that patients prescribed the drug can form a dependency upon it.
2. Service user was prescribed Zopiclone for 18 Years.
3. Despite the deceased being under the care of both a GP and a secondary mental health Trust prior to her death. No clear evidence emerged in this inquest that anyone had reviewed Service user’s use of this drug even when Service user had demonstrated a pattern of high-risk behaviour by deliberately overdosing on prescribed medication.

Following the sad passing of Mrs Amanda Kramer, a number of changes have been implemented. These include:
1. Patients who are initiated on Zopiclone now have a medical review of this medication within at least 2 weeks of the initial prescription date recorded in their care plan, whilst existing patients are being identified and reviewed. Senior clinical oversight has also been put in place to support this review for all patients prescribed this medication. The Trust has also put in place a 6 monthly audit process of this to help support this improvement in practice. The last of these audits was undertaken in October 2023, identifying one patient where a review was required, but that all other reviews had taken place. In circumstances where prescriptions remain in place for longer periods of time, the risks and rationale for this are discussed with patients and medical and care co-ordinator staff are keeping this under careful review. In support of this work, staff have received training on the safe prescribing and management of Z-drugs and Benzodiazepines and this is being arranged on a repeat basis, with the next session taking place on 29 November 2023.
2. A workstream has been established across the primary and secondary care partners in the North East London Integrated Care System. This is overseeing improvements to the co-ordination of medication monitoring for patients receiving Benzodiazepines and Z-Drugs, including significant work on the co-ordination of information between primary and secondary care to ensure that accurate information is in place to enable the effective review and monitoring of patients who have been prescribed such medication.
3. The Trust has also worked with staff to ensure that there is effective handover of information between teams so that responsibilities are clear. In particular, there has been a focus on ensuring comprehensive documentation of patient information at the point of handover from one team to another. The effectiveness of this is being audited, and in the most recent audit undertaken (a random sample of 20 patients), all records were clear and reflected a comprehensive handover of the care plan and responsibilities for different professionals involved. This includes situations in which prescribing is taking place within primary care.
4. Staffing in Crisis and Home Treatment teams has been increased, with the addition of extra pharmacist posts. This will enable improved medicine reconciliation at the point of discharge from hospital, and ensure that prescriptions for Zopiclone amongst other medication are effectively monitored and reconciled throughout the patient’s journey. This increased capacity will also give more pharmacy support to work with individual patients at this point of transfer and transition, including work on medication education for both patients and prescribers that will help to address risks associated with these medications. If I can be of any further assistance or if you would like a further update on the progress made to address your concerns, I would be happy to provide a further update.

Dear Mr Irvine,

Thank you for the Regulation 28 report to prevent future deaths of 11 September about the death of Mrs Amanda Jane Kramer. I am replying as Minister with responsibility for prescribing.

Firstly, I would like to say how saddened I was to read of the circumstances of Mrs Kramer’s death and I offer my sincere condolences to her family and loved ones. The circumstances your report describes are concerning and I am grateful to you for bringing these matters to my attention. Please also accept my sincere apologies for the significant delay in responding to this matter.

The report raises the following concerns:
• Zoplicone is a drug licensed for the treatment of short-term insomnia. The risks associated with the drug are first, that it is a central nervous system depressant and second that patients prescribed the drug can form a dependency upon it;
• Mrs Kramer was prescribed Zoplicone continuously for approximately 18 years;
• Despite the deceased being under the care of both a GP and a secondary mental health trust prior to her death, no clear evidence emerged in the inquest that anyone had reviewed Mrs Kramer’s use of this drug even when she had demonstrated a pattern of high- risk behaviour by deliberately overdosing on prescribed medication.

As I am sure you will be aware, GPs and other prescribers are ultimately responsible for their own prescribing decisions. The decision to prescribe a particular product is a clinical one and should be based on the patient’s medical needs. The process of reviewing medication is one in which the GP or responsible clinician work together

with the patient. It is for the GP or other responsible clinician to discuss with their patient to decide on the most appropriate course of treatment. Where primary and secondary care are working together with one of their patients on a shared care basis, there needs to be clear lines of communication.

NHS England is working to support prescribers in managing repeat prescribing generally and in particular where patients are taking medicines which can cause dependence. As part of their work in response to the recommendations in the report from the then Chief Pharmaceutical Officer for England, “Good for you, good for us, good for everybody: a plan to reduce overprescribing to make patient care better and safer, support the NHS, and reduce carbon emissions” the Royal Pharmaceutical Society has been commissioned to provide a repeat prescribing toolkit. In addition, in March 2023, an action plan was published to help local health care providers to reduce inappropriate prescribing of high strength painkillers and other addiction causing medicines.

prescribed-medicines-associated-with-dependence-or-withdrawal-symptoms/ I am pleased therefore to note that the concerns you have raised have been addressed or are in the process of being implemented following responses by Wood Street Health Centre’s letter to you dated 6 November 2023) and from North East London NHS Foundation Trust’s letter to you dated 20 November 2023.

I hope this response is helpful. Thank you for bringing these concerns to my attention.

Best wishes,

THE RT HON DAME ANDREA LEADSOM DBE MP