部分药品经营企业GSP检查结果的对比分析及思考

对GSP检查中出现的缺陷项目进行对比分析，找出最常见的缺陷项目，分析原因，探讨对策，以提高药品经营质量管理水平。     

广州市2020年第三类医疗器械企业经营许可认证现场检查问题分析

目的：通过对广州市2020年第三类医疗器械企业经营许可认证现场检查结果的分析，指出企业常出现的问题并提出相关建议，促使企业加强医疗器械流通环节的质量管理，进一步促进医疗器械行业的健康发展。方法：以《医疗器械经营质量管理规范现场检查指导原则》为依据，对612份第三类医疗器械企业经营许可认证现场检查结果，采用计量学方法进行分类统计分析。结果：职责与制度方面出现缺陷项目454次；人员与培训方面出现缺陷项目798次；设施与设备方面出现缺陷项目366次；采购、收货与验收方面出现缺陷项目244次；入库、贮存与检查方面出现缺陷项目18次；销售、出库与运输方面出现缺陷项目122次；售后服务方面出现缺陷项目247次。结论：建议企业合理制定质量管理制度，加强全体人员医疗器械相关法律法规的学习、培训和考核，准确理解缺陷内涵，加强企业质量管理内审。除此之外，监管部门也需要严格检查员的准入条件，加强检查员的业务培训和思想建设，重视各种监管手段的创新，共同维护医疗器械的质量可控和安全有效。     

2011年安徽省药品零售企业GSP认证缺陷项目统计分析及建议

目的统计分析药品零售企业实施GSP中存在的主要问题,探讨提高药品零售企业经营质量管理水平的措施。方法通过对2011年安徽省药品零售企业GSP认证中出现的缺陷项目的统计,找出最易出现的缺陷项目,有针对性地进行分析。结果人员和组织机构的管理方面出现过缺陷项目的共有1 912次;设施与设备方面出现过缺陷项目的共有414次;进货与验收方面出现过缺陷项目的共有409次;陈列与储存方面出现过缺陷项目的共有1 576次,销售与售后服务方面出现过缺陷项目的共有1 045次。结论提高药品零售企业经营质量管理水平,应重视教育培训,增强从业人员质量意识;并将法定认证管理与日常监管有效结合,建立药品经营质量管理长效机制。     

社会药店药品经营质量管理规范认证检查中存在的问题分析及对策

目的 分析社会药店药品经营质量管理规范认证检查中发现的缺陷问题,探讨进一步改善对社会药店监管的措施及对策。 方法 对65家社会药店药品经营质量管理规范认证现场检查报告中出现的缺陷项目进行统计,分析存在的主要问题。 结果 共发现缺陷项396项次,其中主要缺陷项目168项次,一般缺陷项目228项次,平均每家6.1条缺陷项。缺陷项目频率较高的主要集中在人员管理、文件、采购与验收方面。 结论 贯彻实施药品经营质量管理规范,深化药品零售监管,应强化宣传教育和培训,加强监管队伍建设,建立信用监管机制,提高舆论监督作用。     

药品批发及零售连锁企业GSP认证跟踪检查结果的统计分析与对策

目的分析药品批发及零售连锁企业GSP认证跟踪检查结果的情况,指出常见的问题并提出相应的对策,促进GSP认证跟踪检查员及日常监管人员实施规范监管的靶向性及树立科学监管的理念。方法从2002～2008年药品批发及零售连锁企业GSP认证跟踪检查结果4032份中,采用计量学方法进行了分类统计分析。结果人员和组织机构的管理方面出现过缺陷项目的共有7143次;设施设备方面出现过缺陷项目的共有4330次;购进验收方面出现过缺陷项目的共有3458次;储存与养护方面出现过缺陷项目的共有5966次;出库运输和销售服务方面出现过缺陷项目的共有2575次。结论GSP认证跟踪检查发现批发及零售连锁企业认证后不规范管理和监管部门管理不到位的现象比较普遍,分析问题产生的原因及制定相应的策略来保证GSP认证质量及阶段性效果,保障所经营药品的质量和企业的健康发展。     

