American Red Cross: Evolution ofvCJD Donor Deferral Criteria and Blood Supply

Peter L. Page, MDSenior Medical OfficerBiomedical Headquarters

TSEAC February 20, 2003

Background 1

March 2000: ARC initiated first vCJD deferrals

Early 2001: ARC developed vCJD geographic donor deferral criteria, based upon concern and uncertainty about upcoming evolution of epidemic, stating policy would be reconsidered annually and as new data accrue

Background 2

October 2001: ARC implemented its initial deferral criteria

January 2002: FDA issues final guidance to take effect 06/02 and 11/02

Spring 2002: ARC decides to relax criteria regarding presence in the UK after 1996 (actual implementation TBD in 2003)

1 Final Guidance 1/9/022 Albania, Austria, Belgium, Bosnia-Herzegovina, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Republic of Ireland, Italy, Liechtenstein,

Luxembourg, Macedonia, Netherlands, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Federal Republic of Yugoslavia.3 Germany, Italy, Netherlands, Switzerland, Austria, Belgium, Spain, Republic of Ireland, Portugal, Denmark, Luxembourg and Liechtenstein

Quick-reference summary of vCJD-related geographic donor deferral criteria as of 1/9/02

Agency In Effect: UK FranceEurope Other Than

France Other CountriesSpecial Rules for US Military Base

Personnel

FDA 11/99-5/02 6 months, 1980-1996

None None None None

ARC 11/99-9/01 6 months, 1980-1996

None None None None

ARC 10/01 forward

3 months, 1980-present

6 months,1980-present

6 months,1980-present, all countries

Gibraltar and Falklands same as UK; Oman same as Europe

Same as country in which military base resides. NOTE: This implies there is not deferral for military staff on bases in Turkey

FDA1 6/02-10/02 3 months, 1980-1996

5 years,1980-present

None Gibraltar and Falklands same as UK

6 months from 1980-1990 for Germany, UK, Belgium and Netherlands;6 months from 1980-1996 for Turkey, Spain, Portugal and Italy

FDA1 11/02 forward

3 months, 1980-1996

5 years,1980-present

5 years, 1980-present, selected countries only2, except Source Plasma donors

Gibraltar and Falklands same as UK

6 months from 1980-1990 for Germany, UK, Belgium and Netherlands;6 months from 1980-1996 for Turkey, Spain, Portugal and Italy

DoD Same as FDA

Same as FDA Same as FDA Same as FDA Same as FDA 6 months from 1980-1996 for bases anywhere in Europe or Turkey

Hema Quebec

9/01 forward 1 month,1980-present

3 months,1980-present

6 months, Western Europe only3

None None

CBS 10/01 forward

3 months,1980-present

3 months,1980-present

5 years, 1980-present, Western Europe only3

None None

ARC XX/03 forward

3 months, 1980-1996

Same Same Same Same

1. UK Deferral CriteriaCurrent ARC criteria: 3 months, 1980-presentUpcoming ARC criteria: 3 months, 1980-1996FDA criteria: 3 months, 1980-1996 ARC to change to FDA’s criteria (cut off at end of 1996) Rationale: Food chain controls implemented in UK by 1996 are now

(2002) deemed to have been effective and sufficient. Results:

ARC consistent with FDA on this issue Individuals’ presence in the UK after 1996, after food controls in

place, would not effect eligibility

2. Rest of Europe Deferral CriteriaOngoing ARC criteria: 6 months for all countries

FDA criteria (11/02): 5 years for most countries ARC Plan: To be re-evaluated in Spring ‘03 Rationale: Continuing lack of active surveillance and effective

food controls in some of those countries now better appreciated in 2002

Results: No operational change for ARC; avoid complexity of

dealing with various U.S. bases

Differences in vCJD geographic deferrals: Current and upcoming ARC and current FDA

ARC FDA

• Oman included• US Military bases in

specified European countries

Yes‘80-present6 months

Whole country

1. 3 months in UK from ‘80-Present’80-’96*

2. Time in Europe from 1980-present

6 months(All European

countries)No

‘80-‘90 or -‘966 months

Only bases

‘80-‘96

5 years(Some European

countries)

*Date of change TBD in 2003

ARC Experience

Donor deferrals*, & blood collections vs. goal

Blood distribution & inventory

*DONOR DEFERRALS = PRESENTING VOLUNTEERS TURNED AWAY FROM DONATION--WHICH DOES NOT INCLUDE INDIVIDUALS WHO DO NOT PRESENT AT ALL, HAVING HEARD ELSEWHERE THAT THEY WOULD BE TURNED AWAY.

0.00%

0.20%

0.40%

0.60%

0.80%

1.00%

1.20%

1.40%

1-Oct

3-Oct

5-Oct

7-Oct

9-Oct

11-O

ct

13-O

ct

15-O

ct

17-O

ct

19-O

ct

21-O

ct

23-O

ct

25-O

ct

27-O

ct

29-O

ct

31-O

ct

vCJD Deferrals in October 2001Percent Deferred re vCJD

By Day

6 months UK

• Bovine insulin

3 months UK6 months rest of Europe• Bovine insulin

2001

0.00%

0.20%

0.40%

0.60%

0.80%

1.00%

1.20%

9-Sep-01

9-Oct-

01

9-Nov-01

9-Dec

-01

9-Jan

-02

9-Feb

-02

9-Mar-

02

9-Apr-0

2

9-May

-02

9-Jun-02

9-Jul-0

2

9-Aug

-02

9-Sep-02

9-Oct-

02

9-Nov-02

9-Dec

-02

vCJD Deferrals September 01– March 02

Percent DeferredBy Week

2001 2002

Puerto Rico

American Red Cross Blood Services Regions by Region Code and Customer Business Unit (CBU)

