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d, to take st2pS to develop good manufacturing practices specifically i r blood

ard blood components ifl order to protect the health of both donors and reciorents;

to rmport to the Woild HeaLth Assembiv on developments in these matces.

dot ehaf of the Leaoue of Red Cross Societies, Dr Z. S. Hantchef briefly expaoted the

ccvstsee of she Luague of Red Cross S’cieties in the area of olood transfusion nd stressed

she imisarit; Its aims and those ad WHO.

2 PRESEHT AND FLAURE NEEDS F1R LAO IND oLOOD COMPONENTS

It was considered whetler a transf a a service, dependent upon voluntar

orovide the neans for d oat r o ent tierapy and sufficient plasr fo

a viOlin and coagulati u t p pheresis has to be ee uLiy vu

with special comp 1 it’ g so c f c artibodies).

xperience rl d ig t be ed as an example of slat cou d e achieved Inas in he r stri ur ie ab ut 0 000 donatioa er yea o r € n iiion

are nece so y to tree t e s or red eel s.

e ed al a n, h h i i-i h in Saitzerland is about 28 000 units per one millionn ach i e it- rg I. g of a bumi If 80L of tie donation req ired o meet

for eryt r cv e a e eluded in a eompoen p ogramme, 837 of these al umis aeedsvered by e p asm thus btr aed,

1- need for anti a r p-ti ic globuli mainl provided as a freezedried mall poe1ry pre’pitate, could 00 o a e r t fror 807 component programme, If on entrate

LAs gloouiin were to u ro ert na ye f r treatment of haem ph iacs ( e uding‘reatraenc , more plas eed d and actor VIII might then d splice albumir as

t e goverar’g factor for the ii sma reede&

It has been shown by pilo tn s a ned out in Berne and in Baden Wurttemberg hat theuse of this high proportion of red cell concentrates is feasible; even so, such a rogrammewould provrde onl-; about 85L of the estrnated need for albumin. The deficit could oe o’er—co-ce LA the a J-’ cious use of plasnn sabsoitces such as gelatin or dextran, preferably theformer, Pt the same time, it would be essential to ensure that albumin is used onla whenthere is a definite medical indrcatron, e.g, to repair a blood volume deficit in specifIccircumstances, provide transport protein In the presence of severe jaundice in haemoticdisease of newborn, and to treat interstitial pulmonary oedema and certain cases of oleus,Whereas aloum;n is indicated for the treatment of certain cases of hypoproteinaemia, it shouldnot be sed as nutrient by the intravenous route.

If some a drogranne is to be deve oped in another country the national backgrou d cannotbe ignored, as the a-zailabilitv of trarred staff and finance are critical factors.

In F’ nianc, a piot study is now-In progress to aetermine whether plasmapheresis ofvoluooar\ onpaid donors could serve as a supplementary source for meeting the national needfa- plasm, If the reasons for cLAs procedure are fully explained to them, it seems chat

can be recrustec withcut undue d ffcLAt-,. In the United Kingdom such doncrs have beenomcaineo achor troth dIfficult, bat the have been recruited onl’- in small numbers 0or special

d’nors of soecifl,. rtidd” olasma,

The ‘-actie’- of t000erung ° c obta n plasma containing certain arcbod

LA LA oonoms Lu ‘caret. hay rnational omits .er millilitre or Let

tha in ortdr art. of j/ of donors have five or tome A tn nc-do for

acesni Pd tntivari

u spaid donorsti- preparation

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Altnogh aThomin is the -subocanuc removed Ln grtatest quantity, there way be others which

of ator porta c,

I Is ad m en,

t o ma ni tein co1cetia ion may

on the extravdscr Lac.

e t ot r p a ia o air de et s as the

e wit in nor al rim. s in t a pres cc of a protei

The observers pointed out that as the Food and Drug Administration, United States of

rc cmi he a ng o 0’60 ocr ca th vouid ill a e to consi ered a

cu a Lt e 0 igof cii to 5 pe year1 P a caphercsis. oseve tcis nit

a, HEALTH HAZARDS OF PLASMAPHERESIS

P’a apte sis a p cr5 to hs rd ively ale i carrie ut it accordan e wi adequate

I re s a y at ari r y eg rdi a ong en fol wup

No onsisteot clirical abrormalities have been etected during periods of up to six years

