Drugs, Essential

药物, 必需
  • 文章类型: Journal Article
    背景:本研究的目的是探索全科医生信息的影响,城市和郊区EM处方行为的动机和行为技能。
    方法:2022年6月至11月,对北京3个市区和4个郊区进行了横断面研究。采用结构方程模型对市区和郊区全科医生基本药物处方行为的影响因素进行分析。
    结果:共收集有效问卷511份。城市GP和郊区GP之间的个人动机和行为技能的平均得分在统计学上存在显着差异。对于城市全科医生,路径分析显示,社会动机对基本药物处方行为有直接影响(β=0.225,p<0.05)。相比之下,对于郊区的全科医生来说,社会动机和个人动机都直接影响基本药物的处方行为,分别为(β=0.175,p<0.05;β=0.193,p<0.01)。
    结论:城市全科医生的社会动机与基本药物处方行为呈正相关。郊区全科医生的社会动机和个人动机与基本药物处方行为呈正相关且显着相关。因此,我国应制定相应的政策和措施来推进国家基本药物政策。
    BACKGROUND: The aim of this study is to explore the influence of GPs\'information, motivation and behavior skills on EM prescribing behavior in urban and suburban districts.
    METHODS: A cross-sectional study was conducted from June to November 2022 cross 3 urban districts and 4 suburban districts in Beijing. The structural equation model was used to analyze the factors influencing the essential medicine prescription behavior among general practitioners in urban and suburban districts.
    RESULTS: A total of 511 valid questionnaires were collected. There was a statistically significant difference in mean scores for personal motivation and behavioral skills between urban GPs and suburban GPs. For urban GPs, the path analysis revealed that the social motivation had a direct effect on the essential medicine prescribing behavior (β = 0.225, p < 0.05). In contrast, for suburban GPs, both social motivation and personal motivation had a direct effect on the essential medicine prescribing behavior, respectively (β = 0.175, p < 0.05; β = 0.193, p < 0.01).
    CONCLUSIONS: Social motivation of urban GPs were positively and significantly associated with essential medicine prescribing behavior. Social motivation and personal motivation of suburban GPs were positively and significantly associated with essential medicine prescribing behavior. Therefore, various corresponding policies and measures should be developed to promote the National Essential Medicines Policy in China.
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  • 文章类型: Editorial
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  • 文章类型: Journal Article
    背景:药物短缺是一个严重威胁公众健康的世界性问题。中国发布了2022年最全面的药品短缺重点监测品种名单。分析清单内药品的属性和特点,为提高我国短缺药品的供应安全提供参考。
    方法:我们使用公共数据来提取有关药物类型的信息,剂型,适应症,临床用途分类,它们是否被包括在国家基本药物等医疗目录中,以及药物和活性药物成分(API)制造商的数量。使用描述性统计分析。
    结果:在列表中的980种药物中,99.59%是化学药品,92.65%是注射剂。血液和造血器官的药物,心血管系统,消化道和新陈代谢位居前三位。医学目录核查显示,90.41%的药品属于国家基本药物,95.10%是医疗药物,2.55%为批量采购药品,14.70%是罕见疾病,儿童占42.04%。在药品供应能力方面,21.33%的药品批件不到10个,甚至有26个药品为独家生产,近90%的制造商需要从外部购买API。在列表中包含的256个API中,152个原料药只有不到10个制造商,甚至全国只有一家企业生产了5种原料药。
    结论:我国药品短缺形势严峻复杂,适应基本医疗保健需求的药品和临床必需的药品严重短缺,以及提高药品生产能力和原料药供应能力的需要。我们建议加强药品监测和储备,加快短缺药品审批,提高药品供应安全。
    BACKGROUND: Drug shortage is a worldwide problem that seriously threatens public health. China released the most comprehensive list of key drug shortage monitoring varieties ever in 2022. We aim to analyze the attributes and characteristics of the medicines within the list to provide a reference for improving China\'s supply security of shortage drugs.
    METHODS: We used public data to extract information on drug types, dosage forms, indications, classification of clinical uses, whether they were included in medical catalogs such as the National Essential Drugs, and the number of drug and active pharmaceutical ingredient (API) manufacturers. A descriptive statistical analysis was used.
