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Claudio VelatiTransfusion Medicine and Haematology Department, Sondrio (Italy)
Donor self sufficiency:plasma
The main topics
• The actual plasma donation situation
• The use of plasma:
– clinical use
– plasma for fractionation
• The needs in the future
• Some ethical aspects
2
The main topics
• The actual plasma donation situation
• The use of plasma:
– clinical use
– plasma for fractionation
• The needs in the future
• Some ethical aspects
3
4
Number of plasma donations by apheresis
321287
0 0 2870
144118
331231
0 0
330000
5264
218000
3257 0
45739
3300
197400
23000
50000
100000
150000
200000
250000
300000
350000
AUT BEL DNK FIN FRA DEU GRC IRL ITA LUX NLD NOR PRT ESP CHE SWE GBR
Blood Transfusion in Europe, The White Book 2005.
5
Self-sufficiency in plasma for clinical use
Yes
No
From AustriaFrom USA
From USA
Blood Transfusion in Europe, The White Book 2005.
6
Percentage of self-sufficiencyin plasma derivatives
100 %
80 %
70 %
60 %
20 %
0 %
Blood Transfusion in Europe, The White Book 2005.
7
Plasmapheresis collections provide source plasma, including plasmawith specific antibodies, for fractionation into medicinal products.In some Countries plasma for transfusion referred to as Fresh FrozenPlasma (FFP) is also collected by apheresis donation.
The volume of plasma collection by apheresis per 1,000 inhabitantsreflects the volume of the national plasmapheresis programs.
In 30 reporting Countries on average 2.5 litres (range 0-14) of plasmaper 1,000 inhabitants is collected by plasmapheresis.
Apparently Austria, Bulgaria, Germany and The Netherlands stand outas Countries with a considerbly more extensive plasmapheresisprogrammes, with about 10 L or more of plasmapheresis plasma per1,000 inhabitants/year.
Modified from: “The Collection, Testing and Use of Blood and Blood Components in Europe(2006 Report EDQM-Council of Europe. C.L. vd Poel, M.P. Janssen, M.-E. Behr-Gross
8
Plasma collected by apheresis(L/x103)
Modified from: “The Collection, Testing and Use of Blood and Blood Components in Europe(2006 Report EDQM-Council of Europe)Modified from: “The Collection, Testing and Use of Blood and Blood Components in Europe(2006 Report EDQM-Council of Europe. C.L. vd Poel, M.P. Janssen, M.-E. Behr-Gross
9
Plasma collected by apheresis(L/x1000 inhabitants)
Modified from: “The Collection, Testing and Use of Blood and Blood Components in Europe(2006 Report EDQM-Council of Europe)
77
Modified from: “The Collection, Testing and Use of Blood and Blood Components in Europe(2006 Report EDQM-Council of Europe. C.L. vd Poel, M.P. Janssen, M.-E. Behr-Gross
The main topics
• The actual plasma donation situation
• The use of plasma:
– clinical use
– plasma for fractionation
• The needs in the future
• Some ethical aspects
10
11
Fresh Frozen Plasma (FFP) has been availablesince 1941 and at first was used as volumereplacement.
After the introduction of plasmaderivativesand hydroxyethyl starch the use of FFP hasbeen reconsidered and its use was indicated incase of bleeding, or to prevent bleeding, inpatients with altered coagulation tests.
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13
14
15
16
Number of transfused plasma units(apheresis and separation units)
103000 95500
39607
247409
942007
169900
25000
498724
313536386 50690
7300099327
330000
0
100000
200000
300000
400000
500000
600000
700000
800000
900000
1000000
AUT BEL DNK FIN FRA DEU GRC IRL ITA LUX NLD NOR PRT ESP CHE SWE GBR
Blood Transfusion in Europe, The White Book 2005.
17
Plasma units transfused / 1000 inhabitants
6
4
17 16
12
8
6
8
1
1110
7
17
0
2
4
6
8
10
12
14
16
18
FINFRA
DEUG
RCIT
ALUX
NLDNO
RESP
SWE
CHE
GBR
POL
Blood Transfusion in Europe, The White Book 2005.
18
Plasma units transfused / 1000 inhabitants
0
5
10
15
20
25
30
35
9
5
15
31
89
6
10
6
13
7
20
28
Modified from: “The Collection, Testing and Use of Blood and Blood Components in Europe(2006 Report EDQM-Council of Europe)Modified from: “The Collection, Testing and Use of Blood and Blood Components in Europe(2006 Report EDQM-Council of Europe C.L. vd Poel, M.P. Janssen, M.-E. Behr-Gross
19
Total quantity of plasma used for fractionation(litres)
336000
TOTAL
217800
2200
70000
0
62300
5500
470160
33317891636
584744
00 00
434456
60944
7300
0 270000
TOTAL
37463
1361
00
280000
20000
80000
TOTAL219000
0
000
200000
400000
600000
800000
1000000
1200000
1400000
1600000
AUT BEL DNK FIN FRA DEU GRC IRL ITA LUX NLD NOR PRT ESP CHE SWE GBR
From fresh frozen plasma Part from other plasma
Blood Transfusion in Europe, The White Book 2005.
