/ CHHS18/032

Canberra Hospital and Health Services

ClinicalProcedure

Immunoglobulin Authorisation and Administration– Adults, Paediatrics and Neonates

Contents

Contents

Purpose

Criteria

Alerts

Scope

Section 1 –Authorisation / approval of Immunoglobulin (IVIg, SCIg, NIg)

Section 2 – Urgent requests for IVIg (submitting an emergency Authorisation request in BloodSTAR)

Section 3 – Ordering product from transfusion laboratory once approval obtained (IVIg, SCIg, NIg)

Section 4 – What to do if the patient does not meet the Criteria

Section 5 – Normal human immunoglobulin NHIg

Section 6 – Patient Information and Consent

Section 7 – Administration of IVIg

Section 8 – SCIg program for home based care

Section 9 – Administration of SCIg/NHIg

Section 10 – Patient Monitoring and Adverse Reaction Management

Section 11 – Maximum Infusion Rates All 10% IVIg Products

Section 12 – Product Storage Conditions

Section 13 – Contact Phone List

Implementation

Related Policies, Procedures and Legislation

References

Search Terms

Attachments

Attachment A – A Training Checklist

Purpose

The purpose of this document is to provide a systematic and consistent approach for the safe and appropriate administration of Intravenous Immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) across ACT Health. All staff involved in transfusion of IVIg and or SCIg are responsible for maintaining and updating their knowledge and practices.

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Criteria

IVIg and SCIg are used in the management of an increasingly wide range of diseases. IVIg and SCIg are used mainly as a source of antibody replacement in primary immunodeficiency (PID) and to modulate the immune system in autoimmune and inflammatory diseases. Access to IVIG and SCIg in Australia is approved by the Australian Red Cross Blood Service (Blood Service). In order for patients to gain approval through the Blood Service, the patients must also meet conditions outlined in the Criteria for the Clinical Use of Intravenous Immunoglobulin in Australiaedition 2012 (the Criteria)

BloodSTAR.

BloodSTAR is an online system that facilitates authorisations, dispensing and reviews of immunoglobulin products such as IVIg and SCIg in Australia in line with the Criteria.

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Scope

Alerts

  • Avoid starting infusion overnight in non urgent cases;
  • IVIg can be administered through a vented giving set.

(E.g.B|BraunInfusomat Space line ref: 8700110SP)

  • IVIg will be given where resuscitation equipment is available, in an area where the patient can be easily observed and monitored;
  • IVIg contains no antimicrobial additives or agents therefore should be infused immediately after opening;
  • A Medical Officer should be accessible (easily reached by phone) at all times during IVIg transfusion.

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Scope

This procedure pertains to Medical and Nursing staff ordering and/or administering IVIg/SCIg across ACT Health.

Products currently approved under the National Blood Arrangements:

IVIg / SCIg
  • Intragam10%
/
  • Evogam NF

  • Privigen 10%
/
  • Hizentra 20%

  • Flebogamma 10 %

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Section 1 –Authorisation / approval of Immunoglobulin(IVIg, SCIg, NIg)

IVIg, SCIgand NHIgare issued in accordance with the Criteria.

Authorisation for Ig under the National Blood Arrangements must be obtained via BloodSTAR available at

SCIg is only approved for patients with a medical condition where there is support for use cited in the Criteria for the Clinical use ofIntravenousImmunoglobulin in Australia, namely:

  • Primary immunodeficiency diseases with antibody deficiency
  • Specific antibody deficiency;
  • Acquired hypogammaglobulinaemia secondary to haematological malignancies (chronic lymphocytic leukaemia, multiple myeloma, non-hodgkin lymphoma and other relevant malignancies, and post-haemopoietic stem cell transplantation)secondary hypogammaglobulinaemia (including iatrogenic immunodeficiency);
  • Being treated by a clinical specialist within a hospital based SCIg program (see below);
  • Where the hospital provides access to all resources and takes full accountability for the management and use of the SCIg product, at no additional cost to patients; and
  • Following a patient-specific SCIg request submitted to, and authorised by, the Australian Red Cross Blood Service (Blood Service).

