On 19th February, Public Health England released guidelines aimed at local authorities for Take Home Naloxone programs. This is aimed at following the recommendations in the letter from Department of Health (Jane Ellison) to Advisory Council for the Misuse of Drugs chair Les Iverson where there was a date for the National implementation for Naloxone programs, and recommendations into the preparation for the programs to be initiated on 1st October, 2015. Although the general consensus around this date is that it is too far in the future and leaves to much scope for a further increase in drug related deaths, this date is the one that NAG (Naloxone Action Group) England are now holding providers to as a set deadline. Here are a few ways in which you can inform / support your local authorities to ensure that this is being implemented locally in time to meet the 2015 deadline.
Follow hyperlink for copy of guidelines: http://www.nta.nhs.uk/uploads/take-home-naloxone-for-opioid-overdose-feb-2015.pdf
THE GUIDELINES INCLUDE CLARITY ROUND UK LAW SURROUNDING NALOXONE
Like all medicines in the UK, naloxone sale and supply is regulated under the Medicines Act of 1968. This act brought together most of the previous legislation on the regulation of medicines but also introduced some new legal provisions for the control of medicines. When thinking about the regulation of medicines, it’s important to recognise that medicines (broadly) fall into one of four categories;
- GSL. General Sales List Medicines sold or supplied direct to the public in an unopened manufacturer’s pack from any lockable premises
- P. Pharmacy Medicines sold or supplied from registered premises by, or under the supervision of a pharmacist
- POM. Prescription Only Medicines sold or supplied to named patients by prescription. Applies to all injectable preparations, including Naloxone
- POM (CD). Controlled Drugs
As stated above, injectable naloxone is a POM and can therefore only be SUPPLIED to a person identified as ‘at risk’ of potential future opiate related overdose. It can be supplied to the friends/loved ones of those identified as at risk, but only with the written consent from the person for whom it’s to be supplied.
Who can administer naloxone?
Anyone can administer naloxone for the purpose of saving a life. In November 2005 naloxone was added to the list of injectable drugs in Article 7 of the Medicines Act, this is the part of the act that covers drugs like insulin for diabetics (and adrenaline, atropine, snake anti-venom etc).
Who can supply naloxone?
Naloxone can be prescribed by any medical doctor, but can also be prescribed by some other registered medical staff using a Patient Group Direction (PGD). This means that naloxone can be given out via drug projects that don’t necessarily have a doctor on their staff.
(Taken from Scottish drugs forum Naloxone: http://www.naloxone.org.uk/)
This would mean that in order to get Naloxone out into the community there needs to be a prescription given to an individual who has been ‘catagorised’ as high risk. This could mean treatment naive community members, those still in treatment, those leaving treatment, including residential rehab, prison leavers, in light, anyone receiving any kind of opioid medication, on prescription.
At this particular moment in time, following a freedom of information request carried out by National Needle Exchange Forum, Release and NAG Engand members, the evidence would suggest that 1 out of every 3 Health and Wellbeing boards are supplying naloxone. Considering the high level of drug related deaths Nationally in 2013. This seems to be a small amount for such a major public health issue.
In light of this information, there are a number of things you can do locally to help push this program forward and to make sure that it is firmly on the agenda in your area in line with the guidelines.
- Identify local champions: Local authorities will be looking to identify local champions. This could be you, or it could be someone who is sympathetic to the need for Take Home Naloxone programs. If your local MP signed the Early day motion 445 – NALOXONE AVAILABILITY – UK then you may well have you local champion there, sympathetic GP’s, Pharmacists, local recovery / harm reduction groups, etc. Identify who your champion is and encourage them to engage with Naloxone Action Group (NAG) This can be done via the NAG England website or via the facebook forum page. This will enure that they have all the support they may need when engaging with any local authority agents on any level.
- Organise an initial ‘informing the managers’ or ‘train the trainer’ session: While this is being done by local authorities, you could be raising awareness of your plan of action to disseminate information into your community. If you are planning local train the trainer sessions or have been asked by your local authorities who might be delivering the training, but are unsure how to go about it, please contact me at email@example.com and I will direct you to your area representative. You can then pass relevant information over to local authorities and support them in initiating the training.
- Consider who will receive Naloxone supplies, and how, users and carers, hostels and pharmacies, etc: The aim here is to have Naloxone freely available in all providers that come in contact with high risk individuals, and eventually, being ambitious, over the counter. However, the first step would be identifying key areas where there are high risk individuals, treatment services, hostels and prisons, might be a good start. The local authorities should be more that aware of where there is an immediate need. You may have to prioritise here as a first step and decide where there is the most benefit to be had. Needle exchange programs, would be an ideal starting point.
