Download Methotrexate - Wolverhampton Formulary

Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Methotrexate (Maxtrex®) – hospital monitored
ESCA: In combination with corticosteroids and/or other immunosuppressive agents to treat and maintain
remission for Uveitis, a group of ocular inflammatory diseases that has vision threatening potential. The
disease entities include Sarcoidosis, Behcets Disease, Sympathetic Ophthalmia, Retinal vasculitides, VKH
syndrome, Birdshot and Serpiginous Choroidopathy.
SECONDARY CARE SECTION TO BE COMPLETED BY INITIATING DOCTOR
Patient’s Name:
NHS Number:
Date of Birth:
Date Treatment Started:
(Add Date)
One copy of information leaflet given to patient
One copy of agreement sent to general practitioner
One copy filed in patients notes
Name of Initiating Doctor:
Consultant:
Speciality:
Fax Number:
PRIMARY CARE SECTION TO BE COMPLETED BY GENERAL PRACTITIONER
I agree*/don’t agree* to enter into a shared care arrangement for the treatment of the above patient with
this medicine (*delete as appropriate)
GP Name:
Signature:
Date:
Once signed please detach this sheet and fax to the number shown above.
File copy in patient’s record and add read code 66S2 or XaK6z depending on GP clinical system.
BACK-UP ADVICE AND SUPPORT
Contact details
Telephone No.
Specialist: Mr S Tarin
Bleep
Fax
Email address
01902 695024
695600
[email protected]
Specialist: Mr Y Yang
01902 695025
695600
[email protected]
Hospital Pharmacy Dept: Fiona McKean
01902 695137
3963
[email protected]
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for Maxtrax® and the Midland
Therapeutic Review and Advisory Committee (MTRAC) verdict and summary sheet (VS97/15)
Date approved: 30 Dec 12
Expiry date: 31/12/2017
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Methotrexate (Maxtrex®) – hospital monitored
ESCA: In combination with corticosteroids and/or other immunosuppressive agents to treat and maintain
remission for Uveitis, a group of ocular inflammatory diseases that has vision threatening potential. The
disease entities include Sarcoidosis, Behcets Disease, Sympathetic Ophthalmia, Retinal vasculitides, VKH
syndrome, Birdshot and Serpiginous Choroidopathy.
Patient’s Name:
Date treatment commenced:
AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE
This shared care agreement outlines suggested ways in which the responsibilities for managing the prescribing of
methotrexate for ocular inflammatory diseases can be shared between the specialist and general practitioner (GP).
GPs are invited to participate. If the GP is not confident to undertake these roles, then he or she is under no
obligation to do so. In such an event, the total clinical responsibility for the patient for the diagnosed condition remains
with the specialist. If a specialist asks the GP to prescribe this drug, the GP should reply to this request as soon as
practicable.
Sharing of care assumes communication between the specialist, GP and patient. The intention to share care should
be explained to the patient by the doctor initiating treatment. It is important that patients are consulted about
treatment and are in agreement with it.
The doctor who prescribes the medication legally assumes clinical responsibility for the drug and the
consequences of its use.
RESPONSIBILITIES and ROLES
Specialist responsibilities
Perform baseline tests (FBC, ESR, LFTs, U&E’s, chest X-ray).
Initiate and stabilise treatment with methotrexate.
Discuss the benefits and side effects of treatment with the patient. Ensure that the patient understands that
dosing is at weekly intervals.
4. Ask the GP whether he or she is willing to participate in shared care, and agree with the GP as to who will
discuss the shared care arrangement with the patient, and provide the patient with a monitoring and dosage
record.
5. FBC, U and Es, LFTs are checked every 2 weeks until 6 weeks after last dose change, then monitored
monthly until stable. Prescribe concomitant folic acid. This is usually once daily except on day of
methotrexate.
6. Recheck result and stop medication if neutrophils < 2.0 x 109/L, platelets <150 x 109/L. Or if any of these
parameters fall by 50% of previous value or LFT shows AST or alkaline phosphatase > 3x upper limit of
normal (reduce dose if there is a steady trend towards these values. If MCV above upper limit of normal,
check red cell folate. Stop treatment if cough or infection develops. Investigate and treat any infection
promptly. Contact specialist immediately if an urgent need to stop treatment arises.
7. Periodically review the patient’s condition and communicate in writing with the GP when treatment is changed.
8. Advise the GP on when to adjust the dose, stop treatment, or consult with specialist.
9. Report adverse events to the MHRA and GP.
10. Ensure that clear backup arrangements exist for GPs to obtain advice and support.
11. Issue the patient with a methotrexate information and monitoring booklet.
General Practitioner responsibilities
1. Reply to the request for shared care as soon as practicable.
2. Prescribe methotrexate at the dose recommended.
3. Ensure compatibility with other concomitant medication.
4. Ensure that the patient understands that dosing is at 2 weekly intervals, and which warning symptoms to
report.
5. Report adverse events to the specialist and MHRA.
6. Complete the methotrexate monitoring booklet with the results of blood tests.
Patient's role
1. Report to the specialist or GP if he or she does not have a clear understanding of the treatment.
2. Share any concerns in relation to treatment with methotrexate.
3. Inform specialist or GP of any other medication being taken, including over-the-counter products.
4. Report any adverse effects or warning symptoms to the specialist or GP whilst taking methotrexate.
5. Keep the methotrexate monitoring booklet and bring it to all consultations with the GP or at the hospital.
1.
