Dear Mr Nieto, Prevention of Future Deaths Report concerning Mrs Margaret Feeney. I write as the Senior Partner at Macklin Street Surgery further to the Inquest into the death of Mrs Feeney that took place on 11 November 2024 and following receipt of your Prevention of Future Deaths Report dated 25 November 2024. You have raised concerns as to the issuing of prescriptions around bank holidays for patients who have been placed on shorter repeat prescription periods with the aim of reducing the risk of overdose. A large number of the patients at the surgery who have been placed on shorter repeat prescriptions are given 7-day prescriptions. This means that they will only be given 7 days’ worth of medication for each prescription. Historically, those prescriptions were issued and sent to a patient’s chosen pharmacy to dispense on a Monday. This was the case with Mrs Feeney. A smaller number of patients are likely to opt to collect a paper copy of their prescription from the surgery to take to their chosen pharmacy. However, as identified this means that when a bank holiday falls on a Monday, the prescription has to be issued on the immediately preceding working day so that patients are still able to access their medication. Usually this would be a Friday but in Mrs Feeney’s case, because of the Easter weekend (and the Friday also being a bank holiday), the prescription was brought forwards to the Thursday. Whilst the surgery could facilitate the issuing of prescriptions on a bank holiday as these could be future-dated, pharmacies are not routinely open on a bank holiday. As such, if the day for the 7-day prescriptions was not moved when a bank holiday arose on a Monday, patients would be unable to access their medication, which could have significant and life-threatening consequences. A number of the patients who are on 7-day prescriptions are receiving such prescriptions for opiate drugs and/or benzodiazepines. If a patient being prescribed these drugs is unable to access a prescription due to a bank holiday and therefore suddenly stops taking this medication, they may suffer acute withdrawal symptoms. The consequences of this can be severe and so the risk of this has to be balanced against the risks associated with a patient

2 having access to an additional few days of medication. Whilst some pharmacies may be open on a bank holiday, it is our experience that the majority are not and which pharmacy is open may differ between the bank holidays. Patients are free to choose which pharmacy they would like their prescriptions to be sent to and so prescriptions from the surgery will be sent to various pharmacies in the area depending on the particular patient’s preference. Having looked into whether there are any pharmacies that are routinely open on bank holidays, I have located one in the area within a supermarket but it does not appear it is open on Christmas Day and it would not be conveniently located for a number of our patients. It would not be possible for the surgery to require patients on 7-day prescriptions to elect to use that pharmacy. In light of Mrs Feeney’s death, the practice conducted a significant event analysis on 8 August 2024 and a copy of that report has been shared with you previously. As part of that review, it was identified that a way of minimising the need to bring forward 7-day prescriptions prior to bank holidays (and therefore reduce the risks associated with patients having additional medication) was to move the day on which 7-day prescriptions were issued. We initially considered changing the issuing day to a Wednesday but we have since decided to move the day of issue to a Tuesday. The surgery has now identified all patients who are on short-term prescriptions (which we have defined as having a prescribing period of 14 days or less) and the prescription day for all of these patients has been moved to a Tuesday. Patients and pharmacies have been advised. An alert has also been placed in the patients' notes. We are implementing a rolling alert so that a clinician will be alerted if a patient moves onto short-term prescriptions in the future. The surgery is currently in the process of ensuring that the notes of all of the patients who have been identified as being on short-term prescriptions are reviewed by a clinician to assess whether each patient is at high or low risk. However, risk is broader than risk of overuse / overdose. Risk includes risk of medication harm, (that is to say, some drugs would present a greater risk of harm than others if overused or taken in overdose). Therefore, a clinician will determine whether a patient is at high or low risk of harm if the patient takes more than their prescribed dose. This will be reviewed at the annual medication review. Now that all short-term prescriptions have been moved to a Tuesday, the issue of having to alter prescription processes will only arise on the years when Christmas Day, Boxing Day or New Year’s Day fall on a Tuesday. If Christmas Day, Boxing Day or New Year’s Day fall on a Tuesday, the prescriptions for those patients who have been identified by a clinician as being at high risk will be split i.e. the prescription week will be divided so that those patients will receive two shorter prescriptions to cover them for the bank holiday. How the prescription will be split will depend on how the bank holiday falls but could take a 3:4 day format thus minimising the risks as far as possible. Unfortunately, it is not possible for the surgery to mitigate risk entirely because of the fact that pharmacies are not routinely open 7 days a week including on all bank holidays and because patients, understandably, have the freedom to choose which pharmacy they would like their prescriptions sent to. As you have identified, this is not an issue that is likely limited to Macklin Street Surgery but is one that is likely to affect all GP surgeries across the country. It should also be appreciated that there are some technical constraints to the digital records system the practice uses (SystmOne) and the reports it is able to generate. This includes clinicians not being able to generate data regarding the total quantity of medication prescribed (tablet strength x quantity of tablets) without extracting data into an exported spreadsheet and SystmOne not being able to report on the duration of prescriptions. Rectification of this is something that would need to be addressed at a national level with the system supplier and NHS Digital.