Plasma for fractionation
• In 31 reporting Countries, an average yield of 7.2 L (range0-26 L) per 1,000 inhabitants is found of plasma forfractionation into medicinal products.
• However, 6 of 31 (19%) reporting Countries deliver 15 L ormore plasma per 1,000 inhabitants.
• In Europe, the main supply of plasma for fractionation isrecovered plasma: in 18 reporting MS, on average 70% ofthe plasma for fractionation is from recovered plasma(range 0-100%).
20
Modified from: “The Collection, Testing and Use of Blood and Blood Components in Europe(2006 Report EDQM-Council of Europe. C.L. vd Poel, M.P. Janssen, M.-E. Behr-Gross)
21
Plasma for fractionation(L/x103)
Modified from: “The Collection, Testing and Use of Blood and Blood Components in Europe(2006 Report EDQM-Council of Europe)Modified from: “The Collection, Testing and Use of Blood and Blood Components in Europe(2006 Report EDQM-Council of Europe. C.L. vd Poel, M.P. Janssen, M.-E. Behr-Gross
22
The main topics
• The actual plasma donation situation
• The use of plasma:
– clinical use
– plasma for fractionation
• The needs in the future
• Some ethical aspects
23
Future demand for plasmaderivatives willbe influenced by:
• Demographics and health services improvementsin emerging countries, growing acceptance,awareness and funding
• New therapeutic indications
• Pricing pressure
• Increased competition from new manufacturers,promotional and educational activities
• Plasma procurement and processing capacity24
Projected Albumin demandbased on the results of several studies
25Marketing Research Bureau
The main topics
• The actual plasma donation situation
• The use of plasma:
– clinical use
– plasma for fractionation
• The needs in the future
• Some ethical aspects
26
27
28
The EBA-IPFA position
Section 2.11 must continue to make explicit reference to agreed internationaldefinitions for VNRBD (eg CoE, WHO, FDA, ISBT). i.e.CoE
• ‘Voluntary unpaid donation shall mean the donation of blood or bloodcomponents by a person of his/her free will and without receiving payment incash or in kind in return which could be considered a substitute for money.This also includes time off work other than that reasonably required fordonation and travel. Small tokens, gratuities, refreshments and thereimbursement of direct costs and direct travel expenses are compatible withthe voluntary and unpaid donation of blood.’
• FDA Status of monetary incentives’
• ‘Cash or cash equivalent Tickets or events where markets for resale exists;
• transferable discounts-coupons convertible to cash; music media wheremarket for resale exists; vouchers for free medical tests; Scholarships paiddirectly to students.’
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Homogeneous assessment of clinical needs is not yet reached: is patientunder-transfused in Spain or over-transfused in Germany, Greeceand Poland?
EU has not yet achieved self-sufficiency in plasma and plasmaderivatives.
About plasmaderivatives, demand, use and needs for patients should bedistinguished (WHO 2010)
Wide variations in per capita use of PDMP in developed countries egIVIg use are observed: former EU excluding UK 2007: 55 g/1000,North America: 120 g/1000.
No evidence that clinical needs are not fulfilled in countries which havedeveloped robust therapeutic evidence based systems to optimal use(eg Germany: 36 g per 1000).
Final considerations (1)
32
Europe is close to self reliance with VNRBD plasma:IVIg use 2007 for 13 countries of the former EU with a total of 3.6million L of plasma collected from European VNRBD, the level ofsufficiency achieved is in the range of 80 to 86%. Getting closer to 100%sufficiency from VNRBD plasma should be further developed.
Potential negative impact of paid donations are to be considered:
On the donor health: plasma pools from paid US high-frequency, high-volume plasmapheresis donors showed significantly lower protein
content (eg total IgG: - 24%), than pools from unpaid EU or US WB orplasmapheresis donors (R Laub et al Vox Sang 2010).
On the blood system: paying donors has been shown as a potential threatto the wider supply of blood products, as many patients need both labileblood products and PDMPs.
Final considerations (2)
EBA and IPFA continue their advocacy for developing VNRBDwith coordinated blood and plasma programmes which wouldbetter meet all patients’ needs and comply with the donor healthrequirements and the European commitment on ethical issuesand unpaid donations.
33
Final considerations (3)
The USA – EU challenge is open!
Some ethical issues have to be clarified: the anti-D paradox.