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Developing Nepal's medicines pricing policy: evidence synthesis and stakeholders' consultation. 制定尼泊尔药品定价政策:证据综述和利益相关者咨询。
IF 4.2 Q1 Health Professions Pub Date : 2024-04-29 eCollection Date: 2024-01-01 DOI: 10.1080/20523211.2024.2346222
Zaheer-Ud-Din Babar, Santosh Dulal, Narayan Prasad Dhakal, Madan Kumar Upadhyaya, Birna Trap

Objectives: The objectives of this paper are to (a) explore stakeholders' opinions regarding Nepal's existing medicines pricing practices/situation and (b) build and present a set of medicines pricing policies for Nepal.

Methods: A review of the literature and field visits to community retail pharmacies, hospital pharmacies, wholesalers, and distributor outlets in Kathmandu were conducted to assess the medicines pricing situation. Following the literature review, preliminary meetings with stakeholders and field visits were held and a draft interview guide was prepared. Consultative sessions subsequently were undertaken in Kathmandu, Nepal, in January 2023 with representatives from the Department of Drug Administration, Ministry of Health and Population, Association of Pharmaceutical Producers of Nepal, consumer groups, Transparency International, Medicines Importers Association of Nepal/ Pharmaceutical Distributors Association of Nepal, Nepal Chemist and Druggist Association, and Nepal Pharmaceutical Association. Notes were taken during these meetings regarding issues and concerns raised as well as experiences and recommendations for the future, as outlined in the interview guide.

Results: The stakeholders in general stated that they do not have any objection to price regulation; however, they believe such regulation should be subject to periodic review. Both the importers and the Ministry of Health and Population have the view that an independent body/authority should be charged with regulating the prices of medicines. A set of policy options to be considered for use in Nepal include cost-plus pricing, external price referencing, internal reference pricing, and mark-up regulations.

Conclusion: Key issues related to pricing were identified and suggest that a set of pricing policies and updated regulations need to be considered to establish changes that are transparent, rational, and acceptable to the related stakeholders. Hence, suggestions made in this paper could be useful to inform a rational and fair pricing structure and to improve access to medicines.

目标本文的目的是:(a) 探讨利益相关者对尼泊尔现行药品定价做法/状况的看法;(b) 为尼泊尔制定并提出一套药品定价政策:为评估药品定价情况,我们查阅了相关文献,并对加德满都的社区零售药店、医院药房、批发商和经销商进行了实地考察。文献审查结束后,与利益相关者举行了初步会议并进行了实地考察,还编写了访谈指南草案。随后于 2023 年 1 月在尼泊尔加德满都与来自卫生和人口部药品管理司、尼泊尔药品生产商协会、消费者团体、透明国际、尼泊尔药品进口商协会/尼泊尔药品分销商协会、尼泊尔化学家和药剂师协会以及尼泊尔制药协会的代表举行了磋商会议。根据访谈指南的概述,在这些会议期间对提出的问题和关切以及经验和对未来的建议进行了记录:利益相关者普遍表示,他们不反对价格监管,但认为这种监管应接受定期审查。进口商和卫生与人口部都认为,应由一个独立的机构/部门负责药品价格的监管。一套可供尼泊尔考虑采用的政策方案包括成本加成定价、外部价格参考、内部参考定价和加价规定:本文指出了与定价有关的关键问题,并建议需要考虑制定一套定价政策和更新法规,以建立透明、合理并为相关利益方所接受的变革。因此,本文提出的建议有助于建立合理、公平的定价结构,并改善药品的可及性。
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引用次数: 0
Innovations in pharmaceutical policies and learnings for sustainable access to affordable medicines 医药政策的创新和可持续获得负担得起的药品的经验教训
IF 4.2 Q1 Health Professions Pub Date : 2024-04-24 DOI: 10.1080/20523211.2024.2335492
S. Vogler, N. Zimmermann, M. Haasis, Verena Knoll, Jaime Espin, A. Mantel-Teeuwisse, Dimitra Panteli, F. Suleman, Veronika J Wirtz, Zaheer Babar
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引用次数: 0