单体药店两轮GSP认证检查缺陷项目比较分析

目的：提升单体药店GSP实施效率,进一步提高质量管理水平,确保公众用药安全。方法：比较分析杭州市江干区单体药店两轮GSP认证现场检查缺陷项目,找出GSP执行中存在的问题并分析原因, 提出建议及对策。结果：第二轮认证检查在条款项数、整改率及平均缺陷项频次较第一轮都有所下降; 两轮认证检查缺陷项目主要集中在文件、人员及陈列与存储环节;*13501、15101、13101及16704是两轮认证检查均易出现的高频次缺陷项目;*16101在第二轮出现频次较第一轮上升明显;*16106和16601是第二轮新出现的高频次缺陷项目。结论：应从企业、监管部门及行业角度多管齐下,加强企业自身建设, 督促落实企业主体责任;加强认证后监管;发挥行业支撑作用,确保GSP有效实施。     

北京市药品生产企业2007年GMP认证检查情况分析

对2007年北京市药品生产企业GMP认证现场检查和跟踪检查中出现的主要缺陷项目进行分析,找出药品生产企业实施GMP存在的主要问题和缺陷,希望能够对药品监管部门进行认证检查、日常监管和药品生产企业实施GMP提供参考.     

2009年安徽省药品生产企业GMP认证缺陷项目分析

该文通过对2009年我省药品生产企业GMP认证现场检查中出现的主要缺陷项目进行分析,找出该省药品生产企业实施GMP的薄弱环节,为进一步加强GMP技术监督提供建议。     

2009年辽宁省药品批发企业GSP认证缺陷项目统计分析及建议

2009年是辽宁省药品批发企业《药品经营质量管理规范（》GSP）集中申报认证的1年。该文通过对现场检查缺陷项目的统计,找出企业易出现的缺陷项目并进行分析,指导企业按GSP要求开展业务工作。     

我省药品经营企业GSP认证跟踪检查情况分析

目的 了解我省药品经营企业GSP认证跟踪现场检查存在缺陷项目情况,掌握我省药品经营企业实施GSP的薄弱环节,并提出一些看法和建议.方法 对58家药品批发(零售连锁)企业认证检查及跟踪检查的缺陷项目进行统计,并作对比分析.结果2005年药品经营企业GSP认证跟踪检查较认证检查时,缺陷发生频次明显下降,平均每个企业减少缺陷1.02次.结论 质量信息档案、企业培训档案、药品养护档案、药品储存流转情况、实施GSP情况内部评审档案、设施设备管理档案、每年进货质量评审档案、药品质量档案等八项为缺陷出现率较高的项目,是当前我省企业实施GSP的共性薄弱环节.     

Bicalutamide

Non metastatic prostate cancer: avoid over-interpretation of flawed clinical trial evidence.     

Development of a genetic algorithm and NONMEM workbench for automating and improving population pharmacokinetic/pharmacodynamic model selection

Journal of Pharmacokinetics and Pharmacodynamics - The current approach to selection of a population PK/PD model is inherently flawed as it fails to account for interactions between structural,...     

血糖、糖化血红蛋白水平与急性脑梗死临床关系的探讨

目的探讨血糖、糖化血红蛋白水平与急性脑梗死患者的临床关系。方法对收治的78例急性脑梗死患者的临床资料进行回顾性分析,根据入院时空腹血糖水平分为正常血糖组、高血糖组,病情好转后对所有患者进行神经系统缺损评分,观察血糖、糖化血红蛋白和临床的关系。结果急性脑梗死患者高血糖组与正常血糖组相比,其神经系统缺损评分高,总有效率低。结论高血糖尤其伴高糖化血红蛋白会增加急性脑梗死神经系统损伤,预后差。故积极预防和治疗高血糖是预防脑梗死的有力措施之一。     

Exploration of the negative correlation between proliferative hepatocellular lesions and lymphoma in rats and mice—Establishment and implications

Data from 1858 mice at Lilly and eight studies from the literature were used to establish a negative correlation between proliferative hepatic lesions and malignant lymphoma in rodents. This negative correlation implies that the rodent model is flawed in the sense that interpretation of hepatic lesions without consideration of malignant lymphoma can lead to the incorrect conclusion that there is something unique about the compound. In fact it is the rodent model that has a unique feature—the negative correlation.     

