Cellular therapy site-preparedness: Inpatient pharmacy implementation at a large academic medical center.

Background: With the recent Food & Drug Administration (FDA) approval of cellular therapy that requires product manipulation prior to administration in combination with a short stability window, the need was identified for local dose preparation within the pharmacy rather than the off-site stem cell processing laboratory. This approval gave rise to assessment of regulatory standards surrounding cellular therapy, evaluation and revision of current standard operating procedures and policies with formal process validation, assessment of occupational exposure mitigation and safety considerations, and development of staff training and education.

Objective: To describe and provide insight into the stepwise process of FACT validation and onboarding of commercially available cellular therapy products that require sterile compounding manipulation within a pharmacy prior to administration.

Formulary Reconciliation: Implementation of a Comprehensive Approach to Formulary Maintenance and Standardization.

At our institution UC San Diego Health, formulary qualifiers such as indication expansions and restrictions based on provider specialty, patient location, or patient characteristics are input as free text into an online formulary platform. Inconsistency in formulary categories and their descriptions since the implementation of the electronic system have led to confusion and inconsistent formulary application amongst staff. We reviewed 880 unique medications with formulary qualifiers to standardize both categories and language.

Implementation of a multidisciplinary inpatient drug desensitization program.

Purpose: The purpose of this project was to analyze the process of adult inpatient drug desensitization and to create a multidisciplinary standardized procedure with the aim of improving patient safety, efficiency, length of stay, and patient satisfaction.

Summary: A team consisting of physicians, pharmacists, nurses, critical care specialists, and operational capacity managers was created. The electronic health system was queried to evaluate the frequency of desensitizations, level of care, implicated medications, and length of stay.

Evaluation of the inpatient use of inotuzumab ozogamicin and creation of appropriate use guidelines.

Inpatient use of inotuzumab ozogamicin (IO) at our academic medical center has increased since its FDA approval in 2017. Administration of IO does not require hospitalization and is appropriate for outpatient use. The aim of this report is to assess the appropriateness of use, overall inpatient utilization, and cost of IO.