Human microbiome: Impact of newly approved treatments on C. difficile infection.

DISCLAIMER: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE: The primary purposes of this review are to provide a brief overview of the microbiome, discuss the most relevant outcome data and key characteristics of each live microbiome agent, and pose questions for consideration going forward as these agents are integrated into clinical practice. SUMMARY: The management of Clostridiodes difficile infection (CDI) remains a difficult clinical conundrum, with recurrent CDI occurring in 15% to 35% of patients and causing significant morbidity and decreased quality of life. For patients with frequent CDI recurrences, fecal microbiota transplantation (FMT) has been demonstrated to have significant benefit but also significant risks, and FMT is not approved by the US Food and Drug Administration (FDA) for that indication. FDA has established a new therapeutic class for agents known as live biotherapeutic products (LBPs) that offer significant advantages over FMT, including standardized screening, testing, and manufacturing as well as known quantities of organisms contained within. Two new live microbiome products within this class were recently approved by FDA for prevention of CDI recurrences in adult patients following treatment for recurrent CDI with standard antimicrobial therapy. Both agents had demonstrated efficacy in registry trials in preventing CDI recurrence but differ significantly in a number of characteristics, such as route of administration. Cost as well as logistics are current obstacles to use of these therapies. CONCLUSION: Live microbiome therapy is a promising solution for patients with recurrent CDI. Future studies should provide further evidence within yet-to-be-evaluated populations not included in registry studies. This along with real-world evidence will inform future use and clinical guideline placement.

Evaluation of Sequential Oral Versus Intravenous Antibiotic Treatment of Enterococcus faecalis Bloodstream Infections.

BACKGROUND: Intravenous (IV) antibiotics have historically been considered standard of care for treatment of bloodstream infections (BSIs). Recent literature has shown sequential oral (PO) therapy to be noninferior to IV antibiotics for certain pathogens and disease states. However, a gap exists in the literature for BSI caused by Enterococcus faecalis. OBJECTIVE: To compare outcomes of definitive sequential PO therapy to definitive IV therapy in patients with E faecalis BSI. METHODS: Multicenter, retrospective, matched cohort study of adult patients with at least one blood culture positive for E faecalis from January 2017 to November 2022. Patients with polymicrobial BSI, concomitant infections requiring prolonged IV antibiotic therapy, those who did not receive antibiotic therapy, and those who died within 72 hours of index culture were excluded. Subjects were matched based on source of infection in a 2:1 (IV:PO) ratio. The primary outcome was a composite of all-cause mortality and treatment failure. Secondary outcomes included hospital length of stay (LOS), antibiotic duration, and 30-day readmission rate. RESULTS: Of the 186 patients who met criteria for inclusion, there was no statistically significant difference in the primary composite outcome for PO compared to IV therapy (14.5% vs 21.8%; OR 0.53 [0.23-1.25]) or 30-day readmission (17.5% vs 29%; OR 0.53 [0.25-1.13]). Hospital LOS was significantly longer in patients receiving IV-only therapy (6 days vs 14 days; P < 0.001). CONCLUSION AND RELEVANCE: Sequential oral therapy for E faecalis BSI had similar outcomes compared to IV-only treatment and may be considered in eligible patients.

Counting the Cost of Daptomycin Versus Vancomycin in Hospitalized Patients: A Cost Minimization Analysis.

Daptomycin use for gram-positive infections has increased. This cost minimization analysis aimed to determine cost and/or time savings of daptomycin over vancomycin. The estimated hospital cost savings was US$166.41 per patient, and pharmacist time saved of almost 20 minutes per patient. Daptomycin has the potential to save both time and money.

Glucagon-like peptide 1 agonists for type 2 diabetes, weight loss, or both?

ABSTRACT: Glucagon-like peptide 1 agonists (GLP1s) and the novel glucose-dependent insulinotropic polypeptide/glucagon-like peptide 1 agonist are effective drugs for reducing A1C and weight in patients with type 2 diabetes. However, clinicians may find it difficult to discern which drug to prescribe in specific clinical scenarios. This article discusses evidence-based clinical use of these drugs.

A Baker's Dozen of Top Antimicrobial Stewardship Intervention Publications in 2022.

Keeping abreast of the antimicrobial stewardship-related articles published each year is challenging. The Southeastern Research Group Endeavor identified antimicrobial stewardship-related, peer-reviewed literature that detailed an actionable intervention during 2022. The top 13 publications were selected using a modified Delphi technique. These manuscripts were reviewed to highlight actionable interventions used by antimicrobial stewardship programs to capture potentially effective strategies for local implementation.

Translating Clinical Decision-Making Skills From a Critical Care Pharmacy Elective to the Required Curriculum.

