Anaemia Management When Administering Total Dose ... · The Anaemia Management Nurse will inform the patient by telephone and / or letter of their appointment times and review times

Anaemia Management When Administering Total Dose Intravenous Iron

Supplement Clinical Guideline

V3.0

July 2019

Anaemia Management When Administering Total Dose Intravenous Iron Supplement Clinical Guideline V3.0 Page 2 of 13

1. Aim/Purpose of this Guideline

1.1. To maintain Hb between 100 and 120 g/l in 85% of patients (NICE 2015) 1.2. 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

1.3. To achieve the above safely

1.4. This protocol applies to all staff who work within renal services and/or staff involved with the care of pre dialysis, transplant and peritoneal renal patients. It is also applicable to all staff who administer Rienso, Ferinject or Monofer and those who intend to administer these drugs. 1.5. This version supersedes any previous versions of this document.

1.6. 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

2.1. Responsibilities All healthcare professionals have a duty of care which cannot be delegated at any time. The practitioners administering Rienso, Ferinject or Monofer are responsible and accountable for their own clinical practice; including clinical competency. The Anaemia Management Nurse employed within renal services is responsible for policy review and update. 2.2. Indications & Contraindications

2.2.1. Indications

Hb less than 120g/l and serum ferritin below 200mcg/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 200mcg/l and % hypochromic red blood cells greater than 6%(unless serum ferritin >800 micrograms/litre)

Transferrin saturation level (TSAT) >20% and serum ferritin level <100

mailto:[email protected]


micrograms/litre (optional)

Monitoring of iron status required during and after iron therapy for individuals receiving erythropoietin. Iron status to be analyzed every 3 months.

2.3. Contraindications Confer with medical staff before administering 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

2.4. Referring a Patient for Intravenous Iron

Medical staff to refer patients to the Anaemia Management Nurse with Hb, ferritin and % hypochromic red blood cells if known

Once referred the patient will be added to the program and reviewed at least every three months for a term no greater than 6 months

The Anaemia Management Nurse will inform the patient by telephone and / or letter of their appointment times and review times

2.5. Monitoring Of Renal Outpatients The Anaemia Management Nurse will review the blood results of those patients that are due for an iron infusion and contact the patients to discuss the need for IV iron therapy 2.6. Prescribing Intravenous Iron Total dose iron products such as Ferinject and Monofer should be prescribed on a pre-printed „Out- Patient IV Iron Prescription‟ sheet. Example Ferinject 1000mgs IV as per protocol. Please ask the Doctor to write diluted dose‟ if applicable. The drug can be prescribed by a competent Non Medical prescriber employed within the Renal Unit, Medical Directorate, RCHT. 2.7. Administration of Intravenous Iron

2.7.1. The patient must be monitored for 30 minutes post infusion. Intravenous iron doses should only be administered by staff who are trained to administer intravenous infusions, recognise and manage anaphylactic reactions in an environment with resuscitation facilities immediately available. 2.7.2. Ferinject and Monofer are total dose IV irons. This means a large dose may be given in a single infusion. 2.7.3. Ferinject dosage and administration – Each 2 ml vial contains 100 mg of iron as ferric carboxymaltose. Each 10 ml vial contains 500 mg of iron as ferric carboxymaltose. Each 20 ml vial contains 1000 mg of ferric carboxymaltose. Ferinject can be administered by intravenous injection using an undiluted solution up to 1000 mg iron. For doses greater than 200 and


up to 500 mg iron, Ferinject should be administered at a rate of 100 mg/min. For doses greater than 500 and up to 1000 mg iron, Ferinject should be administered over 15 minutes. Ferinject must not be administered by the subcutaneous or intramuscular route. (SPC, sourced November 2015) 2.7.4. Monofer dosage and administration – Each 2 ml vial/ampoule contains 200 mg iron as iron(III) isomaltoside 1000. Each 5 ml vial/ampoule contains 500 mg iron as iron (III) isomaltoside 1000. Each 10 ml vial/ampoule contains 1,000 mg iron as iron (III) isomaltoside 1000. Monofer may be administered as a total dose infusion in which the total iron dose is given in a single infusion. Doses of 0-10 mg iron/kg body weight must be infused over 30 mins. Doses of 11-20 mg iron/kg body weight must be infused over 60 mins. Within this policy it is recommended that Monofer is given over 60 minutes ( SPC, sourced November 2015)

2.8. Prior to infusion:

2.8.1. Ensure resuscitation facilities are available 2.8.2. Identify the patient as per RCHT Patient Identification Policy

2.8.3. Explain the need for intravenous iron supplementation, the procedure involved and the side effects that may occur.

