Assessment of Knowledge of Legal Provisions on Organ Donation and Transplantation amongst Healthcare Workers in Nigeria: A Cross-sectional Study.

BACKGROUND: Advancements in the medical field have made organ transplantation an attractive treatment option for patients when indicated. Shortage of organs and commodification of organs are major challenges encountered in organ donation and transplantation. These could potentially breed unethical practices, if the process is not well regulated. AIM: The aim of this study was to assess the knowledge of healthcare workers (HCWs) on the legal provisions regulating organ donation and transplantation in Nigeria. METHODOLOGY: This cross-sectional study was conducted amongst physicians and nurses across Nigeria. Knowledge of legal provisions on organ donation and transplantation was assessed using a validated questionnaire that had 21 questions derived from the National Health Act. Each correctly answered question was given 1 point with a total obtainable score of 21 points. A score of ≥14 points was classified as good knowledge. P <0.05 was considered significant. RESULTS: A total of 836 physicians and nurses with a mean age of 37.61 ± 9.78 years participated in the study. Females and physicians constituted 53.3% and 62.9% of the respondents, respectively. The mean knowledge score of the respondents was 9.70 ± 2.91 points. Eighty-three (9.9%) respondents had a good knowledge score. There was a significantly higher proportion of male HCWs (P < 0.037) and older HCWs (P = 0.017) with good knowledge of legal provisions. On logistic regression, age was the only factor found to be associated with good knowledge of legal provision (adjusted odds ratio: 3.92; confidence interval: 1.33-11.59; P = 0.01). CONCLUSION: The overall knowledge of legal provisions on organ donation and transplant was very poor amongst HCWs in Nigeria. There is a need to educate them on these provisions to curb unethical practices.

Road To Deceased Donor Transplantation in Egypt.

In Egypt, there is presently a growing need to have a deceased donor transplant program. Egypt conducted its first kidney transplant from a living donor in 1976 and a first partial liver transplant in 2001. Since 2009, the Egyptian Health Authorities Combat Transplant Tourism in concordance with ethics codes and the Declaration of Istanbul Custodian Group has been in place. The Egyptian Transplantation Law of 2011 mentions that organs could be procured from deceased donors based on a will and on family consent. This law has had many critics, including religious authorities who have stressed that organs cannot be taken from a person with brain death because, in their view, life ends with death of all organs. Many intensivists disagree over the definition of death. In addition, the media has communicated contradicting and sometimes misleading health care information. Mummification is rooted in pharos practice and linked to religious beliefs. The ancient Egyptians believed that, by burying the deceased with their organs, they may rejoin with them in the afterlife. Since 2019, the transplant community in Egypt has started collaborations with international transplant organizations and campaigns with doctors and celebrities to donate their organs after death, which have stressed that a deceased donor program could help against end-stage organ mortality. In November 2022, after communications with politicians, President Abdelfattah El Sisi directed the government to establish a regional center for organ transplantation, which aimed to be the biggest in the Middle East and North Africa region. The new center will be part of a new medical city that would replace Nasser Medical Institution in Cairo, Egypt. The Ministry of Health issued an official form to be signed by a person before his death, accepting use of organs, to give hope and support to other patients in need.

Organ Donation in Syria.

The first living donor kidney transplant in Syria was performed 44 years ago; by the end of 2022, 6265 renal transplants had been performed in Syria. Kidney, bone marrow, cornea, and stem cells are the only organs or tissues that can be transplanted in Syria. Although 3 heart transplants from deceased donors were performed in the late 1980s, cardiac transplant activities have since discontinued. In 2003, national Syrian legislation was enacted authorizing the use of organs from living unrelated and deceased donors. This important law was preceded by another big stride: the acceptance by the higher Islamic religious authorities in Syria in 2001 of the principle of procurement of organs from deceased donors, provided that consent is given by a first- or second-degree relative. After the law was enacted, kidney transplant rates increased from 7 per million population in 2002 to 17 per million population in 2007. Kidney transplants performed abroad for Syrian patients declined from 25% in 2002 to <2% in 2007. Rates plateaued through 2010, before the political crisis started in 2011. Forty-four years after the first successful kidney transplant in Syria, patients needing an organ transplant rely on living donors only. Moreover, 20 years after the law authorizing use of organs from deceased donors, a program is still not in place in Syria. The war, limited resources, and lack of public awareness about the importance of organ donation and transplant appear to be factors inhibiting initiation of a deceased donor program in Syria. A concerted and ongoing education campaign is needed to increase awareness of organ donation, change negative public attitudes, and gain societal acceptance. Every effort must be made to initiate a deceased donor program to lessen the burden on living donors and to enable national self-sufficiency in organs for transplant.

