医务人员药品不良反应认知度的调查

目的：了解医务人员有关ADR的认知度的情况。方法：采用分层随机抽样的方法抽取样本，通过样本估计总体。从基本知识、执行情况和影响报告ADR的因素三方面进行调研。结果：85％人员认为上市后药品存在或遇到过ADR；仅4％人员填写过ADR报告表；57％人员不清楚《药品管理法》中有无ADR的法律条款；53％人员不清楚所在医院有没有ADR职能机构。结论：大多数医务人员认为ADR监测很有必要，但自己没有责任和义务，而且不清楚如何上报ADR报告。需加强ADR知识在医院内的宣传。并制定合理的奖惩措施。     

医患双方对药物不良反应监测工作认知水平调查分析

目的从医患双方对药品不良反应（ADR）的认知角度出发,探讨我院ADR监测工作中存在的问题,旨在提高ADR监测水平。方法随机抽取2013年6月-2013年12月我院医务工作者300名及住院患者200名,使用自行设计的调查表对ADR认知情况进行问卷调查。结果收回有效调查表492份,总有效率为98.40%,其中医务人员295份（59.96%）,患者197份（40.04%）。药学人员对ADR定义的掌握程度高于其他调查对象（P〈0.05）。60.00%的医务人员对ADR报告程序不了解,48.47%的医务人员对有关ADR监测的条文不清楚,43.73%的医务人员不了解ADR报告途径。45.08%的工作人员认为没有必要上报ADR,63.73%的工作人员应该安排专职人员上报ADR。患者对ADR定义的认识水平整体较低（44.67%）,24.87%的患者不清楚合格药品是否存在ADR,37.06%的患者不清楚ADR的发生是否与药品质量有关,39.59%的患者不清楚ADR是否与药品使用方法有关,29.44%的患者认为中药及其制剂没有ADR,51.27%的患者认为应由院方赔偿ADR相关损失。结论我院医务人员及患者对ADR监测工作相关知识的认识不一,应加强宣传培训,畅通上报途径等,提高ADR监测工作质量。     

我院医务人员药品不良反应认知的初步调查

目的:了解医务人员药品不良反应(ADR)的认识程度,为开展ADR报告和监测工作打好基础。方法:对全院正式职工进行问卷调查,对调查结果作统计分析。结果:医务人员对ADR的基本概念、相关知识的认识程度有差异,其中药学专业和中职以上人员认识程度较高,其他人员认识不足,对实施ADR监测及填报ADR报告的重要性认识不到位。结论:必需加强有关ADR知识的宣传和培训工作,增强医务人员对ADR的认识水平,提高上报意识和监测水平,最大限度减少临床不合理用药及ADR的发生。     

我院医务人员药品不良反应监测认知度调查分析

目的：了解我院医务人员药品不良反应（ADR）监测相关知识掌握情况,为进一步开展ADR报告和监测工作提供参考。方法：将我院在岗人员分类,分别填写“医务人员ADR监测认知度调查表”,以调查我院医务人员ADR报告与监测认知度情况。结果：我院医务人员对ADR概念认识不足,上报范围不清,上报意识淡薄,对上报程序及ADR管理机构不明,ADR法律意识不强。结论：有必要对医务人员进行ADR监测相关知识的培训,以提高其对ADR监测的认知度,使ADR监测工作成为医务人员的自觉行为。     

药品不良反应报告工作在医务人员中的认知情况调查

目的:了解医务人员对药品不良反应(ADR)报告工作的认知情况,促进ADR报告工作的开展。方法:采用问卷调查法,对200名医务人员进行ADR报告工作认知情况调查,以Epidata3.1建立数据库,以SPSS 13.0统计分析数据。结果:回收有效问卷175份,有效回收率87.5%。调查显示医务人员对国家ADR报告工作知晓率不高,认识存在误区,上报倾向不符合要求,模拟上报率较低;缺乏ADR相关知识是限制其报告ADR的主要原因,超过一半人员未参加过相关培训。结论:应加强在医务人员中ADR报告相关知识的培训和学习,加大《药品不良反应监测管理办法》的普法和执法力度。     

