Feeding the Soul via Creation of a Suborganization to Promote a Sense of Community.

Pharmacy faculty commonly report feeling stressed, overwhelmed, exhausted, and burnt out. Women may be disproportionally impacted by personal and professional demands. The purpose of this commentary is to describe one mechanism for creating a suborganization (Circle) that establishes a supportive community to combat burnout and promote professional fulfillment. This commentary is a description of one American Academy of Colleges of Pharmacy (AACP) Women Faculty Special Interest Group (SIG) Circle. The authors describe how one Circle sought to enhance the well-being of its members through the various domains of the Stanford Model of Professional Fulfillment, including personal resilience, workplace efficiency, and creating a culture of well-being. Circles and similar frameworks may be effective tools for combatting burnout, improving fulfillment, and promoting wellness and well-being among women and other groups of faculty.

Tocilizumab for severe COVID-19 related illness - A community academic medical center experience.

The SARS-CoV-2 virus responsible for the COVID-19 pandemic can result in severe or fatal disease in a subset of infected patients. While the pathogenesis of severe COVID-19 disease has yet to be fully elucidated, an overexuberant and harmful immune response to the SARS-CoV-2 virus may be a pivotal aspect of critical illness in this patient population. The inflammatory cytokine, IL-6, has been found to be consistently elevated in severely ill COVID-19 patients, prompting speculation that IL-6 is an important driver of the pathologic process. The inappropriately elevated levels of inflammatory cytokines in COVID-19 patients is similar to cytokine release syndrome (CRS) observed in cell therapy patients. We sought to describe outcomes in a series of severely ill patients with COVID-19 CRS following treatment with anti-IL-6/IL-6-Receptor (anti-IL-6/IL-6-R) therapy, including tocilizumab or siltuximab. At our academic community medical center, we formed a multi-disciplinary committee for selecting severely ill COVID-19 patients for therapy with anti-IL-6 or IL-6-R agents. Key selection criteria included evidence of hyperinflammation, most notably elevated levels of C-reactive protein (CRP) and ferritin, and an increasing oxygen requirement. By the data cutoff point, we treated 31 patients with anti-IL-6/IL-6-R agents including 12 who had already been intubated. Overall, 27 (87%) patients are alive and 24 (77%) have been discharged from the hospital. Clinical responses to anti-IL-6/IL-6-R therapy were accompanied by significant decreases in temperature, oxygen requirement, CRP, IL-6, and IL-10 levels. Based on these data, we believe anti-IL-6/IL-6-R therapy can be effective in managing early CRS related to COVID-19 disease. Further study of anti-IL-6/IL-6-R therapy alone and in combination with other classes of therapeutics is warranted and trials are underway.

HITM-SURE: Hepatic immunotherapy for metastases phase Ib anti-CEA CAR-T study utilizing pressure enabled drug delivery.

In recent years, cell therapy technologies have resulted in impressive results in hematologic malignancies. Treatment of solid tumors with chimeric antigen receptor T-cells (CAR-T) has been less successful. Solid tumors present challenges not encountered with hematologic cancers, including high intra-tumoral pressure and ineffective CAR-T trafficking to the site of disease. Novel delivery methods may enable CAR-T therapies for solid tumor malignancies. A patient with liver metastases secondary to pancreatic adenocarcinoma received CAR-T targeting carcinoembryonic antigen (CEA). Previously we reported that Pressure-Enabled Drug Delivery (PEDD) enhanced CAR-T delivery to liver metastases 5.2-fold. Three doses of anti-CEA CAR-T were regionally delivered via hepatic artery infusion (HAI) using PEDD technology to optimize the therapeutic index. Interleukin-2 was systemically delivered by continuous intravenous infusion to support CAR-T in vivo. HAI of anti-CEA CAR-T was not associated with any serious adverse events (SAEs) above grade 3 and there were no on-target/off-tumor SAEs. Following CAR-T treatment, positron emission tomography-CT demonstrated a complete metabolic response within the liver, which was durable and sustained for 13 months. The response was accompanied by normalization of serum tumor markers and an abundance of CAR+ cells found within post-treatment tumor specimens. The findings from this report exhibit biologic activity and safety of regionally infused CAR-T for an indication with limited immune-oncology success to date. Further studies will determine how HAI of CAR-T may be included in multidisciplinary treatment plans for patients with liver metastases. ClinicalTrials.gov number, NCT02850536.

Implementation of an Opioid Overdose and Naloxone Distribution Training in a Pharmacist Laboratory Course.

Objective. To describe the instructional design, implementation, and evaluation of an opioid overdose response program (ORP) and opioid overdose education and naloxone distribution (OEND) training program to third-year pharmacy (P3) students. Methods. Using the 5-E learning cycle during a three-hour laboratory session, the authors developed an OEND training program. The training began with an engagement exercise encompassing validated pre-Opioid Overdose Knowledge Scale (OOKS) and pre-Opioid Overdose Attitudes Scale (OOAS) assessments. Directly after, students moved to the exploration phase of the program, which consisted of two stations with placebo naloxone products. There, instructors explained key content related to OEND. Students applied what was learned during the elaboration by completing two cases: using group-based point-by-point counseling as well as a scenario with a simulation patient manikin. The class ended with an evaluation exercise that involved completing post-OOKS and post-OOAS. Results. Fifty-six students participated in the ORP certification and OEND training. Significant increases in total scores were seen on the pre- and post-assessment. Additionally, significant increases in student confidence in providing overdose response counseling and dispensing naloxone were observed. Students rated all the learning activities as very effective. Conclusion. Use of the 5-E learning cycle as an educational design method to structure active-learning activities was effective in increasing students' knowledge and improving their attitudes toward and confidence in providing overdose response.