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WORKING IN
PARTNERSHIP
WITH
EFFECTIVE SHARED CARE AGREEMENT (ESCA)
DRUG NAME: MELATONIN
INDICATION/S COVERED: Persistent sleep onset disorders in
children and adolescents with a range of neuro-developmental
problems
Coastal West Sussex Traffic Light system classification: Amber
N.B. The eligibility criteria included here apply to new patients commencing treatment under this agreement &
not to existing patients whose treatment was initiated under the previous version. However, monitoring and
discontinuation criteria apply to all patients.
NOTES to the primary care prescriber
Amber drugs: Prescribing to be initiated by a consultant / specialist but with the potential to transfer to primary
care. The expectation is that this agreement should provide sufficient information to enable primary care
prescribers to be confident to take clinical and legal responsibility for prescribing these drugs .
The questions below will help you confirm this:
 Is the patient’s condition predictable?
 Do you have the relevant knowledge, skills and access to equipment to allow you to monitor treatment as
indicated in this effective shared care agreement?
 Have you been provided with relevant clinical details including monitoring data?
If you can answer YES to all these questions (after reading this ESCA), then it is appropriate for you to accept
prescribing responsibility. Sign and return a copy of the final page to the requesting consultant / specialist.
Until the requesting consultant / specialist has received a signed copy of the final page indicating that shared
care has been agreed all care (including prescribing) remains with the consultant / specialist.
If the answer is NO to any of these questions, you should not accept prescribing responsibility. You should
write to the consultant / specialist 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, which
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 Medicines Management pharmacist will assist you in making decisions
about shared care.
Prescribing unlicensed medicines or medicines outside the recommendations of their marketing authorisation
alters (and probably increases) the prescriber’s professional responsibility and potential liability. The
prescriber should be able to justify and feel competent in using such medicines.
The patient’s best interests are always paramount
The primary care prescriber has the right to refuse to agree to shared care, in such an event the total clinical responsibility will remain with
the consultant
Effective from: 24/10/13
Review date: 24/10/15
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Melatonin for persistent sleep onset disorders in children and adolescents with a range of neuro-developmental
problems, version 2
Information
This is an unusual shared care guideline as it is for an unlicensed medicine. However the South East
Coast Strategic Health Authority’s Health Priorities Support Unit (HPSU) has reviewed the use of
melatonin in under 18s (http://www.sechealthpolicysupportunit.nhs.uk/publications/policyrecommendations/) and this ESCA reflects the HPSU’s advice, which Sussex Partnership NHS
Foundation Trust and Coastal West Sussex Clinical Commissioning Group have agreed to implement.
These guidelines should be used in conjunction with the SPFT information sheets for clinicians and the
recommendations of the consultant / specialist. Prescribers should also refer to the appropriate
paragraph in the current edition of the BNF/BNFC.
1. Link to the relevant SPC website:
As immediate release melatonin formulations are not currently licensed in the UK, there is no published
Summary of Product Characteristics available online, though an SPC for Bio-Melatonin® is available on
request from the manufacturer PharmaNord UK Ltd. However Sussex Partnership NHS Foundation Trust
have provided information sheets for both clinicians and patients/families available from:
http://www.sussexpartnership.nhs.uk/service-users/help/leaflets/medication-leaflets
In addition, information is also available from the Sussex Community NHS Trust website:
http://thepulse/index.cfm?request=b1010001
2. Background to use for the indication/s, including licence status
Melatonin is an endogenous hormone produced by the pineal gland to help regulate circadian rhythm. The
medicinal formulation contains a synthetic version of this hormone and is used in the (unlicensed) treatment
of persistent sleep onset disorders in children and adolescents (4-17 years inclusive) with a range of neurodevelopmental problems, including Attention Deficit Hyperactivity Disorder (ADHD).
Melatonin is only indicated second-line, where non-pharmacological strategies have been tried, but sleep
latency remains a significant problem. Melatonin tends to be well tolerated and is used in preference to
licensed hypnotic medicines which can cause adverse reactions and lead to tolerance and dependence.
3. Dose & administration
Children and adolescents between 4 and 17 years (inclusive) initially 3mg as a single dose, half to one hour
before the intended sleep time. The dose may need to be increased according to response. Maximum dose
for new patients is 6mg, prescribed in multiples of 3mg. Existing patients on doses higher than 6mg may
continue at their current dose.
