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Adverse Events Following Immunization with Novel Oral Polio Vaccine Type 2, and the Experience and Challenges of Reporting in Sierra Leone. 新型口服脊髓灰质炎 2 型疫苗免疫接种后出现的不良事件,以及塞拉利昂在报告方面的经验和挑战。
IF 2.2 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-06-19 eCollection Date: 2024-01-01 DOI: 10.2147/DHPS.S466039
Fawzi Thomas, Onome T Abiri, Joyce M Kallon, Desmond Maada Kangbai, Thomas A Conteh, Sally-Mattu Conteh, Edna G Samuels, Olufunsho Awodele

Background: The manifestation and spread of neuroinvasive circulating vaccine-derived polioviruses (cVDPVs) across several countries, which led to the emergency use of the novel oral polio vaccine type 2 (nOPV2), raised concerns about adverse events following immunization (AEFI) surveillance. We assessed the attributes of AEFI with nOPV2 and examined stakeholder experiences and challenges in AEFI surveillance in Sierra Leone.

Methods: Using a mixed method approach, we retrospectively reviewed passive data collected during a 2021 immunization campaign, and conducted semi-structured, interviews with vaccinators, district AEFI focal persons, and key stakeholders at the national Expanded Program on Immunization and the National Medicines Regulatory Authority. AEFI were categorized using the Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms (PTs) and System Organ Class (SOC). Outcomes were stratified as recovered or not, with preventability and causality assessed using the Schumock and Thornton and World Health Organization (WHO) algorithms, respectively.

Results: A total of 528 suspected AEFI were documented, predominantly affecting children aged 28 days to 23 months (63.3%). Most reported AEFI were administration site conditions and general disorders, with pyrexia being the predominant PT. Of 80 serious cases, 78 recovered, with 74 having an inconsistent causal relationship with the vaccine. Most serious cases (78) were deemed non-preventable, with only two being probably preventable. AEFI reporting was not routinely carried out across the group of people interviewed. AEFI reporting was not consistently performed, with discrepancies in defining reportable events and confusion over responsibility. Challenges with the open data kit (ODK) platform were noted, along with perceived inadequacies in training.

Conclusion: While the nOPV2 is relatively new, the majority of AEFI were not serious, and most serious cases were not causally linked to the vaccine. Participants exhibited variations in experience and awareness of AEFI reporting.

背景:神经侵袭性循环疫苗源脊髓灰质炎病毒(cVDPVs)在多个国家的出现和传播导致了新型口服脊髓灰质炎疫苗 2 型(nOPV2)的紧急使用,这引起了人们对免疫接种后不良事件(AEFI)监测的关注。我们评估了使用新型口服脊髓灰质炎疫苗 2 型的 AEFI 的属性,并研究了塞拉利昂利益相关者在 AEFI 监测方面的经验和挑战:我们采用混合方法回顾了 2021 年免疫接种活动中收集的被动数据,并对接种人员、地区 AEFI 协调员以及国家扩大免疫计划和国家药品监管局的主要利益相关者进行了半结构化访谈。AEFI 采用监管活动医学字典 (MedDRA) 的首选术语 (PT) 和系统器官分类 (SOC) 进行分类。结果分为已康复和未康复,分别采用舒莫克和桑顿算法以及世界卫生组织(WHO)算法评估可预防性和因果关系:共记录了 528 例疑似 AEFI,主要影响 28 天至 23 个月大的儿童(63.3%)。大多数报告的 AEFI 都是用药部位的疾病和全身性疾病,而热病是主要的 PT。在 80 例严重病例中,78 例痊愈,其中 74 例与疫苗的因果关系不一致。大多数严重病例(78 例)被认为不可预防,只有两例可能可以预防。在受访人群中,AEFI 报告并不是常规性的。AEFI 报告的执行并不一致,对可报告事件的定义存在差异,责任也不明确。人们注意到开放数据包(ODK)平台面临的挑战,以及培训方面的不足:结论:虽然 nOPV2 疫苗相对较新,但大多数 AEFI 并不严重,而且大多数严重病例与疫苗没有因果关系。参与者在报告 AEFI 的经验和意识方面存在差异。
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引用次数: 0
Therapeutic Potential of Treprostinil Inhalation Powder for Patients with Pulmonary Arterial Hypertension: Evidence to Date. 曲普瑞司替尼吸入粉对肺动脉高压患者的治疗潜力:迄今为止的证据。
IF 1.6 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-06-05 eCollection Date: 2024-01-01 DOI: 10.2147/DHPS.S372239
Steven J Cassady, Jose Alejandro N Almario, Gautam V Ramani

