Source · Prevention of Future Deaths

Helen Spicer

Ref: 2021-0127 Date: 7 May 2021 Coroner: Guy Davies Area: Cornwall and the Isles of Scilly Responses identified: 2 / 1 View PDF

Oral morphine lacks sufficient controls, including import/export restrictions and safe custody requirements, making it easy to obtain without accountability.

Date 7 May 2021

56-day deadline 2 Jul 2021 est.

Responses identified 2 of 1

Alcohol, drug and medication related deaths Community health care and emergency services related deaths

Coroner's concerns

AI summary

Oral morphine lacks sufficient controls, including import/export restrictions and safe custody requirements, making it easy to obtain without accountability.

View full coroner's concerns

Information Classification: CONTROLLED

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.

Responses

2 respondents

Department of Health and Social Care Central Government

12 Jul 2021 PDF

Noted

The Department of Health and Social Care acknowledges concerns about opioid overuse and misuse. They outline actions taken, including a PHE evidence review, front-of-pack warnings on opioid medications, and structured medication reviews in primary care. (AI summary)

View full response

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)

ACMD Local Authority / Fire Service

PDF

Action Planned

The ACMD acknowledges the concerns and will gather more information on the scale of the issue of morphine sulfate solution misuse, being mindful of its legitimate use. They will request information from DHSC and NHS-E&I regarding patient safety incidents. (AI summary)

View full response

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 supply of medicines: One of the recommendations 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

Report sections

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

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 during her admission prior to her death.
• 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 quantity of morphine of morphine sulphate (schedule 2).
• There is a risk of abuse of oral morphine.

Similar PFD reports

Shared signals

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Report details

Reference: 2021-0127
Date of report: 7 May 2021
Coroner: Guy Davies
Coroner area: Cornwall and the Isles of Scilly

Responses identified

Responses identified 2 of 1

All listed responses identified

Organisations named in PFD reports are normally expected to respond within 56 days. Deadline: 2 Jul 2021 (estimated).

Sent to

Chair of the Advisory Council on the Misuse of Drugs and Minister of State for Mental Health, Suicide Prevention and Patient Safety

Source links

Judiciary.uk page → Report PDF →

Data: judiciary.uk under OGL.