Author: Nigel Brunsdon

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:

The amendment is aimed at making stocks of naloxone available in settings which drug users are likely to access, for example, hostels. It will also allow family members or carers to receive direct supplies of naloxone which they can administer in an emergency if needed.

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.

Ten reasons to distribute ‘take home naloxone’

Naloxone is the opiate antagonist that can prevent overdose. In the US it’s use is increasing and within the UK there are national programmes in Scotland, Wales, and Northern Ireland to distribute it, but not in England, in England it’s left up to local areas to decide if they should distribute it. So, I thought it was time for a top ‘ten reasons to distribute take home naloxone’ article.

1. Conversation Starter

Making naloxone available is a great way to start a conversation about overdose and overdose risks, looking at the myths and the practicalities of what to do when a friend or family member takes too much. Most naloxone programmes include a formal conversation that they require staff to have before distribution, although it has to be pointed out that this doesn’t need to be hours long (there is research showing 5 minutes may be just about the right amount of time).

2. Show that your organisation cares

Distribution of naloxone is a great way to show that your organisation actually cares about the health and wellbeing of people who actively use drugs. If your drug service doesn’t already have an overdose prevention programme than you really have to start one. Just in case you wondered, I also mean Recovery and Rehab services should have naloxone and overdose programmes, after all one of the highest risks for overdose is when someone returns to drug use with no tolerance following a break.

3. Allows people who use drugs to support themselves and each other

Rather than telling people that they are powerless in the face of the drugs they use, naloxone shows people that they can be in control of their own health promotion, and the promotion of their peers. Given access to naloxone drug users will (and do) support each other.

4. Engagement tool for treatment

Services are under continuing pressure in the UK to ‘attract’ more people into treatment. What better way of attracting people who actively use drugs than to provide naloxone. Show people that just because they are continuing to use that this is no barrier to using your services, and once they get to know that the attitude of the project is one that supports people and doesn’t judge them they may be interested in using your other services.

5. Gives people a second chance

Or a third, fourth or even tenth chance. I’m not a fan of the “there is no recovery in a graveyard” type hyperbole, but there is a truth to the fact that NOT allowing people a second chance at life isn’t something that any caring society should do.

6. It saves money

A drug related death investigation costs thousands of pounds, but the Welsh naloxone projects found that even taking training and distribution costs into account naloxone costs around £400 per life saved. You can add to this though, someone who overdoses and doesn’t get help fast runs the risk of long term health issues caused by a prolonged lack of oxygen, earlier intervention of a peer that is there when someone overdoses could prevent this.

7. Support for families and carers

There is increasing pressure both in the UK and the US to make access to naloxone easier for families and carers (watch the ‘Reach for Me‘ film that highlights the story of Denise Cullen who now fights for naloxone access following the death of her son Jeff). Having carer access to naloxone can help remove the feeling of powerlessness that some family members face when thinking about overdose. UK law does allow for carer access to naloxone as long as the person at risk holds a prescription.

8. Protects against future ‘strong’ batches

Public Health, the police and many drug organisations often put out warnings about strong batches of heroin causing overdoses of course that is all it amounts to, a warning, and human psychology being what it is a warning that says “drugs here are stronger” often just leads to increased drug sales. Isn’t it far better to also have an antidote in place in the community already that protects people who overdose, after all as Jennifer Vanderschaeghe of the Alberta AIDS Network Society says:

The best time to start an overdose program was many, many years ago. The second best time is today.

Jennifer Vanderschaeghe

9. Not just heroin users

While heroin use is an obvious focus of most readers of this website, we need to remember that opiates are in many prescribed pain medications, and that these medications are an increasing cause of accidental overdose deaths. Providing an antidote for accidental OD along with any prescriptions for these pain medications seems only logical (I’m looking at the Doctors out there on this one).

10. Brings other groups in

Naloxone provision brings other groups to the discussion, for instance in the US there are now many police forces that carry naloxone to allow them to respond effectively to overdoses (after all they are often first at the scene). This changes the narrative of the police being someone a drug user feels scared of to one where police are actively promoting life and wellbeing.

Ohh I promised you ten reasons and I seem to have ten already… so please consider this a special bonus reason:

NALOXONE SAVES LIVES

Related

The website of the Naloxone Action Group campaigning for wider access to naloxone in England.
Film with Greg Scott talking about having naloxone in a family situation.
A HIT Hot Topics film with Dan Bigg talking about the rising cost of naloxone in the US.
The Naloxone.org.uk website.

Special thanks to Eliza Wheeler, Meghan Ralston and Stephen Malloy for help in putting this article together.

Alternatives to Public Injecting

Harm Reduction Coalition invited experts from several countries to share their various SIF models, planning and policy development process, implementation challenges, and evaluation results. This report is a summary of the proceedings of the consultation.

