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Medication nonadherence after solid organ transplantation is recognized as an important impediment to long-term graft survival. Yet, assessment of adherence is often not part of routine care. In this Personal Viewpoint, we call for the transplant community to consider implementing a systematic process to screen and assess medication adherence. We believe acceptable tools are available to support integrating adherence assessments into the electronic health record. Creating a standard assessment can be done efficiently and cost-effectively if we come together as a community. More importantly, such monitoring can improve outcomes and strengthen provider-patient relationships. We further discuss the practical challenges and potential rebuttals to our position., Competing Interests: Declaration of competing interest The authors of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplant-ation., (Copyright © 2024 American Society of Transplantation & American Society of Transplant Surgeons. All rights reserved.)

As healthcare continues its transition toward value-based care, it is increasingly important for transplant pharmacists to demonstrate their impact on patient care, health-related outcomes, and healthcare costs. Evidence-based quality and performance metrics are recognized as crucial tools for measuring the value of service. Yet, there is a lack of well-developed and agreed-upon specific metrics for many clinical pharmacy specialties, including solid organ transplantation. To address this need, a panel of transplant pharmacy specialists conducted a detailed literature review and engaged in several panel discussions to identify quality metrics to be considered for assessing the value of clinical pharmacy services provided to solid organ transplant recipients and living donors. The proposed metrics are based on the Donabedian model and are categorized to coincide with the typical phases of transplant care. The measures focus on key issues that arise in transplant recipients related to medication therapy, including adverse drug events, nonadherence, and clinical outcomes attributable to medication therapy management. This article proposes a comprehensive set of measures, any number of which transplant pharmacists can adopt and measure over time to objectively gauge the value of services they are providing to transplant recipients, the transplant center, and the overall healthcare system., (Copyright © 2023 American Society of Transplantation & American Society of Transplant Surgeons. Published by Elsevier Inc. All rights reserved.)

The role of the transplant pharmacist is recognized by transplant programs, governmental groups, and professional organizations as an essential part of the transplant multidisciplinary team. This role has evolved drastically over the last decade with the advent of major advances in the science of transplantation and the growth of the field, which necessitate expanded pharmacy services to meet the needs of patients. Data now exist within all realms of the phases of care for a transplant recipient regarding the utility and benefit of a solid organ transplant (SOT) pharmacist. Furthermore, governing bodies now have the opportunity to use Board Certification in Solid Organ Transplant Pharmacotherapy as a mechanism to identify and recognize specialty knowledge and expertise within the field of SOT pharmacotherapy. The purpose of this paper is to provide an overarching review of the current and future state of SOT pharmacy while also identifying major changes to the profession, forthcoming challenges, and expected areas of growth., Competing Interests: Declaration of Competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Lisa Potter reports a relationship with Takeda Pharmaceuticals USA Inc that includes: board membership. Lisa Potter reports a relationship with Veloxis Pharmaceuticals Inc that includes: funding grants and speaking and lecture fees. David Taber reports a relationship with Veloxis Pharmaceuticals Inc that includes: board membership and funding grants. David Taber reports a relationship with Takeda Pharmaceuticals USA Inc that includes: funding grants. David Taber reports a relationship with Merk that includes: funding grants. David Taber reports a relationship with CareDx Inc that includes: funding grants. Rita Alloway reports a relationship with Bristol Myers Squibb Co that includes: funding grants. Rita Alloway reports a relationship with Nobelpharma Co Ltd that includes: funding grants. Rita Alloway reports a relationship with National Institutes of Health that includes: funding grants. Rita Alloway reports a relationship with Veloxis Pharmaceuticals Inc that includes: board membership and speaking and lecture fees. Rita Alloway reports a relationship with Sanofi that includes: speaking and lecture fees. The authors A. B. Lichvar, M. M. Chandran, B. R. Crowther, C. T. Doligalski, and A. J. C. Martinez of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplantation. The following authors of this manuscript have conflicts of interest to disclose as described by the American Journal of Transplantation. L. M. M. Potter reported serving as an advisory board member for Takeda in Dec 2021. E. A. Cohen reported serving for the speaker bureau of Veloxis that ended in Dec 2021 and receiving an investigator-initiated research grant from Veloxis Pharmaceuticals. D. J. Taber reported serving as a board member of the Veloxis grant and advisory board, Takeda grant, Merck grant, and CareDx grant. R. R. Alloway reported BMS, Nobelpharma, Thinker NEXT grant, Veloxis advisory board, Veloxis, and Sanofi speaker bureau., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

