Guide – Setting up a Subcutaneous Immunoglobulin (SCIg) program in a hospital

pdfASCIA HP Guide setting up SCIg Program 2018207.13 KB

Immunoglobulin replacement therapy (IRT) is the standard treatment for most children and adults with primary immune deficiencies and some other medical conditions.  The aim is to replace immunoglobulin to maintain normal IgG levels. The dose used is individualised for each patient. IRT may be given as intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) and pharmacokinetics differ according to administration route.

When prescribing SCIg or IVIg, you must ensure that doses are rounded to the full vial size. Immunoglobulin is a plasma derived product and is a limited resource. Prescribing a dose that uses a partial vial results in unnecessary wastage.  Vial sizes vary between different products.  This must be taken into account before prescribing.

Whilst there are multiple brands that may change over time and rates of administration vary for different products, both IVIg and SCIg:

  • Are effective at reducing infections and hospitalisations
  • Preserve organ function and reduce long term damage from recurrent infections
  • Are associated with significant benefits to patient quality of life
  • Improve the lifespan of patients 

Issues to consider when setting up a SCIg service           

  • Australian hospitals are required to be ‘SCIg approved’ by the National Blood Authority (NBA). For further information go to www.blood.gov.au/Ig-governance   
  • Once a hospital is “SCIg Approved” the site needs to be NBA Bloodstar (Australia) registered (except in NSW – see note below).  All medical officers or nurse practitioners (prescribers) and nurses involved in the management of patients requiring or approved for SCIg at the site also need to be registered on NBA Bloodstar in order to get access to SCIg for their patients. A patient is registered on Bloodstar when the Australian Red Cross Blood Service (ARCBS) approves them for SCIg use – the health site does not need to register the patient. For further information go to: blood.gov.au/bloodstar 
    Note - At the time of developing this document NSW hospitals, staff and patients do not require NBA Bloodstar registration.             
  • Does your hospital or region have a Ig (SCIg/ IVIg) policy or guidelines in place?
    What teaching/training resources are available? To review the ASCIA Position Statement on SCIg go to
    www.allergy.org.au/hp/papers/scig
    Other ASCIA resources are available at www.allergy.org.au/immunodeficiency 
    For further information contact This email address is being protected from spambots. You need JavaScript enabled to view it.  
  • What are the pros and cons of SCIg delivery methods? (refer to table 2 in this document)
  • SCIg product ordering process for the hospital and collection process for the patient

Issues to consider include:

  • Cold chain and transport
  • Prescription (if required) and associated dispensing fee to the patient
  • Frequency and place of collection
  • Special consideration for rural and remote patients
  • Long term management of patients on SCIg

Issues to consider include:

  • Trouble shooting with SCIg and contact details of dedicated staff readily available to patients when       assistance is required or when things do not go to plan (these details should be noted in treatment       plan)
  • Nursing resources
  • Reporting and management of adverse reactions
  • Traveling with SCIg
  • Patient diaries
  • Supply of consumables
Table 1: Comparison of Pros and Cons of IVIg and SCIg therapy      

 

Pros

Cons

IVIg

  • Less frequent infusion (monthly)
  • Rapid increase in serum IgG
  • Does not require patient training
  • Usually hospital based
  • IV access required
  • Risk of immediate and systemic adverse effects
  • Adverse effects from high IgG levels in 12-48 hours post infusion
  • Symptoms related to wear off effects of IgG trough levels

SCIg

  • Home based therapy
  • IV access not needed
  • Few systemic side effects
  • Can be used for patients with previous systemic reactions to IVIg or IV access difficulties - SCIg therapy may be the preferred treatment in these patients
  • Faster infusion duration
  • More consistent IgG levels with no wearing off effects related to IgG trough levels 
  • Improved QOL of patient and family with flexibility, independence and empowerment
  • Reduced hospital costs
  • Reduced patient travel time and associated costs and inconveniences (e.g. time off school/ work, parking costs).
  • Patient can take treatment with them when travelling (e.g. on holiday)
  • Frequent administration (1-3 times per week)
  • Local side effects (swelling, induration, local inflammation, itch), which are usually mild and transient
  • Some patients may require battery or spring driven pumps, although some patients may use the rapid push method which does not require a pump.
  • Requires treatment plan compliance

Source:  Adapted from APIIEG

Table 2: Comparison of Pros and Cons of SCIg infusion methods

 

Pros

Cons

Manual:

Rapid Push

  • Inexpensive (no pump required)
  • Self-empowerment
  • Rapid infusion rate (short duration)
  • Portable and flexible
  • Can be used when pump fails  
  • Requires manual strength and dexterity
  • Manual operation required for the duration of the infusion
  • Larger bore/gauge needle required for infusing

Mechanical infusion pumps:

Spring loaded

(e.g. Springfusor, SCIG 60, Freedom 60)

  • Relatively inexpensive device
  • Robust (no electronics) and doesn’t require servicing
  • Doesn’t require programming
  • Lightweight, portable and flexible
  • Automated
  • Relatively expensive consumable costs
  • Limited control of infusion rate and duration in some devices

Mechanical infusion pumps:

Battery powered

(e.g. Nikki T 34, T34L)

  • Relatively inexpensive consumable costs
  • Automated
  • Infusion rate and duration can be controlled
  • Portable and flexible
  • Usage and compliance can be monitored
  • Relatively expensive device cost
  • Requires service and careful handling
  • Requires programming and set up
  • Batteries require recharging or replacing
  • Repairs may be challenging for rural or remote patients 

Table 3: Suppliers of SCIg equipment - pumps and consumables 

  Supplier Website

Niki T34 syringe driver 

Caesarea Medical Electronics

IDFNZ will fund members in NZ

www.remsystems.com.au/suppliers/caesarea-medical-electronics/

www.remsystems.co.nz/

www.idfnz.org.nz/

SCIg 60 infusion system 

EMED Technologies

www.emedgroup.com.au/

Springfusor® 

Admedus

www.admedus.com/

Freedom 60 infusion system 

Medical Devices

www.medicaldevices.com.au

Freedom Edge infusion system 

Medical Devices

www.medicaldevices.com.au

Winged infusion sets (25 or 24 gauge) 

Terumo

www.terumomedical.com 

Soft-Glide single lumen or double lumen sets

(various gauge sizes)

EMED Technologies

www.emedgroup.com.au/

Neria® single lumen or multi-lumen sets 

Unomedical

www.infusion-set.com/

HIgh Flo single lumen or multi-lumen sets 

Medical Devices

www.medicaldevices.com.au

Flow control tubing for Springfusor®

 (various flow rates) 

Admedus

www.admedus.com/

© ASCIA 2018

ASCIA is the peak professional body of clinical immunology and allergy specialists in Australia and New Zealand  

Disclaimer

This document has been peer reviewed by ASCIA members and is based on expert opinion and the available published literature at the time of review.  Information contained in this document is not intended to replace medical advice and any questions regarding a medical diagnosis or treatment should be directed to a medical practitioner.

This document has been developed independently by ASCIA, with an unrestricted grant from CSL Behring. CSL Behring has not determined the content, and responsibility for this document remains for ASCIA.

Development of this document is not influenced by CSL Behring or any other commercial organisations.

Content updated June 2018

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