Cadaveric Renal Transplantation: Change, Policy and Practice - Research Paper Example

 Cadaveric Renal Transplantation: Change, Policy and Practice Introduction: The establishment of the Transplantation Centre in 1986 marked the beginning of kidney transplantation history in Cyprus. It is an institution that specializes in kidney transplantation with more than 800 renal transplantations since its inception, 60% of them comprising living donor performances. However, the need for human organs for transplantations is becoming more and more imperative since the waiting lists are lengthening year after year, with a figure of 140 by the end of 2008 (PALMES, D. & WOLTERS, H. et el., 2004, pp. 956). Even though Cyprians are considered to be quite altruistic and generous, this concept of cadaver donation has not yet been fully or widely accepted and its correspondence has remained relatively very low. In America for example, there are over 5 thousand deaths per year resulting from cadaveric organ shortage. Europe has 15-30% death prevalence per year on the national waiting lists. With the increasing ESRD prevalence among the population, an increased and concerted effort towards this endeavor should be addressed, which is the major reason why the cadaveric renal transplantation policy was enacted. The Cyprus National Transplant Procurement Policy (CNTPP) was created by the Ministry of Health, and later it was passed by parliament as the “Act for Abstraction and Transplantation of Biological Human Substances of 1987” (BAILEY, LEONARD, 1990, pp. 89). According to the Act, no action of abstraction can be performed if there is evidence of legal documentation indicating the explicit refusal by an individual. In the onset where there is doubt regarding the deceased’s wish during his/her life, then the next of kin has to decide. The policy’s aim is to ensure the Act’s enforcement and to enhance efforts aimed at increasing cadaveric organ donation. This study will highlight some insights into this issue which has remained very controversial and poses major medical dilemmas. The policy drivers and the agendas (aims and objectives) will be enumerated in respect to effectiveness of the policy in the healthcare environment. The Policy: Justification and Relevance: Several discussions have been raised concerning cadaveric renal transplantation since 1987. These led to introduction of a donor’s card in 1999, in which the owner declares that in the case of brain death he/she wishes to become organ and tissue donor. In addition, the post of in-hospital transplant coordinator was decidedly introduced (BRAWER, ORIT, 2005, pp. 264). This policy indicates that much emphasis is needed to encourage cadaveric donation and transplantation. Furthermore, it is necessary to avoid donors who are genetically unrelated to the recipients except, however, for bone marrow and other regenerative tissues’ transplants. Since this implementation by the CTPP in mid 1987, Cyprus has pre-eminently remained among the EU states with high living donor transplantation rate (approximately 54.3 per million of population) (CAPLAN, L., 1998). Such successes are reflected on the policy- practice synergetic relation, and especially because the donor and the recipient are in close proximal relationship, and as thus practitioners could fully implement the procedures with much ease. Contrary to this, cadaveric donation rate has remained low, approximately 5.7 per million of the population, reflecting a disparity between practice and policy (CAPLAN, L., 1998, pp. 146). Some major reasons attributed to this disparity or divergence includes: Lack of systematic and generally acceptable campaigns for the policy as a means of sensitizing and informing the populations about matters regarding cadaveric donation interventions. As a consequence, terms like “transplantation” and “brain death” remain vague in the vocabulary of many (MILLER, BRADLEY, 2006, pp. 72). Legitimate and clear models of obtaining permission for postmortem organ donation have not been adequately addressed. This implies lack of fundamental choice elements such as “presumed consent” and “mandated choice” by which every citizen makes opt-in or opt-out decisions and as a result it is the next of kin who has to make the decisions for them (KOCH, TOM, 2002, pp. 287). Lack of effective and specialized personnel in hospitals to facilitate cadaveric donation. This in return has led to lack of confer with donor and recipient families. The Policy Drivers: Underlying dilemmas must be faced during institutionalization of any policy or policy change. In our case for example, one cannot fail to anticipate the necessity for balance between immediate kidney transplants’ benefits with those that would have been expected if a more suitable or favorable match had been waited for (KASERMAN, 2006, pp. 58). But it is common sense that even with this dilemma, the patients have little if no room to make the choice. This is why it is essential to consider the factors that led to of the policy conception, and why it aims at being patient-inclusive in decision making processes. In this context, a driver is used to refer to anything that influenced consideration and inception of the policy. Some of the drivers that this study