:n donors who have undergone adequately controlled piasmapheresis, but possible effects on

lipid transport and deposition, decreased resistance to infections through frequent removal

of inmunoglobulins and even changes in immune response towards oncogenic viruses cannot be

o ed o on t “xist ng eviderce, isorder might arise out of too frequent plasmapheresis,

active mm nisati ‘nd frequer me mulatior of e d n rs, genetic or environmental

dit or ot °r as yet uckr n fac rs, oth ret spective and prospective ‘tudies are

required, hut olmost no clinicaL, statistical or epidemiolog c methodology currently exists

for performing satisfactory longterm studies of this type. Retrospective studies might

indicate the areas to which prospective studies should be directed, but a very large and

ngthy investigation would be required.

a vie u d a of 1 t t d va nd o f e u e ‘m ls of

eas rdit , N atteim shou be nade to raw fin 1 concl s’ons from a simple

retrospective study and therefore a longtern prospective ir estigation should be undertaken,

Regarding dangers to reciuients of plasma derivatives,

ransrji scion or inact!ou, disease, particularly heuatitis,

be a in I re t, ough o rar casior0 a f

si ntra’issin f ea t d “dccc ore

p £ rtior

the discussion was confined to the

Albumin and iosruneglebulin appear

lty marufactu irg tee rique hasepatiti B antigen ‘c the r spec’

The main risk of transnittiny hepatitis appears to be associated with the coagulation

factor concentrates and its ecgree depends en thu source of plasma, oartitolarly whether toe

donors sere pain or unoaid, The reteetry reoortec ‘utareak of hepatitis ‘n the United

rgdew o-oc’ d wi ntrs ous i cti Fa VL oncer te sas cited as an

ol

AmCtD TRaNs. CS TON each PLjunblFHERasiS IN urTiLOPrs,, wOUnralES

The general cltuatiun of hired transtusion and niasmapheresis in developing areas of the

rid war revoe ed,

to cv we ha

iti ho. cs, vate ur erno i es

‘, o” Am ne natrcnal hearth au , ritres, Fr qenti

rut often frun naib o’n or. but the nunfmer Di

‘ut t”e efforts of Notuai Ran Cross Societies and

morn, a irga atiout D :00 oreeram es ore niy ama

I y nd doe ad nb

iota Red £ ut org ati rat r

nitod s obtained from relatives of cc

voruntar; unpaid donors is increasing

Latin American Associations of Voluntary

reing ceveio—ud as an Increasing nunrer

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c ulo we i se f luwediff to p eti a onor.

y non mirrercial plas apheresis

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3 The part cular attnt on o governmc s stoul be dra n t the mportan of tra fr ices h a might e done t o t inc us on o thic s bject on c nc f Hi

regIonal neetings.

it i a m ral obi at n o the ocst cdv ced ‘ou ri s to Ida othrs n t fito d arc sf ci n and is c t t cc a cc yes ffered b o icr a f ra c

cturn for perJissIon to se up asuapheresis centres and ase paid donor.

The optimum form of ai ha to c a ut d to individual c untres. TI geierdc ci train og is stil th e cc cc bu assis ante iight dc e requir i t

rga zatiin of doror panel , manager cit f blood LranDfusl n service and pradision Ccertain equipment and reagents, Prolonged support, even up to 10 years or more, night tnecessary cc ensure a rirmly estaoiirhed otood transtuslen service,

inc ly, there wa general greenent tha oil teral or mult lateral aid be given oassist countries when needed in the establishment or further development of national transfusion services; the decision concerning the form in which the aid is delivered (bilateralr ii tilateral) is let to he d no oat n and it techn cal c ord ration i ght be r vide

by WHO in close cooperation witf the Leagie of Red Cross Societi a. An outlire of a s it Icprogranene is presented in Annex IV,

6. LEGAL AND ETHICAL PROBLEMS

The therapeutic use of human blood and itsdervaties has become of enormous importancein medicine during the last few years and has given rise to considerable commercial involvementin the collection of human blood and plasma as well as in the production of their derivatives,

This situation, created by the commercialization of human blood, raises ethical and legalproblems, besides the health aspects and has already been discussed by the World HealthAssembly and the League of Red Cross Societies

Rules and legislation are u gently needed in most countries to govern the ahole Hi. Idutilization and supply of human blood and blood derivatives, and should include good manufacturing practices as strongly recommended by the Twenty-eighth World Health Assembly. Importation and exportation of luman blood and its derivatives should be carefully considered ir anylegislation. WHO has prepared a draft report on Good Manufacturing Practices and thisdocument is now being circulated to experts for their views and comments, It is expected ata later stage that it will be distributed to health authorities to assist then in the p—cparat on of tleir natioral legislation.

