Deidre Harvey

Coroner's concerns

AI summary

External consultants had insufficient input into mental health patients' physical care, bureaucratic processes delayed rectifying ligature points, and the system for managing dangerous patient items was ineffective.

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Secretary of State for Health
1. The inquest heard that patients on Mental Health Units often have significant physical problems which treated by outside consultants, who may have Iittle input into their care on the ward or may not even know they are there_ In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus_ The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit; in order that their expertise and knowledge is available to the treating consultant psychiatrist The inquest heard that an obvious ligature point was identified in September 2016 in the Mental Health Unit, and yet bureaucratic processes meant that approval for funding the rectification of this ligature was held up for months, with staff having t "manage" the risk. The Coroner is concerned that there should be a expedited process for rectifying obvious ligature points on Mental Health Units Minister for Health, Welsh Assembly Government
1. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the unit or may not even know they are there. In this inquest the consultant psychiatrist Deidre was not aware of the potentially toxic effects of the drug for her lupus: The Coroner is concerned that outside consultants should have & more active input into the care of the mental health patient on a Mental Health Unit; in order that their expertise and knowledge is available to the treating consultant psychiatrist The inquest heard that an obvious ligature point was identified in September 2016 in the Mental Health Unit, and yet bureaucratic processes meant that approval for funding the_rectification_of_this_ligature was held 4p_for_months with_staff_having_ to had hang home: The hang are point treating point

'manage the risk; The Coroner is concerned that there should be a expedited process for rectifying obvious ligature points on Mental Health Units Chief Executive Cwm Taf University Health Board The inquest heard of the Pod system on the Mental Health Unit in which items of danger to patients were deposited (and then possibly returned to patient): There was no evidence of effective system to identify who had what and when: The Coroner is concerned that there should be an effective system t0 check on what is taken from a patient and then later returned t0 a patient
2. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have Iittle input into their care on the unit or may not even know they are there: In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus: The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit; in order that their expertise and knowledge is available to the treating consultant psychiatrist The inquest heard that there was confusion between staff on the Mental Health Unit and the Community Psychiatric Nurse over management of risk for a patient admitted on the Mental Health Unit; with the result that responsibility for a Risk assessment might not be recognised. The Coroner is concerned that there should be proper management and dissemination of risk management policies to frontline staff to avoid any confusion Editor British National Formulary Hydroxychloroquine
1. The expert evidence given was that Hydroxychloroquine (HCQ) is not contra-indicated in Appendix of the BNF for ati-epileptic drugs. The manufacturers leaflet however does contain caution against using HCQ alongside anti-epileptic drugs: is acknowledged that the text of the BNF does indicate that HCQ should not be used in case of neurological disorders (including epilepsy) but this does not catch patients Dee who was on a anti-epileptic drug (Lamotrigine) for her bipolar condition but was not epileptic The coroner is concerned that the BNF might not fully describe the risk to patients Lamotrigine (or drugs of similar class or composition) alongside Hydroxychloroquine. Royal College of Psychiatrists Hydroxychloroquine
1. The evidence in the inquest showed that the psychiatrists treating Deidre were largely unware of the potential side-effects of Hydroxychloroquine which Deidre was received for her Systemic Lupus Erythematosus_ These include mental changes and psychosis. The Coroner is concerned that consultants treating other mental patients who are receiving this drug should be aware of these side-effects, and is concerned that there should be proper liaison with the consultant dermatologist over its toxic and potential metal health side-effects: In General the Coroner is concerned that the psychiatrists treating a patient in a Mental Health Unit should have the benefit of specialist advice from outside consultants who the any item , like taking may be treating the patient for a physical condition British Association of Dermatologists Hydroxychloroquine
1. The expert evidence received in this inquest revealed that Hydroxychloroquine could build up to toxic levels even with normal dosage pf the Dept of Toxicology, Birmingham Heartlands Hospital reported that there is a clear cross-over between apparently toxic concentrations and apparently therapeutic concentrations_ Dee at the time of her death had a concentration of approximately 25 mg/L and fatalities at 7.5 mgIL; The Coroner is concerned that this drug should not be prescribed t0 a patient suffering from Lupus (which in itself is not Iife-threatening) without an awareness that toxic levels can build up even at the recommended dose; The Coroner is concerned that the dermatologist prescribing this drug should liaise with other consultants treating the patient for other conditions (in Deidre '$ case for mental health problems) so that specialist knowledge about the toxic effects of this drug can be shared. CEO Alerts NHS Hydroxychloroquine
1. The evidence in this inquest is that Deidre (who was a detained patient under Section 3 MHA} was being given a for a physical condition (Lupus) which can build up to toxic levels even at normal doses. The inquest heard that there iS no routine checking of Hydroxychloroquine levels at clinical level, even though said he thought that clinical monitoring of this might be important The Coroner is concerned that there may be other dependent persons suffering from lupus (or other conditions for which Hydroxychloroquine is prescribed in NHS hospitals in England ad Wales) who may also have toxic levels of Hydroxychloroquine in their system unbeknown to their carers.

