Therapeutic Advances in Drug Safety最新文献

{"title":"Adverse event profiles of drug-induced liver injury caused by antidepressant drugs: a disproportionality analysis.","authors":"Aidou Jiang, Chunyan Wei, Weiwei Zhu, Fengbo Wu, Bin Wu","doi":"10.1177/20420986241244585","DOIUrl":"10.1177/20420986241244585","url":null,"abstract":"<p><strong>Background: </strong>Antidepressants are widely used to manage depression and other psychiatric diseases. A previous study revealed that hepatotoxicity was the main adverse event related to antidepressants. Therefore, drug-induced liver injury (DILI) caused by antidepressants deserves more attention.</p><p><strong>Objectives: </strong>To investigate DILI adverse events reported due to antidepressant use in the United States Food and Drug Administration Adverse Events Reporting System (FAERS) database.</p><p><strong>Research design: </strong>A disproportionality analysis of spontaneously reported adverse events was conducted to assess the association between antidepressant drugs and DILI.</p><p><strong>Methods: </strong>FAERS data from 1 January 2004 to 31 December 2021 were compiled and analyzed using the reporting odds ratio (ROR) and information component (IC).</p><p><strong>Results: </strong>As per the FAERS database, of the 324,588 cases that were administered antidepressants, 10,355 were identified as cases with DILI. Among the identified 42 antidepressants, nefazodone (<i>n</i> = 47, ROR = 7.79, IC = 2.91), fluvoxamine (<i>n</i> = 29, ROR = 4.69, IC = 2.20), and clomipramine (<i>n</i> = 24, ROR = 3.97, IC = 1.96) had the highest ROR for cholestatic injury; mianserin (<i>n</i> = 3, ROR = 21.46, IC = 3.99), nefazodone (<i>n</i> = 264, ROR = 18.67, IC = 3.84), and maprotiline (<i>n</i> = 15, ROR = 5.65, IC = 2.39) for hepatocellular injury; and nefazodone (<i>n</i> = 187, ROR = 12.71, IC = 0.48), clomipramine (<i>n</i> = 35, ROR = 2.07, IC = 0.26), and mirtazapine (<i>n</i> = 483, ROR = 1.96, IC = 0.94) for severe drug-related hepatic disorders. Only nefazodone elicited hepatic failure signals (<i>n</i> = 48, ROR = 18.64, IC = 4.16). There are limited reports on the adverse reactions of relatively new antidepressant drugs, such as milnacipran, viloxazine, esketamine, and tianeptine, and those not approved by the Food and Drugs Administration, such as reboxetine and agomelatine.</p><p><strong>Conclusion: </strong>A significant association was observed between DILI and nefazodone. Duloxetine and clomipramine were associated with three DILI categories, except hepatic failure. The disproportionality analysis cannot conclude on a definite causal link between antidepressants and DILI. Additional research is required to assess new-generation antidepressants for their propensity to cause DILI.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11075604/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140877425","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":"Structured medication reviews in Parkinson’s disease: pharmacists’ views, experiences and needs – a qualitative study","authors":"Nicol G. M. Oonk, Lucille D. A. Dorresteijn, Eline te Braake, Kris L. L. Movig, Job van der Palen, Henk-Willem Nijmeijer, Mirjam E. van Kesteren, Christina Bode","doi":"10.1177/20420986241237071","DOIUrl":"https://doi.org/10.1177/20420986241237071","url":null,"abstract":"Background:Executing structured medication reviews (SMRs) in primary care to optimize drug treatment is considered standard care of community pharmacists in the Netherlands. Patients with Parkinson’s disease (PD) often face complex drug regimens for their symptomatic treatment and might, therefore, benefit from an SMR. However, previously, no effect of an SMR on quality of life in PD was found. In trying to improve the case management of PD, it is interesting to understand if and to what extent SMRs in PD patients are of added value in the pharmacist’s opinion and what are assumed facilitating and hindering factors.Objectives:To analyse the process of executing SMRs in PD patients from a community pharmacist’s point of view.Design:A cross-sectional, qualitative study was performed, consisting of face-to-face semi-structured in-depth interviews.Methods:The interviews were conducted with community pharmacists who executed at least one SMR in PD, till data saturation was reached. Interviews were transcribed verbatim, coded and analysed thematically using an iterative approach.Results:Thirteen pharmacists were interviewed. SMRs in PD were considered of added value, especially regarding patient contact and bonding, individualized care and its possible effect in the future, although PD treatment is found already well monitored in secondary care. Major constraints were time, logistics and collaboration with medical specialists.Conclusion:Although community pharmacist-led SMRs are time-consuming and sometimes logistically challenging, they are of added value in primary