PROTOCOL DOES NOT COVER THE INITIATION OF NEW TREATMENT IN ADULT AND ELDERLY PATIENTS OVER THE AGE OF 55 YEARS.

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1 LINCOLNSHIRE CLINICAL COMMISSIPONING GROUPS in association with UNITED LINCOLNSHIRE HOSPITALS TRUST AND LINCOLNSHIRE PARTNERSHIP FOUNDATION TRUST SHARED CARE GUIDELINE: Unlicensed use of Melatonin in the treatment of severe sleep disorders in children with neurological or neurodevelopmental disorders. The shared care protocol covers the initiation of treatment in children and adolescents including learning disabilities. THIS PROTOCOL DOES NOT COVER THE INITIATION OF NEW TREATMENT IN ADULT AND ELDERLY PATIENTS OVER THE AGE OF 55 YEARS. The protocol however can be extended to cover the on-going therapy for existing patients once they have reached 18 years of age who are retained in services. General Principles Shared Care Responsibilities: In its guidelines on responsibility for prescribing (circular EL (91) 127) between hospitals and general practitioners, the Department of Health has advised that legal responsibility for prescribing lies with the doctor who signs the prescription. (BNF 68, September 2014, p. 5) Aims: (1) The aim of shared care guidelines is to provide information and/or guidance to GPs and hospital staff relating to the potentially complex implications of sharing patient care for a specific drug between primary and secondary/tertiary care. (2) Specific shared care guidance should be available for any high cost or high-risk drug therapy or device that may be prescribed for a patient following specialist referral. Such guidance will only be produced where shared care is considered an appropriate option. (3) Each guideline will include a clear statement of the responsibilities of both the GP and the specialist unit within the overall provision of the treatment to the patient. (4) Shared care guidelines will ensure that the GP has sufficient information available to undertake to prescribe a specialist treatment if s/he so wishes. It is not the intention of these guidelines to insist that GPs prescribe such treatment and any doctor who does not wish to accept clinical or legal responsibility to prescribe such a drug is under no obligation to do so. Nonetheless the development of a shared care guideline will only be undertaken within the context of a broad acceptance between Lincolnshire Prescribing and Clinical Effectiveness Forum (PACEF) and secondary/tertiary care that GP prescribing of such a treatment is appropriate within the constraints of formal shared care. Any drug approved for the development of a shared care guideline will automatically be classified as amber on the Lincolnshire Traffic Lights List and, if high-cost, will be supported financially through the High Cost Drugs Reserve. Thus there should be no financial reason why a GP should be deterred from prescribing a high cost drug under a shared care guideline. Further copies of any guideline in this series are available from members of the Greater East Midlands Commissioning Support Unit (GEMS) Prescribing & Medicines Optimisation Team. Date of Issue: Review Date: November 2016 Page 1 of 11

2 Principles of shared care The General Medical Council published their Good Practice in Prescribing and Managing Medicines and which came into effect 25 th February A section of the guidance provides recommendations for the sharing of care which applies to any instance when care is shared between different services. Good practice recommendation 35. Decisions about who and who should take responsibility for continuing care or treatment after initial diagnosis or assessment should be based on patients best interest rather than on convenience or the cost of the medicine and associated monitoring or follow-up Good practice recommendation 36. Shared care requires the agreement of all parties including the patient. Effective communication and continuing liaison between all parties to a shared care agreement is essential. Good practice recommendation 37. If you prescribe at the recommendation of another doctor, nurse or other healthcare professional, you must satisfy yourself that the prescription is needed, appropriate for the patient and within the limits of your competence. Good practice recommendation 38. If you delegate assessment of a patients suitability for a medicine, you must be satisfied that the person to whom you delegate has the qualifications, experience, knowledge and skills to make the assessment. You must give them enough information about the patient to carry out the assessment required Good practice recommendation 39. In both cases, you will be responsible for any prescription you sign. Good practice recommendation 40. If you recommend that a colleague, for example a junior doctor or general practitioner, prescribes a particular medicine for a patient, you must consider their competence to do so. You must satisfy yourself that they have sufficient knowledge of the patient and the medicine, experience (especially in the case of junior doctors) and information to prescribe. You should be willing to answer their questions and otherwise assist them in caring for the patient, as required Good practice recommendation 41 If you share responsibility for a patient s care with a colleague, you must be competent to exercise your share of clinical responsibility. You should: a) Keep yourself informed about the medicines that are to be prescribed for the patient b) Be able to recognise serious and frequently occurring adverse side effects c) Make sure appropriate clinical monitoring arrangements are in place and that the patient and the healthcare professionals involved understand them d) Keep up to date with relevance guidance on the use of the medicines and on the management of the patient s condition Page 2 of 11

