Pub Date : 2021-08-04eCollection Date: 2021-01-01DOI: 10.1177/20420986211025157
Maire O'Dwyer, Lance Watkins, Philip McCallion, Mary McCarron, Martin Henman, Rohit Shankar
Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). Background
{"title":"Optimising medicines use in older adults with intellectual disability who have epilepsy: challenges and perspectives.","authors":"Maire O'Dwyer, Lance Watkins, Philip McCallion, Mary McCarron, Martin Henman, Rohit Shankar","doi":"10.1177/20420986211025157","DOIUrl":"https://doi.org/10.1177/20420986211025157","url":null,"abstract":"Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). Background","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"12 ","pages":"20420986211025157"},"PeriodicalIF":4.4,"publicationDate":"2021-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/20420986211025157","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39313042","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}
Pub Date : 2021-07-25eCollection Date: 2021-01-01DOI: 10.1177/20420986211027451
Chariclia Paradissis, Neil Cottrell, Ian Coombes, Ian Scott, William Wang, Michael Barras
<p><strong>Background: </strong>Medication harm can lead to hospital admission, prolonged hospital stay and poor patient outcomes. Reducing medication harm is a priority for healthcare organisations worldwide. Recent Australian studies demonstrate cardiovascular (CV) medications are a leading cause of harm. However, they appear to receive less recognition as 'high risk' medications compared with those classified by the medication safety acronym, 'APINCH' (antimicrobials, potassium, insulin, narcotics, chemotherapeutics, heparin). Our aim was to determine the scale and type of medication harm caused by CV medications in healthcare.</p><p><strong>Methods: </strong>A narrative review of adult (>16 years) medication harm literature identified from PubMed and CINAHL databases was undertaken. Studies with the primary outcome of measuring the incidence of medication harm were included. Harm caused by CV medications was described and ranked against other medication classes at four key stages of a patient's healthcare journey. Where specified, the implicated medications and type of harm were investigated.</p><p><strong>Results: </strong>A total of 75 studies were identified, including seven systematic reviews and three meta-analyses, with most focussing on harm causing hospital admission. CV medications were responsible for approximately 20% of medication harm; however, this proportion increased to 50% in older populations. CV medications were consistently ranked in the top five medication categories causing harm and were often listed as the leading cause.</p><p><strong>Conclusion: </strong>CV medications are a leading cause of medication harm, particularly in older adults, and should be the focus of harm mitigation strategies. A practical approach to generate awareness among health professionals is to incorporate 'C' (for CV medications) into the 'APINCH' acronym.</p><p><strong>Plain language summary: </strong><b>Patient harm from cardiovascular medications:</b> <b>Background:</b> • Harm from medications can cause poor patient outcomes.• Certain medications have been identified as 'high risk' and are known to cause high rates of harm.• 'High risk' medications are included in medication guidelines used by health professionals.• Cardiovascular medications (e.g. blood pressure and cholesterol medications) are important and have many benefits.• Recent studies have found cardiovascular medications to cause high rates of harm.• Cardiovascular medication harm is often under-recognised in clinical practice.• Some guidelines do not consider cardiovascular medications to be 'high risk'.<b>Method:</b> • This review investigated the extent of harm caused by cardiovascular medications in adults across four healthcare settings:(1) at the time of hospital admission;(2) during hospital admission;(3) after hospital; and(4) readmission to hospital.• Harm caused by cardiovascular medications was ranked against other medication classes.• We investigated the type of cardiova
{"title":"Patient harm from cardiovascular medications.","authors":"Chariclia Paradissis, Neil Cottrell, Ian Coombes, Ian Scott, William Wang, Michael Barras","doi":"10.1177/20420986211027451","DOIUrl":"https://doi.org/10.1177/20420986211027451","url":null,"abstract":"<p><strong>Background: </strong>Medication harm can lead to hospital admission, prolonged hospital stay and poor patient outcomes. Reducing medication harm is a priority for healthcare organisations worldwide. Recent Australian studies demonstrate cardiovascular (CV) medications are a leading cause of harm. However, they appear to receive less recognition as 'high risk' medications compared with those classified by the medication safety acronym, 'APINCH' (antimicrobials, potassium, insulin, narcotics, chemotherapeutics, heparin). Our aim was to determine the scale and type of medication harm caused by CV medications in healthcare.</p><p><strong>Methods: </strong>A narrative review of adult (>16 years) medication harm literature identified from PubMed and CINAHL databases was undertaken. Studies with the primary outcome of measuring the incidence of medication harm were included. Harm caused by CV medications was described and ranked against other medication classes at four key stages of a patient's healthcare journey. Where specified, the implicated medications and type of harm were investigated.</p><p><strong>Results: </strong>A total of 75 studies were identified, including seven systematic reviews and three meta-analyses, with most focussing on harm causing hospital admission. CV medications were responsible for approximately 20% of medication harm; however, this proportion increased to 50% in older populations. CV medications were consistently ranked in the top five medication categories causing harm and were often listed as the leading cause.</p><p><strong>Conclusion: </strong>CV medications are a leading cause of medication harm, particularly in older adults, and should be the focus of harm mitigation strategies. A practical approach to generate awareness among health professionals is to incorporate 'C' (for CV medications) into the 'APINCH' acronym.</p><p><strong>Plain language summary: </strong><b>Patient harm from cardiovascular medications:</b> <b>Background:</b> • Harm from medications can cause poor patient outcomes.• Certain medications have been identified as 'high risk' and are known to cause high rates of harm.• 'High risk' medications are included in medication guidelines used by health professionals.• Cardiovascular medications (e.g. blood pressure and cholesterol medications) are important and have many benefits.• Recent studies have found cardiovascular medications to cause high rates of harm.• Cardiovascular medication harm is often under-recognised in clinical practice.• Some guidelines do not consider cardiovascular medications to be 'high risk'.<b>Method:</b> • This review investigated the extent of harm caused by cardiovascular medications in adults across four healthcare settings:(1) at the time of hospital admission;(2) during hospital admission;(3) after hospital; and(4) readmission to hospital.• Harm caused by cardiovascular medications was ranked against other medication classes.• We investigated the type of cardiova","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"12 ","pages":"20420986211027451"},"PeriodicalIF":4.4,"publicationDate":"2021-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/20420986211027451","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39291468","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}
Pub Date : 2021-07-16eCollection Date: 2021-01-01DOI: 10.1177/20420986211030371
Elizabeth Manias, Md Zunayed Kabir, Andrea B Maier
