Emerging contaminants: presentations at the 2009 Toxicology and Risk Assessment Conference

A session entitled “Emerging Contaminants” was held in April 2009 in Cincinnati, OH at the 2009 Toxicology and Risk Assessment Conference. The purpose of the session was to share information on both programmatic and technical aspects associated with emerging contaminants. Emerging contaminants are chemicals or materials that are characterized by a perceived or real threat to human health or environment, a lack of published health standards or an evolving standard. A contaminant may also be “emerging” because of the discovery of a new source, a new pathway to humans, or a new detection method or technology. The session included five speakers representing the Department of Defense (DoD), the Environmental Protection Agency (EPA), and each of the military services. The DoD created the Emerging Contaminant Directorate to proactively address environmental, health, and safety concerns associated with emerging contaminants. This session described the scan-watch-action list process, impact assessment methodology, and integrated risk management concept that DoD has implemented to manage emerging contaminants. EPA presented emerging trends in health risk assessment. Researchers made technical presentations on the status of some emerging contaminates in the assessment process (i.e. manganese, RDX, and naphthalene).     

Decreasing Medication Turnaround Time with Digital Scanning Technology in a Canadian Health Region

Background:

Reducing medication turnaround time can improve efficiency, patient safety, and quality of care in the hospital setting. Digital scanning technology (DST) can be used to electronically transmit scanned prescriber orders to a pharmacy computer queue for verification and processing, which may help to improve medication turnaround time.

Objectives:

To evaluate medication turnaround time before and after implementation of DST for all medications and for antibiotics only.

Methods:

Medication turnaround times were evaluated retrospectively for periods before (June 6–10, 2011) and after (September 26–30, 2011) implementation of DST at 2 hospital sites in 1 health region. Medication turnaround time was defined as the time from composition of a medication order by the prescriber to its verification by the pharmacy (phase 1) and the time from prescriber composition to administration to the patient by a nurse (total). Median turnaround times were analyzed with SPSS software using the Mann–Whitney U test.

Results:

In total, 304 and 244 medication orders were audited before and after DST implementation, respectively. Median phase 1 turnaround time for all medications declined significantly, from 2 h 23 min before DST implementation to 1 h 33 min after DST implementation (p < 0.001). Antibiotics were also processed significantly faster (1 h 51 min versus 1 h 9 min, p = 0.015). However, total turnaround time for all medications did not differ significantly (5 h 15 min versus 5 h 0 min, p = 0.42).

Conclusions:

Implementation of DST was associated with a 50-min decrease in medication turnaround time for the period from when an order was prescribed to the time it was processed by the pharmacy. Regular evaluation of medication turnaround times is recommended to compare with benchmarks, to ensure that hospital standards are being met, and to measure the effects of policy changes and implementation of new technology on medication-use processes.     

非布司他治疗痛风的快速卫生技术评估

目的 基于快速卫生技术评估(HTA)方法,评价非布司他治疗痛风的有效性、安全性和经济性.方法 系统检索PubMed、Cochrane library等英文数据库和中国知网(CNKI)、万方数据等中文数据库.由2位评价者根据纳入与排除标准独立筛选文献、提取资料和评价质量后,对结果进行定性分析.结果 共纳入2篇HTA报告、...     

条形码扫描技术在我院PIVAS的运行情况分析

目的:提高静脉药物配置中心(PIVAS)工作的信息化管理水平。方法 :将条形码扫描技术应用于PIVAS配药前、配置后成品输液配送前及病区工作人员签收成品输液等环节,总结条形码扫描技术在PIVAS工作中的各项功能及分析其应用前后的效果。结果:条形码扫描技术具有输液配置核对、打包核对、病区签收核对、工作量统计等功能;其在我院使用后输液日平均配置数由53组升至61组,日平均差错数由0.6组降至0.03组,日均药品浪费组数由0.02组降至0.01组,日均查找相关信息时间由4.2小时降至0.5小时,月配置工作量统计平均时间由8小时降至0.5小时。结论:我院PIVAS使用条形码扫描技术后提高了工作效率和工作质量,在风险控制方面起到了积极的作用。     

