利用《药品不良反应信息通报》分析我国药品不良反应监测现状

目的:利用官方发布信息,分析我国药品不良反应监测现状,探索未来重点监测药品类型。方法:对2001年11月以来国家药品不良反应监测中心发布的76期《药品不良反应信息通报》的内容进行整理,提取涉及的药品名称、分类、发布次数、累及的器官或系统、主要不良反应表现以及引发原因,利用Excel进行分类统计分析。结果:截至2018年6月16日,官方共发布的76期《药品不良反应信息通报》中,共涵盖13大类102种药品,其中化学药品76种,占74.51%;中药及中成药26种,占25.49%。二次通报的药品有15种,其中2/3为抗感染药物。所有通报的ADR/ADE累及器官中,皮肤相关的最多,生殖系统和营养代谢相关的最少。结论:我国的药品不良反应通报信息已经成为我国药物警戒的重要环节,起到至关重要的作用。但仍需要更多的关注与完善。     

464例儿童药品不良反应/事件特点及其超说明书用药情况分析

目的:回顾性分析我院2014年主动上报的464例药品不良反应的特点及相应的药品发生超说明书用药情况,为预防药品不良反应和合理用药提供参考。方法:描述性分析464例药品不良反应的特点,统计发生药品不良反应相应的药品超说明书构成比、超说明书类型。结果:发生不良反应情况以儿童组(2~11岁)患儿构成比最高,男女构成比为1.83︰1。发生不良反患儿主要疾病类型以呼吸道感染疾病多见,且临床表现以皮肤及其附件较常见。发生不良反应相应的药品按患儿例数及使用药品例数计超说明书用药发生率分别为49.1%、52.0%。超说明书类型以无儿童用药信息最常见(59.9%)。结论:我院药品不良反应中超说明书用药发生率较高;抗菌药物导致的不良反应可能更多的是剂量相关性不良反应。     

我市26例疑似药品不良反应死亡病例报告分析

目的：分析宁波市2006年以来疑似药品不良反应导致的死亡情况,为临床药品不良反应监测及合理用药提供参考。方法：采用回顾性分类统计,对收集到的26例死亡病例有关数据进行统计、分析。结果：死亡病例多发生于老年人,抗感染药物比例高,静脉给药发生率高,24例存在合并用药,累及的系统器官以全身性损害最多见。结论：慎用注射剂,加强临床ADR监测,加强药品使用管理,提高药品生产工艺和标准,加强药品商品名和说明书管理。     

2007—2009年342例药品不良反应统计分析

目的了解药品不良反应报告与监测的一般情况、特点和影响因素。方法利用全国药品不良反应监测网络系统,采用回顾性分析方法对2007年至2009年上报的342例药品不良反应有效报表进行统计、分析。结果 342例药品不良反应中,50岁以上人群最多,有136例(39.77%);一般的药品不良反应最多,有296例(86.55%);静脉注射给药方式最易导致药品不良反应,有286例(83.63%);护士上报的药品不良反应最多,有256例(74.85%),而乡镇卫生院以医生上报为主;涉及药物以抗微生物类最多,有173例(50.58%),其中又以头孢菌素类引起的药品不良反应居首位,其次为喹诺酮类、大环内酯类等;药品不良反应累及器官/系统以及临床表现主要为皮肤及其附件损害,有187例(54.68%)。结论应加强药品不良反应的报告与监测工作,以保障临床用药安全有效。     

淄博市2007年新的、严重的药品不良反应病例报告分析

目的通过对收集到的新的、严重的药品不良反应病例报告的汇总分析,探讨淄博市新的、严重的ADR的发生规律和特点.方法采用回顾性研究方法,对2007年淄博市药品不良反应监测中心收集上报的899例新的、严重的药品不良反应病例报告进行分类统计和分析.结果899例新的、严重的药品不良反应病例报告涉及的药品以中药及中成药最多,占总数的36.26%,致过敏性休克的药品以抗微生物药物最多,占总数的64.29%.结论合理应用抗微生物药物,加强中药不良反应监测,保障人民群众用药安全.     

