Navigating the journey as a peer reviewer: a roadmap to success.

Peer review is an essential step in scientific progress and clinical improvement, providing opportunity for research to be critically evaluated and improved by one's colleagues. Pharmacists from all job settings are called to serve as peer reviewers in the ever-growing publication landscape of the profession. Despite challenges to engagement such as time and compensation, peer review provides considerable professional development for both authors and reviewers alike. This article will serve as a practical guide for peer reviewers, discussing best practices as well as the handling of different situations that may arise during the process.

Student pharmacist perceptions toward community pharmacy practice.

BACKGROUND: Community pharmacy practice has incurred significant changes in scope of responsibility and workplace environment, particularly during the COVID-19 pandemic. The trends may impact how student pharmacists perceive community pharmacy practice and their future career opportunities. OBJECTIVE: To determine current perceptions that student pharmacists have toward community pharmacy practice. METHODS: A 15-item electronic, cross-sectional questionnaire was distributed to approximately 2200 student pharmacists from March to April 2023. To be included, respondents needed to be a current adult pharmacy student. The questionnaire included items about career interests, perceptions towards 12 different aspects of community pharmacy practice, and demographics. Data were analyzed primarily using descriptive statistics. A priori stratifications included interest to pursue community pharmacy according to class year and according to level of work experience. RESULTS: A total of 146 responses were included (response rate 6.6%). A total of 101 (69.2%) respondents were women, 108 (74.0%) were white, and the mean age was 24 years. Respondents represented all 4 pharmacy professional years, and 113 (77.4%) respondents reported current or previous work experience in community pharmacy. Most respondents were not interested in pursuing community pharmacy directly after graduation 77 (52.7%), nor as a long-term career 87 (59.6%). Student pharmacists found the most appealing aspects of community pharmacy practice to be salary/benefits, job availability and security, interactions with coworkers in the pharmacy, interactions with other medical professionals, relationships and interactions with patients, and teaching responsibilities. Student pharmacists found the work hours and schedule, business management responsibilities, navigating insurance-related tasks, and the pace of the work environment to be unappealing. CONCLUSIONS: Student pharmacists report a low interest in pursuing community pharmacy practice. Minimizing deterrents and enhancing the appealing aspects of community pharmacy as perceived by student pharmacists may help improve recruitment and retainment, as well as improve perceptions of the practice.

Back to the basics: Guidance for designing good literature searches.

The number of scientific publications is growing at an unprecedented rate. Failure to properly evaluate existing literature at the start of a project may result in a researcher wasting time and resources. As pharmacy researchers and scholars look to conceptualize new studies, it is imperative to begin with a high-quality literature review that reveals what is known and unknown about a given topic. The purpose of this commentary is to provide useful guidance on conducting rigorous searches of the literature that inform the design and execution of research. Guidance for less formal literature reviews can be adapted from best practices utilized within the formalized field of evidence synthesis. Additionally, researchers can draw on guidance from PRESS (Peer Review of Electronic Search Strategies) to engage in self-evaluation of their search strategies. Finally, developing an awareness of common pitfalls when designing literature searches can provide researchers with confidence that their research is designed to fill clearly articulated gaps in knowledge.

The effect of potassium supplementation and concomitant medications on potassium homeostasis for hospitalized patients.

PURPOSE: Hospitalized patients receive potassium (K+) supplementation for hypokalemia, with clinicians often estimating a rise in serum K+ levels of 0.1 mEq/L per 10 mEq delivered. However, there is limited evidence to support this expectation. Patients also concomitantly take medications that may alter K+ levels, and it is not known to what degree these may impact interventions to correct K+ levels via supplementation. The objective of this study was to identify the impact of oral and/or intravenous K+ supplementation on serum K+ levels, including the influence of selected concomitant medications, in adult hospitalized patients. METHODS: A single-center, retrospective descriptive study of adult hospitalized patients receiving K+ supplementation at a tertiary hospital between 2021 and 2022 was conducted. Patients were included if they received at least one dose of potassium chloride while admitted to the general medicine ward. The primary outcome was the daily median change in serum K+, normalized per 10 mEq of supplementation administered. The secondary outcome was the impact of selected concomitant medication use on supplement-induced changes in serum K+. RESULTS: A total of 800 patients and 1,291 daily episodes of K+ supplementation were evaluated. The sample was approximately 53% women, was 78% white, and had a median age of 68 years. The overall daily median change in serum K+ level was 0.05 mEq/L per 10 mEq of supplementation delivered. Patients received a median of 40 mEq of supplementation per day, primarily via the oral route (80.6%). Among the concomitant medications assessed, loop diuretics significantly dampened the impact of K+ supplementation. CONCLUSION: Supplementation of K+ in non-critically ill hospitalized patients is variable and dependent on concomitant medication use.

