Annals of Pharmacotherapy最新文献

{"title":"Comment on Severe Acute Respiratory Failure Associated With Trimethoprim/Sulfamethoxazole Among Adolescent and Young Adults: An Active-comparator Restricted Disproportionality Analysis From the FDA Adverse Event Reporting System (FAERS) Database.","authors":"Maheshwari Periyasamy, Mirunalini Ravichandran","doi":"10.1177/10600280251350679","DOIUrl":"https://doi.org/10.1177/10600280251350679","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280251350679"},"PeriodicalIF":2.3,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144493475","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":"Reply: Severe Acute Respiratory Failure Associated With Trimethoprim/Sulfamethoxazole Among Adolescent and Young Adults: An Active Comparator-Restricted Disproportionality Analysis From the FDA Adverse Event Reporting System (FAERS) Database.","authors":"Fatemeh Ahmadi, Niaz Chalabianloo, Flory T Muanda","doi":"10.1177/10600280251350681","DOIUrl":"https://doi.org/10.1177/10600280251350681","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280251350681"},"PeriodicalIF":2.3,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144493476","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":"Are We Ready for Additional Off-Label Use for Dexmedetomidine in the Intensive Care Unit?","authors":"Jay Patel, Huan Mark Nguyen, Maged Tanios","doi":"10.1177/10600280251349581","DOIUrl":"https://doi.org/10.1177/10600280251349581","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280251349581"},"PeriodicalIF":2.3,"publicationDate":"2025-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144482908","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":"Incidence of Methemoglobinemia in Cardiothoracic Surgery ICU Patients on Inhaled Nitric Oxide.","authors":"Tatianna Bourg, Carolyn M Bell, Jeff McMurray, Jaclyn M Hawn","doi":"10.1177/10600280251340182","DOIUrl":"10.1177/10600280251340182","url":null,"abstract":"<p><strong>Background: </strong>Inhaled nitric oxide (iNO) is a selective pulmonary vasodilator utilized for the treatment of right ventricular dysfunction in the cardiac surgery patient population, which carries a risk of developing methemoglobinemia. The actual frequency of methemoglobinemia is not well defined.</p><p><strong>Objective: </strong>The purpose of this study was to evaluate the incidence of methemoglobinemia in a cardiothoracic surgery intensive care unit (ICU) patient population.</p><p><strong>Methods: </strong>This was a single-center, retrospective cohort study of 208 cardiothoracic surgery ICU patients who received at least 24 hours of iNO between July 1, 2020 and July 1, 2022. Patients were excluded if they did not have methemoglobin levels collected, received less than 24 hours of iNO therapy, or had documented use of other inhaled vasodilatory therapy during the same admission.</p><p><strong>Results: </strong>A total of 208 patients were included. Zero patients in this study developed methemoglobinemia. The median duration of iNO therapy was 4 (interquartile range [IQR] = 2.4 to 6.5) days, and the median dose of iNO was 20 (IQR = 20-40) ppm. The median number of methemoglobin levels collected was 3 (IQR = 2-5), with a median methemoglobin level of 1.3% (IQR = 0.9%-1.7 %).</p><p><strong>Conclusion and relevance: </strong>Our findings suggest that treatment with iNO in adult cardiothoracic surgery ICU patients has a low risk of developing methemoglobinemia. In addition, the outcomes collected provide information regarding iNO use, adverse events, and health care resource use in clinical practice. Routine monitoring of methemoglobin levels may not be necessary for this patient population. Further research is needed to assess the true risk of methemoglobinemia and to establish the appropriate frequency of monitoring in this group.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280251340182"},"PeriodicalIF":2.3,"publicationDate":"2025-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144339847","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":"Outcomes of Intravenous Ganciclovir Administration via an Outpatient Parenteral Antimicrobial Therapy Program: A Single-Center Experience.","authors":"Dhruv P Patel, Ryan Mynatt, Ashley Logan, Evelyn Villacorta, Armaghan-E-Rehman Mansoor","doi":"10.1177/10600280251349570","DOIUrl":"10.1177/10600280251349570","url":null,"abstract":"<p><strong>Background: </strong>Intravenous (IV) ganciclovir is used in the management of herpesvirus infections, including cytomegalovirus (CMV). Ganciclovir is usually administered inpatient given the need for close monitoring of laboratory parameters.