Naloxone legal changes (UK)
As a member of the Naloxone Action Group (NAG) England, I have been waiting a year for Regulations to widen the provision of Naloxone, ever since the Department of Health advised that the Medicines and Healthcare Products Regulatory Authority (MHRA) would be drafting these. In truth, the wait has been even longer as in 2012 the Advisory Council on the Misuse of Drugs (ACMD) recommended “actions for government to take to consider naloxone’s role in steps to make an impact on drug-related death rates.”
Last month the Human Medicines (Amendment) (No. 3) Regulations 2015 were laid before Parliament, amending the 2012 Regulations which restrict the supply etc. of medicines, and we got the first glimpse of the changes that are to be introduced from 1st October. The main change is that: “Persons employed or engaged in the provision of drug treatment services”, drugs workers (though a variety of different names apply this role these days) to you and me, will be added to the list of exempted professionals who can supply Naloxone without falling foul of the restrictions. I also think that volunteers working within the drug treatment service will be included within this definition, and so able to give out Naloxone to those accessing the service. The reason for this is that the new exemption is worded exactly the way as the one for “Ampoules of sterile water for injection that contain no more than 2ml of water each”, which volunteers at needle exchanges will distribute as a matter of course. The only difference with Naloxone is that those volunteers supplying it will need to undergo the necessary training to then deliver the training that service users must receive alongside their kits.
Similarly, I would also argue that pharmacists who are providing needle exchange and or supervised consumption of opiate substitution medication will also fit the criteria, and so be able to lawfully supply Naloxone once appropriately trained. I would make a distinction here with pharmacists who aren’t involved in those activities, as they would then not be providing drug treatment services.
You might be reading this thinking ‘I’ve seen Naloxone advertised at drugs services for ages so what will be different?’ You would be right – Naloxone is available at some drug services in England, but this is either prescribed directly by a Doctor or under a Patient Group Directive (PGD) which allows other medical professionals to supply this more generally without having to go back to the Doctor for each individual. PGDs can take a lot of resources to develop and implement as there are a number of legal requirements for them, and they also have to be reviewed every 2 years. So, the amendment is great news in that respect – it removes the need for a PGD and allows those providing drug treatment to supply directly to their clients, without the need for a medical professional to approve it. It is hoped that those services who were put off by the onerous processes surrounding PGDs will now be much more enthusiastic about implementing a programme – there is certainly one less excuse!
But, what is the situation for people who aren’t engaged in drug treatment, and the professionals that they engage with? I’m thinking mainly of hostel workers and those working with homeless people – their clients are just as at risk, or even more so, of overdose. Many of us have been puzzling over whether or not these people will be able to supply Naloxone under the new Regulations. Reading the Impact Assessment (IA) that was conducted before the new legislation was drafted, it would be fair to say that hostel workers are also included. The IA specifically says: “The proposed amendments to the current regulations will mean that organisations, such as homeless hostels, and individuals, such as outreach workers, whose client base includes opiate users, will be able to hold naloxone to use to reverse the effects of an opiate overdose in a client.” However, and it saddens me to say this, I don’t think that the exemption itself can be interpreted in that way. The drug treatment services must be provided by, or on behalf of, or under arrangements made by, one of the following bodies:
- An NHS body
- A local authority
- Public Health England
- Public Health Agency
Unless hostels and homeless outreach workers are commissioned to provide drug treatment services in this way, they do not meet the necessary criteria, and therefore any supply to individuals would not be “in the course of provisions of lawful drug treatment services”; the condition attached to the exemption. It is this condition which also makes me doubt that drugs workers will be able to supply directly to hostel workers, in order that they can then hold a stock to administer when needed, as that would not necessarily be lawful drug treatment services. Unfortunately the new Regulations do not change who Naloxone can be supplied to, which is someone: 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).
Although, as the phrase ‘lawful drug treatment service’ has not been defined – either within these amendments or elsewhere previously – there may be flexibility. That wider interpretation may well be supported given that the MHRA, in their consultation letter in 2013, stated that:
It is worth noting that the amended Regulations do not actually make any specific reference to supply to family members directly, but with the agreement of someone who can be supplied Naloxone, it can also be provided to family members and friends. This was recognised in Public Health England’s (PHE) Guidance issued in February 2015. By supplying multiple kits to each service user, which can be left with family and at other locations the person regularly goes, the aim of ensuring that a wider group of people have the kits can be indirectly achieved. As with any new law where interpretation is unclear, the reality of the situation may not become apparent until the law has been tested. Though I would urge caution as there is the potential for prosecution under the Medicines Act for supply where no exemption applies.
If the intention truly was for homeless and hostel workers to be included within the new Regulations, the MHRA need to clarify this as soon as possible, and certainly before October. Given the time it has taken for this law to be drafted, a redraft might not be a sensible suggestion as it will cause further delay. But perhaps it is possible for a letter of comfort or guidance to be issued, in the same way that the Lord Advocate in Scotland did prior to their national programme being officially rolled out. In fact, I don’t see why this couldn’t be done now for the drug treatment services already specified, in advance of the Regulations formally coming into force, so that there is no further delay.
In the meantime, all is not lost in relation to hostels and homeless organisations though, as I think the way round the potential barriers for is for them to work with drug treatment services to ensure that their clients can access Naloxone. The easiest way for this is perhaps for drug workers to outreach to those groups within those settings, ensuring that those who need Naloxone receive it and also increasing the availability and accessibility within the communities – after all, this is not a medication that will be self-administered. Of course, this doesn’t take into account that additional outreach would need to be funded in some way, but the possibility is definitely there.
In summary, the amended Regulations are a good step forward, but in my opinion they simply don’t go far enough, and definitely do not meet some of the assurances that had been made previously. Ultimately, what we really need is a national programme – as they have in Scotland and Wales – to ensure that everyone at risk of opiate overdose has access to Naloxone.