Expanding access to naloxone
Updated 24 January 2024
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This publication is available at https://www.gov.uk/government/consultations/consultation-on-expanding-access-to-naloxone/consultation-on-expanding-access-to-naloxone
Introduction to naloxone
Naloxone is a drug that reverses the effects of an opioid overdose, and therefore can help to prevent overdose deaths. 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 responses to this consultation to assess the viability of proposals to widen access to naloxone by expanding the list of services and individuals that can give it out without a prescription or other written instruction. Our intention is to prevent at-risk people who use drugs from dying due to an opioid overdose.
These proposals are being considered as a matter of public health and safety in the United Kingdom. Drug-related deaths have doubled since 2012, with the latest statistics showing record numbers of opiate-related deaths across the United Kingdom.
At the 17 September 2020 Drugs Ministerial Event, the Parliamentary Under Secretary of State for Prevention, Public Health and Primary Care made a public commitment to consider amending the Human Medicines Regulations 2012 (HMRs) to allow for naloxone to be more easily distributed to at-risk people who use drugs. There was strong agreement by Ministers from the United Kingdom that the current legislation on naloxone needs to be reviewed.
Naloxone for use in the community currently comes in 2 forms:
- Prenoxad, a pre-filled syringe
- Nyxoid, a nasal spray
Naloxone is also available as ampoules for injection and, although these could be (and previously have been) used in the community, their use is very rare now that there are 2 formulations with a specific community indication. The proposals in this consultation refer to the pre-filled syringe and nasal forms of naloxone.
Current legal position
Naloxone is a prescription-only medicine regulated by the HMRs. This means that there are controls on who can legally administer, sell, and supply naloxone.
Part 12 and Schedule 17 of the HMRs sets out who can sell, supply and administer as well as receive stocks of medicines. Under the HMRs anyone is permitted to administer naloxone to another individual in order 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 which are classed as prescription only (POM) or prescription (P) can only be sold or supplied at registered pharmacy premises (regulation 220). POMs are subject to an additional requirement that they must only be sold or supplied in accordance with an appropriate practitioner’s prescription (regulation 214). An appropriate practitioner includes a doctor, dentist or other independent prescriber.
There are various exceptions to regulations 214 and 220 in a limited set of circumstances, including those in regulation 235 and the associated Schedule 17 of the HMRs. In 2015, an amendment was made to Schedule 17 to allow the injectable form of naloxone to be distributed without a prescription by people who work in drug treatment services that are commissioned by either the NHS, a local authority, Public Health England (PHE) or the Northern Ireland Public Health Agency (PHA). In 2019, a further amendment was made to include nasal naloxone under this exemption.
Patient Group Directions (PGDs) provide 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 certain healthcare professionals (such as nurses, paramedics, midwives and must be signed by a relevant authority such as a health agency, NHS Trust, or chief police officer (regulations 230 to 234).
Additionally, in June 2020, Scotland introduced a temporary measure that enabled individuals other than drug treatment service workers to distribute naloxone to those at risk of overdose, as well as to their families and friends, as long as they were registered to do so with the Scottish Government. The statement of prosecution policy, put in place by the Lord Advocate, is time-limited to the period during which services are disrupted by the COVID-19 pandemic, and aims to relax the rules around who can supply and distribute naloxone in order to maximise its availability during this time.
The real-world consequences of this legislation
The HMR provisions described above mean that no services other than commissioned drug treatment services can supply naloxone to individuals without having a prescription or PGD.
The types of drug treatment services that can currently lawfully supply naloxone without a prescription include:
- drug services provided by primary care services
- drug services provided by secondary care services (including a range of specialised community and inpatient drug services)
- needle and syringe programmes (including those provided by pharmacies, if they are commissioned by local authorities or the NHS)
- pharmacies providing drug treatment such as opioid substitution treatments
Regulations do not limit who can be supplied with naloxone by drug treatment service workers, setting out that it can only be distributed “for the purpose of saving life in an emergency”. The emergency does not need to be occurring at the time of supply, but can be an anticipated future emergency.
