As a component of the European Society for Organ Transplantation (ESOT) call for action in 2022, Transplant International launched a special issue entitled "Diversity, Equity, and Inclusion in Transplantation" (1). The call for papers focused on sex, gender, ethnic and racial disparities in transplant access, management and outcomes. Emphasis was put on the changes of policies/interventions required to address the existing inequities and the needs to build a true global access and foster a culture of diversity and inclusion in transplantation research.With regards to sex and gender inequity, studies from USA and Nepal demonstrated barriers in the liver and kidney transplant processes, limiting the access to women from entering and completing waitlist evaluation (2,3), highlighting how they face barriers to be considered for surgery. Notably, this also reflects the disparity in the living donation process (4): in a context where countries in Southeast Asia were reported to have the lowest rates of deceased donors, the majority of kidney living donors are women, although the highest proportion of recipients are men. To further explore the disparities in this area, a review compared the top organ donor countries, to elucidate possible interventions and establish a fair transplant process in Southeast Asia (5). This article provides a brilliant approach by analyzing the differences in healthcare systems and how resources and organization can impact the effectiveness of transplant programs in addition to education and cultural attitude. Within the variety of economic and developmental backgrounds, the authors identified Malaysia as one of the potential countries able to build an effective deceased donor program, recognizing the general principle that there is no "one size fits all" for organ donation systems, but that government support through financial inputs in healthcare, and therefore access to publicly funded healthcare, is fundamental for successful donation and transplantation activity.Another interesting report dealing with a sustainable model to overcome the gender and social disparity in renal replacement therapy in Low and Middle Income Countries (6) showed that establishing satellite centers reduces patient time and travel costs, with a model of community-government partnership, where dialysis and transplantation are integrated and offered "free of cost" to all in need.Adequate women representation is a known unmet need in clinical science, with a documented discrepancy between the epidemiological prevalence of a disease and the rate of women enrolled in related clinical trials. Vinson et al. found that in the field of kidney transplantation, women's representation is more adequate when compared to other medical disciplines. However, they remain significantly underrepresented in research trials testing immunosuppressive drugs and surgical interventions. This finding is particularly striking in the context of the known increased risk of rejection for women, raising the hypothesis that this might also be partially related to the disparity in accessing interventional research (7).Inequity in transplant access and management was described for rural and remote populations, as well as specific ethnic and caste groups, where cultural beliefs could be inherent causes of bias (8). Particular emphasis was given therefore to the proposal of eliminating race from eGFR calculations (9) in accessing national waitlist, a decision approved a few years ago by the OPTN Board (10), which settled in this way the tone towards a more equitable assessment of prospective transplant and donor candidates. This remarkable change could have consequences for living kidney transplantation; a UK study (11) investigated how to improve decision making from the healthcare professional's perspective for people from diverse ethnic groups, as this precious resource remains underutilized. An education strategy seems realistic to implement the diversity of the organ donor registry, aiming to gain the support of key influencers (such as religious and community leaders, media editors, local figures) and tackle barriers negatively influencing support for organ donation in minority ethnic groups (12,13). To this purpose, it is relevant to stress how difficult it remains to determine the impact of patient ethnicity, race or immigration background, especially in consideration of the inconsistency of how migrant and ethnic minority populations are defined in European studies (14). This is why when analyzing such complex systems, it is recommended to consider an intersectionality approach (15) i.e., non-medical aspects of an individual's life, as where they live, are raised, engage in recreational activities, and their vocation, to better represent the full environmental context leading to disparity in organ transplantation access, management and outcomes.Luckily, the prevention and elimination of inequities related to patient characteristics is increasingly being recognized in transplant research. It has been reported that the demand for organs can largely be reduced if there is a sustained commitment to public health interventions and culturally competent approaches are implemented in the management of long-term conditions, taking also into consideration the demand from underrepresented minority populations, such as migrants (16). In this regard, the current state of the art in Italy was reviewed (17) and described that minority ethnic background individuals and immigrants present significantly higher rates of cardiovascular disease and endocrinological disorders, potentially leading to organ failure. Unfortunately, despite the presence of a public health system with universal healthcare coverage, non-European born residents are less likely to receive living kidney donation transplantation and more likely to have inferior long-term outcomes compared with European born individuals. These findings are not novel in general and reproduce what was already reported in other health national system realities, such as the UK (18) and USA (19).To complete the insights into organ donation and transplantation in the immigrant population in Italy, a mention to the comparison of refusal rates showed that these were higher, especially in some non-native Italian populations countries, supporting the need for communication approaches tailored for cultural diversities, when discussing donation with families with a potential language barrier and a non-western cultural background. (20).It is worth remembering that the standard approaches to patient education and management are less likely to be effective with subjects from immigrant and/or ethnic minority groups, and instead tailored interventions to meet the needs of these populations remain a challenge. For instance, a report found that in abdominal transplant recipients language preference other