Adverse drug reaction reporting in institutions across six Chinese provinces: a cross-sectional study

Background: Although China’s adverse drug reaction (ADR) reporting and monitoring has developed rapidly, many challenges remain. This study assessed ADR monitoring and reporting in China and identified monitoring problems.

Research design and methods: A cross-sectional survey was conducted of ADR reporting institutions in six Chinese provinces in April–December 2014. Questionnaires assessed ADR systems, basic resources, and pharmacovigilance activity.

Results: Of 720 questionnaires distributed, the response rate was 81.8%. About 93% (n = 371) of pharmaceutical companies and medical institutions had established ADR monitoring departments/units. Few institutions (26%, n = 104) allocated an ADR budget; 7% (n = 30) had received ADR monitoring funding in the last year (2013). Almost all institutions (99%, n = 555) had computers and 47% (n = 263) had a network database. Many institutions conducted public education about drug safety (49%, n = 283), medicine utilization reviews/quality surveys (28%, n = 158), and medicine consultation services (88%, n = 511). Institutions in eastern, central, and western China differed significantly on implementation of existing regulations and pharmacovigilance activities.

Conclusions: The institutions surveyed have established ADR monitoring systems. However, these systems have flaws. Urgent improvements are needed in funding, basic resources, reporting processes, and other pharmacovigilance activities.     

美国制药企业不良反应报告和监测工作对我国的启示

通过介绍美国药品生产企业开展不良反应监测工作的情况并与我国医药企业进行比较,分析我国药品生产企业存在的问题与原因,并针对性地提出建议。对此,我国应该借鉴美国药品生产企业开展不良反应监测工作的经验,通过细化法规要求、扩展不良反应信息收集来源、优化内部信息传递途径、引进专业人员及完善反馈机制等举措,提高我国制药企业不良反应报告的自觉性和监测水平。     

金银花配方颗粒评价性抽验结果分析与建议

目的：通过开展金银花配方颗粒评价性抽验,比较分析不同厂家金银花配方颗粒的质量情况,并提出监管建议。方法：收集各企业金银花配方颗粒质量标准,依据企业标准进行法定检验。结果：共抽验117批金银花配方颗粒,涉及9家生产企业。按各自企业标准进行检验,总体合格率为100%。但是各企业之间金银花配方颗粒含量差异较大且每克颗粒相当的药材（饮片）量不同,转移率不同。结论：通过本次抽验发现金银花配方颗粒的整体质量较高,但是不同厂家之间所用原料药材及生产工艺存在一定差异,导致最终产品质量参差不齐。因此,有必要规范中药配方颗粒生产工艺,尽快统一标准,加强监管。     

药品生产企业建立药品不良反应报告和监测管理制度的现状及思考

我国的《药品不良反应报告和监测管理办法》强制要求药品生产企业内部建立药品不良反应报告和监测管理制度。通过分析企业建立报告制度的现状,借鉴欧盟的相关政策要求,探讨改进我国企业落实该报告制度的方法及政府监管方式。     

Tobacco‐Control Policies in Tobacco‐Growing States: Where Tobacco Was King

Context

The 5 major tobacco-growing states (Kentucky, North Carolina, South Carolina, Tennessee, and Virginia) are disproportionately affected by the tobacco epidemic, with higher rates of smoking and smoking-induced disease. These states also have fewer smoke-free laws and lower tobacco taxes, 2 evidence-based policies that reduce tobacco use. Historically, the tobacco farmers and hospitality associations allied with the tobacco companies to oppose these policies.

Methods

This research is based on 5 detailed case studies of these states, which included key informant interviews, previously secret tobacco industry documents (available at http://legacy.library.ucsf.edu), and media articles. This was supplemented with additional tobacco document and media searches specifically for this article.

