EFFECTIVE SHARE CARE AGREEMENT (ESCA)

Transcription

1 Specialist details Patient identifier Name Tel: EFFECTIVE SHARE CARE AGREEMENT (ESCA) Melatonin in the treatment of Sleep Disorders in Children The aim of Effective Shared Care Guidelines (ESCA) is to provide information to General Practitioners (GP s) about complex or high cost therapies that their patients may receive following specialist referral. Guidelines will only be written when it has been agreed that shared care is an appropriate option and will include a statement of Specialist and GP responsibilities. Shared Care Guidelines will ensure that all GP s have sufficient information to enable them to undertake prescribing responsibility for specialist therapies and other therapies which may affect/interact with specialist therapies. This guidance is not intended to be prescriptive and may be amended according to the individual clinicians view and patient circumstances. It is not the intention to insist that GP s prescribe this therapy and any doctor who does not wish to undertake the clinical and legal responsibility is not so obliged. If the GP decides not to agree on the shared care the GP is advised to inform the specialist in writing.

2 ESCA: Melatonin in the treatment of Sleep Disorders in Children AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE This shared care agreement outlines suggested ways in which the responsibilities for managing the prescribing of Melatonin in the treatment of Sleep Disorders in Children between the specialist and general practitioner (GP).* It should be read in conjunction with the Summary of Products Characteristics (SPC; datasheet).gps are invited to participate. If the GP is not confident to undertake these roles, then he or she is under no obligation to do so. In such an event, the total clinical responsibility for the patient for the diagnosed condition remains with the specialist. If the Specialist asks the GP to prescribe this drug, if the GP does not wish to take part in the ESCA, then they should reply to this request as soon as practicable. Sharing of care assumes communication between the specialist, GP and patient. The intention to share care is usually explained to the patient by the clinician initiating treatment. The purpose of this document is to assist the provision of melatonin in children. Initiation of treatment should be the responsibility of a specialist, or a general practitioner who has a specialist interest. Once the patient is stabilised on treatment, it is then appropriate for GP s without a special interest to prescribe this drug over the longer term within the guidance of an ESCA. This document sets out the responsibilities of the specialist and the General Practitioner in the provision of shared care. It is important that patients are consulted about treatment and are in agreement with it. Patients prescribed melatonin should be under regular follow-up, which provides opportunities to discuss drug therapy. The doctor who prescribes the medication legally assumes clinical responsibility for the drug and the consequences of its use. RESPONSIBILITIES and ROLES Areas of care for which the specialist service will be responsible Assess the patient, establish a diagnosis and determine a management strategy Discuss carefully the risks and benefits of treatment with the child/young person and/or their parents, including that either (a) although the medicine is licensed, this indication represents off label use- for Circadin, or (b) although the medicine is unlicensed, this manufacturer operates good manufacturing practice in the UK- for Special Products Ltd. or Penn Pharmaceuticals. Use Circadin as the firstline choice Initiate treatment and provide at least 28 days supply Ask the GP whether he or she is willing to participate in shared care. Supply GP with summary within 28 days of a hospital out-patient review or in-patient stay. Ensure the patient is reviewed by a member of the specialist team to monitor response to treatment regularly (two weeks after initiation and then at least every 6 months Agree to review patient s condition when requested by the patient s GP. Review the treatment regularly, sending a written summary to the GP whenever the patient is reviewed. Discontinue treatment at appropriate intervals under careful supervision when condition is stable, to assess the need to continue medication Provide any other advice or information for the GP if required. Report adverse events to the MHRA. Ensure clear arrangements for GP back-up, advice, and support. Areas of care for which the GP will be responsible If the GP declines shared care he/she will notify the consultant without undue delay Prescribe melatonin by BRAND NAME (Circadin) or by manufacturer (Special Products Ltd. or Penn Pharmaceuticals) after communication with specialist about the need for treatment. Ask patient/carer about side effects and general well being Ask carer about efficacy Report to and seek advice from the specialist on any aspect of patient care that is of concern to the GP and may affect treatment. Report adverse events to specialist and MHRA. Stop treatment on advice of specialist.