Pulmonary arterial hypertension (PAH) is a complex and incurable disease for which pulmonary vasodilators remain the core therapy. Of the three primary pathways that vasodilators target, the prostacyclin pathway was the earliest to be used and currently has the largest number of modalities for drug delivery. Inhaled treprostinil has been introduced as a treatment option in PAH and, more recently, pulmonary hypertension (PH) due to interstitial lung disease (PH-ILD), and the earlier nebulized form has been joined by a dry powder form allowing for more convenient use. In this review, we discuss inhaled treprostinil, focusing on the dry powder inhalation (DPI) formulation, and explore its dosing, applications, and evidence to support patient tolerance and acceptance. Recent trials underpinning the evidence for use of inhaled treprostinil and the most recent developments concerning the drug are discussed. Finally, the review looks briefly into premarket formulations of inhaled treprostinil and relevant early studies suggesting efficacy in PAH treatment.

肺动脉高压(PAH)是一种复杂且无法治愈的疾病,肺血管扩张剂仍是其核心疗法。在血管扩张剂针对的三个主要途径中,前列环素途径是最早使用的,目前也有最多的给药方式。吸入式曲普瑞替尼已成为 PAH 的治疗选择,最近又被用于治疗间质性肺疾病(PH-ILD)引起的肺动脉高压(PH),早期的雾化剂型已被干粉剂型取代,使用更加方便。在本综述中,我们将讨论吸入式曲普瑞司替尼,重点是干粉吸入(DPI)制剂,并探讨其剂量、应用以及支持患者耐受性和接受度的证据。此外,还讨论了支持吸入式曲普瑞替尼使用证据的最新试验以及有关该药物的最新进展。最后,本综述简要介绍了吸入式曲普瑞替尼的上市前制剂以及对 PAH 治疗具有疗效的相关早期研究。
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引用次数: 0
Obstructive Fibrinous Tracheal Pseudomembrane Following Repeated Intratracheal Interventions. 反复气管插管后的阻塞性纤维蛋白气管假膜
IF 1.6 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-03-06 eCollection Date: 2024-01-01 DOI: 10.2147/DHPS.S438510
Wei Tang, Wenlai Zhou, Xiangde Zheng

Obstructive fibrinous tracheal pseudomembrane (OFTP) is a relatively rare complication of endotracheal intubation. Despite being well documented, the exact pathogenesis of OFTP remains unclear. Some studies suggest that it may arise from the early stage of ischemic tracheal wall injury caused by the cuff pressure during intubation. Diagnosis and treatment of OFTP can be facilitated through therapeutic bronchoscopy. In this case report, we describe a patient who presented with dyspnea following repeated intratracheal interventions and was diagnosed with OFTP. The patient was successfully treated with bronchoscopic cryotherapy and was subsequently discharged from the hospital.

阻塞性纤维蛋白气管假膜(OFTP)是气管内插管时一种相对罕见的并发症。尽管已有大量文献记载,但气管阻塞性纤维蛋白假膜的确切发病机制仍不清楚。一些研究表明,它可能源于插管时袖带压力导致的早期气管壁缺血性损伤。通过治疗性支气管镜可以帮助诊断和治疗 OFTP。在本病例报告中,我们描述了一名反复气管插管后出现呼吸困难并被诊断为 OFTP 的患者。患者成功接受了支气管镜冷冻治疗,随后康复出院。
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引用次数: 0
Evaluation of Seven Different Brands of Metformin Hydrochloride Tablets Available in the Market in Gondar City, Ethiopia. 对埃塞俄比亚贡德尔市市场上七种不同品牌的盐酸二甲双胍片剂进行评估。
IF 1.6 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-02-01 eCollection Date: 2024-01-01 DOI: 10.2147/DHPS.S419522
Adane Flatie Alemu, Addisu Afrassa Tegegne, Nurahmed Seid Getaw

Background: WHO estimates that 15.8% of substandard or falsified medical products are used to treat non-communicable diseases which account for 80% of the global burden including diabetes. The increased level of use of metformin hydrochloride tablets in clinical practice creates the need to monitor and ascertain the quality of the various brands available in the drug market for quality control assessment and generic substitution. This study aims to assess the pharmaceutical quality of seven brands of metformin tablets circulating in pharmacy outlets in Gondar City, North West Ethiopia.

Methods: Official Pharmacopoeia tests such as uniformity of weight, disintegration, assay, and dissolution tests were used to assess the physicochemical quality control parameters of metformin hydrochloride tablet brands. The unofficial tests conducted included crushing strength/hardness and friability.

