Strategies in Transplantation

STRATEGIES IN RENAL

TRANSPLANTATION:

The Philippines in Focus

Ma. Nisan T. Manauis, RN, MAN, CRNC

Founding President, Phil. Society of Transplant Nurses

International Society for Organ

Donation and Procurement (ISODP)

STRUGGLES OF A DECEASED

DONOR PROGRAM IN A

DEVELOPING COUNTRY :

PHILIPPINES

Manauis, MNT; Pilar, KAM; Lesaca, RJ; Danguilan, RA; Ona, ET

National Kidney and Transplant Institute

Manila, PHILIPPINES

Philippine Renal Disease Registry; 2008

Number of Transplants according to

Donor Source 2002 - 2008

The Philippine Health Status

Population (2007) 88.6M

10 LEADING CAUSES OF MORTALITY

(Department of Health, 2005)

1. Diseases of the Heart

2. Diseases of the Vascular System

3. Malignant Neoplasm

4. Pneumonia

5. Accidents

6. Tuberculosis, all forms

7. Chronic Lower Respiratory Diseases

8. Diabetes Mellitus

9. Conditions originating in peri-natal

period

10. Nephritis, Nephrotic Syndrome &

Nephrosis

National Bureau of Investigation REPORT, 2000

• 5 Trauma deaths/day in Metro Manila alone

• 1825 potential donors per year

• 3650 potential kidneys for transplant

Struggles of a Deceased Donor Program in

the Philippines

• Objective

▫ To describe the difficulties and struggles in developing and maintaining the Deceased Donor Program in the Philippines and to present the outcome from 2002-2008.

• Methodology

▫ Descriptive study

▫ Review of data from the National Organ Procurement Organization

Number of Deceased Donor Referrals

2002 - 2008 ONLY 62 / 1825 (3%) OF POTENTIAL DONORS ARE REFERRED ANNUALLY

Sources of Deceased Donor Referrals

2002-2008 NUMBER OF

REFERRALS (%)

TYPE OF HOSPITAL

GOVERNMENT 278 (64)

PRIVATE 156 (36)

HOSPITAL AREA

E.R. 346 (89)

ICU 48 (11)

Causes of Deceased Donor Death

2002 - 2008

NUMBER OF CASES (%)

TRAUMA 380 (88)

MEDICAL 54 (12)

CVA 40 (9)

CEREBRAL ANOXIA 6 (1)

PRIMARY BRAIN TUMOR

8 (2)

Consent Challenges

2002 - 2008 NUMBER (%)

PRODUCTIVE CONSENT 191 (44)

UNPRODUCTIVE CONSENT

241 (56)

DELAYED CONSENT 61 (14)

REFUSED 65 (15)

NOT APPROACHED 115 (27)

Reasons for Low Consent Rate • Low level of awareness of Deceased

Organ Donation (98%) • TCs are inappropriately accused of

hastening donor’s death • TCs are reported to the police as trying

to steal organs

• Inability to understand the concept of brain death

• Death was understood as cessation of heartbeat

Medical Professional Challenges

• Refusal of Attending Physicians to sign the Death Certificate form

• Hospital Administrators of private hospitals are not supportive of Deceased Organ Donation and refuse to allow organ retrievals in their facility

Logistical Challenges

• Poor laboratory facilities in referring hospitals

• Inadequate medical supplies for resuscitative measures

• No prioritization in booking commercial flights for the retrieval team and limited available flights

Logistical Challenges

• Organs not allowed to be hand carried, but are checked in as regular luggage

• Lack of knowledge on Deceased Organ Donation by airport security in transporting organs

Number of Organs Retrieved

2002 - 2008

AN AVERAGE OF ONLY 20 KIDNEYS OR 10 DONORS PER YEAR

Number of Kidneys Retrieved vs

Wasted Kidneys 2002 - 2008

CONCLUSION

• Philippine Deceased Donor Program is still in its infancy despite the existence of an organ procurement organization for almost 3 decades and an Organ Donation Law since 1991

• Low level of awareness of the deceased donor program amongst the general public, airport personnel and government employees

CONCLUSION

• There is an urgent need to intensify the educational advocacy campaign on organ donation in both the private and public sectors to improve the deceased donor program

• The medical community likewise needs support in donor management and evaluation to improve the acceptance of organs from deceased donors to avoid wastage of kidneys.

