Melatonin Shared Care Agreement

Transcription

1 For the treatment of sleep disorders in children with visual impairment or blindness, attention deficit hyperactivity disorder, autism (Unlicensed Use). Melatonin is licensed for the short term treatment of insomnia in patients age over 55. 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 can be shared between the specialist and general practitioner (GP). 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. Sharing of care assumes communication between the specialist, GP and patient. The intention to share care is usually explained to the patient by the specialist prescriber initiating treatment. It is important that patients/carers are consulted about treatment and are in agreement with it. The prescriber of the medication legally assumes clinical responsibility for the drug and the consequences of its use. RESPONSIBILITIES and ROLES Specialist Responsibilities 1. Ascertain the need for sleep onset treatment in neurodevelopment disorders. 2. Ensure all relevant investigations for underlying physical causes have been performed and confirm that non-pharmacological strategies have failed. 3. Discuss the benefits and side effects of treatment with the patient, including that the medication is unlicensed. 4. Asses the effectiveness of melatonin and stabilise patient on a maintenance dose, selecting appropriate product and providing patient with appropriate formulation. (See Table 1) 5. Transfer all appropriate information of the treatment to the GP for effective continuity of care. 6. Ensure that patient have enough medication, at least four weeks supply during transfer of care. 7. The specialist must initiate and stabilise the patient on a maintenance dose, they must select the most appropriate product/formulation. If a product other than circadian (licensed product, used off-label) is prescribed they should provide a reason for their choice so this can be reviewed periodically. 8. Have a mechanism in place to receive rapid referral of a patient from the GP in the event of deteriorating clinical condition. 9. Consider a yearly medication review with the GP and give advice on stopping treatment. A trial withdrawal should be considered and result communicated to GP 10. Report adverse events to the CSM and GP 11. Ensure that clear backup arrangements exist for GPs to obtain advice and support. General Practitioner Responsibilities 1. Reply to the request for shared care as soon as possible (within two weeks) 2. Prescribe melatonin within the dose ranges and period of treatment specified or recommended. Adjust the dose as advised by the specialist. 3. Monitor the parameters as listed below and patient response to the medication (see paragraph 4 below) 4. If the GP considers that the patient should be reviewed they should contact the initiating prescriber/camhs/paediatric team but will continue to prescribe until reassessment has occurred (unless an ADR has occurred). Communicate any problems to the specialist or if patient discontinues treatment for any reason, Date Written: April Approved by: xxxxx Review date: 1 of 7

2 asks the specialist to take back the prescribing should unmanageable problems arise (giving a two week notice period at least). 5. Refer patients to the specialist if his or her condition deteriorates. 6. Liaise with the patient s nominated community pharmacy (if required) regarding supply. 7. Consider yearly review to assess appropriateness of prescribing melatonin if patient have been on it for up to one year on the advice of the specialist. 8. Ensure that all relevant staff within the practice are aware of the shared care guidelines 9. Report adverse events to the specialist and MHRA through appropriate means. Patient's / Carer s Role 1. attend appointments 2. Comply with instructions on completing sleep diary to help evaluate efficacy 3. Inform specialist or GP of any other medication being taken, including over-thecounter products. 4. Report to the specialist or GP if he or she does not have a clear understanding of the treatment. 5. Share any concerns in relation to the treatment with melatonin and report any problems to the specialist or GP whilst taking melatonin Effective Shared Care Agreement Form Effective Shared Care Agreement Form Name of patient: NHS No: Date of Birth: Address (include post code): Contact Telephone Numbers (Please supply minimum of two contacts points) & Patient Signature: Date: Advocate/Carer s Name: Contact Details: or Date Written: April Approved by: xxxxx Review date: 2 of 7

