Dear Mr Nieto, Re: Regulation 28 Prevention of Future Deaths Report in respect of Aaron Atkinson I write in response to your regulation 28 report dated 30 June 2025 regarding the sad death of Aaron Atkinson. I would like to express my sincere condolences to Mr Atkinson’s family. We have reflected on the circumstances surrounding Mr Atkinson’s death and the concerns raised in your report. We note your concerns about the clarity and consistency for annual reviews to include ECGs where people are prescribed antipsychotic medication long term. Following receipt of your report, senior clinical advisors within the patient safety team here at NICE have reviewed the concerns raised, they have outlined the following. The link included in the report is to the Clinical Knowledge Summaries (CKS) prescribing information on antipsychotics: bipolar disorder - prescribing information - antipsychotics . It is important to note that this is not NICE guidance. The CKS are developed by an external company called Agilio Software and are designed to summarise the evidence on the treatment of specific health conditions. They use a variety of sources and may include NICE guidance, if there is any that is relevant, but they use many other sources too. We publish them on our website as a source of advice and information for health professionals working in primary care, but as noted above, they do not constitute NICE guidance. The CKS says (about antipsychotics generally): Regular monitoring may subsequently be done in primary care on specialist advice or depending on the person's care plan. This may include:
• Electrocardiography (ECG) - after dose changes. Ideally, also annually. o Mandatory for haloperidol, pimozide, and sertindole; not required for antipsychotics with no effect, or a low-to-moderate effect on the QT interval and where there are no other risk factors for arrhythmia.

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As part of this process, we have shared this report with Agilio Software for their awareness. The publishers of the CKS referred to have outlined that the recommendation on ECGs is taken from the Summary of Product Characteristics (SPC) information for each drug, provided below; Orap 4 mg tablets - Summary of Product Characteristics (SmPC) - (emc) | 6911 Haloperidol Oral Solution BP 10 mg/5 ml - Summary of Product Characteristics (SmPC) - (emc) | 4521 Serdolect 12 Mg Film-Coated Tablets -Summary For each of these, the advice is 'periodic monitoring'; Agilio have added the concept of 'ideally annually' for these drugs as a pragmatic approach, as the manufacturers do not stipulate what they mean by 'periodic monitoring'. Agilio will be adding additional wording to clarify that the manufacturer has described risperidone as a medication which does not require further annual follow up ECG monitoring, as this drug is included in the category referred to in the CKS as 'not required for antipsychotics with no effect, or a low-to-moderate effect on the QT interval and where there are no other risk factors for arrhythmia.' Additional information will be added regarding drug interactions and prolongation on the QT interval in particular and the need for additional monitoring for these patients, almost certainly in secondary care. If further detail is required on the changes to the content of the CKS topic, Agilio Software can be contacted directly. NICE have also published a clinical guideline on bipolar disorder: assessment and management [CG185] which includes the following relevant recommendations:
1.10.6 Before starting antipsychotic medication, offer the person an electrocardiogram (ECG) if:
• it is specified in the drug's summary of product characteristics (SPC) or
• a physical examination has identified a specific cardiovascular risk (such as hypertension) or
• there is a family history of cardiovascular disease, a history of sudden collapse, or other cardiovascular risk factors such as cardiac arrhythmia or
• the person is being admitted as an inpatient. [2014] For risperidone, there is no specific requirement for ECG monitoring in the SPC It says: QT prolongation has very rarely been reported postmarketing. As with other antipsychotics, caution should be exercised when risperidone is prescribed in patients with known cardiovascular disease, family history of QT prolongation, bradycardia, or electrolyte disturbances (hypokalaemia, hypomagnesaemia), as it may increase the risk of

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arrhythmogenic effects, and in concomitant use with medicines known to prolong the QT interval. There is no requirement for continued (e.g. annual) ECG monitoring with risperidone in the SPC, NICE guideline or the British National Formulary (BNF). The local guidelines say the following in annual monitoring: if new medicines or changes to physical health have increased the risk of prolonged QTc arrange ECG. The interaction in the BNF on risperidone and methylphenidate (Ritalin) relates to an increased risk of dyskinesia. In summary, we do not believe there is evidence for justification for annual ECGs for everyone prescribed long term antipsychotics. Prescribing information for risperidone does not include a requirement for continued ECG monitoring, however the publishers of the CKS will make some changes to the prescribing information on this topic to ensure it is clear where ECG monitoring is required. I hope this response has helped outline our role and the guidance that exists in this topic area. I would like to reiterate my sincere condolences to Mr Atkinson’s family.

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 Aaron Atkinson. 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.

Aaron was found deceased on the morning of 20 April 2023 at his home address. His death was completely unexpected.

As his cause of death was not known a postmortem examination was conducted including toxicology. The pathologist’s opinion was that Aaron had died due to a seizure and positional asphyxia.

Aaron’s mother was doubtful of the cause of death proposed and pressed for a second postmortem which was undertaken by a different pathologist. That pathologist considered that a more likely cause of death was cardiac arrhythmia caused by Aaron’s prescription of Risperidone (for behavioural regulation), and Ritalin (for ADHD – attention deficit hyperactivity disorder).

On the court’s assessment of the evidence, applying the balance of probabilities, a probable medical cause of death cannot be determined.

The court notes that Aaron’s medication reviews to check for any complications were conducted in line with local health guidelines. Aaron’s last review took place in November 2021, but Aaron did not attend subsequent reviews which were offered.