RESUSCITATING THE

DECEASED DONOR

PROGRAM

Manauis, MNT; Suguitan,MG; Lesaca, JRJ; Danguilan, RA, Ona, ET

NATIONAL KIDNEY AND TRANSPLANT INSTITUTE Quezon City, PHILIPPINES

HUM

AN

OR

GA

N PRESERVATION

EF

FO

R

T

N K T I

Human Organ Preservation Effort

• Service ▫ Acts as National Organ

Procurement Organization

National Kidney and Transplant Institute’s Organ procurement arm

Established in 1983

Philippine Donor Source

• Despite 18 years of existence, the Deceased Donor Program’s potential to save lives has not been fully maximized.

Philippine Renal Disease Registry; 2008

Objectives

• Review the problems in organ procurement of the Deceased Donor Program

• Identify and implement effective strategies to improve organ yield

Methodology

• In June 2001, a system review of the Deceased Donor Program was done using performance reports as guide to determine system flaws.

• Alternative solutions were drawn October 2001.

• Solutions were implemented 2002-2004.

• Institutionalization was done January 2005.

• Frequencies and percentages were used to measure outputs annually from 2002-2008.

Problems Identified

• Low referral and consent rates

• Delayed response time to referrals

• Poor Donor Management

• Inadequate logistics

• Prolonged laboratory screening and ischemia time

Alternative Solutions

• Low referral / consent rates

▫ Intensified Hospital Development activities

▫ Intensified Community Outreach activities

▫ Designated Hotline for referrals

▫ Designated Donor Coordinators for network hospitals

• Delayed Response Time to Referrals ▫ Revised flow chart of

the donation process

▫ Acquisition of mobile phones for each TC

▫ Direct referrals to TCs

▫ Trained TCs to evaluate and screen potential deceased donors

Alternative Solutions

• Poor Donor Management

▫ Improved Donor Management protocols

▫ Empowered networks for timely referrals

▫ Trained TCs on donor management

▫ Provided pocket sized donor management guides and checklists

• Inadequate logistics

▫ Provided stocks dedicated to donor management

▫ TCs facilitated donor screening procedures and assumed costs

▫ Financial management of organ donation activities

▫ Regular audit of processes

Alternative Solutions

• Prolonged Laboratory Screening Time ▫ Set turnaround times for

screening procedures

▫ Direct access to laboratory results of potential donors

▫ Immunology staff on call for screening procedures

• Prolonged Ischemia Time ▫ Improved donor

management for closer retrieval time to transplant

▫ Designated Placement Coordinator to facilitate organ placement

▫ Improved Enlistment process

▫ Prioritization in OR time for deceased donor organ transplant

Outcome Parameters

2002 2008 ORGAN PROCUREMENT PROCESS

REFERRAL 32 112

CONSENT 20 42

RESPONSE TIME TO REFERRAL

4hrs 1hr

LABORATORY SCREENING 5hrs 2.5hrs

ISCHEMIA TIME 33hrs 16hrs

LOGISTIC AL SUPPORT

REVOLVING FUND None $1,000

ADVOCACY PROGRAMS

NETWORK HOSPITALS 10 28

COMMUNITY OUTREACH 6 15

Results

Conclusion • An improvement in response time to donor

referrals, reduction in time to get results from laboratory screening, improved donor management, shortening of cold ischemia time and improved logistical support led to an increase in deceased organ donor yield

• Constant audit of processes and strategic planning are vital to enhancing the potentials of the Deceased Donor Program.

Conclusion

• There has been a steady increase in the numbers of KT from deceased donors through 2008, but remains at <10% of all transplants

A GOVERNMENT REGULATED

PROGRAM FOR LIVING NON-

RELATED KIDNEY DONATION

IN THE PHILIPPINES

N Manauis, K Pilar, R Lesaca, R Danguilan, R Uriarte, E Ona

National Kidney and Transplant Institute Quezon City, PHILIPPINES October 2009

34

NATIONAL KIDNEY AND TRANSPLANT INSTITUTE

• Largest tertiary referral center for kidney diseases and

transplantation in the Philippines

• Performed 368/679 (54%) kidney transplants in 2008

PREVALENCE OF DIALYSIS PATIENTS,

NEW PATIENTS STARTING DIALYSIS and

NEW KIDNEY TRANSPLANT PATIENTS

PHILIPPINE RENAL DISEASE REGISTRY

DONOR SOURCE OF FILIPINO KIDNEY

TRANSPLANTS Number of Transplants

(5%)

