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The article offers information on the American Society of Health System Pharmacists' Midyear Clinical Meeting and Exhibition to be held in New Orleans, Louisiana from December 8 to 12, 2024.

Background: Chronic insomnia disorder is a common sleep disorder. Previous studies have reported increased demand for anesthetics in patients with chronic insomnia disorder. However, few studies have investigated the effective dose of dexmedetomidine for sedation in patients with chronic insomnia disorder. We aimed to determine the 95% effective dose of dexmedetomidine to induce adequate sedation in patients with chronic insomnia disorder. Methods: This is a biased coin design up-and-down sequential allocation trial in patients aged 18–65 years with chronic insomnia disorder (n = 60). The dose of dexmedetomidine for the subsequent patient was determined based on the response of the previous patient, with an interval of 0.1 µg/kg. Sedation was assessed using the bispectral index. The 95% effective dose was calculated using isotonic regression. Results: The 95% effective dose of dexmedetomidine to induce adequate sedation in patients with chronic insomnia disorder was 1.75 (95% confidence interval, 1.70–1.94) µg/kg. Four patients (6.7%) experienced bradycardia and no other adverse events were observed during the study. Conclusions: The 95% effective dose of dexmedetomidine to induce adequate sedation in patients with chronic insomnia disorder was 1.75 µg/kg. Trials registration: Chinese Clinical Trial Registry (ChiCTR2200063212); first registered 01/09 /2022. [ABSTRACT FROM AUTHOR]

Pueraria is a time-honored food and medicinal plant, which is widely used in China. Puerarin, the main component extracted from pueraria, has a variety of pharmacological characteristics. In recent years, puerarin has received increasing attention for its significant hepatoprotective effects, such as metabolic dysfunction-associated steatotic liver disease, alcohol-related liver disease, and hepatic carcinoma. This paper explores the pharmacological effects of puerarin on various liver diseases through multiple mechanisms, including inflammation factors, oxidative stress, lipid metabolism, apoptosis, and autophagy. Due to its restricted solubility, pharmacokinetic studies revealed that puerarin has a low bioavailability. However, combining puerarin with novel drug delivery systems can improve its bioavailability. Meanwhile, puerarin has very low toxicity and high safety, providing a solid foundation for its further. In addition, this paper discusses puerarin's clinical trials, highlighting its unique advantages. Given its excellent pharmacological effects, puerarin is expected to be a potential drug for the treatment of various liver diseases. [ABSTRACT FROM AUTHOR]

The article offers information on Zevtera ceftobiprole medocaril sodium, a cephalosporin antibacterial drug from Basilea Pharmaceutica International, and discusses its indications, dosage and administration, and warnings and precautions on its use.

Background: Increased patient utilization of cannabidiol (CBD) leads to potential drug interactions with various medications and questions posed to pharmacists. Objective: To quantify the knowledge gap of pharmacists on CBD and CBD-containing products and assess the degree a continuing pharmacy education (CPE) program alters pharmacist confidence and competency on CBD knowledge. Methods: A 1-h CPE activity was offered as a home study from May 9, 2022, through September 30, 2022. Subjects were practicing pharmacy preceptors in Alabama who completed the pre-survey and post-survey for inclusion in matched-pair analyses. The primary outcome measure was participant score improvement between the pre-post surveys. Secondary measures involved pre-post comparisons on self-rated Likert questions concerning participant confidence in counseling, answering drug information questions, and ensuring patient safety regarding CBD. Results: A total of 124 participants completed the course. After matched pairing, 64 and 56 individuals were included in the knowledge-based and confidence ranking analyses, respectively. Participant scoring improved on the knowledge-based questions between the pre-post surveys (50.0% vs 87.8%, P <.001). There was a significant confidence improvement of participants from baseline on counseling patients about prescription or over-the-counter CBD products, answering questions from other healthcare professionals about these products, and ensuring patient safety while using these products (Average 5-level Likert scale increases of 1.75, 1.73, 1.70, respectively; all P <.001). Conclusion: Implementation of a CPE program improved practicing pharmacists' knowledge on information about CBD, which lead to increased competency on counseling patients, answering drug information questions, and promoting patient safety. [ABSTRACT FROM AUTHOR]

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy and Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433. [ABSTRACT FROM AUTHOR]

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433. [ABSTRACT FROM AUTHOR]

The article offers information on Iptacopan hydrochloride. Topics mentioned include the uses of Iptacopan hydrochloride, the drug dosage and administration, the contraindications that patients may experience, the common adverse events, the drug interactions, the mechanism of action and some advice to patients.