3 Signature: Date: Consultant Name: Contact Address or Signature Date General Practioner s Name Contact Address or Signature Date GP s comment: BACK-UP ADVICE AND SUPPORT (Please contact the specialist who initiated the treatment) Contact details Telephone No. Specialist: Consultant Community Paediatricians (Walsall) / Consultant Psychiatrist CAMHS (Walsall) Consultant Community Paediatrician (Dudley) / Consultant Psychiatrist CAMHS (Dudley) / / Dr Adam Kirby, (BCPNFT) Adam.Kirby@bcpft.nhs.uk Other: PCT Head of Medicines Management (Walsall) Prescribing and Medicines Management Team, NHS / Dudley Medicines Information (Pharmacy, Russells Hall Hospital) SUPPORTING INFORMATION 1. Therapeutic Use Melatonin is a hormone that is produced by the pineal gland in the brain. Melatonin is produced naturally by the body during the hours of darkness and is involved in the promotion of sleep. It is used in the treatment of sleep disorders in children with visual impairment or blindness, cerebral palsy, attention deficit hyperactivity disorder, autism, epilepsy and in the treatment of sleep disorders in patients with learning disabilities or dementia. Sleep diary should be completed before use to establish the the level or significant problems with sleep latency before treatment with melatonin is initiated. A sleep diary is available from: Treatment must be initiated by or under the supervision of a physician with appropriate knowledge and experience of childhood behavioural disorders or learning disabilities or dementia. Where melatonin has successfully established a good sleep pattern a trial withdrawal of melatonin should be undertaken before considering transfer of prescribing to primary care to establish continuing need. For some patients where it appears to lose its effect after a while, it should be given for blocks of a few weeks with a few days break before restarting. The continue need for melatonin should be assessed periodically by the specialist by stopping the medicine for up to two weeks each year. Date Written: April Approved by: xxxxx Review date: 3 of 7

4 It may be used in short courses of a few weeks to help re-establish a good sleep routine, or as a continuous medication. Melatonin should be discontinued by late adolescence (by 18 years) on the recommendation of the specialist. 2. Choice of products and NHS Cost. Only one brand of melatonin is licensed in the UK (Circadin - Melatonin 2mg prolongedrelease tablets). Licensed preparation is to be preferred over an unlicensed one and use in many circumstances may be off-label. Prescribers should always consider licensed preparation first and unlicensed products are restricted to where there is need for dose titration or when patients are not be able to take solid dosage. Liquid preparations should only be prescribed for selected patients that truly cannot tolerate solid oral preparations. Prescribers are advised to specify a brand or a manufacturer. Prescriptions should state the drug, strength, form, manufacturer, frequency and quantity to be supplied. 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. The first line option is (Circadin)-Melatonin 2mg prolonged release tablets The MHRA advice is to prescribe in the following order of preference: i. If there is a licensed product available it should be used, even if it is for an unlicensed use. This means Circadin 2mg sustained release tablets. The pack is of 30 tablets so prescribe quantities with care. This should be the preparation of choice unless there are clear reasons why it will be inappropriate ii. There are a number of unlicensed UK specials manufacturers and the import of unlicensed products, particularly from the USA, where melatonin is classed as a food supplement. The standards of manufacture and quality control will be unpredictable. There is likely to be a time delay, and the cost is unspecified. A special clinical need letter should still be provided. 3. Dose and Administration For children: Sleep onset insomnia (initiated under specialist supervision) Delayed sleep phase syndrome (initiated under specialist supervision) Unlicensed use: By mouth using modified-release tablets (circadin) Initially 2 3 mg daily for 1 2 weeks, then increased if necessary to 4 6 mg daily, dose to be taken before bedtime; maximum 10 mg per day. Adult 55 years and over: For prolonged release melatonin (Circadin) - Insomnia (short-term use) 2mg once daily (for up to 13 weeks). The dose should be taken 1-2 hours before bedtime and after food The tablets should be swallowed whole. The manufacturers of Circadin do not recommend that patients break or crush Circadin as this may impact the intended release characteristics. However, a number of patients experience difficulties in swallowing and tablet breaking or sub-division and crushing are commonly used methods to aid dosing in practice. Unlicensed liquid preparations of melatonin are also widely used. Date Written: April Approved by: xxxxx Review date: 4 of 7

