Prevention of Future Deaths reports · 2024
Regulation 28 report to prevent future deaths, reference 2024-0312, written 4 Jun 2024. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 4 Jun 2024 |
|---|---|
| Reference | 2024-0312 |
| Deceased | Nigel Dixon |
| Coroner | Isobel Thistlethwaite |
| Coroner area | Rutland and North Leicestershire |
| Category | Alcohol, drug and medication related deaths · Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | University Hospitals of Leicester NHS Trust |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
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: The Right Hon. Lucy Frazer KC MP, the Secretary of State for Digital Culture, Media and Sport The Right Hon. Victoria Atkins MP, the Secretary of State for Health and Social Care 1 CORONER I am Miss I THISTLETHWAITE, His Majesty's Assistant Coroner for the coroner area of Rutland and North Leicestershire. 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 20 February 2023 I commenced an investigation into the death of Nigel Walter DIXON aged 64. The investigation concluded at the end of the inquest on 4 June 2024. The conclusion of the inquest was: Drug related death The cause of death was established as: I a Morphine and Zopiclone Toxicity I b I c II 4 CIRCUMSTANCES OF THE DEATH Mr Dixon was a 64 year old male who lived alone. A visitor to his property was unable to rouse him on Monday 13 February 2023. Entry was gained by the Fire Service and Mr Dixon was found dead inside. Regulation 28 – After Inquest Document Template Updated 16/05/2023 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 circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows: Pre-amble Mr Dixon was a 64 year old male, an army veteran who served his country as part of an elite unit. He had a past medical history including physical and mental health issues including depression, suicide attempts, being sectioned, chronic alcohol misuse and an opiod dependence. Mr Dixon’s GP monitored him closely in the community and they worked together to reduce the number of prescription drugs Mr Dixon was taking, stopping the prescribing of Zopliclone then Diazepam. Mr Dixon was in the process of being weaned off morphine with the support of his GP when he was admitted to hospital on 3 February 2023 for an opiate overdose. Whilst an inpatient Mr Dixon had an abrupt cessation of his morphine use. Mr Dixon was discharged from hospital on 7 February 2023. The hospital discharge letter was not actioned and Mr Dixon was able to access one weeks’ worth of morphine which had been prescribed to him and the prescription post-dated prior to his stay in hospital. Mr Dixon was found dead at home on 13 February 2023 and at post-mortem his cause of death was found to be 1a) Morphine and Zopiclone Toxicity. Mr Dixon was able to access one weeks’ worth of morphine from his community pharmacy when he was discharged from hospital due. I heard evidence at inquest of improvements to the use of a system at the University Hospitals of Leicester NHS Trust, PharmOutcomes, which will, on the balance of probabilities, prevent this situation arising again by ensuring that the Hospital Pharmacist communicates the cessation of drugs like morphine to community pharmacies. Mr Dixon was honest with his GP about the fact he purchased drugs online to supplement his prescriptions. In August 2017 he advised his GP that he was taking Zopliclone tablets every two weeks, this is 6 times the licenced amount of Zopiclone. Mr Dixon was not being prescribed Zoplicone at the time of his death, his GP stopped prescribing it to him in 2017. Mr Dixon’s family provided me with documentary evidence of him purchasing drugs online before he died, one of those documents is a receipt dated 1 February 2023 . I found, on the balance of probabilities, that the Zopliclone in Mr Dixon’s system at the time of his death was supplied by Concerns Mr Dixon was able to purchase Zopliclone tablets online from a company The GP who gave evidence at the inquest described this as a “huge” amount of the drug. She Regulation 28 – After Inquest Document Template Updated 16/05/2023 tablets in one go confirmed that she would only prescribe 28 days’ worth of Mr Dixon was able to ( purchase). The selling of tablets which are a larger dose and in a much larger quantity than would ordinarily be prescribed online risks an accidental or intentional overdose of the drug and also risks the drug being sold on the black market. The evidence of the GP is it is hard to prescribe safely to people who are supplementing their prescription drugs with online purchases. Further, she raised concerns about the safety and quality control of the drugs being supplied. The evidence of the GP was that the company who supplied these drugs to Mr Dixon did not contact the GP Practice to discuss their suitability or check Mr Dixon’s medical history, nor did they inform the GP’s Practice of the purchase. I have concerns about the dosage of the tablets purchased by Mr Dixon which are larger than those that a GP would prescribe, and also the quantity of the tablets that Mr Dixon was able to purchase. It is gravely concerning that powerful drugs are available online so freely and in such large quantities, with little to nothing in the way of checks and balances around who the drugs are being sold to. There seems to be no regulation of the supply of these drugs and that seems to me to inevitably put the lives of vulnerable people at risk. In this case there was no communication with Mr Dixon’s GP and I would imagine there is no way for these online companies to check whether their customers are placing duplicate orders with other websites, there seems therefore to be a situation where one could purchase almost limitless amounts of these drugs with no checks or balances at all. There seems to be no system for establishing the suitability of the purchaser, nor a system to limit the amount or frequency of medication being purchased. In short, there was no protection offered to Mr Dixon by the online company who sold him these, and other drugs, and it is clear that the drugs purchased from the company have contributed to his death. I understand that other Coroners have raised concerns about the supply of drugs online, and in particular in relation to the gaps in regulation of that industry in other PFD reports. As detailed above, I share those concerns. 