A Comprehensive Analysis of Litigation in Organ Transplantation for Allegations of Insufficient Policy Coverage, Discrimination and Malpractice.

Introduction: Transplantation is a field with unique medical and administrative challenges that involve an equally diverse array of stakeholders. Expectantly, the litigation stemming from this field should be similarly nuanced. There is a paucity of comprehensive reviews characterizing this medicolegal landscape. Design: The Caselaw Access Project Database was used to collect official court briefs of 2053 lawsuits related to kidney, liver, heart, lung, and pancreas transplantation. A thematic analysis was undertaken to characterize grounds for litigation, defendant type, and outcomes. Cases were grouped into policy, discrimination, poor or unsuccessful outcome, or other categories. Results: One hundred sixty-four court cases were included for analysis. Cases involving disputes over policy coverage were the most common across all organ types (N = 55, 33.5%). This was followed by poor outcomes (N = 51, 31.1%), allegations of discrimination against prison systems and employers (N = 37, 22.6%) and other (N = 21, 12.8%). Defendants involved in discrimination trials won with the greatest frequency (N = 29, 90.62%). Defendants implicated in policy suits won 65.3% (N = 32), poor outcomes 62.2% (N = 28), and other 70% (N = 14). Of the 51 cases involving poor outcomes, plaintiffs indicated lack of informed consent in 23 (45.1%). Conclusion: Reconsidering the informed consent process may be a viable means of mitigating future legal action. Most discrimination suits favoring defendants suggested previous concerns of structural injustices in transplantation may not be founded. The prevalence of policy-related cases could be an indication of financial burden on patients. Future work and advocacy will need to substantiate these concerns and address change where legal recourse falls short.

Transplantation in the Context of Migration and Refugees: A Summary of the DICG and TTS Ethics Committee Workshop, Buenos Aires, Argentina, September 2022.

Global conflicts and humanitarian crises have resulted in an unprecedented number of refugees and migrants. This challenges the limited resources of health care systems and jeopardizes the availability of transplant care for these deserving migrants and refugees. This was the basis for a workshop held during the Congress of the Transplantation Society (Buenos Aires, 2022). We elaborate on the proceedings of the workshop entitled "Transplantation in the Context of Migration and Refugees," organized by the Ethics Committee of The Transplantation Society and Declaration of Istanbul Custodian Group. Transplant providers from around the world shared strategies of how each region has responded to providing access to care for refugees and migrants in need of transplant services. The potential exploitation of this vulnerable group leading to illicit organ removal was addressed for each region. The Transplantation Society, Declaration of Istanbul Custodian Group, and global transplant community should continue to focus on the status of refugees and migrants and collaborate on strategies to provide access to transplant care for this deserving population. Global cooperation will be essential to provide vigilant oversight to prevent exploitation of this vulnerable population.

Canadian Society of Transplantation White Paper: Ethical and Legal Considerations for Alcohol and Cannabis Use in Solid Organ Listing and Allocation.

Alcohol and cannabis use as a contraindication to organ transplantation is a controversial issue. Until recently, patients in Canada with alcohol-associated liver disease were required to demonstrate abstinence for 6 mo to receive a liver transplant. There is no equivalent rule that is applied consistently for cannabis use. There is some evidence that alcohol and cannabis use disorder pretransplant could be associated with worse outcomes posttransplantation. However, early liver transplantation for patients with alcohol-associated liver disease in France and in the United States has led to challenges of the 6-mo abstinence rule in Canada in the media. It has also resulted in several legal challenges arguing that the rule violates human rights laws regarding discrimination in the provision of medical services and that the rule is also unconstitutional (this challenge is still before the court). Recent legalization of cannabis use for adults in Canada has led to questions about the appropriateness of limiting transplant access based on cannabis use. The ethics committee of the Canadian Society of Transplantation was asked to provide an ethical analysis of cannabis and alcohol abstinence policies. Our conclusions were as follows: neither cannabis use nor the 6-mo abstinence rule for alcohol use should be an absolute contraindication to transplantation, and transplant could be offered to selected patients, further research should be conducted to ensure evidence-based policies; and the transplant community has a duty not to perpetuate stigma associated with alcohol and cannabis use disorders.

The Clinical Conundrum of Cannabis: Current Practices and Recommendations for Transplant Clinicians: An Opinion of the Immunology/Transplantation PRN of the American College of Clinical Pharmacy.