</p><p><strong>Objective: </strong>This study describes our experience with administering IV ganciclovir via an outpatient parenteral antimicrobial therapy (OPAT) program.</p><p><strong>Methods: </strong>This is a retrospective review of patients discharged on IV ganciclovir via OPAT at a tertiary medical center from August 2019 to August 2024. Demographics and treatment outcomes were collected.</p><p><strong>Results: </strong>Ganciclovir was the preferred agent in all patients either due to concern for gastrointestinal absorption or provider preference. Eighteen patients with a median age of 59.5 (interquartile range [IQR]: 53-65) years met criteria. The most common underlying immunocompromising condition was receipt of a transplanted organ in 16 (88.9%) patients, most commonly heart (8 patients) and kidney transplants (7 patients). Median duration of therapy after hospital discharge was 22 (IQR: 20-27) days. Fifteen (83.3%) patients transitioned to valganciclovir on completion of parenteral therapy either as secondary prophylaxis or continuation of therapy. The most common adverse event was leukopenia in 6 (33.3%) patients. One patient developed acute kidney injury (AKI) requiring dose modification and eventual discontinuation.</p><p><strong>Conclusion and relevance: </strong>Ganciclovir via OPAT is a viable option in patients requiring an extended duration of IV therapy. In our cohort of 18 patients, only one had early discontinuation of therapy due to ganciclovir-related AKI. Close monitoring of labs and an established OPAT protocol can allow for successful completion of therapy.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280251349570"},"PeriodicalIF":2.3,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144332341","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":"Safety of Intravenous Push Administration of High-Dose (≥3 g) Levetiracetam.","authors":"Ming May Zhang, Nicole A Leshko, Gerald C Elliott","doi":"10.1177/10600280251345079","DOIUrl":"https://doi.org/10.1177/10600280251345079","url":null,"abstract":"<p><strong>Background: </strong>Levetiracetam administration via intravenous push (IVP) may improve outcomes in status epilepticus (SE) by decreasing time to administration. However, there is a paucity of literature describing the safety of IVP administration of higher loading doses used for early management of SE.</p><p><strong>Objective: </strong>The purpose of this evaluation was to investigate the safety of high-dose IVP levetiracetam.</p><p><strong>Methods: </strong>This was a retrospective, single-arm cohort study conducted at an academic medical center. Patients were included if they received IVP levetiracetam ≥3000 mg. The primary outcome was a composite of clinically significant adverse events (AEs) within 1-hour post-administration of levetiracetam: hypotension, hypertension, bradycardia, tachycardia, arrhythmia, and/or injection site reaction.</p><p><strong>Results: </strong>A total of 140 patients met inclusion criteria, receiving a median levetiracetam dose of 4000 mg (interquartile range [IQR] = 3000, 4500). Seventeen (12.1%) patients experienced a clinically significant AE. The most common clinically significant AE was hypotension (9.2% [10/109]), followed by tachycardia (3.6% [4/112]), arrhythmia (1.8% [2/112]), hypertension (0.9% [1/109]), and injection site reaction (0.7% [1/140]). Eighty percent [8/10] of patients who experienced clinically significant hypotension were on at least 1 medication with potential confounding hemodynamic effects.</p><p><strong>Conclusion and relevance: </strong>In this retrospective, single-arm analysis, high-dose (≥3000 mg) IVP levetiracetam was relatively well-tolerated but associated with a higher rate of clinically significant hypotension than has been reported in the previous literature, although several confounding factors may have contributed to this outcome. Our findings support the continued use of high-dose IVP levetiracetam with appropriate hemodynamic monitoring; hemodynamic effects should be further explored in future studies.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280251345079"},"PeriodicalIF":2.3,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144301051","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":"Denosumab-bbdz: A Review of the Interchangeable Biosimilar for the Treatment of Osteoporosis.","authors":"Kaitlyn North, Brandi Dahl, KariLynn Dowling-McClay, McKenzie Highsmith","doi":"10.1177/10600280251342581","DOIUrl":"https://doi.org/10.1177/10600280251342581","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this article is to review the pharmacologic and clinical profile of denosumab-bbdz (GP2411, SDZ-deno), the first interchangeable RANK ligand inhibitor biosimilar for the treatment of osteoporosis and to increase bone mass.