This viewpoint aims to "set the stage" and provide the rationale for the proposed development of a large-scale, comprehensive survey assessing transplant patients' perceived unmet immunosuppressive therapy needs. Research in organ transplantation has historically focused on reducing the incidence and impact of rejection on allograft survival and minimizing or eliminating the need for chronic immunosuppressive therapies. There has been less emphasis and investment in therapies to improve patient-reported outcomes including health-related quality of life and side-effects. Patient-focused drug development (PFDD) is a new and important emphasis of the Food and Drug Administration (FDA) that provides a guiding philosophy for incorporating the patient experience into drug development and evaluation. The American Society of Transplantation (AST) Board of Directors commissioned this working group to prepare for the conduct of a comprehensive patient survey assessing unmet immunosuppressive therapy needs. This paper aims to describe the basis for why it is important to conduct this survey and briefly outline the plan for broad stakeholder engagement to ensure the information gained is diverse, inclusive, and relevant for advancing PFDD in organ transplant recipients., (© 2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Immunosuppression regimens used in solid organ transplant have evolved significantly over the past 70 years in the United States. Early immunosuppression and targets for allograft success were measured by incidence and severity of allograft rejection and 1-year patient survival. The limited number of agents, infancy of human leukocyte antigen (HLA) matching techniques and lack of understanding of immunoreactivity limited the early development of effective regimens. The 1980s and 1990s saw incredible advancements in these areas, with acute rejection rates halving in a short span of time. However, the constant struggle to achieve the optimal balance between under- and overimmunosuppression is weaved throughout the history of transplant immunosuppression. The aim of this paper is to discuss the different eras of immunosuppression and highlight the important milestones that were achieved while also discussing this in the context of rational agent selection and regimen design. This discussion sets the stage for how we can achieve optimal long-term outcomes during the next era of immunosuppression, which will move from universal protocols to patient-specific optimization., (© 2020 Pharmacotherapy Publications, Inc.)

Despite being in existence for >40 years, the application of telemedicine has lagged significantly in comparison to its generated interest. Detractors include the immobile design of most historic telemedicine interventions and the relative lack of smartphones among the general populace. Recently, the exponential increase in smartphone ownership and familiarity have provided the potential for the development of mobile health (mHealth) interventions that can be mirrored realistically in clinical applications. Existing studies have demonstrated some potential clinical benefits of mHealth in the various phases of solid organ transplantation (SOT). Furthermore, studies in nontransplant chronic diseases may be used to guide future studies in SOT. Nevertheless, substantially more must be accomplished before mHealth becomes mainstream. Further evidence of clinical benefits and a critical need for cost-effectiveness analysis must prove its utility to patients, clinicians, hospitals, insurers, and the federal government. The SOT population is an ideal one in which to demonstrate the benefits of mHealth. In this review, the current evidence and status of mHealth in SOT is discussed, and a general path forward is presented that will allow buy-in from the health care community, insurers, and the federal government to move mHealth from research to standard care., (© 2017 The American Society of Transplantation and the American Society of Transplant Surgeons.)

The previous literature indicates that patients receiving ongoing care in both Veterans Affairs (VA) and non-VA setting (dual care) may have reduced health outcomes. The objective of this study was to assess the impact of dual care provided to a veteran solid organ transplant population. This was a retrospective cohort study of stable solid organ transplant recipients receiving care at both a Veterans Affairs Medical Center and transplant center. Forty-six veteran organ transplant recipients met inclusion criteria. At baseline, mean age at transplant was 57 ± 10 years; 93% were male, 61% received kidney transplants. Thirty-nine percent of patients did not receive immunosuppressant concentrations at the recommended intervals. The incidence of veterans that had at least 2 providers caring for the same comorbidity was 63% for hypertension, 58% for diabetes, and 27% for dyslipidemia. Approximately one-third of veterans had documentation of care provided by the other institutions (30%-37%), and 93% of patients had medication regimen discrepancies between health-care systems, with 52% of patients having at least 1 medication discrepancy involving an immunosuppressant. Most veteran solid organ transplant recipients receive care across multiple health-care systems, with significant care coordination issues leading to gaps and duplications in their management. Improved communication between health systems is imperative to optimize outcomes in dual use veterans such as organ transplant recipients.