A systematic review of the economic burden of diabetes mellitus: contrasting perspectives from high and low middle-income countries 糖尿病经济负担的系统性审查:高收入国家和中低收入国家的对比视角
IF 4.2 Q1 Health Professions Pub Date : 2024-04-19 DOI: 10.1080/20523211.2024.2322107
M. Butt, S. C. Ong, Azra Rafiq, Muhammad Nasir Kalam, Ahsan Sajjad, Muhammad Abdullah, Tooba Malik, Fatima Yaseen, Zaheer-Ud-Din Babar
ABSTRACT Introduction Diabetes increases preventative sickness and costs healthcare and productivity. Type 2 diabetes and macrovascular disease consequences cause most diabetes-related costs. Type 2 diabetes greatly costs healthcare institutions, reducing economic productivity and efficiency. This cost of illness (COI) analysis examines the direct and indirect costs of treating and managing type 1 and type 2 diabetes mellitus. Methodology According to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, Cochrane, PubMed, Embase, CINAHL, Scopus, Medline Plus, and CENTRAL were searched for relevant articles on type 1 and type 2 diabetes illness costs. The inquiry returned 873 2011–2023 academic articles. The study included 42 papers after an abstract evaluation of 547 papers. Results Most articles originated in Asia and Europe, primarily on type 2 diabetes. The annual cost per patient ranged from USD87 to USD9,581. Prevalence-based cost estimates ranged from less than USD470 to more than USD3475, whereas annual pharmaceutical prices ranged from USD40 to more than USD450, with insulin exhibiting the greatest disparity. Care for complications was generally costly, although costs varied significantly by country and problem type. Discussion This study revealed substantial heterogeneity in diabetes treatment costs; some could be reduced by improving data collection, analysis, and reporting procedures. Diabetes is an expensive disease to treat in low- and middle-income countries, and attaining Universal Health Coverage should be a priority for the global health community.
ABSTRACT 引言 糖尿病会增加预防性疾病的发病率,并导致医疗保健和生产成本的增加。2 型糖尿病和大血管疾病的后果导致了大部分与糖尿病相关的费用。2 型糖尿病大大增加了医疗机构的成本,降低了经济生产力和效率。本疾病成本(COI)分析研究了治疗和管理 1 型和 2 型糖尿病的直接和间接成本。方法 根据《系统综述和元分析首选报告项目》指南,检索了 Cochrane、PubMed、Embase、CINAHL、Scopus、Medline Plus 和 CENTRAL 中有关 1 型和 2 型糖尿病疾病成本的相关文章。结果共检索到 873 篇 2011-2023 年的学术文章。在对 547 篇论文进行摘要评估后,本研究收录了 42 篇论文。结果 大多数文章来自亚洲和欧洲,主要涉及 2 型糖尿病。每位患者的年度成本从 87 美元到 9581 美元不等。基于患病率的成本估算从不到 470 美元到超过 3475 美元不等,而每年的药品价格从 40 美元到超过 450 美元不等,其中胰岛素的差异最大。并发症的治疗费用普遍较高,但不同国家和问题类型的费用差异很大。讨论 本研究揭示了糖尿病治疗费用的巨大差异;通过改进数据收集、分析和报告程序,可以减少其中一些差异。在中低收入国家,糖尿病是一种治疗费用昂贵的疾病,实现全民医保应成为全球卫生界的优先事项。
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引用次数: 0
Methylprednisolone use in hospitalised COVID-19 patients: a retrospective study 住院的 COVID-19 患者使用甲基强的松龙的情况:一项回顾性研究
IF 4.2 Q1 Health Professions Pub Date : 2024-04-17 DOI: 10.1080/20523211.2024.2337125
Nur Fatin Najwa Azemi, F. Islahudin, Rahela Ambaras Khan, S. Saffian, Leong Chee Loon
ABSTRACT Introduction Trials have demonstrated the benefits of methylprednisolone in the treatment of coronavirus disease 2019 (COVID-19). However, data on optimal dose, duration and timing of administration are limited. This study investigates the outcome of various methylprednisolone treatment regimens among hospitalised COVID-19 patients. Methods A retrospective cohort study was conducted on hospitalised adult COVID-19 patients admitted between June and August 2021 in general COVID-19 wards, treated with methylprednisolone. Clinical outcomes