San Marino 23 June, 2012 for Safe Blood Donation and ... · The blood system is run under a thoroughly public governance scheme. Blood activities can be performed only by public blood

INTERNATIONAL SEMINAR San Marino 23 June, 2012

Management of Best Standards and Practices

for Safe Blood Donation and Transfusion

Giuliano Grazzini Centro Nazionale Sangue

Italian policies for blood and blood product

self-sufficiency and safety

http://www.fiods.org/0000

Source: WHO Global Database on Blood Safety (GDBS), 2009 survey


Source: WHO Global Database on Blood Safety (GDBS), 2009 survey

*

ITALY HDI = Human Development Index

BLOOD DONATION IN THE WORLD

BY HUMAN DEVELOPMENT INDEX


Voluntary, anonymous, non-remunerated blood donation

is recognized as an essential activity for the National Health Service.

The social value and the strategic role of qualified

associations and federations of voluntary blood donors are institutionally recognized.

Founding principles - 1

THE ITALIAN BLOOD SYSTEM


National self-sufficiency of blood and blood products

(including plasma-derived medicinal products) is recognized as a primary need for the Nation.

Blood transfusion and transfusion medicine (TM) activities are recognized as “essential healthcare services” (LEA – “Livelli Essenziali di Assistenza”), to be delivered equitably, impartially and free of charge to any citizen needing them.




Quality and safety of blood and blood products and of TM

activities are primary goals of the blood system, to be pursued complying with the pertinent national and European regulatory provisions.

The blood system is run under a thoroughly public

governance scheme. Blood activities can be performed only by public blood transfusion organizations*.

* Blood collection can be outsourced to qualified blood donor associations upon

specific licensing and accreditation, under the technical supervision of public Blood Services.




The vein-to-vein transfusion process, from blood donor

selection to haemovigilance, must be managed, carried out and inspected complying with specific licensing and accreditation requirements, defined according to the pertinent national and European regulatory provisions

Appropriateness of the management and utilization of

blood and blood products is recognized as a primary goal, aimed at best transfusion practices and at contributing to local and national self sufficiency.





Quantitative and qualitative self-sufficiency of blood and

blood products (including plasma-derived medicinal products) as a supra-local and supra-regional goal of the NHS.

Promotion and development of voluntary non-remunerated, regular / repeat blood donation and donor retention.

High quality and safety of blood components, transfusion

medicine activities and plasma-derived medicinal products.

Strategic goals - 1



Achievement of full compliance with national and European regulatory provisions on blood, blood components and hematopoietic stem cells

Appropriate management and clinical utilization of blood

resources

Continuous development of transfusion medicine, aligned with scientific progress

System’s accountability, effectiveness, sustainability

Strategic goals - 2


2011 Blood Donors: 1,733,398

Male: 69.9% Female: 30.1% Repeat: 1,413,376 (81.5%) Frequent *: 641,865 (35.5%) * Donating at least once a year, every year, in the last 5 years

142.745

270.312

436.294

372.424

181.969

9.632

17,7

35,1

46,0

54,161,8

72,7

0

10

20

30

40

50

60

70

80

0

50.000

100.000

150.000

200.000

250.000

300.000

350.000

400.000

450.000

500.000

18-25 26-35 36-45 46-55 56-65 over 65

%n.

Classi di età

Donatori periodici di cui hanno donato almeno una volta all'anno negli ultimi 5 anni

% “Frequent” donors by age groups


BLOOD DONORS

Blood donors

Average increase/year 2001-2011 = + 3.1%

2010-2011 = + 0.6%

228.617

349.063

519.444

426.598

199.710

9.9660

100.000

200.000

300.000

400.000

500.000

600.000

700.000

800.000

18-25 26-35 36-45 46-55 56-65 over 65

Distribuzione dei donatori totali per classi di età anno 2011

66% aged 36-65

Donors by age groups - 2011


2011 Total donations: 3,373,347 per 1,000 pop: 54 ‰*

Whole blood: 2,763,912 per 1,000 pop: 46 ‰

Apheresis: 509,435 per 1,000 pop: 8 ‰ * Average CoE Member States: 43 ‰

Ospedale pediatrico Kinbondo, Kinshasa


BLOOD DONATIONS

Blood donations

2001 - 2011

2.000.000

2.200.000

2.400.000

2.600.000

2.800.000

3.000.000

3.200.000

3.400.000

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

Average increase/year 2001-2011 = + 3.9%

2010-2011 = + 5.3%


Italy 2010 - Population by age groups and gender in percentage of total population in each group