Background and aims: Inappropriate medication prescription is highly prevalent in older adults and is associated with adverse health outcomes. The aim of this study was to examine the associations between potentially inappropriate medications (PIMS) and potential prescribing omissions with physical function in older adults situated in diverse environments. Methods: A systematic search was completed using the following databases: MEDLINE, CINAHL, PsycINFO, EMBASE and COCHRANE. Results were extracted from the included studies. Results: In total, 55 studies reported on 2,767,594 participants with a mean age of 77.1 years (63.5% women). Study designs comprised 26 retrospective cohort studies, 21 prospective cohort studies and 8 cross-sectional studies. Inappropriate medications in community and hospital settings were significantly associated with higher risk of falls (21 out of 30 studies), higher risk of fractures (7 out of 9 studies), impaired activities of daily living (ADL; 8 out of 10 studies) and impaired instrumental ADL (IADL) score (4 out of 6 studies). Five out of seven studies also showed that PIMs were associated with poorer physical performance comprising the Timed Up and Go test, walking speed, grip strength, time to functional recovery, functional independence and scale of functioning. Many medication classes were implicated as PIMs in falls, fractures and impairment in physical performance including antipsychotic, sedative, anti-anxiety, anticholinergic, antidiabetic, opioid and antihypertensive medications. For patients not receiving musculoskeletal medications, such as calcium, vitamin D and bisphosphonates, older adults were found to be at risk of a hospital admission for a fall or fracture. Conclusion: Inappropriate medication prescriptions are associated with impaired physical function across longitudinal and cross-sectional studies in older adults situated in diverse settings. It is important to support older people to reduce their use of inappropriate medications and prevent prescribing omissions. Plain language summary Inappropriate medications and physical function Background and aims: The use of inappropriate medications is very common in older adults and is associated with harmful health problems. The aim was to examine associations between potentially inappropriate medications and potential prescribing omissions with physical function in older adults situated in diverse environments. Methods: Library databases were examined for possible studies to include and a systematic search was completed. Relevant information was obtained from the included studies. Results: In total, 55 studies reported on 2,767,594 participants who were an average age of 77.1 years and about 6 out of 10 were women. A variety of different study designs were used. Inappropriate medication prescriptions in community and hospital settings were significantly associated with higher risk of falls (21 out of 30 studies), higher risk of fractures (7 out of 9
背景和目的:不适当的药物处方在老年人中非常普遍，并与不良的健康结果相关。本研究的目的是研究在不同环境下的老年人中，潜在的不适当药物(PIMS)和潜在的处方遗漏与身体功能之间的关系。方法:采用MEDLINE、CINAHL、PsycINFO、EMBASE、COCHRANE等数据库进行系统检索。结果从纳入的研究中提取。结果:总共有55项研究报告了2,767,594名参与者，平均年龄为77.1岁(63.5%为女性)。研究设计包括26项回顾性队列研究，21项前瞻性队列研究和8项横断面研究。社区和医院环境中不适当的药物治疗与较高的跌倒风险(30项研究中的21项)、较高的骨折风险(9项研究中的7项)、日常生活活动受损(ADL;10项研究中的8项)和工具性ADL (IADL)评分受损(6项研究中的4项)。七项研究中有五项还表明，pim与较差的身体表现有关，包括Timed Up and Go测试、步行速度、握力、功能恢复时间、功能独立性和功能规模。许多药物类别都与跌倒、骨折和身体机能受损有关，包括抗精神病药、镇静剂、抗焦虑药、抗胆碱能药、抗糖尿病药、阿片类药物和抗高血压药。研究发现，对于没有接受钙、维生素D和双膦酸盐等肌肉骨骼药物治疗的老年人，他们有因跌倒或骨折而入院的风险。结论:在不同环境的老年人的纵向和横断面研究中，不适当的药物处方与身体功能受损有关。重要的是要支持老年人减少使用不适当的药物并防止处方遗漏。背景和目的:使用不适当的药物在老年人中很常见，并与有害的健康问题有关。目的是研究在不同环境下的老年人中，潜在的不适当药物和潜在的处方遗漏与身体功能之间的关系。方法:对图书馆数据库进行检查，以纳入可能的研究，并完成系统检索。从纳入的研究中获得相关信息。结果:总共有55项研究报告了2,767,594名参与者，平均年龄为77.1岁，其中约六成是女性。采用了多种不同的研究设计。在社区和医院环境中，不适当的药物处方与较高的跌倒风险(30项研究中的21项)、较高的骨折风险(9项研究中的7项)、日常生活活动(ADL)问题(如进食、洗澡、穿衣、修饰、行走和如厕)(10项研究中的8项)以及辅助ADL问题(如管理药物、房屋清洁和购物)(6项研究中的4项)显著相关。七项研究中有五项还表明，不适当的药物治疗与身体表现较差有关，包括Timed Up and Go测试、步行速度、握力、功能恢复时间、功能独立性和功能规模。许多种类的药物被证明与跌倒、骨折和身体机能问题的风险有关。遗漏的药物也与跌倒和骨折有关。结论:药物处方不当与躯体功能问题相关。重要的是要支持老年人减少使用不适当的药物并防止处方遗漏。
{"title":"Inappropriate medications and physical function: a systematic review.","authors":"Elizabeth Manias, Md Zunayed Kabir, Andrea B Maier","doi":"10.1177/20420986211030371","DOIUrl":"https://doi.org/10.1177/20420986211030371","url":null,"abstract":"Background and aims: Inappropriate medication prescription is highly prevalent in older adults and is associated with adverse health outcomes. The aim of this study was to examine the associations between potentially inappropriate medications (PIMS) and potential prescribing omissions with physical function in older adults situated in diverse environments. Methods: A systematic search was completed using the following databases: MEDLINE, CINAHL, PsycINFO, EMBASE and COCHRANE. Results were extracted from the included studies. Results: In total, 55 studies reported on 2,767,594 participants with a mean age of 77.1 years (63.5% women). Study designs comprised 26 retrospective cohort studies, 21 prospective cohort studies and 8 cross-sectional studies. Inappropriate medications in community and hospital settings were significantly associated with higher risk of falls (21 out of 30 studies), higher risk of fractures (7 out of 9 studies), impaired activities of daily living (ADL; 8 out of 10 studies) and impaired instrumental ADL (IADL) score (4 out of 6 studies). Five out of seven studies also showed that PIMs were associated with poorer physical performance comprising the Timed Up and Go test, walking speed, grip strength, time to functional recovery, functional independence and scale of functioning. Many medication classes were implicated as PIMs in falls, fractures and impairment in physical performance including antipsychotic, sedative, anti-anxiety, anticholinergic, antidiabetic, opioid and antihypertensive medications. For patients not receiving musculoskeletal medications, such as calcium, vitamin D and bisphosphonates, older adults were found to be at risk of a hospital admission for a fall or fracture. Conclusion: Inappropriate medication prescriptions are associated with impaired physical function across longitudinal and cross-sectional studies in older adults situated in diverse settings. It is important to support older people to reduce their use of inappropriate medications and prevent prescribing omissions. Plain language summary Inappropriate medications and physical function Background and aims: The use of inappropriate medications is very common in older adults and is associated with harmful health problems. The aim was to examine associations between potentially inappropriate medications and potential prescribing omissions with physical function in older adults situated in diverse environments. Methods: Library databases were examined for possible studies to include and a systematic search was completed. Relevant information was obtained from the included studies. Results: In total, 55 studies reported on 2,767,594 participants who were an average age of 77.1 years and about 6 out of 10 were women. A variety of different study designs were used. Inappropriate medication prescriptions in community and hospital settings were significantly associated with higher risk of falls (21 out of 30 studies), higher risk of fractures (7 out of 9 ","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"12 ","pages":"20420986211030371"},"PeriodicalIF":4.4,"publicationDate":"2021-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/20420986211030371","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39277116","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}
Pub Date : 2021-07-15eCollection Date: 2021-01-01DOI: 10.1177/20420986211027101
J K Akintunde, J A Ajiboye, E O Siemuri, O O Olabisi
Aim: Fansidar (FAN) is widely used as an antimalarial drug, but it may cause hepatoxicity, nephrotoxicity, and neurotoxicity. Hence, the study examines the cytoprotection of selenium (Se) and zinc (Zn) tablets against FAN induced toxicity.
Method: Group I was given distilled water. Groups II, III, IV, and V received 50 mg/kg FAN by gavage. Group III was co-treated with a 50 mg/kg Se tablet. Group IV was co-treated with a 50 mg/kg Zn tablet. Group V was co-treated with a 50 mg/kg Se tablet + 50 mg/kg Zn tablet. The exposure lasted for 7 days (sub-acute exposure).
Result: FAN causes cytotoxicity through significant (p < 0.05) alteration of antioxidant molecules and hepatic enzymes. It also significantly (p < 0.05) induces renal, hepatocyte, and purkinje cell damage, but no visible lesion on testicular cells. The FAN induced cytotoxicity was significantly (p < 0.05) reversed on treatment with both single and combined antioxidant tablets.
Conclusion: Our study supports the view that antioxidant micronutrient (Se and Zn) tablets may be a useful modulator in alleviating FAN induced oxidative stress and cytotoxicity in male rats.
Plain language summary: Combined selenium and zinc capsules: better therapy against cytotoxicity Fansidar was approved by United States' Food and Drug Administration as an anti-malarial drug to treat acute and complicated malaria fever among patients in West Africa; however, its usage elicits toxicity to several organs of the body. It was elucidated that the combination of selenium and zinc capsules promotes organ wellness on co-treatment with Fansidar.
