SHARED CARE AGREEMENT
METHOTREXATE TABLETS
This document should be read in conjunction with the current SPC.
1. REFERRAL CRITERIA
 Shared Care is only appropriate if it provides the optimum solution for the patient.
 Prescribing responsibility will only be transferred when it is agreed by the consultant and the patient’s GP. This
agreement is reached by the GP completing and returning the form provided.
 When transfer agreed the patient will be issued with four weeks supply.
2. AREAS OF RESPONSIBILITY
GP responsibilities
a) Respond promptly to the shared care request.
b) Monitor the patient’s overall health and wellbeing and ensure compatibility with other
concomitant medication.
c) Prescribe the recommended Methotrexate dose
(always using 2.5mg tablets) and adjust as
advised by specialist.
d) Prescribe the recommended Folic Acid
according to the specialist.
e) Arrange on-going monitoring as agreed with the
specialist.
f) Monitor FBC, U&E, and LFTs at recommended
frequencies and refer if abnormal.
g) Raise any concerns or changes in the patients’
physical health with the specialist.
h) Re-affirm the use of contraception.
i) Report adverse events to the specialist and if
relevant the MHRA yellow card scheme.
j) Ensure patient has Methotrexate record / advice
book, and ensure the dose and treatment day
are recorded along with latest blood results.
k) Re-affirm and confirm the use of contraception.
l) Stop treatment on the advice of the specialist or
immediately if any urgent need arises.
m) Ensure the patient is offered an annual flu
vaccination and a one off pneumococcal
vaccination.
n) Ensure the patient receives NO live vaccinations
which includes the shingles vaccination.
o) Seek advice if patient travelling to a country
where live vaccinations are required.
p) In the GP clinical system use the appropriate
read code to denote the patient is receiving
treatment under a shared care agreement.
In Emis 8BM5, System One XaB58.
q) If patient fails to attend more than 2 monitoring
visits it is not safe to continue treatment –
contact the specialist for advice.
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Consultant responsibilities
a) Discuss diagnosis, treatment options and
agree care package with patient.
b) Discuss potential benefits and adverse
effects of proposed treatment.
c) Undertake baseline tests including FBC,
LFTs, U&Es, and where appropriate Chest Xray, CRP, ESR and for DERMATOLOGY
ONLY P111NP.
d) Provide baseline test results.
e) Exclude pregnancy before commencement
and ensure adequate precautions are used.
f) Provide Methotrexate prescriptions until a
stable dose is reached.
g) Titrate dose to a therapeutic level before
seeking shared care prescribing ensuring
patient is stable.
h) Request shared care via clinic letter
supplying a copy of this shared care
agreement.
i) Recommend dose of Methotrexate and
frequency of monitoring.
j) Supply patient with a copy of this shared care
agreement.
k) Initiate Folic Acid 5mg three times a week.
l) Review patient periodically (no less than
annually) and advise when to adjust the
dose, stop treatment or consult with the
specialist.
m) Provide and update patient with Methotrexate
treatment booklet and complete at each
assessment.
n) Communicate with GP promptly when
treatment changes.
o) Ensure a mechanism is in place to address
clinical queries or concerns from GPs relating
to this agreement in a timely manner.
p) Report adverse events to MHRA Yellow card
scheme and GP.
q) Where appropriate, inform, refer and educate
patients regarding the transition to
subcutaneous Methotrexate. Inform GP of
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r)
the same.
Ensure a nurse advice line is available for
GP to contact department if necessary and
respond promptly to messages left by GPs
on the nurse advice line.
Patient responsibilities
a) To take the prescribed dose on the agreed day each week unless advised not to by specialist / GP.
b) To attend all appointments with specialist and GP for all monitoring, always providing Patient Record
Book.
c) Inform specialist and GP of any other medication being taken including over the counter products.
d) Agree methods of contraception for during treatment and at least three months after for both men and
women.
e) Report any concerns or adverse effects to GP or consultant promptly. Do not wait for routine
appointment if there are signs of unusual bruising, persistent sore throat, cough or breathing difficulties.
f) Carry and present Patient Record Booklet to GP and community pharmacy at each prescribing and
dispensing activity.
3. CLINICAL INFORMATION
Licensed Indications
 Rheumatoid Arthritis (RA)
 Psoriasis
i. Prescribed indications
ii. Therapeutic summary
Unlicensed indications
 Psoriatic arthritis
 Inflammatory bowel disease
 Connective Tissue Disease
(SLE, myositis and
vasculitis)
 Crohn’s Disease
 Asthma
 Sarcoidosis (to confirm)
 Uvetitis
Methotrexate is licensed as a disease modifying agent for the treatment of
Rheumatoid Arthritis and severe psoriasis, there is also significant evidence
of benefit in psoriatic arthritis and inflammatory bowel disease. It is
speculated that Methotrexate produces its effects via anti folate activity
immunosuppressive and other anti-inflammatory actions.
