Prevention of Future Deaths reports · 2023
Regulation 28 report to prevent future deaths, reference 2023-0070, written 22 Feb 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 22 Feb 2023 |
|---|---|
| Reference | 2023-0070 |
| Deceased | Jacqueline Campbell |
| Coroner | Sean Cummings |
| Coroner area | Milton Keynes |
| Category | Alcohol, drug and medication related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
Regulation 28: REPORT TO PREVENT FUTURE DEATHS NOTE: This form is to be used after an inquest. REGULATION 28 REPORT TO PREVENT DEATHS THIS REPORT IS BEING SENT TO: 1 Hilltops Medical Centre, Kensington Drive, Great Holm, Milton Keynes 2 3 Community Services - NHS England National Director for Primary Care and Keynes Integrated Care Board - Chief Medical Director, Bedfordshire, Luton and Milton 1 CORONER I am Sean CUMMINGS, Assistant Coroner for the coroner area of Milton Keynes 2 CORONER’S LEGAL POWERS I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. 3 INVESTIGATION and INQUEST On 04 July 2022 I commenced an investigation into the death of Jacqueline Sharman CAMPBELL aged 56. The investigation concluded at the end of the inquest on 08 February 2023. The conclusion of the inquest was that: Ms Jacqueline Sharman Campbell died on the 30th June 2022 at her home address. She had battled chronic backpain for more than 20 years. It was difficult to manage. She was prescribed large doses of gabapentin, tramadol and amitriptyline. She was also prescribed fentanyl patches and oral diazepam. She likely inadvertently overdosed on tramadol and that, in combination with the other medicines, all possessing the ability to depress the central nervous system, had the synergistic effect of causing respiratory depression and death. 4 CIRCUMSTANCES OF THE DEATH Ms. Campbell was medically retired. She worked for Transport for London and had an accident over 20 years ago where she injured her back. This resulted in continuing chronic back pain for which she took prescribed medication. Family report that she was not very good at managing this medication. During the late evening of Wednesday the 29th of June 2022 Jace Campbell, the son of Jacqueline came home and found his mother collapsed in her ensuite bathroom. Other family members have been contacted and came to Jace’s assistance. Paramedics were called but they were unable to save Jacqueline and they confirmed her death on the 30th of June 2022. 5 CORONER’S CONCERNS During the course of the investigation my inquiries revealed matters giving rise to concern. In my opinion there is a risk that future deaths could occur unless action is taken. In the Regulation 28 – After Inquest Document Template Updated 30/07/2021 circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows: (brief summary of matters of concern) , , gabapentin and fentanyl , amitriptyline to be applied every 72 hours. Ms Campbell had experienced a work-place related accident approximately 20 years prior to her death when she had fallen off a broken chair at work. She suffered with back pain, which became chronic, thereafter. She had a number of interventions including referral and attendance at pain clinics, manual therapy, CBT and pharmaceuticals. During her time with pain no clear cause was identified on MRI and other imaging. She was treated for chronic low back pain of indeterminate cause. Over the years she was treated with multiple, and escalating doses of, medications. These included at the time of her death, diazepam tramadol patches She was found collapsed at home in her bathroom and there was a possibility of a positional component to the respiratory depression consequent on the long-lie. The medical cause of death was given by the pathologist as 1a Central Respiratory Depression 1b Tramadol excess with fentanyl II Long lie following a fall, chronic post traumatic back injury. The police and paramedics attending the scene describe the finding of “hundreds” of packets of medications, some opened, some unopened. This polypharmacy was identified by the pathologist who conducted the post mortem (taking from the toxicology report) as “In summary, excess Tramadol ( metabolite ( death. Although lower than levels typically seen in fatalities, the moderate excess in conjunction with other prescribed drugs, most notably fentanyl are sufficient to have produced central respiratory depression. No other significant post mortem findings were noted, and the prolonged lie following a fall may well have contributed a postural component to the respiratory depression” Her GP, management of patients who describe intractable debilitating pain is challenging and difficult and that requests for other or increasing doses of medication can be difficult to resist. to be dangerous. He told me that after a certain point the benefits of increasing or adding doses or medications in terms of pain relief were minimal. This scenario seems to be an invidious one for GP’s and patients alike. agreed that the prescribing of the various drugs identified had potential ) are indicative of recent moderately excessive ingestion prior to , gave clear and candid evidence. I accept the ) and a told me that subsequent to Ms