国内外卫生技术评估方法学指南的系统评价

目的:系统评价国内外卫生技术评估(HTA)方法学指南,为我国HTA方法学指南的科学制订提供参考和借鉴。方法:计算机检索PubMed、Embase、国际指南网络以及26个国家的政府及学术组织的83个官方网站,收集HTA方法学指南,检索时限均为建库起至2020年4月。由两位研究者独立筛选文献、提取资料,包括指南的基本特征、涉及内容以及评估内容,对HTA方法学指南的基本情况进行描述性分析。结果与结论:共纳入指南19篇。纳入的19篇指南均发表于2001-2018年,其中有7篇指南(占36.8%)发表于2015年以后;除1篇指南来自世界卫生组织以外,有14篇指南(占73.7%)来自欧洲,有2篇指南(占10.5%)来自北美洲,各有1篇指南(各占5.3%)来自南美洲和亚洲;有11篇指南(占57.9%)的制订机构为学术组织,8篇(占42.1%)指南的指定机构为卫生行政部门;有11篇(占57.9%)为循证指南,8篇(42.1%)为非循证指南;19篇指南均明确了评估目的、评估内容和评估客体,18篇指南明确了其评估方法(占94.7%),16篇指南(占84.2%)明确了其评估主体,14篇指南(占73.7%)明...     

The impact of COVID-19 on the cell and gene therapies industry: Disruptions,opportunities, and future prospects

Coronavirus 2019 (COVID-19) has caused significant disruption to the cell and gene therapy (CGT) industry, which has historically faced substantial complexities in supply of materials, and manufacturing and logistics processes. As decision-makers shifted their priorities to COVID-19-related issues, the challenges in market authorisation, and price and reimbursement of CGTs were amplified. Nevertheless, it is encouraging to see that some CGT developers are adapting their efforts toward the development of promising COVID-19-related therapeutics and vaccines. Manufacturing resilience, digitalisation, telemedicine, value-based pricing, and innovative payment mechanisms will be increasingly harnessed to ensure that market access of CGTs is not severely disrupted.     

Applying health technology assessment to pharmaceutical care: pitfalls and future directions

It has been argued in previous issues of this journal that health technology assessment can be used as a tool to assess the efficiency of pharmaceutical care by linking its impact on clinical and humanistic outcomes to the resources required to achieve these outcomes. Additionally, as policy-makers appreciate the need to evaluate projects on the basis of their costs and benefits, the application of health technology assessment to pharmaceutical care may serve as a way of communicating with policy-makers and informing policy on pharmaceutical care.This article elaborates on this idea by arguing that policy-makers will be more likely to appreciate the value of pharmaceutical care if researchers pay more attention to some methodological principles underlying health technology assessment in the context of pharmaceutical care, and if they take into account the decision-making context facing policy-makers. In order to raise the methodological quality of studies, researchers need to take care to define better the pharmaceutical care intervention; to evaluate the costs of the intervention and its impact on the utilization of other health services; and to aggregate the various clinical and humanistic outcome measures that are commonly used in this type of research. In order to increase the usefulness of study findings to policy-makers, researchers need to identify the multiple objectives that policy-makers pursue, and show how study findings will aid policy-makers in attaining these objectives.     

GRADE在卫生技术评估中应用的实例解析

对GRADE在卫生技术评估中应用的现状进行系统分析,通过实例解析在卫生技术评估中使用GRADE进行证据质量分级的方法和要点.     

共聚焦激光扫描显微镜在药剂学中的应用

共聚焦激光扫描显微镜(CLSM)是近年来一项新的、快速发展的、对样品无损害的成像技术.文章介绍了CLSM的基本原理,并参阅具有代表性的最新文献,分析和讨论了CLSM在药剂学研究领域的应用.随着CLSM技术的进一步发展和完善,它必在药学研究各领域发挥更大作用.     

