Post on 04-Jan-2016
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American Red Cross,vCJD Donor Deferral Criteria, and Blood Supply
Peter L. Page, MD
Senior Medical Officer
Biomedical Headquarters
TSEAC 06/27/02
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 as new data accrue
Background 2
October 2001: ARC implemented its criteria
January 2002: FDA issues final guidance to take effect 06/02 and 11/02
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
Differences in vCJD geographic deferrals: Ongoing ARC and recent/upcoming 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
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)
1. UK Deferral CriteriaOngoing ARC criteria: 3 months, 1980-present
Recent FDA criteria: 3 months, 1980-1996 ARC Plan: In 11/02, 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 Criteria
Ongoing ARC criteria: 6 months for all countries
Upcoming FDA criteria (11/02): 5 years for most countries
ARC Plan: No change
Rationale: Continuing lack of active surveillance and effective food controls in some of those countries now better appreciated
Results: No operational change for ARC; avoid complexity of
dealing with various U.S. bases
ARC Experience
Donor deferrals, and blood collections vs. goal
Blood distribution and inventory
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
23-S
ep7-
Oct
21-O
ct
4-Nov
18-N
ov
2-Dec
16-D
ec
30-D
ec
13-J
an
27-J
an
10-F
eb
24-F
eb
10-M
ar
24-M
ar
vCJD Deferrals September 01– March 02
Percent DeferredBy Week
2001 2002
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
Deferrals and Collections
0%
2%
4%
6%
8%
10%
12%
14%
16%
Deferral RateAll Donors, All Reasons
By Month
400,000
450,000
500,000
550,000
600,000
650,000
700,000
750,000
800,000
Jan-0
0
Feb-
00
Mar
-00
Apr-00
May
-00
Jun-0
0
Jul-0
0
Aug-00
Sep-00
Oct-0
0
Nov-00
Dec-00
Jan-0
1
Feb-
01
Mar
-01
Apr-01
May
-01
Jun-0
1
Jul-0
1
Aug-01
Sep-01
Oct-0
1
Nov-01
Dec-01
Jan-0
2
Feb-
02
Mar
-02
Apr-02
Budgeted Collections Actual Collections
WB Allogeneic CollectionsBy Month
August 2000
Switch from ear to finger sample, +4.5% deferral for hemoglobin
14,000
14,500
15,000
15,500
16,000
16,500
17,000
17,500
18,000
Jan-0
0
Feb-
00
Mar
-00
Apr-0
0
May
-00
Jun-
00
Jul-0
0
Aug-0
0
Sep-0
0
Oct-0
0
Nov-0
0
Dec-0
0
Jan-0
1
Feb-
01
Mar
-01
Apr-0
1
May
-01
Jun-
01
Jul-0
1
Aug-0
1
Sep-0
1
Oct-0
1
Nov-0
1
Dec-0
1
Jan-0
2
Feb-
02
Mar
-02
Apr-0
2
0
50,000
100,000
150,000
200,000
250,000
300,000
350,000
Jan-0
0
Feb-
00
Mar
-00
Apr-0
0
May
-00
Jun-
00
Jul-0
0
Aug-0
0
Sep-0
0
Oct-0
0
Nov-0
0
Dec-0
0
Jan-0
1
Feb-
01
Mar
-01
Apr-0
1
May
-01
Jun-
01
Jul-0
1
Aug-0
1
Sep-0
1
Oct-0
1
Nov-0
1
Dec-0
1
Jan-0
2
Feb-
02
Mar
-02
Apr-0
2
May
-02
Distribution and InventoryAverage Net Daily Distribution
By Month
Average Daily InventoryBy Month
Summary
When anticipated and planned for, new donor deferral criteria can be accommodated by increased donor recruitment efforts
After the increase in deferrals from a new measure, there is culling, and the deferral rate drops
More regular volunteer blood donations continue to be needed to prevent seasonal shortages