《国家基本药物目录》《WHO儿童基本药物目录》和其他国家基本药物目录中抗变态反应药物比较分析

目的:比较我国《国家基本药物目录》(NEML)、《世界卫生组织儿童基本药物目录》(WHO-EMLc)和其他19个国家基本药物目录中抗变态反应药物的差异,为进一步完善我国基本药物目录提供参考。方法:检索WHO官网,收集各国基本药物目录。通过Excel分析工具,比较抗变态反应药物种类、数量、剂型、规格等差异,探讨基本药物对儿童的适宜性,总结收录的抗变态反应药物在我国的上市情况。结果:NEML与WHO-EMLc中相同的抗变态反应药物为氯雷他定。与NEML比较,WHO-EMLc和其他19国目录中抗变态反应药物增加了适合儿童使用的口服溶液剂,且部分国家注明了氯苯那敏和西替利嗪药物的年龄限制。各目录中收录的抗变态反应药物在我国上市剂型主要为普通片剂,适合儿童使用的颗粒剂、糖浆剂等特殊剂型虽有上市,但生产厂家较少。结论:以NEML与WHO-EMLc为基础,借鉴瑞典、马来西亚、马尔代夫等国家的经验,建议适当增加适宜儿童使用的第二代抗组胺药物剂型和规格,保障儿童临床用药的安全有效,完善国家基本药物目录。     

《国家基本药物目录》（2012年版）与WHO《基本药物示范目录》（第17版）的比较

目的：了解国家基本药物目录（2012年版）与WHO基本药物示范目录（第17版）的差异,为后续修订国家基本药物目录提供参考.方法：比较目录的结构、分级、各类药物特点.结果：WHO基本药物示范目录结构清晰严谨,目录分级精细有序,目录中各类药品的收录全面,充分考虑了安全性、有效性、经济性和地域性等综合因素,并且充分体现了基于循证学思想的基本药品遴选原则.结论：WHO基本药物示范目录对我国修订和完善国家基本药物目录具备借鉴作用和指导价值.     

Availability of essential medicines: A primary health care perspective

The present study was undertaken to assess the availability of the essential medicines to the people of Kunijarla, Khammam district, AP. This was done in two steps: 1) Comparison of PHC-EML (primary health care essential medicines list) with AP-EML (Andhra Pradesh essential medicines list) and NEML (National essential medicines list); and 2) Assessment of availability of the listed medicines in adequate quantity to meet the needs of people of kunijarla. Results showed that the PHC-EML is on par with AP-EML and NEML. The hospital has 100% availability of the listed medicines; however, there was a need for certain add-on drugs like phenytoin tablets, valproic acid, and activated charcoal since they were prescribed frequently and were not included in PHC-EML. All the drugs which were listed in PHC-EML were being used and none were considered as non-utility supply. Suggestions were given for the revision of PHC-EML according to the criteria for identifying medicines for inclusion in the revised list which was mentioned in NEML.     

2018版《国家基本药物目录》与2019版《世界卫生组织基本药物标准清单》中抗肿瘤药物目录的比较和分析

目的:分析2019版《世界卫生组织基本药物标准清单》中抗肿瘤药物目录的变动情况,并将2018版《国家基本药物目录》与2019版《世界卫生组织基本药物标准清单》中抗肿瘤药物目录的差异性进行比较,并结合我国基本国情和恶性肿瘤流行病学特征,为《国家基本药物目录》中抗肿瘤药物目录的科学调整和完善提供参考和建议.方法:比较两版目...     

多层级基本药物目录中含儿科使用信息药物的对比分析

目的：从儿科药可获得性的角度比较分析WHO、国家和省三层级基本药物目录。方法：通过统计WHO 2013版《儿童基本药物示范目录》、2012版《国家基本药物目录》和2011版《江苏省基本药物目录》中含儿科使用信息的药物,对3个目录中儿科适宜药物进行比较分析。结果与结论：2012版《国家基本药物目录》能够满足一定的儿科需求,但缺乏一些儿科专用品种和适用剂型规格,我国应针对无明确儿童用法用量信息的药品进行儿科评价。江苏省可参考2011版增补目录并借鉴WHO《儿童基本药物示范目录》,针对本省的用药需求补充儿童适用的品种、剂型和规格。     

从WHO最新技术报告看WHO基本药物遴选调整进展

WHO的最新版基本药物目录在抗病毒药物部分调入了奥赛米韦,在心血管疾病药物部分将阿替洛尔替换为比索洛尔;提出了合理用药的下一步战略;WHO明确指出基本药物的调入申请应包含所有发表和未发表的证据。我国应借鉴WHO的经验,完善我国基本药物目录、基本药物的合理使用及基本药物的调入申请的评价。     

