Trust Guideline for the Management and Administration of Intravenous Iron in Adults under the Gastroenterology Directorate

Transcription

1 A clinical guideline recommended for use For Use in: The Gastroenterology Directorate By: Registered nurses competent in the administration of intravenous therapy and medical staff For: Adult patients under gastroenterology with iron deficiency anaemia Division responsible for document: Medical Division (Including Emergency) Venofer, Ferinject, Ferritin, Haemoglobin Key words: (Hb), Iron, Iron Deficiency Anaemia (IDA), Inflammatory Bowel Disease (IBD) Name of document author: Natasha Thomson, Nicki Fisher Job title of document author: Inflammatory Bowel Disease Nurse Specialists Name of document author s Line Manager: Dr Simon Rushbrook Job title of author s Line Manager: Consultant Gastroenterologist Supported by: Dr Mark Tremelling Consultant Gastroenterologist (NNUH) Assessed and approved by the: Date of approval: 29/09/2017 Ratified by or reported as approved to (if applicable): To be reviewed before: 29/09/2020 Clinical Guidelines Assessment Panel If approved by committee or Governance Lead Chair s Action; tick here Clinical Standards Group, Clinical Safety and Effectiveness Sub-board To be reviewed by: Authors Reference and / or Trust Docs ID No: Version No: 2 Changes to key personnel and Each 20mL ampoule contains 1000mg ferric carboxymaltose ad- Description of changes: ded. Compliance links: None If Yes - does the strategy/policy deviate from the recommendations of N/A NICE? If so why? This guideline has been approved by the Trust's Clinical Guidelines Assessment Panel as an aid to the diagnosis and management of relevant patients and clinical circumstances. Not every patient or situation fits neatly into a standard guideline scenario and the guideline must be interpreted and applied in practice in the light of prevailing clinical circumstances, the diagnostic and treatment options available and the professional judgement, knowledge and expertise of relevant clinicians. It is advised that the rationale for any departure from relevant guidance should be documented in the patient's case notes. The Trust's guidelines are made publicly available as part of the collective endeavour to continuously improve the quality of healthcare through sharing medical experience and knowledge. The Trust accepts no responsibility for any misunderstanding or misapplication of this document. Available via Trust Docs Version: 2 Trust Docs ID: Page 1 of 13

2 Quick Reference guideline/s Use of Venofer and Ferinject for patients with Inflammatory Bowel Disease / gastro related conditions Indications for use: Patients with Iron Deficiency Anaemia (IDA) who have Inflammatory Bowel Disease or a Gastro-related condition Inclusion criteria for use of Venofer and Ferinject : Any patient intolerant of oral iron preparations, no response to oral iron preparations or need rapid correction. Patients under the care of a Gastroenterologist who have been diagnosed with IDA. Exclusion criteria for use of Venofer and Ferinject : Anaemia not caused by iron deficiency e.g. macrocytic anaemia. The patient is allergic to iron or any of the excipients of Venofer or Ferinject. The patient is in the first 3 months of pregnancy. The patient has any infections (clinical advice to be sought from gastro doctors) Dosage and frequency of Venofer : Correct dose calculated on recent weight, Hb and Ferritin (Appendix 1). Given in minimum dose of 100mg up to Maximum dose of 200mg. Can be given up to 3 times a week (at least 48 hours between doses). Given as an infusion or bolus. Dosage and frequency of Ferinject : Correct dose calculated on recent weight, Hb and Ferritin (Appendix 2). Given in minimum dose of 100mg up to Maximum dose of 1000mg. Given once a week. Given as an infusion. Monitoring: Ensure - medical cover is available during infusion. Record - on 1st dose blood pressure, temperature, pulse, oxygen saturations and respirations. Observe - Acute or delayed reactions. Blood tests monthly for 3 months after the correction. Side effects: Headache, hypotension, taste disturbance, nausea and vomiting, dizziness, diarrhoea, constipation. If patient experiences side effects consider reducing the dose and/or rate of administration of Venofer and Ferinject after clinical advice has been sought. Very rarely anaphylactic reactions occur. Available via Trust Docs Version: 2 Trust Docs ID: Page 2 of 13

