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. There were 537 items with inpatient restrictions (eg, restricted to service), 147 items with a restriction to outpatient use only, 94 items with a formulation restriction, 91 items with associated guidelines, and 11 items with formulary expansions. Formulary status descriptions were updated to be consistent and clear. A standardized and well-maintained formulary, via formulary reconciliation, can provide concise and informative insight to the formulary status for frontline healthcare staff.

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. DISCUSSION: A multidisciplinary effort is required to attain FACT certification and implement pharmacist compounding of cellular therapy products.1 Local preparation within a pharmacy facilitates a sound operational workflow and provides a pathway to perform aseptic manipulations of cellular therapy products safely and efficiently. CONCLUSION: Safe and successful administration of cellular therapies handled and compounded by pharmacy department staff along with program validation requires a preemptive review utilizing a multidisciplinary approach for process development. This manuscript will provide a foundation based on consistency and transparency in effective cellular therapy sterile compounding and aseptic manipulation, proper handling and disposal procedures, increased communication through creation and optimization of treatment plans and order-sets, standardized medical center staff education, and development of policies and standard operating procedures for the entire health care team.

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. An electronic desensitization request form was created along with a desensitization team and email listserver for notification of key stakeholders. CONCLUSION: A standardized, safe, and efficient process for inpatient drug desensitization requires advance planning and participation from all disciplines involved. Operational and logistical aspects of desensitization are crucial components of rapid drug desensitization. A structured, multidisciplinary approach to inpatient desensitization is feasible.

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. This is a retrospective chart review of patients that received at least one dose of IO while admitted to the hospital. Data points included rationale for inpatient IO administration, hospital admission reason, number of IO doses and number of vials used, length of stay, in-hospital mortality, percentage of admissions that were new-starts, outpatient continuation of IO, use of concomitant regimens, and CD22 positivity. Between September 1, 2017, and June 30, 2022, 55 doses of IO were identified. Of the 29 unique admissions, common rationales for inpatient IO use included high disease burden/tumor lysis syndrome risk (31%) and use of a regimen requiring hospitalization (28%). The rationale for hospitalization was most commonly 'chemotherapy administration' (34%) and 'relapsed/refractory disease' (38%). Median length of stay was 23 days, most were new starts (76%), and 5 patients died during the associated admission. Only 63% of patients continued therapy in the outpatient setting. The inpatient use of IO was associated with a prolonged length-of-stay, a 17% in-hospital mortality, and represents a significant cost burden to the health system. As a result of these findings, guidelines for inpatient use of IO were implemented across the health system.

Physician and Pharmacist: Attitudes, Facilitators, and Barriers to Prescribing Naloxone for Home Rescue.

BACKGROUND AND OBJECTIVES: We implemented a naloxone education and distribution program in our academic health system. Despite the program, naloxone prescribing was not fully realized. This study aimed to identify the barriers to prescribing. METHODS: We conducted a prospective, cross-sectional, mixed-methods study of naloxone prescribers. Participants completed a questionnaire regarding their prescribing practices, attitudes, facilitators, and barriers to prescribing naloxone. Participants were then invited for an interview to further explore these topics and elicit more in-depth explanations. RESULTS: Sixty-four physicians and eight pharmacists completed the questionnaire (n = 72). The most commonly reported barrier to prescribing naloxone was time constraints (33%). During the interviews, 14 subthemes emerged within four themes: provider competency, provider beliefs, health care system, and patient factors/social climate. DISCUSSION: Prescribers identified barriers to naloxone prescribing despite implementation of an institutional overdose education and naloxone distribution (OEND) program. The results were similar to those previously reported prior to initiation of such programs. CONCLUSION: In this study, we examined barriers and facilitators to naloxone prescribing. Although previous studies have shown that health care providers endorsed similar barriers, our study indicates that some of those barriers persist despite a concerted effort to educate and promote prescribing via an OEND. While our study is limited by a small, selective sample size the results indicate that improvements to our OEND program are warranted. SCIENTIFIC SIGNIFICANCE: Our study addressed an unexplored area of OEND research and may inform future program development. (Am J Addict 2019;00:00-00).

Outcomes of Inpatient Administration of Restricted Antineoplastic Medications at a Large Academic Medical Institution.

BACKGROUND: Restricting oncology and hematology medications to outpatient infusion centers may be considered when infrequent administration is required, a low risk of serious adverse effects exists, or when prompt amelioration of a condition is not expected. At the University of California, San Diego (UCSD), we created a new formulary status for medications designated "formulary, outpatient-restricted use only." This designation could optimize payer reimbursement, as well as improve patient comfort, by negating the need for inpatient admission. When the inpatient administration of a restricted medication is requested at UCSD, there ensues a loosely defined review process involving an informal conversation between the requesting prescriber and the oncology pharmacy and therapeutics (P&T) chair. Patient outcomes associated with this formulary status and informal request process are limited. The purpose of this study is to describe the use of formulary, outpatient-restricted oncology and hematology medications in the inpatient setting at a single-center, academic, and comprehensive cancer center. METHODS: A retrospective chart review was conducted between January 1, 2015 and May 1, 2017. The primary outcome was to determine the percentage of formulary, outpatient-restricted oncology or hematology medications that were administered in the inpatient setting and continued to the outpatient setting. Secondary outcomes included overall survival, hospice enrollment, disease progression status, level of evidence supporting the medication usage, and cost. RESULTS: Twenty-three patients and 24 outpatient-restricted medications met the inclusion criteria. Thirteen (54%) medications were continued upon discharge and eight (33%) were not continued in the outpatient setting. Five of those eight medications were discontinued as a result of patient death. CONCLUSION: In this single-center study, approximately one-third of the outpatient-restricted medications were not continued upon discharge. The findings suggest that our informal approval process could result in the suboptimal use of formulary outpatient-restricted medications for oncology and hematology indications. A more formalized request process might lead to the more effective utilization of these medications.