Structure Building for Self-Sufficiency in Organ Transplantation in Korea

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2018, Vietnam Society Of Transplantation Structure Building for Self-Sufficiency in Organ Transplantation in Korea Curie Ahn, MD Chair, Vitallink Division of Nephrology, Seoul National Univ. Hospital Transplantation Center, Seoul National Univ. Hospital

Organ Transplantations in Korea 1969 1979 1988 1992 2001 1970 1980 1990 2000 1966 1983 1992 1996

Patient Survival Rate after Transplantation (2017) Patient survival rate of living donor transplantation Patient survival rate of deceased donor transplantation Source : KOTRY Annual data report 2017

Economic Aspect of Organ Transplantation Freedom from Patient Caring Reduction of Medical Expenses Table 1. Comparison of Medical Expenses ESRD Cancer Total # of Patients 54,000 Pt s 213,000 Pt s Total Medical Cost KW 781.6Bil KW 1.107Tril. Medical Cost/Pt s KW 14.5Mil. KW 4.7Mil. Table 2. Health Insurance Cost & ESRD Pt s Total ESRD Pt s Population 40Mil. 54,000 Pt s Medical Cost KW 28 Tril. KW 782 Mil.

Increasing Number of Patients on Waiting! Number of Patients on the Waiting List Increasing waiting time Kidney 1,955 days, Liver 155 days, Heart 234 days, Lung 116 days Death while waiting 8~10% of Waiting List 2017: 1,596 cases (4.4cases/day) KONOS, 2017

Patterns of Organ Trading Organ Selling Coercion to Donate Without Consent Organ Tradin g Abduction Murder

2 nd Class Citizen, Children, Female, Immigrant workers, Homeless, etc.!

Changing Patterns of Organ Trading Individual Marketing Systemize d Web-based Overseas Low-income individuals Underground organization Crime Syndicate Organ Sale Overseas Organ Trade

Solid Organ Transplantation (2015, GODT)

Is organ trading one of many personal problems? NO! Organ trading is a Societal, National, and Global Problem

Lack of Organ s Death during waiting period Organ Traffickin g Istanbul Declaration Indifferenc e Ego- Centrism Kidnap? Murder?

National Responsibility & Global Cooperation Hospital Bioethics Government Protection from organ selling Stop Organ Trading National Self Sufficiency

Status of Organ Transplantation in Korea Increasing No. of Patients Stable or decreasing Sources of Living Donors A few Deceased Donors Increasing No. of Pts & Waiting Time Sig. mortality while waiting Illegal Organ Trade SOLUTION?

Health Systems and Services Courtesy : Prof. Jeremy Chapman Essential Health Technologies 14 The Madrid Resolution LEGISLATION DATA REGISTRIES HEALTHCARE FACILITIES HUMAN RESOURCES REGIONAL COOPERATION CULTURAL & RELIGIOUS ENVIRONMENT FUNDING SUFFICIENCY CAPACITIES CAPACITIES ACHIEVEMENTS NATIONAL ACCOUNTABILITIES CAPACITY CONTROL REGULATORY CONTROL ETHICAL CONTEXT RESPONSIBILITIES OPPORTUNITIES FOR CARE CKD CLD CARDIAC RESPIRATORY DIABETES OTHER EDUCATION VACCINATION SCREENING PREVENTION BRIDGING Rx DONATION TRANSPLANT RESEARCH Courtesy by Jeremy Chapman

System Development of Organ Transplantation in Korea 1999 2000 1979/2003* 1991 1969 1 st Legislation National Authority OPO Public Education (NGOs) Transplantation Center Regulation KONOS KODA KODONET Hospital 1 Waiting Lists HOPO1 1980 One- Body One- Spirit Hospital 2 Organ allocation HOPO2 1991 Korean Organ Donor Program Hospital 3 *1979: 1 st Deceased Kidney Transplantation 2003: Hospital based OPO HOPO 36 1994 Lifeshare Hospital 105 2009 Vitallink

Revision of Organ Transplantation Law 1988 Legislative proposal for brain death by the Korean Society for Transplantation & the Korean Society of Nephrology 1993 Design legislation of brain death 1996 Organize promotion committee for Organ Transplantation Law 1999.2 Establishment of Organ Transplantation Law 2010.5 Revision of Organ Transplantation Law Definitions of brain death Legislation concerning trafficking National Organ Transplantation Authority Establishment of independent IOPO Reporting system of candidate deceased donors Establishment of National Database(post-TPL)

