SULFASALAZINE (Adults)

Transcription

1 Shared Care Guideline DRUG: Introduction: SULFASALAZINE (Adults) Indication: Disease modifying drug for rheumatoid arthritis, psoriatic arthritis, undifferentiated arthritis, spondyloarthropathies, Crohn s disease and ulcerative colitis Formulations: Enteric coated tablets (EN) of 500mg for joint disease. Tablets (non enteric coated) of 500mg for bowel disease. Suppositories of 500mg for rectal disease. Liquid 250mg/5mL (only licensed for Crohn s disease and ulcerative colitis) Prescribing: Only enteric coated tablets should be used for joint disease. Only non enteric coated tablets should be used for bowel disease (suppositories may be prescribed for rectal disease). Pregnant patients require co-prescription of folic acid 5mg daily. Please contact specialist for advice. Dosage & administration: Treatment is started at 500mg-1g twice daily and increased at intervals of 1-2 weeks to a maximum of 40mg/kg daily in divided doses (typically two to three grams daily in divided doses). Contraindications & Warnings: Contra-indicated in hypersensitivity to sulfasalazine, its excipients, sulphonamides or salicylates (slow acetylator status) Contra-indicated in patients with porphyria Caution in patients with severe allergies or bronchial asthma, G-6PD deficiency. Caution in hepatic or renal impairment, blood dyscrasias May cause reversible infertility in men. Ensure adequate hydration. Pregnancy and breast feeding - No evidence of teratogenicity and no evidence of harm caused by breastfeeding a healthy infant. Please consult specialist in cases of pregnancy and breastfeeding. Interactions: Digoxin - co-administration may lead to sub-therapeutic digoxin levels Hypoglycaemic agents - closely monitor patients as hypoglycaemic episodes may be more likely. 6-mercaptopurine or azathioprine - avoid co-administration unless on specialist advice. Name: Sulfasalazine Shared Care Guideline Page 1 of 5

2 For full list see BNF or SPC at Adverse Effects: In general side effects appear within the first 3-6 months of treatment and are considered to be dose related. Most will resolve on reduction of sulfasalazine dose or on cessation of treatment. Common Nausea, headache continue treatment if possible. May consider slowing dose increases in new patients. Dividing doses into a four times daily regimen may help. Raised temperature see GP responsibilities section below Rash - see GP responsibilities section below Orange-yellow colouration of urine and permanent staining of extended wear contact lenses. Less Common Neutropenia, thrombocytopenia see GP responsibilities section below Haemolytic anaemia, aplastic anaemia Kidney stone formation Loss of appetite Responsibilities of the specialist initiating treatment: For full list see SPC at General: As per national, regional and local guidelines, to ensure that the patient/carer has received counselling and understands the therapy, its benefits, limitations, continued monitoring (where applicable), adverse effects, and is aware of actions to take if adverse effects are suspected. Go through patient information leaflet with patient. Inform patients of the long term monitoring requirements and provide a monitoring booklet. Inform the GP of the information provided to the patient Carry out disease and initial drug monitoring as listed below. To review the patient at agreed intervals and copy all relevant results to the GP Formally hand over to GP by letter and patient informed - send a copy (either electronically or paper copy) of the Shared Care Guideline to the GP and ask whether they are willing to participate in shared care. Prescribing: Issue all prescriptions for 8 weeks minimum until patient is safely established on sulfasalazine and specialist team are satisfied that it is appropriate to share care. Disease & drug monitoring: - Monitor bloods according to schedule: FBC LFTs U&Es 2 weekly for first 8 weeks whilst under secondary care then as advised by specialist team (see responsibilities of GPs- monitoring). Name: Sulfasalazine Shared Care Guideline Page 2 of 5

