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ORGAN DONATION and ADVANCE DIRECTIVES Why?  Will it increase donations?  facts & figures in Malta  what has increased donations?  Will it reduce abuse?

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Presentation on theme: "ORGAN DONATION and ADVANCE DIRECTIVES Why?  Will it increase donations?  facts & figures in Malta  what has increased donations?  Will it reduce abuse?"— Presentation transcript:

1 ORGAN DONATION and ADVANCE DIRECTIVES Why?  Will it increase donations?  facts & figures in Malta  what has increased donations?  Will it reduce abuse? What are the relevant issues ?  Informed Consent: Opt - in vs Opt – out  Conflict with Advance Directive?  Information / counseling How?  Can it be done?  infrastructure – US example  Will it be accepted?  public attitudes  no literature relating people’s reaction to living wills for transplantation issues

2 2 Organs Harvested in Malta 1999-2008 Transplanted in KidneyCorneaHeartLiverLungPancreasTotal Malta - all 1041396000249 Abroad - all 10010372261 1999-2008 Donors by Age: 22 live [10M, 12F] 91 cadaver [67M, 24F] <1515-2425-3435-4445-5455-6465-74>75Total Male212101115197177 Female413610111036 Total6131317253081113 1999-2008 All Recipients by Age [104 kidney, 139 cornea] <1515-2425-3435-4445-5455-6465-74>75Total Male617173023351110149 Female38161714171510100 Total925334737522620249, data by Mr. A. Bugeja, Transplant Coordinator, MDH and Mr. M. Debono, Staff Nurse, MDH Waiting list: DOI, September 2009: 95 waiting for an organ transplant 12 persons/ day are dying in Europe as they wait

3 3 WHY? Will it increase donations? Will it reduce Abuse? Cannot answer question : lack of literature Increase in Donations:  Consent: Antwerp opt-in system & enhanced education policy kept same rate while in Leuven, opt-out system, donors rose by 15-40/year over 3 yrs  Education: higher education & socio-professional level relate to positive views  Infrastructure: Spain attributed increase to new mechanism for transplant co- ordination rather than their version of presumed consent  Communication: campaigns have positive consequences  discussion with family has a strong influence on willingness to donate  increase in organ card donors  more positive attitudes towards organ donation  easier to approach families as issues in media and families expect approach Reduction in Abuse:  voluntary unpaid donation first recognised in Spain, 1979  Commission 2006: ‘donors cannot be remunerated but may receive compensation strictly limited to making good the expenses and inconvenience related to the donation’  procurement organisations / teams must work on a non-profit basis  How many on waiting lists are seeking organs through payment ??

4 4 WHAT ? OPT IN CONSENT OPT OUT  England, Malta, Canada  cadaver organs retrieved only if permission from family  donor card (or driving licence or passport - not legal) signed by deceased does not give doctors right to harvest organs donors  register with authority and obtain donor card following adequate information, enabling informed consent  request refusal by relatives: no published information The ‘required request’ policy in USA  mandatory for doctors to ask family if willing to donate organs, before ventilator is switched off  illegal, irresponsible to disconnect ventilator from person declared brain stem dead without first making proper enquiry as to possibility of harvesting tissues and organs - revised Uniform Anatomical Gift Act 1987  Spain, Austria, Belgium, Italy, Sweden  harvesting cadaver organs, without family permission - ‘presumed consent’ - exception if deceased objected to donation  BUT in Italy, Sweden, Spain relatives allowed to object to donation  Belgian Law: no donation if objection from first degree relative or spouse living with donor, unless objection is contrary to deceased’s donor’s wishes  relatives not asked to consent but told of proposed harvesting so ‘may register objection’  Spain: law requires family to confirm, in writing, that donor had not objected system operates more along lines of informed, than presumed, consent and permission of relatives is routinely sought  BMA: ‘presumed consent, with safeguards’  suggests possibility of opting out through GPs  not to proceed if donor’s wishes not known & donation would cause distress or if relatives volunteer unregistered objection  if deceased had no objection, relatives still informed before harvesting

5 5 WHAT ? CONSENT: THE OPT IN SYSTEM Uniform Anatomical Gift Act, 2006 amendment of 1987 law DONOR  donor rights law, effective January 2006, in > 40 states  no need to ask for relatives’ consent once donor is in a registry RELATIVES  right of relatives to make an anatomical gift of deceased’s organs if deceased had not made a gift during life  strengthens right of an individual not to donate by signing a refusal that also bars others from making a gift of his/her organs THE QUESTION : CONFLICT?  if unconscious patient with a donor card also has a living will stating he does not want to remain on a ventilator?  critics argue Act favours donation rather than living will  not every doctor agrees, so states are to ensure family is consulted to determine what donor would have wanted  Caplan: ‘I think a person's instructions for end-of-life care should always take precedence over make me an organ donor’

