EmailHospital Circular 08/2004
Date Issued: 16 March 2004
Distribution: Public Hospitals, Private Hospitals
Subject: Intravenous Immunoglobulin (IVIG) Shortages
Purpose: To advise hospitals on critically low stocks of Intravenous Immunoglobulin (IVIG, Intragam P) in Victoria and to inform restrictions on the use of this product.
This circular replaces 06/2004 issued on 12 March 2004 with the following amendment; Sandoglobulin ® is imported and sold by CSL Ltd - Bioplasma Division.
1. Background
In Australia, intravenous immunoglobulins (IVIG) are produced exclusively by CSL Limited. They are manufactured by voluntarily donated plasma collected around Australia by the Australian Red Cross Blood Service (ARCBS). Funding for the manufacture of IVIG is provided by governments and the product is issued free of charge to patients in Australia and supplied to end-users by the ARCBS.
In addition, a TGA registered overseas product , Sandoglobulin ® , is imported and sold in Australia by CSL Ltd - Bioplasma Division. Funding for this product comes from individual hospital budgets and/or patients.
2. Current Status of Supply
Australia is facing anticipated supply shortages of Intragam P ® as the clinical demand for IVIG continues to increase rapidly. Current stock holdings of this product are worsening and will be exhausted in the very short term.
Urgent action is required to manage demand as supply of available Intragam P ® to Victoria is now being restricted to the historical usage levels over the last two years.
Currently, Intragam P ® is issued in accordance with guidelines released in 2000 by a Working Party of the Australian Health Ministers' Council (AHMAC) Blood and Blood Products Committee. The current situation means that Agencies (Public Hospitals, Private Hospitals and Private Pathology Laboratories) must ensure that usage of Intragam P ® is managed as stringently as possible to maximise available supply to meet critical clinical need.
Health Services and/or patients also have the option of purchasing Sandoglobulin ® from hospital and/or individual budgets.
3. Prioritisation of use of intragam P ®
The critical shortage of Intragam P ® necessitates the prioritisation of the use of Intragam P ® and restriction of this product to life threatening conditions. In accordance with the Review of the Use and Supply of Intravenous Immunoglobulins in Australia guidelines, prioritisation of the use of IVIG in periods of acute shortage should be based on clinical need as determined by the following consensus criteria:
- Clinical significance using the level of therapeutic effect as judged by improvement of quality of life and/or survival;
- Availability of other forms of treatment including a consideration of cost-effectiveness; and
- Risks involved with IVIG treatment.
4. Establishment of IVIG User Group
Given the seriousness of the current situation, the Australian Red Cross Blood Service - Victoria is convening an IVIG User Group on Tuesday 23 March at 5.30pm. Senior Departmental officers will be in attendance and good representation from a broad spectrum of clinical areas is expected. Discussions will focus on how to manage the short and long term demand of IVIG.
Departmental Contacts:
Trevor Sutherland (03) 9616 1302
Tania Nallathamby (03) 9616 1316
Dr Chris Brook
Executive Director
Rural and Regional Health & Aged Care Services
