Examples and further details regarding Naloxone status and use in the following European countries: United Kingdom, France and Italy .

There are a limited number of published papers on the subject of naloxone-on-release within European countries. A mapping review conducted (Horton et al. 2017) showed that the majority of papers looked at attitudes towards naloxone-on-release and were mainly from the USA or the UK.

The information below has been taken mainly from these limited published papers and from the EMCCDA report (EMCDDA, 2016a) and also gives a brief highlight of community distribution in Europe.


The availability of naloxone for people who use drugs in France was made available in two phases:

Phase One

Firstly, a Temporary Cohort Use Authorisation (ATUc) from the French National Agency for the Safety of Health Products (ANSM, the French drug agency) for the NALSCUE® product (naloxone nasal spray from Indivior), was authorised on 5th November 2015 and was made available from 26th July 2016.

The ATUs allow a therapeutic treatment of which efficacy and safety of use are strongly presumed, to be dispensed in a controlled manner for a defined population with the authorisation of the ANSM, pending a marketing authorisation that the pharmaceutical company undertakes to request.

The ATUc allows treatment to be made available before the marketing authorisation, but with an inclusion by a doctor, delivery of treatment by a hospital pharmacy, and provision of medical follow-up data to be transmitted by the prescriber to the pharmaceutical company, which communicates them to the ANSM.

During the ATUc, NALSCUE® could be provided in all specialised addict-logic care settings (medico-social settings called CSAPA, the most common specialised settings in the community with more than 450 centres throughout France), emergency services, hospital addiction unit, Addiction Care and Liaison Teams (ELSA) in hospitals, penitentiary health units as well as by centres and structures with mobile care teams for people in a precarious or excluded situation managed by non-profit organisations.

ATUc limitations: Harm reduction settings (called CAARUDs in France: Centres d’ Accueil et d’ Accompagnement à la réduction des risques pour fewer usagers de Drogues) are not authorised for regulatory reasons within the framework of the ATUc to dispense naloxone despite their crucial role in preventing harms among active drug users. The main reason is that they are not medicalised and usually only provide harm reduction tools and not medical treatments.

Phase Two

Within the framework of the marketing authorisation: The ANSM issued a marketing authorisation for NALSCUE®(naloxone 0.9mg/0.1 ml) on 28th July 2017. Discussion on the price of the product is ongoing.

Once the discussion on the price of the drug and reimbursement rate is complete, NALSCUE® will then be available as a non-mandatory prescription treatment, with dispensing to patients who have received specific training in its use. This is already the case for patients who have been included in the ATU NALSCUE® protocol, but the training of users and professionals must continue.

In addition to the previous settings, CAARUDs will be allowed to deliver naloxone to the people they follow, provided that staff are trained to provide tailored information for people who use drugs, their relatives and peers.

United Kingdom

In the UK, a change was made to the Medicines Act in 2005 which added naloxone to a list of medications that can be administered, by injection, by anyone for the purpose of saving a life. Because of its Prescription Only Medicine (POM) status it is not available over the counter and was initially supplied using a Patient Group Direction (PGD) or in some cases a prescription, however, due to a regulation change in October 2015, it is now much more widely available and accessible without the need for a PGD or prescription.

PGDs, similar to Standing Orders used in some countries, are written instructions (signed by a doctor and a pharmacist) to allow the supply or administration of POMs by nurses and pharmacists without the need for an individual prescription from a doctor.

Naloxone can be supplied to anyone who is likely to witness an overdose which includes family members, friends, staff working in services in contact with people who use drugs and most importantly, people who use drugs.

The supply is no longer restricted to nurses/pharmacists and can now be provided by anyone working in a drugs service.

In 2008, the UK Medical Research Council awarded funding for the N-ALIVE pilot trial. Any prison inmate of at least 18 years of age, with a minimum duration of imprisonment of 7 days and a history of injection heroin use, was eligible for participation in the trial, which started in May 2012. Participants from 16 prisons in England were randomized to participate in the N-ALIVE trial.

Upon release from prison, those randomized to the take-home naloxone arm would receive an N-ALIVE wallet containing a pre-filled naloxone syringe and an instruction leaflet, as well as a DVD containing video instructions on overdose management and naloxone administration.

Study subjects in the control group learnt, at the point of their release, that the N-ALIVE wallet given to them contained no naloxone.

Randomization to the N-ALIVE trial ended on 8 December 2014, partly due to the evidence from Scotland’s national naloxone programme (EMCDDA, 2016a).

Availability of naloxone in England is improving and is provided in 138 of 151 local authority areas. However in a recent report (Release, 2017) analysis of the coverage of THN in each locality was variable;

Out of 151 local authorities, 117 provided details on the number of take-home naloxone kits given out in the 2016/17 financial year. Among these:

Meanwhile, Wales now has a national programme that commenced in 2009 (as a pilot) and up until March 2017, 15037 kits had been supplied to 6302 unique individuals.
It has been reportedly used 1654 times in overdose situations (Morgan and Smith, 2017).

There are six male-only prisons located within Wales, three of which provide THN to individuals identified at risk upon release. During 2016-17 distribution of THN was successfully implemented within HMP Eastwood Park in Gloucestershire (serving as Wales’ closest female prison) and police custody suites within Wales.


Commencing in 2015, 31 individuals were trained as trainers with close to 600 taking part in multi-agency training sessions for the naloxone demonstration project (Health Service Executive, 2016).

95 prescriptions of THN were issued during the project by 6 GPs in Dublin and Limerick.

5 potentially fatal overdoses were prevented with THN which was administered on 4 occasions by staff and once by a peer.

The Irish prison service participated in the rollout of the training and delays regarding prescribing were experienced but resolved towards the end of the project.


THN has been available over-the-counter in pharmacies in Italy since the late 80s and was distributed as early at 1991 to people who use drugs, their families and friends but has never been formally evaluated.

THN forms part of the overdose prevention strategy and is now distributed from 57 low-threshold harm reduction services although availability can vary regionally, with notably the south and the islands lacking in this provision. The majority of THN supplies are from drop-ins and mobile needle exchanges. As well as being provided by workers in these services, there is also a strong peer-to-peer education and supply network in operation (Ronconi et al. 2016).

Despite THN being available in pharmacies, the pharmacists themselves do not play an active role in distributing it to people who use drugs and this is seen as a shortfall in the programme.

In 2015, of the 57 services that distributed THN to their clients, 2 did not provide data. The 55 services for which activity data is known, showed a total volume of 14.999 vials distributed, an average of 272 vials per year.

There are little to no harm reduction services provided in prisons in Italy and this is recognized as an area where THN distribution would be valuable.

This research from Italy derived a number of conclusion and recommendations. The ones specific to the Italian context are noted below.




In Italy, from 1991, the practice of distributing THN was initiated when doctors took the responsibility to allow the harm reduction staff to do so in response to the rising numbers of drug-related deaths (Ronconi et al. 2016).

Naloxone was then formally classified as an over-the-counter drug in 1996 by the Minister of Health. This means it is now sold in pharmacies without the need for a prescription, available to anyone and pharmacies are obliged to have it available as it is a life-saving medication.

The legislation in the Italian Penal Code is also very clear about lay people being first responders. This is covered by two articles – emergency situations and omission of first aid. Essentially, lay people are covered legally by administering naloxone to someone who appears to be in a life-threatening condition and may face prosecution for not assisting someone who appears to be in danger.

Published: 2021
In partnership with:
Correlation Network