Responses

5 respondents

Welsh Government Devolved Administration

10 Aug 2018 PDF

Action Planned

The Welsh Government will discuss the incident at the all Wales Serious Incidents Group in October to improve learning and develop/disseminate further guidance across professional groups. They will also keep the case under ongoing review. (AI summary)

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Dear Mr Woolley Regulation 28 Report to Prevent Future Deaths Deidre Harvey Thank you for your letter of 10 August 2018, enclosing the above Regulation 28 report following your investigation into the death of Deidre Harvey: am responding on behalf Vaughan Gething Cabinet Secretary for Health and Social Services in Wales. We know the interaction between mental and physical health has important consequences at all levels of a patient's care and treatment: 46% of people with severe mental illness also have significant long term physical conditions Admission to a mental health inpatient facility should be seen as an opportunity to improve person's mental and physical health: It is also an opportunity to review the medications that a person takes, particularly in terms of their side effects and interactions with other medications It is encouraging to see several of the Royal Colleges and other educational bodies are already undertaking work to explore the addition to the new components of the professional educational curricula, in order to achieve the person-centred approach which combines the various aspects of a person's physical and mental health conditions in a holistic fashion. We expect any outside consultants to work collaboratively with the team involved with a patients to care to ensure any decisions taken concerning patients treatment plan are based on their holistic health needs. NHS organisations are expected to ensure that units wards are safe for the patents being cared within them: Fixtures and fittings should therefore be assessed to ensure they are anti- ligature. Where ligature risk points are identified but cannot be immediately addressed_ it is the responsibility of the professionals caring for people on such a unit and the health board generally to robust measures in place to mitigate the risks: In the shorter term, Welsh Government officials will be taking this tragic incident for discussion at the all Wales Serious Incidents Group in October: Led by the NHS Delivery Unit, it will contribute to improve learning and the development and dissemination of further guidance to be shared across the differing professional groups. Ffon/Tel: 03000258899 ADLADOMMANrOa Parc Cathays, Caerdydd CF10 3NQ Cathays Park, Cardiff CF10 3NQ MONITT EbostEmail PSChiefMedicalOfficer@wales: gOv.uk day - day- put ~gsi.

do assure you that Welsh Government will keep this case and the learning that arises under ongoing review.

