Subcutaneous methotrexate: Shared care protocol (Formularies)

Cautions 

• Renal impairment (reduce dose to 50% if eGFR stable at 30 to 59mL/min and avoid if<30mL/min
• Hepatic impairment 
• Patients with third distribution space (eg pleural effusion, ascites) 

Contraindications

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 
• Pregnancy and breast feeding - adequate contraception should be used by females during treatment and for at least 3 months after discontinuation.  There is no need to stop treatment in males prior to conception.  
• Concurrent vaccination with live vaccines - see the Rheumatology home page on the intranet (vaccinations in the immunocompromised person) 
• Severe renal insufficiency (eGFR<30mL/min) 

Typical dosage regimen

• Please see responsibilities of secondary care service, which outlines the information given to the patient.
• FBC, U&Es, LFTs within 3 months of initiation.
• PFTs and CXR are not done routinely, but might be requested by the team in the presence of respiratory symptoms and/or pre-existing respiratory disease (eg COPD, ILD, etc)

• See resources for DMARD monitoring guideline. 

Responsibilities of secondary care (Consultant)

• To organise baseline investigations (bloods and, if appropriate, PFTs  and CXR). Consultant will act on results of abnormal baseline investigations, including PFTs.
• To clearly detail starting dose and any planned increments in dose to primary care with recommendation on monitoring.
• To provide patient with patient information leaflet relevant to DMARDs being commenced and to discuss with patient requirement for blood monitoring and side effects.
• 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.
• To provide details on frequency of monitoring covering the first year, then can be at discretion of primary care team according to protocol.
• To provide advice to primary care on abnormalities in monitoring bloods or clinical side effects.
• To provide the first prescription of subcutaneous methotrexate for administration by specialist nurse.
• To provide all purple topped sharps bins to patients, and receive full bins from patients.

Responsibilities of Secondary Care (Specialist Nurse)

• 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.
• Education of patient on importance of monitoring.
• To explain risks of varicella in non-immune individuals and if uncertainty to organise baseline varicella serology.
• 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.
• Training of patient to deal with spillage and disposal of injections.

Responsibilities of primary care (General Practitioner) 

• 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.
• To ensure that the monitoring is kept up to date and consider withdrawing treatment if patient doesn’t comply with monitoring requirements.
• 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).
• Provision of pneumococcal and influenza vaccination.
• Avoiding co-prescription of interacting drugs, except leflunomide, ciclosporin, where advised by secondary care.
• To follow guidance on exposure to varicella in non-immune individuals (see resources)
• GP queries should be submitted to duty rheumatologist via clinical dialogue

Responsibilities of patient 

• To report adverse effects to their GP or specialist.
• To attend for GP visits and blood monitoring visits.
• 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: 01463 704019.

GP queries should be submitted to duty rheumatologist via clinical dialogue.