Proposals to expand access to take-home naloxone supplies: government response
Updated 14 May 2024
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This publication is available at https://www.gov.uk/government/consultations/proposals-to-expand-access-to-take-home-naloxone-supplies/outcome/proposals-to-expand-access-to-take-home-naloxone-supplies-government-response
Summary
Naloxone is a life-saving drug that reverses the effects of an opioid overdose and can help to prevent overdose deaths. Anyone can administer naloxone in an emergency, but current legislation allows only drug and alcohol treatment services to supply it to individuals for future use (usually called take-home naloxone).
We consulted on proposals to widen access to naloxone through amendments to the Human Medicines Regulations 2012 (HMRs). We analysed all consultation responses and found that the response to these proposals was overwhelmingly supportive.
As a result of the overwhelming support, we are proceeding with the proposed legislative changes during spring 2024.
Introduction
Reducing opioid-related deaths
Opioid-related deaths make up the largest proportion of drug misuse deaths across the UK. In 2022, opioids were involved in:
- 73% of drug misuse deaths registered in England
- 60% of drug misuse deaths registered in Wales
- 82% of drug misuse deaths registered in Scotland
- 60% of drug misuse deaths registered in Northern Ireland
The UK Government is committed to preventing drug-related deaths as outlined the flagship cross-government 10-year drug strategy. By the end of 2025 we expect this strategy to have prevented nearly 1,000 deaths in England, reversing the upward trend in drug poisoning deaths for the first time in a decade. Through its substance use strategy, Preventing Harm, Empowering Recovery, the Northern Ireland Executive has also prioritised reducing alcohol and drug related deaths.
Naloxone, the highly effective opioid overdose reversal drug, is a vital part of achieving this aim. It can be administered by anyone in an emergency, but current regulations only allow drug and alcohol treatment services to supply it to individuals for future use. We want people who are at risk of an overdose, or who know someone at risk of an overdose, to be able to access take-home naloxone as quickly and easily as possible. The second part of Dame Carol Black’s independent review of drugs highlighted increasing access to naloxone as a vital harm reduction measure that will save lives. We will amend the HMRs to make it easier for people who need naloxone to access it.
Proposed routes to supply naloxone
Through this consultation, we sought views on the viability of proposals to widen access to naloxone through 2 routes.
Route 1: named services and professionals
Route 1 introduces further amendments to the HMRs, for example to Schedule 17 (exemption for sale, supply or administration by certain persons), specifying certain additional individuals and services that will be exempt from the regulations. This means naming a number of services and professionals in the legislation, which would give them the enabling power to supply naloxone without a prescription. These services and professionals 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 staff
- probation officers
- registered midwives
- registered nurses
- registered pharmacy professionals
- registered paramedics
This list includes expanded definitions of named services from the original 2021 consultation. For instance, amending ‘police officers’ to ‘police forces’ will enable wider, non-officer police roles to carry out this function. Services and professionals named in this list will not be required to supply naloxone. The powers in this draft legislation are enabling only and not enforceable, allowing services and professionals to supply naloxone without a prescription.
We have also proposed that there are mandatory training requirements for new services and professionals taking on this role. This training would give participants an understanding of appropriate practices around storing and supplying naloxone, and how to support a person being supplied with naloxone.
Route 2: registration with a naloxone supply network co-ordinator
We proposed a second route to expand naloxone access by establishing a new registration service to enable professionals and organisations not named in the legislation to supply naloxone (subject to appropriate training and safeguards).
Consultation responses
The consultation asked about the extent to which respondents agreed or disagreed with the proposals. All questions were optional and gave respondents the opportunity to justify their answer, or provide more information in a free text box.
The consultation ran for 6 weeks and closed on 6 March 2024.
In total, we received 325 responses, including responses from each part of the UK. Of these 325 responses, almost a third (101) were on behalf of organisations, with the rest (224) coming from individuals sharing either their personal or professional views and experiences. The responses covered a range of organisations, including:
- charities
- NHS trusts
- public health
- social care
- local authorities
- housing organisations
Of the 224 individuals who provided information on where they live, there was representation from across the UK. This included:
- 68% from England
- 14% from Wales
- 13%from Scotland
- 5% from Northern Ireland
Overall, there was strong support for the proposals outlined in the consultation. The main findings were:
- 95% of respondents either agreed or strongly agreed with route 1
- 92% of respondents either agreed or strongly agreed with route 2
- 95% of respondents either agreed or strongly agreed that training requirements should include the storage and supply of naloxone, as well as how to support people supplied with naloxone
- 84% of respondents either agreed or strongly agreed that named services and professionals that supply naloxone to individuals should be provided with a legislative gateway to support data sharing for the supply of naloxone
What we did with the consultation responses
In the consultation, we asked questions in 2 forms: multiple-choice questions that were mandatory and free text responses that were optional.