evaluated include in-hospital mortality, thirty-day mortality, clinical efficacy (C-reactive protein (CRP), total white blood cells (TWBC) and oxygen requirement) as well as the safety of methylprednisolone. Results Of 278 patients, 1(0.4%) received weight-based dosing of 1 mg/kg/day, 101(36.3%) received weight-based dosing of 2 mg/kg/day, 130(46.8%) received fixed dosing methylprednisolone 250 mg/day and 46(16.5%) received fixed dosing methylprednisolone 500 mg/day. There was a significant difference in in-hospital mortality rates following different methylprednisolone doses whereby in-hospital mortality occurred in 22.5% (n = 23) of patients with 1 or 2 mg/kg/day methylprednisolone, 32.3% (n = 42) with 250 mg/day and 39.1% (n = 18) with 500 mg/day (p = 0.023). On the other hand, no significant difference in thirty-day mortality, clinical efficacy and safety was observed between different dosing regimens (p > 0.05). Conclusion The use of methylprednisolone weight-based dosing in hospitalised COVID-19 patients should be considered due to the positive outcome associated with lower in-hospital mortality.
ABSTRACT 引言 试验证明,甲基强的松龙对治疗 2019 年冠状病毒病(COVID-19)有好处。然而,有关最佳剂量、持续时间和给药时机的数据却很有限。本研究调查了各种甲泼尼龙治疗方案在住院COVID-19患者中的疗效。方法 对 2021 年 6 月至 8 月期间入住 COVID-19 普通病房、接受甲基强的松龙治疗的 COVID-19 住院成人患者进行回顾性队列研究。评估的临床结果包括院内死亡率、30 天死亡率、临床疗效(C 反应蛋白 (CRP)、总白细胞 (TWBC) 和需氧量)以及甲基强的松龙的安全性。结果 在278名患者中,1人(0.4%)按体重每天服用1毫克/千克,101人(36.3%)按体重每天服用2毫克/千克,130人(46.8%)按固定剂量每天服用甲基强的松龙250毫克,46人(16.5%)按固定剂量每天服用甲基强的松龙500毫克。使用不同剂量的甲基强的松龙后,院内死亡率存在明显差异,使用甲基强的松龙1或2毫克/千克/天的患者院内死亡率为22.5%(23人),使用甲基强的松龙250毫克/天的患者院内死亡率为32.3%(42人),使用甲基强的松龙500毫克/天的患者院内死亡率为39.1%(18人)(P=0.023)。另一方面,不同剂量方案的 30 天死亡率、临床疗效和安全性均无明显差异(P > 0.05)。结论 对住院的 COVID-19 患者应考虑使用甲基强的松龙按体重给药,因为这可降低院内死亡率。
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引用次数: 0
Vaccine storage and stock management practices in Vihiga County, Kenya 肯尼亚维希加县的疫苗储存和库存管理做法
IF 4.2 Q1 Health Professions Pub Date : 2024-04-17 DOI: 10.1080/20523211.2024.2337128
Eclayne Naswa Wanyonyi, E. Sagwa, Stany Banzimana, D. Asingizwe
ABSTRACT Background Effective vaccine management is crucial to maintain vaccine potency. To achieve this, elements, such as temperature management, stock management, infrastructure, cold chain equipment and waste management, need to be properly implemented. Therefore, this study was conducted to assess the vaccine storage and stock management practices in public health facilities within Vihiga County. Methods A descriptive cross-sectional design was used. Eighty-six public health facilities were selected and one staff involved in handling vaccines from each facility participated in the study. The study utilised survey questionnaires and observational checklists to collect data. Results All facilities visited use standard vaccine requisition forms for ordering and receiving vaccines and physical stock counts are done in all facilities. The majority of immunising healthcare workers knew how to condition icepacks 88.4%; however, 57.0% did not know all the heat-, cold- and light-sensitive vaccines. Status of vaccine equipment, knowledge of healthcare workers and stock management practices were positively associated with vaccine cold chain management at 52.8%. Conclusion Knowledge of vaccine handlers and stock management practices should be improved to enhance effective vaccine management. Besides, there is a need for the County Government of Vihiga to purchase sufficient WHO-recommended refrigerators.
