blood donors: red cells sufficiency

5
Blood Donors: Red Cells Sufficiency M. A. Vesga & M. Azkarate Basque Country Blood Transfusion and Human Tissues Service (CVTTH), Galdakao, Spain In any country, total blood donation still is the main type of donation for the organisational strategy of transfusion medicine, being the availability of red cell concentrates the main objective when designing the logistics for recruiting donors and organising blood donation events. Indeed, this is usually the determining factor in setting priorities in transfusion centres, despite the fact that self-sufficiency is even harder to achieve for plasma derivatives. Self-sufficiency in red cell concentrates is evidently a key strategy for any healthcare system, because without it the whole system could be severely compromised. It is, however, more difficult to establish clear thresholds of blood donation, below which it can be predicted that there is a considerable risk to the system due to lack of red blood cells. The degree of sufficiency of a country is the result of a series of fundamental variables, including specificity and management of the donor base, the impact of demographic changes, the level of healthcare complexity, and the adop- tion of policies to optimise the management and use of blood components [1]. There is a general concern that in the next few decades the ageing of the population [2], along with a less positive attitude towards donation, may put the self-sufficiency in red blood cells that has been achieved in the west at risk. In recent years, several theoretical studies [3–6] have been published attempting to predict the medium-term trends in certain countries, such as the United Kingdom, Germany or the Netherlands. The conclusions reached vary consider- ably. Some authors forecast a substantial increase in demand in the coming years, together with a significant reduction in the number of donors, while others believe that the adoption of measures to optimize use will be able to compensate for the negative effect of the ageing popula- tion and other demographic changes. Nevertheless, the authors seem to share the opinion that there is a need to increase the size of the donor base. It is difficult to draw conclusions when we analyse the data provided by the various member states to organisa- tions such as the Council of Europe [7]. There is great vari- ability between countries and the registers are difficult to combine or even compare, in particular regarding the use of red cell concentrates, because in many cases the data represent products distributed rather than components actually transfused. Nevertheless, all the evidence suggests that blood donations and the use of red cell concentrates are evolving in a similar way across the region, with mean indicators of around 39 total blood donations and red cell concentrates transfusions per 1000 people per year. We should note, however, that the actual figures vary widely between European countries, ranging from 10 to 65 per 1000 inhabitants per year. Management of donors The first element to bear in mind in the organization of donation is the acceptance of voluntary non-remunerated blood donation as a key principle, as established by the Council of Europe and the Ethics Code of the ISBT. This implies that is it necessary to have a stable, loyal and responsible donor base, which means a complex organisa- tion for promoting and creating loyalty, based on well- established training and marketing techniques with strong social backing. In most cases, the programmes are run by the transfusion centres themselves, but often with the sup- port of a large number of volunteers. In order that the management of the donor base is effec- tive and appropriate decisions can be taken, there should be an information system that allows complete data to be col- lected and processed safely and reliably. Currently, various types of software that help to increase the soundness of this data as well as ensure their validity have been widely adopted internationally. However, it is also true that these tend not to serve all local needs, because the management of donors and donations is conditioned by many region- specific, cultural and organisational determinants. Another task is to clearly define the status of donors in terms of their degree of commitment that is essential to be able to take effective measures to minimise dropouts focus- ing efforts on those people who are more likely to stop donating and to recover or replace ‘lost’ donors. To date, the most commonly used definitions are those that have been drawn up by the Council of Europe and adopted in European Union Directives. However, the DOMAINE [8] project has proposed a new set of definitions, covering gaps in those given in the EU Directives, which may help to manage donor bases more effectively. Correspondence: Miguel Angel Vesga, Medical Director, Centro Vasco de Transfusión y Tejidos Humanos, 48960, Galdakao, Vizcaya, España E-mail: [email protected] ISBT Science Series (2011) 6, 193–197 STATE OF THE ART 4C-S19 ª 2011 The Author(s). ISBT Science Series ª 2011 International Society of Blood Transfusion 193

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Page 1: Blood Donors: Red Cells Sufficiency

Blood Donors: Red Cells SufficiencyM. A. Vesga & M. AzkarateBasque Country Blood Transfusion and Human Tissues Service (CVTTH), Galdakao, Spain

In any country, total blood donation still is the main type

of donation for the organisational strategy of transfusion

medicine, being the availability of red cell concentrates the

main objective when designing the logistics for recruiting

donors and organising blood donation events. Indeed, this

is usually the determining factor in setting priorities in

transfusion centres, despite the fact that self-sufficiency is

even harder to achieve for plasma derivatives.