Why can't we be friends? The manufactured fear of pharmacist "scope creep".

The American Medical Association has engaged in a longitudinal campaign against "scope creep" in other health care professions, characterized as a threat to patient safety. Arguments made by the organization regarding the lack of training and ability of pharmacists to engage in services beyond dispensing fail to accurately characterize our value. The expansion of pharmacist scope of practice has support across much of the health care community and is further reinforced by ample scientific evidence. In addition, already existing models of expanded scope are available in many states and several other countries. Now, more than ever, professional organizations within medicine and pharmacy should focus their efforts on solving a myriad of pressing issues for health care workers and patients, as opposed to engaging in turf battles.

Back to the basics: Guidance for formulating good research questions.

Good science is driven by rigorous questions. Much like the foundation of a house, a research question must be carefully constructed to prevent downstream problems in project execution. And yet, pharmacy researchers and scholars across all career stages may find themselves struggling when developing research questions. The purpose of this commentary is to provide useful guidance on composing and evaluating rigorous research questions. A variety of frameworks, such as PICO (Patient/population; Intervention; Comparison; Outcome), are available to researchers and can assist them in ensuring that their research question has covered all relevant components. Additionally, the FINER (Feasible; Interesting; Novel; Ethical; and Relevant) criteria can help researchers with evaluating their research questions for practical considerations. Finally, building awareness of common pitfalls when composing research questions can aid researchers to avoid issues that they may not otherwise discover until their manuscript undergoes peer review.

The use of buprenorphine to-go packs in the emergency department.

OBJECTIVE: Buprenorphine is an effective treatment for opioid use disorder (OUD). Patients in the emergency department (ED) can be initiated or continued on buprenorphine as a bridge to follow-up in the outpatient setting, but gaps in care may arise. The objective was to evaluate the impact of buprenorphine to-go packs as a continuing treatment option for patients presenting to the ED with OUD across a health system. METHODS: Adult patients discharged with a buprenorphine to-go pack from one of ten EDs within a major health system were included. The primary outcomes assessed within 30 days of ED discharge were: (1) return to a health system ED, and (2) fill history of buprenorphine in the state prescription drug monitoring program database. Data was analyzed using descriptive statistics in Microsoft Excel (Redmond, WA). RESULTS: A total of 124 patients received buprenorphine to-go packs. The sample was primarily male (79; 63.7%), white (89; 71.8%), on Medicaid (79; 63.7%), and had a mean age of 40.9 years. A total of 43 patients (34.7%) were initiated on buprenorphine for the first time, while 81 (65.3%) had received buprenorphine (prescription or to-go) previously. At 30 days post-visit, 76 (61.3%) had filled buprenorphine prescriptions, and 40 (32.3%) returned to an ED within the health system for opioid withdrawal (17; 42.5%), non-OUD-related reasons (22; 55%), or overdose (1; 2.5%). CONCLUSION: The implementation of a system-wide buprenorphine to-go supply at ED discharge is a feasible option to provide continuity of care to patients with OUD.

Commentary: Making Space for Reading as a Faculty Member.

In academia, significant emphasis is given to the importance of writing. However, reading may be given less prominence in faculty work lives. The purpose of this commentary is to explore the educator's relationship with academic reading, habits that support this practice, and points of reflection for creating space for reading in our professional lives. The authors engaged in a reflexivity exercise and discussion of our own motivations, emotions, and experiences associated with reading, and how these may change across our careers. We discuss the need to make space for reading in our work, and additionally, provide recommendations for better integrating the habit of reading into our professional lives.

Cephalosporins for the treatment of uncomplicated pyelonephritis: A systematic review.

