{"title":"Pharmacovigilance of Radiopharmaceuticals: Challenges and Opportunities","authors":"Sara Martins, Ângelo Jesus, Ana Martín- Suárez","doi":"10.1177/87551225241266172","DOIUrl":"https://doi.org/10.1177/87551225241266172","url":null,"abstract":"","PeriodicalId":505060,"journal":{"name":"Journal of Pharmacy Technology","volume":"2 11","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141797498","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Bao Anh C. Tran, Raechel T. White, K. Bullers, Cyrille K. Cornelio
{"title":"A Review of the Potential Role of Sotagliflozin: A Dual SGLT2 and SGLT1 Inhibitor—in the Treatment of Heart Failure","authors":"Bao Anh C. Tran, Raechel T. White, K. Bullers, Cyrille K. Cornelio","doi":"10.1177/87551225241261040","DOIUrl":"https://doi.org/10.1177/87551225241261040","url":null,"abstract":"Objective: This review provides an overview of the pharmacology, efficacy, and safety of sotagliflozin, a dual inhibitor of sodium-glucose cotransporters 1 and 2 (SGLT1 and SGLT2), to reduce the risk of cardiovascular death and hospitalization in those with heart failure. Data sources: A search of Embase via Elsevier, PubMed, Web of Science—All Databases, and The Cochrane Library for clinical trials in CENTRAL, as well as the MedRxiv and BioRxiv pre-print servers, was conducted from inception through December 1, 2023. Search terms included sotagliflozin, lx 4211, lp 802034, sar 439954, and (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol. Study selection and data extraction: Published phase 1, phase 2, and phase 3 clinical trials, meta-analyses, and systematic reviews. Studies were included if they were published in English and evaluated sotagliflozin pharmacology, pharmacokinetics, efficacy, or safety. Data synthesis: The Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure (SOLOIST-WHF) and Sotagliflozin on Cardiovascular and Renal Events in Patients with Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk (SCORED) phase 3 trials compared sotagliflozin with placebo in patients with type 2 diabetes mellitus. In both the SCORED and SOLOIST-WHF trials, treatment with sotagliflozin resulted in a statistically significant reduction in the primary composite outcome of death from cardiovascular causes, hospitalizations due to heart failure (HF), and urgent visits for HF. Conclusions: Dual SGLT1 and SGLT2 inhibition with sotagliflozin is efficacious in reducing myocardial infarction (MI), stroke, and HF hospitalizations and urgent visits in the SCORED and SOLOIST-WHF trials. However, its impact on reducing cardiovascular mortality remains uncertain due to premature study discontinuation. Owing to these factors and lack of generalizability, further studies are needed to establish its role in renal protection and cardiovascular mortality in broader populations. At this time, more evidence is warranted to definitively establish sotagliflozin in HF.","PeriodicalId":505060,"journal":{"name":"Journal of Pharmacy Technology","volume":"7 11","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141797882","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A Narrative Review of Novel Agents for Managing Heavily Treatment-Experienced People Living With HIV","authors":"Christina Beran, Joan Duggan, Eric G. Sahloff","doi":"10.1177/87551225241259894","DOIUrl":"https://doi.org/10.1177/87551225241259894","url":null,"abstract":"Objective: The objective of this review is to compare ibalizumab, fostemsavir, and lenacapavir, present the clinical trials evaluating each agent, and provide guidance on their use in highly-treatment experienced (HTE) population living with HIV (PWH). Data sources: A search of PubMed and clinicaltrials.gov was conducted using the search terms: ibalizumab, fostemsavir, and lenacapavir. Study selection and data extraction: English-language, clinical publications were included. Data synthesis: Ibalizumab, fostemsavir, and lenacapavir, are each first-in-class agents, that have major differences in mechanism of action, route and frequency of administration, pharmacokinetic parameters, including elimination half-life, potential for drug-drug interactions, safety profiles, and cost. Each has been shown, when combined with an optimized background regimen (OBR) with at least one other active agent, to achieve virologic suppression in HTE-PWH. Conclusion: In HTE-patients, adding ibalizumab, fostemsavir, and/or lenacapavir to at least one other active agent can lead to virologic suppression in this difficult to treat population. Monotherapy with any of these agents is not recommended and will lead to a high likelihood of drug resistance. Selection of which agent(s) to include with an OBR will depend on other patient factors including concomitant medications, acceptance of formulations (oral vs. subcutaneous vs. intravenous infusion), and potential access (both insurance-based and transportation). Adherence to all agents in the regimen is paramount to successful outcomes.","PeriodicalId":505060,"journal":{"name":"Journal of Pharmacy Technology","volume":"4 6","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141797480","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Aditya Krishnan, Sowmya K. Suryanarayanan, Ishak A. Mansi
