Verdachtsfälle von Impfkomplikationen nach dem Infektionsschutzgesetz und Verdachtsfälle von Nebenwirkungen (von Impfstoffen) nach dem Arzneimittelgesetz vom 1. 1. 2004 bis zum 31. 12. 2005

Sufficient post-marketing surveillance is necessary for safety monitoring of vaccines. In this respect the spontaneous reporting system of reporting suspected adverse drug reactions (ADR) following vaccination is an essential tool for safety monitoring. The marketing authorization holder and/or pharmaceutical manufacturer has the legal obligation to report suspected adverse drug reactions (German Drug Law and European Regulation). In addition physicians and traditional healers have to report suspected cases of complications after immunizations pursuant to the German Infection Protection Act (Infektionsschutzgesetz, IfSG). The reports are medically assessed and stored in a database at the Paul Ehrlich Institute. For the publication referenced here, all reported suspected cases of adverse drug reactions after immunizations were evaluated for the period from January 1, 2004-December 31, 2005 according to different criteria. In 2004 (2005) a total of 1237 (1393) suspected cases of adverse drug reactions or suspected complications after immunizations were notified. 858 (919) of these adverse drug reactions (ADR) were serious (69 % and 66 %, respectively). 414 (517) of the ADRs (i.e. 33 % and 37 %, respectively) were reported by physicians according to the IfSG; the other reports were from industry and other reporting sources. 251 (229) i.e. 61 % (44 %) of these reactions were serious. The total number of reports divided by the total number of vaccine doses launched on the German market during the observation period (according to the data provided by the pharmaceutical industry) revealed an overall "reporting rate" of approx. 3 reports per 100,000 vaccine doses. The age groups with the highest absolute number of reported cases were infants and young children (0-2 years), and adults (18-59 years) accounting for approx. one third each of the reports. The age distribution of the suspected cases was comparable with that of previous years. In both years, approx. half of all suspected adverse drug reactions following immunization were of transient nature, i.e. there was a complete recovery (restitution ad integrum). In both years, a very small proportion of cases were reported as permanent damage (30 and 34 cases respectively; 2.4 % of all cases) or resulted in death (35 or 23 cases, respectively; 2.8 % or 1.7 %, respectively). With a few exceptions these adverse events were considered to be related to other diseases and unlikely related to vaccination. Overall, the association between vaccination and adverse events was assessed by the PEI as "possible" in 58 % (62 %) of all cases, respectively, as "likely" in 6 % (8 %) of all cases, and as "certain" in 0.4 % (0.6 %) of all cases. In 14 % (13 %) of the cases, the causal relation was stated as "unlikely". In 17 % (15 %) of all cases, a scientific evaluation was not possible on the basis of the data provided. A separate analysis of reports was conducted for all suspected adverse drug reactions following varicella immunization. According to these data varicella vaccination is considered to be well tolerated. With the exception of an increase in local reactions following pneumococcal polysaccharide vaccination no new safety signal has been recognised during the observation period.     

A nonparametric method to detect increased frequencies of adverse drug reactions over time

Signal detection is routinely applied to spontaneous report safety databases in the pharmaceutical industry and by regulators. As an example, methods that search for increases in the frequencies of known adverse drug reactions for a given drug are routinely applied, and the results are reported to the health authorities on a regular basis. Such methods need to be sensitive to detect true signals even when some of the adverse drug reactions are rare. The methods need to be specific and account for multiplicity to avoid false positive signals when the list of known adverse drug reactions is long. To apply them as part of a routine process, the methods also have to cope with very diverse drugs (increasing or decreasing number of cases over time, seasonal patterns, very safe drugs versus drugs for life‐threatening diseases). In this paper, we develop new nonparametric signal detection methods, directed at detecting differences between a reporting and a reference period, or trends within a reporting period. These methods are based on bootstrap and permutation distributions, and they combine statistical significance with clinical relevance. We conducted a large simulation study to understand the operating characteristics of the methods. Our simulations show that the new methods have good power and control the family‐wise error rate at the specified level. Overall, in all scenarios that we explored, the method performs much better than our current standard in terms of power, and it generates considerably less false positive signals as compared to the current standard.     

