湖北省药品不良反应报告和监测工作现状调查与展望

目的 通过了解医疗机构、药品生产企业、药品经营企业的药品不良反应（ADR）的上报情况和工作开展现状及对医药工作者关于ADR知识的认知度调查来找到ADR报告率低的原因,进一步推进ADR报告和监测工作.方法 采取现场查看和随机分层抽样法,对30所涉药单位的ADR报告和监测工作进行调研,对收集、上报的ADR事件报告表进行统计学分析,同时抽取15%的医药人员作为样本对其进行问卷调查,并实施行政干预性的教育和培训.结果 被查单位仅有7个单位向不良反应监测中心上报ADR事件表.在调查的1 090名医药工作者中,59.4%的人员回答曾经遇到ADR,但仅有 42.3%的人员报告过ADR;ADR测试合格率仅占26.68%.通过行政干预培训,医药人员ADR认知度得到显著提高（X^2＝80.728,P＜0.05）.药品生产、经营、使用单位之间认知得分差异有显著性（X^2＝62.277,P＜0.05）,不同层次的单位的医药人员对ADR认知得分差异有显著性（X^2＝167.771,P＜0.05）.此外,不同职业认知得分差异有显著性（X^2＝326.315,P＜0.05）.结论 应加强各涉药单位医药人员关于ADR知识的法规宣传和岗位培训,提高医药工作者对ADR知识的整体认知水平和ADR的报告率;各药品生产、经营、使用单位要高度重视ADR监测工作,建立ADR监测专职机构和专业人员,加大经费投入才能顺利贯彻实施《药品不良反应报告和监测管理办法》.     

深圳市龙岗区幽门螺杆菌感染状况分析

目的:调查分析深圳市龙岗区幽门螺杆菌(HP)感染状况。方法:统计分析深圳市龙岗区6家二级以上医院就诊患者胃镜检查结果和幽门螺杆菌感染状况,分析不同方法治疗HP根除率。结果:10 618例就诊患者HP感染率为42.70%,636例体检者HP感染率为35.85%,两者比较差异有统计学意义(P<0.05);不同病种HP感染率比较,差异有统计学意义(P<0.05),HP感染率与性别、年龄、季度无关(P>0.05);三联疗法HP根除率为60.29%,伴随疗法为88.89%,两者比较,差异有统计学意义(P<0.05)。结论:就诊患者HP感染率高于体检者,不同病变HP感染率有差异,就诊患者HP感染率及根除率均处于国内外较低水平。     

安徽省合肥地区医务人员对药品不良反应认知度和态度的研究

目的了解合肥地区各级医院医务人员对药品不良反应(ADR)认知和态度。方法分层抽取合肥地区三级医院1所、二级医院5所、一级医院7所,整群抽取上述医院于调查日在岗的医务人员,进行现场调查,EPI info 6.04建立数据库,SPSS11.5统计软件分析。结果合肥地区各级医务人员对ADR概念、ADR呈报程序、ADR临床表现特点等知识认知度基本一致(P>0.05);对ADR性质、ADR监测主管部门等认知度差异具有显著性(P<0.05),等级高的医院医务人员认知度通常好于等级低医院,但也有个别问题反之;医务人员对ADR呈报态度总体端正,但也存在误区。结论加强ADR知识宣传培训,端正态度,增强医务人员上报意识,提高ADR监测水平。     

乙型肝炎病毒感染与食管、胃疾病的关系

目的:探讨乙型肝炎病毒感染与食管、胃疾病关系。方法:2004年4～12月因消化不良症状而行内镜检查患者分成2组,A组为HBsAg阳性患者71例,B组为HBsAg阴性患者93例,对结果进行统计学处理分析。结果:消化性溃疡总的发生率31.7%,其中A组为42.3%(30/71),B组为23.7%(22/93)(x2=6.55,P<0.05)。总HP感染率为55.5%,其中A组为64.8%(46/71),B组为48.4%(45/93)(x2=3.95,P<0.05)。糜烂性胃炎的总发生率为23.2%,A组为33.8%(24/71),B组为15.1%(14/93)(x2=8.02,P<0.01),食管癌、胃癌总发生率3.7%,其中A组7.0%(5/71),B组1.1%(1/93)(校正x2=442,P<0.05)。结论:HBV感染与消化性溃疡、HP感染、糜烂性胃炎、上消化道肿瘤等疾病密切相关,须重视对HBV感染患者的胃、食管疾病。     

