Take-home naloxone from October 2015 Alcohol, Drugs & Tobacco Division, PHE September 2015 v1

Disclaimer This information was correct to the best of our knowledge at the time of publication but is not legal advice. Commissioners and services will need to satisfy themselves that any planned naloxone provision is lawful. Take-home naloxone after October 2015

Background Naloxone reverses the effect of opiate overdoses if given promptly An ambulance should be called in all instances of opiate overdose but it is generally best to administer naloxone as soon as possible before the ambulance arrives In 2012 the Advisory Council on the Misuse of Drugs (ACMD) recommended that take-home naloxone should be made more widely available Naloxone is also recommended by the World Health Organization In 2014 the Medicines and Healthcare products Regulatory Agency (MHRA) consulted on a proposal to make naloxone more widely available. Responses were almost unanimously in favour of the proposal On 1 October 2015, new legislation will come into force that will enable naloxone to be supplied to individuals by drug services without prescription This slide pack provides summary information about the situation after October 2015 and builds on PHE’s February 2015 advice on ‘Take-home naloxone for opioid overdose in people who use drugs’, which still stands Take-home naloxone after October 2015

Before October 2015 Naloxone is a prescription-only medicine and must be prescribed directly to a named patient (ie, someone who uses, or has used, opiates and is at risk of overdose), or supplied to an individual by means of a patient specific direction (PSD) or a patient group direction (PGD). It can therefore be supplied using these mechanisms to anyone: currently using illicit opiates, such as heroin receiving opioid substitution therapy leaving prison with a history of drug use who has previously used opiate drugs (to protect in the event of relapse) With the agreement of someone to whom naloxone can be supplied, it can also be provided to their family members, carers, peers and friends. Take-home naloxone after October 2015

The new legislation specifies 3 things 1. Who can supply naloxone: “Persons employed or engaged in the provision of drug treatment services provided by, on behalf of or under arrangements made by one of the following bodies– (a) an NHS body; (b) a local authority; (c) Public Health England; or (d) Public Health Agency.” 2. What they can supply: “A prescription only medicine for parenteral administration containing naloxone hydrochloride but no other substance that is classified as a product available on prescription only.” 3. Under what conditions they can supply: “The supply shall be only in the course of provisions of lawful drug treatment services and only where required for the purpose of saving life in an emergency.” Take-home naloxone after October 2015

So, from October 2015 ALL THE SAME AS BEFORE OCTOBER! But in addition: Naloxone can be supplied by a drug treatment service commissioned by a local authority or the NHS to any individual needing access to naloxone for saving a life in an emergency So it can be supplied without prescription (or PGD or PSD) to: someone who is using or has previously used opiates (illicit or prescribed) and is at potential risk of overdose a carer, family member or friend liable to be on hand in case of overdose a named individual in a hostel (or other facility where drug users gather and might be at risk of overdose), which could be a manager or other staff There is no need for the usual Prescription Only Medicine requirements, just a requirement that the supply is suitably recorded Take-home naloxone after October 2015

What is a drug treatment service? Commissioned by a local authority or the NHS (or by Public Health Wales or Public Health England, which doesn’t commission services but is there in case of any future changes) Services are not defined in legislation but generally understood to include: Specialist drug treatment services Primary care drug services Needle and syringe programmes, including those provided from pharmacies A pharmacy providing supervised consumption of opioid substitute medication These services will be able to order naloxone from a wholesaler Take-home naloxone after October 2015

Who can supply to who? People employed or engaged in drug treatment services will be able to supply naloxone where it is required for saving life in an emergency. The usual prescription restrictions will not apply The law doesn’t specify exactly who can supply naloxone but local areas will want to ensure that it is being supplied by competent staff and that the supply is safe These staff can supply individuals. The law does not list these so they could be a drug user, carer, friend, family member, hostel manager or an individual working in another facility where there may be a risk of opioid overdose Outreach workers would be able to carry stocks of naloxone and supply it to drug users Take-home naloxone after October 2015

What can’t be done? Under the new legislation: Naloxone cannot be supplied by a service that is not a commissioned drug treatment service A drug service cannot supply stocks to another service or organisation But this is just about the new legislation. There are still ways to supply naloxone under the existing legislation, for example: A drug service may already have a wholesale dealer’s licence and be able to supply some organisations A police medical officer could order supplies of naloxone and issue it to police officers who could then administer it to someone in an emergency A doctor working for a homeless people’s healthcare service can still prescribe naloxone to individual people in the service’s care A GP or independent non-medical prescriber can prescribe naloxone to a patient A range of registered health professionals can supply naloxone under a patient group direction Take-home naloxone after October 2015

To clarify supply for hostels ... Under the new legislation: A hostel that is not a commissioned drug treatment service cannot supply naloxone to individuals A drug treatment service can’t supply naloxone to a hostel, which is an organisation But: A drug treatment service could supply naloxone to an individual in a hostel, such as its manager The hostel manager could then arrange for the naloxone to be available for staff or resident use in case of an overdose in the hostel An outreach worker from a drug treatment service could supply individual staff or residents in the hostel A hostel might be commissioned as a drug treatment service And, under the existing legislation: The hostel’s doctor or residents’ GPs could prescribe naloxone to individual residents at risk Hostel residents in treatment could be provided with naloxone by prescription or supply from their drug treatment service Take-home naloxone after October 2015