3 Good practice recommendation 42 In proposing a shared care arrangement, specialists may advise the patient s general practitioner which medicine to prescribe. If you are recommending a new or rarely prescribed medicine you should specify the dosage and means of administration and agree a protocol for treatment. You should explain the use of unlicensed medicines and departures from authoritative guidance or recommended treatments and provide both the general practitioner and the patient with sufficient information to permit the safe management of the patient s condition. Good practice recommendation 43 If you are uncertain about your competence to take responsibility for the patients continuing care you should seek further information or advice from the clinician with whom the patient s care is shared or from another experienced colleague. If you are still not satisfied you should explain this to the other clinician and to the patient and make appropriate arrangements for their continuing care. Introduction Sleeps disorder may affect 20 30% of children aged 1 to 5 years and can often persist in later childhood. Disorders include problems getting to sleep (dyssomnias) or undesirable phenomena during sleep (parasomnias), such as sleep terrors and sleepwalking. Children with neurodevelopmental or psychiatric comorbidities are at greater risk of sleep disorders. Melatonin is prescribed as an unlicensed or off-label indication for the treatment of sleep-wake disorders in children and young people with developmental and psychiatric disorders. NICE states if a prescriber decides to prescribe an unlicensed or off-label medicine, they must follow their professional guidance. For doctors this is the General Medical Council's good practice guidelines. This guidance includes giving information about the treatment and discussing the possible benefits and harms so that the patient, and their parent or carer if appropriate, has enough information to decide whether or not to have the treatment. This is called giving informed consent. Melatonin is a naturally occurring hormone produced by the brain. It is involved in regulating a person's body clock and helping to regulate sleep patterns. Although one melatonin product - Circadin Flynn Pharma Ltd - is licensed for use in treating sleep disorders in the UK, it is not licensed for use in people less than 55 years of age. Its use in children and young people is therefore known as off-label. It is available as a prescription-only prolonged-release preparation. Other melatonin products, often described as immediate-release capsules, tablets or liquids, are available from specialist suppliers and on the internet. These are not licensed for use in any patient group in the UK and so are known as unlicensed'. Licensed Indications Melatonin is unlicensed for the treatment of severe sleep disturbances in children with neurological or neuro-developmental disorders. The aim of treatment is to Page 3 of 11

