Future directions in Australian haemovigilance
Adverse event reporting for non‑fresh products
This report is confined to haemovigilance with respect to fresh blood components, such as red blood cells, platelets, fresh frozen plasma, cryodepleted plasma and cryoprecipitate. The Australian medical community also makes significant use of many plasma and recombinant products.
A range of valuable products is manufactured from plasma through the process of fractionation, in which different proteins found in blood plasma are separated, purified and concentrated into distinct therapeutic products. Most plasma derived products supplied in Australia are manufactured from plasma collected by the Blood Service and fractionated by CSL Behring. Some are imported.
Alternative recombinant product versions of plasma derived products are also available. These are manufactured by the expression of equivalent proteins from genetically engineered cell lines.
Important plasma and recombinant products are:
- intravenous and subcutaneous immunoglobulin
- hyperimmune immunoglobulin products
- albumin products
- clotting factors and other products.
Health professionals are required to report adverse events that occur as a result of administration of all blood and blood products. It is a requirement under NSQHS Standard 7[33] to report all adverse events into that facility's incident management and investigation system, as well as to the state and/or national haemovigilance system. As plasma and recombinant products are classified as medicines, reports of adverse events are directed to the TGA.[39]
The TGA maintains a reporting service for adverse events or defects in medicines in Australia. The reporting is mandatory for sponsors (serious adverse events only) and voluntary for other groups such as hospitals and general practitioners. The TGA publishes annual adverse event statistics. In 2013, the TGA receives over 17,500 adverse event reports of which 55% were by sponsors, 4% by general practitioners and 10% by hospitals. The TGA also publishes the adverse event data received through the Database of Adverse Event Notifications. Information on TGA reporting can be found on the TGA's website[40] and reports can be submitted in various ways.
Products for haemophilia and bleeding disorders
The Australian Bleeding Disorders Registry (ABDR)[41] was introduced in December 2008. The ABDR was further developed (to Version 4) in August 2012. A patient self-recording module, MyABDR, was launched in February 2014.
The ABDR is a clinical registry for patients in Australia with bleeding disorders. It is administered by the NBA, and used on a daily basis by clinicians in all Australian haemophilia treatment centres to assist in managing the treatment of people with bleeding disorders and to gain a better understanding of the incidence and prevalence of bleeding disorders.
The ABDR includes information on the following types of adverse events:
- an allergic or acute reaction possibly linked to a treatment administered to the patient
- a transfusion transmitted infection possibly linked to a treatment administered to the patient
- a malignancy possibly acquired from a treatment administered to the patient
- thrombosis possibly caused by a treatment administered to the patient
- the development of an inhibitor possibly caused by a treatment administered to the patient
- death of the patient possibly linked to a treatment administered to the patient
- poor efficacy or other adverse events possibly linked to a treatment administered to the patient.
The NBA produces ABDR annual reports and adverse event reporting will become more prominent as the dataset matures.
Intravenous immunoglobulin (IVIg)
Intravenous immunoglobulin (IVIg) is a fractionated blood product made from pooled human plasma. It is registered for use in Australia for the treatment of a number of diseases where immunoglobulin replacement or immune modulation therapy is indicated. IVIg is used to treat a growing number of unregistered indications where there is some evidence for its utility. IVIg is a life-saving therapy in appropriately selected patients and clinical circumstances.
Since the 1980s, the demand for IVIg has greatly increased, both internationally and in Australia. In the late 1990s, worldwide shortages prompted action by Australian governments to ensure that IVIg was available for those patients most in need. Since that time, strategies to ensure supply have included:
- rationalising the use of IVIg by specifying conditions and limiting IVIg access under the national blood arrangements to those patients meeting the specified conditions and eligibility criteria
- increasing the manufacture of IVIg in Australia
- importing IVIg from overseas.
The continual significant annual growth in IVIg usage, the high cost of IVIg products and the potential for supply shortages have all maintained the focus of Australian governments on ensuring use remains consistent with an evidence‑based approach and that IVIg is able to be accessed under the National Blood Arrangements for those patients with the greatest clinical need.
The Criteria for the clinical use of intravenous immunoglobulin[42] in Australia describes current arrangements for access to IVIg funded under the national blood arrangements and the conditions for its use. The criteria have been developed to help clinicians and medical professionals identify the conditions and circumstances for which the use of IVIg is appropriate and funded.
The TGA collects information from hospitals and general practitioners on IVIg-related adverse reactions occurring in Australia. The NBA may work with the TGA on the inclusion of such data in future reports.