药品生产企业质量保证系统要点分析

通过对国内外药品生产质量管理规范中有关质量保证规定的梳理,从质量管理角度对质量保证系统进行分析,明确药品生产企业质量保证系统及其各要素。通过对近几年国内外药品检查中发现的药品生产企业在质量保证系统中存在缺陷的分析,对文件管理、偏差处理、变更控制、质量回顾、自检与外部检查、投诉、不良反应报告与监测、纠正与预防措施、召回、管理评审等质量保证系统各关键要素常见问题进行总结与提炼。为我国制药行业进一步加强质量保证系统的建设提供参考,同时也为药品检查工作中对质量保证系统相关要素的高效检查提供借鉴。     

香港特别行政区公立医院药品采购模式给内地医改的启示

目的 通过对香港特区公立医院药品采购模式的研究分析,探讨我国内地医疗改革的方向.方法 采用查阅文献资料、对比分析、归纳演绎等方法分析香港特区公立医院药品采购模式.结果与结论 香港特区公立医院药品采购模式对内地公立医院药品采购模式改革具有参考意义.     

谈GSP与质量保证体系

ＧＳＰ是英文ＧｏｏｄＳｕｐｐｌｙｉｎｇＰｒａｃｔｉｃｅ的缩写 ,直译为良好的药品供应规范 ,在我国即称谓《药品经营质量管理规范》。它是指药品流通过程中 ,针对计划采购、购进验收、储存、销售和售后服务等环节而制定的保证药品符合质量标准的一项管理制度。其核心是通过控制企业药品经营全过程中可能发生质量事故的各种因素 ,确保企业所经营药品的质量。它是指导药品经营企业建立完善质量保证体系并使之有效运行的规范性文件。为加快我国ＧＳＰ认证步伐 ,推进实施ＧＳＰ工作进程 ,国家药品监督管理局最近决定 ,药品经营企业实施ＧＳＰ…     

药品GMP检查中质量控制与质量保证方面存在的主要问题及建议

目的：探讨安徽省药品GMP检查中质量控制和质量保证方面缺陷项目的分布规律和特点,为药品上市许可持有人有针对性地提升质量控制与质量保证水平和监管部门加强药品生产监管提供依据和思路。方法：对2017-2018年安徽省230家药品生产企业GMP现场检查中发现的质量控制与质量保证方面缺陷项目进行汇总分析。结果：大多数企业对样品检验、实验室物料管理和偏差调查等方面的条款理解不透彻,执行不到位,与药品GMP要求有一定差距。结论：药品上市许可持有人是药品质量的责任主体,应不断提高认识,在药品的质量控制与质量保证方面持续改进,确保人民群众的用药安全有效。     

原料药杂质研究与控制浅析

原料药质量优劣是药品质量控制的关键和源头。原料药杂质研究及控制又是原料药质量保证的关键要素之一,也是保证药品安全性和可控性的重要评价指标。本文从原料药的杂质分类、杂质分析方法、国内外原料药杂质研究现状等方面阐述了原料药中杂质检查与控制的重要性,对于药物研究、药物生产、储存、运输等环节确保药品安全有效具有一定的实用价值。     

浅谈药品生产的过程质量控制

过程质量控制是保证药品质量可靠的、有效的手段.做好过程质量控制,首先应建立完善的质量保证体系,应建立切实可行的过程质量控制体系文件.生产操作人员是过程质量控制的主体,应做好生产操作人员的培训工作.应持续改进.不断完善过程质量控制体系.应制定完善的质量奖惩机制,确保过程质量控制体系的有效运行,切实做好药品生产过程的质量控制,以确保药品质量.     

香港特区药物采购策略与内地基本药物采购机制比较

目的:借鉴香港特区成功经验,为完善内地基本药物集中采购工作提供参考。方法:通过对香港特区医院管理局药物采购政策和策略与内地基本药物采购机制的分析比较,发掘可借鉴的经验,并提出内地需改进的建议。结果与结论:信息化建设是实现基本药物招采结合、量价挂钩采购模式的基础。建议建立全国范围的规范、统一、科学的药品分类方法和系统药物采购政策,采取多种采购方式和途径,保证基本药物供应,实现基本药物可及性要求。     

合理把握药品招标中药品质量与价格的均衡

目的:为完善我国药品招标制度提供参考。方法:搜集文献资料,总结目前我国药品招标采购制度现状,分析原因并提出解决措施。结果与结论:药品集中招标采购的做法是可取的,但是在招标过程中要坚持"质量优先",正确处理药品质量与价格的关系,对流通领域的药品供应、药品的招标采购行为进行规范,保证药品价格的合理,合理把握药品质量与价格的均衡,保障群众能够安全用药。     

加强效期药品的管理,确保药品质量

目的 加强药品的效期管理制度.方法 建立管理制度,合理的控制药品的采购、入库、陈列、出库过程.结果 确保药品的储存养护质量,防止药品过期失效.结论 加强效期管理,保证药品的有效性和安全性.     

