FRAMEWORK - SHARED CARE



|Shared Care Guideline: Prescribing Agreement |

|Melatonin (Circadin®) for persistent sleep disorders in school age children with neurodevelopmental disabilities |

|Section A: To be completed by the hospital consultant initiating the treatment |

|GP Practice Details: |Patient Details: |

|Name: ……………………………………… |Name: ……………………………………………… |

|Address: …………………………………… |Address: …………………………………………… |

|Tel no: ……………………………………… |DOB: ……/………/………… |

|Fax no: ……………………………………… |Hospital number: ………………………………… |

| e-mail: …………………………… |NHS number (10 digits): ………………………… |

|Consultant name: …………………………… |

|Clinic name: …………………………………. |

|Contact details: |

|Address: ......................................................................................................................... |

|Tel no: ……………………………………… Fax no: ……………………………………… |

| e-mail: …………………………… |

|Diagnosis: |Drug name & dose to be prescribed by GP: |

|…………………………………………………… |……………………………………………………………. |

|Next hospital appointment: ……/……/…….. |

|Dear Dr. …………………….., |

|Your patient was seen on …../..…/………and I have started Circadin® modified release (MR) tablets ………mg nocte for Persistent Sleep Disorder. A |

|sleep diary and sleep questionnaire have been completed and show evidence of a persistent sleep disorder. I am requesting your agreement to |

|sharing the care of this patient from …../.…./…….. in accordance with the (attached) Shared Care Prescribing Guideline Melatonin for persistent|

|sleep disorders in school age children (4 years - 18 years) with neurodevelopmental disabilities (approval date: …./…./……..). Please take |

|particular note of Section 2 where the areas of responsibilities for the consultant, GP and patient for this shared care arrangement are |

|detailed. |

| |

|Patient information has been given outlining potential aims and side effects of this treatment and ……………………………………* supplied (* insert any |

|support materials issued such as patient held monitoring book etc where applicable). The patient has given me consent to treatment possibly |

|under a shared care prescribing agreement (with your agreement) and has agreed to comply with instructions and follow up requirements. |

|. |

|The following investigations have been performed on ……/……/……… and are acceptable for shared care. Please monitor every 6 months. |

|Test |

|Result |

|Test |

|Result |

| |

|Weight |

| |

|Height |

| |

| |

|BMI |

| |

| |

| |

| |

|Other relevant information: ……………………………………………………………………………………….. |

|……………………………………………………………………………………………………………………….. |

|Section B: To be completed by the GP and returned to the hospital consultant as detailed in Section A above |

|Please sign and return your agreement to shared care within 14 days of receiving this request |

|Tick which applies: |

|□ I accept sharing care as per shared care prescribing guideline and above instructions |

|□ I would like further information. Please contact me on:………………………. |

|□ I am not willing to undertake shared care for this patient for the following reason: |

|………………………………………………………………………………………………………………. |

| |

|GP name: ………………………………………….………. |

| |

|GP signature: ………………………………………………Date: …/…/….. |

working in partnership

| |

|SHARED CARE PRESCRIBING GUIDELINE |

|Melatonin for persistent sleep disorders in school age children with neurodevelopmental disabilities |

|NOTES to the GP |

|The expectation is that these guidelines should provide sufficient information to enable GPs to be confident to take clinical and legal responsibility |

|for prescribing this drug. |

| |

|The questions below will help you confirm this: |

|Is the patient’s condition predictable or stable? |

|Do you have the relevant knowledge, skills and access to equipment to allow you to monitor treatment as indicated in this shared care prescribing |

|guideline? |

|Have you been provided with relevant clinical details including monitoring data? |

| |

|If you can answer YES to all these questions (after reading this shared care guideline), then it is appropriate for you to accept prescribing |

|responsibility. Prescribe only 28 days at a time with a review date of every 6 months. |

| |

|If the answer is NO to any of these questions, you should not accept prescribing responsibility. You should write to the consultant within 14 days, |