Self-sufficiency in red cell concentrates is evidently a

key strategy for any healthcare system, because without it

the whole system could be severely compromised. It is,

however, more difficult to establish clear thresholds of

blood donation, below which it can be predicted that there

is a considerable risk to the system due to lack of red blood

cells. The degree of sufficiency of a country is the result of

a series of fundamental variables, including specificity and

management of the donor base, the impact of demographic

changes, the level of healthcare complexity, and the adop-

tion of policies to optimise the management and use of

blood components [1].

There is a general concern that in the next few decades

the ageing of the population [2], along with a less positive

attitude towards donation, may put the self-sufficiency in

red blood cells that has been achieved in the west at risk. In

recent years, several theoretical studies [3–6] have been

published attempting to predict the medium-term trends in

certain countries, such as the United Kingdom, Germany or

the Netherlands. The conclusions reached vary consider-

ably. Some authors forecast a substantial increase in

demand in the coming years, together with a significant

reduction in the number of donors, while others believe

that the adoption of measures to optimize use will be able

to compensate for the negative effect of the ageing popula-

tion and other demographic changes. Nevertheless, the

authors seem to share the opinion that there is a need to

increase the size of the donor base.

It is difficult to draw conclusions when we analyse the

data provided by the various member states to organisa-

tions such as the Council of Europe [7]. There is great vari-

ability between countries and the registers are difficult to

combine or even compare, in particular regarding the use

of red cell concentrates, because in many cases the data

represent products distributed rather than components

actually transfused. Nevertheless, all the evidence suggests

that blood donations and the use of red cell concentrates

are evolving in a similar way across the region, with mean

indicators of around 39 total blood donations and red cell

concentrates transfusions per 1000 people per year. We

should note, however, that the actual figures vary widely

between European countries, ranging from 10 to 65 per

1000 inhabitants per year.

Management of donors

The first element to bear in mind in the organization of

donation is the acceptance of voluntary non-remunerated

blood donation as a key principle, as established by the

Council of Europe and the Ethics Code of the ISBT. This

implies that is it necessary to have a stable, loyal and

responsible donor base, which means a complex organisa-

tion for promoting and creating loyalty, based on well-

established training and marketing techniques with strong

social backing. In most cases, the programmes are run by

the transfusion centres themselves, but often with the sup-

port of a large number of volunteers.

In order that the management of the donor base is effec-

tive and appropriate decisions can be taken, there should be

an information system that allows complete data to be col-

lected and processed safely and reliably. Currently, various

types of software that help to increase the soundness of this

data as well as ensure their validity have been widely

adopted internationally. However, it is also true that these

tend not to serve all local needs, because the management

of donors and donations is conditioned by many region-

specific, cultural and organisational determinants.

Another task is to clearly define the status of donors in

terms of their degree of commitment that is essential to be

able to take effective measures to minimise dropouts focus-

ing efforts on those people who are more likely to stop

donating and to recover or replace ‘lost’ donors. To date,

the most commonly used definitions are those that have

been drawn up by the Council of Europe and adopted in

European Union Directives. However, the DOMAINE [8]

project has proposed a new set of definitions, covering gaps

in those given in the EU Directives, which may help to

manage donor bases more effectively.

Correspondence: Miguel Angel Vesga, Medical Director, Centro Vasco deTransfusión y Tejidos Humanos, 48960, Galdakao, Vizcaya, EspañaE-mail: [email protected]

ISBT Science Series (2011) 6, 193–197

STATE OF THE ART 4C-S19 ª 2011 The Author(s).ISBT Science Series ª 2011 International Society of Blood Transfusion

193

Page 2: Blood Donors: Red Cells Sufficiency

The key element is to attract a suitably large number of

highly motivated individuals who donate on a regular

basis (along with an appropriately high rate of recruitment

of new volunteers to this pool of regular donors to ensure

replacement of dropouts). In general, the availability of

30–40 regular donors per 1000 people, who donate on

average 1Æ5–2 times every year, with an annual recruit-

ment of an average of 10–15% new donors, ensures the

supply of red blood cell concentrates for normal needs

without too many problems. A reasonable target would be

to achieve 4% of the population aged between 18 and

65 years becoming regular donors. The difficulty is how to

achieve this objective across Europe, and how to adapt

ourselves in the future to potential new requirements and

demographic changes. To achieve and maintain these rates

is a difficult task implying a long-term investment of spe-

cific resources over generations to create an environment

that encourages donation in a way that most people read-

ily identify with.