This review article provides an in-depth examination of various aspects related to tirzepatide, a synthetic peptide given the positive signal by the "United States Food and Drug Administration" for managing type 2 diabetes. Beginning with an overview of diabetes introduction, epidemiology, and issues related to β-cell dysfunction, is explored in the narrative. It further delves into the significance of incretins in the context of diabetes and introduces tirzepatide as a novel "twincretin" owing to its dual agonistic activity on the glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide (GIP) receptors. The document delves into the chemistry and structure of tirzepatide, providing insights into its unique composition of 39 amino acids derived from native GLP-1, GIP, and semaglutide sequences. Tirzepatide's pharmacology, with a focus on its pharmacokinetic characteristics, and its mechanism of action (MOA) are extensively discussed. Notably, tirzepatide exhibits a preference for GIP receptors, leading to effective reduction of hyperglycemia and positive effects on pancreatic β-cells. Clinical trials examining tirzepatide's impact on glycemic and obesity control are detailed, demonstrating its efficacy in reducing body weight and appetite. Furthermore, the review article explores tirzepatide's effects on cardiovascular and kidney function, highlighting potential renal benefits for diabetic and elevated cardiovascular risk individuals. The narrative also addresses the association between tirzepatide and NAFLD, emphasizing potential benefits in mitigating NAFLD outcomes. Additionally, a comprehensive overview of tirzepatide's side effects, supported by scientific trials, is presented in this article. In conclusion, this review article provides a thorough examination of tirzepatide's multifaceted impact on diabetes management, shedding light on its pharmacological properties, clinical implications, and potential side effects. The information presented contributes to a comprehensive understanding of tirzepatide's role in the evolving landscape of T2D therapeutics. [ABSTRACT FROM AUTHOR]

Elafibranor (IQIRVO®) is a first-in-class peroxisome proliferator-activated receptor (PPAR) agonist being developed by Ipsen, under license from Genfit, for the treatment of primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC). On 10 June 2024, elafibranor received accelerated approval based on reduction of alkaline phosphatase (ALP) in the USA for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. Elafibranor has also received a positive opinion in the EU. This article summarizes the milestones in the development of elafibranor leading to this first approval for PBC. [ABSTRACT FROM AUTHOR]

Ensifentrine, an inhaled, selective phosphodiesterase (PDE) 3 and PDE4 inhibitor, is being developed by Verona Pharma plc for the treatment of respiratory diseases, including chronic obstructive pulmonary disease (COPD). In June 2024, ensifentrine (OHTUVAYRE™) inhalation suspension was approved for the maintenance treatment of COPD in adult patients in the USA. This article summarizes the milestones in the development of ensifentrine leading to this first approval for the maintenance treatment of COPD. [ABSTRACT FROM AUTHOR]

Imetelstat (RYTELO™), an oligonucleotide telomerase inhibitor, is being developed by Geron Corporation for the treatment of myeloid hematologic malignancies. In June 2024, imetelstat was approved in the USA for use in adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA). This article summarizes the milestones in the development of imetelstat leading to this first approval for the treatment of adult patients with low- to intermediate-1 risk MDS with transfusion-dependent anemia. [ABSTRACT FROM AUTHOR]

Ivonescimab (依达方®) is a first-in-class, humanized, tetravalent bispecific monoclonal antibody targeting programmed cell death protein 1 (PD-1) and vascular endothelial growth factor (VEGF)-A being developed by Akeso Biopharma for the treatment of non-small cell lung cancer (NSCLC) and other solid tumours, including breast cancer, liver cancer and gastric cancer. Ivonescimab simultaneously blocks the binding of PD-1 to its ligand (PD-L1), thereby relieving PD-1/PD-L1-mediated immunosuppression, and blocks the binding of VEGF-A to its receptor (VEGFR2), thus blocking tumour angiogenesis in the tumour microenvironment. In May 2024, ivonescimab, in combination with pemetrexed and carboplatin, received its first approval in China for the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have progressed after tyrosine kinase inhibitor (TKI) therapy. Clinical studies of ivonescimab are underway in multiple countries worldwide. This article summarizes the milestones in the development of ivonescimab leading to this first approval for EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have progressed after TKI therapy. [ABSTRACT FROM AUTHOR]

