Expanding Access to Naloxone Supplies Consultation Response

Published: 19/02/24

The Department of Health and Social Care are consulting on proposals to improve access to and distribution of Naloxone. Drug-related deaths have doubled since 2012, with even recent efforts to tackle this only showing modest impact.

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A 2021 consultation (which CPS responded to and supported) proposed allowing a wide range of named professionals and services to not only hold and use Naloxone without license, but crucially enabling them to pass on kits for future use. Following years of extensive engagement, this consultation now seeks to further expand the list of individuals and services that can supply take-home Naloxone as well as introducing new reporting requirements.

The full consultation can be found here. And for reference, the closing date is 6th of March 2024.

Route 1: Named Services and Professionals

Proposed list of named services and professionals that can supply naloxone without a prescription.

The approach for this route broadly follows the 2021 consultation. We are proposing that a number of services and professionals are named in the legislation and directly given the enabling power to supply naloxone without a prescription.

The services and professionals we are proposing to be named in the legislation are:

• drug and alcohol treatment services (who already have this power)

• medical services of the armed forces

• police forces, including drug treatment workers commissioned to work in these settings

• prison officers (orderly officers and duty governors)

• probation officers

• registered midwives

• registered nurses

• registered pharmacy professionals

• registered paramedics

We are proposing to expand the definitions of some of these named services from the original consultation. The first of these is the change from ‘police officers’ to ‘police forces’ or the ‘Police Service of Northern Ireland’. This is to enable other police roles, such as special constabulary roles, to also carry out this function.

We have also expanded ‘pharmacists’ to ‘registered pharmacy professionals’ (in England, Wales and Scotland), because this will enable registered pharmacy technicians to supply naloxone without a prescription.

Services and professionals named in the legislation will not be required to supply naloxone. The powers set out in the draft legislation are enabling, so simply allow these services and professionals to supply naloxone without a prescription.

1. Although supplying naloxone will not be a requirement, we strongly encourage all named services and professionals to carry out this role. Guidance will be issued by the UK Government and each of the devolved administrations to support this.

Question 1

To what extent do you agree or disagree with the proposed list of named services and professionals that can supply naloxone without a prescription?

• Strongly agree

Proposed training requirements for named services and professionals

To ensure that naloxone supply across all these services and professions is safe, we are proposing certain requirements around training. The draft legislation requires all new services and professionals taking on this role, other than armed forces personnel, to complete training to:

• understand appropriate practice around storing and supplying naloxone

• ensure they can properly support an individual being supplied with naloxone, including how to store and administer the medicine

The appropriate national authorities will set the details of the training obligations, but the expectation is that these will require all named services and professionals to ensure that people being supplied with naloxone complete training on storing and administering naloxone.

Question 2

To what extent do you agree or disagree that the training requirements for named services and professionals should include the storage and supply of naloxone, as well as how to support those supplied with naloxone with its storage and administration?

• Strongly agree

Please explain your answer. (Maximum 500 words)

We strongly agree that training for named services and professionals should include information on how to store as well as administer and supply naloxone to others. We also strongly agree that named services and professionals should undergo training which enables them to support those supplied with naloxone to appropriately store naloxone so if and when administration is required, naloxone is in its stable and safe condition to be used. Furthermore, training should be given to individuals supplied with naloxone on how to administer it correctly and safely. This administration training should be provided, as part of this service, by named services and professionals outlined in this draft legislation as this is essential for individuals to understand not only how to handle naloxone but how to administer it correctly to save a life in the event of a drug related overdose.

According to The World Health Organisation (WHO), in August 2023, those who are most likely to witness an opioid overdose are:

• people at risk of an opioid overdose themselves

• friends and families of people who use opioids on a regular basis

• health-care workers, the emergency services, people providing accommodation to people who use opioids, and peer education and outreach workers as well as others whose work brings them into contact with people who are at risk of overdose.

Therefore, the need for the proposed training is crucial to deliver effective interventions in a timely manner to those affected by opioid overdose. By providing training to named services and professionals, it opens access to supply of naloxone and the availability of information and education in the use of naloxone to those both supplying and being supplied. Community pharmacy teams are the experts in medicines and have the relationships with their patients and the public that would enable them to play a significant part in ensuring that a Naloxone kit is always nearby in the event of an overdose.

