Safety and Supply

Treatment product safety is a high priority for Australian blood bank services, manufacturers, the National Blood Authority and regulatory bodies, such as the Therapeutic Goods Administration, and the bleeding disorders community.

Manufacture of blood products, such as plasma factor concentrates, is carefully regulated and monitored to make sure that blood products are now as safe as possible from infections that can be transmitted by blood, such as Human Immunodeficiency Virus (HIV), hepatitis B and C and variant Creutzfeldt-Jakob Disease (vCJD):
 

• In Australia blood donors are screened and blood donations are tested for HIV, hepatitis B and C, human T-cell lymphotropic virus (HTLV) and syphilis
• When they are manufactured, factor concentrates made from human plasma are treated with several processes to remove or inactivate HIV and viral hepatitis and, as far as possible, exclude other known infectious agents that are passed on by blood
• Most people in Australia are now treated with recombinant clotting factor or non-factor therapies. They are genetically engineered and contain little or no human or animal material. There have been no reports that viruses have been transmitted by recombinant or non-factor products.

In Australia during the mid-1980s some people with bleeding disorders acquired HIV from contaminated clotting factor concentrates made from human plasma. During the early 1990s many people with bleeding disorders also found that they had been exposed to hepatitis C through the clotting factor concentrates they used for their treatment. 

The risk of new infections from using human blood products is now thought to be extremely low.  However, it cannot be entirely excluded, particularly if the risk came from a new or unknown type of blood-borne virus or other micro-organisms causing disease.  Because of this, people using these products and patient advocacy organisations such as HFA continue to take a strong and watchful interest in product safety. 

For more information on blood safety, visit the Lifeblood website.
Date last reviewed: September 2023

variant Creutzfeldt-Jakob disease

UPDATE (FEB 2009)

Health authorities in the United Kingdom recently announced that a man with haemophilia A who died from unrelated causes was found to have evidence of infection with the agent which causes variant Creutzfeldt-Jakob disease (vCJD), the human form of "mad cow disease".

Abnormal prion proteins (the infectious agent causing vCJD) were detected in the spleen during a post mortem, which had been undertaken as part of a UK surveillance study. This is the first time that a person with haemophilia has been found to have any evidence of vCJD infection, although there has been concern that this may occur.

The patient concerned had been treated with UK-produced clotting factor concentrate, which was later identified as having been made from plasma from a donor who developed vCJD after making the donation. Health authorities in the UK have identified this exposure to clotting factor as the most likely source of prion transmission to this patient.

It is important to note this is not the only possible source and the man had other potential risk factors. Whilst there was evidence of abnormal prion proteins, the man did not have vCJD and his death occurred due to unrelated causes. The follow-up investigations are not yet complete.

Although it can never be stated that there is a zero risk of transmission of infectious diseases by clotting factor concentrates, amongst people with haemophilia, it is those who were exposed to concentrates manufactured with UK-sourced plasma between 1980 - 2001 who are thought to be at increased risk of vCJD. Although this risk was considered theoretical and likely to be small, a number of precautions to reduce the risk were put in place and continue to apply.

Firstly from 1998, no UK-sourced plasma has been used in the manufacture of plasma products worldwide. Secondly, blood donors in Australia cannot donate blood to the Australian Red Cross Blood Service if they have resided in the UK between 1980 - 1996 for a total (cumulative) time of six months or more, or have received blood transfusions in the UK since 1 January 1980.

In Australia, recombinant treatment products which are manufactured with little or no human or animal material are used widely by people with haemophilia for their treatment in preference to plasma derived clotting factors. Nevertheless, some people with bleeding disorders still need to use plasma derivatives or choose to do so. Regulators require a number of steps to be taken in plasma derived products registered for use in Australia which result in these products being considered to be of minimal risk of vCJD. This includes donor deferral policies to exclude potentially at risk plasma, and processes and methods to reduce the risk of prions.

HFA is working with the Australian health authorities, Australian Haemophilia Centre Directors' Organisation and other organisations to keep aware of the UK situation and will provide further ongoing information to the bleeding disorders community.

People who are concerned about the implications of this information for their own health are encouraged to speak with their haemophilia doctor.

Further information about the UK situation is available from the following web sites:

UK Health Protection Agency news 17 Feb 2009

UK Haemophilia Centre Doctors' Organisation - Patient information page

UK Health Protection Agency - Variant CJD and plasma products

HFA does not give medical advice. This material is provided for general information only. Patients should refer to their treating doctor or haemophilia treatment centre for medical advice and/or advice about the treatment products they use. For contact details of haemophilia treatment centres go to Treatment Services.

Date last reviewed: 4th June 2009

23 February 2017 - Roche clinical trial update

You may be aware that Roche is currently conducting a clinical trial of the medication emicizumab (ACE 910), which is an investigational molecule that mimics the function of factor VIII. 

HFA was saddened to learn of the recent death of a haemophilia A patient who had been participating in the trial. Roche has advised HFA that the death has been reported and assessed as unrelated to the drug emicizumab.  

HFA understands that Roche will provide further information to doctors who are involved in the trial when it becomes available. 

People with haemophilia who are participating in the clinical trial are encouraged to speak to their doctor at their local Haemophilia Treatment Centre if they have questions. 

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9 March 2012 - CSL Biostate safety

CSL Biotherapies notified the TGA on 7 March 2012 that some batches of human albumin solutions manufactured by CSL in Australia prior to 25 January 2012 have been contaminated with ethylene glycol as a consequence of an equipment failure.

As a result the Therapeutic Goods Administration took steps to quarantine all batches of albumin in hospitals around Australia until further tests were conducted to ensure the safety of the product.

As human albumin is also used in the manufacture of plasma derived factor VIII, Biostate, people with haemophilia A who use this product may be concerned. However, the TGA has issued an advice today that the small amounts of ethylene glycol in Biostate are unlikely to pose a health risk. If anyone who uses Biostate remains concerned they should contact their doctor for further information.

Imported recombinant clotting factor products are not affected by this incident. CSL has also advised HFA that neither Prothrombinex – VF (PTX) nor MonoFIX (pdFIX) contain albumin.

www.tga.gov.au/safety/alerts-medicine-biostate-powder-120309

Date last reviewed: 23 February 2017