Results: In all seven tests, the tested brands passed the BP official tests for uniformity of weight, friability, disintegration, and dissolution. Each product had a friability of less than 1% with a maximum of 0.385%. In contrast, none of the brands passed the non-official hardness test. Each product disintegrated in seven to twelve minutes, meeting the USP standards. Drug release rates in 45 min ranged from 78.9 to 92.6%, and drug content results were within the USP guidelines (96.55-102.76%).

Conclusion: The current study demonstrated that all seven brands of metformin hydrochloride 500 mg tablets adhered to the quality control parameters specified in the pharmacopeia, except for the hardness test across all brands.

背景:世卫组织估计,15.8%的不合格或伪造医疗产品被用于治疗非传染性疾病,这些疾病占全球负担的 80%,其中包括糖尿病。随着盐酸二甲双胍片在临床实践中使用量的增加,有必要监测和确定药品市场上各种品牌的质量,以便进行质量控制评估和仿制药替代。本研究旨在评估埃塞俄比亚西北部贡德尔市药店销售的七个品牌二甲双胍片剂的药品质量:方法:采用官方药典测试(如重量均匀性、崩解、化验和溶出测试)来评估盐酸二甲双胍片剂品牌的理化质量控制参数。非官方测试包括压碎强度/硬度和易碎性:在所有七项测试中,受测品牌都通过了英国药典的重量均匀性、易碎性、崩解性和溶解性官方测试。每种产品的易碎性都低于 1%,最高为 0.385%。相比之下,没有一个品牌通过非官方硬度测试。每种产品均在 7 到 12 分钟内崩解,符合美国药典标准。45 分钟内的药物释放率从 78.9% 到 92.6% 不等,药物含量结果符合美国药典标准(96.55%-102.76%):本研究表明,除硬度测试外,所有七个品牌的盐酸二甲双胍 500 毫克片均符合药典规定的质量控制参数。
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引用次数: 0
Validity of Routine Health Data To Identify Safety Outcomes of Interest For Covid-19 Vaccines and Therapeutics in the Context of the Emerging Pandemic: A Comprehensive Literature Review 在新流感大流行的背景下,常规健康数据在确定 Covid-19 疫苗和治疗药物相关安全性结果方面的有效性:综合文献综述
IF 1.6 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-01-01 DOI: 10.2147/DHPS.S415292
Kirsty Andresen, Marina Hinojosa-Campos, B. Podmore, Myriam Drysdale, Nawab Qizilbash, Marianne Cunnington
Introduction Regulatory guidance encourages transparent reporting of information on the quality and validity of electronic health record data being used to generate real-world benefit-risk evidence for vaccines and therapeutics. We aimed to provide an overview of the availability of validated diagnostic algorithms for selected safety endpoints for Coronavirus disease 2019 (COVID-19) vaccines and therapeutics in the context of the emerging pandemic prior to December 2020. Methods We reviewed the literature up to December 2020 to identify validation studies for various safety events of interest, including myocardial infarction, arrhythmia, myocarditis, acute cardiac injury, vasculitis/vasculopathy, venous thromboembolism, stroke, respiratory distress syndrome (RDS), pneumonitis, cytokine release syndrome (CRS), multiple organ dysfunction syndrome, and renal failure. We included studies published between 2015 and 2020 that were considered high quality assessed with QUADAS and that reported positive predictive values (PPVs). Results Out of 43 identified studies, we found that diagnostic algorithms for cardiovascular outcomes were supported by the highest number of validation studies (n=17). Accurate algorithms are available for myocardial infarction (median PPV 80%; IQR 22%), arrhythmia (PPV range >70%), venous thromboembolism (median PPV: 73%) and ischaemic stroke (PPV range ≥85%). We found a lack of validation studies for less common respiratory and cardiac safety outcomes of interest (eg, pneumonitis and myocarditis), as well as for COVID-specific complications (CRS, RDS). Conclusion There is a need for better understanding of barriers to conducting validation studies, including data governance restrictions. Regulatory guidance should promote embedding validation within real-world EHR research used for decision-making.
