The formulary process for biosimilar additions at a comprehensive cancer center.

Biological products may be used to diagnose, prevent, treat, and cure diseases and medical conditions, including cancer. Biosimilar agents, approved under an abbreviated 351(k) pathway, continue to increase in number and market share for biologic agents, especially for cancer care. Although biosimilars offer the potential for improved access to care, their introduction to the marketplace has created significant disruption. It is imperative that health systems providing care to patients with cancer develop a well-defined process to address the challenges associated with biosimilars. This descriptive article outlines pharmacy considerations for biosimilars and describes the current practices at The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at The Ohio State University. Biosimilars have and will continue to significantly impact oncology care. Organizations must understand the clinical, operational, and financial challenges associated with the use of these products.

Pharmacy utilization of electronic patient-reported outcomes in oncology populations.

Telehealth applications are demonstrated to be useful tools for patients with cancer to facilitate improvements in quality of care. The use of electronic patient-reported outcomes is one way to leverage telehealth to better understand outcomes important to patients. However, use of electronic patient-reported outcomes and direct involvement of pharmacists is not yet a standard practice across cancer centers. The use of pharmacist-led telehealth services offers a unique opportunity for pharmacists to provide cost-effective and convenient patient care interventions. This survey work describes the current practices of pharmacy utilization of electronic patient-reported outcomes in oncology populations at National Comprehensive Cancer Network member institutions. Of survey respondents, only 33% of the institutions reported current engagement with electronic patient-reported outcomes. These initiatives largely focused on symptom management. Limitations in staff, resources, and competing priorities limit many institutions from introducing or expanding upon direct pharmacist involvement in electronic patient-reported outcomes. Further work developing the involvement of pharmacists in electronic patient-reported outcomes will be an important way to leverage the growing landscape of telehealth within oncology and highlight the value of the pharmacist.

Identification of protein kinase C activation as a novel mechanism for RGS2 protein upregulation through phenotypic screening of natural product extracts.

Biochemical high-throughput screening is widely used in drug discovery, using a variety of small molecule libraries. However, broader screening strategies may be more beneficial to identify novel biologic mechanisms. In the current study we used a ß-galactosidase complementation method to screen a selection of microbial-derived pre-fractionated natural product extracts for those that increase regulator of G protein signaling 2 (RGS2) protein levels. RGS2 is a member of a large family of proteins that all regulate signaling through G protein-coupled receptors (GPCRs) by accelerating GTPase activity on active Gα as well as through other mechanisms. RGS2(-/-) mice are hypertensive, show increased anxiety, and are prone to heart failure. RGS2 has a very short protein half-life due to rapid proteasomal degradation, and we propose that enhancement of RGS2 protein levels could be a beneficial therapeutic strategy. Bioassay-guided fractionation of one of the hit strains yielded a pure compound, Indolactam V, a known protein kinase C (PKC) activator, which selectively increased RGS2 protein levels in a time- and concentration-dependent manner. Similar results were obtained with phorbol 12-myristate 13-acetate as well as activation of the Gq-coupled muscarinic M3 receptor. The effect on RGS2 protein levels was blocked by the nonselective PKC inhibitor Gö6983 (3-[1-[3-(dimethylamino)propyl]-5-methoxy-1H-indol-3-yl]-4-(1H-indol-3-yl)-1H-pyrrole-2,5-dione), the PKCß-selective inhibitor Ruboxastaurin, as well as small interfering RNA-mediated knockdown of PKCß. Indolactam V-mediated increases in RGS2 protein levels also had functional effects on GPCR signaling. This study provides important proof-of-concept for our screening strategy and could define a negative feedback mechanism in Gq/Phospholipase C signaling through RGS2 protein upregulation.

Understanding the problem of digital medication inventory visibility in health systems.

PURPOSE: This project describes and quantifies the perceived degree of digital visibility to medication inventory throughout 6 large health systems. METHODS: In this project, 6 large health systems evaluated their physical medication inventory for digital visibility, or the degree to which physical medication inventory information is viewable in electronic systems, during a 2-year period (2019-2020). Inventory reports included medication items with either a National Drug Code (NDC) or a unique institutional identifier. Physical inventory reports contained the medication item name and a corresponding NDC or identifier, the quantity on hand, and the physical locations and the storage environments of the inventory items at the time of the audit. Investigators independently reviewed physical inventory reports and categorized medication line items by degree of digital visibility: (1) no digital visibility, (2) partial digital visibility without accurate quantities, (3) partial digital visibility with accurate quantities, or (4) full digital visibility. Data were anonymized, aggregated, and analyzed to characterize the degree of digital visibility across the health systems and to identify locations and storage environments where the greatest improvement is needed. RESULTS: Overall, less than 1% of medication inventory was judged to have full digital visibility. The majority of the evaluated inventory items were categorized as having partial digital visibility, with or without accurate quantities. Analysis by both units of inventory and inventory valuation indicated that only 30% to 35% of inventory had full digital visibility or partial digital visibility with accurate quantities. CONCLUSION: Most of the medication inventory within 6 large academic centers is either not digitally visible or partially digitally visible but without accurate quantities. Full digital visibility of inventory is rare. Better digital visibility can minimize disruption from recalls and decrease waste. Technology vendors and health systems must collaborate to develop improved automation and systems to make medications on hand more digitally visible.