Ritlecitinib (Litfulo™) is a valuable new option for the treatment of severe alopecia areata in individuals aged ≥ 12 years. Of note, ritlecitinib, a dual selective Janus kinase (JAK)-3/TEC family kinase inhibitor, is the first targeted treatment for severe alopecia areata to be approved for use in adolescents. In the pivotal, randomised, double-blind, placebo-controlled, phase 2b/3 ALLEGRO trial in adults and adolescents with alopecia areata with ≥ 50% scalp hair loss, once-daily oral ritlecitinib 50 mg significantly increased the percentage of patients achieving ≤ 20% scalp hair loss at 24 weeks. Ritlecitinib therapy was also associated with eyebrow and eyelash regrowth. Response rates for key efficacy outcomes in the pivotal trial continued to increase with treatment up to 48 weeks. Longer-term data indicate that responses are sustained with continued treatment. Ritlecitinib is generally well tolerated, with most adverse events being of mild severity and not requiring dose interruption or treatment discontinuation. Plain Language Summary: Alopecia areata is an autoimmune disease characterised by hair loss, including from the scalp, face and/or body. It has a lifetime incidence of approximately 2% globally, affecting both children and adults, and can be associated with a significant psychological burden. For severe disease (generally defined as ≥ 50% scalp hair loss), there are few effective treatments available. Ritlecitinib (Litfulo™) is a valuable new treatment option, approved in the EU, the USA and several other countries for the treatment of severe alopecia areata in individuals aged ≥ 12 years, making it the first targeted treatment to be approved for use in adolescents. As demonstrated in the pivotal ALLEGRO-2b/3 clinical trial, ritlecitinib, taken orally (as a capsule) once daily, provides clinically meaningful hair regrowth (including eyebrow and eyelash regrowth) in patients with alopecia areata with ≥ 50% scalp hair loss. Furthermore, hair regrowth is sustained longer term with continued treatment. Ritlecitinib is generally well tolerated, with most adverse events being of mild severity. [ABSTRACT FROM AUTHOR]

The article discusses the European Geriatric Medicine Society's (EuGMS) view on improving drug evaluation in older patients as of September 2024. Topics covered include guidance on evaluating patients' frailty and morbidity status, the challenge of older subjects' heterogeneity in determining medication, and concerns on the choice of outcomes for them. Also noted is the need to consider outcomes that matter most to older people.

Many examples of the use of real-world data in the area of pharmacoepidemiology include "big data," such as insurance claims, medical records, or hospital discharge databases. However, "big" is not always better, particularly when studying outcomes with narrow windows of etiologic relevance. Birth defects are such an outcome, for which specificity of exposure timing is critical. Studies with primary data collection can be designed to query details about the timing of medication use, as well as type, dose, frequency, duration, and indication, that can better characterize the "real world." Because birth defects are rare, etiologic studies are typically case‑control in design, like the National Birth Defects Prevention Study, Birth Defects Study to Evaluate Pregnancy Exposures, and Slone Birth Defects Study. Recall bias can be a concern, but the ability to collect detailed information about both prescription and over-the-counter medication use and other exposures such as diet, family history, and sociodemographic factors is a distinct advantage over claims and medical record data sources. Case‑control studies with primary data collection are essential to advancing the pharmacoepidemiology of birth defects. This article is part of a Special Collection on Pharmacoepidemiology. [ABSTRACT FROM AUTHOR]

Purpose In high-acuity situations such as cardiac arrest, clinicians rely on prepared medications stocked in code carts to provide timely and accurate pharmacotherapy. We examined shortage trends for medications commonly used in code carts. Methods Drug shortage data from 2001 to 2022 were retrieved from the University of Utah Drug Information Service (UUDIS) to characterize shortages reported for commonly used code cart medications. Data extracted included the number of shortages, shortage duration, drug characteristics, and reason for the shortage. Results From 2001 to 2022, 71 drug shortages for code cart medications were reported. The number of new shortages peaked in 2010, and the number of total shortages peaked in 2010. At the end of the study period, 61 (84.7%) shortages had been resolved. For resolved shortages, the mean shortage duration was 18.2 months. The drug with the greatest number of reported shortages was dextrose (10 total), the drug with the longest resolved shortage was calcium chloride injection (116 months), and the drug with the longest active shortage was atropine injection (165 months at the end of the study period). Throughout the entire study period, only 2 suppliers provided commercially available prefilled syringes of dextrose for stocking on code carts. The most common reason for shortages, when reported, was manufacturing delays. Conclusion Medications commonly used in code carts were frequently impacted by drug shortages, which have the potential to impact patient care. Institutional protocols for mitigation and larger efforts to promote a more resilient drug supply chain are critical to ensure patient safety and quality care. [ABSTRACT FROM AUTHOR]