enumerates as having prominently led to inception of this policy include the following: Economic aspects of cadaveric kidney transplantations The increased demand for cadaveric renal transplants Ethical connotations in respect to allocation criteria, anonymity, informed consent and organ trafficking Economic Aspects of Cadaveric Transplantations: Over the last few decades, there has been considerable attention towards programs involved with end stage renal complications and cadaveric transplantations worldwide. Furthermore, there have been substantial increases in cadaveric renal transplantation, with a survival rate increase of 7% and 3% in living and cadaveric donors respectively between 1980 and 1985. During the same period, there was an annual increase of about 10% in the total number of renal transplantations. This is partially so due to the cyclosporine introduction (BARNETT, 1996, pp. 341). The above statistics indicate why this driver became an integral part in advocacy of cadaveric renal transplantations. It was scrutinized in two dimensions: a) there were and still are high costs involved in hemodialysis treatment and management which directly increases proportionally with the increase in the ESRD patient numbers, and b) before the kidney transplantation centre was established, local patients requiring transplantation were forced to travel long and expensive distances, along with their relatives to access the services. On the same note, the issue of globalization for example played a significant role in advocating for equitable and favorable government funding because this process is among the most expensive medical treatments (JENSEN, 2000). Ethical and Legal Issues in Cadaveric Renal Transplantation: The policy explicitly provides for the “free concept” principle in all matters related to donation and transplantation of cadaveric renal and other organs. Undue pressure and inducements are strictly prohibited for the adults and the minors, and in the event of violation of this principle, perpetrators are subject to prosecution because this act constitutes a criminal offence. Minors’ protection is assured through the minor’s clear comprehension of the consent as well as the parent(s) consent and/or the consent of a legal guardian among other prevailing conditions. Prior permission should be sought from independent bodies such as courts, and in case a minor objects, such objection must prevail over all other consents or considerations. As a general rule, informed consent is mandatory in any organ donation and transplantation procedure. For the case of donors who have undergone a “brain death”, it is the rightful duty of the next of kin to provide informed consent on behalf of the donor. They should provide legal documentation to prove that the donor didn’t object to organ donation. Human organ trafficking is among the major controversies in the world today. The policy fundamentally supports the global rule against human organ trafficking for compensation or entrepreneurial practices in either organ recovery or implantation. The major reason for organ trafficking criminalization is because it endangers life and equality in health care access. Predominantly underprivileged persons’ lives would be greatly compromised by unfair political and social inequalities. There are provisions for the various prohibition methods in the jurisdiction of this policy, one of which is encouraging and promoting altruistic donation and transplantation through public appeal and advertisements in accordance with the World Health Assembly resolution-WHA42.5, which prevents sale and purchase of human organs (LOUIS, 2002, pp. 524). In addition, this should only be done for medical reasons including ex gratia, scientific medical diagnosis for therapeutic purposes and medical treatment. Moreover, this must be done only in authorized and registered medical institutions where only medical professionals with the knowledge (actual or constructive) of removal and intermediate management as well as implantation should be involved. In any case, the concept of genetic compatibility must be put into consideration before transplantation process is begun. It is inherently necessary to avoid donors who are genetically unrelated to the recipients. It is therefore the responsibility of governments and other authorities to discourage any form of coercive or voluntary sale and purchase of cadaveric and living renal organs and tissues. Additionally, responsible clinicians within the realms of ethical medicine must avoid involvement in coerced or paid transplantations. In most jurisdictions, when this offence is identified, it carries a punishment of up to five years imprisonment and/or revoking the practice certificate of the offending physician. Ensuring donor and recipient anonymity in matters regarding human organ exchanges, especially those of cadaveric nature, is vital. This is particularly so because of the discomfort that exposure may cause between these parties. Different people have different opinions and attitudes towards this process based on religious and cultural orientations. There are those who believe it is a worthy course in saving human life while others would strongly object to any form of human organ donation and