- Consider who will pay for Naloxone supplies in different areas: Commissioning for such programs sits firmly with Department of Health as the overseers of Public Health but on a local level responsibility sits with the CCG (clinical commissioning groups) following a transfer of responsibilities through localism. To find out your local CCG contact details: NHS England » CCG Directory Also as a matter of interest here Frontier Medical Group are now the official distributor of Prenoxad / Naloxone kits for Martindale Pharma so they will be the single point of contact for provision of supplies.
- Agree how you will re-supply people when Naloxone is used or it expires, and who will pay. Will you have a system that flags up appraoching expiry dates to keyworkers, pharmacies, etc: As with any form of medication there needs to be a medication management database for monitoring purposes. This would need to monitor all needs and results pertaining to Naloxone provision. How many kits were given, when given, adverse effects of medication, etc. Once the basics for this are done then it would need to be reviewed to see how to monitor a case by case study of each individual involved in the program. All input would need to be evidence based and precise in it’s records. Medication regimens for every naloxone reciever need to be monitored and also all different naloxone products of there is to be intranasal available as well as injectable, etc. Most of this should be in place for already existing medications in the community and it would simply be a matter of adding Naloxone to the list of medications already monitored. Another thing that may need to be discussed here is the need to expand the monitoring to co-morbid conditions and socioeconomic status, substance use, homelessness, chronic health conditions, employment status, etc. As already stated there should already be a monitoring system in pace which could provide the basis on which to ad the information needed regarding Naloxone provision. This action lay with local authorities primarily so does not hold any weight on what you might be forming as a part of your action plan to offer support locally.
- Hold regular meetings for Naloxone champions – including people who use drugs – to encourage progress, discuss barriers of concerns, and learn from each other: This is already happening in a number of areas so it is simply a matter of inviting the local authorities to come along and join the already existing platform that you have provided. If there is no platform locally, you can create one in the form of a local Harm Reduction Cafe where local provision and action plans can be discussed and implimented. All you need to set one up is available on the website. This should be publicised and openly supported / attended by all providers who deal in the care of those considered at risk in the community. Also as stated attended by local service user reps, groups, and people who are currently using substances.
- Explore the products and prices available, speaking to the local pharmaceutical representative, and decide together with local providers which to purchase: At this moment in time in the UK there is only one licensed product available and that is Prenoxad Injection This sight gives you all the relevant information around this particular product. The main suppliers of this product as stated before are Frontier Medical Group A kit costs £18 and there is an agreement in the contract with the pharmaceutical company that this price will stand unchanged for at least the first three years of the contract. It has been advised that two kits are complimentary to the needs of those who would be accessing services for it. One to carry on their person and one to leave in home environment. So if you can find out the local statistics pertaining to injecting drug users then you will effectively be able to get a rough estimate of how much is needed to ensure enough kits are bought in to meet the needs of your user community. There may be an online needs assessment for local IV users on your local authority webpage that can help you with this.
- Complete the paperwork and processes of a PGD, working with the local CCG and director of public health as appropriate:A PGD is a written agreement that in the case of naloxone allows nurses or pharmacists to distribute the drug to people at risk of overdose. It’s important to note that a PGD is only related to the supply of the drug and has nothing to do with administration (as we’ve stated above anyone can legally administer naloxone to save a life). A PGD should contain the following information:
- The name of the business to which the direction applies
- The date the PGD comes into force and the date it expires
- A description of the medicine(s) to which the direction applies
- The class of health professionals able to supply or administer the medicine (as named individuals)
- Signature of a doctor or dentist, as appropriate, and a pharmacist
- Signature by a representative of an appropriate health organisation
- The clinical condition to which the direction applies
- A description of those patients excluded from treatment under the direction (if applicable)
- A description of the circumstances in which further advice should be sought from a doctor and the arrangements for referral
- Details of the appropriate dosage and maximum total dosage, quantity, pharmaceutical form and strength, route and frequency of administration, and minimum or maximum period over which the medicine should be administered. Legal status of the drug should also be indicated
- Relevant warnings, including potential adverse reactions
- Details of any necessary follow-up action and the circumstances
- A statement of records to be kept for audit purposes
- Inform and liaise with police, local coroners, ambulance service lead, hostel managers and pharmacies: This one is also something that is best coming from local authorities as experience tells us that correspondence is less than positive when coming from action groups. However if you have been identified as local champion then it might be possible to be cc-d in on any local correspondence or contact to keep you up to date with progress and to put you in a position to inform the local action group of that progress. By all accounts local police should be trained and equipped and it is surprising how many police do not know what Naloxone is, following a number of ‘stop and question’ scenarios I was asked a number of questions surrounding the medication but when I suggested training options they never came to anything. Lcal coroners could be a valuable asset with regards to them being able to give first hand statistical data on causes of death, although this is jaded as cause of death isn’t always recorded correctly. This is for the benefit of the family afterwards. And also there are times when the actual cause of death cannot be attributed to one single underlying cause. This can at times work in favour of some research but in this particular case it does not. Local ambulance crews should be aware of the fact that naloxone is locally available and also on a national scale this needs to be addressed as when you call in a situation, at present, the best way to get a response is to not mention drugs at all and if you do mention that you are equipped and trained you are told under no circumstances to administer. Hostel managers should be a priority with regards to involvement in the program as they are involved in the care and support of some of the more vulnerable in the community. There are number of areas where hostels were approached first for training in preparation. This can also be something that can be carried out by local action groups in support.