Purpose This report describes the step-by-step process that led to expansion of ambulatory care pharmacy services at a newly established internal medicine clinic within a patient-centered medical home in North Carolina. Summary Implementation of clinical pharmacist services at the clinic was led by a postgraduate year 2 (PGY2) pharmacy resident and guided by the 9 steps described in the book Building a Successful Ambulatory Care Practice: A Complete Guide for Pharmacists. After a needs assessment and review of the demographics and insurance status of the clinic's target population, it was determined that pharmacist services would focus on quality measures including diabetes nephropathy screening, diabetes eye examination, blood glucose control in diabetes, discharge medication reconciliation, annual wellness visits, and medication adherence in diabetes, hypercholesterolemia, and hypertension. Clinic appointments were conducted under 3 models: a pharmacist-physician covisit model, a "floor model" of pharmacist consultation on drug information or medication management issues during medical resident sign-out sessions with supervising physicians (medical residents could also see patients along with the pharmacist at a covisit appointment), and a covisit model of stacked physician and pharmacist appointments. The pharmacist's services were expanded from 2 half-day clinic sessions per week initially to 5 or 6 half-day clinic sessions by the end of the residency year. Conclusion By the fourth quarter of the first PGY2 residency year in which ambulatory care pharmacy services were provided in the clinic, the clinical and financial impact of those services justified the addition of a second full-time pharmacist to the clinic team. [ABSTRACT FROM AUTHOR]

Purpose: Ascorbic acid has been proposed as an alternative treatment for methemoglobinemia in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. However, its efficacy has never been compared to that of methylene blue given the inability of patients with G6PD deficiency to receive methylene blue. We present a case of methemoglobinemia treated with ascorbic acid in a patient without G6PD deficiency who had previously received methylene blue. Summary: A 66-year-old male was treated for methemoglobinemia deemed to be secondary to benzocaine throat spray. He received intravenous (IV) methylene blue but had a severe reaction: diaphoresis, lightheadedness, and hypotension. The infusion was stopped prior to completion. Approximately 6 days later he presented with methemoglobinemia following an additional overconsumption of benzocaine and was treated with ascorbic acid. In both instances his methemoglobin levels were >30% on arterial blood gas on admission and decreased to 6.5% and 7.8%, respectively, after administration of methylene blue and ascorbic acid. Conclusion: Ascorbic acid had a similar effect on decreasing the concentration of methemoglobin compared to methylene blue. Further research into use of ascorbic acid as a recommended agent for treatment of methemoglobinemia is warranted. [ABSTRACT FROM AUTHOR]

In the last decade, the glucagon-like peptide-1 (GLP-1) receptor agonist (RA) drug class has revolutionized treatment for type 2 diabetes mellitus and some of its comorbidities, including obesity and cardiovascular disease. Continued advancements in the GLP-1 RA space show clinical promise for patients, though challenges--including barriers to care such as drug expense and availability--exist. This article provides an overview of available GLP-1 RAs and their mechanisms of action, indications, adverse reactions, and risks, providing practical pearls for providers along the way. [ABSTRACT FROM AUTHOR]

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433. [ABSTRACT FROM AUTHOR]

Background: Medication dosing in overweight and obese children often involves complex weight-based calculations, leading to higher dosing errors, particularly with intravenous drugs. Currently, tools to aid in dosage calculations are lacking for these patients, especially in Thai population. Objective : This study aimed to develop a mobile application with the intent of utilizing it as a tool to enhance the efficiency and accuracy of dosing calculations required for obese and overweight Thai children. Methods: The performance of the application was assessed in 3 key aspects using a sample of 30 healthcare professionals. These key aspects included: 1) the accuracy of dosage calculations, assessed through pre- and posttests comparing manual calculations to app-based calculations using a 10-item questionnaire, 2) the time taken for calculations before and after app usage, 3) user satisfaction, which was measured through a questionnaire. Results: The integration of applications into the calculation demonstrated a significant improvement when compared to the manual calculation in both accuracy (6.10 vs 9.33 out of 10, P <.001) and efficiency (10.40 vs 8.53 minutes per 10 questions, P =.008). Also, the application elicited high levels of satisfaction among users, as reflected by an overall mean satisfaction score of 4.57 on a 5-point scale. Conclusion : The integration of this application to assist in dosage calculations for overweight and obese pediatric Thai patients has yielded favorable outcomes concerning accuracy, efficiency, and user satisfaction. Further development should be pursued within a larger cohort, with an emphasis on real-world implementation in clinical settings. [ABSTRACT FROM AUTHOR]

Background & Problems: Patients with liver transplantation must take lifelong immunosuppressant medication to maintain the function of their hepatic graft. Based on clinical experience, we found that these patients were affected by both insufficient and remaining medication when they returned for outpatient service visits. After investigating the current situation, It was found that post-transplantation perceptions regarding medication were low in this patient group. After analysis, the identified causes of this included: (1) poor learning effect due to the interference from the multiple therapeutic catheter placement postoperatively; (2) delayed timing of assessing the awareness of information or perception of medication and lack of a post-operative follow-up mechanism; and (3) insufficient educational tools and materials for patients. Purposes: This study was designed to increase medication awareness from the current average of 68.3% to > 91% and to increase patient satisfaction with medication guidance from the current 63.0% to > 85% in patients who had received liver transplantation. Resolutions: The improvement strategy included: designing a health education sheet including related medication information and a daily medication record; designing a mnemonic, interactive video, or test to improve medication perception; creating measures associated with a monitor mechanism to assess medication knowledge. Results: After strategy implementation, medication awareness increased from 68.3% to 92.5% and satisfaction with medication guidance increased from 63.0% to 87.2%. Conclusions: The implementation of several strategies concurrently can enhance medication awareness in patients after liver transplantation and increase patient satisfaction with medication guid [ABSTRACT FROM AUTHOR]

