Chronic Renal Failure Patients Undergoing Haemodialysis

Chronic Renal Failure Patients Undergoing Haemodialysis Requiring

Intravenous (IV) Iron Clinical Guideline

V3.0

August 2019

Chronic Renal Failure Patients Undergoing Haemodialysis Requiring Intravenous (IV) Iron Clinical Guideline V3.0

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Summary

Key:

Yes

No

Follow RMS

guidance

CLICK HERE FOR GUIDELINE

End

ED/MAU/SRU/Acute GP/Amb-Care

In-patient wards

Is the renal patient iron deficient ?

Investigation: Anaemia CNS to review patient for contraindications to commencing treatment

Patient safe to have IV iron?

Anaemia nurse

referring medic

to notify

GP/SWASFT General Notes


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1. Aim/Purpose of this Guideline

1.1. This guideline applies to patients with anaemia caused by chronic kidney disease or acute renal failure receiving haemodialysis. Renal function will be determined by creatinine level and estimated glomerular filtration ratio (eGFR). The guideline will be implemented following a referral from a member of the medical team by nursing staff employed within RCHT renal services. This protocol is appropriate for staff who work within renal services and/or staff involved with the care of renal patients receiving haemodialysis treatments. All healthcare professionals have a duty of care which cannot be delegated at any time. Practitioners administering IV iron are responsible and accountable for their own clinical practice; including clinical competency. The Renal Anaemia Nurse Specialist is responsible for policy review and update. 1.2. This version supersedes any previous versions of this document. 1.3. Data Protection Act 2018 (General Data Protection Regulation – GDPR) Legislation The Trust has a duty under the DPA18 to ensure that there is a valid legal basis to process personal and sensitive data. The legal basis for processing must be identified and documented before the processing begins. In many cases we may need consent; this must be explicit, informed and documented. We can’t rely on Opt out, it must be Opt in.

DPA18 is applicable to all staff; this includes those working as contractors and providers of services.

For more information about your obligations under the DPA18 please see the ‘information use framework policy’, or contact the Information Governance Team [email protected]

2. The Guidance

The aim of the policy is to maintain haemoglobin (Hb) between 100 and 120g/l (NICE 2006, updated 2015); to monitor, correct and maintain these patients iron stores in order that they may achieve a Hb of 100-120 g/l with or without EPO therapy and to achieve the above safely.

2.1 Indications:

Hb less than 120g/l and serum ferritin below <600mcg/l

Hypochromic red blood cells >6%

Reticulocyte haemoglobin (Hb) content < 29 pg. Only use reticulocyte Hb if hypochromic red blood cell measurement is not possible.

Serum ferritin greater than >600mcg/l and % hypochromic red blood cells greater than 6%(unless infection markers grossly elevated)

Transferrin saturation level (TSAT) >20%

Iron status to be analyzed every 3 months unless otherwise indicated.

mailto:[email protected]


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2.2 Contraindications: Confer with medical staff before administering IV iron to patients with any of the following conditions

A history of asthma, eczema and other atopic allergic disorders

Iron overload

An acute or chronic infection

A history of cirrhosis or hepatitis

A history of hypotension 2.3 Prescribing Intravenous Iron Currently Iron III Hydroxide Sucrose Complex (Venofer) is administered to patients undergoing haemodialysis. The drug is electronically prescribed utilizing an algorithm on a renal specific computer system (currently Vitaldata). The dosing algorithm for Venofer is shown below.

Ferritin Range Dose Units Frequency Instructions

<100 200 mg 1 x week IV 15 mins

>=100 - 200 150 mg 1 x week IV 15 mins

>=200 - 400 75 mg 1 x week IV 10 mins

>=400-600 25 mg 1 x week IV 5 mins

>600 0 mg N/A N/A

2.4 Monitoring of Iron Levels in the Blood:

Ferritin level and hypochromic count to be taken every 3 months unless otherwise requested. Venofer does not need to be discontinued before blood samples are taken. The patient is to be investigated for iron loss which may entail being referred for endoscopy investigations if iron levels/Hb indicate poor response to treatment.

2.5 Risk of an anaphylactic reaction: As with all intravenous drugs there is a risk of anaphylaxis or an allergic reaction whilst administering IV iron for the first and subsequent doses.

2.5.1 Minor symptoms:

Skin flushing, pruritis, urticaria

Treatment: stop administering iron and call a doctor.

