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 TACROLIMUS [RENAL Patients]
(Adults Only)
Applies to: NHS Grampian / Version 3 /
Prepared by / Authorised for issue by / Document no:
NHSG/RenalSCPTacrO/MGPG718
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
PATIENT NAME 
CHI NUMBER
ADDRESS
DATE OF BIRTH
 Insert patient sticker here  / HOSPITAL
TELEPHONE NO
CONSULTANT (print name)
SIGNATURE / WARD
DATE
THERAPEUTIC INDICATION FOR THIS PATIENT:
(To be completed by consultant)
DOSAGE/FREQUENCY OF ADMINISTRATION (prescribe Prograf® or Advagraf® by brand name):
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); Blood Pressure; U&E; Creatinine; Blood Glucose Levels; BUN and Coagulation Tests.
  1. Copy of results to be sent to GP.
  1. Exclude pregnancy before starting therapy.
  • If contraception needed non-hormonal methods should be used.
  • Advise the patient to contact their physician immediately should pregnancy occur.
  1. Initiation of therapy and recommendations for dose increments. This will be controlled by the Renal Unit.
  1. Monitoring clinical response to treatment.
  • Weekly full blood counts for 4 weeks then fortnightly for 2 months then monthly for one year then 3 monthly thereafter.
  • U&E, creatinine, blood pressure, LFT and blood glucose every 3 months.
  • Whole blood 12-hour trough tacrolimus level7 days after each dose change.
  1. Patients should be asked about the presence of sore throat, rash or abnormal bruising at each visit.
The two preparations of Tacrolimus available on the formulary Prograf® and Advagraf®are not bioequivalent. Hence, prescribe by brand name. / 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 doneby 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 and increased risk of malignancy – benign, malignantneoplasmsand skin malignancies
  • Changes to visual status and Gastrointestinal upset
  • Drug interactions.
4.Patients should be asked about the presence of sore throat, rash or abnormal bruising at each visit.
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
TACROLIMUS oral (RENAL patients, adults only continued)
Abnormal Monitoring Results / Action To Be Taken
  • WBC < 4.0 x 109/L
/ Discuss with renal unit/registrar on call or consultant
  • Neutrophils < 2.0 x 109 /L
/ Discuss with renal unit/registrar on call or consultant
  • Platelets < 150x109 /L
/ Discuss with renal unit/registrar on call or consultant
  • Potassium >5.0mmol/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
  • Creatinine rises ≥ 30% from baseline
/ Discuss with renal unit/registrar on call or consultant
  • Abnormal bruising, sore throat, rash, oral ulceration
/ Discuss with renal unit/registrar on call or consultant
For specific product information please consult the current summary of product characteristics ( and the BNF ()Other information
Other Information
  • Live vaccines should be avoided in patients takingtacrolimus.
  • A single dose of pneumococcal polysaccharide vaccine and annual influenza vaccine should be given.
  • Tacrolimus capsules should be swallowed whole with plenty fluid, preferably on an empty stomach at least one hour before or 2-3 hours after a meal.
  • There are a number of drug interactions that must be considered when a new drug is prescribed. Please referto Summary of Product Characteristics, BNF, or contact Medicines Information.
Some important interactions to consider include the following
  • Do not give with ciclosporin due to increased risk of nephrotoxicity.
  • Grapefruit and grapefruit juice should not be taken at the same time as tacrolimus.
  • Potassium sparing diuretics and potassium salts should be used with caution due to the risk of hyperkalaemia.
  • Significantly increased tacrolimus blood levels have been noted with the following drugs that inhibit CYP3A4 – ketoconazole, fluconazole, intraconazole, voriconazole, erythromycin and HIV Protease inhibitors. Caution also advised with weaker CYP3A4 inhibitors eg omeprazole and nifedipine.
  • Inducers of CYP3A4 shown to decrease the blood levels of tacrolimus include rifampicin, phenytoin, phenobarbitone and St John’s Wort.
  • Methylprednisolone has been reported to increase ordecrease tacrolimus plasma levels.
  • Enhanced nephrotoxicity has been observed following the administration of either of the following drugs in conjunction with tacrolimus – amphotericin B or ibuprofen.
  • As tacrolimus may alter the metabolism of steroid based contraceptive agents, particular care should be exercised when deciding upon contraceptive measures. Non-hormonal contraceptives should be used.
Pregnancy
Discuss with consultant. Effective contraception is required during treatment. Tacrolimus capsules alter the metabolism of oral contraceptives, so non-hormonal methods should be used. Advise the patient to contact their physician immediately should pregnancy occur.
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 tacrolimusif 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 -

Grampian Medicines Management Website, Shared Care Policies webpage -

UNCONTROLLED WHEN PRINTEDReview Date: January 2017 (sooner if recommendations change)NHSG/RenalSCPTacrO/MGPG718- 1 -

Shared Care Policy and Prescribing Information for Tacrolimus Oral [Renal Patients] (Adults only)- Version 3, January 2015