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Analysis of Data on Adverse Drug Events Reported to the Food and Drugs Administration of the United States of America

机译:向美国食品和药物管理局报告的不良药物事件数据的分析

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Background: The Spontaneous Reporting System (SRS) of the Food and Drugs Administration (FDA) of the United States of America (US), known as the FDA Adverse Event Reporting System (FAERS), is a mechanism for collecting information on safety concerns associated with the use of drugs for redress, as they are used on large scale. The data which is the subject of this paper came from the FAERS database. This paper reports on the analysis of data covering 2013 to 2018 period, but compares the observed trends in the variables during this period with that of the 2007 to 2012 period to ascertain whether the trends change over time;as this paper is, in a sense, a sequel to an earlier one with a similar title as this but covering the period 2007 to 2012. Objectives: The objectives of the study reported in this paper were to: i) explore the trends in the variables involved with the adverse events problem in the 2013 to 2018 period and compare these trends with that found in the study covering the 2007 to 2012 period;ii) determine whether or not the level of missing variable values in the 2013 to 2018 period is lower than, the same or higher than it was in the 2007 to 2012 period;iii) find out how the first twenty principal suspect drugs most cited to be involved in adverse events occurring during drug use in the 2013 to 2018 period compare with that of the 2007 to 2012 period. Methods: The Food and Drugs Administration (FDA) makes extracts from the FAERS database freely available to the public on quarterly basis. Fourteen (14) out of over fifty (50) variables contained in these extracts were reckoned to be connected with the objectives of the study and were examined using the tools of frequencies, proportions and averages, on account of the nature of the data. Results: For the period 2013 to 2018, adverse events reports submitted to the FDA (US) more than doubled (2.1 times), accounting for an annual average growth rate of 15.8 %, which is considerably lower than the annual average growth rate of 22.1% for the 2007 to 2012 period. However, the reported number of cases for 2015 was 53.8% more than that of 2014. Consistent with the results for 2007 to 2012 period, the 2013 to 2018 period saw Female subjects accounting for over 60% of the annual and the overall number of reports. Overall, non-health professionals appear to have a slight edge over health professionals in reporting adverse drug events in the 2013 to 2018 period, with an indication that reports from non-health professionals are on the decline and that from health professionals is on the rise. Non-health professionals and health professionals were almost equally likely to report adverse events in the 2007 to 2012 period. Also, the findings for the 2013 to 2018 period suggest that the older one gets the more vulnerable one becomes to adverse events associated with drug use, which is consistent with the findings for the 2007 to 2012 period. Conclusion: The dangers that come with the use of drugs is an evolving one and therefore there is the need to examine SRS data from time to time so that emerging drug safety concerns can be dealt with timeously.
机译:背景:美利坚合众国(美国)的食品和药物管理局(FDA)的自发报告系统(SRS)被称为FDA不良事件报告系统(FAEERS)是收集有关相关安全问题信息的机制随着药物用于补救,因为它们是大规模使用的。本文主题的数据来自FAERS数据库。本文报告了2013年至2018年数据的数据分析,但在此期间与2007年至2012年期间的观察到趋势进行了比较,以确定趋势随着时间的推移是否发生变化;众所周知,将续集到早期的续集,具有类似标题的,但涵盖2007年至2012年的时间。目标:本文报告的研究目标是:i)探讨与不良事件问题涉及的变量中的趋势2013年至2018年期间,并比较这些趋势在研究2007年至2012年期间的研究中发现; II)确定2013年至2018年期间缺失的变量价值水平低于,相同或高于其在2007年至2012年期间; III)了解最多二十名主要嫌疑人,最多是在2013年至2018年期间在毒品使用期间发生的不良事件,与2007年至2012年期间相比。方法:食品和药物管理局(FDA)在季度季度自由地提供给公众的提取物。在这些提取物中包含的超过五十(50)个变量中的十四(14)被估算与研究的目标相连,并且考虑到数据的性质,使用频率,比例和平均工具进行检查。结果:2013年至2018年期间,向FDA(美国)提交的不良事件报告增加了一倍以上(2.1倍),占年均增长率为15.8%,其年平均增长率约为22.1 2007年至2012年期间的%。但是,报告的2015年案件数量超过2014年的案件数量为53.8%。与2007年至2012年期间的成果一致,2013年至2018年期间占年度的女性受试者占年度年度的60%以上和总数的报告总数。总体而言,非健康专业人员似乎对健康专业人员略微偏见,在2013年至2018年期间报告了不良药物事件,迹象表明非卫生专业人员的报告正在下降,从卫生专业人员崛起。非健康专业人士和卫生专业人士几乎同样可能在2007年至2012年期间报告不利事件。此外,2013年至2018年期间的调查结果表明,较旧的调查结果将获得更脆弱的人成为与药物使用相关的不良事件,这与2007年至2012年期间的调查结果一致。结论:使用药物的危险是一种不断发展的危险,因此需要不时检查SRS数据,以便可以随时处理新兴的药物安全问题。

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