The collection of blood and the preparation of its components and derivatives should beunder the control of medically—directed establishments, on a non—profit basis. The voluntarynon—remunerated donation of olasma as well as bloof was considered to be the only acce ableba i fo a s und developmen i thi ii d

7, INTERNATIONAL COOPERATION BETWEEN NATIONAL NON-PROFIT BLOOD TRANSFUSION SERVICES FOR THEEXCHANGE OF BLOOD AND BLOOD PRODUCTS

Ihe basis of interrational exchange of blood ard b ood products is the avoidarce ofwastage arid therefore any surpius components or derivatives should be sent to where thew areneeded, An example of this was gisen unere surplus red blood cell concectrates were sent rorn

nt y t ano h r ho eve ouci a ran’ter equires good organization ard r Irims iitt ig disease sb Id e to Si red £ untries hould aim at self sufficie y I

should avoid bleeding racre than the required amount for their our neecs, Their own plasmacould be procesced abound wtien necessary and their deriwatives returned,

d o ott s ros o t on bou da sbect atboriis

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Recommendation 3

tic 1 gt ffect I re e od asmap crcsi, d y r or r ax 1

tL nor r. not 1 k a, b r etr’cti ad pr. act cnnt ci ies ad

be undertaken to idenifv and evalua e the health ozards that may ae inhereac in these

orocedures, anu to serve as a basis for future regulations and operating praccioes,

Pasmapheesis hou1d not be perrormed f the’e is an’ reaso to soswco :hac iatec

sease or mali tnt 0 miglt e pr ent,

International aid programmes should be established to assist countries to set or or

improve national blood transfusion services; this aid might be given chrcogh WHO in

collaboration with the League of Sed Cross Societies or a’ least coordinated ty t°ese

organizations. Suitable guidelines concerning such assistance are contaiaed in Annex II

ecommcadation 5

National blood services which have a surplus of blood, blood components or derivatives

should be encouraged to offer them on a non—profit basis to other national non-profit voluntary

blood services in need of them with due recognition of the possible hazards which may be

involved,

Recommendation 6

National health authorities should have the responsibility of blood transfusion services

in all countries. The participation of national docieties which are members of the League

of Red Cross Societies should be encouraged, their role ard activities sould be determined

in consultation with national health authorities,

Recommendation 7

Effective legislation should be enacted in all countries regulating blood donation

(including the collection of plasma by plasmapheresis), processing, distribution, export and

import of blood and blood products. Such legislation should take into account the medical

and ethical problems involved, and protect donors and recipients against c mmercial

exploitation,

LAB/7 6, 2page 9

ANNEX I

iJnve a LiegeLbo r de Croc

41, r4000 ejBelgiun

r 3. Asval Director ot Hospitai DivIsionDirectorate oi Health ServicesMinistry of Social AftairsOslo-Dep, Oslo INorway

Pr’fessor ‘4 Benabadji Directeur du Centre de flansfusion sanguineHCpital MustaphaiersAlgeria

profes azal Dire cur C ntre Cgi n 1 de Traas’ sbsanp c Lrile-Jearb au

ellierFranc e

Dr C. Ehrich The New York Blood Center310 East 6ch StreetNew YorkNew York 10021United St cc of Pjneric

n’esig1 rwa Can ry s Rea sf cc r Serv

Wank I a cc 10, OSwitz d

Professor u, Hollan2 Vice-Chairman National rstitute ot Mae atology and BloodTrans fusion

Daroczi ut 241113 BudapestHungary

Dr Kellner Vice-Chairman The Ne To’k BlooC Cente‘iO Ba tO Stret

LAB/76.2ags. 10

Pr I ssor 3. 3 an Logher D rector, Central Laboratory of the Net erlands

Red Cross Bbod Transfusion Service

Plesmalaan 125

Postbus 200

Amsterdam NNetneriants

U iversity Deoa trrent I xrerimen urgery

Ine pital

3000 BerneSwitzerland

Dr N, dA. Maycock - Rapporteur Consultant AdviserBlood Products LaboratoryThe Lister Institute of Preventive Medicine

(University of London)

Elstree, Hertfordshire WDÔ 3AX

England

Dr J P. Morris Rapporteur Australian Red Cross Blood Transfusion Service

(Vic Div) 114 Flinders Street

Melbourne 3000Aust’alia

Professor I-i, Nevanlinna Finnish Red Cross Blood Transfusion Service

Kivihaantie 7

00310 Helsinki 31

Finland

Dr R Perrault Rapporteur National 0 rector

Blood Transfusion Service

Canadian Red Cross Society

95, Wellesley Street East

Toronto, Ontario M4Y 1H6

Canada

Professor F. Weilbauer Head of Red Cross Blood Bank

P.O. Box 6260

V cc residert for Scientifi Affair’

Director of Planning and Development

Cutter Laboratorier Inc.rourth and Parker StreetsBerkelv California 94710United States a: America

113

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Dr Z !art her Chief l4edj.ca officer lrak,t.asJor.