{"title":"Utilization of Glucagon-Like Peptide-1 Receptor Agonist and Dipeptidyl Peptidase-4 Inhibitors at the Veterans Health Administration","authors":"Aditya Krishnan, Sowmya K. Suryanarayanan, Ishak A. Mansi","doi":"10.1177/87551225241266773","DOIUrl":"https://doi.org/10.1177/87551225241266773","url":null,"abstract":"Background: Glucagon-like peptide-1 receptor agonists (GLP-1RA) and dipeptidyl peptidase-4 inhibitors (DPP-4i) are incretin-based therapies commonly used in the management of type 2 diabetes. Public interest in GLP-1RA soared after discovering their ability to lower body weight in patients without diabetes. Objective: To examine recent trends in usage of GLP-1RA and DPP-4i in the Veterans Health Administration (VHA). Methods: We extracted GLP-1RA and DPP-4i use from the national VHA Corporate Data Workhouse (CDW) between fiscal years (FYs) 2011 to 2021, which encompass medication class, name, dosage, date of filled prescription, and patients’ characteristics. Results: A total of 3 037 006 prescriptions for DPP-4i and 2 183 294 prescriptions for GLP-1RA were filled during FY 2011 to 2021. More patients were prescribed DPP-4i (273 002 subjects) compared with GLP-1RA (157 209 subjects) from FY 2011 to 2021. Overall, 10.7% used DPP-4i for 90 days or less in comparison to 9.1% in GLP-1RA ( P < 0.001). The proportion of patients prescribed DPP-4i who were 75 years of age or older was relatively stable over the years 2011 to 2021 (mean proportion = 19%). However, the proportion of patients who were 75 years of age or older prescribed GLP-1RA increased from 4.2% in 2011 to 16.9% in 2021. Conclusions: Incretin-based therapies have become a well-established class of drugs within the VHA. Even though DPP-4i usage in older adults has remained stable over the past 10 years, prescriptions for GLP-1RA in older adults have increased multifold over the last few years, which might be attributed to recent trial evidence showing benefit in cardiovascular outcomes and weight reduction.","PeriodicalId":505060,"journal":{"name":"Journal of Pharmacy Technology","volume":"4 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141797961","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ashwin Jagadish, Shahnawaz N Notta, Gerald Falasca
{"title":"Mirtazapine Therapy for a Patient With Weight Loss and Gastroparesis Associated With Limited Systemic Sclerosis","authors":"Ashwin Jagadish, Shahnawaz N Notta, Gerald Falasca","doi":"10.1177/87551225241250282","DOIUrl":"https://doi.org/10.1177/87551225241250282","url":null,"abstract":"Objective: Gastroparesis may be present in individuals with systemic sclerosis. In the United States, metoclopramide is the only medication approved for treating gastroparesis. Our case involves using mirtazapine therapy to help with weight loss and gastroparesis associated with systemic sclerosis. Case: A 70-year-old female with limited systemic sclerosis and sicca syndrome began experiencing weight loss, dysphagia, nausea, and abdominal fullness. Neither an esophageal dilation procedure nor six weeks of metoclopramide therapy alleviated her symptoms. However, 15 mg of mirtazapine once daily provided some symptomatic relief. A gastric emptying scan confirmed gastroparesis. The dose of mirtazapine was later increased to 30 mg once daily. With the mirtazapine therapy, the patient experienced both symptomatic improvement and weight gain benefits. Discussion/Conclusion: Mirtazapine therapy has anti depressive, appetite stimulating, anti-emetic, and prokinetic benefits. Consideration of mirtazapine therapy for patients with weight loss and gastroparesis associated with systemic sclerosis may be beneficial.","PeriodicalId":505060,"journal":{"name":"Journal of Pharmacy Technology","volume":" 27","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140992938","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Tiered Licensure for Pharmacy Technicians: Is the Advanced Pharmacy Technician (APhT) License the Model for State Regulators?","authors":"Alex J. Adams, Timothy P. Frost","doi":"10.1177/87551225241247687","DOIUrl":"https://doi.org/10.1177/87551225241247687","url":null,"abstract":"Two states—Connecticut and New Hampshire—have created or attempted to create advanced pharmacy technician (APhT) licenses. Both licenses, proposed and actual, have high barriers to entry, such as requiring 1 to 3 years of prior technician experience and passage of various assessments or trainings, such as a state-specific jurisprudence exam. Those obtaining APhT licensure are granted additional authority, such as performing final product verification (e.g., tech-check-tech) and vaccine administration. Compared with practices in other states, the APhT role in CT and NH provides minimal scope gains relative to the requirements imposed; as a result, there has been limited uptake (<1%) among current technicians. As such, it appears unlikely that tiered licensure for technicians will be the preferred mechanism for states to expand the role of pharmacy technicians in the future.","PeriodicalId":505060,"journal":{"name":"Journal of Pharmacy Technology","volume":"26 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141008265","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Clinical Pertinence and Determinants