VCJD: Further precautionary measures announced to groups of patients, UK

Main Category: CJD / vCJD / Mad Cow Disease
Article Date: 21 Sep 2004 - 14:00 PDT

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Selected groups of patients are this week being notified about the results of a risk assessment exercise for blood plasma products.

The notification exercise, which relates to the possible transmission of variant Creutzfeldt-Jakob disease through blood products, was announced by Health Secretary John Reid on September 9.

To reduce the risk of onward transmission through surgery, selected patients have been told that, because they have received certain batches of plasma products in the past, they could be at a small increased risk of carrying the vCJD agent.

This advice is highly precautionary and is based on recommendations made by the expert CJD Incidents Panel.

These patients (and their healthcare professionals) are being advised that they have in the past received batches of plasma products which were derived from blood donated from someone who has later gone on to develop vCJD. As a precautionary measure, a number of steps should be taken to reduce any possible onward patient-to-patient transmission of vCJD.

People who may be affected are:

• Some people with haemophilia and other bleeding disorders. All of these people (around 6,000) will receive letters about the background to this exercise to keep them fully informed. The number who may be affected directly is estimated to be around 4,000 people

• A small group of people suffering from primary immunodeficiency, estimated to number around 50 people

• A small number of people who have been treated with large quantities of particular plasma products for a range of conditions (e.g. secondary immunodeficiency).

It is not possible to know exact numbers of people in any of these groups until the patient records have been examined. This process began on 9 September.

Although any additional risk to these people is likely to be very small, it is necessary to take some simple steps to minimise any chance of passing on the infection.

These steps include not donating blood, tissue or organs, and ensuring they tell their doctors and dentists if they undergo treatment in future.

The situation has arisen because, since December last year, two instances have been reported where vCJD is suspected to have been passed on by blood transfusion.

Blood donated by a small number of people who went on to develop vCJD has been traced. People who received direct, one-to-one transfusion of 'whole blood' from these donors were contacted earlier this year and told about any additional risk they may face.

Now plasma from these same donors used to manufacture products such as clotting agents has also been traced. Plasma products are manufactured from pools of many thousands of donations, greatly reducing any risk of vCJD being passed on.

A detailed risk assessment has been undertaken which has recommended the groups listed above are notified that they might face a slightly increased risk.

This notification process is taking place this week.

A dedicated NHS Direct helpline has been set up to answer queries about this issue. Its number is 0845 850 9850

Chief Medical Officer Sir Liam Donaldson said:

"Throughout our handling of the issue of vCJD we have adopted a highly precautionary approach, taking a series of steps as new evidence became available to maximise the protection of the public.

"This risk assessment continues this approach and identifies three groups of patients who need to know that they may be at a small increased risk of developing vCJD than the rest of the population who ate beef during the 1980s and 1990s.

"This information will enable these people and their doctors to take the necessary steps to minimise the risk of onward transmission of vCJD."

Health Secretary John Reid said:

"Two principles have guided my department's handling of the issue of vCJD and its possible transmission through blood - maximum caution and maximum openness.

"That is why, since the first report of suspected transmission via whole blood transfusion last December, we have taken further steps to maximise the safety of the UK's blood supply.

"We have also been open with the public, Parliament and health professionals about each step we have taken and the expert advice behind it. We are continuing this approach today by announcing the results of this risk assessment exercise.

John Reid added:

"We have, however, been concerned to do everything practicable to ensure the patients directly affected are informed by the specialist doctors who care for them, so they can be given all appropriate information and support.

"I know this information may be difficult to absorb, which is why we are working with their doctors and other clinicians, to ensure they have the information and support they need."

Notes to editor

1. This exercise has been undertaken by the Health Protection Agency on behalf of the Department of Health. Further relevant material has been placed on the HPA website on the link provided:

2. The exercise is based on the recommendations of the independent CJD Incidents Panel. The panel drew on a risk assessment by Det Norske Veritas Consulting, published at the link attatched.

3. Previous measures taken to improve the safety of blood in relation to vCJD include the following:

• Since 1998, plasma derivatives, such as clotting factors, have been prepared from plasma imported from the USA.

• Since October 1999, white blood cells (which may carry a significant risk of transmitting vCJD) have been removed from all blood used for transfusion.

• In August 2002 we announced that fresh frozen plasma for treating babies and young children born after 1 January 1996 would be obtained form the USA.

• On 16 December 2002, the Department of Health completed its purchase of the largest remaining independent US plasma collector, Life Resources Incorporated. This secures long-term supplies of non-UK blood plasma for the benefit of NHS patients.

• In April 2004, individuals who had themselves received a transfusion of whole blood components since January 1980 were excluded from donating blood.

• The exclusion criteria for blood donation was extended on 2nd August 2004 to include two new groups, who have received transfusions of whole blood components since 1980:

• Previously transfused apheresis donors; and

• Donors who were unsure if they had previously had a blood transfusion

UK Dept of Health

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