Dear Mr Burge

Thank you for your Report to Prevent Future Deaths of 14 November 2024 informing us of the death of John Ellis on 6 November 2022. We were sorry to hear of his passing and pass on our sincere condolences to his family and friends.

For background, the Veterinary Medicines Directorate (VMD) is an executive agency of the Department of the Environment, Food and Rural Affairs (Defra). We promote animal health and welfare by assuring the safety, quality and efficacy of veterinary medicines.

However, we should explain that the Home Office is responsible for the legislation regarding controlled drugs. That includes controlled drugs used for veterinary purposes and/or human use. The VMD has no regulatory powers to make changes to controlled drugs legislation.

We do provide guidance on the use and storage of veterinary controlled drugs on our website and are producing an article which we aim to publish shortly on our blog page reminding vets of their responsibilities when ordering, storing, supplying and using controlled drugs.

The Royal College of Veterinary Surgeons (RCVS) also has published very useful guidance online for controlled drugs where they state that whilst pentobarbital is not subject to safe custody requirements, it should be kept locked in a suitable controlled drugs cabinet when not in use. We echo that guidance and during inspections we ensure vets are aware that they are responsible for these products, that they are stored appropriately, and access is only given to persons they have authorised to have access.

We also include a link to the Vetlife website in our inspection reports to vet practices. Vetlife is a charity that provides independent, confidential and free emotional, financial and mental health support to the veterinary community including veterinary nurses, students and non- clinical staff.

Your report highlighted concerns around how Mr Ellis was able to procure the drug in this situation and whether adequate controls are in place to stop such instances occurring in the future.

The Veterinary Medicines Regulations 2013 (as amended) (VMR) sets out the rules that must be followed for the supply of all veterinary medicines. These regulations were amended in 2024, however the previous version of the regulations were in effect at the time that Mr Ellis appears to have obtained the medicine.

The VMR in effect at the time states in Schedule 3 paragraph 2 regarding the wholesale supply of veterinary medicines that: (1) Only a holder of a marketing authorisation, the holder of a manufacturing authorisation or the holder of a wholesale dealer’s authorisation granted by the Secretary of State may supply a veterinary medicinal product wholesale, or be in possession of it for that purpose. (2) A person mentioned in sub-paragraph (1) may only supply a veterinary medicinal product if-
a. The authorisation in question relates to that product, and
b. The supply is to another person who is entitled to supply that product under these Regulations, either wholesale or retail. (3) If the supply is to a suitably qualified person, it must be to the premises approved in accordance with paragraph 14. (4) It is immaterial whether or not the supply is for profit. (5) This paragraph does not apply in relation to a retailer of veterinary medicinal products who supplies another retailer with such products for the purpose of alleviating a temporary supply shortage that could be detrimental to animal welfare.

For retail supply, Schedule 3 paragraphs 3, 4 and 5 apply which states that a medicine with the legal category POM-V (Prescription Only Medicine – Veterinarian) may only be supplied by a vet or pharmacist and must be supplied in accordance with a prescription from a vet.

The person supplying it either must have prescribed the medicine themselves or it must be supplied to them under a written prescription that includes all the information required by the VMR.

The person supplying the medicine under a written prescription may only supply the product specified in the prescription, must take all reasonable steps to be satisfied that the prescription has been written and signed by a person entitled to prescribe the product and must take all reasonable steps to ensure that it is supplied to the person named in the prescription.

Without having more information of how the supply took place it is difficult to state categorically whether the supply was in line with the VMR or not. If you can provide further information of where the medicine was procured, then we can investigate how the supply took place and whether it was in accordance with the VMR.

If we identify, or receive information to say that someone has breached the VMR then we take appropriate action in line with our published Enforcement Policy: Enforcement policy for animal medicines – GOV.UK

We also conduct risk-based inspections of vet practices and wholesalers to check their compliance with the requirements of the regulations. The RCVS conducts assessments of vet practices that are part of their Practice Standards Scheme where RCVS assessors will check compliance with the VMR as part of their assessment.

