Therapeutic Advances in Drug Safety最新文献

{"title":"Expression of Concern","authors":"","doi":"10.1177/20420986241239903","DOIUrl":"https://doi.org/10.1177/20420986241239903","url":null,"abstract":"","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"36 1","pages":""},"PeriodicalIF":4.4,"publicationDate":"2024-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140072448","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Harmonization of individual case safety reports transmission requirements among PAHO reference authorities: a review of their current regulation.","authors":"Antonio Lomeli-Silva, Homero Contreras-Salinas, Mayra Yolanda Barajas-Virgen, Maria Soledad Romero-Lopez, Lourdes Yolotzin Rodríguez-Herrera","doi":"10.1177/20420986241228119","DOIUrl":"10.1177/20420986241228119","url":null,"abstract":"<p><p>To perform optimal monitoring of the safety profile in the postmarketing phase, Marketing Authorization Holders and National Regulatory Authorities (NRAs) must evaluate the adverse drug reactions (ADRs) that occurred and characterize their nature, frequency, and severity. Management is possible through Individual Case Safety Reports (ICSRs), which are the reports of organized and processed data. Globally, the International Council for Harmonisation (ICH) E2B guideline suggests harmonized activities for the ICSR electronic content and transmission. In America, the Pan American Health Organization (PAHO) is the agency responsible to implement cooperation among its members, which are recognized as National Regulatory Authorities of Reference (NRARs) such as Argentina, Brazil, Canada, Chile, Colombia, Cuba, Mexico, and the United States. PAHO published the 'Good Pharmacovigilance Practices for the Americas' suggesting improvement and harmonization in the region. After reviewing the regulatory framework, it is assumed that all NRARs have a regulated ICSR transmission system (i.e. a systematic vigilance system for collecting, analyzing, and disseminating information from ADRs). However, significant differences exist, such as the requirement for social media vigilance, expedited and non-expedited ICSRs, coding, severity, and transmission. The volume of ICSRs has significantly increased, due to using electronic standards managed by the NRAs, which facilitates early identification of new ADRs, allowing the implementation of novel minimization activities, contributing to the continuous assessment of the benefit-risk balance of medicines. Nevertheless, there is still area for improvement, especially in Latin America.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"15 ","pages":"20420986241228119"},"PeriodicalIF":4.4,"publicationDate":"2024-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10846002/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139698385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Short-term prognosis of polypharmacy in elderly patients treated in emergency departments: results from the EDEN project.","authors":"Jesus Ruiz Ramos, Aitor Alquézar-Arbé, Ana Juanes Borrego, Guillermo Burillo Putze, Sira Aguiló, Javier Jacob, Cesáreo Fernández, Pere Llorens, Francisco de Borja Quero Espinosa, Susana Gordo Remartinez, Rocio Hernando González, Miguel Moreno Martín, Sara Sánchez Aroca, Alicia Sara Knabe, Rebeca González González, Marina Carrión Fernández, Alberto Artieda Larrañaga, Maria Adroher Muñoz, Jeong-Uh Hong Cho, María Teresa Escolar Martínez Berganza, Sara Gayoso Martín, Goretti Sánchez Sindín, Martina Silva Penas, Bárbara Gómez Y Gómez, Roser Arenos Sambro, Juan González Del Castillo, Òscar Miró","doi":"10.1177/20420986241228129","DOIUrl":"10.1177/20420986241228129","url":null,"abstract":"<p><strong>Background: </strong>Polypharmacy is a growing phenomenon among elderly individuals. However, there is little information about the frequency of polypharmacy among the elderly population treated in emergency departments (EDs) and its prognostic effect. This study aims to determine the prevalence and short-term prognostic effect of polypharmacy in elderly patients treated in EDs.</p><p><strong>Methods: </strong>A retrospective analysis of the Emergency Department Elderly in Needs (EDEN) project's cohort was performed. This registry included all elderly patients who attended 52 Spanish EDs for any condition. Mild and severe polypharmacy was defined as the use of 5-9 drugs and ⩾10 drugs, respectively. The assessed outcomes were ED revisits, hospital readmissions, and mortality 30 days after discharge. Crude and adjusted logistic regression analyses, including the patient's comorbidities, were performed.</p><p><strong>Results: </strong>A total of 25,557 patients were evaluated [mean age: 78 (IQR: 71-84) years]; 10,534 (41.2%) and 5678 (22.2%) patients presented with mild and severe polypharmacy, respectively. In the adjusted analysis, mild polypharmacy and severe polypharmacy were associated with an increase in ED revisits [odds ratio (OR) 1.13 (95% confidence interval (CI): 1.04-1.23) and 1.38 (95% CI: 1.24-1.51)] and hospital readmissions [OR 1.18 (95% CI: 1.04-1.35) and 1.36 (95% CI: 1.16-1.60)], respectively, compared to non-polypharmacy. Mild and severe polypharmacy were not associated with increased 30-day mortality [OR 1.05 (95% CI: 0.89-2.26) and OR 0.89 (95% CI: 0.72-1.12)], respectively.