3 Patients suitable for intravenous iron infusions Nurse Gives Examines Records Ensures - full explanations of procedure to patient - patient for best venous access - baseline vital signs - blood test results have been performed and reviewed within the last month Nurse Weighs Calculates Prepares Establishes - patient - total dose of iron (weight, Hb and Ferritin) - infusion according to package insert - venous access using cannula Nurse Ensures Ensures Ensures Ensures Records Observes - medical cover is available. - resuscitation equipment is to hand. - Adrenaline, Hydrocortisone and Chlorphenamine is available and in date. - oxygen and tubing is connected. - temperature, pulse, blood pressure, oxygen saturations and respirations. - for acute reaction during and within 1 hour of first infusion. First infusion of VENOFER - 200mg Venofer mixed with 10mls of Normal Saline. A test dose must be given: 2mls (20mg Venofer ) infused as a test dose over a period of 2 minutes. If no adverse reaction occurs within 15 minutes of completing test dose, then the remaining 18mls (180mg Venofer ) can be given over 5 minutes. First infusion of FERINJECT - mixed with 250mls of Normal Saline, no test dose required. Reactions: Management by: - reducing infusion rate. - if bolus is given, change to infusion. - reduced dose. Iron should be discontinued if: - Anaphylaxis Report and record ANY adverse reaction, and Yellow Card completed. End of infusion Flush cannula with normal saline. Venofer - leave in situ for one hour on first infusion, when safe to do so remove cannula as per cannulation policy, write in medical notes. Ferinject - when safe to do so remove cannula as per cannulation policy, write in medical notes. Patient Give follow up appointment. Alert to potential side effects and give contact numbers in case of problems. Available via Trust Docs Version: 2 Trust Docs ID: Page 3 of 13

4 Objective/s To ensure all healthcare professionals are aware of best practice for administration of intravenous (IV) iron to patients with Inflammatory Bowel Disease (IBD) or gastro related iron deficiency anaemia (IDA). Rationale This guideline has been produced to inform other healthcare professionals how to manage iron deficiency anaemia using evidence based research for the correction of iron deficiency anaemia. Broad recommendations Anaemia is Hb below the lower limit of normal and is defined by the World Health Organisation as: Men Non Pregnant Women Pregnant Women Hb 130 g/l Hb 120 g/l Hb 110 g/l (Gasche, C et al 2007) Iron deficiency anaemia occurs when iron stores are exhausted and the supply of iron to the bone marrow is compromised, (Gasche, C et al 2007). Diagnostic criteria for iron deficiency anaemia depends on the level of systemic inflammatory response: - Without any clinical evidence of inflammation appropriate criteria are a serum ferritin <23 ug/l. - With inflammation the lower limit of serum ferritin consistent with normal iron stores is 100 ug/l, (Gasche, C et al 2007). During or shortly after intravenous iron therapy, serum ferritin levels do not correlate with body iron stores. In patients with active IBD, certain cytokines or hepcidin may reduce iron absorption, retain iron with in cells of the reticular-endothelial system, and inhibit erythropoiesis. (Gasche, C et al 2007). It is recommended that any level of anaemia should be investigated if iron deficiency is noted, (Goddard, A et al 2011). Treatment of anaemia requires adequate iron stores and adequate available iron. Iron deficiency is common, (Gasche, C et al 2007). Patients with or at risk of cardiovascular instability due to iron deficiency anaemia should be given a blood transfusion, (Goddard, A et al 2011). The aim of treating iron deficiency anaemia should be to restore Hb concentrations and red cell indices to normal, and replenish iron stores. There is no clear evidence on maintenance iron therapy, it has been suggested by Goddard, A et al (2011) that once patient's Hb is in normal range they should have 3 monthly blood tests for at least a year. All patients who do not respond to parenteral iron therapy should be referred back to their Consultant for further investigation, (Goddard, A et al 2011). Available via Trust Docs Version: 2 Trust Docs ID: Page 4 of 13