Cannabis, or marijuana, comprises many compounds with varying effects. It has become a treatment option for chronic diseases and debilitating symptoms, and evidence suggests that it has immunomodulatory and antiinflammatory properties. Transplant centers are more frequently facing issues about cannabis, as indications and legalization expand. As of February 2020, 33 states and the District of Columbia have legalized medical cannabis, and 14 have legalized recreational cannabis. Moreover, 8 states have passed legislation prohibiting the denial of transplant listing solely based on cannabis use. Studies demonstrate the potential for significant pharmacokinetic and pharmacodynamic interactions between cannabis and immunosuppression. Additionally, safety concerns include increased risk of myocardial infarction, ischemic stroke, tachyarrhythmias, malignancy, neurocognitive deficits, psychosis, other neuropsychiatric disorders, cannabis use disorder, respiratory symptoms, and infection. A recent retrospective database study found a negative association between documented cannabis use disorder and graft survival, but little additional evidence exists evaluating this relationship. In the absence of robust clinical data, transplant centers need a clear, reasoned, and systematic approach to cannabis. The results of our national survey, unfortunately, found little consensus among institutions. As both recreational and medicinal cannabis become more ubiquitous nationwide, transplant centers will need to develop comprehensive policies to address its use.

Uncontrolled Donation After Circulatory Death: A Unique Opportunity.

Uncontrolled donation after circulatory death (uDCD) refers to donation from persons who die following an unexpected and unsuccessfully resuscitated cardiac arrest. Despite the large potential for uDCD, programs of this kind only exist in a reduced number of countries with a limited activity. Barriers to uDCD are of a logistical and ethical-legal nature, as well as arising from the lack of confidence in the results of transplants from uDCD donors. The procedure needs to be designed to reduce and limit the impact of the prolonged warm ischemia inherent to the uDCD process, and to deal with the ethical issues that this practice poses: termination of advanced cardiopulmonary resuscitation, extension of advanced cardiopulmonary resuscitation beyond futility for organ preservation, moment to approach families to discuss donation opportunities, criteria for the determination of death, or the use of normothermic regional perfusion for the in situ preservation of organs. Although the incidence of primary nonfunction and delayed graft function is higher with organs obtained from uDCD donors, overall patient and graft survival is acceptable in kidney, liver, and lung transplantation, with a proper selection and management of both donors and recipients. Normothermic regional perfusion has shown to be critical to achieve optimal outcomes in uDCD kidney and liver transplantation. However, the role of ex situ preservation with machine perfusion is still to be elucidated. uDCD is a unique opportunity to improve patient access to transplantation therapies and to offer more patients the chance to donate organs after death, if this is consistent with their wishes and values.

Deceased Organ Donation in Syria: Challenges and Solutions.

The first living-donor kidney transplant in Syria was performed 41 years ago; by 2019, 5407 renal transplants had been performed there. Three heart transplants from deceased donors were performed in the late 1980s; cardiac transplant activities have since discontinued. In 2003, a new, national Syrian legislation was enacted authorizing the use of organs from living unrelated donors and from deceased donors. This important law was preceded by another big stride in this regard: the acceptance by the higher Islamic religious authorities in Syria in 2001 of the principle of procurement of organs from deceased donors, provided that consent is given by a first- or second-degree relative. After the enactment of this law, kidney transplant rates increased from 7 per million population in 2002 to 17 per million population in 2007. Kidney transplants performed abroad for Syrian patients declined from 25% in 2002 to < 2% in 2007. Kidney transplants continued at comparable rates until 2010, before the beginning of the political crisis in 2011. Four decades after the first successful kidney transplant in Syria, however, patients needing an organ transplant must rely on living donors only. Moreover, 17 years after the law authorizing use of organs from deceased donors, a program is still not in place in Syria, and additional improvement of the legal framework is needed. The war, limited resources, and lack of public awareness about the importance of organ donation and transplant appear to be major factors inhibiting initiation of a deceased-donor program in Syria. A concerted and ongoing education campaign is needed to increase awareness of organ donation, change negative public attitudes, and gain societal acceptance. Every effort must be made to initiate a deceased-donor program to lessen the burden on living donors and to enable national self-sufficiency in organs for transplant.

Early impact of COVID-19 on transplant center practices and policies in the United States.

COVID-19 is a novel, rapidly changing pandemic: consequently, evidence-based recommendations in solid organ transplantation (SOT) remain challenging and unclear. To understand the impact on transplant activity across the United States, and center-level variation in testing, clinical practice, and policies, we conducted a national survey between March 24, 2020 and March 31, 2020 and linked responses to the COVID-19 incidence map. Response rate was a very high 79.3%, reflecting a strong national priority to better understand COVID-19. Complete suspension of live donor kidney transplantation was reported by 71.8% and live donor liver by 67.7%. While complete suspension of deceased donor transplantation was less frequent, some restrictions to deceased donor kidney transplantation were reported by 84.0% and deceased donor liver by 73.3%; more stringent restrictions were associated with higher regional incidence of COVID-19. Shortage of COVID-19 tests was reported by 42.5%. Respondents reported a total of 148 COVID-19 recipients from <1 to >10 years posttransplant: 69.6% were kidney recipients, and 25.0% were critically ill. Hydroxychloroquine (HCQ) was used by 78.1% of respondents; azithromycin by 46.9%; tocilizumab by 31.3%, and remdesivir by 25.0%. There is wide heterogeneity in center-level response across the United States; ongoing national data collection, expert discussion, and clinical studies are critical to informing evidence-based practices.