</p><p><strong>Data sources: </strong>PubMed was searched for all indexed literature published prior to January 1, 2025, using the keywords <i>GP2411</i>, <i>SDZ-deno</i>, and <i>denosumab-bbdz</i>. Information was also extracted from the denosumab-bbdz package insert and a gray literature search.</p><p><strong>Study selection and data extraction: </strong>Phase I and III studies of the pharmacokinetic, pharmacodynamic, and clinical profile of denosumab-bbdz were reviewed.</p><p><strong>Data synthesis: </strong>Denosumab-bbdz received Food and Drug Administration approval based on the phase I/III ROSALIA trial which demonstrated similar pharmacokinetics, pharmacodynamics, efficacy via bone turnover rates, immunogenicity, and safety between denosumab-bbdz and reference product denosumab. Denosumab-bbdz carries a boxed warning and Risk Evaluation and Mitigation Strategy for severe hypocalcemia in patients with advanced chronic kidney disease.Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:Denosumab-bbdz has interchangeable status which allows substitutions without prescriber approval and reduces costs. Denosumab-bbdz assumes the same place in therapy as other denosumab products. In addition to other indications, it is a first-line option for postmenopausal osteoporosis with high or very high fracture risk after achieving equivalence in pharmacologic properties, safety, and markers for bone formation.</p><p><strong>Conclusions: </strong>Denosumab-bbdz is the first interchangeable biosimilar for denosumab. This approval has the potential to reduce costs to patients and the healthcare system and sets an encouraging future for the potential of biosimilars.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280251342581"},"PeriodicalIF":2.3,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144282032","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":"Eco-Responsible Awareness Raising interventions To reduce the Use of Long-Acting MDIs and Carbon Footprint in a University Hospital Center (EARTH).","authors":"Sophia Groguhé, Olivier Landry, Christine Sirmalis, David Williamson, Alessandra Stortini, Maude Fortier","doi":"10.1177/10600280251343947","DOIUrl":"https://doi.org/10.1177/10600280251343947","url":null,"abstract":"<p><strong>Background: </strong>There are very limited data studying strategies designed to enhance environmentally conscious MDI prescribing habits. This study aimed to evaluate the impact of a multicomponent strategy promoting more environmentally responsible inhaler prescribing practices on the use of long-acting MDIs.</p><p><strong>Objectives: </strong>What is the impact of a multicomponent eco-responsible inhaled medication prescribing awareness program on the prescription rate of long-acting MDIs in hospitalized patients?</p><p><strong>Methods: </strong>This interrupted time series was conducted by retrospectively collecting long-acting inhaler metrics from digitalized records before and after awareness raising interventions. The primary outcome was to assess the impact of the multicomponent awareness campaign on the proportion of long-acting MDIs relative to the total number of long-acting inhalers prescribed on all in-patient hospital wards. The secondary endpoint was to evaluate the difference in proportion of long-acting MDI prescriptions between hospital admission and discharge in selected wards.</p><p><strong>Results: </strong>A total of 7452 inhalers was collected. A significant relative decrease in level of 20.1% (<i>P</i> = 0.017) was observed between the preintervention and postintervention periods (27.9% and 22.3%, respectively). The slope of the proportion of long-acting MDIs was not significantly different (-0.2%, <i>P</i> = 0.319). There was no significant difference in the level or slope between admission and discharge for the secondary outcome.</p><p><strong>Conclusion and relevance: </strong>A 20.1% reduction in the prescription rate of MDIs could be observed following awareness interventions focused on eco-responsible inhaler prescribing in a hospital setting. This is explained mainly by an initial decrease in the number of prescriptions postintervention and that change remained stable over time.