3 Responsibilities of other prescribers (GPs): Discuss shared care arrangement with patient. Support and advise GPs as required. Assess response to treatment and initiate any dose changes as clinically appropriate including discontinuation of treatment. General and Prescribing: To reply to the request for shared care within 2 weeks of receipt of the Consultant letter. Prescribe follow up prescriptions for sulfasalazine - ensure continued prescribing of sulfasalazine remains clinically appropriate at dose advised by initiating team Ensure there are no drug interactions with any other medications initiated in primary care. Disease & drug monitoring: Carry out drug monitoring as listed and communicate abnormal results to the Specialist. Urgent drug discontinuation/ referral to specialist as clinically appropriate To stop treatment on the advice of the specialist. To refer back to the Specialist if the patient s condition deteriorates. Identify adverse effects to sulfasalazine and report these to the Specialist and where appropriate to the Commission on Human Medicines/MHRA (Yellow card scheme). Unless otherwise stated by the secondary care Specialist, apply the following monitoring frequencies following handover from secondary care: FBC LFTs U&Es Monthly for 4 months then every 3 months (unless abnormal blood results) Results should be recorded in such a way that trends can be easily monitored. Discontinue sulfasalazine and seek advice from initiating team if: WCC <3.5 Neutrophils <2.0 Platelets <150 AST or ALT or ALK PHOS >3 times the normal range Mouth or throat ulceration Abnormal bruising or bleeding Fever, rash Responsibilities of the Patient / Carer: Summary: Report any possible side effects to their GP. Ensure they have adequate supply of medication. Attend appointments and take along monitoring book Name: Sulfasalazine Shared Care Guideline Page 3 of 5

4 Communication: Costs: Inform GP urgently if unexpected pregnancy is suspected Disease & drug monitoring: As above contact GP or initiating team if side effects develop (see adverse effects) and attend appointments including those for routine blood tests/investigations Patients should be warned to report any sore throat, malaise, fever or unexpected non-specific illness. Specialist to GP: The specialist will inform the GP when they have initiated sulfasalazine and when there are any subsequent changes in treatment standard clinic letter. Send a copy (either electronically or paper copy) of the Shared Care Guideline to the GP and ask whether they are willing to participate in shared care. Inform the GP of the information provided to the patient GP to Specialist: To reply to the request for shared care within 2 weeks of receipt of the Consultant letter. Irrespective of whether you accept prescribing responsibility or not, you should inform the consultant of relevant medical information regarding the patient and changes to the patient s medication regime irrespective of indication. Notify Consultant if treatment with sulfasalazine is discontinued. Contact names & details: If you have any concerns regarding individual patients, see consultant letter for medical contact details or contact one of the following: Name Title/Location Telephone / Bleep / Rheumatology advice line Rheumatology secretaries Gastroenterology Scarborough Dr Isdale Drs Brown and Green Drs Quinn and Saleem IBD Specialist Nurse Drs Robins and Kelly Drs Turnbull and Turvill Drs Smale and Millson Prof J Macfie Miss C McNaught Dr Z S S Al-Saffar Drug Tariff Jan 2013 (1 month supply 1g bd) Sulfasalazine 500mg x 112 = 7.83 Sulfasalazine e/c 500mg x 112 = Sulfasalazine liquid 250mg/5ml 1120ml = (500ml = 36.00) Name: Sulfasalazine Shared Care Guideline Page 4 of 5

5 References: Yorkshire Regional Guidelines on the Monitoring of Adult Patients on Disease Modifying Drugs (DMARDS) Including Biologic Therapies. 5 th Edition. March 2009 BNF 63 Salazopyrin SPC accessed on 31 st May 2012 Document Control: This information is not inclusive of all prescribing information and potential adverse effects. Please refer to the SPC (data sheet) or BNF for further prescribing information. The original Microsoft Word file of this document is located on: York Teaching Hospital NHS Foundation Trust Pharmacy Department X:\MEDICINES INFORMATION\Shared Care Guidelines\Approved Shared Care Guidelines\ISULFASALAZINE Shared Care Guideline V1.0 Shared Care Guidelines are also available electronically via Prepared by: Checked by: Version: Vikki Furneaux Date of Issue / Review: June 2013 Date for next Review: June 2015 Jane Crewe / Stuart Parkes Clair Ranns (Pharmacist NY and Humber Commissioning Support Unit) 1.1 (Updated August 2013 to include new x drive location) Approved by: Drug & Therapeutics Committee June 2013 Name: Sulfasalazine Shared Care Guideline Page 5 of 5