Implementation and Use of Risk Evaluation and Mitigation Strategies Programs in Practice: A Scoping Review of the Literature.

BACKGROUND: Risk Evaluation and Mitigation Strategy (REMS) programs intend to improve medication safety but can add significant administrative burdens to providers and health systems. Various stakeholders have made efforts to use technology to improve REMS programs. OBJECTIVES: The objective of this scoping review is to describe studies evaluating workflows, automation, or electronic data exchange related to REMS programs. METHODS: A literature search of PubMed, Embase, and Web of Science was performed for articles published between January 2007 and July 2021. Studies were identified using the relevant Medical Subject Headings terms and related keywords. Articles must have described a workflow change and measured the impact of the workflow change. RESULTS: Of 299 citations initially identified, 7 were included in the final review after removing duplicates and articles not meeting predefined inclusion criteria. Included studies consisted of three manuscripts and four conference abstracts. Electronic health record interventions, such as customized order sets and clinical decision support alerts, were the most common strategy reported. Other strategies included developing a portal to verify REMS enrollment, requiring prescribers to contact the dispensing pharmacy, provider education, and restrictions based on the provider specialty. One study evaluated automated data exchange for REMS program processes in a mock environment. Although only three studies reported baseline metrics for comparison, all studies noted an improvement or benefit to the implemented workflow process changes. CONCLUSION: There is limited evidence describing REMS workflows, automation, and electronic data exchange. Various strategies to address REMS program requirements were reported, but no studies described the use of data exchange standards in a real-world setting despite efforts by the Food and Drug Administration and other stakeholders. Additional efforts are needed to automate REMS programs.

MRSA nasal swab PCR to de-escalate antibiotics in the emergency department.

BACKGROUND: Methicillin-resistant Staphylococcus aureus (MRSA) nasal swab polymerase chain reaction (PCR) assay has a 96.1-99.2% negative predictive value (NPV) in pneumonia and may be used for early de-escalation of MRSA-active antibiotic agents. Xu (2018), File (2010) [1,2]. OBJECTIVE: The objective of our study was to determine if a negative MRSA PCR nasal swab collected in the emergency department (ED) improves early MRSA-active antibiotic de-escalation. METHODS: A single center observational cohort study used ICD-10 codes to identify records for adults admitted to the ED with a hospital discharge diagnosis of pneumonia. The primary outcome was proportion of patients with early de-escalation on an MRSA-active agent (≤ 1 dose). Secondary outcomes included rate of acute kidney injury (AKI), positive MRSA cultures (blood culture, respiratory sputum, tracheal aspirate), hospital length of stay (LOS), in-hospital mortality, and 30-day readmission rates. RESULTS: A total of 341 patients were included in the study. Of the patients with an MRSA PCR swab, 35.2% of patients with a negative swab received >1 dose of MRSA-active agent compared to 52% of patients without an MRSA nasal swab (p < 0.01). There were no significant differences in secondary outcomes except readmission rate of 1.6% of patients that did not have an MRSA swab in the ED vs 6.6% of patients that received an MRSA swab in the ED. CONCLUSION AND RELEVANCE: MRSA PCR nasal swabs in the ED may serve as a useful tool for early MRSA-active antibiotic de-escalation when treating pneumonia.