Download TWC21i Melatonin shared care guideline 201606

Working in partnership
Shared Care 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 / IAPTus number: ……………………………
NHS.net e-mail: ……………………………
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: …/…/…..
Date approved: June 2016
Review date: May 2019
Version: 201705
1
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:
June 2016
Approved by (date approved):
SWLStG Drug & Therapeutic Committee: June 2016
Mental Health Interface Prescribing Forum: June
2016
Review date:
May 2019
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
NHS Kingston CCG
SWL & St. George’s Mental Health Trust
Dr Anthony Hughes, GP on behalf of Medicines
Dr M Zwi (Consultant Psychiatrist & DTC Deputy
Management Committee
Chair)
Seema Buckley, Chief Pharmacist
Dianne Adams (DTC secretary & Chief Pharmacist)
NHS Richmond CCG
Dr Stavroula Lees, lead GP for Mental health
Emma Richmond, Head of Medicines Management
NHS Merton CCG
Dr Andrew Otley, Mental Health Lead
Sedina Agama, Chief Pharmacist
NHS Wandsworth
Dr Gillian Ostrowsky, Associate Medical Director
Nick Beavon, Chief Pharmacist
NHS Sutton CCG
Dr Chris Keers, Mental Health Lead
Sarah Taylor, Chief Pharmacist
Date approved: June 2016
Review date: May 2019
Version: 201705
2
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
Consultant
1. 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).
Date approved: June 2016
Review date: May 2019
Version: 201705
3
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 name
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
Date approved: June 2016
Review date: May 2019
Version: 201705
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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® is 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 46mg 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 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.
Duration of treatment:
Summary of adverse
effects:
(See Melatonin [Circadin®]
Summary of Product
Characteristics (SPC) for
full list)
Date approved: June 2016
Review date: May 2019
Version: 201705
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
Nausea
Uncommon
Dizziness
Uncommon
No management concerns. Offer
reassurance that memory of
dreams has improved.
Usually transient. Try taking
melatonin with or after food.
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.
5
Monitoring
Requirements:
Clinically relevant drug
interactions:
(See Summary of
Product Characteristics
(SmPC) for a full list)
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.
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:
Key references:
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) and swallow both halves 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.
1. NICE Evidence summary ESUOM2: Sleep disorders in children and young
people with attention deficit hyperactivity disorder: melatonin (Published
04/01/13) accessed 06/06/16
2. Summary of product characteristics – Circadin® 2 mg prolonged-release
tablets
http://www.medicines.org.uk/emc/medicine/25643/SPC/Circadin/#tableOfCont
ents – accessed 06/06/16
3. British National Formulary for Children accessed June 2016
https://www.medicinescomplete.com/mc/bnfc/current/PHP2149melatonin.htm?q=melatonin&t=search&ss=text&tot=22&p=1#_hit
4. Stockley’s drug interactions accessed
June2016https://www.medicinescomplete.com/mc/stockley/current/interaction
s.htm?q=melatonin&searchButton=+
Date approved: June 2016
Review date: May 2019
Version: 201705
6
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 can be comforted) or
night terrors (waking up
screaming/distressed/confused/frightened and difficult to
get back to sleep after comforting)?
Yes/No
What time does your child normally go to bed?
School days:
If yes, which ones and what happens?
Weekends:
What time does your child wake up?
School days:
Weekends:
Does your child experience any breathing difficulties (e.g.
gasping, pause in breathing) at night?
Yes/No
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
Date approved: June 2016
Review date: May 2019
Version: 201705
7
Appendix 2
Day:
Monday
Sleep Diary
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday
Date:
Sleepy during the
day (Yes/No)
Duration of any
daytime sleep
Time of any
snacking.
(e.g. chocolate,
fizzy drinks, tea,
coffee, sweets)
Daytime activities
Activities 1 hour
before bedtime
Time to bed
Times woke up in
the night
How long did your
child stay up for
when waking in the
night?
Time awake in the
morning
Mood on waking
Night time sleep
duration
What did you do to
aid your child’s
sleep?
Give a score of 0-5
0 = Did not help
5 = most helpful
Date approved: June 2016
Review date: May 2019
Version: 201705
8
Melatonin prescribing and monitoring
Information for GPs (supporting shared care)
Melatonin is a natural hormone from the pineal gland that helps regulate
circadian rhythm. The medicine contains a synthetic version of melatonin.
In the UK, “Circadin,” a prolonged-release product licensed for use in people
over 55, is now available. The MHRA has advised that this product be used
wherever it meets the clinical need of the patient, even where that patient is
outside the terms if its licence (e.g. in children). If this product does not meet
the clinical need (e.g. prolonged release is not suitable, swallowing difficulties
or the patient cannot tolerate the prolonged release and crushing Circadin is
not successful), an unlicensed preparation may be used. Where this applies,
the psychiatrist will have given careful consideration to prescribing it, and will
have discussed the implications fully with the family.