|outlining your reasons for NOT prescribing. If you do not have the confidence to prescribe, we suggest you discuss this with your local |

|Trust/specialist service, who will be willing to provide training and support. If you still lack the confidence to accept clinical responsibility, you |

|still have the right to decline. Your CCG pharmacist will assist you in making decisions about shared care. |

| |

|It would not normally be expected that a GP would decline to share prescribing on the basis of cost. |

|The patient’s best interests are always paramount |

| |

|Date prepared: Sept 2013 |Review date: Sept 2015 |

|Approved by (date approved): | |

|SWLStG Drug & Therapeutic Committee: Sept 2013 | |

|Mental Health Interface Prescribing Forum: Sept 2013 | |

This shared care prescribing guideline has been signed off by the following individuals on behalf of their respective organisations:

|Participating Clinical Commissioning Groups (CCG) |Participating Hospital Trusts |

|Kingston CCG |SWL & St. George’s Mental Health Trust |

|Dr Anthony Hughes, GP on behalf of Medicines Management Committee |Dr M Zwi (Consultant Psychiatrist & DTC Deputy Chair) |

|Seema Buckley, Chief Pharmacist |Dianne Adams (DTC secretary & Chief Pharmacist) |

|Richmond CCG | |

|Dr Stavroula Lees, lead GP for Mental health | |

|Emma Richmond, Head of Medicines Management | |

|Merton CCG | |

|Dr Andrew Otley, Mental Health Lead | |

|Sedina Agama, Interim Chief Pharmacist | |

|NHS Wandsworth | |

|Dr Gillian Ostrowsky, Associate Medical Director | |

|Nick Beavon, Chief Pharmacist | |

|Sutton CCG | |

|Dr Chris Keers, Mental Health Lead | |

|Sarah Taylor, Interim Chief Pharmacist | |

|Melatonin (Circadin ®) |

CIRCUMSTANCES WHEN SHARED CARE IS APPROPRIATE

Prescribing responsibility will only be transferred when the consultant and the GP are in agreement that the patient’s condition is stable or predictable.

Patients will only be referred to the GP once the GP has agreed in each individual case and the hospital will continue to provide prescriptions until successful transfer of responsibilities as outlined below.

Areas of responsibility

|Consultant |

|To assess the patient and establish the need for sleep onset treatment in neurodevelopmental disabilities. |

|To only prescribe melatonin second-line where non-pharmacological strategies have failed, and underlying physical causes are managed where they |

|exist. |

|To prescribe only where parents, carers or where appropriate the patient has completed a sleep questionnaire (see Appendix 1) and sleep diary (see |

|Appendix 2) highlighting problems with sleep latency. |

|Consider and discuss treatment options. This should include consideration of contra-indications, interactions and cautions, a discussion of the |

|reasons for treatment, the possible adverse effects and the lack of information in relation to longer-term outcomes including effectiveness and |

|adverse effects. |

|Provide verbal and written information to the parents, carers, and where appropriate the patient and answer their questions about melatonin. |

|Obtain consent for the off label prescribing of melatonin. |

|Perform baseline checks of physical health (including height, weight) |

|Initiate licensed melatonin (Circadin®) 2mg prolonged release tablets |

|Assess and monitor the patient’s response to treatment and make dose adjustments where necessary. |

|If treatment is ineffective and discontinued check for possible complications following discontinuation. |

|Assess the continuing need for melatonin every 6 months and consider stopping melatonin e.g. 14 day break every 6 months using an appropriate sleep |

|monitoring tool (see attached) and advise GPs on this. Provide supervision and assessment of the patient during these periods. Ensure the patient is |

|aware of the need to review the melatonin every 6 months. |

|Provide the GP with appropriate clinical information and individual patient information. |

|Communicate treatment changes to the GP promptly within Trust recommended times. |

|Unlicensed formulations of melatonin are available and may only be prescribed after SWLStG Drug and therapeutics approval on an individual basis. |