Campbell’s death the practice had convened and discussed the circumstances and agreed on regular reviews for patients taking these sorts of medication. There were no plans identified to actively look for these patients and to work to rationalize and / or reduce their medications. I am of the view that polypharmacy including gabapentinoids and opiates represents a severe safety risk in patients with a iatrogenic drug dependency. I consider that the risk in individuals like Ms Campbell of an inadvertent overdose of medications which have a cumulative and synergistic effect to depress the central nervous system can easily become extreme and lead to death. There have been a number of deaths in the Milton Keynes, Bedfordshire and Luton areas related to concomitant use of high dose and combination gabapentinoids and opioids. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe you (and/or your organisation) have the power to take such action. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by April 19, 2023. I, the coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the Regulation 28 – After Inquest Document Template Updated 30/07/2021 timetable for action. Otherwise you must explain why no action is proposed. 8 COPIES and PUBLICATION I have sent a copy of my report to the Chief Coroner and to the following Interested Persons I have also sent it to who may find it useful or of interest. I am also under a duty to send a copy of your response to the Chief Coroner and all interested persons who in my opinion should receive it. I may also send a copy of your response to any person who I believe may find it useful or of interest. The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a copy of this report to any person who he believes may find it useful or of interest. You may make representations to me, the coroner, at the time of your response about the release or the publication of your response by the Chief Coroner. 9 Dated: 22/02/2023 Sean CUMMINGS Assistant Coroner for Milton Keynes Regulation 28 – After Inquest Document Template Updated 30/07/2021
2 responses published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
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Partners:
Associates:
Coroners Office
Via email
19th April 2023
Re: Ms. Jacqueline Campbell
Thank you for the Section 28 Report dated 22.02.2023. You have requested a response to
this report from Hilltops Medical Centre outlining the actions we have taken and proposed
actions with the timeline.
We have reviewed this case in depth and have taken the following actions.
1) Following the unexpected death on 30/06/2022- We discussed this in our weekly Multi-
Disciplinary Meeting on 1/7/2022 to review the care provided.
2) In March 2022 we carried out an audit of patients on high dose opioids ( > 120mg oral
morphine equivalent) and arranged a review of these patients. We repeated this Audit in
November- December 2022 and are currently in the process of redoing this audit and
consideration given to dose reduction where appropriate.
3) Practice pharmacist and prescribing lead attended the Opiate Prescribing session during
Protected Learning time and shared in our Multi-Disciplinary Meeting on 25/03/2022.
4) We have identified other patients on combination of
Opiates+Gabapentinoids+Benzodiazepines/Z-drugs who have now been reviewed.
5) We are ensuring that these patients are reviewed 3 monthly, with robust recall systems in
place, preferably face to face and with named clinician to review and rationalise the
medication.
6) We have also identified patients on a combination of opioids and benzodiazepines and are
arranging reviews for these patients currently.
7) We have discussed and agreed that patients on a combination of
Opiates+gabapentinoids+Benzodiazepines/Z drugs are reviewed 3 monthly and patients on
high dose Opioids are reviewed 6 monthly. We agreed to use the Arden’s ‘Opioid Initiation
and Monitoring’ template during the reviews to ensure all areas of review are covered.
8) We had a meeting with the Integrated care Board on 9/3/2023 discussing about completing
a Significant Event Analysis. Discussion about Medicine Management personnel from the
Kensington Drive, Great Holm, Milton Keynes MK8 9HN
01908 568446
www.hilltopsmedicalcentre.org
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Integrated care Board coming into the practice, who visited on the 17/4/2023 to support run
searches/identify patients.
9) We are liaising with the Integrated Care Board to enquire about other services available and
have been advised they are currently working on this aspect.
10) The Primary Care Network prescribing lead has presented the case in the regional meeting
to share with other clinicians and Integrated Care Board Medication safety group, other
regions in Integrated Care Board and Commissioning Services.
11) The practice has arranged a meeting for the clinicians to review the NICE guidelines on safe
prescribing/managing drugs that can cause dependence and withdrawal (NG215), NICE
guidelines on Assessment and Management of Chronic pain in over 16s ( NG193) and
General Medical Council- Good Practice in Prescribing and Managing Medicines and Devices.