    RESULTS: Of the 980 drugs on the list, 99.59% were chemicals and 92.65% were injectables. Drugs for blood and hematopoietic organs, the cardiovascular system, and the digestive tract and metabolism ranked among the top three shortages. Verification of the medical catalogs showed that 90.41% of the drugs belonged to the national essential drugs, 95.10% were medicare drugs, 2.55% were volume-based procurement drugs, and 14.70% were for rare diseases, and 42.04% were for children. In terms of drug supply capacity, 21.33% of drug approvals are less than 10, and there were even 26 drugs for exclusive production, close to 90% of manufacturers need to purchase APIs from outside. Among the 256 APIs included in the list, 152 APIs had less than 10 manufacturers, and there were even 5 APIs produced by only one enterprise nationwide.
    CONCLUSIONS: The situation of drug shortages in China was severe and complex, with serious shortages of medicines adapted to basic medical and healthcare needs and clinically necessary medicines, and a need to improve the production capacity of drugs and the ability to supply APIs. We recommend strengthening drug monitoring and stockpiling and accelerating the approval of shortage drugs to improve drug supply security.
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  • 文章类型: Journal Article
    目的:为了评估可用性,成本,南京抗癌药物的承受能力,江苏。
    方法:于2016-2020年对南京市26家医疗机构的24种基本抗癌药物(EAM)和17种创新抗癌药物(IAM)进行纵向跟踪调查。可用性,成本,研究了EAM和IAM的药物利用和可负担性。
    结果:在南京,EAM的可用性没有显着变化,但IAMs的可用性在2018年和2019年表现出显著增长,并在2020年趋于稳定。对于EAM,LPG(最低价格的仿制药)的DDDc(定义的每日剂量成本)没有显着变化,OBs(OriginatorBrands)和IAMs的DDDc显著下降。EAM(LPG)的DDDs(定义的每日剂量)自2016年以来呈下降趋势,2019年再次上升。总的来说,2016年至2020年,EAM(LPG)的DDDs下降了25.18%,但2020年选择用于临床治疗的比例仍为67.35%.EAM(OBs)和IAM的DDDs均呈逐年上升趋势,比例增长207.72%和652.68%,分别;但2020年选择用于临床治疗的比例分别仅为16.09%和16.56%。EAM(LPG)对城市居民的承受能力较好,但对农村居民的承受能力较差;EAM(OBs)和IAM对城乡居民的承受能力较差。
    结论:EAM(LPG)的可用性和成本没有显着变化,较低的价格显示出更好的负担能力。尽管它们在药物利用方面的相对变化呈下降趋势,他们仍然主导着临床治疗。在国家药品价格谈判(NDPN)政策的推动下,IAMs的可用性正在上升。有必要进一步制定和加强基本药物采购评估政策,以提高EAM的可及性。
    OBJECTIVE: To evaluate the availability, cost, affordability of anti-cancer medicines in Nanjing, Jiangsu.
    METHODS: A longitudinal tracking investigation study was performed to collect information about 24 essential anti-cancer medicines (EAMs) and 17 innovative anti-cancer medicines (IAMs) in 26 healthcare institutions in Nanjing from 2016 to 2020. The availability, cost, drug utilization and affordability of EAMs and IAMs were investigated.
    RESULTS: The availability of EAMs showed no significant changes in Nanjing, but the availability of IAMs showed a significant increase in 2018 and 2019 and tended to stabilize in 2020. For EAMs, the DDDc(Defined Daily Dose cost) of LPGs (Lowest-Priced Generics) showed no significant changes, and the DDDc of OBs (Originator Brands) and IAMs significantly decreased. The DDDs(Defined Daily Doses) of EAMs (LPGs) showed a decreasing trend since 2016 and rose again in 2019. Overall, the DDDs of EAMs (LPGs) decreased by 25.18% between 2016 and 2020, but the proportion selected for clinical treatment remained at 67.35% in 2020. The DDDs of EAMs (OBs) and IAMs both showed an increasing trend year by year, with a proportional increase of 207.72% and 652.68%, respectively; but the proportion selected for clinical treatment was only 16.09% and 16.56% respectively in 2020. EAMs (LPGs) had good affordability for urban residents but poor affordability for rural residents; the affordability of EAMs (OBs) and IAMs was poor for both urban and rural residents.