care in general, and also in PD, of which treatment occurs mainly in secondary care. It emphasizes the pharmacist’s role in PD treatment and might tackle future drug-related issues. Improvements concern multidisciplinary collaboration for optimized SMR execution and results.","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140832756","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":"Abemaciclib pharmacology and interactions in the treatment of HR+/HER2− breast cancer: a critical review","authors":"Federica Martorana, Maria Vita Sanò, Maria Rosaria Valerio, Stefano Fogli, Paolo Vigneri, Romano Danesi, Vittorio Gebbia","doi":"10.1177/20420986231224214","DOIUrl":"https://doi.org/10.1177/20420986231224214","url":null,"abstract":"Abemaciclib (ABE) in combination with endocrine therapy represents the mainstay treatment for either endocrine-resistant metastatic or high-risk early-stage HR+/HER2− breast cancer patients. Hence, an adequate knowledge of this agent pharmacodynamic, pharmacokinetic, and of its drug–drug interactions (DDIs) is crucial for an optimal patients management. Additionally, ABE interference with food and complementary/alternative medicines should be taken into account in the clinical practice. Several online tools allow to freely check DDIs and can be easily consulted before prescribing ABE. According to one of this instruments, ABE display the lowest number of interactions among the available cyclin-dependent kinase 4/6 inhibitors. Still, clinicians should be aware that online tools cannot replace the technical datasheet of the drug as well as a comprehensive clinical assessment for each patient. Here we critically review the main pharmacological features of ABE, then focusing on its potential interactions with drugs, food, and alternative medicine, in order to provide a guide for its optimal use in the treatment of HR+/HER2− breast cancer patients.","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140798088","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":"Drug–drug interaction between tacrolimus and caspofungin in Chinese kidney transplant patients with different CYP3A5 genotypes","authors":"Yundi Zhang, Bowen Shen, Yue Li, Huiying Zong, Xiaoming Zhang, Xiaohong Cao, Fengxi Liu, Yan Li","doi":"10.1177/20420986241243165","DOIUrl":"https://doi.org/10.1177/20420986241243165","url":null,"abstract":"Background:The effect of drug–drug interaction between tacrolimus and caspofungin on the pharmacokinetics of tacrolimus in different CYP3A5 genotypes has not been reported in previous studies.Objectives:To investigate the effect of caspofungin on the blood concentration and dose of tacrolimus under different CYP3A5 genotypes.Design:We conducted a retrospective cohort study in The First Affiliated Hospital of Shandong First Medical University and Shandong Provincial Qianfoshan Hospital from January 2015 to December 2022. All kidney transplant patients were divided into the combination or non-combination group based on whether tacrolimus was combined with caspofungin or not. Patients were subdivided into CYP3A5 expressers ( CYP3A5*1/*1 or CYP3A5*1/*3) and CYP3A5 non-expressers ( CYP3A5*3/*3).Methods:Data from the combination and the non-combination groups were matched with propensity scores to reduce confounding by SPSS 22.0. A total of 200 kidney transplant patients receiving tacrolimus combined with caspofungin or not were enrolled in this study. Statistical analysis was conducted on the dose-corrected trough concentrations ( C<jats:sub>0</jats:sub>/ D) and dose requirements ( D) of tacrolimus using independent sample two-sided t-test and nonparametric tests to investigate the impact on patients with different.Results:In this study, the C<jats:sub>0</jats:sub>/ D values of tacrolimus were not significantly different between the combination and non-combination groups ( p = 0.054). For CYP3A5 expressers, there was no significant difference in tacrolimus C<jats:sub>0</jats:sub>/ D or D values between the combination and non-combination groups ( p = 0.359; p = 0.851). In CYP3A5 nonexpressers, the C<jats:sub>0</jats:sub>/ D values of tacrolimus were significantly lower in the combination than in the non-combination groups ( p = 0.039), and the required daily dose of tacrolimus was increased by 11.11% in the combination group.Conclusion:Co-administration of caspofungin reduced tacrolimus blood levels and elevated the required daily dose of tacrolimus. In CYP3A5 non-expressers, co-administration of caspofungin had a significant effect on tacrolimus C<jats:sub>0</jats:sub>/ D values. An approximate 10% increase in the weight-adjusted daily dose of tacrolimus in CYP3A5 non-expressers is recommended to ensure the safety of tacrolimus administration.","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140625864","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":"Olanzapine for the prevention of postoperative nausea and vomiting