Gemima Christodoulou-Peace
PFD Report
All Responded
Ref: 2024-0391
All 1 response received
· Deadline: 16 Sep 2024
Response Status
Responses
1 of 1
56-Day Deadline
16 Sep 2024
All responses received
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Organisations named in PFD reports must respond within 56 days explaining what actions they are taking.
Source: Courts and Tribunals Judiciary
Coroner’s Concerns
the MATTERS OF CONCERN as follows. –
1. Currently a treating clinician would need to undertake independent review on every prescription medication a patient is taking, to identify if any of those medications have a reported side-effect of increasing suicidal behaviour. For some medications this side-effect is very rare, so it is highly unlikely that a treating clinician could know all the medications identified as having a risk of increasing suicidal behaviour. At present there is no single reference point which a treating clinician can access, to readily and quickly identify if a patient is on a prescribed medication which is known to increase suicidal behaviour in some patients.
2. There are currently only a limited number of calls going into the Norfolk and Suffolk Foundation Trust which are being recorded. As such, should the clinician taking the call suddenly need to be absent (e.g. sudden ill health, domestic emergency, etc) and therefore cannot provide details of the call, there is no way any other treating clinician can respond to needs of that patient, or address any risks to that patient identified in that call. In addition, without a recording of calls there is no opportunity to review cases were there may be some doubt as to what a patient or clinician has said, or when a different clinician wishes to hear the patient themselves to independently assess the patients presentation, or for a Multi-Disciplinary Team to review the contents of that call. As many interactions between the NSFT and patients are telephone based, the availability of accurate recording of those conversations, and increased accessibility to them, would improve patient safety.
3. Gemima first reported a decline in her mental health in March 2023 and requested to be put back onto her previous medication. Gemima’s GP could not do this without input from a prescribing mental health practitioner, so a referral to secondary Mental Health Services was made. Gemima’s March request did not result in her obtaining an appointment with a prescribing mental health practitioner, at that time. Gemima reported her continuing low mood to her GP again on the 3rd July 2023, but as she had been referred to a Wellbeing Team, was told to contact NHS 111 Option 2 if she was ‘in crisis’. On the 19th July 2023 Gemima told her GP her anxiety was ‘through the roof’ so an urgent referral to the Mental Health Services was made. Gemima was assessed over the telephone six days later on the 25th July 2023, and was offered crisis support which she declined, as Gemima wanted a medication review with the mental health team she had seen previously. On the 25th July 2023 a risk assessment was undertaken with Gemima, and using the RAG (Red, Amber, Green) system, Gemima was deemed to be an ‘Amber’, and therefore ‘moderate’ risk. The court heard that any case risk rated ‘Red’, had a target response time of 4-72 hours (if the patient was in crisis) and 7 days for other ‘Red’ cases. Any case risk rated ‘Amber’ had a target response time of 2 to 4 weeks, and any case rated ‘Green’ had a target response time of 28 days. All treating clinicians who gave evidence in Gemima’s case said ‘in an ideal world’ resources would allow for much more timely interventions than those currently possible, especially those cases rated ‘Red’ or ‘Amber’. Although Gemima herself had recognised the need to be back on her mental health medication, resource pressures meant that at the time of her death, she had still not seen a treating mental health practitioner who could prescribe her previous mental health prescription. Gemima’s treatment assessment was booked for the 8th August 2023, 14 days after her tragic death.
1. Currently a treating clinician would need to undertake independent review on every prescription medication a patient is taking, to identify if any of those medications have a reported side-effect of increasing suicidal behaviour. For some medications this side-effect is very rare, so it is highly unlikely that a treating clinician could know all the medications identified as having a risk of increasing suicidal behaviour. At present there is no single reference point which a treating clinician can access, to readily and quickly identify if a patient is on a prescribed medication which is known to increase suicidal behaviour in some patients.
2. There are currently only a limited number of calls going into the Norfolk and Suffolk Foundation Trust which are being recorded. As such, should the clinician taking the call suddenly need to be absent (e.g. sudden ill health, domestic emergency, etc) and therefore cannot provide details of the call, there is no way any other treating clinician can respond to needs of that patient, or address any risks to that patient identified in that call. In addition, without a recording of calls there is no opportunity to review cases were there may be some doubt as to what a patient or clinician has said, or when a different clinician wishes to hear the patient themselves to independently assess the patients presentation, or for a Multi-Disciplinary Team to review the contents of that call. As many interactions between the NSFT and patients are telephone based, the availability of accurate recording of those conversations, and increased accessibility to them, would improve patient safety.