医务人员漏报药品不良反应原因调查与分析

目的调查医院医务人员报告药品不良反应(ADR)情况,分析漏报原因,为做好ADR上报工作提供依据。方法采用调查问卷的方式,就ADR监测状况的相关问题,对医院医务人员进行调查分析。结果共发放问卷470份,回收有效问卷447份。能正确理解ADR概念的医务人员仅占45.41%,54.36%医务人员不能正确认识ADR评价准则;63.98%医务人员从未上报过ADR;不知道ADR报告程序、不会写ADR报告、诊断有困难不能确定ADR、填写报告太复杂、科室没有考核要求、医院无法查阅有关ADR信息及顾虑担心引起医疗纠纷是影响医务人员漏报ADR的主要因素。结论对医务人员ADR知识培训和宣传力度不够是ADR漏报的主要原因。应加强对医务人员教育培训力度,深刻认识ADR的危害性和ADR上报工作的重大意义,提高医务人员上报ADR的积极性,是减少ADR漏报率的重要措施。     

我院医务人员药品不良反应认知度调查

目的:了解我院医务人员对药品不良反应(ADR)的认知和重视程度,为开展ADR报告与监测工作制定有效措施。方法:对我院医务人员进行药品不良反应问卷调查,对问卷调查内容进行统计分析。结果:各类医务人员对ADR定义理解完全正确的占63.2%,认为有必要报告ADR的占61.0%,在实际工作中报告过ADR的仅占28.2%。结论:我院医务人员对ADR定义、报告和监测相关制度的认知还不够,应加强ADR培训和上报监管,以提高医疗质量,减少药害事件的发生,促进临床合理用药。     

我院254例药品不良反应/事件调查分析

目的：了解我院药品不良反应/事件(adverse drug reaction/Events,ADR/ADE)发生规律及特点,促进临床合理用药。方法：收集我院2013年上报的254例ADR/ADE报告,按照患者的年龄、药品种类、给药途径、药品不良反应累及系统-器官及临床表现、合并用药情况进行分类统计与分析。结果：254例ADR/ADE报告中以抗微生物药物的发生例次为首位,占37.66%;中药注射剂次之,占15.82%。静脉滴注是引发ADR/ADE的主要给药途径,占68.99%;ADR/ADE累及的主要系统-器官为皮肤系统,临床表现主要以皮疹、瘙痒为主。结论：应加强ADR相关知识的培训,提高临床医务人员对ADR/ADE监测工作的认识,增强上报意识,减少药品不良反应的发生,确保患者的用药安全。     

广州市药品不良反应公众认知度调查

目的：调查广州市公众对药品不良反应认知的现状,为相关单位和部门提供信息依据和参考。方法：在医院、药店和高校随机进行调查,发放调查表320份,回收312份,有效300份。并对有效调查表进行分析。结果：公众对药品不良反应的定义及相关知识认识不足。18．4％的普通患者和63．5％的医务人员对ADR定义能正确理解;54．4％的普通患者和13．5％的医务人员认为ADR就是医疗事故。结论：应加强普及ADR相关知识,及时公布药品安全信息,向公众宣传科学、合理的用药知识。     