3 The policy will be included in induction and locum packs. Training will be offered at induction for reception staff / new GPs / locums / GP registrars. The prescribing team will maintain a log of staff trained. The surgery will write to the Integrated Care Board seeking advice on how we use the ICB system's central clinical pharmacy / medicines management expertise to assist practices with the management of high-risk patients. We will liaise with the Integrated Care Board to determine how our learning from this experience could be shared with other local GP surgeries to assist them in improving their processes around short-term prescribing. We will also highlight to the ICB any potential national level digital constraints. I hope that the above clarifies the situation, reassures you that the surgery has taken this matter seriously and that we are doing everything we can to reduce this risk within the limitations of which we much necessarily work.

Dear Mr Nieto, Thank you for the Regulation 28 report of 25th November 2024 sent to the Secretary of State for Health and Social Care about the death of Margaret Mary Feeney. I am replying as the Minister with responsibility for medicine regulation and prescribing. Firstly, I would like to say how saddened I was to read of the circumstances of Margaret Mary Feeney’s death and may 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. Thank you also for the additional time given to the Department to respond to the concerns raised in your report. The report raises the following concerns:
• measures were/are not in place at Macklin Street Surgery and Daynight pharmacy in Derby to prevent prescription of excess medication to patients recognised to be at risk of overdose, either intentional or unintentional, who are ordinarily issued shorter period repeat prescriptions to reduce those risks;
• this situation arose/arises when early prescriptions are issued due to statutory holiday periods when most pharmacies are likely to be closed;
• there were/are no procedures in place relating to longer bank holiday periods (e.g. Easter) and;
• ineffective utilisation of electronic patient record and data systems

I note that Derby and Derbyshire Integrated Care Board (ICB), Macklin Street Surgery and Daynight pharmacy are also recipients of this report and will be providing their own response to your report. You outlined in your report that Ms Feeney had a long history of being prescribed benzodiazepines and codeine and had become dependent on them. It is important to note that the decision to prescribe a particular drug is a clinical one and should be based on the patient’s medical needs. Decisions about what medicines to prescribe are made by the doctor or healthcare professional responsible for that part of the patient’s care and

prescribers are accountable for their prescribing decisions, both professionally and to their service commissioners. Clinicians should work with their patient and decide on the best course of treatment, with the provision of the most clinically appropriate care for the individual always being the primary consideration. Clinicians must take into account best prescribing practice and the local commissioning decisions of their respective integrated care boards (ICBs) as well as appropriate national guidance on clinical and cost effectiveness. Pharmacists are also expected to use their judgement to make sure that any prescription they dispense is clinically appropriate. The pharmacist may decide to delay dispensing pending further consultation with the patient and/or prescriber where concerns arise.

The General Medical Council (GMC) is the regulator of all medical doctors, anaesthesia associates (AAs) and physician associates (PAs) practising in the UK. It sets and enforces the standards all doctors, AAs and PAs must adhere to. The GMC has published guidelines on good practice in proposing, prescribing, providing and managing medicines and devices. GMC guidance states that when prescribing controlled drugs and other medicines where additional safeguards are needed, doctors should propose, prescribe or provide a limited quantity and dose – one that is sufficient to make sure the patient receives suitable care until a) they are able to see an appropriate health professional who has access to the relevant information from their medical records or b) the doctor is able to verify that information themselves.

