Closed consultation

Proposals to expand access to take-home naloxone supplies

Published 24 January 2024

Introduction

The Department of Health and Social Care (DHSC), the Department of Health in Northern Ireland (NI DOH), the Scottish Government and the Welsh Government are seeking your views on proposals to widen access to naloxone without a prescription. Naloxone is a life-saving medicine that reverses the effects of an opioid overdose. Anyone can administer naloxone in an emergency but currently only drug treatment services can legally supply it to an individual for future use.

Previous consultation

In August 2021, DHSC, the NI DOH, the Scottish Government and the Welsh Government launched the consultation Expanding access to naloxone on changes to the Human Medicine Regulations 2012 (HMR). This initial consultation sought to expand the list of named services and individuals that can distribute naloxone without a prescription or other written instruction. We published a summary of feedback to this consultation in March 2022.

In the 2021 consultation, we asked for views on naming the following settings in legislation:

• outreach and day services for people who experience homelessness or rough sleeping
• supported accommodation services (including hostels, approved premises and refuges) for people with substance use disorders and people who experience homelessness or rough sleeping

This consultation: new proposals

This consultation follows on from the 2021 consultation.

Following significant engagement between the devolved administrations, it has not been possible to agree a legal definition of these services across the UK. So, we cannot name these settings in legislation.

The government is seeking views on legislative proposals to expand the number of services and professionals that can supply naloxone across the UK, by:

• route 1: an amended list of named professionals and services that could supply take-home naloxone
• route 2: a new registration service through a network co-ordinator that would enable professionals and organisations not named in the legislation to supply naloxone (including homelessness and supported accommodation services), subject to appropriate training and safeguards

As part of this, the government is also seeking views on specific data reporting requirements to enable more consistent reporting for both routes.

Current situation in the UK

Since we held the first 2021 consultation, there have been a number of changes to drug policy and strategy in the UK, as well as changes in drug use and drug-related deaths.

In December 2021, the UK Government published its 10-year drug strategy. By the end of 2024 to 2025, we expect this cross-government plan to have prevented nearly 1,000 deaths, reversing the upward trend in drug deaths for the first time in a decade. The strategy makes a number of other commitments to reducing drug misuse deaths, including through improving the capacity and capability of drug and alcohol treatment services, in England. It also contains a specific commitment that the UK Government would work with the devolved administrations to review relevant legislation to make naloxone more accessible.

In September 2021, working with stakeholders, including people in treatment services and their families, the NI DOH published Preventing harm, empowering recovery. This strategy for Northern Ireland aims to prevent and address the harms related to all substance use. The strategy contains a commitment to expand the supply of naloxone to at risk groups, and people likely to come into contact with them.

Opioid-related deaths make up the largest proportions of drug-related deaths across the UK. In 2021, opioids were involved in:

• 73% of drug misuse deaths in England
• 71% of drug misuse deaths in Wales
• 84% of drug misuse deaths in Scotland
• 59% of drug misuse deaths in Northern Ireland

Our interest in widening access to naloxone to help save lives coincides with the recent increase in the presence of new synthetic opioids in the illicit drug supply. These synthetic opioids are more potent, so are more deadly than other opioids traditionally available through illicit drug supply. This has led to increases in overdoses and deaths in some areas. So, it is more important than ever to increase access to naloxone products, which we know are effective in saving lives.

We consider these proposals a matter of public health and safety in the UK. Drug misuse deaths have doubled since 2012. While the impact of synthetic opioids on opioid related deaths is yet to be fully understood, work is ongoing to assess the impact of the rise of synthetic opioids. There is strong agreement from the UK Government and the devolved administrations that we need to revise the current legislation on naloxone.

Naloxone reverses the effects of an opioid overdose, and so can help to prevent overdose deaths. Although naloxone is a prescription-only medicine, the HMR allows drug and alcohol treatment services to supply naloxone to an individual without a prescription.