2.8.4. Obtain verbal consent as per RCHT Policy for Consent to treatment / examination before administering each dose.

2.8.5. Record baseline observations before commencing

2.8.6. Give as an infusion via a 26 gauge needle or butterfly over 30 mins observing patient for any signs of reaction. If administering Monofer this is to be given over 60 mins.

2.8.7. Monitor pulse and BP post dose

2.8.8. Flush the cannula/butterfly with normal saline and ask patient to wait up to 30 mins in case of delayed reaction. Remove the cannula/butterfly after 10 mins

2.8.9. Inform patient of action to take if reaction should occur eg phone 999 / GP depending on severity

2.8.10. Highlight to the patient to inform the Healthcare professional of prior iron infusion

2.9. Risk of an anaphylactic reaction: As with all intravenous drugs there is a risk of anaphylaxis or an allergic reaction whilst administering Ferinject or Monofer for the first and subsequent doses. All common, uncommon and rare symptoms are detailed in Appendix 3.


2.10. Minor symptoms:

Skin flushing, pruritis, urticaria

Treatment: stop administering iron, call a doctor and prepare anti-histamine and hydrocortisone drugs

2.11. 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

General - nausea and vomiting, headache, dizziness, confusion

Treatment: Stop administering the iron, fast bleep a doctor, prepare hydrocortisone, anti-histamine and adrenaline drugs and/or prepare drugs from anaphylactic kit. (If drug is being given in the community, the above should be followed and the patient’s G.P should be contacted immediately or dial 999 depending on the severity of the reaction rather than a doctor being fast bleeped.)

2.12. 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, a yellow card must be completed and sent to pharmacy


3. Monitoring compliance and effectiveness

Element to be monitored

2.4. Referring a Patient For Intravenous Iron

Lead Anaemia Management Nurse employed within Renal Services, RCHT.

Tool The Anaemia Management Nurse will contact the patients to discuss the need for IV iron therapy. Community sites will notify the patient of their appointment times for IV iron to be given. Appointment communications will be either written or via telephone contact. If the patient does not attend their appointment the community site will arrange a second appointment. If a patient does not attend (DNA) a second time the community site will contact the Anaemia management Nurse and he/she will contact the patient. A record will be kept of patients who do not attend their appointments.

Frequency The number of non attendees will be monitored every 6 months. A report on non attendees will be written and shared annually.

Reporting arrangements

The medic who referred the patient will be notified by the Anaemia Management Nurse if a patient does not attend the second appointment. The report on non attendees will be sent to the governance lead for renal services. The report should identify, if known, the reason why each patient DNA‟d. The governance lead and Anaemia Management Nurse will review the report and identify actions to reduce the number of DNA‟s.

Acting on recommendations and Lead(s)

The Anaemia Management Nurse will act on recommendations within 3 months of the annual report review.

Change in practice and lessons to be shared

The patient‟s non attendance will be shared with their GP. The GP will be advised that he/she can refer the patient to the Anaemia Management Nurse if the patient wishes treatment in the future. The GP will be notified of the plan in writing by the Anaemia Management Nurse. This letter will be sent from Maxims.

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/


Appendix 1. Governance Information

Document Title Anaemia Management When Administering Total Dose Intravenous Iron Supplement Clinical Guideline V3.0

Date Issued/Approved: 22.01.19

Date Valid From: July 2019

Date Valid To: July 2022

Directorate / Department responsible (author/owner):

Sharon Benton, Anaemia Coordinator

Contact details: 01872 253499

Brief summary of contents

The policy details the process for administering total dose IV iron in renal patients. The policy includes guidance should the patient not attend for treatment.

Suggested Keywords:

Anaemia,Kidney, Renal, Ferinject, Iron, intravenous IV, Community, Ferritin, Hypochromic %, Monofer, Rienso

Target Audience RCHT CFT KCCG

Executive Director responsible for Policy:

Medical Director

Date revised: 22.01.19

This document replaces (exact title of previous version):

Anaemia Management When Administering Total Dose Intravenous Iron Supplementation V2.0

Approval route (names of committees)/consultation:

Dr Giorgio Gentile, Medical Division Lead for Governance and Safety, RCH

Care Group General Manager confirming approval processes

Sidwell Lawler, General Manager

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}


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 Policy NMC Code of Conduct, Performance and Ethics Prescription or Patient Group Direction for appropriate medications as detailed within this protocol

NICE -National Institute for Health and Care Excellence (2015) Chronic Kidney Disease: managing anaemia nice.org.uk/guidance/ng8 UK Renal Association (2007) Clinical Practice Guidelines; Module One Chronic Kidney Disease, (2nd Edition) UK Renal Association, Hampshire.

Training Need Identified?