than English was independently associated with delay to vaccination in the USA (21). It would be therefore worth exploring alternative ways, for example by the use of digital technology, as the reconstruction of education after the COVID-19 pandemic (22) revealed an unforeseen potential.Could then modern technology help in pushing the boundaries of the XXI century transplant outcomes? Medical digitalization is nowadays being increasingly utilized in clinical practice, and it was suggested that blockchain technology (23), defined as a peer-to-peer distributed database without centralized authority, could soon become of pivotal importance in overcoming some limitations of transplant programs. In particular, it was suggested that distribution ledger technology could affect the organ donor traffic in the black market, by providing a real integration between different national health systems with real-time auditability.What could be the role of scientific societies, institutions and stakeholders? According to a survey by the Equity, Diversity, and Inclusion Committee of ESOT, reported as a qualitative research approach, the main areas of intervention included initiatives aiming to foster a culture of transparency in selection procedures, always considering diversity when evaluating candidates and anonymizing applications to eliminate inherent bias, using different languages in meetings and diverse panels in conferences, limiting the tenure of Council members, and promoting a bottom-up instead of a top-down organization (24). The recruitment of professionals from a variety of countries, backgrounds, and ethnicities or the facilitation of combining career and family life could be supported by initiatives such as access to digital learning solutions, i.e, webinars and online courses. In fact, the disparities described above could significantly hinder career development, which limits creativity and innovation by professionals from minority groups. Individuals from all backgrounds should instead have equal opportunities to enter and excel in their field and this will also promote scientific advancement and better care for the patients (25).Our modern Society increasingly embraces the general concept of equity for all individuals, and organ donation and transplantation must follow this ethical principle and have a transparent system to assure no discrimination is carried out (26). To achieve health equity, the same treatment options must be available to any individual affected by end-stage organ failure, regardless of sex, gender, race, ethnicity, socioeconomic backgrounds and their interplay. As the transplantation journey is a multistep process, the disparity affecting one or more phases, from clinician's referral for evaluation to the actual moment when transplant occurs, should be explored for possible interventions to reduce the existing evidence in disparity when receiving an organ transplant. The aim of this special issue is to build on the promotion of health care and social equity worldwide, by highlighting possible areas of interventions, following what professional groups in the transplant community have identified as strategic initiatives or explicit goals in their mandates.As a component of the European Society for Organ Transplantation (ESOT) call for action in 2022, Transplant International launched a special issue entitled "Diversity, Equity, and Inclusion in Transplantation" (1). The call for papers focused on sex, gender, ethnic and racial disparities in transplant access, management and outcomes. Emphasis was put on the changes of policies/interventions required to address the existing inequities and the needs to build a true global access and foster a culture of diversity and inclusion in transplantation research.With regards to sex and gender inequity, barriers in the liver transplant process, preventing female patients from entering and completing transplant evaluation were demonstrated in studies both from the USA and Nepal (2,3), highlighting how women, encounter barriers to enter the waitlist. Notably, this also reflects the disparity in the living donation process (4), as countries in Southeast Asia were reported to have the lowest rates of deceased donors. To further empasize this concept, a review compared the top 10 organ donor countries with in Southeast Asia, to elucidate possible interventions and establish a fair transplant process (5): despite the variety of economic and developmental backgrounds making the comparison difficult, the authors identified Malaysia as one of the potential countries able to build an effective deceased donor program, similar to those of the Western world, recognizing the general principle that there is no "one size fits all" for organ donation systems, but that government support through financial inputs in healthcare is fundamental for a successful shortening of the waiting list time.Another interesting report dealing with a sustainable model to overcome the gender and social disparity in renal replacement therapy in Low and Middle Income Countries (6) showed that establishing satellite centers reduces patient time and travel costs, with a model of community-government partnership, where dialysis and transplantation are integrated and offered "free of cost" to all in need.Interestingly, despite the better representation of women in clinical trails in the field of kidney transplantation compared to other medical disciplines, one study highlighted how females remain underrepresented in research trials examining post-transplant immunological related aspects and long-term outcomes (7).Inequity in transplant access and management was described for rural and remote populations, as well as specific ethnic and caste groups, where cultural beliefs could be inherent causes of bias (8). Particular emphasis was given therefore to the proposal of eliminating race from eGFR calculations (9) in accessing national waitlist, a decision approved a few years ago by the OPTN Board (10), which settled in this way the tone towards a more equitable assessment of prospective transplant and donor candidates. This remarkable change could have consequences for living kidney transplantation; a UK study (11) investigated how to improve decision making from the healthcare professional's perspective for people from diverse ethnic groups, as this precious resource remains underutilized. An education strategy seems realistic to implement the diversity of the organ donor registry, aiming to gain the support of key influencers (such as religious and community leaders, media editors, local figures) and tackle barriers negatively influencing support for organ donation in minority ethnic groups (12,13). To this purpose, it is relevant to stress how difficult it remains to determine the impact of patient ethnicity, race or immigration background, especially in consideration of the