OBJECTIVE: To examine the impact of a critical care pharmacy elective (CCPE) on student performance in other courses in the Doctor of Pharmacy curriculum that emphasize clinical reasoning and decision making. METHODS: This is a retrospective, cohort study including all students from the 2019-2021 graduating classes enrolled in required courses, Pharmacotherapy and Integrated Patient Cases (IPCs). Students were divided for comparison based on completion of the CCPE. The primary outcome was outstanding performance, defined by a final course grade ≥90%, in Pharmacotherapy and IPC. Baseline characteristics and outcomes were analyzed using descriptive statistics and the χ2 test or two-sided t test for categorical and continuous variables, respectively. Binary logistic regression models were constructed to identify variables associated with the primary outcome. RESULTS: Of 377 students included, 129 (34%) completed the CCPE. Baseline characteristics were similar between both groups, except more females completed the CCPE. Students that completed the CCPE were not more likely to demonstrate outstanding performance in Pharmacotherapy III (20% vs 30%) or Pharmacotherapy IV (27% vs 24%), but were more likely in IPC (34% vs 23%). In the adjusted analysis, CCPE students were almost twice as likely to exhibit outstanding performance in IPC. CONCLUSION: Students that completed the CCPE were more likely to demonstrate outstanding performance in IPC, but not in either of the Pharmacotherapy courses. Students may benefit from practicing clinical reasoning earlier in the curriculum to build-up to effective and efficient clinical decision-making. Implications of course structure on student performance should be further explored.

Outcomes of Intravenous Push versus Intermittent Infusion Administration of Cefepime in Critically Ill Patients.

The equivalence of intravenous push (IVP) and piggyback (IVPB) administration has not been evaluated in the critically ill population for most medications, but it is especially relevant for antibiotics, such as cefepime, that exhibit time-dependent bactericidal activity. A single center, retrospective, observational pre/post-protocol change study included critically ill adults who received cefepime as empiric therapy between August 2015 and 2021. The primary outcome was treatment failure, which was defined as a composite of escalation of antibiotic regimen or all-cause mortality. Secondary outcomes included adverse drug events, days of cefepime therapy, total days of antibiotic therapy, and ICU and hospital length of stay. Outcomes were compared using Chi-squared, Mann Whitney U, and binary logistic regression as appropriate. A total of 285 patients were included: 87 IVPB and 198 IVP. Treatment failure occurred in 18% (n = 16) of the IVPB group and 27% (n = 54) of the IVP group (p = 0.109). There were no significant differences in secondary outcomes. Longer duration of antibiotics (odds ratio [OR] 1.057, 95% confidence interval [CI] 1.013-1.103), SOFA score (OR 1.269, 95% CI 1.154-1.397) and IVP administration of cefepime (OR 2.370, 95% CI 1.143-4.914) were independently associated with treatment failure. Critically ill patients who received IVP cefepime were more likely to experience treatment failure in an adjusted analysis. The current practice of IVP cefepime should be reevaluated, as it may not provide similar clinical outcomes in the critically ill population.

Perceptions and knowledge of personal finance in doctor of pharmacy versus undergraduate students: More wisdom or just more debt?

BACKGROUND AND PURPOSE: Evolution of personal finance beliefs over the course of a college career are unknown. The purpose of this study is to compare perceptions and knowledge of personal finance in undergraduate and pharmacy students at baseline and after completing a personal finance course. EDUCATIONAL ACTIVITY AND SETTING: A personal finance elective course was implemented for second- and third-year doctor of pharmacy (PharmD) students and for undergraduate freshman students. On the first and last day of class, students completed an anonymous survey evaluating demographics, opinions and knowledge regarding personal finance, and current financial status. Baseline data between undergraduate and pharmacy students was compared and the impact of the personal finance course was assessed. FINDINGS: The median score on the baseline knowledge assessment was 58% for freshman (n = 19) and 50% for pharmacy students (n = 28) (P = .571). Five percent of freshman and 86% of pharmacy students reported having debt at baseline (P < .001) compared to 84% and 68%, respectively, having savings (p = .110). After completing the personal finance course, knowledge assessment scores were 54% and 73% for freshman and pharmacy students, respectively (P < .001). SUMMARY: Despite additional years of education and life experience, PharmD students had similar knowledge and perceptions of personal finance while reporting more debt than freshmen. Pharmacy students, however, exhibited improvement in knowledge after taking a personal finance course, while freshman students did not. Personal finance-focused education may help empower graduating pharmacists for financial decision-making upon entering the workforce.

Penicillin-allergy delabelling resources for clinicians practicing in resource-limited settings: a full educational resource review of the grey literature.