League of Rea Cr’ss Socei.ies

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WHO Headquarters

LAB/7 6.2

00

AN’cEX II

AGENDA

1 Intrd tin

2. Present and future needs for blood and blood components

Physiology of replacement of plasma constituents after plasmaoheresis

4 P aith faard p asmaphers s

5. Blood transfusion and plasmapheresis in developing countries

6, Legal and ethica problems

7 In ernaional c operation between national, nonprofit blood transfusion services for the

exchange of blood ano blood products

8 utu e role of the World Health Organization and the League of Red Cross Societies in the

fe1d of blood transfusion

9 Final recommendations

C

ornex Ill

c”crhtors so as tu ,‘rcdore a Lsui r fo’e ,trOc1 or rEctor as ‘a or

i’t’ 10 our exaruot’ ,,‘ 13 0’Oa’ 0 orjt

ul C C ,,e ,sit

±iov’eaer, there is ample evc1e°ce that tEas 2 5 POt or even ir health” 4si5UaOP—

door s Our sg the irsc st g Lb mis deple I s, t e Jora y 1,0 s of i r V

a aunin is balanced by a ncr transfer or oroteln from Lbs excravascular space, which a

dep cted n th face f in appa cc 1 rial s,a us us f’rct scige Lb lb mm e’e

‘s’glt have been present in ore nonora examined hy Shanbrom cc al,,22 who found or coargc

r’e serum proteir lavcl’ Be hat s ‘t ma’, the ‘econd stage or a manifest mrarao”car

aLbumin depletion, whmch occurs 1qhen the extravascular rese yes av beer exhau tc , s i’en

recorded by the mejor,,tyo ni’rhorc as a sequel of mntensive plosmapheresis

Salvaggio and coworkcrs2L harvested 2 a 800 ml of plasma per week for perious or more

than t o ye r iron 8 a h , ‘0 or eer r so orates n fourd aigrif c n ( <0 d

ahronLb depression of the serum albumin revel by 0,50,6 g Colen & Oberman8 remcved x

500 ml of plasna per week n a mal grouo programme predom”nant’y incolviag medical or

paramedical hous sLaf mcmlx s, 1 e otal s rum Troren rsp I cc ecrease - - g

t0io one to three months of bcgmonina olasmaoheresis or 85’ cf these donorc, ard the

p e om m s re or e f OP u r or o f se p og a or a e a r s r o o c

three months. The albumin fraction in percentage was reported to te unchaogeu, :-or as

T P we t down the abso nte lb mis evols ‘ii s Iso h v been low redS m a tore e cc

study oublished sy the sante group, the mmmunogloto4ins were found to decline signmlcantiy,

but data on the absolute albumin ieocl acre omitted,

Eliman et investigated the secuels of weekri psasma l055e5 lx toe hure cause

cc cc 5 and 5. 1 p cc s e It y b ud onor The r comm t at x , the

‘2 sres rate of loss °no obvious e’feccs on the serum protein mevels acre seer” is reiuted

stat’sti al analys 0 s usor c tort of the p rd or ginal ata pre’e ted Lb “heir

or ‘hirh is summarized oeor

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or moduced nephrosis, a’s i, cora1e a or,c tm,c the a or. dl evergr s cxceportrai usc

—us-se is has nor-sr tee1 lx’crd ‘-‘ - or- ‘E’r—-’r-- rue ‘1D”ci eve5 ,-,s,sa’,’- 4’

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0 a oe n oar-co-aid Ca toes to Do dented a- - i :ot-Th,’

a’ nf.crtio ‘n tt n-id c

rsti a Lb t eedcel -o’ rc p ar-apcrnr foo r t

F1R noe vcd ftar one on - cr’ a 10 - I - I

ttan the moot a° eason d for - ncg’ rfl i ; cori -‘a- - o

the >vntoesn o alaani. tj2 c n tc don

Final v n ndy not n mdc ant t coo nrc no I 2 - Ca

plo mapheimsie nonors it cb to-n c:crxig ir the dnecon ln- °°o nnerc

dn ace’n & nsd n-oi to ant hia of art I -C - n

protcinorra argra - a to -moanare to - a- -r n- a

noors. Thelc.trlrnn o tic lovoLettloacrn lj nr

harvest of 2 a 500 ml at otasma as nor o crated by ooo::can re5an too’. - an ad aid-n--en

