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:
Name: ………………………………………
Address: ……………………………………
Tel no: ………………………………………
Fax no: ………………………………………
NHS.net e-mail: …………………………… / Patient Details:
Name: ………………………………………………
Address: ……………………………………………
DOB: ……/………/…………
Hospital / IAPTus number: ……………………………
NHS number (10 digits): …………………………
Consultant name: ……………………………
Clinic name: ………………………………….
Contact details:
Address: ......
Tel no: ……………………………………… Fax no: ………………………………………
NHS.net 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: …/…/…..
1
South West London and St George’s Mental Health NHS Trust
working in partnership
SHARED CARE PRESCRIBING GUIDELINEMelatonin 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: Aug 2014 / Review date: Sept 2016
Approved by (date approved):
SWLStG Drug & Therapeutic Committee: Sept 2014
Compliance & Clinical Practice Standards Group: 11Nov2014
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 TrustsKingston CCG
Dr Anthony Hughes, GP on behalf of Medicines Management Committee
Seema Buckley, Chief Pharmacist / SWL & St. George’s Mental Health Trust
Dr M Zwi (Consultant Psychiatrist & DTC Deputy Chair)
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
2
Date approved: Nov 2014
Review date: Sept 2016
SHARED CARE PRESCRIBING GUIDELINE
Melatonin (Circadin ®)1. 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.
2. Areas of responsibility
Consultant1. To assess the patient and establish the need for sleep onset treatment in neurodevelopmental disabilities.
2. To only prescribe melatonin second-line where non-pharmacological strategies have failed, and underlying physical causes are managed where they exist.
3. 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.
4. 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.
5. Provide verbal and written information to the parents, carers, and where appropriate the patient and answer their questions about melatonin.
6. Obtain consent for the off label prescribing of melatonin.
7. Perform baseline checks of physical health (including height, weight)
8. Initiate licensed melatonin (Circadin®) 2mg prolonged release tablets
9. Assess and monitor the patient’s response to treatment and make dose adjustments where necessary.
10. If treatment is ineffective and discontinued check for possible complications following discontinuation.
11. 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.
12. Provide the GP with appropriate clinical information and individual patient information.
13. Communicate treatment changes to the GP promptly within Trust recommended times.
14. 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.
15. To take responsibility for stopping the melatonin or to agree aftercare when the patient reaches 18 years of age.
GP
1. Monitor the patient’s overall health and well-being.
2. Review the patient in accordance with specialist advice every 6 months.
3. Prescribe melatonin (Circadin®) once the treatment has been established, the patient stabilised and the care of the patient has been transferred and accepted.
4. 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.
5. Advise patient to attend specialist appointments (at least annually).
6. Re-refer the patient or seek specialist advice from the psychiatrist if there are on-going sleep problems, side-effects or swallowing difficulties.
7. 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. https://yellowcard.mhra.gov.uk/
8. 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.
9. GPs may have other patients that are either not being seen by a Mental Health Trust Psychiatrist or by another specialist.
10. 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).
3. Communication and support
Hospital contacts:(the referral letter will indicate named consultant) / Out of hours contacts & procedures:
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): http://www.choiceandmedication.org/swlstg-tr/
· Summary of product characteristics - Circadin 2 mg prolonged-release tablets http://www.medicines.org.uk/emc/medicine/25643/SPC/Circadin/#tableOfContents
4. CLINICAL INFORMATION
Indication(s): / Sleep onset insomnia and delayed sleep phase syndrome in children and adolescents (4-18years) 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 use: / Circadin® contains lactose. Patients with rare hereditary problems of galactose intolerance, the LAPP 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:
(See Melatonin [Circadin®] Summary of Product Characteristics (SPC) for full list) / Adverse effect / Frequency / Management
Headaches / Uncommon (more than 1 in 1,000 to less than 1 in 100 people might get these) / Simple analgesia (e.g. paracetamol). Refer back to psychiatric team if persistent or 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 to less than 1 in 1000 people might get these) / Stop medicine refer back to psychiatrist. No routine full blood count is recommended.
Monitoring Requirements: / 1. Under shared care Psychiatrists should monitor continued positive impact on sleep and review every 6 months by discontinuing the medicine to assess continued benefit.
2. Monitor weight and standard monitoring of growth and sexual development (this has been seen in animals but not in human use of melatonin).
3. Although leukopenia is a known (rare) side effect, regular FBCs are not specifically required.
Clinically relevant drug interactions:
(See Summary of
Product Characteristics
(SmPC) for a full list) / 1. Increased sedative effect when given with antipsychotics, other hypnotics and sedating antihistamines
2. Avoid combination with fluvoxamine as melatonin levels can be increased due to enzyme inhibition.
3. Cautious combination of cimetidine, oestrogens (eg contraception) due to potential to increase melatonin levels.
4. Co –administration of CY1A2 inducers such as Carbamazepine and rifampicin may give rise to reduced plasma concentrations of melatonin.
5. 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: / 1. 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.
2. Refer to the local specials guideline.
3. Note that crushing would no longer render it a modified-release
preparation; careful halving may preserve some of the
modified-release characteristics.
4. 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.
5. If Circadin® is not appropriate for the following reasons (patient unable to tolerate it, swallowing difficulties) an unlicensed preparation may be used.
6. 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: / 1. 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
2. Summary of product characteristics – Circadin® 2 mg prolonged-release tablets http://www.medicines.org.uk/emc/medicine/25643/SPC/Circadin/#tableOfContents – accessed 16/07/13
3. British National for Children accessed August 2013
http://www.medicinescomplete.com/mc/bnfc/current/PHP12119-melatonin.htm?q=melatonin&t=search&ss=text&p=1#_hit
4. Stockley’s drug interactions 2013 pocket companion
5. London Procurement Partnership, Medicines Use & Procurement Productivity Workstream Choosing between melatonin formulations for treatment of sleep disorders July 2013 http://lpp.nhs.uk/_store/documents/melatoninbulletin2013v1.pdf
Appendix 1