Download Sodium oxybate - Coastal West Sussex Formulary

WORKING IN
PARTNERSHIP WITH
EFFECTIVE SHARED CARE AGREEMENT (ESCA)
DRUG NAME: Sodium Oxybate
INDICATION/S COVERED: Treatment of severe narcolepsy and cataplexy in adult
patients.
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: March 2014
Review date: March 2016
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Sodium oxybate, version 2
Information
This information sheet does not replace the Summary of Product Characteristics (SPC), which should
be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in
the current edition of the BNF.
1. Link to the relevant SPC website:
http://www.medicines.org.uk/emc/medicine/17364
2. Background to use for the indication/s, including licence status
Narcolepsy is a sleep disorder characterised by excessive daytime sleepiness, fragmented night-time sleep
and sometimes cataplexy (sudden onset of muscle weakness often in response to strong emotion).
Untreated cataplexy is associated with significant physical and psychological morbidity.
At present there is no cure for narcolepsy so treatment focuses on the control of symptoms. It is a debilitating
condition that is not life threatening but is life altering. The excessive daytime sleepiness associated with
very rapid onset sleep in narcolepsy can be severely debilitating and have profound effects on patients’
occupations and careers. Likewise patients suffering from severe cataplexy can be similarly disabled.
There is a group of patients with severe narcolepsy and / or cataplexy who do not respond adequately to
existing therapies (modafinil and methylphenidate for narcolepsy and tricyclic antidepressants (TCAs),
selective serotonin re-uptake inhibitor antidepressants (SSRIs) and serotonin-noradrenaline re-uptake
inhibitors (SNRIs) for cataplexy). There are also patients who do not tolerate these first and second line
therapies or in whom they are contra-indicated. Clomipramine is licensed for the adjunctive treatment of
cataplexy associated with narcolepsy but treatment may be limited by anticholinergic side effects or
tolerance. Treatment with sodium oxybate (Xyrem) is directed at these groups of patients.
Sodium oxybate has been shown to significantly reduce cataplexy within four weeks, with near abolition
within six months. It also significantly reduces drowsiness and improves nocturnal sleep which is fragmented
in narcolepsy. In cataplexy, sodium oxybate also has the advantage of fewer side effects than
antidepressants which are used off-licence for this indication. Sodium oxybate (Xyrem) is licensed for the
treatment of narcolepsy with cataplexy.
3. Dose & administration
Sodium oxybate is available as a licensed 500mg/1ml oral solution (Xyrem®).
The recommended starting dose is 4.5g daily in two equally divided doses of 2.25g. The doses should be
titrated to effect based on efficacy and tolerability up to a maximum dose of 9g daily, given as two divided
doses of 4.5g.
The doses must be adjusted up or down in increments of 1.5g (as two divided doses of 0.75g) daily. A
minimum of one to two weeks is recommended between dose increments.
Both measured doses of sodium oxybate should be prepared in separate dosing cups prior to retiring. Each
dose must be diluted with 60ml of water. Food reduces the bioavailability of sodium oxybate and patients are
advised to take the doses at least 2-3 hours after eating and should continue to observe this same timing in
relation to meals. The first dose should be taken when retiring at bedtime and the second dose 2.5 to 4
hours later.
Patients with hepatic impairment must receive half the normal adult dose on initiation and response must be
monitored closely at dose increments.
Patients with renal impairment should consider dietary recommendations to reduce salt intake (see cautions).
Elderly patients must be monitored closely for impaired motor and/or cognitive function.
If the patient stops taking the medicinal product for more than 14 consecutive days, titration should be
restarted from the lowest dose.
Effective from: March 2014
Review date: March 2016
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Sodium oxybate, version 2
4. Cautions
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Sodium oxybate can potentially induce respiratory depression. Special precautions should be observed in
patients with underlying respiratory disorders. Because of the higher risk of sleep apnoea, patients with a
BMI ≥40 kg/m2 should be monitored closely.
Sodium oxybate has abuse potential and physicians must evaluate the patient’s history and susceptibility
to drug abuse and should monitor the patient closely.
The combined use with alcohol or any CNS depressant with sodium oxybate can result in the potentiation
of the CNS depressant effects of the sodium oxybate.
Avoid combination of sodium oxybate and benzodiazepines, due to the risk of respiratory depression.
May cause confusion, anxiety, psychosis, paranoia, hallucinations and agitation. The emergence of
thought disorder and/or behavioural abnormalities when patients are treated with sodium oxybate
requires careful and immediate evaluation. Patients with a history of depressive illness and/or suicidal
attempts should be monitored closely for the emergence of depressive thoughts.