</p><p><strong>Conclusion: </strong>Polypharmacy was common among the elderly treated in EDs and associated with increased risks of ED revisits and hospital readmissions ⩽30 days but not with an increased risk of 30-day mortality. Patients with polypharmacy had a higher risk of ED revisits and hospital readmissions ⩽30 days after discharge.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"15 ","pages":"20420986241228129"},"PeriodicalIF":4.4,"publicationDate":"2024-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10846059/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139698386","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of early retinal changes in patients on long-term hydroxychloroquine using optical coherence tomography angiography.","authors":"Huanhuan Zhao, Menglu Pan, Yaping Liu, Fangyue Cheng, Zongwen Shuai","doi":"10.1177/20420986231225851","DOIUrl":"10.1177/20420986231225851","url":null,"abstract":"<p><strong>Background: </strong>Connective tissue diseases (CTD), including systemic lupus erythematosus and rheumatoid arthritis (RA), have long been treated with hydroxychloroquine (HCQ). However, prolonged HCQ use poses a risk of adverse effects, particularly retinopathy.</p><p><strong>Objective: </strong>To detect early retinal changes assessed by optical coherence tomography angiography (OCTA) in CTD patients with long-term HCQ treatment and to explore the relationship between OCTA parameters and the concentrations of HCQ and its metabolites.</p><p><strong>Design: </strong>A cross-sectional study conducted from March 2020 to October 2021 at the First Affiliated Hospital of Anhui Medical University.</p><p><strong>Methods: </strong>The area and perimeter of the foveal avascular zone (FAZ), the thickness of the fovea and parafovea, and the vascular density of the superficial capillary plexus (SCP) and deep capillary plexus (DCP) in each area of the macula were measured by OCTA in 43 CTD patients treated with HCQ for over 6 months. Meantime, blood concentrations of HCQ and its metabolites were determined by high-performance liquid chromatography-tandem mass spectrometry, and the clinical documents of all 43 involved patients were collected.</p><p><strong>Results: </strong>There is no significant correlation between OCTA outcomes and the patient's age, disease duration, and weight-dependent dose. HCQ cumulative duration positively correlated with FAZ area and perimeter (<i>r</i> = 0.419, <i>p</i> = 0.005 and <i>r</i> = 0.407, <i>p</i> = 0.007, respectively) and negatively correlated with the foveal vessel density in DCP (<i>r</i> = -0.378, <i>p</i> = 0.012). HCQ cumulative dose had a positive correlation with FAZ area and perimeter (<i>r</i> = 0.445, <i>p</i> = 0.003 and <i>r</i> = 0.434, <i>p</i> = 0.004, respectively) and had a negative correlation with foveal vessel density in SCP and DCP (<i>r</i> = -0.383, <i>p</i> = 0.011 and <i>r</i> = -0.424, <i>p</i> = 0.005, respectively). OCTA outcomes did not correlate with HCQ and its metabolite concentrations.</p><p><strong>Conclusion: </strong>OCTA could be used to detect microvascular changes in the macula of CTD patients with long-term HCQ therapy. It was not found the concentrations of HCQ and its metabolites were associated with retinal vascular changes.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"15 ","pages":"20420986231225851"},"PeriodicalIF":3.4,"publicationDate":"2024-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10823852/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139672753","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Physiologically based pharmacokinetic modeling of candesartan to predict the exposure in hepatic and renal impairment and elderly populations.","authors":"Lingfeng Guo, Xinyu Zhu, Lei Zhang, Yichao Xu","doi":"10.1177/20420986231220222","DOIUrl":"10.1177/20420986231220222","url":null,"abstract":"<p><strong>Background: </strong>Candesartan cilexetil is a widely used angiotensin II receptor blocker with minimal adverse effects and high tolerability for the treatment of hypertension. Candesartan is administered orally as the prodrug candesartan cilexetil, which is wholly and swiftly converted to the active metabolite candesartan by carboxylesterase during absorption in the intestinal tract. In populations with renal or hepatic impairment, candesartan's pharmacokinetic (PK) behavior may be altered, necessitating dosage adjustments.</p><p><strong>Objectives: </strong>This study was conducted to examine how the physiologically based PK (PBPK) model characterizes the PKs of candesartan in adult and geriatric populations and to predict the PKs of candesartan in elderly populations with renal and hepatic impairment.</p><p><strong>Design: </strong>After developing PBPK models using the reported physicochemical properties of candesartan and clinical data, these models were validated using data from clinical investigations involving various dose ranges.