Conclusions

At the risk of ‘spoilers’ here are the conclusions of the report:

  • People who use SIFs take better care of themselves, reduce or eliminate their needle sharing, use their drugs more safely, and ultimately reduce their drug use;
  • SIF participants gain access to other medical and social services and entry into drug treatment;
  • There has not been a single overdose death in any of these programs over many years of operation and many thousands supervised of injections;
  • SIFs do not increase drug use in the area, nor do they encourage young people to initiate drug use;
  • Crime and public nuisance decrease in the areas around these programs.

Community Management of Opioid Overdose

These guidelines produced by the World Health Organisation aim to reduce the number of deaths from opioid overdose by providing evidence-based recommendations on the availability of naloxone for people likely to witness an opioid overdose along with advice on the resuscitation and post-resuscitation care of opioid overdose in the community.

Specifically, these guidelines seek to:

  • increase the availability of naloxone to people likely to witness an opioid overdose in the pre-hospital setting;
  • increase the preparedness of people likely to witness an opioid overdose to respond safely and effectively by carrying naloxone and being trained in the management of opioid overdose;
  • increase the rate of effective resuscitation and post-resuscitation care by persons witnessing an opioid overdose

Tips For Supplying Foil

So foil is now legal in the UK (since September 5th), needle programmes across the country are now (hopefully) stocking it and offering it as a possible tool for change or early engagement route for people who smoke rather than inject their drug of choice. So here’s a bit of advice for those workers giving it out.

Foil for change

One of the many roles of a needle programme is supporting people to move away from injecting to a safer route of administration, this is of course where foil is most likely to be used as a tool for most of us. But getting someone who injects to just move over to smoking is a pretty hard sell so bear these points in mind:

  • Timing is everything: An ideal time to move over to smoking is when someone is already considering a change in their use, it might be because they are having problems getting a vein, or that they want to reduce the risk of overdose following a personal or witnessed OD. Be aware of these opportunities to positively change behaviours.
  • You don’t have to change all at once: Moving to smoking is a big step for some people. If someone is having problems with their veins then smoking, even just once a day, rather than injecting can help give those veins a bit of much needed rest.
  • If you’re reducing, it’s easier to dose when smoking: Although injecting is perceived as cheaper we have to remember that no matter what the strength of the deal thats injected you are getting it all, with smoking if the drug is stronger you can adapt your use easier. This is especially useful when reducing the amount used as it’s likely people only want to get rid of withdrawals rather than getting high.

Of course, if someone has been injecting for a while then they may be out of practice with smoking, and the worries they have about smoking being more expensive might prevent them from even trying it. The perception has always been that injecting is more cost effective, but bear in mind that if someone is using an acidifier (Citric or VitC) to prep their injection they are probably using too much and destroying some of their drug. That said though, it’s important to make sure we make smoking as cost effective as possible to help encourage the change. The video below shows how to make the foil ‘pipe’ to maximise the amount of drug you can ‘recycle’ from reside. I’d recommend all drugs workers to be familiar with making these.

Burning foil myth

There are a few myths connected with foil, one of the most mentioned ones (this even made it’s way into some leaflets) is that you have to ‘burn’ a residue off the foil before smoking from it as this is ‘poisonous’, for some reason a lot of people think it’s plastic. Think about this for a moment…

… a poisonous coating on something that is put on food, and then in an oven at high temperatures. Doesn’t really make sense when you think it through does it. There is a shiny side and a dull side on foil, but this is because during the process for making foil it goes over a roller at high speed, this polishes one side. On domestic foil there is a slight palm oil residue (again from the rollers) but this is likely harmless. On the foil that Exchange Supplies produce there is no oil residue. Burning foil before using it will actually make it more brittle.

Foil is an important and logical addition to the equipment we use in needle programmes, not everyone will use it, but having a stock of it available can reduce a few peoples instances of injecting.

Buy foil from Exchange Supplies Foil Video

Foil Legal At Last

From the 5th of September foil is going to be legal to distribute from needle programmes in the UK. Another important piece of harm reduction kit that we can now have in our ‘toolbox’ of interventions and engagement. But changes like this still take far too long to happen.

Background

Back in the 1980s the UK government took the decision to begin syringe distribution to injecting drug users as a way to prevent the spread of HIV. This, of course, worked very well (the UK rate of HIV in injecting drug users is far lower than in countries that didn’t support NSP). This involved having an exception to Section 9a of the Misuse of Drugs Act so ANYONE can give someone else a syringe.

In 2001 more items became exempt (citric, swabs, filters, disposable spoons and water ampules under 2ml in volume); this was in response to the spread of Hepatitis C. After a delay of two years Vit C was added. (For more on the history of paraphernalia laws in the UK Click Here).