If a patient experiences urinary or faecal incontinence during therapy the prescriber must consider
pursuing investigation to rule out underlying aetiologies.
Sleepwalking has been reported in clinical trials with patients taking sodium oxybate. Any episodes of
sleepwalking should be fully evaluated and appropriate interventions considered.
Sodium oxybate contains contains 3.96 mmol Na+/mL. Patients taking sodium oxybate will have an
additional daily intake of sodium that ranges from 0.82g (for a 4.5g daily dose) to 1.6g (for a 9g daily
dose). A dietary recommendation to reduce sodium intake should be carefully considered in the
management of patients with heart failure, hypertension or compromised renal function.
Patients with hepatic impairment will have an increased elimination half life and systemic exposure to
sodium oxybate. The starting dose should therefore be halved in these patients and response to dose
increments monitored closely.
Elderly patients should be monitored closely for impaired motor and/or cognitive function.
Sodium oxybate is not recommended in patients under the age of 18.
Sodium oxybate is not recommended in patients with epilepsy.
In some patients, cataplexy may return with a higher frequency on cessation of sodium oxybate therapy
however this may be due to the normal variability in disease.
Not recommended during pregnancy or breast feeding.
5. Contraindications
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Hypersensitivity to the active substance or to any of the excipients.
Patients with major depression
Patients on barbiturates or opiates.
Patients with succinic semialdehyde dehydrogenase deficiency.
Although not listed as a contra-indication in the product SPC it is considered unsafe for use in porphyria.
6. Side effects
Sodium oxybate is generally well tolerated. Most commonly reported adverse effects are dizziness, nausea
and headaches which occur in 10% to 25% of all patients. Other common side effects are confusion,
depression, abnormal dreams, sleep disorder, abdominal pain and hypertension.
Please see SPC for the full comprehensive list of side effects.
Sodium oxybate has a major influence on the ability to drive and operate heavy machinery. For at least six
hours post dose patients must avoid activities that require complete mental alertness or motor co-ordination.
This is extremely important when patients first start treatment.
7. Interactions
The combined use of alcohol and sodium oxybate may result in potentiation of CNS depressant effects. It
should not be used in combination with sedatives (including alcohol, opioid analgesics or sedative hypnotics)
or other CNS depressants.
The possibility of interactions with antidepressants can not be ruled out due to the risk of additive effect. The
rates of adverse effects have increased when used with tricyclic antidepressants.
Sodium oxybate is metabolised by GHB dehydrogenase thereby there is potential for an interaction with
drugs that stimulate or inhibit this enzyme (e.g. valproate, phenytoin or ethosuximide). No studies have been
conducted in human subjects.
The effects of sodium oxybate are possibly enhanced by concomitant use of antipsychotics.
Effective from: March 2014
Review date: March 2016
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Sodium oxybate, version 2
8. Criteria for use
Sodium oxybate has a place in therapy where conventional agents have failed or are contra-indicated.
Sodium oxybate (Xyrem) will be used locally when patients have either had inadequate control of
sleepiness on modafinil and methylphenidate or both these drugs are not tolerated. It may also be used in
severe cataplexy which has not been adequately controlled on tricyclic antidepressants, SSRIs or SNRIs, or
where all 3 classes of these drugs are not tolerated or contra-indicated.
9. Any further information (e.g. supporting therapies)
10. References
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UCB Pharma Limited, Xyrem 500mg/ml Oral Solution – Summary of product characteristics, updated
29/07/2011. eMC, Datapharm communications Ltd. Available at:
http://www.medicines.org.uk/emc/medicine/17364 [accessed 17/2/14]
BMJ Group and RPSGB, The British National Formulary [online], The Pharmaceutical Press,
February 2014. Available at: http://www.bnf.org/bnf/index.htm [accessed 17/2/14]
Effective from: March 2014
Review date: March 2016
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Sodium oxybate, version 2
RESPONSIBILITIES and ROLES
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Consultant / Specialist responsibilities
Confirmation of diagnosis and identification of suitable patients
Request agreement of shared care with primary care prescriber
Initiation of appropriate therapy
Discussion of risks and benefits with patients, outline possible side effects
Titration of the sodium oxybate dose to the optimum, stable level
Monitoring for response and adverse drug reactions (ADRs) during the titration period
Issuing initial prescription(s) until the patient is stabilised (minimum of two to three months) and until ESCA is in
place
Ensure that all newly treated patients (and/or their carers) receive appropriate education and advice regarding
their drug therapy and shared care arrangements. This should include written information where appropriate
Providing primary care prescriber with clinic letter stating planned introduction and reviews
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 for clinical review or drug monitoring
Transfer prescribing of sodium oxybate to the primary care prescriber once the patient is stable.