3 Inform specialist of all relevant medical information regarding the patient and any changes to the patient s medication irrespective of indication. Liaise with the patient s nominated community pharmacy if required regarding supply. Patient/carer's role Report any adverse effects to the specialist or GP whilst taking melatonin. Share any concerns in relation to treatment with melatonin. Report to the specialist or GP if they do not have a clear understanding of their treatment. BACK-UP ADVICE AND SUPPORT Contact details Telephone No. Bleep: Fax: address: Specialist: GP: Other: Or any primary care prescriber Contacts Dr Zala Ibrahim. Dudley Group NHS FT Dr Kate Gingell, Dudley CAMHS Dr Arpita Gandhi, Dudley CAMHS Dr Adam Kirby, (BCPNFT) Adam.Kirby@bcpft.nhs.uk Jane Elvidge, Medicines Information (Pharmacy, Russells Hall Hospital) Prescribing and Medicines Management Team, NHS Dudley,

4 SUPPORTING INFORMATION Insomnia is a widespread problem in children with neurodevelopmental or psychiatric disorders such as autistic spectrum disorder & attention deficit hyperactivity disorder (ADHD). Behavioural therapy can be very effective in some forms of paediatric insomnia however children with neuropsychiatric disorders tend to have a lower response rate to behavioural therapy and may required drug treatment. Currently there are no licensed treatments for sleep disorders in children in the UK. Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone produced by the pineal gland during the dark hours of the day and night. It is used as a treatment of sleep disorders in children. The use of melatonin is supported by NICE in their Clinical Guidelines on the diagnosis and management of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) in adults and children. The NICE guidelines states that melatonin may be considered for children and adolescents with CFS/ME who have sleep difficulties, but only under specialist supervision. Indication Melatonin is indicated for treating sleep disorders in children and adults with neurodevelopment disorders and conditions such as visual impairment, cerebral palsy, attention deficit hyperactivity disorder and autism. It is also sometimes used before EEG investigations. Licensed Indications Circadin 2mg M/R prolonged-release tablets is the only melatonin product licensed in the UK. It is licensed for short-term use in over 55s only. However, the MHRA have stipulated that licensed products should be used wherever possible, even if it means using a product off-label and outside its licensed indications. Hence, Circadin 2mg MR is the preferred option. PRACTICAL GUIDANCE FOR PRESCRIBING MELATONIN 1. Before starting treatment, traditional non pharmacological sleep hygiene methods must have been tried and failed. 2. For full dosage and administration details see below. Doses higher than 10mg are not considered to be of greater efficacy. If no benefit is seen after 2 weeks, then melatonin should be stopped. 3. It is recommended that melatonin be given on an empty stomach, since the absorption may be delayed when taken with large meals. It should be taken minutes before bedtime. 4. The aim is to establish healthy sleep habits with the lowest effective dose. At least six months of an improved sleep pattern should elapse before withdrawal takes place. Withdrawal should occur over a period of 3-4 weeks. For some children however withdrawal is not successful and treatment may be necessary long term. 5. It is recommended that the patients are followed up every six months to ensure continuing benefit of melatonin. 6. The licensed product melatonin 2 mg MR (Circadin ) is to be used first line, for an off-label indication, if clinically appropriate. Once stabilised, shared care is appropriate, in accordance with the ESCA. It is worth noting that Circadin is a modified release tablet, which cannot be crushed 7. Special Products Ltd and Penn Pharmaceuticals are two companies that are able to supply melatonin capsules that are manufactured in the UK according to Good Manufacturing Practice (GMP). The prescription must specify the brand/manufacturer to ensure the patient receives melatonin manufactured according to GMP. Special Products Ltd can supply melatonin at the lowest cost and should be first choice when immediate release capsules or liquid are required.