    CONCLUSIONS: There were no significant changes in the availability and cost of EAMs (LPGs), whose lower prices showed better affordability. Although their relative change in drug utilization showed a decreasing trend, they still dominated clinical treatment. Driven by the national drug price negotiation (NDPN) policy, the availability of IAMs was on the rise. It is necessary to further develop and strengthen policies for essential medicines procurement assessment to improve the accessibility of EAMs.
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  • 文章类型: Journal Article
    背景:世界卫生组织基本药物清单(WHOEML)指导国家基本药物清单和标准治疗指南,以明确确定疾病优先事项,特别是在低收入和中等收入国家。这项研究比较了世卫组织非洲区域国家国家基本药物清单中推荐用于儿童和年轻人风湿性疾病的药物篮子的程度,对应于2021年世卫组织EML和世卫组织儿童EML,作为可用性的代理。
    方法:对WHO药品和卫生技术门户网站的在线搜索,卫生部54个非洲国家的网站,pubmed和谷歌学者,带有“国家基本药物清单”的搜索词,和/或\'标准治疗指南\'和\''和\'列塔国家医疗要点\'和/或\'列塔国家医疗要点\'和非洲和/或<非洲国家名称>进行。根据预定义的药物模板比较了国家清单上的药物数量;并计算了相似度百分比。描述性统计数据是使用STATA得出的。
    结果:世卫组织非洲地区的47个国家制定了国家基本药物清单。11个国家没有列出任何治疗风湿性疾病的药物。大多数国家与世卫组织EML在儿童和青少年风湿性疾病方面的相似性小于或等于50%,中位数3种药物(IQR1-4)。非洲国家名单上最常见的药物是甲氨蝶呤,柳氮磺吡啶和硫唑嘌呤,在6个国家/地区使用etanercept。七个国家只有一种药物,乙酰水杨酸列在“青少年关节疾病”一节中。国家清单上药品数量的预测因素的多元线性回归模型建立了20%的变异性是由人均卫生支出预测的,社会人口统计学指数和风湿病服务(成人和/或儿科)的可获得性p=0.006,社会人口统计学指数(p=0.035,95%CI0.64-16.16)和风湿病服务的可获得性(p=0.033,95%CI0.13-2.90)显著.
    结论:非洲有四个国家(8.5%)更新了国家基本药物清单,以反映对患有风湿性疾病的儿童和年轻人的适当护理。往前走,努力应侧重于使现有药物与世卫组织EML保持一致,加强风湿病和药学服务的医疗保健政策,获得负担得起的护理和药品。
    BACKGROUND: The World Health Organisation Essential Medicines List (WHO EML) guides National Essential Medicines Lists and Standard Treatment Guidelines for clearly identified disease priorities especially in low- and middle-income countries. This study compares the degree to which the basket of medicines recommended for rheumatic diseases in children and young people in National Essential Medicines Lists of countries in the WHO Africa region, corresponds to the 2021 WHO EML and WHO EML for children, as a proxy of availability.
    METHODS: An online search of the WHO medicines and health technology portal, the Health Ministry websites of the 54 African countries, PUBMED and Google Scholar, with search terms for \'National Essential Medicines List\', AND/OR \'standard treatment guidelines\' AND/OR \'Lista Nacional de Medicamentos Essenciais\' AND/ OR \'Liste Nationale de Medicaments Essentiels\' AND Africa AND/OR < Name of African country > was conducted. The number of medicines on the national lists were compared according to a predefined template of medicines; and the percentage similarity calculated. Descriptive statistics were derived using STATA.
    RESULTS: Forty-seven countries in the WHO Africa region have developed a National Essential Medicines List. Eleven countries do not have any medicines listed for rheumatic diseases. The majority of countries had less than or equal to 50% similarity with the WHO EML for rheumatic disease in children and young people, median 3 medicines (IQR 1- 4). The most common medicines on the national lists from Africa were methotrexate, sulfasalazine and azathioprine, with etanercept available in 6 countries. Seven countries had only one medicine, acetylsalicylic acid listed in the section \'Juvenile Joint diseases\'. A multiple linear regression model for the predictors of the number of medicines on the national lists established that 20% of the variability was predicted by health expenditure per capita, socio-demographic index and the availability of rheumatology services (adult and/or paediatric) p = 0.006, with socio-demographic index (p = 0.035, 95% CI 0.64-16.16) and the availability of rheumatology services (p = 0.033, 95% CI 0.13 - 2.90) significant.