IVIg can be obtained under National Blood Arrangements or Direct Order arrangements(see section 4)

Patients travelling overseas

Provision for the supply of product for patients temporarily travelling or studying overseas maybe granted in accordance with the Policy for Issuing Blood Products and Blood Related Productsin Australia for Use Overseas. For more information, please refer to the NBA website at

Dosage

Dosage of Immunoglobulin (Ig) is dependent on the condition for which it is being administered; with the aim of using the lowest possible dosage that achieves an appropriate clinical outcome for each patient. Please refer to the Criteria.

Equipment

  • BloodSTARregistration portal;
  • Blood Transfusion Request form.

Procedure for authorisation of Ig

Register with BloodSTAR

Treating clinicians must seek approval for Ig via BloodSTAR.

If approval has already been granted go directly to section 3-Ordering product from transfusion laboratory.

Alert
BloodSTAR User Registration is a two part process comprised of:
  1. BloodPortal User Registration– Creating a single username and password for all NBA systems, and
  2. B. BloodSTAR Role Request– Requesting a role and location for access to your facility

  1. Access
  2. Select BloodPortal
  3. Login with your BloodPortal User Name and Password.
  4. If you do not have an account already, please select “New User? Create an account” link next to the login button.
  1. Once you have Blood Portal access select the BloodStar tile :

For BloodSTAR prescriber tip sheet see

  1. Request access in the My Account drop down menu

  1. Select “add role to access request”, complete all mandatory fields and save.
  2. Accept terms and conditions and ‘Submit’.
  3. A CHHS systems administrator will accept your request allowing access to request for Ig.

Request authorisation

  1. Make new authorisation request by selecting the Authorisation Requests tab at the top of the BloodStar home page and click New Initial Authorisation Request.
  • A patient search window will appear.
  • Enter the full name and date of birth of the patient, and click Search.
  • If there is an exact match, the patient will appear for you to select and continue with a patient already in BloodSTAR; a partial match will not return results.
  • If there is no match, select Create New Patient to progress with an authorisation request after entering the extra required details for that patient.
  1. Enter patient details and obtain consent to store patient data in BloodSTAR

Alert
Patients must consent to having their details stored in BloodSTAR. Copies of the consent form and information for patients as to what details are recorded and why are available on the consent page in BloodSTAR.
Enter in your patient’s consent status,
  • Select whether the consent granted was verbal or written, who granted the consent and the date it was obtained.
  • You can nominate if the consent status is recorded in the medical record and also upload a scanned copy of any consent you have received in writing.
  • If this form is used it should be uploaded into BloodSTAR as it has not been approved for use by CHHS

  1. Add treating administering facility details.
  2. Add diagnosis.
  3. Add patient weight.
  4. Add dose required.
  5. The product type and dosage per kilogram will be pre-populated and is determined by the entered diagnosis.
  6. Enter the details of the treatment, including frequency, date required and any notes.
  7. If you need to select a different product, tick the box marked Request a different product. A field will appear for you to select an alternate product and to provide a reason for the change. This reason is mandatory.
  8. Treatment duration and amount per kilogram is calculated automatically off the weight entered for the patient. If you need to prescribe more than the recommended maximum of product per kilogram, enter this under Dose/Kg. If the Dose/Kg is higher than the recommended amount under the criteria you must enter a reason.
  9. When all details are completed, select Save and Continue.
  10. Confirm all details and check the box Accepting Terms and Conditions. Click Submit to complete the request.
  11. All requests will be reviewed by the Blood Service and prescribers will be notified ( by email) dispensing facilities will also be notified via BloodNET.

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Section 2 – Urgent requests for IVIg (submitting an emergency Authorisation request in BloodSTAR)

An important function in BloodSTAR is the ability for a Medical Officer who does not yet have full access to be able to place an Emergency Authorisation Request.

You must submit an access request but do not have to have the access approved before you can lodge an emergency request for a patient. You will only be able to place one emergency authorisation request before you are fully approved as a Medical Officer by thefacility administrator.

