PGD 1 PATIENT GROUP DIRECTION (PGD) FOR THE ADMINISTRATION OF DARBEPOETIN ALFA BY RENAL NURSES TO PATIENTS ATTENDING THE RENAL UNIT, MONKLANDS HOSPITAL, FOR HAEMODIALYSIS /HAEMODIAFILTRATION This document authorises the administration of darbepoetin alfa by the registered group of nurses.to patients who meet the criteria for inclusion under the terms of the document. THE NURSE.SEEKING TO ADMINISTER DARBEPOETIN ALFA MUST ENSURE THAT ALL PATIENTS HAVE BEEN SCREENED AND MEET THE CRITERIA AS SET OUT IN THIS PGD BEFORE ADMINISTRATION TAKES PLACE. This document does not exclude the Renal Unit doctors giving darbepoetin alfa under the above circumstances. The purpose of this patient group direction is to help patients by providing more convenient access to an efficient and clearly defined service.
PATIENT GROUP DIRECTION FOR ADMINISTRATION OF DARBEPOETIN ALFA BY RENAL NURSES TO PATIENTS ATTENDING THE RENAL UNIT, MONKLANDS HOSPITAL, FOR HAEMODIALYSIS /HAEMODIAFILTRATION Part 1. Clinical condition to which the direction applies (i) Definition of condition to be treated, by whom and the clinical setting (ii) Clinical criteria for inclusion (iii) Clinical criteria for exclusion (iv) Action if patient is excluded from treatment To be administered by renal nurses to patients attending the renal unit for haemodialysis/haemodiafiltration. In patients with kidney failure, the manufacture of erythropoietin (EPO) is impaired resulting in anaemia. This can be corrected by the administration of darbepoetin alfa Patients with end stage renal failure on haemodialysis or haemodiafiltration Patients with haemoglobin below 110g/l Ferritin 100 Uncontrolled secondary hyperparathyroidism Allergy to darbepoetin alfa or erythropoetin beta or erythropoetin alfa Breast feeding mothers Presence of erythropoetin antibodies Pure red cell aplasia Poorly controlled hypertension Liver disease Latex allergy Sickle cell anaemia Epilepsy Document in notes. Refer to medical staff (v) Action if patient declines treatment from nurse Document in notes. Refer to medical staff
Part 2. Characteristics of staff authorised to take responsibility for the supply or administration of medicines under the Patient Group Direction (PGD) (i) Qualifications required Registered Nurse (ii) Additional requirements, specialist qualifications, training, experience and competence necessary Experience in anaemia management in renal patients Clinical competence assessed by consultants and peers Has successfully completed a locally approved training course in haemodialysis / haemodiafiltration nursing and been deemed competent. Has undergone training and been deemed competent in the administration of the PGD. Has successfully completed a locally recognised course in intravenous administration of medicines. (iii) Continuing Training requirements Continuous training in anaemia Regular attendance at anaemia study days Through annual Personal Development Plan can demonstrate that they have kept up to date with recent research in the use of darbepoetin alfa its indications and contra-indications. (iv) Location of list of staff approved to use the PGD NHS Lanarkshire Associate Director of Nursing Renal Unit
PATIENT GROUP DIRECTION FOR ADMINISTRATION OF DARBEPOETIN ALFA BY RENAL NURSES TO PATIENTS ATTENDING THE RENAL UNIT, MONKLANDS HOSPITAL, FOR HAEMODIALYSIS /HAEMODIAFILTRATION Part 3. Description of treatment available under the Patient Group Direction (PGD) (i) Name/form/strength of medicine 10micrograms 15micrograms 20micrograms 30micrograms 40micrograms 50micrograms 60micrograms 80micrograms 100micrograms 150micrograms Darbepoetin alfa prefilled syringe300micrograms 500micrograms (ii) Route/method of administration Subcutaneous or Intravenous via the venous limb of the extracorporeal dialysis circuit in both haemodialysis and haemodiafiltration. (iii) Dose of medicine to be administered/ supplied Starting dose 0.45 micrograms/kg body weight. Dose should be adjusted by 25% up or