基于B/S结构的超说明书用药管控系统的设计与实现

目的:建立超说明书用药管控系统,实现医师开具处方时对超说明书用药的系统自动提示。方法:基于B/S结构设计超说明书用药管控系统的模块及流程图,通过对处方中药品适应证、剂量,患者年龄、性别,用药途径等方面逐一校验,发现临床用药与系统预设值不符的情况;同时,以抗菌药物医嘱提示数量为例对该系统使用后管控效果进行评价。结果:目前我院设计的超说明书用药管控系统共涉及药品品规数265种,从系统启用至今,该系统共提示超说明书处方/医嘱数五万余条,约占同期总处方/医嘱数的0.3%。在超说明书用药类型中,监测期内超单次剂量用药的医嘱最多(745条),其次是超适应证医嘱(706条)、超单日剂量用药医嘱(671条);系统启用3个月内,提示的抗菌药物超单日剂量用药的医嘱数量逐月减少。结论:我院建立的超说明书用药管控系统运行稳定、操作简便、实用性较强,实现了对部分药品的超说明书用药监控。     

对1041例药品不良反应报告的分析及对策

目的分析药品不良反应的发生特点和规律,探讨促进临床合理用药的对策及措施,预防、减少药品不良反应发生。方法查阅收集近两年来15余篇文章中有关药品不良反应综合报告中的1041例,进行分类统计和分析。结果 1041例药品不良反应中,女性547例高于男性494例;老年人(60岁)发生例数最多为331例,占31.8%;经静脉给药方式引发的药品不良反应为830例,占79.73%;抗感染药物和中药制剂引发的药品不良反应最多,分别占44.09%、21.04%;药品不良反应主要临床表现以皮肤及其附件损害最多为556例,占47.16%。结论药品不良反应监测中应加强对抗感染药物和中药制剂的监测,提高合理用药水平是减少发生的关键,针对药品不良反应的特点和规律实施防范和干预措施,保障患者用药安全。     

我院162例药品不良反应报告分析

目的了解医院药品不良反应(ADR)的发生特点,为临床合理用药提供参考。方法采用回顾性分析方法,对医院收集到的162份药品不良反应报告进行分类统计、分析。结果涉及的药物品种共46个,其中抗感染药物居首位(18种80例,占49.38%),调节水、电解质及酸碱平衡用药排第2位(4种41例,占25.31%);给药途径以静脉用药为主(153例,占94.44%);主要药品不良反应类型为皮肤及其附件损害,占71.60%;属一般药品不良反应有121例,新的一般药品不良反应有40例,严重药品不良反应有1例;报告人以护士最多(93.83%),药剂师最少(仅0.62%)。结论应关注和重视药品的不良反应,合理使用药物,做好药品不良反应监测工作,促进临床安全合理用药。     

从清开灵ADR/ADE报告和说明书分析看儿童安全用药

目的通过分析861例儿童清开灵注射液的药品不良反应/不良事件报告及药品说明书,为儿童合理用药与企业完善说明书提供参考。方法采用回顾性研究方法 ,对河南药品不良反应监测中心数据库收集的2004年～2009年清开灵的药品不良反应/不良事件报告及国内9个厂家的药品说明书进行统计和分析。结果 3岁以下儿童364例（占42.28%）;联合用药140例（16.26%）,其中3岁以下儿童64例（45.71%）;超适应证242例（28.11%）;说明书中儿童安全用药信息和用法用量缺失。结论关注儿童合理用药,完善药品说明书,保障儿童用药安全。     

江苏省2031例抗菌药物致老年人不良反应报告分析

目的:分析抗菌药物致老年人药品不良反应(ADR)发生的相关因素,为促进临床合理用药提供依据。方法:采用回顾性研究方法,利用Excel 2007建立数据库,分别对江苏省ADR监测中心2008年1月—2009年1月收集的抗菌药物致老年患者ADR报告2031例,并对其年龄、性别、给药途径、合并用药情况、涉及药品种类以及ADR主要临床表现等情况进行分类统计和分析评价。结果:2031例ADR报告涉及抗菌药物13大类,87个品种;抗菌药物致ADR发生例数最多的是喹诺酮类,858例(42.25%);其次是头孢菌素类,487例(23.98%);静脉滴注导致ADR例数最多,1740例(85.67%);抗菌药物引发严重ADR71例。结论:临床应高度重视老年人抗菌药物使用的安全性,加强ADR报告和监测工作。     

Documentation and evaluation of adverse drug reactions (ADR)--contribution from a poison information center

The Department of Clinical Pharmacology in Jena is a pharmacovigilance center in a study on intensified spontaneous adverse drug reaction reporting. Physicians specialized in clinical pharmacology screen admissions to the Department of Internal Medicine for possible adverse drug reactions. Because of the collaboration between the Pharmacology Department and the nearby Poison Information Center (PIC) in Erfurt the question occurred whether the latter might contribute to adverse drug reaction monitoring. We compared the ADR registered by the intensified spontaneous reporting system in 1999 with those of the PIC during the same period. Each symptom observed was regarded as 1 case. Every suspected drug was also treated separately. The symptoms were classified using adverse reaction terminology. The drugs were classified according to the WHO Anatomical Therapeutic Chemical (ATC) classification index. The causality assessment was based upon bibliographic data and the method of Bégaud et al. [1985]. Only possible, probable or very probable ADR were compared. The PIC registered mainly psychiatric and nervous system disorders sedation and extrapyramidal disorders were the most frequent reactions - unlike the pharmacovigilance study which registered primarily gastrointestinal and heart rate disorders. The PIC registered mainly drugs used in the therapy of disorders of the central nervous system, i.e. mostly psycholeptics and drugs acting on the alimentary tract, mostly anticholinergics. Drugs for the therapy of sensory organs disorders were frequent owing to the systemic and local adverse drug effects of anticholinergic mydriatics. The PIC and pharmacovigilance centers can benefit from co-operation. The PIC provides easy access to qualified drug information and is thus a useful tool in ADR evaluation. Although the number of adverse reactions assessed was small, their evaluation revealed problems in drug usage which would not otherwise be reported. The evaluation has enlarged the pool of ADR data which is the basis for signal detection.     