transplantation. Similarly, the prevalence of professional bias in prioritizing allocation of the organs is a driving force that warranted the policy reviews. Increasing Demand for Cadaveric Transplants: As mentioned earlier, cadaveric transplants are liberating practices for ESDR patients from the much more taxing hemodialysis units they must undergo without it. Prior policies however, had not considered all the patient sets awaiting the process due to long queues in international facilities offering the practice. This was particularly worse in case of the elderly patients who don’t have a long wait time as compared to the pediatrics and younger individuals (DHOOPER, 1994, pp. 48). There was paramount importance therefore to consider the inception of a policy that would provide equity in cadaveric renal transplantation and at a shorter wait period. This does not mean the policy completely reduced wait time but the significance of its inception is felt especially where mismatches occurred and an urgent re-transplant had to be done. In general, these drivers emerged as local needs to a few individuals in smaller institutions, but today they have proved to have been so strong that they have led to national and international recognition. Policy Agendas: For any effective policy change to occur there must be some coherent strategic agendas in place. Agendas in this context imply objectives and aims of cadaveric renal transplantation. A few of these agendas include: Enhancing the overall objective of achieving the “Act for Abstraction and Transplantation of Biological Human Substances of 1987” requirements in cadaveric organs procurement procedures. The policy’s entry point into this crucial assignment was mainly through appraisal of the new center’s certification as a long-term agenda and promotion of improved mechanisms and institutions even under constrained budgetary allocations. This ensured increased emphasis to promote less expensive medical procedures to benefit many, not very expensive ones that would only be accessible to a relatively fewer number of beneficiaries (HARDY, 1986). Promotion of increased cadaveric renal organs and tissue donation in an effort to meet the increasing demands. To achieve this end, the policy has adopted substantive development attitudes including utilization of inputs like; broadcast and print media, proper organ procurement management, updated evaluation of new inventions in surgical procedures, and financing sources (MCCONNELL, 2000). However, some researchers have constantly held the opinion that there is dire need to regularly critique the role of the media even though it is eminently clear that media has powerfully affected cadaveric transplant policy. To mitigate for inclusive decision making processes. This must involve the donors and recipients at all possible levels. The policy has maneuvered its means and gained recognition by larger regional and international organizations such as EKHA- the European Kidney Health Alliance. EKHA (founded in 2007), combines the efforts of European organizations that concerns themselves with kidney disease patients as well as their relatives/families’ representation expertise, the dedicated scientists or researchers in this field and the professionals in cadaveric healthcare who are responsible for the patients treatments alongside clinical investigations (YOUNGNER, 1986, pp. 337). Through such involvement, cadaveric renal transplantation has earned international and multicultural standards which have placed it in a better position to enhance policy implementation and communication for improved organ donation leading to increased and efficient transplantations. Ensure increased awareness of the cadaveric renal transplant procedures to the patients, relatives and the general public which comprise a significant donor group. According to BAINES, 2003, the policy has to possess the nature of reconciling the myriad conflicting ideas and myths that have surrounded the cadaveric transplants for decades. This has proved a great success in increasing clear concept understanding from the individual level to international acceptance of new and modernized methods, which in turn has contributed to increased donations and quicker donors and recipients’ recovery. Make comparative analysis that should show how effectively the long cadaveric kidney transplants waiting lists have been managed. As long as the involved parties understands, follows and knows the rules and procedures, the process of queuing will be readily accepted. Distributive justice and the scarcely available medical resources rationing have been the major areas which this policy delves in for success. Furthermore, modifications in organ procurement have profoundly reduced the disparity between the desired and actual performance levels since the inception of this policy (HOWIE, 2002, pp. 114). This is mainly because anxiety and uncertainty are predominantly reduced by involvement and information delivery mechanisms, which are integral agendas that the policy has addressed succinctly. Conclusion: The paper evidently established that cadaveric renal transplantation policy has undergone a positive metamorphosis from its local inception ideals to reach a wider health care objective of meeting