Blood donation

age

In 2010 Italy was the second “oldest” country in OECD (after Japan) as to demographic evolution, with only 2.6 persons in working age (20-64) related to those in retirement age (65+).

OECD. Pensions at a Glance 2011:

Retirement Income Systems in OECD

and G20 Countries.

http://www.oecd.org/els/social/pensions

The future of blood donation in Italy

FUTURE !








http://en.wikipedia.org/wiki/File:OECD.svg


2011

Red blood cells (units): 2,701,988 Units / 1,000 pop: 44.6 ‰

Platelets (units*): 279,418 Units / 1,000 pop: 4.6 ‰

Plasma (units**): 3,105,173 Units / 1,000 pop: 51.2 ‰

Other (including by-products): 1,636,841

Total: 7,723,420 * Adult therapeutic dose

** Whole blood and apheresis


BLOOD COMPONENT PRODUCTION


Blood Components transfused 2011

Red Blood Cells (units): 2,532,664 Units / 1,000 pop: 41.8 ‰

Platelets (units*): 216,586 Units / 1,000 pop: 3,6 ‰

Plasma (units**): 338,905 Units / 1,000 pop: 5,6 ‰

Total: 3,088,136 Units / 1.000 pop: 51 ‰

8,460 blood components transfused / day * Adult therapeutic doses ** Whole blood and apheresis

Transfused patients 2011

685,419

(preliminary data)

11.3 / 1,000 pop / year

Average n. blood components transfused per patient: 4.5

Ospedale pediatrico Kinbondo, Kinshasa


BLOOD COMPONENT TRANSFUSION


Prospective observational study of red cell transfusion in north England. Wells AW, Mounter PJ, Chapman CE, Stainsby D, Wallis JP

BMJ 2002;325:1-4

WHERE DOES BLOOD GO ?


HOW MUCH BLOOD IS NEEDED ?

BLOOD DEMAND TERTIARY CARE SETTING

BLOOD DEMAND PRIMARY AND TERTIARY CARE SETTINGS

2008-2030 PROJECTIONS

BLOOD DONATION/SUPPLY 2007-2030 PROJECTIONS


• According to the “New discipline of blood transfusion activities

and national production of plasma-derived medicines” (21st October 2005 law, n. 219), a self-sufficiency program must be issued by the Ministry of Health every year.

• Annual technical proposals for this program are to be provided

for by the National Blood Centre (NBC) after consultation with the relevant stakeholders (Regional Blood Centres and Blood Donor Associations).

• The annual self-sufficiency program includes

recommendations, indications and objectives both on blood and blood product demand and on blood collection and plasma for fractionation production.

Blood & blood product self-sufficiency The Regulatory Framework



Monthly monitoring


Annual national program for blood and blood product self-sufficiency


Annual national program

for blood and blood product self-sufficiency

DRIVING PRODUCTS

1) RED BLOOD CELLS

2) PLASMA FOR FRACTIONATION



Red Blood Cell production and consumption - 2011 Units/ 1,000 pop / y

The gaps among Italian Regions

40 - 50

30 - 40

< 30

50 - 60

> 60

ITALY: 44.6‰

RBC production

ITALY: 43.6 ‰

RBC consumption

Blue line: Non self-sufficient

Region



15-20

10-15

5-10

< 5 Kg

ITALY: 12,2

Kgs/1,000 pop/y 2011

Plasma for fractionation – 2011 (delivered to fractionation company for contract manufacturing)


> 20

MAX 22.5

MIN 3.9

Plasma for fractionation 2001-2011

742,365 Kgs

2011

Average increase / year = + 6.4%


Albumin demand (tons) Trend 2007-2010

Self-sufficiency plan

Demand analysis

Product availability analysis

Appropriateness plan

Regulatory framework

Immunoglobulin demand (Kgs) Trend 2008-2010

Anti-hemophilia Factor VIII demand (U.I. x 106)

Trend 2008-2010


Blood & blood product self-sufficiency Plasma-derived medicinal products demand

!?


