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This publication is available at https://www.gov.uk/government/publications/widening-the-availability-of-naloxone/widening-the-availability-of-naloxone
Naloxone is the emergency antidote for overdoses caused by heroin and other opiates or opioids (such as methadone, morphine 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 can supply it without a prescription. And anyone can use it to save a life in an emergency.
1. Drug services can supply naloxone without a prescription
Under regulations that came into force in October 2015, people working in or for drug treatment services can, as part of their role, supply naloxone to others that their drug service has obtained, if it is being made available to save a life in an emergency. You do not need a prescription to supply naloxone in this way.
The regulations were amended in February 2019 to include nasal naloxone.
For example, a worker in a recognised drug treatment service could supply naloxone for use in an emergency to a family member or friend of a person using heroin, or to an outreach worker for a homelessness service whose clients include people who use heroin.
The regulations define drug treatment services as those “provided by, on behalf of, or under arrangements made by, one of the following bodies:
- an NHS body
- a local authority
- Public Health England (PHE)
- Public Health Agency” (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 treatments through supervised consumption prison drug services
Current clinical guidance recommends that drug services provide suitable training and advice to people when supplying naloxone.
1.1 Supply outside the 2015 and 2019 Regulations
The Human Medicines Regulations (updated in 2015 and 2019) mean that commissioned drug treatment services can supply both injectable and nasal naloxone to individuals without the need for a prescription or the need for patient group directions (PGDs) or patient specific directions (PSDs). These directions are like prescriptions and require written instructions, signed by a prescriber, for the supply of medicines to a named patient or group of patients.
However, PGDs and PSDs are still available and people supplying medicines can use them whenever appropriate. They may be particularly useful in some situations, such as when supplying naloxone outside of a local-authority-commissioned or NHS-commissioned drug treatment service. For example, when a police and crime commissioner is funding a service.
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 referencing the above advice.
1.2 Local police forces and custody suites
Under pre-existing legislation, police doctors can order stocks of naloxone and give it to individual police officers who may come across opiate users, for example in custody suites.
Police and crime commissioners who have commissioned custody suite intervention services for drug users will need to use PGDs or PSDs.
2. Products that drug services can supply
The Regulations specify that drug services can supply naloxone products 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.
There should be suitable advice and training to help those supplying and receiving the naloxone to understand the product and its use.
3. Responsibility for deciding who can supply naloxone
Organisations responsible for commissioning and providing drug treatment services will, as part of normal clinical governance, need to ensure that competent individuals working in treatment services are suppling naloxone, and that the supply by them is safe.
Advice is available in the open letter from Professor John Strang chair of the Clinical Guidelines Update Working Group, indicating “a minimum level of training in how to assemble and use the particular product” is essential and that “other training will also be helpful”.
Local decisions about how best to supply naloxone in line with this guidance may determine which employees or volunteers in the drug treatment service are most suitable to supply the naloxone.
4. People who can be supplied naloxone by a drug service
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”. Therefore, drug services can supply naloxone to:
- an outreach worker
- a hostel manager
- a drug user at risk
- a carer, a friend, or a family member of a drug user at risk
- any individual working in an environment where there is a risk of overdose for which the naloxone may be useful
The Regulations do not allow people who have been given the naloxone by a drug treatment service 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.
4.2 Children and young people
If any drug treatment service is considering providing a child or young person under 18 with naloxone, or training 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 under the legislation on the supply to children or young persons of naloxone by a drug treatment service. However, any decision to supply naloxone to a child would need very careful consideration and oversight and would need to be made on a case by case basis.
An appropriately competent professional acting within a suitable clinical governance framework would have to consider the needs of each child or young person, taking account of potential benefits to the child of the intervention and any risks. They are expected always to take proper account of the child or young person’s ability to understand the issues involved and to 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 quite complex.
The drug treatment service should take account of any relevant guidance, including guidance on consent in children and young people and child safeguarding.
5. Using naloxone to save a person’s life without their permission
Under the Regulations, it is legal for a drug service to provide a family member or friend of a heroin or opioid user with naloxone without the express permission of the person who is using the heroin or opioid, if it is being supplied to save life in an emergency. However, services that are supplying naloxone need to consider the ethics of supplying naloxone to friends or family without the drug user knowing or agreeing.
We would expect drug services to address this issue in local protocols and through local clinical decision-making processes.
6. Clinical governance in drug treatment services
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.
However, authoritative guidance recommends that services provide relevant advice and training alongside the arrangements for supply of naloxone. This may include developing suitable local protocols which might summarise who can receive naloxone in what circumstances, product choice, training, storage, monitoring and record keeping.
7. Guidance for hostels, homeless shelters and housing associations
7.1 Acquiring and storing naloxone
You should contact your local drug treatment service and discuss 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
7.2 Storing and using naloxone
There are no legally set protocols on storing and using naloxone. However, it is good practice to ensure that you have robust protocols in place covering use of naloxone, for example, training, record keeping, storage, access and use in emergency.
PHE advice on naloxone, includes points on record keeping that you may find helpful.
You should discuss these issues with the drug service that is providing the naloxone.
7.3 Paying for the supply of naloxone and training
You should contact your local drug treatment services and work with them to see whether and how, with the support of commissioners, they can train and support relevant members of staff, volunteers and service users. The Regulations enable commissioned drug treatment services to supply naloxone to individuals without the need for a prescription, but do not address the issue of funding for naloxone or training. Commissioners will need to take these decisions with local treatment services.
8. Side effects associated with naloxone
Like other medicines, naloxone can cause side effects in some individuals. Side effects reported include:
- feeling or being sick
- over-breathing (associated with an abrupt return to consciousness)
- fast heart beat or disturbed heart rhythm
- increased or decreased blood pressure
- fluid on the lungs
However, because you normally give naloxone to an individual you believe is facing an imminent fatal opiate overdose, such risks of side effects are largely irrelevant in the decision on whether to use it or not.
Reducing unnecessary side effects and discomfort, through careful, graduated, use of naloxone according to the instructions for the particular product, is likely to be part of the advice and training you provide. Such careful use may also have the benefit of limiting the unpleasant withdrawals the heroin or opioid user may feel as they come round.
Another important but uncommon side effect, is the risk of triggering cardiac problems in susceptible people, which in some cases could be fatal, particularly if a person receives high doses of naloxone quickly, But given that you intend to give naloxone to someone already facing the risk of a fatal overdose, the small risk of triggering such a serious cardiac problem is not a reason to avoid its use.
The advice on using naloxone for overdose already addresses its careful use to try to mitigate such risks. Clinical guidelines recommend starting with a sufficient but relatively small dose of naloxone, providing further small doses as needed. Taking this graduated approach to giving the naloxone, in simple steps, will be an important element of any locally-provided information materials and training.