inconsistency of how migrant and ethnic minority populations are defined in European studies (14). This is why when analyzing such complex systems, it is recommended to consider an intersectionality approach (15) i.e., non-medical aspects of an individual's life, as where they live, are raised, engage in recreational activities, and their vocation, to better represent the full environmental context leading to disparity in organ transplantation access, management and outcomes.Luckily, the prevention and elimination of inequities related to patient characteristics is increasingly being recognised in transplant research. It has been reported that the demand for organs can largely be reduced if there is a sustained commitment to public health interventions and culturally competent approaches are implemented in the management of long-term conditions, taking also into consideration the demand from underrepresented minority populations, such as migrants (16). In this regard, the current state of the art in Italy was reviewed (17) and described that minority ethnic background individuals and immigrants present significantly higher rates of cardiovascular disease and endocrinological disorders, potentially leading to organ failure. Unfortunately, despite the presence of a public health system with universal healthcare coverage, non-European born residents are less likely to receive living kidney donation transplantation and more likely to have inferior long-term outcomes compared with European born individuals. These findings are not novel in general and reproduce what was already reported in other health national system realities, such as the UK (18) and USA (19).To complete the insights into organ donation and transplantation in the immigrant population in Italy, a mention to the comparison of refusal rates showed that these were higher, especially in non-native Italian populations from non Western countries, with the exception of individuals from Sri Lanka (20).It is worth to remember that the common approaches to patient education and management are less likely to be effective with subjects from immigrant and/or ethnic minority groups and instead that tailored interventions to meet the needs of these populations remain a challenge, in fact because of language barriers. For instance, a report found that in abdominal transplant recipients language preference other than English was independently associated with delay to vaccination in the USA (21). It would be therefore worth exploring alternative ways, for example by the use of digital technology, as the reconstruction of education after the COVID-19 pandemic ( 22) revealed an unforeseen potential.Could then modern technology help in pushing the boundaries of the XXI st century transplant outcomes? Medical digitalization is nowadays being increasingly utilized in clinical practice, and it was suggested that blockchain technology (23), defined as a peer-to-peer distributed database without centralized authority, could soon become of pivotal importance in overcoming some limitations of transplant programs. In particular, it was suggested that distribution ledger technology could affect the organ donor traffic in the black market, by providing a real integration between different national health systems with real-time auditability.What could be the role of scientific societies, institutions and stakeholders? According to a survey by the Equity, Diversity, and Inclusion Committee of ESOT, a substantial contribution was identified in initiatives aiming to foster a culture of transparency in selection procedures, always considering diversity when evaluating candidates and anonymizing applications to eliminate inherent bias, using different languages in meetings and diverse panels in conferences, limiting the tenure of Council members, and promoting a bottom-up instead of a top-down organization (24). The recruitment of professionals from a variety of countries, backgrounds, and ethnicities or the facilitation of combining career and family life could be supported by initiatives such as access to digital learning solutions, i.e, webinars and online courses. In fact, the disparities described above could significantly hinder career development, which limits creativity and innovation by professionals from minority groups. Individuals from all backgrounds should instead have equal opportunities to enter and excel in their field and this will also promote scientific advancement and better care for the patients (25).Our modern Society inc reasingly embraces the general concept of equity for all individuals, and organ donation and transplantation must follow this ethical principle and have a transparent system to assure no discrimination is carried out (26). To achieve health equity, the same treatment options must be available to any individual affected by end-stage organ failure, regardless of sex, gender, race, ethnicity, socioeconomic backgrounds and their interplay. As the transplantation journey is a multistep process, the disparity affecting one or more phases, from clinician's referral for evaluation to the actual moment when transplant occurs, should be explored for possible interventions to reduce the existing evidence in disparity when receiving an organ transplant. The aim of this special issue was to build on the promotion of health care and social equity worldwide, by highlighting possible areas of interventions, following what professional groups in the transplant community have identified as strategic initiatives or explicit goals in their mandates.
Angela Q. Maldonado, Reed C. Hall, Nicole A. Pilch, Christopher R. Ensor · 7 authors
Evidence of pharmacists’ contributions to the care of organ transplant recipients has existed since the 1970s. Since then, literature describing pharmacist’s impact on clinical and pharmacoeconomic outcomes has grown exponentially,1–14 with pharmacists establishing themselves as integral members of the transplantation community and expanding their presence in multiple areas, including pharmaceutical industry, research, academia, quality improvement, and clinical settings.15–20 Transplant pharmacists (sometimes referred to as clinical transplant pharmacists or solid organ transplantation pharmacists) have a strong presence in the areas of pharmacogenomics, innovative collaborative drug therapy management (CDTM), and prospective practice management. The United Network for Organ Sharing (UNOS) and the Centers for Medicare & Medicaid Services (CMS), respectively, require transplantation centers document the participation of a clinical transplant pharmacist or pharmacology expert on multidisciplinary transplantation teams in order to meet accreditation standards. These regulations make transplant pharmacy the only pharmacist specialty practice in the United States to have such a requirement.21–24 These mandates outline the