</p><p><strong>Methods: </strong>Comparing predicted and observed blood concentration data and PK parameters was used to assess the fit performance of the models.</p><p><strong>Results: </strong>Doses should be reduced to approximately 94% of Chinese healthy adults for the Chinese healthy elderly population; approximately 92%, 68%, and 64% of that of the Chinese healthy adult dose in elderly populations with mild, moderate, and severe renal impairment, respectively; and approximately 72%, 71%, and 52% of that of the Chinese healthy adult dose in elderly populations with Child-Pugh-A, Child-Pugh-B, and Child-Pugh-C hepatic impairment, respectively.</p><p><strong>Conclusion: </strong>The results suggest that the PBPK model of candesartan can be utilized to optimize dosage regimens for special populations.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231220222"},"PeriodicalIF":4.4,"publicationDate":"2023-12-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10752084/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139075104","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of four machine learning models for signal detection.","authors":"Daniel G Dauner, Eleazar Leal, Terrence J Adam, Rui Zhang, Joel F Farley","doi":"10.1177/20420986231219472","DOIUrl":"10.1177/20420986231219472","url":null,"abstract":"<p><strong>Background: </strong>Logistic regression-based signal detection algorithms have benefits over disproportionality analysis due to their ability to handle potential confounders and masking factors. Feature exploration and developing alternative machine learning algorithms can further strengthen signal detection.</p><p><strong>Objectives: </strong>Our objective was to compare the signal detection performance of logistic regression, gradient-boosted trees, random forest and support vector machine models utilizing Food and Drug Administration adverse event reporting system data.</p><p><strong>Design: </strong>Cross-sectional study.</p><p><strong>Methods: </strong>The quarterly data extract files from 1 October 2017 through 31 December 2020 were downloaded. Due to an imbalanced outcome, two training sets were used: one stratified on the outcome variable and another using Synthetic Minority Oversampling Technique (SMOTE). A crude model and a model with tuned hyperparameters were developed for each algorithm. Model performance was compared against a reference set using accuracy, precision, F1 score, recall, the receiver operating characteristic area under the curve (ROCAUC), and the precision-recall curve area under the curve (PRCAUC).</p><p><strong>Results: </strong>Models trained on the balanced training set had higher accuracy, F1 score and recall compared to models trained on the SMOTE training set. When using the balanced training set, logistic regression, gradient-boosted trees, random forest and support vector machine models obtained similar performance evaluation metrics. The gradient-boosted trees hyperparameter tuned model had the highest ROCAUC (0.646) and the random forest crude model had the highest PRCAUC (0.839) when using the balanced training set.</p><p><strong>Conclusion: </strong>All models trained on the balanced training set performed similarly. Logistic regression models had higher accuracy, precision and recall. Logistic regression, random forest and gradient-boosted trees hyperparameter tuned models had a PRCAUC ⩾ 0.8. All models had an ROCAUC ⩾ 0.5. Including both disproportionality analysis results and additional case report information in models resulted in higher performance evaluation metrics than disproportionality analysis alone.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231219472"},"PeriodicalIF":4.4,"publicationDate":"2023-12-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10752114/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139075103","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Acceptability of a cross-sectoral hospital pharmacist intervention for patients in transition between hospital and general practice: a mixed methods study.","authors":"Charlotte Arp Sørensen, Linda Jeffery, Klaus Roelsgaard, Solveig Gram, Jannik Falhof, Philipp Harbig, Charlotte Olesen","doi":"10.1177/20420986231213714","DOIUrl":"https://doi.org/10.1177/20420986231213714","url":null,"abstract":"<p><strong>Background and objective: </strong>Drug-related problems (DRPs) are often seen when a patient is transitioning from one healthcare sector to another, for example, when a patient moves from the hospital to a General Practice (GP) setting. This transition creates an opportunity for information on medication changes and follow-up plans to be lost. A cross-sectoral hospital pharmacist intervention was developed and pilot-tested in a large GP clinic. The intervention included medication history, medication reconciliation, medication review, follow-up telephone calls, identification of possible DRPs and communication with the GP. It is unknown whether the intervention is transferable to other GP clinics. The aim of the study was to explore similarities and differences between GP clinics in descriptive data and intervention acceptability.