5 Registered Nurse Procedures and Guidelines 1) Patient Inclusion Criteria Any patient intolerant of oral iron preparations, non response to oral iron preparations. Patients under the care of a Gastroenterologist who have been diagnosed with iron deficiency anaemia. 2) Patient Exclusion Criteria Anaemia is not caused by shortage of iron e.g. macrocytic anaemia The patient is allergic to iron or any of the excipients of Venofer or Ferinject. The patient is in the first 3 months of pregnancy. The patient has any infections (clinical advice to be sought). Unstable asthmatics (refer to SPC's). 3) Indications for the administration of intravenous iron (Venofer, Ferinject ) Treatment with an iron preparation is only justified in the presence of a demonstrable iron-deficiency state. Before initiating iron therapy it is important to exclude other serious underlying causes of anaemia such as gastric bleeding. In order to keep the ferritin range for patients between ug/l. Hb above 130g/dL in men, above 120g/L in non-pregnant women and 110g/L in pregnant women. Inflammatory Bowel Disease patients who have active disease may demonstrate an above normal ferritin level, therefore to discuss with clinician prior to administrating further parental iron. 4) Pre infusion A decision to prescribe intravenous iron must be made by the patient s Consultant or Registrar. Referral should be via intravenous iron referral proforma (see appendix 3). Before commencing the infusion the following equipment must be within easy access: Dynamap machine and cardiac arrest trolley. Ensure as required drugs have been prescribed and readily available for use in the event of an acute infusion reaction: - Paracetamol PO 1g prn - Chlorphenamine IV mg prn - Hydrocortisone IV mg prn - Adrenaline 1:1000 IM (0.5ml) - Salbutamol nebuliser 2.5mg Insert cannula and flush according to Trust Cannulation Policy. Available via Trust Docs Version: 2 Trust Docs ID: Page 5 of 13

6 5) Pre infusion checklist Ensure patient does not have any known sensitivity to iron. Patient has been informed of the risks, benefits and possible infusion reactions of treatment and has been supplied with verbal information to support this. Has patient consented verbally for treatment? Ensure results from routine bloods have been reviewed by doctor (FBC& Ferritin). Ensure patient s weight is measured and correct. Has the patient any signs of infection? If yes, contact a Doctor from the Gastroenterology team to assess the patient before commencing iron. Monitor base line observations: pulse, BP, temperature and oxygen saturation levels, respirations and record on nursing documentation. Ensure anaphylaxis medication and resuscitation equipment is readily accessible. Ensure oxygen mask and tubing are connected. 6) Preparation VENOFER prescribed by Consultant or Registrar. Each 5mL ampoule contains 100mg of iron sucrose to be diluted with 5mls of normal saline. FERINJECT prescribed by Consultant or Registrar. Each 20mL ampoule contains 1000mg ferric carboxymaltose. Each 10mL ampoule contains 500mg ferric carboxymaltose Each 2mL ampoule contains 100mg ferric carboxymaltose. Must be added to normal saline, please see appendix 2 for maximum dilution required. 7) Monitoring Observations must be recorded every 15 minutes for the first hour until the patient is discharged. Measurements must be documented (first infusion only). Observe the cannula site for extravasation and the infusion for any changes in colour or consistency. Monitor for paravenous leakage as may lead to pain, inflammation, tissue necrosis, sterile abscess and brown discolouration of the skin. If happens the bolus or infusion of iron must be stopped immediately, cannula flushed with normal saline, cold compress applied. Patient given reassurance, informed need for regular monitoring of site and when must report for further medical advice. Report and record any adverse reactions. The cannula must remain in situ until the patient is ready for discharge and then removed. On discharge ensure that the patient has contact numbers in case of side effects Available via Trust Docs Version: 2 Trust Docs ID: Page 6 of 13