上消化道疾病患者2617例幽门螺杆菌感染情况分析

目的:探讨我院上消化道疾病患者幽门螺杆菌(helicobarter,pylori,HP)感染率与一些常见上消化道疾病的关系.方法:对我院门诊及住院病例中,有上消化道症状患者2 617例均采用14C-尿素呼气试验,检测HP感染情况.结果:2 617例中HP感染率22.96%,男女比例1∶1.09,各年龄组比较,除50～59岁年龄段外,男女感染率及各年龄段男女感染率比较差异无统计学意义.不同上消化道疾病HP感染差异有统计学意义(x2=72.19,P<0.001).结论:HP感染率低于国人平均水平,防治HP仍具有重要意义.     

公众对药品安全的认知度及满意度调查

目的:了解公众对药品安全知识的认知度与满意度,为药品安全监管提供决策参考。方法:采用随机抽样法,对三甲医院的候诊或探访人员开展药品安全知识的认知度及满意度自填式问卷调查。结果:公众的药品安全知识认知度合格率为65.1%,平均得分为(6.25±2.17)分,对安全用药原则认知度偏低,合格率仅占33.8%。不同地区、不同年龄、不同学历人员认知得分比较,差异均有统计学意义(P<0.01),整体认知得分分值呈正态分布。多因素分析显示,地区、年龄、文化程度与认知度高低有关。对药品安全满意度调查显示,不满意人员占30.7%,未接受过药品安全教育培训的人占68.7%,使用过抗菌药的人高达79.5%,74.2%的人有建立药品不良反应(ADR)救济与赔偿制度的需求。结论:公众安全用药认知度偏低,抗菌药普遍滥用,三成以上人员不满意药品安全状况。今后应加强医院合理用药考核,建立公众药品安全教育体系与ADR救济与赔偿制度,保障公众用药安全。     

我院医务人员药品不良反应报告认知度研究

目的:了解我院医务人员对药品不良反应(ADR)报告的认知程度。方法:采取随机整群抽样法现场调查我院临床医生、临床护士和药学人员,问卷采用EPI6.04录入、SPSS11.5软件处理数据。结果:获得有效调查表1077份,回收率89.8%。我院医务人员对ADR基本知识认知度总体较好。其中药学人员较医生、护士认知度高;医务人员随着学历提高,认知得分增加,差异有统计学意义;不同工作年限、不同职称医务人员之间认知度差异均无统计学意义;我院医务人员对ADR报告态度基本端正,但也存在一些误区。结论:加强ADR知识培训,逐步提高广大医务人员ADR上报意识、鉴别能力和监测水平,尽量减少ADR发生,从而避免因ADR引发的严重后果。     

广东省公众对药品不良反应的认知现状调查分析

目的:了解公众对药品不良反应(ADR)认知的现状,为完善ADR报告系统提供依据。方法:采用现场填写、当场回收问卷的方法对广东省珠三角、粤东、粤西、粤北地区的1 379名普通公众进行ADR认知情况的调查,并分析相关影响因素。结果:共发放调查问卷1 500份,回收有效问卷1 379份,有效回收率为91.9%。受访者中,正确回答ADR概念的有931人(占67.5%),其中居住粤北地区、40岁及以上、低学历人群选择正确率最低;仅36.1%能正确认识ADR的成因;只有388人(占28.1%)表示知晓个人可以报告ADR;有723人(占52.4%)认为医院对ADR应该承担责任;一旦出现ADR,62.2%的受访者会选择到医院报告;对报告地点、方式以及哪些是相关部门不了解,报告方式不便利以及程序烦琐为阻碍个人上报ADR的主要因素。结论:被调查的公众对ADR概念认知度不高,参与报告ADR积极性较低。故应加强公众对ADR认识的宣传力度,鼓励公众积极参与ADR报告,并拓宽ADR个人上报的渠道。     

