Progress in Transplantation

Self-management is important in ensuring good clinical results in kidney transplant recipients. It was unclear whether the current education program at a single kidney transplant center sufficiently prepares recent transplant recipients for the many complex self-management tasks required.

To evaluate the completeness of and the satisfaction with the current inpatient kidney transplant education program and to determine recipients' needs for information in the first months after discharge.

We used a concurrent mixed-methods design, including 31 kidney transplant recipients who were assessed via a semistructured interview (qualitative part) and a questionnaire specifically designed for this study, consisting of 30 Likert-type and open-ended questions (quantitative part).

Kidney transplant patients reported having received extensive information about medication use after transplant surgery (antirejection medication, 93.5%). Information about healthy lifestyle (physical activity and rehabilitation, 54.8%), return to work (54.8%), and emotional coping (25.8%) was considered suboptimal, although most patients expressed a need for such information. Patients indicated a need for more concrete and practical information, not only during their hospital stay, but also in the long term after transplant.

This is the first mixed-models approach showing that our education program immediately after transplant focuses on the transfer of factual knowledge, which seems to insufficiently train patients in developing self-management skills. Updates of our program are warranted to overcome the gaps in the information provided, to provide more practical tips, and to repeat education in the long-term after the transplant surgery, tailored to the patients' needs.

United Network for Organ Sharing (UNOS) 2011 bylaws and Centers for Medicare and Medicaid Services (CMS) regulations require a transplant pharmacist to be an active participant in the care of transplant patients. Transplant centers must be members in good standing with UNOS in order to perform transplants and must be certified by CMS to participate with Medicare.

To identify characteristics of transplant-related pharmacy services at comprehensive transplant centers.

Survey regarding number of full-time equivalent (FTE) transplant pharmacists relative to number of annual transplants, transplant pharmacy model, roles in inpatient and clinic environments, training and specialization, funding sources, and expansion plans.

Surveys were received from 14 (74%) of 19 identified centers that performed 200 to 400 kidney, liver, pancreas, simultaneous kidney/pancreas, heart, and lung transplants in 2010, representing 55 transplant pharmacists. Results—A mean of 325 transplants were performed in 2010 at the surveyed centers. The mean number of pharmacist FTEs was 4.25, which yielded a transplant-to-pharmacist ratio of 76.5. Nine centers (64%) practiced in a pharmacy specialist-only model, 12 (86%) practiced in a service-based fashion, and 10 (71%) saw patients in clinic. Fifty-four pharmacists (98%) had obtained a PharmD degree, 45 (82%) had completed 1 postgraduate year, and 28 (51%) had completed 2 postgraduate years of training. Nine centers (64%) funded FTEs solely through the pharmacy department. Ten centers (71%) plan to expand transplant pharmacist staff by a mean of 1.4 FTEs.

Large comprehensive transplant centers use multiple transplant pharmacists to perform patient care in the inpatient and outpatient environments. Most centers plan to expand FTEs. Further characterization of transplant pharmacists appears warranted.

The increasing number of marginal deceased kidney donors and an aging recipient population, prolonged hospitalization, and increased costs have destabilized the economic viability of kidney transplants.

To determine if a delay in the administration of the day-of-discharge dose of rabbit antithymocyte globulin would result in equivalent clinical outcomes with cost savings.

Single-center, prospective, observational before-and-after study of adult kidney transplant recipients who received induction with rabbit antithymocyte globulin. Intervention—Patients who received a transplant between June 2006 and February 2009 and received rabbit antithymocyte globulin served as the control group. Patients who received a transplant between March 2009 and August 2010 and received rabbit antithymocyte globulin had the day-of-discharge dose delayed to the following day and administered in the clinic. A total of 231 patients (146 in the control group, 85 in the study group) were included. Baseline demographic and clinical characteristics were similar in the 2 groups.

Patients who had delayed administration of rabbit antithymocyte globulin had shorter stays (3.9 vs 3.1 days, P .001) and reduced inpatient costs for rabbit antithymocyte globulin (mean $860/patient); these changes were achieved without affecting acute rejection rates (5% vs 5%, P>> .99) or readmission rates. In conclusion, delayed inpatient administration of rabbit antithymocyte globulin provided identical clinical outcomes while helping to reduce inpatient costs and increase timely discharges.

A report released in 2004 by the Institute of Medicine estimated that as many as 90 million Americans do not have the necessary skills required to manage complex treatment regimens or navigate through current health care systems successfully.

To identify the level of health literacy in patients seen at a suburban transplant center by using the Newest Vital Sign tool to assess health literacy.