导言:监管指南鼓励透明地报告电子健康记录数据的质量和有效性信息,这些数据被用于生成疫苗和疗法的真实世界效益-风险证据。我们旨在概述在 2020 年 12 月之前新出现的大流行背景下,针对 2019 年冠状病毒病(COVID-19)疫苗和疗法的特定安全性终点所采用的有效诊断算法的可用性。方法 我们查阅了截至 2020 年 12 月的文献,以确定各种相关安全性事件的验证研究,包括心肌梗死、心律失常、心肌炎、急性心脏损伤、血管炎/血管病变、静脉血栓栓塞、中风、呼吸窘迫综合征 (RDS)、肺炎、细胞因子释放综合征 (CRS)、多器官功能障碍综合征和肾衰竭。我们纳入了 2015 年至 2020 年间发表的、经 QUADAS 评估为高质量且报告了阳性预测值 (PPV) 的研究。结果 在 43 项已确定的研究中,我们发现心血管结果诊断算法得到了最多验证研究(17 项)的支持。心肌梗死(PPV 中位数为 80%;IQR 为 22%)、心律失常(PPV 范围大于 70%)、静脉血栓栓塞(PPV 中位数为 73%)和缺血性中风(PPV 范围≥85%)都有准确的算法。我们发现缺乏对不常见的呼吸和心脏安全结果(如肺炎和心肌炎)以及 COVID 特定并发症(CRS、RDS)的验证研究。结论 需要更好地了解开展验证研究的障碍,包括数据管理限制。监管指南应促进将验证纳入用于决策的真实 EHR 研究中。
{"title":"Validity of Routine Health Data To Identify Safety Outcomes of Interest For Covid-19 Vaccines and Therapeutics in the Context of the Emerging Pandemic: A Comprehensive Literature Review","authors":"Kirsty Andresen, Marina Hinojosa-Campos, B. Podmore, Myriam Drysdale, Nawab Qizilbash, Marianne Cunnington","doi":"10.2147/DHPS.S415292","DOIUrl":"https://doi.org/10.2147/DHPS.S415292","url":null,"abstract":"Introduction Regulatory guidance encourages transparent reporting of information on the quality and validity of electronic health record data being used to generate real-world benefit-risk evidence for vaccines and therapeutics. We aimed to provide an overview of the availability of validated diagnostic algorithms for selected safety endpoints for Coronavirus disease 2019 (COVID-19) vaccines and therapeutics in the context of the emerging pandemic prior to December 2020. Methods We reviewed the literature up to December 2020 to identify validation studies for various safety events of interest, including myocardial infarction, arrhythmia, myocarditis, acute cardiac injury, vasculitis/vasculopathy, venous thromboembolism, stroke, respiratory distress syndrome (RDS), pneumonitis, cytokine release syndrome (CRS), multiple organ dysfunction syndrome, and renal failure. We included studies published between 2015 and 2020 that were considered high quality assessed with QUADAS and that reported positive predictive values (PPVs). Results Out of 43 identified studies, we found that diagnostic algorithms for cardiovascular outcomes were supported by the highest number of validation studies (n=17). Accurate algorithms are available for myocardial infarction (median PPV 80%; IQR 22%), arrhythmia (PPV range >70%), venous thromboembolism (median PPV: 73%) and ischaemic stroke (PPV range ≥85%). We found a lack of validation studies for less common respiratory and cardiac safety outcomes of interest (eg, pneumonitis and myocarditis), as well as for COVID-specific complications (CRS, RDS). Conclusion There is a need for better understanding of barriers to conducting validation studies, including data governance restrictions. Regulatory guidance should promote embedding validation within real-world EHR research used for decision-making.","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"265 33‐37","pages":"1 - 17"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139395226","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Assessment of Medication Prescribing Pattern in COVID-19 Admitted Patients by Using WHO Prescribing Indicators at Eka Kotebe General Hospital, Addis Ababa, Ethiopia; Retrospective Cross-Sectional Study. 埃塞俄比亚亚的斯亚贝巴Eka Kotebe综合医院使用世界卫生组织处方指标评估新冠肺炎住院患者的药物处方模式;回顾性横断面研究。
IF 1.6 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2023-11-03 eCollection Date: 2023-01-01 DOI: 10.2147/DHPS.S416310
Belete Birhanu, Solomon Debebe, Tsegaye Nigussie, Alemayehu Dandana