Dosing 400 The principle is to use the minimum needed to reverse an overdose without throwing someone into unpleasant (and occasionally dangerous) withdrawal So: Give 400 micrograms naloxone (0.4ml of 1mg/1ml naloxone hydrochloride solution or, less commonly, 1ml of 0.4mg/1ml naloxone hydrochloride solution) Wait Repeat according to effect every minute or so Depending on the product supplied, up to five 400-microgram doses may be available If five doses have been given and the patient is still not responding, the diagnosis of opiate overdose should be reviewed Take-home naloxone after October 2015

Product A range of products is licensed to treat respiratory depression arising from opiate overdose Prenoxad™ is specifically licensed for use in the community. It contains five 400-microgram doses in a glass pre-filled syringe, with two needles and patient information in a sealed box that serves as a sharps box after the product has been used Other products may have different concentrations and amounts of naloxone, may need to be drawn up from an ampoule into a syringe, and may not come with a needle or sharps box Some areas have paid for their own naloxone kits to be made up with a suitable product, syringe and needle, and information The working group updating the 2007 clinical guidelines and UK Medicines Information are planning further advice on products but these may not be available for a while A suitable product in your area will depend on local circumstances and arrangements, including what training is provided Take-home naloxone after October 2015

Overdose and naloxone training Local areas will want to consider what training is appropriate to different groups of people according to their circumstances and how naloxone is supplied to them Training should be about responding to an overdose, not just naloxone. It will usually cover: overdose risks: polydrug (especially benzodiazepines) and alcohol use, getting older, post-detox/rehab/prison what naloxone can and can’t do: it just reverses opiate overdose. If someone has also taken too many other drugs or too much alcohol, it won’t reverse their effects how to identify an opiate overdose – lack of consciousness, shallow or no breathing, ‘snoring’, and blueing of the lips and fingertips steps to take in responding to an overdose (see next slide) how to use naloxone, including addressing any fears about needles and injecting how to get naloxone replaced when it has either been used or is approaching its expiry date Take-home naloxone after October 2015

Responding to an overdose Steps to take in responding to an overdose: 1. Call an ambulance 2. Give rescue breaths if the person is not breathing 3. Put them in the recovery position 4. Inject the initial recommended small amount of naloxone (usually 400mcg), wait (about 1 minute). If unresponsive, inject another small amount. Repeat as necessary* 5. Stay with the person at least until the ambulance arrives Chest compressions will usually not be necessary unless the person’s heart has stopped There is no requirement for everyone receiving naloxone to receive extensive training in CPR, although this may be useful for some *If five doses have been given and the patient is still not responding, opiate overdose alone may not be the problem. Hopefully the ambulance will have arrived and paramedics can review the diagnosis Take-home naloxone after October 2015

Record keeping As a minimum, there is an expectation that suitable records should be kept of naloxone supply. These might include: identifying details of the person supplied details of the naloxone supplied (product, batch number, expiry date, etc) overdose training provided It will likely also be useful to record other information in cases where naloxone has been used and needs to be replaced, such as: circumstances of the overdose: who, when, where, etc whose naloxone was used by whom how many naloxone doses were given and their effects the response of emergency services (time to ambulance arrival, additional naloxone administered, person taken to hospital, etc) advice given to the overdosed person outcome of the overdose and its treatment Take-home naloxone after October 2015

Commissioning take-home naloxone Health and public health commissioners will want to work with local drug treatment services, homelessness services and others to consider: Which risk groups to target for naloxone supply – this might include people in or out of or leaving treatment, leaving prison, at risk of suicide, homeless or living in hostels, etc What product(s) are most suitable to be supplied by different drug service outlets Which services should provide what training to which groups Who pays for training and for naloxone supply and re-supply: It may be that this will be different for different mechanisms of supply For the new arrangement, the impact assessment assumes public health grant But the legislation does not specify and it is for local agreement So, could be local public health but could also be NHS What records should be kept to track supplies made, naloxone used, outcomes and re-supply (after use or before the supplied product’s expiration date) Take-home naloxone after October 2015

More information and references PHE (2015) Take-home naloxone for opioid overdose in people who use drugs: www.nta.nhs.uk/uploads/take- home-naloxone-for-opioid-overdose-feb-2015.pdf ACMD (2012) Consideration of naloxone: www.gov.uk/government/publications/naloxone-a-review World Health Organization (2014) Community management of opioid overdose: www.who.int/substance_abuse/publications/management _opioid_overdose Preliminary guidance from the clinical guidelines update working group: www.nta.nhs.uk/uploads/chairsletter- naloxone-22july2015.pdf The legislation, explanatory memorandum and impact assessment: ww.legislation.gov.uk/uksi/2015/1503/made Naloxone FAQs: will be available at www.nta.nhs.uk and GOV.UK Take-home naloxone after October 2015