Royal Wolverhampton
NHS Trust /
Wolverhampton Shared Care Agreement / Wolverhampton City
Clinical Commissioning Group
Black Country Cluster

Sevelamer(Renagel®)

ESCA: For the treatment ofhyperphosphataemia in patients on dialysis

SECONDARY CARE SECTION TO BE COMPLETED BY INITIATING DOCTOR

Patient’s Name: / NHS Number:
Date of Birth: / Date Treatment Started:
(Add Date)
One copy of information leaflet given to patient
One copy of agreement sent to general practitioner
One copy filed in patients notes
Name of Initiating Doctor:
Consultant:
Speciality:
Fax Number: / 01902

PRIMARY CARE SECTION TO BE COMPLETED BY GENERAL PRACTITIONER

I agree*/don’t agree* to enter into a shared care arrangement for the treatment of the above patient with this medicine (*delete as appropriate)
GP Name:
Signature: / Date:
Once signed please detach this sheet and fax to the number shown above.
File copy in patient’s record and add read code 66S2 or XaK6z depending on GP clinical system.

BACK-UP ADVICE AND SUPPORT

Contact details / Telephone No. / Bleep: / Fax: / Email address:
Specialist: Dr P Carmichael / 01902 696134 / 7865 / 695734 /
Specialist: Dr J Nicholas / 01902 696133 / 695734 /
Specialist: Dr P Rylance / 01902 696131 / 1410 / 695734 /
Specialist: Dr K Sandhu / 01902 696145 / 695734 /
Specialist: Dr S Cherukuri / 01902 695452 / 695734 /
Hospital Pharmacy Dept:
Fiona McKean / 01902 695137 / 3963 /
Other: Sr Jean Shears (INP) / 01902 695454 / 7645 / 695734 /

Patient’s Name: Date treatment commenced:

AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE

This shared care agreement outlines suggested ways in which the responsibilities for managing the prescribing of sevelamer for adults can be shared between the specialist and general practitioner (GP). GPs are invited to participate. If the GP is not confident to undertake these roles, then he or she is under no obligation to do so. In that case, the total clinical responsibility for the patient for the diagnosed condition remains with the specialist. If a specialist asks the GP to prescribe this drug, the GP 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 should be explained to the patient by the doctor initiating treatment. It is important that patients are consulted about treatment and are in agreement with it. Patients with interstitial pulmonary fibrosis are under regular follow-up, which provides opportunities to discuss drug therapy.

The doctor who prescribes the medication legally assumes clinical responsibility for the drug and the consequences of its use.

RESPONSIBILITIES and ROLES

Specialist responsibilities
  1. Diagnosis of hyperphosphataemia and initiation of sevelamer treatment.
  2. Discuss the benefits and side effects of treatment with the patient.
  3. Dose stabilisation: initial dosage adjustment until the serum phosphate concentration is stable. Thereafter, during maintenance treatment, advice to the GP on any further dose adjustments required.
  4. Ask the GP whether he or she is willing to participate in shared care, and agree with the GP as to who will discuss the shared care arrangement with the patient.
  5. Monitor serum phosphate and calcium levels and any other parameters considered necessary.
  6. Communicate promptly with the GP when treatment is changed.
  7. Have a mechanism in place to receive rapid referral of a patient from the GP in the event of deteriorating clinical condition.
  8. Advise the GP on stopping treatment (if appropriate).
  9. Report adverse events to the MHRA.
  10. 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. Prescribe sevelamer at the dose recommended.
  3. Adjust the dose as advised by the specialist.
  4. Report to and seek advice from the specialist on any aspect of patient care that is of concern and may affect treatment.
  5. Refer patient to the specialist if his or her condition deteriorates.
  6. Stop treatment on the advice of the specialist or immediately if an urgent need to stop treatment arises.
  7. Report adverse events to the specialist and MHRA.

Patient's role
  1. Report to the specialist or GP if he or she does not have a clear understanding of the treatment.
  2. Share any concerns in relation to treatment with sevelamer.
  3. Report any adverse effects to the specialist or GP whilst taking sevelamer.

SUPPORTING CLINICAL INFORMATION
Indications
Sevelamer is ‘indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. It should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 – dihydroxy vitamin D3 or one of its analogues to control the development of renal bone disease.
Dosage and Administration
Sevelamer is available as an 800mg tablet. For patients who are not on phosphate binders dosage is determined individually based on serum phosphate concentrations (refer to the SPC for further details).
If the dose is to replace an existing phosphate binder treatment then it should be calculated on an equivalent mg weight basis compared with the patient’s previous calcium-based phosphate binder. Patients should take sevelamer with meals and adhere to their dietary advice.
Contraindications
Sevelamer is contraindicated in patients with hypophosphataemia and patients with bowel obstruction.
Side Effects
In trials, the most common adverse effects were gastrointestinal events. The SPC states that the following have been reported in 10% of patients (but were not necessarily attributable to sevelamer treatment): pain, diarrhoea, nausea, vomiting, dyspepsia, constipation, infection, headache, respiratory disorder, cough, hypotension, dizziness, dyspnoea, thrombosis, peripheral oedema, chest pain, abdominal pain, fever, leg cramps, hypertension and pruritus.
Serious suspected reactions (even if well recognised or causal link uncertain) should be reported to the MHRA.
Monitoring
The SPC recommends monitoring levels of serum phosphorus, calcium, as well as vitamins A, D, E and K as a deficiency in one or more of these may develop in dialysed patients. Many haemodialysis patients will be treated with vitamin D and calcium supplements.
Drug Interactions
None stated in the SPC.
Vaccination
The use of LIVE vaccine is not recommended during drug treatment with immunosuppressant drugs. This section may be excluded if the shared care agreement related to a drug which is not an immunosuppressant.
Acknowledgements
Refer to MTRAC VS07/17.
Version Control
Version / Date of Issue / Author/s / Brief Description of Changes
1.0
1.1 / 25/06/2013 / R Eardley / Removal of pharmacy fax numbers

This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for Renagel® and the Midlands Therapeutics Review and Advisory Committee (MTRAC) Verdict & Summary sheet (VS07/17)

Date approved: 30 Dec 12Expiry date: 31/12/2017