Yes Staff administering total dose IV iron for the first time will require clinical supervision. This can be provided by the Anaemia Management Nurse. Staff who are proficient and competent at administering total dose iron can train other staff.

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


Version Control Table

Date Version

No Summary of Changes

Changes Made by (Name and Job Title)

16.09.13

V1.0

Policy already exists for multiple small dose IV iron therapy in CKD population. New policy written to support total IV iron doses enabling larger single dose treatments.

Sharon Benton, Anaemia Management Nurse

17.11.15

V2.0

Policy expires January 2016. Policy updated as per NICE guideline 2015.

Sharon Benton, Anaemia Management Nurse

22.01.19

V3.0

Rienso® removed, no longer licensed for use

in renal medicine Sharon Benton, Anaemia Management 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.


Appendix 2. Initial Equality Impact Assessment Form

Name of the strategy / policy /proposal / service function to be assessed

Anaemia Management When Administering Total Dose Intravenous Iron Supplement Clinical Guideline V3.0

Directorate and service area: Renal

New or existing document: Existing

Name of individual completing assessment: Sharon Benton, Anaemia Coordinator

Telephone: 01872 253499

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

To maintain Hb between 10.0 and 12.0g/l in 85% of patients (NICE 2006, updated 2011) To monitor, correct and maintain our patients iron stores in order that they may achieve an Hb of 10.0-12.0 g/l with or without EPO To achieve the above safely

2. Policy Objectives*

To ensure correct administration of total dose intravenous iron supplementation

3. Policy – intended Outcomes*

To achieve the above safely

4. *How will you measure the outcome?

As per section 3 of this guideline

5. Who is intended to benefit from the policy?

Patients with chronic kidney disease or failure referred for treatment with intravenous iron. All staff administering total dose intravenous iron.

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

√

Dr Giorgio Gentile, Medical Division Lead for Governance and Safety, RCH. (Updated policy reviewed at Renal Governance Meeting.)

What was the outcome of the consultation?

Policy approved


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.


Date of completion and submission

22.01.2019

Members approving screening assessment

Policy Review Group (PRG) APPROVED

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.


Appendix 3. Common, Uncommon and Rare Symptoms of Anaphylactic Reaction

Nervous system disorders : Cardio-vascular disorders:

Common (≥ 1/100, < 1/10):

transient taste perversions (in particular metallic taste), dizziness, headache

Uncommon (≥ 1/1000, < 1/100):

hypotension and collapse, tachycardia and palpitations. Flushing Hypertension.

Uncommon (≥ 1/1000, < 1/100):

paraesthesia

Rare (≥ 1/10000, < 1/1000):

syncope, loss of consciousness, burning sensation.

Rare (≥ 1/10000, < 1/1000):

Arrhythmia

Respiratory, thoracic and mediastinal disorders: Gastrointestinal disorders:

Uncommon (≥ 1/1000,

< 1/100):

bronchospasm, dyspnoea. Uncommon (≥ 1/1000, < 1/100):

nausea; vomiting, abdominal pain, diarrhea, faeces discoloured, constipation, flatulence

Rare (≥ 1/10000, < 1/1000):

Epistaxis

Skin and subcutaneous tissue disorders: Musculoskeletal, connective tissue and bone disorders:

Uncommon (≥ 1/1000, < 1/100):

pruritus, urticaria, rash, exanthema, erythema, sweating, skin reaction

Uncommon (≥ 1/1000, < 1/100):

muscle cramps, spasms or pains, myalgia, back pain

General disorders and administration site disorders: Immune system disorders :

Uncommon (≥ 1/1000, < 1/100):

fever, shivering, flushing, chest pain and tightness. Injection site disorders such as superficial phlebitis, burning, swelling.

Uncommon (≥ 1/1000, < 1/100):

Hypersensitivity including anaphylaxis

Rare (≥ 1/10000, < 1/1000):

arthralgia, peripheral oedema, fatigue, asthenia, malaise, feeling hot, oedema.

Rare (≥ 1/10000, < 1/1000):

anaphylactoid reactions.

Blood and lymphatic system disorders: Metabolism and nutrition disorders: Rare (≥ 1/10,000 to < 1/1,000)

Eosinophilia, haemolysis Uncommon (≥ 1/1,000 to < 1/100)

Decreased appetite Increased appetite

Rare (≥ 1/10,000 to < 1/1,000)

Dehydration, gout and/or hyperkalaemia

Eye disorders and labyrinth dis orders : Hepatitic: Rare (≥ 1/10,000 to < 1/1,000)

Lacrimation increased Vision blurred, transient deafness

Rare (≥ 1/10,000 to < 1/1,000)

Hepatic function abnormal