But all this is responding to people who are already injecting, what we needed was some way of engaging people BEFORE they injected and an option to help people route transition away from it. Almost all NSP workers have tales of people who come in asking for foil, but when we tell them they can’t have it they take needles. Some services distributed foil anyway (with no one prosecuted), but many – including some of the large charities – remained risk averse and in at least one case I know of, a great worker lost their job over promoting foil as a sensible intervention.

A number of organisations including Release and the National Needle Exchange Forum have spent years campaigning for a further law change to allow legal foil provision. This change has taken over a decade to happen, a delay which has not only possibly caused more people to have blood borne virus infections, but also one that’s reduced the likelihood of some of the big services investing in it.

The change

From September the 5th people can legally distribute foil, within certain limitations. In Theresa May’s statement regarding foil last year she said:

…only offered by drug treatment providers as part as part of structured efforts to get individuals into treatment, on the road to recovery and off of drugs.

I really hope we see services adopting this as a tool, it will help reduce the instances of HIV and Hep C infection, prevent some of the risks cause by vein damage and of course greatly reduce the risks of overdose death.

However funding towards harm reduction focused interventions is being stretched very thin, some areas are moving to a pharmacy only delivery (which would be difficult to class as ‘structured’) and we have some large charities that are desperate to show how ‘recovery orientated’ they are by dis-investing in their existing NSP spending (which ignores NSPs place within ‘Recovery’).

Foil is something we should invest in

As an early intervention and engagement tool foil is a great piece of kit to have. And added to that foil can be used as a discussion point with injectors about changing their risk levels and it becomes obvious that any organisation working with active drug users should have packs available.

World Health Organisation Calls For The Decriminalisation Of Drug Use

This month, the World Health Organisation (WHO) – the UN agency that coordinates international health responses – launched a new set of guidelines for HIV prevention, diagnosis, treatment and care for key populations. The new document is the culmination of months of consultation and review, and pulls together existing guidance for five groups: men who have sex with men, people in prisons and other closed settings, sex workers, transgender people, and people who inject drugs.

These key populations are the most-at-risk of HIV, yet the least likely to access services – a fact that “threatens global progress on the HIV response” according to WHO. By consolidating previous guidance, the document is able to highlight common barriers and needs – including recommendations for legal reforms to support service delivery.

The guidance puts forward a “comprehensive” package of interventions that governments should provide:

a) Essential health sector interventions:

  1. Comprehensive condom and lubricant programming
  2. Harm reduction interventions for substance use, in particular needle and syringe programmes and opioid substitution therapy
  3. Behavioural interventions
  4. HIV testing and counselling
  5. HIV treatment and care
  6. Prevention and management of co-infections and other comorbidities, including viral hepatitis, TB and mental health conditions
  7. Sexual and reproductive health interventions

b) Essential strategies for an enabling environment

  1. Supportive legislation, policy and financial commitment, including decriminalization of behaviours of key populations
  2. Addressing stigma and discrimination
  3. Community empowerment
  4. Addressing violence against people from key populations

As well as reaffirming the previous WHO, UNODC and UNAIDS guidance on harm reduction (and particularly the importance of needle and syringe programmes and opioid substitution therapy), the new WHO Guidance goes further to explicitly recommend, for the first time, that people who use drugs should have access to naloxone – the WHO Essential Medicine designed to reverse opioid overdose. This endorsement is a major step forward by WHO, and hundreds of thousands of lives will be saved if this recommendation is followed by governments.

Crucially, the WHO Guidance also recommends that “Laws, policies and practices should be reviewed and, where necessary, revised by policymakers and government leaders, with meaningful engagement of stakeholders from key population groups”. Within this so-called ‘critical enabler’ (see graphic) is an explicit calls for the decriminalisation of drug use in order to reduce incarceration – as well as calls to reform laws and policies that block harm reduction services, and the end of compulsory treatment for people who use drugs. The Guidance also cites the experience of Portugal in terms of decriminalisation – citing successes such as the increase in people accessing treatment, the fall in HIV cases among people who use drugs (from 907 cases in 2000 to 267 in 2008), reductions in drug use and less overcrowding within the criminal justice system. According to the press release accompanying the Guidance, “Bold policies can deliver bold results”.

The new WHO Guidance therefore represents the latest high-level, evidence-based call for the end of criminal sanctions for people who use drugs – and one of the most prominent calls from within the United Nations itself. The Guidance will be launched and disseminated at the International AIDS Conference 2014 in Melbourne, calling on governments to strengthen their HIV responses so that all key populations are included.

This article first appeared on the IDPC website and is shared here with permission

Low Dead Space Syringes

Robert Heimer, William Zule and Andrew Preston talk about the importance of low dead space syringes for blood borne virus prevention.


Images and content © Nigel Brunsdon unless stated otherwise, all rights reserved.

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