我院口服缓控释制剂及其服药问题分析

目的:调查驻马店市第一人民医院口服缓控释制剂的种类,探讨其正确服用方法。方法:按照临床用药咨询记录中记载的有关口服缓控释制剂服药问题进行分析。结果:口服缓控释制剂的服用方法、服用次数和服用时间等因素要严格按照说明书指导使用,患者不能嚼碎,只能整片吞服或按说明在片剂划痕处掰开。结论:医师和药师要向患者详细交代服用方法,以保证患者安全、有效、合理的用药。     

406种口服药品说明书用药时间与方法的统计分析

目的调查某院2018年度口服药品说明书服药时间和服药方法的标注情况,为提高患者用药安全提供参考依据。方法调查某院精配软件系统中2018年度有使用过的406种口服药品电子版说明书。根据药品说明书中的用法用量和注意事项下的内容,对药品的用药时间和用药方法标注情况进行统计分析。结果406份口服药品说明书中,标注服药时间的共186份(占45.81%),未标注的220份(占54.19%)。其中餐前服用28份(占6.90%),餐中服用23份(占5.67%),餐后服用33份(占8.13%),空腹服用31份(占7.64%),晚上(或睡前)服用16份(占3.94%),服药不受进食影响55份(占13.55%)。标注具体服用方法的有67份(占16.50%),未标注的339份(占83.50%)。结论406份口服药品说明书不管是服用时间还是服用方法标注率都偏低,这样的药品说明书标注现状对于患者用药是存在安全隐患的。所以药品说明书的修订和完善还需要相关部门加强管理,不断改进,确保临床用药安全有效。     

口服缓控释制剂服药问题分析

目的 探讨口服缓控释制剂的服用方法.方法 查阅相关文献资料,进行总结与归纳.结果 口服缓控释制剂要求患者不能嚼碎,只能整片吞服或按说明在片剂划痕处掰开;用药次数及服药时间等因素要严格按说明书使用.结论 药师要做到详细交代,才能指导患者安全、有效、合理的用药.     

对207种口服药品说明书服药时间的调查分析

目的 为医院药师指导患者合理用药提供参考.方法 对北京市崇文区第一人民医院门诊西药房207份药品说明书进行整理和归纳.结果 207份药品说明书中标注服药时间的仅有67份,仅占全部说明书的32.37%.结论 不规范的药品说明书不能满足药师用药指导需要,不利于临床合理用药.     

501种口服药品说明书用药时间和方法的统计分析

目的：调查口服药品说明书中关于服药时间和方法的标注情况,为提高患者用药安全和医院药学信息化建设提供参考。方法：统计某院口服药物共501种药品说明书中服用时间和方法的标注情况并进行整理、归纳和分析。结果：501份药品说明书中,标注服用时间的共计128份,占比25.55%,其中餐前服用占12.18%,餐中服用占2.20%,餐后服用占6.99%,晚上服用占4.19%,标注特殊服用方法共计50份,占比为9.98%,未标注共335份,占66.87%。结论：口服药品说明书对服药时间和方法的标注率偏低,同成分不同厂家的口服药品说明书标注存在差异,使临床用药存在一定风险,药品说明书信息仍需进一步规范和完善。     

本院常用口服缓、控释制剂说明书分析

目的:了解本院常用口服缓、控释制剂说明书标注内容的完整性和准确性,为临床合理使用缓控释制剂提供参考.方法:对本院所使用的所有口服缓、控释制剂说明书内容进行调查,并对其中相关内容进行统计分析.结果:本次调查共纳入29个品种说明书,制剂品种以心血管系统用药为多,制剂工艺以缓释片剂为主.说明书项目中规定应有的项目标注率较高,但与缓控制剂工艺相关内容标注率较低.同一成分不同厂家的药品说明书中有关药物动力学的内容差异较大.结论:建议说明书中添加缓控释原理、可否破坏制剂完整性等内容,详细描述制剂的服用方法和药物动力学参数,以便临床更安全、有效、合理地使用缓控释制剂.     