Critical issues in determining the basis of decree on Human Organ, Tissue and Cell Transplantation The extent of inclusion of all medical products of human origin Basis of Consent Opt in or Opt out? The Definitions of Death Structure of National Authority Courtesy: Prof. Jeremy Chapman

The extent of inclusion of all medical products of human origin ORGAN $ $ Stem Cells Advanced Therapies Organ Hematopoietic Stem Cells Gametes Embryos Societal Values Protection of the Donor Safety of the Recipient Public Health Safety Health Systems and Innovation Tissues Blood Plasma Secretions Excretions Patient Safety Programme Human Derived Drugs

Basis of Consent : Opt in or Opt out? OPT IN Explicit Consent = OPT IN Presumed Consent = OPT OUT The legal authority to recover organs from deceased adult individuals unless a refusal to donate was registered Spain, Portugal, France, Italy, Belgium, Greece, Croatia, South America, Czech Republic, Poland, Hungary, Norway, Finland, Courtesy: Prof. Jeremy Chapman

First Person Authorization Consent Adult individuals have the right to make a legally binding anatomical gift prior to death. First Person Authorization makes the indication of an adult s intent to donate some or all organs and/or tissue via a driver license, a donor card, or other documents legally binding. Self-determination concept that adult individuals should be able to make their own decisions about donation of organs after their death Consistent with ethical principles behind other advanced directives Courtesy: Prof. Jeremy Chapman

Definition of Death and Brain Death TOTAL BD

Structure of National Authority KONOS MOH Korean Network for Organ Sharing (KONOS, 2000 KONOS 1 Waiting list 2 Organ allocation 3 Coordination Organ transplantation policy 관련기관 4 Regulation, Monitoring Evaluation 장기이식등록기관 뇌사판정의료기관 뇌사판정대상자관리전문기관 장기구득기관 장기이식의료기관 http://konos.go.kr/

Legislative Framework Infrastructures for Successful Organ Transplantation Transplantation hospitals Operational Requirements Organ procurement organization(opo) Public Education(NGOs) Organ allocation Regulatory Requirements Regulation and Coordination Database

Annual Number of Deceased Donors Legislation Yr 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 No 162 52 52 36 68 86 91 141 148 256 261 268 368 409 416 446 501 573 515

Revision of Organ Transplantation Law 1988 Legislative proposal for brain death by the Korean Society for Transplantation & the Korean Society of Nephrology 1993 Design legislation of brain death 1996 Organize promotion committee for Organ Transplantation Law 1999.2 Establishment of Organ Transplantation Law 2010.5 Revision of Organ Transplantation Law Definitions of brain death Legislation concerning trafficking National Organ Transplantation Authority Establishment of independent IOPO Reporting system of candidate deceased donors Establishment of National Database(post-TPL)

IOPO : Status of Organ Procurement Organization in Korea In 2012, there were 36 hospital based OPO(HOPO) in Korea Little interest in organ procurement in non-hopo hospitals Activate organ procurement in non- HOPO hospitals Reduced utilization of donated organs in some hospitals HOPO vs IOPO Differences in policy on organ donation between HOPOs Maximam utilization of donated organs Standardized policy on organ donation Excessive competition in recruiting organ donors among large hospitals Link to Tissue & Eye donation Programs Lack of standardization in Organ Procurement Standardized procedure in Organ Harvest

IOPO : Korean Organ Donation Agency (KODA) (2009)

IOPO : Korean Organ Donation Agency (KODA) (2009) (Korea Organ Donation Agency KODA) (2009)

Medical Personnel : Emergency Unit, ICU, Neurosurgery The incidence rate of brain deaths Ventilator care organ donation Ye s Ventilator care No Hospital General situation 1 Risk of conflict with family of potential donor Oh MS. Research & research; 2009 2 Poor knowledge regarding organ donation (32% had history of education about organ donation) %

I. Identification & Referral Step 31 Donation Improvement Program Structural brain damage GCS 4 On Ventilato r In hospital DIP LINK Early point donor referral system Set up Save the time medical monitoring & the donor s family support Courtesy: Prof. JW Ha and KODA

Legislative Framework Infrastructures for Successful Organ Transplantation transplantation hospital Operational Requirements Organ procurement organization(opo) Public Education(NGOs) Organ allocation Regulatory Requirements Regulation and Coordination Database