江苏某药企营销人员对药品不良反应的认知及影响因素分析

摘要：目的:了解药品生产企业营销人员对药品不良反应(ADR)的认知及其影响因素,发挥营销人员主动参与ADR的上报,更好地配合《关于药品上市许可持有人直接报告不良反应事宜的公告》的实施。方法:采用单纯随机抽样方法,对某药企营销人员进行自填式问卷调查,内容涉及基本概念、上报及用药安全,采用频数及构成比描述调查结果,影响因素分析采用χ~2检验及多因素Logistic回归分析。结果:共调查498人,回收有效问卷480份,有效回收率为96.39%。56.45%的营销人员为男性,平均年龄(35.81±7.26)岁。绝大多数营销人员知晓ADR(93.54%),75.63%的被调查者知道我国实行ADR报告制度,但只有61.25%的人认为生产企业也要上报ADR,而且21.67%无法准确判断何种情况的ADR应该上报。依据10道客观题回答正确情况,营销人员平均得分为5.75分,处于较低水平。单因素和多因素分析结果均显示,文化程度、职称等因素与认知程度高低有关(P<0.05),营销人员的文化程度或职称越高,认知程度越好。结论:受访的药企营销人员对ADR认知程度欠佳,对于生产企业作为报告主体之一的责任还不了解,而且对何种ADR该上报并不清晰。加强对低文化程度和低职称营销人员开展ADR专业知识的培训,对于提高生产企业ADR报告率显得非常必要。     

不同人群药品不良反应认知度调查

目的调查不同人群对药品不良反应相关知识的认知程度,为完善和促进药品不良反应监测工作提供依据。方法对社会公众、药品生产与经营单位的涉药人员、医疗机构医务人员进行药品不良反应认知度问卷调查,并对回收的有效调查表进行统计分析。结果本次调查共发放问卷3100份,回收有效问卷3026份。被调查人群中,了解药品不良反应的占95．3％,对药品不良反应的发生原因了解不确切的占64．7％,发生药品不良反应不知道应报告的占19．5％,不知道如何报告药品不良反应的占25．8％。另有近50％的被调查者认为需要提高药品不良反应相关知识,认为有必要进行药品不良反应的相关知识培训的占86．1％。结论应加强宣传教育,提高广大市民特别是医药企业和医疗机构专业人员的药品不良反应报告意识。同时,应强化药品监管部门职能,并与卫生行政部门共同推进药品不良反应监测相关法规的修订与完善,保障公众用药安全。     

Attitudinal survey of voluntary reporting of adverse drug reactions

AIMS: Voluntary adverse drug reaction (ADR) reporting schemes have operated since the early sixties in many Western countries. It is generally recognized, however, that only a small proportion of ADRs is actually reported. The current survey was conducted to assess attitudes towards reporting of ADRs, and to study which types of ADRs are reported. METHODS: A questionnaire seeking reasons for nonreporting was sent to a random sample of 10% of medical practitioners in The Netherlands in October 1997. After 6 weeks, a reminder was sent to those who had not responded. RESULTS: One thousand four hundred and forty-two (73%) questionnaires were returned, of which 94% were complete. The percentage of GPs (51%) which had ever reported an ADR to the national reporting centre was significantly higher than the percentage of specialists (35%), who reported more often to the pharmaceutical industry (34% vs 48%). 86% of GPs, 72% of surgical specialists and 81% of medical specialists had ever diagnosed an ADR, which they had not reported. Uncertainty as to whether the reaction was caused by a drug (72%), the ADR being trivial (75%) or too well known (93%) were the most important reasons for not reporting. 18% were not aware of the need to report ADRs, 22% did not know how to report ADRs, 38% did not have enough time, 36% thought that reporting was too bureaucratic and only 26% of Dutch physicians knew which ADRs to report. A serious ADR, an unlabelled ADR, an ADR to a new drug, history of reporting of one or more ADRs, and specialty were all independently associated with reporting of 16 hypothetical ADRs. Surgical and medical specialists tended to report less often than GPs. CONCLUSIONS: There is a considerable degree of underreporting, which might partly be explained by lack of knowledge and misconceptions about spontaneous reporting of adverse drug reactions.     