Introduction: Drug therapy is a crucial component of health care and plays a vital role in preserving life. However, the irrational utilization of medications is a worldwide issue, particularly in developing nations.

Objective: To assess the prescription patterns of medications based on the World Health Organization's prescribing indicator among patients who were admitted with COVID-19 to Eka Kotebe General Hospital in Addis Ababa, Ethiopia, in June 2021.

Methods: A retrospective cross-sectional analysis was conducted to evaluate the prescription patterns of medications in patients admitted with COVID-19 at Eka Kotebe General Hospital from June 2021 to September 15, 2021. The data were extracted using card review formats and prescription assessment questionnaires, and a systematic random sampling procedure was employed to collect the data. Finally, the data were coded and analyzed using SPSS version 26 to meet the study's objectives. Descriptive statistics were employed to determine the frequency and prevalence, and the results were presented using tables and figures.

Results and discussion: The average number of medications prescribed per encounter was 2.64, which is above the WHO standard. The percentage of encounters in which antibiotics and injections were prescribed was 80.20% and 99.2%, which exceeds the upper limit of WHO standard range (20-26.8%) and (13.4-24.1%), respectively. All medications were prescribed using generic names and were included in Eka Kotebe General Hospital's essential drug list, which is in line with WHO standards.

Conclusion: The degree of polypharmacy and the prescription practices for antibiotics and injections at Eka Kotebe General Hospital deviated from the World Health Organization's standards. As a result, there is a need to enhance medical education programs to rationalize the prescription of antibiotics and injection use.

引言:药物治疗是医疗保健的重要组成部分,在保护生命方面发挥着至关重要的作用。然而,药物的不合理使用是一个全球性问题,尤其是在发展中国家。目的:根据世界卫生组织的处方指标,评估埃塞俄比亚亚的斯亚贝巴Eka Kotebe综合医院新冠肺炎患者的药物处方模式,方法:对2021年6月至2021年9月15日在Eka Kotebe综合医院收治的新冠肺炎患者的药物处方模式进行回顾性横断面分析。使用卡片审查格式和处方评估问卷提取数据,并采用系统随机抽样程序收集数据。最后,使用SPSS 26版对数据进行编码和分析,以达到研究目的。采用描述性统计来确定频率和患病率,并使用表格和数字显示结果。结果和讨论:每次用药的平均处方数为2.64,高于世界卫生组织的标准。使用抗生素和注射的比例分别为80.20%和99.2%,超过了世界卫生组织标准范围(20-26.8%)和(13.4-24.1%)的上限。所有药物均使用通用名称开具处方,并列入Eka Kotebe综合医院的基本药物清单,该清单符合世界卫生组织标准。结论:Eka Kotebe综合医院的多药化程度以及抗生素和注射剂的处方实践偏离了世界卫生组织的标准。因此,有必要加强医学教育计划,使抗生素处方和注射使用合理化。
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引用次数: 0
Safety Aspects and Rational Use of Single Intramuscular Dose Ceftriaxone: Clinical Insights on the Management of Uncomplicated Gonococcal Infections. 单次肌内剂量头孢曲松的安全性和合理使用:对非复杂淋球菌感染管理的临床见解。
IF 1.6 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2023-11-03 eCollection Date: 2023-01-01 DOI: 10.2147/DHPS.S350763
George P Allen, Haley L Morrill

Gonorrhea, a sexually transmitted infection caused by Neisseria gonorrhoeae, is a grave public health concern. Gonorrhea is the second most reported sexually transmitted infection worldwide. The treatment of uncomplicated gonococcal infections has evolved dramatically in response to the emergence of antimicrobial resistance. Multiple resistance mechanisms (for example, beta-lactamase production, antimicrobial efflux, and target site modification) exist, some of which may cause multidrug-resistance. Ceftriaxone was first recommended as an option for uncomplicated gonococcal infections in 1985, and it is now a mainstay of therapy in all clinical practice guidelines. Ceftriaxone has consistently shown high microbiologic cure rates in clinical trials, and it has demonstrated an excellent safety profile. Although its use may be limited in patients with hypersensitivity to penicillins, the risk of using ceftriaxone in such patients is overestimated. The emergence of reduced ceftriaxone susceptibility in N. gonorrhoeae, coupled with a lack of diverse treatment alternatives and the limited pipeline of new antimicrobials, is a significant threat to the treatment of gonorrhea.

淋病是一种由淋病奈瑟菌引起的性传播感染,是一个严重的公共卫生问题。淋病是世界上第二大报告的性传播感染。无并发症淋球菌感染的治疗方法随着抗微生物耐药性的出现而发生了巨大的变化。存在多种耐药机制(例如,β-内酰胺酶的产生、抗菌药物外排和靶位点修饰),其中一些可能导致多药耐药性。1985年,头孢曲松首次被推荐为治疗无并发症淋球菌感染的一种选择,现在它已成为所有临床实践指南中的主要治疗方法。头孢曲松在临床试验中始终显示出较高的微生物治愈率,并且具有良好的安全性。尽管它在对青霉素过敏的患者中的使用可能受到限制,但在这类患者中使用头孢曲松的风险被高估了。淋病奈瑟菌对头孢曲松的易感性降低,再加上缺乏多样化的治疗替代品和新的抗菌药物渠道有限,对淋病的治疗构成了重大威胁。
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引用次数: 0
The Prevalence and Severity of Potential Drug-Drug Interactions in Internal Medicine Ward at Soba Teaching Hospital. 索巴教学医院内科病房潜在药物相互作用的患病率和严重程度。
IF 1.6 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2023-11-01 eCollection Date: 2023-01-01 DOI: 10.2147/DHPS.S436458
Riham M Hamadouk, Einass Mahmoud Alshareif, Huda M Hamad, Bashir A Yousef

Background: Multiple drug therapies are commonly used to achieve a desired therapeutic goal, especially in hospitalized patients. However, drug-drug interactions might occur and threaten the patients' safety.

