Shared Care Guideline: Prescribing Agreement Section A: To be completed by the hospital consultant initiating the treatment GP Practice Details: Name: Address: Tel no: Fax no: NHS.net e-mail: Consultant name: Clinic name:. Contact details: Patient Details: Name: Address: DOB: / / Hospital number: NHS number (10 digits): Address:... Tel no: Fax no: NHS.net e-mail: Diagnosis: Drug name & dose to be prescribed by GP:. Next hospital appointment: / /.. Dear Dr..., Your patient was seen on../.. / and I have started.(insert drug name and dose) for the above diagnosis. I am requesting your agreement to sharing the care of this patient from../../.. in accordance with the (attached) Shared Care Prescribing Guideline (approval date:././..). Please take particular note of Section 2 where the areas of responsibilities for the consultant, GP and patient for this shared care arrangement are detailed. Patient information has been given outlining potential aims and side effects of this treatment and * supplied (* insert any support materials issued such as patient held monitoring book etc where applicable). The patient has given me consent to treatment possibly under a shared care prescribing agreement (with your agreement) and has agreed to comply with instructions and follow up requirements. The following investigations have been performed on / / and are acceptable for shared care. Please monitor...every.. Test Result Test Result. Other relevant information:.... Section B: To be completed by the GP and returned to the hospital consultant as detailed in Section A above Please sign and return your agreement to shared care within 14 days of receiving this request Tick which applies: I accept sharing care as per shared care prescribing guideline and above instructions I would like further information. Please contact me on:. I am not willing to undertake shared care for this patient for the following reason:. GP name:.. GP signature: Date: / /..
Shared Care Guidelines for the prescribing and monitoring of Azathioprine and 6- Mercaptopurine in adults for inflammatory bowel disease (unlicensed) and Azathioprine for Rheumatoid Arthritis (licensed) NOTES to the GP The expectation is that these guidelines should provide sufficient information to enable GPs to be confident to take clinical and legal responsibility for prescribing this drug. The questions below will help you confirm this: Is the patient s condition predictable or stable? 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. If the answer is NO to any of these questions, you should not accept prescribing responsibility. You should write to the consultant 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, which 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. It would not normally be expected that a GP would decline to share prescribing on the basis of cost. The patient s best interests are always paramount Date Prepared: August 2012 Approved on behalf of Croydon CCG by; Croydon Prescribing committee Date approved; 4 th January 2013 Review date; January 2015 Prepared by; Helen McGowan, Senior Pharmacist, CHS Dr Mendall, Consultant Gastroenterologist This box should be used to confirm that shared care has been agreed between the consultant and GP. And faxed to the choice support team on fax number 0208 2746184 Patient Name; Drug Name; Patient ID / DOB; Indication; Consultant Name; Consultant Signature; GP Name; GP Signature;
1. CIRCUMSTANCES WHERE SHARED CARE IS APPROPRIATE; Prescribing responsibility will only be transferred when the consultant and the GP are in agreement that the patient s condition is stable or predictable. Patients will only be referred to the GP once the GP has agreed in each individual case and the hospital will continue to provide prescriptions and blood monitoring until successful transfer of responsibilities as outlined below. The hospital will provide the patient with a minimum initial supply of 8 weeks therapy. 2. AREAS OF RESPONSIBILITY Consultant Pre-treatment checks:- Consider possible drug interactions with current medication. Conduct baseline tests; FBC, LFTs, U&Es, TPMT. Patient education:- Discuss benefits vs risks with the patient and explain the need for long term monitoring. Provide adequate verbal and written information for patients and relatives on the disease, treatment and side effects obtain written consent. Include contact number if patient experiences adverse effects or feels unwell. Issue / explain Patient held medicines monitoring record booklet. Record baseline blood tests in the booklet. Educate patient on the increased risk of bleeding and what action to take. Discuss pregnancy with the patient and advise on contraception. Inform and document that patient is aware of unlicensed indication. Starting of treatment:- Issue hospital prescriptions until patient is stabilised and shared care agreed, (Prescriptions to be issued in 4 week amounts with a minimum of 8 weeks.) Communicate test results to GP Subsequently:- Provide monitoring until the GP has agreed to participate in shared care. Report adverse events to the CSM and GP. Shared care:- Send completed shared care protocol to GP and ask GP to continue prescribing and monitor blood results. Inform GP of baseline test results and next review date Advise the GP of any dosage adjustments required, when to refer back and when and how to stop treatment. The specialist will assess and monitor the patient s response to treatment. GP Shared Care Notify hospital within 14 days, once GP has been asked to take on prescribing, if not willing to prescribe Azathioprine / 6-Mercaptopurine under shared care. Save copy of signed shared care guideline in patient s records. Return/fax back GP signed copy of shared care to hospital and choice team for record. Continue to prescribe and monitor Azathioprine / 6-Mercaptopurine in line with hospital recommendation, (see page 4 monitoring requirements.) Record indication, dosing information, monitoring requirements, blood tests on practice computer system. Extract relevant information from letters if necessary. Record blood tests in the Patient held Medicines Monitoring record booklet and practice computer system. Check patient dose record book prior to issuing each prescription Inform patient of monitoring schedule and repeat prescribing arrangements Refer to guidelines if results are not within the normal range, or if there is an adverse effect and take the appropriate action given. Monitor for drug interactions see under clinical information. Adjust dose/ stop treatment as advised by specialist. Monitor the patient s overall health status. Report adverse events to the specialist and CSM. Ensure patients on Azathioprine / 6- Mercaptopurine are given priority GP appointments if they have symptoms of sore throat/sore mouth, cough, breathlessness, bruising, bleeding etc. Ensure practice staff are aware of this.