6 6 WHAT ? : INFORMATION / COUNSELING  Convention on Human Rights and Biomedicine, Oviedo,1997, article 5, General Rule:  An intervention in health field may only be carried out after person has given free and informed consent. This person shall beforehand be given appropriate information as to purpose and nature of intervention as well as on its consequences and risks.  Additional Protocol on Transplantation of Organs and Tissues of Human Origin, 2002, article 8: Information for health professionals and the public: Parties shall provide information for health professionals and for public on need for organs and tissues. They shall also provide information on conditions relating to removal and implantation of organs and tissues, including matters relating to consent or authorization, in particular with regard to removal from deceased persons.  article 5: Information for the recipient: The recipient and, where appropriate, the person or body providing authorization for the implantation shall beforehand be given appropriate information as to the purpose and nature of the implantation, its consequences and risks, as well as on the alternatives to the intervention.  QUESTIONS : Does Living Will fulfill these conditions? Is there adequate information before signing? What if electronic? What if donor changes views?  ANSWERS: mandatory counseling / annual update /Data Protection Information Society DG is supporting creation of European online registry on organs, cells, tissues through EUROCET project

7 7 HOW ? : LIVING WILL INFRASTRUCTURE US Patient Self-Determination Act effective December 1991  mandatory to inform patients on admission / registration to hospital /homes, about legal rights regarding Advance Directives, including  right to participate in and direct their own health care decisions;  right to accept or refuse medical or surgical treatment;  right to prepare an AD; and  information on provider’s policies that govern utilization of these rights  act prohibits institutions from discriminating against patient who does not have an AD  obliges health institutions to provide education on Advance Directives System: U.S. Living Will Registry (private organization)  will is registered : labels for driver's license and insurance card, and a wallet card indicate registration is legally binding  annual letter to confirm donor’s wishes have not changed, and allow any changes to contact information  automated secure Internet and telephone/fax systems  information available to health care providers across country easily  if form for Living Will does not include section on organ donation, add wishes in "comments" section, or submit letter of intent for organ donation  family decides on donation but helped by knowing wishes (as donor cards)

8 8 HOW ? : ORGAN DONATION INFRASTRUCTURE Uniform Anatomical Gift Act, 2006 Registry of Secretary of State Organ /Tissue Donor Program  law establishes standards for donor registries  computerized registries and electronic signatures, but not for those who do not want to be donors  enables access of procurement organizations to donor registries, medical records, records of state motor vehicle department  regulates cooperation and coordination between organizations and coroners / medical examiners  procurement co-ordinators  initial contact with potential applicant (> 18) - provide information and obtain medical history - ask family if want feedback regarding donation  at time of imminent death  if patient is registered, support provided to family  if patient not registered, offer families possibility to donate, giving full information  hospitals notify organ procurement organization to evaluate deaths / imminent deaths for potential donation - assess medical eligibility

9 9 2007 EURO- BAROMETER EU averageMaltaHollandScandinaviaBelgium Discussed with family 42% for EU2544%75%Sweden 66%Portugal 28% Austria 24% Never discussed58% Ready to donate56%75%69%Sweden 81% Finland 73% Denmark 69% 71% Against donation26%10% No opinion18% Ready to donate relative’s organs 54%71%66%Sweden 74 % Finland 73 % Denmark 63% 65% Against23%10% Favour Donor Card 4/5 14% F 10% M 8% school leavers <16 18% school till >20 National campaign success 7%, 9%, 13%, 14% over 4 surveys HOW ? : PUBLIC ATTITUDES : Promising in Malta

10 10 THE MALTA SITUATION Infrastructure: Required  Transplant Authority  Transplant co-ordinator/s - specific training and formal job descriptions  Donor Register, centralised, accessible, electronic: Data Protection  Transplant Support Group (Malta)  favours legislation for organ donation to legalise practices  advocates for Official Donor Register, with mandatory update  against opt-out system - donation altruistic following adequate information  insist potential donor should inform family - if relatives know the deceased’s wishes, their decision is much easier Opinion: Living Will unlikely to increase donations in Malta Public Attitudes: Promising Legislation: no law on Organ Donation for Transplantation as yet  no regulation on restricting / prohibiting advertising for human tissues, cells, with a view to financial gain or comparable advantages  BUT Criminal Code, article 248C: trafficking is illegal  article 248A(2): illegal to obtain organs by violence, threats, abduction, deceit, fraud, misuse of authority, influence or pressure, giving or receiving payments or benefits to achieve consent

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