327例精神科药物不良反应回顾性分析

目的分析精神科药物不良反应的发生特点及相关影响因素,为临床用药提供参考。方法回顾性分析2013~2015年我院上报的327例药品不良反应,对患者性别、年龄、给药途径、剂型、药品种类、药物不良反应涉及器官或系统及主要表现、引起药品不良反应最多的前10种药物及其主要临床表现等进行分析。结果 327例发生药物不良反应的患者中,男性158例,女性169例,女性发生率高于男性;19~40岁患者药品不良反应发生率较高,有168例(51.38%);主要涉及的精神科药物是抗精神病药(69.97%),其次为抗抑郁药(13.70%);口服发生的药物不良反应更常见,以消化系统最常见(31.40%),其次是神经系统(14.25%),涉及最少的是呼吸系统(0.79%)。一般的药物不良反应占多数,奥氮平的药物不良反应发生率最高(13.98%)。结论精神科药物品种多,用药情况复杂,应加强临床用药的管理和监测,合理使用精神科药物,保障患者的用药安全。     

中国药品不良反应信息通报15年回顾分析

摘 要 目的：对2001～2015年发布的药品不良反应（ADR）信息通报进行汇总分析,以期为中国药物警戒的发展提供借鉴。方法：对69期信息通报中被通报的药物和不良反应情况进行统计分析。结果：通报发布的期数和药品种类呈上升趋势,对不同品种的不同类型ADR,国家采用多种灵活的管理措施来控制药品风险。通报的西药中,抗微生物药物所占比例最大。69期中被通报的中药有26种,其中中药注射剂不良反应尤其受到关注。此外,全球药品的最新安全性信息通报也为我国药品的临床使用风险控制提供了有益的补充。所有通报的ADR中,以皮肤及其附件的不良反应最多,严重ADR以过敏性休克居多。结论：我国的ADR通报工作在指导医药生产、使用单位对于药品风险的认识和管控中的作用已经凸显。如能在ADR通报的基础上,加强高风险品种的主动监测,同时完善现有的法律法规,针对中国的情况制定药品风险管理指南,将会进一步促进我国药物警戒工作的发展。     

The role of hospital and community pharmacists in pharmacovigilance

In this paper, we give an overview of the role pharmacists actually have and could have in collecting reports of adverse drug reactions (ADRs) and more widely in pharmacovigilance.In the literature, several ways are mentioned in which the pharmacist, both the community pharmacist and the hospital pharmacist, can contribute to the safe use of drugs. In addition to their responsibilities regarding drug dispensing and compliance, they can have a substantial role in ADR reporting.Especially, hospital pharmacists can play a significant role in ADR reporting because the most serious adverse drug events occur in hospitals, and ADRs account for a substantial proportion of hospital admissions.Community pharmacists, however, can also play an important role in ADR reporting. This is, for example, the case in the Netherlands where community pharmacists contribute substantially, both in numbers and in quality of ADR reports.The contribution of the pharmacist to pharmacovigilance should, however, not be limited to ADR reporting. The various pharmaceutical disciplines could also greatly enhance our understanding of the nature of ADRs. If those involved in pharmaceutical disciplines can rise to this challenge, they will significantly help deepen our insights into ADRs.     

Drug-induced adverse reactions via breastfeeding: a descriptive study in the French Pharmacovigilance Database

Purpose

Most drugs are excreted in maternal milk and may therefore be ingested by children during breastfeeding. Data concerning the safety of the use of drugs by breastfeeding women are patchy, and almost nothing is known about this issue for many drugs.

Methods

The aim of this study was to describe the adverse drug reactions of drugs transmitted in breast milk on the basis of the data collected in the French Pharmacovigilance Database. All spontaneous reports of adverse drug reactions (ADRs) in breastfed infants recorded in the National Pharmacovigilance Database by the 31 French regional pharmacovigilance centres between 1984 and June 2011 were investigated.