BACKGROUND: The 2011 Infectious Diseases Society of America and European Society of Clinical Microbiology and Infectious Diseases guidelines recommend ciprofloxacin or sulfamethoxazole-trimethoprim (SMX-TMP) as first-line agents to treat uncomplicated acute pyelonephritis (APN). OBJECTIVE: With increasing antimicrobial resistance rates and recent changes in practice patterns, the objective of this systematic review was to describe the effectiveness of cephalosporins for uncomplicated APN in more recently published literature. METHODS: Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were used for reporting. We searched PubMed, Embase, and Scopus for publications between January 2010 and September 2022. Eligible articles detailed patients with uncomplicated APN, treated with first- to fourth-generation cephalosporins, and identified a clinical, microbiological, or health care utilization outcome. Studies with more than 30% of complicated APN patients, non-English-language studies, case reports, case series, pharmacodynamic or pharmacokinetic studies, and in vitro laboratory or animal studies were excluded. Screening, review, and extraction were performed independently by 2 researchers, plus a third for conflict resolution. Critical appraisal of studies was performed using Joanna Briggs Institute checklists. RESULTS: Eight studies met inclusion, including 5 cohort studies (62.5%), 2 randomized controlled trials (25%), and 1 nonrandomized experimental study (12.5%). Cephalosporins most used across the studies included cefazolin, cephalexin, cefuroxime, cefotaxime, cefdinir, cefditoren, and ceftriaxone. Outcomes assessed were diverse, including clinical or microbiological success and time to defervescence or symptom resolution. Cephalosporins displayed effectiveness for the treatment of acute uncomplicated APN regardless of study design or the presence of a comparison group. No trials reported inferiority of clinical treatment outcomes compared with a fluoroquinolone or SMX-TMP. CONCLUSION: Cephalosporins may be viable treatment options for the management of uncomplicated APN.

Attitudes, beliefs, knowledge, and practices for over-the-counter syringe sales in community pharmacies: A systematic review.

BACKGROUND: Community pharmacies are an important resource for people who inject drugs (PWID) to purchase over-the-counter (OTC) syringes. Access to sterile injection equipment can reduce the transmission of blood-borne illnesses. However, pharmacists and their staff ultimately use discretion over sales. OBJECTIVE: To identify staff attitudes, beliefs, knowledge, and practices in the sale of OTC syringes in community pharmacies. METHODS: This systematic review was reported according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and registered with PROSPERO (CRD42022363040). We systematically searched PubMed, Embase, and Scopus from inception to September 2022. The review included peer-reviewed empirical studies regarding OTC syringe sales among community pharmacy staff (pharmacists, interns, and technicians). We screened records and extracted data using a predefined data extraction form. Findings were narratively synthesized, and critical appraisal was conducted using the Mixed Methods Appraisal Tool. RESULTS: A total of 1895 potentially relevant articles were identified, and 35 were included. Most studies (23; 63.9%) were cross-sectional descriptive designs. All studies included pharmacists, with seven (19.4%) also including technicians, two (5.6%) including interns, and four (11.1%) including other staff. Studies found relatively high support among respondents for harm reduction-related services within community pharmacies, but less common reports of staff engaging in said services themselves. When studies investigated the perceived positive or negative impacts of OTC syringe sales, prevention of blood-borne illness was widely understood as a benefit, while improper syringe disposal and safety of the pharmacy and its staff commonly reported as concerns. Stigmatizing attitudes/beliefs toward PWID were prevalent across studies. CONCLUSION: Community pharmacy staff report knowledge regarding the benefits of OTC syringes, but personal attitudes/beliefs heavily influence decisions to engage in sales. Despite support for various syringe-related harm reduction activities, offerings of services were less likely due to concerns around PWID.

Pharmacist and Student Knowledge and Perceptions of Herbal Supplements and Natural Products.