|Unlicensed formulations must be supplied by a Hospital Pharmacy. |

|To take responsibility for stopping the melatonin or to agree aftercare when the patient reaches 18 years of age. |

|GP |

|Monitor the patient’s overall health and well-being. |

|Review the patient in accordance with specialist advice every 6 months. |

|Prescribe melatonin (Circadin®) once the treatment has been established, the patient stabilised and the care of the patient has been transferred and |

|accepted. |

|Refer patients back to the specialist if there is delayed sexual development or failure to gain weight and height for the expected age and familial |

|characteristics. |

|Advise patient to attend specialist appointments (at least annually). |

|Re-refer the patient or seek specialist advice from the psychiatrist if there are on-going sleep problems, side-effects or swallowing difficulties. |

|To report any adverse drug reactions to the psychiatrist and to the Medicines and Healthcare Products Regulatory Authority (MRHA) as part of the |

|Yellow Card Scheme. |

|Unlicensed formulations of melatonin are available and may only be prescribed after SWLStG Drug and Therapeutics approval on an individual basis. |

|Unlicensed formulations must be supplied by a Hospital Pharmacy. |

|Melatonin not under shared care. |

|GPs may have other patients that are either not being seen by a Mental Health Trust Psychiatrist or by another specialist. |

|GPs may review such patients following the advice in appendix 3 or may refer to a specialist for review. |

|Parent, carer and patient |

|Complete a sleep questionnaire and sleep diary prior to commencing treatment and as recommended by the psychiatrist for on-going monitoring of |

|treatment. |

|Attend follow up appointments with psychiatrist (at least annually). |

Communication and support

|Hospital contacts: |Out of hours contacts & procedures: |

|(the referral letter will indicate named consultant) |Psychiatrist & Pharmacist available via the |

| |Hospital Switchboard 020 3513 5000 |

|ADD YOUR | |

|CAMHs Clinic/Hospital name | |

|Consultant names | |

|Tel: | |

|Fax: | |

|E-mail: | |

|Specialist support/resources available to the GP including patient information: |

|Contact CAMHS service |

|South West London and St George’s Mental Health Trust Medicines Information 0203 513 6829 |

|Information leaflets, choice of treatment for illnesses & illness leaflets (funded by SWLStG): |

|Summary of product characteristics - Circadin 2 mg prolonged-release tablets |

| |

CLINICAL INFORMATION

|Indication(s): |Sleep onset insomnia and delayed sleep phase syndrome in children and adolescents (1 month-18years) and |

| |persistent sleep disorders in school-age children with neurodevelopmental disabilities. These indications |

| |are unlicensed but Circadin® are approved for use in SWL for these indications. |

| | |

| |Circadin® is licensed for use in those over 55 years of age for short term use with a primary diagnosis of |

| |insomnia. It is not approved for this indication in SWL. |

|Place in Therapy: |Second-line where non-pharmacological strategies have failed and underlying physical causes are managed. |

| |Treatment should be initiated by or under the supervision of a specialist Consultant and transferred to GP |

| |for prescribing after 3 months. |

|Therapeutic summary: |Melatonin is a naturally occurring hormone produced by the pineal gland in the brain. It is involved in |

| |coordinating the body's sleep-wake cycle and helping to regulate sleep. |

|Special warning and precautions for |Circadin® contains lactose. Patients with rare hereditary problems of galactose intolerance, the LAPP |

|use: |lactase deficiency or glucose-galactose malabsorption should not take this medicine. |

| |If the child wakes during the night, an extra dose of melatonin should not be given. |

|Dose & route of administration: |Prescribe licensed Melatonin (Circadin®) MR tablets 2 mg, first line, if clinically appropriate. |

| |Initiate at 2mg 1-2 hours before bedtime. Swallow tablet whole with plenty of water. |

| |Increase dosage according to response. Dose can be increased to 4-6mg daily after 1-2 weeks. |