loss l mOn. cr weca, e a on a dn n n -tta - - € o

donor square y into the categor- of a ne- hrntc --atienc _c erc rn-ti

The timehononemedicat prinoipaa at °‘rr-n-n nil nonrc nnne ‘•-cn nnpen’r- nan

it the case of living pcnons wfc cons°n to treir bode ; nn ret e oc -

benefit of othPrs. In tberr a’ tuatlon, adeooae safegoamis nasa arc; d0 0 dat onto: aganst

the generation al manifest ijlness In auth v ota roe, Dot a so ara t i V r r C n

from the norna —tate of eher’- bade, Faced a° tIn-: are •totb neater heatoh ‘tends thor the

more fortuaatc members of secrete’, the ndcrrancg a o a sp a i r c

A transent haemoglobie oefrcrt fello lrg e oc a en o € o d os c I ‘c

acceptable, but no one would terioumla ada-nate bleedtng at a oacc naII-tarnarf Inst -‘tate

There i no reason why plasespher ns on s si’uld b c a o di C 0 r

rhy they shoold “e made to soffer plasma proten losses oçailaog hasa “I nc neo,,r t

drsease. The conclusion in st hctc5are to h t etc 510 I e a a r I

p ant per yeatm. as now recnasended by Enropern aatnorrtna ilt a,’n ta..

withdrawn per sess on, and the n orval bense wo ch e s d s

weeks,

nan

wn

L?B,/76,.2

l. Rothscid, 4, A , Baiman, A., Yalow R. S. & Berson, S. A. Tissue distribu:in ot

ci [u ul um t ho i t owg iLitLaVOn s dmi o r on

5&cthscnild. N. A,, Oratz, N. & Schreiber, S. S. Current concepts of albumin metaooiisn,

A revcw, Garoentero’, 58, 402 (190)

P thsc rId, . P Orata, , , Zionon, U,, Schreiber, S. S Wciner, L & Caneg em, . V

Azu:ain synthesis in cirrhotic subjects with ascites studied with carhonater4 C.

J. din, Invest,, 48, 344 (1969)

S vo J , A ue urg , B’c. crc, J & Bite, D The effect of rr looged asma

pheresis on irainunoglobulins, other serum proteins, delayed hypersensitiv ty and

nhytohemagg1utinininduced lymphocyte transformation. rch,All, 41, 883

(97i)

2 Shob om, F Lundak L, & Walford, R, L Longterm plasmapheresis’ effects or

specific plasma proteins. Transfusion, 12, 162 (1972)

93 SIillman, J J., Awwad, H. K, & Moore, F, 0, Plasma protein kinetics of the early

transcapillary refill after hemorrhage in man, 12, 983

( 067

2. Srn’th, H. W. Theiine_idne. Structure and function in health and disease. Oxford Univ.

Press New York, 1958

2 5 b-Co i’ittee of Specialists on Blood Problems, Council of Europe,

Series, No. 468, 1971

W lsw th, C R Rc overy fr m acute hemorrhage in normal men and women

(lond, 12°, 58 (1955)

27, Wochrxer, R, U,, Weissman, S. M,, Waldmann, T. A., Houston, U. & Berlin, N. I. Direct

rieasur -nent of the rates oi synthesis of plasma proteins in control subjects and

te c w t gas ro inte”tinal protein loss, J. din invest , 47 9 (1968)

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nee.k,as and s’-nnges. The reagents ti’at aght£ ‘IV sWG flt fl to tiE. I ‘S

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;rric.i.... .f ectra hencica. elect Lc p.an:s, Lap..

“ad and to bprne tnt facilitIes for trai’iing.

e needed would include blood zrouping sera,ci .be ‘er.. .n • en I s c:. 1f b od us scz’cr c suck shedfld wasL bas.a3 it viea 3 t.e extra w rk

I— th.- •econd year the pnjecc ir L pr.sposea tc run Pt the improvea flood transfu—

‘ioa entre, a six—week training course in zasic enentials for the organization and

operatia of blood t ansi io service for 15 parti ipan a fr a countries with a in! 1 r

- r g r d. Oze ‘15 c. .0 q’r di d e en

..ou d bt needc.d a.. aell a t ri qaiç tent nd r age s, - lowarces aid travel costs for be

participants and allowancts tor z’anonal teaching %tafI.

4