deceased organ donation ac lectures/may 6/1_30-3_00...republic act no. 7170, also known as the...

DECEASED ORGAN DONATIONJUAN PAOLO DLC. LAGUNZAD, M.D.Philippine Society of NephrologyCommittee on Advocacy

06 May 2014

Session Objective:

To discuss the current status of deceased organ donation in the country and how internists can contribute.

Outline:

I. Introduction

II. Outcomes of cadaveric kidney transplants

III. Current status of deceased organ donation

IV.Challenges to developing deceased organ donation

V. The internist’s roles in deceased organ donation

TRANSPLANT

Presenter

Presentation Notes

Basically, transplantation is the moving of a tissue or organ (in our case, the kidneys) from one body to another or from one donor site to another location on the patient’s own body, for the purpose of replacing the recipient’s damaged or absent tissue or organ. The organ being transplanted can either come from a living donor, related or non-related, or from a deceased or cadaveric donor.

Which organs can be procured from a potential deceased

organ donor?

Deceased Organ & Tissue Donation

• Kidneys• Liver• Cornea• Bones• Heart• Lungs• Pancreas• Spleen• Intestines

• Other tissues: skin, tendon, menisci, heart valves, blood vessels

Intensive Care Society. Guidelines for Adult Organ and Tissue Donation. UK, 2005

Republic Act No. 7170: Organ Donation Act of 1991

An Act Authorizing the Legacy of Donation of All or Part of a Human Body After Death

for Specified Purposes

Congress of the Philippines, 07 January 1992.

Presenter

Presentation Notes

Republic Act No. 7170, also known as the “Organ Donation Act of 1991”, laid the ground for the practice of deceased organ donation and transplantation in the Philippines. This is an act authorizing the legacy of donation of all or part of a human body after death for specified purposes, particularly organ transplantation.

Republic Act No. 7170: Organ Donation Act of 1991Congress of the Philippines, 07 January 1992.

• Any individual, at least 18 years of age may give by way of legacy all or part of his body

• Introduce the organ donation program in a humane manner to relatives of the potential donor

• Public information campaign

• DOH Secretary to make an appeal for human organ donation.

Republic Act No. 7170. Congress of the Philippines, 1992.

Presenter

Presentation Notes

According to this act, any individual, at least 18 y/o and of sound mind, may give by way of legacy, to take effect after his death, all or part of his body. Trained hospital staff of authorized transplant centers shall handle the task of introducing the organ donation program in a humane and delicate manner to the relatives of the potential deceased donor. It also states that to obtain the maximum benefits from this act, the DOH as well as other institutions concerned should undertake a public information program. Furthermore, the Secretary of Health shall endeavor to persuade all health professionals, both government and private, to make an appeal for human organ donation.

"Death”• irreversible cessation of

circulatory and respiratory functions; or,

• irreversible cessation of all functions of the entire brain, including the brain stem


Republic Act No. 7170: Organ Donation Act of 1991Congress of the Philippines, 07 January 1992.

Presenter

Presentation Notes

But most importantly, this act formed the legal basis of deceased organ donation in the country by defining death as either the irreversible cessation of circulatory and respiratory functions (circulatory death) -or- the irreversible cessation of all functions of the entire brain, including the brain stem (brain death). This means that patients who have been deemed to be brain dead based on certain criteria which I will be mentioning later, even if the heart is still beating, may be legally declared or certified to be dead and may be considered potential deceased organ donors.

• Government organ procurement organization established in 1983

• In earlier years, functions included both organ procurement and allocation

Human Organ Preservation Effort (HOPE)

Presenter

Presentation Notes

Just a little bit of history… In 1983, HOPE which is a government organ procurement organization.was established. In the earlier years, its functions included both organ procurement and allocation.

DOH Administrative Order No. 2010-0019

Establishment of a National Program for Sharing of Organs from Deceased Donors

Presenter

Presentation Notes

This was until the DOH Administrative Order No. 2010-0019 came about in 2010. This AO talks about the establishment of a national program for sharing of organs from deceased donors.

DOH Administrative Order No. 2010-0019 Republic of the Philippines

Objectives:

This order sets policies and guidelines for the efficient and equitable sharing of organs from deceased donors.