2012版《国家基本药物目录》中儿童用药与《WHO儿童基本药物标准清单》及《母亲和儿童的重点药物目录》的比较分析

目的：为循证制订中国儿童基本药物目录提供参考。方法：描述性分析比较2012版《国家基本药物目录》中儿童用药与世界卫生组织（WHO）发布的{WHO儿童基本药物标准清单》及《母亲和儿童的重点药物目录》在内容组成、纳入条件、标志符号、药物分类原则、药物种类、药物剂型和年龄限制上的异同。结果：2012版《国家基本药物目录》基本覆盖了儿童常用药类别,但未包含《WHO儿童基本药物标准清单》中的血液制品、消毒剂和新生儿特殊用药;缺乏儿童适宜的剂型和规格以及药物年龄限制和说明。结论：WHO发布的两份目录是基于全球儿童的疾病负担而制定,并不完全适合中国,直接套用存在安全隐患。建议借鉴两份目录的制订标准和方法,并遵循中国国情,依据循证医学和药物经济学制订符合中国国情的儿童基本药物目录,以完善国家基本药物制度,从而保障儿童用药更安全、有效、方便。     

山东省公立医疗机构2018—2019年抗肿瘤类基本药物配备使用情况及药学服务能力分析

目的对比分析《国家基本药物目录(2018年版)》颁布前后各一年,山东省公立医疗机构抗肿瘤类基本药物配备使用情况的变化,并对药学服务能力进行调研。方法利用山东省卫健委大数据平台进行数据提取,并结合问卷调查的方式,对2018—2019年山东省二级及以上公立医疗机构中抗肿瘤类基本药物的采购金额、医疗机构配备使用情况、日治疗费用、药学服务能力等进行调研分析。结果山东省17地市中,济南市抗肿瘤类基本药物采购金额最大,潍坊市采购金额增幅最大。二级医疗机构抗肿瘤类基本药物的配备率低于三级医疗机构。靶向药物、辅助用药、激素类、烷化剂类药物的采购金额呈增长趋势,抗代谢药、抗生素、植物成分药、其它类抗肿瘤药物用量减少。首次进入《国家基本药物目录》的5种新型抗肿瘤药物使用金额较前增长明显。表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)中,目前吉非替尼的使用量居首位,且日治疗费用最低。对于医疗机构肿瘤患者随访工作,药师参与度低;不良反应收集与上报是抗肿瘤药物安全监测与评价的主要手段。结论山东省各地市各级医疗机构中,各类抗肿瘤类基本药物间的配备使用情况差距大;《国家基本药物目录(2018年版)》的颁布有效促进了抗肿瘤药物在山东省内各级医疗机构的配备和使用;目录新纳入药物,特别是新型抗肿瘤药物,在医疗机构中的配备使用增加明显;医疗机构整体抗肿瘤药学服务能力有待提高。     

中国中药上市企业运行效率研究

目的:为研究中国中药上市企业当前的运行效率以及存在的问题。方法:本文选取全国52家中药上市企业2008-2017年的相关数据指标,运用DEA方法和聚类分析方法对企业的运行效率趋势进行了实证分析。结果:依据上市企业运行效率技术效率和规模效率结果,将中国上市中药企业大致分为四种类型:全面高效型、配置低效型、规模低效型和持续改进型。结论:中药上市企业在保障规模效率稳定的基础上,推进技术效率的持续增长。     

2018版与2012版《国家基本药物目录》中抗微生物药物收录情况的比较研究

目的:研究2018年版《国家基本药物目录》与2012年版《国家基本药物目录》中抗微生物药物的差异,探讨2018年版中抗微生物药物变动情况及原因。方法:比较新旧国家基本药物目录中抗微生物药物的分类、品种、剂型、规格等方面的异同,对抗微生物药物目录的变动原因进行分析。结果:我国2018年版《国家基本药物目录》与2012年版相比,抗微生物药物目录中新增1个分类,为其他抗菌类;新增13个品种,为哌拉西林钠他唑巴坦钠、米诺环素、莫西沙星、伊曲康唑、两性霉素B、卡泊芬净、小檗碱、更昔洛韦、奥司他韦、恩替卡韦、索磷布韦维帕他韦、替诺福韦二吡呋酯、重组人干扰素;删减2个品种,为地红霉素和制霉素;4个品种发生剂型及规格调整,头孢菌素类头孢呋辛和抗真菌药氟康唑均增加了分散片剂型,克林霉素新增0.075 g规格,抗结核药利福平片剂删去0.3 g规格。结论:2018年版《国家基本药物目录》与2012年版相比,抗微生物药物的分类、品种、剂型和规格的合理性有所提高,能够更好地服务各级医疗卫生机构,促进该类药物规范、合理使用。但我国基本药物的遴选仍有很大优化空间,尤其是抗微生物药物,可借鉴世界卫生组织基本药物目录遴...     