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433. [ABSTRACT FROM AUTHOR]

Background: In the healthcare field, there has been a growing interest in using artificial intelligence (AI)-powered tools to assist healthcare professionals, including pharmacists, in their daily tasks. Objectives: To provide commentary and insight into the potential for generative AI language models such as ChatGPT as a tool for answering practice-based, clinical questions and the challenges that need to be addressed before implementation in pharmacy practice settings. Methods: To assess ChatGPT, pharmacy-based questions were prompted to ChatGPT (Version 3.5; free version) and responses were recorded. Question types included 6 drug information questions, 6 enhanced prompt drug information questions, 5 patient case questions, 5 calculations questions, and 10 drug knowledge questions (e.g., top 200 drugs). After all responses were collected, ChatGPT responses were assessed for appropriateness. Results: ChatGPT responses were generated from 32 questions in 5 categories and evaluated on a total of 44 possible points. Among all ChatGPT responses and categories, the overall score was 21 of 44 points (47.73%). ChatGPT scored higher in pharmacy calculation (100%), drug information (83%), and top 200 drugs (80%) categories and lower in drug information enhanced prompt (33%) and patient case (20%) categories. Conclusion: This study suggests that ChatGPT has limited success as a tool to answer pharmacy-based questions. ChatGPT scored higher in calculation and multiple-choice questions but scored lower in drug information and patient case questions, generating misleading or fictional answers and citations. [ABSTRACT FROM AUTHOR]

Givinostat (DUVYZAT™), an orally available histone deacetylase inhibitor, is being developed by Italfarmaco for the treatment of muscular dystrophy and polycythemia vera. Givinostat received its first approval on 21 March 2024, in the USA, for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older. Approval was based on the results of the multinational phase III EPIDYS trial, in which givinostat recipients showed less decline than placebo recipients in the time taken to perform a functional task. Givinostat represents the first nonsteroidal treatment for DMD to be approved for use in patients irrespective of the specific genetic variant underlying their disease. Givinostat is available as an oral suspension to be administered twice daily with food. The recommended dosage is based on the body weight of the patient. In the EU, regulatory review of givinostat in DMD is currently underway. This article summarizes the milestones in the development of givinostat leading to this first approval for DMD. [ABSTRACT FROM AUTHOR]

Bexagliflozin (Brenzavvy®), the fifth sodium-glucose transport 2 (SGLT2) inhibitor to be approved in the USA, is a useful option to consider for the treatment of type 2 diabetes mellitus (T2DM). Developed to be more affordable than existing SGLT2 inhibitors, bexagliflozin is indicated in the USA for use as an adjunct to diet and exercise to improve glycemic control in adults with T2DM. It is taken orally once daily in the morning, with or without food. Data from randomized, double-blind, placebo-controlled phase 3 clinical trials show that bexagliflozin significantly improves glycemic control when used as monotherapy and in combination with other antidiabetic medications in adults with inadequately controlled T2DM, including in patients with moderate kidney impairment or at increased risk of cardiovascular events. Noninferiority to sitagliptin, glimepiride (titrated up to a maximum dose of 6 mg), and dapagliflozin in improving glycemic control was also demonstrated in phase 3 trials. Bexagliflozin is generally well tolerated, with a tolerability and safety profile consistent with that of other SGLT2 inhibitors. Plain Language Summary: Type 2 diabetes mellitus (T2DM) is a common, chronic metabolic disorder that results in high blood glucose levels. Although a range of medications are available to treat T2DM, many people do not reach and maintain target blood glucose levels using currently available treatments, with medication affordability identified as one potential barrier to effective treatment. Bexagliflozin (Brenzavvy®) is a sodium-glucose transport 2 (SGLT2) inhibitor, which works by increasing the amount of glucose excreted in the urine. In clinical trials, bexagliflozin improved blood sugar levels in patients with inadequately controlled T2DM when used alone or in combination with other T2DM medications and had noninferior efficacy to sitagliptin, glimepiride, and dapagliflozin. It is generally well tolerated, with a tolerability and safety profile consistent with that of other medications in its class. Bexagliflozin, which was developed as a more affordable SGLT2 inhibitor, is a useful treatment option to use alongside diet and exercise to improve blood glucose control in adults with T2DM in the USA. [ABSTRACT FROM AUTHOR]