3. Gemima first reported a decline in her mental health in March 2023 and requested to be put back onto her previous medication. Gemima’s GP could not do this without input from a prescribing mental health practitioner, so a referral to secondary Mental Health Services was made. Gemima’s March request did not result in her obtaining an appointment with a prescribing mental health practitioner, at that time. Gemima reported her continuing low mood to her GP again on the 3rd July 2023, but as she had been referred to a Wellbeing Team, was told to contact NHS 111 Option 2 if she was ‘in crisis’. On the 19th July 2023 Gemima told her GP her anxiety was ‘through the roof’ so an urgent referral to the Mental Health Services was made. Gemima was assessed over the telephone six days later on the 25th July 2023, and was offered crisis support which she declined, as Gemima wanted a medication review with the mental health team she had seen previously. On the 25th July 2023 a risk assessment was undertaken with Gemima, and using the RAG (Red, Amber, Green) system, Gemima was deemed to be an ‘Amber’, and therefore ‘moderate’ risk. The court heard that any case risk rated ‘Red’, had a target response time of 4-72 hours (if the patient was in crisis) and 7 days for other ‘Red’ cases. Any case risk rated ‘Amber’ had a target response time of 2 to 4 weeks, and any case rated ‘Green’ had a target response time of 28 days. All treating clinicians who gave evidence in Gemima’s case said ‘in an ideal world’ resources would allow for much more timely interventions than those currently possible, especially those cases rated ‘Red’ or ‘Amber’. Although Gemima herself had recognised the need to be back on her mental health medication, resource pressures meant that at the time of her death, she had still not seen a treating mental health practitioner who could prescribe her previous mental health prescription. Gemima’s treatment assessment was booked for the 8th August 2023, 14 days after her tragic death.
Responses
The DHSC reports that NHS England's Shared Care Records (since 2021) allow sharing of patient medication information. Norfolk and Suffolk NHS Foundation Trust (NSFT) implemented system changes and a SOP for recording calls in July 2023, and a revised Trust Strategy in May 2024 to improve services, including enhanced clinical leadership and new governance structures.
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Dear Mr Parsley, Thank you for your Regulation 28 report to prevent future deaths dated 22 July 2024 about the death of Gemima Christodoulou-Peace. I am replying as the Minister with responsibility for Patient Safety and Mental Health. Firstly, I would like to say how saddened I was to read of the circumstances of Gemima’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. Thank you for highlighting your concerns about the need for treating clinicians to be able to quickly access and identify information on potential side effects when prescribing medicines; the recording of telephone calls at Norfolk and Suffolk NHS Foundation Trust; and the difficulties accessing mental health services and ensuring continuity of care. In preparing this response, departmental officials have made enquiries with NHS England, Norfolk and Suffolk NHS Foundation Trust and the Medicines and Healthcare Products Regulatory Agency (MHRA). I understand your concerns around the difficulties faced by a treating clinician in quickly identifying if a prescribed medication is known to increase suicidal behaviour in some patients. Since 2021, all primary and secondary care organisations have been able to share a subset of the patient information they hold – the core information standard – between providers within their own integrated care board footprint as part of a shared care
record. This shared care record joins up information, including medications a patient has been prescribed, based on an individual rather than an organisation, and is a safe and secure way of bringing an individual’s separate records from different health and care organisations together. NHS England is working on plans to make shared care records link together regardless of where a person lives or receive care in England. The MHRA has advised me that it keeps the safety of all medicines and medical devices under continual review, including montelukast (which Gemima had been prescribed). It closely monitors reports from healthcare professionals, patients and parents or carers via the Yellow Card scheme, which is the UK system for collecting information on suspected side effects, and is used to investigate reports of suspected adverse reactions and other issues. Together with independent expert advice from the Commission on Human Medicines, the MHRA is responsible for ensuring that the overall balance of benefits and risks of all medicines is positive at the time of licensing and throughout the post-licensing period. Information including the reported frequency of adverse drug reactions can be found in the Patient Information Leaflet and Summary of Product Characteristics which accompanies every licensed medicine marketed in the UK, including montelukast. The Summary of Product Characteristics forms the legal basis for the correct use of a medicinal product. It provides all the necessary information for prescribers to use a product safely and should be used to inform any discussions with a patient about the risks as well as the benefits of their treatment. The Patient Information Leaflet supplied with a patient’s medicine also supports those discussions and can be a useful reference to ensure patients are informed about their treatment. It is the prescriber’s responsibility to prescribe a drug based on the information contained within the Summary of Product Characteristics. In 2023 the MHRA initiated a safety review of the known risk of neuropsychiatric side effects with montelukast to consider any new evidence, the impact of the risk minimisation measures already in place, and whether any additional measures were required. The review took into consideration the lived experiences of patients and caregivers, and independent clinical advice from paediatricians, specialists in mental and respiratory health, as well as experts in medicines safety at Expert Advisory Groups of the CHM. The MHRA’s review confirmed that while the risk of neuropsychiatric reactions with montelukast remained unchanged, Yellow Card reports had indicated this risk was potentially not well known by healthcare professionals, patients and their caregivers. As a result, the neuropsychiatric warnings in the Patient Information Leaflet and the Summary of Product Characteristics for all montelukast products in the UK were strengthened and highlighted within a black box for greater emphasis, with a reminder issued in April 2024. Additionally, a new Drug Safety Update was published on 29 April 2024 to communicate these changes. Drug Safety Updates allow healthcare professionals to be aware of and learn about new emerging safety issues relating to medicines and provide appropriate messaging to support conversations with patients. This remains an ongoing review and the MHRA is considering additional measures to better inform patients and healthcare professionals of this risk. These warnings are also replicated in the British National Formulary, which is widely regarded by doctors, pharmacists and other healthcare professionals as an up to date and highly authoritative information resource on medicines prescribed in the UK and made available on the National Institute for Health and Care Excellence’s website.