This descriptive study used survey methods. The convenience sample included 44 adult patients, both English and Spanish speaking, who attended a routine clinic visit at a suburban transplant center.

The Newest Vital Sign tool was administered during routine outpatient medical visits. Demographic information collected included age, sex, highest level of education, and whether or not the participant was on dialysis or received a kidney transplant. Descriptive statistics were completed for each answer on the tool. Chi-square analyses were done to determine whether demographic factors or the presence of dialysis affected health literacy in this sample. A 1-way analysis of variance between-subjects test was run to compare the effect of primary language and educational level on scores.

Of the 44 participants, 18 (41%) had scores indicating a possible likelihood to a high likelihood of limited health literacy. Twenty-nine percent of the English-speaking participants and 89% of the Spanish-speaking participants scored in this range. An association was also found between performance on the survey and level of education. However, assessment of educational level alone is not predictive of health literacy; 8 participants (18%) had a high school or college education yet scored as having limited health literacy.

To review the history of risk evaluation and mitigation strategies (REMS) with the mammalian target of rapamycin (mToR) inhibitors, evaluate their required REMS elements, and delineate the reasons for them being released from their REMS requirements.

Articles were identified through a literature search of MEDLINE and EMBASE (January 2007-July 2012) using the search terms: risk evaluation and mitigation strategies, REMS, everolimus, sirolimus and organ transplant (individual organs also were searched). Information from the Federal Register, the Food and Drug Administration, and the manufacturers of the mToR inhibitors was also evaluated.

REMS are strategies implemented to manage known or potential risks associated with medications and to ensure ongoing pharmacovigilance throughout the life of a pharmaceutical product. The mToR inhibitors have been associated with several potential risks, including proteinuria, graft thrombosis, and wound-healing complications. The Food and Drug Administration approved REMS programs for both sirolimus and everolimus. The manufacturers of both medications complied with the components of their approved REMS, but after less than 2 years, both medications have been relieved of their REMS obligations.

The only element of the sirolimus REMS was a medication guide, whereas the everolimus REMS consisted of a medication guide and a communication plan. The sirolimus REMS was implemented more than 10 years after its initial approval by the Food and Drug Administration, but was released from its REMS requirement within 7 months of its implementation. The everolimus REMS was instituted upon initial approval and was removed approximately 2 years later. Both medications' REMS were always intended to educate health care providers and patients about the potential risks associated with this transplant immunosuppressant. Transplant practitioners should be familiar with the mToR inhibitors' associated risks and properly educate patients regarding the inhibitors' risk-benefit profiles.

To review the components of the Congressional mandate for risk evaluation and mitigation strategies (REMS) managed by the Food and Drug Administration and assess their impact on health care providers practicing within the organ transplant arena.

A non-date-limited search of MEDLINE and EMBASE (January 2007-June 2012) was conducted by using the following search terms: risk evaluation and mitigation strategies, REMS, and organ transplant, including a query of the individual organs. Information from the Federal Register and the Food and Drug Administration was also evaluated.

REMS are strategies implemented to manage known or potential risks associated with medications and to ensure ongoing pharmacovigilance throughout the life of a pharmaceutical product. Elements of REMS programs may consist of 3 levels: a medication guide, communication plan, and elements to assure safe use. A medication guide is used to help prevent serious adverse events, aid in patients' decision making, and enhance medication adherence. Communication plans help educate health care providers and encourage adherence with REMS. The elements to assure safe use is a restrictive process implemented when it is deemed necessary to ensure safe access for patients to products with known serious risks. In transplant medicine, REMS currently exist for belatacept (medication guide and communication plan) and the mycophenolic acid derivatives (medication guide and elements to assure safe use).

REMS are another step in the evolution of the development and marketing of pharmaceutical agents. Use of REMS in solid-organ transplant is becoming common. Transplant clinicians must provide required patient education and become involved with other aspects of REMS implementation to reduce the serious risks of pharmaceuticals and to improve patients' outcomes.

To review the elements and components of the risk evaluation and mitigation strategies (REMS) for the costimulation blocker belatacept and associated implications for health care providers working with transplant recipients.

The MEDLINE and EMBASE databases (January 1990 to March 2012) were searched by using risk evaluation and mitigation strategies, REMS, belatacept, and organ transplant as search terms (individual organs were also searched). Retrieved articles were supplemented with analysis of information obtained from the Federal Register, the Food and Drug Administration, and the manufacturer of belatacept.