    CONCLUSIONS: Four countries (8.5%) in Africa have updated their National Essential Medicines Lists to reflect adequate care for children and young people with rheumatic diseases. Moving forward, efforts should focus on aligning available medicines with the WHO EML, and strengthening healthcare policy for rheumatology and pharmaceutical services, for affordable access to care and medicines.
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  • 文章类型: Journal Article
    获得优质基本药物的差距仍然是低收入和中等收入国家(LMICs)有效照顾癌症儿童的主要障碍。世界卫生组织报告说,只有不到30%的低收入国家能够持续获得儿童癌症药物,与高收入国家的95%相比。本政策简介中提供的信息来自文献综述和发表在《柳叶刀肿瘤学》上的混合方法研究,该研究分析了肯尼亚儿童获得癌症药物的决定因素。坦桑尼亚,乌干达,卢旺达。提出了三个关键政策选择,以指导战略政策方向和关键卫生系统规划,以加强儿童获得癌症药物的机会:集中采购,基于证据的预测,和监管程序的区域协调。加强区域集合采购,解决市场分散问题,改善药品供应,投资于卫生信息系统,以改善儿童癌症医学需求的预测和规划,建议在东非地区促进监管协调以简化药品审批和质量保证。这份政策简报是为政策制定者准备的,临床医生,以及参与采购的卫生系统规划者,供应链管理,儿童癌症药物的政策和融资。
    Gaps in access to quality essential medicines remain a major impediment to the effective care of children with cancer in low-and middle-income countries (LMICs). The World Health Organization reports that less than 30% of LMICs have consistent availability of childhood cancer medicines, compared to over 95% in high-income countries. Information provided within this policy brief is drawn from a review of the literature and a mixed-methods study published in the Lancet Oncology that analyzed determinants of cancer medicine access for children in Kenya, Tanzania, Uganda, and Rwanda. Three key policy options are presented to guide strategic policy direction and critical health system planning for strengthening access to cancer medicines for children: pooled procurement, evidence-based forecasting, and regional harmonization of regulatory processes. Enhancing regional pooled procurement to address fragmented markets and improve medicine supply, investing in health information systems for improved forecasting and planning of childhood cancer medicine needs, and promoting regulatory harmonization to streamline medicine approval and quality assurance across East Africa are recommended. This policy brief is intended for policymakers, clinicians, and health-system planners involved in the procurement, supply chain management, policy and financing of childhood cancer medicines.
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  • 文章类型: Journal Article
    活性药物成分(API)的全球供应链在某些国家高度集中,容易受到供应链冲击。然而,在突发公共卫生事件期间,没有系统的监测或全球协调来管理风险并确保公平的供应连续性。在这项研究中,我们对装运级海关数据应用了准实验方法,以确定从印度出口的原料药的价格和出口量如何受到COVID-19大流行的影响。我们发现,在世界卫生组织宣布大流行后的一年中,未用于COVID-19的关键基本药物的API价格没有显着变化,但是销量下降了80%。推测用于COVID-19的药物价格,如羟氯喹和伊维菌素,与非用途药物的价格相比,增加了250%,但只有伊维菌素的体积有所减少。对原料药市场进行系统监测,促进供应多样化的投资,和法律和政治改革,以抑制价格投机可以支持供应链的弹性和保障获取药品。
    Global supply chains for active pharmaceutical ingredients (APIs) are highly centralized in certain countries and are susceptible to supply-chain shocks. However, there is no systematic monitoring or global coordination to manage risk and ensure equitable supply continuity during public health emergencies. In this study, we applied quasi-experimental methods on shipment-level customs data to determine how prices and export volume for APIs exported from India were affected by the COVID-19 pandemic. We found that API prices for key essential medicines not used for COVID-19 did not change significantly in the year after the World Health Organization pandemic declaration, but volume decreased by 80 percent. Prices for medicines speculatively repurposed for COVID-19, such as hydroxychloroquine and ivermectin, increased by as much as 250 percent compared with prices for nonrepurposed medicines, but only ivermectin saw a decrease in volume. Systematic monitoring of API markets, investments to promote supply diversification, and legal and political reforms to disincentivize price speculation could support supply-chain resilience and safeguard access to medicines.