  1. Complete Blood Portal registration (see section 1)
  2. Request BloodSTAR access as per section 1 (point 5-6)
  3. For BloodSTAR prescriber tip sheet see
  4. Once your access request has been submitted, you will be navigated to the Access Request History Page. You can submit an emergency request by clicking the link + Emergency Authorisation Request
  1. A warning will appear, specifying that you may only complete this function for an emergency and that you will be notified by email of the outcome, as well as informing you that you are able to search for a direct match for an existing patient but will not be able to see all patients for the site, as that access is restricted to approved users. Your provisional access will be removed after 48 hours if not approved by the facility administration.

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Section 3 –Ordering product from transfusion laboratory once approval obtained (IVIg, SCIg, NIg)

All approved requests for supply of IVIg/ SCIgto the clinical area must be written on a Blood Transfusion Request form and signed by the requesting Medical Officer or Nurse Practitioner. Documentation must be legible and include:

  • Patient surname, full given name, date of birth and the medicalrecord number (MRN);
  • Gender;
  • Name and signature of requesting doctor;
  • Product to be transfused;
  • Date and time the product is required;
  • Relevant clinical history;
  • Dose required in grams.

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Section 4 – What to do if the patient doesnot meet the Criteria

Where the patient does not meet the Criteria:

Patients that do not meet the Criteria can,in some instances receive Ig under the Jurisdictional Direct Order (JDO), where imported Ig is available to approved recipients. In these circumstances the treating clinician must submit a request to the hospital
Drug Therapeutics Committee (DTC) for approval.

Contact details for DTC:Email:email

Secretariat ext. 42121

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Section 5–Normal human immunoglobulinNHIg

NHIg, a scarce resource produced from the same plasma pool as domestically produced IVIg and SCIg,may be supplied under the national blood arrangements for two purposes, as follows:

  1. NHIg may be supplied for public health disease control activities, to treat susceptible contactsof an indicated infectious disease (hepatitis A, measles, poliomyelitis or rubella), where directedby the public health physicians, infectious disease consultants or clinical microbiologists. Advice and guidance to public health units in responding toa notifiable disease event can be found in the Series of National Guidelines (SoNGs) at:
  1. NHIg may be supplied for the treatment of immunodeficiency conditions for which the productis indicated, for patients for whom treatment with IVIg and SCIg (where available) are bothcontraindicated, provided that:
  • The diagnosis and written prescription is provided by a relevant medical specialist;
  • The same diagnostic, qualifying, exclusion and review criteria and authorisation process for the relevant conditions are used to authorise the supply of NHIg, as would apply for the supply of IVIg or SCIg for those conditions;
  • At the time of seeking authorisation, the prescribing specialist clinician confirms in writing the specific clinical reason why treatment with IVIg and SCIg are both contraindicated;
  • The governing requirements for SCIg are applied where NHIg is proposed to be used outside of the hospital setting;
  • Ongoing access to supply of NHIg may cease if the required review and supporting documentation demonstrating clinical effectiveness against the review criteria have not been met.

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Section6– Patient Information and Consent

Documented consent for Blood and Blood Products is required under National Safety and Quality Health Care Standard - Standard 7. Significant risks, benefits and alternatives to IVIg/SCIg including the patient’s right to refuse should be discussed and documented in the patient progress notes in accordance with ACT Consent to Treatment Policy and Procedures (Including sections:Consent and Treatment: Blood and Blood Products; Consent and Treatment : Children or Young People; and Consent to treatment : Capacity and Substitute Decision maker) .

Consent for IVIg/ SCIg should also be documented on the Blood and Blood Products Prescription and Checklist document, available on the clinical forms register.

All patients should be routinely provided with written information prior to commencement of the IVIg/ SCIg.

