3 Patient Safety Programme Health Systems and Innovation Jose R. Nuñez MD, PhD Medical Officer Transplantation

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14 Patient Safety Programme Health Systems and Innovation KidneyLiverHeartLungPancreas GKT/ GODT Global Observatory on Donation and Transplantation Organs Transplanted Globally in 2011 ≈ 112,600 organs transplanted (≈ 10% of estimated global needs) ≈ 5.1 % increase over countries reported to the Global Observatory on Organ Donation and Transplantation South Africa, India and China - are 2010 estimates

15 Patient Safety Programme Health Systems and Innovation Original procurement from a human donor. Need to meet essential ethical and safety requirements inherent to their human origin Living donor

16 Patient Safety Programme Health Systems and Innovation KidneyLiverHeartLungPancreas GKT/ GODT Global Observatory on Donation and Transplantation Organs Transplanted Globally in 2011 ≈ 112,600 organs transplanted (≈ 10% of estimated global needs) 103 countries reported to the Global Observatory on Organ Donation and Transplantation South Africa, India and China - are 2010 estimates

17 Patient Safety Programme Health Systems and Innovation KidneyLiverHeartLungPancreas Living Donor Living Donor ,5%17,8% 2008 GKT/ GODT ≈ 112,600 organs transplanted (≈ 10% of estimated global needs) 103 countries reported to the Global Observatory on Organ Donation and Transplantation South Africa, India and China - are 2010 estimates Global Observatory on Donation and Transplantation Organs Transplanted Globally in 2011

18 Patient Safety Programme Health Systems and Innovation Original procurement from a human donor. Need to meet essential ethical and safety requirements inherent to their human origin Living donor Without alternative of comparable benefit Often last option “Radical” treatment Cross border

19 Patient Safety Programme Health Systems and Innovation 1.9 million tissue grafts distributed by AATB accredited tissue banks each year > 200,000 tissues grafts a year in Germany 46,000 corneas distributed by Sri Lanka Eye Bank over 30 years > 100,000 tissues imported into Korea in one year 5,000 cornea transplants in Italy each year 20,000 tissue transplants in France in one year Deirdre Fehily, Kuala Lumpur, WPR Regional Meeting 8-10 June 2009

20 Patient Safety Programme Health Systems and Innovation Original procurement from a human donor. Need to meet essential ethical and safety requirements inherent to their human origin Living donor Without alternative of comparable benefit Often last option “Radical” treatment Cross border Scanty resource

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23 Health Systems Policies and Workforce Health Systems and Innovation Clinical Procedures To meet patients needs: 1.Government responsibility Organization 2.Equity In the burden of donation In allocation (UHC) WHA Education To donation To prevention 4.Trust of the Public Transparency Professionalism Donation is a civic gesture, an expectation but not an exception

24 Health Systems Policies and Workforce Health Systems and Innovation Clinical Procedures 24 Professionals Authorities The Magnificent Seven, John Sturges,1960

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26 Patient Safety Programme Health Systems and Innovation “ Health products of an exceptional nature”

27 Patient Safety Programme Health Systems and Innovation * GUIDING PRINCIPLE 10 WHO Guiding Principles On Human Cell, Tissue And Organ Transplantation Endorsed by the sixty-third World Health Assembly in Resolution WHA 63.22

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30 Patient Safety Programme Health Systems and Innovation  Prohibition of financial gain on the human body and its parts as such, recognizing that procurement through financial incentives and profit on some human body parts as such (e.g. plasma and gametes) is not forbidden in some countries, in which case respect of other requirements starting with transparency is even more important;  Responsibility for the provision of MPHO placed with authorities and through them the individual citizen and resident;  Genuine consent of donors and recipients;  Protection of the incompetent  Equity as a goal, in the burden of donation and in allocation of MPHO  Use of MPHO justified by evidence and absence of comparable alternative;

31 Patient Safety Programme Health Systems and Innovation  Council of Europe Convention on Human Rights and Biomedicine (Oviedo 1997) and Additional Protocol concerning Transplantation of Organs and Tissues of Human Origin  Draft Council of Europe Convention against Trafficking in Human Organ (Council of Europe - CDPC)  Charter of Fundamental Rights of the European Union Citizen

32 Patient Safety Programme Health Systems and Innovation  Traceability and accountability mandated throughout the process, from donors to recipients, including long term outcomes and vigilance and surveillance under the oversight of national competent authorities;  Transparency and openness to scrutiny indispensable even if confidentiality and anonymity when required must be preserved;

33 Patient Safety Programme Health Systems and Innovation Allow: easier information transfer + traceability + interoperability across MPHO, and between countries in routine and emergency + cost containment From the transfusion experience Coding is a priority

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35 Patient Safety Programme Health Systems and Innovation Terminology Nomenclature Translations Coding Unique identifiers Centers Donations Recipient(s) Formatting standards Delivery means Inter-operability across Medical Products of Human Origin

36 Patient Safety Programme Health Systems and Innovation  Duty to constantly optimize the safety, quality and efficacy of procurement, process and clinical application of MPHO

37 Patient Safety Programme Health Systems and Innovation Dr Luc Noël EHT/CPR "Clinical Procedures" Bologna Initiative for Global Vigilance and Surveillance BIG V&S

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39 Patient Safety Programme Health Systems and Innovation A database of all types of severe adverse events and reactions that have been reported arising from procurement and processing to clinical application of cells, tissues and organs for transplantation as well as of medical products of human origin used in assisted reproduction technologies. 1. A reference for professionals focused on diagnostic and investigation 2. but also providing evidence for donor selection, 3. A source of information for candidate recipients and living donors 4. A database for further study

40 Patient Safety Programme Health Systems and Innovation Scope: organs, tissues and cells for transplantation and for assisted reproduction. Blood ? Aim: to create and maintain a compendium of cases of adverse reactions/events for donors and recipients of organs, tissues or cells, noting how they were detected, confirmed and documented and to develop guidance based on the information collected.

41 Patient Safety Programme Health Systems and Innovation Utilized Standard Definitions Severe Adverse Reactions: An adverse response that HAS occurred, including a communicable disease, in a recipient or in a living donor Serious Adverse Events: An adverse occurence that MIGHT lead to harm in a recipient or a living donor Uniform Definitions of Donor Derived Infections  Garzoni C, Ison MG. Transplantation. 2011; 92: 1297 – Review of published reports of SARE Standardized summaries including: Adverse Incident, Substance Type, Latency, Alerting Symptoms, Frequency Data and Estimates, Demonstration of Imputability, Keywords, References

42 Patient Safety Programme Health Systems and Innovation The NOTIFY Library More than 900 documented case types can be searched in a structured way by organ, tissue or cell type and/or incident type  associated bibliographic references and expert analyses. Reactions  Infectious transmissions of all types, malignancy transmissions, and genetic transmissions to transplant recipients and to the offspring of children born from donated gametes. Events  caused by process failures and reactions in living donors Site and search tools publicly available (without username and password) Language specific interface in Regions.

43 Patient Safety Programme Health Systems and Innovation The establishment of globally agreed principles for the governance of MPHO would represent significant progress towards the goal of meeting minimum standards, as well as serving: to underline the cross cutting concerns regarding all MPHO, inherent to their human origin; to demonstrate respect for the human body and hence the dignity of persons; To increase safety and enhance ethical practices; To encourage donation by generating trust in procedural safeguards such as consent requirements and protocols for care and follow-up of donors; To avoid distortions in practices due to the undermining effect of bad examples, such as the justification of payment for organs by appeal to legal trade in plasma.

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Health System Governance and Service Delivery Health Systems and Services 45 Clinical Procedures