We aimed to collect parallel perspectives from pharmacists and pharmacy students on their use, knowledge, attitudes, and perceptions about herbal supplements/natural products. Two cross-sectional descriptive survey questionnaires-one focusing on pharmacists and the other focusing on pharmacy students-were administered from March to June 2021 via Qualtrics. The surveys were sent out to preceptor pharmacists and pharmacy students currently enrolled at a single U.S. school of pharmacy. The questionnaires were composed of five main sections, including (1) demographics; (2) attitudes/perceptions; (3) educational experience; (4) resource availability; and (5) objective knowledge of herbal supplements/natural products. Data analysis primarily utilized descriptive statistics with relevant comparisons across domains. A total of 73 pharmacists and 92 pharmacy students participated, with response rates of 8.8% and 19.3%, respectively. A total of 59.2% of pharmacists and 50% of pharmacy students stated they personally used herbal supplements/natural products. Most respondents (>95% for both groups) considered vitamins/minerals safe, although a lower percentage agreed on this for herbal supplements/natural products (60% and 79.3% for pharmacists and pharmacy students, respectively). Patient inquiries in the pharmacy setting were most seen for vitamin D, zinc, cannabidiol, and omega-3. A total of 34.2% of pharmacists reported having training in herbal supplements/natural products as a required part of their Pharm.D. training, and 89.1% of pharmacy students desired to learn more. The median score on the objective knowledge quiz was 50% for pharmacists and 45% for pharmacy students. Ultimately, herbal supplements/natural products are recognized by pharmacists/pharmacy students as a consistent and embedded part of pharmacy practice, although there is a need to enhance knowledge and skills in this area.

Quetiapine and olanzapine misuse prevalence in a US general population sample.

Introduction: Second-generation antipsychotics (SGA) are associated with misuse potential; however, there are limited data describing the prevalence and characteristics of this misuse. This study was conducted to identify and describe quetiapine and olanzapine misuse among US adults. Methods: This cross-sectional survey questionnaire was conducted online using Qualtrics research panel aggregator service to identify a quota-based sample of respondents constructed to mimic the general US population aged 18 to 59 years, with regards to gender, geographic region, ethnicity, income, and education level. Misuse was defined as using quetiapine or olanzapine for treatment outside of medical recommendations, for reasons other than a diagnosed medical condition, or obtaining without a prescription. A logistic regression was used to identify factors associated with SGA misuse, incorporating relevant covariates. Results: Among 1843 total respondents, 229 had a history of quetiapine or olanzapine use. Misuse prevalence was estimated to be 6.3% (95% CI: 5.2, 7.5%). Although most respondents (∼70%) using quetiapine or olanzapine reported doing so to treat a diagnosed medical condition, those misusing them most commonly did so because prescribed medications failed to relieve their symptoms. Misuse was commonly reported (∼50%) concomitantly with opioids, benzodiazepines, or alcohol. Factors significantly associated with quetiapine or olanzapine misuse included employment (OR = 4.64), previous substance use disorder treatment (OR = 2.48), and having riskier attitudes toward medication misuse (OR = 1.23). Discussion: Misuse of quetiapine and olanzapine, while fairly limited in prevalence, appears to be primarily associated with under-treatment of existing medical conditions.

Pharmacist, prescriber, and drug policy expert opinions on gabapentinoid misuse.

BACKGROUND: Gabapentinoids (gabapentin and pregabalin) are widely used in clinical practice, but recent evidence indicates that they carry an increased risk of misuse. As healthcare professionals (HCPs) and policymakers plan different strategies to promote harm reduction, it is important to understand different interested party viewpoints. OBJECTIVE: To explore prescriber, pharmacist, and drug policy expert (DPE) awareness, opinions, and experiences regarding gabapentinoid misuse. METHODS: A qualitative description study using individual semi-structured virtual interviews was conducted between February and April 2021. Participants included prescribers (physicians, physician assistants [PA], or nurse practitioners [NP]) and pharmacists practicing in outpatient, ambulatory, or community-based healthcare settings; individuals with relevant drug policy expertise were also included. Qualtrics (Provo, Utah) and Zoom (San Jose, California) were used to facilitate quantitative (for initial screening and participant characteristics) and qualitative (interview) data collection. Data were coded and organized into themes in NVivo (QSR International; Burlington, Massachusetts) using thematic analysis steps. RESULTS: A total of 43 individuals participated in this study, including 16 (37.2%) pharmacists, 13 (30.2%) physicians, seven (16.3%) NPs, four (9.3%) DPEs, two (4.7%) pharmacist/DPEs, and one (2.3%) PA. Results were organized along four themes: (1) challenges/opportunities in gabapentinoid use; (2) gabapentinoid misuse awareness; (3) solutions to gabapentinoid misuse and (4) contributing barriers in pain management. Participants invoked different opinions in their consideration of gabapentinoid misuse, including the desire for harm reduction, the limitations of the current healthcare and insurance system, the lack of options for pain and substance use disorder treatment, and the influence of patient expectations. CONCLUSIONS: Gabapentinoid misuse was commonly framed in comparative fashion to ongoing concerns with opioids, and proposed solutions often focused less on regulatory control and more toward patient and HCP education and an overhaul of the health system approach to substance use and healthcare overall.