Through repeated supply of naloxone via the proposed channels, also comes the ability to deliver repeated, up-to-date training on storage and administration. Recurrent intervention of this type enables continual public education and an increase in understanding of naloxone and its place in reducing drug related deaths.

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Route 2: Registration with a Naloxone Supply Network Co-ordinator

Supplying naloxone by registering with a network co-ordinator

The main policy intention for these legislative updates and consultation is to make naloxone as accessible as possible. So, as well as naming particular services and professionals in the legislation, we are also proposing a second route to enable more services, which may not be public bodies or have statutory functions, to make arrangements with a network co-ordinator to supply naloxone without a prescription. We would expect this generally to follow a registration model, similar to what has been happening in Scotland.

The draft legislation enables the UK Government and the devolved administrations to select an organisation or multiple organisations that will act as a supply network co-ordinator and hold the register for a supply network in that part of the UK.

Any service or organisation that wants to supply naloxone without a prescription will be able to register with the network co-ordinator, providing they meet certain conditions. The supply network co-ordinator will not necessarily supply naloxone to services and organisations on the register, they may just hold the register. They will hold the register to enable the service or organisation to legally supply naloxone to an individual, after obtaining it through relevant wholesale arrangements.

Question 3

To what extent do you agree or disagree with enabling services and organisations to supply naloxone without a prescription, through the registration route?

• Strongly agree

Please explain your answer. (Maximum 500 words)

We strongly agree with the proposal to enable services and organisations to supply naloxone without a prescription through this registration route, as this allows the service to capture those vulnerable to drug related overdoses outwith a clinical or professional setting. Accessibility to naloxone would be increased, allowing people to receive naloxone as and when they require it, and in emergency situations, outwith standard working hours. This takes away the barrier of healthcare services and professional setting opening times, whilst putting the access to intervention treatment in sites where overdoses are likely to occur including homelessness and supported accommodation services. According to the Office for National Statistics, an estimated 259 deaths of homeless people registered in 2021 in the UK were related to drug poisoning, accounting for 35.0% of all estimated deaths. This second route to supply naloxone is therefore crucial in providing lifesaving treatment interventions in all possible locations of a vulnerable individuals life.

Conditions for supplying naloxone under route 2

The following conditions are proposed amendments to the HMR to ensure there is appropriate governance and safeguarding in place for the supply of a prescription medication. Under the current draft of the legislation, services registering will be required to:

• have a named individual who manages the naloxone storage and handling in the service.

• ensure all staff members who may supply naloxone are named in a register or a record managed by the service.

• ensure all staff members who may supply naloxone complete appropriate training - the training obligations will be set out in guidance from each part of the UK, including expectations for regular refresher training and all relevant training will need to be recorded in the register.

• ensure that anyone who is supplied with take-home naloxone has completed training for administering it in an emergency if the national arrangements allow - the requirements for appropriate training in each part of the UK will cover what the organisation’s staff need to be taught to do themselves and what they need to teach others to do.

• hold relevant information on all the above requirements that organisations supplying naloxone can check if required, and share with the national body where necessary.

• provide regular reporting data to the network co-ordinator, for example on the number and type of naloxone kits supplied to people, in line with the determined and approved approach in each part of the UK - the network co-ordinator will be enabled to share this with relevant government administrations or the regulator if it does not already have this power.

Question 4

If you think there are any other requirements that services under route 2 should meet to ensure safe supply of naloxone, please outline them. (Maximum 500 words)

All individuals and staff members who are supplying naloxone under route 2, should be given the opportunity to receive relevant blood borne virus vaccinations to prevent the spread of blood borne viruses through accidental needle stick injuries.

Supply routes for naloxone across the UK under route 2

Supply routes for services and professionals supplying take-home naloxone will vary across the UK.

In Scotland, Wales and Northern Ireland, we expect that services and professionals registering to supply naloxone through the network co-ordinator will access naloxone through existing wholesaler arrangements. If the network co-ordinator is not also a wholesaler, we would not expect them to have a direct relationship with medicines wholesalers.

