# Presentation: 784780

## Deferral of Blood and Plasma Donors for History of Transfusion in BSE Countries of Europe  

- Deferral of Blood and Plasma Donors for History of Transfusion in BSE Countries of Europe

- Alan E. Williams, Ph.D.
- Director, Division of Blood Applications
- Office of Blood Research and Review
- CBER, FDA
- TSE Advisory Committee
- February 8, 2005

##  Current FDA Recommendations:  vCJD –Related Donor Deferral

- Guidance to Industry January, 2002
- _>_ 3 months residence/travel in U.K. 1980 - 1996
- _>_ 5 years residence/travel in Europe
- For donors of Source Plasma this criterion applies only to France (5-10% consumption of UK beef)
- 	  _>_ 6 months on certain US military bases in Europe  	between 1980-1990 or 1980-1996 (up to 35% UK 	beef consumed)
- 	 Transfusion in the U.K. 1980 – present
- Receipt of bovine insulin sourced in the U.K. after 1980

## TSEACOctober 14, 2004

- Review of current FDA recommendations regarding vCJD-related donor eligibility
- No TSEAC recommendations for further FDA actions to protect the blood supply
- Discussion:
- Predictive value of donor questions to exclude TSE risk
- Feasibility of deferral for history of transfusion outside of the UK

## Predictive value of the donor questionnaire

- Limited data.  True validation of donor screening process  is  complex/expensive
- DH Task Force - Major progress to improve and streamline the donor questionnaire from a design and cognitive understanding standpoint

## Estimates of false negative donor responses derived frompost-donation research studies

- Anonymous REDS mail surveys post-donation demonstrated  2 – 3 %  overall  “deferrable risk”  (0.1 – 0. 5% for individual behavioral risks;  higher for less-well-defined exposures) JAMA 1997 277(12):967-972
- Parallel findings from other similarly-designed studies       (Canada,  Hong Kong)
- Numerous studies based on post-donation interviews of test-positive donors show a high prevalence of deferrable  risk

## Post Donation Information (PDI) linked to Biological Product Deviation Reports

- Biological Product Deviation Reports (BPDR)
- Reported to FDA _only when implicated product was issued_. (May substantially underestimate true incidence of  actual deviations in some situations)
- PDI – most common Biological Product Deviation Report (BPDR)
- vCJD travel was most common PDI reported in FY ‘03

## Post Donation Information (PDI) linked to Biological Product Deviation Reports

- Source of PDI*
- Subsequent donation – 92%
- Telephone call from donor – 4.2%
- Third party (e.g., doctor, family member – 3.8%
- When deferral was known by donor*
- Known at time of donation but not provided – 91.8%
- Not known at time of donation – 8.1%

## BPDRs for Blood and Plasma Donor Centers

| FY | BPDRs | PDIs |  | PDIs due to vCJD Travel |  |
| --- | --- | --- | --- | --- | --- |
|  |  | # | % | # | % |
| FY01 | 23,363 | 18,256 | 78.1 | 2,879 | 15.8 |
| FY02 | 32,162 | 23,162 | 72 | 3,966 | 17.1 |
| FY03 | 38,994 | 30,321 | 77.8 | 8,369 | 27.6 |
| FY04 | 36,238 | 26,854 | 74.1 | 6,420 | 23.9 |

## Summary – Predictive value of donor screening

- Estimates of the predictive value of donor screening are crude, however based upon available data, false negative self-report of donor eligibility may be in ~ 3-5% range of donors deferred on-site, and may be higher in relation to complex questions

## Donor Deferrals for History of Transfusion

- Current FDA recommendation is deferral for transfusion in the U.K. (1980 – present)
- Recent developments:
- Probable vCJD transmissions by transfusion
- Prior donations by vCJD case in France
- Donor deferral for any previous transfusion
- France – 1998
- The Netherlands – 2004 (est 8% donor loss)

## Range of possible policy extensions

- Transfusion in France since 1980
- Transfusion in any BSE country in Europe since 1980
- Any transfusion since 1980

## Estimated Donor Loss Related to History of Transfusion in UK and France   

- Hx tx (UK - deferral already accomplished)  0.4 x 0.05 = **2/10,000**
- Hx Tx (France) 0.4 x 0.7 x 0.05 = **1.4/10,0000**
- (Source Plasma donor impact expected to be less due to younger age)
- Assumptions:
-  5% prevalence of transfusion in US donors overall (REDS data)
-  >/= 5 yr travel/residence CONSERVATIVELY approximates lifetime transfusion exposure (4/10,000 donors have > 5 year UK exposure)
- rate of tx among long term residents/travelers to Europe and UK = overall US donor prevalence
- prevalence of travel to France  = 0.7 x travel to UK

## Estimated Donor Loss Related to Deferral for a History of Transfusion in Europe  

- Hx Tx (any Europe, excl. UK)   0.7% x 0.05  = ** 3/10,000**
- (Source Plasma donor impact expected to be less due to younger age)
- Assumptions:
-  5% prevalence of transfusion in US donors overall (REDS data)
-  >/= 5 yr travel/residence CONSERVATIVELY approximates lifetime transfusion exposure (7/10,000 donors reported > 5 year exposure in non-UK Europe)
- rate of tx among long term residents/travelers to Europe  = overall US donor prevalence

## Slide 14

## Slide 15

## The Euroblood program

- Began in the early 1970’s
- At its peak represented one third of the New York area RBC supply and approximately 2.0 % of the total US RBC supply
-  Over 200 New York Metropolitan-area hospitals  supplied with Euroblood over the 30 year period of importation (est. >4 million components )

## The Euroblood Program

- In the absence of a massive lookback effort, Euroblood recipients currently living in the US are largely untraceable.
- The Euroblood program ended in the months prior to the 10/31/02  implementation of FDA deferral recommendations (Phase II)

## Questions for the Committee

## Question 1.

- Based upon the available scientific information, does the committee recommend deferral of _blood donors_ transfused since 1980
- a. In France?
- b. In other BSE countries of Europe?

## Question 2.

- Based upon the available scientific information, does the committee recommend deferral of _Source Plasma donors_ transfused since 1980
- a.  In France?
- b.  In other BSE countries of Europe?