In the UK, both medications that are suitable for use with The Sinclair Method (TSM) are approved for prescription on the National Health Service (NHS). So you might reasonably assume, therefore, that a consultation with a medical professional to have an informed discussion about the various medical treatments approved for Alcohol Use Disorder (AUD) would be a relatively uncomplicated process. Feel sure that your health professional will include the latest approved treatments in the discussion, yes?
What is the role of the MHRA?
The Medicines and Healthcare Products Regulatory Agency (MHRA) licenses medications and medical devices. This means that they look at ALL the evidence provided for a particular medical product, including medicines, and approve it for use in a particular way.
What is the role of NICE?
Since 1999, the National Institute for Health and Care Excellence (NICE) has provided the NHS with high quality advice on cost-effective and safe healthcare. Once NICE have approved a MHRA-approved medication for use within the NHS in England and Wales, the NHS is legally obliged to fund the provision of the medication for those whom it could help.
Any advice and guidelines that NICE issues to the NHS are for guidance only. Any medically trained and suitably qualified physician can prescribe any MHRA-approved medication if they wish, either by following the licensing outlines provided by the MHRA, or by prescribing it ‘off-license’ (i.e. for a use not suggested by the MHRA).
What is the purpose of the NHS Constitution?
The NHS Constitution for England and Wales establishes the principles and values of the NHS, setting out the rights that patients, staff and the general public can expect from the NHS and its associated service providers.
Among its pledges are:
that you have the RIGHT to drugs and treatments that have been recommended by NICE for use on the NHS if your physician says they are clinically suitable for you.
that you have the RIGHT to be treated with a professional standard of care, and by appropriately QUALIFIED AND EXPERIENCED staff.
that you have the RIGHT to have any complaint that you may need to make against NHS services acknowledged within 3 working days and to have it properly investigated.
MEDICATIONS SUITABLE FOR USE WITH THE SINCLAIR METHOD
Naltrexone – this medication is approved by NICE for use within the NHS, but is licensed for use by those who are already abstinent to help them manage their cravings. Additional psychological support is also recommended by NICE. Though naltrexone is suitable for TSM, it is rarely prescribed off-licence in this way. If you wish to read how NICE recommend this medication is used, you can find more information in their guidance CG115. On reading this, you will appreciate that the guidance itself, published in February 2011, is very ambiguous – saying in one sentence that naltrexone can be considered following a successful withdrawal, and then in another, that naltrexone should be discontinued if drinking persists 4 to 6 weeks after starting the drug.
Nalmefene (Selincro) – this medication is approved by NICE for use within the NHS, and is licensed to help people by acting as an aid to reducing their drinking. As with naltrexone, NICE also recommend that additional psychological support is provided to complement the medication and obtain the best results from it. The prescribing instructions are as per TSM, but TSM is not referred to by name, and this is the medication you are more likely to be prescribed if you are still currently drinking. Again, further guidance on how NICE recommends the use of this medication on the NHS is provided in their guidance, TA325, published in November 2014.
WHAT IS THE ROLE OF THE LOCAL HEALTH AUTHORITY?
Each local health authority (LHA) is responsible for providing funding and resources for NICE-approved NHS recommendations within their area. The idea is that local, rather than national, involvement will be able to provide more appropriate services that are more in line with the requirements of both the local community and local government. Ultimately, the responsibility for providing local services, including health, has been entrusted to your local council. If you are struggling with your local alcohol services, a useful resource that can help you move things forward is actually, and quite surprisingly, your local MP.
So, the NHS has a legal responsibility to provide funding and the appropriate aftercare for NICE-approved medications, but HOW they provide that is entirely a matter for each individual health authority, in partnership with the local council.
So, simply explained, NICE will provide an overall guidance (or ‘pathway’) for how the NHS should most appropriately provide assessments for obtaining a medication on the NHS, but the local health authority will also establish their own local pathway, or instruction, to physicians within their area, that will be in keeping with the NICE guidance but may include local differences unique to their area.
THE RED, AMBER, GREEN LIST
The Red, Amber, Green (RAG) list is the system that the NHS uses to categorise each medication and quickly help medical professionals identify the recommended professional able to prescribe the medication in question. This guidance is, however, advisory, and individual medical practitioners can prescribe any medicine available to the NHS as appropriate to the patient’s needs, after a clinical assessment.
In reality of course, and possibly due in part to the high-litigation world we live in today, this rarely happens! A GP is often unlikely to prescribe against local guidelines, especially when it comes to a medication – or condition such as Alcohol Use Disorder, of which they have little experience or expertise. It would be like a GP taking it upon him or herself to prescribe a medication for cancer, against local guidelines, without first referring you to a cancer specialist….
RED status means that it is recommended that only a specialist initiates the treatment and continues to provide support to the patient.
AMBER status means that it is recommended that only a specialist initiates the treatment and continues to provide support to the patient, but that the local GP may, if in agreement, continue to issue the prescription to make collection as convenient as possible for the patient.