ABSTRACT 背景 有效的疫苗管理对于保持疫苗效力至关重要。为实现这一目标,需要妥善实施温度管理、库存管理、基础设施、冷链设备和废物管理等要素。因此,本研究对维希加县公共卫生机构的疫苗储存和库存管理方法进行了评估。方法 采用描述性横断面设计。研究选取了 86 家公共卫生机构,每家机构有一名参与疫苗处理的工作人员参与研究。研究利用调查问卷和观察核对表收集数据。结果 所有受访机构均使用标准疫苗申请表订购和接收疫苗,所有机构均进行了实际库存清点。88.4%的大多数免疫医护人员知道如何调节冰袋;但是,57.0%的医护人员不知道所有对热、冷和光敏感的疫苗。疫苗设备状况、医护人员知识和库存管理方法与疫苗冷链管理呈正相关,比例为 52.8%。结论 应提高疫苗处理人员的知识水平和库存管理方法,以加强疫苗的有效管理。此外,维希加县政府有必要购买足够的世界卫生组织推荐的冰箱。
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引用次数: 0
Abstracts from the 5th PPRI conference 2024: ensuring access to affordable medicines through innovative policies, Vienna, Austria, 25–26 April 2024 2024 年第五届公共采购政策研究所会议摘要:2024 年 4 月 25-26 日,奥地利维也纳,通过创新政策确保获得负担得起的药品
IF 4.2 Q1 Health Professions Pub Date : 2024-04-12 DOI: 10.1080/20523211.2024.2331920
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引用次数: 0
Academia-pharmaceutical industry linkage: An academic perspective 学术界与制药业的联系:学术视角
IF 4.2 Q1 Health Professions Pub Date : 2024-04-05 DOI: 10.1080/20523211.2024.2332872
Zobia Mubarak, Nasir Abbas, F. Hashmi, S. Husnain, N. Bukhari
ABSTRACT Background: The pharmaceutical sector in Pakistan has grown over a period, however, there are several barriers in the framework governing the growth of the country’s pharmaceuticals. The lack of academia-industry linkage (AIL) is among the critical barriers; hence the focus of the study is to find out the reasons for the lack in the above collaboration. Understanding barriers may help their redressal. Method: This qualitative phenomenology-based study has been conducted in the most prominent pharmacy institutes, located in Lahore, Islamabad, Peshawar, Sargodha, and Quetta. Academic participants, with a minimum experience of 10 years and designation of assistant professor or above were recruited with a two-stage selection process, purposive sampling and snowball sampling. The data were collected using semi-structured interviews with academic experts. Thematic content analysis was employed to conclude the data. Results: Analysis of data yielded 8 themes with 18 codes. The main reasons for neglected AIL were explained by a partial or complete lack of industrial research and development activities. Other key factors for the scarcity of AILs were the lack of positive attitude from both industry and academia, applied research in academics, and the research and development of the new molecules in the pharmaceutical industry. Support by the government and the drug regulatory authority of Pakistan in terms of regulatory and academic policies was also perceived to be absent. New horizons in research and development could be opened by providing applied research to industry, including but not limited to new molecule development. Conclusion: Academia-industry linkage could be boosted with government-backed funded projects and policies. Academia should focus on the industrial-demanded applied research.