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  • 文章类型: Editorial
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  • 文章类型: Journal Article
    这项横断面研究调查了通货膨胀之间是否存在关联,经济政策变化,以及退休人员在阿根廷获得药品的机会。
    This cross-sectional study investigates whether there are associations between inflation, economic policy changes, and retirees’ access to medicines in Argentina.
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  • 文章类型: Journal Article
    背景:在印度,使用米非司酮和米索前列醇的药物流产可在妊娠63天。这占该国所有堕胎的67.5%。我们进行了评估,以确定药物流产药物的可用性,特别是组合包,在印度。
    方法:我们在国家一级应用了世界卫生组织景观评估协议。评估协议包括对现有可用性框架的五步调整,包括在线数据收集,案头审查,国家一级的关键线人访谈,和分析,以确定障碍和机会,以提高医疗流产的可用性。评估于2021年8月至3月间进行。
    结果:药物流产药物被列入国家基本药物清单,并在印度有处方。评估确定了由35家制造商开发的42种组合包装产品。药物流产药物的质量由国家当局监管;但是随着健康移交给各州,有显著的州际差异。这在整个融资过程中都可以看到,采购,制造,和药物流产药物分发前质量保证的监测机制。有必要加强供应链系统,确保训练有素的提供者的一致可用性,并提高社区对使用药物流产药物进行早期流产的认识,在评估时。
    结论:存在提高药物流产药物的可用性和质量的机会。例如,统一执行监管标准,在制造过程中更加重视质量保证,以及各州采购和供应链系统的标准化。需要对提供者进行药物流产的定期在职培训。最后,需要在证据传播和社区参与方面进行创新,以了解最近修订的堕胎法。
    药物流产在印度很流行,并受益于自由的法律背景。重要的是要了解该国优质流产药物的可用性。使用世界卫生组织国家评估协议和药物流产药物的可用性框架,我们从供应到需求检查了这些药物的可用性。我们利用这些信息来确定增加质量保证的药物流产的机会。我们发现,药物流产的背景因各州而异。加强采购和供应链管理,应在国家一级更加重视质量保证和制造业监管。还需要培训,以增加提供者对最新国家准则和法律的了解,以确保尊重和以人为本的服务。最后,应该让公众了解药物流产是一种安全有效的选择,尤其是早期流产。
    BACKGROUND: Medical abortion with mifepristone and misoprostol can be provided up to 63 days\' gestation in India. This accounts for 67.5 percent of all abortions in the country. We conducted an assessment to determine the availability of medical abortion medicines, specifically the combi-pack, in India.
    METHODS: We applied the World Health Organization landscape assessment protocol at the national level. The assessment protocol included a five-step adaptation of an existing availability framework, including online data collection, desk review, country-level key informant interviews, and an analysis to identify barriers and opportunities to improve medical abortion availability. The assessment was conducted between August and March 2021.
    RESULTS: Medicines for medical abortion are included in the national essential drug list and available with prescription in India. The assessment identified 42 combi-pack products developed by 35 manufacturers. The quality of medical abortion medicines is regulated by national authorities; but as health is devolved to states, there are significant inter-state variations. This is seen across financing, procurement, manufacturing, and monitoring mechanisms for quality assurance of medical abortion medicines prior to distribution. There is a need to strengthen supply chain systems, ensure consistent availability of trained providers and build community awareness on use of medical abortion medicines for early abortions, at the time of the assessment.
    CONCLUSIONS: Opportunities to improve availability and quality of medical abortion medicines exist. For example, uniform implementation of regulatory standards, greater emphasis on quality-assurance during manufacturing, and standardizing of procurement and supply chain systems across states. Regular in-service training of providers on medical abortion is required. Finally, innovations in evidence dissemination and community engagement about the recently amended abortion law are needed.
    Medical abortion is popular in India and benefits from a liberal legal context. It is important to understand the availability of quality abortion medicines in the country. Using the World Health Organization country assessment protocol and availability framework for medical abortion medicines we examined the availability of these medicines from supply to demand. We used this information to identify opportunities for increasing availability of quality-assured medical abortion medicines. We found that the context for medical abortion varies across states. Strengthening procurement and supply chain management, with a greater emphasis on quality-assurance and regulation of manufacturing should be instituted at the state-level. Training is also needed to increase provider knowledge of the latest national guidelines and laws to ensure respectful and person-centered services. Finally, the public should be informed about medical abortion as a safe and effective choice, especially for early abortions.
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