responsibilities of the transplant pharmacist in preoperative and postoperative pharmaceutical management and education of transplant recipients. In response to the demand for pharmacists to meet these accreditation standards, some transplantation programs may meet the need by utilizing pharmacists without specific transplantation training or experience due to lack of fully trained personnel or funding resources. As of 2016, there were over 30,000 solid organ transplantations performed annually in the United States, and over 500,000 have been performed since the year 2000.25 Despite the volume of transplantations per year, there was a median of 1.4 transplant pharmacist full-time equivalents (FTE) per 100 transplantations performed, according to a national workforce survey conducted by the American Society of Transplantation across accredited U.S. transplantation programs.26 The median number of FTE did not increase beyond 1.4 FTE even in programs with >400 transplantations per year. These data indicate that transplant pharmacy services are provided by nonspecialists in many of these programs. Currently, there is no standard of practice for the provision of transplant pharmacy services, as the CMS Conditions of Participation allow for a broad interpretation for how to best meet the needs for each patient.27 This broad interpretation allows for a wide spectrum of transplant pharmacy services, with some centers providing a more inclusive model than others. This variability has led to recent CMS citations during program-specific surveys when the pharmacists involved in the care of transplant patients and donors were unable to provide sufficient evidence of qualifications, training, and expertise in transplantation. In 2011, the American Society of Transplantation (AST) Transplant Pharmacy Community of Practice, in collaboration with the American College of Clinical Pharmacy (ACCP) Immunology/Transplantation Practice and Research Network, developed a white paper that provided a blueprint for the training and qualifications of pharmacists working in transplant patient care and detailed the contributions of pharmacists serving the transplantation population.21 These guidelines augment the previously published work by promoting understanding of the evolving role of pharmacists’ contribution to the care of transplant recipients and living donors, helping define the role of the transplant pharmacist, suggesting goals for providing services to meet institution-specific needs, and describing best practices for transplant pharmacy services. These guidelines were developed based on primary literature, expert consensus on best practices, and CMS and Organ Procurement and Transplant Network (OPTN) bylaws, and are meant to aid transplant pharmacists, administrators, physicians, surgeons, allied health professionals (e.g., nurses, dietitians, financial coordinators, business managers), accreditors, surveyors, and others with a need to understand transplant pharmacy services. Although the nature of these services are unique to each solid organ and with each institution’s protocols and resources, these guidelines describe both transplant pharmacist services that meet the minimum required by regulations (as of publication) as well as optimal services. In conjunction with pharmacy, transplant surgery, and medicine administrators, each transplant pharmacist should use his or her professional judgment to individually weigh the factors that determine which services should be provided. These factors include the patient populations served, the number of pharmacists and time dedicated to services provided to the care of transplant patients, whether corresponding duties are required of transplant pharmacists in other areas of the hospital, and the extent of time dedicated to administrative, research, and quality endeavors. Finally, it should be noted that the many responsibilities described in these guidelines could not be provided by a single pharmacist. When used in these guidelines, the term transplant pharmacist should not be interpreted to imply that a single pharmacist could or should be expected to provide every service described. The pretransplantation phase includes all activities related to the assessment and evaluation of a donor or candidate’s readiness for transplantation and the execution of any plans to increase a donor or candidate’s success. This includes the initial assessment and any re-evaluation that may occur during the waiting list period, as described in Appendix A. At a minimum, a transplant pharmacist should be present during the multidisciplinary patient selection committee meeting. Transplant pharmacists are expected to present an objective assessment of the candidate’s pharmacologic and nonpharmacologic risks pertaining to transplantation.28,29 Although each assessment should be tailored to the individual patient, an assessment of anticoagulation, drug interactions, medications related to mental health, medications for chronic pain, medication allergies, hormonal contraception and replacement therapy, current use of immunosuppressants or immunomodulators, issues with drug absorption, illicit substance use or abuse, and use of herbal supplements or nutraceuticals should be completed. Although not universal, an assessment of immunologic risk as it pertains to induction therapy selection and need for desensitizing therapies during the selection meeting provides an opportunity to discuss protocol versus off-protocol decisions and may expedite the perioperative immunosuppressant selection process. The impact of current pharmacologic therapies on pretransplantation testing (i.e., false-positive drug screens, timing of vaccinations in relation to antibody titers) and peri- and post-transplantation risks should be discussed at this time. In addition, an assessment of nonpharmacologic risks and socially related risks should be presented, in conjunction with members of the multidisciplinary team, including transplant social workers and financial coordinators.28,29 Transplant pharmacists are well-suited to identify gaps in health literacy, markers of medication nonadherence, and preexisting intolerances and adverse effects to pharmacotherapy that may affect post-transplantation immunosuppressant adherence. Along with financial coordinators, pharmacy technicians and community/specialty pharmacy partners, transplant pharmacists should be involved in conversations regarding pharmacy benefit and out-of-pocket medication costs and proactively understand the specific distribution requirements of each patient’s pharmacy benefit manager. Along with the initial assessment, a thorough mitigation plan, when warranted, should be presented, along with any risks identified. Risks may be identified in one of two ways. The first is a basic chart review, which includes assessing the demographics of the patient (age, race, height, weight, body surface area, body mass index, distance from transplantation program, type of insurance), basic vitals, a complete medication list (including nonprescription medications, dietary supplements, and herbal remedies) and immunologic history (cause of end-stage organ disease, calculated panel reactive antibody, unacceptable antigens, deceased versus live-donor transplant). This type of review is limited in the breadth of information available and in its dependence on the accuracy of information provided. A more comprehensive face-to-face assessment includes the elements of the basic chart review and may include a health literacy assessment, an interview to elucidate barriers to adherence, accuracy of the medication history, and provision of initial medication education. of transplant pharmacy services in the pretransplantation meet the requirements for individual centers based on developed in with CMS Conditions of Participation and in the care of a patient a transplant is to from the pretransplantation phase from the transplantation Transplant pharmacists work with professionals in all of care to a provision of transplantation medication and each of Transplant pharmacists are with providing comprehensive pharmacy services to transplant recipients during the performed as of this of services are in Appendix A. In the transplant pharmacist workforce was to data including perioperative pharmacy services the of the pharmacists performed medication and review, to both and medications, performed as of the multidisciplinary team, and provided medication education to the transplant As of comprehensive pharmacy services, the transplant pharmacist as the medication provides drug information to all members of the (including information regarding and in collaborative at the for the transplant medications used for induction and therapy as well as in the for on use per The role of the transplant pharmacist may on the and of medications, such as and and of (e.g., to patient and a presence the of optimal therapy, and in a the it is that transplant pharmacists be provided or factors to include the of the transplant pharmacist’s clinical duties information (e.g., order as well as the and with or The of living related and of and is factors to this and and the of transplantation. The transplant pharmacist is for providing comprehensive pharmacy services to the living donor as well as the transplant These services include and and education on the expertise of the transplant pharmacist is to medication to the risk to the or to its health and Transplant pharmacists are required members of the multidisciplinary transplant Transplant pharmacists provide services to the team, as described in Appendix A. collaboration with all members of the should be by the transplant pharmacist. In to participation in preoperative evaluation and as a of the patient selection the transplant pharmacist with their primary and as well as with in the perioperative to to as described collaboration with the transplantation social financial and others should be to medication to and on work during the When collaboration on with members of the provide patients with to As described by and to pharmacotherapy is with which is to decisions regarding medication by CMS in the United States on the and are for in transplantation and are in transplantation. to medications for and patient by The transplant pharmacist with transplant coordinators, social coordinators, and to for and to such medications multiple to include and pharmaceutical and others and should be by members of the transplant in with a transplant pharmacist. transplant pharmacists provide information to the of both in drug information and the A practice in transplantation is the of and specialty pharmacy transplant pharmacists are integral in the of the initial of medications of medications is for education (including the use of of medication and of the accuracy of and (i.e., versus This in of barriers to medications, such as the need for or need for patient programs. As the medication the transplant pharmacist is the on the multidisciplinary to provide or education to the and As described to the post-transplantation is related to organ education medication adherence, education the transplant pharmacist provides medication education to the and and the of understanding or such as include which may include or for or patients, medication training, and on CMS the for evidence of comprehensive pharmacy services provided to individual transplant recipients and transplant pharmacist in multidisciplinary In the perioperative period, the transplant pharmacist is required to their multidisciplinary care at minimum how the transplant pharmacist is involved in the transplant phase and phase of care for each transplant Transplant pharmacists should be to provide evidence of collaboration on sufficient and understanding of patient and education to and the medication of and expected is that there is evidence of the transplant pharmacist’s in the transplant and phase of transplantation is the of transplant pharmacists are in the management of transplant recipients. transplant recipients should have to a transplant pharmacist for the of their and the transplant pharmacist be of the multidisciplinary providing care to transplant patients, as described in Appendix A. and and are integral of the transplant pharmacist. As transplant pharmacists from a model to a role that prospective and participation on and in the is of patient care participation in selection and of medication and mitigation of adverse and of education regarding and of practices by the and teams at the time of is an expected of pharmacotherapy provided by a transplant pharmacist. The is to be present during and and a of the multidisciplinary on the number of patients and their these activities may be tailored to on the patients or on medications that a risk of patient when are used in are with of adverse or the activities may be based on a developed with or without clinical of the transplant pharmacist’s activities during the and with the multidisciplinary be to of care from the to as well as from each to the In to the management of transplantation the selection and of postoperative and in is a standard role for transplant and guidelines, centers each have their specific the of are with or require and medication in the are a when or medications, in for which are the of These medications have with and of and be both when are and when are and when are services provided by the transplant pharmacist that the of transplantation are drug therapy to other and providing patients with the need to understand their medication to medication expertise is an integral of patient adherence, and and such education the transplant to provide care to each patient therapy be in a number of and these according to the practice at a A of is during