Background: Granulocyte-colony stimulating factors (G-CSFs) are administered to many pediatric patients undergoing myelosuppressive cancer treatment to prevent febrile neutropenia. The most common side effect of G-CSF administration is bone pain, which can be debilitating and result in treatment delays and complications. The use of loratadine to safely and effectively manage G-CSF-induced bone pain in this population is examined. Methods: A literature review was performed using PubMed to locate relevant articles. Search terms included histamine antagonists, loratadine, granulocyte-colony stimulating factor, G-CSF bone pain, pegfilgrastim, and cancer-related bone pain. Ultimately, 18 peer-reviewed articles are included in this narrative review. Results: Current treatment options to manage bone pain are largely reliant on acetaminophen, nonsteroidal anti-inflammatory drugs, and opioids, but are not always feasible or effective. More recently, loratadine has been studied for its use in treating G-CSF-induced bone pain. As a second-generation antihistamine, loratadine is non-sedating and has shown to be beneficial in treating bone pain with minimal side effects. Conclusions: There appears to be benefit in the use of loratadine to treat bone pain with minimal risk. Although loratadine has been used extensively to treat bone pain caused by G-CSF in the adult population, more research is needed specifically in the pediatric setting. Evidence also suggests that loratadine may prove beneficial in treating other types of cancer-related bone pain as well, but more research is needed before making evidence-based practice recommendations. [ABSTRACT FROM AUTHOR]

Despite >1 in 5 children taking prescription drugs in the United States, offlabel drug use is common. To increase the study of drugs in children, regulatory bodies have enacted legislation to incentivize and require pediatric drug studies. As a result of this legislation, novel trial approaches, and an increase in personnel with pediatric expertise, there have been numerous advancements in pediatric drug development. With this review, we aim to highlight developments in pediatric pharmacology over the past 6 years for the most common disease processes that may be treated pharmacologically by the pediatric primary care provider. Using information extracted from label changes between 2018 and 2023, the published literature, and Clinicaltrials.gov, we discuss advances across multiple therapeutic areas relevant to the pediatric primary care provider, including asthma, obesity and related disorders, mental health disorders, infections, and dermatologic conditions. We highlight instances in which new drugs have been developed on the basis of a deeper mechanistic understanding of illness and instances in which labels have been expanded in older drugs on the basis of newly available data. We then consider additional factors that affect pediatric drug use, including cost and nonpharmacologic therapies. Although there is work to be done, efforts focused on pediatric-specific drug development will increase the availability of evidence-based, labeled guidance for commonly prescribed drugs and improve outcomes through the safe and effective use of drugs in children. [ABSTRACT FROM AUTHOR]

The article focuses on investigating Egyptian drug consumers' perceptions and usage of Consumer Medicines Information (CMI) leaflets. It aims to understand how these leaflets are utilized, their effectiveness, and the potential challenges faced by consumers. It provides insights into the importance of these leaflets in educating patients about their medications and highlights the need for more localized research in this area.

Severe asthma (SA) is still a demanding challenge in clinical practice. Type 2 inflammation is the most common phenotype in children and adolescents with SA. As a result, anti-inflammatory drugs, mainly corticosteroids (CSs), represent the first choice to reduce type 2 inflammation. However, SA patients may require high inhaled and oral CS doses to achieve and maintain asthma control. Some SA patients, despite the highest CS dosages, can even display uncontrolled asthma. Therefore, the biological era constituted a breakthrough in managing this condition. Dupilumab is a monoclonal antibody directed against the IL-4 receptor α-subunit (IL-4Rα), antagonizing against both IL-4 and IL-13, and has been approved for pediatric severe type 2 asthma. This review presents and discusses the most recent published studies on dupilumab in children and adolescents with SA. There is convincing evidence that dupilumab is a safe and effective option in managing SA as it can reduce asthma exacerbations, reduce CS use, and improve lung function, asthma control, and quality of life, also for caregivers. However, a thorough diagnostic pathway is mandatory, mainly concerning phenotyping. In fact, the ideal eligible candidate is a child or adolescent with a type 2 allergic phenotype. [ABSTRACT FROM AUTHOR]

