{"title":"Philosophical and Ethical Underpinnings of the Medical Decision-Making Process: A Focus on Patient Values and Preferences.","authors":"Brian L Erstad","doi":"10.1177/10600280241289133","DOIUrl":"10.1177/10600280241289133","url":null,"abstract":"<p><p>Current clinical practice is based on the principles of evidence-based medicine (EBM) with clinical practice guidelines (CPGs) often serving as a source of information for the medical decision-making process. There are philosophical and ethical tenets underlying this process including those pertaining to patient values and preferences. Despite their importance, these tenets may receive less attention than the empirically derived recommendations in CPGs based on the principles of EBM. The purpose of this article is to provide an overview of the philosophical and ethical underpinnings of the medical decision-making process with a focus on patient values and preferences so pharmacists and other clinicians can appreciate the interplay between science, philosophy and ethics when providing patient- or person-centered care. Appreciation of these discussions should help practitioners to recognize the limitations and challenges when attempting to incorporate population-based evidence into a patient-specific medical decision-making process that often necessitates reconciliation and negotiation between the clinician and patient when striving to provide optimal care.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"666-670"},"PeriodicalIF":2.3,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142612184","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Daniel Wroblewski, Lindsay A Brust-Sisti, Matthew Bridgeman, Mary Barna Bridgeman
{"title":"Reply: FDA Approved mRESVIA: Embracing the New Era of RSV Prevention With Advanced mRNA Technology.","authors":"Daniel Wroblewski, Lindsay A Brust-Sisti, Matthew Bridgeman, Mary Barna Bridgeman","doi":"10.1177/10600280241301430","DOIUrl":"10.1177/10600280241301430","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"678-679"},"PeriodicalIF":2.3,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142799122","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Justin Zimmerman, Christopher Giuliano, Pramodini B Kale-Pradhan
{"title":"Ceftobiprole Medocaril: A New Fifth-Generation Cephalosporin.","authors":"Justin Zimmerman, Christopher Giuliano, Pramodini B Kale-Pradhan","doi":"10.1177/10600280241293773","DOIUrl":"10.1177/10600280241293773","url":null,"abstract":"<p><strong>Objective: </strong>The objective was to review the pharmacology, efficacy, and safety of intravenous ceftobiprole in the treatment of bloodstream infections, acute bacterial skin and skin structure infections (ABSSSIs), community-acquired pneumonia (CAP), and hospital-acquired pneumonia (HAP), or ventilator-associated pneumonia (VAP).</p><p><strong>Data sources: </strong>PubMed and ClinicalTrials.gov were searched using the following terms: ceftobiprole, ceftobiprole medocaril, ceftobiprole medocaril sodium, Zevtera, and BAL5788.</p><p><strong>Study selection and data extraction: </strong>Articles published in English between January 1985 and August 15, 2024, related to pharmacology, safety, efficacy, and clinical trials were reviewed.</p><p><strong>Data synthesis: </strong>Ceftobiprole has shown similar efficacy to comparator antibiotics in CAP, ABSSSIs, and bloodstream infections. Overall treatment success in patients with bacteremia was 69.8% and 68.7%; 91.3% and 88.1% with ABSSSIs and 86.6% and 87.4% with CAP in ceftobiprole and comparator groups, respectively. Finally, in the management of HAP and VAP, ceftobiprole was inferior in the VAP population. Ceftobiprole had a favorable safety profile with gastrointestinal adverse effects occurring more frequently than comparators.Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:Clinicians have limited options to treat multidrug-resistant infections. Ceftobiprole has demonstrated efficacy against causative pathogens in specific infections including methicillin-resistant <i>Staphylococcus aureus</i> bacteremia (SAB), ABSSSI, and CAP and may be considered a viable alternative. However, ceftobiprole's impact on HAP, VAP, and febrile neutropenia needs to be further delineated.