Our study aimed to compare objective therapeutic drug monitoring outcomes after the implementation of a pharmacist driven tacrolimus management protocol (post-protocol initiation) to prior management by providers (pre-protocol initiation).

The Ohio State University Wexner Medical Center (OSUWMC) is a 700-bed academic medical center in Columbus, Ohio. On average, OSUWMC completes more than 300 kidney transplants each year. There are 6 abdominal transplant pharmacists (including one PGY2 transplant pharmacy resident) that rotate through the inpatient and outpatient setting.

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.

This single center retrospective analysis included adult kidney transplant recipients on de novo tacrolimus. Patient’s tacrolimus levels were evaluated for 6 months following transplant. The mean tacrolimus percent time within therapeutic range (TTR) and the median coefficient of variation (CV) were calculated and compared in post-protocol initiation group (n=85) versus pre-protocol initiation group (n=39). TTR was calculated utilizing the Rosendaal method.

There was no significant difference between the pre-protocol initiation and post-protocol initiation group mean TTR (59.6% vs 60.5%, P = 0.723), mean CV from 0-3 months post-transplant (36.3 vs 36.0, P = 0.900), and mean CV from >3-6 months post-transplant (24.5 vs 22.7, P = 0.351). Rejection rates, development of donor specific antibodies, and renal function were similar between groups.

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 when compared to primary management by other transplant providers. The delegation of tacrolimus management to clinical pharmacists is a viable alternative to primary management by outpatient practitioners.

Accepted: June 16, 2022

Received in revised form: June 1, 2022

Received: August 4, 2021

Kathryn Owen, PharmD Medstar Georgetown University Hospital, Washington, DC - Solid Organ Transplant Clinical Pharmacist (Past affiliation: The Ohio State University Wexner Medical Center, Columbus, OH – PGY2 Solid Organ Transplant Pharmacy Resident) ORCHID: https://orcid.org/0000-0001-6624-8496: Methodology, Investigation, Data Curation, Visualization, Writing – Original Draft

Holli Winters, PharmD, BCPS – The Ohio State University Wexner Medical Center, Columbus, OH - Solid Organ Transplant Clinical Pharmacist: Supervision, Project Administration

Marilly Palettas, MPH – The Ohio State University Wexner Medical Center, Columbus, OH - Biostatistician: Data Curation, Formal Analysis

Olya Witkowsky, PharmD, BCPS – The Ohio State University Wexner Medical Center, Columbus, OH - Solid Organ Transplant Clinical Pharmacist: Conceptualization, Methodology, Supervision, Project Administration, Writing - Review & Editing

Data is available upon request via the corresponding author.

DOI: https://doi.org/10.1016/j.japh.2022.06.007

© 2022 Published by Elsevier Inc. on behalf of the American Pharmacists Association.