Guidance on our inspection processes and actions that we may take where we identify non- compliance can be found on our website: Retail of veterinary medicines - GOV.UK Apply for veterinary medicine wholesale dealer's authorisation (WDA) - GOV.UK

1 RCVS response to Coroner’s Regulation 28 report in respect of John Robert Ellis Introduction
1. Firstly, we wish to express our deep sadness having read the tragic circumstances of Dr Ellis’ death. In addition to the great personal loss to his family and friends who held him in such high regard, it is clear from the evidence given at the inquest that Dr Ellis was a talented vet who had a bright future and a great deal to contribute to animal health and welfare.
2. Whilst the RCVS had been informed of Dr Ellis’ death, we were unaware of the circumstances until the Regulation 28 report (‘the report’) was received. As you know, the RCVS was not called to give evidence at the inquiry nor were we invited to attend. As such, we base our below response on the report and the recording of the inquiry that has been provided to us.
3. We wish to thank the Assistant Coroner for highlighting the issues in this case relevant to the veterinary profession and for the opportunity to provide the following comments and information. Background
4. Before moving on to the specific issues raised regarding veterinary medicines, it may be of assistance to set out some background. Research suggests that suicidal ideation is not higher in the veterinary profession as compared to the general population, however, we recognise that the likelihood of completion is increased due to knowledge of, and access to, lethal means. As such, reducing instances of suicide in the veterinary profession has been an area of focus in many aspects of our work in recent years.
5. The RCVS takes supporting mental health within the profession very seriously, and, as well as taking steps to be a compassionate regulator and minimise the impact of our complaints process on veterinary practitioners, we have also run the Mind Matters Initiative (MMI) for the last ten years. MMI aims to support the mental health and wellbeing of all members of the veterinary team, by supporting systemic change, and the research needed to underpin it, as well as providing training and resources to protect mental health and help veterinary team members to thrive.
6. We also financially support the independent organisations Vetlife and Vet Support, who offer confidential support to individuals in need. In addition, we provide free or heavily subsidised training in Mental Health First Aid and civility, and more is planned for the coming year. Furthermore, we spend a significant amount of time at universities, colleges and veterinary conferences to help normalise and destigmatise accessing mental health and wellbeing support. At an international level, senior leaders engage with overseas bodies and regulators on an ongoing basis to share best practice and latest insights, and to further promote accessing of mental health support.
7. Our RCVS Academy, in conjunction with our MMI and Leadership & Inclusion workstreams, has a variety of free-to-access training. Many of these courses promote a healthy and positive culture within practice, especially looking at leadership and management and unconscious bias, as these skills generate psychological safety within the workplace.
8. In the last year we have undertaken a survey of veterinary students and qualified veterinary professionals to look at disability, chronic illness, neurodiversity and mental health. This is a groundbreaking study that will inform future policies and activities, as well as serving as a learning opportunity for leaders to consider the needs of their employees given the prevalence of these conditions within the professions.

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RCVS Practice Standards Scheme

9. Our Practice Standards Scheme (PSS) is a voluntary initiative to promote and maintain the highest standards of veterinary care. Whilst membership of the PSS is voluntary, around 66% of eligible UK practices are part of it. There are three different levels of accreditation a practice premises can apply for, depending on the type of premises, services offered, and species treated. Core level (the most basic level) covers RCVS Code of Professional Conduct requirements and legislation, and is applicable to all practices whether or not they are part of PSS. The following requirement is included at Core, and practices are required to evidence this as part of their PSS assessment:
16.1.12 The practice takes reasonable care to prevent issues surrounding mental health in the workplace from occurring, and to deal with them appropriately when they do.
10. At General practice level we have a further two requirements, however, please note that only practices at GP level (the middle tier of PSS) and above are required to comply:
16.2.7 Line managers should have clear guidance on how to deal with mental health issues in the workplace.
16.2.10 The practice displays information and resources on mental health and wellbeing e.g. Samaritans, Mind Matters, Vetlife. Veterinary medicines
10. Regarding veterinary medicines, it should be noted that many of the requirements around controlled drugs are set out in the Misuse of Drugs Act 1971, the Misuse of Drugs Regulations 2001 and the Misuse of Drugs (Safe Custody) Regulations 1973. As you will know, the Home Office is the relevant government department with responsibility for this legislation.