120例药品不良反应报告的分析

目的:了解药品不良反应(ADR)发生和分布情况,为临床合理用药提供科学依据,从而提高临床合理用药水平,达到保障公众用药安全、有效的目的。方法:对我院收集到的2006年4月至2008年4月的120例ADR病例报告进行统计分析。结果:药品不良反应涉及的药品,静脉滴注方式给药引发的ADR为64例占53.3%,口服给药42例占35.0%,静脉推注、皮下注射各3例各占2.5%,肌肉注5例占4.2%,外用2例占1.6%,雾化吸入1例占0.8%。结论:药品不良反应的发生与多种因素有关,应全方位加强药品不良反应的监测工作,加快药品不良反应的信息传递,促进临床合理用药,以减少和避免不良反应的发生。     

一线抗结核药不良反应发生情况及对继续治疗的影响

目的了解北京市怀柔区疾病预防控制中心结核病科门诊免费抗结核化疗的肺结核患者不良反应发生情况,为预防和降低不良反应发生提供科学依据。方法由结核科专业医师查阅2006—2010年病例资料,包括大病例、病程、服药记录、实验室检查等,回顾性分析抗结核药物所致不良反应的发生情况。结果共出现药物不良反应的有183例,占查阅病例的35.1%。其中轻度反应75例,中度反应101例,重度反应7例;有95%的患者不良反应发生在服药2个月内,有79例患者因不良反应而停(换)药,有2例患者死亡。结论抗结核药物引起的不良反应发生率相对较高,对肺结核的治疗产生了一定的影响,要积极监测并及时正确处理药物不良反应,使患者能够坚持完成治疗,避免发生严重后果。     

我院325例喹诺酮类药物不良反应调查分析

目的:分析我院使用喹诺酮类抗菌药物出现不良反应患者的临床资料,为临床用药提供参考依据。方法:对我院近年来2783例喹诺酮抗菌药物使用者,进行回顾性调查分析药物不良反应情况。结果:喹诺酮类使用最多的是氧氟沙星,其次是环丙沙星;喹诺酮类药物不良反应发生率为11.68%;静脉用药发生不良反应最高,其次是口服用药;不良反应主要表现在消化、神经、皮肤、呼吸、泌尿、血液系统。结论:临床应用喹诺酮类抗菌药物时,要做到合理应用并加强监管,以减少不良反应的发生。     

氟喹诺酮药物不良反应分析及合理应用

目的分析氟喹诺酮类药物的不良反应和合理应用,为临床上提供用药依据。方法选取2010年1月—2013年1月该院使用氟喹诺酮类药物发生不良反应的120例患者,对其不良反应的药物种类、给药途径、临床表现进行分析。结果 120例不良反应涉及5种氟喹诺酮类药物,左氧氟沙星和加替沙星和分别占48例(40.0%)和37例(30.8%),不良反应的发生率明显高于其他药物;静脉给药的不良反应发生率71.7%大于口服给药的28.3%;不良反应共累及人体9个系统,主要是皮肤及其附件不良反应45例(37.5%),其次为胃肠道系统34例(28.3%)和神经系统20例(16.7%)。结论氟喹诺酮类药物易发生不良反应,在临床应用时要密切观察,提高用药的安全性和合理性。     

279例药品不良反应报告回顾性分析

目的分析某院药品不良反应发生的原因及特点,为临床合理用药以及药物安全性评价提供依据,促进合理用药。方法收集该院上报279例ADR报告进行回顾性分析。结果 279例ADR报告中,各年龄段均有分布;给药途径以静脉滴注为主,250例,占89.61%;引起ADR最常见的药物为抗感染药物,共185例(61.67%);以皮肤及附件损害为主,占37.28%。结论药品不良反应的发生与多种因素有关,应加强ADR的监测。     

某院2013年1-6月药品不良反应报告分析

目的：：了解药品不良反应（ADR）发生特点,为促进合理用药,深入ADR检测提供依据。方法：对某医院2013年1~6月上报的50例ADR报告进行分类统计、分析。结果：50例ADR中,抗菌药物所占比例最高,共有10例（20.00%）。引发ADR的抗菌药物,依次为喹诺酮类（占60.00%）、头孢菌素类和青霉素类（占20.00%）。50例ADR累及多个器官或系统,最常见的是免疫系统（占34.00%）,其次为皮肤及附件损害（28.00%）和循环系统（26.00%）。结论：应控制抗菌药物的合理使用,加强ADR监测工作,促进合理用药。     