</p><p><strong>Methods: </strong>A convergent mixed methods study design was used. The intervention was tested in four GP clinics with differing characteristics. Quantitative data on the GP clinics, patients and pharmacist activities were collected. Qualitative data on the acceptability were collected through focus group interviews with general practitioners, nurses and pharmacists. The Theoretical Framework of Acceptability was used.</p><p><strong>Results: </strong>Overall, the intervention was found acceptable and relevant by all. There were differences between the GP clinics in terms of size, daily physician work form and their use of pharmacists for <i>ad hoc</i> tasks. There were similarities in patient characteristics across GP clinics. Therefore, the intervention was found equally relevant for all of the clinics. Shared employment with unique access to health records in both sectors was important in the identification and resolution of DRPs. Economy was a barrier for further implementation.</p><p><strong>Conclusions: </strong>The intervention was found acceptable and relevant by all; therefore, it was considered transferable to other GP clinics. Hospital pharmacists were perceived to be relevant healthcare professionals to be utilized in GP, in hospitals and in the cross-sectoral transition of patients.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231213714"},"PeriodicalIF":4.4,"publicationDate":"2023-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10725152/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138799858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Understanding, readiness, and response of healthcare professionals in combating falsified medical products in Eritrea: a population-based survey.","authors":"Yodit Fitsum, Azania Werede, Abubeker Mahmud Saleh, Eyasu H Tesfamariam, Francis Magombo, Freminatos Misghina, Hermella Yemane, Iyassu Bahta, Liya Abraham, Merhawi Bahta, Merhawi Debesai, Meron Tesfagaber, Michael Ghirmai, Sirak Tesfamariam, Mulugeta Russom","doi":"10.1177/20420986231213713","DOIUrl":"10.1177/20420986231213713","url":null,"abstract":"<p><strong>Background: </strong>The circulation of falsified medical products is a global threat and is expected to be higher in low- and middle-income countries.</p><p><strong>Objective: </strong>This study was conducted to assess the understanding, readiness, and response of Eritrea's healthcare professionals (HCPs), and identify potential areas of intervention to combat circulation of falsified medical products.</p><p><strong>Design: </strong>This was a nationwide population-based cross-sectional survey, conducted in December 2021.</p><p><strong>Methods: </strong>This study enrolled representative samples of HCPs working in public and private health facilities. Two-stage stratified cluster sampling was used to select study participants and data were collected through face-to-face interviews. Descriptive statistics, Mann-Whitney <i>U</i> test, Kruskal-Wallis test along with their post hoc tests, Jonckheere-Terpstra, and logistic regression analyses were performed as appropriate.</p><p><strong>Results: </strong>The study enrolled 707 HCPs, and 96.6% were successfully surveyed. The majority of the participants (62.5%) encountered products with suspected quality defects and 63.8% claimed that they had reported the incident(s) at least once. About 85% reported that complaints should be submitted to the Eritrean Pharmacovigilance Centre and 74.0% indicated that it should be reported at the earliest time possible even if the reporter lacks details. The standard reporting form for suspected product quality issues was correctly recognized by 13.8%. Overall, the median knowledge and attitude scores were found to be 9 out of 17 (interquartile range, IQR: 4.0) and 30 out of 35 (IQR: 4.0), respectively. Not knowing how to report (55.6%) and what to report (34.9%), no/delayed feedback from the regulatory authority (30.0%), and unavailability of reporting forms (29.0%) were the frequently reported barriers to reporting. In addition, profession (<i>p</i> = 0.027), no/delayed feedback (adjusted odds ratio [AOR]: 4.70; 95% CI: 2.17-10.18; <i>p</i> < 0.001), and not knowing how to report (AOR: 0.12; 95% CI: 0.05-0.28; <i>p</i> < 0.001) were found to be determinants of reporting suspected product quality defects.</p><p><strong>Conclusion: </strong>The readiness and response of Eritrea's HCPs in detecting and reporting falsified medical products seems promising, although a significant knowledge gap was observed.