The listed conditions are generally life-long and require specialist initiation but
are considered suitable for GP prescribing provided adequate monitoring is in
place.
ALWAYS PRESCRIBE USING 2.5mg TABLETS
See BNF for full list of licensed and unlicensed doses.
Licensed indications
Rheumatoid arthritis - 7.5mg – 25mg orally ONCE WEEKLY on Monday at
10pm.
iii. Dose & Route of
administration
Unlicensed indications
Crohn’s Disease - maintenance of remission of severe Crohn’s disease 10 –
25mg orally ONCE WEEKLY Monday at 10pm.
Folic Acid 5mg DAILY for 3/7(5mg on Friday, Saturday and Sunday) should
be prescribed whilst patient remains on Methotrexate.
The specialist will be responsible for titrating to an effective dose. For all other
indications see BNF or as per specialist advice. Lower doses should be
considered for the frail elderly and for those with renal impairment.
iv. Duration of treatment
Indefinite
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Side Effects
Nausea, vomiting and acute minor GI upsets
These are common and may occur at any stage of treatment.
Mouth ulcers- these are usually responsive to a temporary cessation of the
drug and re-introduction at a lower dose.
Myelosuppression and decreased resistance to infection
This is especially in relation to respiratory, urinary tract and
shingles/Chickenpox. Temporarily withhold / advise stopping if patient is
systemically unwell with significant infection requiring anti-infective
treatment.
Alopecia, rash and diarrhoea
If severe inform specialist team after stopping Methotrexate.
v. Adverse effects
See BNF / SPC for full list
Pulmonary Symptoms
A small minority of patients develop symptoms of interstitial pneumonitis soon
after commencing treatment indicated by persistent dry cough / shortness of
breath. STOP Methotrexate and refer to specialist or A & E if urgent.
Cytopenia
Withdraw Methotrexate and inform specialist team or haematologist.
See BNF for full list of side effects.
Alcohol and Surgery
Alcohol should be kept to a minimum as the risk of liver damage from
alcohol is increased in patients taking Methotrexate.
Consider stopping Methotrexate from the week of surgery and for two
weeks following. Consider withholding for longer if infection is present
or poor wound healing.
Pre-treatment investigations:
 FBC
 LFT’s
 U&E
 Chest x-ray unless done in previous 3 months. Pulmonary function
tests and chest HRCT should be considered in selected patients.
 DERMATOLOGY ONLY - Serum Pro-Collagen III
Monitoring continues as the responsibility of the specialist in accordance with
local protocol until the patient is on a stable therapeutic dose.
vi. Monitoring Requirements
Ongoing monitoring
Rheumatology- FBC, LFT and U&E’s two weekly for twelve weeks then
monthly thereafter. Two weekly bloods must be resumed if dose increased or
when results are abnormal. In addition ESR should be monitored every three
months for disease progression.
In Dermatology-FBC, LFT’s , creatinine and U&E’s every 2-3 months once
stablilised.P111NP may also be needed for psoriasis patients both at
baseline and 3 monthly.
In Gastroenterology- the BSG advises monthly FBC and LFTs when treating
IBD.
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Responding to abnormal results
WBC <3.5x109/L
Neutrophils <2 x109/L
Platelets <150 x109/L
AST/ALT > 2 times the upper
limit of normal
Unexplained fall in serum
albumin in absence of active
disease
Oral ulceration, sore throat,
nausea, vomiting, diarrhoea
New or increasing dyspnoea
or dry cough
Patient develops mildmoderate renal impairment
MCV( Mean cell volume) >
105fl ( investigate and
supplement if B12 and folate
are low)
Abnormal bruising or severe
sore throat
CRP/ESR measured to allow
disease activity evaluation
vii. Clinically relevant drug
interactions
For a full list of interactions
please refer to the BNF
viii. Contraindications and
cautions
Withhold until discussed with specialist
team
Withhold until discussed with specialist
team
Withhold until discussed with specialist
team
Withhold until discussed with specialist
team
Withhold until discussed with specialist
team
Withhold until discussed with specialist
team
Withhold until discussed with specialist
team
Dose requires adjustment - discuss
with specialist team
Withhold until discussed with specialist
team
Withhold until discussed with specialist
team
Withhold until discussed with specialist
team
NB – a rapidly increasing or decreasing trend in any value should prompt
caution irrespective of actual value.
Drug Interactions
 NSAIDS- reduce excretion and therefore increase toxicity of
methotrexate, but are not contra-indicated. Doses should be adjusted
to accommodate in accordance with blood test results. BNF states
that NSAIDS are suitable for concomitant use with Methotrexate but
clinically significant interactions with NSAIDS are extremely rare.