Specific Objectives:

1. To establish the Philippine Network for Organ Sharing (PHILNOS)

2. To initiate and maintain the Philippine Organ Donor and Recipient Registry System (PODRRS)

3. To promote organ donation from the deceased

Republic of the Philippines, Department of Health A.O. No. 2010-0019

DOH Administrative Order No. 2010-0019 Republic of the Philippines

• PHILNOS shall act as the central coordinating body for all deceased organ donation and transplantation activities

• The function of the PHILNOS shall be carried out through organ procurement organizations (OPO)

• All tertiary hospitals and trauma centers are required to have a procurement transplant coordinator

• All patients deemed to be brain dead must be referred to the transplant coordinator for evaluation as a potential organ donor


Presenter

Presentation Notes

According to this AO, PHILNOS shall be the organization that will facilitate and oversee organ donation and organ transplantation involving deceased donors in the country. It shall serve as the central coordinating body for all deceased organ/tissue donation and transplantation activities. The function of the PHILNOS shall be carried out through special organ procurement service units called organ procurement organizations (OPO) that need to be DOH accredited. All tertiary hospitals and trauma centers are required to have a procurement transplant coordinator in order to optimize the identification and referral of potential deceased organ donors. All patients deemed to be brain dead or in a state of imminent brain death must be referred to the transplant coordinator for evaluation as a potential multiple organ donor.

Niñalga, HD et al. Graft and Recipient Outcome of Cadaveric Transplantation at the National Kidney and Transplant Institute from 1995-2001. National Kidney and Transplant Institute Proceedings 2005;1:63-70.

Mallari, J et al. Graft and Recipient Outcome of the deceased Renal Transplantation Program at the National Kidney and Transplant Institute from 2002-2007.Overio, Y et al. Graft and Recipient Outcome of Cadaveric Renal Transplantation at NKTI from 2007 to 2010.

Knowledge, attitudes, perceptions of Filipinos on organ donation

(2001 vs 2005)2001 2005

Knew about kidney donation 82% 77%Donor source for transplant

Living donors onlyDeceased donors onlyBoth

49%14%37%

50%9%

41%Willing to become donors 64% 87%Willing to become deceased donors 16% 78%

Uriarte, RDB; Amarillo, MI; Ampil, RS; Manauis, MNT, Philippine Information Agency; Danguilan, RA; Ona, ET. Comparison of national survey on knowledge, attitudes, perceptions of Filipinos on organ donation 2001-2005. Berlin, 2009.

64%

36%

willing to become donorsnot willing to become donors

87%

13% 16%

84%

willing to become deceased donorsnot willing to become deceased donors

78%

22%2001 2005 2001 2005

Kidney Transplants and Donor Source2007

Global Observatory on Donation & Transplantation. Dec 2008.

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Deceased kidneys pmp Live kidneys pmp

Presenter

Presentation Notes

However, despite the improvement in patient outcomes and public awareness, if we look at our registry data, we can see that we still have a long way to go in terms of maximizing the potential of deceased organ donation in our country. This graph shows us how we are doing compared to the other countries.

Philippine Renal Disease Registry; PRDR Annual Report, Renal Disease Control Program (REDCOP), National Kidney and Transplant Institute (NKTI) and National Epidemiology Center (NEC) of the Department of Health (DOH), 2012.

Presenter

Presentation Notes

This area graph shows us the distribution of donor sources among Filipino ESRD patients who underwent KT from 2003-2012. As you can see, deceased organ donors constitute only around 10-20% of the total organ donor pool. There has been a slight increase in the latter years, but still quite small compared to transplants from living donors.

Outcome of Organ Donation Referral to HOPE(2009-2012)

Suguitan, MGA; Casasola, CC; Danguilan RA; Jaro JM. Outcome of Deceased Organ Donation Referral to NKTI.

437

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Referrals Consented fordonation

Donor retrieval amongthose who consented

Presenter

Presentation Notes

264 (60%) 104 (23%)

Outcome of Organ Donation Referral to HOPE(2009-2012)


437

264

104

0

50

100

150

200

250

300

350

400

450


Donor retrievalamong those who

consented

Reasons for non-retrieval:

• Medically unsuitable

• Donor expired prior to organ procurement

• Retracted consent

• Improved sensorium

• No recipient available

• Rejected by recipient’s AP− abnormal urinalysis− azotemia− hypertension− kidney stones

CHALLENGES TO DEVELOPING DECEASED ORGAN DONATION

1. Regulatory environment

2. Logistic capability

3. Health care financing

4. Public awareness and trust

Challenges to Developing Deceased Organ Donation

1. Regulatory environment

Republic Act No. 7170: Organ Donation Act of 1991

Congress of the Philippines07 January 1992

DOH Administrative OrderNo. 2010-0019

Department of Health2010

Presenter

Presentation Notes

Of course there is always the question: “Is it legal?”. Are there laws and policies that support the practice of deceased organ donation in the country? The government’s answer to these concerns are these 2 important documents which I have mentioned earlier. The RA 7170 or the Organ Donation Act of 1991 forms the legal basis for and has been fundamental to the advancement of deceased organ donation, especially by including brain dead patients as potential organ donors, while the DOH AO 2010-0019, with the establishment of the PhilNOS, ensures equitable allocation of organs and regulates all deceased organ transplant activities in the country.