ISO9001过程方法在规范药品付款程序中的应用

目的:规范药品付款程序,保证帐物同步、报帐及时准确、资金流动与药品采购形成良性循环.方法:运用ISO9001质量管理体系的过程方法对药品付款程序进行规范管理.结果:可有效实施对药品付款程序的规范管理.结论:保证了帐物同步、报帐及时准确、资金流动与药品采购形成良性循环.     

Quality assurance standards for purchasing and inventory control

A process is described for quality assurance in pharmaceutical purchasing and inventory control. A quality assurance program should ensure that quality drugs are purchased at the lowest price, drug products are available when needed, the system is managed efficiently, internal controls are provided, drug products are stored under appropriate conditions, and laws, regulations, accreditation standards, and procedures are followed. To meet these objectives, product quality, vendor performance, the department's system of internal controls, purchasing data, and storage conditions should be monitored. A checklist for evaluating purchasing and inventory practices and a sample audit form listing quality assurance criteria, standards, procedures, and recommended actions are provided. A quality assurance program for pharmaceutical purchasing and inventory control should define institution-specific criteria and standards and use these standards for continual evaluation of all aspects of the purchasing and inventory control system. Documentation of quality assurance activities should be provided for use by the purchasing department, hospital administration, and regulatory bodies.     

药物临床试验质量控制与质量保证体系探讨

摘 要 通过解析和阐述我国药物临床试验各参与方申办者、研究者、临床试验机构及药品监督管理部门在试验质量控制与质量保证中的应有职责和存在问题,针对存在问题提出相应对策,为加强和完善我国药物临床试验质量控制与质量保证体系提出建议与期望。     

香港澳门药品注册管理的比较研究

目的：将香港澳门的药品注册管理进行系统的比较研究,为内地药品到港澳上市提供参考。方法：运用文献研究和政策分析法,对港澳地区的药品注册管理体系、药品注册要求以及注册申报程序进行对比分析。结果：港澳的药品注册管理机制不同,香港的药品管理法律体系呈平行管理的特点,对中西药独立监管注册,中药实行中成药注册分类制度,并根据注册组别不同提交不同资料;而澳门的药品法律体系尚未统一,对药品集中注册管理,实行预先登记机制,中药实行中药预先许可制度。结论：内地药品在港澳注册上市,有利于提高内地企业的国际化和药物研发水平;内地企业在港澳申请注册时,应熟悉港澳药品注册管理政策,并与当地经销商合作,积极开展国际多中心临床试验;而提高内地企业药品研发质量,促进三地临床数据互认,有利于实现三地互利共赢的目标。     

Is Hong Kong Experiencing Normalization of Adolescent Drug Use? Some Reflections on the Normalization Thesis

The upsurge of consumption of party drugs among adolescents in recent years in Hong Kong has been part of the global trend of adolescent recreational use of drugs at rave parties, discos and similar party settings. Scholars in Western societies have recently proposed the thesis of “normalization of adolescent drug use” to describe such a trend. The normalization thesis points at three major aspects of the normalization phenomenon, namely, a rapid increase of the prevalence of drug use in young people, the widespread popularity of recreational drug use that is closely linked with the recent arrival of dance club culture, and a receptive attitude towards drug use as a normal part of leisure. This article aims to examine whether the normalization thesis can be applied to analyze the situation of adolescent drug use in Hong Kong. Data are drawn from official statistics and a recent survey conducted in 2002–2004 of drug use of Hong Kong marginal youths (N = 504). The case of Hong Kong only partially supports the thesis. Our findings show that the normalization of drug use among young people has occurred in Hong Kong, but the extent of normalization is smaller than those in Western societies like the United Kingdom. They also suggest that a recognition of possible cultural differences may be complementary to the normalization thesis. Limitations of the study are also noted.     