Integration of pharmacists into multidisciplinary transplant patient care has advanced in recent years, with limited data available to evaluate the current status of the profession. This was a national survey developed as an AST Pharmacy COP initiative. Responses were solicited from pharmacists practicing at U.S. transplant programs based on UNOS listing; 176 participants from 113 centers (41%) responded, with 79% practicing ≤10 years. There is a median of 1.4 pharmacist full-time equivalents (FTEs) (range 0.1-7.1) for every 100 transplants. The predominant activities performed by pharmacists during the transplant phase include medication review (95%), lab review (92%), allergy review (88%), medication therapy management (92%), bedside rounds (87%), medication education (79%), documentation (71%), and coordinating discharge medications (58%). Similar activities were reported during the other phases, but participation was less common. The involvement of dedicated transplant pharmacists within multidisciplinary care has become standard at a large number of centers, although expansion is still needed to ensure core pharmaceutical care components are provided to all transplant recipients across all centers. These results inform on the typical responsibilities of pharmacists practicing within the field of transplantation and illustrate that the level of pharmacist involvement significantly varies across transplant centers and the phases of transplantation., (© Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Greater than 50% of medication errors are estimated to occur during transitions of care, and solid-organ transplant recipients are at an increased risk for errors due to significant changes in their medication regimen following transplantation. This prospective, observational study with a historical control group was conducted to evaluate the discharge process for transplant recipients and determine if transplant pharmacist involvement would improve safety. During the prospective period, a total of 191 errors were made on discharge medication reconciliations (n = 64, mean rate 3.0 per patient); however, pharmacists prevented 119 of these errors (1.9 errors per patient). In the retrospective period, none of the 430 errors identified were prevented at the time of discharge (n = 128, p < 0.0001). The 72 errors not prevented at the time of discharge in the prospective cohort were identified by the pharmacist at the patient's first clinic visit (1.1 errors per patient). In the historical cohort, all 430 errors made at discharge persisted until at least the time of the first clinic visit (3.4 errors per patient, p < 0.0001). This study demonstrates that transplant recipients are at a high risk for medication errors and that transplant pharmacist involvement leads to improved safety through the significant reduction of medication errors., (© Copyright 2013 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Transplant pharmacists have been recognized as an essential part of the transplant team by their colleagues along with several governing and professional organizations. The specific education, training and responsibilities of the transplant pharmacist have not been clearly delineated in the literature. Various pharmacists across the country have been called upon to serve on the transplant team necessitating standardization of their fundamental and desirable activities. Therefore, the purpose of this manuscript is to describe the training and role of a transplant pharmacist on the patient care team and provide a roadmap to implementation of novel transplant pharmacy services., (©2011 The Authors Journal compilation©2011 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Background: Cytomegalovirus (CMV) is a significant cause of morbidity, mortality, and cost in solid organ transplant recipients. This study was conducted to measure both the clinical efficacy and the pharmacoeconomic impact of implementing, as standard of care, an abbreviated preemptive monitoring strategy compared with universal prophylaxis in a large teaching hospital., Methods: This prospective observational study included only recipients at moderate risk for CMV infection, specifically recipients who were CMV seropositive before transplant. Recipients transplanted between February 2006 and December 2006 received prophylactic valganciclovir for 90 days after transplant, and those transplanted between January 2007 and December 2007 were enrolled in a preemptive monitoring strategy that included no anti-CMV prophylaxis but instead used serial CMV polymerase chain reactions in weeks 4, 6, 8, 10, 12, 16, 20, and 24 to monitor the development of CMV DNAemia. Costs were analyzed from a societal perspective., Results: A total of 130 patients were included in this study. Baseline and transplant demographics are well matched between groups. CMV syndrome occurred in three patients in each group, and one patient in the preemptive group developed CMV disease. Thirty-seven percent of patients in the preemptive group developed CMV DNAemia, 68% of these patients received antiviral therapy. Personnel and laboratory monitoring costs were significantly higher in the preemptive group, whereas medication cost was significantly higher in the prophylaxis group., Conclusions: Although outcomes and the overall cost of (1) universal prophylaxis and (2) preemptive monitoring are similar, universal prophylaxis places the cost burden on the patient whereas preemptive monitoring shifts the cost burden to the healthcare system.

Background: Drotrecogin alfa (activated) (DAA), a recombinant human activated protein C, is indicated for the reduction of mortality in patients with severe sepsis who have a high risk of death. In the initial trial, DAA demonstrated a significant reduction in mortality at 28 days for patients treated with DAA in comparison with standard supportive treatment (placebo). However, solid organ transplant recipients were excluded from the study. Transplant recipients are at an increased risk for sepsis and there is minimal literature describing the safety and efficacy of DAA in the transplant population., Methods: Thirteen solid organ transplant recipients who received DAA between November 2001 and January 2004 were included in this case series. Patients were prospectively identified and data collection occurred concurrently and by retrospective chart review. All patients met the DAA use criteria based on the institutional standard protocol., Results: We report the outcomes of the 13 adult transplant patients who received a total of 14 courses of DAA for severe sepsis. At the time of DAA initiation, all patients required mechanical ventilation, 86% necessitated vasopressor support, and had a median of 3 dysfunctional organs. The median Acute Physiology and Chronic Health Evaluation (APACHE) II score at initiation was 30. Overall, hemodynamic stability and APACHE II score improved at the end of DAA infusion. Causes of early discontinuation were bleeding (57%), scheduled procedure (14%), increased international normalized ratio (14%), and death (14%). In-hospital, 28-day, and 1-year mortality was 69%, 62%, and 83%, respectively., Conclusion: DAA appears to be safe with appropriate monitoring. However, transplant recipients had a higher incidence of bleeding events leading to early discontinuation of DAA. Efficacy is difficult to assess without an appropriate control group for comparison.