2. Logistical Capability

KT centers KT living KT deceasedNCR 19 273 88Luzon 3 6 2Visayas 7 9 0Mindanao 4 1 0

Prevalent HD pxs

KT deceased Proportion

NCR 5183 88 1.7%Luzon 6288 2 0.03%Visayas 2030 0 0Mindanao 2142 0 0

Philippine Renal Disease Registry; PRDR Annual Report, Renal Disease Control Program (REDCOP), National Kidney and Transplant Institute (NKTI) and National Epidemiology Center (NEC) of the Department of Health (DOH), 2011.

Presenter

Presentation Notes

19 out of 33 transplant centers in the country are located in the NCR, and consequently there is a gross disparity between the number of kidney transplants performed in NCR compared to the other regions. If you take a look at the table below… Medical expertise and facilities might be concentrated in NCR and patients in the provinces might not have adequate access to deceased donor and transplant services.


2. Logistical Capability

Improving access to deceased donors:

PhilNOS is currently in the process of organizing regional OPOs

Zone 1: Region I Medical Center, Dagupan Zone 2: Bicol Regional Medical Center, Naga Zone 3: Vicente Sotto Medical Center, CebuZone 4: Southern Philippines Medical Center, Davao

Regional Hospital, TagumNCR: HOPE



Inability to pay for a transplant is at least as important a factor in limiting transplants as lack of donors.

Cost of a kidney transplant: ≥ P 800,000

Immunosuppression medications: ≥ P 30,000(per month)



• The PhilHealth Z package became available in 2012

• P600,000 to cover hospital bills for members who fulfill the inclusion criteria

• Excludes patients who are considered “high risk”

• Currently available only at the National Kidney and Transplant Institute


4.Public awareness and trust

437

264

104

0

50

100

150

200

250

300

350

400

450


Donor retrievalamong those who

consented

Reasons for consent refusal:

• Families do not believe in organ donation

• Families do not want the patient to “suffer more”

• Legal next of kin do not want to be “blamed”

• Families want the body to be “whole” when they bury it

• Legal next of kin wanted remuneration

• Religious belief of the family

• Wanted only 1 kidney to be retrieved




• Some doctors hesitant to sign death certificate with a brain dead, heart beating donor

• Air transport companies unfamiliar with procedures for transporting organs

• Unfamiliarity with concept of brain death have led to accusations of death being caused by donation

Manauis, Pilar, Lesaca, Danguilan, Ona, 2009.



• It is essential that the whole health care body receives clear and scientific information, and learn the necessary skills for:

Diagnosis of brain death

Physiology and treatment of the organs of potential deceased donors

Legal and ethical aspects of donation

• Public information campaigns to be initiated by the medical community

ADVANCINGDECEASED ORGAN

DONATION

Instructional Module:

Presenter

Presentation Notes

The PSN Committee on Advocacy in cooperation with the PCP, is actually coming up with an Instructional Module entitled “Advancing Deceased Organ Donation”. Knowledge on deceased organ donation will be included in the required terminal competencies for IM residency training programs.

General Objective:

To increase the number of end-stage kidney disease patients undergoing kidney transplantation by increasing the rate of organ donation from deceased donors.

Specific Objectives:To provide IM residents-in-training with adequate knowledge on deceased organ donation to enable them to:

1) identify potential deceased organ donors (Module 1)2) initiate the organ donation process, and; (Module 1)3) manage deceased organ donors in (Module 2)

preparation for organ donation.

Unique Challenges

• Increase the number of organs for transplantation

• Increase access to transplantation, and renal replacement therapy

• Allocate organs equitably considering the absence of universal coverage, and the prospect of only the rich benefiting from a successful deceased organ donation program

The internist’s roles…

1. Identify a potential deceased organ donor

Who may or may not be considered candidates for deceased organ donation?