目的：芬斯达（FAN）作为一种抗疟药物被广泛使用，但它可能会引起肝中毒、肾中毒和神经中毒。因此，本研究探讨了硒（Se）和锌（Zn）片对 FAN 引起的毒性的细胞保护作用：方法：I 组给予蒸馏水。方法：I 组给予蒸馏水，II、III、IV 和 V 组灌胃 50 mg/kg FAN。第三组同时服用 50 毫克/千克 Se 片剂。第四组同时服用每公斤 50 毫克的锌片。第五组同时服用 50 毫克/千克硒片剂和 50 毫克/千克锌片剂。暴露持续 7 天（亚急性暴露）：结果：FAN 通过显著的细胞毒性（p p p p 结论：抗氧化剂对细胞毒性的影响很小：我们的研究支持这样一种观点，即抗氧化微量营养素（硒和锌）片剂可能是一种有效的调节剂，可减轻 FAN 对雄性大鼠诱导的氧化应激和细胞毒性。研究表明，硒和锌胶囊的组合可促进与 Fansidar 同时治疗的器官的健康。
{"title":"Fansidar drug induces cytotoxicity in some vital tissues in a rat model: combination defensive effect of selenium and zinc capsules.","authors":"J K Akintunde, J A Ajiboye, E O Siemuri, O O Olabisi","doi":"10.1177/20420986211027101","DOIUrl":"10.1177/20420986211027101","url":null,"abstract":"<p><strong>Aim: </strong>Fansidar (FAN) is widely used as an antimalarial drug, but it may cause hepatoxicity, nephrotoxicity, and neurotoxicity. Hence, the study examines the cytoprotection of selenium (Se) and zinc (Zn) tablets against FAN induced toxicity.</p><p><strong>Method: </strong>Group I was given distilled water. Groups II, III, IV, and V received 50 mg/kg FAN by gavage. Group III was co-treated with a 50 mg/kg Se tablet. Group IV was co-treated with a 50 mg/kg Zn tablet. Group V was co-treated with a 50 mg/kg Se tablet + 50 mg/kg Zn tablet. The exposure lasted for 7 days (sub-acute exposure).</p><p><strong>Result: </strong>FAN causes cytotoxicity through significant (<i>p</i> < 0.05) alteration of antioxidant molecules and hepatic enzymes. It also significantly (<i>p</i> < 0.05) induces renal, hepatocyte, and purkinje cell damage, but no visible lesion on testicular cells. The FAN induced cytotoxicity was significantly (<i>p</i> < 0.05) reversed on treatment with both single and combined antioxidant tablets.</p><p><strong>Conclusion: </strong>Our study supports the view that antioxidant micronutrient (Se and Zn) tablets may be a useful modulator in alleviating FAN induced oxidative stress and cytotoxicity in male rats.</p><p><strong>Plain language summary: </strong><b>Combined selenium and zinc capsules: better therapy against cytotoxicity</b> Fansidar was approved by United States' Food and Drug Administration as an anti-malarial drug to treat acute and complicated malaria fever among patients in West Africa; however, its usage elicits toxicity to several organs of the body. It was elucidated that the combination of selenium and zinc capsules promotes organ wellness on co-treatment with Fansidar.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"12 ","pages":"20420986211027101"},"PeriodicalIF":4.4,"publicationDate":"2021-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/fe/ad/10.1177_20420986211027101.PMC8287264.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39277115","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}
<p><strong>Objectives: </strong>The aim of this study was to conduct a meta-analysis to assess the clinical safety of ceftolozane-tazobactam for the treatment of acute bacterial infections in adult patients.</p><p><strong>Methods: </strong>The PubMed, Embase, and Cochrane databases were searched from their inception until May 2020 for relevant randomized controlled trials (RCTs). Only RCTs evaluating the risk of adverse events (AEs) for ceftolozane-tazobactam and comparative treatments for acute bacterial infections in adult patients were included.</p><p><strong>Results: </strong>Overall, four RCTs including a total of 2924 patients (1475 in the ceftolozane-tazobactam group and 1449 in the control group) were included in the meta-analysis. The rate of treatment-emergent AEs was 51.3% (748/1458) in the ceftolozane-tazobactam group, which was comparable to the control group, 49.9% [714/1430; odd's ratio (OR), 1.06; 95% confidence interval (CI), 0.91-1.25; <i>I</i> <sup>2</sup> = 0%]. In addition, no difference was observed between the ceftolozane-tazobactam and control groups in terms of the risk of serious AEs (OR, 1.22; 95% CI, 0.93-1.61; <i>I</i> <sup>2</sup> = 15.5%) and the risk of discontinuing the study drug due to AEs (OR, 0.85; 95% CI, 0.55-1.33; <i>I</i> <sup>2</sup> = 0%). The rate of all-cause mortality did not significantly differ between the ceftolozane-tazobactam and control groups (OR, 1.11; 95% CI, 0.82-1.50; <i>I</i> <sup>2</sup> = 0%). The only exception was the risk of <i>Clostridiodes difficile</i> (<i>C. difficile</i>) colitis, where ceftolozane-tazobactam treatment was associated with a significantly higher risk compared with the control group [0.72% (10/1376) <i>versus</i> 0.14% (2/1391), OR, 3.84; 95% CI, 1.23-11.97; <i>I</i> <sup>2</sup> = 0%].</p><p><strong>Conclusion: </strong>Ceftolozane-tazobactam treatment is as tolerable as comparative treatment options for acute bacterial infections in adult patients, however it has an increased risk of <i>C. difficile</i> infection. As a novel broad-spectrum antibiotic, ceftolozane-tazobactam could be a safe therapeutic option for use in common clinical practice.</p><p><strong>Plain language summary: </strong><b>The safety of ceftolozane-tazobactam (an antibiotics) for the treatment of acute bacterial infections</b> <b>Objective(s):</b> Ceftolozane-tazobactam is an effective antibiotic for the treatment of acute bacterial infections. This study conducts a meta-analysis to assess the clinical safety (side effects) of ceftolozane-tazobactam for the treatment of acute bacterial infections in adult patients compared with other drugs. <b>Methods:</b> We extracted data from four randomized controlled trials, including a total of 2924 patients (1475 in the ceftolozane-tazobactam group and 1449 in the control group). <b>Results:</b> The rate of treatment related adverse events (AEs) was similar in the ceftolozane-tazobactam group (51.3%) and control group (49.9%). There was also no differe
{"title":"The safety of ceftolozane-tazobactam for the treatment of acute bacterial infections: a systemic review and meta-analysis.","authors":"Li-Ting Wang, Wei-Ting Lin, Chih-Cheng Lai, Ya-Hui Wang, Cheng-Hsin Chen, Yen-Teh Chang, Chao-Hsien Chen, Cheng-Yi Wang","doi":"10.1177/20420986211027096","DOIUrl":"https://doi.org/10.1177/20420986211027096","url":null,"abstract":"<p><strong>Objectives: </strong>The aim of this study was to conduct a meta-analysis to assess the clinical safety of ceftolozane-tazobactam for the treatment of acute bacterial infections in adult patients.</p><p><strong>Methods: </strong>The PubMed, Embase, and Cochrane databases were searched from their inception until May 2020 for relevant randomized controlled trials (RCTs). Only RCTs evaluating the risk of adverse events (AEs) for ceftolozane-tazobactam and comparative treatments for acute bacterial infections in adult patients were included.</p><p><strong>Results: </strong>Overall, four RCTs including a total of 2924 patients (1475 in the ceftolozane-tazobactam group and 1449 in the control group) were included in the meta-analysis. The rate of treatment-emergent AEs was 51.3% (748/1458) in the ceftolozane-tazobactam group, which was comparable to the control group, 49.9% [714/1430; odd's ratio (OR), 1.06; 95% confidence interval (CI), 0.91-1.25; <i>I</i> <sup>2</sup> = 0%]. In addition, no difference was observed between the ceftolozane-tazobactam and control groups in terms of the risk of serious AEs (OR, 1.22; 95% CI, 0.93-1.61; <i>I</i> <sup>2</sup> = 15.5%) and the risk of discontinuing the study drug due to AEs (OR, 0.85; 95% CI, 0.55-1.33; <i>I</i> <sup>2</sup> = 0%). The rate of all-cause mortality did not significantly differ between the ceftolozane-tazobactam and control groups (OR, 1.11; 95% CI, 0.82-1.50; <i>I</i> <sup>2</sup> = 0%). The only exception was the risk of <i>Clostridiodes difficile</i> (<i>C. difficile</i>) colitis, where ceftolozane-tazobactam treatment was associated with a significantly higher risk compared with the control group [0.72% (10/1376) <i>versus</i> 0.14% (2/1391), OR, 3.84; 95% CI, 1.23-11.97; <i>I</i> <sup>2</sup> = 0%].