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280251343947"},"PeriodicalIF":2.3,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144214656","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":"Believing FDA's Assurance of Quality Pharmaceutical Products Can Be Dangerous to Your Patients' Health.","authors":"C Michael White, Lyla R White","doi":"10.1177/10600280251343626","DOIUrl":"https://doi.org/10.1177/10600280251343626","url":null,"abstract":"<p><p>The Food and Drug Administration (FDA) exists to protect US consumers. However, while drug manufacturing has shifted dramatically to developing countries like India and China, the FDA first silently followed a \"trust and not verify\" strategy with virtually no overseas inspections until overwhelming evidence of patient harm had occurred. The implementation of the Generic Drug User Fee Act helped alleviate this problem, but the issue recurred after the COVID-19 pandemic set the FDA far behind in foreign inspections. Regardless, the FDA has never attained parity in inspection frequency and rigor in these countries versus the United States. The FDA still over relies on reports of adverse events, whistleblower reports, and independent laboratory findings to prompt an investigation. When serious issues are found in a manufacturing plant, they redact the products manufactured there so clinicians and patients are unprotected. This has directly harmed US citizens, exposed them to cancer-causing agents, and provided products without the expected benefits. When rates of adverse events were recently compared by manufacturer location, they were found to be markedly higher for manufacturers in emerging countries than advanced countries, especially when a drug's patent has been expired for a longer time. Clinicians may be dismissive of patients claiming that a new version of a generic drug isn't as effective as their previous one or is causing new adverse events, but that could be the case. Healthcare professionals should report these cases to the FDA to raise awareness of potential issues.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280251343626"},"PeriodicalIF":2.3,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144207461","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":"Impact of a Treatment Protocol for Hospitalized Adults With Acute Immune Thrombocytopenia.","authors":"Justin Presutto, Abby Rose Broomfield, Sierra Parsons, Morgan LaMarc, Andre McMahon, Bren Magruder","doi":"10.1177/10600280251338604","DOIUrl":"https://doi.org/10.1177/10600280251338604","url":null,"abstract":"<p><strong>Background: </strong>Definitive management of acute immune thrombocytopenia (ITP) in hospitalized patients remains variable. A lack of standardized treatment protocols has led to varying treatment sequences and inconsistent utilization of resources. A viable remedy exists in developing a standardized sequential treatment protocol balancing therapeutic efficacy with financial responsibility.</p><p><strong>Objective: </strong>The purpose of this study was to evaluate the pharmacoeconomic impact and clinical efficacy of an inpatient pharmacist-developed sequential ITP treatment protocol. The primary objective was to evaluate drug cost of ITP treatment per patient pre- versus post-protocol implementation. Secondary objectives included hospital length of stay and platelet count at discharge.</p><p><strong>Methods: </strong>This multicenter, retrospective, quasi-experimental, institutional review board-approved study assessed hospitalized patients treated for acute ITP between October 2018 and June 2023 at Sarasota Memorial Health Care System. The ITP protocol was implemented on June 1, 2022. Retrospective chart review was performed on adult patients diagnosed with ITP who received one or more medications to treat ITP. Patients less than 18 years old, pregnant, or with sustained platelet counts greater than 100 x 10³/µL throughout admission were excluded. Propensity score matching was used to estimate the protocol effect on primary and secondary outcomes.</p><p><strong>Results: </strong>Of the 450 patients screened, 168 met inclusion criteria, with 115 patients assigned to the pre-protocol arm and 53 patients assigned post-protocol. In the pre-protocol cohort, 53 propensity-matched pairs were evaluated. The median drug cost of treatment was significantly higher in the pre- protocol arm compared with post-protocol ($24 899 vs $13 833; <i>P</i> < 0.001). There was no difference in either secondary outcome of median length of hospital stay (5.5 vs 5.2 days; <i>P</i> = 0.987) or median platelet count at discharge (82 vs 72; <i>P</i> = 0.477).</p><p><strong>Conclusion and relevance: </strong>Implementation of a standardized sequential ITP treatment protocol at a community hospital resulted in substantial cost savings while maintaining positive clinical outcomes.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280251338604"},"PeriodicalIF":2.3,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144207462","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}