The measure of impact: Proposal of quality metrics for solid organ transplant pharmacy practice.

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.

The expanded role of the transplant pharmacist: A 10-year follow-up.

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.

Poor tolerability of cystic fibrosis transmembrane conductance regulator modulator therapy in lung transplant recipients.

Elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) is a highly effective therapy for patients with cystic fibrosis (CF) with potential benefits in lung transplant recipients (LTRs) for extrapulmonary CF manifestations; however, tolerability and efficacy in this population are largely unknown. We report our experience with ELX/TEZ/IVA in LTRs for extrapulmonary complications of CF including tolerability, drug-drug interactions, and therapeutic benefit. All LTRs at a single center initiated on ELX/TEZ/IVA were reviewed. Adverse events and patient-reported outcomes attributed to ELX/TEZ/IVA were documented. Pulmonary function, tacrolimus requirements in mg/kg/dl, body mass index (BMI), and reason for initiation were assessed at the initiation of ELX/TEZ/IVA, and at 12 months post-initiation or at the time of discontinuation for those in whom therapy was discontinued. Thirteen LTRs were initiated on ELX/TEZ/IVA at a mean of 115 ± 92 months post-transplant. All were initiated on ELX/TEZ/IVA for sinus or sinus and gastrointestinal CF manifestations. Five (38.4%) patients discontinued therapy due to declining pulmonary function (2/5, 40%), mood disturbances (2/5, 40%), or lack of benefit (1/5, 20%). Of the eight patients who remain on ELX/TEZ/IVA, four reported adverse effects and three LTRs temporarily held therapy. Six (46.2%) LTRs reported improvement in sinus symptoms, while four (30.7%) reported improved gastrointestinal symptoms. Weight declined in the cohort overall. Tacrolimus dose requirements decreased following initiation of ELX/TEZ/IVA therapy, with a 50% decline in dose requirements observed. In our experience, ELX/TEZ/IVA in LTRs is poorly tolerated with modest perceived extrapulmonary benefit and a significant effect on tacrolimus dose requirements. More data are needed to determine the benefits of ELX/TEZ/IVA therapy in LTRs.

Device-Related Thrombosis in Continuous-Flow Left Ventricular Assist Device Support.

Advanced heart failure therapy has been revolutionized with the advent of continuous-flow ventricular assist devices (CF-LVADs) which have improved both survival and quality of life. Despite this, support with CF-LVADs is frequently complicated, with 70% of recipients experiencing a major complication in the first year of durable support. The most concerning of these complications to emerge is device-related thrombosis, which is associated with increased morbidity and mortality. Pathophysiology and diagnosis are multifaceted and complex, with pump-specific and patient-specific factors to be considered. Incidence estimates are evolving with increases seen in the past 2 years compared with earlier implant data. Evidence for treatment is limited to case series and reports, which are subject to significant publication bias. Finally, appropriate primary and secondary prophylaxis is imprecise with multiple antiplatelet and antithrombotic strategies described. This review seeks to summarize the current literature surrounding the pathophysiology, diagnosis, and management of thrombosis in CF-LVAD recipients.

Incidence and Risk Factor Analysis for Gastrointestinal Bleeding and Pump Thrombosis in Left Ventricular Assist Device Recipients.

Left ventricular assist devices (LVADs) are associated with hemostatic complications. We describe the incidence and risk factors for gastrointestinal bleeding (GIB) and pump thrombosis (PT) to optimize patient selection/management. An IRB-approved retrospective review of first LVAD implants between October 1, 2011 and September 30, 2013 at a single center was conducted. Endpoints included epidemiological and risk factor analyses for GIB and PT. Descriptive statistics, chi-squared, and t-tests were used. Sixty-four patients received continuous-flow LVADs. The 12-month incidence of GIB and PT was 23.4% and 12.5%. Time to first GIB was 72.6 days (9-160). The 1-, 3-, and 6-month rate of PT was 1.6%, 6.25%, and 12.5%, respectively. All PT required pump exchange. Females (50% vs. 16%, P = 0.026) and patients without antiplatelet therapy (12.5% vs. 50%, P = 0.046) were at increased risk of PT. No pre-implant comorbidities were associated with PT. Infection was not identified as a risk factor in our cohort (25% vs. 51.8%, P = 0.156). Mean INR preceding event was not different from nonevent patients (2.1 vs. 2.24, P = 0.24). Regarding biomarkers preceding event, elevated plasma free hemoglobin (pfHg) did not reach significance (75% vs. 58%, P = 0.383) while lactate dehydrogenase was elevated significantly (744 vs. 298, P < 0.001). Receiver operating characteristic (ROC) analysis demonstrated that an LDH of >500 was highly sensitive and specific for PT. No pre-implant factors were associated with GIB. Post-implant risk factors for GIB included infection (80% vs. 38.8%, P = 0.005) and infrequent elevations in pfHg (13.3% vs. 63.3%, P < 0.001). Increased pump speed as a GIB risk factor was confirmed (HeartMate II 9560 rpm vs. 9490 rpm, P < 0.001; HeartWare 2949 rpm vs. 2710 rpm, P < 0.001). Anticoagulation/antiplatelet therapy did not affect GIB: mean INR preceding event was not different from nonevent patients (2.21 vs. 2.27, P = 0.67) and antiplatelet use was not different (46.7% vs. 46.9%, P = 0.985). LVADs are associated with early hemostatic-related morbidity. Few pre-implantation risk factors were elucidated; however, post-implantation factors including antiplatelet therapy, infection, and pump speed were identified.

Sublingual administration of tacrolimus: current trends and available evidence.

Widespread anecdotal use of sublingual tacrolimus administration has arisen, although little literature exists to guide practice. Given the paucity of data, we conducted a survey to evaluate the practice of sublingual tacrolimus administration at transplant centers across the United States and evaluated the literature that is currently available. A 10-question online survey assessing the current state of sublingual tacrolimus use was distributed to pharmacists at transplant centers that each performed more than 100 solid organ transplantations in 2013. In addition, a literature review was performed by searching the PubMed database to identify available evidence for the sublingual administration of tacrolimus. The online survey was completed by 59 (65.6%) of the 90 targeted transplant centers, representing 51.3% of all solid organ transplantations performed in 2013. Sublingual administration of tacrolimus was used in all solid organ transplant populations, with ~67% of lung transplant centers using this route for tacrolimus. The most common dose conversion was 2 mg oral to 1 mg sublingual, with 92% of centers opening oral capsules and administering the contents sublingually. Home use of sublingual administration and use in the pediatric population was uncommon. Seven peer-reviewed reports and one abstract were identified in the literature review. Seven of the eight publications reported favorably on sublingual administration, although no consistent dose conversion or method of administration was elucidated. The majority of the transplant centers surveyed found sublingual tacrolimus a viable alternative when oral administration is unavailable. A large robust prospective evaluation of sublingual administration of tacrolimus is imperative to provide the most effective care to solid organ transplant recipients and to ensure optimal safety for both patients and providers who administer the drug.

Drug interactions: a primer for the gastroenterologist.

One of the most clinically significant complications related to the use of pharmacotherapy is the potential for drug-drug or drug-disease interactions. The gastrointestinal system plays a large role in the pharmacokinetic profile of most medications, and many medications utilized in gastroenterology have clinically significant drug interactions. This review will discuss the impact of alterations of intestinal pH, interactions mediated by phase I hepatic metabolism enzymes and P-glycoprotein, the impact of liver disease on drug metabolism, and interactions seen with commonly utilized gastrointestinal medications.