EFFECTIVE SHARE CARE AGREEMENT

Transcription

1 Specialist details Patient identifier Name: Tel: EFFECTIVE SHARE CARE AGREEMENT For the specialist use of Erythropoietin Stimulating Agent (ESA) Therapy (formerly known as EPO) for the correction of Anaemia in Pre-Dialysis and non-renal patients registered with a Dudley GP. The aim of an Effective Shared Care Agreement (ESCA) is to provide information to General Practitioners (GPs) about complex or high cost therapies that their patients may receive following specialist referral. An ESCA will only be written when it has been agreed that shared care is an appropriate option and will include a statement of Specialist and GP responsibilities in addition to describing the role of the patient. Shared Care Guidelines will ensure that all GPs have sufficient information to enable them to undertake prescribing responsibility for specialist and other therapies. This guidance is not intended to be prescriptive and may be amended according to the individual clinician s view and patient circumstances. It is not the intention to insist that GPs prescribe this therapy and any doctor who does not wish to undertake the clinical and legal responsibility is not so obliged. If the GP decides not to agree on the shared care the GP is advised to inform the specialist in writing. Page 1 of 6

2 For the specialist use of Erythropoietin Stimulating Agent (ESA) Therapy for the correction of Anaemia in Pre-Dialysis and non-renal patients. ESCA: For the specialist use of Erythropoietin Stimulating Agent (ESA) Therapy (formerly known as EPO) for the correction of Anaemia in Pre-Dialysis and nonrenal patients registered with a Dudley GP. AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE This shared care agreement outlines suggested ways in which the responsibilities for managing the correction of anaemia in pre-dialysis (Chronic Kidney Disease) and non-renal patients that can be shared between the specialist (Consultant Nephrologist /Consultant Haematologist) and General Practitioner (GP). GPs are invited and requested to participate. If the GP is not confident to undertake these roles, then he or she is 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 the specialist asks the GP to prescribe this drug, if the GP does not wish to take part in the ESCA, then they 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 is usually explained to the patient by the clinician initiating treatment. It is important that patients are consulted about treatment and are in agreement with it. Patients on ESA should undergo regular follow-up, which provides opportunities to discuss drug therapy. The clinician who prescribes the medication legally assumes clinical responsibility for the drug and the consequences of its use. RESPONSIBILITIES and ROLES Specialist (Consultant Nephrologist /Consultant Haematologist) responsibilities: 1 Diagnosis of anaemia. 2 Assess the patient and confirm treatment with ESA is indicated and necessary. 3 Confirm this is for either pre-dialysis or non-renal indications. If this is for a dialysis patient then this ESCA does not apply as prescribing in this case is commissioned by NHSE. 4 Discuss the potential benefits, side effects of treatment, and possible drug interactions with the patient. 5 Educate patients on all aspects of erythropoietic therapy including administration (or arrange administration in primary care) and storage of product. 6 Initiation of ESA treatment and dose stabilisation: initial dosage adjustment until haemoglobin levels are stable and between 100 and 120 g/litre for adults, young people and children aged 2 years and older, and between 95 and 115g/litre for children younger than 2 years of age, reflecting the lower normal range in that age group. Thereafter, during maintenance treatment, advice to the GP on any further dose adjustments required in response to monitoring 7 Ask the GP whether he or she is willing to participate in shared care. 8 Monitor haemoglobin, iron status, blood pressure and any other parameters considered necessary, or request the GP to take on this responsibility. The specialist and GP should agree the parameters to be monitored and the frequency of monitoring. 9 Review patient periodically in-line with clinical need. 10 Communicate promptly with the GP when treatment is changed (including dosage adjustments), results of the monitoring undertaken, and assessment of adverse events. 11 Have a mechanism in place to receive rapid referral of a patient from the GP in the event of deteriorating clinical condition. 12 Advice to GPs on when to stop treatment (if appropriate). 13 Reporting adverse events via 14 Ensure that clear backup arrangements exist for GPs to obtain advice and support. General Practitioner responsibilities 1 Reply to the request for shared care as soon as practicable. 2 In the patient's notes, using the Read Code 8BM5.00 (shared care prescribing); denote that the patient is receiving treatment under a shared care agreement. 3 Prescribe the ESA at the dose recommended by the Specialist (Consultant Nephrologist/Consultant Haematologist). 4 Adjust the dose as advised by the Specialist (Consultant Nephrologist/Consultant Haematologist). 5 Monitor haemoglobin, iron status, blood pressure and any other parameters considered necessary, if agreed with the Specialist (Consultant Nephrologist/Consultant Haematologist) to do so. 6 If Hb rises above 120g/L then the GP should contact the Specialist to discuss whether a dose reduction and Page 2 of 6