Deceased Organ Donation

“Any patient who is deemed to be brain dead or in a state of

imminent brain death may be considered a potential multiple

organ donor.”

Republic of the Philippines, Department of Health A.O. No. 2010-0019.

Republic Act No. 7170Congress of the Philippines 1992

"Death”• irreversible cessation of

circulatory and respiratory functions; or,

• irreversible cessation of all functions of the entire brain, including the brain stem


Brain DeathThe following steps must be undertaken before

declaring brain death:

1. Demonstrate absence of cerebral and brain stem functions.

2. Establish irreversibility of coma.

3. Exclude conditions which may confound the diagnosis of brain death.

4. Perform ancillary tests when necessary.

Philippine Neurological Association (PNA) Committee on National Policies, 07 Feb 2012.American Academy of Neurology. Practice Parameters: Determining Brain Death in Adults. US, 1994.

Intensive Care Society. Guidelines for Adult Organ and Tissue Donation. UK, 2005.Manual of Kidney Transplantation, National Kidney and Transplant Institute, 2008.

Philippine General Hospital Kidney Transplant Manual (unpublished).

Death CertificationWho may certify brain death?

• “…attending physician and another physician, preferably a neurologist or a neurosurgeon or an internist or anesthesiologist…”

- Philippine Neurological Association (PNA)

• “…two licensed medical doctors, at least one of whom is a consultant, and neither one is a member of an organ procurement organization (OPO) or the transplant team…”

- Republic of the Philippines, Department of Health A.O. No. 2010-0019

Philippine Neurological Association (PNA) Committee on National Policies, 07 Feb 2012.Republic of the Philippines, Department of Health A.O. No. 2010-0019.

Deceased Organ DonationAbsolute contraindications

• Presence of malignancy except primary non-invasive brain tumors, non-melanotic non-metastasizing skin tumors, and cancer in-situ of uterine cervix

• Presence of infection such as HIV, active and untreated tuberculosis, acute hepatitis B and C, and severe untreated systemic sepsis and viral infection

• History of cardiac arrest > 10 minutes• High risk factors for vascular disease like long-standing

and uncontrolled hypertension (BP >160/100), long-term diabetes with proteinuria

• Presence of chronic renal disease (calculated creatinine clearance of < 60 ml/min or with significant proteinuria)

• Persistent oliguric acute renal failureEuropean Best Practice Guidelines (EBPG) for Renal Transplantation (Part 1). EBPG Expert Group on Renal Transplantation.

Nephrol Dial Transplant, (2000) 15 [Suppl 7]: 39-51.Intensive Care Society. Guidelines for Adult Organ and Tissue Donation. UK, 2005

Manual of Kidney Transplantation, National Kidney and Transplant Institute, 2008Philippine General Hospital Kidney Transplant Manual (unpublished)


2. Introduce the option of organ donation to relatives of the deceased

Consent for Organ Donation• Since the patient lacks the capacity to

consent to organ donation, seek to establish the patient's prior consent by:

– referring to an advance statement if available (i.e., driver’s license, organ donor card)

– exploring with those close to the patient whether the patient had expressed any views about organ donation.

• The patient’s prior consent to organ donation is not a prerequisite but it helps in obtaining consent from the patient’s family.

• Despite the presence of prior consent from the patient, the decision of the patient’s family must always be respected.

NICE Clinical Guideline: Organ Donation for Transplantation.National Institute for Health and Clinical Excellence, UK, 2011

Consent for Organ Donation

• Consent for organ donation may be obtained from the legal next-of-kin in the following order of priority:

• Legal spouse• Son or daughter of legal age• Either parent• Brother or sister of legal age• Guardian over the deceased person at the

time of death

Republic of the Philippines, Department of Health A.O. No. 2010-0019Republic Act No. 7170. Congress of the Philippines, 1992.

Consent for Organ Donation

• Securing consent for organ donation from the family of the deceased shall be the sole responsibility of theTRANSPLANT COORDINATOR.

• The Transplant Coordinator shall obtain consent for organ donation AFTER brain death certification.


Consent for Organ DonationThe Physician’s roles…

• Inform the patient’s family of the patient’s death and address any questions or concerns the family may have regarding the patient’s death

• Ask the relatives to consider the option of organ donation

• Encourage the relatives to agree to discuss the process of organ donation with a transplant coordinator

• Introduce the transplant coordinator to the patient’s family

Consent for Organ DonationFAQs…

– “Paano kayo nakasisiguro na patay na ang anak ko?”(How can you be sure that my son is really already brain dead?)

