ABSTRACT
BACKGROUND: Over the past 2 years of the several strategies recommended to help fight COVID-19, nirmatrelvir/ritonavir is a novel drug shown in the EPIC-HR phase 2 to 3 clinical trial to lower COVID-19-related death or hospitalization at day 28 when compared with placebo. OBJECTIVE: Our study's aim was to explore the reported adverse events (AEs) associated with nirmatrelvir/ritonavir use for COVID-19. METHOD: We conducted a retrospective analysis using the FDA Adverse Event Reporting System (FAERS) database for AEs, listing nirmatrelvir/ritonavir as the primary drug between January and June 2022. The primary outcome was the incidence of reported AEs associated with nirmatrelvir/ritonavir. The OpenFDA database was queried using Python 3.10 to collect the AEs and Stata 17 was used to analyze the database. Adverse events were analyzed by associated medication, with "Covid-19" excluded. RESULTS: A total of 8098 reports were identified between January and June 2022. Most reported complaints in the AE system were COVID-19 and disease recurrence. The most common symptomatic AEs were dysgeusia, diarrhea, cough, fatigue, and headache. Event rates significantly rose between April and May. Disease recurrence and dysgeusia were the most commonly reported complaints for the top 8 concomitant drugs identified. Cardiac arrest, tremor, akathisia, and death were reported in 1, 3, 67, and 5 cases, respectively. CONCLUSIONS AND RELEVANCE: This is the first retrospective study done on reported AEs associated with nirmatrelvir/ritonavir use for COVID-19. COVID-19 and disease recurrence were the most reported AEs. Further monitoring of the FAERS database is warranted to periodically reassess the safety profile of this medication.
ABSTRACT
(1) Background: Jersey Shore University Medical Center (JSUMC) is a 646-bed tertiary medical center located in central New Jersey. Over the past several years, development and maturation of tertiary services at JSUMC has resulted in tremendous growth, with the inpatient volume increasing by 17% between 2016 and 2018. As hospital floors functioned at maximum capacity, the medical center was frequently forced into crisis mode with substantial increases in emergency department (ED) waiting times and a paradoxical increase in-hospital length of stay (hLOS). Prolonged hLOS can contribute to worse patient outcomes and satisfaction, as well as increased medical costs. (2) Methods: A root cause analysis was conducted to identify the factors leading to delays in providing in-hospital services. Four main bottlenecks were identified by the in-hospital phase sub-committee: incomplete orders, delays in placement to rehabilitation facilities, delays due to testing (mainly imaging), and delays in entering the discharge order. Similarly, the discharge process itself was analyzed, and obstacles were identified. Specific interventions to address each obstacle were implemented. Mean CMI-adjusted hospital LOS (CMI-hLOS) was the primary outcome measure. (3) Results: After interventions, CMI-hLOS decreased from 2.99 in 2017 to 2.84 and 2.76 days in 2018 and 2019, respectively. To correct for aberrations due to the COVID pandemic, we compared June-August 2019 to June-August 2020 and found a further decrease to 2.42 days after full implementation of all interventions. We estimate that the intervention led to an absolute reduction in costs of USD 3 million in the second half of 2019 and more than USD 7 million in 2020. On the other hand, the total expenses, represented by salaries for additional staffing, were USD 2,103,274, resulting in an estimated net saving for 2020 of USD 5,400,000. (4) Conclusions: At JSUMC, hLOS was found to be a complex and costly issue. A comprehensive approach, starting with the identification of all correctable delays followed by interventions to mitigate delays, led to a significant reduction in hLOS along with significant cost savings.