donor self sufficiency: plasma - avis regionale veneto isbt... · 2016-02-17 · definitions for...

1

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



– clinical use




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


6

Percentage of self-sufficiencyin plasma derivatives

100 %

80 %

70 %

60 %

20 %

0 %


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



– clinical use




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.

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



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


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


From fresh frozen plasma Part from other plasma


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

The main topics



– clinical use




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



– clinical use




26

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.’

30

31

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.


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


The USA – EU challenge is open!

Some ethical issues have to be clarified: the anti-D paradox.

donor self sufficiency: plasma - avis regionale veneto isbt... · 2016-02-17 · definitions for...

Documents