</p><p><strong>Conclusion: </strong>Ceftolozane-tazobactam treatment is as tolerable as comparative treatment options for acute bacterial infections in adult patients, however it has an increased risk of <i>C. difficile</i> infection. As a novel broad-spectrum antibiotic, ceftolozane-tazobactam could be a safe therapeutic option for use in common clinical practice.</p><p><strong>Plain language summary: </strong><b>The safety of ceftolozane-tazobactam (an antibiotics) for the treatment of acute bacterial infections</b> <b>Objective(s):</b> Ceftolozane-tazobactam is an effective antibiotic for the treatment of acute bacterial infections. This study conducts a meta-analysis to assess the clinical safety (side effects) of ceftolozane-tazobactam for the treatment of acute bacterial infections in adult patients compared with other drugs. <b>Methods:</b> We extracted data from four randomized controlled trials, including a total of 2924 patients (1475 in the ceftolozane-tazobactam group and 1449 in the control group). <b>Results:</b> The rate of treatment related adverse events (AEs) was similar in the ceftolozane-tazobactam group (51.3%) and control group (49.9%). There was also no differe","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"12 ","pages":"20420986211027096"},"PeriodicalIF":4.4,"publicationDate":"2021-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/20420986211027096","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39277114","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}
Pub Date : 2021-06-24eCollection Date: 2021-01-01DOI: 10.1177/20420986211016173
Paige L Morizio, Sara R Britnell, Andreina A Ottman
<p><strong>Background and aims: </strong>Chemical impurities discovered in angiotensin receptor blocker (ARB) products in late 2018-2019 resulted in recalls of various products and has likely had downstream effects for patients and prescribers. The purpose of this study is to determine how the valsartan recall impacted clinical endpoints and prescribing of antihypertensives.</p><p><strong>Methods: </strong>This was a retrospective, single-center, cohort study including patients receiving recalled valsartan with essential hypertension who were mailed a recall letter on 12 March 2019. Mean blood pressure endpoints were collected 6 months before (pre-recall) and after the recall letter was mailed (post-recall). Antihypertensive medication changes and titrations were also characterized post-recall.</p><p><strong>Results: </strong>A total of 300 patients meeting eligibility criteria were included. There was no statistically significant difference in mean systolic blood pressure (SBP) or diastolic blood pressure (DBP) when pre- and post-recall blood pressures were compared (SBP: 137.2 mmHg <i>versus</i> 135.8 mmHg, <i>p</i> = 0.125; DBP: 78.6 mmHg <i>versus</i> 78.5 mmHg, <i>p</i> = 0.900). In addition, the percentage of patients with controlled blood pressure readings was similar in the pre- and post-recall timeframes (28% <i>versus</i> 27%, <i>p</i> = 0.72). A total of 33 medication changes involving valsartan occurred, with approximately one-third being changed to another ARB (<i>n</i> = 11) or drug class (<i>n</i> = 12). In total, 11 valsartan medication changes were specifically documented to be related to the valsartan recall.</p><p><strong>Conclusion: </strong>The results of this study indicate the valsartan recalls that occurred in 2019 did not significantly impact the clinical outcomes of the studied population.</p><p><strong>Plain language summary: </strong>Impact of a medication recall on Veterans' outcomes<b>Background::</b> Chemical impurities discovered in a class of blood pressure medications known as angiotensin receptor blockers (ARBs) occurred in late 2018-2019. This resulted in recalls of various products and has likely had downstream effects for patients and prescribers.<b>Objective::</b> The purpose of this study is to determine how the recall of valsartan, which is a medication in the ARB class, impacted clinical endpoints and prescribing of medications for blood pressure.<b>Methods::</b> This was a retrospective, single-center, cohort study including patients receiving recalled valsartan with high blood pressure who were mailed a recall letter on 12 March 2019. Blood pressure endpoints were collected 6 months before (pre-recall) and after the recall letter was mailed (post-recall). Medication changes and titrations were also characterized post-recall.<b>Results::</b> Three hundred patients meeting eligibility criteria were included. There was no difference found in systolic blood pressure (SBP) or diastolic blood pressure (DBP) w
背景和目的:2018年底至2019年在血管紧张素受体阻滞剂(ARB)产品中发现的化学杂质导致各种产品被召回，并可能对患者和处方者产生下游影响。本研究的目的是确定缬沙坦召回对临床终点和抗高血压药物处方的影响。方法:这是一项回顾性、单中心、队列研究，纳入了2019年3月12日收到召回信的接受召回缬沙坦治疗的原发性高血压患者。收集召回前6个月(召回前)和召回后6个月(召回后)的平均血压终点。召回后抗高血压药物的变化和滴定也有特征。结果:共纳入300例符合入选标准的患者。当比较回忆前和回忆后的血压时，平均收缩压(SBP)和舒张压(DBP)无统计学差异(SBP: 137.2 mmHg vs 135.8 mmHg, p = 0.125;舒张压:78.6 mmHg vs 78.5 mmHg, p = 0.900)。此外，在回忆前后，血压读数得到控制的患者比例相似(28%对27%，p = 0.72)。总共发生了33例涉及缬沙坦的药物改变，其中约三分之一的患者被改为另一种ARB (n = 11)或药物类别(n = 12)。总共有11例缬沙坦药物改变被明确记录为与缬沙坦召回有关。结论:本研究结果表明，2019年发生的缬沙坦召回事件对研究人群的临床结果没有显著影响。背景:2018年底至2019年，在一类被称为血管紧张素受体阻滞剂(ARBs)的降压药中发现了化学杂质。这导致了各种产品的召回，并可能对患者和处方者产生下游影响。目的:本研究的目的是确定缬沙坦(ARB类药物)的召回对临床终点和降压药处方的影响。方法:这是一项回顾性、单中心、队列研究，纳入了接受召回缬沙坦治疗的高血压患者，这些患者于2019年3月12日收到召回信。分别在召回前(召回前)和召回信寄出后(召回后)6个月采集血压终点。药物变化和滴定也被描述为召回后的特征。结果:300例患者符合入选标准。当比较回忆前和回忆后的血压时，收缩压(SBP)和舒张压(DBP)没有差异(SBP: 137.2 mmHg vs 135.8 mmHg;舒张压:78.6 mmHg vs 78.5 mmHg)。此外，在回忆前后，血压读数得到控制的患者比例相似(28%对27%)。总共发生了33例涉及缬沙坦的药物改变，其中约三分之一的患者被改为另一种ARB (n = 11)或药物类别(n = 12)。11种缬沙坦药物变化被特别记录为与缬沙坦召回有关。结论:本研究结果表明，2019年发生的缬沙坦召回事件对研究人群的临床结果没有显著影响。
{"title":"Impact of national valsartan recalls on Veterans' outcomes.","authors":"Paige L Morizio, Sara R Britnell, Andreina A Ottman","doi":"10.1177/20420986211016173","DOIUrl":"https://doi.org/10.1177/20420986211016173","url":null,"abstract":"<p><strong>Background and aims: </strong>Chemical impurities discovered in angiotensin receptor blocker (ARB) products in late 2018-2019 resulted in recalls of various products and has likely had downstream effects for patients and prescribers. The purpose of this study is to determine how the valsartan recall impacted clinical endpoints and prescribing of antihypertensives.</p><p><strong>Methods: </strong>This was a retrospective, single-center, cohort study including patients receiving recalled valsartan with essential hypertension who were mailed a recall letter on 12 March 2019. Mean blood pressure endpoints were collected 6 months before (pre-recall) and after the recall letter was mailed (post-recall). Antihypertensive medication changes and titrations were also characterized post-recall.</p><p><strong>Results: </strong>A total of 300 patients meeting eligibility criteria were included. There was no statistically significant difference in mean systolic blood pressure (SBP) or diastolic blood pressure (DBP) when pre- and post-recall blood pressures were compared (SBP: 137.2 mmHg <i>versus</i> 135.8 mmHg, <i>p</i> = 0.125; DBP: 78.6 mmHg <i>versus</i> 78.5 mmHg, <i>p</i> = 0.900). In addition, the percentage of patients with controlled blood pressure readings was similar in the pre- and post-recall timeframes (28% <i>versus</i> 27%, <i>p</i> = 0.72). A total of 33 medication changes involving valsartan occurred, with approximately one-third being changed to another ARB (<i>n</i> = 11) or drug class (<i>n</i> = 12). In total, 11 valsartan medication changes were specifically documented to be related to the valsartan recall.</p><p><strong>Conclusion: </strong>The results of this study indicate the valsartan recalls that occurred in 2019 did not significantly impact the clinical outcomes of the studied population.</p><p><strong>Plain language summary: </strong>Impact of a medication recall on Veterans' outcomes<b>Background::</b> Chemical impurities discovered in a class of blood pressure medications known as angiotensin receptor blockers (ARBs) occurred in late 2018-2019. This resulted in recalls of various products and has likely had downstream effects for patients and prescribers.