11. In light of the known risk factors, the RCVS consistently goes beyond what is required by legislation with the aim of reducing misuse of drugs, including controlled drugs. For example, although quinalbarbitone (aka Somulose) is a schedule 2 controlled drug (CD), it is exempted from the safe custody in the legislation. In February 2023, we issued guidance requiring that veterinary surgeons and veterinary nurses lock quinalbarbitone away in a manner equivalent to ‘safe custody’, i.e. specific requirements for safe storage of certain CDs as set out in the regulations cited above. Similarly, the barbiturates (including ) are schedule 3 CDs and as such, not subject to safe custody under the relevant legislation. Again, in 2021 we issued guidance requiring veterinary surgeons and veterinary nurses to securely lock them away.

12. In addition, we advise that, wherever possible, controlled drugs should be returned to the controlled drugs cabinet at the practice for storage overnight. (See Practice Standards Scheme standards, 10.1.12 (small animal), 8.1.12 (farm animal), 9.1.12 (equine)).

13. As well as the ongoing work by the RCVS, the profession itself is also working to reduce instances of suicide. Innovations such as Euthasafe, a storage box requiring two-factor authentication and additional information to be provided before allowing access to the lethal medicines inside, is one such example.

14. As you will appreciate, access to and knowledge of how to use lethal medicines is a necessary part of a veterinary surgeon’s role. As such, in terms of barriers to access, there is a balance to be struck between keeping the veterinary team safe and ensuring animal health and welfare is protected. For example, one suggestion has been that the RCVS should

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require two veterinary surgeons to be involved whenever euthanasia drugs are accessed. We recognise that this may work for some practices and species areas, and we note it is one of the measures put in place by Animed following Dr Ellis’ death. However, for ambulatory practitioners and those on call overnight in rural areas, a two-person rule is largely impractical and would likely be detrimental to animal welfare. In light of this, we believe an individualised approach that works for each specific practice is key, as opposed to a single set of guidance with general application. This inquiry
15. Moving to this specific case, whilst recognising the unique personal and professional relationships involved, it is commendable that Animed has recognised that its processes fell short and has taken steps to remedy this. As you may be aware, supply of veterinary medicines is tightly controlled under the Veterinary Medicines Regulations 2013 (as amended) (VMR) and the Veterinary Medicines Directorate (VMD) gives guidance on how those regulations should be applied. The following points are relevant in this case:

a. Only a holder of a manufacturing authorisation or a wholesale dealer’s authorisation granted by the Secretary of State may supply veterinary medicinal products wholesale, or be in possession of it for that purpose

b. Wholesalers may only deliver veterinary medicinal products to registered premises

c. Prescription-only veterinary medicines (POM-Vs) – which includes controlled drugs of all schedules – may only be supplied by a veterinary practice (or a pharmacist) in accordance with a prescription from a veterinary surgeon (although the VMR does allow practices to supply other practices with medicines ‘for the purpose of alleviating a temporary supply shortage that could be detrimental to animal welfare’).

d. Veterinary prescriptions can be oral or written, however the VMD advises that:

‘A written prescription is required when a prescription product is supplied by an RQP [Registered Qualified Person, e.g. a veterinary surgeon] working from a different business or premises from where the product was initially prescribed.’

e. According to the VMR, a written prescription must contain specific information including the animal the medicine has been prescribed for and the owner’s details.

16. In view of the above, and as has already been acknowledged by Animed, in this case the medicine should not have been supplied to Dr Ellis (as a non-employee) without a written prescription. Proposed actions and timetable
17. As required by the report, we have reviewed the existing measures in place to prevent future deaths and assessed what more could be done. Following this review, the actions set out in the table below have been agreed.

Action Date 1 Relevant RCVS committees to consider additional Core requirement(s) in PSS requiring practices to have individualised suicide prevention plans. The aim being to reduce incidents, and protect staff and the wider public. February 2025

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2 RCVS Standards Committee to review the legislative requirements for schedule 2 CDs and decide what (if any) provisions may be extended to schedule 3 CDs via RCVS guidance, for example, requirement to record use in the CD register.

February 2025 3 RCVS Standards Committee to review the guidance on returning CDs to the practice when off duty.

February 2025 4 Explore methods of communicating the legal and regulatory requirements relating to lethal medicines to the profession (e.g. via RCVS Academy), including signposting to advisory/support services.

Spring 2025 5 Continue to engage with the Home Office in respect of implementing additional safeguards for controlled drugs used for euthanasia in veterinary medicine.

Ongoing