The aforementioned DOMAINE [8] project, led by the

European Blood Alliance (EBA) and the European Union

(EU) is the result of an extensive analysis of the organisa-

tion of blood transfusion in Europe based on data collected

through a very detailed survey completed by a considerable

number of European countries. Among the findings, it is

notable that 44% of the countries claimed that they did not,

in general, suffer from a shortage of red blood cell concen-

trates, whereas 56% admitted having problems at some

points during the year. The resulting report is a unique

body of data for Europe, containing descriptions of regional

experiences and practical recommendations, in particular

concerning:

• clear definitions of terms;

• producing performance indicators and analysing

trends;

• economic and financial aspects of the management

of donors;

• use of marketing techniques in the recruiting donors

and developing donor loyalty;

• data and IT tools which are necessary to optimise

management;

• new ethical issues tied to voluntary non-remuner-

ated blood donation, the basis of the current transfu-

sion system.

Application of DOMAINE project indicators

In this study, we report the application of the indicators

and definitions proposed by the DOMAINE project to a par-

ticular area, namely, the Basque Country, located in the

north of Spain. This is a small region (population of 2Æ1million) and has a transfusion system based on voluntary

non-remunerated donations, as established by the Council

of Europe. Every year, there are around 96 000 total blood

donations and, in addition, 6000 apheresis donations pro-

viding a variable amount of red blood cells by erythrocy-

tapheresis. Combined, these represent nearly 48 donations

per 1000 people per year, providing stable self-sufficiency

for red blood cells without periods of shortages. In this

region, the hospitals have high levels of surgical activity,

including transplants, and also oncological treatment, and

blood donation can be considered to be a well-established

practice in the society.

The main indicators of our donor base in 2010 were:

• Total number of active donors in 2010: 54 893,

accounting for 3Æ78% of the population aged between

18 and 65 years old.

• Distribution by blood group: O+: 36Æ03%; A+: 32Æ9%;

B+: 5Æ24%; AB+: 2Æ24%; O): 12Æ15%; A): 9Æ51%; B):

1Æ36%; and AB): 0Æ57%. In relation to this, we should

highlight the significantly higher proportion of Rh D-

negative individuals among the native population

with respect to other areas in Europe.

• Distribution by age and sex: 18- to 25-year olds

(12Æ6% of the donor population and 4Æ07% of the pop-

ulation in this age range); 26- to 40-year olds (30Æ4%

and 3Æ20%); 41- to 55-year olds (40Æ2% and 4Æ47%);

and 56- to 65-year olds (16Æ8% and 3Æ45%). Looking

at the data as a function of sex, there are notably

higher rates among women in the 18- to 25-year-old

group (4Æ30% vs. 3Æ84%), whereas, remarkably, in the

older age groups men dominate, women being less

likely to donate regularly. Analysis focusing on year-

on-year changes in the subgroups of those between 41

and 65 years old confirms that the trend in recent

years is a progressive ageing of our donors (Figs 1–3).

• In 2010, 6590 of the regular donors were returning

donors, but 9520 people failed to give regularly (laps-

ing donors) and 22 275 became inactive donors. It is

0

10

20

30

40

50

60

70

80

90

<25 26–40 41–55 >55Age groups

Perc

enta

ge (%

)

Blood donorsGeneral populationRed cells recipients

Fig. 1 Donors, general population and transfused patients distribution.

194 M. A. Vesga& M. Azkarate

� 2011 The Author(s).ISBT Science Series � 2011 International Society of Blood Transfusion, ISBT Science Series (2011) 6, 193–197

Page 3: Blood Donors: Red Cells Sufficiency

clear therefore that there is a real risk of losing donors

with the corresponding need to take measures to

re-recruit and to minimise the numbers of current

donors that join the groups who stop giving

blood temporarily or for good, in particular, those

who do so without reporting their decision to the

centre.

• Those temporarily deferred should also be carefully

monitored to avoid them losing the habit of donating.

During 2010, 10 340 people were temporarily defer-

red from donating, accounting for 18Æ8% of active

donors.

The distribution of our donor population, according to

the DOMAINE criteria, is shown in Table 1.