<b>Objective::</b> The purpose of this study is to determine how the recall of valsartan, which is a medication in the ARB class, impacted clinical endpoints and prescribing of medications for blood pressure.<b>Methods::</b> This was a retrospective, single-center, cohort study including patients receiving recalled valsartan with high blood pressure who were mailed a recall letter on 12 March 2019. Blood pressure endpoints were collected 6 months before (pre-recall) and after the recall letter was mailed (post-recall). Medication changes and titrations were also characterized post-recall.<b>Results::</b> Three hundred patients meeting eligibility criteria were included. There was no difference found in systolic blood pressure (SBP) or diastolic blood pressure (DBP) w","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"12 ","pages":"20420986211016173"},"PeriodicalIF":4.4,"publicationDate":"2021-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/20420986211016173","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39174289","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}
<p><strong>Background: </strong>Hiccups are usually benign and self-limiting, but can sometimes be persistent. If left untreated, they can provoke severe discomfort, and even death. Hiccups can be idiopathic, organic, psychogenic, and caused by drugs. Although some case reports have suggested a possible association between tramadol and hiccups, to our knowledge, no study has analyzed this possible relationship. The aim of this study was to analyze whether a disproportionate number of cases of hiccups are reported for tramadol in the EudraVigilance database.</p><p><strong>Methods: </strong>A case-noncase study was conducted to assess the association between hiccups and tramadol, calculating reporting odds ratios (RORs) from 1 January 1995 to 11 September 2020. Cases were selected using the preferred term 'Hiccups'. The noncases used as controls were all other adverse drug reaction reports recorded in EudraVigilance during the same period. Exposure was defined as exposure to tramadol among cases and noncases. To reduce the risk of confounding by indication, the RORs for tramadol compared with other opioids were obtained. Additionally, we performed a confirmatory analysis in the World Health Organization pharmacovigilance database, VigiBase<sup>®</sup>.</p><p><strong>Results: </strong>There were 3089 cases of hiccups in the 7,213,623 reports. Tramadol was involved in 50 cases. The ROR for tramadol exposure was 3.35 [95% confidence interval (CI) 2.53-4.43]. This association persisted when comparing tramadol with other opioids; ROR: 2.13 (95% CI 1.52-2.99). Disproportionality was also observed in VigiBase<sup>®</sup>: ROR 1.69 (95% CI 1.47-1.93).</p><p><strong>Conclusion: </strong>Our study confirms, for the first time, a possible signal for a tramadol-hiccups association. Nevertheless, observational analytical studies are needed to confirm these results.</p><p><strong>Plain language summary: </strong>Evaluation of the relationship between the tramadol and the risk of hiccups<b>Introduction:</b> Hiccups are sudden involuntary contractions of the diaphragm. This involuntary contraction causes the vocal cords to close very briefly, which produces the characteristic sound of a hiccup. Hiccups are usually benign and self-limiting, but can sometimes be persistent. If left untreated, they can provoke severe discomfort, depression, disability, and in the most extreme cases, even death. Drugs are a rare cause of hiccups.<b>Methods:</b> This study investigated the possible association between tramadol and hiccups (an unmentioned adverse drug reaction in the Summary of Product Characteristics) in the European pharmacovigilance database (EudraVigilance) and a confirming analysis in the World Health Organization pharmacovigilance database (VigiBase).<b>Results:</b> Our analysis shows that hiccups is relatively more frequently reported in association with tramadol than with other medicinal products, with EudraVigilance and VigiBase confirming this association.<b>C
背景:打嗝通常是良性和自限性的，但有时也会持续。如果不及时治疗，它们会引起严重的不适，甚至死亡。打嗝可以是特发性的、器质性的、心因性的，也可以是药物引起的。尽管一些病例报告表明曲马多和打嗝之间可能存在关联，但据我们所知，还没有研究分析过这种可能的关系。本研究的目的是分析eudravilance数据库中曲马多报告的打嗝病例数量是否不成比例。方法:采用病例-非病例研究，通过计算1995年1月1日至2020年9月11日的报告优势比(RORs)，评估打嗝与曲马多之间的关系。病例选择使用首选术语“打嗝”。作为对照的非病例为同期eudravilance中记录的所有其他药物不良反应报告。暴露定义为病例和非病例的曲马多暴露。为了减少因适应症引起的混淆风险，我们比较了曲马多与其他阿片类药物的RORs。此外，我们在世界卫生组织药物警戒数据库VigiBase®中进行了验证性分析。结果:7213623例报告中打嗝3089例。50例病例涉及曲马多。曲马多暴露的ROR为3.35[95%可信区间(CI) 2.53-4.43]。当将曲马多与其他阿片类药物进行比较时，这种关联仍然存在;Ror: 2.13 (95% ci 1.52-2.99)。在VigiBase®中也观察到歧化:ROR 1.69 (95% CI 1.47-1.93)。结论:我们的研究首次证实了曲马多-呃逆相关的可能信号。然而，需要观察性分析研究来证实这些结果。摘要:评价曲马多与呃逆风险之间的关系简介:呃逆是横膈膜突然的不自主收缩。这种不自觉的收缩会导致声带短暂关闭，从而产生打嗝的特征声音。打嗝通常是良性的，可以自限性的，但有时也会持续。如果不及时治疗，它们会引起严重的不适、抑郁、残疾，在最极端的情况下，甚至会导致死亡。药物是打嗝的罕见原因。方法:本研究调查了曲马多与欧洲药物警戒数据库(EudraVigilance)中打嗝(产品特征摘要中未提及的药物不良反应)之间的可能关联，并在世界卫生组织药物警戒数据库(VigiBase)中进行了确认分析。结果:我们的分析显示，与其他药物相比，曲马多与打嗝相关的报道相对更频繁，EudraVigilance和VigiBase证实了这一关联。结论:曲马多是一种阿片类镇痛药，可单独或与右酮洛芬或扑热息痛联合用于各种原因的疼痛，因此医护人员和患者应意识到这种可能的关联。
{"title":"Tramadol-induced hiccups: a case-noncase study in the European pharmacovigilance database.","authors":"Montserrat García, Unax Lertxundi, Carmelo Aguirre","doi":"10.1177/20420986211021230","DOIUrl":"https://doi.org/10.1177/20420986211021230","url":null,"abstract":"<p><strong>Background: </strong>Hiccups are usually benign and self-limiting, but can sometimes be persistent. If left untreated, they can provoke severe discomfort, and even death. Hiccups can be idiopathic, organic, psychogenic, and caused by drugs. Although some case reports have suggested a possible association between tramadol and hiccups, to our knowledge, no study has analyzed this possible relationship. The aim of this study was to analyze whether a disproportionate number of cases of hiccups are reported for tramadol in the EudraVigilance database.</p><p><strong>Methods: </strong>A case-noncase study was conducted to assess the association between hiccups and tramadol, calculating reporting odds ratios (RORs) from 1 January 1995 to 11 September 2020. Cases were selected using the preferred term 'Hiccups'. The noncases used as controls were all other adverse drug reaction reports recorded in EudraVigilance during the same period. Exposure was defined as exposure to tramadol among cases and noncases. To reduce the risk of confounding by indication, the RORs for tramadol compared with other opioids were obtained. Additionally, we performed a confirmatory analysis in the World Health Organization pharmacovigilance database, VigiBase<sup>®</sup>.</p><p><strong>Results: </strong>There were 3089 cases of hiccups in the 7,213,623 reports. Tramadol was involved in 50 cases. The ROR for tramadol exposure was 3.35 [95% confidence interval (CI) 2.53-4.43]. This association persisted when comparing tramadol with other opioids; ROR: 2.13 (95% CI 1.52-2.99). Disproportionality was also observed in VigiBase<sup>®</sup>: ROR 1.69 (95% CI 1.47-1.93).</p><p><strong>Conclusion: </strong>Our study confirms, for the first time, a possible signal for a tramadol-hiccups association. Nevertheless, observational analytical studies are needed to confirm these results.</p><p><strong>Plain language summary: </strong>Evaluation of the relationship between the tramadol and the risk of hiccups<b>Introduction:</b> Hiccups are sudden involuntary contractions of the diaphragm. This involuntary contraction causes the vocal cords to close very briefly, which produces the characteristic sound of a hiccup. Hiccups are usually benign and self-limiting, but can sometimes be persistent. If left untreated, they can provoke severe discomfort, depression, disability, and in the most extreme cases, even death. Drugs are a rare cause of hiccups.<b>Methods:</b> This study investigated the possible association between tramadol and hiccups (an unmentioned adverse drug reaction in the Summary of Product Characteristics) in the European pharmacovigilance database (EudraVigilance) and a confirming analysis in the World Health Organization pharmacovigilance database (VigiBase).<b>Results:</b> Our analysis shows that hiccups is relatively more frequently reported in association with tramadol than with other medicinal products, with EudraVigilance and VigiBase confirming this association.<b>C","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"12 ","pages":"20420986211021230"},"PeriodicalIF":4.4,"publicationDate":"2021-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/20420986211021230","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39073702","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}