7 following discharge. 8) General Information If the patient is receiving Venofer for the first time a test dose MUST be given: 2ml (20mg Venofer ) infused as a test dose over a period of 1 to 2 minutes. If no adverse reaction occurs within 15 minutes of completing the test dose, then the remaining 18ml (180mg Venofer ) can be given as a slow bolus over 5 minutes. If unable to tolerate bolus delivery can convert to infusion (Appendix 1). Ferinject does not need a test dose. September 2013 the MHRA issued a Drug Safety Update with regards to the use of intravenous iron and the risk of hypersensitivity reactions; this was the result of a European wide review. The results of the review indicate that hypersensitivy reactions can occur even after test doses and in patients who may have previously received intravenous iron. One major areas of change are that: - patients should be monitored for at least 30 minutes after every administration Administration and Dosing of VENOFER via Intravenous Bolus or Infusion Iron boluses can be administered through a peripheral vein, preferably in the dominant hand. Iron boluses and infusions will be administered through a cannula. Venofer may be administered by slow intravenous injection over 5 minutes. Infusion given over minimum of 15 minutes. Venofer 200mg up to maximum of 3 times a week with 48 hours between each dose until given total dose that has been calculated for individual patient. Please refer to appendix 1 Venofer dosing table to calculate total dose required. 9) Administration and Dosing of FERINJECT via Intravenous Infusion Ferinject administered by short infusion 100mg 1000mg over 15 minutes. Ferinject - the maximum weekly infusion dose is 1000mg over 15 minutes. Ferinject is diluted with normal saline in a volume of up to 250mls. A cumulative dose of 500mg should not be exceeded for patients less than 35Kg. Ferinject is administered weekly initially with maximum dose of 1000mg given at one time. Ferinject drug calculations as follows: Hb (g/l) Body weight 35 kg to <70kg Body weight 70kg < mg 2000mg mg 1500mg (Vifor Pharma, 2011) Available via Trust Docs Version: 2 Trust Docs ID: Page 7 of 13

8 10) Side Effects Iron overload or disturbance in utilisation of iron. Most reactions will be mild, such as: headache, hypotension, taste disturbance, nausea and vomiting, dizziness, diarrhoea. If a patient experiences side effects, consider reducing the dose and/or rate of administration of Venofer and Ferinject after clinical advice has been sought. Very rarely anaphylactic reactions occur. In the event of an anaphylactic reaction, summon medical aid immediately. Should cardiac or respiratory distress occur, follow the normal Trust cardiac arrest procedure. For all side effects or adverse reactions, clinical advice must be sought. Resuscitation drugs (Adrenaline 1:1000 injection 1mg in 0.5ml, hydrocortisone 200mg in 2ml, Chlorphenamine 10mg in 1ml) should always be immediately available during the administration of IV iron. Any adverse events must be documented in the patient s case notes and a yellow reporting card completed (legal requirement). In addition a full record of any adverse event must be made in the patients medical notes to ensure that future care takes account of possible allergies. 11) Post Treatment and Follow up monitoring Record any suspected side effects. Inform patient of possible side effects post parental iron and to when to seek medical advice. Full Blood count and Ferritin levels are repeated 4 weeks after initial treatment to check correction levels have been achieved, then repeated monthly for 3 months to assess the need for maintenance therapy. Maintenance therapy may commence once blood level targets have been achieved. Full Blood Count and Ferritin should be repeated monthly whilst on treatment, or unless otherwise directed by patient s clinician. Clinical audit standards To ensure that this guideline is compliant with the above standards, the following audits will be undertaken by the Gastroenterology Specialist Nurse responsible for managing the iron service: All data will be recorded on Gastroenterology Iron Database and reviewed 6 monthly. Annual audit to demonstrate patients meet the referral criteria. Annual audit to demonstrate patients achieve their calculated correction. The audit results will be sent to the Lead Gastro Nurse Specialist in charge of managing iron service and Clinical Director, Gastroenterology who will ensure that these are discussed at relevant governance meetings to review the results and make recommendations for further action. Available via Trust Docs Version: 2 Trust Docs ID: Page 8 of 13