University Health Board

16 Aug 2018 PDF

Action Taken

The University Health Board has implemented a safe system of work for recording items stored in patient PODS, disseminated risk management policies via ward meetings with staff sign-off, and is developing a standard list of documents for disclosure at inquest. (AI summary)

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Dear Mr Woolley RE: Regulation 28 - Deidire Harvey Thank you for the correspondence in relation to the above Regulation 28 received on 16 August 2018, which details the areas of concern following the conclusion of the inquest held between 16- 27 July 2018. Please be assured that the Health Board has taken this matter extremely seriously, has learnt lessons following investigation and the matters raised at the inquest into the circumstances. Comprehensive and robust action has been taken to minimise the risk of any recurrence.
1. Action taken to plan and monitor improvements A corrective Action Plan for Improvement was developed following Mrs Harvey's death. This has been updated to reflect the concerns identified within the Regulation 28 Report.
2. Actions Implemented A number of actions have been taken forward by the Mental Health Directorate, the progress with these actions is reflected in the attached action plan which include: A safe system of work has been implemented to ensure that staff are recording items stored in and taken from patient PODS. Dissemination of risk management policies to frontline staff are now shared by team leaders through ward meetings and staff sign off individually to demonstrate sharing. A standard list of documents for disclosure at inquest is being developed. Return Address: Cwm Taf University Health Board, Headquarters, Navigation Park, Abercynon, CF45 4SN Chair/ Cadeirydd; Professor Marcus Longley Chief Executive/ Prif Weithredydd: Mrs A Williams Cwm Taf University Health Board is the operational name of the Cwm Taf University Health Board/Bwrdd lechyd Prifysgol Cwm Taf yw enw gweithredol Bwrdd lechyd Prifysgol Cwm Taf

I sincerely hope that this information and enclosed Action Plan will reassure you that the Health Board has learnt important lessons from the investigation into the care provided to Mrs Harvey and that effective action has now been taken to prevent further deaths. I would like to convey once again my deepest sympathy and sincere apologies to Mrs Harvey's family for the failings identified.

NHS England NHS / Health Body

25 Sep 2018 PDF

Noted

NHS Improvement supported the MHRA by searching the National Reporting and Learning System, which reinforced the importance of annual eye screening for patients on long-term Hydroxychloroquine. They stand ready to support the MHRA in ensuring any future changes to monitoring reach healthcare professionals. (AI summary)

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Dear Mr Woolley, Re: Regulation 28 Coroner's Report HARVEY Thank you for your Regulation 28 letter of 25th September 2018, following the inquest into the death of Deidre Harvey: was to hear of her death in such sad circumstances and wish to extend my condolences to her family: In order to avoid confusion given multiple persons addressed, will be responding only to the issue directed at me: However please note that NHS Improvement works closely with our counterparts in Wales to share information to improve the safety of patients and quality of care, including in area of management of ligature points, and my patient safety team has also supported other persons and bodies addressed in your letter in their responses t0 you_ You have raised the issue that there may be other patients with conditions requiring Hydroxychloroquine, who may be at risk of toxic levels of this in their system, and that new guidance for healthcare professionals may be required in relation to monitoring of this medication. You directed this concern jointly to me and the CEO of the Medicine and Healthcare products Regulatory Agency (MHRA), who we have worked closely with on this issue. You kindly granted us an extension of our reply until 3rd December 2018 to allow more time to explore this issue_ collaboration trust respect innovation courage compassion sorry the drug

The issue of monitoring for toxicity that you raised is primarily in the remit of the MHRA, and they will provide the substantive reply to you on this issue. We have supported their work through undertaking a search of the National Reporting and Learning System: This did not identify any additional cases where systematic toxicity from Hydroxychloroquine had been identified, but did reinforce the importance of annual eye screening for patients on long-term Hydroxychloroquine, as set out in current guidance from the British Society for Rheumatology and British health Professionals in Rheumatology 'Guideline for the prescription and monitoring of non- biologic disease-modifying anti rheumatic drugs (see https Ilcks nice org ukldmards#tlscenario 8) We stand ready to support the MHRA in ensuring any future changes to monitoring reach all appropriate healthcare professionals and patients, including through our shared national network of Medication Safety Officers. Thank you for giving us this opportunity to work with our partners to identify any action needed to prevent future deaths.

