Shared care policies are developed when sophisticated or complex treatments that were initiated in secondary care are then prescribed by a GP. They set out the process that needs to be followed for the GP to take on prescribing responsibility. The term 'Effective Shared Care Agreement' (ESCA) is now being used. ESCAs should be patient specific and encompass all aspects relevant to that particular patient.
Clinical responsibility should be considered for transfer to primary care only where it is agreed that the patient's clinical condition is stable or predictable.
Shared Care Policy And Prescribing Information For Oral CICLOSPORIN (Neoral®) [RENAL Patients](Adults Only)
Applies to: NHS Grampian / Version 3 /
Prepared by / Authorised for issue by / Document no:
NHSG/RenalSCP/Ciclos/MGPG714
Author(s) as job title(s) / Medicines Guidelines
and Policies Group / Effective date: January 2015
Brian Porteous / Caroline Hind / Review Date: January 2017 or sooner if recommendations change
Supersedes: Version 2, 2006
Please keep this document in the patients notes
æPATIENT NAME ö
CHI NUMBER
ADDRESS
DATE OF BIRTH
è Insert patient sticker here ø / HOSPITAL
TELEPHONE NO
CONSULTANT (print name)
SIGNATURE / WARD
DATE
THERAPEUTIC INDICATION FOR THIS PATIENT:
(To be completed by consultant)
DOSAGE/FREQUENCY OF ADMINISTRATION (Neoral®):
SAFE PRACTICE IS THAT THE CLINICIAN WHO ORDERS THE TEST MUST ACT ON THE RESULT
CARE WHICH IS THE RESPONSIBILITY OF THE HOSPITAL CONSULTANT
1. Baseline:
Full Blood Count (FBC); liver function tests
(LFTs); urea, U&Es; lipids, urinalysis & blood pressure (BP)
2. Copy of results to be sent to GP.
3. Initiation of therapy and recommendations for dose increments. This will be controlled by the Renal Unit.
4. Decision on final dose required for patient.
5. Monitoring clinical response to treatment.
· U&Es (incl. creatinine and potassium) fortnightly until dose and results have been stable for three months, then monthly thereafter.
· FBC and LFTs (inc. ALT and Alk Phos) monthly until dose and results stable for three months, then three monthly.
· Fasting lipids should be checked every six months
· BP should be checked at each monitoring visit.
· Whole blood 12 hour trough ciclosporin A level 7 days after each dosage change. / CARE WHICH IS THE RESPONSIBILITY OF THE
GENERAL PRACTITIONER (GP)
1. Prescribing of medication (by brand name) under guidance of consultant.
2. To preserve vital venous access, monitoring will be done by the renal service at ARI unless otherwise notified.
3. The GP should be aware that the drug can cause
· Nephrotoxicity
· Increase in blood pressure
· Infection
· Increase risk of malignancy – lymphoma, skin and other
tumours
· Drug interactions
When the patient has an intercurrent illness a FBC, U&E and LFTs should be done and any abnormal results including those noted above should be reported to the consultant or on call Registrar.
NOTE: In addition to absolute value for haematological indices a rapid fall or a consistent downward trend in any value should prompt caution and extra vigilance.
When writing laboratory request forms always include details of the patient’s medication
NOTE: If something unexpected occurs contact Renal Unit/On Call Registrar or Consultant.
Shared Care Policy and Prescribing information for General Practitioners
CICLOSPORIN (Renal patients, adults only continued)
Abnormal Monitoring Results / Action To Be Taken
· Platelets <150 X 109/L / Discuss with Renal Unit/registrar on call or Consultant
· > 2-fold rise in ALT or Alk Phos (from upper limit of reference range) / Discuss with Renal Unit/registrar on call or Consultant
· Potassium rises to above normal range / Discuss with Renal Unit/registrar on call or Consultant
· Creatinine rises > 30% from baseline / Discuss with Renal Unit/registrar on call or Consultant
· Abnormal bruising, sore throat, rash, oral ulceration / Check FBC. Discuss with Renal Unit/Registrar on call or Consultant
· Significant rise in lipids / Discuss with Renal Unit/registrar on call or Consultant
· Malignancies / Discuss with Renal Unit/registrar on call or Consultant
· BP rise to >140/90 on two consecutive readings, 2 weeks apart / Treat BP if not controlled. Discuss with Renal Unit/registrar on call or Consultant
For specific product information please consult the current summary of product characteristics (http://www.medicines.org.uk/emc/) and the BNF (https://www.medicinescomplete.com/mc/)
Other information
· NEORAL® Soft Gelatin Capsules and NEORAL® Oral Solution are bioequivalent and can be interchanged.
· Live vaccines should be avoided in patients taking ciclosporin.
· A single dose of pneumococcal polysaccharide vaccine and annual influenza vaccine should be given.
· There are a number of drug interactions that must be considered when a new drug is prescribed. Please refer to Summary of Product Characteristics, BNF, or contact Medicines Information.
o Do not give with tacrolimus due to increased risk of nephrotoxicity.
o Potassium sparing diuretics, ACE inhibitors, angiotension-II receptor antagonists and potassium salts should be used with caution as co-administration may lead to hyperkalaemia.
o Colchicine, statins and digoxin levels can be increased by ciclosporin. Monitor response and use the lowest effective dose. Rosuvastatin is specifically contra-indicated with ciclosporin.
o Drugs that decrease ciclosporin levels include barbiturates, Antiepileptics and St John’s Wort.
o Drugs or foods that increase ciclosporin levels include grapefruit, macrolide antibiotics (mainly erythromycin and clarithromycin) and azole antifungals (ketoconazole, fluconazole, intraconazole and voriconazole). Close monitoring is essential. This should be carried out by the prescriber of the interacting agent.
· To minimise the risk of skin cancer, exposure to sunlight and Ultra Violet light should be limited by wearing protective clothing and using sunscreen with a high protection factor.
Pregnancy
Discuss with consultant. Ciclosporin should not be given to patients who are pregnant or likely to become pregnant without careful assessment of risk versus benefit.
Breast-feeding
Discuss with Aberdeen Maternity Hospital. Manufacturer advises avoid.
Responsibilities of GPs
A GP should:
· Contact a consultant or registrar in the Renal Unit in the event of a drug reaction or monitoring abnormality or anything you are unhappy about.
· Only continue to prescribe ciclosporin if it is being satisfactorily monitored.
· Be alert for any of the known adverse reactions.
** The patient should be encouraged to ensure blood tests are taken at the correct intervals. **
Reference
DH Shared Care Guidelines - http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/Browsable/DH_4898588
Grampian Medicines Management Website, Shared Care Policies webpage - http://www.nhsgrampian.org/nhsgrampian/GJF_general_new.jsp?pContentID=4382&pMenuID=464&pElementID=470&p_service=Content.show
UNCONTROLLED WHEN PRINTED Review Date: January 2017 (sooner if recommendations change) NHSG/RenalSCP/Ciclos/MGPG714 - 1 -
Shared Care Policy and Prescribing Information for Ciclosporin (Neoral®) [Renal Patients] (Adults only) – Version 3, January 2015