昏迷患者合并肺部感染的相关因素分析及护理

目的 研究昏迷患者引起肺部感染的相关因素,为临床护理提供依据.方法 对我院神经外科自2009年6月至2011年6月期间住院的长期昏迷合并肺部感染65例患者回顾性分析.结果 误吸、置管时间长、排痰不畅、抗生素的不合理应用等是引起肺部感染的常见原因.结论 针对以上原因,采取不同的护理策略,加强管理,有效的预防和减少肺炎的发生率.     

Immortal time bias in observational studies of drug effects

PURPOSE: Recent observational studies suggest that various drugs are remarkably effective at reducing morbidity and mortality. These cohort studies used a flawed approach to design and data analysis which can lead to immortal time bias. We describe the bias from 20 of these studies and illustrate it by showing that unrelated drugs can be made to appear effective at treating cardiovascular disease (CVD). METHODS: The illustration used a cohort of 3315 patients, with chronic obstructive pulmonary disease (COPD), identified from the Saskatchewan Health databases, hospitalised for CVD and followed for up to a year. We used the biased approach to assess the effect of two medications, namely gastrointestinal drugs (GID) and inhaled beta-agonists (IBA), both unknown to be effective in CVD, on the risk of all-cause mortality. We also estimated these effects using the proper person-time approach. RESULTS: Using the inappropriate approach, the rates ratios of all-cause death were 0.73 (95%CI: 0.57-0.93), with IBA and 0.78 (95%CI: 0.61-0.99), with GID. These rate ratios became 0.98 (95%CI: 0.77-1.25) and 0.94 (95%CI: 0.73-1.20), respectively, with the proper person-time analysis. CONCLUSIONS: Several recent observational studies used a flawed approach to design and data analysis, leading to immortal time bias, which can generate an illusion of treatment effectiveness. Observational studies, with surprising beneficial drug effects should be re-assessed to account for this source of bias.     

Some Problems with the Anti-Prohibitionist Position on Legalization of Drugs

The pro-legal position has mounted cogent arguments to support conclusions that the existing prohibition policy has failed and that legalization, while not a solution to the drug use problem, will effectively eliminate drug related crime. The premise of this article is that a legalization policy is wrong in that the basic assumptions underlying the anti-prohibitionist position are flawed. Prohibition has operated in a social vacuum. It has been an isolated effort substituting for an integrated and well coordinated approach which includes prevention, treatment as well as enforcement and supported by an educated public resolve against illicit drugs.     

医院药品采购管理审计浅析

目的 为防范医院药品采购风险提供参考.方法 归纳总结医院药品采购计划不科学、操作不规范、合同不完善、商业回扣不能彻底避免等问题,并进行科学分析.结果与结论 医院应当加强对药品采购管理的审计监督,规范药品采购操作,防控药品采购过程中的职务安全风险和财物安全风险,促进合理采购药品,实现医院社会效益和经济效益的双赢.     

Behavioral Teratology: What's Not in a Name: A reply to Cattabeni and Abbracchio

A recent critique of behavioral teratology by Cattabeni and Abbracchio stated four principle criticisms of the field. These were, first, that the documented effects in the literature in this field are poorly understood and may not represent genuine cases of adverse effects upon the progeny. Second, that the field is filled with suspect 'positives' as evidenced by the long list of agents identified as behavioral teratogens. Third, that the term 'behavioral teratology' defines itself in terms of "subtle behavioral effects [occurring] in the absence of overt signs of neurotoxicity." Fourth, that 'behavioral teratology' is a misnomer. First, the assertion that most of the effects in this field are unknown as to whether they are beneficial or adverse is untrue. Most of the effects observed in experimental animals can be compared to those in humans and to established developmental neurotoxins (positive controls). Second, the number of agents identified as behavioral teratogens in experimental animals is not an indication that the methods in the field are flawed. More agents have been identified experimentally as behavioral teratogens than have been confirmed or disconfirmed in humans partly due to a lack of adequate data in humans and partly because behavioral teratogenicity obeys the same principle as occurs in all fields of toxicology, i.e., dose-dependency. Since many of the identified effects are observed at dosages many times those to which humans are exposed, just as occurs for teratogenicity, carcinogenicity, and mutagenicity, this is not an indication of flawed methodology. Third, the notion that behavioral teratogenesis is defined in terms of 'subtle' effects is refuted by examining recent reviews.(ABSTRACT TRUNCATED AT 250 WORDS)