ABSTRACT 背景:巴基斯坦的制药业在一段时期内得到了发展,但在制约该国制药业发展的框架中存在着一些障碍。缺乏学术界与工业界的联系(AIL)是关键障碍之一;因此,本研究的重点是找出缺乏上述合作的原因。了解障碍可能有助于解决这些问题。研究方法:这项基于现象学的定性研究在位于拉合尔、伊斯兰堡、白沙瓦、萨尔古达和奎达的最著名药学院进行。通过目的性抽样和 "滚雪球 "抽样两个阶段的筛选过程,招募了至少有 10 年工作经验且职称为助理教授或以上的学术参与者。通过对学术专家进行半结构式访谈收集数据。采用主题内容分析法对数据进行总结。结果:数据分析得出了 8 个主题和 18 个代码。部分或完全缺乏工业研发活动是造成非洲基础设施投资被忽视的主要原因。缺乏 AIL 的其他关键因素还包括:产业界和学术界缺乏积极态度、学术界的应用研究以及制药业对新分子的研究和开发。巴基斯坦政府和药品监管机构在监管和学术政策方面也缺乏支持。通过向产业界提供应用研究,包括但不限于新分子的开发,可以开辟研发的新天地。结论:政府支持的资助项目和政策可促进学术界与产业界的联系。学术界应把重点放在产业需求的应用研究上。
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引用次数: 0
Comparing pharmacy practice in health facilities with and without pharmaceutically trained dispensers: a post intervention study in Tanzania 比较有和没有经过药学培训的配药员的医疗机构的药学实践:坦桑尼亚的一项干预后研究
IF 4.2 Q1 Health Professions Pub Date : 2024-04-02 DOI: 10.1080/20523211.2024.2323091
R. Mbwasi, Kelvin Msovela, Fiona Chilunda, Sia Tesha, R. Canavan, K. Wiedenmayer
ABSTRACT Background: The critical shortage of comprehensively trained healthcare staff in Tanzania affects the capacity to deliver essential health services, attain universal health coverage and compromises health outcomes. There is a specific lack of suitably trained pharmaceutical professionals, thus, an increase in the use of unqualified or poorly trained staff. Following the introduction of a one-year pharmacy dispenser course intervention, this study explored the impact that the new cadre of graduates had on pharmacy practice compared to healthcare facilities with non-pharmacy trained dispensers (NPTDs). Methods: A post intervention assessment was conducted in 2021 using questionnaires formulated to measure indicators of Good Pharmacy Practice, comparing 29 public health facilities employing pharmacy-trained dispensers (PTD) with 32 public health facilities with NPTDs in Dodoma, Shinyanga and Morogoro regions of Tanzania. Data were collected by experienced pharmacists or pharmaceutical technicians and subsequently aggregated and statistically analysed. Results: The dispensing times for medicines were found to be the same for PTDs and the NPTDs (2 min). There were no statistically significant differences in the adequacy of labelling elements between PTDs and NPTDs. Patients’ level of knowledge of the medicines dispensed to them, from both PTDs and NPTDs, showed no difference. Moreover, no differences were observed in storage practice and documentation performance, records of dispensed medicines, handling of medicines and the dispensing area cleanliness between both groups. Overall, facilities with PTDs averaged a higher availability of tracer medicines (77%) than those with NPTDs (70%), however, availability of health commodities in all health facilities in the three regions was low and there was no statistically significant difference between both groups. Conclusion: The study showed no significant difference in performance of pharmacy practice between PTDs and NPTDs despite the former undertaking a one-year training course intended to improve knowledge and skills. Practice application not only depends on effective training but on the working environment. Clear job descriptions, appropriate tools and references to guide, Standard Operating Procedures, acceptance by management of the training undertaken to actively encourage recruits to apply these new skills could improve PTDs performance. Training and knowledge alone do not seem to lead to better practice and performance.