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

Whilst Aaron had annual GP reviews related to prescription of anti-psychotic medication (Risperidone, although the inquest heard that prescription of Ritalin was also a relevant factor, particularly in combination with Risperidone), to check for signs of adverse side effects and physical health complications, those reviews did not include ECGs (electrocardiograms) to check for signs of adverse effects on electrical activity of the heart. On the medical evidence before the inquest antipsychotic medication carries recognised risk of QT interval prolongation and lethal cardiac arrhythmias. It does not appear that the recognised risk of QT interval prolongation and lethal cardiac arrhythmias from long term prescription of antipsychotic medication is reflected in guidance to medical practitioners and prescribers, nationally or locally in terms of performing ECGs. The relevant NICE (National Institute for Clinical Excellence) guidance (web link below) refers to ECG testing under How should I monitor someone taking antipsychotics? and recommends

Electrocardiography (ECG) - after dose changes. Ideally, also annually. The local Derbyshire Integrated Care Board guidance (web link below) does not identify need for ECG to be included in annual monitoring in primary care unless if new medicines or changes to physical health have increased the risk of prolonged QTc arrange ECG. It appears there is lack of clarity and consistency for annual reviews to include ECGs where people are prescribed antipsychotic medication long term. Given the recognised risks explained at inquest then not providing annual ECGs for long term users of those medications appears to pose risk of death.

NICE web link: https://cks.nice.org.uk/topics/bipolar- disorder/prescribinginformation/antipsychotics/

Derbyshire web link (DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC)):

_BNF_chapter_prescribing_guidelines/BNF_chapter_4/Antipsychotics_Prescribing_and_Manage ment.pdf

Derby and Derbyshire ICB Response

Guideline review

The Coroner identified a variance between the local Joint Area Prescribing Committee (JAPC) recommendation, which states: “If new medicines or changes to physical health have increased the risk of prolonged QTc arrange ECG” (page 9 of Derbyshire antipsychotic guidance), and the NICE Clinical Knowledge Summary (CKS) recommendation: “Electrocardiography (ECG) – after dose changes. Ideally, also annually.” It is also important to note that within the NICE CKS, the only medications where ECG monitoring is mandated are haloperidol, pimozide and sertindole (only available in UK on named patient basis
– specialist use). Furthermore, the Summary of Product Characteristics (SmPC), of these medications varies slightly from the NICE CKS: For Haloperidol 'A baseline ECG is recommended before treatment. During therapy, the need for ECG monitoring for QTc interval prolongation and for ventricular arrhythmias must be assessed for all patients.' For Pimozide 'An ECG should be performed prior to initiation of treatment with pimozide, as well as periodically during treatment.' Sertindole – SmPC unavailable as unlicensed. For all other medications referenced, including Risperidone and methylphenidate, ECG monitoring is recommended as good clinical practice but is not mandatory.

Our considered position is that the ICB will amend the JAPC recommendation to align with the NICE CKS by advising ECG monitoring for all patients on antipsychotics after dose changes and ideally, also annually. This local change will be implemented while awaiting any future national guidance revisions from NICE, which would require country-wide adoption.

Non engagement with monitoring

Our local guideline will also be updated to reflect advice available on our JAPC guideline 'prescribing in primary care', which reinforces the importance of regular engagement. This is of particular importance with respect to antipsychotic medications: ISSUING OF PRESCRIPTIONS 'The patient’s condition is monitored appropriately, and prescriptions are not issued for patients who require further examination or assessment. This is particularly important in the case of medicines with potentially serious side-effects.'

To further support patients and their carers, an overview of the Derbyshire Healthcare NHS Foundation Trusts 'local support services' will be added to the guideline, including a link to the webpage. Colleagues can use this link to signpost patients to appropriate support networks should they wish. This link will also be accessible on our medicines management website for ease of access. As part of the ICB's GP quality visits, data is included and discussed relating to the severe mental illness register/ reviews. The discussion at these visits includes a way of encouraging these patients to attend their reviews. We have reached out to the named GP, to support any actions they identify. Our aim is to share learning across the system to enable the scaling of improvements. In addition to the actions identified above, we are looking to identify any practice processes for non – engagement from patients.

Actions to Address Concerns In light of these points, the ICB is undertaking the following steps:
1. Revision of Local Guidance o Update Derbyshire antipsychotic prescribing guidance to add NICE CKS recommendations on annual ECGs for patients on antipsychotic therapy and after dose changes, matching NICE recommendations.
2. Await NICE response o Await NICE's response to case and potential updates to national guidance regarding ECG monitoring standards for patients prescribed antipsychotics

3. Shared learning o Share lessons learned and guidance updates next steps with primary care clinicians and across relevant networks o Share local support services link with colleagues across the system to raise awareness of support available to patients and carers that colleagues can signpost to.

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. Identify relevant lessons learnt from GP quality visits 6/10/25 1b Review response from NICE and acknowledge local updates if required. Plan further actions based on potential guidance changes. 6/10/25 1c Update JAPC guideline 'Antipsychotic Prescribing and Management for mental health conditions' and medicines management webpage, as identified above. 25/11/25 REVIEW AND COMMUNICATIONS 2a Extract shared learning from the practice and NICE responses 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 through existing governance routes 6/11/25 2b Collated learning to be shared through existing communications as identified above. Following Derbyshire Prescribing Group (DPG) 4/12/25. 2c At the Clinical Governance Leads meeting with general practice the Learning report Following Derbyshire Prescribing Group (DPG) 4/12/25.

will be discussed as part of the Patient safety standard agenda item.