5 If the tablet is crushed, the manufacturers have advised that the release characteristics are approximate to an immediate release dose form. From a practical standpoint therefore, wherever possible, the patient should be encouraged to swallow the tablet whole. Where this is not possible, halving or quartering the tablet, to aid administration might be expected to have some, but limited impact on its intended characteristics. The in-vitro release from a crushed or powdered tablet is expected to provide an immediate release profile similar to that from an unlicensed immediate release tablet or (unlicensed) oral liquid and as such provides a viable alternative to either of these options. However, as Circadin is a licensed product, its use outside of licence (in so far as the tablet is broken or crushed) is considered preferable to using an unlicensed presentation of melatonin. The clinical effect of this is not known. 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. 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. 4. Monitoring Requirements: The need to continue melatonin therapy should be reviewed every 6 months. 5. Side Effects Parameter Frequency of monitoring Action Height Annual By Specialist or GP by agreement Weight Annual By Specialist or GP by agreement Pubertal development Annual By Specialist or GP by agreement Melatonin appears to have very few short adverse effects such as worsen seizures and exacerbate asthma, so should be used with caution in patients with a history of seizures and respiratory disorders. The most common adverse reactions were headache, nasopharyngitis, back pain, and arthralgia, which were common, by MedDRA definition, in both the Circadin and placebo treated groups. Please refer to Melatonin SPC for detailed information on adverse effects. Other reported side effects include headaches, dizziness, nausea and excessive drowsiness. There is limited information about long term adverse events, so routine screening for side effect is recommended. All suspected reactions (including those considered not to be serious and even where the causal link is uncertain) should be reported to the CSM 6. Contraindications Hypersensitivity to the active substance or to any of the excipients in section 6.1 of the melatonin SPC (see melatonin SPC).. 7. Special warnings and precautions for use 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. Circadin contains lactose. Patients with rare hereditary problems of galactose intolerance, the LAPP lactase deficiency or glucose-galactose malabsorption should not take this medicine. Date Written: April Approved by: xxxxx Review date: 5 of 7

6 8. Effects on ability to drive and use machines Circadin has moderate influence on the ability to drive and use machines. 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. 9. Drug Interactions Melatonin s metabolism is mainly mediated via CYP1A enzymes. Therefore interactions may occur between melatonin and other drugs affecting or metabolised by CYP1A enzymes e.g. fluvoxamine, cimetidine, ciprofloxacin and other quinolones, carbamazepine, omeprazole, oestrogens (oral contraceptives and HRT), rifampicin, theophylline and. Increase in blood pressure with nifedipine and reduced prothrombin with warfarin have been reported There is a large amount of data in the literature regarding the effect of adrenergic agonists/antagonists, opiate agonists/antagonists, antidepressant medicinal products, prostaglandin inhibitors, benzodiazepines, tryptophan and alcohol, on endogenous melatonin secretion. Whether or not these active substances interfere with the dynamic or kinetic effects of Circadin or vice versa has not been studied. Alcohol should not be taken with Circadin, because it reduces the effectiveness of Circadin on sleep. Circadin may enhance the sedative properties of benzodiazepines and non-benzodiazepine hypnotics, such as zaleplon, zolpidem and zopiclone. In a clinical trial, there was clear evidence for a transitory pharmacodynamic interaction between Circadin and zolpidem one hour following co-dosing. Concomitant administration resulted in increased impairment of attention, memory and co-ordination compared to zolpidem alone. Circadin has been co-administered in studies with thioridazine and imipramine, active substances which affect the central nervous system. No clinically significant pharmacokinetic interactions were found in each case. However, Circadin co-administration resulted in increased feelings of tranquility and difficulty in performing tasks compared to imipramine alone, and increased feelings of muzzy-headedness compared to thioridazine alone. Refer to Melatonin SPC for detailed information with regards to renal/hepatic impairment, pregnancy and lactation. Date Written: April Approved by: xxxxx Review date: 6 of 7

7 References BNF for children NHS Quality Improvement Scotland. Evidence Note. No. 14. Dec 2006 Regional Drug and Therapeutics Centre: Drug Update. No. 44. November Great Manchester Interface Prescribing Group. Shared Care Guideline for Melatonin for Sleep Disorder LNDG review: Melatonin in paediatric sleep disorders (Sep 2008) Evidence/Drug-Specific-Reviews/Melatonin-inpaediatric-sleep-disorders/?query=melatonin&rank=4 North Essex Partnership NHS FT Melatonin Continuing Care Guidelines (2010) Walsall CCG Shared Care Guideline for Melatonin for Sleep Disorder Dudley Group of Hospitals NHS Foundation Trust & NHS Dudley- ESCA: Melatonin in the treatment of Sleep Disorders in Children, June 2012 Summary Product characteristics Circadin, last updated July Available at: Melatonin (Spot-list) Prescqipp community interest company, Available at: bulletin-108-melatonin-spot-list Date Written: April Approved by: xxxxx Review date: 7 of 7