Prevention of Future Deaths reports · 2021
Regulation 28 report to prevent future deaths, reference 2021-0127, written 7 May 2021. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 7 May 2021 |
|---|---|
| Reference | 2021-0127 |
| Deceased | Helen Spicer |
| Coroner | Guy Davies |
| Coroner area | Cornwall and the Isles of Scilly |
| Category | Alcohol, drug and medication related deaths · Community health care |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
Information Classification: CONTROLLED REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1) REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. Dr Drugs , Chair of the Advisory Council on the Misuse of 2. Nadine Dorries, Minister of State for Mental Health, Suicide Prevention and Patient Safety 1 CORONER I am Guy Davies, Her Majesty’s Assistant Coroner for Cornwall & the Isles of Scilly. 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. [HYPERLINKS] 3 INVESTIGATION and INQUEST On 8th February 2019 I commenced an investigation into the death of 43 year old Helen Spicer. The investigation concluded at the end of the inquest on 16th April 2021. The conclusion of the inquest was as follows • Drug Related Death The four statutory questions – who, how, when and where were answered as follows • Helen Louise SPICER died on 4 October 2018 at Royal Cornwall Hospital Truro from an unintentional overdose of prescription morphine against a background of opiate dependency following treatment of chronic pain due to fibromyalgia. The medical cause of death was recorded as • 1a acute opioid toxicity with high tolerance • 1b fibromyalgia with long term opioid requirement • II Poorly controlled type 2 diabetes with established end organ damage and fatty liver Information Classification: CONTROLLED 4 CIRCUMSTANCES OF THE DEATH Helen was admitted to Royal Cornwall Hospital Truro on 1st October 2018 with with diarrhoea and vomiting. Helen’s regular medications on admission included oral morphine on an as required basis. Helen was in pain throughout her admission and received morphine on a controlled and limited basis. The findings of fact included the following. • Sometime after her admission on 1st October 2018 Helen acquired oramorph, without the knowledge of the medical team that were treating Helen. • These of oramorph were lawfully dispensed on 2nd October 2018 following the presentation of a prescription issued to Helen. • Helen consumed her death. during her admission prior to • The toxicology revealed that Helen consumed a significant quantity of oramorph after midnight on 4th October 2021, sufficient to cause her death at 5am that same morning. • The investigation and inquest were unable to ascertain who collected that morphine from the chemist on 2nd October 2018. This is because there are no requirements in relation to the dispensing of liquid morphine as regards the need for the prescription to be signed for on collection. • The Misuse of Drugs Regulations SI 2001 No.3998 sets out ‘Regimes of Control’ by dividing controlled drugs into 5 schedules in descending order of control, the most stringent controls applying to schedule 1 (Pharmacy and Medicines Law pg.215). Depending on the preparation, the same drug might be classified in more than one schedule. Morphine is classed as a Schedule 2 controlled drug for almost all preparations (injections, capsules, tablets, suppositories, granules and concentrated oral solution), however the morphine sulphate oral solution is classified as a schedule 5 controlled drug (BNF 78 page 465). Schedule 5 preparations are deemed as having negligible risk of abuse. There are no restrictions on the import, export, possession or administration of these preparations, and safe custody requirements do not apply to them (including the need for them to be signed for when collecting from a community pharmacy) (Pharmacy and Medicines Law pg.218). This is despite a morphine sulphate oral solution (schedule 5) containing the same of morphine sulphate quantity of morphine (schedule 2). • There is a risk of abuse of oral morphine. 5 CORONER’S CONCERNS During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths will occur unless action is taken. In the circumstances it is my statutory duty to report to you. Information Classification: CONTROLLED The MATTERS OF CONCERN are as follows. – The absence of restrictions on the import, export, possession or administration of oral morphine, and the fact that safe custody requirements do not apply to them, including the need for them to be signed for when collecting from a community pharmacy. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe you and your organisation have the power to take such action. I would be pleased to hear from you in relation to these concerns. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 2nd July 2021. I, the coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the 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. • • , Helen’s husband , Helen’s father and mother I have also sent it to who may find it useful or of interest. , Chief Pharmacist, Royal Cornwall Hospital. I am also under a duty to send the Chief Coroner a copy of your response. 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 7th May 2021 Guy Davies
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.