down to keep Hb within target range of 110 125g/l Actual dose will depend on patients weight and response. (see Appendix A) (iv) Frequency of dose One dose calculated as in (iii) is given weekly or fortnightly depending on patient s response. (v) (vi) (vii) (viii) Total dosage/number of times the treatment can be administered and over what time period. Pre-treatment assessment, monitoring, and follow up treatment or monitoring Warnings, adverse reactions and contraindications. Advice to be given to patient before the treatment. A copy of all advice listed here must be given to the Weekly or fortnightly for as long as the patient is on haemodialysis or haemodiafiltration Fortnightly Hb check until target Hb achieved Monthly haemoglobin check after target Hb achieved Ferritin level checked every 2 months Serum iron and transferrin saturation checked every 2 months Monitor potassium levels. Contra-indications as in Part1 (iii) Warnings: May interact with ciclosporin and tacrolimus, if given concomitantly blood levels of these should be monitored and the dose age adjusted as the haemoglobin rises. Undesirable Effects: Hypertension Headaches, confusion, fits due to sudden rise in blood pressure Thrombosis of arteriovenous fistula Mild discomfort around injection site after subcutaneous injection Arthralgia Fluid retension Rash, urticaria Dyspnoea Peripheral oedema Patients will be informed what the drug is and why they need it
patient They will be told about the above potential side effects Patients will be asked about any allergies Patients will be asked to report any side effects immediately (ix) Referral for medical advice Adverse reactions Hyporesponsiveness to epoetin despite adequate iron stores (x) Facilities and supplies required on site Prefilled syringes of darbepoetin alfa 10micrograms, 15micrograms, 20micrograms, 30micrograms, 40micrograms, 50micrograms, 60micrograms, 80micrograms, 100micrograms, 150micrograms, 300micrograms, 500micrograms Locked drug fridge Emergency resuscitation facilities. (xi) Details of treatment records required Name of drug strength, dose, date, route of administration and outcome, time of administration, is entered by the nurse in patient s record and signed for. Any adverse reactions and action taken are recorded in the patient s notes and the appropriate documentation completed i.e. clinical incident form and yellow card.
PATIENT GROUP DIRECTION ADMINISTRATION OF DARBEPOETIN ALFA BY RENAL NURSES TO PATIENTS ATTENDING THE RENAL UNIT, MONKLANDS HOSPITAL, FOR HAEMODIALYSIS /HAEMODIAFILTRATION Part 4. Record of Persons Preparing and Approving the PGD Professionals preparing the PGD Name and Status Date Practitioner(s) Consultant(s) Dr Ilona Shilliday Senior Pharmacist Professionals approving the PGD Name and Status Date Senior Nurse / Professional Manager Service Manager Clinical Director Consultants Once all sections are completed and signed this form must be submitted to the hospitals Dr micrograms Administration Review Group (DARG), via the Pharmacy Manager. The DARG
group will review the document for accuracy and then have it reviewed for its impact on other clinical specialities.
LANARKSHIRE ACUTE HOSPITALS (PGD2) Patient Group Direction Authorisation for Use and Indemnification Title: ADMINISTRATION OF DARBEPOETIN ALFA BY RENAL NURSES TO PATIENTS ATTENDING THE RENAL UNIT, MONKLANDS HOSPITAL, FOR HAEMODIALYSIS /HAEMODIAFILTRATION PGD Ref.: The Drug Administration Review Group will attach Forms PGD2 and PGD3 to the above document and initiate the review process. Review The above PGD has been reviewed for drug and licensing issues (Pharmacy Manager to sign) The above PGD has been reviewed for completeness by the Drug Administration and Review Group and was found to be satisfactory (DARG Chairman to sign on behalf of this group). The above PGD has been reviewed for clinical implications for other specialities and was found to be satisfactory (Chairman of Acute Drug &Therapeutics Committee to sign on behalf of the Committee). Chairman of DARG Committee: Date: Pharmacy Manager: Date: Chairman Acute D & T: Date: The PGD should be returned to the Directorate for the Authorisation and Indemnification stage. Authorisation Forms PGD1 and PGD2 should be submitted by the Directorate to the Hospital Management Team for authorisation to use the PGD and indemnification of staff providing the service. The above PGD has been authorised for use within the hospital and the approved practitioners indemnified for actions taken in accordance with the directions therein
(Medical Director / Associate Medical Director to sign on behalf of the Trust / Hospital Management). Medical / Assoc. Director: Date: The PGD should be returned to the Directorate for the Training and Archiving stage.