Medicines and Healthcare Products Regulatory Agency Other

28 Nov 2018 PDF

Noted

The MHRA acknowledged the concerns and requested further information regarding the case to determine if regulatory action is required, including observed drug concentrations, symptoms of overdose, concomitant medications, post-mortem sample details, and renal/liver function test results. (AI summary)

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Dear Mr Woolley 0 3 DEC 2018 Reference: 9930 Thank you for sending Us the Regulation 28/29 Prevent Future Death report concerning death of Mrs Deidre Harvey. Further to your agreement to extend the deadline for response to the 3r December 2018,we have assessed the data in relation to the question you raised for the MHRA:
1. The evidence in this inquest is that Deidre (who was a delained patient under Section 3 MHA) was given drug for a physical condition (Lupus) which can build up to toxic levels even at normal doses The inquest heard that there is no routine checking of Hydroxychloroquine levels at clinical level , even though said he thought that clinical monitoring of this drug might be important: We have further considered your concerns that there may be other dependent persons suffering from lupus (or other conditions for which hydroxychloroquine is prescribed in NHS hospitals in England and Wales) who may also have toxic levels of hydroxychloroquine in their system unbeknown t0 their carers_ Some symptoms of hydroxychloroquine toxicity can be observed commonly at therapeutic doses as described in section 4.8 of the Summary of Product Characteristics (SmPC) for this drug: Other adverse reactions occur at a lower frequency. Monitoring of toxicity is mainly recommended by way of ophthalmological examinations before trealment initiation at least every 12 months thereafter. Monitoring of blood levels is currently only recommended in patients with severely compromised renal Or hepatic function. However, caution should be applied when using hydroxychloroquine in patients with hepatic or renal disease, and in those taking drugs known to affect those organs. On 21st November 2018, we sought the advice of the Commission o Human Medicines' Pharmacovigilance Expert Advisory Group (PEAG) on the available data including the information outlined in the report of Mrs Harvey's death. PEAG advised that in order l0 ensure that actions are evidence based, further details on (he report would be helpful: We would therefore be very grateful ifyou could provide us with further information on the following points, if available: The blood concentration observed in the patient is not clear as in section 4 (page 1) >15 mgldL and in section 5 (page 4) 25mg/L is stated: Would you be able to confirm the observed concentration? the being and The any

Assuming a blood concentration of 15-25mg/L the patient would have been expected to present with severe hydroxychloroquine toxicity such as headache; visual disturbances, cardiovascular collapse, convulsions, and hypokalaemia: Could you please confirm if symptoms of overdose were observed in Mrs Harvey? It is stated in the report that Mrs Harvey sufferad from several concomitant physical conditions _ and indicated that she received mood stabilisers and anti-depressants. However, only lamotrigine is specified as a concomitant drug: Would you be able lo confirm if lamotrigine was indeed the only concomitant medication? If nolt; could you provide us with delails of any other concomilant drugs Mrs Harvey received as there is a possibility of drug interactions with hydroxychloroquine which may have contributed to the high observed blood levels. In addition, concomitant drugs may explain the patient's hyponatraemia. Hydroxychloroquine is widely distributed in the body ad following death redistribution into the circulatory system occurs. It is therefore possible that the observed blood concentration does not reflect the drug level at the time when Mrs Harvey was still alive. Would you be able to confimm that the observed concentration derived from a post-mortem blood sample? And if so, could you provide information on the time elapsed following her death until the sample was taken? Is there any information on a renal andl or liver function test for Mrs Harvey? Would you be able to confirm that the patient was compliant in (aking her medication? Thank you for your help with these questions, which will enable us to reach a position on whether regulatory action is required: look forward to hearing from YOU:

Department of Health Social Care Central Government

6 Dec 2018 PDF

Action Taken

NHS England is working to ensure that by 2020/21, 280,000 more people with serious mental illness have their physical health needs met. NHS Improvement issued an Estates and Facilities Alert on 'Assessment of ligature points' on 19 September 2018. (AI summary)