3 further monitoring is required. 7 Report to and seek advice from the Specialist (Consultant Nephrologist/Consultant Haematologist) on any aspect of patient care that is of concern and may affect treatment. 8 Refer patient to the Specialist (Consultant Nephrologist/Consultant Haematologist) if his or her condition deteriorates. 9 Stop treatment on the advice of the Specialist (Consultant Nephrologist/Consultant Haematologist) or immediately if an urgent need to stop treatment arises (e.g. dangerously high blood pressure). 10 Report adverse events to the specialist and via Patient's role (or that of carer) 1 Report to the Specialist(Consultant Nephrologist/Consultant Haematologist) or GP if he or she does not have a clear understanding of the treatment. 2 Share any concerns in relation to treatment with the Specialist or GP. 3 Report any adverse effects to the Specialist or GP. 4 Comply with treatment monitoring as advised by the GP and/or Specialist and attend regular outpatient appointments with the Specialist. BACK-UP ADVICE AND SUPPORT Contact details Telephone No. Bleep: Fax: address: Specialist Renal Unit, Dudley Group of Hospitals (DGH) Hospital Pharmacy Dept: Medicines Information Dept Pharmaceutical Public Health Team Dudleymedman@nhs.net Supporting Information: ESA therapy will be initiated by the specialist in line with NICE NG8 (Chronic Kidney Disease: Managing Anaemia) Killick et al. Guidelines for the diagnosis and management of adult myelodysplastic syndromes British Journal of Haematology, ; See SPC for NeoRecormon range, Eprex range, Aranesp range, MirCera for complete details available at Criteria for patient selection for ESA therapy to follow NICE Guideline NG 8 Chronic Kidney Disease: managing anaemia (3 rd June 2015), and The Renal Association Clinical Practice Guidelines update of the 5 th Edition (June 2017). These are summarised as: Angina or heart failure aggravated by anaemia Haemoglobin concentration <110g/l) secondary to renal failure (after excluding any other causes). Livelihood threatened by anaemia Transfusion dependence Other causes of anaemia excluded / treated / taken into consideration Treatment Targets: Aspirational Haemoglobin (Hb) range between 100 and 120g/litre for adults and young people Blood Pressure <140/90mmHg. ESAs may continue to be administered up to 180/90mmHg but antihypertensive therapy should be adjusted to improve BP control. ESA should be withheld and specialist contacted to advise should BP rise above these levels. Specific to Renal: Serum ferritin and Transferrin saturation o Transferrin saturation (TSAT) level above 20% o Serum ferritin level above 200micrograms/litre (unless serum ferritin is greater than 800 micrograms/litre). Monitoring of ESA therapy ESA is prescribed to achieve a target rise in Haemoglobin of 1-2g/dl each month (Correction phase) with a target Haemoglobin of g/litre. Once this has been achieved Hb can often be maintained at a Page 3 of 6

4 reduced dose and subsequently titrated to maintain response as necessary (Maintenance phase). To keep the Hb within the aspirational range, do not wait until Hb levels are outside the aspirational range before adjusting treatment. a) Correction Phase Haemoglobin checked 2 to 4 weekly. (GP may be asked to assist with monitoring this if patients have any difficulty attending DGH). Patients receiving haemodialysis have monthly Hb checks in their satellite dialysis unit (DGH monitoring responsibility). Serum ferritin checked monthly. b) Maintenance Once target haemoglobin level has been achieved Hb monitoring is required 1 to 3 monthly according to assessed need for each individual patient. The marker of iron status should be monitored every 1 to 3 months in people receiving haemodialysis. Serum ferritin level and TSAT checked 1 to 3 monthly. In people who are pre-dialysis or receiving peritoneal dialysis, levels are typically monitored every 3 months. If these people have a normal full blood count there is little benefit in checking iron status. Monitor Hb more actively after adjusting ESA dose c) Blood Pressure Patients who are self-administering their ESA may be taught to take their own blood pressure or asked to visit their GP surgery on a monthly basis. District or practice nurses administering ESA will be provided with a protocol advising on blood pressure targets and the need to call the anaemia team if they identify blood pressure problems. Haemodialysis patients have their blood pressure monitored at each dialysis session. Normalisation of blood pressure is to be recommended, aiming to maintain all patients at less than 140/90mmHg. Where possible regular monitoring will be undertaken by the Renal Unit, but if the patient is reasonably unable to attend DGH the GP may be requested to assist with blood tests and BP monitoring. We will however gladly advise on dose titration as results are made known to us or answer any other queries that may arise. Every effort will be made by this unit to ensure that minimum doses are prescribed to achieve optimum response. We will ensure that GPs are kept well informed about their patients progress but if there are any queries we can be contacted at any time. Areas of care for which the hospital will be responsible: Monitoring response for patients receiving haemodialysis or peritoneal dialysis. Monitoring response in non-dialysis patients with some assistance from GPs as required. Advising on dose titration and / or required supplements. Therapeutic Uses and Licensed indications o Epoetin beta, NeoRecormon (Roche) licensed for all patients with renal anaemia, it is administered one to three times weekly in the initial correction phase but may be reduced to once a fortnight in the maintenance phase. Initial dose is 60 international units (IU)/Kg body weight in divided doses 1 3 times weekly. It is available in a full range of prefilled syringes. Cartridges of 10,000, 20,000 IU are available for use in the Reco-Pen which is designed solely for self-administration, similar to insulin pens. o Epoetin Alpha, Eprex (Orthobiotech) similar license to epoetin beta administered at an initial prescribed dose of 50 iu/kg body weight 1-3 times per week. Available in a full range of pre-filled syringes from ,000 international units o Darbepoetin Alpha, Aranesp (Amgen) is administered on a once weekly basis at 0.45mcg/kg/week. This can be reduced to once a fortnight and / or once monthly in maintenance phase. Available in a full range of syringes mcg. There are also pens with larger individual doses for single use by the patient, known as Aranesp S pens. To convert from epoietin alpha, beta or delta, divide total weekly dose by 200 e.g. Total weekly dose units = 60mcg Aranesp once weekly Page 4 of 6