after gynecologic laparoscopic surgery: a randomized controlled trial","authors":"Nanjin Chen, Shuman Ji, Junfei Liu, Liping Wang, Fenglin Chen, Yanwu Zhu, Jiao Li, Minjuan Chen, Lingyang Chen, Mingcang Wang, Ruyi He, Xiaopeng Mei, Zhanqin Zhang, Shengwei Jin, Jingming Zheng, Yongpo Jiang","doi":"10.1177/20420986241244593","DOIUrl":"https://doi.org/10.1177/20420986241244593","url":null,"abstract":"Purpose:This study was designed to investigate the prophylactic effect of oral olanzapine in postoperative nausea and vomiting after gynecologic laparoscopic surgery.Methods:ASA I–II, aged 18–75 years, planned to undergo gynecologic laparoscopic surgery with general anesthesia in adult female patients. Using the randomized numbers table, the patients were placed in two groups. Oral olanzapine 5 mg or placebo was given 1 h before anesthesia. All patients received standard antiemetic prophylaxis with dexamethasone and granisetron. The primary outcome was nausea and/or vomiting in the 24 h after the postoperative.Results:A total of 250 patients were randomized, and 241 were analyzed. The primary outcome occurred in 10 of 120 patients (8.3%) in the olanzapine group and 23 of 121 patients (19.2%) in the placebo group ( p = 0.014). According to Kaplan–Meier analysis, the probabilities of nausea and/or vomiting in the 24 h after the postoperative in the olanzapine group were lower than in the placebo group (log-rank p = 0.014). In a multivariate Cox analysis, the variables of use of olanzapine [hazard ratio (HR): 0.35, 95% confidence interval (CI): 0.16–0.79; p = 0.012] and use of vasoactive drugs (HR: 2.48, 95% CI: 1.07–5.75; p = 0.034) were independently associated with nausea and/or vomiting in the 24 h after the postoperative.Conclusion:Our data suggest that olanzapine relative to placebo decreased the risk of nausea and/or vomiting in the 24 h after gynecologic laparoscopic surgery.Trial registration:The trial was registered prior to patient enrollment at The Chinese Clinical Trial Registry ( https://www.chictr.org.cn/showproj.html?proj=166900 , link to registry page, Principal investigator: Nanjin Chen, Date of registration: 25 April 2022).","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140625813","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":"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":null,"pages":null},"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":null,"pages":null},"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":null,"pages":null},"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":null,"pages":null},"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":"Medication errors by caregivers in the homes of children discharged from a pediatric department in Ghana","authors":"G. Sabblah, F. van Hunsel, K. Taxis, Mahama Duwiejua, S. K. Seaneke, Eugène van Puijenbroek","doi":"10.1177/20420986231225850","DOIUrl":"https://doi.org/10.1177/20420986231225850","url":null,"abstract":"Medication errors (MEs) by caregivers at home are a cause of morbidity and mortality, shortly after discharge from the hospital. The objective of this study was to determine the rate and types of MEs at the homes of children discharged from a hospital in Ghana and to explore the factors associated with these errors. This was a cross-sectional study of infants and children discharged from the hospital to review medication administration practices. Caregivers of children discharged from the hospital after at least 24 hours of admission were interviewed at their homes about medication administration practices. The study assessed potential harm associated with MEs made by caregivers using the Harm Associated with Medication Error Classification tool. The Least Absolute Shrinkage and Selection Operator regression were used to identify the variables associated with MEs. A total of 95 children (mean age: 28.6 months, 52.6% female) and their caregivers were included. Overall, 65 (68.4%) children experienced one or more MEs. Out of a total of 232 medications reviewed, 102 (44.0%) (95% CI: 37.6–50.4) were associated with a ME. The top two errors, wrong time errors and errors in the frequency of dosing were, 45.1% and 21.6%, respectively. Understanding the information on the disease condition being treated and the medicines dispensed was associated with committing fewer MEs. The number of medicines prescribed was associated with a higher likelihood of MEs. Out of 102 MEs, 48 (47.1%) were assessed as posing potentially no harm, 26 (25.5%) minor harm, 15 (14.7%) moderate harm, and 13 (12.8%) serious harm to the patients. Importantly, none of the MEs were assessed as posing potentially severe or life-threatening harm to the patients. MEs in children following discharge are high, and systems should be developed to prevent these errors.","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139634574","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}