中国药品安全综合评价指标体系研究

目的：尝试建立药品安全综合评价指标体系.方法：采用文献综述、专家会议和定性访谈的方法.结果：首先采取文献综述的方法,系统收集中文数据库、英文数据库、中文网站和英文网站的相关信息,以系统整理和归纳药品风险,并在此基础上提出了药品安全综合评价备选指标.而后经专家会议和定性访谈等多种方法收集、整理、筛选和补充,最终确立了药品安全综合评价指标,共包括4个一级指标,13个二级指标和69个三级指标.结论与建议：为了进一步完善指标评价体系,建议进一步收集和整理药品质量管理规范检查资料;分部门分类别统计药品抽验结果;逐步开展医疗机构合理用药管理的检查和信息整理;提高对医疗机构处方评价资料的整理和利用;逐步开展公众合理用药调查工作;稳步推动药品不良反应哨点监测工作.     

农村药品领域现存问题分析和政策建议

目的:探索农村药品领域出现的各项问题,并提出政策建议.方法:基于文献回顾和现场定性访谈的方法.结果:农村药品市场秩序混乱,药品流通企业众多,医疗机构不合理用药问题突出.结论:加强对药品领域的全局规划,探索农村药品补偿机制和监管体系,提高医务人员科学用药能力.     

药品不良事件的成因与责任研究

目的探讨药品不良事件的原因与责任。方法本文通过分析药品不良事件的形成原因以及如何界定各部门及人群应承担的责任,详细论述药品不良事件的成因及责任之间的关系。结果药品不良事件的成因主要有五种,分别是:药品标准缺陷、药品质量问题、药品的不良反应、用药失误及药物滥用。其涉及的主要部门及人群有药品监管者、药品研究者和生产者、药品流通商、药师、医生和护士、患者和消费者。结论要积极采取措施,切实保障用药安全。     

我国药品监管体系发展和改革历程

药品监管涉及药品的研制、生产、流通、使用等各个环节,也包括药品价格的管制,是保障用药安全、有效,维护人民健康和用药的合法权益的重要手段.文章从药品监管体系发展脉络入手,着重分析了改革开放30年以来药品监管体系发展和改革的历程,并总结其成效和经验.     

2011年国家药品不良反应监测年度报告

药品不良反应是指合格药品在正常用法用量下出现的与用药目的无关的有害反应。自1988年我国试行药品不良反应监测制度以来,药品不良反应监测已成为发现药品安全性信息、加强药品安全监管、促进临床安全合理用药、控制药品风险的重要途径和手段,对保障群众用药安全发挥了重要作用。为全面反映我国药品不良反应监测监管情况、提高安全用药     

农村药品安全追溯和信息综合服务系统研究与应用

随着经济的发展及国民生活质量的提高,作为关系到人们健康和国家民生的药品安全问题,逐渐受到越来越多人的关注。在我国,农村人口占大多数,农村药品安全关乎国民健康。本文笔者从农村现存药品安全问题、农村药品信息综合服务系统建立的必要性、信息综合服务系统的建设目标和整体功能框架、信息综合服务系统的应用等方面进行综述,以期促进药品的流通监管、检查管理、药品信息管理、统计分析等功能的实现,进一步确保农村用药的安全性、经济性和便捷性。     

我院药品不良反应报告和监测

目的:加强我院药品监管,及时、有效控制药品风险,保障患者用药安全.方法:获知或者发现可能与用药有关的不良反应,及时通过国家药品不良反应监测信息网络报告,报告内容应当真实、完整、准确.结果:2010年我院共上报药品不良反应15例,其中抗生素注射剂5例,中药注射剂4例,其他6例.     

药品降价保供:国家打出一记重拳

正2019年1月,国务院办公厅印发《国家组织药品集中采购和使用试点方案》,对4个直辖市和7个副省级城市的药品招标采购工作做出新的部署。全国性的药品集中采购试点究竟能在患者用药可及性上起到什么作用?企业和政府如何通力合作,打通从研发到患者的路径,建立以价值为中心的价格制定体系?是否能在保障患者用得起药的同时,确保用药安全和质量?创新药获批上市后,在招采、流通、医保、医院、医生使用等各个环节还面临哪些问     

我国基本药物制度政策效果评价——基于山东、湖北、四川三省的监测数据

目的：从政策目标层面评价我国基本药物制度的实施效果。方法：文献法与问卷调查法相结合,内容包括基层医疗卫生机构的药品费用、合理用药情况及基本药物质量等。结果：2011年1—9月次均门诊药品费用和次均住院药品费用较2010年同期分别下降25.93%和25.22%,基本药物价格显著下降,基本药物可及性得到保障与提高;注射剂使用率、抗生素使用率、抗生素联用率、激素使用率及单张处方金额均有所降低,合理用药水平提高;通过基本药物电子码监管与国家药监局飞行检查两大途径,基本药物质量得到保障。结论：我国基本药物制度政策实施效果显著,但仍存在一些问题,需从药物目录调整、合理用药培训、药物质量监管、长效补偿机制以及药品采购机制等方面进行完善。     