At a national level NHS England has a clear responsibility in providing systems oversight for the management and use of controlled drugs, including benzodiazepines and opioids. NHS England’s Controlled Drugs Accountable Officers (CDAOs)1 undertake this role within each geographical region across England. They provide assurance that all healthcare organisations, including 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 Clinical Commissioning Groups 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 CQC: www.cqc.org.uk/content/controlled-drugs-accountable- officers.

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’. The 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 benzodiazepines and opioids by:
• Optimising personalised care for adults prescribed medicines associated with dependence or withdrawal symptoms.

1 https://www.england.nhs.uk/contact-us/privacy-notice/how-we-use-your- information/safety-and-quality/controlled-drugs-accountable-officer-alerts-etc/

• 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. As you may be aware, the National Institute for Health and Care Excellence (NICE) is the independent body responsible for translating evidence into authoritative evidence-based guidance for the health and care system on best practice to drive improved outcomes for patients. Guidelines describe best practice and NHS organisations are expected to take them fully into account in designing services that meet the needs of their local populations. NICE has published guidelines on:
• 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. The National overprescribing review report was published in Sept 2021, 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. You may find it helpful to know that a number of interventions are being delivered by NHS England to address and reduce overprescribing including: o 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 are encouraged to select opportunities for delivery. o Support for delivering Structured Medication Reviews (SMR), including:
• NHSE contract for Primary Care Networks specifies use of SMRs for high-risk groups of patients. It also specifies using medicines optimisation strategies for reducing polypharmacy, minimising risk of prescribing harm, reducing overprescribing and managing the risk of dependency on prescription drugs.
• Funding of Clinical Pharmacists through the Additional Roles Reimbursement Scheme (ARRS). to support the primary care team with medicines optimisation and carry out SMRs. 
• Further NHSE guidance advising that high-risk groups should be prioritised for SMRs, including those on prescribed medicines that may cause dependence and withdrawal.

• Training and education for prescribers to help build GP and prescribing health care professionals' confidence in, and understanding of, the complex issues surrounding stopping inappropriate medicines safely.
• Patient facing materials to help patients and carers prepare for an SMR. o 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. o Publication of the RPS and RCGP Repeat prescribing toolkit, commissioned by NHSE to improve repeat prescribing processes. o Publication of the Oversupply Dashboard to support general practice and primary care networks identify oversupply and target improvements. 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 2022/23 18 Integrated Care Systems received intensive support to develop and implement improvements in care and a further 15 are participating 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. I hope this response is helpful. Thank you for bringing these concerns to my attention.

Regulation 28 Report to Prevent Future Deaths Derby and Derbyshire Integrated Care Board Response Derby and Derbyshire Integrated Care Board (DDICB) would like to extend our sympathies to the family and friends of Margaret Feeney. Please find below the ICBs response and future plans in regard to the Regulation 28 Report to Prevent Future Deaths. If there are any areas which you feel you would like more information or to discuss in person this will be arranged. On 11 April 2024 the coroner commenced an investigation into the death of Margaret Mary Feeney aged 78. The investigation concluded at the end of the inquest on 11 November
2024. The conclusion of the inquest was that: – Margaret died due to taking excess prescribed medication which she had become dependent on and addicted to. She had access to excess medication because of medical prescribing decisions and arrangements leading up to a bank holiday period. Margaret was found deceased at her home address on 1 April 2024 by her friend and cleaner. She had last been spoken to in a telephone call on 30 March 2024. Post-mortem examination with toxicology identified the medical cause of Margaret’s death as the combined toxic effects of prescribed medication which she had taken in excess. She was also identified to have pneumonia which contributed to her death. A high total morphine level suggests the potential additional taking of a morphine-based substance. Margaret had a long history of being prescribed benzodiazepines and codeine, the latter medication for pain for diagnosed conditions. Unfortunately Margaret had become dependent on those medications and was recognised to overuse them. As a consequence, she was given seven-day prescriptions. On 26 March Margaret’s friend was concerned that Margaret was confused, and the friend and Margaret attended a GP appointment that afternoon. The GP wanted to reduce Margaret’s diazepam and issued a prescription for a lower dose in a daily dose blister pack. The codeine prescription was not altered. The new diazepam prescription was with Margaret on 27 March. This was the week prior to the Easter holiday period. Margaret had received her usual Monday prescription (25 March) including diazepam and codeine. With the new diazepam prescription received on 27 March Margaret had an excess of five days of that drug. Because of the pending bank holiday Margaret received an early prescription of codeine on 28th March, which meant she had four days excess codeine. Clearly, given her recognised dependence and overuse, there was a real and foreseeable risk that Margaret would take excess diazepam and codeine that was available to her between 27 March and her death. In addition to the toxicological evidence, when she was found deceased there were empty or near empty blister packs from the excess medication prescribed to her. On the evidence there is no reason to consider that Margaret had deliberately taken the excess medication to cause her own death.