</p><p><strong>Conclusion: </strong>Ceftobiprole's broad-spectrum activity makes it a viable option for treating patients hospitalized with CAP, ABSSSI, and SAB. Further studies are needed in severely ill HAP or VAP, febrile neutropenia, and pediatric patients.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"657-665"},"PeriodicalIF":2.3,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142791023","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Zainab Anfaal, Zmarak Ahmed Khan, Muhammad Ammar Aslam
{"title":"FDA Approves mRESVIA: Embracing the New Era of RSV Prevention With Advanced mRNA Technology.","authors":"Zainab Anfaal, Zmarak Ahmed Khan, Muhammad Ammar Aslam","doi":"10.1177/10600280241301432","DOIUrl":"10.1177/10600280241301432","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"676-677"},"PeriodicalIF":2.3,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142799121","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Melanie Mills, Haley Torr, Nicolette Centanni, Richard R Riker, David Gagnon, Ashley Gale
{"title":"Safety of Intermittent Parenteral Midazolam Injection in Hospitalized Patients Admitted to Non-Intensive Care Nursing Units: A Retrospective Matched-Cohort Study.","authors":"Melanie Mills, Haley Torr, Nicolette Centanni, Richard R Riker, David Gagnon, Ashley Gale","doi":"10.1177/10600280241299059","DOIUrl":"https://doi.org/10.1177/10600280241299059","url":null,"abstract":"<p><strong>Background: </strong>The prescribing information for parenteral midazolam contains a Boxed Warning stating its use may precipitate respiratory arrest, and its safety in non-intensive care unit (ICU) nursing units has been understudied.</p><p><strong>Objective: </strong>To characterize the safety of intermittent midazolam injections in patients admitted to non-ICU nursing units relative to lorazepam injections.</p><p><strong>Methods: </strong>This single-center, retrospective, matched-cohort study included patients ≥18 years of age who received intermittent midazolam in non-ICU nursing units. Midazolam administrations were matched 1:1 to lorazepam administrations. Safety outcomes included hypotension, bradycardia, bradypnea, and escalation in level of nursing unit care or oxygen requirement.</p><p><strong>Results: </strong>A total of 94 midazolam administrations were matched to lorazepam administrations. Demographic data were similar between groups. Midazolam was more commonly given intravenously (95.7% vs 85.1%, <i>P</i> = 0.02) and in an intermediate care nursing unit (31.9% vs 14.9%, <i>P</i> = 0.009). The lorazepam cohort had significantly fewer concomitant respiratory depressants administered, and there were no differences in the use of beta-blockers or antihypertensives. There were no differences in the incidence of hypotension (1.1% vs 2.1%, <i>P</i> = 1), bradycardia (5.3% vs 2.1%, <i>P</i> = 0.44), bradypnea (1.1% vs 0%, <i>P</i> = 1), escalation in level of care (2.1% vs 2.1%, <i>P</i> = 1), or escalation in oxygen requirement (5.3% vs 3.2%, <i>P</i> = 0.72).</p><p><strong>Conclusion and relevance: </strong>The administration of parenteral midazolam in non-ICU nursing units resulted in a similar incidence of hypotension, bradycardia, bradypnea, escalation in oxygen requirement, and escalation in level of care compared with lorazepam. These results suggest that midazolam may have a similar safety profile to lorazepam, supporting its use in non-ICU nursing units.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":"59 7","pages":"620-627"},"PeriodicalIF":2.3,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144141165","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sarah M Beasley, Tasneem Zaihra Rizvi, Philip E Grgurich