multidisciplinary patient care and patient care in the order and use of collaborative practice protocols as members of the transplantation medication to patients and their may include use of and medication medication during and The provision of medication education is an in transplantation. this education is provided by transplantation coordinators, dedicated or pharmacy in to transplant the primary education is provided by other than a transplant pharmacist, the transplant pharmacist should as the of the of the of medication adherence. Although this is provision of education in the post-transplantation phase is for the patient’s as well as assessment of the patient’s needs over time. pharmaceutical education the of care is a service each should The transplant pharmacist has the and to each in with At a minimum, the transplant pharmacist should provide education during the or from the transplantation include provision of education on adverse and goals of therapy of transplantation and A or should be to from and education on areas of should be provided on an in the post-transplantation should be provided beyond the post-transplantation time period, at transplantation at a minimum, more to adherence. activities that transplant pharmacists should be involved with or in a role include of transplantation medications, education on use of such as medication of medication use of medication of health and aid from the transplantation for medication medication or as well as the health Transplant pharmacists an integral role in the and of post-transplantation These protocols should not only the postoperative include care the of the collaborative practice and the transplant pharmacist is involved in of post-transplantation care to in with each The need to from protocols due to factors is a The transplant pharmacist is to identify adverse drug effects identified both and patient of protocol from a or from a or programs identify areas of need for protocol and When adverse drug effects are the transplant pharmacist is involved in and face-to-face patient regarding and of Evidence of therapy management and patient education in all should be the The of care from the transplantation to the post-transplantation is a for the transplant patient to The transplant pharmacist a role in patient and meeting The optimal model is for transplant pharmacists to have in medication from the to the transplantation to information and patient are medication during the which may due to and related to and patient Transplant pharmacists as a for medication medication and patient with optimal and medication patients are at risk for and chronic of protocols for the management of and chronic or is an integral role of the transplant or in each organ the transplant pharmacist be with the specific to each organ of these of These are and should only be used when and of the transplant pharmacist should the medication the transplant patient are to patient from disease, the of transplantation. such as and are the of these many of the medications for transplantation these As transplantation centers and transplant patients the need for transplantation to and collaborative practice many of these be by a transplant pharmacist along with The transplant pharmacist has the to medications and best practices to Transplant pharmacists in the care of patient populations as described in Appendix A. In a transplant pharmacist may have impact on the care provided to patients, the risks and unique issues with this transplant recipients present pharmacology such as an evolving in and of and many of these transplant pharmacists for patients need to be in of and patients may require not and transplant pharmacists as a for and for Along with pharmacology transplant recipients have and barriers unique to this Transplant pharmacists have a role in the and care of transplant recipients. A transplant pharmacist’s responsibilities include and assessment of and participation in of nonadherence, of education with and patients medication to and participation in to or this may be to for Transplant pharmacists with to including that chronic effects of transplantation is not and it is that transplant pharmacists have a role in and These should be by both transplantation and in are to medications that are due to limited data regarding during or care of patients or are transplant pharmacists should work with transplant to a for to a for including a that for the in of that occur as a and provide education to patients regarding their including such as medication transplant pharmacists in the care of of is the provision of risk evaluation and mitigation and elements to use education for As of transplantation medication transplant pharmacists provide education regarding timing of and to transplant pharmacists work with transplant and teams for management during and The breadth and of the transplant is and as the and medication management the transplant pharmacist. such as and patients, as well as patients with multiple require of transplant and the to the of best practices to the The transplant pharmacist is to provide patients with the optimal care in these to the requirements unique to transplantation transplant pharmacists many as described in Appendix A. As integral members of the multidisciplinary transplantation team, transplant pharmacists have the that allows to and transplantation and to quality and a of care for all transplant recipients and Transplantation is the of all pharmacy is that transplant pharmacists with the requirements in all of transplantation based on their which be in with As members of the multidisciplinary have in all of transplantation and transplant pharmacists are to have a role in of collaborative practice and Transplant pharmacists have been in of protocols to and and to transplantation as a for is an that transplant pharmacists quality related to pharmaceutical including not limited to the evaluation of adverse drug and in with and and transplant pharmacists from the have transplantation quality and the are to this unique their experience clinical research, of adverse and care during the and post-transplantation and transplantation protocol and review is to quality of review of and transplant pharmacists use and data to and and transplant of and immunosuppressant have been In addition, transplant pharmacists are in a unique to aid in of guidelines and protocols to and and the and issues that transplantation as a of post-transplantation are required as of for transplant pharmacists for transplant recipients. The transplantation pharmacy community is to pharmacist and in this specialty to the of clinical expertise is transplant pharmacists from to Transplant pharmacists are expected to and quality related to clinical as described in Appendix A. of include transplant pharmacist professional on a and national as well as including research, of and