- Purchase the naloxone kits and make the necessary arrangements for stocking and distributing them, and for re-supply when naloxone has been used or expired: The arrangements for re-supply should be straight forward, all services in possession of naloxone should encourage those who lose, use or have a kit that expires to come in to get a kit replaced. The ideal place for distribution would be Needle exchanges, pharmacies and prison healthcare. Any other places that you may consider should be suggested at any meetings with local authorities.
- Provide training for all drug keyworkers, all opioid substitution therapy (OST) prescriber’s locally, dispensing pharmacists, local service user groups, all of whom can contribute to the onward dissemination of information: This target has already been partially reached in a number of places and training has or is being done already. This is where local service user groups come into their own and provide an invaluable part of the localised agenda. If you have been on point with the call to arms then you will already have been trained locally and can then put yourself or your group forward to disseminate the training and relevant information around naloxone, basic life support and administration, individual certificated training can be done online at SMMGP – Substance Misuse Management in General Practice website. There are also local reps strategically placed nationally to deliver training, if you contact me at firstname.lastname@example.org then I can direct you towards your local train the trainer.
- Arrange for training to be provided to people who use drugs, patients and clients, and their families and friends, Consider who is best placed to deliver this training. Offer this training to as many people as possible: It stands to reason that those who are in the best position to cascade the training out to their communities are those out there on the frontline, this again would fall into the responsibilities of the local service users groups. If your group is not trained then then I wold suggest that you look into arranging training and put this in place. It may hold up the process or put the partnership options that are presenting into the hands of someone else. Once trained you are then in a position to offer yourselves as local trainers and pass this onto everyone you meet who has an interest. And id you are anything like me, even even those that don’t.
- Consider whether and how you will record the numbers of kits dispensed, and report the number of times naloxone was used: Part of the initial training and something that is also advocated for in an overdose situation is that an ambulance is always called. This is to reduce risk of the individual slipping back into an overdose as the naloxone wears off after 20-40 minutes. The research around this does state that the effects of street heroin is not much more but the risk is still relevant as due to prohibitive laws surrounding illicit heroin there is no quality control, etc. There are however times when they may not be called, a formula may need to be discussed as to how to monitor this, The number of kits dispensed should be easily monitored and most uses, hopefully, recorded by ambulance call outs, etc. This message is something that you can carry out into your communities. We have fought long and hard to get this far, in order for it to stay as part of service provision then we need to ensure that we are responsible, sensible and accountable for our part in the program which includes carrying the message that supports those who support us in maintaining the program at a local level.
ALL IN ALL WE HAVE PUSHED TO GET THIS TO THE LEVEL IT HAS NOW REACHED, THE JOB LAID OUT FOR LOCAL AUTHORITIES IN THESE GUIDELINES IS NOT SIMPLE ONE AND IT IS A TURNING POINT OF THE CAMPAIGN, YOUR NEXT STEPS SHOULD BE TO OFFER SUPPORT TO YOUR LOCAL AUTHORITIES TO ENSURE THAT THIS IS SUSTAINABLE. YOU DEMANDED NALOXONE, NOW YOUR ROLE SHOULD BE TO SUPPORT THE LOCAL AUTHORITIES TO GIVE YOU IT.