| |Maximum BNFC dose 10mg |

| |Circadin® may be crushed to give an immediate-release profile.(see practical issues below) |

|Duration of treatment: |Duration of treatment should be determined on an individual basis. Treatment should be discontinued every 6|

| |months to assess if it is still beneficial. |

| |GPs should prescribe only 28 days at a time with a review date of every 6 months. |

| |GPs may contact the professional initially recommending the prescription or Medicines Information  for |

| |advice and support to undertake this review. |

|Summary of adverse effects: |Adverse effect |Frequency |Management |

|(See Melatonin [Circadin®] Summary of | | | |

|Product Characteristics (SPC) for full | | | |

|list) | | | |

| | | | |

| | | | |

| | | | |

| | | | |

| |Headaches |Uncommon (more than 1 in 1,000 to|Simple analgesia (e.g. paracetamol). Refer back |

| | |less than 1 in 100 people might |to psychiatric team if persistent or |

| | |get these) |troublesome. |

| |Abnormal dreams |Uncommon |No management concerns. Offer reassurance that |

| | | |memory of dreams has improved. |

| |Nausea |Uncommon |Usually transient. Try taking melatonin with or |

| | | |after food. |

| |Dizziness |Uncommon |Try not to change posture too quickly. Refer |

| | | |back to psychiatric team if persistent or |

| | | |troublesome. |

| |Leukopenia |Rare (more than about 1 in 10,000|Stop medicine refer back to psychiatrist. No |

| | |to less than 1 in 1000 people |routine full blood count is recommended. |

| | |might get these) | |

|Monitoring Requirements: |Under shared care Psychiatrists should monitor continued positive impact on sleep and review every 6 months|

| |by discontinuing the medicine to assess continued benefit. |

| |Monitor weight and standard monitoring of growth and sexual development (this has been seen in animals but |

| |not in human use of melatonin). |

| |Although leukopenia is a known (rare) side effect, regular FBCs are not specifically required. |

|Clinically relevant drug interactions: |Increased sedative effect when given with antipsychotics, other hypnotics and sedating antihistamines |

|(See Summary of | |

|Product Characteristics |Avoid combination with fluvoxamine as melatonin levels can be increased due to enzyme inhibition. |

|(SmPC) for a full list) | |

| |Cautious combination of cimetidine, oestrogens (eg contraception) due to potential to increase melatonin |

| |levels. |

| | |

| |Co –administration of CY1A2 inducers such as Carbamazepine and rifampicin may give rise to reduced plasma |

| |concentrations of melatonin. |

| | |

| |Co administration with CY1A2 inhibitor such as quinolones may give rise to increased melatonin levels. Be |

| |aware that that excessive drowsiness and related side effects may occur with concurrent use with |

| |quinolones. |

|Practical issues: |Clinicians concerned over the possibility of sleep latency when prescribing the prolonged release tablets |

| |may advise patients to halve (preferably using a tablet crusher) or crush the tablets. |

| |Refer to the local specials guideline. |

| |Note that crushing would no longer render it a modified-release |

| |preparation; careful halving may preserve some of the |

| |modified-release characteristics. |

| |There is no stability data for crushed tablets so the powder would need to be administered immediately. Mix|

| |the crushed tablets with cold food or drinks to aid ingestion. There is no information for enteral |

| |administration. |

| |If Circadin® is not appropriate for the following reasons (patient unable to tolerate it, swallowing |

| |difficulties) an unlicensed preparation may be used. |

| |Prescribing unlicensed melatonin requires careful consideration by the psychiatrist and discussion with the|

| |parents or carer. Unlicensed formulations of melatonin may only be prescribed after SWLStG Drug and |

| |therapeutics approval on an individual basis. Unlicensed formulations must be supplied by a Hospital |

| |Pharmacy. |

|Key references: |NICE Evidence summary ESUOM2: Sleep disorders in children and young people with attention deficit |

| |hyperactivity disorder: melatonin (Published 04/01/13) accessed 16/07/13 |

| |Summary of product characteristics – Circadin® 2 mg prolonged-release tablets |

| | – accessed 16/07/13 |

| |British National for Children accessed August 2013 |

| |

| |it |

| |Stockley’s drug interactions 2013 pocket companion |

| |London Procurement Partnership, Medicines Use & Procurement Productivity Workstream Choosing between |

| |melatonin formulations for treatment of sleep disorders July 2013 |

| | |

Appendix 1

Sleep Questionnaire

Using these tools will help you and the Doctor review your child’s sleep and develop the care plan.