This means drug treatment services can supply naloxone to, for example, people who use drugs, hostel and homeless shelter managers, policy officers and outreach workers, and carers or family members of people who use drugs (provided that there is an agreement in place between them). But these individuals and services cannot pass said naloxone on to other people to keep for future use.
The extent of naloxone availability therefore varies nationally and is contingent on the specifics of local agreements between drug treatment services and other services who are regularly in contact with at-risk people who use opioids, such as homeless shelters.
Question 1: To what extent do you agree that the current regulations mean naloxone is difficult to access in the event of an overdose?
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Please provide a reason for your answer and any evidence to support it, including any experiences you or your organisations have had trying to access naloxone (max 1,000 words).
Proposals
Our intention is to introduce 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 regulations 214 and 220 with respect to supply of injectable and nasal naloxone.
2 types of service we would like this exemption to be extended to are:
- 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
The inclusion of these services is supported by the evidence base. They have been identified in research by the charity Release as those which come into contact particularly frequently with people who use opioids, and so would especially benefit from being allowed to distribute naloxone. The Medicines and Healthcare products Regulatory Agency (MHRA) also sought advice from the Commission on Human Medicines (CHM) on expanding access to this type of service; they agreed that this would be advisable.
Additional settings
We also seek views on extending the exemptions available under the HMRs with respect to supply of naloxone by registered nurses, paramedics, midwives, and pharmacists. These individuals are all highly likely to come into contact with people who use opioids at risk of overdosing or who have overdosed, and currently the only way they can supply naloxone without a prescription is via the use of a PGD. This requirement can lead to problems with the supply of naloxone: PGDs can be difficult to procure, and they must be reviewed frequently.
Additionally, we seek views on extending the exemption to police officers, duty governors and orderly officers in prisons, and probation workers.
Police officers come into very regular contact with people who use drugs at risk of an overdose and some already carry naloxone so that they can administer it in case of emergency. Under this proposal, officers could also provide naloxone to people who use drugs for use in case of future emergency.
Prisoners who use drugs frequently go on to overdose immediately after being released. Some prisons have NHS-commissioned drug treatment service workers on hand to give naloxone to prisoners upon release, but this is not always the case; extending an exemption to prison officers themselves would allow increased flexibility on this point.
Probation officers and probation service officers come into close contact with people who use drugs who have just been released from prison—allowing them to supply naloxone would serve as a way to continue the provision after release and protect the people who use drugs when they are particularly vulnerable to overdosing.
Finally, we also seek views on a change to the existing legislation on the supply of naloxone by drug treatment service workers. Currently, the legislation allows drug treatment service workers to supply naloxone only if their service is commissioned by an NHS body, a local authority, PHE or PHA. The England and Wales Police and Crime Commissioners, the Scottish Police Authority, and the Northern Irish Policing Board commission drug treatment service workers to be present in police custody suites, but because these service workers are not commissioned by one of the bodies listed above, they cannot legally distribute naloxone to the people who use drugs they come into contact with. We would therefore like to add Police and Crime Commissioners to the list of commissioners on behalf of which drug treatment service workers can distribute naloxone.
Question 2: To what extent do you agree that the following settings or individuals should be able to supply take-home naloxone without a prescription?
Outreach and day services for people who experience homelessness or rough sleeping:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Temporary or supported accommodation services for people with substance use disorders or people who experience homelessness or rough sleeping:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Police officers:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Drug treatment workers commissioned by Police and Crime Commissioners (PCCs) to work in police custody suites:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Prison officers (orderly officers and duty governors):
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Probation officers:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Registered nurses:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Registered paramedics:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Registered midwives:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Pharmacists:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Please provide a reason for your answers with reference to any, some or all of the above settings and any supporting evidence (max 1,000 words).
Question 3: If you represent any of the following services or individuals, do you think it is likely that they would keep a stock of and supply naloxone if the regulations were changed such that they were eligible to do so?