建立院内药物警戒制度的实践

药物警戒(pharmacovigilance)是发现、评估、理解和预防药物不良作用或任何其他药物相关问题的科学和活动~([1-2]).药物警成的概念较传统的药品不良反应监测更广泛,因为它还关注不合理用药和药品质量等问题~([3-4]).其最终目的是综合评价药物的风险效益,提高临床合理用药水平和保障公众用药安全.有资料表明,大量严重的不良反应事件发生在医院中,记录和预防医院中的不良反应事件非常重要,国外药剂师在这方面发挥了重要作用~([5]).国内不少医院及时转载了国家食品药品监督管理局发布的各期<药物警戒快讯>和<药品不良反应信息通报>,给临床提供了大量有价值的信息,但医院内部开展药物警戒目前还少有文献报道.     

Myocarditis and pericarditis: Case definition and guidelines for data collection,analysis, and presentation of immunization safety data

Myocarditis and/or pericarditis (also known as myopericarditis) are inflammatory diseases involving the myocardium (with non-ischemic myocyte necrosis) and/or the pericardial sac. Myocarditis/pericarditis (MPC) may present with variable clinical signs, symptoms, etiologies and outcomes, including acute heart failure, sudden death, and chronic dilated cardiomyopathy. Possible undiagnosed and/or subclinical acute myocarditis, with undefined potential for delayed manifestations, presents further challenges for diagnosing an acute disease and may go undetected in the setting of infection as well as adverse drug/vaccine reactions.The most common causes of MPC are viral, with non-infectious, drug/vaccine associated hypersensitivity and/or autoimmune causes being less well defined and with potentially different inflammatory mechanisms and treatment responses. Potential cardiac adverse events following immunization (AEFIs) encompass a larger scope of diagnoses such as triggering or exacerbating ischemic cardiac events, cardiomyopathy with potential heart failure, arrhythmias and sudden death. The current published experience does not support a potential causal association with vaccines based on epidemiologic evidence of relative risk increases compared with background unvaccinated incidence. The only evidence supporting a possible causal association of MPC with a vaccine comes from case reports.Hypersensitivity MPC as a drug/vaccine induced cardiac adverse event has long been a concern for post-licensure safety surveillance, as well as safety data submission for licensure. Other cardiac adverse events, such as dilated cardiomyopathy, were also defined in the CDC definitions for adverse events after smallpox vaccination in 2006. In addition, several groups have attempted to develop and improve the definition and adjudication of post-vaccination cardiovascular events. We developed the current case definitions for myocarditis and pericarditis as an AEFI building on experience and lessons learnt, as well as a comprehensive literature review. Considerations of other etiologies and causal relationships are outside the scope of this document.     

我国医疗安全不良事件研究热点和前沿分析

目的梳理近10年我国医疗安全不良事件领域研究文献,分析研究热点和前沿。方法检索中国知网（CNKI）2011年1月1日—2021年12月31日医疗安全不良事件领域相关文献,利用CiteSpace 5.8.R3可视化软件对纳入文献的发表时间、作者和关键词等进行分析。结果共纳入3 836篇文献。2011年—2021年医疗安全不良事件领域文献整体呈逐年增长趋势。研究热点集中在不良事件与满意度、风险管理、护理质量、跌倒、医疗器械以及院内转运和手术室。研究前沿为护理管理与重症患者安全。结论我国医疗安全不良事件研究广泛,但尚未形成核心作者群。未来应进一步打破信息及合作壁垒,形成规模化合作网络,关注患者安全关键环节,推动医疗安全不良事件研究持续深入。     

The risk we bear: the effects of review speed and industry user fees on new drug safety

Drug review speed has increased substantially in the 1990s, largely due to industry-funded user fees. Following several drug withdrawals, however, new questions have emerged about the effects of this change on drug safety. This article examines the impact of review speed and user fees on counts of serious adverse reactions among drugs approved in 1990-2001. The analysis controls for the influence of drug utilization, patient conditions, drug novelty, black box warnings, foreign drug launch, US launch lags, patient age, and gender on drug reactions. Results show that drugs receiving faster reviews are associated with increased counts of serious adverse drug reactions. Other results show that novel drugs, drugs with black box warnings, drugs first launched abroad, and drugs with shorter US launch lags also have increased adverse drug reactions. Although any increase in risks must be weighed against benefits, the results show a trade-off between review speed and drug safety.     

药物不良反应自觉报告制度的发展与作用

避孕药物和器具的效益与危险性和其它治疗药物或医疗器具一样,须要接受广泛的市场后监察,及时发现和淘汰对人体具有严重危害的产品。许多国家建立了全国性药物监察网络。自觉报告制度是一种费用低、效果好的市场后安全性监察实用方法。重点监察项目则在样本人群中深入调查研究药物或器具与不良反应事故的因果关系;医药刊物也是报道不良反应案例的另一个重要信息资源。从生殖健康前景看,开展药物警戒学研究,设立全国性监察体制,加强对节育技术合并症或不良反应的市场后监察,将是评价影响避孕药具使用和提高计划生育服务质量的重要措施。     

Drug utilization and reported adverse reactions in hospitalized children.