澳门居民对假/劣药品的认知度调查

目的:了解澳门居民对假/劣药品认知程度,为澳门特区政府制定长远政策提供理论依据。方法:采用不干预性的横断面研究方法,在澳门7个堂区对200名18岁或以上澳门居民进行问卷调查,内容包括受访者基本数据、药物认知、购药习惯、药物质量及监管4部分。结果:在191份有效问卷中,懂得分辨假/劣药者占68.8%;相当部分有外购药物习惯,到我国内地及香港购药的分别为33.5%及22%;通过网络邮购药物及保健品的仅有1.6%;购买过假药者占8.4%。结论:澳门居民普遍具备基本的药学知识,但对假/劣药品的认知仍不够,且有去澳门以外地区购药的习惯,因此澳门特区政府应加大资源投入对居民进行药物知识普及,加强与周边地区合作,加大打击制造及贩卖假/劣药品的力度,保障居民用药安全。     

Is Hong Kong experiencing normalization of adolescent drug use? Some reflections on the normalization thesis

The upsurge of consumption of party drugs among adolescents in recent years in Hong Kong has been part of the global trend of adolescent recreational use of drugs at rave parties, discos and similar party settings. Scholars in Western societies have recently proposed the thesis of "normalization of adolescent drug use" to describe such a trend. The normalization thesis points at three major aspects of the normalization phenomenon, namely, a rapid increase of the prevalence of drug use in young people, the widespread popularity of recreational drug use that is closely linked with the recent arrival of dance club culture, and a receptive attitude towards drug use as a normal part of leisure. This article aims to examine whether the normalization thesis can be applied to analyze the situation of adolescent drug use in Hong Kong. Data are drawn from official statistics and a recent survey conducted in 2002-2004 of drug use of Hong Kong marginal youths (N = 504). The case of Hong Kong only partially supports the thesis. Our findings show that the normalization of drug use among young people has occurred in Hong Kong, but the extent of normalization is smaller than those in Western societies like the United Kingdom. They also suggest that a recognition of possible cultural differences may be complementary to the normalization thesis. Limitations of the study are also noted.     

Purchasing and inventory control systems management

This article introduces a 13-part series of articles on managing the purchasing and inventory control systems for the hospital pharmacy department. The series will focus on the various components of the purchasing and inventory control process. Though the purchasing and inventory control functions are substantially interrelated, each will be presented separately. Most installments will present examples of applications in a wide variety of institutional settings. Topics to be discussed include historical perspectives, assessment of vendors and product selection, bid solicitation and contract negotiation, evaluation of drug procurement alternatives, development of a purchasing system, coordinating the purchasing process, objectives of inventory control, quantitative measurement of inventory control, methods of inventory control, management of the system, automated information systems, and quality assurance.     

香港医院感染控制工作情况介绍—北京医院协会药事管理专业委员会赴港考察见闻

笔者通过2010年4月参观考察香港医院感染控制工作,感到香港医管局总体管理所辖医院的感染控制工作,每所医院设立有感染控制小组,负责重点患者的监测、手术切口感染监测,细菌检测.抗菌药物使用管理等工作,具有组织严密、规范有序、富有人性化的特点.在抗菌药物的使用管理方面,各医院按照医管局推荐的统一模式,对使用重要抗菌药物的处方实施审批制度,严格规定适应证,并对每一例使用者追踪监控,从而保证了合理使用,杜绝滥用情况发生.香港医院先进的设施、结合周密的收治流程既围绕感控主题又体现人文关怀.医管局感染控制处负责制定感染控制指引,提供感染控制培训,进行感染的流行病学调查,监测感染风险,拟定传染病处理方案等.利用感染控制信息系统对医院进行MRSA监测及围手术期抗菌药物管理的工作组织严密、规范有序,方法值得内地医院借鉴.通过此次考察,希望内地药事管理部门能达成共识,借鉴香港模式推进内地相关工作的开展.     

Drug Use and Drug Policy in Hong Kong: Changing Patterns and New Challenges

This paper is a sociohistorical examination of drug misuse and drug policy in Hong Kong. It briefly traces the history of drug policy since Hong Kong became a colony of Britain in the nineteenth century, and then highlights the major drug issues that have emerged in the past several decades. Drug policy in Hong Kong has gone through three stages, from “Government Opium Monopoly” (1841–1945) to “The Prohibition Era” (1946–1960) to “Enlightened Prohibition” (1961–1995). The evolution in drug policy is analyzed in the light of both domestic and international social, economic, and political forces affecting Hong Kong. The major drug issue in the past two decades has been the trends of rising levels of drug use among young people and the increasing popularity of psychoactive drugs among young drug users. It is argued that these trends may be understood in terms of rapid social change resulting from industrialization and socioeconomic growth since the 1960s, and the presence of conditions favorable to the demand and supply of psychoactive drugs. Lastly, major challenges to future drug policy in Hong Kong are discussed. [Translations are provided in the International Abstracts Section of this issue.]