螺旋CT扫描和三维重建在脊柱病变中的应用

目的：探讨螺旋CT扫描和三维重建在脊柱病变中的临床应用价值。方法：对43例脊柱疾病患者采用螺旋CT扫描和三维重建进行诊断。结果：椎管狭窄症和椎间盘突出症23例，脊柱骨折10例，畸形2例，肿瘤7例，寰枢椎不稳定1例均得到正确诊治。结论：螺旋CT扫描及三维重建技术可广泛应用于脊柱病变的诊断，能多方位、立体地显示脊柱病变的形态、位置，明显减少脊柱病变的漏诊和误诊。     

替格瑞洛用于急性冠脉综合征的卫生技术评估

摘 要 目的：评估新型血小板P2Y12受体抑制药替格瑞洛治疗急性冠脉综合征（ACS）的有效性、安全性和经济性,为临床用药和决策提供证据支持。方法：计算机检索PubMed、Embase、the Cochrane Library、Web of Science、CNKI和SinoMed等数据库,按照纳入排除标准筛选已发表的HTA报告、系统评价/Meta分析、RCT、药物经济学分析,并评价其研究质量。对RCT研究结果进行Meta分析,对其他研究结果进行定性分析。结果：在有效性上,与氯吡格雷相比,替格瑞洛可显著降低主要心脏不良事件的发生率（RR=0.86,95%CI：0.79~0.94,P=0.000 4）、心血管死亡率（RR=0.77,95%CI：0.68~0.88,P＜0.000 1）、全因死亡率（RR=0.81,95%CI：0.71~0.91,P=0.000 8）、心肌梗死发生率（RR=0.82,95%CI：0.73~0.91,P=0.000 2）、支架内血栓发生率（RR=0.74,95%CI：0.61~0.91,P=0.004）。在安全性上,与氯吡格雷相比,替格瑞洛对主要出血发生率（RR=1.04,95%CI：0.96~1.13,P=0.30）和心动过缓发生率（RR=1.12,95%CI：0.98~1.28,P=0.08）无明显影响,但增加了主要或次要出血的发生率（RR=1.28,95%CI：1.04~1.58,P=0.02）和呼吸困难的发生率（RR=1.76,95%CI：1.62~1.91,P<0.000 01）。在经济性上,替格瑞洛比氯吡格雷和基因检测指导的抗血小板治疗更具有经济性。结论：替格瑞洛用于ACS具有有效性、安全性和经济性。     

智能软件联合条码扫描技术在自动包药机加药流程中的应用

目的 建立并优化住院药房自动包药机加药机制,实现加药过程中药品核对及药品库存与效期的精细化管理,降低差错发生率,提高工作效率,保障患者用药安全。方法 利用智能软件联合条码扫码技术,对自动包药机加药流程中易出错环节进行智能干预,对比智能干预前后的加药差错发生率(%)、日平均加药时间(min)和月盘存裸片数量差错率(%)。结果 与优化前相比,自动包药机加药流程优化后的加药差错发生率由0.11%降为0%;日均加药时间由(96.50±21.84) min缩短至(64.23±19.59) min (P<0.01),均值减少32.27 min;月盘存裸片数量差错率由(9.42±1.13)%降低至(3.42±0.88)%(P<0.01)。结论 优化后的自动包药机加药流程操作快捷、简便,准确度高,可实时追溯和管理包药机库存及效期等药品信息,保障患者用药安全,推动智慧药房管理体系发展,提升药学服务质量。     

培哚普利治疗高血压的卫生技术评估

摘 要 目的：比较培哚普利与血管紧张素Ⅱ受体拮抗药（ARB）治疗高血压的有效性、安全性和经济性,为临床治疗和决策者提供循证依据。 方法：系统检索PubMed、Embase、Cochrane Library、中国学术期刊网络出版总库（CAJD）、中国生物医学文献数据库（SinoMed）等数据库和卫生技术评估（HTA）相关网站,根据纳入和排除标准筛选文献、提取数据和评价质量后,对研究结果进行定性分析和定量分析。 结果：共纳入1篇Meta分析和41项随机对照试验研究。培哚普利与坎地沙坦相比,降压有效率差异无统计学意义（P＞0.05）,而降低收缩压和舒张压能力均较弱（P＜0.05）。培哚普利与与其他ARB类药相比,差异均无统计学意义（P＞0.05）;培哚普利与氯沙坦相比,在降低左室重量指数、左心室后壁厚度和虚弱等方面差异无统计学意义（P＞0.05）。培哚普利与ARB类药相比增加咳嗽的发生率5.3%～10.1%,但在完全规范高血压管理的情况下,全国范围内每年可节约医疗成本（9.13～10.2）亿元。结论：培哚普利用于高血压的治疗具有良好的有效性和经济性,但增加咳嗽的发生率。为节省医疗成本,建议优先选用血管紧张素转化酶抑制药。     

