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From: TSS (216-119-139-242.ipset19.wt.net)
Subject: Variant Creutzfeldt-Jakob disease and plasma products: implementation of public health precautions in the UK
Date: September 23, 2004 at 9:49 am PST

-------- Original Message --------
Subject: Variant Creutzfeldt-Jakob disease and plasma products: implementation of public health precautions in the UK
Date: Thu, 23 Sep 2004 11:56:12 -0500
From: "Terry S. Singeltary Sr."
To: Bovine Spongiform Encephalopathy


------------------------------------------------------------------------

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

Anna Molesworth (anna.molesworth@hpa.org.uk
), Helen Janacek, 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 now known to have developed vCJD.
Collectively, they have made 23 plasma donations. The donated plasma has
been 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
patients 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 Agencys (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

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.http://www.eurosurveillance.org/ew/2004/040923.aspTSS






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