对基层医药人员药品不良反应报告与监测认知度的调查

［摘要］目的了解基层医药工作者对药品不良反应（ADRs）报告的认知度情况，找出ADRs报告率低的原因，提高ADRs报告率。方法采用随机抽样法，通过调查问卷的形式，对基层医药人员进行关于ADRs知识认知度调查。结果在调查的 500名对象中,ADRs概念知晓率23.2%，法规知识测试合格率仅占30.2 %；曾经见过ADRs的医药工作者占55.6%，但仅有 36.4%的人员报告过 ADRs;87.2 %人员不知道ADRs监测专业机构；医药人员认为ADRs与医疗纠纷有关的占46.2%，整体认知得分，药品生产、经营、使用单位之间的得分差异有显著性（Χ2=136.528,P＜0.05），不同职业之间得分差异有显著性（Χ2=326.315,P＜0.05）。此外，21～40岁年龄组得分最高（8.659±2.987），各年龄组人群得分差异有显著性（Χ2=101.394,P＜0.05）。通过行政干预培训，医药人员ADRs认知得到显著性提高（培训前合格率为18.59%，培训后合格率为75.70%）。结论基层医药工作者对ADRs法规认知度低和基层缺乏ADRs监测专业机构及专职人员是ADRs报告率低的主要原因。加强对医药工作者的教育和培训，增强医药人员对ADRs的认识是提高ADRs监测的主要方法。     

694例癫痫医师药师联合门诊患者药品不良反应分析

目的 分析癫痫医师药师联合门诊患者药品不良反应(ADR)发生率、常见类型及其相关因素,为癫痫个体化治疗提供依据。方法 回顾性调查2020年1月1日至2021年12月31日于某院癫痫医师药师联合门诊就诊的患者,对患者性别、年龄及ADR发生情况进行描述性统计,并对患者ADR发生率与性别、年龄、是否联合用药的相关性进行卡方检验。结果 694例癫痫医师药师联合门诊患者中ADR发生率为36.17%(251/694)。男性和女性患者ADR发生率分别为37.08%(142/383)、35.05%(109/311),两者比较无统计学差异(χ²=0.306,P=0.580)。≤14岁、15～44岁、45～64岁、≥65岁年龄组的ADR发生率分别为24.00%、33.88%、42.96%、55.10%;4个年龄组的ADR发生率之间有统计学差异(χ²=16.226,P=0.001)。合并用药与无合并用药的ADR发生率分别为45.00%和26.65%,两者比较有统计学差异(χ²=25.279,P=0.000)。结论 癫痫的药物治疗强调个体化,应...     

对嘉峪关市医务人员药品不良反应认知度的调查与研究

目的了解嘉峪关市各级医院医务人员对药品不良反应(ADR)认知度,为开展ADR监测工作提供参考依据。方法采用调查问卷的形式,对嘉峪关市不同级别医院的医务人员进行抽样调查。结果医务人员对ADR概念、严重ADR的范畴、引发ADR药品类别等相关知识认知度具有显著性差异(P<0.05);不同职业者对药品不良反应知识的认知度差异具有显著性(P<0.05),其中药学人员的认知度最高,管理人员认知度最低。结论应加强有关ADR知识的宣传与培训,提高医务人员对ADR的认知度,提升其在ADR监测工作中的自觉性。     

太原市医务人员药品不良反应认知情况调查研究

目的调查太原市医务人员对药品不良反应（ADR）的认知程度,为进一步促进和完善ADR报告和监测提供参考。方法采用调查问卷的形式,对太原市不同级别医院和诊所的医务人员进行抽样调查。结果太原市医务人员对ADR基本知识如ADR的概念、是否只有新药才发生ADR等有所了解,但存在ADR报告意识淡薄,对报告程序不了解,ADR的法律意识不强等问题。结论应加强有关ADR知识的宣传与培训,提高太原市医务人员对ADR的认知度,提升其在ADR监测工作中的自觉性。同时,应完善ADR监测体系,保障公众用药安全。     

上海市公众药品不良反应认知调查与分析

目的调查研究上海市公众对药品不良反应（ADR）的知识、态度和行为。方法采用问卷调查法,随机选取350人进行一对一问卷调查,对回收的320份有效问卷进行统计分析。结果不知道ADR确切含义的占31．9％;认为仅西药会产生ADR的占39．4％;年龄越大者对ADR的知晓度越低;学历越高者对ADR的知晓度越高;认为应该由医院、药厂和药店对ADR承担责任的比例分别为71．9％、51．3％和15．9％;确定自己用药时曾出现过ADR的占25．9％;表示一旦自己出现ADR会去就诊的占81．9％。结论专业机构应该采取更加通俗易懂的方式向公众宣传ADR相关知识。     