{"title":"A Comparative Study of Fentanyl Versus Hydromorphone in Mechanically Ventilated Intensive Care Unit Patients.","authors":"Sarah M Beasley, Tasneem Zaihra Rizvi, Philip E Grgurich","doi":"10.1177/10600280241300648","DOIUrl":"https://doi.org/10.1177/10600280241300648","url":null,"abstract":"<p><strong>Background: </strong>Although the SCCM PADIS guidelines suggest fentanyl or hydromorphone infusions for analgesia during mechanical ventilation (MV), few studies compare patient-centered outcomes.</p><p><strong>Objective: </strong>This study evaluated therapeutic outcomes and adverse effects of fentanyl and hydromorphone in MV intensive care unit patients.</p><p><strong>Methods: </strong>This single-center, retrospective cohort study evaluated adult MV patients who were intubated for 1 to 14 days and received either hydromorphone or fentanyl infusion for analgesia, while targeting light sedation. The primary endpoint was 28-day MV-free survival. Select secondary endpoints included cumulative and hourly opioid doses during MV, duration of MV, and time within goal pain and sedation score ranges during MV. Multivariate regression analysis was performed for patients intubated more than 72 hours.</p><p><strong>Results: </strong>A total of 238 patients were included; 144 received fentanyl and 94 received hydromorphone. Baseline characteristics were similar between groups with a median age of 66 years, weight 78 kg, and 33% female. Median 28-day MV-free survival was 22 and 21 days for the fentanyl and hydromorphone groups, respectively (<i>P</i> = 0.36). Patients given fentanyl received higher cumulative opioid doses, expressed in fentanyl equivalents, during MV compared to hydromorphone-treated patients, 4241 (interquartile range [IQR] 1817-8146) mcg and 2448 (IQR 1012-4926) mcg (<i>P</i> < 0.001), respectively, and higher hourly average doses, 55 (IQR 39-75) mcg/h and 37 (IQR 29-51) mcg/h (<i>P</i> < 0.001), respectively.</p><p><strong>Conclusion and relevance: </strong>There was no difference in 28-day MV-free survival with fentanyl- and hydromorphone-based analgesia, but hydromorphone was associated with lower cumulative and hourly opioid requirements.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":"59 7","pages":"593-603"},"PeriodicalIF":2.3,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144141164","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Krishn S Patel, Gretchen L Sacha, Heather Torbic, Stephanie Bass, Lu Wang, Abhijit Duggal, Michael A Rudoni
{"title":"Evaluation of Response to Weight-based Dosing Strategies of Continuous, Fixed-Rate Atracurium Infusions in Critically Ill, Obese Adults With Acute Respiratory Distress Syndrome.","authors":"Krishn S Patel, Gretchen L Sacha, Heather Torbic, Stephanie Bass, Lu Wang, Abhijit Duggal, Michael A Rudoni","doi":"10.1177/10600280241304406","DOIUrl":"10.1177/10600280241304406","url":null,"abstract":"<p><strong>Background: </strong>Fixed-rate infusions of weight-based neuromuscular blocking agents (NMBAs) were adopted during the COVID pandemic to limit caregiver exposure during titrations. Although fixed-rate infusions are supported in studies of acute respiratory distress syndrome (ARDS), the optimal scalar for weight-based NMBAs in patients with obesity remains controversial.</p><p><strong>Objective: </strong>This study sought to compare change in oxygenation using two weight-based dosing strategies for atracurium in obese patients with ARDS. Secondary outcomes included total atracurium dose, mortality, and intensive care unit (ICU) and ventilator-free days.</p><p><strong>Methods: </strong>Following an institutional practice update to use ideal body weight (IBW) for patients with obesity, we retrospectively compared adults (≥18 years) with ARDS and a body mass index (BMI) ≥ 30 kg/m<sup>2</sup> who received atracurium (15 µg/kg/min) based on actual body weight (ABW) with those using IBW. The primary outcome was change in PaO<sub>2</sub>/FiO<sub>2</sub> ratio (P/F) 48 hours after atracurium initiation. Analysis-of-covariance compared change in P/F between groups after adjustment for confounders.