摘要 背景:坦桑尼亚严重缺乏训练有素的医护人员,这影响了提供基本医疗服务、实现全民医保的能力,并损害了医疗成果。特别是缺乏经过适当培训的药剂专业人员,因此,使用不合格或训练不足的工作人员的情况有所增加。在引入为期一年的药房配药员课程干预措施后,本研究探讨了与使用未经药学培训的配药员(NPTDs)的医疗机构相比,新的毕业生队伍对药学实践的影响。方法:在 2021 年进行了一项干预后评估,使用了为衡量良好药学实践指标而制定的调查问卷,比较了坦桑尼亚多多马、欣扬加和莫罗戈罗地区 29 家聘用经过药学培训的配药员(PTD)的公共医疗机构与 32 家聘用未经药学培训的配药员(NPTD)的公共医疗机构。数据由经验丰富的药剂师或制药技术人员收集,然后进行汇总和统计分析。结果PTD 和 NPTD 的配药时间相同(2 分钟)。在标签内容的充分性方面,公共交通服务点和非公共交通服务点没有明显的统计学差异。患者对配发给他们的药品的了解程度,在公共药房和非处方药房均无差异。此外,两组在储存方法和文件记录、配药记录、药品处理和配药区清洁度方面也无差异。总体而言,与使用非处方药的医疗机构(70%)相比,使用处方药的医疗机构的示踪药品平均供应率较高(77%),但三个地区所有医疗机构的医疗用品供应率都较低,两组之间在统计上没有显著差异。结论研究表明,尽管 PTD 和 NPTD 接受了旨在提高知识和技能的为期一年的培训课程,但他们在药学实践方面的表现并无明显差异。实践应用不仅取决于有效的培训,还取决于工作环境。明确的工作描述、适当的指导工具和参考资料、标准操作程序、管理层对所接受培训的认可以及积极鼓励新聘人员应用这些新技能,都可以提高 PTD 的工作绩效。单靠培训和知识似乎并不能提高实践能力和工作绩效。
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引用次数: 0
Conscientious objection – a cross-sectional, vignette-based, mixed methods exploration of Australian pharmacists’ perspectives 出于良心拒服兵役--对澳大利亚药剂师观点的横断面、基于小故事的混合方法探讨
IF 4.2 Q1 Health Professions Pub Date : 2024-04-02 DOI: 10.1080/20523211.2024.2323086
S. Isaac, A. Mirzaei, Andrew J McLachlan, B. Chaar
ABSTRACT Background: Conscientious objection (CO) in healthcare is a controversial topic. Some perceive CO as freedom of conscience, others believe their professional duty-of-care overrides personal-perspectives. There is a paucity of literature pertaining to pharmacists’ perspectives on CO. Aim: To explore Australian pharmacists’ decision-making in complex scenarios around CO and reasons for their choices. Method: A cross-sectional, qualitative questionnaire of pharmacists’ perspectives on CO. Vignette-based questions were about scenarios related to medical termination, emergency contraception, IVF surrogacy for a same-sex couple and Voluntary Assisted Dying (VAD) Results: Approximately half of participants (n = 223) believed pharmacists have the right to CO and most agreed to supply prescriptions across all vignettes. However, those who chose not to supply (n = 20.9%), believed it justifiable, even at the risk of patients failing to access treatment. Strong self-reported religiosity had a statistically significant relationship with decisions not to supply for 3 of 4 vignettes. Three emergent themes included: ethical considerations, the role of the pharmacist and training and guidance. Conclusion: This exploratory study revealed perspectives of Australian pharmacists about a lack of guidance around CO in pharmacy. Findings highlighted the need for future research to investigate and develop further training and professional frameworks articulating steps to guide pharmacists around CO.