我院医护人员对不良药物反应监测认知度调查

目的调查江油市903医院医护人员对药品不良反应（ADR）的认识程度,为该院的药品不良反应监测工作制定更加有效的干预措施。方法对全院医护人员进行药品不良反应ADR认知度的问卷调查,对问卷各项内容进行分析。结果该院医护人员对药品不良反应ADR的概念和上报内容基本明确,但上报意识淡漠,对上报程序和专业机构了解不够。结论医护人员对药品不良反应ADR的认识度直接影响ADR的上报率,有必要对医院医护人员进行药品不良反应专业知识培训,以提高其对药品不良反应ADR监测的认识程度,提高ADR的上报率。     

我院医护人员对药品不良反应认知情况调查分析

目的了解该院医护人员对药品不良反应(ADR)的认知情况,分析该院ADR上报率低的原因。方法采取随机抽样法,通过调查问卷的形式对该院医护人员进行ADR认知度调查。结果回收有效问卷209份,回收率为96.2%,问卷有效率为90.8%。共调查医师126人,护理人员83人;ADR概念正确知晓率为41.6%,62.7%的人认为ADR与医疗纠纷有关,63.6%的人认为ADR与医疗质量有关;仅有20.1%的人知道ADR应上报给医院哪个部门,15.8%的人不知道医院有不良反应监测及上报制度,41.6%的人曾经报告过ADR,其中35人通过填写ADR报告上报,正确上报率为16.7%;97.6%的人认为报告ADR是医务工作者的职责,46.9%的人认为应将ADR上报作为一项临床工作人员年度考核指标,52.6%的人认为应给予漏报ADR的人员处罚,67.9%的人认为报告ADR应给予相应报酬,79.9%的人认为医院内需设置从事ADR监测工作的专职人员。结论该院医护人员对ADR法规及知识的整体认知度、监测及报告制度及程序的认知度偏低,ADR的正确上报率偏低,是造成我院ADR报告率低的主要原因。加强对医护人员的相关法规及知识教育和培训;设置ADR上报专员,明确责任,落实奖惩;临床药师应在协助医护人员进行不良反应监测、鉴别及上报等方面发挥积极作用,提高我院ADR上报数量及质量。     

对我院医务人员药品不良反应知识水平的调查分析

目的了解我院医务人员对药品不良反应(ADR)知识的认识和掌握情况,为开展ADR报告和监测工作提供方向和依据。方法对我院医务人员进行现场问卷作答,调查结果录入Excel电子表格进行数据分析与处理。结果医务人员对ADR定义的答对率为12.50%;93.33%认为应报告所见ADR,但仅有39.58%报告过ADR;68%以上认为ADR与医疗纠纷或医疗质量有关。院内刊物在提高《国家药品不良反应信息通报》知晓率和认识程度方面发挥了重要作用。结论医务人员ADR知识水平整体偏低、职能部门认识不足、管理脱节、培训不到位和监管不力,是目前ADR上报率低的主要原因。医院应提高重视程度,努力把工作落到实处。     

医护人员对药品不良反应监测的认识程度调研

目的:了解我市医护人员对药品不良反应(ADR)监测的认识程度。方法:采用“医护人员对ADR认识度调研问卷”形式,调查我市400名医护人员对ADR概念认识、报告意识、ADR上报范围及原因、ADR的报告程序、ADR的专业机构、ADR的法律意识等。结果:我市医护人员对ADR上报范围及原因基本明确,但存在对其概念认识不足,上报意识较淡薄,对上报程序及ADR专业机构不明,ADR的法律意识不够强等现象。结论:有必要对医护人员进行ADR专业知识及法律、法规等有关知识的培训,以提高其对ADR监测的认识程度,使ADR监测工作成为医护人员的自觉行为。     