Objective: This study aims to assess the prevalence and severity of potential drug-drug interactions (PDDIs) in the internal medicine ward at Soba Teaching Hospital.

Methods: A retrospective cross-sectional hospital-based study was carried out in the internal medicine ward at Soba Teaching Hospital from June 2021 to December 2021. The data was collected from patients' medical records. PDDIs were identified using Lexicomp® drug interaction software.

Results: A total of 377 patients were included in this study, and overall prevalence of PDDIs was 62.9%. We have identified 989 potential DDIs and 345 pairs of interacting drugs, the mean of the PDDIs per patient was 4.17 ± 4.079. Among 345 PDDIs most were of moderate interactions 70.1% (n=242) followed by Minor interactions 19.1% (n=66). The most common type of interaction was of category C representing 63.5% (n=219). A significant association was observed between the occurrence of PDDIs with patients' age, presence of chronic diseases, length of hospital stay, and number of medications received by the patients.

Conclusion: Drug-drug interactions were highly prevalent in the internal medicine ward. Therefore, certain attempts are required to increase the awareness of the physicians about these interactions and minimize their occurrence.

背景:多种药物治疗通常用于实现预期的治疗目标,尤其是在住院患者中。然而,药物与药物的相互作用可能会发生,并威胁患者的安全。目的:本研究旨在评估索巴教学医院内科病房潜在药物相互作用(PDDI)的发生率和严重程度。方法:于2021年6月至2021年12月在索巴教学医院内科病房进行回顾性横断面医院研究。这些数据是从患者的医疗记录中收集的。使用Lexicomp®药物相互作用软件鉴定PDDI。结果:本研究共纳入377名患者,PDDI的总患病率为62.9%。我们已经确定了989个潜在的DDI和345对相互作用的药物,每个患者的PDDI平均值为4.17±4.079。在345个PDDI中,大多数为中度相互作用70.1%(n=242),其次为轻度相互作用19.1%(n=66)。最常见的相互作用类型为C类,占63.5%(n=219)。PDDI的发生与患者的年龄、慢性病的存在、住院时间和患者接受的药物数量之间存在显著关联。结论:内科病房药物相互作用普遍存在。因此,需要进行某些尝试,以提高医生对这些互动的认识,并尽量减少其发生。
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引用次数: 0
Evaluating the Sensitivity, Specificity, and Accuracy of ChatGPT-3.5, ChatGPT-4, Bing AI, and Bard Against Conventional Drug-Drug Interactions Clinical Tools. 评估ChatGPT-3.5、ChatGPT-4、Bing AI和Bard对抗常规药物相互作用临床工具的敏感性、特异性和准确性。
IF 2.2 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2023-09-20 eCollection Date: 2023-01-01 DOI: 10.2147/DHPS.S425858
Fahmi Y Al-Ashwal, Mohammed Zawiah, Lobna Gharaibeh, Rana Abu-Farha, Ahmad Naoras Bitar

Background: AI platforms are equipped with advanced ‎algorithms that have the potential to offer a wide range of ‎applications in healthcare services. However, information about the accuracy of AI chatbots against ‎conventional drug-drug interaction tools is limited‎. This study aimed to assess the sensitivity, specificity, and accuracy of ChatGPT-3.5, ChatGPT-4, Bing AI, and Bard in predicting drug-drug interactions.

Methods: AI-based chatbots (ie, ChatGPT-3.5, ChatGPT-4, Microsoft Bing AI, and Google Bard) were compared for their abilities to detect clinically relevant DDIs for 255 drug pairs. Descriptive statistics, such as specificity, sensitivity, accuracy, negative predictive value (NPV), and positive predictive value (PPV), were calculated for each tool.

Results: When a subscription tool was used as a reference, the specificity ranged from a low of 0.372 (ChatGPT-3.5) to a high of 0.769 (Microsoft Bing AI). Also, Microsoft Bing AI had the highest performance with an accuracy score of 0.788, with ChatGPT-3.5 having the lowest accuracy rate of 0.469. There was an overall improvement in performance for all the programs when the reference tool switched to a free DDI source, but still, ChatGPT-3.5 had the lowest specificity (0.392) and accuracy (0.525), and Microsoft Bing AI demonstrated the highest specificity (0.892) and accuracy (0.890). When assessing the consistency of accuracy across two different drug classes, ChatGPT-3.5 and ChatGPT-4 showed the highest ‎variability in accuracy. In addition, ChatGPT-3.5, ChatGPT-4, and Bard exhibited the highest ‎fluctuations in specificity when analyzing two medications belonging to the same drug class.

