Download 44 - Coastal West Sussex Formulary

WORKING IN
PARTNERSHIP
WITH
EFFECTIVE SHARED CARE AGREEMENT (ESCA)
DRUG NAME: Riluzole
INDICATION/S COVERED: Adults with Motor Neurone Disease
(Amyotrophic Lateral Sclerosis type)
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: 22/3/13
Review date: 22/3/15
Page 1 of 6
Effective Shared Care Agreement for riluzole in adults with Motor Neurone Disease (Amyotrophic Lateral
Sclerosis type), 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 and to the relevant NICE technology appraisal guidance.
1. Link to the relevant SPC website:
http://www.medicines.org.uk/EMC/medicine/1672/SPC/Rilutek+50+mg+film-coated+tablets/
2. Background to use for the indication/s, including licence status
Licensed to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis
(ALS).
3. Dose & administration
Dose: 50mg twice daily (every 12 hours).
Route: Oral.
4. Cautions
 Liver impairment - Riluzole should be prescribed with care in patients with a history of abnormal liver
function (with baseline transaminases up to 3 times the upper limit of normal).
 Neutropenia - Any reports of febrile illness symptoms should prompt physicians to check white blood cell
counts and to discontinue riluzole in case of neutropenia.
 Interstitial lung disease - Perform chest x-ray if symptoms such as dry cough or dyspnoea develop;
discontinue if interstitial lung disease is diagnosed.
 Renal impairment - Not recommended for use in patients with impaired renal function.
5. Contraindications

Hypersensitivity to the active substance or any of the excipients.

Hepatic disease or baseline transaminases greater than 3 times upper limit of normal.

Patients who are pregnant or breast feeding.

