WORKING IN PARTNERSHIP WITH EFFECTIVE SHARED CARE AGREEMENT (ESCA) DRUG NAME: SULFASALAZINE TABLETS INDICATION/S COVERED Chronic inflammatory conditions in adults as determined by the appropriate hospital specialist NHS West Sussex/NHS Brighton and Hove Traffic Light system classification: Amber N.B. The eligibility criteria included here apply to new patients commencing treatment under this agreement and not to existing patients whose treatment was initiated under the previous version. However, monitoring and discontinuation criteria apply to all patients. NOTES to the primary care prescriber Amber drugs: Prescribing to be initiated by a consultant / specialist but with the potential to transfer to primary care. The expectation is that these guidelines should provide sufficient information to enable primary care prescribers to be confident to take clinical and legal responsibility for prescribing these drugs. The questions below will help you confirm this: Is the patient currently under your care? (e.g. Shared care should not be agreed if the patient is currently in intermediate care following hospital discharge.) 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 effective shared care agreement? Have you been provided with relevant clinical details including monitoring data? If you can answer YES to all these questions (after reading this ESCA), then it is appropriate for you to accept prescribing responsibility. Sign and return a copy of the final page to the requesting consultant / specialist. Until the requesting consultant / specialist has received a signed copy of the final page indicating that shared care has been agreed all care (including prescribing) remains with the consultant / specialist. If the answer is NO to any of these questions, you should not accept prescribing responsibility. You should write to the consultant / specialist within 14 days, 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 primary care prescriber 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 Valid from: 1st August 2011 Version: 1 Review date: 1st August 2013 Supersedes version: N/A Prepared by: Dr Kelsey M Jordan/Dr Stewart Glaspole Updated by: Approved by (Specialist/consultant): Dr Kelsey M Jordan Approved by (Chief Trust pharmacist): Jatinder Harchowal Approved by (PCT pharmacist(s)): Katy Jackson Clare Andrews Approved by NW Sussex Area Prescribing Committee on: 14th September 2011 Approved by NHS Brighton and Hove Medicines Management Committee on:23 rd August 2011 Information This information sheet does not replace the Summary of Product Characteristics (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. 1. Link to the relevant SPC website: http://www.medicines.org.uk/EMC/medicine/10722/SPC/Salazopyrin+En-Tabs/#INDICATIONS 2. Background to use for the indication/s, including licence status Sulfasalazine is used as a disease modifying agent to induce and maintain remission in several types of rheumatic & gastrointestinal inflammatory diseases. It can reduce inflammation and affect the immune system and is therefore used for a number of other conditions. Sulfasalzine has marketing authorisation for use in ulcerative colitis, Crohn’s disease and rheumatoid arthritis. 3. Dose & administration 500 mg/day orally increasing by 500mg weekly to 2.0–3.0 g/day. Occasionally doses above 3.0 g/day are prescribed 4. Cautions (including for pregnancy & lactation where relevant) Glucose-6-phosphate dehydrogenase deficiency (G6PD): May cause haemolysis. Seek specialist advice. Renal impairment (GFR 10-20ml/min): May cause significant crystalluria and must ensure high fluid intake. In case of severe renal failure (GFR <10ml/min) do not use. Slow–acetylators of the drug: May cause drug-induced lupus-like syndrome. It is not necessary to assess acetylator phenotype. Pregnancy and Lactation There are NO contra-indications to use in pregnancy or lactation Doses 2g/day are recommended Folic acid should be prescribed to those wanting to conceive and throughout the pregnancy, particularly those with G6PD deficiency 5. Contraindications Sulfasalazine is contra-indicated in those who are hypersensitive to sulphonamides / co-trimoxazole and aspirin / NSAIDs 6. Side effects Include nausea, diarrhoea, dizziness, headaches and rashes. Body fluids may turn orange/yellow with discolouration of contact lenses Uncommonly, leucopoenia, anaemia, liver function disturbance, hypersensitivity reactions & oligospermia 7. Interactions Combination therapy with azathioprine may contribute to bone marrow toxicity. Cardiac glycosides – possibly reduces the absorption of digoxin. Prescribers are advised to check the BNF or ask a pharmacist for advice where required. 