expectations and challenges associated with the need for concise delivery of kidney donation and transplantation, as a means of ensuring increased patient opportunities to get kidney transplantations as well as maximization of long quality life of the organs and the patients’ health. Equality to access quality kidney transplants has been significantly achieved. The policy relentlessly aims at being an outstanding legal instrument in advocating for safety and quality standards relating to cadaveric renal donation and transplantation. The study fundamentally expounded three major objectives as they have been significantly achieved by the policy. These are: improved quality transplant services and equality in access; assured opportunities of acquiring a kidney transplant donation; and quality post transplantation health for both the patient and the organ. However, it is necessary to note that though much has been done by this policy, further improvements are welcome in order to harmonize the non-ending policy-practice interface disparity. References: BAILEY, LEONARD. (1990). Organ Transplantation: A Paradigm of Medical Progress. The Hastings Center Report, Vol. 20, pp. 89 BAINES, LYNDSAY (2003). The Struggle for Life: A Psychological Perspective of Kidney Disease and Transplantation. Praeger, pp. 82 BARNETT, H. (1996). Scope, Learning, and Cross-Subsidy: Organ Transplants in a Multi-Division Hospital- an Extension. Southern Economic Journal, Vol. 62, pp. 341 BRAWER, ORIT (2005). Organ Donation and Transplantation: Body Organs as Exchangeable Socio-Cultural Resources. Praeger, pp. 264 CAPLAN, L. (1998). The Ethics of Organ Transplants: The current Debate. Prometheus Books, pp. 146 DHOOPER, SINGH (1994). Social Work and Transplantation of Human Organs. Praeger Publishers, pp. 48 HARDY, MARK (1986). Positive Approaches to Living with End Stage Renal Disease: Psychosocial and Thanatologic Aspects. Praeger Publishers, pp. 230 HOWIE, JOHN (2002). Ethical Issues for a New Millennium. Southern Illinois Press, pp. 114 JENSEN, TROY (2000). Organ Procurement: Various Legal Systems and Their Effectiveness. Houston Journal of International Law, Vol. 22, pp. 196 KASERMAN, DAVID (2006). Inefficiency in Cadaveric Organ Procurement. Southern Economic Journal, Vol. 73, pp. 58 KOCH, TOM (2002). Scarce Goods: Justice, Fairness, and Organ Transplantation. Praeger, pp. 287 LOUIS, J. (2002). A Primer on Organ Donation. Journal of Law and Health, Vol. 17, pp. 524 MCCONNELL, TERRANCE (2000). Inalienable Rights: The Limits of Consent in Medicine and the Law. Oxford: oxford University Press, pp. 74 MILLER, BRADLEY (2006). Strange Harvests: Organ Transplants, Denatured Bodies and the Transformed Self. Journal of Law and Health, Vol. 20, pp. 72 PALMES, D. & WOLTERS, H. et el. (2004). Strategies for compensating for the declining numbers of cadaver donor kidney transplants, Nephrol. Dial. Transplants., Vol. 19(4): pp. 952-962 YOUNGNER, STUART (1986). Human Values in Critical Care Medicine. Praeger Publishers, pp. 337 Appendix: Policy summary The Cyprus National Transplantation and Procurement Policy (CNTPP) was created and enacted in 1987 by the Cyprus Ministry of Health. It is based on the “Act for Abstraction and Transplantation of Biological Human Substances of 1987” to regulate live and cadaveric organ procurement and transplantation. Some constituents of the policy include the following sub-sections. Part A: Definition of terms including: abstraction, donor, recipient, human biological substances, cadaveric renal transplantation Reasons for donation and transplantation of cadaveric and live human organs: donation for scientific medical diagnosis, ex gratia, and medical treatment Necessity for donor and recipient anonymity Institutions involved with donation and transplantation of cadaveric renal organs: the medical professionalism and ethical provisions Part B: Conditions for live human organs abstraction: Informed consent form that must be signed by the donor, and for the minors, by the parent(s) or legal guardians Abstractions must strictly be done by qualified professionals for diagnosis and/or medical treatment Donor and recipients life and health safety must be emphasized Only compatible organs are allocated to recipients equally without any discrimination on any ground All operation must be performed only in registered and designated institutions by the government through the Ministry of Health Part C: Conditions for cadaveric (deceased) organ abstraction: Should be done only after death diagnosis within the specified diagnostic procedures In case where there is no legal evidence indicating the explicit refusal by an individual. Can be done if a donor’s next of kin provides a signed informed consent form. Part D: Legal requirements and Penal Offences: Any performed abstraction action prior to competent death diagnosis Any donation for pecuniary or entrepreneurial purposes Any unauthorized disclosure of recipient or donor identity Any performance in institutions other than those registered and authorized by the Ministry of Health Any form of physical or emotional coercion in procurement of organs and tissues: Any form of human organ trafficking Any other human organ use for purposes outside the jurisdiction of the Act. Read More