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New GMC guidance to UK doctors on prescribing unlicensed medicines

Discussion in 'General ME/CFS Discussion' started by charles shepherd, Nov 20, 2015.

  1. charles shepherd

    charles shepherd Senior Member

    New (November 2015) guidance from the GMC to UK doctors on the prescribing of unlicensed medicines:
    Hot topic: Prescribing unlicensed medicines
    November 2015
    For clarity, in GMC guidance the term ‘unlicensed medicines’ refers to both medicines with no UK licence, and those being used outside of the terms of their licence (commonly referred to as ‘off-label’). Although there are of course differences between medicines which do not hold any UK licence and those used outside of the terms of their licence – our guidance is the same for both circumstances which is why they are grouped together in this context.

    Recent debates around the Off Patent Drugs Bill have highlighted that our guidance on prescribing may be seen by some doctors as a barrier to the appropriate use of unlicensed medicines. We are keen to ensure that this is not the case and we have been working closely with the Department of Health, MHRA, NICE and others to understand the challenges faced by doctors in this area.

    We recognise that unlicensed medicines are commonly used in many areas of medicine such as paediatrics, psychiatry and palliative care. This Hot Topic aims to explain our guidance and assure doctors that the GMC does not wish to prevent doctors from prescribing unlicensed medicines when clinically appropriate.

    When is it appropriate to prescribe unlicensed medicines?

    While you should usually prescribe licensed medicines in accordance with the terms of their licence, we recognise that there may be instances where you conclude for medical reasons that unlicensed medicines are necessary to meet your patient’s needs. This could be for a variety of reasons, for example if there is no suitable licensed treatment available, or the licensed treatment is temporarily unavailable.

    What do I need to consider when prescribing unlicensed medicines?

    When deciding on the best treatment for a patient you should weigh up all of the options, taking into account the evidence available. You should be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy.

    Decisions should be made in collaboration with the patient by discussing the options with them and ensuring that they have sufficient information about the medicine to allow them to make an informed decision.

    We expect you to use your judgement when deciding on the level of information needed. Some medicines are routinely used outside the terms of their licence, for example in treating children. In emergencies or where there is no realistic alternative treatment and such information is likely to cause distress, it may not be practical or necessary to draw attention to the licence. In other cases, where prescribing unlicensed medicines is supported by authoritative clinical guidance, it may be sufficient to describe to the patient in general terms, why the medicine is not licensed for the proposed use.

    You must always answer questions from patients (or their parents or carers) about medicines fully and honestly. You should listen to their concerns, ask for and respect their views, and encourage them to ask questions.

    You should also consider discussing the options with colleagues or experts and getting advice from them on the appropriateness of the treatment.

    Am I putting my registration at risk when I prescribe unlicensed medicines?

    Doctors are often worried about prescribing unlicensed medicines as we say that they must take responsibility for the prescription, but of course we expect this whether the medicine is licensed or not. You are responsible for all prescriptions you sign and your decisions and actions when supplying and administering medicines and devices (or when they authorise or instruct others to do so).

    Contrary to recent suggestions, GMC guidance does not include reference to any extra personal liability in relation to prescribing unlicensed medicines.

    We expect you to carefully consider any treatment that you prescribe, and we expect you to be able to justify your decisions and actions when prescribing, administering and managing medicines regardless of whether they are licensed or unlicensed.

    Importantly, prescribing unlicensed medicines will not put your registration at risk any more than other areas of practice covered by our guidance.
  2. charles shepherd

    charles shepherd Senior Member

    This new guidance is relevant to both the symptomatic management (especially drugs used to relieve pain) of ME/CFS as well as the possible use of drugs aimed at the underlying disease process in ME/CFS

    In relation to pain management, low dose amitriptyline does not have a product license for treating neuropathic pain: of neuropathic pain 2013 refresh.pdf

    Page 2 >>


    Treatment and care should take into account patients’ needs and preferences. People with neuropathic pain should have the opportunity to make informed decisions about their care and treatment, in partnership with their healthcare professionals. Good communication between healthcare professionals and patients is essential.

    Choice of Therapy.

    Patients receiving TCAs were significantly more likely to report at least 30% pain reduction and global improvement compared with patients receiving placebo. Although amitriptyline is not licensed for neuropathic pain, the evidence base for treatment efficacy was deemed sufficient to make this positive recommendation 1.

    Nortriptyline and Imipramine
    Although these drugs are not licensed for use in neuropathic pain, they should be used as alternatives to amitriptyline in patients who have achieved satisfactory pain reduction with amitriptyline but not able to tolerate the side effects. Both are relatively low-cost drugs, and there is evidence on efficacy in relation to global improvement for these drugs 1.

    Duloxetine has been associated with an increase in blood pressure, and clinically significant hypertension in some patients. Cases of hypertensive crisis have been reported with duloxetine, especially in patients with pre-existing hypertension. Therefore, in patients with known hypertension and/or other cardiac disease, blood pressure monitoring is recommended, especially during the first month of treatment. Duloxetine should be used with caution in patients whose conditions could be compromised by an increased heart rate or by an increase in blood pressure 2.
    Patients receiving SNRIs were significantly more likely to report at least 30% pain reduction.
    Response to treatment should be evaluated after 2 months. In patients with inadequate initial response, additional response after this time is unlikely.

    Although not mentioned in NICE CG 96, there is a large body of high quality evidence that gabapentin is effective in neuropathic pain. Patients receiving gabapentin were significantly more likely to report at least 50% pain reduction and global improvement compared with patients receiving placebo3.

    Patients receiving pregabalin were significantly more likely to report at least 30% pain reduction, at least 50% pain reduction and global improvement compared with patients receiving placebo 1.

    Review Date: September 2013
    1) NICE clinical guideline 96 - Neuropathic pain The pharmacological management of neuropathic pain in adults in non-specialist settings: Mar 2010 (

    2) SPC Cymbalta 30mg hard gastro-resistant capsules, Cymbalta 60mg hard gastro-resistant capsules ( 60mg hard gastro-resistant capsules/)

    3) Wiffen PJ,McQuayHJ, Rees J,Moore RA.Gabapentin for acute and chronic pain. Cochrane Databaseof Systematic Reviews 2005, Issue
    aimossy and Scarecrow like this.
  3. aimossy

    aimossy Senior Member

    Would Melatonin now be able to be a prescription option for sleep treatments as well? It doesn't help everyone but I heard that trying this wasn't even an option in the UK. It helps me so much for sleep. It is really great news that you will have more drug possibilities available in the tool kit!
  4. Ellie_Finesse

    Ellie_Finesse Senior Member

    Melatonin is prescribed in uk for sleep problems. Its mainly given to children who have Autism, ADHD etc.
  5. SilverbladeTE

    SilverbladeTE Senior Member

    Somewhere near Glasgow, Scotland
    about damn time they decriminalized drugs and made marijuana and it's derivatives available for medical use and research

    Would really like to try it in edible form, i.e. "hash cakes" (cannot abide smoke/cigarettes, ugh), as the pain/distress is really getting too much
  6. charles shepherd

    charles shepherd Senior Member

    Melatonin is an interesting example because there is a commercial product (Circadin) available which is licensed for short term treatment of insomnia in adults over the age of 55

    However, despite the lack of any robust evidence from RCTs, the NICE guideline on ME/CFS says that melatonon can be considered for use in children and adolescents under specialist supervision

    So this is another case where 'clinical judgement' could be used to prescribe an unlicensed medication in ME/CFS

    Interestingly, there is a manufacturer caution on the use of melatonin in autoimmune disease......
    Scarecrow and aimossy like this.

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