Impact of pharmaceutical price controls on the cost of cardiovascular drugs: does essentiality matter?

ABSTRACT

Background

With the goal of improving the affordability of medicines, governments across the globe have instituted various forms of price controls. Since 2013, India has been regulating the prices of drugs included in its national list of essential medicines (NLEM). Here we evaluate the cost variations among available cardiovascular drugs and perform cost-analysis comparing essential and non-essential drugs.     

Analysis of patents on anti-allergic therapies issued in China from 1988 to 2008

Background: The prevalence of allergic diseases has increased dramatically in recent decades. Therefore, there is a pressing need for the development of effective anti-allergic services worldwide. However, little is known what anti-allergic products have been patented in China and what the potential drug candidates for patents are in China.

Objective: To analyze the patents of anti-allergic products for the last 20 years and help pharmaceutical companies and individuals to understand the potential candidates for anti-allergic patents in China.

Methods: Data were obtained from the People’s Republic of China Country Intellectual Property Rights Bureau website and United States Patent and Trademark Office website.

Results: A total of 789 anti-allergic patents have been granted in China during the past 20 years, which all focused on synthetic compounds, traditional Chinese medicines (TCM), combinations of synthetic compounds and TCM, biological products and medical apparatus. It appears that more and more effective therapeutic components of TCM rather than whole herbs have been patented in recent years and alteration of natural molecules to produce more therapeutically effective molecules has emerged as a novel trend for the modernization of TCM. The patents on synthetic anti-allergic compounds in China mainly focus on well-known targets, such as histamine receptor and leukotrienes, which consist of 93% of patents for validated targets.

Conclusion: The number of anti-allergic patents applied in China is far lower than that in the US. Therefore, there are great opportunities for obtaining anti-allergic patents, particularly patents on active ingredients from TCM in China.     

基于WHO/HAI标准化法的陕西省零售药店儿童基本药物可获得性及价格研究

目的:为我国儿童基本药物目录的出台及改善儿童药物使用现状提供参考。方法:采用世界卫生组织和国际健康行动组织共同制定的WHO/HAI标准化法,于2012年对陕西省6个城市的60家零售药店的28种儿童基本药物进行调研,将零售药店药品零售价格与国际参考价进行对比研究。结果:儿童基本药物在陕西省零售药店的可获得性低;原研药零售价格远高于国际参考价,而最低价格仿制药零售价格较为合理;治疗急性病的儿童基本药物的可负担性较好。结论:应尽快出台儿童基本药物目录;加大研发适宜儿童使用的剂型、规格及包装;对原研药合理定价;鼓励零售药店采购和销售基本药物。     

Herbal medicines: challenges in the modern world. Part 2. European Union and Russia

Introduction: Herbal medicines (HMs) have been well known to people of the European Union (EU) and Russia for centuries. Currently, Western HMs can be classified into two categories, plant-derived conventional medicines and dietary supplements. Interest to HMs has grown rapidly in all countries during the past two decades.

Areas covered: The main goal of this review article is to present the history of HMs in the EU and Russia, forms of modern HMs, including Oriental Medicines that are popular among consumers of both countries. Additional discussion points comprise safety and adulteration issues associated with HMs, including regulatory changes and new legislative measures undertaken by the authorities. Materials available from legislative and governmental websites, PubMed and news media were used.

Expert commentary: Due to cultural diversities in the EU and Russia, traditional HMs of other regions, particularly Chinese Traditional and Ayurvedic medicines, are also popular. Recently, dietary supplements containing multiple herbal and other natural products have flooded the EU and Russian markets. Pharmacovigilance in these markets is challenging in terms of establishing quality and safety of ingredients, determining efficacy, and defining risks of herb-herb and herb-drug interactions. Both the EU and Russia have introduced new legislation aimed to overcome these deficiencies.     

Adaptation of a microbead assay for the easy evaluation of traditional anti-sickling medicines: application to DREPANOSTAT and FACA

Context: Sickle cell disease is a common inherited blood disorder affecting millions of people worldwide. Due to lack of progress in drug discovery for a suitable treatment, sufferers often turn to traditional medicines that take advantage of the plant extracts activity used by traditional healers.

Objective: This study optimizes an anti-sickling screening test to identify preparations capable of reverting sickle cells back to the morphology of normal red blood cells. We focused on the miniaturization and practicability of the assay, so that it can be adapted to the laboratory conditions commonly found in less developed countries.