4 improve the onset and duration of sleep unresponsive to behavioural therapy and establish a regular nocturnal sleep pattern. Melatonin is not usually considered first line for the treatment of sleep disorders. Behavioural interventions and good sleep hygiene measures should be considered first line. If these are unsuccessful consider melatonin. Diagnosis should only be made by a specialist psychiatrist, paediatrician or other healthcare professional with training and expertise in the diagnosis of sleep and developmental disorders. Diagnosis should be made according to DSM-5 criteria or the guidelines in ICD-10. Drug treatment should only be recommended by a healthcare professional with expertise in sleep-wake disorders. Treatment should be based on comprehensive assessment. Drug treatment should always be part of comprehensive treatment plan that includes psychological, behavioural and educational advice and interventions. GPs may continue prescribing and monitoring drug treatment under shared care arrangements. The option to share care is an invitation to the GP, not an expectation hence they retain the right to refuse to prescribe. The consultant also retains the right to refuse to prescribe. In this status quo the GP will be solely responsible for prescribing and monitoring an alternative medicine. Drug choice is the responsibility of the healthcare professional with expertise in sleep-wake disorders and should be based on: Co-morbidities Different adverse effects of drug treatments Potential problems with compliance Potential risk of misuse and diversion Preferences of child/young person and their parent/carer. NICE advises: A licensed medicine meets acceptable standards of efficacy; safety, and quality. Clinical situations will arise where the use of unlicensed medicines or the use of medicines to treat conditions for which they are not licensed may be judged by the prescriber to be in the best interest of the patient. If there is a choice of more than one drug use the drug with the lowest overall cost. Where ever possible, Circadin, the UK licensed formulation of melatonin should be used. This also includes using it for clinical indications not covered by the UK product license e.g. off label or unlicensed use. The MHRA have since clarified this advice stating that the off label use of a medicine with a UK product license carries less risk than that of un- assessed unlicensed products. Circadin is a modified release formulation and is only available as a 2mg MR (prolonged release) tablet. The usual starting dose is between 2-3mg daily in all ages of children given before bedtime and increased if necessary after 1-2weeks to 4-6mg. The posology for Circadin in 55 is 1-2 hours before bedtime and after food (to delay absorption). There is no data on timing of the dose in children. The maximum dose is 10mg at night. Circadin should be swallowed whole. Circadin has both an immediate release (40%) component and a delayed release component (60%) which combined offer the prolonged release property. Circadin Page 4 of 11

5 can be halved using a tablet cutter. Careful halving may preserve some of the modified-release characteristics. At the discretion of the clinician Circadin can be crushed and dispersed in water if an immediate release profile is desired. Melatonin can be stopped abruptly should the need arise. There should be no adverse effects associated with this. There are no monitoring requirements associated with melatonin apart from continued therapeutic benefit and checking for side-effects. The MHRA have issued further advice in 2008 on suitable alternatives in terms of the quality, safety and efficacy of the preparations available. This can be summarised as: 1st line treatment - off label use of Circadin 2mg MR tablets. This decision is on the basis of licensing, cost and quality assurance of the product. 2nd line treatment Bio-melatonin 3 mg tablets manufactured by Pharma Nord if an immediate release preparation is required. This tablet can be crushed immediately before administration. 3rd line Liquid formulations and strengths specified in the Drug Tariff, section VIIIB. For details of all these products please refer to preparations section on page 4 Specialist Responsibilities The specialist includes CAMHS, adult learning disabilities, ULHT paediatric services and neurologists. The specialist secondary/tertiary care service will: 1. Assess suitability of the patient for the recommended treatment. 2. Discuss treatment options with the patient, their parent(s) or carer(s). The discussion should include an explanation of the unlicensed use of melatonin and the risks and benefits of the proposed treatment. Provide the person/parent/carer with all necessary information on their condition and treatment. 3. The choice of initial drug treatment and any changes to the choice of treatment is the responsibility of the specialist service. 4. Send a letter to the GP requesting that the GP participates in shared care. As part of the communication the GP should be signposted to where they can find a copy of the shared care protocol e.g. the PACEF website 6. Prescribe melatonin by brand, if applicable, clearly stating strength and formulation to be used. 7. The consultant may recommend the required treatment by phone, GP letter or fax and the GP prescribe or the consultant may initiate and titrate dose then the GP continue to prescribe or in complex patients the consultant may initiate, titrate and stabilise, undertake monitoring of therapeutic and clinical side-effects then transfer to GP to prescribe. 8. Liaise with GP and any other agency involved with the person. This must include Details of the frequency of specialist review. Page 5 of 11

