Naloxone: the opioid overdose antidote

Naloxone is the emergency antidote for overdoses caused by heroin and other opiates or opioids (such as methadone, morphine, nitazenes and fentanyl).

The main life-threatening effect of heroin and other opiates is to slow down and stop breathing. Naloxone blocks this effect and reverses the breathing difficulties.

Naloxone is a prescription-only medicine, so pharmacies cannot sell it over the counter. But drug services and others can supply it without a prescription if they are making it available for the purpose of saving lives. Anyone can use available naloxone to save a life in an emergency.

People who can supply naloxone without a prescription

Relevant legislation

Under The Human Medicines (Amendment) (No. 3) Regulations 2015, people working for drug treatment services can give out naloxone without a prescription.

The regulations were amended in February 2019 to include nasal naloxone.

In December 2024, The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 enabled a wider range of people to supply naloxone without a prescription, under either route 1 (named professionals and services) or route 2 (others registered to supply naloxone). Under these arrangements, these people can supply:

take home naloxone
naloxone products to be carried in case they are needed

They can only supply naloxone if they:

are suitably trained
want to (the power is enabling (or optional), not mandatory)

Supplying naloxone without a prescription

As well as people working for drug treatment services, others who can supply naloxone without a prescription under route 1 of the legislation include:

people employed or engaged by:
- medical services of the armed forces
- police forces and services, including drug treatment workers commissioned to work in these settings
- prison services
- probation and youth justice services
registered nurses and midwives
pharmacists and pharmacy technicians
registered paramedics

Any one of these could supply naloxone for use in an emergency, for example to:

a person at risk of overdose
a family member or friend of a person at risk of overdose
an outreach worker for a homelessness service whose clients include people who use opioids

Drug services

The regulations define drug treatment services as those:

provided by or on behalf of, or under arrangements with, one of the following—

(i) an NHS body,

(ii) a local authority,

(iii) the Secretary of State, or

(iv) the Public Health Agency [in Northern Ireland]

The types of drug treatment services that can supply naloxone include, but may not be limited to:

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 treatment through supervised consumption
prison drug services

Registration service for non-named professionals and services to supply take home naloxone

The legal framework enables individuals in professions and services that are not named in the legislation (route 1) to supply take home naloxone subject to registration with a new registration service (route 2). Work to set up this registration service is ongoing and we will provide further information in due course.

Supply outside the 2015, 2019 and 2024 regulations

The Human Medicines Regulations (updated in 2015, 2019 and 2024) enable the listed services and professionals to supply both injectable and nasal naloxone to individuals without the need for:

a prescription
patient group directions (PGDs)
patient specific directions (PSDs)

PGDs and PSDs are similar to prescriptions and require written instructions, signed by a prescriber, for the supply of medicines to a named patient or group of patients.

People supplying medicines can continue to use PGDs and PSDs whenever appropriate. They may be particularly useful in some situations, such as when supplying naloxone outside of one of the services listed.

When renewing a PGD or PSD it may be helpful to write to your medicines management committee (or equivalent body) to state the case for renewing the PGD or PSD and referring to the above advice.

Police forces and custody suites

Under pre-existing legislation, police doctors could already order stocks of naloxone and give it to individual police officers who may come across opiate users, for example in custody suites or on the streets.

The 2024 regulations enable police forces to buy naloxone directly from pharmaceutical suppliers without the need for specific orders from police doctors.

Police and crime commissioners who have commissioned custody suite intervention services for drug users and who previously needed to use PGDs or PSDs can now buy take home naloxone and supply it without them.

Products that services and professionals can supply

The regulations specify that services and professionals named in the legislation can supply naloxone products in nasal (sprayed into the nose) or intramuscular (injected into the muscle) form without a prescription if they solely contain naloxone.

There are different ways in which manufacturers deliver their naloxone products, and how they package and support the products with written information and training.