Information Classification: CONTROLLED From: ACMD To: Guy Davies Cc: ACMD Subject: RE: Regulation 28 report on the death of Helen Louise Spicer Dear Mr Davies, Thank you for setting out your concerns in the Regulation 28 notice about a death which involved the unintentional overdose of morphine sulfate oral solution . The role of the Advisory Council on the Misuse of Drugs (ACMD) is to keep under review the situation in the UK with respect to drugs which are being or appear to them likely to be misused and of which the misuse is having or appears to them capable of having harmful effects sufficient to constitute a social problem. Firstly, I would like to set out the work which has already been completed by the ACMD on this important issue. In 2016, the ACMD published a major report on diversion and illicit One of the recommendations supply of medicines: in that report concerned setting up a monitoring system for emerging prescribed substances with the potential for diversion and illicit supply. The ACMD’s Secretariat has recently developed a standard operating procedure and a watch-list for medicines misuse as proposed in the report above which will be overseen by the ACMD’s Technical Committee going forward. In fulfilment of that recommendation, a number of Government departments have agreed to provide information relevant to misuse of prescription medicines and to make this information available to the ACMD. I would like to assure you that there are currently actions being taken forward by the ACMD. The ACMD has published a standard operating procedure on the use of evidence in ACMD reports. This SOP details how the ACMD collects, analyses and presents evidence in reports, available at: The Regulation 28 notice was discussed at a recent ACMD Full Council meeting, where the ACMD agreed that there was a need to gather more information on the scale of the issue, being mindful of the legitimate use of morphine sulfate solution. The ACMD has interaction with the MHRA through representation at ACMD meetings and data provided from the Yellow Card System. The MHRA are able to raise any issues concerning misuse of medicines to the ACMD. The ACMD will also request information from DHSC and NHS-E&I regarding patient safety incidents recorded throughout the National Reporting and Learning System (NRLS) to help us assess the evidence. Best regards, Secretary to the ACMD
From the Lord Bethell Parliamentary Under Secretary of State for Innovation 39 Victoria Street London SW1H 0EU Mr Guy Davies HM Assistant Coroner, Cornwall & the Isles of Scilly HM Coroner's Office The New Lodge Newquay Road Truro TR4 9AA 12 July 2021 Dear Mr Davies Thank you for your letter of 7 May 2021 about the death of Helen Spicer. I am replying as Minister with responsibility for medicines. Firstly, I would like to say how saddened I was to read of the circumstances of Helen Spicer’s death and I offer my sincere condolences to her family and loved ones. The circumstances your report describes are very concerning and I am grateful to you for bringing these matters to my attention. Decisions on the scheduling of controlled drugs under the relevant legislation are taken by the Home Office. This is done with the provision of advice from the Advisory Council on the Misuse of Drugs (ACMD) and any decisions made by the ACMD weigh up the risks of misuse, abuse and diversion, against not impeding legitimate use within healthcare. I note that you have issued your report to the ACMD and am aware that it has responded to you directly on this matter. I can assure you that the Department of Health and Social Care, and its Arm’s Length Bodies, work closely with the Home Office and the ACMD to help inform such decisions. In relation to the wider context and the increasing concern internationally and here in the UK, about the overuse and misuse of opioids leading to a growing problem of dependence and addiction, I would like to outline the range of action that has been taken to protect patients from harm. In 2017, the Government asked Public Health England (PHE) to conduct an evidence review to identify the scale, distribution and causes of prescription drug dependence, and what might be done to address it. PHE’s report of the review was published in September 20191, providing evidence for dependence on, and withdrawal from, prescribed medicines, with the aim of making sure that local healthcare systems build awareness and support to enhance clinician and patient decision making. In support of this, NHS England and NHS Improvement (NHSEI) is co-ordinating a programme to implement the recommendations of the review, working closely with relevant health system partners. The programme covers five classes of medicines including benzodiazepines; Z-drugs; gabapentinoids; opioids, for chronic non-cancer pain; and antidepressants. The Medicines and Healthcare products Regulatory Agency (MHRA) recently reviewed the risk of addiction and dependence with opioid medicines, as a result of which, all opioid medications now carry prominent front-of-pack warnings that the product contains opioids and may cause addiction. In addition, warnings on the risk of dependence in product information have been strengthened and harmonised. The MHRA has also worked closely with stakeholders and Trades Associations to develop an additional, user-tested, safety information leaflet for distribution directly to patients at pharmacies and on the MHRA government website. Finally, since October 2020, Primary Care Networks of GPs have been required to identify and prioritise patients, including patients using potentially addictive pain management medication, who would benefit from a structured medication review2. You may also wish to note that further to the February 2020 update to the GP contract agreement 2020/21 to 2023/243, a Quality Improvement Module in the Quality and Outcomes Framework for general practice on preventing prescription drug dependency is in development. I hope this response is helpful. LORD BETHELL 1 Prescribed medicines review: summary - GOV.UK (www.gov.uk) 2 Report template - NHSI website (england.nhs.uk) 3 Criteria for registration as a pharmacy technician in Great Britain (england.nhs.uk)
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