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Home Eurosurveillance Weekly Release  2004: Volume 8/ Issue 39 Article 1 Printer friendly version
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Eurosurveillance, Volume 8, Issue 39, 23 September 2004
Articles

Citation style for this article: Molesworth AM, Janecek H, Gill N, Connor N. Variant Creutzfeldt-Jakob disease and plasma products: implementation of public health precautions in the UK. Euro Surveill. 2004;8(39):pii=2552. Available online: http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=2552

Variant Creutzfeldt-Jakob disease and plasma products: implementation of public health precautions in the UK

Anna Molesworth (anna.molesworth@hpa.org.uk), Helen Janecek, Noel Gill, Nicky Connor, Health Protection Agency Communicable Disease Surveillance Centre, London, United Kingdom

The CJD Incidents Panel (CJDIP), a United Kingdom expert committee set up to advise on the management of ‘incidents’ of potential transmission of Creutzfeldt-Jakob disease) between patients, has issued recommendations on the management of variant CJD (vCJD) risk from implicated plasma products.

To date, nine UK plasma donors are known to have developed vCJD. Collectively, they made 23 plasma donations. The donated plasma was used to manufacture factor VIII, factor IX, antithrombin, intravenous immunoglobulin G, albumin, intramuscular human normal immunoglobulin, and anti-D.

The potential risk of vCJD infection following treatment with any implicated plasma products, on top of the risk from dietary exposure to the bovine spongiform encephalopathy (BSE) agent, is very uncertain. So far, there are no recorded instances of vCJD being spread through surgery, nor have there been any cases among recipients of plasma products sourced from individuals who later developed vCJD. In December 2003, the death from vCJD of a person some years after receiving a blood transfusion from a donor who had died of vCJD was announced [1]. In July 2004 a second probable case of transfusion-associated vCJD infection was identified [2]. These two events have increased concern about the potential infectivity of blood and plasma products.

Public health precautions against vCJD
The CJDIP now recommends that certain special public health precautions need to be taken for some recipients of UK sourced plasma products that were manufactured using donations from individuals who subsequently developed vCJD. This is in order to reduce any possible risk of iatrogenic transmission of vCJD.

The CJDIP has used a vCJD blood risk assessment (http://www.dnv.com/consulting/news_consulting/RiskofInfectionfromvariantCJDinBlood.asp), together with information on how the particular batches of plasma products were manufactured, to assess the potential levels of infection that patients were exposed to.

The CJDIP advises certain special public health precautions need to be taken for recipients of UK sourced plasma products who have been exposed to a 1% or greater potential additional risk of vCJD infection as these patients could pose a risk to others in defined circumstances. These at risk patients are asked:

  • not to donate blood, organs or tissues,
  • to inform their clinician if they need medical, surgical or dental treatment, so that infection control precautions (http://www.advisorybodies.doh.gov.uk/acdp/tseguidance/) can be taken to reduce any possible risk of spreading vCJD, and to consider informing their family, in case they (the patients) need emergency surgery in the future.

The CJDIP has categorised each batch of implicated plasma products according to the likelihood that special public health precautions need to be taken as follows:

  • High: the amount of potential infectivity in product batches was high enough to warrant special public health precautions following the administration of a very small dose. These batches should be traced, and the recipients advised of their exposure and asked to take special public health precautions.
  • Medium: substantial quantities of the material in question would need to have been administered to warrant special public health precautions. Efforts should be made to trace these batches and assess the additional risk to individual recipients to determine if special precautions should be taken.
  • Low: the potential additional risk to recipients is considered negligible. These batches do not need to be traced and the individual recipients do not need to be informed.

This categorisation is based on very cautious assumptions, and the uncertainties underlying the assessment of ‘risk’ are great. The CJDIP guidance is to limit any possible iatrogenic human-to-human transmission of vCJD. It should NOT be interpreted as an estimate of an individual patient’s additional risk of developing vCJD, which is uncertain, and likely to be very low.

The patients who may be affected include some patients with bleeding disorders, some patients with primary immunodeficiency (PID), and some patients with other conditions, who may include, for example, patients with secondary immunodeficiencies, certain neurological and autoimmune conditions, plasma exchange recipients and patients with severe burns, and with some other conditions requiring critical care.

Patients in the UK who are ‘at-risk’ of vCJD for public health purposes are being contacted by their doctors and informed of the precautions they will need to take.

The product manufacturers are providing details to individual countries to which parts of batches with a ‘High’ or ‘Medium’ likelihood that public health precautions might be required were exported. The UK Department of Health and the Health Protection Agency are providing further details to authoritative bodies in these countries as well as to the European Commission and WHO.

The Health Protection Agency’s (HPA) CJD section at the Communicable Disease Surveillance Centre is coordinating the patient notification in England, Wales, and Northern Ireland. The Scottish Centre for Infection and Environmental Health (SCIEH) is coordinating this notification in Scotland. Background information about vCJD with useful links is available from their websites:

HPA: http://www.hpa.org.uk/infections/topics_az/cjd/menu.htm
SCIEH: http://www.show.scot.nhs.uk/scieh

*Editorial note, 24 September 2004: the second paragraph of this report has been re-edited for grammatical corrections since publication.

References:
  1. Llewelyn CA, Hewitt PE, Knight RS, Amar K, Cousens S, Mackenzie J, et al. Possible transmission of variant Creutzfeldt-Jakob disease by blood transfusion. Lancet 2004;363(9407):417-21.
  2. Peden AH, Head MW, Ritchie DL, Bell JE, Ironside JW. Preclinical vCJD after blood transfusion in a PRNP codon 129 heterozygous patient. Lancet 2004;364(9433):527-9.

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