Initiation of oral antihypertensives in hospitalized patients with hypertensive urgency: A descriptive study.

PURPOSE: In hypertensive urgency, guidelines recommend oral antihypertensives, but with limited guidance on implementation. The objective of this study was to determine whether time to initiation of oral antihypertensives impacts blood pressure (BP) reduction in patients with hypertensive urgency. METHODS: A descriptive study was conducted of adult hospitalized patients with hypertensive urgency from November 2018 through November 2021. Patients with a systolic BP (SBP) of 180 mm Hg or higher or a diastolic BP (DBP) of 120 mm Hg or higher and receipt of oral antihypertensives within 48 hours of presentation were included. The primary outcome was the percentage change in SBP from baseline at 12 to 24 hours and 24 to 48 hours. Secondary outcomes included the change in DBP and mean arterial pressure (MAP), time to 3 consecutive goal SBP readings, continuation of home oral antihypertensives, administration of intravenous (IV) antihypertensives, and length of stay (LOS). Patients were stratified by quartile (Q1 through Q4) based on time to first oral antihypertensive. RESULTS: A total of 220 patients were included. A significant difference in SBP was observed among the quartiles, due to the greater sustained SBP reduction in Q1 at 12 to 24 hours and 24 to 48 hours (median [interquartile range, IQR], 22.9% [13.1%-30.5%] and 22.5% [IQR, 15.8%-32.9%] reduction, respectively). There were also reductions in DBP and MAP, with Q1 consistently having larger reductions than Q4. Patients in Q1 had 3 consecutive goal SBP readings earlier than those in the other quartiles (median [IQR], 13.1 [7.0-21.5] hours). Continuation of home medications, number of IV antihypertensives, and LOS did not differ among the quartiles. CONCLUSION: In this analysis, earlier administration of oral antihypertensives was associated with a larger sustained reduction in SBP.

Safety and efficacy of cefiderocol for off-label treatment indications: A systematic review.

PURPOSE: Cefiderocol is a siderophore cephalosporin recently approved by the United States Food and Drug Administration for the treatment of hospital- and ventilator-acquired bacterial pneumonia and complicated urinary tract infections. However, there is potential for cefiderocol utility for a variety of other infections. The purpose of this systematic review was to identify literature examining the safety and efficacy of cefiderocol for off-label indications. METHODS: The PRISMA guidelines were utilized for reporting. Databases searched included PubMed, Scopus, and Embase, from inception to September 2021. Manuscripts describing cefiderocol off-label use in clinical settings were included. Exclusion criteria were studies focused on labeled indications, animal studies, pharmacodynamic/pharmacokinetic studies, in vitro or laboratory studies, and manuscripts in languages other than English or Arabic. Each stage of review utilized two independent investigators, with conflicts resolved and critical appraisal performed. Data regarding presentation, clinical course, and infection characteristics were extracted and descriptively analyzed. RESULTS: The search identified a total of 985 records, narrowed to a final set of 27 studies. Among studies included were 18 (66.7%) case reports, 8 (29.6%) case series, and 1 (3.7%) phase 3 clinical trial. Cefiderocol was most frequently used off-label for bacteremia/sepsis with or without an identified source in 51 (67.1%) out of a total of 76 included patients. Among case series/reports with available data, 43 of 53 patients (81.1%) received combination antibiotic therapy. The most common pathogens identified included multi/extensively drug-resistant Pseudomonas aeruginosa and/or Acinetobacter baumannii. Various clinical end points were reported, while microbiological end points were reported in 18 (66.7%) studies. Cefiderocol-related side effects were uncommon and rarely use-limiting. CONCLUSIONS: This systematic review depicts relative clinical effectiveness of off-label cefiderocol, most commonly for P. aeruginosa and A. baumannii infections as combination antibiotic therapy. Further study is needed to elucidate the safety and efficacy of cefiderocol across an expanded set of patients and indications.

Gabapentin initiation in the inpatient setting: A characterization of prescribing.