Outreach and day services for people who experience homelessness or rough sleeping:
- highly likely
- somewhat likely
- somewhat unlikely
- highly unlikely
- I do not represent these individuals
Temporary or supported accommodation services for people with substance use disorders or people who experience homelessness or rough sleeping:
- highly likely
- somewhat likely
- somewhat unlikely
- highly unlikely
- I do not represent these individuals
Police officers:
- highly likely
- somewhat likely
- somewhat unlikely
- highly unlikely
- I do not represent these individuals
Drug treatment workers commissioned by PCCs to work in police custody suites:
- highly likely
- somewhat likely
- somewhat unlikely
- highly unlikely
- I do not represent these individuals
Prison officers (orderly officers and duty governors):
- highly likely
- somewhat likely
- somewhat unlikely
- highly unlikely
- I do not represent these individuals
Probation officers:
- highly likely
- somewhat likely
- somewhat unlikely
- highly unlikely
- I do not represent these individuals
Registered nurses:
- highly likely
- somewhat likely
- somewhat unlikely
- highly unlikely
- I do not represent these individuals
Registered paramedics:
- highly likely
- somewhat likely
- somewhat unlikely
- highly unlikely
- I do not represent these individuals
Registered midwives:
- highly likely
- somewhat likely
- somewhat unlikely
- highly unlikely
- I do not represent these services
Pharmacists:
- highly likely
- somewhat likely
- somewhat unlikely
- highly unlikely
- I do not represent these individuals
Please provide a reason for your answers (max 1,000 words).
Question 4: Are there any settings not explicitly cited in the above questions that you would support being able to obtain or supply naloxone?
Please provide a reason for your answer with reference to any supporting evidence (max 1,000 words).
Consequential changes may be required to Part 13 of the HMRs (for example, regulation 258 and Schedule 25) to remove certain requirements on the labelling of naloxone, such as the need to label the name of the individual being supplied with the medicine. We would welcome views on the advisability of removing such requirements for supply of naloxone by the individuals and services described above.
Question 5: To what extent do you agree that the labelling requirements on prescription-only medicines, such as the name of the individual to whom the medicine is being supplied, should be disapplied when naloxone is given out by services without a prescription?
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Consultation responses
We are proposing amending the Human Medicines Regulations 2012 so that certain services other than drug treatment services can supply naloxone to individuals without a prescription and supplied other than at a registered pharmacy premises. We will do so using the enabling powers in Part 2 of the Medicines and Medical Devices Act 2021 (“the MMDA”).
Section 45(1) of the MMDA includes a statutory requirement for the appropriate authority (here the DHSC and NI DoH) to carry out a public consultation on proposed amendments to the Human Medicines Regulations 2012. As the proposed changes to legislation would apply throughout the United Kingdom, this consultation is being made available in England, Wales, Scotland and Northern Ireland, and has been published in the joint names of all 4 Governments. However, this policy is reserved rather than devolved, meaning that only the DHSC and the NI DoH have the power to make the legislative changes using the MMDA.
This consultation document is intended to provide members of the public with information about the proposed changes and an opportunity to comment. One of the purposes of the current consultation is to identify which services or settings would most benefit from being included in an exemption on the provision of naloxone. We welcome views and evidence regarding in which settings it would be appropriate to enable naloxone distribution in order to prevent opioid-related deaths. Responses will be accepted via the gov.uk portal over a course of 8 weeks.
Section 2 of the MMDA requires that, in making regulations about human medicines, the appropriate authority’s overarching objective must be ‘safeguarding public health’. Our proposals contribute towards this overarching objective. Drug-related deaths are at an all-time high in the United Kingdom; this is largely due to record numbers of deaths from opioid overdoses. Expansion of naloxone availability is one clear policy solution to reduce the number of opioid-related deaths: making naloxone more easily obtainable by people who use drugs and their support groups and networks will mean that when an opioid overdose occurs, there is an increased likelihood that there will be naloxone nearby that can be administered in order to save a life.
This is supported by a strong evidence base. The 2012 Advisory Council on the Misuse of Drugs (ACMD) consideration of naloxone report presented data showing that increased naloxone provision reduces rates of drug-related death, and recommended that the restrictions on who can supply naloxone should be eased. Additionally, an unpublished survey by the charity Release provided evidence showing that homeless outreach and accommodation services being allowed to distribute naloxone would reduce the time lag between someone needing a dose of naloxone, and its being available to administer.