Thanking you,
Yours Sincerely,
General Practitioner
Kensington Drive, Great Holm, Milton Keynes MK8 9HN
01908 568446
www.hilltopsmedicalcentre.org
Mr Sean Cummings
The Coroner’s Office
Civic Offices
1 Saxon Gate East
Central Milton Keynes
MK9 3EJ
Dear Mr Cummings,
National Medical Director
NHS England
Wellington House
133-155 Waterloo Road
London
SE1 8UG
17 April 2023
Re: Regulation 28 Report to Prevent Future Deaths – Ms Jacqueline Campbell
who died on 30 June 2022
Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 22
February 2023 concerning the death of Ms Jacqueline Campbell on 30 June 2022. In
advance of responding to the specific concerns raised in your Report, I would like to
express my deep condolences to Jacqueline’s family and loved ones. NHS England
are keen to assure the family and the coroner that the concerns raised about
Jacqueline’s care have been listened to and reflected upon.
NHS England is the facilitator of system partners in their work to deliver the 2019
Public Health England (PHE)’s 'Dependence and withdrawal associated with some
prescribed medicines: an evidence reviews' (the review) recommendations. These
system partners include the Department of Health and Social Care (DHSC), Arm's
Length Bodies (ALBs) including the National Institute for Health and care Excellence,
(NICE), Care Quality Commission (CQC), Medicines and Healthcare products
Regulatory Agency (MHRA) and Health Education England (HEE) to ensure cross
system improvements can be delivered. NHS England is not responsible for the
implementation of recommendations assigned to other organisations.
The National overprescribing review report commissioned by DHSC in 2018 evaluated
the extent, causes and consequences of overprescribing and made 20
recommendations to address it. NHS England aims to make long term sustainable
reductions to overprescribing and is working on several outputs to help implement the
review’s recommendations. Outputs include national resources to help practices
improve the consistency of repeat prescribing processes, supported by appropriate
training; and resources to enhance structured medication reviews for patients who
may experience harm from taking multiple medicines.
The NHS Medicines Safety Improvement Programme (which forms a key part of the
NHS Patient Safety Strategy) has launched a focussed programme of work to improve
the care of people with chronic pain and a reduction in the use of prescribed opioids
by aiming to reduce harm from opioid medicines by reducing high dose prescribing
(>120mg oral Morphine equivalent), for non-cancer pain by 50%, by March 2024. 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.
As of 31 March 2023, 17 Integrated Care Systems will be receiving intensive support
to develop and implement improvements in care and a further 17 will be participating
in shared learning events.
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 by:
a. Optimising personalised care for adults prescribed medicines associated with
dependence or withdrawal symptoms.
b. Informing ICB (Integrated Care Boards) 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.
c. Ensuring a whole system approach and pathways involving multiple
interventions, to improve care for people prescribed medicines associated
with dependence and withdrawal symptoms.
Additionally, the National Institute for Health and Care Excellence (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.
Commissioning of services to support people with chronic pain (including services to
support people to safely withdraw from opioid use) now lies with ICBs. NHS England
expects ICBs to commission appropriate services to meet the needs of the population
that the ICB geographically covers.
We have been sighted on the response from Bedfordshire, Luton and Milton Keynes
Integrated Care Board (BLMK ICB) who advise that Hilltops Surgery regularly
undertake an opiate prescribing audit. This is to identify patients on high doses of
opioids and flags that a conversation with the patient is needed to look at reducing
their medication. The Surgery advises that discussions took place with Ms Campbell
on multiple occasions to look at reducing her medication and that other patients have
also been identified through this audit. We note that a conversation has taken place
with the ICB on how this cohort of patients require their medication reviews to be
undertaken more frequently and that the ICB will continue to work to review medicines
management for patients with multiple prescriptions where there may be safety
implications.
Hilltop Surgery also advised that they have implemented improvements to their
prescribing processes to include ensuring face to face medication reviews with
patients and operating a call and recall system that ensures the number of prescription
reauthorisations are limited to three before a next review takes place.
I would also like to provide further assurances on national NHSE 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 preventable deaths are shared across the NHS at both a national
and regional level and helps us 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.
Yours sincerely,
National Medical Director
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