Il percorso italiano del PBM

Dr. Giancarlo Maria LiumbrunoDirettore Generale, Centro Nazionale Sangue

Istituto Superiore di Sanità, Roma

Cagliari, 29 giugno 2018

Disclosure

I do declare that I have no relevantfinancial or nonfinancial relationshipswithin the products or services described,reviewed, evaluated or compared in thispresentation.

• This resolution of the World Health Assemblyurges all 189 member states of the UnitedNations to implement various transfusionrelated strategies including Patient BloodManagement with its three pillar approach.

http://apps.who.int/gb/ebwha/pdf_files/WHA63/A63_R12-en.pdf

Padilla A, WHO 2010

• According to the Health MinistryDecree of 4th September 2012regarding the national self-sufficiencyplan of blood and blood componentsthe concept of PBM was firstintroduced as a tool to pursue theobjective of achieving the nationalself-sufficiency.

• To achieve this goal the Decreeestablished that it was necessary “todefine and implement innovative andmore effective methods and tools toensure the appropriate clinical andorganizational management ofblood”.

• The 2013 national self-sufficiency plan dealt withthe same issue introducingclearly the wording PBMand recommending to“promote amultidisciplinary andevidence-based approachaiming at improving thepatient’s outcome throughthe 3 pillars of PBM”.

Prevalenza dell’anemia pre-operatoria nei pazienticandidati a interventi di chirurgia maggiore

Muñoz M, Blood Transfus 2015

Anem

ia p

re-o

pera

toria

(%)

Mis

ta

Colo

n

Gin

ecol

ogia

Card

ioch

.

Vasc

olar

e

Uro

logi

ca

Ort

oped

ica

de Benoist B, et al. Worldwide Prevalence of Anaemia 1993–2005: WHO Global Database on Anaemia. Geneva, Switzerland: World Health Organization Press; 2008.Available at: http://whqlibdoc.who.int/publications/2008/9789241596657_eng.pdf

24.8% of world population is anaemic

1.62 billion people

Worldwide prevalence of anaemia

Anemia preoperatoria e outcome postoperatorio inchirurgia non cardiaca: uno studio retrospettivo di coorte

Il problema: l‘anemia preoperatoria

Musallam K et al. Lancet 2011;378:1396-407Retrospective, 227,425 patients

Modificato da Zacharowski K, SIMTI 2016

0

2

4

6

8

10

12

0,78

3,52

10,17

Mor

talit

àa

30 g

g(%

)

Anemia assente(n = 158.196)

Anemia lieve(Hb 9-12 g/dl)(n = 57.870)

Anemia grave (Hb < 9 g/dl)(n = 11.359)

5x

13x

227.425 pazienti; 69.229 anemici: 30,44%

Arthroplasties in Italy(Hip & Knee: HA,KA), year 2013

162,162

Anaemic patients (HA, KA) to be managedin peri-operative period in Italy, year 2013:

From 8,108 to 32,270

Italy 2013

~ 3-10% mortality (Musallam K, 2011)

~ From 243-811 to 968-3,227 preventable deaths

In the 2014 national self-sufficiency plan a project, coordinated by the NationalBlood Centre, foreseeing the first pilot application in the field of elective majororthopaedic replacement surgery was introduced

In Italy, every year more than 160,000arthroplasties are performed in 750facilities. Total estimated cost only forsurgical DRGs: ≅ 1 billion €

Torre M et al. Il Registro Italiano Artroprotesi (RIAP): stato dell’arte. Giornale Italiano di Ortopedia e Traumatologia 2013; 39: 90-95

2013 - 2014

• Italian Society of TransfusionMedicine andImmunohaematology (SIMTI)

• Italian Society of ItalianSociety of Orthopaedics andTraumatology (SIOT)

• Italian Society ofAnaesthesia, Analgesia, Resuscitation and IntensiveTherapy (SIAARTI)

• Italian Society for the Studyof Haemostasis andThrombosis (SISET)

• The National Association ofHospital Medical Directors(ANMDO)

Multidisciplinary recommendations on PBM in elective majororthopaedic surgery - July 2015 - 5 scientific societies

January 2016

Fowler AJ, BJS 2015

The fact that it has beenproved that preoperativeanaemia is associated withpoor outcomes aftersurgery makes it an idealtool to create an urgentneed for PBMimplementation

949,445 patients371,594 with anaemia

(39.1%)mortality, acute kidneyinjury, infections, stroke

Art. 25 Transfusion safety 5. For the prevention of avoidable transfusions andwith particular reference to the preparation of thepatient who will undergo pre-scheduled surgicaltreatments, specific programmes are defined andimplemented nationwide (Patient BloodManagement) on the basis of guidelines to beissued by the National Blood Centre within sixmonths after entry into force of the present Decree.

Provisions on quality and safety of blood andblood components

Blood Transfus 2017

Recommendations for the pre-, intra- and post-operative period

Recommendation N. 4: pre- intra- and post-operative period – Inclinically stable inpatients needing (allogeneic or autologous) RBCtransfusions a single unit blood transfusion policy shall beadopted. Further RBC units shall be transfused after a thoroughclinical reassessment of the patient.

THE RIGHT TRANSFUSION?