摘要 背景:医疗保健中的良心反对(CO)是一个有争议的话题。一些人认为良心反对是良心自由,另一些人则认为他们的专业护理职责高于个人观点。有关药剂师对良心反对的看法的文献很少。目的:探讨澳大利亚药剂师在复杂情况下围绕 "CO "做出的决策及其选择的原因。方法:就药剂师对一氧化碳的看法进行横向定性问卷调查。小插曲式问题涉及医疗终止妊娠、紧急避孕、同性伴侣试管婴儿代孕和自愿辅助死亡(VAD)等相关情景:大约一半的参与者(n = 223)认为药剂师有权提供处方,而且大多数人同意在所有情景中提供处方。然而,那些选择不提供处方的参与者(n = 20.9%)认为,即使冒着病人无法获得治疗的风险,也要提供处方。在 4 个案例中,有 3 个案例中的强烈自我宗教信仰与不提供处方的决定有显著的统计学关系。三个新出现的主题包括:伦理考虑、药剂师的角色以及培训和指导。结论:这项探索性研究揭示了澳大利亚药剂师的观点,即药房缺乏有关一氧化碳的指导。研究结果强调了未来研究的必要性,即进一步调查和开发培训与专业框架,阐明指导药剂师处理 CO 的步骤。
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引用次数: 0
Frequency, management and impact of adverse events on treatment outcomes in patients with multidrug resistant tuberculosis in Balochistan, Pakistan 巴基斯坦俾路支省耐多药结核病患者不良事件的发生频率、管理及其对治疗结果的影响
IF 4.2 Q1 Health Professions Pub Date : 2024-04-02 DOI: 10.1080/20523211.2024.2332878
Sara Rafique, N. Ahmad, Shereen Khan, Amjad Khan, Muhammad Atif, Abdul Wahid, A. Khan, Hira Waheed
ABSTRACT Background: Early detection, monitoring, and managing adverse events (AEs) are crucial in optimising treatment for multidrug-resistant tuberculosis (MDR-TB) patients. Objectives: To investigate the incidence, factors, management, and impact of AEs on treatment outcomes in MDR-TB patients. Methods: This study reviewed the medical records of 275 MDR-TB patients at Fatimah Jinnah Institute of Chest Diseases in Quetta, Pakistan. Patient information was collected using a designed data collection form. Mann–Whitney U and Kruskal–Wallis tests examined the difference in AEs occurrences based on patients’ characteristics. Multiple binary logistic regression identified factors associated with unsuccessful outcomes, with statistical significance set at a p-value < 0.05. Results: Almost all patients (99.6%) experienced at-least one AE (median = 4/patient, interquartile range:3-6). The most common were GI disturbance (95.3%), arthralgia (80.4%), body pain and headache (61.8%), ototoxicity (61.4%), psychiatric disturbance (44%), hypokalaemia (40.4%), dermatological reactions (26.2%) and hypothyroidism (21.5%). AEs led to treatment modification in 7.3% patients. Educated patients, those with a history of TB treatment, previous use and resistance to any second-line drug had significantly higher number of AEs. A total of 64.0% were declared cured, 3.6% completed treatment, 19.6% died and 12.7.9% were lost to follow-up. Patients’ age of 41-60(OR = 9.225) and >60 years(OR = 23.481), baseline body weight of 31–60 kg(OR = 0.180), urban residence(OR = 0.296), and experiencing ototoxicity (OR = 0.258) and hypothyroidism (OR = 0.136) were significantly associated with unsuccessful treatment outcomes. Conclusion: AEs were highly prevalent but did not negatively impact treatment outcomes. Patients at higher risk of developing AEs and unsuccessful outcomes should receive special attention for its early management.
摘要 背景:早期发现、监测和管理不良事件(AEs)对于优化耐多药结核病(MDR-TB)患者的治疗至关重要。研究目的调查 AEs 的发生率、因素、管理以及对 MDR-TB 患者治疗结果的影响。方法本研究查阅了巴基斯坦奎达法蒂玛-真纳胸部疾病研究所 275 名 MDR-TB 患者的病历。使用设计好的数据收集表收集患者信息。Mann-Whitney U和Kruskal-Wallis检验根据患者的特征检验了AEs发生率的差异。多重二元逻辑回归确定了与治疗结果不成功相关的因素,统计显著性设定为 p 值 60 岁(OR = 23.481)、基线体重 31-60 公斤(OR = 0.180)、城市居民(OR = 0.296)、耳毒性(OR = 0.258)和甲状腺功能减退(OR = 0.136)与治疗结果不成功显著相关。结论AEs发生率很高,但不会对治疗结果产生负面影响。发生 AEs 和治疗结果不成功的风险较高的患者应得到特别关注,以便及早治疗。
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引用次数: 0
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