REMS are risk-management strategies implemented to ensure that a product's benefits outweigh its known safety risks. Although belatacept offers a novel strategy in maintenance immunosuppression and was associated with superior renal function compared with cyclosporine in phase 2 and 3 trials, belatacept is also associated with increased risk of posttransplant lymphoproliferative disorder and central nervous system infections. The Food and Drug Administration required development of a REMS program as part of belatacept's approval process to ensure safe and appropriate use of the medication and optimization of its risk-benefit profile. Conclusion—Elements of the belatacept REMS include a medication guide that must be dispensed with each infusion and a communication plan. In the management of a complex population of patients, it is essential that those who care for transplant recipients, and patients, recognize the implications of potential and known risks of belatacept. The REMS program aims to facilitate careful selection and education of patients and vigilant monitoring.

As kidney transplant is the preferred mode of management of advanced kidney disease and economic trends for kidney transplant procedures are not well known, data were analyzed to assess these trends.

Annual data for 1998 to 2008 from the Nationwide Inpatient Sample, Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality were used to analyze characteristics of patients discharged from hospitals in the United States with kidney transplant as the primary procedure.

The population more than 65 years old had the most significant increase in hospitalizations for kidney transplant procedures (P < .01). The mean length of stay decreased by 2.8 days over the period studied (P = .02). Mean hospital charge increased despite a decrease in length of stay resulting in a 225% increase in charge per day of hospitalization, from $6907 in 1998 to $22484 in 2008. The national aggregate hospital charges for kidney transplant procedures rose from $0.9 billion in 1998 to $3.1 billion in 2008. Kidney transplant was overall ranked sixth by mean cost per hospitalization and ranked seventh by mean charge per hospitalization among the Clinical Classification Software's Services and Procedures in this database in 2008.

Despite shorter hospital stays, the economic burden of kidney transplants increased from 1998 to 2008.

Aging, higher prevalence of diabetes, worsening obesity, and hyperglycemia among potential donors increase the likelihood that pancreata will be declined by transplant centers. Hemoglobin A_lc testing, also known as glycated hemoglobin testing, identifies a donor's average blood glucose concentration for the preceding 2 to 3 months and is the standard test for identifying prolonged periods of hyperglycemia.

To compare pancreas utilization rates before and after implementation of hemoglobin A_lc testing.

A retrospective study of data from the New York Organ Donor Network was conducted. Potential donors were defined as standard criteria donors who had no history of diabetes and were not seropositive for hepatitis B or C. Criteria for “ideal” potential pancreas donors were based on age, body mass index, lipase level, and terminal creatinine level. Potential donors who did not meet the criteria for ideal donors were considered “expanded” potential pancreas donors. Pancreas utilization rate was defined as the number of pancreata transplanted divided by the number of potential pancreas donors.

Of 779 standard criteria donors, 691 (89%) were potential pancreas donors: 251 ideal (36%) and 440 expanded (64%) donors. In 2005 and 2006, before hemoglobin A_lc testing, pancreas utilization rates were 21% and 18%, respectively. In 2008, 2009, and 2010, after hemoglobin A_lc testing was incorporated, utilization rates were 27%, 28%, and 32%, respectively. Utilization of ideal donors increased from 33% to 51% (P = .003), and utilization of expanded donors increased from 11% to 17% (P = .05). Pancreas utilization increased 51.0%, and pancreas discards decreased 50.8% with the implementation of hemoglobin A_lc testing.

Hemoglobin A_lc testing may increase utilization of ideal and expanded criteria pancreata.

The request process for eye and tissue donation is different from the process that families of organ donors experience, but the research into eye/tissue-only decision making has been sparse.

To determine the concerns of families approached over the phone for eye/tissue donations and to study the impact of the donor registry on those decisions.

Written instrument filled out by family services coordinators while speaking with families about donation via phone in the San Diego, California, area during 2011.

Responses marked on a 21-item instrument, contextual notes, donor registrations, and decisions made.

With a 60% refusal rate, the most common reasons reported for declining donation are that the potential donor said during life he/she did not want to donate (26%) or that the family, not knowing the potential donor's wishes, opted not to donate (13%). Other specific reasons for not donating were as follows: wanting the body buried whole (8%), concerns about age and prior health (7%), and incompatibility with religion or culture (7%). Consenting families had different concerns: worries about delays (36%), the potential donors' age and health (25%), how the body might look for viewing (14%), the amount of paperwork (10%), for-profit status of beneficiaries (9%), international distribution (8%), and family disunity (8%). Registry-related refusals weighted against donations of tissues from registered donors amounted to a deficit of 92 potential donations. When donations lost to faulty assumptions based on public education are added, the deficit increases to 122 lost donations.