6 9. Respond to any request from the GP to review the patient due to adverse effects of therapy. 10. Report any adverse effects of therapy to the Medicines and Health care products Regulatory Agency (MHRA) 11. Advise the GP on continuing or stopping the medication following medical review of the patient and associated drug therapy. Community Pharmacist Responsibilities The community pharmacist: 1. Has a responsibility to ensure any unlicensed medication ordered is of good quality 2. Provide the appropriate measuring device e.g. spoon, or oral syringe, with the medication. GP Responsibilities The GP will: 1. Notify the consultant in writing, within two weeks, if they agree to share care. 2. Ensure that the patient, their carer(s) has understood and consented to unlicensed use of melatonin. 3. Prescribe melatonin by brand for the patient once dose is stabilised. (For further details see section - preparations available page 4) 4. A clinician letter may be required for any melatonin product other than Circadin. The form this letter takes varies depending on which manufacturer or wholesaler is involved. (The community pharmacy or practice dispensary where the prescription is dispensed has the responsibility of ensuring the necessary documentation is completed and returned to the supplier, but this will require the co-operation of the prescriber to provide the necessary clinical information). 5. Monitor the patients overall health and wellbeing, on a needs led basis. 6. Monitor the patient for adverse drug reactions and liaise with the consultant regarding any complications of treatment. Carry out any investigations that are communicated and deemed appropriate. Referral Criteria 1. Patients will have been assessed by the specialist service. 2. Patients will either have received at least one month s supply of melatonin, or the GP will have reached a prior agreement with the specialist to initiate treatment on the required brand and dose. 3. The specialist will either have carried out an assessment of efficacy or the GP will be notified as to the planned follow-up for the patient. Recommended dose The BNF for Children states the dose of melatonin is 2-3mg daily before bedtime for children aged 1month 18 years, increasing if necessary after 1-2 weeks to 4-6mg daily, maximum dose 10mg daily. Page 6 of 11

7 Preparations Available 1st line product Melatonin prolonged release 2mg tablets (Circadin ) UK product licensed for the short term treatment of primary insomnia in adults aged over 55 years. Prescribe by brand as Circadin 2mg prolonged release tablets. 2nd line product Melatonin immediate release 3mg tablets (Bio-melatonin - Pharma Nord). Imported product unlicensed in UK but licensed in Hungary. Prescribe as Bio-melatonin 3mg tablets (Pharma-Nord). 3rd line products Melatonin oral solution 2mg/5ml or melatonin oral solution 5mg/5ml which are unlicensed products manufactured in the UK in facilities which comply with GMP (Good Manufacturing Practice) and are included in section VIII of the Drug Tariff. Most of these products do not have a brand name. On the prescription clearly state the strength and formulation of melatonin which is required along with the manufacturers name e.g. Penn Pharmaceuticals or Special Products ltd. The NHS Business Services Authority has confirmed that prescriptions annotated in this way will be passed for payment. Writing the prescription in this way will ensure that the patient receives the melatonin product that the prescriber intended. Adverse Effects Circadin Melatonin is generally well tolerated with only a few adverse side effects having been reported. Most commonly reported side effects include headaches, nausea and drowsiness ADR details Uncommon: Irritability, nervousness, restlessness, insomnia, abnormal dreams, anxiety, Migraine, lethargy, psychomotor hyperactivity, dizziness, somnolence Uncommon: Dermatitis, night sweats, pruritus, rash, pruritus generalised, dry skin Uncommon: Hypertension Management of ADR Refer to specialist service and if ADR is clinically significant discontinue medicine prior to referral Refer to specialist service and if ADR is clinically significant discontinue medicine prior to referral Refer to specialist service and discontinue medicine prior to referral Page 7 of 11

