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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/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 and cannot therefore be sold over the counter. It can however be supplied without prescription by drug services. It can be used by anyone 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 employed or engaged in the provision of drug treatment services can, as part of their role, supply naloxone that has been obtained by their drug service to others, as long as it is supplied for the purpose of being available to save life in emergency. A prescription is not needed for the naloxone to be supplied in this way.
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.
‘Drug treatment services’ for this purpose are 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 (Northen Ireland)
The sorts of drug treatment services that meet this definition to be suppliers of naloxone include but may not be limited to:
- drug services commissioned from primary care providers
- drug services commissioned from secondary care providers (including a range of specialised community and inpatient drug services)
- needle and syringe programmes – including those provided from pharmacies, as long as they are commissioned by local authorities or the NHS
- pharmacies providing drug treatment such as opioid substitution treatments through supervised consumption
- prison drug services
The regulations do not allow those individuals who have been supplied naloxone by a lawful drug treatment service to supply it to a third party for use at a later date. However it remains the case that in an emergency situation anyone can use any available naloxone to save a life.
Current clinical guidance recommends that such naloxone supply should be accompanied by provision of suitable training and advice for those who are supplied the naloxone.
1.1 Supply outside the 2015 regulations
The October 2015 regulations mean that commissioned drug treatment services are able to supply naloxone directly to individuals without the need for a prescription or the need for Patient Group Directions (PGDs) or Patient Specific Directions (PSDs).
However, PGDs and PSDs are still available and can still be used whenever appropriate. They may be particularly useful in some situations, such as when naloxone is to be supplied outside of a local-authority-commissioned or NHS-commissioned drug treatment service, for example, when a service is commissioned by a police and crime commissioner.
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 force doctors are able to order stocks of naloxone, which can be given to individual police officers who may come across opiate users, for example in custody suites.
Custody suite intervention services for drug users that are commissioned by police and crime commissioners will need to use Patient Group Directions or Patient Specific Directions.
2. Products that drug services can supply
The regulations specify that the naloxone products that can be supplied without prescription by drug services:
- solely contain naloxone
- are prescription only medicines
- have been produced to be given ‘parenterally’, in other words by injection
There are different ways in which available products are put together to deliver the naloxone, and in how they are packaged and supported by written information and training. There should be suitable advice and/or training to help those supplying and receiving the product to understand the product and its use.
3. Responsibility for deciding who can supply naloxone locally
Organisations responsible for commissioning and providing drug treatment services as part of normal clinical governance, will need to ensure that naloxone is being supplied by competent individuals employed or engaged in treatment services, and that the supply by them is safe.
See the further advice section for:
- further guidance on how naloxone products can be provided safely for this purpose
- guidance from PHE on what training should cover and how to respond to an overdose
Advice is also 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 within the drug treatment service are considered to be 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, naloxone could be supplied to any of the following:
- 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 it is considered there is a risk of overdose for which the naloxone may be useful
Although the regulations do not allow those individuals who have been supplied the naloxone by a lawful drug treatment service to supply it on to others for their possible future use at a later date, it remains the case that in an emergency situation anyone can use any available naloxone to save a life.
4.1 Children and young people
Any drug treatment service considering providing a child or young person under 18 with training on overdose management or on the use of naloxone, or considering direct supply of naloxone, should act in line with established clinical principles for the treatment of children and young people. This is the case whether the goal of such consideration is to reduce risks to a young person who is using drugs or to reduce risk for others (such as an opioid-using parent).
While there is no legal restriction under the October 2015 legislation on the supply to children or young persons of naloxone by a drug treatment service, such a decision 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 exercises a carer role for a drug-using parent, consideration of the interests of the child can be quite complex.
The drug treatment service and competent drug workers should take account of any relevant guidance (including that relating to consent in children and young people and regarding child safeguarding).
5. Using naloxone to save a person’s life without their permission
Under the October 2015 regulations, it is legal for a drug service to provide a family member or friend of a heroin/opioid user with naloxone without the express permission of the person who is using the heroin/opioid, as long as it is being supplied to save life in an emergency. There is, however, an ethical question for local areas concerning the appropriateness of such supply without the drug user knowing or agreeing. We would expect this issue to be addressed in local protocols and through local clinical decision-making processes.
6. Clinical governance in drug treatment services
The October 2015 regulations do not create any legal requirements or make recommendations to services on the clinical governance procedures they should have in place covering the acquisition, storage or use of naloxone. However, authoritative guidance has been produced recommending that relevant advice and training should be provided alongside the arrangements for supply of naloxone. This may include developing suitable local protocols covering choice and supply of naloxone (which may include summarising indications for supply locally, product choice, training, storage, monitoring and record keeping).
7. Guidance for hostels/homeless shelters/housing associations, etc
7.1 Acquiring and storing naloxone
You should contact your local drug treatment service and discuss with them, with the support of commissioners, issues such as how much naloxone your staff, residents, volunteers etc may need to have supplied, its safe storage and review, and suitable record keeping of any supply and use.
7.2 Storing and using naloxone
There are no legally set protocols. 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.
We would suggest that you also 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 and/or volunteers and/or services users.
The October 2015 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. These decisions will need to be taken locally.
7.4 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, as naloxone is given to an individual who is believed to be facing a potentially 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 involved is likely to be a common element of advice and training provided. Such careful use may also have the benefit of limiting the unpleasant withdrawals the heroin/opioid user may feel as they come round.
An additional important, uncommon, side effect reported from naloxone use, particularly if high doses of naloxone are given rapidly, is the risk of triggering cardiac problems in susceptible people, which in some cases could be fatal. As noted above, given that the naloxone is intended be given to an individual 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. It is recommended to start 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 a key element of any locally provided information materials and/or training.
8. Further advice
Public Health England has produced guidance for commissioners and providers.
Detailed advice is included in the updated UK Guidelines on the Clinical Management of Drug Misuse and Dependence.
Your local drug treatment service will also be able to offer advice and help. Their details can be found through NHS Choices.
You can also contact the Department of Health.