Background: The clinical and financial consequences associated with a penicillin-allergy label are increasingly evident and have garnered support from international organizations to prioritize penicillin-allergy delabelling programmes. Most settings lack access to resources including drug allergy specialists and rely on general practitioners (GPs) and pharmacists. Objectives: The aim of this scoping review was to identify and describe freely available penicillin-allergy delabelling materials to guide clinicians practising in resource-limited settings with initiative application. Methods: This scoping review searched two grey literature databases, six targeted websites and consulted content experts to identify freely available materials in the English language that provided evidence-based and actionable penicillin-allergy delabelling strategies. Study investigators ranked and voted on which screened resources should be included in the final review. Characteristics of resources were evaluated and compared. Results: Out of 1191 total citations, 6 open-access resources were included. Penicillin-allergy toolkits featuring various delabelling strategies were identified in four resources. The toolkits supported a broad range of downloadable and adaptable materials, predominantly targeted towards GPs. Patient educational materials were also provided. Another resource highlighted a point-of-care penicillin-allergy risk assessment calculator via a free mobile app that quickly and accurately identified low-risk penicillin-allergic patients. The final resource, a supplemental instructional video, presented impactful and standardized delabelling strategies that clinicians can adopt into daily practices. Conclusions: Limited penicillin-allergy delabelling materials are available in the grey literature but existing resources provide broad and diverse opportunities. Additional support from health protection agencies is critical to augment ongoing delabelling efforts.

Evaluation of Dalbavancin in Vancomycin Allergic Patients: A Case Series.

PURPOSE: There is a paucity of data regarding dalbavancin use in patients with a vancomycin allergy because of potential cross-reactivity between the 2 glycopeptide antibiotics. METHODS: A retrospective medical record review was performed between February 2016 and February 2021 in patients with a listed vancomycin allergy who received dalbavancin as an outpatient infusion and had a listed vancomycin allergy in the electronic health record. FINDINGS: There were 559 unique patients during the study period who received dalbavancin as an outpatient infusion, 10 of whom had a documented vancomycin allergy in the electronic health record. Four of the 10 patients had a history of a type I IgE-mediated reaction to vancomycin, 1 patient reported delayed rash, 2 patients reported a vancomycin infusion reaction, 2 patients reported acute kidney injury, and 1 patient reported intolerance with general malaise. All 10 patients received at least 1 dose of dalbavancin with no reported adverse events. IMPLICATIONS: This case series displays that all patients who received dalbavancin tolerated the infusion well with no adverse events reported. Dalbavancin may be a viable option for patients with a listed vancomycin allergy.

A Baker's Dozen of Top Antimicrobial Stewardship Intervention Publications in Non-Hospital Care Settings in 2021.

The scope of antimicrobial stewardship programs has expanded beyond the acute hospital setting. The need to optimize antimicrobial use in emergency departments, urgent, primary, and specialty care clinics, nursing homes, and long-term care facilities prompted the development of core elements of stewardship programs in these settings. Identifying the most innovative and well-designed stewardship literature in these novel stewardship areas can be challenging. The Southeastern Research Group Endeavor (SERGE-45) network evaluated antimicrobial stewardship-related, peer-reviewed literature published in 2021 that detailed actionable interventions specific to the nonhospital setting. The top 13 publications were summarized following identification using a modified Delphi technique. This article highlights the selected interventions and may serve as a key resource for expansion of antimicrobial stewardship programs beyond the acute hospital setting.

A Baker's Dozen of Top Antimicrobial Stewardship Intervention Publications for Hospitalized Patients in 2021.

Keeping abreast of the antimicrobial stewardship-related articles published each year is challenging. The Southeastern Research Group Endeavor (SERGE-45) identified antimicrobial stewardship-related, peer-reviewed literature that detailed an "actionable" intervention among hospitalized populations during 2021. The top 13 publications were selected using a modified Delphi technique. These manuscripts were reviewed to highlight "actionable" interventions used by antimicrobial stewardship programs in hospitalized populations to capture potentially effective strategies for local implementation.

Which pharmacists are performing antimicrobial stewardship: A national survey and a call for collaborative efforts.