Materials and methods: We tested two traditional anti-sickling herbal medicines, FACA^® and DREPANOSTAT^®, composed of Zanthoxylum zanthoxyloides (Lam.) Zepern. &; Timler (Rutaceae) and Calotropis procera (Aiton) Dryand. (Apocynaceae) at screening concentrations of hydroethanol extracts from 0.2 to 1?mg/mL. Potential bioactive molecules present in the extracts were profiled using Ultra High Performance Liquid Chromatography coupled with High Resolution Mass Spectrometry (UHPLC-HRMS/MS) method, identified through HRMS, MS/MS spectra and in silico fragmentation tools.

Results: Hydroethanol extracts of FACA^® and DREPANOSTAT^® showed low anti-sickling activity, inhibiting less than 10% of the sickling process. The UHPLC-HRMS/MS profiles identified 28 compounds (18 in FACA^® and 15 in DREPANOSTAT^®, including common compounds) among which l-phenylalanine is already described as potential anti-sickling agent. When used as positive control, 7?mg/mL phenylalanine reduced the sickled RBC to 52%.

Discussion and conclusions: This assay has been optimized for the easy screening of plant extracts or extracted compounds from bioassay guided fractionation, valuable to laboratories from less developed countries.     

Structure and activities of pharmacy and therapeutics committees among public hospitals in South Africa; findings and implications

Introduction: The WHO identified Pharmacy and Therapeutics Committees (PTCs) as a pivotal model to promote rational medicine use in hospitals. This matches a key South African (SA) government objective to establish PTCs in all hospitals to ensure rational, efficient and cost-effective use of medicines. However, documentation on the functionality of PTCs in public hospitals in SA is limited. Areas covered: This study aimed to address this. A 3-phased mixed methods approach involving questionnaires, observations of PTC meetings and semi-structured interviews was used. The findings were converged during the interpretation phase. Expert commentary: Most professionals were represented in the PTCs, with variations across hospitals. Membership of PTCs included a pharmacist, who in the majority of cases was the secretary. PTC activities included dissemination of decisions (100%) and formulary management (89.5%). However, reporting of adverse drug reactions (ADRs) and medication errors was typically poor at all hospital levels. Lack of expertise of pharmacoeconomic analysis and evidence-based decision-making in formulary management was identified as a key challenge in formulary management. In conclusion, future programmes should strengthen PTCs in specialised aspects of formulary management. Further training in the principles of pharmacovigilance is needed to enhance ADR reporting, as well as to ensure compliance with both WHO and provincial guidelines.     

国家基本药物目录(2018年版)收载药品(西药部分)在河南省医药采购平台的挂网情况分析

目的 为国家基本药物目录的动态调整和优化提供参考和建议。方法 对国家基本药物目录（2018年版）收载药品（西药部分）在河南省公共资源交易中心医药采购平台中的挂网情况进行统计，筛选出未挂网和独家挂网的基本药物。结果 2018年版目录中共有146个规格（涉及100个品种）未在河南省公共资源交易中心医药采购平台中挂网。其中，整个品种未挂网的国家基本药物共有10个，某一大类剂型整体未挂网的国家基本药物共有4个。另外，整个品种名称下只有一个规格挂网，且为生产企业独家挂网的国家基本药物共有44个。结论 造成国家基本药物在整个河南省未挂网采购的原因可能与药品供应出现短缺或临床实际需求减少有关。对于易发生短缺的基本药物，医疗机构和各级卫生健康行政部门应加强监测和分类应对。而对于临床实际需求减少，经评价后认为不适宜作为国家基本药物的，建议在国家基本药物目录动态调整时予以调出。     

完善我国基本药物制度若干政策建议

目的:对完善我国基本药物制度提出建议。方法:分析我国实施基本药物制度存在的问题及其他国家的成功经验。结果与结论:鉴于我国医药经济发展水平和药品研发能力的现实情况,应从世界卫生组织和其他发达国家成功的基本药物实践经验中获得启发,改善《基本药物目录》遴选方法,赋予基本药物制度法律地位,根据我国国情建立基本药物的生产、采购、配送体系,最终建立适合我国的基本药物制度。     

A review of existing and emerging digital technologies to combat the global trade in fake medicines

Introduction: The globalization of the pharmaceutical supply chain has introduced new challenges, chief among them, fighting the international criminal trade in fake medicines. As the manufacture, supply, and distribution of drugs becomes more complex, so does the need for innovative technology-based solutions to protect patients globally.

Areas covered: We conducted a multidisciplinary review of the science/health, information technology, computer science, and general academic literature with the aim of identifying cutting-edge existing and emerging ‘digital’ solutions to combat fake medicines. Our review identified five distinct categories of technology including mobile, radio frequency identification, advanced computational methods, online verification, and blockchain technology.

Expert opinion: Digital fake medicine solutions are unifying platforms that integrate different types of anti-counterfeiting technologies as complementary solutions, improve information sharing and data collection, and are designed to overcome existing barriers of adoption and implementation. Investment in this next generation technology is essential to ensure the future security and integrity of the global drug supply chain.