2.5.2 Major symptoms:

Respiratory- dyspnoea, chest tightness, wheezing, laryngeal oedema causing stridor and cough, feeling of lump in throat

Cardiovascular- reduced cardiac output, myocardial ischaemia, hypotension tachycardia, dysrhythmias, and peripheral vasodilation


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General- nausea and vomiting, headache, dizziness, confusion

Treatment: Stop administering the iron, fast bleep a doctor or dial 4444 for assistance; prepare hydrocortisone, anti-histamine and adrenaline drugs.

2.6 Should a reaction occur:

Ensure details of the reaction are documented within the nursing and medical notes and on the front page of the prescription chart

If a patient experiences a reaction or side effects after a dose of iron please discuss with the patients consultant re: continuing iron therapy

In the event of an adverse reaction, the Yellow Card scheme must be completed and sent to pharmacy.

3. Monitoring compliance and effectiveness

Element to be monitored

2.0 Commencing IV iron: (Haemodialysis Patients)

Lead Anaemia Management Nurse employed within Renal Services, RCHT.

Tool IV iron for haemodialysis patients is to be electronically prescribed on the current electronic system employed in Renal Services, RCHT. The system should not allow prescribing of the drug unless there is a ferritin level on the system. The individual prescribing the drug will review the patient’s ferritin level and previous IV iron regime before prescribing further drug treatment.

Frequency The IV iron dose, frequency, ferritin level and hypochromic percentage or reticulocyte haemoglobin (Hb) content will be monitored by the Anaemia Management Nurse every 3 months. This data will be shown on excel documents stored on Oesdata13_server\Data13. This is a shared drive accessible by staff employed within renal services. The Anaemia Management Nurse will present this data annually at renal audit meeting.

Reporting arrangements

If the ferritin level remains <100 ug/l after a 6 week period of receiving Venofer 200 mgs weekly the Anaemia Management Nurse will report this to the patient’s consultant nephrologist. Any Venofer prescribing undertaken by the Anaemia Nurse will be subject to clinical review by the consultant nephrologists at haemodialysis patient reviews. If discrepancies are identified at these reviews they will be reported to the medical divisional lead for governance and safety, RCHT and the Anaemia Nurse Manager will be subject to further training and education.

Acting on recommendations and Lead(s)

The Anaemia Management Nurse will act on recommendations within 1 month of prescribing discrepancy being identified.


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Change in practice and lessons to be shared

If discrepancies are identified following consultant review of prescribing undertaken by the Anaemia Nurse Manager the clinical supervision sessions will take place more frequently; every 3 months. Lessons learned will be shared with all the relevant stakeholders.

4. Equality and Diversity

4.1. This document complies with the Royal Cornwall Hospitals NHS Trust service Equality and Diversity statement which can be found in the 'Equality, Inclusion & Human Rights Policy' or the Equality and Diversity website.

4.2. Equality Impact Assessment The Initial Equality Impact Assessment Screening Form is at Appendix 2.

http://www.rcht.nhs.uk/GET/d10268876

http://www.rcht.nhs.uk/GET/d10268876

http://intranet-rcht.cornwall.nhs.uk/shelf/equality-and-diversity/


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Appendix 1. Governance Information

Document Title


Date Issued/Approved: 28 May 2019

Date Valid From: August 2019

Date Valid To: August 2022

Directorate / Department responsible (author/owner):

Sharon Benton, Anaemia Nurse Specialist

Contact details: 01872 253499

Brief summary of contents

The policy details the process for the use of IV iron in haemodialysis patients. The policy includes guidance to support effective and safe prescribing of the drug.

Suggested Keywords: Anaemia, Kidney, Renal, Venofer, Iron intravenous IV, Ferritin, Hypochromic % reticulocyte haemoglobin (Hb)

Target Audience RCHT CFT KCCG

Executive Director responsible for Policy:

Medical Director

Date revised: 28 May 2019

This document replaces (exact title of previous version):

Venofer Protocol For Chronic Renal Failure Patients Undergoing Haemodialysis V2.3

Approval route (names of committees)/consultation:

Dr S J Dickinson, Medical Division Lead for Governance and Safety, RCHT

Care Group General Manager confirming approval processes

Sidwell Lawler

Name and Post Title of additional signatories

Not Required

Name and Signature of Care Group/Directorate Governance Lead confirming approval by specialty and care group management meetings

{Original Copy Signed}

Name: Becky Osborne

Signature of Executive Director giving approval

{Original Copy Signed}


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Publication Location (refer to Policy on Policies – Approvals and Ratification):

Internet & Intranet Intranet Only

Document Library Folder/Sub Folder Clinical / Renal

Links to key external standards

Nice Clinical Guideline 39: Anaemia Management in People with Chronic Kidney Disease. NICE, London http://guidance.nice.org.uk/CG114

Related Documents:

RCHT Patient Identification Policy RCHT Consent to Treatment/Examination RCHT Standards of Record keeping RCHT Infection Control NMC Code of Conduct, Performance and Ethics Prescription or Patient Group Direction for appropriate medications as detailed within this protocol.