Question 6: To what extent do you agree that allowing the below settings or individuals to supply take-home naloxone without a prescription would help to reduce the incidence of opioid overdose and drug-related deaths?
Outreach and day services for people who experience homelessness or rough sleeping:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Temporary or supported accommodation services for people with substance use disorders or people who experience homelessness or rough sleeping:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Police officers:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Drug treatment workers commissioned by PCCs to work in police custody suites:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Prison officers (orderly officers and duty governors):
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Probation officers:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Registered nurses:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Registered paramedics:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Registered midwives:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Pharmacists:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Please provide a reason for your answers with reference to any, some or all of the above settings and any supporting evidence (max 1,000 words).
Section 2 of the MMDA specifies that where the regulations may have an impact upon the safety of human medicines, the appropriate authority may only make the regulations if the benefits outweigh the risks. In conjunction, section 45(3) requires that the consultation carried out by the appropriate authority must include a summary assessment of how proposed changes might affect:
- the safety of human medicines
- the availability of human medicines
- the likelihood of the relevant part of the United Kingdom being seen as a favourable place in which to:
- carry out research relating to human medicines
- conduct clinical trials
- manufacture or supply human medicines
- the third point is not considered relevant in relation to these proposals
The proposed changes will affect the second point, the availability of human medicines; above we have described how this would positively impact upon public health.
We do not judge that the proposed changes will impact upon the first point, namely the safety of human medicines. Naloxone is an extremely safe drug and has zero effect when administered in the absence of opioids. The main risk involved in the use of naloxone is that due to its shorter half-life than many opioids, it may wear off before the patient is fully recovered, meaning that a second dose of naloxone will need to be administered. This information is, however, clearly set out in the leaflets that are present within naloxone kits. In order to reduce the risk of naloxone even further, its supply by the services we are proposing should be accompanied by training in which recipients are taught how to identify an opioid overdose, when and how to administer one or more doses of naloxone, and the importance of calling the emergency services in addition to naloxone administration.
The appropriate authority will continue to assess the matters set out in section 2(2) to (4) before making any regulations under section 2 to give effect to the policy proposed in this consultation.
Question 7: To what extent do you agree that there are risks associated with the administration of naloxone in either nasal or injectable form?
Nasal naloxone:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Injectable naloxone:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Please provide a reason for your answer and any evidence to support it, making sure to be clear which form of naloxone you are referring to (max 1,000 words).
Question 8: What safeguards do you think should be required in the settings from which naloxone is supplied? (max 1,000 words).
Question 9: If your organisation distributes naloxone, have you received training on how to use it?
- yes
- no
- not applicable to me
If ‘yes’, do you believe said training is sufficient? (max 1,000 words).
How easy do you think it would be to expand this training to additional settings?
Please provide a reason for your answer and any evidence to support it, making sure to be clear if referring only to nasal or injectable naloxone (max 1,000 words).
Question 10: Is there anything else you would like to share on the risks and benefits of naloxone which you have not provided in answers above?
If so, please provide further information and include any evidence and research you may have to support your response (max 1,000 words).
When exercising functions, such as designing policies, the Secretary of State must comply with the Public Sector Equality Duty which is an obligation to have due regard to the need to:
- eliminate unlawful discrimination under the Equality Act 2010
- advance equality of opportunity
- foster good relations between different groups
In Northern Ireland new policies must be screened under Section 75 of the Northern Ireland Act 1998 which places a statutory duty on public authorities, to mainstream equality in all its functions – so that equality of opportunity and good relations are central to policy making and service delivery. In addition new or revised policies must be rural proofed in line with the Rural Needs Act (NI) 2016 which requires public authorities to have due regard to rural needs.
We do not consider that our proposals risk impacting different people differently with reference to their protected characteristics or where they live in NI. We welcome views on this point.
Question 11: Do 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?
If so, please provide details (max 1,000 words).
Annex A – summary of consultation questions
Question 1: To what extent do you agree that the current regulations mean naloxone is difficult to access in the event of an overdose?
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Please provide a reason for your answer and any evidence to support it, including any experiences you or your organisations have had trying to access naloxone (max 1,000 words).