Naloxone for use in the community currently comes in 3 forms:

• one pre-filled syringe (injectable)
• 2 nasal sprays (nasal)
• ampoules for injection

Although ampoules could be (and previously have been) used in the community, their use is very rare now that there are 3 formulations with a specific community indication (injectable and nasal).

The proposals in this consultation, apply in practice, to the pre-filled syringe and nasal forms of naloxone and indirectly to any new formulations that become available.

Current legal position

Controls on who can administer, sell and supply naloxone

Naloxone is a prescription-only medicine regulated by the HMR. This means that there are controls on who can legally administer, sell and supply naloxone.

Under the HMR, anyone is permitted to administer naloxone to another individual to save their life in an emergency (see regulation 238, and the associated schedule 19). However, there may not always be naloxone available at the site of an opioid overdose.

Under part 12, medicines that are classed as ‘prescription-only medicines’ or ‘prescription’ can only be sold or supplied at registered pharmacy premises (regulation 220). Prescription-only medicines are subject to an additional requirement that they must only be sold or supplied in line with an appropriate practitioner’s prescription (regulation 214, part 1). An appropriate practitioner includes:

• a doctor
• a dentist
• other independent prescriber

Current exemptions to naloxone controls

There are various exemptions to regulations 214 and 220 in a limited set of circumstances, including those in regulation 235 and the associated schedule 17 of the HMR. In 2015, an amendment was made to schedule 17 to allow the injectable form of naloxone to be supplied without a prescription by people who work in drug and alcohol treatment services that are commissioned by:

• the NHS
• a local authority
• Public Health England (PHE)
• the Northern Ireland Public Health Agency (PHA)

In 2019, a further amendment was made to include nasal naloxone under this exemption.

A patient group direction (PGD) provides another exemption route from regulations 214 and 220. A PGD is a written instruction for the supply or administration of medicines to patients in a defined clinical situation. They can only be used by particular healthcare professionals (such as nurses, paramedics and midwives) and must be signed by a relevant authority (such as a health agency, NHS trust or chief police officer) (regulations 230 to 234).

In June 2020, Scotland introduced a temporary measure that enabled individuals other than drug treatment service workers to supply naloxone to people at risk of overdose, and to their families and friends, if they were registered to do so with the Scottish Government. The Lord Advocate’s statement of prosecution policy to supply naloxone was limited to the period during which services are disrupted by the COVID-19 pandemic. It aims to relax the rules around who can supply and distribute naloxone to maximise its availability. A broad range of services have signed up with the Scottish Government to supply naloxone without a prescription. This includes a ‘click and deliver’ service run by Scottish Families Affected by Alcohol and Drugs, which enables people to have naloxone delivered anonymously to their door.

Expanding the number of services and professionals that can supply naloxone

Background to the legislative change

Following the positive responses to the previous consultation, we are seeking to amend HMR legislation to expand the number of services and professionals that can supply naloxone without a prescription. This will fulfil the ambition of the government’s drug strategy to reduce 1,000 drug-related deaths, and help meet the increasing need for action against synthetic opioids,

Many of these services or their commissioners (such as police and crime commissioners) are legally defined, so can be named in the updated legislation. However, some services are not defined in legislation in a consistent way across the UK Government and devolved administrations and the legislation does not cover all relevant services. This is true for temporary or supported accommodation and outreach and day services.

Proposed routes to supply naloxone without prescription

We are proposing 2 routes for services or professionals to be able to legally supply naloxone without a prescription. These are:

• route 1: services, commissioners of services or professionals are named in the legislation and directly given this enabling power
• route 2: a registration route, enabling any service or organisation to supply naloxone without a prescription, subject to safeguards

Given this approach enables services and professionals that may not have a qualification to prescribe medicine to supply a naloxone without a prescription, it is important to put certain safeguards within the policy. So, we are proposing certain requirements for training and information in both routes. These are detailed in the relevant sections below.