Patient reporting of potential adverse drug reactions: a methodological study

AIMS: To develop a systematic generic method of enabling patients to report symptoms which they believe to be due to a particular prescribed drug. METHODS: A piloted body system-based questionnaire was distributed to patients registered with 79 medical practices in Grampian prescribed one of nine recently marketed 'black triangle' drugs. These comprised four antidepressants, three antiepileptics and two analgesics. This requested respondents to identify any symptoms experienced over the previous year which they thought could be due to the 'black triangle' drug they had used. A sample of medical records was examined to compare symptoms recorded with those reported by patients. A classification system was developed for the study to enable the assessment of symptoms reported for their potential relationship to patients' drug therapy. All symptoms reported were classified, taking into account information provided by patients on their concomitant drugs and diseases. A specialist pharmacist independently re-classified a sample of the symptoms to validate the process. RESULTS: A 36.3% response rate was obtained (837/2307) with 742 respondents (88.6%) reporting at least one symptom. The median per patient was 6.0 (range 0--71), with almost half (406, 48.5%) reporting fewer than five symptoms. Most symptoms (71.0%) were classified as being probably or possibly related to the drugs studied. Agreement between researcher and specialist on the classification of 75.3% of 716 symptoms was obtained (Kappa=0.563). Responses from patients prescribed antidepressant drugs were more likely to include symptoms potentially caused by these drugs (74.5% of all symptoms reported) than those from patients prescribed analgesics (67.4%) or antiepileptics (65.1%, chi2 = 23.858, d.f. = 2, P < 0.001). Patients reporting large numbers of symptoms were more likely to report some which were classed as unlikely to be an ADR or unattributable (chi2 = 80.587, d.f. = 3, P < 0.001). Of the 742 reporting symptoms in questionnaires, 402 (54.2%) claimed to have reported some or all of these to their doctor. Only 162 (22.6%) of 716 patient-reported symptoms were documented in the primary care medical records of 103 patients prescribed tramadol or venlafaxine. CONCLUSIONS: Respondents were clearly willing to report symptoms, the majority of which were classed as possibly/probably related to the drugs studied. The results suggest that patients do not report all symptoms they suspect to be ADRs to their GP and that GPs do not record all symptoms which may be reported to them. The method could help to identify problems which patients perceive as being related to their drug therapy and contribute to increased ADR reporting.     

Attitudes to reporting adverse drug reactions in northern Sweden

OBJECTIVES: This study was designed to investigate attitudes of general practitioners (GPs) and hospital physicians in Sweden towards spontaneous reporting of adverse drug reactions (ADRs). METHOD: Two areas in the northern region of Sweden were selected for the study. A knowledge and attitude questionnaire followed by a reminder letter 2 weeks later was addressed to all GPs and hospital physicians in the study areas. RESULT: The total response rate from the study areas was 748 of the 1274 questionnaires sent out (58.7%). Of those who responded, 236 were GPs, 433 were hospital physicians and 79 had other positions. Of the responders, 252 stated that they had never reported any ADR and 488 that they had reported at least once in their career. Issues that came out as important in the decision to report or not to report were whether the reaction was considered well-known or not, the severity of the reaction, hesitance to report only on suspicion, lack of knowledge of existing rules, giving priority to other matters and lack of time to report ADRs. Only minor differences in these regards were observed between male and female physicians. CONCLUSION: Our investigation shows that the physicians in northern Sweden have a fairly good knowledge about the existing rules for reporting ADRs in Sweden. However, the attitudes leave room for considerable under-reporting due to matters related mainly to the medical impact of the reaction and of reporting it, but also to the scientific "paradox" of reporting only on suspicion and of course due to lack of time in the health care setting.     

当前社会大众对ADR概念理解的调查分析

目的了解当前社会大众对ADR（药品不良反应）概念的理解程度。方法以该院患者家属为对象，采用问卷调查的方法。结果被调查者中，知道服用药品可能会发生不良反应的占83．33％，但能正确理解ADR概念的人群只有55．11％；有83．33％的人在购买药品时阅读说明书，但从药品说明书中获取ADR的信息的只占被调查人数的44．62％；当发生ADR时，84．68％的被调查者选择立刻停药并找医生咨询。结论需加大对社会大众进行ADR知识的普及与宣传。