Plasma produced by blood establishments is delivered to an Italian

private pharmaceutical company* according to contract fractionation agreements which – at the moment - envisage the production of:

– IVIgs – Albumin – Plasma-derived FVIII – Plasma-derived FIX – Antithrombin – Prothrombin Complex

* New legislative provisions coming into force within July 2012

establish opening the market of contract fractionation to other companies whose fractionation plants are located in EU Member States fully adhering to the Oviedo treaty, i.e. where human plasma cannot be commercialized

Blood & blood product self-sufficiency Plasma-derived medicinal products



Forthcoming inter-regional / national plans for the

production of: Specific IV/IM Igs (HBV) Fibrin glue “Orphan” PD drugs

Blood & blood product self-sufficiency Plasma-derived medicinal products



PLASMA FOR FRACTIONATION DEMAND

850,000 – 900,000 Kgs (?)

Several variables influence plasma for fractionation demand (inappropriate clinical use, unused intermediate fractions, driving products, low-demand products, lack of flexibility in the specific legislative framework, production gaps among regions, etc.)

Regional and national health authorities shall consider only appropriate plasma-derived medicinal product needs (hence, NOT “demand”) as the main reference point to plan plasma for fractionation production



Self-sufficiency: achievements – 1

RED BLOOD CELLS, PLATELETS AND PLASMA FOR TRANSFUSION

Quantitative and qualitative self-sufficiency has been achieved nationally for several years

Notwithstanding, national annual plans, systematic monitoring and timely regulatory updating have proven to be indispensable in order to: maintain adequate blood donor recruitment and retention

improve blood donation flexibility in order to make it optimally coherent with blood component and plasma for fractionation demand

increase the number of regular/repeat donors and reduce the number of first-time donors

optimize inter-regional blood component balance/exchange (reduce occasional / emergency exchange in favor of planned exchange)

promote continuous clinical governance of blood component utilization and optimal management of blood resources

timely update quality and safety requirements according to the evolution of transfusion medicine, epidemiological changes, new mandatory standards, etc.



Self-sufficiency: achievements - 2

PLASMA FOR FRACTIONATION

Self-sufficiency of national plasma is NOT yet achieved nationwide and plasma-derived medicinal product self-

sufficiency differs according to single products

Significant gaps among regions have existed over the last two decades and still exist, being most south-central and southern regions and the greater islands far / very far from plasma product self-sufficiency

Most of the central-northern regions have achieved / are close to achieve substantial self-sufficiency and are facing the challenging problem of exceeding intermediate fractions (e.g. cryoprecipitate fraction) and/or finished products

There remains a strong need to correct the inappropriate clinical use of albumin and antithrombin



Main policies for quality and safety

Compliance with European regulatory provisions (Directives, GMPs) concerning

blood and blood components and plasma for fractionation

Application of quality systems compliant with licensing and accreditation requirements in all blood establishments and blood collection units

New regional and national blood inspection system

New national haemovigilance system (in place since 2009), compliant with Directive 2005/61/EC

National mandatory standards for blood donor selection, blood and blood component collection, testing, storage, issuing and distribution

National guidelines implementing specific safety / quality measures (e.g.: prevention of TRALI, safety of blood component production, pathogen inactivation, etc.)