Equipment

  • Blood and Blood Products Prescription and Checklist document
  • For Consumer information IVIg (selectappropriate Hyperlink):

Intragam® 10%Human Normal Immunoglobulin

Privigen®Normal immunoglobulin (Human) 10% (100 g/L)

Flebogamma 10%

  • For Consumer information SCIg (selectappropriate Hyperlink):

Evogam®Human Normal Immunoglobulin 16% (16 g/100 mL)

Hizentra®Human Normal Immunoglobulin 20% (20 g per 100 mL)

Procedure

Treating medical officer to:

  1. Discuss clinical decision to administer IVIg/SCIg with patient or authorised patient advocate.
  2. Discuss risks, benefits with patient or authorised patient advocate.
  3. Provide appropriate consumer information.
  4. Document consent on the Blood and Blood Products Prescription and Check list document
  5. If patient or authorised patient advocate is unable to consent, or refuses consent, this must also be documented in clinical record.

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Section 7– Administration of IVIg

Alert precautions

  • IVIg must only be administered intravenously.
  • IVIg contains traces of IgA which may provoke anaphylaxis in patients with IgA antibodies.
  • IVIg must be administered separately from other IV fluids or medications -administer via a dedicated line or lumen

Equipment

  • IVIg Product
  • Blood and Blood Product Prescription and Checklist
  • Vented IV giving setBraun Infusomat Space line ref: 8700110SP
  • Infusion Pump
  • MEWS Observation Chart

Procedure

  1. Ensure consistent practice with ACT Health Hand Hygiene practices.
  2. Ensure there is a current medical order written up on Blood and Blood Products Prescription and Checklist.
  3. Ensure that the patient has received adequate education and has had the opportunity to ask questions about blood product transfusions.
  4. Ensure the patient has given informed consent to receiving the transfusion and this is documented in the clinical record.
  5. Order trough IgG levels prior to infusion where appropriate.
  6. Allow IVIg to reach room temperature before opening.
  7. Check IVIg against transfusion sheet with two nursing staff, one of which must be a Registered Nurse, AT THE PATIENTS BEDSIDE in line with standard IV management:
  • Check correct IVIg product and concentration of product;
  • Correct Dosage;
  • Expiry date; and
  • Batch number (attach batch number sticker to transfusion document supplied by the laboratory).
  1. Patient must be wearing an identification wristband.
  2. Ask patient to state and spell their given name, surname and date of birth.
  3. Check full name, MRN and date of birth exactly match written orders, Patient ID band and Transfusion Sheet.
  4. Record baseline vital signs (temperature, heart rate, blood pressure, respirations/SaO2andLOC).
  5. Give premedication if indicated. See Section 7 -Adverse Reactions
  6. Remove plastic cover from the seal on the vial and wipe the exposed rubber stopper with an alcohol swab and allow to dry.
  7. Use a vented giving set e.g. B|BraunInfusomat Space line ref: 8700110SP;
  8. Ensure IV Cannula (IVC) is patent by flushing with 5-10mL Normal Saline.
  9. IVIg must be administered separately from other IV fluids or medications -administer via a dedicated line or lumen.
  10. Prime the IV line with the Ig product.
  11. Program infusion pump using appropriate guard rails.
  12. Commence infusion.
  13. Continue observation and titrate infusion via appropriate protocol see Section 10 Infusion Rates.
  14. When infusion complete document completion time, flush and remove cannula if no further IV treatment is required.

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Section 8 – SCIgprogram for home based care

Referral to SCIg Program

All referrals to the SCIg home based program from the treating consultant must be directed to the SCIg Nurse and the Haematology/ Oncology Outpatient CNC.

See contact phone list Section 13 Pg 15

Patients must meet the clinical authorisation criteria outlined in Section 1

In addition,patients mustundergo a nursing assessment to establish their suitability for the program i.e.

  • Patients/carer understanding of the responsibilities of home based care
  • Psychosocial status
  • Cognitive status
  • Suitable home environment to safely administer at home

Patients will be triaged by the SCIg Nurse and referring consultant according to need.

Induction program

Induction and assessment of competency will be determined by the SCIg Nurse utilising the A Training Checklist.Example at Attachment A

Completed check list is to be scanned and recorded in CHARMTM by the SCIg Nurse.

Session 1:

Orientation to the SCIg support network and facilities.

Establishment of a ‘buddy system’ (i.e. having a support person at home while they are infusing the product).

SCIg Nurse demonstrates nominated procedure (push/ pump) and associated safety criteria to patient /carer.