Results

Between January 1985 and June 2011, 276 adverse drug reactions in 174 breastfed children were notified to the French Pharmacovigilance Network. The most frequently reported adverse drug reactions were neurological (28.6 %) and gastrointestinal (20.3 %). Sixty-five of the adverse drug reactions recorded were considered to be serious (37.4 %). The results of our study confirm that certain drugs were frequently implicated in serious adverse drug reactions. Two cases of ADRs (1.1 %) had a ‘certain’ causality score (I4) and 13 (7.5 %) a ‘likely’ score (I3). The suspected drugs include antiepileptic drugs, opiate analgesics and benzodiazepines. These results also demonstrate that some drugs that were thought to be anodyne or for which no data were available, such as ketoprofen and hydroxyzine, may be implicated in adverse effects. Finally, these data show that certain drugs, like pseudoephedrine, which should not be used during breastfeeding, were nevertheless implicated in several of the adverse drug reactions recorded.

Conclusion

This study shows that ADR via breastfeeding are rarely reported due to low awareness or low occurrence of ADR via breast milk. These results highlight the need for additional pharmacokinetic, clinical and epidemiological studies, given the paucity of published data. They also demonstrate the need to improve information for the general public about drugs and self-medication during breastfeeding.     

213例抗精神病药物不良反应分析

目的: 分析某院抗精神病药引起的药物不良反应(ADR)的发生特点、规律及影响因素。方法: 对某院2011-2015年的上报的213例抗精神病药ADR报表进行回顾性统计。结果: 213例抗精神病药引起的ADR共涉及13个药物品种,其中ADR发生率排在前5位的药品是氯氮平、利培酮、氟哌啶醇、氯丙嗪、氨磺必利;累及器官或系统以神经系统最多,共125例(55.31%),消化系统的损害次之,共54例(23.89%)。结论: 精神科医务工作者应重视抗精神病药引起的ADR的监测与上报,建议加强重点人群及新药、ADR高发药物的监测,定期分析数据,为临床及时干预和疏导提供参考,促进临床合理用药。     

基于上市许可持有人的药品不良反应主动监测模式的构建与评估研究

目的：探讨药品上市许可持有人（Marketing Authorization Holder,MAH）的药品不良反应主动监测创新模式的构建及其效果评估,为落实MAH药物警戒主体责任提供实证参考。方法：首先针对MAH药物警戒的现存挑战,基于中国医院药物警戒系统（Chinese Hospital Pharmacovigilance System,CHPS）设计MAH针对药品不良反应的主动监测模式,包括不良反应的监测、识别、评估及控制;再以注射用卡瑞利珠单抗为例分析主动监测效果。结果与结论：从MAH视角,构建基于CHPS整合循证证据和真实世界数据开展ADR主动监测的创新模式,包括运行模式、数据挖掘及模型构建。该主动监测模式被成功应用到以卡瑞利珠单抗为例的临床实践中,取到良好的效果。该研究成果不仅能帮助MAH开展药品监测工作,落实药品全生命周期主体责任,还能丰富药物警戒的内涵,为促进药物警戒发展和合理用药提供具有可操作性的实证参考。     

Monitoring of adverse drug reactions associated with antihypertensive medicines at a university teaching hospital in New Delhi

Aim

To monitor the adverse drug reactions (ADRs) caused by antihypertensive medicines prescribed in a university teaching hospital.

Methods

The present work was an open, non-comparative, observational study conducted on hypertensive patients attending the Medicine OPD of Majeedia Hospital, Jamia Hamdard, New Delhi, India by conducting patient interviews and recording the data on ADR monitoring form as recommended by Central Drugs Standard Control Organization (CDSCO), Government of India.

Results

A total of 21 adverse drug reactions were observed in 192 hypertensive patients. Incidence of adverse drug reactions was found to be higher in patients more than 40 years in age, and females experienced more ADRs (n = 14, 7.29%) than males, 7 (3.64%). Combination therapy was associated with more number of adverse drug reactions (66.7%) as against monotherapy (33.3%). Calcium channel blockers were found to be the most frequently associated drugs with adverse drug reactions (n = 7), followed by diuretics (n = 5), and β-blockers (n = 4). Among individual drugs, amlodipine was found to be the commonest drug associated with adverse drug reactions (n = 7), followed by torasemide (n = 3). Adverse drug reactions associated with central nervous system were found to be the most frequent (42.8%) followed by musculo-skeletal complaints (23.8%) and gastro-intestinal disorders (14.3%).

Conclusions

The present pharmacovigilance study represents the adverse drug reaction profile of the antihypertensive medicines prescribed in our university teaching hospital. The above findings would be useful for physicians in rational prescribing. Calcium channel blockers were found to be the most frequently associated drugs with adverse drug reactions.