Objectives: To determine how pharmacists with formal antimicrobial stewardship program (ASP) responsibilities prioritize their time and pharmacists without formal antimicrobial stewardship program responsibilities contribute to ASP activities. Design: A nationwide survey. Respondents: Members of the American College of Clinical Pharmacy who subscribe to the following practice and research network e-mail listservs: infectious diseases, adult medicine, cardiology, critical care, hematology-oncology, immunology and transplantation, and pediatrics. Methods: A survey was distributed via listservs. Respondents were asked about their personal and institutional demographics and ASP activities. Results: In total, 245 pharmacists responded: 135 pharmacists with formal antimicrobial stewardship program responsibilities; 110 pharmacists without formal antimicrobial stewardship program responsibilities. Although most respondents had completed a general pharmacy residency (85%), only 20% had completed an infectious diseases (ID) specialty residency. Among pharmacists with formal antimicrobial stewardship program responsibilities, one-third had no formal training or certification in ID or ASP. Pharmacists without formal antimicrobial stewardship program responsibilities spent ∼12.5% of their time per week on ASP activities, whereas pharmacists with formal antimicrobial stewardship program responsibilities spent 28% of their time performing non-ASP activities. Pharmacists with formal antimicrobial stewardship program responsibilities were more likely than pharmacists without formal antimicrobial stewardship program responsibilities to perform antibiotic guideline development (P < .001), antibiotic-related education (P = .002), and direct notification of rapid diagnostic results (P = .018). Pharmacists with formal antimicrobial stewardship program responsibilities without formal ID training or certification spent less time on ASP activities and were more likely to perform lower-level interventions. Conclusions: Many ASP activities are being performed by pharmacists without formal ID training. To ensure the future success of ASPs, pharmacists with formal antimicrobial stewardship program responsibilities should have adequate training to meet more advanced metrics, and more pharmacists without formal antimicrobial stewardship program responsibilities should be included in basic interventions.

Is Three Company or a Crowd? Comparing and Contrasting U.S. and European Clostridioidesdifficile Clinical Practice Guidelines.

In 2021, the American College of Gastroenterology (ACG), the Infectious Diseases Society of America in conjunction with the Society for Healthcare Epidemiology of America (IDSA/SHEA), and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) published updated clinical practice guidelines (CPGs) for the management of Clostridioides difficile infections. The differences, sometimes subtle, between these guideline recommendations have caused some debate among clinicians. This paper delves into select key recommendations from each respective CPG and analyzes the differences and evidence associated with each. One primary difference between the CPGs is the preference given to fidaxomicin over vancomycin for initial treatment in non-severe and severe disease endorsed by IDSA/SHEA and ESCMID guidelines, while the ACG-sponsored CPGs do not offer a preference. The emphasis on cost effective data was also a noticeable difference between the CPGs and thus interpretation of the available evidence. When using guidelines to help support local practice or institutional treatment pathways, clinicians should carefully balance CPG recommendations with local patient populations and feasibility of implementation, especially when multiple guidelines for the same disease state exist.

From Start to Finish: Examining Factors Associated With Higher Likelihood of Publication Among Abstracts Presented at an International Infectious Diseases Scientific Meeting.

Background: The landscape of infectious diseases research by interprofessional teams continues to change in both scope and engagement. Limited information exists regarding publication metrics and factors associated with publication of abstracts presented at professional infectious diseases meetings. Methods: This was a retrospective, observational study evaluating abstracts presented at IDWeek in 2017 and 2018. The primary endpoint was the proportion of abstracts that were subsequently published in peer-reviewed journals. Factors associated with publication were evaluated, and a description of publication metrics was reported. Results: Of the 887 abstracts analyzed from the IDWeek meetings, 236 (26.6%) were published. Significantly more abstracts were published if they were presented as a platform presentation versus poster presentation (35% vs 21%, P < .001). Inclusion of a PhD author significantly increased the likelihood of publication (P = .0014). Prospective studies, greater number of authors, and greater number of study subjects were more common among published abstracts. Median time to publication was 10.9 months, and the majority were published in infectious diseases journals, with an overall average impact factor of 7.7 across all journals. Conclusions: Abstracts from IDWeek presented as oral platforms and those including a PhD author were more likely to be published. Large, diverse authorship teams were common among published abstracts. The high quality of resulting manuscripts is evident by the destination journals and their respective impact factors. These data may be used to inform and motivate clinicians and trainees engaging in infectious diseases-related research.

Break time: Examining pharmacy residency application deadlines and the potential impact of a proposed timeline shift.

INTRODUCTION: Many pharmacy residency programs set their application deadlines around the first of the calendar year, only weeks following the American Society of Health-System Pharmacists (ASHP) meeting in mid-December. This contributes to a condensed timeframe for applicants and reference writers to complete and submit materials over the winter holidays. This study examined pharmacy residency program application deadlines and respective timing of application and reference letter submissions. METHODS: This retrospective, observational study evaluated all residency programs within the ASHP residency directory. Several scenarios were examined for impact of a universal earliest deadline (UED) designation spanning early January. Subsequent analysis included compilation of application and reference submission dates from a sample of ASHP-accredited residency programs to determine timing of submission in regard to application deadline. RESULTS: A total of 2449 programs representing 4927 positions were identified for the 2018-2019 application cycle. The mean deadline was 5 January (± three days), and 11% of programs had a deadline prior to 1 January. Among the five first-year residency programs that provided application and reference submission data spanning the 2016-2020 application cycles, the average time from submission to application deadline was four days for applicants and 11 days for references. CONCLUSIONS: Most pharmacy residency programs have deadlines in early January. Implementation of a UED would cause a major shift for these programs but is only one component of change for the application process.