Conclusion: Bing AI had the highest accuracy and specificity, outperforming Google's Bard, ChatGPT-3.5, and ChatGPT-4. The findings highlight the significant potential these AI tools hold in transforming patient care. While the current AI platforms evaluated are not without limitations, their ability to quickly analyze potentially significant interactions with good sensitivity suggests a promising step towards improved patient safety.

背景:人工智能平台配备先进‎有潜力提供广泛‎医疗保健服务中的应用。然而,有关人工智能聊天机器人准确性的信息‎传统的药物相互作用工具是有限的‎. 本研究旨在评估ChatGPT-3.5、ChatGPT-4、Bing AI和Bard在预测药物相互作用方面的敏感性、特异性和准确性。方法:比较基于人工智能的聊天机器人(即ChatGPT-3.5、ChatGPT-4、Microsoft Bing AI和Google Bard)检测255对药物的临床相关DDI的能力。计算每种工具的描述性统计数据,如特异性、敏感性、准确性、阴性预测值(NPV)和阳性预测值(PPV)。结果:当使用订阅工具作为参考时,特异性从低0.372(ChatGPT-3.5)到高0.769(Microsoft Bing AI)不等。此外,微软Bing AI的性能最高,准确率为0.788,ChatGPT-3.5的准确率最低,为0.469。当参考工具切换到免费DDI源时,所有程序的性能都有了总体改善,但ChatGPT-3.5的特异性(0.392)和准确性(0.525)最低,Microsoft Bing AI的特异性和准确性(0.892)最高。在评估两种不同药物类别的准确性一致性时,ChatGPT-3.5和ChatGPT-4显示最高‎准确性的可变性。此外,ChatGPT-3.5、ChatGPT-4和Bard的表现最高‎当分析属于同一药物类别的两种药物时,特异性的波动。结论:Bing AI具有最高的准确性和特异性,优于谷歌的Bard、ChatGPT-3.5和ChatGPT-4。这些发现突显了这些人工智能工具在改变患者护理方面的巨大潜力。虽然目前评估的人工智能平台并非没有局限性,但它们能够以良好的灵敏度快速分析潜在的重大交互,这表明朝着提高患者安全性迈出了有希望的一步。
{"title":"Evaluating the Sensitivity, Specificity, and Accuracy of ChatGPT-3.5, ChatGPT-4, Bing AI, and Bard Against Conventional Drug-Drug Interactions Clinical Tools.","authors":"Fahmi Y Al-Ashwal, Mohammed Zawiah, Lobna Gharaibeh, Rana Abu-Farha, Ahmad Naoras Bitar","doi":"10.2147/DHPS.S425858","DOIUrl":"10.2147/DHPS.S425858","url":null,"abstract":"<p><strong>Background: </strong>AI platforms are equipped with advanced ‎algorithms that have the potential to offer a wide range of ‎applications in healthcare services. However, information about the accuracy of AI chatbots against ‎conventional drug-drug interaction tools is limited‎. This study aimed to assess the sensitivity, specificity, and accuracy of ChatGPT-3.5, ChatGPT-4, Bing AI, and Bard in predicting drug-drug interactions.</p><p><strong>Methods: </strong>AI-based chatbots (ie, ChatGPT-3.5, ChatGPT-4, Microsoft Bing AI, and Google Bard) were compared for their abilities to detect clinically relevant DDIs for 255 drug pairs. Descriptive statistics, such as specificity, sensitivity, accuracy, negative predictive value (NPV), and positive predictive value (PPV), were calculated for each tool.</p><p><strong>Results: </strong>When a subscription tool was used as a reference, the specificity ranged from a low of 0.372 (ChatGPT-3.5) to a high of 0.769 (Microsoft Bing AI). Also, Microsoft Bing AI had the highest performance with an accuracy score of 0.788, with ChatGPT-3.5 having the lowest accuracy rate of 0.469. There was an overall improvement in performance for all the programs when the reference tool switched to a free DDI source, but still, ChatGPT-3.5 had the lowest specificity (0.392) and accuracy (0.525), and Microsoft Bing AI demonstrated the highest specificity (0.892) and accuracy (0.890). When assessing the consistency of accuracy across two different drug classes, ChatGPT-3.5 and ChatGPT-4 showed the highest ‎variability in accuracy. In addition, ChatGPT-3.5, ChatGPT-4, and Bard exhibited the highest ‎fluctuations in specificity when analyzing two medications belonging to the same drug class.</p><p><strong>Conclusion: </strong>Bing AI had the highest accuracy and specificity, outperforming Google's Bard, ChatGPT-3.5, and ChatGPT-4. The findings highlight the significant potential these AI tools hold in transforming patient care. While the current AI platforms evaluated are not without limitations, their ability to quickly analyze potentially significant interactions with good sensitivity suggests a promising step towards improved patient safety.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"15 ","pages":"137-147"},"PeriodicalIF":2.2,"publicationDate":"2023-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/18/c7/dhps-15-137.PMC10518176.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41111482","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evaluation of Rational Drug Use Based on WHO/INRUD Core Drug Use Indicators in a Secondary Care Hospital: A Cross-Sectional Study in Western Uganda. 基于世界卫生组织/INRUD核心药物使用指标的二级护理医院合理药物使用评估:乌干达西部的一项跨部门研究。
IF 1.6 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2023-09-14 eCollection Date: 2023-01-01 DOI: 10.2147/DHPS.S424050
Narayana Goruntla, Joackim Ssesanga, Bhavana Reddy Bommireddy, Durga Prasad Thammisetty, Veerabhadrappa Kasturi Vishwanathasetty, Joseph Obiezu Chukwujekwu Ezeonwumelu, Sarad Pawar Naik Bukke