of Potential Drug–Drug Interactions in Chronic Kidney Disease Patients: A Cross-sectional Study","authors":"Janvi Khanna, Siddharth Kumar, Sudhir Mehta, Jasmine Chaudhary, Akash Jain","doi":"10.1177/87551225241241977","DOIUrl":"https://doi.org/10.1177/87551225241241977","url":null,"abstract":"Background: Chronic kidney disease (CKD) is one of the major health issues effecting around 15% of world population, and its further complications has raised the need of polypharmacy for management. But this polypharmacy also upsurges the risk of potential drug-drug interactions (pDDIs) in CKD patients, which may further be responsible for increased morbidity and mortality. Objective: The main objective is therefore to evaluate the distribution, severity, causes, associated drug interactions, and clinical relevance of determination of pDDIs in CKD patients. Methods: Medical files of CKD patients examined at nephrology department, Maharishi Markandeshwar Institute of Medical Sciences and Research (MMIMSR), Mullana, between December 2022 and May 2023 were cross-sectionally assessed for this study. Medscape drug interaction checker was used to study patient profiles for pDDIs, and suggestive measures to minimize those pDDIs were studied using DDInter to ensure better clinical decision-making and patient safety. IBM SPSS (version 24) was utilized for statistical analysis. Results: The data reveal that 74.5% of the 200 medical files being evaluated had 839 pDDIs in total, out of which nearly 78.3% of patients had moderate, 15.6% had minor, and 6.07% had serious interactions. The potential adverse outcomes of pDDIs included an irregular heartbeat, hypokalemia, central nervous system (CNS) adverse effects, hypoglycemia, and a decline in therapeutic efficacy. The prevalence of pDDIs was discovered to be substantially correlated with age ≥60 years, (odds ratio [OR] = 0.65; 95% CI = 0.4-0.9; P = 0.040), length of stay ≥10 days (OR = 4.0; 95% CI = 1.29-6.1; P = 0.016), and number of prescribed drugs ≥10 (OR = 5.5; 95% CI = 2.45-10.69; P = 0.004). Conclusion: Patients with CKD have a high incidence of pDDIs (mainly mild to moderate). Older age, duration of hospital stays, and polypharmacy all raise the risk of pDDIs. Healthcare professionals (physicians and clinical pharmacist) should use drug interaction checker software programs like Medscape and DDInter to acquire knowledge about different pDDIS and their alternative measures so that the associated adverse drug reactions (ADRs) can be controlled and rational drug combination can be prescribed for management of CKD ensuring better patient care.","PeriodicalId":505060,"journal":{"name":"Journal of Pharmacy Technology","volume":"378 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140749861","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Evaluation of Anticonvulsant-Induced Leukocytosis: A Review of Evidence for Carbamazepine, Lamotrigine, and Phenobarbital","authors":"Samantha Sutton, Lauren Csurgo, Justin P. Reinert","doi":"10.1177/87551225241228100","DOIUrl":"https://doi.org/10.1177/87551225241228100","url":null,"abstract":"Objective: The objective was to determine the incidence of leukocytosis associated with carbamazepine, lamotrigine, and phenobarbital. Data sources: A comprehensive literature review was conducted with the assistance of a medical reference librarian on PubMed, MEDLINE, Embase, and Google Scholar through June 2023 using the following search terminology: “leukocytosis/chemically induced”[MeSH Terms] AND (“Anticonvulsants”[MeSH Terms] OR (“Anticonvulsants”[Pharmacological Action] OR “Anticonvulsants”[MeSH Terms] OR “Anticonvulsants”[All Fields] OR “anticonvulsant”[All Fields] OR “anticonvulsion”[All Fields] OR “anticonvulsive”[All Fields] OR “anticonvulsives”[All Fields]) OR (“Anticonvulsants”[Pharmacological Action] OR “Anticonvulsants”[MeSH Terms] OR “Anticonvulsants”[All Fields] OR “antiepileptic”[All Fields] OR “antiepileptics”[All Fields])). Study selection and data extraction: Thirteen reports were included from 64 potential results of our literature review following the application of inclusion and exclusion criteria: 7 of the reports involved carbamazepine, 4 of the reports involved lamotrigine, and 2 of the reports involved phenobarbital. Data synthesis: Drug-induced leukocytosis is commonly a diagnosis of exclusion and is a phenomenon that has numerous ramifications to patients and clinicians at the bedside, including mandating a full infectious evaluation, the identification of confounding variables, and the eventual discontinuation of the offending agent. Despite several medications and medication classes possessing this adverse drug effect, an evaluation of the specific clinical presentation and management strategies for drug-induced leukocytosis associated with anticonvulsant medications has not been elucidated in the literature. Conclusions: Clinicians should be judicious when evaluating leukocytosis in patients on potentially precipitating medications, including carbamazepine, lamotrigine, and phenobarbital.","PeriodicalId":505060,"journal":{"name":"Journal of Pharmacy Technology","volume":"333 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140473220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}