The tablets should usually be swallowed whole with a beaker of water, milk or orange juice but can be
crushed if there are difficulties swallowing. Stability data demonstrates the tablet may be crushed and
dissolved in up to 200mls of water. The dissolved tablet may be flushed through a PEG tube or NG tube.
If the child or adolescent wakes during the night, an extra dose of melatonin should not be given.
4. Cautions
Melatonin should be used with caution in patients with a history of epilepsy or asthma (as it may exacerbate
these conditions). Also with autoimmune, renal or hepatic disorders due to limited safety data.
Supraphysiological doses (>500 micrograms in adults) may delay the onset of puberty.
Since melatonin may cause drowsiness, appropriate caution should be exercised with skilled tasks such as
driving.
5. Contraindications
 Pregnancy and breast feeding
 Known hypersensitivity to melatonin or to any of its excipients.
6. Side effects
Please refer to the current BNF or BNFC for full list of less common and rare side effects.
Melatonin is generally well-tolerated and side effects fairly uncommon. Somnolence (drowsiness),
headaches, morning tiredness, nausea, dyspepsia, dizziness, skin disorders, restlessness, increased pulse
and itching have all been reported as side effects associated with melatonin use.
If overdose occurs, drowsiness is to be expected and may be accompanied by symptoms listed above.
Clearance of the active substance is expected within 12 hours after ingestion.
Effective from: 24/10/13
Review date: 24/10/15
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Melatonin for persistent sleep onset disorders in children and adolescents with a range of neuro-developmental
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7. Interactions
 It is advisable not to prescribe melatonin if the patient is receiving antipsychotics or
antidepressants.
 Concomitant prescribing of melatonin and oral anticoagulants should be avoided.
 Melatonin may reduce the effectiveness of nifedipine and other calcium channel blockers.
 It is safe for a child or adolescent to take paracetamol in the dosage recommended for their age
alongside melatonin.
 Other medicines should be prescribed with caution especially if they have any sedating or
tranquillising effect (e.g. some antidepressants, antihistamines etc).
8. Criteria for use – As described in section 2.
9. Any further information (e.g. supporting therapies)
Important notes:
 Parents, carers or older adolescents (if appropriate), are required to complete a sleep diary
showing significant problems with sleep latency before treatment with melatonin is initiated. This
is to be maintained after treatment has been started to establish efficacy.
A sleep diary is available from: http://www.patient.co.uk/showdoc/23068989/
 If improvements of symptoms are not observed after one month, melatonin should be
discontinued. This should be on the recommendation of the specialist.
 If melatonin has successfully established a good sleep pattern, it is considered good practice for
the specialist to consider the place of a trial withdrawal of treatment at a clinically appropriate
time in individual cases before considering transfer of prescribing to primary care to establish
continuing need. The specialist should assess the continuing need for melatonin periodically by
stopping the medicine for up to two weeks each year.
 Melatonin will usually be discontinued by late adolescence (by 18 years) on the recommendation
of the specialist.
 Full information about melatonin and other treatment options must be given to the family, carer or
patient (if appropriate) in a format they can understand, usually in the form of a written leaflet. An
opportunity to ask questions must be provided before formal written consent is obtained.
 Evidence available supports the use of immediate release melatonin formulations. The BioMelatonin® brand of melatonin should be used as this brand is licensed in the EU as a medicine.
When prescribing put the brand name in brackets after melatonin and state that immediate
release is needed to induce sleep.
 The launch of a licensed sustained release product (Circadin®) does not affect this clinical
decision to prescribe immediate release formulation of melatonin (Bio-Melatonin®).
INFORMATION TO PATIENTS
A SPFT produced patient information leaflet (PIL) will be provided when initiating treatment, available from:
http://www.sussexpartnership.nhs.uk/service-users/help/leaflets/medication-leaflets
In addition, information is also available from the Sussex Community NHS Trust website:
http://thepulse/index.cfm?request=b1010001
A pharmaceutical company patient information leaflet (PIL) will be provided with each original pack of BioMelatonin®.
INFORMATION TO BE RECEIVED BY THE GP FROM SECONDARY CARE SPECIALIST
A review letter will be sent after initial assessment and following each further appointment.
INFORMATION TO BE RECEIVED BY THE SECONDARY CARE SPECIALIST FROM GP
In the event that the GP is unwilling to assume prescribing responsibility for the patient the specialist should
be informed promptly on receipt of the specialist’s letter. In such cases the GP must inform the specialist of
all relevant medical information regarding the patient and any changes to the patient’s medication regime
irrespective of indication.