3. CLINICAL INFORMATION Indication 1. Treatment of inflammatory bowel disease, including ulcerative colitis and crohn s disease. (Unlicensed indication CPC has approved the use of these drugs for these unlicensed indication) 2. Treatment of rheumatoid arthritis. Place in Therapy As above Therapeutic summary 6-Mercaptopurine is a metabolite of Azathioprine. It is an antimetabolite agent. Its precise mechanism of action is unknown. Dose and route of Azathioprine (for inflammatory bowel disease): administration PO route; Adult over 18 years, 2-2.5mg/kg daily. Azathioprine (for rheumatoid arthritis): PO route; Adult over 18 years,1-3mg/kg daily Summary of adverse effects (See summary of product characteristics (SPC) for full list) Very common: 1/10 Common: 1/100 and <1/10 Uncommon: 1/1000 and <1/100 : >1/10,000 and <1/1000 Very rare: <1/10,000 Monitoring requirements 6-Mercaptopurine (for inflammatory bowel disease only:) PO route; Adult over 18 years, 1-1.5mg/kg daily. Adverse Effect Frequency Depression of bone marrow function; leucopenia Very Common Thrombocytopenia Common Anaemia Uncommon Agranulocytosis, pancytopenia, aplastic anaemia, megaloblastic anaemia, erythriod hypoplasia Pancreatitis Severe diarrhoea in IBD population Cholestasis and degeneration of liver functions Uncommon Viral, fungal and bacterial infections Uncommon Reversible pneumonitis Very rare Alopecia, photosensitivity Hypersensitivity reaction Uncommon Steven s Johnson s syndrome and toxic Very rare epidermal necrolysis. Baseline tests will be performed by the specialist and prescriptions will be issued at 4 week intervals until patient is stabilised and GP agrees shared care. Prescribing and monitoring responsibilities are retained by the hospital until shared care is accepted. Monitoring to be performed by GP once shared care accepted. Monitoring requirements; Test FBC & LFTs Urea, Creatinine and egfr TPMT Varicella statue Frequency At initiation, twice weekly for 8 weeks, then monthly for 4 months, then 3 monthly if stable. At initiation then 3 monthly At initiation At initiation
Summary of Management of Adverse Effects Clinically relevant drug interactions Croydon Health Services NHS Trust Blood Test Results Lymphocytes <0.5 x 10 9 /L Neutrophils < 2.0 x 10 9 /L < 1.5 x 10 9 /L Platelets Action Discuss with specialist hospital nurse / clinician. Discuss with specialist hospital nurse / clinician Stop and discuss with specialist hospital nurse / clinician < 150 x 10 9 /L Discuss with specialist hospital nurse / clinician Liver function tests >2 fold rise in AST, ALT Discuss with specialist hospital nurse / clinician (from upper limit of reference range) > 4 fold rise in AST, ALT Stop 6-mercaptopurine / Azathioprine and discuss with specialist hospital nurse / clinician immediately. Symptoms Action Rash (significant new) Stop 6-mercaptopurine / Azathioprine and check FBC. If FBC abnormal contact specialist nurse or clinician. Wait until rash resolved and consider restarting at reduced dose, providing no blood dyscrasias. Severe or persistent Stop 6-mercaptopurine /Azathioprine, check FBC infections, fever, chills. and contact specialist nurse or clinician. Do not Persistent sore throat restart until results of FBC known. For sore throat throats, take FBC and discuss with Abnormal bruising or bleeding Varicella Nausea hospital specialist. Stop 6-mercaptopurine/ Azathioprine until recovery and check FBC. Do not restart if blood test abnormal, contact specialist nurse or clinician. If in contact with the virus, contact hospital specialist nurse or clinician. Advise patient to divide dosage and take with food. If no improvement, reduce dosage or stop and contact specialist nurse or clinician if reducing dose is ineffective Allopurinol; Enhanced effect and increased toxicity of Azathioprine /6- Mercaptopurine when given with Allopurinol (Reduce the dose of Azathioprine / 6- Mercaptopurine to one quarter of usual dose.) Coumarins including Warfarin; Azathioprine / 6-Mercaptopurine possibly reduces the anticoagulant effect. Ribavirin; Myelosuppressive effects of Azathioprine possibly enhanced. Febuxostat; Avoidance of Azathioprine / 6-Mercaptopurine advised by the manufacturer. Co-trimoxazole / Trimethoprim; Increased risk of haematological toxicity when given together with Azathioprine /6-Mercaptopurine. This has been seen in transplant patients. Other evidence suggests the drugs may be used safely together and the combination is used frequently in practice. Infliximab; May increase levels of Azathioprine / 6-Mercaptopurine.
References Summary of Product Characteristics Imuran Tablets 25mg. http://www.medicines.org.uk/emc/medicine/2881/spc/imuran+tablets+25mg/#pharma CODYNAMIC_PROPS Accessed on 30/7/12. British National Formulary 63. March 2012. Stockleys Drug Interactions. Accessed via www.medicinescomplete.com on 30/7/12. NPSA RRR001 Risks of incorrect dosing of anticancer medicines 22/1/08. Accessed via http://www.nrls.npsa.nhs.uk/resources/type/alerts/?entryid45=59880&p=3 on 24/10/12. 4. COMMUNICATION AND SUPPORT Hospital contacts (the referral letter will indicate named consultant): Croydon University Hospital Tel: 020 401 3000 Gastroenterology Dr Mike Mendall; via 3101 Dr Sanjay Gupta; via 3101 IBD Nurse;4484 Rheumatology Dr Natalie Horwood; via 3010 Dr Sarah Levy; via 3010 Dr Rosh Sathanathan; via 3010 Pharmacy Medicines information:3059 Out of hours contacts and procedure; Medical Registrar on call