William Green

Dear Coroner, Re: Regulation 28 Report to Prevent Future Deaths – William Stephen Green who died on 9 July 2023.

Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 28 February 2025 concerning the death of William Stephen Green on 9 July 2023. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to William’s family and loved ones. NHS England are keen to assure the family and the Coroner that the concerns raised about William’s care have been listened to and reflected upon.

Your Report raises the concern that there is no written record explaining or counselling patients on the side-effects, and what to do if side-effects are experienced, when a patient at The Royal Shrewsbury Hospital is initiated on a new prescribed drug during an admission. Your Report also raises that there is no provision in place for patients who lack capacity to understand an explanation of the side-effects of prescribed drugs, even when this may be offered. In William’s case, he was prescribed an anti-epileptic and seizure drug called Lamotrigine between 5 June 2023 and 8 July 2023.

My response to the Coroner has been aided by engagement with NHS England’s National Clinical Director for Prescribing and two experienced Clinical Pharmacologists.

When administering a new prescribed drug to patients, there should be shared decision-making and potential risks or complications relevant to the patient should be verbally discussed with them, even if very rare. The counselling of patients on their medications, including documenting a record of these discussions (or a lack of capacity to engage with such discussion) is a matter of professional duty and is described by both professional and organisational regulatory bodies. It is not standard practice in hospitals to document or record if a patient has been counselled about the risk of medicines, apart from in certain circumstances where consent is required (e.g., completing an Acknowledgement of Risk form for the prescription of isotretinoin) or to provide written information on the risk.

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

14 April 2025

However, NHS England will take your concern about counselling, and keeping a written record of such counselling, to an appropriate forum for further discussion and consideration of any actions we need to take.

It should also be noted that, on discharge from hospital, patients will be provided with the ‘original pack’ medication, and these will contain the Patient Information Leaflet (PIL) which outlines the risks and side-effects. In the case of Lamotrigine, the PIL states: ‘A small number of people taking Lamotrigine get an allergic reaction or potentially life- threatening skin reaction, which may develop into more serious problems if they are not treated. These can include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). You need to know the symptoms to look out for while you are taking Lamotrigine Tablets. This risk may be associated with a variant in genes in people from Asian origin (mainly Han Chinese and Thai). If you are of such origin and have been tested previously carrying this genetic variant (HLA-B* 1502), discuss this with your doctor before taking Lamotrigine Tablets.’ Your Report does not mention whether William was given the original pack medication on discharge from hospital.

Regarding the capacity of patients, there is clear NHS guidance on how to proceed with treatment when someone may lack capacity. There is also legislation (The Mental Capacity Act 2005), which provides a framework for decision-making on behalf of people who lack capacity. We would expect Trusts to have their own local policies on the administration of new medications, and most Trusts’ Medicine Policies will contain guidance on counselling patients. However, as above, they may not direct that this counselling needs to be recorded in the patient’s notes, as this is not standard practice.

NHS England has also engaged with NHS Shropshire, Telford and Wrekin Integrated Care Board (ICB), the responsible commissioner for services delivered by Shrewsbury and Telford Hospital NHS Trust, on the concerns raised in your Report. We are advised that the Trust have developed a Safety Improvement Plan, with actions including:

• A Working Group to review patient counselling and informed consent regarding medications being prescribed in hospital
• Learning from William’s case to be used to deliver training to junior doctors
• A new Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis (severe muco- cutaneous reactions usually caused by certain medicines) pathway to be developed and published within the Trust.

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 William, 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 Westman,

Thank you for your letter dated 28th February 2025 issued under Regulation 28: Report to prevent future deaths, in relation to the risks you identified through the inquest examining the death of the late William Stephen Green. I write to provide details of the steps that we have taken and plan to address the issues highlighted in your letter.
1. Once any patient at The Royal Shrewsbury Hospital is initiated on a new prescribed drug during an admission, no written record is ever made anywhere by anyone including pharmacy; nurses; doctors or consultants explaining or counselling the patient upon the possible side-effects or complications as a result of taking a specific prescribed drug; nor is there any written record on what to look out for and what to do in such circumstances and where they can get assistance.
2. No provision seems to be in place to record what should happen when the patient lacks capacity to understand such an explanation even when it is offered.