THE GP SHOULD INFORM THE SPECIALIST OF ANY ADVERSE EFFECTS EXPERIENCED BY THE
PATIENT.
Effective from: 24/10/13
Review date: 24/10/15
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Melatonin for persistent sleep onset disorders in children and adolescents with a range of neuro-developmental
problems, version 2
COST AND AVAILABILITY OF TREATMENT (as of August 2013 and until at least August 2015)
Bio-Melatonin® brand (PIL available)
3mg x 60 tablets = £44.95 (maximum cost in primary care)
Available from the following UK medical wholesalers only:
 PHOENIX Healthcare distribution
 Quantum Pharmaceutical
10. References
 Armour D, Paton C. Melatonin in the treatment of insomnia in children and adolescents.
Psychiatric Bulletin (2004); 28: 222-224
 Phillips L, Appleton R. Systematic review of melatonin in children with neurodevelopmental
disabilities and sleep impairment. Development Medicine & Child Neurology (2004); 46: 771-775
 Harkness L, Erskine D. Melatonin in paediatric sleep disorders. London New Drugs Group.
APC/DTC Briefing January 2008. Available from: www.nelm.nhs.uk (accessed 17/10/2012)
 Bio-Melatonin® Summary of Product Characteristics. Pharma Nord UK Ltd. October 2012.
 RE Appleton, et al. The use of MElatonin in children with Neurodevelopmental Disorders and
impaired Sleep: a randomised, double-blind, placebo-controlled, parallel study (MENDS) Health
Technology Assessment 2012; Vol. 16: No. 40
 Van Geijlswijk I, et al. Dose finding of melatonin for chronic idiopathic childhood sleep onset
insomnia: an RCT. Psychopharmacology, 2010 212:379–91.
Effective from: 24/10/13
Review date: 24/10/15
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Melatonin for persistent sleep onset disorders in children and adolescents with a range of neuro-developmental
problems, version 2
RESPONSIBILITIES and ROLES
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Consultant / Specialist responsibilities
Confirm the diagnosis and ascertain the need for sleep onset treatment in neurodevelopment disorders.
Ensure all relevant investigations are performed.
Only prescribe melatonin second-line where non-pharmacological strategies have failed, and underlying
physical causes are managed.
Prescribe only where parents, carers or an older adolescent has completed a sleep diary highlighting problems
with sleep latency.
Request agreement of shared care with the primary care prescriber.
Discussion of risks and benefits with parents, carers or an older adolescent patient, outlining possible side
effects.
Initiation of appropriate therapy.
Assess the effectiveness of melatonin and stabilise the dose.
It is considered good practice for the specialist to consider the place of a trial withdrawal of treatment at a
clinically appropriate time in individual cases.
Issue initial prescription(s) until the patient is stabilised and until ESCA is in place.
Ensure that all newly treated patients (and/or their families or carers) receive appropriate education and advice
regarding their drug therapy and shared care arrangements (including written information where appropriate)
and get written consent.
Advise and support parents, carers and older adolescents.
Provide the primary care prescriber with clinic letter stating planned introduction and reviews.
Review the patient annually or sooner if indicated to assess the benefits of continued treatment. A trial
withdrawal should be considered at this point. Act on the results appropriately and communicate these results
to the primary care prescriber.
Provide outpatient reviews, monitor effectiveness/side effects.
Give a copy of the information sheet to the patient / carer and explain their roles.
Notify the primary care prescriber of the patient’s failure to attend appointments for clinical review or drug
monitoring and give advice on stopping the medication.
Take responsibility for stopping the melatonin or to agree aftercare when the patient reaches 18 years of age.
Report any adverse reactions to the MHRA via the Yellow Card Reporting Scheme
(http://yellowcard.mhra.gov.uk/ ).
Primary care prescriber responsibilities
1 Initial referral to consultant/specialist.
2 Inform the consultant if unwilling to enter into shared-care arrangements.
3 Provide repeat prescriptions (for the unlicensed Bio-Melatonin® preparation) once ESCA is agreed and in place
and the patient is stabilised, a good sleep pattern has been established and after a trial discontinuation to
establish long-term need has been considered by consultant/specialist. It is recommended that no more than
one month’s prescription should be issued at a time. A demonstrable system should be in place to ensure that
prescribing is reviewed by the primary care prescriber if there is no record of the fact that monitoring has taken
place within the agreed time scales.
4 Record any changes in therapy in the prescribing record on receipt of such communication from
consultant/specialist.