In England, it’s likely that a competition will be launched in 2024 for a central organisation to act as both the wholesaler and the supply network co-ordinator. Services that do not need to register with the network co-ordinator will also be able to access supplies of naloxone from this central organisation. This will enable any relevant funding arrangements across services to be simplified, without placing wholesaler licence requirements on any public bodies.

Wholesaler dealer’s licence under route 2

A wholesaler dealer’s licence is normally needed to provide naloxone to a service or professional so they can supply an end user. Having a wholesaler dealer’s licence involves specific requirements which may be a burden for any organisation carrying out that role.

We have considered the possibility of network co-ordinators being able to distribute naloxone without having a wholesale dealer’s licence, because the draft legislation does not currently enable this. It would be possible to provide powers to remove the need to hold a licence to supply naloxone.

Question 5

If you think there are other requirements that non-public or statutory services and organisations under route 2 should meet to ensure safe supply of naloxone, please outline them. (Maximum 500 words)

Whilst we fully support the principle of simple structures and free-flowing access to Naloxone kits, we must raise some concern over the lack of medicines governance that would result from completely removing the requirement to hold a wholesale dealer’s licence. A charity or police force should not have to carry this burden, but in our view any body that ends up distributing medicines on an industrial scale (e.g. as described in the centralised proposal for England) should be subject to oversight and application of standards.

We are proposing specific data reporting requirements for each route to enable more consistent reporting across the UK.

The UK Government and the devolved administrations will develop guidance about implementing the proposed data reporting requirements. The guidance will include information on relevant training and data processes.

In addition to the training requirements, we are also proposing data reporting on the supply of naloxone using a legislative gateway for named services and professionals. This type of gateway is a legal provision that gives statutory authority for information sharing by these services and professionals.

This gateway is intended to resolve any difficulties that services or professionals might have in sharing confidential information. However, the gateway will not be sufficient to enable sharing of sensitive personal data about individual patients. The data that it will apply to would be sought on a regular basis and the approach may differ across the UK and service or professional group.

All training and data requirements will need be determined and approved by each national body and communicated through guidance.

Question 6

To what extent do you agree or disagree that the named services and professionals that supply naloxone to individuals should be provided with a legislative gateway to support the sharing of data on the supply of naloxone?

• Strongly agree

This consultation summarises the proposals in the draft legislation. However, we have attached the draft statutory instrument to this consultation so responders can see the full detail. We welcome further thoughts on the finer detail of this legislation.

Question 7

If you have any further comments on the detail of the draft legislation, please outline them. (Maximum 500 words)

By setting up the requirement for registration of a service or organisation to a network co-ordinator, the UK Government then creates a platform in which valuable supply data can be received. We strongly encourage this as it will allow data to be collected and reviewed, giving key insights into the activity within nations, regions, NHS trusts and health boards throughout the UK. By creating a platform which would allow naloxone supply to be tracked the information could then be utilised to develop service needs further in the future, ensuring service delivery is balanced throughout the population areas with the greatest need. All data which would be collected could be shared collaboratively to also enhance other service developments and analyse how the service is impacting a reduction in drug related overdoses.

In October 2023 the Naloxone Emergency Supply Service was added to the list of public health services which are available in each community pharmacy in Scotland. The aim of this service is to contribute to a reduction in drug related deaths within Scotland by providing overdose awareness training for community pharmacy teams, and naloxone for immediate emergency supply and emergency administration from community pharmacies across Scotland. Although it is too early to determine the direct impact of this new service and opportunity for intervention, it is part of the overall steps to implementing Standard 4 of the Medication Assisted Treatment (MAT) standards in Scotland, which were published in May 2021. With the above proposals set out to expand the access to take-home naloxone kits, we believe this will compliment and strengthen the service which is already in place in Scotland.

Question 8

If you think the proposals risk impacting people differently, or could impact adversely on any of the protected characteristics covered by the public sector equality duty set out in section 149 of the Equality Act 2010 or by section 75 of the Northern Ireland Act 1998, please outline them. (Maximum 500 words)

N/A

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