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Royal Wolverhampton NHS Trust Wolverhampton City Clinical Commissioning Group Wolverhampton Shared Care Agreement Black Country Cluster Sulfasalazine EC (Salazopyrin®) - hospital monitored ESCA: For the treatment of rheumatological conditions in adults 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 695736 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. Rheumatology Nurse Helpline 01902 695491 Rheumatology Secretaries 01902 695492 01902 695495 Hospital Pharmacy Department Mrs S. Reed 01902 695136 Email address: [email protected] This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for Sulfasalazine (Salazopyrin) Date approved: September 2012 Expiry date: 31/12/2017 Royal Wolverhampton NHS Trust Wolverhampton City Clinical Commissioning Group Wolverhampton Shared Care Agreement Black Country Cluster Sulfasalazine EC (Salazopyrin®) - hospital monitored ESCA: For the treatment of rheumatological conditions in adults 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 *** disease can be shared between the specialist and general practitioner (GP). GPs are invited to participate. If GPs are not confident to undertake these roles, then they are 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 1. 2. 3. 4. 5. 6. 7. 8. 9. 1. 2. 3. 4. 5. 6. 7. 1. 2. 3. 4. Specialist responsibilities Discuss the benefits and side effects of treatment with the patient. Dose stabilisation: initial dosage adjustment until stable. Thereafter, during maintenance treatment, advice to the GP on any further dose adjustments required. 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. Monitor liver function tests and blood count (including differential white cell count) every month for three months. If dose and bloods are stable for 3 months, then this is done every 3 months. If the dose increases, then repeat bloods 1 month after dose increase, if stable revert to usual monitoring. These will be checked regularly at outpatient visits. Communicate promptly with the GP when treatment is changed. Have a mechanism in place to receive rapid referral of a patient from the GP in the event of deteriorating clinical condition. Advise the GP on stopping treatment (if appropriate). Report serious adverse events to the MHRA. 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 sulfasalazine at the dose recommended. Adjust the dose as advised by the specialist. Report to and seek advice from the specialist on any aspect of patient care that is of concern and may affect treatment. Refer patient to the specialist if his or her condition deteriorates. Stop treatment on the advice of the specialist or immediately if an urgent need to stop treatment arises. 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 sulfasalazine. Report immediately if he or she develops sore throat, fever, malaise, pallor, purpura, jaundice which may indicate myelosuppression, haemolysis or Hepatotoxicity. Report any other adverse effects to the specialist or GP whilst taking sulfasalazine. This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for Sulfasalazine (Salazopyrin) Date approved: September 2012 Expiry date: 31/12/2017 Royal Wolverhampton NHS Trust Wolverhampton City Clinical Commissioning Group Wolverhampton Shared Care Agreement Black Country Cluster Sulfasalazine EC (Salazopyrin®) - hospital monitored ESCA: For the treatment of rheumatological conditions in adults SUPPORTING CLINICAL INFORMATION Indications Treatment of rheumatoid arthritis which has failed to respond to non-steroidal anti-inflammatory drugs (NSAIDs). Dosage and Administration Treatment of rheumatoid arthritis – starting dose is 500mg daily, increased by one tablet each week until a maximum dose of 4 to 6g is reached. Adequate fluid intake should be ensured during treatment as sulfasalazine causes crystalluria and kidney stone formation. Contraindications Infant under the age of 2 years. Patients with a known hypersensitivity to sulfasalazine, its metabolites or any of the excipients as well as sulfonamides or salicyclates. Patients with porphyria. Side Effects The most common side effects with sulfasalazine are nausea, headache, rash, loss of appetite and raised temperature. Blood disorders such as leucopenia, thrombocytopenia, agranulocytosis, aplastic anaemia, haemolytic anaemia, Heinz body anaemia, hypoprothrombinaemia, lymphadenopathy, macrocytosis, megaloblastic anaemia, methaemoglobinaemina, neutropenia and pancytopenia have been reported. Insomnia, depression, dizziness, taste disorders, tinnitus, conjunctival and scleral infection. Cough, stomatitis, pruritis, arthralgia, fever have also been commonly reported Hepatic failure and hepatitis may occur. Monitoring Full blood count (including differential white cell), renal function and liver function tests should be monitored regularly and drug discontinued if patient develops signs or symptoms of myelosuppression, haemolysis or Hepatotoxicity. Drug Interactions Bone marrow suppression may occur when mercaptopurine or its prodrug azathioprine are used in combination with sulfasalazine. 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 This section may be excluded if this document has been created developed without reference to another organisation’s documentation. 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 This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for Sulfasalazine (Salazopyrin) Date approved: September 2012 Expiry date: 31/12/2017