LANARKSHIRE ACUTE HOSPITALS (PGD3) Patient Group Direction Training and Archiving Record Title : ADMINISTRATION OF DARBEPOETIN ALFA BY RENAL NURSES TO PATIENTS ATTENDING THE RENAL UNIT, MONKLANDS HOSPITAL, FOR HAEMODIALYSIS /HAEMODIAFILTRATION PGD Ref.: On authorisation of the above PGD, the original forms must be passed to the Associate Nurse Director for implementation of the PGD and for identification of the necessary management and training requirements. Training Training requirements detailed within the patient group direction will be provided by the following staff and records of training recorded as detailed. Responsible Manager : Training Format : Training Record : Training Staff : Archiving All patient group direction original documents require to be stored in a safe manner for retrieval and review purposes after 2 years. If discontinued the original must be retained for a period of thirty years after withdrawal. Review Date :
Name : Title : Associate Director of Nursing Signature : Date :
LANARKSHIRE ACUTE HOSPITALS ( PGD4) PGD TITLE ADMINISTRATION OF DARBEPOETIN ALFA BY RENAL NURSES TO PATIENTS ATTENDING THE RENAL UNIT, MONKLANDS HOSPITAL, FOR HAEMODIALYSIS /HAEMODIAFILTRATION DATE FORM PREPARED PRACTITIONERS Name Position Signature Date
This list must be updated 6 monthly Review Date: PGD4-form.doc Appendix A RENAL ANAEMIA MANAGEMENT DARBEPOETIN (ARANESP) GUIDELINES AMGEN'S DEVELOPMENT OF DARBEPOETIN (ARANESP) Darbepoetin) (Aranesp) is a Novel Erthropoiiesis stimulating protein designed and developed for the treatment of anaemia which occurs in patients with chronic renal failure or cancer. Darbepoetin (Aranesp) has a unique amino acid sequence that allows the addition of five N-linked carbohydrate chains compared with the three chains present on endogenous erythropoietin (Amgen 2001). COMMENCING DARBEPOETIN (ARANESP) Haemodialysis and haemodiafiltration The recommended starting dose is 0.45micrograms/kg once weekly Monitoring Hb concentration should be monitored fortnightly after initiation of Aranesp Monitor Hb every 4 weeks once target Hb achieved. Hb concentration should not exceed 125g/L If a dose adjustment is required to maintain Hb at the desired level, it is recommended that the dose is adjusted by approx. 25% A rise in Hb of greater than 20g/L over a four week period should be avoided
CONVERSION FROM r-huepo TO DARBEPOETIN (ARANESP) 200 International Units r-huepo = 1 microgram DARBEPOETIN (ARANESP) for patients treated with r-huepo 2 or 3 times a week Divide the total weekly r-huepo dose (international units) by 200 to give the once weekly dose of darbepoetin (Aranesp) (micrograms) Total weekly dose r-huepo dose (international units) 200 = Once weekly darbepoetin (Aranesp) dose (micrograms) EXAMPLE 6000 international units 200 = 30 micrograms weekly for patients treated with r-huepo once weekly Divide the total weekly r-huepo dose (international units) by 200 and multiply by 2 to give the fortnightly dose of darbepoetin (Aranesp) (micrograms) EXAMPLE (2000international units) X 2 200 = 20 micrograms fortnightly METHOD OF ADMINISTRATION Aranesp can be administered subcutaneously (sc) or intravenously (iv). The preferred choice within the Renal unit is intravenously When changing route of administration the same dose must be used and Hb should be monitored monthly. Haemodialysis and haemodiafiltration Darbepoetin (Aranesp) can be administered subcutaneously or intravenously No change in dosage required.
PRECAUTIONS * Blood pressure should be monitored in all HD patients, particularly during initiation of darbepoetin (Aranesp) therapy. Patients should be encouraged to comply with any antihypertensive medication and nutritional advice they have been prescribed. DO NOT WITHOLD ARANESP WITHOUT CONSULTING THE ANAEMIA CO- ORDINATOR or ANAEMIA SUPPORT NURSE. Implemented: 28.08.06 Review date: 28.08.08 Contact person: Dr I Shilliday