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231213713"},"PeriodicalIF":4.4,"publicationDate":"2023-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10725142/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138800007","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Modified Dixon sequential method to determine the effective dose of alfentanil compounded with propofol for day-case hysteroscopy.","authors":"Chenyang Xu, Rui Peng, Xiali Qian, Shanwu Feng, Hongmei Yuan","doi":"10.1177/20420986231214992","DOIUrl":"https://doi.org/10.1177/20420986231214992","url":null,"abstract":"<p><strong>Background: </strong>Propofol combined with alfentanil is suitable for intravenous anesthesia for day-case hysteroscopy.</p><p><strong>Objective: </strong>To investigate the median effective dose (ED₅₀) and 95% effective dose (ED₉₅) of alfentanil compounded with propofol for day-case hysteroscopy.</p><p><strong>Design: </strong>In all, 29 patients who volunteered for painless hysteroscopy in 2022 were recruited. 1.5 mg/kg propofol was given as a sedative to all patients. The trial was conducted using the modified Dixon sequential method, with an initial dose of 10 μg/kg of alfentanil, and the subject's alfentanil dose depended on whether the prior hysteroscopy had failed, which was defined as inadequate cervical dilatation and hysteroscope placement with the patient exhibiting body movement, frowning, or a MOAA/S score >1. If the hysteroscopy failed (i.e. a positive response), the subsequent subject's alfentanil dosage was raised, and conversely (i.e. a negative response), the dose was decreased, with the adjacent dose ratio always being 1:1.2. The formal test begins with the first crossover wave and lasts until seven crossover waves materialize.</p><p><strong>Methods: </strong>The probit method was used to calculate the ED₅₀, ED₉₅, and corresponding 95% confidence intervals (CIs) of alfentanil compounded with propofol for hysteroscopy.</p><p><strong>Results: </strong>The ED₅₀ and ED₉₅ of alfentanil combined with propofol for day-case hysteroscopy were 5.701 (95% CI: 3.841-7.069) μg/kg and 8.817 (95% CI: 7.307-20.868) μg/kg, respectively.</p><p><strong>Conclusion: </strong>Alfentanil at 8.817 μg/kg in conjunction with propofol is a successful and safe approach for day-case painless hysteroscopy.</p><p><strong>Trial registration: </strong>The trial registry name: Modified sequential method to determine the half-effective dose of alfentanil compounded with propofol for ambulatory hysteroscopy. The URL of registration is https://www.chictr.org.cn/showproj.html?proj=171786, where the full trial protocol can be accessed. Registration number: ChiCTR2200061619.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231214992"},"PeriodicalIF":4.4,"publicationDate":"2023-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10702409/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138799831","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Inappropriate quetiapine use at a large academic medical center: frequency of misuse and associated costs of adverse effects.","authors":"Winter Roth, David Dadiomov, Michelle Chu","doi":"10.1177/20420986231213173","DOIUrl":"https://doi.org/10.1177/20420986231213173","url":null,"abstract":"<p><strong>Background: </strong>Quetiapine is an antipsychotic with dose-related receptor affinity, which is commonly prescribed by specialties outside of psychiatry. Quetiapine can have adverse effects including weight gain, hyperglycemia, and falls. Therefore, quetiapine is a good focus medication to assess the need for an antipsychotic stewardship protocol.</p><p><strong>Objective: </strong>To assess the need for an antipsychotic stewardship protocol at a large, urban academic medical center by evaluating quetiapine usage.</p><p><strong>Design: </strong>A retrospective review of quetiapine dispensing history for all strengths (immediate release: 25, 50, 100, 200, 300 mg; extended release: 50, 150, 200, 300 mg) over 1 year (1 December 2021 to 30 November 2022) in patients aged 18 and older was conducted at a large, urban academic medical center.</p><p><strong>Methods: </strong>An antipsychotic protocol for safe and effective quetiapine use was developed utilizing its package insert, clinical guidelines, and primary peer-reviewed literature. Once identified by prescription fill, a retrospective chart review was completed for quetiapine indication, dose, and frequency. Each prescription was reviewed for appropriateness using the antipsychotic stewardship protocol.</p><p><strong>Results: </strong>Out of 521 quetiapine prescriptions for 181 unique patients, 67% of scripts were inappropriate. The costs associated with this inappropriate use were extrapolated to be over $350,000 per year when accounting for long-term harms associated with the development of type 2 diabetes mellitus and falls in older adults.</p><p><strong>Conclusion: </strong>Promoting the safe and effective use of antipsychotics through developing and implementing an antipsychotic stewardship protocol may reduce patient harm and associated costs from inappropriate use.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231213173"},"PeriodicalIF":4.4,"publicationDate":"2023-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10702410/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138799825","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}