Not for use in children, due to a lack of data on the safety and efficacy.
6. Side effects
Very common: abnormal (usually transient) liver function tests, asthenia, nausea.
Common: diarrhoea, abdominal pain, vomiting, headache, dizziness, oral paraesthesia, somnolence,
tachycardia, pain.
Dizziness or vertigo may affect performance of skilled tasks such as driving.
7. Interactions
There have been no clinical studies to investigate interactions with other medicinal products.
In vitro studies suggest that inhibitors of CYP 1A2 (e.g. caffeine, diclofenac, diazepam, nicergoline,
clomipramine, imipramine, fluvoxamine, phenacetin, theophylline, amitriptyline and quinolones) could
potentially decrease the rate of riluzole elimination, while inducers of CYP 1A2 (e.g. cigarette smoke,
charcoal-broiled food, rifampicin and omeprazole) could increase the rate of riluzole elimination.
8. Criteria for use
NICE TA20 motor neurone disease - riluzole http://guidance.nice.org.uk/TA20
9. Any further information (e.g. supporting therapies)
Clinical trials have demonstrated that riluzole extends survival for patients with ALS. Survival was defined as
patients who were alive, not intubated for mechanical ventilation and tracheotomy-free.
There is no evidence that riluzole exerts a therapeutic effect on motor function, lung function, fasciculations,
muscle strength and motor symptoms. Riluzole has not been shown to be effective in the late stages of ALS.
Safety and efficacy of riluzole has only been studied in ALS. Therefore, riluzole should not be used in patients
with any other form of motor neurone disease.
In case of overdose, treatment is symptomatic and supportive. Neurological and psychiatric symptoms, acute
toxic encephalopathy with stupor, coma, and methemoglobinemia have been observed in isolated cases of
overdose.
Effective from: 22/3/13
Review date: 22/3/15
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Effective Shared Care Agreement for riluzole in adults with Motor Neurone Disease (Amyotrophic Lateral
Sclerosis type), version 2
10. References
Summary of Product Characteristics: Rilutek 50 mg film-coated tablets, Sanofi, last updated 07/07/2009.
Available at: http://www.medicines.org.uk/EMC/medicine/1672/SPC/Rilutek+50+mg+film-coated+tablets/
<accessed on 15/02/13>
British National Formulary: 64, BMJ Group and Pharmaceutical Press, September 2012.
Available at: www.bnf.org
NICE Technology Appraisal 20 - Motor neurone disease – riluzole. Available at:
http://guidance.nice.org.uk/TA20 <accessed on 15/02/13>
Effective from: 22/3/13
Review date: 22/3/15
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Effective Shared Care Agreement for riluzole in adults with Motor Neurone Disease (Amyotrophic Lateral
Sclerosis type), 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.
Ensure and take responsibility for baseline initial monitoring and ongoing monitoring outlined below (6 – 14),
act on the results appropriately and communicate these results to the GP, not initiating if ALT is greater than 3
times ULN.
Arrange monthly blood tests including FBC, urea, electrolytes, and liver function tests for the first 3 months.
If these test results are normal then reduce test frequency to every 3 months.
The Neurology Nurses will liaise with the patients regarding these tests, provide the blood forms and monitor
the results.
Inform the primary care prescriber and patient of the results.
No dose adjustments required. If adverse events occur/riluzole is not tolerated/patient decides to discontinue,
riluzole can be stopped immediately. Please inform Neurology Nurse Specialists.
Monitoring of benefits/side effects.
Undertake chest x-ray if patient is symptomatic with respiratory symptoms.
Undertake white blood cell count if patient is symptomatic with febrile illness.
Discontinue if:
ALT levels increase to 5 times the ULN
Interstitial lung disease is diagnosed
Neutropenia occurs
Issuing initial prescription(s) until the patient is stabilised (minimum of 3 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.
Refer to Community based MND Respiratory Specialist Nurse.
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.
Obtain funding and ongoing renewals for drug costs for the duration of secondary care prescribing.
Primary care prescriber responsibilities
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 3 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.
To monitor patients overall health and well-being and to report any adverse drug reactions or interactions to
secondary care. The monitoring requirements above are the responsibility of the consultant/specialist.
Liaise with Neurology Department 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.
Patient's / Carer’s role
Ask the Consultant Neurologist/Neurology Nurse Specialist/MND Nurse Specialist/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 riluzole.
Tell the consultant Neurologist/Neurology Nurse Specialist/MND Nurse Specialist 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 Consultant Neurologist/Neurology Nurse Specialist/MND Nurse Specialist or primary care prescriber.
Arrange blood tests as per Neurology Nurse Specialist Request.
Report to their doctor any such symptoms such as febrile illness or respiratory symptoms.
Effective from: 22/3/13
Review date: 22/3/15
Page 4 of 6
Effective Shared Care Agreement for riluzole in adults with Motor Neurone Disease (Amyotrophic Lateral
Sclerosis type), version 2
BACK-UP ADVICE AND SUPPORT
Specialist /
Consultant:
Alternative
specialist (e.g.
departmental
contact):
Hospital
Pharmacy:
Out of hours (e.g.
medical team on
call):
Name / position
Consultant Neurologists,
Worthing Hospital
Telephone
01903 205111
Email
Dr Chalmers/
Dr Wickremaratchi
ext 5401
ext 5419
[email protected]
[email protected]
Neurology Nurse Specialists,
Worthing Hospital
Christine Kershaw
Rosemary Bradley
Helen Moore
Worthing Hospital
01903 205111
ext 5534
[email protected]
[email protected]
[email protected]
01903 205 111, ext
5698
01243 788 122, ext
[email protected]
St Richards Hospital
On call physicians
On call Neurologist
Version History
Document Name:
Effective Shared Care Agreement for riluzole in adults with Motor Neurone Disease
(Amyotrophic Lateral Sclerosis type)
Document Type:
Effective Shared Care Agreement
Relevant to:
All primary care prescribers working within Coastal West Sussex and all relevant
clinicians at Western Sussex Hospitals NHS Trust.
Version No.
Date
Author of original development or
review
Details of document development
1
25/02/12
Neurology Team, Worthing
Hospital
Original development
2
22/3/13
Nick Rutherford, Medicines
Management Technician, Coastal
West Sussex CCG
Full review and re-draft
Approval for organisational use
ESCA
authorised for
use in Coastal
West Sussex by
Specialist/consultant: Dr Richard Chalmers and Dr Mirdhu Wickremaratchi, Consultant
Neurologists, WSHT 25/1/12
Coastal West Sussex Area Prescribing Committee (APC): 25/1/12
Effective from: 22/3/13
Review date: 22/3/15
Page 5 of 6
Effective Shared Care Agreement for riluzole in adults with Motor Neurone Disease (Amyotrophic Lateral
Sclerosis type), version 2
EFFECTIVE SHARED CARE AGREEMENT (ESCA)
DRUG NAME: Riluzole
INDICATION: Adults with Motor Neurone Disease (Amyotrophic Lateral
Sclerosis type)
Agreement for transfer of prescribing to PRIMARY CARE PRESCRIBER
Patient details:
Name:
Address:
DoB:
NHS No:
Hospital No:
Drug name and dose: Riluzole 50mg twice daily
The following tests and investigations have been carried out:
Diagnosis confirmed, baseline blood screening.
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: Dr
Agreement to shared care, to be
signed by primary care prescriber and
consultant/specialist.
Address: Neurology Department
Worthing Hospital
Lyndhurst Road
Worthing
West Sussex
BN14 0EB
Consultant/specialist signature:
Contact Number: 01903 205111 ext. 5419, 5401, 5534
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:
Contact Number:
Key worker if appropriate:
Contact Number:
Effective from: 22/3/13
Review date: 22/3/15
Page 6 of 6