To provide the primary care prescriber with updates after all follow up review visits. This can change to annual
reviews after the first year.
To take immediate action in the event of a reported serious adverse effect or contraindication to sodium
oxybate.
To provide primary care prescriber with any relevant information as requested
Primary care prescriber responsibilities
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Initial referral to secondary care.
To inform the consultant if unwilling to enter into shared-care arrangements.
To provide repeat prescriptions once ESCA is agreed and in place and the patient is stabilised (not before initial
two to three months stabilisation period). 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.
To record any changes in therapy in the prescribing record on receipt of such communication from secondary
care.
Monitoring the patient’s overall health and well being and make consultant aware of change circumstances e.g.
pregnancy/breast feeding
Liaise with QVH Sleep Disorder Clinic if any cause for concern or drug discontinued.
To provide a copy of this ESCA to the patient to ensure that they are familiar with all roles and responsibilities
Inform the consultant of any new indication or concomitant therapy that may interact with, prove to be a contraindication to or will effect therapy of sodium oxybate
Observing the patient for evidence of ADRs or any abnormalities and raising with secondary care clinician if
necessary
Patient's / Carer’s role
Ask the specialist sleep physician or primary care prescriber for information, if he or she does not have a
clear understanding of the treatment.
Share any concerns in relation to treatment with sodium oxybate
Tell the specialist sleep physician or primary care prescriber of any other medication being taken, including
over-the-counter products.
Read the patient information leaflet included with the medication and report any side effects or concerns to
the specialist sleep physician or primary care prescriber.
Arrange blood tests as per specialist sleep physician request.
Report to their specialist sleep physician any previously unreported symptoms.
Effective from: March 2014
Review date: March 2016
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Sodium oxybate, version 2
BACK-UP ADVICE AND SUPPORT
Specialist /
Consultant:
Name / position
Telephone
Email
Angus Nisbet
01342 414604
[email protected]
01342 414604
[email protected]
Consultant Neurologist and
Specialist Sleep Physician
Queen Victoria Hospital
NHS Foundation Trust
Alternative
specialist (e.g.
departmental
contact):
Peter Venn
Consultant Anaesthetist
and Specialist Sleep
Physician
Queen Victoria Hospital
NHS Foundation Trust
Hospital Pharmacy:
Out of hours (e.g.
medical team on
call):
Queen Victoria Hospital
NHS Foundation Trust
01342 414214
01342 414215
Contact local A&E
Contact local A&E
Version History
Document Name:
Sodium oxybate shared care agreement
Document Type:
Effective Shared Care Agreement
Relevant to:
All primary care prescribers working within Coastal West Sussex and all relevant
clinicians at Queen Victoria Hospital NHS Foundation Trust.
Version
No.
Date
Author of original
development or review
Details of document development
1
20.8.13
Amanpreet Sidhu
Original development
Specialist Pharmacist
2
27.2.14
Nick Rutherford
Full review and re-draft
Medicines Management
Technician, CWS CCG
Approval for organisational use
ESCA
authorised for
use in Coastal
West Sussex by
Specialist/consultant: Dr Angus Nisbet Consultant Neurologist & Sleep physician,
Judy Busby, Chief Pharmacist 9.1.14
Coastal West Sussex Area Prescribing Committee (APC): March 2014
Effective from: March 2014
Review date: March 2016
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Sodium oxybate, version 2
EFFECTIVE SHARED CARE AGREEMENT (ESCA)
DRUG NAME: Sodium oxybate
INDICATION: Treatment of severe narcolepsy and cataplexy in adult
patients
Agreement for transfer of prescribing to PRIMARY CARE PRESCRIBER
Patient details:
Name:
Address:
DoB:
NHS No:
Hospital No:
Drug name and dose: Sodium Oxybate at dose of
The following tests and investigations have been carried out:
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:
Consultant Neurologist & Sleep physician : Dr Angus
Nisbet
Address: Sleep Disorder Centre
Queen Victoria Hospital
Holyte Road
East Grinstead
West Sussex
RH19 3DZ
Agreement to shared care, to be
signed by primary care prescriber and
consultant/specialist.
Consultant/specialist signature:
Date:
Contact Number: 01342 41400 ext 4604
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:
Contact Number:
Key worker if appropriate:
Contact Number:
Effective from: March 2014
Review date: March 2016
Page 7 of 7