The following report and action plan is in response to the matters of concern revealed through the course of the inquest as below. The concerns have been reviewed with actions to prevent future deaths captured in the action plan at the end of the report. This will be reviewed as per the timescales included within the report. Coroner concerns I am concerned that measures are not in place at Macklin Street Surgery and Daynight pharmacy to prevent prescription of excess medication to patient’s recognised to be at risk of overdose, either intentional or unintentional, who are ordinarily issued shorter period repeat prescriptions to reduce those risks. This situation arises when early prescriptions are issued due to statutory holiday periods when most pharmacies are likely to be closed. I have been informed that measures have been introduced to prevent excess prescribing by taking account of single day bank holidays, but there are no measures relating to longer bank holiday periods (e.g. Easter). With electronic patient record and data systems it seems a reasonable presumption that suitable solutions can be identified. As I imagine that the substance of my concern is likely to apply to other GP practices and pharmacies, I have also sent this report to the Department of Health and Social Care and NHS Derby and Derbyshire Integrated Care Board. Derby and Derbyshire ICB Response Having reviewed your report and the outlined circumstances, DDICB recognises the serious implications of the matters raised. Addressing the concerns you have highlighted is a priority for the ICB, and are committed to taking steps to minimise the risk of similar incidents in the future. Good Practice Effective management of at-risk patients is critical to preventing harm and improving outcomes. In this case, several good practices were evident and should be acknowledged as part of the ongoing commitment to patient safety. These measures provide a foundation for further improvements and system-wide learning.  The patient was appropriately identified as having a dependence on certain medications and was managed with: o Weekly prescriptions to minimise the risk of overdose. o A prompt review by a prescriber immediately after side effects (confusion) were reported.  We have reached out to Macklin Street Surgery to support any actions they identify. Our aim is to share learning across the system to enable the scaling of improvements. Although we have not yet received the investigation summary, our offer of support has been acknowledged, and we await their response after their coroner's response is finalised. Additionally, due to the nature of the medications, the ICB has engaged with the NHS England - Midlands Controlled Drugs Area Team who have volunteered to liaise with the Community Pharmacy and to share their response when available.

Resources A range of resources are available to support healthcare providers in managing high-risk medications and ensuring safe prescribing practices. These tools and initiatives aim to equip teams with the knowledge and frameworks needed to reduce harm and improve patient outcomes, particularly in cases of opioid stewardship and medication dependency.  Opioid Change Management Programme: A collaborative project between Joined Up Care Derbyshire and Health Innovation East Midlands, providing tools for opioid stewardship: o Quality Improvement Toolkit: A resource for practices to implement opioid prescribing quality improvements, aligned with the National Medicines Safety Improvement Programme. o Minimum Standards for Opioids Repeat Prescribing: Guidelines for practices to develop robust repeat prescribing processes while maintaining safety and quality standards. o Opioid Tapering Resource: A concise guide to support opioid reduction efforts.  Clinical System Searches: Tools available across all utilised GP systems to assist in identifying at-risk patients and supporting optimised management. Process Updates Ensuring that robust and flexible processes are in place is essential to managing atypical situations, such as those arising during extended bank holiday periods and when there is a change in prescribed medicines required (such as this case with identified side effects). Process improvements should prioritise patient safety while minimising disruptions to established routines. Outlined are proposed updates that are to be shared with all GP practices to enhance continuity of care and safeguard against future risks.  Prescription Scheduling Adjustments: o Practices to change processes for prescription collection dates for patients with regular collection schedules to mid-week (e.g., Wednesday) to avoid clashes with bank holidays and minimise re-scheduling to manage prescription collections during extended bank holiday periods.  Consider Patient-Specific Needs: o Patients with more frequent collection schedules (e.g., twice weekly) should have these routines considered during changes to prescription dates or new patient management plans. o Interim or one-off acute prescriptions must also account for existing schedules to avoid overlaps or gaps.  Acknowledge Atypical Prescribing Situations: o Assess patient routines and the potential impacts of changes to prevent adverse effects, particularly on vulnerable individuals.