5 8. The off-label or unlicensed use of melatonin should be documented in the patient s clinical notes recording that it has been discussed with the patient and / or the carers and parents. 9. Usage and expenditure of melatonin products will be monitored regularly. The MHRA has issued guidance on the use of melatonin. Many non-pharmaceutical grade products of melatonin are being imported from countries where melatonin products are classed as food supplements, not medicines, they are not required to be manufactured to the standard of Good Manufacturing Practice (GMP) normal for pharmaceuticals. It is believed that at least 50 melatonin preparations are being imported into, or manufactured in the UK. To encourage the use of melatonin manufactured according to GMP the MHRA advised that if imported melatonin was used then the special clinical need should be provided to the importer for submission to the MHRA. Melatonin 2mg prolonged release (Circadin ) is now licensed as monotherapy for the short term treatment of primary insomnia in adults aged 55 years and over. The MHRA advised It is therefore important to ensure that the licensed product available in the UK is used where possible. The MHRA would prefer an off-label licensed product be used if it can meet the clinical need, than an unassessed, unlicensed product. If Circadin is not appropriate a melatonin product manufactured according to GMP should be used, although this will be an unlicensed product. In both cases there should be an explanation to parents/carers as to the off-label or off licence use of melatonin. Appropriate consent should be obtained and filed in the patient s notes. PREFERRED SUPPLIERS In accordance with the MHRA advice the following is recommended within the trust: 1. First line -The licensed product melatonin 2 mg MR (Circadin ) for an unlicensed indication. 1. Second line - Melatonin manufactured in the UK according to GMP. Special Product Ltd and Penn Pharmaceuticals have been identified as two companies able to supply melatonin manufactured according to GMP in a number of strengths as an immediate release formulation. A liquid formulation is also available from Special Products Ltd. Always specify the brand/manufacturers name on the prescription to ensure the patient receives a product manufactured according to GMP. It will also ensure that the patient continues to receive the same formulation. Dose and Administration For prolonged release melatonin (Circadin) Initially 2mg once at night and increased if necessary The dose should be taken 1-2 hours before bedtime and after food The tablets should be swallowed whole. They should NOT be crushed or cut in half The maximum dose of Circadin is not set in children however the usual maximum of 10mg per day is advisable. For immediate release melatonin Initially 1-3mg at night, increasing after 1-2 weeks to 4-6mg (if response or partial response). Maximum of 10mg/day (although 12mg has been used) The dose should be taken about an hour before bedtime. If the child wakes during the night, the same dose can be repeated during the night Melatonin is available as a capsule or liquid, depending where the medication is obtained from. Changing from immediate release melatonin to prolonged release melatonin When the dose of melatonin capsules is equivalent to a dose of Circadin then this can be changed to the same dose e.g. 6mg of unlicensed melatonin capsules to 3 x 2mg of Circadin. For patients not on an equivalent dose, this can be changed to the next nearest dose e.g. 2.5mg capsules to 2mg tablets or 3mg capsules to 2 x 2mg Circadin.

6 For those patients who have difficulty swallowing tablets or who open capsules should not be changed. If in doubt seek advice from the specialist who initiated treatment. Liquid preparations If only a liquid preparation is suitable, ensure this is prescribed as per the drug tariff version i.e. Melatonin 5mg/5ml oral solution x 200ml. If patients are prescribed other non tariff strengths (i.e. 2.5mg/5ml or 10mg/5ml) or formulations (i.e. suspension), these individuals should be changed (with equivalent volume of dose amendment) to the tariff listed strength and formulation. Adverse effects, precautions and contraindications Melatonin is well tolerated in children; but those adverse events that have been reported rarely include: daytime drowsiness, headache, dizziness, a reduction in body temperature, transient depressive symptoms, mild tremor, mild anxiety, abdominal cramps, irritability, confusion, nausea and hypotension. Use with caution in children with epilepsy monitor seizure frequency. Melatonin can be stopped suddenly without any side effects. Drug and other forms of Interaction There is limited data on drug interactions with melatonin. In theory, effects of melatonin may be additive with other medications that cause CNS depression e.g. tranquilisers or antidepressants. Fluvoxamine: can significantly increase melatonin levels. Warfarin: INR may be increased. Melatonin might also increase the anticoagulant effect of other drugs with anticoagulant/antiplatelet properties. Herbal remedies with anticoagulant/antiplatelet (e.g. ginkgo biloba, ginseng) or sedative properties (e.g. St John s Wort, valerian) may also enhance therapeutic and adverse effects of melatonin. Concurrent antihypertensives: melatonin can increase BP and HR in patients treated with antihypertensive medication. Immunosuppressive therapy: melatonin can stimulate immune function and might interfere with immunosuppressive therapy. References Dudley Group of Hospitals NHS Foundation Trust & NHS Dudley- ESCA: Melatonin in the treatment of Sleep Disorders in Children, June 2010 South Staffordshire & Shropshire Healthcare Foundation NHS Trust- ESCA- Melatonin in children & adolescents and adults with a learning disability, Sept 2010 NHS Brighton & Hove- Melatonin Shared Care guidelines Tees, Esk & Wear Valleys NHS Foundation Trust- Guidance for the safe prescribing of melatonin in children and adults, March 2011 Summary of Product Characteristics: Interface Pharmacist Network Specialist Medicines: Greater Manchester Interface Prescribing Group Melatonin Shared Care Guideline Wassmer E and Whitehouse WP. Melatonin and sleep in children with neurodevelopmental disabilities and sleep disorders. Current Paediatrics;2006:16:132-8 Arendt J. Melatonin. British Medical Journal 1996;312: Drug Procurement Advise. Restrictions on the import of unlicensed melatonin products following the grant of a marketing authorisation for Circadin 2mg tablets. MHRA August 2008 Dudley Group NHS Foundation Trust NHS Dudley Original June 2010 Updated Nov 2011 Review date Nov 2013