8. Criteria for use Chronic inflammatory conditions unresponsive to first line therapy as determined by the appropriate hospital specialist. 9. Any further information (e.g. supporting therapies) N/A 10. References N/A 2 RESPONSIBILITIES and ROLES Consultant / Specialist responsibilities 1 2 3 4 5 6 7 8 Identify patients requiring sulfasalazine and counsel patients appropriately Undertake pre-treatment blood tests (FBC, U&E, LFT) Adjust dose during initial monitoring period Monitor according to speciality guidelines during first 3 months and until stable Provide patient with hand-held information on sulfasalazine including a monitoring booklet and explain to the patient / carer their roles Review efficacy of treatment at regular intervals and ensure drug treatment changes are communicated to the patient and GP. This would include a yearly review in stable patients. Report any adverse events to the CSM and GP Explain to the patient / carer their roles Primary care prescriber responsibilities 1 2 3 4 5 6 7 8 Return a signed copy of the shared care invitation to the hospital team Subsequent prescribing of sulfasalazine 500mg tablets at the dose recommended. Monitoring of FBC, LFT & Creatinine 3 monthly for one year. If stable, reduce monitoring to each 6-12 months Prescribe any change in sulfasalazine dose as advised by the hospital team Monitor for adverse effects throughout treatment and check for drug interaction on initiating new treatments Record results, when possible, in a patient held record book Report adverse events to the CSM and hospital team Ensure that if care of the patient is transferred to another prescriber that the new prescriber is made aware of the ESCA. 1 2 3 4 5 6 7 Monitor FBC, LFT and Creatinine 3 monthly for one year. If stable reduce to 6-12 monthly monitoring WBC < 3x109/L and/or Neutrophil < 1.5x109/L : Withhold and discuss with hospital team ALT / AST > 2.5 X upper limit of normal: Withhold and discuss with hospital team Sore throat, significant oral ulceration, significant bruising: Check FBC and withhold until FBC result available New or increasing dyspnoea or cough: Assess chest and withhold treatment until discussed with hospital team Significant deterioration in renal function: Reduce dose (discuss with hospital team) If urinary dipstick is 2+ send an MSU. If infection, treat appropriately. If sterile proteinuria seek advice Monitoring requirements and appropriate dose adjustments (if relevant to specific drug) 1 2 3 4 5 Patient's / Carer’s role Ask the consultant / specialist or primary care prescriber for information, if any aspects of treatment are not fully understood Share any concerns in relation to treatment with sulfasalazine Tell the consultant / specialist or primary care prescriber of any other medication being taken, including overthe-counter products. Read the patient information leaflet included with the medication and report any side effects or concerns to the consultant / specialist or primary care prescriber. Bring any hand held shared care monitoring booklet to consultant/specialist and GP appointments BACK-UP ADVICE AND SUPPORT Name / position Telephone Specialist / Consultant: Alternative specialist (e.g. departmental contact or Shared care co-ordinator): Hospital Pharmacy: Out of hours (e.g. medical team on call): 3 Email EFFECTIVE SHARED CARE AGREEMENT (ESCA) DRUG NAME: SULFASALAZINE TABLETS INDICATION: Agreement for transfer of prescribing to PRIMARY CARE PRESCRIBER Patient details: Name: Address: DoB: NHS No: Hospital No: Drug name and strength: The following tests and investigations have been carried out: Date treatment initiated: At the last patient review the drug appeared to be effectively controlling symptoms / providing benefit: Yes/No The patients has now been stabilised on a dose of: I will arrange to review this patient regularly. Date of next clinic appointment: Consultant/specialist: Agreement to shared care, to be signed by primary care prescriber and consultant/specialist. Address: Consultant/specialist signature: Contact Number: Date: Primary care prescriber: Primary care prescriber signature: Address: Contact Number: Date: Main Carer: If shared care is agreed and the primary care prescriber has signed above please return a copy of this page to the requesting consultant/specialist or alternatively fax to: (please insert appropriate fax number). Contact Number: Key worker if appropriate: Contact Number: 4