5 o Methoxypolyethyleneglycol-erythropoietin beta, MirCera (Roche) Licensed Use for adults with CKD only. Dose 0.6mcg / kg once a fortnight in correction phase reducing to once monthly at a dose equivalent to the previous fortnightly dose for maintenance For individual licensed indications please refer to the Summary of Product Characteristics. Posology and Administration All brands listed above are equally effective and cost equivalent but may differ in their length of action. All may be administered by the subcutaneous or intravenous route although subcutaneous administration remains the preferred route as it results in the best bone marrow response and is generally considered the most economical. Self-administration by patients in the community is most desirable as it gives them control over their treatment but occasionally district or practice nurse support may be requested. Adverse effects, precautions and contraindications ESA therapy is associated with a low incidence of adverse events. Regular monitoring particularly in the correction stage of therapy can largely avert such events. Patients are taught to recognise significant events related to therapy and report these to the Renal Unit immediately. 1. Hypertension is the main complication, particularly associated with the correction phase of therapy (usually in the first 3-4 months). Hypertension should be well controlled prior to commencing therapy and then carefully monitored. Previously normotensive patients may develop hypertension and rarely, hypertensive seizures have occurred. These may be preceded by severe headache, which could therefore be regarded as a possible warning sign. 2. Flu-like symptoms have been reported at the start of therapy, although this is usually only associated with intravenous administration. 3. Isolated cases of hyperkalaemia have occasionally been reported in dialysis patients. Potassium and Hb is checked monthly the haemodialysis units. 4. Acne-like symptoms have also rarely been reported. 5. Though individual cases remain very rare, the development of Pure Red Cell Aplasia due to rhuepo antibodies has been reported. Datasheets advise about importance of unbroken cold chain storage in reducing risk. Drug Interactions Ciclosporin & tacrolimus there is a potential for interaction since the immunosupressants are bound to red blood cells. Monitor immunosuppressant leveland adjust dose if Hb rises. Presentations Pre-filled disposable injection syringes. Supplementary Therapies for Anaemia Management Coexistent iron deficiency is especially prevalent in patients with renal disease and Hb may sometimes be maintained with iron supplements alone. Usually ESA therapy is started in conjunction with iron supplementation to optimise response. This may be either oral or intravenous for pre-dialysis patients, patients receiving peritoneal dialysis or renal transplant recipients. Intravenous iron will almost always be necessary for patients on haemodialysis and will be supplied by the Renal Unit. Optimal Vitamin B12 and serum folate levels are required to ensure ESA response and we will occasionally request supplementation where required References 1. Summary of Product Characteristics for NeoRecormon range, Eprex range, Aranesp range available at 2. NICE Guideline 8. Chronic Kidney Disease: managing anaemia.3 June nice.org.uk/guidance/ng8 3. Killick et al. Guidelines for the diagnosis and management of adult myelodysplastic syndromes British Journal of Haematology, ; The Renal Association. Clinical Practical Guideline: Anaemia of Chronic Kidney Disease. June Shared Care Protocol UHBFT for the prescription of erthropoietic stimulating agents (ESA) therapy (formerly known as EPO) for the correction of the anaemia of chronic kidney disease Page 5 of 6

6 I agree to participate in this shared care agreement for the treatment of the below named patient with ESA for correction of the Anaemia in Pre-Dialysis or a non-renal condition General Practitioner Name (please print) Signature Date Hospital Specialist/Consultant Name (please print) Signature Date Patient Name (please print) Signature Date Patient s name Date of birth Sex Home Address NHS Number Page 6 of 6