医务人员对药品不良反应认知度和报告态度的调查分析

目的:为促进药品不良反应(ADR)监测工作提供参考。方法:分层抽取萍乡地区三级医院5所、二级医院15所以及一级医院14所,对上述医院在岗的医务人员实施现场问卷调查,建立数据库,利用SPSS 13.0统计软件分析。结果:萍乡地区各级医院医务人员对ADR英文缩写、ADR概念、上市后药品及中药是否存在ADR等知识认知度较好,而对医院ADR监测负责部门、ADR是否为医疗差错、《中华人民共和国药品管理法》是否有ADR法律条文等认知度较差;不同岗位对ADR知识的认知度存在差异,药学人员对ADR的认知度明显高于其他三类人员;医务人员对ADR呈报态度总体基本端正,但也存在误区;医疗卫生机构ADR监测工作还不够深入,工作重视程度不够。结论:应加强ADR知识宣传培训,端正ADR报告态度,增强医务人员报告意识,强化医疗卫生机构重视程度,提高ADR监测水平。     

Attitude of Czech physicians to adverse drug reaction reporting

This survey was carried out to test physicians' knowledge of the principles of adverse drug reaction (ADR) reporting. Structured interviews were carried out with 500 physicians in all regions of the Czech Republic. The questions were aimed at observing ADR, the obligation and the means of reporting, and the source of drug information used in practice. Ninety percent (n=448) reported that they faced ADR in their practice, and 92% (n=458) were aware of the obligation to report, but most (180 general practitioners, 138 specialists) were unclear as to what should be reported. Knowledge of the subject of ADR reporting was significantly lower (18.4%) among physicians who used primarily the drug information provided by pharmaceutical companies than among those who used other information sources (38.4%). The low level of knowledge of ADR spontaneous reporting system found in our study is one of the reasons for the substantial underreporting of ADR in the Czech Republic compared to other European countries.     

长沙地区县级医院中年慢性病患者健康商数及其影响因素的研究

目的 了解长沙地区县级医院中年慢性病患者健康商数指数及其影响因素,帮助中年人群提升健康自我管理能力.方法 采用随机抽样的方法对长沙地区4所县级医院的808名中年慢性疾病患者进行一般情况和健商问卷调查,所有资料均采用SPSS 13.0统计软件进行分析.结果 （1）健康商数状况调查结果中各维度得分均较低,在相应临界值水平左右,其中自我保健、生活方式、精神状态维度未低于相应临界值,精神状态维度得分相对较高,为（24.73±5.49） 健康知识维度的得分较低,为（21.47±5.89）,甚至低于安全健康商数维度的临界值.（2）不同年龄段、不同家庭住址、不同文化程度、不同体检频度患者在健康商数四个维度的得分均具有统计学意义（P＜0.05） 不同体质指数的患者在健康知识和精神状态维度的得分有统计学意义（P＜0.05）.结论 （1）长沙地区县级医院中年慢性病患者健康商数状况总体不容乐观,尤其是健康知识维度较为薄弱,提示此类患者应成为护理工作针对性健康教育的重点对象,而健康知识普及应成为健康教育的重点内容.（2）年龄段、家庭住址、文化程度和体检频度是住院中年慢性病患者健康商数的重要影响因素,据此可为护理工作中开展个体化的干预策略提供参考依据.     

Assessment of knowledge,attitude and practice of adverse drug reaction reporting among healthcare professionals in secondary and tertiary hospitals in the capital of Pakistan

Adverse Drug Reactions (ADRs) underreporting is a great challenge to pharmacovigilance. Healthcare professionals should consider ADR reporting as their professional obligation because the effective system of ADR reporting is important to improve patient care and safety. This study was designed to assess the knowledge, attitude, practice and factors associated with ADR reporting by healthcare professionals (physicians and pharmacists) in secondary and tertiary hospitals of Islamabad. A pretested questionnaire comprising of 27 questions (knowledge 12, attitude 4, practice 9 and factors influencing ADR reporting 2) was administered to 384 physicians and pharmacists in public and private hospitals. Respondents were evaluated for their knowledge, attitude and practice related to ADR reporting. Additionally, the factors which encourage and discourage respondents to report ADRs were also determined. The data was analysed by using SPSS statistical software. Among 384 respondents, 367 provided responses to questionnaire, giving a response rate of 95.5%. The mean age was 28.3 (SD?=?6.7). Most of the respondents indicated poor ADR reporting knowledge (83.1%). The majority of respondents (78.2%) presented a positive attitude towards ADR reporting and only a few (12.3%) hospitals have good ADR reporting practice. The seriousness of ADR, unusualness of reaction, new drug involvement and confidence in the diagnosis of ADR are the factors which encourage respondents to report ADR whereas lack of knowledge regarding where and how to report ADR, lack of access to ADR reporting form, managing patient is more important than reporting ADR legal liability issues were the major factors which discourage respondents to report ADR. The study reveals poor knowledge and practice regarding ADR reporting. However, most of the respondents have shown a positive attitude towards ADR reporting. There is a serious need for educational training as well as sincere and sustained efforts should be made by Government and Hospital Authorities to ensure proper implementation of ADR reporting system in all of the hospitals.     