Record of counselling The counselling of a patient in hospital should be undertaken by the medical staff on prescribing the medication, by the nursing staff and pharmacy staff in preparation for discharge. All professions have a role in drug counselling, our pharmacists are the specialists in medication and counselling and have access to additional resources and referral services. Pharmacy led counselling/documentation:
• The current medication counselling standard operating procedure (SOP) only requests a memo is entered into the eScript software (the pharmacy drug management system) if there is concern a patient does not fully understand the explanation of the new medication. This SOP is being updated to require all counselling episodes to be documented. This will be fully implemented by the end of May 2025.
• A referral to the community-based support services (see below) will also require documented evidence on eScript.

Mr Heath Westerman, Assistant Coroner HM Coroners Service Shirehall Abbey Foregate Shrewsbury Shropshire SY2 6ND

• A new patient medication leaflet has been designed and is being introduced to help provide further patient information. This leaflet will signpost patients to the NHS drug information website that has patient directed information on many of the drugs prescribed, including specific information on high-risk drugs and immediate actions to take for serious side-effects. This leaflet will be available by September 2025; it has been drafted and is currently being taken through the trust accessibility and governance processes. o The community services outlined below will supplement the patient information leaflet for those patients where the leaflet is not adequate.

Nurse led counselling:
• The nursing staff have a role in providing information especially around the time of discharge. The printed discharge summaries will be adapted with the NHS drug website highlighted to aid this counselling process.
• When a patient is discharged from a non-inpatient area, the patient information leaflet will be available to give to patients as they are counselled.

Informed consent/counselling when prescribing a new medication: Treating clinicians have a duty and responsibility to ensure patients are aware of any material risk associated with planned treatment, this includes significant side effects of medication.
• All senior doctors have statutory training which include safe prescribing. This case will be incorporated into this training as a learning example, highlighting the importance of adequate counselling, the importance of documenting the process and reminding them of the support available for patients who may not immediately understand. The training is delivered by the trust pharmacists.

Ongoing support and counselling Not all patients may be able to fully understand and comprehend the new medications started in hospital for a variety of reasons. It is also recognised that some medications are high risk, they have potentially serious implications of not complying with the medication or have potentially serious complications (anti-epilepsy medication is included in this list). Once a patient has been discharged from hospital, there are two Integrated Care System (ICS) led services that patients can be referred to for ongoing support and monitoring. The Discharge Medication Service (DMS) and the Structured Medication Review (SMR) service. The DMS is a service where patients identified in the acute care setting who require additional support in relation to their medication management can be referred by the pharmacy team. The hospital ward staff, doctors or nurses can highlight patients of concern to pharmacy to trigger a referral. The general referral criteria are: Admitted patients only, patients initiated on a high-risk medication or patients who have been identified with compliance concerns. The referral is directed to the patients nominated community pharmacist who will provide counselling and additional support in a less stressful environment.

The SMR is a service where referral is to the GP or the PCN pharmacist for a full medication review. This service is to review patient compliance and provide further information/education and counselling. There will also be a review of all the medications to ensure they are appropriate and optimised. The pharmacy team at SaTH would initiate a referral to this service. Following the death of Mr Green and as a result of the internal investigation, a multi-disciplinary working group has been set up to address the concerns raised and ensure appropriate actions are developed, implemented and embedded in future care. Thank you for bringing your concerns to my attention. I hope that you are assured that I have taken them seriously, investigated then appropriately and we are putting in place systems and processes to reduce future harm. If I can provide any further information, please do not hesitate to contact me at the above address.