Indication
Melatonin (Circadin) is on the formulary for the (unlicensed) treatment of
persistent sleep disorders in school-age children (4-18 years) with neurodevelopmental disabilities. Sleep problems are common in this group. Where
good “sleep hygiene” methods fail, medication may be considered.
The regular hypnotic medicines can cause adverse reactions and lead to
tolerance & dependence, and so melatonin is being used.
Melatonin is licensed in the UK for the treatment of a diagnosis of primary
insomnia in the over 55s for 13 weeks.
Dosage and prescribing
 The dosage of melatonin will be established by the psychiatrist and will be
within the range 2mg to a maximum of 10mg per day.
 It should be taken as a single dose, 30-120 minutes before sleep time.
 The medicine is usually swallowed whole, with a drink of water.
 If the child wakes during the night, an extra dose of melatonin should not
be given.
Crush if there are concerns over sleep
Circadin MR 2mg
latency or swallowing difficulties. Mix
1st line
tablets
with cool food stuffs e.g. yoghurt or
porridge.
Melatonin 3mg tablets Only use if patient cannot tolerate
(Bio-melatonin)
Circadin.
2nd line
Melatonin 5mg/5ml
oral solution
Date approved: June 2016
Review date: May 2019
Version: 201705
9
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, and 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:
Medicines Information on 0203 513 6829
Date approved: June 2016
Review date: May 2019
Version: 201705
10
Melatonin Review, Information for Parents
A handy leaflet about why melatonin is used and what the main side-effects are may be
found on the local Mental Health Trust’s information website. Find it by going to the Trust
website, information for patients: www.swlstg-tr.nhs.uk or typing:
www.choiceandmedication.org/swlstg-tr/
Insomnia is a sleep disturbance causing children to have trouble falling asleep or staying
asleep at night or waking up too early. The insomnia arises when there is a feeling that the
sleep does not have its restorative function and it affects the daytime function of the child.
Long-term insomnia occurs three times a week for a month or longer and may be caused
by factors for which your child may have been prescribed melatonin (eg, depression,
anxiety, pain, medical problems). However, there may be no obvious reason at all.
What is unlicensed melatonin and why should it be switched to the licensed
branded UK product?
Until recently melatonin was only available when manufactured or imported for specific
children. A licensed UK approved product called Circadin® modified release 2mg tablets
is now available. The Medicines and Healthcare products Regulatory authority advise
professionals in the UK that where a UK approved product exists to treat an indication it
must be used in preference for those that are imported or made individually for patients.
This advice is to reduce the risk of harm to a patient from their medicines. Imported and
individually manufactured products carry a greater risk of their use due to the less
stringent controls and assessment of their production in comparison to UK approved
products. Imported or individually manufactured products can be 100 times the cost of UK
approved products and thus, do not provide value for money for the NHS and its users in
most cases.
Can melatonin products be switched easily?
Yes. There is lots of experience that shows us that patients do not show any signs of
withdrawal when melatonin is stopped or switched from one product to another. There
have been some concerns that after switching from immediate release melatonin to the
UK approved modified release melatonin: it may take longer for the onset of sleep. In
most that has not occurred and the UK approved tablets may be crushed if needed.
What review does melatonin require?
There are no specific physical monitoring requirements for melatonin. The causes of
insomnia can be complex and change over time. Stopping the melatonin for a two week
period every 6-12 months is a good idea to ensure the medicine is still needed. A sleep
diary and questionnaire available on the Mental Health Trust’s website is a good way of
monitoring this. Complete the diary for at least a week before and after stopping melatonin
to get a good view of the sleep pattern. This review may be supported by the GP or a
specialist, depending on who is leading on the care of the child’s mental health
Date approved: June 2016
Review date: May 2019
Version: 201705
Approved by: SWLStG DTC. Publication number TWC21i
11
Further advice and support:
 Good sleep hygiene tips: http://www.nhs.uk/Conditions/Insomnia/Pages/Prevention.aspx
 & http://www.sleepcouncil.org.uk/pdf-downloads/the_good_night_guide_for_children.pdf
 Circadin® manufacturer leaflet http://www.medicines.org.uk/emc/medicine/27475
 Melatonin leaflet: http://www.choiceandmedication.org/swlstg-tr/medications/124/
 Melatonin Easy read: http://www.choiceandmedication.org/swlstg-tr/pdf/quillmelatonin.pdf
 Your local metal health team or specialist medicines information 020 3513 6829
Date approved: June 2016
Review date: May 2019
Version: 201705
12