8 Uncommon: Abdominal pain, abdominal pain upper, dyspepsia, mouth ulceration, dry mouth, hyperbilirubinaemia Refer to specialist service and if ADR is clinically significant discontinue medicine prior to referral Drug Interactions Increased sedative effect when given with antipsychotics and other hypnotics. Interaction of melatonin with selective serotonin re uptake inhibitors has been observed. Melatonin may potentiate the effectiveness of warfarin or other oral anticoagulants, and may increase the effectiveness of monoamine oxidase inhibitors. Melatonin may reduce the effectiveness of nifedipine and other calciumchannel blockers. Precautions and Contraindications Cautions for melatonin 3mg tablets (Bio Melatonin ): Must be used under medical supervision. Melatonin may cause drowsiness. Caution should be exercised in patients with epilepsy, autoimmune, renal or hepatic disorders. Cautions for melatonin 2mg MR tablets (Circadin ): Circadin may cause drowsiness. Therefore the product should be used with caution if the effects of drowsiness are likely to be associated with a risk to safety. No clinical data exist concerning the use of Circadin in individuals with autoimmune diseases. Therefore Circadin is not recommended for use in patients with autoimmune diseases. Patients with rare hereditary problems of galactose intolerance, the LAPP lactase deficiency or glucose galactose malabsorption should not take this medicine. Monitoring Standard monitoring of growth and sexual development is recommended i.e. to check that height, weight and pubertal development progress is as expected. Indication of Likely Cost of Therapy in Primary Care Melatonin product Strength Cost per pack (pack size) Circadin 2mg m.r tablet (30 tabs) Bio-Melatonin 3mg tablet (60 tabs) Melatonin 2mg/5ml oral solution (100ml) Melatonin 5mg/5ml oral solution (200ML) Information given to patient Pre-treatment information sheet may be provided. Contact Details COMMUNITY PAEDIATRICIANS Page 8 of 11

9 Dr M. Pervez Boston Health Clinic Dr E Ikhena Boston Health Clinic Dr J. Clarke Acting Grantham and District Hospital Dr O. Akinsoji Grantham and District Hospital Dr S Gandhi Lincoln County Hospital ext Dr J Derbyshire Lincoln County Hospital ext Dr F. Johnson Lincoln County Hospital ext LPFT Contact Details CHILD AND ADOLESCENT PSYCHIATRISTS Dr S Nazir (Interim Medical Director) Grantham Health Clinic Tel Dr S Hakim Ash Villa Tel Dr S Timimi (Director of Medical Education) Horizon Centre Tel Dr Sabine Schaefer Boston Archway Centre Tel Dr Anne Thompson Grantham Health Clinic Tel Dr A Nadkarni Horizon Centre Tel Page 9 of 11

10 Dr K Telford Meridian Centre, Louth County Hospital Tel Dr W Sorour Freshney Green Centre Tel Dr E Avevor Freshney Green Centre Tel LEARNING DISABILITIES PSYCHIATRISTS Dr E Bonell Long Leys Court Tel Dr T Abbas Long Leys Court Tel Dr N Brown Long Leys Court Tel Dr David Brooks Long Leys Court Tel Dr P Speight (Deputy Medical Director) Department of Psychiatry, Pilgrim Hospital, Boston Tel NON-MEDICAL PRESCRIBERS Donna Readman - Specialist Nurse Carholme Court Tel Emma Cameron - Specialist Nurse Beaconfield Centre Tel Gaynor Bryant - DART Team Co-Ordinator Babbage House Tel Mark Pearson Community Psychiatric Nurse United House Paul Forster - Specialist Nurse Carholme Court Tel Rebecca Eccles - LD Nurse Long Leys Court Tel Samantha Martin - LD Nurse Windsor House Page 10 of 11

11 Sarah Harding - Specialist Nurse ADHD Freshney Green Centre Tel References 1. MHRA Drug procurement advice EL (08) A/11 Restrictions on the import of unlicensed melatonin products following the grant of marketing license for Circadin 2mg tablets. 15th August MHRA. Supply of melatonin MHRA s position. September BNF for Children BNF 68 September Leicestershire Medicines Strategy Group, Melatonin Guidelines in Primary and Secondary Care, accessed Authors Cathy Johnson Interface Lead Pharmacist, GEMSCU in consultation with: Shiraz Haider, Chief Pharmacist, Lincolnshire Partnership NHS Foundation Trust Dr Folasade Johnson,, Lincoln County Hospital Dr Enrique Bonell, Consultant Psychiatrist, Lincolnshire Partnership NHS Foundation Trust Page 11 of 11