Pharmaceutical companies’ views on a health technology assessment (HTA) entity in Saudi Arabia

Saudi Arabia is undergoing a massive healthcare transformation to fulfill its new, national “Vision 2030.” To align with this objective, Saudi Arabia is establishing a new, independent and evidence-based health technology assessment (HTA) entity to help it maximize health gains through efficient use of resources. This study was designed to ascertain how pharmaceutical companies perceive the creation of such a national HTA entity in Saudi Arabia; what they think about it and expect from it. To achieve the study’s aim, we held a workshop in Riyadh, Saudi Arabia, lasting four and a half hours and hosted by the Saudi Ministry of Health (MOH). We invited 16 market access directors and managers from different multinational pharmaceutical companies to discuss the establishment of a national HTA entity. The findings from the workshop were structured around three axes: vision and remit; HTA method; and implementation and practical considerations. Overall, the pharmaceutical company participants were positive about HTA’s value for the Saudi healthcare system and expressed willingness to adapt to meet its future requirements.     

播客技术在临床健康教育中的应用效果

目的 探索播客技术对妇科住院患者健康教育效果的影响。方法 选择2014年11月至12月在安徽省立医院妇科住院的126例患者,分为对照组(77例)和试验组(49例)。对照组按临床护理路径进行健康教育;试验组运用播客技术按临床护理路径进行健康教育,比较两组患者健康教育知晓率、住院期间满意度。结果 试验组患者住院期间健康教育知晓率、住院期间满意度均高于对照组,差异有统计学意义(P<0.05)。结论 运用播客技术可明显提高患者住院期间健康教育知晓率、住院期间的满意度,而且可以普及医疗卫生知识,提高患者预防意识,值得推广。     

氟维司群500 mg治疗晚期乳腺癌的卫生技术评估

摘 要 目的：评估氟维司群500 mg（F500）治疗晚期乳腺癌的有效性、安全性和经济性,为医保决策和临床用药提供证据支持。方法：以氟维司群250 mg（F250）为媒介,对F500与其他常用内分泌治疗药物进行比较。按纳入排除标准,系统检索已发表的卫生技术评估报告、系统评价/Meta分析、随机对照试验、药物经济学分析,提取数据并评价其研究质量。对随机对照试验进行Meta分析,对其他研究进行定性分析。结果：共纳入37篇文献,系统评价/Meta分析、随机对照试验及药物经济学分析分别为12、18和7篇。F250与其他常用内分泌治疗药物相比,有效性相似,并可降低部分不良事件发生率,具有显著的经济性优势;F500与F250、阿那曲唑相比,有效性具有显著优势,可显著延长疾病进展时间/无进展生存时间 [HR=0.79(95%CI：0.68~0.91), HR=0.66(95%CI：0.47~0.92)]和总生存时间 [HR=0.81(95%CI：0.69~0.96), HR=0.70(95%CI：0.50~0.98)],安全性指标差异无统计学意义,并具有显著的经济性优势。结论：F500治疗晚期乳腺癌具有良好的有效性、安全性和经济性。     

The validity and reliability of an interactive computer tobacco and alcohol use survey in general practice

Background

Uncertainty regarding the accuracy of the computer as a data collection or patient screening tool persists. Previous research evaluating the validity of computer health surveys have tended to compare those responses to that of paper survey or clinical interview (as the gold standard). This approach is limited as it assumes that the paper version of the self-report survey is valid and an appropriate gold standard.

Objectives

First, to compare the accuracy of computer and paper methods of assessing self-reported smoking and alcohol use in general practice with biochemical measures as gold standard. Second, to compare the test re-test reliability of computer administration, paper administration and mixed methods of assessing self-reported smoking status and alcohol use in general practice.

