american red cross, vcjd donor deferral criteria, and blood supply peter l. page, md senior medical...
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![Page 1: American Red Cross, vCJD Donor Deferral Criteria, and Blood Supply Peter L. Page, MD Senior Medical Officer Biomedical Headquarters TSEAC 06/27/02](https://reader036.vdocument.in/reader036/viewer/2022062321/56649f1b5503460f94c311df/html5/thumbnails/1.jpg)
American Red Cross,vCJD Donor Deferral Criteria, and Blood Supply
Peter L. Page, MD
Senior Medical Officer
Biomedical Headquarters
TSEAC 06/27/02
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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
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Background 2
October 2001: ARC implemented its criteria
January 2002: FDA issues final guidance to take effect 06/02 and 11/02
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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
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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)
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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
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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
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ARC Experience
Donor deferrals, and blood collections vs. goal
Blood distribution and inventory
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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
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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
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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
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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
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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
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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