9 Staff selection and training Only Registered Nurses who have successfully completed the Trust's IV Drug Therapy Clinical Skills Study Day, or equivalent, and understand the assessment and management of administration of IV iron infusions. It is the responsibility of the nurse to remain updated with research and developments in the area of treatment. Summary of development and consultation process undertaken before registration and dissemination The author Natasha Thomson, Inflammatory Bowel Disease Nurse Specialist in conjunction with Nicki Fisher, Lead Inflammatory Bowel Disease Nurse Specialist drafted this guideline on behalf of Dr Simon Rushbrook, Gastroenterology Consultant who has agreed the final content. During its development it was has been circulated for comment to: Gastroenterology Consultants, Senior Nurse Kay Marrison, Assistant Director of Nursing Dawn Collins, and Practice Development and Education Department. This version has been endorsed by the Clinical Guidelines Assessment Panel (CGAP) Distribution list/ dissemination method Gastroenterology Directorate Guist Ward Practice Development and Education Department Trust Intranet via Trust Docs References Gasche, C et al (2007) Guidelines on the Diagnosis and Management of Iron Deficiency and Anaemia in Inflammatory Bowel Dieases. Inflammtory Bowel Disease, Vol 13 (12): Goddard, A et al (2011) Guidelines for the Management of Iron Deficiency Anaemia. Gut; 60: (September 2013) Vifor Pharma. Ferinject Summary of Product Characteristics. Date of last renewal November 2016 Bibliography Boyd, J. Policy for Peripheral Intravenous Cannulation and Cannula Care in Adults (16 years and over); Norfolk and Norwich University Hospital, Ref No. E2/Trust Docs ID Moore, A et al (2011) Meta-analysis of Efficacy and Safety of Intravenous Ferric Carboxymaltose (Ferinject) from Clinical Trial Reports and Published Trial Data. BMC Blood Disorders; 11:4/ Available via Trust Docs Version: 2 Trust Docs ID: Page 9 of 13

10 Evststiev, R et al (2011) FERGIcor, A Randomized Controlled Trial on Ferric Carboxymaltose for Iron Deficiency Anaemia in Inflammatory Bowel Disease. Gastroenterology; 41: Bhandari, S (2011) Update of a Comparative Analysis of Cost Minimization Following the Introduction of Newly Available Intravenous Iron Therapies in Hospital Practice. Therapeutics and Clinical Risk Management; 7: Arnott, I et al (2009) Quality Care- Service Standards for the Healthcare of People who have Inflammatory Bowel Disease (IBD). IBD Standards; Available via Trust Docs Version: 2 Trust Docs ID: Page 10 of 13

11 Appendix 1 Venofer Dosage Table Increase in Hb required (g/dl) I.e. Target Hb Actual Hb + 500mg Body Weight In Kg (Syner-Med, 2006) Venofer dose = number of 100mg vials for Hb increase includes 500mg to replenish iron stores Venofer Administration Table Test Dose (first dose only) Administration Administration Frequency Iv Injection Inject first 20mg over 1-2 minutes wait 15mins 100mg diluted with 5mls normal saline 200mg diluted with 10mls normal saline 100mg to 200mg up to 3 times a week Iv Infusion 1 st 25mg over 15 minutes 100mg in 100mls of normal saline over at least 15 minutes 200mg in 100mls normal saline over at least 15 minutes may be given minimum of 24 hours apart (Syner-Med, 2006) Available via Trust Docs Version: 2 Trust Docs ID: Page 11 of 13

12 Appendix 2 Ferinject Dosage Table Ferinject only requires patient's current weight and current haemoglobin (Hb) level to calculate the required dose of iron. Hb (g/l) Body weight 35 kg to <70kg Body weight 70kg < mg 2000mg mg 1500mg (Vifor Pharma, 2011) A cumulative iron dose of 500mg should not be exceeded for patients with a body weight <35 kg. For patients with an Hb 14 g/dl, an initial dose of 500mg should be given and iron parameters checked prior to repeat dosing. Ferinject Administration Table Dose Maximum Dilution Minimum Administration Time 100 to 200 mg 50 ml to 500 mg 100 ml 6 minutes 500 to 1000 mg 250 ml 15 minutes (Vifor Pharma, 2011) Available via Trust Docs Version: 2 Trust Docs ID: Page 12 of 13

13 Appendix 3 Department of Gastroenterology Only REQUEST FORM FOR INTRAVENOUS IRON: Patient Label: Doctor Requesting Consultant: Date of Request: All Parts Are Mandatory, If Form Not Completed In Full Referral Will Be Rejected Indication for Treatment with Parental Iron: Taking Oral Iron Yes / No Intolerant of Oral Iron Yes / No If No Reason For Parental Iron: Previous Parental Iron: Yes / No If Yes which preparation (if known): Blood Results Within the Last Month Current Weight (needed for drug calculation): Date of blood test (dd/mm/yyyy): Hb Ferritin MCV MCH Treatment Duration: Correction Only Maintenance / As Required Available via Trust Docs Version: 2 Trust Docs ID: Page 13 of 13