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From Jackie Doyle-Price MP Parliamentary Under Secretary of State for Mental Health; Department RECEIED end Suicide Prevention of Health & 0 6 DEC 2018 39 Victoria Street Social Care London SW1H OEU 020 7210 4850 Your Ref: 9930 Our Ref: PFD-1145655 Christopher John Woolley HM Assistant Coroner; South Wales Central Coroner's Office The Old Courthouse Courthouse Street Pontypridd CF37 IJW December 2018 9ea , Wv Thank you for your correspondence of 10 August to the former Health Secretary, Jeremy Hunt; about the death of Ms Deidre Harvey. I am replying as Minister with portfolio responsibility for mental health and I am grateful for the additional time in which to do so. Your report directs two matters of concern to the Secretary of State for Health which I will address in turn giving the policy position in England. You will appreciate that responsibility for the NHS in Wales is a devolved matter: Firstly, on the management of physical health care within mental health settings, my officials have made enquiries with NHS England: Improving the physical healthcare of people with serious mental illness in both inpatient and community settings is a priority for NHS England as set out in the Five Year Forward View for Mental Health- As part of this programme, NHS England wants to ensure that individuals cared for on inpatient wards have access to the same quality of physical healthcare as would in community settings. NHS England has committed to leading work to ensure that by 2020/21,280,000 more people with serious mental illness have their physical health needs met by increasing early detection and expanding access to evidence based physical health https: WWW england nhs ukywp-contentluploads 2016/02 Mental-Health-Taskforce-EYEV-finalpdf Abouuy key - they living

care assessment and intervention each This is to be delivered across primary and secondary care settings To date, NHS England has overseen significant progress to improve physical healthcare for people with serious mental illness Within inpatient and community mental health providers this has been driven by the national Improving physical healthcare to reduce premature mortality in with severe mental illness? CQUIN (commissioning for quality and innovation) and implementation support. Also highlighted in the Five Forward View for Mental Health is the lack of appropriate data sharing to enable organisations to identify co-morbidities, anticipate problems and plan care in a holistic fashion People with poor mental health may require primary care; secondary physical care and social care; as well as mental health services, but we acknowledge that the lack of linked datasets hinders effective provision. The Summary Care Record (SCR) is an attempt to address this by including primary care information about an individual such as medication; allergies and adverse reactions However; it does not routinely include care plan information or allow access to mental health care records (or physical care records) which is a significant missed opportunity. The Five Forward View for Mental Health acknowledged that more work is needed to ensure data can be linked across public agencies; to promote integration of care To assist with the safe and secure sharing of data, a number of professionally endorsed interoperability standards have been defined: This includes being able to share mental health discharge summaries from acute to other care settings. NHS England, in conjunction with the Local Government Association, has also established the Local Health and Care Record' initiative that has commenced with five exemplar sites covering around 40 per cent of the population These exemplars will look to establish a longitudinal record of care for access and contribution by care professionals and patients Its use will be demonstrated through a number of priority care pathways such as Frailty, Delirium; Cancer and Long Term Conditions. https: WWW englandhs uklmental-health/resourceslsmi https: WWW england nhs uklwp-content/uploads 2018/0S local-health-and-carc-record-exemplars-summarypdf year: people- Year key Year