</p><p><strong>Results: </strong>The IBW group (<i>n</i> = 123), compared with the ABW group (<i>n</i> = 133), had lower baseline P/F (85.0 [71.0, 118.3] vs 93.3 [76.0, 128.3], <i>P</i> = 0.025) and sequential organ failure assessment (SOFA) score (9.7 ± 2.6 vs 10.5 ± 2.6, <i>P</i> = 0.015), with greater use of steroids (96% vs 89%, <i>P</i> = 0.032) and prone positioning (72% vs 58%, <i>P</i> = 0.015). No difference was detected in change in P/F at 48 hours (adjusted least squares mean [95% confidence interval, CI]: 55.8 [37.0, 74.5] vs 56.9 [39.6, 74.1], <i>P</i> = 0.90). Atracurium doses were higher in the ABW group (97.4 mg/h [84.4, 110.3] vs 55.4 [47.2, 65.7], <i>P</i> < 0.001). There was no difference in hospital mortality, ICU mortality, and ICU-free days or ventilator-free days.</p><p><strong>Conclusion and relevance: </strong>In patients with obesity with ARDS receiving fixed-rate atracurium infusions, the change in P/F at 48 hours did not differ based on weight. Atracurium dosed on IBW may use less total drug without compromising ability to improve oxygenation. This is the first study comparing the dosing weight used for continuous infusion atracurium in hospitalized, critically ill ARDS patients with obesity. Additional studies are warranted to optimize dosing in obese patients.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"612-619"},"PeriodicalIF":2.3,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142852215","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Efficacy and Safety of Mifepristone and Misoprostol Compared to Misoprostol Alone for the Resolution of Miscarriage and Intrauterine Fetal Death: A Systematic Review and Meta-Analysis.","authors":"Rachael G Pirrami, Justin P Reinert","doi":"10.1177/10600280241289968","DOIUrl":"10.1177/10600280241289968","url":null,"abstract":"<p><strong>Objective: </strong>To determine the efficacy and safety of mifepristone and misoprostol together (intervention) compared to misoprostol alone (comparator) for the resolution of miscarriage and intrauterine fetal death.</p><p><strong>Data sources: </strong>A systematic review and meta-analysis were conducted following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) methodology through July 2024 that evaluated the efficacy and safety of mifepristone and misoprostol together compared to misoprostol alone for the resolution of miscarriage and intrauterine fetal death through July 2024.</p><p><strong>Study selection and data extraction: </strong>Primary endpoints were overall delivery success, 24-hour delivery success, and incidence of safety outcomes. A <i>P</i>-value of <0.05 was considered statistically significant, and heterogeneity was reported as the I<sup>2</sup> value.</p><p><strong>Data synthesis: </strong>Twelve randomized controlled trials (RCTs) were included. Overall delivery success was higher in the intervention group (0.73 [CI 0.64-0.82], <i>P</i> < 0.01). Twenty-four-hour delivery rate was higher (1.54 [CI 1.32-1.77], <i>P</i> = 0.06), and a shorter time to delivery interval (9.22-18.78 vs 15.47-37.1 hours) was observed in the intervention group. Gastrointestinal adverse effects were more frequent in the intervention group (0.04 [CI -0.03 to 0.12], <i>P</i> < 0.01).</p><p><strong>Relevance to patient care and clinical practice: </strong>Mifepristone and misoprostol together demonstrated higher delivery success rates and comparable safety outcomes to misoprostol alone, demonstrating the potential of improving patient care and positively impacting the time to successful delivery for patients at the bedside.</p><p><strong>Conclusions: </strong>The use of mifepristone and misoprostol together for the resolution of miscarriage and intrauterine fetal death is warranted over the use of misoprostol alone.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"636-647"},"PeriodicalIF":2.3,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142493077","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A Disproportionality Analysis of Treprostinil Based on FDA Adverse Event Reporting System Database.","authors":"Lingling Li","doi":"10.1177/10600280241299114","DOIUrl":"10.1177/10600280241299114","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"674-675"},"PeriodicalIF":2.3,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142724812","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}