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.

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

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
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree

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

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
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree

Please explain your answer. (Maximum 500 words)

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 

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
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree

Please explain your answer. (Maximum 500 words)

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

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)

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

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)

Data collection on naloxone supply for routes 1 and 2

It is important that we have a good understanding of how much naloxone is being supplied, so we can analyse the possible impacts on drug-related deaths. This will be particularly important if there are multiple routes for supply because it will enable policy makers across the UK to better understand what routes are more effective and where more work can be done.

Data collection and reporting is not currently mandated in the HMR, and approaches vary across the UK.

Current data approaches across the UK

In England, take-home naloxone supply is recorded by the National Drug Treatment Monitoring System (NDTMS), which drug and alcohol treatment services complete. It only records supply of take-home naloxone to people in registered treatment, and not other people who may also be supplied with naloxone, like friends or family of people in treatment. Also, the data is not consistently recorded, so we do not have a complete understanding of how much naloxone is reaching the people that need it across England.

In Northern Ireland, there is a national take-home naloxone scheme operated by the PHA and annual reports are available on the Take-home naloxone reports page on the PHA website.

Wales has a harm reduction database operated by Neo and managed by Public Health Wales, with a specific module for take-home naloxone. Every person who is trained in administering naloxone and issued with a naloxone kit is recorded in the database. The database contains a range of data and is updated if there is any further supply of naloxone. Public Health Wales publishes a Harm reduction database Wales: drug related mortality annual report (pdf, 3mb), which provides in-depth information about naloxone distribution and use.

In Scotland there is ongoing work to improve the ways that naloxone data is collected, to:

• better inform policy making
• get a better understanding how naloxone supply and distribution helps to save lives
• understand where the focus of naloxone distribution should be, based on latest data

As part of Scotland’s national naloxone programme, Public Health Scotland publishes annual monitoring reports and quarterly monitoring bulletins on the number of take-home naloxone kits provided in Scotland.

Data reporting proposals

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

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
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree

Amending the legislation

We are seeking to amend the HMR so that more services, other than drug treatment services, can supply naloxone to individuals without a prescription. We will do so using the enabling powers in part 2 of the Medicines and Medical Devices Act 2021 (MMDA).

Section 45(1) of the MMDA includes a statutory requirement for the appropriate authority (here it’s DHSC and NI DOH) to carry out a public consultation on proposed amendments to the HMR. Since the proposed changes to legislation would apply throughout the UK, we have made this consultation available in England, Wales, Scotland and Northern Ireland, and has been published in the joint names of all 4 administrations. However, this policy is reserved rather than devolved in Scotland and Wales, which means that this is a statutory consultation by DHSC and NI DOH. This is because it is the DHSC and NI DOH ministers who have the power to make the legislative changes using the MMDA.

The enabling powers require that the legislation is passed by both the UK Parliament and the Northern Ireland Assembly. So, a final draft of the legislation will need to be laid before the UK Parliament and Northern Ireland Assembly, and debated by both. If it is not possible to lay legislation in Northern Ireland when the legislation is ready, we may lay a Great Britain-only version of the update. This would mean that the current legal position would be maintained in Northern Ireland until the Northern Ireland Assembly is back in place and can consider the legislation.

Comments on the full legislation

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

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

Question

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)

How to respond

You can respond to this consultation by completing the online survey.

The consultation will be open for 6 weeks. Send your response by 11:59pm on 6 March 2024.

Next steps

When we have had the opportunity to consider your feedback to the consultation, we will publish a response on GOV.UK.

Following the consultation period, the UK Government and devolved administrations intend to bring forward legislation as soon as possible.

Privacy notice

Introduction

This notice sets out how we will use the information collected through this online consultation, as well as your rights as a respondent under the UK General Data Protection Regulation (GDPR).

Data controller

DHSC is the data controller.