and of pharmacy for the and professional of transplant include the of Clinical and on the Immunology/Transplantation Practice and Research Network, the Transplant Pharmacy Community of Practice, and the Society for and Transplantation on Pharmacy and These are transplantation that during on and and provide In to the of these transplant pharmacists have for not only the the including such as Transplant pharmacists have been to on the of as well as and committee are to the work of the and provide in areas of and The of Pharmacy solid organ transplantation pharmacy as a specialty in is that practice a pharmacy specialty has been by the should in the specialty an be to the needs of current as an increase in the number of education and training in transplantation for pharmacists as well as pharmacy and Transplant pharmacists have in the education of other that in the transplant pharmacy of pharmacy have on with many pharmacy first to the or pharmacy practice or on is an to transplant pharmacy as a specialty for training of pharmacists provides a of and are in this specialty and to quality care of the transplant are year training programs as well as two in transplantation. A recent workforce survey that of the transplant centers in the centers could not in the survey due to not a dedicated transplant A primary of these guidelines is to the of training of pharmacists in transplantation to allow for all transplant patients to have to an transplant pharmacist to in the care provided to all transplantation recipients across all Appendix a list of and that the and provided in these transplantation in the United States is required to identify transplant pharmacology as of multidisciplinary teams to provide and care to transplant recipients and living donors and to organ These services and patient care of transplant recipients and donors and are tailored to meet and standards. the of pharmacy education and and training, to include transplantation and and program-specific to a workforce with the training to these required and pharmacy services. has funding from The other have no of the of Clinical and and by the of on to the and for these guidelines not imply American of of Pharmacy American College of Clinical Pharmacy (ACCP) and Immunology/Transplantation Practice and Research of Clinical and on American Society of Transplantation Transplant Pharmacy Community of of for Society for and Transplantation on Pharmacy and Pharmacy Society of for and The pretransplantation phase includes the initial assessment and any that may occur during the The transplant pharmacist pharmacologic risks (e.g., anticoagulation, drug interactions, medications related to mental health, medications for chronic pain, medication allergies, hormonal contraception and replacement therapy, current use of immunomodulators, issues with drug absorption, illicit substance use of herbal immunologic risk as it pertains to induction selection and need for desensitizing the impact of current pharmacologic therapies on testing and perioperative and post-transplantation and the for medication The transplant pharmacist nonpharmacologic risks and socially related risks in conjunction with members of the multidisciplinary team, including transplant social workers and financial The transplant pharmacist risks and mitigation plans as of the multidisciplinary selection The transplant pharmacist document transplant pharmacy services provided in with requirements for individual centers based on developed in with CMS Conditions of Participation and Transplant pharmacists work with professionals involved in all of the transplantation to a provision of transplant medication and each of The transplant pharmacist provides services for medications related to and and their impact on other or on medication during the of in drug information to transplantation surgeons, organ specific physicians, nurses, and other care to living donors, including and management and education of and provides medication education to the and to The transplant pharmacist document transplant pharmacy services provided in with requirements for individual centers based on developed in with CMS Conditions of Participation and transplantation is the of transplant pharmacists are in the management of transplant recipients. a transplantation have to a transplant pharmacist for the of their and the transplant pharmacist be of the multidisciplinary providing care to these The transplant pharmacist according to needs, adverse and and provides medication and education. The transplant pharmacist and plans for and chronic and based on and and provides in and management of The transplant pharmacist specific and experience in the of and The transplant pharmacist provides pharmacotherapy management for management. to the requirements unique to transplantation transplant pharmacists many Transplant pharmacists and transplantation and to quality and a of care for all transplant recipients and The transplant pharmacist provides in and collaborative practice and The transplant pharmacist quality related to pharmaceutical including not limited to the evaluation of adverse drug and of and in with and The transplant pharmacist and and transplantation protocols and as of Transplant pharmacists and quality related to clinical The transplant pharmacist should in professional on a and national The transplant pharmacist should and including research, of and and The list that should be in to the and provided in the The are and are in order by the primary of and Centers for Medicare and Medicaid Organ transplant guidelines Organ Procurement and Transplantation Network (OPTN) United Network for Organ Sharing (UNOS) Society for and Transplantation transplant pharmacy professionals first of pharmacy services at comprehensive transplant centers in the United A national survey assessing the current workforce of transplant pharmacists across accredited solid organ transplant programs. Practice of the role of the transplant pharmacist on the multidisciplinary transplant Transplant of patient of a clinical medication in a transplant of clinical pharmacy services on transplant and of a pharmaceutical care on transplant with a transplant education and transplant pharmacy a for transplant pharmacy services. pharmacologic and nonpharmacologic risks in for transplantation. The expanding role of the transplant pharmacist in the multidisciplinary practice of transplantation. transplant patient pharmacist medication the of immunosuppressant on risk transplant recipients. patient and outcomes with a comprehensive in transplant recipients. a business to a transplantation pharmacy practice of solid organ pharmacists in transplant to therapy solid organ A on risks and mitigation