Optimisation of the use and management ofblood components

As indicated in other recently published studies from Eur-

ope, in our region there is also a considerable increase in

the use of red cell concentrates with age. A total of 277 738

red blood cells units were transfused in the last 4 years in

public hospitals in our region, and the distribution by ages

is striking: 0–1 years (0Æ7%), 1–15 years (1Æ2%), 16–

25 years (1Æ2%), 26–40 years (5Æ2%), 41–60 years (18Æ6%),

60–80 years (48Æ4%) and ‡80 years (24Æ7%). This means

that 25% of the population uses more that 73% of the red

cell concentrates produced (Figs 4–6).

Given this, the impact that demographic changes in the

coming decades could have on the use of red blood cells is

clear, it is being estimated that the population of over 60-

year olds may double from its current size. It is reasonably

39

40

41

42

43

44

45

2005 2006 2007 2008 2009 2010Year

Age

ave

rage

TotalMenWomen

Fig. 2 Blood donor age evolution.

05

1015202530354045

<25 26–40 41–55 >55Blood donors age groups

Perc

enta

ge

200520062007

200820092010

Fig. 3 Blood donors age groups evolution 2005–2010.

Table 1 2010 Blood donor types from the Basque Country database

First time Regular Returning Lapsing Inactive Donor attrition

7Æ5% 49Æ4% 7Æ4% 10Æ7% 25% 17Æ3%

0

500

1000

1500

2000

2500

3000

3500

4000

4500

0–1 1–15 15–25 25–40 40–60 60–80 >80

Num

ber o

f pat

ient

s

Men 2007 Men 2008

Men 2009 Men 2010Women 2007 Women 2008

Women 2009 Women 2010

Fig. 4 56 697 patients transfused by sex and age.

–300 –200 –100 0 100 200 3001

6

1111

1616

2121

2626

3131

3636

4141

4646

5151

5656

6161

6666

7171

7676

8181

8686

9191

9696

10101

FemalesMales

1

6

11

16

21

26

31

36

41

46

51

56

61

66

71

76

81

86

91

96

101

Fig. 5 Red cells recipients in 2010 by sex and age.

Approach to a supply and demand balance 195

� 2011 The Author(s).ISBT Science Series � 2011 International Society of Blood Transfusion, ISBT Science Series (2011) 6, 193–197

Page 4: Blood Donors: Red Cells Sufficiency

likely that there will be an increase in the demand for red

blood cells: in Germany [9] conservative estimates indicate

that there will be an increased demand of around 750 000

units by 2030 due to ageing in its population, whereas in

the United Kingdom [3], it is predicted that the require-

ments will grow by around 20% over the next two decades.

What is more, these increases are expected to be accompa-

nied by a decrease in the number of potential donors due to

the same population changes.

Optimisation of the use of blood products is a critical

issue in relation to quality control in transfusion processes.

Proper monitoring would, on the one hand, enable equilib-

rium to be established in some centres allowing them to

decrease their collection and processing of red cells in the

short term and calmly develop their strategic plan for the

future. It would, on the other hand, oblige other centres,

still developing their transfusion processes, to increase their

stocks to avoid red blood cell shortages at any given time.

There is a growing number individual and joint initiatives

across Europe to encourage responsible use of blood prod-

ucts by detecting inappropriate transfusions. Many of these

initiatives have clear institutional backing, giving rise to

projects, such as following:

(1) The Optimal Blood Use Project (EBA-UE [10]). Its objec-

tive is to improve the quality of clinical transfusion

using donated blood in a safe, clinically effective and

efficient manner. This is important given that the opti-

misation of the use of blood is an essential pre-requisite

to developing sound, stable policies concerning the

supply of red blood cells.

(2) An International Symposium organised jointly by the

Council of Europe and various German institutions

involved in Transfusion Medicine held in Wildbad

Kreuth [11]. This was a follow-up to the symposium on

an initiative for the optimal use of transfusions held

10 years ago in the same place, and attracted the par-

ticipation of multidisciplinary professionals related to

clinical transfusion practice from across Europe. The

recommendations arising from the symposium with

regards to the supply of red cell concentrates are clear

as follows:

• increase public awareness of potential future short-

ages due to demographic changes;

• enlarge donor bases at the regional level;

• improve clinical practice by developing evidence-

based guidelines;

• promote a benchmarking project in Europe.

• establish effective degree programmes in this field;

• reduce inappropriate use and optimise the manage-

ment of hospital stocks;

• set up regular programmes for exchanging blood

components within Europe;

• establish clinical audit programmes to monitor

appropriate use.