Turning to your concerns around the recording of incoming phone calls made to the Norfolk and Suffolk NHS Foundation Trust, I can appreciate the potential risks this may pose, as you have highlighted. The Trust has advised that it has recently considered the issue of recording clinical calls and taken the decision that it would be proportionate to extend clinical call recording from NHS 111 (option 2) only to within crisis teams within the organisation and all phone lines which have been designated as requiring recording facility have now been enabled. The Trust’s view was that it would be disproportionate to record all clinical calls within all clinical teams in the organisation. However, it is currently looking at how this works across other trusts, and has requested feedback on this via the Mental Health and Learning Disabilities Nursing Directors Forum. Finally, turning to your concerns around Gemima not being able to access appropriate mental health services or receiving the continuity of care that she was looking for, I understand that, following wider concerns about the performance of the Trust and the risk to patients, the Trust implemented a revised Trust Strategy in May 2024 to improve services, outcomes and experiences for patients, families and carers and become a safer, kinder and better Trust with a clear and detailed improvement plan and new Trust values. It has enhanced clinical leadership across the Trust and has implemented a new place- based leadership structure to reduce unwarranted clinical variation, improve quality and safety and deliver consistent, patient-centred care, as well as setting up a Service User and Carer Council to strengthen the voice of patients, carers and families. A Learning from Deaths group has also been established with membership from partners, patients, carers, bereaved families and Healthwatch. More broadly, it is unacceptable that too many people, like Gemima, are not receiving the mental health care they need when they need it and we know that waits for mental health services are far too long. We are determined to change that. As part of our mission to build an NHS that is fit for the future and that is there when people need it, we will modernize the Mental Health Act to give greater choice, autonomy, enhanced rights and support, and ensure everyone is treated with dignity and respect throughout treatment and recruit an additional 8,500 mental health workers to reduce delays and provide faster treatment which will also help ease pressure on busy mental health services. These new workers will be specially trained to support people at risk of suicide. I hope this response is helpful. Thank you again for bringing these concerns to my attention.
record. This shared care record joins up information, including medications a patient has been prescribed, based on an individual rather than an organisation, and is a safe and secure way of bringing an individual’s separate records from different health and care organisations together. NHS England is working on plans to make shared care records link together regardless of where a person lives or receive care in England. The MHRA has advised me that it keeps the safety of all medicines and medical devices under continual review, including montelukast (which Gemima had been prescribed). It closely monitors reports from healthcare professionals, patients and parents or carers via the Yellow Card scheme, which is the UK system for collecting information on suspected side effects, and is used to investigate reports of suspected adverse reactions and other issues. Together with independent expert advice from the Commission on Human Medicines, the MHRA is responsible for ensuring that the overall balance of benefits and risks of all medicines is positive at the time of licensing and throughout the post-licensing period. Information including the reported frequency of adverse drug reactions can be found in the Patient Information Leaflet and Summary of Product Characteristics which accompanies every licensed medicine marketed in the UK, including montelukast. The Summary of Product Characteristics forms the legal basis for the correct use of a medicinal product. It provides all the necessary information for prescribers to use a product safely and should be used to inform any discussions with a patient about the risks as well as the benefits of their treatment. The Patient Information Leaflet supplied with a patient’s medicine also supports those discussions and can be a useful reference to ensure patients are informed about their treatment. It is the prescriber’s responsibility to prescribe a drug based on the information contained within the Summary of Product Characteristics. In 2023 the MHRA initiated a safety review of the known risk of neuropsychiatric side effects with montelukast to consider any new evidence, the impact of the risk minimisation measures already in place, and whether any additional measures were required. The review took into consideration the lived experiences of patients and caregivers, and independent clinical advice from paediatricians, specialists in mental and respiratory health, as well as experts in medicines safety at Expert Advisory Groups of the CHM. The MHRA’s review confirmed that while the risk of neuropsychiatric reactions with montelukast remained unchanged, Yellow Card reports had indicated this risk was potentially not well known by healthcare professionals, patients and their caregivers. As a result, the neuropsychiatric warnings in the Patient Information Leaflet and the Summary of Product Characteristics for all montelukast products in the UK were strengthened and highlighted within a black box for greater emphasis, with a reminder issued in April 2024. Additionally, a new Drug Safety Update was published on 29 April 2024 to communicate these changes. Drug Safety Updates allow healthcare professionals to be aware of and learn about new emerging safety issues relating to medicines and provide appropriate messaging to support conversations with patients. This remains an ongoing review and the MHRA is considering additional measures to better inform patients and healthcare professionals of this risk. These warnings are also replicated in the British National Formulary, which is widely regarded by doctors, pharmacists and other healthcare professionals as an up to date and highly authoritative information resource on medicines prescribed in the UK and made available on the National Institute for Health and Care Excellence’s website.
