Jacqueline Campbell

Coroner's concerns

AI summary

Dangerous polypharmacy involving escalating doses of synergistic pain medications led to central respiratory depression, exacerbated by difficulties for GPs in managing drug dependency and a lack of proactive medication review protocols.

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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 , amitriptyline , tramadol , gabapentin and fentanyl patches to be applied every 72 hours. 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 ( ) and a metabolite ( ) are indicative of recent moderately excessive ingestion prior to 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, , gave clear and candid evidence. I accept the 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. agreed that the prescribing of the various drugs identified had potential 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. 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.

Responses

2 respondents

NHS England NHS / Health Body

22 Feb 2023 PDF

Noted

NHS England expresses condolences and explains its role as a facilitator for system partners working to deliver recommendations from a Public Health England review on prescribed medicines. It describes national resources and notes actions taken by the BLMK ICB and Hilltop Surgery regarding opiate prescribing audits and medication reviews. The response also mentions a working group that shares learnings from PFD reports. (AI summary)

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Dear Mr Cummings,

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

17 April 2023

(>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.

Hilltops Surgery

19 Apr 2023 PDF

Action Taken

Hilltops Surgery reviewed the case, audited patients on high-dose opioids, ensured 3-monthly reviews for certain patient groups, discussed the case with the Integrated Care Board, and arranged a meeting to review NICE guidelines on safe prescribing. The surgery also implemented face-to-face medication reviews and a call-and-recall system. (AI summary)

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kkkk

Kensington Drive, Great Holm, Milton Keynes MK8 9HN

01908 568446

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

kkkk

Kensington Drive, Great Holm, Milton Keynes MK8 9HN

01908 568446

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,

Report sections

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.

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.

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