Background: Global antipsychotic usage, including off-label prescriptions, has increased in recent decades. However, trends in China, particularly for children and adolescents, remain unclear. This study explored these trends from 2016 to 2021 and identified factors associated with off-label prescriptions. Methods: In this retrospective study, we analyzed on-label and off-label prescriptions based on drug information approved by the China National Medical Products Administration. To identify factors associated with off-label prescriptions, we conducted multivariate logistic regression analysis. Results: Our study included 48,258 antipsychotic prescriptions, 52.4% (25,295) of which were prescriptions for males. Of these, 61.7% (29,813) were off-label. Over time, the number of antipsychotics and the percentage of off-label prescriptions for children and adolescents overall increased from 2016 to 2021. The use of atypical antipsychotics increased, whereas that of typical antipsychotics decreased. For off-label usage, all of the factors in our study were associated with off-label usage, including age, sex, year, region, department, reimbursement, antipsychotic type, drug expense, number of polypharmacy and diagnoses. Additionally, tiapride (15.8%) and aripiprazole (18.6%) were the most common typical and atypical antipsychotics, respectively. For pediatric diseases, common diagnoses included mood or affective disorders (31.7%) and behavioral and emotional disorders, with onset usually occurring in childhood and adolescence (29.1%). Furthermore, a depressive state was the most common diagnosis for which antipsychotic polypharmacy was used for treatment. Conclusion: In this retrospective study, off-label antipsychotic prescriptions were common, with trends generally increasing among children and adolescents from 2016 to 2021. However, there is a lack of evidence supporting off-label usage, thus emphasizing the need for studies on the efficacy and safety of these treatments. [ABSTRACT FROM AUTHOR]

Statins are widely prescribed and highly susceptible to pharmacokinetic (PK)‐based drug–drug interactions (DDIs). To date, there has not been a comprehensive analysis of the basis upon which statin DDI recommendations in US Food and Drug Administration (FDA) prescribing information (PI) are derived. We have conducted such an analysis. We also assessed the degree of concordance of statin DDI recommendations in FDA PI and those provided in common tertiary clinical resources. We catalogued statin DDI information, including PK data and management recommendations, for statin precipitant drugs approved from 2010 to 2021, available from FDA PI and tertiary clinical resource databases. Recommendations were categorized and mapped with associated PK data to assess consistency in the PK basis for labeling recommendations. From the 80 precipitant drugs evaluated, 180 statin DDIs were identified in FDA PI. Dedicated clinical DDI studies were conducted for 54% (n = 97) of these DDIs and 34% (n = 61) of DDI recommendations were extrapolated from clinical data with other statins. Overall, we found that PK‐based statin recommendations were consistent across PI. These findings highlight regulatory precedence for translating information across statins without conducting dedicated clinical DDI studies, which may support future efforts toward streamlining the approach to investigation and labeling of statin DDIs. In addition, with the exception of some notable discrepancies, general concordance was observed between FDA and tertiary resources regarding "Dose Adjustment" and "Avoid Coadministration" recommendations. However, further analyses are warranted across other DDI pairs to determine whether discordance can routinely lead to different clinical recommendations depending on the drug information resource. [ABSTRACT FROM AUTHOR]

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433. [ABSTRACT FROM AUTHOR]

Purpose: Medication history is the method many organizations use to adhere to The Joint Commission's (TJC) National Patient Safety Goal (NPSG) to communicate accurate patient medication information. Literature is sparse comparing the number of medication histories completed in-person versus virtually. Methods: This is a single system, multi-site, retrospective observational study. Patients included were admitted through the Emergency Department during October 2022. The primary aim of this study compared the percent capture rates of medication history between 2 hybrid sites to an in-person site within a health-system. Our secondary objective compared the differences in the 'medication history acuity score' (MHAS), defined as the total number of edits, additions, and deletions made during a medication history. Results : The medication history capture rate at the in-person site was 74% and at the hybrid sites were 91% and 80%. There were no differences in total medications on each medication history between in-person and hybrid (11 [5-16] vs 11 [6-16]; P =.252). There were no differences in changes made on medication histories between in-person and hybrid (4 [1-7] vs 3 [1-7]; P =.595). Conclusions: Our study demonstrates that medication history capture rates and MHAS are comparable in both in-person and hybrid environments. This similarity suggests the feasibility of implementing hybrid models for medication history services in diverse healthcare settings, potentially enhancing the capacity of health systems to meet TJC NPSG. These findings indicate that hybrid models could be an effective strategy for healthcare systems to optimize their medication history services, especially in settings with varied patient volumes and site specialties. [ABSTRACT FROM AUTHOR]

