Evaluation of Sodium-Glucose Transport Protein 2 (SGLT2) Inhibitor Prescribing Patterns in Heart Failure Patients at Hospital Discharge.

Background: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) dapagliflozin and empagliflozin are indicated for heart failure with reduced ejection fraction (HFrEF) for cardiovascular death and heart failure hospitalization risk reduction. Due to the recent nature of these data, prescribing of SGLT2is may be suboptimal. Objective: This study sought to assess the prevalence of SGLT2i prescriptions at hospital discharge for HFrEF. Methods: A retrospective chart review was conducted on HFrEF patients discharged from April 1st to December 31st, 2021 from one academic medical center in the United States. The primary objective was to determine the percentage of eligible patients prescribed SGLT2i at discharge and the secondary objective was to characterize covariates impacting prescription. Results: Overall, 115 patients were included. The mean age was 72 ± 14.25 years. The majority were male (73.9%) and Caucasian (74.8%). At discharge, 15.7% of patients were prescribed an SGLT2i, although 94.8% were eligible. Baseline characteristics and concomitant medications did not differ significantly, although the mean number of discharge medications differed significantly between those prescribed an SGLT2i (15.78 ± 6.77) and those not (12.05 ± 5.28) (P = 0.023). Conclusions: SGLT2is are under-prescribed at discharge for HFrEF patients, despite many being eligible. Further studies should be done to elucidate factors that influence the under-prescription of SGLT2is.

Medication Management Through Collaborative Practice for Children With Medical Complexity: A Prospective Case Series.

OBJECTIVE: Care coordination for children and youth with special health care needs and medical complexity (CYSHCN-CMC), especially medication management, is difficult for providers, parents/caregivers, and -patients. This report describes the creation of a clinical pharmacotherapy practice in a pediatric long-term care facility (pLTCF), application of standard operating procedures to guide comprehensive medication management (CMM), and establishment of a collaborative practice agreement (CPA) to guide drug therapy. METHODS: In a prospective case series, 102 patients characterized as CYSHCN-CMC were included in this pLTCF quality improvement project during a 9-month period. RESULTS: Pharmacists identified, prevented, or resolved 1355 drug therapy problems (DTP) with an average of 13 interventions per patient. The patients averaged 9.5 complex chronic medical conditions with a -median length of stay of 2815 days (7.7 years). The most common medications discontinued due to pharmacist assessment and recommendation included diphenhydramine, albuterol, sodium phosphate enema, ipratropium, and metoclopramide. The average number of medications per patient was reduced from 23 to 20. A pharmacoeconomic analysis of 244 of the interventions revealed a monthly direct cost savings of $44,304 ($434 per patient per month) and monthly cost avoidance of $48,835 ($479 per patient per month). Twenty-eight ED visits/admissions and 61 clinic and urgent care visits were avoided. Hospital -readmissions were reduced by 44%. Pharmacist recommendations had a 98% acceptance rate. CONCLUSIONS: Use of a CPA to conduct CMM in CYSHCN-CMC decreased medication burden, resolved, and prevented adverse events, reduced health care-related costs, reduced hospital readmissions and was well-accepted and implemented collaboratively with pLTCF providers.

A 15 Year Review (2006-2020) of Patient-Reported Outcome (PRO) in United States Oncology Product Labeling and Trends in Sponsor Size and Oncology Experience.

Objectives: Despite wide use of PRO tools in clinical development, resulting data is rarely incorporated into the US label. This study reviewed oncology product labels approved by the Food and Drug Administration (FDA) between 2006 and 2020 to determine if the number of PRO included in labeling has meaningfully changed. Sponsors were assessed to identify demographic trends in achieving PRO label success. Methods: FDA-approved drugs were searched utilizing the Drugs@FDA database by month from January 2015 to December 2020 for novel drug and biologic approvals. Products approved between 2006-2014 were identified utilizing the Gnansakthy et al., 2012 and 2016 publications. Labels were reviewed for inclusion of PRO data in the label and product summary basis of approval (SBA). Sponsor size and experience were measured for each year of product approval. Results: 155 oncology products received initial approval between 2006-2020, of which only 7 contained PRO data in the label. More than half (53.5%) of products had PRO data described in the SBA. Over time, PRO information has increasingly been included in the product marketing application. Sponsors utilizing PRO data tend to be experienced in oncology development and larger in size. Conclusions: There has been a small increase in inclusion of PRO data in oncology product labeling over the past 15 years. Utilization and analysis of appropriate PRO tools and data remains a challenge to sponsors. Further collaboration with FDA is needed for the development of disease specific PRO tools that provide meaningful data to the targeted patient population.