PURPOSE: Gabapentin is a widely prescribed analgesic with increased popularity over recent years. Previous studies have characterized use of gabapentin in the outpatient setting, but minimal data exist for its initiation in the inpatient setting. The objective of this study was to characterize the prescribing patterns of gabapentin when it was initiated in the inpatient setting. METHODS: This was a retrospective cohort study of a random sample of adult patients who received new-start gabapentin during hospital admission. Patients for whom gabapentin was prescribed as a home medication, with one-time, on-call, or as-needed orders, or who died during hospital admission were excluded. The primary outcome was characterization of the gabapentin indication; secondary outcomes included the starting and discharge doses, the number of dose titrations, the rate of concomitant opioid prescribing, and pain clinic follow-up. Patients were stratified by surgical vs nonsurgical status. RESULTS: A total of 464 patients were included, 283 (61.0%) of whom were surgical and 181 (39.0%) of whom were nonsurgical. The cohort was 60% male with a mean (SD) age of 56 (18) years; surgical patients were younger and included more women. The most common indications for surgical patients were multimodal analgesia (161; 56.9%), postoperative pain (53; 18.7%), and neuropathic pain (26; 9.2%), while those for nonsurgical patients were neuropathic pain (72; 39.8%) and multimodal analgesia (53; 29.3%). The mean starting dose was similar between the subgroups (613 mg for surgical patients vs 560 mg for nonsurgical patients; P = 0.196). A total of 51.6% vs 81.8% of patients received gabapentin at discharge (P < 0.0001), while referral/follow-up to a pain clinic was minimal and similar between the subgroups (1.1% vs 3.9%; P = 0.210). CONCLUSION: Inpatients were commonly initiated on gabapentin for generalized indications, with approximately half discharged on gabapentin. Further studies are needed to assess the impact of this prescribing on chronic utilization.

Xylazine poisoning: a systematic review.

PURPOSE: Xylazine is an alpha-2-adrenergic agonist used for its sedative and analgesic properties in veterinary medicine. While not approved by the Food and Drug Administration for use in humans, anecdotal evidence suggests that exposures in humans is on the rise. We sought to systematically review and synthesize the evidence on xylazine exposure in humans focusing on the clinical presentation, management, and outcomes. METHODS: We conducted a systematic review of the literature including PubMed, Embase, and Scopus from their inception to September 9, 2021. We searched abstracts from selected emergency medicine and toxicology conferences from 2011 through 2021. We included clinical reports of xylazine exposure in humans. We excluded animal studies, in vitro studies, laboratory studies, or articles in a language other than English. From each included article, we extracted subjective and objective data that focused on clinical presentation, management, and outcomes of patients exposed to xylazine. RESULTS: We evaluated a total of 1409 records, rendering a final set of 17 articles and 2 abstracts meeting inclusion criteria. We identified a total of 98 patients amongst reports ranging from 1979 to 2020 and across nine countries. The most common types of xylazine exposures reported were unintentional exposure and intentional misuse/abuse. Common symptoms on presentation included hypotension, bradycardia, drowsiness, lethargy, while apnea with intubation and death were less frequently reported. CONCLUSION: Human exposure to xylazine appears to be a rising concern within the prehospital and emergency medicine setting. Although a standardized treatment algorithm cannot be recommended at this time, further research is needed to improve the care of patients exposed to xylazine.

Clinical use of lefamulin: A first-in-class semisynthetic pleuromutilin antibiotic.

Lefamulin is a novel antibiotic agent within the pleuromutilin derivative class approved for the treatment of community-acquired bacterial pneumonia (CABP) by the United States Food and Drug Administration and the European Commission in 2019 and 2020, respectively. The objective of this article is to provide a summary of clinically relevant data underlying lefamulin and to provide recommendations for its place in therapy. In vitro data establish lefamulin's activity against a number of Gram-positive, Gram-negative and atypical organisms relevant in the treatment of CABP, including Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Legionella pneumophila, Mycoplasma pneumoniae and Chlamydophila pneumoniae. Two phase-3 studies, the Lefamulin Evaluation Against Pneumonia trials, established non-inferiority of lefamulin against moxifloxacin in the treatment of CABP, including the sequential transition from intravenous to oral therapy and across a broad set of patient demographics and severities. Pooled and post hoc analyses have confirmed these effects for a variety of subgroups and secondary endpoints. Real-world study data post-approval have largely not yet emerged for lefamulin, and there is a need for further investigation into safety/efficacy for off-label indications such as acute bacterial skin and skin structure infections and sexually transmitted infections. Further data regarding tolerability, particularly with long-term use, as well as the emergence of resistance over time, are still undefined.