5 Monitor patients overall health and well-being and to report any adverse drug reactions or interactions to
secondary care.
6 Contact the consultant / specialist if there are on going sleep problems.
7 Monitor the prescribing rate of melatonin for individual patients and liaise with consultant / specialist if any
cause for concern or drug discontinued.
8 Act upon recommendations communicated by the specialist, including recommendations on stopping
melatonin.
9 Review the appropriateness of prescribing for patients who have not been seen by a specialist for over one
year.
10 Ensure all relevant staff within the practice are aware of the shared care agreement.
11 Provide a copy of this ESCA to the patient to ensure that they are familiar with all roles and responsibilities
Effective from: 24/10/13
Review date: 24/10/15
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Melatonin for persistent sleep onset disorders in children and adolescents with a range of neuro-developmental
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Patient's / Carer’s role
1 To attend appointments.
2 To complete a sleep diary before initiation and during treatment to help evaluate efficacy.
3 Ask the consultant / specialist or primary care prescriber for information, if he or she does not have a clear
understanding of the treatment.
4 Share any concerns in relation to treatment with melatonin and inform the primary care prescriber if any
health problems arise.
5 Tell the consultant / specialist or primary care prescriber of any other medication being taken, including overthe-counter products.
6 Read the patient information leaflet included with the medication and report any side effects or concerns to
the consultant / specialist or primary care prescriber.
BACK-UP ADVICE AND SUPPORT
Specialist /
Consultant:
Alternative
specialist (e.g.
departmental
contact):
Hospital Pharmacy:
Name / position
Dr Michelle Bond,
Clinical Director for West Sussex Paediatrics
Sussex Community NHS Trust,
West Sussex Designated Dr for Children
Looked After Child Development Centre.
Child and Adolescent Mental Health Service
(CAMHS) Teams:
Worthing
Chichester
Telephone
01243 793652
Worthing Hospital
01903 205 111,
ext 5698
01243 788 122,
ext
N/A
St Richards Hospital
Out of hours (e.g.
medical team on
call):
N/A
Email
[email protected]
N/A
01903 296754
01243 815514
[email protected]
N/A
Version History
Document Name:
Melatonin for persistent sleep onset disorders in children and adolescents with a range of
neuro-developmental problems
Document Type:
Effective Shared Care Agreement
Relevant to:
All primary care prescribers working within Coastal West Sussex and all relevant
clinicians at Sussex Partnership NHS Foundation Trust.
Version No.
Date
Author of original development
or review
1
04/2009
2
10/2012
Ray Lyon, Chief Pharmacist,
Sussex Partnership NHS
Foundation Trust
Nick Rutherford, Medicines
Management Technician,
Coastal West Sussex CCG
Details of document development
Original development
Full review and re-draft
Approval for organisational use
ESCA
authorised for
use in Coastal
West Sussex by
Specialist/consultant: Dr Birbal Copra, CAMHS DTG representative, 25/9/13
Coastal West Sussex Area Prescribing Committee (APC): 25/9/13
Effective from: 24/10/13
Review date: 24/10/15
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Melatonin for persistent sleep onset disorders in children and adolescents with a range of neuro-developmental
problems, version 2
EFFECTIVE SHARED CARE AGREEMENT (ESCA)
DRUG NAME: MELATONIN
INDICATION: Persistent sleep onset disorders in children and
adolescents with a range of neuro-developmental problems
Agreement for transfer of prescribing to PRIMARY CARE PRESCRIBER
Patient details:
Name:
Address:
DoB:
NHS No:
Hospital No:
Drug name and dose: <insert>
The following tests and investigations have been carried out:
<insert details of tests>:
Date treatment initiated:
At the last patient review the drug appeared to be effectively controlling symptoms / providing benefit:
Yes/No
The patients has now been stabilised on a dose of:
I will arrange to review this patient regularly. Date of next clinic appointment:
<Insert title of specialist>: <insert name>
Agreement to shared care, to be
signed by primary care prescriber and
consultant/specialist.
Address: <insert relevant department>
<insert relevant hospital address>
Consultant/specialist signature:
Contact Number: <insert telephone number and extension>
Date:
Primary care prescriber:
Primary care prescriber signature:
Address:
Contact Number:
Date:
Main Carer:
If shared care is agreed and the
primary care prescriber has signed
above please return a copy of this
page to the requesting consultant or
alternatively fax to: <insert>
Contact Number:
Key worker if appropriate:
Contact Number:
Effective from: 24/10/13
Review date: 24/10/15
Page 7 of 7