The right transfusion therapy

1. THE RIGHT PATIENT

3. THE RIGHT PRODUCT

4. THE RIGHT DOSE

5. THE RIGHT TIME

6. THE RIGHT ROUTE

2. THE RIGHT INDICATION

7. THE RIGHT DOCUMENTATION

8. THE RIGHT RESPONSE

Leahy MF, Transfusion 2014

Transfusion, May 2017

Leahy MF, Transfusion 2014

Time needed to get significant results

0

20.000

40.000

60.000

80.000

100.000

120.000

140.000

160.000

180.000

200.000

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

donated units transfused units

Autologous blood - Italy: 1996-2017

9,610

4,000

Recommendation N. 6: “Predeposit autologous blood donationprogrammes shall be carried out pursuant to the pertinent law inforce” (“At the moment, predeposit autologous donation isindicated for: i) patients with rare erythrocyte phenotype or withcomplex alloimmunisations for whom it is difficult to obtaincompatible homologous blood components; ii) donors of bonemarrow haematopoietic stem cells; iii) children who are to undergoscoliosis surgery”.)

Autologous whole blood units/total whole blood (%)

0 0 0 0.01 0.01 0.01 0.02 0.020.11 0.14 0.14

0.20.3

1.5

0

0,5

1

1,5

2

2,5

% a

utol

ogou

swho

lebl

ood

units

2011 2012 2013 2014

EDQM, modified

Provisions on quality and safety ofblood and blood components

Italy 2016: 0.5% (13,930 autologous WB units)

Italy 2017: 0.37% (9,610 autologous WB units)

Anemizzazione da prelievoSa

ngue

pre

leva

to (m

L/di

e)

Smoller BR, N Engl J Med 1986

Il prelievo ematico per esami dilaboratorio è associatoindipendentemente all’insorgenza dianemia acquisita durante il ricoveroospedaliero(Salisbury AC, Arch Intern Med 2011)

Blood Transfus 2017

Recommendations for the pre-operative period

Blood Transfus 2017

1. Iron status can be easilyevaluated and normal ferritinconcentrations exclude irondeficiency

2. Non-anaemic iron deficiency doesnot require any intervention

3. Oral iron is "always" efficacious ifpatients tolerate high daily doses

4. The use of intravenous ironshould be restricted to severecases of anaemia

5. There is no need for re-assessment after iron repletionwith intravenous iron

6. All intravenous iron formulationsare alike

7. Intravenous iron is associatedwith a high risk of anaphylaxis

8. Premedication reduces infusionreactions during intravenous ironadministration

9. Intravenous iron may increasethe risks of infection andoxidative stress

10. No adjuvant iron is needed witherythropoiesis stimulating agenttreatment if the ferritin level isnormal

Vaglio S, Blood Transfus 2017

Recommendations for the intra-operative period

Blood Transfus 2017

• In January 2017 the Health Ministry sent PBM (regulatory)guidelines to all Regions and Autonomous Provinces invitingthem to ensure the compliance of hospitals and clinics

• The aim was to deliver effective therapies, to containtransfusion needs, to enhance healthcare and to reducecosts

Recommendations for the post-operative period

• The adoption of PBM regulatoryguidelines…..

• Is a strategy to maintain self-sufficiency and has the potentialto significantly contain costs andnot only those associated totransfusion therapy

• The Italian National Blood Centrethrough the Regional BloodCentres will monitor theirapplication with ad hocperformance indicators

2016 - (Italy: RBCs transfused)

Red blood cell production, consumption and transfusion/1,000 pop: Italy 2009-2017

42.4

43.3

43.8

44.5

44.1

42.2 42.3 42.4 42.3

42.4

42.8

43.3

44.1 44

42.2 42.3 42.3

41.9

40.641

41.441.8

41.5

40.440.7 40.7 40.6

39

40

41

42

43

44

45

2009 2010 2011 2012 2013 2014 2015 2016 2017

RBC

units

/1,0

00 p

op

produced consumed transfused

Legend*: preliminary 2017 data

Frequency of blood transfusion in hospitalised patients

Patients transfused during hospitalisation: 1 out of 10

Blood transfusionIntubation for mechanical ventilationHaemodyalisisKnee replacement

Disc

harg

edpa

tient

sx 1

,000

Trentino KM, Transfusion 2015

2018

Appropriate delivery of essential health-care services (EHCSs)

The Regions that appropriately deliver EHCSs receive anadditional 2% of the national health-care fundassigned to them

Essential Health-Care Services

Legend

OKOK, improvementneeded

CriticalNot verified

2018 Performance IndicatorAPPOINTMENT OF THE HAEMOSTASIS & THROMBOSIS SPECIALIST

• “Patients with acquired or congenital coagulopathies and/orthrombocytopathies or positive bleeding anamnesis or those beingtreated with anticoagulants and/or anti-platelet drugs shall be managedin cooperation with haemostasis and thrombosis specialists”

• As regards the initial implementation of PBM, hospitals arerequired to provide documentation related to theappointment of a haemostasis and thrombosis specialist forthe management of the above-mentioned patients in pre-intra- and post-operative period

• Therefore, Regions shall be considered compliant (= able toappropriately deliver essential health-care services) when atleast 40% of their hospitals have appointed a haemostasisand thrombosis specialist

(Possible) future Performance IndicatorsMULTIDISCIPLINARY ANAEMIA CLINICS

• Setting up of multidisciplinary Anaemia Clinicswhich will act as case manager with thecooperation (at least) of the following specialists:transfusion medicine, haemostasis &thrombosis, clinicalhaematology, cardiology, anaesthesia, and anyother specialist needed to treat patients undergoingelective surgery

Possible future Performance IndicatorsREDUCTION OF RED BLOOD CELL TRANSFUSIONS

• Reduction of RBC transfusions in hospitalisedpatients

REDUCTION OF AUTOLOGOUS BLOOD TRANSFUSION

• Reduction of autologous RBC transfusions inhospitalised patients

Blood Transfus 2017, in press

Thanks for your attention!