What information we collect

When you respond to the consultation online, we will collect some personal information, which is:

• where you live in the UK
• your email address
• your profession

Please do not include any other personal information in your responses to free text questions in the survey.

How we use your information

We collect your information as part of the consultation process:

• for statistical purposes, for example to understand how representative the results are and whether views and experiences vary across organisations
• so that DHSC can contact you for further information about your response
• to reduce the likelihood of individuals being able to submit multiple responses

If you have given consent, DHSC can contact you to allow you to amend or delete your response or to send you a reminder before the consultation closes, if you have not submitted your final response.

Legal basis for processing your information

The legal bases for processing your information are:

• to perform a task carried out in the public interest. In this case asking the public to answer questions about expanding access to naloxone
• because it’s necessary for reasons of public interest in public health. It helps us ensure that our proposals on expanding access to naloxone considers the views and experiences of different demographic groups who have different experiences

The legal basis for processing your special category data (in this case, personal data revealing racial or ethnic origin) is that it’s necessary for reasons of public interest in health or social care under article 9 of the UK GDPR. It helps us ensure that this consultation considers the views and experiences of different demographic groups and with different knowledge and experience of naloxone distribution.

For more information, you can read this guide to special category data.

Who your information may be shared with

Responses to the online consultation may be seen by:

• DHSC officials manging this consultation process and analysing the responses
• DHSC and NHS England officials working on relevant policy such as medicines, pharmacy or ambulances
• Home Office officials working on drug or policing policy
• Department for Levelling Up, Housing and Communities officials working on policy relating to rough sleeping and homelessness
• Medicines and Healthcare products Regulatory Agency (MHRA) officials
• devolved administration officials working on drugs policy
• DHSC’s third-party supplier (SocialOptic), which is responsible for running and hosting the online survey

Officials in other relevant DHSC policy teams and those at MHRA, NHS England, Home Office and the devolved administrations will receive anonymised data only.

International data transfers and storage locations

Storage of data by DHSC is provided via secure computing infrastructure on servers located in the European Economic Area. DHSC platforms are subject to extensive security protections and encryption measures.

Storage of data by SocialOptic is provided via secure servers located in the UK.

How long we keep your information

We will hold your personal information for up to one year after the online consultation closes. Anonymised information may be kept indefinitely.

We will ask SocialOptic to securely delete the information held on their system one year after the online consultation closes.

How we protect your information and keep it secure

DHSC uses a range of technical, organisational and administrative security measures to protect any information we hold in our records from:

• loss
• misuse
• unauthorised access
• disclosure
• alteration
• destruction

We have written procedures and policies that are regularly audited and reviewed at a senior level.

SocialOptic is Cyber Essentials certified. This is a government backed scheme that helps organisations protect themselves against the most common cyberattacks.

Your rights

By law, you have a number of rights and processing your data does not take away or reduce these rights, under the UK GDPR and the UK Data Protection Act 2018.

You have the right to:

• ask for and receive copies of information about you
• get information about you corrected if you think it’s inaccurate
• limit how your information is used, for example you can ask for it to be restricted if you think it’s inaccurate
• object to your information being used
• get information deleted

Some of these rights might not apply when the information is being used for research. We will let you know if this is the case.

Contact us or make a complaint

We will always try to respond to concerns or queries that you have about your data.

If you are unhappy about how your information is being used, or if you want to complain about how your data is used as part of this consultation, you should email data_protection@dhsc.gov.uk or write to:

Data Protection Officer
1st Floor North
39 Victoria Street
London
SW1H 0EU

If you are still not satisfied, you can complain to the Information Commissioner’s Office (ICO). You can find out how to contact them at the ICO website. Their postal address is:

Information Commissioner's Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Changes to this privacy notice

We keep our privacy notice under regular review, and we will update it if necessary. All updated versions will be marked by a change note on the Proposals to expand access to take-home naloxone supplies consultation page.