WORKING IN PARTNERSHIP East Surrey CCG, Guildford & Waverley CCG, North West Surrey CCG, Surrey Downs CCG, Surrey Heath CCG, North East Hampshire & Farnham CCG, Crawley CCG, Horsham & Mid-Sussex CCG SHARED CARE PRESCRIBING GUIDELINE Sulfasalazine for Rheumatoid Arthritis Surrey Prescribing Clinical Network classification: Amber N.B. The eligibility criteria included here apply to new patients commencing treatment under this guideline & not to existing patients whose treatment was initiated under the previous version. However, monitoring and discontinuation criteria apply to all patients. NOTES to the GP Amber drugs: Prescribing to be initiated by a hospital specialist (or if appropriate by a GP with specialist interest) but with the potential to transfer to primary care. The expectation is that these guidelines should provide sufficient information to enable GPs to be confident to take clinical and legal responsibility for prescribing these drugs. The questions below will help you confirm this: Is the patient s condition predictable? Do you have the relevant knowledge, skills and access to equipment to allow you to monitor treatment as indicated in this shared care prescribing guideline? Have you been provided with relevant clinical details including monitoring data? If you can answer YES to all these questions (after reading this shared care guideline), then it is appropriate for you to accept prescribing responsibility. Sign and return a copy of page 4 to the requesting consultant at the Acute Trust. Until the requesting consultant at the Acute Trust has received a signed copy of page 4 indicating that shared care has been agreed all care (including prescribing) remains with the consultant at the Acute Trust. If the answer is NO to any of these questions, you should not accept prescribing responsibility. You should write to the consultant outlining your reasons for NOT prescribing. If you do not have the confidence to prescribe, we suggest you discuss this with your local Trust/specialist service, who will be willing to provide training and support. If you still lack the confidence to accept clinical responsibility, you still have the right to decline. Your PCT pharmacist will assist you in making decisions about shared care. Prescribing unlicensed medicines or medicines outside the recommendations of their marketing authorisation alters (and probably increases) the prescriber s professional responsibility and potential liability. The prescriber should be able to justify and feel competent in using such medicines. The patient s best interests are always paramount The GP has the right to refuse to agree to shared care, in such an event the total clinical responsibility will remain with the consultant Reason for Update: New Prepared by: Valid from: July 2012 Review date: July 2014 Approved by: Version: 0.1 Supersedes version: Approved by:
This information sheet does not replace the SPC, which should be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in the current edition of the BNF. Link to the relevant SPC website: http://www.emc.medicines.org.uk Background Sulfasalazine is a disease modifying antirheumatic drug used in the treatment of rheumatoid arthritis Dosage The dose of sulfasalazine should be increased slowly: WEEK 1 500mg each morning WEEK 2 500mg morning and evening WEEK 3 1g each morning and 500mg each evening WEEK 4 1g morning and evening Thereafter continue with 1g BD. Occasionally doses up to 3g/day may be prescribed. It may be between 6-12 weeks before a marked effect is seen. Drug Interactions Reduced absorption of digoxin Hypoglycemia has occurred in patients receiving sulfonamides. Patients receiving sulfasalazine and hypoglycemic agents should be closely monitored Azathioprine bone marrow suppression and leucopenia have been reported when used with sulfasalazine Adverse Effects About 75% of ADRs occur within 3 months of starting therapy, and over 90% by 6 months. Some undesirable effects are dose-dependent and symptoms can often be alleviated by reduction of the dose. The most commonly encountered ADRs are nausea headache rash loss of appetite raised temperature Others adverse effects are blood disorders, cough, sore throat, insomnia, proteinuria, tinnitus, stomatitis and pruritus refer to the Summary of Product Characteristics or BNF for further guidance Note sulfasalazine can cause a yellow/brown discolouration of urine and contact lenses. 2
Table 1. Side effects and actions to take for abnormal results SIDE EFFECT WBC < 3.5 X 10^9/l Neutrophils < 2.0 X 10^9/l Platelets < 150 X10^9/l Liver function > 2.0 fold rise in AST/ALT MCV >105fl Acute widespread skin rash Oral ulceration Nausea, vomiting, dizziness headache Diarrhoea Bruising, sore throat, unexplained bleeding ACTIONS Withhold, and repeat WBC. If abnormal discuss with rheumatologist. Withhold and look for alternative causes. Repeat LFT s. If abnormal discuss with rheumatologist Check folate, TFT, B12 and treat if appropriate. If WCC normal repeat in 4 weeks. Withhold and seek urgent (preferable dermatological) advice Withhold, urgent FBC, investigate alternative cause. If settles promptly re-challenge with a lower dose. If symptoms recur stop and contact rheumatologist. Often transient. If possible continue with use of anti - emetic or reduce dose by 500mg Reduce dose by 500mg. If persistent, consult rheumatologist. Withhold and check FBC urgently Please note that in addition to absolute values. A rapid fall/rise or consistent downward/upward trend in haematological or biochemical index should prompt caution and extra vigilance Contraindications