Subcutaneous methotrexate - shared care protocol

• Renal impairment (reduce dose to 50% if eGFR stable at 20 to 50ml/min and avoid if <20ml/min).
• Hepatic impairment.
• Patients with third distribution space (eg pleural effusion, ascites).

Relative 

• Liver insufficiency.
• Alcohol abuse.
• Pre-existing blood dyscrasia.
• Pre-existing ulcers of oral cavity or active gastrointestinal ulcer disease.

Absolute

•  Hypersensitivity to methotrexate.
• Serious acute or chronic infection (eg TB, HIV or other immunodeficiency syndromes).
• Pregnancy and breast feeding – adequate contraception should be used by males and females during treatment and for at least 3 months after discontinuation.
• Concurrent vaccination with live vaccines – see the Rheumatology Home Page on the Intranet (Vaccinations in the Immunocompromised Person).
• Severe renal insufficiency (eGFR <20 ml/min).

• Trimethoprim or cotrimoxazole – increased risk of blood cell dyscrasia.
• NSAIDs – avoid over the counter NSAIDs but when prescribed at low or stable dose then it would be rare to have issues at the doses of methotrexate used for rheumatological conditions.
• Clozapine – increased risk of blood cell dyscasia.
• Probenecid – excretion of methotrexate reduced.
• Acitretin – plasma methotrexate levels increased with increased risk of liver toxicity.
• Pyrimethamine – increased risk of blood cell dyscrasia.
• Leflunomide/ciclosporin – increased risk of blood cell dyscrasias but still sometimes used when enhanced clinical effect required.
• Cisplatin – increased pulmonary toxicity.
• Antibiotics – unpredictable effect on methotrexate levels and we generally advise that if an antibiotic course is going to be over 1 week in duration then methotrexate is temporarily withheld.

• Please see responsibilities of acute care service which outlines the information given to the patient.
• FBC, U&Es, LFTs within 3 months and CXR within 6 months of initiation.
• PFTs are currently done in the majority of patients near the beginning of therapy where practical but treatment should not wait until the results being available unless this is stated in letter from specialist care. We are looking for a TLCO >70% to initiate methotrexate.

1. To organise baseline investigations including CXR, bloods and if appropriate PFTs with documentation of CXR and blood results in notes. PFTs will not be reported other than in SCI store. Consultant will act on results of abnormal baseline investigations including PFTs.
2. To clearly detail starting dose and any planned increments in dose to primary care with recommendation on monitoring.
3. To provide patient with patient information leaflet relevant to DMARDs being commenced and to discuss with patient requirement for blood monitoring and side effects.
4. To provide GP with GP information leaflet on DMARDs being prescribed by both electronic letter to GP either via letter handed to patient or by printed letter, ideally within 14 days of clinic appointment.
5. To provide details on frequency of monitoring covering the first year, then can be at discretion of primary care team according to protocol.
6. To provide advice to primary care on abnormalities in monitoring bloods or clinical side effects.
7. To provide the first prescription of subcutaneous methotrexate for administration by specialist nurse.
8. To provide all purple topped sharps bin to patients, and receive full bins from patients.

1. Training of patient in the administration of methotrexate by the subcutaneous route and supervision of first injection. If not practical then this has to be negotiated with nurse closer to home location and deviation from protocol documented in case notes.
2. Education of patient on importance of monitoring.
3. To explain risks of varicella in non-immune individuals and if uncertainty to organise baseline varicella serology.
4. To provide advice to primary care on abnormalities in monitoring bloods or clinical side effects including appropriate referral back to consultant when it is likely to involve a significant long term change in treatment plan.
5. Training of patient to deal with spillage and disposal of injections.

1. To monitor and prescribe (after first injection) in collaboration with the specialist according to this protocol. Prescriptions should normally be for 12 weeks duration, dispensed monthly.
2. To ensure that the monitoring is kept up to date and consider withdrawing treatment if patient doesn’t comply with monitoring requirements.
3. Symptoms or results are appropriately actioned, recorded and communicated to acute care when necessary and where there is suspension of treatment (except where methotrexate being withheld for temporary antibiotic course).
4. Provision of pneumococcal and influenza vaccination.
5. Avoiding co-prescription of interacting drugs except leflunomide, ciclosporin where advised by secondary care.
6. To follow guidance on exposure to varicella in non-immune individuals – http://intranet.nhsh.scot.nhs.uk/Org/DHS/SSU/MedicalDir/Rheumatology/Documents/Chickenpox%20exposure.pdf.

1. To report adverse effects to their GP or specialist.
2. To attend for GP visits and blood monitoring visits.
3. To attend hospital appointments for specialist review.Failure of the patient to attend hospital or GP visits will result in medication being stopped.

Specialist Rheumatology Nurse (South of Dingwall area) 01463 704019.

Specialist Rheumatology Nurse (North of Dingwall area) 01349 868791.