National Kidney Foundation (2000) Kidney Disease Outcome Quality Initiative: Clinical Practice Guidelines For Anemia Of Chronic Kidney Disease. National Kidney Foundation

NICE with National Collaborating Centre for Chronic Conditions (2006, updated 2015) Nice Clinical Guideline 39: Anaemia Management in People with Chronic Kidney Disease. NICE, London

UK Renal Association (2007) Clinical Practice Guidelines; Module One Chronic Kidney Disease, (2nd Edition) UK Renal Association, Hampshire.

Training Need Identified? No

http://guidance.nice.org.uk/CG114


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Version Control Table

Date Version

No Summary of Changes

Changes Made by (Name and Job Title)

10 Jun 10

V1.0

Initial Issue

Andrew Rogers Corporate Records

Manager

1 Feb 11

V2.0

Addition of Monitoring Compliance table.


Manager

15 Jan 12

V2.1 Governance information moved to an appendix. EIA updated. Governance information amended to align with format of


Manager

5 Aug 13

V2.2

Updated governance information table to include KCCG.


Manager

19 Jan 2016

V2.3 Policy updated as per NICE guideline 2015 and Pathology Harmonisation Guidance 2007

Sharon Benton, Anaemia Nurse

Specialist

28 May 2019

V3.0 Full review. Reformatted to latest trust template and changed name of system at Section 2.3 from Renal+ to Vitaldata

Sharon Benton, Renal Anaemia Specialist Nurse

All or part of this document can be released under the Freedom of Information Act 2000

This document is to be retained for 10 years from the date of expiry.

This document is only valid on the day of printing

Controlled Document This document has been created following the Royal Cornwall Hospitals NHS Trust Policy for the Development and Management of Knowledge, Procedural and Web

Documents (The Policy on Policies). It should not be altered in any way without the express permission of the author or their Line Manager.


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Appendix 2. Initial Equality Impact Assessment Form


Directorate and service area: Renal

New or existing document: Existing

Name of individual completing assessment: Sharon Benton

Telephone: 01872 253499

1. Policy Aim* Who is the strategy / policy / proposal / service function aimed at?

To maintain Hb between 100 and 120g/l in 85% of patients (NICE 2006, updated 2015) To monitor, correct and maintain our patients iron stores in order that they may achieve an Hb of 100-120 g/l with or without EPO To achieve the above safely

2. Policy Objectives*

To ensure correct administration of intravenous iron supplementation

3. Policy – intended Outcomes*

To achieve the above safely

4. *How will you measure the outcome?

As per section 2.0 Monitoring compliance and effectiveness

5. Who is intended to benefit from the policy?

Patients on haemodialysis receiving IV iron All staff administering IV iron to haemodialysis patients

6a Who did you consult with b). Please identify the groups who have been consulted about this procedure.

Workforce Patients Local groups

External organisations

Other

X

Renal Governance Group

What was the outcome of the consultation?

Approved


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Are there concerns that the policy could have differential impact on:

Equality Strands: Yes No Unsure Rationale for Assessment / Existing Evidence

Age

Sex (male,

female, trans-gender / gender reassignment)

Race / Ethnic communities /groups

Disability - Learning disability, physical impairment, sensory impairment, mental health conditions and some long term health conditions.

Religion / other beliefs

Marriage and Civil partnership

Pregnancy and maternity

Sexual Orientation, Bisexual, Gay, heterosexual, Lesbian

You will need to continue to a full Equality Impact Assessment if the following have been highlighted:

You have ticked “Yes” in any column above and

No consultation or evidence of there being consultation- this excludes any policies which have been identified as not requiring consultation. or

Major this relates to service redesign or development

8. Please indicate if a full equality analysis is recommended. Yes No

9. If you are not recommending a Full Impact assessment please explain why.

Not indicated

7. The Impact Please complete the following table. If you are unsure/don’t know if there is a negative impact you need to repeat the consultation step.


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Date of completion and submission

28 May 2019

Members approving screening assessment

Policy Review Group (PRG) ‘APPROVED’ to be added here once reviewed at PRG.

This EIA will not be uploaded to the Trust website without the approval of the Policy Review Group. A summary of the results will be published on the Trust’s web site.