• PROMOTE research in well-defined sets of patients

focused on improving our knowledge concerning the

safety and efficacy of red blood cell transfusions.

Finally, one other essential factor to optimise the use of

these products is that of training professionals, making

them aware of the latest information concerning indi-

cations for transfusion and thereby encouraging evidence-

based practice. Initiatives such as that of the German

Medical Association to develop guidelines for treatment

with blood components [12] (‘cross-sectional guidelines

for therapy with blood components and plasma deriva-

tives’) are steps in the direction indicated by the findings

of the aforementioned institutional projects. In these

guidelines, there are two levels of recommendation: level

1, for cases where there are data with which to judge the

benefits of transfusion against the potential risks; and

level 2, where no definitive data are available for this

risk-benefit assessment; as well as several levels of evi-

dence: A, data arising from large randomised prospective

studies; B, data from prospective studies with contradic-

tory results or methodological weaknesses; C, data from

descriptive non-randomised studies; and C+, data from

case studies and non-randomised studies but that are

conclusive and have been confirmed by various different

methods. For each of these categories, recommendations

are made that support decision-making in clinical

practice.

Disclosures

The author declares that there are no potential conflicts of

interest.

References

1 Devine DV, Sher GD, Reesink HW, et al.: International Forum.

Inventory management. Vox Sang 2009.

0

500

1000

1500

2000

2500

3000

3500

4000

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 >15Number of red cells

Rec

ipie

nts

WomenMen

Fig. 6 Number of red cells transfused by patient in 2010.

196 M. A. Vesga& M. Azkarate

� 2011 The Author(s).ISBT Science Series � 2011 International Society of Blood Transfusion, ISBT Science Series (2011) 6, 193–197

Page 5: Blood Donors: Red Cells Sufficiency

2 Ali A, Auvinen MK, Rautonen J: The aging population poses a

global challenge for blood services. Transfusion 2010; 50:584–

588

3 Currie CJ, Patel TC, McEwan P, et al.: Evaluation of the future

supply and demand for blood products in the United Kingdom

National Health Service. TransfusMed 2004; 14:19–24

4 Borken-Raven Barbara A, Janssen Mart P, van der Poel Cees L:

Demographic changes and predicting blood supply and demand

in the Netherlands. Transfusion 2010; 50:2455–2460

5 Greinacher A, Fendrich K, Alpen U, et al.: Impact of demo-

graphic changes on the blood supply: Mecklenburg-West Pom-

erania as a model region for Europe. Transfusion 2007;

47:395–401

6 Barr PJ, Donnelly M, Morris K, et al.: The epidemiology of red

cell transfusion. Vox Sang 2010; 99:239–250

7 Council of Europe: The collection, testing and use of blood and

blood products in Europe, yearly reports 2001–5. Strasbourg,

Council of Europe, 2006

8 DOMAINE (DOnor MAnagement IN Europe) project. Donor

Management Manual. Editor: Wim De Kort (Sanquin Blood

Supply Foundation, The Netherlands), 2010:56–80.

9 Seifried E, Klueter H, Weidmann C, et al.: How much blood is

needed? Vox Sang 2010; 100:10–21

10 Optimal Blood Use Project: Manual of Optimal Blood Use, Sup-

port for Safe, Clinically Effective, and Efficient Use of blood in

Europe. McClelland DBL, Pirie E, Franklin IM, 2010

11 Optimal Clinical Use of Blood Components: Proceedings. Inter-

national Symposium co-organised by the EDQM & Health-

Care ⁄ DBO – Transfusion medicine, Council of Europe, PEI, The

German Official National Agency for Biologicals, The Transfu-

sionsmedizin und Haemostaseologie, Klinikum der Universitaet

Munchen. Wildbad Kreuth, Bavaria, Germany, April 2009.

12 The Board of the German Medical Association on the Recom-

mendation of the Scientific Advisory Board: Cross-Sectional

Guidelines for Therapy with Blood Components and Plasma

Derivatives. 4th revised edn. Special reprint for the XXXIst

International Congress of the ISBT in joint cooperation with the

43rd Congress of the DGTI, Berlin, Germany, 2010.

Approach to a supply and demand balance 197

� 2011 The Author(s).ISBT Science Series � 2011 International Society of Blood Transfusion, ISBT Science Series (2011) 6, 193–197