<p><strong>Introduction: </strong>Older adults continue to receive potentially inappropriate medications necessitating the need for medication optimization, by deprescribing. To ensure a holistic approach to deprescribing, it is essential to understand the perception of older adults towards deprescribing. This study aimed to assess the attitude of older ambulatory patients towards deprescribing and to identify factors predicting their willingness to deprescribe.</p><p><strong>Methods: </strong>A cross-sectional survey was conducted in central Nepal between March and September 2019 among 385 older ambulatory care patients (aged ⩾65 years) who were taking at least one regular medicine. The perception of patients towards deprescribing was assessed using the revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire <i>via</i> a face-to-face interview method. Descriptive statistics were performed to describe patients' characteristics and their attitudes towards deprescribing. A multivariate logistic regression analysis was used to determine predictors of the willingness of older ambulatory patients towards deprescribing.</p><p><strong>Results: </strong>The median [interquartile range (IQR)] age of patients was 72 (8) years. Nearly three in five patients (64.9%) had hypertension, with 11.2% having polypharmacy. More than half of the patients (57.4%) would be willing to stop one or more of their regular medicines if their doctor said it was possible to do so. Regression analysis showed that age [odds ratio (OR) 0.946; 95% CI 0.913, 0.981; <i>p</i> = 0.003] and concerns about stopping medicine score (OR 0.541; 95% CI 0.334, 0.876; <i>p</i> = 0.013) were predictors of the willingness of the older patients towards deprescribing.</p><p><strong>Conclusion: </strong>One in two older ambulatory care patients in Nepal would be willing to have one or more of their medicines deprescribed. The factors predicting their willingness to deprescribe are their age and concerns about stopping medicines. Clinicians should consider discussing the possibility of deprescribing with older patients for the prevention of potential medication-related harms.</p><p><strong>Plain language summary: </strong>What do older Nepalese patients think about withdrawal or dose reduction of an inappropriate medication?<b>Introduction:</b> Research suggests that older adults (aged ⩾65 years) continue to receive medications that have the potential for harm rather than a benefit. This necessitates the need for withdrawal or dose reduction of such inappropriate medications, the process known as deprescribing. Understanding what older patients think about this process could be a stepping-stone to the general approach for its implementation. Data on deprescribing is lacking from Nepal. Therefore, we designed a survey to explore the attitude of older patients towards deprescribing and factors that could predict their willingness to deprescribe.<b>Methods:</b> This study was conducted
{"title":"Attitudes of ambulatory care older Nepalese patients towards deprescribing and predictors of their willingness to deprescribe.","authors":"Shakti Shrestha, Roshan Giri, Hari Prasad Sapkota, Siddhartha Sharma Danai, Ahsan Saleem, Shreeshab Devkota, Sagar Shrestha, Bhojraj Adhikari, Arjun Poudel","doi":"10.1177/20420986211019309","DOIUrl":"10.1177/20420986211019309","url":null,"abstract":"<p><strong>Introduction: </strong>Older adults continue to receive potentially inappropriate medications necessitating the need for medication optimization, by deprescribing. To ensure a holistic approach to deprescribing, it is essential to understand the perception of older adults towards deprescribing. This study aimed to assess the attitude of older ambulatory patients towards deprescribing and to identify factors predicting their willingness to deprescribe.</p><p><strong>Methods: </strong>A cross-sectional survey was conducted in central Nepal between March and September 2019 among 385 older ambulatory care patients (aged ⩾65 years) who were taking at least one regular medicine. The perception of patients towards deprescribing was assessed using the revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire <i>via</i> a face-to-face interview method. Descriptive statistics were performed to describe patients' characteristics and their attitudes towards deprescribing. A multivariate logistic regression analysis was used to determine predictors of the willingness of older ambulatory patients towards deprescribing.</p><p><strong>Results: </strong>The median [interquartile range (IQR)] age of patients was 72 (8) years. Nearly three in five patients (64.9%) had hypertension, with 11.2% having polypharmacy. More than half of the patients (57.4%) would be willing to stop one or more of their regular medicines if their doctor said it was possible to do so. Regression analysis showed that age [odds ratio (OR) 0.946; 95% CI 0.913, 0.981; <i>p</i> = 0.003] and concerns about stopping medicine score (OR 0.541; 95% CI 0.334, 0.876; <i>p</i> = 0.013) were predictors of the willingness of the older patients towards deprescribing.</p><p><strong>Conclusion: </strong>One in two older ambulatory care patients in Nepal would be willing to have one or more of their medicines deprescribed. The factors predicting their willingness to deprescribe are their age and concerns about stopping medicines. Clinicians should consider discussing the possibility of deprescribing with older patients for the prevention of potential medication-related harms.</p><p><strong>Plain language summary: </strong>What do older Nepalese patients think about withdrawal or dose reduction of an inappropriate medication?<b>Introduction:</b> Research suggests that older adults (aged ⩾65 years) continue to receive medications that have the potential for harm rather than a benefit. This necessitates the need for withdrawal or dose reduction of such inappropriate medications, the process known as deprescribing. Understanding what older patients think about this process could be a stepping-stone to the general approach for its implementation. Data on deprescribing is lacking from Nepal. Therefore, we designed a survey to explore the attitude of older patients towards deprescribing and factors that could predict their willingness to deprescribe.<b>Methods:</b> This study was conducted ","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"12 ","pages":"20420986211019309"},"PeriodicalIF":4.4,"publicationDate":"2021-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/91/9c/10.1177_20420986211019309.PMC8216397.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39073703","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}
Pub Date : 2021-06-14eCollection Date: 2021-01-01DOI: 10.1177/20420986211021233
Allison L Naleway, Bradley Crane, Stephanie A Irving, Don Bachman, Kimberly K Vesco, Matthew F Daley, Darios Getahun, Sungching C Glenn, Simon J Hambidge, Lisa A Jackson, Nicola P Klein, Natalie L McCarthy, David L McClure, Lakshmi Panagiotakopoulos, Catherine A Panozzo, Gabriela Vazquez-Benitez, Eric S Weintraub, Ousseny Zerbo, Elyse O Kharbanda