and cautions Contraindicated in patients with a known hypersensitivity to sulfasalazine, its metabolites or any of the excipients as well as sulfonamides or salicylates. Contraindicated in patients with porphyria Patients with impaired hepatic or renal function or with blood dyscrasias, unless the potential benefit outweighs the risk. Caution in patients with severe allergy or bronchial asthma Caution in patients with G-6-PD deficiency as can cause haemolytic anaemia Folic acid deficiency as sulfasalazine inhibits the absorption and metabolism potentially resulting in serious blood disorders (e.g., macrocytosis and pancytopenia) Oligospermia and infertility may occur in men treated with sulfasalazine. Discontinuation of the drug appears to reverse these effects within 2 to 3 months Coadministration of oral sulfasalazine and methotrexate to rheumatoid arthritis patients can cause an increased incidence of gastrointestinal adverse events, especially nausea Ensure adequate fluid intake as sulfasalazine can cause crystalluria and kidney stone formation Monitoring Requirements Pre-treatment: FBC, U & E s, egfr, LFT s, ESR and CRP and urinanalysis Ongoing: FBC, U&Es, LFTs 3 monthly with CRP 3
RESPONSIBILITIES and ROLES Specialist responsibilities 1. Diagnosis and assessment of suitability of patient for sulfasalazine treatment 2. Discuss the aims, benefits and side effects of treatment with the patient as well as their role 3. Explain to the patient the treatment plan including the dosing schedule up to and including remission. 4. To do baseline pre-treatment assessments and for the first 3 months (at weeks 2, 4, 6, 8 and 12): FBC, U & E s, egfr, LFT s, ESR and CRP and urinanalysis 5. To prescribe sulfasalazine until the dose is stable and a decision has been made to continue (minimum 3 months) 6. Monitor and evaluate response to treatment, including adverse drug reactions, with the patient and to continue / discontinue treatment in line with the agreed treatment plan 7. Monitor patients as detailed in the ongoing monitoring requirements stated on page 3 and prescribe until GP formally agrees to shared care when the patient is considered stable enough 8. Discuss the possibility of shared care with the patient and ensure they understand the plan for their subsequent treatment 9. Supply GP with summary of patient review (including anticipated length of treatment if appropriate) and a copy of the share care guideline recommending that a shared care arrangement is initiated 10. Advise GP if treatment is to discontinue at any point 11. Inform GP if patient does not attend planned follow-up General Practitioner responsibilities 1. Subsequent prescribing of sulfasalazine at the dose recommended. 2. To ensure that sulfasalazine is added to the patient s drug record. 3. To carry out the following monitoring and take the appropriate action, set out in table 1., when necessary : 4. FBC, U&Es, LFTs 3 monthly with CRP. ESR may be used in some cases but it is often elevated in chronic disease so may be less useful. Enquire about the presence of any rash or oral ulceration at each visit FBC should be checked in the presence of any unexplained fever. After any dose changes repeat FBC and LFTs after 1 month 5. Use the dosage regimen documented in this agreement above. 6. Warn patients to report immediately any unexplained bleeding, bruising, purpure, sore throat, fever or malaise and take the actions set out in Table 1. as a result. 7. Patients suffering from chicken pox or active skin lesions in shingles withhold sulfasalazine and inform rheumatologist 8. Pregnancy and breast feeding - analysis of risks and benefits should be undertaken. Doses should not exceed 2g/day. Folic acid supplementation is required if patient trying to conceive and during pregnancy. Small amounts may be excreted in breast milk which is not thought to be a risk to a healthy infant. Refer to rheumatologist if concerned. 9. Monitor patient s overall health and well being 10. Refer patient back to the consultant for review if any concerns. 11. Report adverse effects to the hospital consultant 12. Assist with monitoring the progression of disease Patient s / Carer role and responsibilities 1. Ask the specialist or GP for information, if he or she does not have a clear understanding of the treatment. 2. Share any concerns in relation to treatment with sulfasalazine. 3. Tell the specialist or GP of any other medication being taken, including over-the-counter products. 4. Read the patient information leaflet included with your medication and report any side effects or concerns you have to the consultant or GP 5. To attend appointments and undertake required monitoring. BACK-UP ADVICE AND SUPPORT Contact details Name: Telephone No. Email address: Specialist: Hospital Pharmacy: 4
SHARED CARE PRESCRIBING GUIDELINE Sulfasalazine for the treatment of Rheumatoid Arthritis Agreement for transfer of prescribing to GP Patient details / address: Name.. Address...... DOB. Hospital No. Drug name and dose: Sulfasalazine dosage as outlined in agreement Pretreatment assessments completed at rheumatology clinic Date... I will arrange to review this patient after... Consultant: Address: Contact Number GP: Address: Contact Number Main Carer: Contact Number: Key worker if appropriate: Agreement to shared care, to be signed by GP and Consultant. Consultant Signature:.. Date: GP Signature: Date: If shared care is agreed and GP has signed above please return a copy of this page to the requesting consultant or alternatively fax to: Acute Trust please insert appropriate Fax Number: Contact Number: 5