Organ transplantation in persons with HIV.

: With current antiretroviral therapy, the lifespan of newly diagnosed persons with HIV (PWH) approaches that of uninfected persons. However, metabolic abnormalities related to both the disease and the virus itself, along with comorbidities of aging, have resulted in end-organ disease and organ failure as a major cause of morbidity and mortality. Solid organ transplantation is a life-saving therapy for PWH who have organ failure, and the approval of the HIV Organ Policy Equity Act has opened and expanded opportunities for PWH to donate and receive organs. The current environment of organ transplantation for PWH will be reviewed and future directions of research and treatment will be discussed.

Evolving ethical issues with advances in uterus transplantation.

While uterus transplantation was once considered only a theoretical possibility for patients with uterine factor infertility, researchers have now developed methods of transplantation that have led to successful pregnancies with multiple children born to date. Because of the unique and significant nature of this type of research, it has been undertaken with collaboration not only with scientists and physicians but also with bioethicists, who paved the initial path for research of uterus transplantation to take place. As the science of uterus transplantation continues to advance, so too must the public dialogue among obstetrician/gynecologists, transplant surgeons, bioethicists, and other key stakeholders in defining the continued direction of research in addition to planning for the clinical implementation of uterus transplantation as a therapeutic option. Given the rapid advances in this field, the time has come to revisit the fundamental questions raised at the inception of uterus transplantation and, looking forward, determine the future of this approach given emerging data on the procedure's impact on individuals, families, and society.

Assessing the Potential Impact of the Declaration of Istanbul 2008 on Internet Reporting of Human Organ Transplantation-Related Crimes Using Interrupted Time Series Analysis and Meta-Analysis Approaches.

BACKGROUND: A severe shortage in donor organs is the major driver for organ transplantation-related crimes. The Declaration of Istanbul 2008 (DOI) was created to stop such crimes. We investigated the impact of DOI on Internet reporting of transplantation-related crimes. METHODS: We conducted Google Advanced Searches to collect data on "kidney trade," "kidney sale," "organ trafficking," and "transplant tourism" in 15 original participant and 10 nonparticipant countries, 6 years prior through 8 years after the promulgation of DOI. The data were normalized for population and transformed to a logarithmic scale. Interrupted time series analysis (ITSA) was applied to estimate the changes in slopes of the outcome variables before and after DOI, and then the overall intervention impact was calculated by meta-analysis. RESULTS: The combined results indicated that the overall impact of DOI on the reporting of "organ trafficking" and "transplant tourism" was statistically negative (reporting reduced significantly) as intended but on "kidney sale" and "kidney trade" was statistically positive (reporting increased significantly), and the increase was higher in the nonparticipant countries compared to the participant countries. The rate of reporting on "transplant tourism" declined in the participant countries more pronouncedly than in the nonparticipant countries. CONCLUSIONS: DOI has a positive impact on the reporting of "organ trafficking" and "transplant tourism" but not on the reporting of "kidney sale" and "kidney trade." The increased reporting of "kidney sale" and "kidney trade" can be indicative of an impact of DOI on public awareness and increased reporting of the residual transplantation-related crimes.

Assessment of Somatic Support Process for Pregnant Brain Death Patients Occurring in a Transition Country Between Asia and Europe from Medical, Ethical, Legal and Religious Aspects.

In spite of the fact that brain death during pregnancy is not a common occurrence, it is an important ethical problem for all cultures and religions can have a significant influence on the donation decision after brain death. Therefore, this study aimed to present the case of a pregnant patient developing brain death which occurred in our intensive care unit and to compare the medical, ethical and legal problems relating to pregnant cases developing brain death with 24 cases in the literature. A 21-year-old 19-week pregnant case with gestational diabetes was monitored in the anesthesia intensive care unit and developed brain death due to intracranial mass and intraventricular hemorrhage. Though brain death is a situation well understood by organ transplant professionals, brain death developing in pregnant patients still involves many medical, ethical and legal problems.

Legal policies of organ transplantation in India: Basics and beyond.

The Organ Transplantation Act issued by the Government of India 1994 has undergone major and minor changes in the form of addition of rules and amendments in order to improve the Act to make it much acceptable legally. Over a period of time, with an increase in cadaver organ donations, the rules and policies with regard to the same have been defined and redefined over the years. In this article, the Act, the rules, the amendments, the quick essentials of approach, and the forms are reviewed.