Utilisation of NHS EPS (electronic prescribing system) prescriptions Clinical systems are integral to supporting safe prescribing practices and ensuring clear communication between healthcare providers. Leveraging available system functionalities can enhance the management of high-risk medications and prevent issues arising from unconventional prescribing scenarios. One key functionality within the NHS Electronic Prescribing System (EPS) is the ability to post-date and schedule prescriptions to download only on specified dates. This feature reduces the likelihood of prescriptions being dispensed ahead of time, particularly during extended bank holiday periods, where excess medication might otherwise be provided inadvertently. These prescriptions can also be cancelled ahead of time to prevent inadvertent dispensing – useful in the event of medication changes. We recommend promoting the use of this feature across all practices as part of a broader effort to strengthen the scheduled prescription process. Sharing this learning with system users can help make prescription management more robust and prevent potential medication-related risks. Communication of changes / updates  Communication with Providers: o Notify community pharmacy immediately of medication changes, especially for high-risk patients or medications with significant harm potential. o Establish clear dialogue during consultations to align on prescription collection schedules and current patient stocks.  Patient and Caregiver Engagement: o Clearly communicate any changes to medication or collection schedules to the patient and/or their caregiver to ensure understanding and avoid inappropriate use.  Shared Care Records: o Ensure shared care records are updated promptly to reflect any changes in patient management. Clinical system updates We acknowledge that updates to provider clinical systems could play a crucial role in addressing the issues identified. However, given the operational and developmental oversight of these systems lies with their respective clinical system providers, we believe they are best positioned to evaluate and enact the necessary changes. As these changes are likely to involve system-wide implications and require alignment with broader national or regional policies. We will share our learning and concerns with clinical system providers with a request to consider and implement solutions that may prevent further occurrences. It may be most effective if the coroner were to also engage directly with the clinical system providers. This direct communication would allow the coroner to convey their concerns comprehensively and advocate for updates grounded in the findings of this case, ensuring a coordinated and impactful response. Learning to Be Shared Across the System Sharing the lessons learned from this case with stakeholders across the healthcare system is essential to fostering a culture of continuous improvement. By disseminating

these insights and recommendations, we can ensure that the entire system benefits and that similar incidents are less likely to occur in the future.  Identify At-Risk Patients: o Proactively flag and monitor patients vulnerable to medication dependency or overdose risks.  Strengthen Provider Communication: o Ensure timely updates between healthcare providers, particularly around patient management changes.  Assess Bank Holiday Arrangements: o Recognise and plan for bank holiday disruptions well in advance to mitigate risks.  Consider EPS prescriptions (post dated) o This would reduce the likelihood of prescriptions being issued ahead of time To ensure system wide uptake and action, the ICB will ensure engagement and cascade through the following channels;
- Community Pharmacy Derbyshire Newsletter
- GP Key messages delivered to practices by the ICB Pharmacy Directorate team
- ICB Pharmacy Directorate Team Medicines safety messages shared with practices
- Prescribing Leads Forums Please see below a timeline of proposed actions Action number Overview of DDICB actions Proposed completion date INVESTIGATION AND SUPPORT 1a Review investigation and lessons learnt/ actions identified by the practice. With support of the ICB primary care quality team and ICB patient safety team, identify support required 7/2/25 1b Review investigation and lessons learnt/ actions at community pharmacy. With support of Midlands controlled drugs area team and primary care commissioning team, identify support required. 7/2/25 REVIEW AND COMMUNICATIONS 2a Extract shared learning from the practice and community pharmacy reports and add lessons to be shared additionally to those raised above, into an incident report, ready to be shared with system colleagues. Learning report ratified 14/2/25

through existing governance routes 2b Collated learning to be shared through existing communications as identified above. Following Derbyshire Prescribing Group (DPG) 6/3/25. 2c At the Clinical Governance Leads meeting with general practice the Learning report will be discussed as part of the Patient safety standard agenda item. Following Derbyshire Prescribing Group (DPG) 6/3/25.