Question 2: To what extent do you agree that the following settings or individuals should be able to supply take-home naloxone without a prescription?
Outreach and day services for people who experience homelessness or rough sleeping:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Temporary or supported accommodation services for people with substance use disorders or people who experience homelessness or rough sleeping:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Police officers:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Drug treatment workers commissioned by PCCs to work in police custody suites:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Prison officers (orderly officers and duty governors):
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Probation officers:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Registered nurses:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Registered paramedics:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Registered midwives:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Pharmacists:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Please provide a reason for your answers with reference to any, some or all of the above settings and any supporting evidence (max 1,000 words).
Question 3: If you represent any of the following services or individuals, do you think it is likely that they would keep a stock of and supply naloxone if the regulations were changed such that they were eligible to do so?
Outreach and day services for people who experience homelessness or rough sleeping:
- highly likely
- somewhat likely
- somewhat unlikely
- highly unlikely
- I do not represent these individuals
Temporary or supported accommodation services for people with substance use disorders or people who experience homelessness or rough sleeping:
- highly likely
- somewhat likely
- somewhat unlikely
- highly unlikely
- I do not represent these individuals
Police officers:
- highly likely
- somewhat likely
- somewhat unlikely
- highly unlikely
- I do not represent these individuals
Drug treatment workers commissioned by PCCs to work in police custody suites:
- highly likely
- somewhat likely
- somewhat unlikely
- highly unlikely
- I do not represent these individuals
Prison officers (orderly officers and duty governors):
- highly likely
- somewhat likely
- somewhat unlikely
- highly unlikely
- I do not represent these individuals
Probation officers:
- highly likely
- somewhat likely
- somewhat unlikely
- highly unlikely
- I do not represent these individuals
Registered nurses:
- highly likely
- somewhat likely
- somewhat unlikely
- highly unlikely
- I do not represent these individuals
Registered paramedics:
- highly likely
- somewhat likely
- somewhat unlikely
- highly unlikely
- I do not represent these individuals
Registered midwives:
- highly likely
- somewhat likely
- somewhat unlikely
- highly unlikely
- I do not represent these individuals
Pharmacists:
- highly likely
- somewhat likely
- somewhat unlikely
- highly unlikely
- I do not represent these individuals
Please provide a reason for your answers (max 1,000 words).
Question 4: Are there any settings not explicitly cited in the above questions that you would support being able to obtain or supply naloxone? Please provide a reason for your answer with reference to any supporting evidence (max 1,000 words).
Question 5: To what extent do you agree that the labelling requirements on prescription-only medicines, such as the name of the individual to whom the medicine is being supplied, should be disapplied when naloxone is given out by services without a prescription?
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Question 6: To what extent do you agree that allowing the below settings or individuals to supply take-home naloxone without a prescription would help to reduce the incidence of opioid overdose and drug-related deaths?
Outreach and day services for people who experience homelessness or rough sleeping:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Temporary or supported accommodation services for people with substance use disorders or people who experience homelessness or rough sleeping:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Police officers:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Drug treatment workers commissioned by PCCs to work in police custody suites:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Prison officers (orderly officers and duty governors):
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Probation officers:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Registered nurses:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Registered paramedics:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Registered midwives:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Pharmacists:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Please provide a reason for your answers with reference to any, some or all of the above settings and any supporting evidence (max 1,000 words).
Question 7: To what extent do you agree that there are risks associated with the administration of naloxone in either nasal or injectable form?
Nasal naloxone:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Injectable naloxone:
- strongly agree
- agree
- neither agree nor disagree
- disagree
- strongly disagree
Please provide a reason for your answer and any evidence to support it, making sure to be clear which form of naloxone you are referring to (max 1,000 words).
Question 8: What safeguards do you think should be required in the settings from which naloxone is supplied? (max 1,000 words).
Question 9: If your organisation distributes naloxone, have you received training on how to use it?
- yes
- no
- not applicable to me
If ‘yes’, do you believe said training is sufficient? (max 1,000 words).
How easy do you think it would be to expand this training to additional settings? Please provide a reason for your answer and any evidence to support it, making sure to be clear if referring only to nasal or injectable naloxone (max 1,000 words).