Where respondents were invited to answer a multiple-choice question, we counted and confirmed the responses and expressed these as absolute figures and percentages. We used the quantitative data to create graphs that set out the distribution of responses.
We used a process of qualitative analysis for the free text responses and tagged them with appropriate themes. More than one person analysed responses and we compared outcomes for consistency. We identified the main themes and these form the basis on this consultation response.
What the responses said
Overall themes
We identified the main themes across the consultation responses, which were as follows.
Support for the legislation
Respondents said that they supported the legislation and were pleased to see changes being made. They highlighted the essential role of naloxone in saving lives.
Increasing accessibility
Respondents recognised the steps to widen access to naloxone through route 1 and route 2.
Synthetic opioids
Some respondents emphasised the importance of expanding access to naloxone to prevent more deaths from overdoses while the prevalence of synthetic opioids is increasing.
Removing barriers to access
Many respondents highlighted the important role this legislation could have in removing barriers to people accessing naloxone. They stressed that implementing routes 1 and 2 should not be a burden for services supplying the take-home naloxone.
Training
Respondents consistently highlighted the need for training on safety, including storing naloxone and administering it. They thought this was essential for both proposed routes. We are reviewing the training requirements in line with these amendments and will build on current guidance. We will provide further information during the implementation phase of the policy later this year.
Data reporting
Respondents agreed that data reporting was important to develop an understanding of naloxone use, including:
- how it is being used
- where it is being used
- who is using it
- where it is having the most impact
- whether the needs of people at risk are being met
Respondents also raised some concerns about data reporting putting people off accessing naloxone, and the need for ensuring individuals’ privacy.
Route 1: expanding the list of services and professionals named in the legislation
Overall, there was widespread agreement that the proposed list of named services and professionals set out in our proposals should be able to supply naloxone without a prescription. The vast majority (95%) of respondents strongly agreed or agreed with the proposed list of services and professionals.
Figure 1: list of named services and professionals
| Agree or disagree | Percentage of respondents |
|---|---|
| Strongly agree | 80% |
| Agree | 15% |
| Neither agree nor disagree | 2% |
| Disagree | 2% |
| Strongly disagree | 2% |
Note: figures may not add up to 100% due to rounding.
A number of responses suggested that more services and professionals should be exempt from regulations 214 and 220 than are currently proposed in route 1.
The UK-wide nature of the legislation means that any professional or service that is named in legislation needs to have an agreed statutory definition across the UK Government and devolved administrations. Where this agreed definition does not exist, we cannot make these settings exempt from regulations. However, route 2 ensures that settings not explicitly named in the legislation will be able to register and gain the same ability to supply take-home naloxone as those who are exempt through route 1. This includes professionals who work in housing and homelessness settings, which emerged in the responses as a particular group who would benefit from being able to supply naloxone.
The majority of respondents also agreed with the need for training requirements and thought that this should include the safe storage and supply of naloxone, as well as how to support people supplied with naloxone. Several respondents raised safeguarding as a specific topic to include in training, in particular how to safely store away from children.
Other training-related themes that arose were the benefits of peer-support and proper storage and handling of the medication including:
- how to avoid needle-stick injuries
- the importance of expiry dates
While many respondents supported the need for training, they also said it’s important to reduce any barriers to professionals being able to supply naloxone and to ensure the process is as simple and straightforward as possible.
Figure 2: responses to the need for training to be included in legislation
| Agree or disagree | Percentage of respondents |
|---|---|
| Strongly agree | 76% |
| Agree | 19% |
| Neither agree nor disagree | 2% |
| Disagree | 2% |
| Strongly disagree | 1% |
Route 2: establishing a new registration service
Consultation responses showed very high levels of agreement with the proposals set out in route 2. The vast majority (92%) of respondents strongly agreed or agreed that route 2 is a suitable way to enable take-home naloxone provision.
Figure 3: responses to the creation of a registration route to enable services and organisations to supply naloxone without a prescription
| Agree or disagree | Percentage of respondents |
|---|---|
| Strongly agree | 74% |
| Agree | 18% |
| Neither agree nor disagree | 4% |
| Disagree | 3% |
| Strongly disagree | 1% |
Many respondents highlighted the importance of this route to help make naloxone available to all professionals in contact with people at risk of an overdose. They also mentioned the lives this approach could save.
A number of respondents highlighted the benefits of being able to monitor distribution through data collection requirements, as part of route 2. One respondent said:
The registration route for distribution ensures that there is a controlled yet flexible system in place. It allows for tracking and monitoring of naloxone distribution, ensuring responsible use, and also provides an opportunity for educating recipients about overdose prevention and the correct use of naloxone. This approach can significantly enhance community preparedness and response to opioid overdoses.