Both injectable and nasal formulations are available. Current products are:

Prenoxad intramuscular injection
Nyxoid nasal spray
naloxone 1.26 milligram (mg) nasal spray

Suitable advice and training is required to enable services and professionals supplying and receiving the naloxone to understand the product and how to use and store it safely. We summarise the training requirements below.

Deciding who can supply naloxone to whom

As part of their normal governance, services and professionals will need to ensure that people supplying naloxone are competent, and that they are supplying it in a safe way.

Local decisions about how best to supply naloxone in line with this guidance may require working out which employees or volunteers are most suitable to supply the naloxone.

People who can be supplied naloxone

Regulations do not limit supply to specific individuals, except to state that the “supply shall be for the purpose of saving life in an emergency”. So, services and professionals named in the legislation could supply naloxone to, for example:

a person who uses drugs
a carer, a friend, a family member or a peer of someone who uses drugs
an outreach worker
a hostel manager
any individual working in an environment where there is a risk of someone overdosing

The regulations do not allow people who have been given naloxone by one of the above individuals to supply it on to others for their possible future use. However, in an emergency, anyone can use any available naloxone to save a life.

Children and young people

If any service or professional is considering providing a child or young person aged 17 and under with naloxone, or training them on the use of naloxone or overdose management, they need to act in line with established clinical principles for the treatment of children and young people. This is the case whether the goal is to reduce risks to a young person who is using drugs, or to reduce risk for others (such as an opioid-using parent).

There is no legal restriction on supplying naloxone to children or young people, so anyone aged 17 and under can be supplied with and use naloxone to save a life. However, any decision to supply naloxone to a child or young person would need careful consideration and on a case-by-case basis.

The different naloxone formulations are licensed for different age groups.

Nyxoid nasal spray has a marketing authorisation for use in young people and adults aged 14 and over.

Prenoxad intramuscular injection and naloxone 1.26mg nasal spray are only authorised for use in adults aged 18 and over.

A marketing authorisation ensures that medicines are safe and effective before they are made available to patients. However, providing medicines to young people outside of their marketing authorisation (known as ‘off-label’ use) is well-established and can be done as long as appropriate care is taken.

An appropriately competent professional acting within a suitable clinical governance framework would have to consider:

the needs of each child or young person
the potential benefits to the child or young person of the intervention
any risks to the child or young person
the child or young person’s ability to understand the issues involved and provide suitable consent

In the case of a child who has a carer role for a drug-using parent, considering the interests of the child can be complex.

The service should take account of any relevant guidance, including guidance on consent in children and young people and child safeguarding. Any decision to supply or withhold naloxone to a young person should be documented.

Clinical and other governance

The regulations do not create any legal requirements or make recommendations to services on the clinical governance procedures they should have in place covering the purchase, storage or use of naloxone. The legislation sets out the need for appropriate training and data-sharing responsibilities for services or professionals that are providing take home naloxone without prescription.

For drug services, the UK’s national drug treatment clinical guidelines recommend that services provide relevant advice and training alongside the arrangements for supply of naloxone. This may include developing suitable local protocols which summarise:

who can receive naloxone in what circumstances
product choice
training
storage
monitoring
record keeping

Training

1. Training for people supplying naloxone. This will usually be administrative in nature and will include:

how to order stock
how to keep stock
record keeping
the need to recall and replace products before their expiry date

2. Training for people providing naloxone to others to use. Anyone training other people to administer naloxone (as in 3 below) will need training themselves.

3. Training for people being given naloxone to administer it in an emergency. This should include as a minimum:

how to identify a possible opioid overdose
the importance of calling 999 (or getting someone else to call) and:
- asking for an ambulance
- letting them know you have naloxone and have been trained to use it
- following their instructions
how to unpackage and assemble (if necessary) the supplied product, and how to administer it
the importance of staying with the person who has overdosed, of being ready to tell the ambulance what they have taken (if you know) and how much naloxone you have administered

Depending on who is being trained and the time available, the training might go further and cover:

wider overdose awareness, such as high risk situations and drug combinations
first aid, including resuscitation (more information is available from Resuscitation Council UK)

The 3 UK naloxone manufacturers and suppliers provide online educational videos on responding to an overdose and administering their naloxone products. These include:

Data collection and record keeping

You should keep a record of the naloxone you supply. This has multiple purposes, listed below.