An intensive drug surveillance program has been developed to study the clinical effects of drugs in hospitalized children. This program collects information on drug exposures and the occurrence of adverse clinical events. The 1669 children monitored to date received an average of 7.6 drugs during an average hospital stay of 8.4 days. A group of specified adverse clinical events, whether or not drug attributed, occurred in 45.7% of the patients; drug-attributed events (adverse drug reactions) occurred in 16.8%. Both drug use and reported adverse reactions tended to increase with age, except that newborns received many drugs but had the lowest reported adverse reaction rates. Newborns, however, had the highest rate of adverse events not attributed to drugs, suggesting that perhaps some of these latter events include presently unrecognized adverse drug reactions.     

Lessons from a patient partnership intervention to prevent adverse drug events.

BACKGROUND: Patient safety 'best practices' that call for patient participation to prevent adverse drug events have not been rigorously evaluated. OBJECTIVE: To consider lessons learned from a patient partnership intervention to prevent adverse drug events among medical in-patients. DESIGN: Prospective randomized, controlled pilot trial. SETTING: Boston teaching hospital. Patients. Two hundred and nine adult in-patients on a general medicine unit. INTERVENTION: Intervention patients (n = 107) received drug safety information and their medication list; controls (n = 102) received drug safety information only. Measurements. Adverse drug events and close-call drug errors were identified using chart review and incident reports from nurses, pharmacists, and physicians. Patients and clinicians were surveyed about the intervention. RESULTS: In 1053 patient-days at risk, 11 patients experienced 12 adverse drug events and 16 patients experienced 18 close calls. There was a non-significant difference between intervention patients and controls in survey responses and in the adverse drug event rate (8.4% versus 2.9%, P = 0.12) and close-call rate (7.5% versus 9.8%, P = 0.57). Eleven percent of patients were aware of drug-related mistakes during the hospitalization. Among nurse respondents, 29% indicated that at least one medication error was prevented when a patient or family member identified a problem. CONCLUSION: Partnering with in-patients to prevent adverse drug events is a promising strategy but requires further study to document its efficacy.     

基于文献计量学的我国患者安全信息化管理领域研究现状及热点分析

目的梳理我国患者安全信息化管理领域的现状和热点,为进一步深入研究指明方向。方法在中国知网、维普、万方三大数据库中检索并筛选2010年-2021年我国患者安全信息化管理领域相关文献,利用CiteSpace软件生成作者、研究机构以及关键词共现图谱。结果共纳入920篇文献。相关文献数量呈逐年阶段性增长趋势,但作者与作者、机构与机构之间合作不够。研究热点主要集中在医疗安全信息化管理、护理安全信息化管理、用药安全信息化管理、信息化闭环管理以及不良事件信息化管理等方面。结论未来应加强多区域、多中心合作,关注医疗设备安全问题,并增强对护理安全、用药安全、不良事件数据挖掘等的重视程度和研究深度。     

Vaccinovigilance in Europe--need for timeliness, standardization and resources

OBJECTIVE: To identify gaps in the systems for reporting adverse events following immunization (AEFI) in Europe by means of an interactive database constructed using a standardized approach. METHODS: A comparative survey was conducted in 1999-2000, using structured questionnaires addressed to the government authorities responsible for national immunization programmes and drug safety surveillance in all European Union (EU) Member States and in Norway and Switzerland. FINDINGS: The reporting of adverse vaccine reactions (AVRs) is covered by regulations in 13 of the 17 countries. Four countries have a specialized expert group with responsibility for vaccine safety. Only six professionals work full-time on vaccine safety in the 17 countries; in four of these countries the person is medically qualified. Fourteen countries have centralized reporting systems; in 14 countries the responsible authority is the drug regulatory agency. AEFI are reported using the procedure used for adverse drug reactions (ADRs) in all except four countries. The reporting form is not usually designed for vaccines and important details may therefore not be requested. Clinical definitions for vaccine reactions are not available. Twelve countries have appropriate official definitions for events or reactions, but the list of reportable events varies considerably between countries. The assessment of adverse vaccine reactions (AVRs) is hampered by lack of exact denominator data. Feedback to the rapporteurs was provided in 13 countries, but its quality was highly variable. CONCLUSION: The database facilitated a simple comparison of vaccinovigilance systems across participating countries. Most of the problems identified related to the reporting and analysis of AEFI could be solved through standardization and intensified international collaboration. On a national level, functional vaccinovigilance systems should be the shared responsibility of the drug regulatory authority and the national immunization programme. The resources for development and management of vaccine safety systems should be urgently improved.