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 July 30, 2024. 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. COPIES and PUBLICATION 8 I have sent a copy of my report to the Chief Coroner and to the following Interested Persons The University Hospitals of Leicester NHS Trust Leicestershire Partnership NHS Trust , Mr Dixon’s daughters Regulation 28 – After Inquest Document Template Updated 16/05/2023 Long Lane Surgery 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: 04/06/2024 Miss I THISTLETHWAITE His Majesty's Assistant Coroner for Rutland and North Leicestershire Regulation 28 – After Inquest Document Template Updated 16/05/2023
1 response 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.
From Minister of State for Health 39 Victoria Street London SW1H 0EU 08 August 2024 Our ref: Miss I Thistlethwaite HM Assistant Coroner Rutland and North Leicestershire area HM Coroner's Office Leicestershire County Council County Hall Glenfield Leicester LE3 8RA By email: Dear Miss Thistlethwaite, Thank you for the Regulation 28 report of 4 June 2024 sent to the Department of Health and Social Care about the death of Mr Nigel Walter Dixon. I am replying as the Minister with responsibility for medicines regulation. Firstly, I would like to say how saddened I was to read of the circumstances of Mr Dixon’s death, and I offer my sincere condolences to their family and loved ones. The report raises concerns over how Mr Dixon was able to obtain large quantities of online from an illicit suppler, without the knowledge of Mr Dixon’s GP. I share the desire to learn from Nigel’s death and it is essential that we do all we can to reduce the risks to patient safety from online supply of illicit medicines. In preparing this response, Departmental officials have made enquiries with the Department for Science, Innovation and Technology (DSIT), the Medicines and Healthcare products Regulatory Agency (MHRA), and the General Pharmaceutical Council (GPhC), as the independent regulators of medicine and pharmacy, respectively. Enforcement action against illicit trade of medicines The GPhC regulates pharmacists, pharmacy technicians and pharmacies in Great Britain. is not a business registered with the The company GPhC and operates outside the UK jurisdiction. As such, this matter falls to the MHRA. From Minister of State for Health 39 Victoria Street London SW1H 0EU The MHRA, acting on behalf of the Secretary of State for Health and Social Care, is responsible for the regulation of all medicines and medical devices in the UK by ensuring they work and are safe. This includes applying the legal controls on the retail sale, supply and advertising of medicines which are set out in the Human Medicines Regulations 2012. These regulations apply equally to medicines advertised, sold, or supplied via the internet. The MHRA and its Criminal Enforcement Unit also actively seeks to identify individuals involved in unlawful activity and, where appropriate, prosecute those who put public health at risk. The efforts of the MHRA and its partners in this regard, have led to increasing levels of medicines being seized, significant custodial sentences for offenders, the forfeiture of criminal profits and considerable disruption to the illegal trade online. In 2023, the MHRA and its partners seized more than 15.5 million doses of illegally traded medicines with a street value in excess of £30 million. It also disrupted more than 15,000 links to websites and social media pages selling medical products to the public illegally. However, the sale and supply of unregulated medicinal products is a global problem. Online portals play a significant role in transnational medicines crime and many websites proliferate across the internet. Currently, there is no legal mechanism for UK law enforcement to seize control of illicit domains or compel registrars to suspend them when domains are registered beyond the reach of UK jurisdiction. The website referenced in the Regulation 28 notice falls into this category, being registered outside of the UK. The MHRA can confirm that the website in question is subject to an active criminal investigation, and that arrests had been made prior to the issuing of the Regulation 28 Report. The MHRA has also issued multiple formal requests to the registrar (the company that manages the website's domain name) to suspend the website, which has thus far been unsuccessful. Other MHRA efforts to minimise the risk this website poses to the public have included: • Delisting from the UK’s major search engine providers, meaning the offending website has been removed from standard search results. • Website added to British Telecom’s parental blocking list, rendering it barred to customers with active parental controls. • Website details passed to anti-cybercrime partners in the internet industry for further attempts at takedown. • Request sent to the registry (the provider of domain name