Liver disease is a significant problem in Pakistan. In a country of approximately 200 million people, 5% (10 million) are infected with hepatitis C virus, and more than 2 million are in need of liver transplantation to save their life.1,2 Pakistan's first liver transplant was performed in 2003 in an international collaborative effort at the Sind Institute of Urology and Transplantation in Karachi. Activities in liver transplantation had been on a hiatus until 2011 when a team of local doctors performed a deceased donor liver transplant in Lahore. From 2012 onward, a number of centers undertook the challenges in developing living donor liver transplant programs across the country. The provinces of Punjab and Sind have been in the forefront of liver transplant activity in Pakistan (Figure 1).FIGURE 1: Centers with liver transplant activity across Pakistan until February 28, 2017.MEDICAL AND SURGICAL CHALLENGES Certain factors have been highlighted as potential obstacles to successful liver transplant activity in Pakistan.3 In the recent past, there has been a significant progress in assessing the burden of need while improving public awareness and readiness of medical facilities. However, a significant gap remains in supply and demands and is linked to funds, technical competence, skill transfer, and sustainability through incentivization and outcome assessment. The most critical factor in developing high-volume transplant programs across the country remains a lack of skilled workforce. Other than in 2 centers run by local teams, transplant numbers in centers that work with international collaboration remain very low (Table 1). Security concerns and visa delays make frequent travel by international teams a difficult proposition. Moreover, the parachuting approach of international transplant teams at various centers for short periods leads to interruptions in the continuity of care. Thus, the presence of efficient local transplant teams is critical in developing successful and sustainable transplant programs (Table 1). Until February 28, 2017, a total of 539 liver transplants have been performed in Pakistan, and approximately 95% of these were performed in the 2 centers run by local teams.TABLE 1: Transplant activity across various centers in the country up to February 18, 2017HEALTH ECONOMICS AND INSURANCE PATTERNS With the exception of a few countries, healthcare in the developed world is the government's responsibility.4 In contrast, healthcare financing in Pakistan is predominantly out of pocket.5 Although the healthcare system in Pakistan has evolved to a well-planned, district-based network of health facilities, the present system is finding it difficult to cope with growing pressure from an ever increasing population and awareness in people regarding their civil rights.4 Living donor liver transplantation is different from deceased donor liver transplantation in that, although requiring highly skilled surgical, medical, and intensive care facilities and infrastructure, it can be successfully accomplished by focusing resources and expertise in a single hospital rather than attempting to develop an entire transplantation infrastructure.6 Insurance coverage has not gained widespread acceptance in Pakistan owing to various sociopolitical and financial reasons. It has been shown that information asymmetry, adverse selection, moral hazard, and fraud raise concerns for the sustainability of insurance programs in developing countries.7 A living donor liver transplant in Pakistan costs between US $35 000 and US $45 000. Most of our patients are self-funded; however, in recent years, there has been increased support from government and philanthropic organizations. Financial restrictions continue to be the biggest hurdle in making liver transplant accessible to patients in need. RECIPIENT AND DONOR OUTCOMES Most transplant programs are still in their infancy in Pakistan, and published outcomes have therefore been limited. Nevertheless, 1-year survival rates of 87% have been demonstrated by one of the busiest transplant centers in Pakistan.3 Grade 3 or above Clavien-Dindo complications were seen in 52% patients, with 23% patients experiencing biliary complications. With regard to donor outcomes, an overall morbidity of 17% has been reported with a biliary complication rate of 3%.8 Based on personal communication, one donor mortality has been reported from one of the institutes in the Sind province resulting in a donor mortality of 0.2% in the country (Gambat Institute of Medical Sciences, oral communication, November 30, 2016). Until February 28, 2017, we have performed 408 LDLTs in our center. Estimates of 1- and 4-year overall survival are 83% and 77%, respectively. Overall, 21.4% of patients had a biliary complication, and there was no donor mortality. With a limited availability of deceased donors, auxiliary, swap, and domino transplants have also been performed to increase the donor pool. We have also accepted donors with hepatitis B core antibody positivity and Gilbert syndrome. ETHICS The Human Organ and Transplantation Authority regulates legal and ethical aspects of liver transplantation in Pakistan. The donors have to be legally (spouse, brother/sister-in-law) or blood related to the patient to be eligible for donation. This has been mandated based on previous reports of commercialization in kidney donations in the country.9 The decentralization of Human Organ and Transplantation Authority with the 18th amendment under the constitution of Pakistan has moved various ministries including the Ministry of Health from a central to a provincial control.10 Those changes have resulted into 5 autonomous provincial bodies regulating transplant activity, allowing a more stringent legal and regulatory process at the provincial level. At the same time, the current decentralized approach challenges the implementation of a future national transplant registry that may monitor transplantation activity and outcomes countrywide. FUTURE DIRECTIONS It is expected that transplant activity will continue to rise in the near future in Pakistan based on the tremendous burden of chronic liver disease and hepatocellular carcinoma. With structured training programs in place, current limitations in surgical/medical workforce are expected to improve. The self-sufficiency in regard to transplant infrastructure will reduce the reliance on international collaborations while providing a continuity of care for the ever increasing numbers of cirrhotic patients. Financial constraints will play a major role in expanding private sector transplant centers. The government will have to consider innovative ideas including private-public sector partnerships and proper incentivization of transplant personnel to make liver transplantation available to the underprivileged in Pakistan. The implementation of a National Transplant Registry is inevitable to ensure transparency in various steps of organ donation and outcome reporting while providing transplant services of international credibility.