Hospital transfusion committees (should also focus on PBM – Patient Blood Management)

National guidelines for the appropriate and safe clinical utilization and management of blood components



TTIs surveillance SARs in blood

donors

SARs in transfused patients and human

errors

SAEs throughout the transfusion

process

Haemovigilance fields


The Haemovigilance System


European Commission

ST = Blood Transfusion Centres CRS = Regional Blood Centres CNS = National Blood Centre

The Haemovigilance System



Blood Transfusion Centres

Regional Blood Centres National Blood Centre International networks

Single

notification

local annual

report regional annual

report

regional annual

reports

Notifications

National

annual report

Web-based system

THE NATIONAL BLOOD INFORMATION SYSTEM

RBC transfusion: adverse reactions

42,1

20,7

16,1

5,4

2,9

3,1

2,0

Reazione febbrile non emolitica Manifestazioni allergiche

Altro Dispnea associata alla trasfusione

Sovraccarico circolatorio (TACO) Ipotensione

Ipertensione

Dal 01/01/2009 al 31/12/2011 sono stati segnalati 2.323 effetti

indesiderati alla trasfusione di globuli rossi

The Italian Haemovigilance System


Plasma transfusion: adverse reactions


Dal 01/01/2009 al 31/12/2011 sono stati segnalati 684 effetti

indesiderati alla trasfusione di plasma

Plasma transfusion: adverse reactions



Dal 01/01/2009 al 31/12/2011 sono stati segnalati 10.034 effetti indesiderati nei donatori (donazioni totali 9.638.366)


Blood and blood component donation: adverse reactions


0,0

50,0

100,0

150,0

200,0

250,0

300,0

2008 2009 2010

Do

na

tori

po

siti

vi

x 1

00

.00

0 d

on

ato

ri

Tasso di prevalenza

HIV

HCV

HBV

TP

0,0

2,0

4,0

6,0

8,0

10,0

12,0

14,0

2009 2010

Do

na

tori

po

sit

ivi

x 1

00

.00

0 d

on

ato

ri

Tasso d'incidenza

HIV

HCV

HBV

TP

Blood donor epidemiological surveillance Prevalence and incidence of HIV, HBV, HCV and TP

x 100,000 donors (2008-2010)

Transfusion transmissible diseases surveillance


Policies for quality and safety in the blood system Some results still to be achieved

In Italy, the overall safety of blood, blood components and transfusion

medicine activities is at a good level, especially as concerns transfusion-transmissible diseases.

Notwithstanding, continuous improvement and optimization of safety strategies must be pursued, taking into account risk management techniques, cost/benefit of interventions and their overall sustainability.

Full compliance with EU blood directives and GMPs as concerns application of regulatory quality standards and inspections shall be achieved nationwide by 31st December 2014.

Improvement in the application of guidelines/criteria for the appropriate management and clinical utilization of blood resources is of paramount importance as it represents a fundamental “parallel tool” to maintain self-sufficiency both quantitative and qualitative. National PBM policies shall be implemented in the near future.



Final comments

A significant burden of present and future challenges affects blood

systems in developed countries: • Ageing of population with increasing transfusion needs for 65+ patients and parallel

decrease of blood donors

• Increasing demand for purest, safest and highly standardized blood components

• New regulatory requirements / testing / development of pathogen inactivation techniques associated to increasing demand for blood safety

• Emerging pathogens affecting (or re-affecting) unexpected geographical areas due to globalization

• RBC storage lesions and their potential implications on clinical outcomes in transfused patients and on blood component production / stocking

• Increasing costs of blood and blood products in a critical economic framework

• ………

Implementation and continuous improvement of proactive and rational strategies aimed at coping with the above burden are strongly required to guarantee adequate performances and, at the same time, their sustainability.

BLOOD SYSTEMS


INTERNATIONAL SEMINAR San Marino 23 June, 2012

Management of Best Standards and Practices

for Safe Blood Donations and Transfusions

THANK YOU FOR YOUR ATTENTION

AND FOR ANY COMMENTS AND SUGGESTIONS


Documents

San Marino 23 June, 2012 for Safe Blood Donation and ... · The blood system is run under a thoroughly public governance scheme. Blood activities can be performed only by public blood