 Increased risk of toxicity with Ciprofloxacin, Doxycycline,
Sulfonamides, Tetracycline and Penicillins. CO-TRIMOXAZOLE AND
TRIMETHOPRIM SHOULD NEVER BE PRESCRIBED WITH
METHOTREXATE.
 Increased risk of agranulocytosis when Methotrexate given with
Clozapine.
 LIVE vaccines should be avoided.
Contraindications
 Pregnancy and breastfeeding – both men and women should be
advised not to plan to conceive during treatment. A reliable method of
contraception should be advised to all patients for the duration of
treatment and for three months after discontinuation of treatment. If
pregnancy does occur the Methotrexate should be stopped and a
discussion had with the specialist team. Women receiving
Methotrexate should not breastfeed.
 Suspected local and systemic infections
 Severe renal or hepatic impairment
 Chronic or recurrent infections or lung disease
 Bone marrow failure indicated by cytopenia or anaemia
 Leukopenia or thrombocytopenia
 Untreated folate deficiency
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Cautions
 Use with caution in patients with history of alcohol abuse.
 Patients with clinically significant renal impairment from any cause.
 Localised or systemic infection including hepatitis B or C and a
history of TB.
 History of cancer.
ALWAYS PRESCRIBE USING 2.5mg TABLETS
ix. Supply, storage and
reconstitution instructions
4. COMMUNICATION AND SUPPORT
x. Hospital contacts:
Burton Hospitals 01283 511511 / 566333
Rheumatology
Consultants;
Dr M Nisar ext 4111
Dr R Laximinarayan ext 4068
Clincial Rheumatology Nurse Specialist ext 4112
Bleep 274 available during office hours.
Dermatology
Dr Beswick and Dr Cartwight secretary ext 4061
Dr Elston and Dr Tudor secretary 5202
xi. Out of hours contacts and procedures:
Burton Hospitals 01283 511511 / 566333 ask for on-call
pharmacist via switchboard
Rheumatology
Messages can be left on the nurse advice line out of hours.
01283 511511 ext 4112.
If the advice line is not staffed messages may be left 24
hours a day. The team aim to respond at latest within two
working days. The specialist nurses may also be bleeped
via switchboard for urgent enquiries.
Gastroenterology
Dr Palejwala secretary ext 4221
Dr Watmough secretary ext 4008
IBD Nurse Specialist ext 5854
xii. Specialist support/resources available to GP including patient information
Patient information leaflet:http://www.medicines.org.uk/emc/medicine/15727
Improving Compliance with oral methotrexate guidance :http://www.nrls.npsa.nhs.uk/resources/?entryid45=59800
Methotrexate information issued by hospital to patient (rheumatology only) –
BHFT Methotrexate
leaflet.pdf
xiii. Prepared by
Sam Hardy-Ainger - Interface Pharmacy Technician
Jane Whitmore - Lead Clinical Nurse Specialist Rheumatology
In consultation with
Dr M Nisar – Lead Consultant Rheumatology
Dr D Watmough – Lead Consultant Gastroenterology
Dr Alina Tudor – Consultant Dermatologist
Reviewed by
Date Prepared
Oct 2016
Review date
Oct 2018
Acknowledgements
Derbyshire Joint Area Prescribing Committee (JAPC)
References
1. 1. Derbyshire Medicines Management Share Care guideline 2. http://www.derbyshiremedicinesmanagement.nhs.uk/assets/Clinical_Guidelines/Shared_Care_Guidelines/Methotrexate.p
df
3. 2.SPC Methotrexate https://www.medicines.org.uk/emc/medicine/12033
3.‘Shared Care Guidelines from Methotrexate Therapy’ Department of Rheumatology Burton Hospitals NHS Foundation
Trust JAL/Rheum 16/03/2012
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GP RESPONSE TO SHARED CARE
Shared care is produced by GPs and specialists knowledgeable in the field of that drug usage. This allows a more
convenient service to the patient and cost effective use of NHS resources.
Patient:
NHS No:
Consultant:
Medicine requested for shared care: Methotrexate
tablets
Current Dose:
Date last prescription was provided:

I agree to participate in this shared care agreement for the treatment of the above named patient
with Methotrexate.

I will NOT be undertaking the GP responsibilities as described in the agreed shared care guideline.
My clinical reasons for declining shared care for this patient are listed in the box below:
Yours sincerely
{GP name}
{Surgery}
Please send a copy of this response to:
1. The specialist / consultant requesting shared care
2. It is the responsibility of the specialist / consultant requesting the shared care agreement to forward any declined
responses to the Medicines Management Interface Technician, Pharmacy Department Burton Hospitals.
(Sending a copy of this form to the interface technician will help to identify the reasons shared care is not being
undertaken allowing for changes to be made in future updates to improve patient care.)
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