Impact of a pharmacist-led tacrolimus management protocol in the outpatient setting.

BACKGROUND: Clinical pharmacists are often used to make recommendations regarding tacrolimus therapy in the post transplant setting.Therapeutic drug monitoring (TDM) of tacrolimus after transplant is based on trough levels in the setting of predetermined institutional immunosuppression goals. To evaluate time within therapeutic range (TTR) of tacrolimus the Rosendaal method can be utilized. OBJECTIVE: Our study aimed to compare objective therapeutic drug monitoring outcomes after the implementation of a pharmacist driven tacrolimus management protocol (postprotocol initiation) with previous management by providers (preprotocol initiation). PRACTICE DESCRIPTION: The Ohio State University Wexner Medical Center (OSUWMC) is a 700-bed academic medical center in Columbus, OH. On average, OSUWMC completes more than 300 kidney transplants each year. There are 6 abdominal transplant pharmacists (including one postgraduate year 2 transplant pharmacy resident) that rotate through the inpatient and outpatient setting. PRACTICE INNOVATION: A pharmacist-led tacrolimus management protocol in kidney transplant recipients was initiated in October 2018 at our institution, which enabled pharmacists to dose and adjust tacrolimus in the outpatient setting in accordance with prespecified goals. EVALUATION METHODS: This single-center retrospective analysis included adult kidney transplant recipients on de novo tacrolimus. Patient's tacrolimus levels were evaluated for 6 months after transplant. The mean tacrolimus percent TTR and the median coefficient of variation (CV) were calculated and compared in postprotocol initiation group (n = 85) with preprotocol initiation group (n = 39). TTR was calculated using the Rosendaal method. RESULTS: There was no statistically significant difference between the preprotocol initiation and postprotocol initiation group mean TTR (59.6% vs. 60.5%, P = 0.723), mean CV from 0-3 months after transplant (36.3 vs. 36.0, P = 0.900), and mean CV from at least 3-6 months after transplant (24.5 vs. 22.7, P = 0.351). Rejection rates, development of donor-specific antibodies, and renal function were similar between groups. CONCLUSION: Based on our findings, transplant pharmacists were equally as effective at maintaining tacrolimus percent TTR and CV in the designated kidney transplant recipients included in the management protocol compared with primary management by other transplant providers. The delegation of tacrolimus management to clinical pharmacists is a viable alternative to primary management by outpatient practitioners.

Antithymocyte induction dosing and incidence of opportunistic viral infections using steroid-free maintenance immunosuppression.

BACKGROUND: Currently, there is limited literature evaluating rATG induction dosing and incidence of opportunistic viral infections when using steroid-free maintenance immunosuppression. METHODS: This single-center, retrospective, study compared high rATG (>4.5 mg/kg) versus low (<4.5 mg/kg) induction dosing and the overall incidence of early opportunistic viral infection at 180 days in the setting of maintenance immunosuppression consisting of tacrolimus, mycophenolate, rapid steroid withdrawal, and a tiered antiviral prevention strategy based on donor-recipient Cytomegalovirus (CMV) serostatus. RESULTS: A total of 209 patients were included; 76 patients received low-dose and 133 patients received high-dose rATG. Incidence of overall opportunistic viral infection occurred more frequently in patients who received high compared to low dose (29.8% vs 25% p = .030). Incidence of CMV infection was also significantly increased in the high-dose group (31.6% vs 18.4% p = .039). In a multivariable model, rATG dose, as a continuous variable, remained a significant independent predictor of infection along with CMV risk (OR 1.46, 95% CI 1.02-2.09) controlling for age and CMV risk. There were no differences in graft-related outcomes at 180 days. CONCLUSION: Higher cumulative rATG induction dose was associated with increased incidence of opportunistic viral infections, in the setting of a steroid-free maintenance immunosuppression in the early post-transplant period.

Largest Experience of Safety and Efficacy of Patiromer in Solid Organ Transplant.

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The utilization of sirolimus and the impact on wound-healing complications in obese kidney transplant recipients.

BACKGROUND: Wound healing is a known complication associated with sirolimus therapy. Previous studies have demonstrated that obesity is a risk factor for wound-healing complications (WHC) in patients receiving sirolimus therapy; however, the incidence has not been defined. METHODS: This is a single-center, retrospective cohort study of de novo kidney transplant recipients (KTR) transplanted with a body mass index (BMI) of ≥ 30 kg/m(2) between January 2002 and April 2011 receiving sirolimus vs. sirolimus-free maintenance immunosuppression. RESULTS: A total of 317 KTR, 71 sirolimus-free patients and 246 sirolimus patients, were eligible for inclusion. There was no difference in the primary outcome of WHC within six months of transplant (sirolimus 32.1% vs. sirolimus-free 29.6%, p = 0.107). Sirolimus exposure was not found to influence WHC (OR 2.906, 95% CI 0.922-9.160); however, BMI Class II (OR 1.830, 95% CI 1.051-3.186) and Class III (OR 3.154, 95% CI 1.484-6.705) were significant predictors of WHC. There was no difference in WHC between the sirolimus group and sirolimus-free group among patients in obesity Class I (27.3% vs. 15.1%, p = 0.064), Class II (36.6% vs. 34.8%, p = 0.195), or Class III (48.0% vs. 53.3%, p = 0.243). CONCLUSION: In our experience, sirolimus does not increase WHC in obese KTR and can be safely used as maintenance immunosuppression immediately following transplant.

Extended-spectrum beta-lactamase-producing bacterial infections in adult solid organ transplant recipients.

BACKGROUND: Limited research is available evaluating infections due to extended-spectrum ß-lactamase (ESBL)-producing organisms in adult recipients of solid organ transplant (SOT). OBJECTIVE: To evaluate clinical response and rate of recurrence of ESBL-producing organisms in 20 SOT recipients. METHODS: In a retrospective case series, records of adult SOT recipients with an admitting diagnosis of infection and a positive culture for an ESBL-producing organism from January 2003 through August 2006 were reviewed. RESULTS: Twenty patients met inclusion criteria. The median time to infection following transplant was 3.5 years (range 1-23 years). Overall, 85% of the patients received inadequate empiric antibiotic therapy, including ciprofloxacin or piperacillin/tazobactam, to manage their infection. Nineteen patients had clinical resolution; however, 12 patients required at least 1 readmission due to infection recurrence. One patient's death occurred during the study period. The median time to readmission for a recurrence was 41 days (18-455 days). All recurrent infections were caused by the same ESBL-producing pathogen and 10 of 12 (83%) infections occurred at the same site as the initial infection. Among patients with recurrent infections, 75% received inadequate empiric therapy upon readmission. All 12 patients with recurrent infections had successful clinical responses to both initial and recurrent infections. CONCLUSIONS: The provision of inadequate empiric therapy for new and recurrent infections due to ESBL-producing pathogens was common in this study population. SOT recipients with a history of infection due to an ESBL-producing organism presenting with a new infection should receive adequate empiric therapy with a carbapenem agent until a definitive diagnosis can be established.