Methods

A randomised cross-over design was used. Consenting patients were randomly assigned to one of four groups; Group 1. C–C : completing a computer survey at the time of that consultation (Time 1) and a computer survey 4–7 days later (Time 2); Group 2. C–P: completing a computer survey at Time 1 and a paper survey at Time 2; Group 3. P–C: completing a paper survey at Time 1 and a computer survey at Time 2; and Group 4. P–P: completing a paper survey at Time 1 and 2. At Time 1 all participants also completed biochemical measures to validate self-reported smoking status (expired air carbon monoxide breath test) and alcohol consumption (ethyl alcohol urine assay).

Results

Of the 618 who were eligible, 575 (93%) consented to completing the Time 1 surveys. Of these, 71% (N = 411) completed Time 2 surveys. Compared to CO, the computer smoking self-report survey demonstrated 91% sensitivity, 94% specificity, 75% positive predictive value (PPV) and 98% negative predictive value (NPV). The equivalent paper survey demonstrated 86% sensitivity, 95% specificity, 80% PPV, and 96% NPV. Compared to urine assay, the computer alcohol use self-report survey demonstrated 92% sensitivity, 50% specificity, 10% PPV and 99% NPV. The equivalent paper survey demonstrated 75% sensitivity, 57% specificity, 6% PPV, and 98% NPV. Level of agreement of smoking self-reports at Time 1 and Time 2 revealed kappa coefficients ranging from 0.95 to 0.98 in each group and hazardous alcohol use self-reports at Time 1 and Time 2 revealed kappa coefficients ranging from 0.90 to 0.96 in each group.

Conclusion

The collection of self-reported health risk information is equally accurate and reliable using computer interface in the general practice setting as traditional paper survey. Computer survey appears highly reliable and accurate for the measurement of smoking status. Further research is needed to confirm the adequacy of the quantity/frequency measure in detecting those who drink alcohol. Interactive computer administered health surveys offer a number of advantages to researchers and clinicians and further research is warranted.     

依替巴肽治疗急性冠脉综合征的卫生技术评估

摘 要 目的：明确依替巴肽临床使用的获益与风险,为临床治疗和决策者提供循证依据。方法：系统检索PubMed、Embase、The Cochrane Library、CNKI、CBM等数据库,以及国内外卫生技术品评估（HTA）机构官方网站。由2位评价者根据纳入与排除标准独立筛选文献、提取资料和评价质量后,对结果进行定性和定量分析。结果：共纳入3篇Meta分析、29篇随机对照研究(RCTs)和9篇经济学研究。依替巴肽与阿昔单抗和替罗非班等阳性对照药比较主要复合终点、全因死亡、心肌梗死、卒中、紧急血运重建等事件发生率方面的差异均无统计学意义(P＞0.05)。与安慰剂相比能显著降低主要复合终点(RR=0.77, 95%CI：0.65～0.90)、紧急血运重建事件(RR=0.74, 95%CI：0.60～0.90)的发生率。与阿昔单抗和替罗非班相比,依替巴肽不增加大出血、血小板减少等发生率。与安慰剂、阿昔单抗、替罗非班相比,依替巴肽更具经济学优势。结论：依替巴肽用于急性冠脉综合征的治疗具有良好的有效性、安全性和经济性。     

基于卫生技术评估联合多准则决策分析建立我国儿童用药临床综合评价方法

摘 要为促进临床合理用药,使药品回归临床价值,我国亟需建立儿童用药临床综合评价体系。英国NICE卫生技术评估（HTA）的经验可为我国儿童用药临床综合评价方法的建立提供借鉴。国际最新研究表明结构化的HTA报告结合多准则决策分析（MCDA）能够增加决策的透明度并提高决策质量。本研究提出HTA联合MCDA是非常适宜作为我国儿童用药临床综合评价体系的方法学框架,并以哮喘控制类用药评价为例初步验证其可行性。未来,希望由权威的评价机构制定我国儿童用药临床综合评价方法,推动儿童用药临床综合评价工作全面实施。