Stock and medicines management

You will need to record the naloxone you supply so you can track your stock and understand when to reorder more.

It is also good practice to keep records of supply of a prescription-only medicine. Although naloxone can be supplied by specified and registered services and individuals without prescription, it remains a prescription-only medicine subject to the other usual requirements for such medicines, for example around labelling and record-keeping. You should be able to demonstrate that naloxone has been supplied appropriately, for use in an emergency.

Monitoring

Keeping a record of what naloxone products you supply to whom will enable local and national monitoring of naloxone provision that can be assessed alongside hoped-for reductions in overdose deaths. It may also be needed for contract and performance management.

You should also monitor who has received training to ensure equitable provision to different groups.

Replacing expiring naloxone

Keeping a record of what naloxone products you supply, to whom (subject to data protection) and when, will enable you to offer to replace supplied naloxone as it approaches its expiry date.

Acquiring and storing naloxone

Naloxone can be supplied to services and professionals named in the legislation, and to those registered under route 2, by a pharmaceutical wholesaler. Currently:

Prenoxad is available from AAH Pharmaceuticals and Alliance Healthcare
Nyxoid and naloxone 1.26mg nasal spray are only available wholesale from AAH Pharmaceuticals

Drug services and others enabled by the legislation to supply naloxone to individuals cannot supply naloxone to organisations unless they hold a wholesale distribution authorisation, also known as a wholesale dealers’ licence.

You should consider issues such as:

how much naloxone you might need to supply your staff, residents or volunteers
naloxone safe storage and review
suitable record keeping of any supply and use

Storing and using naloxone

The Human Medicine Regulations set out the need for safe storage of naloxone as part of the requirements to be able to provide take home naloxone. However, there are no legally set protocols on storing and using naloxone.

It is best practice to ensure that you have protocols in place covering use of naloxone, for example:

training
record keeping
storage
access and use in an emergency

Paying for the supply of naloxone and training

Services that are not drug treatment services should contact their local drug treatment service and work with them to see whether and how they can train and support relevant members of staff, volunteers and service users. This will need the support of commissioners.

Funding for naloxone or for training should be agreed locally.

Dosing and side effects associated with naloxone

Like other medicines, naloxone can cause side effects in some people. Side effects reported are rare but have included:

feeling or being sick
tremors
sweating
over-breathing (associated with an abrupt return to consciousness)
fast heartbeat or disturbed heart rhythm
increased or decreased blood pressure
fluid on the lungs
fits

However, because you would normally give naloxone to a person you believe is facing an imminent fatal opiate overdose, the potential of such side effects is largely irrelevant in the decision on whether to administer it or not.

Reducing unnecessary side effects and discomfort, through careful, graduated use (see below for more information) of naloxone according to the instructions for the particular product, is likely to be part of the advice and training you provide. Careful use may also have the benefit of limiting the unpleasant withdrawals the person may feel as they regain consciousness.

Another important but uncommon side effect is the very small risk of triggering cardiac problems in susceptible people. In some cases this could be fatal, particularly if a person receives high doses of naloxone quickly. But since naloxone is administered to someone already facing a fatal overdose, the small risk of triggering a cardiac problem is not a reason to avoid using it.

The drug treatment clinical guidelines set out advice on how to carefully administer naloxone to mitigate such risks (see section 6.4). It recommends starting by administering a sufficient but relatively small dose of naloxone and providing further small doses as needed. Taking this graduated approach to administering naloxone will be an important element of any locally-provided information materials and training.

There have been reported cases where more naloxone is needed to reverse an overdose from an especially potent opioid, such as nitazenes and fentanyl. It may be that a greater total number of doses will be needed in these cases, but it is still important to keep to the graduated process of administering a standard dose and waiting for an effect before administering a further dose.

Supplying take home naloxone without a prescription