– “Kapag pumayag kami i-donate ang organs ng anak ko, gagawin niyo pa rin ba ang lahat para alagaan siya?”(If we agree to donate my son’s organs, will my son still receive the best medical care?)

– “Kanino mapupunta ang mga organs na ido-donate ng anak ko?”(Who will receive my son’s donated organs?)

– “Ano ang mangyayari sa katawan ng anak ko pagkatapos niya mag-donate ng organs?”(What will happen to my son’s body after he donates his organs?)

– “Matatagalan ba bago namin makuha ang katawan ng anak ko kung magdo-donate siya ng organs?”(Will it take long before we can get my son’s body if ever we decide to donate his organs?)

– “Meron ba kaming gagastusin kung pumayag kaming i-donate ang mga organs ng anak ko?”(Do we have to pay any additional fees if we agree to donate his organs?)


3. Institute initial donor management

Objectives:

1. Maintain hemodynamic stability and ensure adequate organ perfusion

2. Manage fluids and electrolytes and acid-base balance

3. Work-up, diagnose, and treat infections

Donor Management


4. Initiate the process of deceased organ donation

THE PROCESS OF DECEASED ORGAN DONATION

Yes

No

P A T I E N T

Quick Hx/PEInitial medical management Initial diagnostic tests

Notify AP / Service consultant / Senior resident

Continue appropriate management

Does the patient show signs of brain death?


Neurology service available?

Yes

No


Refer to available consultant for death

certification

Neurology service available?

Refer to Neurology for death certification

No


Death certified?

Communicate patient’s death to patient’s family

Is the patient eligible for deceased organ donation?

Yes

Yes

No

Transplant coordinator available?

Refer to Hospital Transplant Coordinator

Consent obtained for deceased organ donation?

Refer to OPO Transplant

Coordinator

Yes

No



Is the patient eligible for deceased organ donation?


Consent obtained for deceased organ donation?

Refer to Organ Procurement Organization

YesNo

Continue donor management until time of organ procurement

ORGAN PROCUREMENT

PHILNOS

Location:

Department of Health, NCDPC-DDO, 2nd floor, Bldg 9, Manila 1003 Philippines

Phone:

+63 2 731 8234

Email:

[email protected]

Website:http://podrrs.doh.gov.ph/philnos/

NKTI-HOPE

Location:Human Organ Preservation Effort (HOPE) Office4th Floor, NKTI Diagnostic BuildingNational Kidney and Transplant Institute, East Avenue, Quezon City 1100 Philippines

Phone:924-HOPE (+63 2 924 4673)981 0300 / 981 0400 loc 4410 – 4413

Email:[email protected]@[email protected]

PSN

Location:24/F One San Miguel Ave Condominium, corner San Miguel Ave & Shaw Blvd, Pasig City, Metro Manila, 1603 Philippines

Phone:+63 2 687 1198

Telefax:+63 2 687 1187

Mobile:+63 917 823 6726

Email:[email protected]@gmail.com

Website:www.psn.ph

Presenter

Presentation Notes

We still have a long way to go in terms of maximizing the potential of deceased organ donation in the country. But rest assured that there are institutions which are taking some measures to overcome the challenges to the advancement of deceased organ donation. We are counting on your support. Basically, Im sure our ultimate goal is the same, and that is to be able to provide the optimal medical care for our Filipino patients.

“I’m a lifeline!”http://globalnation.inquirer.net/99706/ph-breaks-record-on-donation-of-organs

Presenter

Presentation Notes

Last Feb 28, the Philippines broke the Guinness World Record for the most number of volunteers who signed for organ donations in a span of one hour. Previously, the record was held by India, but we took it from them when we came up with 3,548 registrants in one hour. This project was initiated by DOH and PhilNOS setting up simultaneous registration areas nationwide including PUP in Sta Mesa, Manila; Quezon Memorial Circle in QC; San Fernando, La Union; Tuguegarao, Cagayan; Naga, in Cam Sur; and Davao City. This picture shows Dr. Eric Tayag and company very happy about this accomplishment.

Presenter

Presentation Notes

I would like to thank the PSN for allowing me to give this talk. Dr. Susan Dela Rama, Dr. Connie Casasola, and of course Dr. Benita Padilla, our boss in the PSN Committee on Advocacy, for helping me with the contents of this presentation.

deceased organ donation ac lectures/may 6/1_30-3_00...republic act no. 7170, also known as the...

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