Findings

The tobacco companies were particularly concerned about blocking tobacco-control policies in the tobacco-growing states by promoting a pro-tobacco culture, beginning in the late 1960s. Nevertheless, since 2003, there has been rapid progress in the tobacco-growing states’ passage of smoke-free laws. This progress came after the alliance between the tobacco companies and the tobacco farmers fractured and hospitality organizations stopped opposing smoke-free laws. In addition, infrastructure built by National Cancer Institute research projects (COMMIT and ASSIST) led to long-standing tobacco-control coalitions that capitalized on these changes. Although tobacco production has dramatically fallen in these states, pro-tobacco sentiment still hinders tobacco-control policies in the major tobacco-growing states.

Conclusions

The environment has changed in the tobacco-growing states, following a fracture of the alliance between the tobacco companies and their former allies (tobacco growers and hospitality organizations). To continue this progress, health advocates should educate the public and policymakers on the changing reality in the tobacco-growing states, notably the great reduction in the number of tobacco farmers as well as in the volume of tobacco produced.     

1987—2011年湛江市水泥生产企业尘肺病回顾性研究

目的了解湛江市水泥生产企业粉尘作业工人的尘肺发病情况,为今后防治工作提供科学依据。方法对1987年1月—2011年12月的湛江市的水泥生产企业粉尘作业人员职业健康检查资料和职业病诊断资料进行回顾性分析。结果 25年来检出尘肺患者21例,观察对象32例(其中15例进展为尘肺)。尘肺患者平均检出年龄(52.1±7.0)岁和平均接尘时间(19.5±7.1)a分别高于观察对象的平均检出年龄(46.8±5.2)岁和接尘时间(13.2±3.6)a,差异有统计学意义(P0.05,P0.01)。尘肺患者病死率达28.6%。结论水泥粉尘接触工人尘肺发病与接触年龄、工龄有关。应建立合理有效的管理机制,加强水泥生产企业尘肺病的防治工作。     

浅谈我国药品生产企业委托生产的管理

目的促进药品生产企业加强委托生产的管理。方法研究相关法律、法规,总结药品委托生产管理经验。结果与结论提出我国药品生产企业加强药品委托生产管理的一些建议,供同行参考。     

两厂头孢米诺钠治疗泌尿系感染成本-效果分析

目的:分析不同厂生产的头孢米诺钠治疗泌尿系感染的疗效和用药费用,从而指导临床更合理选择和应用药物。方法:将64例随机分为A组和B组各32例,分别给予静脉滴注进口的头孢米诺钠1g和国产的头孢米诺钠1g,bid,连续用药7d。结果:A组临床有效率为93.8%,B组为90.6%,两组安全性较好;A组药费为1 820.0元,B组药费为1 030.4元,B组要比A组节省789.6元。结论:在两组治疗效果无显著性差异情况下,B组治疗泌尿系感染是一种经济有效的治疗方案。     

两厂产克拉霉素治疗消化性溃疡成本-效果分析

目的:分析不同厂家生产的克拉霉素治疗消化性溃疡的疗效与用药费用,从而指导临床更合理选择和应用药物。方法:病例随机选择96例经胃镜检查确诊为活动期消化性溃疡患者,分为A组和B组各48例,A组给予口服奥美拉唑胶囊20mg,qd,进口的克拉仙片500mg,bid,甲硝唑片0·4g,bid;B组给予口服奥美拉唑胶囊20mg,qd,国产的克拉霉素分散片500mg,bid,甲硝唑片0·4g,bid,均用药1个月。结果:A组和B组的总有效率分别为95·9%和93·8%,治愈率分别为89·6%和81·3%,1个月总药费A组为1604·4元,B组为1240·8元。结论:在两组治疗效果无显著性差异情况下,B组方案治疗消化性溃疡是一种经济有效的治疗方案。     

从COS搁置谈原料药生产企业如何通过国际认证现场检查

目的:为我国原料药出口生产企业顺利通过国际认证现场检查提供借鉴。方法:跟踪国外原料药进出口相关法规变化,分析我国原料药生产企业欧洲药典适用性证书(COS)被搁置的原因并提出建议。结果与结论:生产现场存在与欧盟《药品生产质量管理规范》(GMP)要求不符的重大缺陷是导致COS被搁置的主要原因,提高原料药生产过程的GMP管理水平是企业顺利通过国际认证现场检查的关键所在。