2.
3.
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for Maxtrax® and the Midland
Therapeutic Review and Advisory Committee (MTRAC) verdict and summary sheet (VS97/15)
Date approved: 30 Dec 12
Expiry date: 31/12/2017
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Methotrexate (Maxtrex®) – hospital monitored
ESCA: In combination with corticosteroids and/or other immunosuppressive agents to treat and maintain
remission for Uveitis, a group of ocular inflammatory diseases that has vision threatening potential. The
disease entities include Sarcoidosis, Behcets Disease, Sympathetic Ophthalmia, Retinal vasculitides, VKH
syndrome, Birdshot and Serpiginous Choroidopathy.
Ensure that the results of blood tests are entered into the booklet.
SUPPORTING CLINICAL INFORMATION
Indications
In combination with corticosteroids and/or other immunosuppressive agents to treat and maintain remission for
Uveitis, a group of ocular inflammatory diseases that has vision threatening potential. The disease entities include
Sarcoidosis, Behcets Disease, Sympathetic Ophthalmia, Retinal vasculitides, VKH syndrome, Birdshot and
Serpiginous Choroidopathy (all unlicensed indications)
Dosage and Administration
Methotrexate is started at a dose of 7.5mg orally once weekly, or divided oral doses of 2.5mg at 12 hour intervals for
3 doses (7.5mg) as a course once weekly. The schedule may be adjusted gradually to achieve an optimal response
but should not exceed a total weekly dose of 20mg. The lowest possible effective dose should be used.
Methotrexate should be used with extreme caution in elderly patients and a lower dose should be considered.
Contraindications
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

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profound impairment of renal or hepatic function or haematological impairment
liver disease including fibrosis, cirrhosis, recent or active hepatitis; active infectious disease; and overt or
laboratory evidence of immunodeficiency syndrome(s)
serious cases of anaemia, leucopenia, or thrombocytopenia
pregnancy or breast-feeding
patients with a known allergic hypersensitivity to methotrexate
Side Effects
Low-dose methotrexate may be associated with a number of serious adverse effects, including:
 hepatotoxicity
 pulmonary toxicity
 bone-marrow toxicity
Other common non-life-threatening adverse effects of low-dose methotrexate are those affecting the gastrointestinal
system (nausea, diarrhoea and stomatitis), and the central nervous system (headaches, drowsiness, blurred vision).
The risk of minor adverse effects may be reduced by giving regular folic acid. An annual influenza vaccination is
recommended.
Methotrexate was launched in 1989 and no longer has black triangle (▲) status. Serious suspected reactions (even if
well recognised or causal link uncertain) should be reported to the CSM.
Monitoring
FBC, U&E, LFT every 2 weeks until dose and monitoring stable for 6 weeks; thereafter monthly, until the
dose and disease is stable for a year. Thereafter based on clinical judgement and following discussion with
specialist team consider reducing frequency of monitoring to every 2 - 3 months.
Drug Interactions
Methotrexate is extensively protein-bound and may be displaced by other protein-bound drugs (e.g. diuretics,
salicylates, hypoglycaemics), with a potential for increased toxicity. Concomitant use of other drugs with nephrotoxic
or hepatotoxic potential (including alcohol) should be avoided. Folate antagonists such as trimethoprim should not
be given concomitantly. The British Society for Rheumatology Guidelines state that NSAIDs are not contraindicated
with the above doses of methotrexate.
Vaccination
The use of LIVE vaccine is not recommended during drug treatment with immunosuppressant drugs. This section
may be excluded if the shared care agreement related to a drug which is not an immunosuppressant.
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for Maxtrax® and the Midland
Therapeutic Review and Advisory Committee (MTRAC) verdict and summary sheet (VS97/15)
Date approved: 30 Dec 12
Expiry date: 31/12/2017
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Methotrexate (Maxtrex®) – hospital monitored
ESCA: In combination with corticosteroids and/or other immunosuppressive agents to treat and maintain
remission for Uveitis, a group of ocular inflammatory diseases that has vision threatening potential. The
disease entities include Sarcoidosis, Behcets Disease, Sympathetic Ophthalmia, Retinal vasculitides, VKH
syndrome, Birdshot and Serpiginous Choroidopathy.
Acknowledgements
Refer to MTRAC VS 97/15.
The National Patient Safety Agency has published actions to reduce the risks associated with oral methotrexate (see
website below).
Version Control
Version
Date of Issue
Author/s
Brief Description of Changes
25/06/2013
R Eardley
Removal of pharmacy fax numbers
1.0
1.1
References
.
Quick reference guideline for monitoring of disease modifying anti-rheumatic drug (DMARD) therapy
Prepared by the BSR/ BHPR DMARD guideline group, May 2007 updated November 2009 British Society for
Rheumatology. Available at:
http://www.rheumatology.org.uk/includes/documents/cm_docs/2009/d/dmard_grid_november_2009.pdf Accessed
MTRAC guidance VS97/15.
National Patient Safety Agency. www.npsa.nhs.uk
Wyeth Pharmaceuticals. Methotrexate sodium tablets 2.5 mg. Summary of Product Characteristics 2011.
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for Maxtrax® and the Midland
Therapeutic Review and Advisory Committee (MTRAC) verdict and summary sheet (VS97/15)
Date approved: 30 Dec 12
Expiry date: 31/12/2017