Clinical pharmacy services, pharmacy staffing, and adverse drug reactions in United States hospitals

Adverse drug reactions (ADRs) were examined in 1,960,059 hospitalized Medicare patients in 584 United States hospitals in 1998. A database was constructed from the MedPAR database and the National Clinical Pharmacy Services survey. The 584 hospitals were selected because they provided specific information on 14 clinical pharmacy services and on pharmacy staffing; they also had functional ADR reporting systems. The study population consisted of 35,193 Medicare patients who experienced an ADR (rate of 1.8%). Of the 14 clinical pharmacy services, 12 were associated with reduced ADR rates. The most significant reductions occurred in hospitals offering pharmacist-provided admission drug histories (odds ratio [OR] 1.864, 95% confidence interval [CI] 1.765-1.968), drug protocol management (OR 1.365, 95% CI 1.335-1.395), and ADR management (OR 1.360, 95% CI 1.328-1.392). Multivariate analysis, performed to further evaluate these findings, showed that nine variables were associated with ADR rate: pharmacist-provided in-service education (slope -0.469, p=0.018), drug information (slope -0.488, p=0.005), ADR management (slope -0.424, p=0.021), drug protocol management (slope -0.732, p=0.002), participation on the total parenteral nutrition team (slope 0.384, p=0.04), participation on the cardiopulmonary resuscitation team (slope -0.506, p=0.008), medical round participation (slope -0.422, p=0.037), admission drug histories (slope -0.712, p=0.008), and increased clinical pharmacist staffing (slope -4.345, p=0.009). As clinical pharmacist staffing increased from the 20th to the 100th percentile (from 0.93+/-0.77/100 to 5.16+/-4.11/100 occupied beds), ADRs decreased by 47.88%. In hospitals without pharmacist-provided ADR management, the following increases were noted: mean number of ADRs/100 admissions by 34.90% (OR 1.360, 95% CI 1.328-1.392), length of stay 13.64% (Mann-Whitney U test [U]=11047367, p=0.017), death rate 53.64% (OR 1.574, 95% CI 1.423-1.731), total Medicare charges 6.88% (U=111298871, p=0.018), and drug charges 8.16% (U=108979074, p<0.001). Patients in hospitals without pharmacist-provided ADR management had an excess of 4266 ADRs, 443 deaths, 85,554 patient-days, $11,745,342 in total Medicare charges, and $1,857,744 in drug charges. The implications of these findings are significant for our health care system, especially considering that the study population represented 15.55% of 12,261,737 Medicare patients and 5.71% of the 34,345,436 patients admitted to all U.S. hospitals.     

Knowledge and Barriers Among Physicians Toward Adverse Drug Reaction Reporting at a Tertiary Care Hospital in Saudi Arabia

Background:Spontaneous reporting systems are essential as they help detect serious unknown adverse drug reaction (ADR). However, underreporting of ADR is a commonly associated problem. This research work aims to assess knowledge, barriers, and factors that encourage the reporting of ADR among physicians.Methods:A total of 600 physicians working at a tertiary referral hospital in Riyadh, Saudi Arabia, were included in this cross-sectional study. A pretested questionnaire was used.Results:Out of the 600 physicians, 240 (40%) completed the questionnaire. Most of the participants (85.4%) could correctly define ADR; nearly 75% physicians were unaware of the spontaneous reporting of ADR in Saudi Arabia. A total of 175 (72.9%) physicians had not reported any ADR among their patients in the last year; 40% of the physicians said that they did not report ADR because they were unaware of the online reporting of ADR. Providing guidelines and regular bulletins on the reporting of ADR is a critical aspect that encourages physicians to report ADR (51%). Education and training are the most recognized measures for improving the reporting of ADR.Conclusion:Physicians were adequately aware of ADR but inadequately aware of the reporting system and reporting authorities. Continuing medical education, training, and integration of the reporting of ADR into physicians’ various clinical activities may improve ADR reporting.