Public Education for Organ Donation: Status for Organ Donation KONOS One-Body One-spirit (Catholic) Korean Organ & Tissue Donation Program (Protestant) Life-Share Association (Buddhism) Korea Foundation for the Prevention of Blindness Korea Kidney Patients Association Korea Eye Donation Center

Public Education for Organ Donation: Level of Understanding 1 2 3 4 Education for Organ Donation Promotion by media and promotional materials Campaigns, events Driver s License, organ donation ribbon, donation card I have heard about organ donation: 97.6% Level of Community Awareness 5 Donor day I understand about organ donation : 11% CDC Report 2017 12

Roadmap for Effective Education for Organ Donation I. SET UP THE ORDER OF PRITORITY 1. Health professional 2. School 3. Family members of donors 4. General public III. COORDINATION 1. Organized Networking 2. Communication V. PLANNING Short- and long-term policies Step 1 Step 2 Step 3 Step 4 Step 5 II. DEVELOPMENT OF TEACHING AIDS 1. Target specific 2. Consistent and Correlated 3. Adequate degree of difficulty 4. Standardized information 5. Education skill IV. EVALUATION 1. Index of evaluation 2. Regular monitoring 3. Impact of Incentive Page 37

COORDINATION Organ Donation Education Structures Government Driven Private Organization Driven OC Planning Office OC Public School Hospital NGO 1 NGO 2 NGO 3 Education Media Campaign Systematic Reliable Education Self-starting Media Promptness Campaign

COORDINATION : Alliance of NGOs : Donate Life America

Korean Organ Donation Network (KODONET 2010.9.11) One spirit One body

Number of Organ Donation Card Holders Donor Card 출처 : 2017 장기등이식및인체조직기증통계연보

Life Sharing Week & Memorial Park Law(2017.10.24) 1 In order to commemorate the love and spirit of the neighbors of long-term registered adults and to spread the culture of sharing, a week is held every year on the second Monday of September. 2 The state and local governments can conduct commemorative events appropriate to the purpose of the week of life sharing. 3 The state and local governments can create parks or construct sculptures to honor the neighbor's love and spirit of sacrifice of long-term registered adults and to use them as educational grounds for spreading a culture of sharing life.

Legislative Framework Infrastructures for Successful Organ Transplantation transplantation hospital Operational Requirements Organ procurement organization(opo) Public Education(NGOs) Organ allocation Regulatory Requirements Regulation and Coordination Database

Global Organ Transplantation Database Europe : CTS China : CLTR USA : SRTR Australia : ANZDATA 44

Korean Organ Transplantation Registry Nationwide Transplant Registry Link to Other Public Data Current Status Reporting Risk Factor Identification Biomarker Research Resource of Transplant Research To Improve Utility of Organ Transplantation 45

Building Infrastructure Web-based Database on icreat Kidney General information Recipient data Donor data Immunosuppressive regimen Transplantation result graft & patient survival Allograft function monitoring Acute rejection Surgical complication PTDM Post transplant malignancy Post transplant infection Post transplant cardiovascular disease Post transplant bone disease 46

Homepage : www.kotry.org Annual report, Discussion board, Data request (Korean) International Collaboration (English) Recent Anuual Report Data Request(Only for Members) English: http://www.kotry.org 47

Asian Transplantation Registry Homepage ww.astreg.org 48

Asian Transplantation Registry Homepage kotry@kotry.org ; Vivian Cho

KOTRY Social Contribution Projects International Support KOTRY foundation Asian DB National DB Transplantation Program Research ASTREG-C ASTREG Country Waiting list Project I Harmony ASTREG-H Hospital Deceased Organ Donation Project II Others ASTREG-I Individual Donor Card 5 0

Legislative Framework Infrastructures for Successful Organ Transplantation transplantation hospital Operational Requirements Organ procurement organization(opo) Public Education(NGOs) Organ allocation Regulatory Requirements Regulation and Coordination Database

No. of Transplantation Tourists and Deceased Donor OT ** DD * KOT RY KOD A Pilot project IOPO Reporting system Organ Transplantation Act Vitallin k Revision, Law *DD: Deceased Donor **OT: Overseas Transplant DO I Revision, Chinese Law Madrid Resolution Chinese Criminal Law Doha meeting

Number of Brain Death Donors in Korea http://www.transplantobservatory.org/ http://www.irodat.org/

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