<p><strong>Background: </strong>Identifying pregnancy episodes and accurately estimating their beginning and end dates are imperative for observational maternal vaccine safety studies using electronic health record (EHR) data.</p><p><strong>Methods: </strong>We modified the Vaccine Safety Datalink (VSD) Pregnancy Episode Algorithm (PEA) to include both the International Classification of Disease, ninth revision (ICD-9 system) and ICD-10 diagnosis codes, incorporated additional gestational age data, and validated this enhanced algorithm with manual medical record review. We also developed the new Dynamic Pregnancy Algorithm (DPA) to identify pregnancy episodes in real time.</p><p><strong>Results: </strong>Around 75% of the pregnancy episodes identified by the enhanced VSD PEA were live births, 12% were spontaneous abortions (SABs), 10% were induced abortions (IABs), and 0.4% were stillbirths (SBs). Gestational age was identified for 99% of live births, 89% of SBs, 69% of SABs, and 42% of IABs. Agreement between the PEA-assigned and abstractor-identified pregnancy outcome and outcome date was 100% for live births, but was lower for pregnancy losses. When gestational age was available in the medical record, the agreement was higher for live births (97%), but lower for pregnancy losses (75%). The DPA demonstrated strong concordance with the PEA and identified pregnancy episodes ⩾6 months prior to the outcome date for 89% of live births.</p><p><strong>Conclusion: </strong>The enhanced VSD PEA is a useful tool for identifying pregnancy episodes in EHR databases. The DPA improves the timeliness of pregnancy identification and can be used for near real-time maternal vaccine safety studies.</p><p><strong>Plain language summary: </strong><b>Improving identification of pregnancies in the Vaccine Safety Datalink electronic medical record databases to allow for better and faster monitoring of vaccination safety during pregnancy</b> <b>Introduction:</b> It is important to monitor of the safety of vaccines after they have been approved and licensed by the Food and Drug Administration, especially among women vaccinated during pregnancy. The Vaccine Safety Datalink (VSD) monitors vaccine safety through observational studies within large databases of electronic medical records. Since 2012, VSD researchers have used an algorithm called the Pregnancy Episode Algorithm (PEA) to identify the medical records of women who have been pregnant. Researchers then use these medical records to study whether receiving a particular vaccine is linked to any negative outcomes for the woman or her child.<b>Methods:</b> The goal of this study was to update and enhance the PEA to include the full set of medical record diagnostic codes [both from the older International Classification of Disease, ninth revision (ICD-9 system) and the newer ICD-10 system] and to incorporate additional sources of data about gestational age. To ensure the validity of the PEA following these enhancements,
背景：使用电子健康记录（EHR）数据进行孕产妇疫苗安全性观察研究时，必须识别妊娠事件并准确估计其开始和结束日期：方法：我们修改了疫苗安全数据链（VSD）妊娠期事件算法（PEA），将国际疾病分类第九版（ICD-9 系统）和 ICD-10 诊断代码都包括在内，纳入了额外的妊娠年龄数据，并通过人工病历审查验证了这一增强算法。我们还开发了新的动态妊娠算法（DPA）来实时识别妊娠事件：结果：VSD PEA 增强版识别出的妊娠事件中，约 75% 为活产，12% 为自然流产 (SAB)，10% 为人工流产 (IAB)，0.4% 为死产 (SB)。99% 的活产、89% 的 SB、69% 的 SAB 和 42% 的 IAB 均已确定胎龄。在活产婴儿中，PEA 指定的妊娠结果与文摘员确定的妊娠结果日期之间的一致性为 100%，但在妊娠丢失婴儿中，两者之间的一致性较低。如果病历中提供了胎龄，则活产的一致性更高（97%），但流产的一致性较低（75%）。DPA 与 PEA 的一致性很高，89% 的活产婴儿在结果日期前 6 个月⩾发生妊娠：结论：增强型 VSD PEA 是在电子病历数据库中识别妊娠事件的有用工具。DPA 提高了妊娠识别的及时性，可用于近乎实时的孕产妇疫苗安全性研究。 简明摘要：改进疫苗安全数据链接电子病历数据库中的妊娠识别，以便更好、更快地监测孕期疫苗接种的安全性：在疫苗获得美国食品药品管理局批准和许可后，对其安全性进行监测非常重要，尤其是在孕期接种疫苗的妇女中。疫苗安全数据链（Vaccine Safety Datalink，VSD）通过大型电子病历数据库中的观察性研究来监测疫苗的安全性。自 2012 年起，VSD 的研究人员开始使用一种名为 "妊娠事件算法"（PEA）的算法来识别怀孕妇女的医疗记录。然后，研究人员利用这些医疗记录来研究接种特定疫苗是否与妇女或其子女的任何不良后果有关：本研究的目标是更新和增强 PEA，使其包含全套医疗记录诊断代码（既包括较早的《国际疾病分类》第九版（ICD-9 系统），也包括较新的《国际疾病分类》第 10 版系统），并纳入有关孕龄的其他数据来源。为了确保 PEA 在这些改进后的有效性，我们人工审核了医疗记录，并将结果与算法进行了比较。我们还开发了一种新算法--动态妊娠算法 (DPA)，以识别妊娠早期的妇女，使我们能够更及时地进行疫苗安全性评估：结果：新版 PEA 在 VSD 数据库中识别出 2,485,410 名孕妇。由于有了新的胎龄数据来源，增强版算法更精确地估计了妊娠的开始时间，尤其是那些没有导致活产的妊娠：结论：与 PEA 相比，我们的新算法 DPA 能成功识别妊娠早期的孕妇。增强的 PEA 和新的 DPA 将使我们能够更好地评估当前和未来在妊娠期或妊娠期前后接种疫苗的安全性。
{"title":"Vaccine Safety Datalink infrastructure enhancements for evaluating the safety of maternal vaccination.","authors":"Allison L Naleway, Bradley Crane, Stephanie A Irving, Don Bachman, Kimberly K Vesco, Matthew F Daley, Darios Getahun, Sungching C Glenn, Simon J Hambidge, Lisa A Jackson, Nicola P Klein, Natalie L McCarthy, David L McClure, Lakshmi Panagiotakopoulos, Catherine A Panozzo, Gabriela Vazquez-Benitez, Eric S Weintraub, Ousseny Zerbo, Elyse O Kharbanda","doi":"10.1177/20420986211021233","DOIUrl":"10.1177/20420986211021233","url":null,"abstract":"<p><strong>Background: </strong>Identifying pregnancy episodes and accurately estimating their beginning and end dates are imperative for observational maternal vaccine safety studies using electronic health record (EHR) data.</p><p><strong>Methods: </strong>We modified the Vaccine Safety Datalink (VSD) Pregnancy Episode Algorithm (PEA) to include both the International Classification of Disease, ninth revision (ICD-9 system) and ICD-10 diagnosis codes, incorporated additional gestational age data, and validated this enhanced algorithm with manual medical record review. We also developed the new Dynamic Pregnancy Algorithm (DPA) to identify pregnancy episodes in real time.</p><p><strong>Results: </strong>Around 75% of the pregnancy episodes identified by the enhanced VSD PEA were live births, 12% were spontaneous abortions (SABs), 10% were induced abortions (IABs), and 0.4% were stillbirths (SBs). Gestational age was identified for 99% of live births, 89% of SBs, 69% of SABs, and 42% of IABs. Agreement between the PEA-assigned and abstractor-identified pregnancy outcome and outcome date was 100% for live births, but was lower for pregnancy losses. When gestational age was available in the medical record, the agreement was higher for live births (97%), but lower for pregnancy losses (75%). The DPA demonstrated strong concordance with the PEA and identified pregnancy episodes ⩾6 months prior to the outcome date for 89% of live births.</p><p><strong>Conclusion: </strong>The enhanced VSD PEA is a useful tool for identifying pregnancy episodes in EHR databases. The DPA improves the timeliness of pregnancy identification and can be used for near real-time maternal vaccine safety studies.</p><p><strong>Plain language summary: </strong><b>Improving identification of pregnancies in the Vaccine Safety Datalink electronic medical record databases to allow for better and faster monitoring of vaccination safety during pregnancy</b> <b>Introduction:</b> It is important to monitor of the safety of vaccines after they have been approved and licensed by the Food and Drug Administration, especially among women vaccinated during pregnancy. The Vaccine Safety Datalink (VSD) monitors vaccine safety through observational studies within large databases of electronic medical records. Since 2012, VSD researchers have used an algorithm called the Pregnancy Episode Algorithm (PEA) to identify the medical records of women who have been pregnant. Researchers then use these medical records to study whether receiving a particular vaccine is linked to any negative outcomes for the woman or her child.<b>Methods:</b> The goal of this study was to update and enhance the PEA to include the full set of medical record diagnostic codes [both from the older International Classification of Disease, ninth revision (ICD-9 system) and the newer ICD-10 system] and to incorporate additional sources of data about gestational age. To ensure the validity of the PEA following these enhancements,","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"12 ","pages":"20420986211021233"},"PeriodicalIF":4.4,"publicationDate":"2021-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/dc/2b/10.1177_20420986211021233.PMC8207278.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39112476","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}