Turning to your concerns around the recording of incoming phone calls made to the Norfolk and Suffolk NHS Foundation Trust, I can appreciate the potential risks this may pose, as you have highlighted. The Trust has advised that it has recently considered the issue of recording clinical calls and taken the decision that it would be proportionate to extend clinical call recording from NHS 111 (option 2) only to within crisis teams within the organisation and all phone lines which have been designated as requiring recording facility have now been enabled. The Trust’s view was that it would be disproportionate to record all clinical calls within all clinical teams in the organisation. However, it is currently looking at how this works across other trusts, and has requested feedback on this via the Mental Health and Learning Disabilities Nursing Directors Forum. Finally, turning to your concerns around Gemima not being able to access appropriate mental health services or receiving the continuity of care that she was looking for, I understand that, following wider concerns about the performance of the Trust and the risk to patients, the Trust implemented a revised Trust Strategy in May 2024 to improve services, outcomes and experiences for patients, families and carers and become a safer, kinder and better Trust with a clear and detailed improvement plan and new Trust values. It has enhanced clinical leadership across the Trust and has implemented a new place- based leadership structure to reduce unwarranted clinical variation, improve quality and safety and deliver consistent, patient-centred care, as well as setting up a Service User and Carer Council to strengthen the voice of patients, carers and families. A Learning from Deaths group has also been established with membership from partners, patients, carers, bereaved families and Healthwatch. More broadly, it is unacceptable that too many people, like Gemima, are not receiving the mental health care they need when they need it and we know that waits for mental health services are far too long. We are determined to change that. As part of our mission to build an NHS that is fit for the future and that is there when people need it, we will modernize the Mental Health Act to give greater choice, autonomy, enhanced rights and support, and ensure everyone is treated with dignity and respect throughout treatment and recruit an additional 8,500 mental health workers to reduce delays and provide faster treatment which will also help ease pressure on busy mental health services. These new workers will be specially trained to support people at risk of suicide. I hope this response is helpful. Thank you again for bringing these concerns to my attention.
Action Should Be Taken
In my opinion action should be taken in order to prevent future deaths, and I believe you or your organisation have the power to take any such action you identify.
Report Sections
Investigation and Inquest
On 1st August 2023 I commenced an investigation into the death of Gemima CHRISTODOULOU-PEACE The investigation concluded at the end of the inquest on 17th July 2024. The conclusion of the inquest was that the death was the result of:- Gemima died as the result of a suspension hanging, but there is insufficient evidence to show that at all material times she intended her death, due to impulsivity associated with her diagnosed mental illness, and the intoxicating effect of The medical cause of death was confirmed as: 1a Suspension Hanging
Circumstances of the Death
Gemima Christodoulou-Peace was declared deceased on Monday 31st July 2023 at , in Suffolk. Gemima had been found inside the premises, suspended by her neck from a ligature. A subsequent post-mortem examination identified marks on Gemima’s neck consistent with death by suspension by a ligature. Police investigations of digital media evidence identified on a balance of probabilities, that Gemima died on, or about the 26th July 2023. Gemima was known to suffer with her mental health (Emotionally Unstable Personality Disorder, anxiety, and depression), had previously taken overdoses of medication, and had previously been admitted to hospital mental health units. At the time of her death Gemima was found to have a high level of in her system, which can induce feelings of detachment, confusion, altered perception of space and time, and panic attacks. In addition, in May 2023 Gemima received a repeat prescription of a drug called Montelukast, which in rare cases is known to increase suicidal behaviour. It is however not known when Gemima last took this drug, and none was found in Gemima’s system at the time of her death.
Copies Sent To
2. The other listed IP’s in this case
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Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.