Purpose: Rational drug use (RDU) promotes safe, efficient, and cost-effective utilization of medicines in hospital settings. The aim of this study was to assess rational drug use based on the World Health Organization (WHO) and the International Network for Rational Use of Drugs (INRUD) core drug use indicators.

Patients and methods: This prospective, descriptive, hospital-based cross-sectional study was conducted among patients attending the Outpatient Department of a secondary care hospital located in the Sheema District of Western Uganda. A total of 450 prescriptions were prospectively collected from eligible patients and subjected to evaluation by using the WHO/INRUD core drug use indicators (prescribing, patient care, and health-facility indicators).

Results: The average number of drugs prescribed per encounter was found to be 3.2 (optimal value=1.6-1.8). The percentages of drugs prescribed by their generic name (90.48%) and from the Essential Medicine List (96.23%) were close to the WHO reference (100%). The percentage of antibiotics (66.22%) and injections (25.22%) per encounter exceeded the WHO standards (antibiotics=20.0-26.8; injections=13.4-24.1). Among the patient-care indicators, the average consultation time (5.41 minutes), average dispensing time (131.03 seconds), percentage of medicines dispensed (76.11%), percentage of medicines adequately labeled (59.74%), and percentage of patients with dosage knowledge (49.50%) did not meet the WHO reference. Facility indicators such as the percentage of key medicines available in the stock (66.67%) did not conform to the WHO optimal value. The hospital made the EML hundred percent available to all practitioners.

Conclusion: The study concludes that the prescribing, patient care, and health facility indicators at Sheema District Secondary Care Hospital deviate from the optimal values recommended by the WHO. Therefore, this study indicates a need for improvement on these indicators and a requirement for the ongoing educational initiatives focused on rational drug prescribing, dispensing, and patient use in order to comply with the standards set by the WHO.

目的:合理用药(RDU)促进医院环境中药物的安全、高效和成本效益利用。本研究的目的是根据世界卫生组织(世界卫生组织)和国际合理用药网络(INRUD)的核心药物使用指标来评估合理用药。患者和方法:这项前瞻性、描述性、基于医院的横断面研究是在乌干达西部希马区一家二级护理医院门诊部的患者中进行的。从符合条件的患者中前瞻性地收集了总共450张处方,并通过使用世界卫生组织/INRUD核心药物使用指标(处方、患者护理和健康功能指标)进行评估。结果:发现每次用药的平均处方数为3.2(最佳值=1.6-1.8)基本药物清单(96.23%)接近世界卫生组织参考(100%)。每次使用抗生素(66.22%)和注射(25.22%)的百分比超过世界卫生组织标准(抗生素=20.0-26.8;注射=13.4-24.1)。在患者护理指标中,平均咨询时间(5.41分钟)、平均配药时间(131.03秒)、配药百分比(76.11%)、,不符合世界卫生组织参考的患者比例为49.50%。库存中关键药品的百分比(66.67%)等设施指标不符合世界卫生组织的最佳值。医院百分之百地为所有医生提供EML。结论:该研究得出的结论是,希马地区二级护理医院的处方、患者护理和卫生设施指标偏离了世界卫生组织推荐的最佳值。因此,这项研究表明,需要改进这些指标,并要求持续开展以合理开药、配药和患者使用为重点的教育举措,以符合世界卫生组织制定的标准。
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引用次数: 0
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Drug, Healthcare and Patient Safety
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