<p><strong>Background: </strong>Patients with diabetic kidney disease (DKD) are at an increased risk of frailty. The exposure to muscle relaxants frequently leads to adverse effects despite their modest therapeutic efficacy, but whether muscle relaxants predispose users to frailty remains unclear.</p><p><strong>Methods: </strong>Patients with DKD from a population-based cohort, the Longitudinal Cohort of Diabetes Patients, were identified between 2004 and 2011 (<i>N</i> = 840,000). Muscle relaxant users were propensity score-matched to never-users in a 1:1 ratio based on demographic features, comorbidities, outcome-relevant medications, and prior major interventions. Incident frailty, the study endpoint, was measured according to a modified FRAIL scale. We used Kaplan-Meier analyses and Cox proportional hazard regression to analyze the association between cumulative muscle relaxant use (⩾ 28 days) and the risk of incident frailty.</p><p><strong>Results: </strong>Totally, 11,637 users and matched never-users were enrolled, without significant differences regarding baseline clinical features. Cox proportional hazard regression showed that patients with DKD and received muscle relaxants had a significantly higher risk of incident frailty than never-users [hazard ratio (HR) 1.26, 95% confidence interval (CI) 1.04-1.53]. This increase in frailty risk paralleled that in cumulative muscle relaxant dosages (quartile 1 <i>versus</i> 2 <i>versus</i> 3 <i>versus</i> 4, HR 0.91 <i>versus</i> 1.22 <i>versus</i> 1.38 <i>versus</i> 1.45, <i>p</i> = 0.0013 for trend) and in exposure durations (quartile 1 <i>versus</i> 2 <i>versus</i> 3 <i>versus</i> 4, HR 1.12 <i>versus</i> 1.33 <i>versus</i> 1.23 <i>versus</i> 1.34, <i>p</i> = 0.0145 for trend) of muscle relaxants.</p><p><strong>Conclusion: </strong>We found that cumulative muscle relaxant exposure might increase frailty risk. It is prudent to limit muscle relaxant prescription in patients with DKD.</p><p><strong>Plain language summary: </strong><b>Does cumulative muscle relaxant exposure increase the risk of incident frailty among patients with diabetic kidney disease?</b> <b>Background:</b> Frailty denotes a degenerative feature that adversely influences one's survival and daily function. Patients with diabetes and chronic kidney disease are at a higher risk of developing frailty, but whether concurrent medications, especially muscle relaxants, aggravate this risk remains undefined.<b>Methods:</b> In this population-based study including 11,637 muscle relaxant users and matched never-users with diabetic kidney disease, we used a renowned frailty-assessing tool, FRAIL scale, to assess frailty severity and examined the incidence of frailty brought by muscle relaxant exposure.<b>Results:</b> We found that users exhibited a 26% higher risk of developing incident frailty compared with never-users, and the probability increased further if users were prescribed higher doses or longer durations of muscle relaxants.<b
背景:糖尿病肾病(DKD)患者虚弱的风险增加。暴露于肌肉松弛剂经常导致不良反应，尽管其适度的治疗效果，但肌肉松弛剂是否易使使用者虚弱仍不清楚。方法:从2004年至2011年以人群为基础的糖尿病患者纵向队列(N = 840,000)中确定DKD患者。根据人口统计学特征、合并症、与结果相关的药物和先前的主要干预措施，肌肉松弛剂使用者与从未使用过的人按1:1的比例进行倾向评分匹配。事件虚弱，研究终点，是根据修改的虚弱量表来测量的。我们使用Kaplan-Meier分析和Cox比例风险回归来分析累积肌肉松弛剂使用(小于或等于28天)和事件虚弱风险之间的关联。结果:共有11,637名使用者和匹配的从未使用者入组，基线临床特征无显著差异。Cox比例风险回归显示，患有DKD并接受肌肉松弛剂治疗的患者发生衰弱的风险明显高于从未使用过的患者[风险比(HR) 1.26, 95%可信区间(CI) 1.04-1.53]。这种衰弱风险的增加与肌肉松弛剂的累积剂量(四分位数1 vs 2 vs 3 vs 4，风险比0.91 vs 1.22 vs 1.38 vs 1.45，趋势p = 0.0013)和暴露时间(四分位数1 vs 2 vs 3 vs 4，风险比1.12 vs 1.33 vs 1.23 vs 1.34，趋势p = 0.0145)相似。结论:我们发现累积的肌肉松弛剂暴露可能增加虚弱的风险。DKD患者应谨慎限制肌肉松弛剂处方。总结:累积的肌肉松弛剂暴露是否会增加糖尿病肾病患者发生虚弱的风险?背景:虚弱是指一种退化的特征，对一个人的生存和日常功能产生不利影响。糖尿病和慢性肾脏疾病患者发生虚弱的风险较高，但同时服用药物，特别是肌肉松弛剂，是否会加剧这种风险仍不清楚。方法:在这项以人群为基础的研究中，包括11,637名肌肉松弛剂使用者和匹配的从未使用过的糖尿病肾病患者，我们使用著名的虚弱评估工具虚弱量表来评估虚弱的严重程度，并检查肌肉松弛剂暴露带来的虚弱发生率。结果:我们发现，与从不使用肌肉松弛剂的人相比，使用肌肉松弛剂的人发生偶发性虚弱的风险高出26%，如果使用肌肉松弛剂的人服用剂量更高或持续时间更长，这种可能性会进一步增加。结论:我们得出的结论是，在糖尿病肾病患者中，肌肉松弛剂的累积使用与发生虚弱的高风险相关，这表明在这一人群中，肌肉松弛剂的适度使用可能具有潜在的重要性。
{"title":"Muscle relaxant use and the associated risk of incident frailty in patients with diabetic kidney disease: a longitudinal cohort study.","authors":"Szu-Ying Lee, Jui Wang, Hung-Bin Tsai, Chia-Ter Chao, Kuo-Liong Chien, Jenq-Wen Huang","doi":"10.1177/20420986211014639","DOIUrl":"https://doi.org/10.1177/20420986211014639","url":null,"abstract":"<p><strong>Background: </strong>Patients with diabetic kidney disease (DKD) are at an increased risk of frailty. The exposure to muscle relaxants frequently leads to adverse effects despite their modest therapeutic efficacy, but whether muscle relaxants predispose users to frailty remains unclear.</p><p><strong>Methods: </strong>Patients with DKD from a population-based cohort, the Longitudinal Cohort of Diabetes Patients, were identified between 2004 and 2011 (<i>N</i> = 840,000). Muscle relaxant users were propensity score-matched to never-users in a 1:1 ratio based on demographic features, comorbidities, outcome-relevant medications, and prior major interventions. Incident frailty, the study endpoint, was measured according to a modified FRAIL scale. We used Kaplan-Meier analyses and Cox proportional hazard regression to analyze the association between cumulative muscle relaxant use (⩾ 28 days) and the risk of incident frailty.</p><p><strong>Results: </strong>Totally, 11,637 users and matched never-users were enrolled, without significant differences regarding baseline clinical features. Cox proportional hazard regression showed that patients with DKD and received muscle relaxants had a significantly higher risk of incident frailty than never-users [hazard ratio (HR) 1.26, 95% confidence interval (CI) 1.04-1.53]. This increase in frailty risk paralleled that in cumulative muscle relaxant dosages (quartile 1 <i>versus</i> 2 <i>versus</i> 3 <i>versus</i> 4, HR 0.91 <i>versus</i> 1.22 <i>versus</i> 1.38 <i>versus</i> 1.45, <i>p</i> = 0.0013 for trend) and in exposure durations (quartile 1 <i>versus</i> 2 <i>versus</i> 3 <i>versus</i> 4, HR 1.12 <i>versus</i> 1.33 <i>versus</i> 1.23 <i>versus</i> 1.34, <i>p</i> = 0.0145 for trend) of muscle relaxants.</p><p><strong>Conclusion: </strong>We found that cumulative muscle relaxant exposure might increase frailty risk. It is prudent to limit muscle relaxant prescription in patients with DKD.</p><p><strong>Plain language summary: </strong><b>Does cumulative muscle relaxant exposure increase the risk of incident frailty among patients with diabetic kidney disease?</b> <b>Background:</b> Frailty denotes a degenerative feature that adversely influences one's survival and daily function. Patients with diabetes and chronic kidney disease are at a higher risk of developing frailty, but whether concurrent medications, especially muscle relaxants, aggravate this risk remains undefined.<b>Methods:</b> In this population-based study including 11,637 muscle relaxant users and matched never-users with diabetic kidney disease, we used a renowned frailty-assessing tool, FRAIL scale, to assess frailty severity and examined the incidence of frailty brought by muscle relaxant exposure.<b>Results:</b> We found that users exhibited a 26% higher risk of developing incident frailty compared with never-users, and the probability increased further if users were prescribed higher doses or longer durations of muscle relaxants.<b","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"12 ","pages":"20420986211014639"},"PeriodicalIF":4.4,"publicationDate":"2021-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/20420986211014639","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39112475","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}
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