registry services and internet infrastructure) for takedown. From Minister of State for Health 39 Victoria Street London SW1H 0EU Through a combination of public empowerment, technological innovation, traditional methods of law enforcement and close collaboration with partners, the MHRA is constantly working to develop new and innovative ways to tackle the online trade in illegal medicines. Some of these future criminal countermeasures will include: • Enhanced collaboration with search engines and UK internet service providers (ISPs) aimed at blocking harmful content through targeted ISP-filtering. • Collaboration with the Office of Communications (Ofcom) to explore fresh preventative opportunities presented by the Online Safety Act (further details below), which will create new rules for social media companies and search engine providers. • Boosted collaboration with UK Border Force, allowing the MHRA to grow its operational footprint at the border and increase the seizure rates of illegally trafficked medicines. • The use of cutting-edge technology to identify, track and seize the proceeds of crime, including cryptocurrency. • • Rollout of a web-based online pharmacy checker that will allow users to search if a website or social media listing has been deemed fraudulent by the MHRA. Implementation of a web-based reporting scheme allowing users to report suspicious websites, online marketplaces, and social media listings to the MHRA. internet law to enhancing collegiate working across • Continued commitment including private sector and international infrastructure community, enforcement partners. DSIT has also taken steps to tackle criminal activity online. The Online Safety Act (the ‘Act’) received Royal Assent in October 2023. The Act will require search services and platforms that facilitate user-to-user interactions to take robust action to protect their users from harm and illegal content and activity. Under the Act, user-to-user platforms such as online marketplaces are required to put in place systems to reduce the risk their services are used for sales of illegal drugs and other ‘priority offences’. Search services will also have duties to reduce the risk that users will encounter content amounting to priority offences in search results or when they click on them. Offences designated as ‘priority offences’ reflect the most serious and prevalent illegal content and activity, such as the sale of illegal drugs or weapons and the promotion or facilitation of suicide. From Minister of State for Health 39 Victoria Street London SW1H 0EU Ofcom is the independent regulator of the Act’s regime and is taking a phased approach to implementation. The illegal content safety duties in the Act are expected to take effect in early 2025. Ofcom will have robust powers to take enforcement action against companies who do not comply with their new duties and protect users from harm. Following the change of government, DSIT will be considering the issues raised in the report very carefully in deciding how to move forward in ensuring greater online safety. Improving communication between secondary care and community pharmacy Whilst the primary concern of the report is the illicit supply of medicines, the report also identifies concerns in the communication between secondary care and the community pharmacy charged with dispensing Mr Dixon’s prescriptions. The Discharge Medicines Service (DMS) is an essential service provided by all community pharmacy contractors in England, which enables hospitals to refer discharged patients to community pharmacies for support. By referring patients to community pharmacy on discharge with information about medication changes made in hospital, community pharmacy can better support patients to improve outcomes and prevent harm, making sure the patient and primary care prescriber do not inadvertently continue with legacy medicine regimes. Although there is currently no contractual requirement for NHS trusts to participate in the DMS, it is recommended that clinical staff refer eligible patients to community pharmacy into the DMS in the interests of patient safety and in line with their professional responsibility. NHS England has been actively promoting this service to hospital chief pharmacists, to further facilitate its implementation and will introduce improved IT to improve the interoperability between the two settings to remove existing barriers preventing Trusts from fully engaging with the service. If the University Hospitals of Leicester NHS Trust had completed a DMS referral via their chosen IT provider (such as PharmOutcomes - as referenced) the community pharmacy team would have been made aware that morphine treatment had ceased in hospital which would have flagged that any legacy prescriptions should not be dispensed. As noted in the report the Trust have committed to make improvements to reduce the risk of similar reoccurrence in future Mr Dixon’s case sadly demonstrates the dangers of purchasing illicit medicines online and the importance of robust enforcement of the law. I am assured that the swift action of the MHRA and the strengthening of regulation around online content will help prevent similar incidences and give enforcement agencies greater powers to tackle and remove online content concerning illicit drugs and medicines. From Minister of State for Health 39 Victoria Street London SW1H 0EU I would like to take the opportunity to thank you for highlighting these matters of concern, and for giving us the opportunity to respond. I hope this response is helpful. Yours sincerely, MINISTER OF STATE FOR HEALTH
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