Download Methotrexate - Wolverhampton Formulary

Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Methotrexate - hospital monitored
ESCA: For the treatment of Juvenile Idiopathic Arthritis (JIA)
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:
01902 695616
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.
Bleep
Fax
Email address
Specialist: Dr A Copeman
5172
7819
695616
[email protected]
Specialist: Dr K. Davies
5172
7238
695616
[email protected]
Hospital Pharmacy Department: Mr K Bird
5136
7543
[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: January 2013
Expiry date: 31/12/2017
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Methotrexate - hospital monitored
ESCA: For the treatment of Juvenile Idiopathic Arthritis (JIA)
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 Juvenile idiopathic arthritis and other inflammatory disorders, as mentioned above 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
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Specialist responsibilities
Perform baseline tests (FBC, ESR, CRP, LFTs, U&Es, 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.
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.
Recommend dose and timing of any concomitant folic acid.
Monitor FBC, U & E and LFT every 2 weeks until dose and monitoring stable for 6 weeks; thereafter monthly
until dose and disease stable for 1 year. Frequency of monitoring could be reduced to every 2 to 3 months
after this time.
Recheck result and stop medication if neutrophils < 2.0 x 109/L, platelets <120 x 109/L. Or if any of these
parameters fall by 50% of previous value or LFT shows ALT 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.
Periodically review the patient’s condition and communicate in writing with the GP when treatment is changed.
Advise the GP on when to adjust the dose, stop treatment, or consult with specialist.
Report adverse events to the MHRA and GP.
Ensure that clear backup arrangements exist for GPs to obtain advice and support.
General Practitioner responsibilities
Reply to the request for shared care as soon as practicable
Prescribe methotrexate at the dose recommended
Ensure compatibility with other concomitant medication
Ensure that the patient understands that dosing is at weekly intervals, and which warning symptoms to report
Report adverse events to the specialist and MHRA
Patient's role
Report to the specialist or GP if he or she does not have a clear understanding of the treatment.
Share any concerns in relation to treatment with methotrexate.
Inform specialist or GP of any other medication being taken, including over-the-counter products.
Report any adverse effects or warning symptoms to the specialist or GP whilst taking methotrexate.
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: January 2013
Expiry date: 31/12/2017
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Methotrexate - hospital monitored
ESCA: For the treatment of Juvenile Idiopathic Arthritis (JIA)
SUPPORTING CLINICAL INFORMATION
Indications
Methotrexate is not licensed for use in children but it is the standard accepted treatment for Juvenile Idiopathic
Arthritis.
Dosage and Administration
In children the dose is 15mg/m2 once weekly.
Contraindications
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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 MHRA.
Monitoring
Regular monitoring during treatment is essential to detect adverse reactions at an early stage and patients should be
counselled about the risk factors and to report all signs and symptoms of toxicity. The MHRA has advised that a full
blood count (FBC) and renal and liver function tests (LFTs) be done before starting treatment and repeated weekly
until therapy is stabilised. Thereafter patients should be monitored every two to three months. The British Society
for Rheumatology Guidelines advises monthly monitoring of FBC and LFTs after stabilisation of the dose, and renal
function testing every 6 to 12 months. They also list threshold laboratory values and symptoms that need discussion
with the specialist (i.e. wbc <4.0x109/l, neutrophils <2x109/l, platelets <150x109/l, >2-fold rise in ALT or AST from
upper limit of reference range, unexplained fall in albumin, rash or oral ulceration, new or increasing dyspnoea or
cough).
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.
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).
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: January 2013
Expiry date: 31/12/2017
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Methotrexate - hospital monitored
ESCA: For the treatment of Juvenile Idiopathic Arthritis (JIA)
Version Control
Version
Date of Issue
Author/s
Brief Description of Changes
2
16.01.13
Ian Perry
Monitoring information; responsibility for monitoring sits with specialist
2.1
25/06/2013
R Eardley
Removal of pharmacy fax numbers
References
National Guidelines for the Monitoring of Second Line Drugs. British Society for Rheumatology. July 2000.
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: January 2013
Expiry date: 31/12/2017