(67%)

(28%)

PHILIPPINE RENAL DISEASE REGISTRY

Department of Health issued

Administrative Order No. 124

in June, 2002

“A National Policy on

Kidney Transplantation from

Living Non-Related Donors”

OBJECTIVES

• Describe the regulations set-up by the

Department of Health to safeguard the LNRD

from exploitation and abuse

• Look at the medical and economic outcome

of LNRDs enrolled under this program at the

National Kidney and Transplant Institute

SALIENT POINTS

• Creation of the National Transplant Ethics

Committee

• Establish Hospital Transplant Ethics

Committee in every transplant facility to

evaluate all LNRDs

• Prohibition of organ sale

• Accreditation of transplant facilities

SALIENT POINTS cont

• Creation of a National Kidney Transplant Candidate Waiting List and LNRD Registry

• Centralized allocation of kidneys from LNRDs

• Creation of a Donor Monitoring Unit in each transplant facility

• 10% cap on allocation to foreigners

SALIENT POINTS cont

• Providing donors the following-

• Medical follow-up for 10 years

• “Gifts of gratitude”

• Reimbursement of lost income during the

donation process, operation and recovery

• Health and Life insurance

• Educational plan

• Employment opportunities or livelihood training

Amended Administrative Order, March 2008

• Created Philippine Board of Organ

Donation and Transplantation

• Established the Philippine

Network of Organ Donation and

Transplantation (PHILNETDAT)

• National agency charged to

oversee all aspects related to organ

donation and transplantation

• Strict enforcement of regulations

with sanctions to all hospitals with

accredited transplant programs

and its health practitioners

DEPT OF HEALTH

PHIL. BOARD OF ORGAN

DONATION AND

TRANSPLANTATION

PHILNETDAT

NATL TRANSPLANT

ETHICS COM

RESULTS

• 2004 -2007

• DEMOGRAPHICS

▫ 80% Males

▫ Age 21- 40 years (68%)

▫ Single 55%

RESULTS cont

NUMBER (%)

NUMBER OF DONORS EVALUATED 1266

ACCEPTED 278 (22)

REJECTED 988 (78)

RETRACTED CONSENT 605 (61)

SALE 120 (12)

MEDICALLY UNSUITABLE 173 (17)

ETHICS DISAPPROVED 90 (9)

RESULTS cont

• 163 donors transplanted since 2007 • 78% complied with medical follow-up schedule • Trace proteinuria in 3 donors, but resolved

after 6 months

• Hypertension in 1 donor at 4-years post donation

MEAN SERUM CREATININE POST-DONATION

N=127/163

TIME POST-DONATION

EMPLOYMENT PRE-DONATION AND

6 MONTHS POST- DONATION

EMPLOYMENT

STATUS

PRE-DONATION

N=163

NUMBER (%)

POST-DONATION

N=161

NUMBER (%)

UNEMPLOYED 21 (13) 9 (6)

BLUE COLLAR 136 (83) 5 (3)

WHITE COLLAR 2 (1) 3 (2)

SMALL SCALE

ENTREPRENEUR 4 (2) 144 (89)

AVERAGE DAILY

INCOME (USD$) $ 5.40 $ 18.00

CONCLUSIONS

• Majority of LNRDs were male, single, age 21-40

• At 4 years follow up ▫ Improved socio-economic status ▫ Normal renal function

• A government regulated LNRD Program can provide equitable donor allocation that can safeguard donors’ rights, avoid donor exploitation and organ sale

CONCLUSIONS

• A regulated program is a viable option to

the organ donor shortage

• Long-term follow-up is needed to determine if the economic improvement of donors is maintained

New Issuances

• AO 2010-0018

▫ No more transplants from LNRD

▫ Main donor sources

LRD

DDP

DOH, Philippines

The Challenge

• DM and HTN are leading causes of ESRD. How can a patient get transplanted when he could not get a donor from his own family?

▫ When a family member is eligible but doesn’t want to donate, shall he be coerced into donating as that is the only recourse?

• Nearing its 3rd decade of existence, the DDP has only provided <10% of the total transplants in the Philippines. How long will the patients with above condition wait to get transplanted? Will they be still alive by then?

- JACK KEROUAC