Under the current draft of the legislation, services registering under this route will be required to meet a number of conditions, as outlined in the consultation document. These conditions will ensure there is appropriate governance and safeguarding in place to supply prescription medication. Respondents thought that these conditions are an important part of providing a safe and effective take-home naloxone service.
A small proportion of respondents outlined concerns about funding routes for naloxone. We will outline the funding routes available to different services and individuals in the next phase of the policy implementation and this will be available in updated guidance to be published in due course.
A small number of responses also highlighted the need to make sure the process should have minimum impact on resources, to reduce potential burden. This is particularly important for smaller services with fewer resources.
Overall, respondents recognised that route 2 is an essential part of widening access to naloxone, highlighting the limitations of only drug and alcohol services being able to supply naloxone. Many responses recognised the importance of this route and agreed with the proposal, while emphasising the need for appropriate safeguards such as training and data reporting.
Data reporting and the legislative gateway
As well as establishing training requirements for professionals registering through route 2, this legislation proposes:
- establishing data reporting requirements for organisations supplying take-home naloxone
- creating a legislative gateway that enables this information sharing
This type of gateway is a legal provision that gives statutory authority for information sharing by these services and professionals. This is to help services and the Department of Health and Social Care to understand where naloxone has been supplied and to ensure that the needs of the population are being met.
Overall, 84% of the respondents either agreed or strongly agreed with the proposal to establish a legislative gateway to support data sharing.
Figure 4: responses to the creation of a legislative gateway for data sharing
| Agree or disagree | Percentage of respondents |
|---|---|
| Strongly agree | 55% |
| Agree | 29% |
| Neither agree nor disagree | 11% |
| Disagree | 3% |
| Strongly disagree | 2% |
Many respondents believed that this proposal would provide the opportunity to collect essential information without creating a logistical burden that prevents services from efficiently supplying take-home naloxone.
A number of respondents also said that data privacy should be considered, including the concern that fear for their privacy could prevent vulnerable people from accessing naloxone. We will consider this point carefully in the implementation of the policy and ensure that data privacy is maintained.
Requirement for 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 that may be a burden for any organisation carrying out that role. We have considered the possibility of a network of co-ordinators being able to distribute naloxone without having a wholesale dealer’s licence. We could do this by providing powers to remove the need to hold a licence to supply naloxone.
To better understand what requirements may be needed in a situation where the need for a wholesale dealer’s licence is removed, we asked,
‘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.’
Responses to this question broadly supported addressing the need for a wholesaler’s licence. They recognised the importance of removing a wholesaler dealer’s licence for widening the availability of naloxone and reducing potential administrative barriers.
A few responses flagged concerns about maintaining the training and general safety of naloxone provision in the potential absence of wholesale licences. Work on wholesaler licences in future will prioritise appropriate guidance about training for naloxone administration. This will help to maintain safety and make sure that the administrative burden is as minimal as possible for all parties involved, taking into account differences across the UK.
Wider comments on naloxone and the legislation
As well as seeking views on the specific proposals, we also welcomed wider thoughts on the overarching intentions of the proposed legislation. Many responses highlighted the need for this expansion to protect vulnerable people. Many also believed that naloxone should be available in any setting, and to any person, that might encounter an overdose.
Respondents outlined some practical barriers that could prevent people accessing naloxone, including variations in funding for naloxone across different areas due to differences in local authority funding. The specific sources of funding and ways to buy naloxone will be set out in the implementation phase of the legislation and will be included in updated guidance, to be published in due course.
We also heard views about future policy changes on naloxone. For instance, a number of responses highlighted that reassessing and potentially reclassifying naloxone away from being prescription-only would be a better way to increase access to the medication and would remove any remaining barriers. This is outside the scope of this consultation.
A number of responses highlighted the work in Scotland and Wales to use existing mechanisms to supply naloxone more widely, and the need to learn from the experience of those services. The UK Government and the devolved administrations have worked together extensively to develop this policy and will continue to do so as we implement the next steps outlined in this response.
Finally, many responses mentioned the positive impact in helping vulnerable people. For example, some responses said that vulnerable groups may now have better access to naloxone through other services they are in contact with, which may not have previously been able to supply naloxone.
Conclusion and next steps
Responses to this consultation demonstrated overwhelming support for allowing more organisations and individuals to supply take-home naloxone. There is consensus across respondents from many sectors, organisations and individuals that widening access to naloxone will save lives.
On this basis, the UK Government and devolved administrations will continue to bring forward the legislative changes outlined in the consultation. We aim to enact these changes over the course of this year, subject to parliamentary scrutiny in the UK Parliament and the Northern Ireland Assembly. We have engaged and consulted across the UK throughout this process and will continue to do this during the implementation and delivery of proposals.