我院102例药品不良反应报告分析

目的分析2008年3月＂2009年3月我院药品不良反应发生的特点,促进临床合理用药。方法采用回顾性分析方法,对我院2008年3月~2009年3月收集的药品不良反应报告,分别从患者年龄、给药途径、涉及药物种类以及临床具体表现等方面进行统计、分析。结果药物种类以抗菌药引起的ADR最多,占总数的71．6％。药物引起的不良反应以皮疹反应表现为多见。给药途径以静脉注射给药造成的ADR较多,占79．4％。结论应加强对药物不良反应的监测意识,完善相关报告分析制度,确保临床安全、有效、合理用药。     

医院药品不良反应调查分析

目的了解药品不良反应(ADR)的基本情况,以提高今后对ADR的重视和上报率。方法采用回顾性研究方法,对某医院收集的57例ADR报告,分别按各年度上报例数、报告来源及不上报ADR的调查原因、药品种类、涉及器官或临床表现等方面进行统计、分析。结果 57例ADR报告中,2007年度ADR上报率最高(占38.6%),医师上报数最多(占79.0%),涉及药品以抗感染药居多(占75.4%),ADR累及的临床表现为皮肤及其附件损害最多(占43.9%)。结论对用药引起的不良反应不容忽视,应采取有效的措施提高报告率。     

我院102例药品不良反应报告分析

目的分析2008年3月～2009年3月我院药品不良反应发生的特点,促进临床合理用药。方法采用回顾性分析方法,对我院2008年3月～2009年3月收集的药品不良反应报告,分别从患者年龄、给药途径、涉及药物种类以及临床具体表现等方面进行统计、分析。结果药物种类以抗菌药引起的ADR最多,占总数的71.6%。药物引起的不良反应以皮疹反应表现为多见。给药途径以静脉注射给药造成的ADR较多,占79.4%。结论应加强对药物不良反应的监测意识,完善相关报告分析制度,确保临床安全、有效、合理用药。     

1994至2010年《中国医院知识数据库》拉莫三嗪片不良反应文献分析

目的 分析临床使用拉莫三嗪(LTG)所导致不良反应及其相关因素.方法 计算机检索1994至2010年<中国医院知识数据库>(CHKD),即关于LTG所致不良反应的相关文献,检索关键词包括:拉莫三嗪,LTG,lamotrigine等.采用回顾性分析法对相关检索结果进行统计学分析.结果 自检索有关LTG不良反应文献共计356篇.LTG导致的不良反应包括皮肤损害、血液系统损害、中枢及神经系统损害、消化系统不良反应和诱发自身免疫性疾病及致畸等.该药导致的多数不良反应,经对症治疗或停药,均可恢复正常,无死亡病例的文献报道.LTG所致不良反应与个体性别、联合用药及给药剂量有一定关联.结论 临床应用LTG时,应重视个体性别、药物相互作用与给药剂量,加强临床观察,减少不良反应发生.     

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.     

171例药品不良反应分析

目的为了解我院药品不良反应的发生情况,促进我院安全、有效、合理用药。方法收集我院2006～2009年171例药品不良反应(ADR)报告资料并进行分类统计和分析。结果在171例ADR中,女性与男性比例为2.6∶1,多发于20～40岁的年龄段。引发ADR给药方式以静脉给药为主,占87.73%。抗感染药物是发生例数最多的一类药物,占85.38%,其中头孢菌素类药物发生例数为116例,占抗感染药物发生例数的79.45%。ADR涉及的器官/系统以皮肤及其附件为主,占77.19%。     

基于HIMSS EMRAM 7 标准的合理用药系统建立与应用

目的利用信息化技术构建合理用药系统,促进临床合理用药,提高患者安全用药水平。方法基于系统功能实现对超说明书用药、抗菌药物管理等进行事前提示、事中干预和事后监管。结果系统为临床获取医学、药学相关信息提供了便捷,促进了抗菌药物的合理使用,提高了药品不良反应上报例数。结论合理用药信息化建设有助于促进临床合理用药,应在实践中对之进行不断优化改进,充分发挥系统对合理用药的监管作用