84

67

20

21

17

9

2

49

55

11

32

4038

18

4

19

41

26

3

36

24

1

33

29

22

53

30

27

35

42

16

50

13

2

54

South Central

CBU

Western CBU

North Central CBU

North Atlantic

CBU

0.00%

0.20%

0.40%

0.60%

0.80%

1.00%

1.20%

1.40%

1.60%

1 4 22 27 29 30 33 35 53 9 13 16 17 18 32 38 40 42 50 3 11 12 19 24 26 36 41 54 55 2 6 7 20 21 49 84

3/0110/15-12/14/01

vCJD Specific Donor Deferral Rates by RegionFor 03/01 and 10/15-12/14/01

North Atlantic

North Central

South Central

Western

Region CodeCBU:

3/01 ≥ 6 months UK, in place for 12 months

10/15-12/14/01 ≥ 3 months UK, ≥ 6 months Europe, newly implemented

0.00%

0.20%

0.40%

0.60%

0.80%

1.00%

1.20%

1.40%

1.60%

1 4 22 27 29 30 33 35 53 9 13 16 17 18 32 38 40 42 50 3 11 12 19 24 26 36 41 54 55 2 6 7 20 21 49 84

July 2002-Dec 20023/02

10/15-12/14/01

vCJD Specific Donor Deferral Rates by RegionFor 10/15-12/14/01, 3/02 and 7-12/02

North Atlantic

North Central

South Central

Western

Region CodeCBU:

3/01 ≥ 6 months UK, in place for 12 months

10/15-12/14/01 ≥ 3 months UK, ≥ 6 months Europe, newly implemented

3/02 ≥ 3 months UK, ≥ 6 months Europe, in place for 6 months

Summary:vCJD Deferrals by Region and Time

Time Period

Number of Donors Deferred

re vCJD per Month

March 01 361

10/15 – 12/14/01* 5,631

March 02

ARC FDARange Average

Regional Donor vCJD Deferral Rate

0.00% - 0.18% 0.06%

0.21% - 1.45% 0.88%

0.25% - 1.15% 0.62% 3,764

*New criteria started 10/15/01**Lessening of UK deferrals not after implemented

December 02** 0.08% - 0.83% 0.38% 2,108

0%

2%

4%

6%

8%

10%

12%

14%

16%

Jan-00

Feb-00

Mar-00

Apr-00

May-00

Jun-00

Jul-0

0Aug-0

0Sep

-00Oct-

00Nov-0

0Dec

-00Ja

n-01Feb

-01Mar

-01Apr-0

1May

-01Ju

n-01Ju

l-01

Aug-01

Sep-01

Oct-01

Nov-01

Dec-01

Jan-02

Feb-02

Mar-02

Apr-02

May-02

Jun-02

Jul-0

2Aug-0

2Sep

-02Oct-

02Nov-0

2Dec

-02

Deferrals and CollectionsDeferral Rate

All Donors, All ReasonsBy Month

WB Allogeneic CollectionsBy Month

August 2000Switch from ear to finger sample, +4.5% deferral for hemoglobin

400,000

450,000

500,000

550,000

600,000

650,000

700,000

750,000

800,000

Jan-00

Feb-00

Mar-00

Apr-00

May-00

Jun-00

Jul-0

0Aug-0

0Sep

-00Oct-

00Nov-0

0Dec

-00Ja

n-01Feb

-01Mar

-01Apr-0

1May

-01Ju

n-01Ju

l-01

Aug-01

Sep-01

Oct-01

Nov-01

Dec-01

Jan-02

Feb-02

Mar-02

Apr-02

May-02

Jun-02

Jul-0

2Aug-0

2Sep

-02Oct-

02Nov-0

2Dec

-02

Budgeted Collections Actual Collections

14,000

14,500

15,000

15,500

16,000

16,500

17,000

17,500

18,000

Oct-00

Nov-00

Dec-00

Jan-01

Feb-0

1

Mar-01

Apr-01

May-01

Jun-0

1Ju

l-01

Aug-01

Sep-01

Oct-01

Nov-01

Dec-01

Jan-02

Feb-0

2

Mar-02

Apr-02

May-02

Jun-0

2Ju

l-02

Aug-02

Sep-02

Oct-02

Nov-02

Dec-02

0

50,000

100,000

150,000

200,000

250,000

300,000

350,000

Oct-00

Nov-00

Dec-00

Jan-01

Feb-0

1

Mar-01

Apr-01

May-01

Jun-0

1Ju

l-01

Aug-01

Sep-01

Oct-01

Nov-01

Dec-01

Jan-02

Feb-0

2

Mar-02

Apr-02

May-02

Jun-0

2Ju

l-02

Aug-02

Sep-02

Oct-02

Nov-02

Dec-02

Distribution and InventoryAverage Net Daily Distribution

By Month

Average Daily InventoryBy Month

Summary When anticipated and planned for, new donor deferral

criteria should be accommodated by increased donor recruitment and collection efforts, albeit expensive

After the increase in deferrals from a new measure, there is culling, and the deferral rate for that reason then drops

Deferral for TSE concerns is only one of several recently added deferral criteria, each of which increases the cost of donor recruitment and collection to try to make up for it

More regular volunteer blood donations continue to be needed to prevent seasonal shortages and to develop a reserve for unanticipated occurrences