Turning to your second matter of concern; 0n the removal of ligature points in mental health settings, it is for mental health providers in England to ensure have policies in place to effectively assess and manage environmental risk in line with available guidance*5. NHS organisations in England are expected to have ligature risk assessment policies in place that allow them to assess the risk, mitigate the risk and prioritise removal of the risk once a ligature has been identified in any facility. The principles of ligature management should consider multiple environmental, clinical and operational health and safety factors such as height, access, room usage, patient population risks including infection control, dementia and self-harm, plus staff resource and the ability to adequately observe patients. This will include ligature point removal, or adequate controls with a record of the agreed mitigations put in place. You will be interested to note that NHS Improvement issued an Estates and Facilities Alert on 19 September 2018 on the Assessment of ligature points' The alert has not been made available in the public domain for patient safety reasons as it was deemed that it may give ideas to people with intention to self-harm However; it has been placed on the central alert system operated by the Medicines and Healthcare products Regulatory Agency (MHRA) (https: ILwww cas mhra gov uk Home aspx= and so is available to providers of services, including in Wales. Finally, I am aware that the MHRA and NHS Improvement are responding separately to your matter of concern on the monitoring of patients who are prescribed Hydroxychloroquine. [ hope that response is helpful. Thank you for bringing your concerns to our attention: bul JACKIE DOYLE-PRICE https: WWwgov uklgovemmenupublications environmental-design-guide-adult-medium-secure-services https: WW gov uklgovemmenupublicationsbbest-praclice-design-and-plnning-adult-acute mental-health-units they point point

Report sections

Investigation and inquest

In April 2017 commenced a investigation into the death of Deidre Harvey: The investigation concluded at the end of the inquest where sat with a jury between 161h and 27h July 2017.The medical cause of death was: 1.a Hanging: The jury returned conclusion as follows: Accident contributed to by neglect;

Circumstances of the death

Deidre Harvey had had long history of bipolar disorder, having first undergone treatment in 19905. She had period of stability in the community between 2006 and 2016 but on October 13ih 2016 her condition worsened and she was admitted to the Mental Health Unit; Royal Glamorgan Hospital: From admissions she was transferred to Ward 22 0n 1st November 2016. She was discharged on 218 November 2016 but took a overdose on 24lh November and a serious suicide attempt on 8th December: She was again admitted to the admissions ward after two days and then on 4th January 2017 was transferred to Ward 22 again. She remained on that ward until her death on 10ih April 2017 , She was made subject to a Section 3 Mental Health Act order on 21s' February 2017 and this was continued until her death: Deidre suffered from several concomitant physical condition including Systemic Lupus Erythematosus for which she was prescribed the drug Hydroxychloroquine This had been administer34ed to her at 200 mg per mid-November 2016 until her death. At the time of her death blood analysis showed that she had accumulated toxic levels of this drug in her system (more than 15 mgIDL which is above the level at which cardiac arrhythmias have been noted (3.6 mgIL) and death (7.5 mgIDL): In the event however the pathologist did not attribute Deidre s death to Hydroxychioroquine toxicity: Deidre's mood from January to April was fluctuating: The team on Ward also struggled to get her hyponatraemia under control and this compromised both the individual mood stabilisers ad anti-depressants they were able t0 give,as well as the the long HDU, day from quantity at which they were able to give them: The team said they planned to give ECT but this not been administered by the 1h April 2017. While the Hydroxychloroquine continued to be administered there was no dialogue between the mental health ward and the consultants treating her other conditions (dermatology and gynaecology): In February 2017 Deidre cut her wrists (13/2) and on the 20ih February 2017 she made a disclosure to a nurse that she had attempted to herself with a dressing gown cord. She was placed on a Section 3 Mental Health Act order on the 21s February. In March Deidre and her daughter both reported that she was putting on a front, or putting on a mask. Her mood fluctuated but she made comments that she wanted to end it On 10th April 2017 she appea4rd to be brighter and looking forward to going She went to the communal bathroom on the ward and told staff that she was having a shower at 8.40 am At 8.55 am staff went into the bathroom and found that Deidre had died after attaching a ligature to her neck ligature used was dressing gown cord which had previously been removed from her after a threat she made to herself with it, The cause of death was given by the pathologist as Ia Hanging:

Action should be taken

In my opinion action should be taken to prevent future deaths and believe that you have the power t0 take such action.

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