Complete for two weeks.

|Name: DOB: RiO/patient ID/NHS number: |

|List any current medications, total daily doses or allergies: |

| |

|Do you find that your child has trouble getting off to sleep at bedtime? |Yes/No |

|Do you find that your child wakes up after bedtime? |Yes/No |

| |If yes, how many times? |

|Does your child have any trouble getting back to sleep when they wake during the night? |Yes/No |

|Does your child experience any sleepwalking, nightmares (wakes up from a ‘bad’ dream but |Yes/No |

|can be comforted) or night terrors (waking up screaming/distressed/confused/frightened and|If yes, which ones and what happens? |

|difficult to get back to sleep after comforting)? | |

| | |

| | |

|What time does your child normally go to bed? |School days: |

| |Weekends: |

|What time does your child wake up? |School days: |

| |Weekends: |

|Does your child experience any breathing difficulties (e.g. gasping, pause in breathing) |Yes/No |

|at night? | |

|Do you find that your child snores loudly at night? |Yes/No |

|Do you think your child has enough sleep? |Yes/No |

|Do you find that your child has difficulty waking up in the morning? |Yes/No |

|Do you find that your child is sleepy during the daytime? |Yes/No |

|Do you find that your child naps during the day? |Yes/No |

|Do you find that your child tires easily during the day? |Yes/No |

Appendix 2 Sleep Diary

|Day: |Monday |Tuesday |

|Date: | | |

|2nd line |Melatonin 3mg tablets (Bio-melatonin) |Only use if patient cannot tolerate Circadin. |

| |Melatonin 5mg/5ml oral solution | |

Side effects (see BNF or SmPC for full info)

The most common problem with melatonin is that it simply does not improve the child’s sleeping pattern. Side effects are fairly uncommon, but may include headache, fatigue, dizziness. Other rarer side effects have included restlessness, increased heart rate, itching & nausea.

Based on its physiological effects in animals there is a theoretical potential for melatonin to delay puberty, but this has not been reported in humans.

Drug interactions (see BNF or SmPC for full info)

Be cautious with sedating & antihypertensive medicines. Enzyme inhibitors & inducers may cause clinically significant changes in melatonin serum levels (e.g. ritonavir and carbamazepine).

Monitoring & review

The child should be monitored for the effect of melatonin on their sleep and for any of the potential side effects as described above. In addition, standard monitoring of growth and sexual development is recommended (check height, weight, pubertal development is progressing as expected).

Those patients under the care of South West London & St Georges NHS Trust will have this review done by their specialist. Where the GP has a patient taking melatonin not being seen by a specialist, they should stop the melatonin abruptly every 6-12 months to assess the need for continued supply using a sleep chart for two weeks. GPs may contact the professional initially recommending the prescription or Medicines Information (number below) for advice and support to undertake this review.

Melatonin has an elimination half-life of up to 50mins. Stopping a prescription for melatonin is not expected to cause withdrawal effects, apart from a possible worsening in sleep pattern if there is continued benefit.

Source of supply

South West London & St George’s formulary encourages its clinicians to prescribe unlicensed formulations on Hospital only prescriptions. Circadin may be prescribed on FP10 and transferred to GPs as part of shared care.

For more information & advice please contact:

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|Approved by: SWLStG DTC: May 2009, updated Sept 2013 Publication number SU043 |

020 3513 6829

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