Directive D2000-01: Donor Exclusion to Address Theorerical Risk of Transmission of Varient CJD Through the Blood Supply

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Directive D2000-01: Donor Exclusion to Address Theorerical Risk of Transmission of Varient CJD Through the Blood Supply (PDF Version, 84 Kb)
Date: 2000-08-30

DATE: August 30, 2000

FROM: A/Director General, Therapeutic Products Programme

TO: Licensed Canadian Blood Establishments

SUBJECT: Donor Exclusion to Address Theoretical Risk of Transmission of variant CJD through the Blood Supply

1. PURPOSE

The purpose of this Directive is to advise all licenced Canadian blood establishments which collect and manufacture blood and blood components to take measures to reduce the theoretical risks of transmission of variant Creutzfeldt-Jakob Disease (vCJD) through the blood supply by excluding from donating blood or blood components all persons who have spent time in France, exclusive of French territories outside the European continent, amounting, cumulatively, to a period of 6 months or more between the years 1980 to 1996, inclusive. The requirements in this Directive do not apply to autologous donations. Other, non-Canadian manufacturers will be requested to follow similar deferral criteria. This directive is additional to previous directives and guidelines issued on the subject of Creutzfeldt-Jakob Disease and its variant.

2. BACKGROUND

Variant Creutzfeldt-Jakob disease (vCJD), first described in 1996, is a "new" disease, linked with the outbreak of Bovine Spongiform Encephalopathy (BSE) in cattle.

While, to date, there have been no cases of vCJD attributable to the use of blood or plasma derivatives, lack of experience with this condition and the causative agent, together with certain biological effects associated with infection, suggest that vCJD may have the potential to spread through blood or blood derivatives.

In considering this potential risk and measures to deal with it, the principle has been adopted that one must seek to apply measures which will reduce the targeted risk without jeopardizing the safety of the blood system in other ways.

Since the issuance, on August 17, 1999, of Directives requiring the exclusion from blood donation of all persons who had spent time amounting, cumulatively, to a period of 6 months or more, in the United Kingdom between the years 1980 to 1996, inclusive, it has become apparent that there is a risk of acquiring variant CJD which is associated with residence in France. This risk is manifest in the occurrence of two cases of vCJD which have been confirmed, both of which are believed to have been acquired during residence in France. France has recently acknowledged a third, apparently indigenous, case which meets clinical diagnostic criteria for vCJD.

It currently appears likely that these cases have been acquired through the consumption of beef or beef products originating in the United Kingdom during the period 1980 to 1996. Thus, the risk period of concern is the same as that declared for the U.K. i.e. 1980 to 1996 inclusive.

In recognition of uncertainties regarding the epidemic potential of this disease in either the UK or France, it has been decided that the criterion relating to length of stay in France would remain as had been applied to the UK, i.e. persons who had, cumulatively, resided in France for six months or longer, would be required to be deferred from donation.

At this time, the theoretical risk of acquiring vCJD through residence in the UK and that incurred through residence in France are not thought to be the same. Health Canada does not intend to require deferral based on the combination of time spent in the UK with time spent in France. The impact of a combination of different time periods spent in each of these countries that may total six months or greater, on donor populations and the supply of blood, is not clear from the surveys undertaken by Canadian Blood Services (CBS) and Héma-Québec (HQ), and would be very difficult to estimate. Consequently, Health Canada cannot recommend deferrals based on combined residency periods in the U.K. and France since this may risk creating shortages of unknown magnitude of essential blood components.

Consideration has been given to widening the scope of this Directive to include non-Canadian manufacturers of plasma derivatives. Such a requirement, however, is judged to have the potential of restricting the availability of such products to the Canadian market. Restricted availability will affect practitioners' access to drugs of choice for their patients and may result in shortages which have the potential to harm the health of Canadians. As a consequence of those considerations, this Directive will have application to manufacturers procuring blood and plasma in Canada. A letter is being issued recommending that manufacturers outside the scope of this Directive also apply these deferral criteria in the collection of plasma used to produce derivative products sold in Canada.

The Therapeutic Products Programme, in conjunction with the Centre for Infectious Disease Prevention and Control, will continue to monitor the developing science around vCJD and the impact of the policy on the blood system. Blood operators will be required to report semi-annually on the impact of CJD donor deferrals on their donor bases and the supply of blood.

It is recognized that information will continue to come forward relating to risks associated with acquisition of vCJD. Health Canada will continue to evaluate such data and may update its guidance in response to new knowledge.

3. SCOPE

This Directive applies to blood or plasma collections performed in Canada at licensed blood establishments.

4. LICENSING REQUIREMENTS

Blood establishments are required to submit a Licence Amendment Submission to the Therapeutics Products Programme, Bureau of Biologics and Radiopharmaceuticals for review.

An attachment must be included which indicates both the impacts that this measure will have on your donor base and the measures you plan to mitigate any such effects. Operators are also encouraged to develop materials to be used in explaining these deferral actions to affected donors in order to foster an appropriate understanding of these actions.

Regarding the withdrawal of prior donations by deferred donors, Health Canada will require, as in the case of donors who are deferred because of six months or longer residence in the UK, that all available components collected from deferred donors, that have not been transfused or pooled for further manufacture be retrieved.

5. COMPLIANCE DATE

The exclusion is to be introduced as soon as operationally feasible, but not later than (three) months from the date of issue of this document.

The information detailing changes in your operating procedures to incorporate the above exclusion information is required as soon as possible but no later than November 1, 2000.

6. ADDITIONAL INFORMATION

Questions concerning the Donor Exclusion to Address Theoretical Risk of Transmission of variant CJD through the Blood Supply should be directed to:

Director, Bureau of Biologics and Radiopharmaceuticals
Therapeutic Products Programme
3rd Floor LCDC Building #6
Postal Locator 0603C
Tunney's Pasture
Ottawa, Ontario
KIA 0L2

Attention: Blood and Tissues Division.

Robert G. Peterson, M.D. PhD. MPH