Rozanolixizumab (rozanolixizumab-noli; RYSTIGGO®), a humanized IgG4 monoclonal antibody with a high affinity and specificity for human neonatal Fc receptor (FcRn; which plays a vital role in the transport, distribution and persistence of IgG), is an effective and generally well tolerated treatment option in adults with acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) autoantibody-positive generalized myasthenia gravis (gMG). Administered subcutaneously once weekly for 6 weeks, with subsequent treatment cycles based on clinical evaluation, it is approved for the treatment of adults with gMG in the EU, Japan and the USA. In the pivotal, multinational, phase 3 MycarinG study, one 6-week cycle of rozanolixizumab ≈ 7 mg/kg or ≈ 10 mg/kg improved multiple disease-related outcomes versus placebo, with the benefits sustained following repeated treatment cycles according to a pooled analysis of data from the phase 3 study and two phase 3 extension studies. While increased infection susceptibility could be a consequence of the transient reduction in IgG levels with rozanolixizumab therapy, no severe or serious infections were reported in either rozanolixizumab group in the pivotal study. Plain Language Summary: Myasthenia gravis (MG) is a disease in which an individual's own IgG antibodies damage the communication between nerves and voluntary muscles, thereby weakening the muscles. Eye movements, speech, swallowing, breathing and use of the limbs are affected. A cure is not yet available, with treatment (based on changing or suppressing the immune system) aimed at easing symptoms and improving well-being. Rozanolixizumab (rozanolixizumab-noli; RYSTIGGO®) is an IgG4 antibody that targets a receptor that plays a vital role in the transport, distribution and persistence of IgG. It is administered under the skin once weekly for 6 weeks, with further treatment based on the initial response to rozanolixizumab. In adults with generalized MG, the administration of rozanolixizumab once weekly for 6 weeks improved various disease-related outcomes versus placebo, with the benefits sustained following repeated treatment. Rozanolixizumab was generally well tolerated by these patients, with repeated treatment associated with an acceptable safety profile. Headache was the most frequently reported treatment-emergent adverse event. Thus, rozanolixizumab is an effective and generally well tolerated treatment option in adults with generalized MG. [ABSTRACT FROM AUTHOR]

The article highlights the changes in safety labeling approved by the U.S. Food and Drug Administration (FDA) from October to December 2023. Topics mentioned include the life-threatening respiratory depression caused by opioid Actiq, the risks associated with the use of central nervous system depressant benzodiazepines, and the interaction of Actiq with cytochrome P450 3A4.

Onasemnogene abeparvovec (OA) is the approved intravenous gene therapy for the treatment of spinal muscular atrophy (SMA). A functional copy of the human SMN1 gene was inserted into the target motor neuron cells via a viral vector, AAV9. In clinical trials, OA was infused through a peripheral venous catheter, and no data are available on central catheter use. Recently, we had a case where OA was administered directly into the right atrium via a peripherally inserted central catheter (PICC) instead of a peripheral line, as recommended. The patient was a female child aged 4 months, diagnosed as SMA type I. For practical reasons, a dose of OA according to the weight of the patient (1.1 × 1014 vectorial genomes/kg) was administered via PICC in 1 h, as the product information recommends. The drug was well tolerated, with no hypersensitivity reactions or initial elevation of transaminases or other adverse effects. To our knowledge, this is the first case reported where OA was administered via a central line. This type of administration is not contraindicated, but it is not specifically contemplated or recommended. It is unknown whether central line administration could have any implications for transduction efficiency and immunogenicity. Future studies should clarify these aspects, as each gene therapy has a specific optimal dose recorded that depends on the site and route of administration of the drug, the AAV variant and the transgene. [ABSTRACT FROM AUTHOR]

Prescribing information and adverse event reporting for Kapruvia®▾ (difelikefalin) can be found at the end of this article ((UK-DFK-2400065) April 2024) Itchy skin is a common symptom for people with advanced chronic kidney disease (CKD), and it has a significant impact on outcomes of treatment. Due to a combination of patient and healthcare related factors, it remains under-reported, under-diagnosed and inadequately treated. Recently, the landscape for treatment has changed. Although the pathogenesis of CKD-associated pruritus (CKD-aP) is complex and multifactorial, the role of the endogenous opioid pathway is now much better understood. Difelikefalin is a peripherally acting kappa opioid receptor agonist indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on in-centre haemodialysis with a favourable safety profile; it does not produce typical opioid side-effects and is the first approved therapy for CKD-aP in Europe. People on dialysis should be asked 'do you itch?', and evidence-based management pathways should be used to treat this debilitating symptom much more effectively. [ABSTRACT FROM AUTHOR]

In this month's article, George Winter discusses the potential for repurposed drugs to change the therapeutic landscape [ABSTRACT FROM AUTHOR]

The article provides information on givinostat hydrochloride, a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy (DMD) . Topics discussed include dosage and administration, drug interactions, and advice to patients, including reading the U.S. Food and Drug Administration (FDA)-approved patient labeling.

The article provides information on aprocitentan, an endothelin receptor antagonist indicated for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. Topics include dosage and administration, warnings and precautions, and drug interactions.