GREEN status means that it is recommended that the treatment is suitable for both prescribing and monitoring in Primary Care (i.e. GPs).
NICE have deemed naltrexone to be a ‘red’ medication, and nalmefene is a recommended ‘green’ medication, but the majority of local health authorities have re-categorised both medications as ‘red’ or ‘amber’ due to their local GPs not having the required funding, skills or time to provide the additional psychological support that is also required for both medications.
THE BARRIERS TO TREATMENT
As I am sure you can now understand from reading the above, the barriers to receiving treatment for AUD on the NHS are all to clear. Faced with such difficulties, people often look elsewhere, and if they have the financial ability, may approach a private doctor. Others will obtain an online consultation for the medication with reputable companies such as Leeds-based Pharmacy2U.
Listed below are the most common barriers to obtaining this treatment on the NHS, and how to overcome them. Please note, that if you still have difficulty in obtaining an assessment to see if this medication is suitable for you, your right to complain is explained in full on the NHS choices website.
Choice of medication
Nalmefene (Selincro) is the official medication used for The Sinclair Method protocol in the UK. If you ask for naltrexone, you are likely be refused as, although it is suitable for TSM, naltrexone is only licensed for use by those who have already achieved abstinence. Remember, that it is not officially called The Sinclair Method in this country, so you simply need to be asking for nalmefene to help reduce your alcohol consumption.
GP vs. Specialist
Due to the RAG list mentioned above, there are very few GPs who will prescribe nalmefene for you. In many cases, they may not have even heard of it! When they look it up on their computer they will likely see that it is either categorised as ‘red’ or ‘amber’ and comes with instructions from their LHA to refer the patient to the local alcohol services unit for assessment.
In all of my research to date, I have found that the Leicestershire area is the only one to have categorised nalmefene in line with NICE recommendations, therefore allowing GPs to prescribe and monitor without the involvement of the local alcohol services unit in their area. Well done to the Leicestershire Area NHS!
If you wish to try your GP, then please do so. In some cases, the difficulty they have meeting the local guidelines isn’t with prescribing nalmefene itself, but with providing the additional support required. If this is the case, then C3 Europe provide free accredited counselling support that meets this purpose.
In many cases, you may often self-refer yourself to the local alcohol services unit if you wish, and avoid the time it takes to get a GP appointment.
It is shocking to think that in modern times, those of us with addiction issues are often still subjected to stigma – and, in some cases, from those who really should know better. Sadly, this includes a lot of people in the medical sector who have long-standing, but misguided, beliefs that we should be able to ‘just stop drinking’ or that somehow our illness is self-inflicted.
Of course, I hope this is a small minority of medical professionals, but be prepared for the fact that you may need to stand your ground. If you find this difficult, ask a friend or relative to accompany you at your appointment, to provide moral support. Keep telling yourself that you are suffering from a medical illness and that you have a right to be treated as an individual and with respect.
In addition, and despite the fact that nalmefene is NICE-approved for use by moderate drinkers, the re-categorising of the medication to ‘red’ or ‘amber’ status by the local health authorities means that those potentially suitable for the treatment are being informed that they must attend clinics run by the alcohol and drug services unit in their town, in order to even be assessed for the medication in the first instance.
Many I have spoken to are also uncomfortable with the idea of being referred to local alcohol service units for assessment and counselling, when these agencies are also frequented by those with more severe addiction issues. It is too big of a jump to make for many people who otherwise see themselves as productive members of society, with a job, a home and families.
Lack of knowledge/procedure
Though nalmefene was approved by NICE in November 2014, we are still hearing from people whose doctors and addiction counsellors have never heard of it, or what it does.
We also hear that, in many cases, even those working at the alcohol services units are not aware of the procedures set in place by their local health authority that give them the remit to undertake an assessment for this medication.
You may find that their help consists mostly of individual or group therapy and various other forms of support, and that medical treatments for helping you are not discussed. This may be due to your appointed support worker not knowing about it, not having been instructed or trained in it, or is simply operating under instructions that they ‘don’t provide anti-craving medications’.
As a result, you may need to state quite firmly that you wish to be seen by the prescribing physician to be medically assessed for this treatment. Remember, under the NHS Constitution, it is your RIGHT to be provided with NICE-approved treatments IF they are clinically suitable for you. You cannot be provided with these treatments if you are not assessed by a medical physician – a support worker (unless medically qualified) cannot do this for you.
No-one working for the NHS is permitted to impose their personal beliefs upon you. This is unprofessional at best and against the pledges made in the NHS Constitution. Many alcohol support workers are people who have suffered issues with alcohol themselves, and they may not believe in medical help with your problem. This is their problem, not yours! Do not let their beliefs, or their lack of knowledge, stop you from asking for what you are entitled to.
This then brings me to my final point for this article, which is all about how to get sat in front of the correct people/NHS department in the first instance!
GET YOURSELF PREPARED USING C3 FOUNDATION EUROPE’S RESOURCE SERVICE