常用中成药说明书用法用量的调查分析

目的 :调查中成药说明书关于用法用量的标注情况,为临床合理用药提供参考。方法:收集北京市销售排名前325的中成药说明书,对给药时间有特殊要求、明确有儿童用法用量、需要药引、用前需特殊处理以及没有明确频次和剂量的分别进行统计分析。结果:本次统计的325份药品说明书中,113个品种用法用量有特殊要求,占全部品种的34.77%。其中有23个品种明确有儿童使用频次和剂量占全部品种的7.08%;267个口服制剂中,21个品种明确规定了用药时间,占口服制剂的7.87%;27个外用制剂中,有12个品种没有详细的用法用量,占外用制剂的44.44%。结论:中成药说明书仍需不断完善,药师应善于归纳总结,做好用药指导,保证患者用药安全、有效。     

对103种口服消化系统药物服药时间的调查与分析

目的帮助药房药师更好地指导患者合理用药,提高患者的用药依从性。方法对103份口服消化系统药品说明书进行整理和归纳,并查阅参考书。结果 103份药品说明书中体现用药时间的67份。结论药品说明书不能完全满足临床用药指导需要,但为合理用药提供了信息。     

药品说明书中“服药时间”项的调查分析

口服给药的时间有空腹服用、餐前服用、餐时服用、餐后服用、清 (早 )晨服用、睡前 (晚间)服用等几种类型 ,它是根据药物在体内的吸收、药物的生物利用度、药物与食物的关系以及药物不良反应等多种因素来决定的。掌握正确的服药时间是保证药物治疗效果的要素之一 ,而指导患者正确服药的最重要的依据是药品说明书。为了规范调剂工作中的发药交待环节 ,笔者对口服药物药品说明书中的“服药时间”项进行了调查、分析。1资料与方法随机查阅重庆长航医院和成都市第三人民医院2002年12月以前正在使用的口服药物药品说明书349份 ,分别按药理作用及…     

142份抗肿瘤药物说明书用药信息标注情况调查与分析

目的 分析抗肿瘤药物说明书用药信息标注情况,为药品说明书规范化及临床合理用药提供参考。方法 收集现行抗肿瘤药物的药品说明书,按《药品说明书和标签管理规定》和《化学药品和治疗用生物制品说明书规范细则》,统计抗肿瘤药物说明书中常见问题,及说明书各项信息的标注情况,比较同一品种、同一剂型不同厂家的抗肿瘤药物说明书信息标注差异,统计注射用抗肿瘤药物的静脉溶液配制信息标注情况。结果 共收集抗肿瘤药物说明书142份,其中国产药物99份(口服剂35份,注射剂64份),进口药物43份(口服剂28份,注射剂15份);存在的主要问题有标注信息内容前后矛盾、文字表达不清、部分项目内容简单、汉字错误、项目缺失;进口抗肿瘤药物各项用药信息的标注率高于国产抗肿瘤药物;35组同一品种和剂型但不同厂家的药物,其说明书信息标注在适应证范围、药品不良反应、注意事项、特殊人群用药、药物相互作用及药物过量等方面存在一定差异。多数静脉注射剂溶液配制信息仅标注了推荐剂量和滴注时间,缺溶剂选择、配制浓度和注意事项,进口静脉注射剂溶液配制信息比国产注射剂完整。结论 抗肿瘤药物说明书用药信息标注存在较多问题,尤其是国产抗肿瘤药物说明书的规范化程度有待提高,国家和企业应高度重视,以促进和保障临床安全用药。     

贝伐珠单抗应用分析与合理性评价

目的：了解贝伐珠单抗在肿瘤治疗中的临床应用现状。方法：对其院2015年1月-2016年1月期间使用过贝伐珠单抗的209例患者,897次用药情况进行回顾性分析,按原发疾病分类,参考说明书及药品信息对患者治疗情况进行统计、评价及安全性评估。结果：209例患者数据分析中显示,适应证应用基本符合中国CFDA、美国FDA审批批准的范围,说明书内适应证治疗用药比例为53.73%,超说明书用药比例为46.27%,其中包含FDA批准适应证、NCCN指南推荐及其他超说明书用药。贝伐珠单抗应用期间所出现的不良反应（ADR）基本与说明书相符。结论：贝伐珠单抗超说明书应用普遍存在,部分超说明书应用有一定的循证学依据。应加强对超说明书用药的监管规范,确保药物安全合理使用。     

关于用药指导的思考与建议

目的探讨用药指导依据不足的问题,促进患者合理用药。方法对药品说明书、参考书中存在的相关问题进行对比、分析,并提出建议。结果部分药品说明书、参考书中存在药品应用描述不完善或不一致的情况,给用药指导带来困难。结论应加大力度完善临床用药资料,提高合理用药水平。     

The federal standard medication plan in practice: An observational cross-sectional study on prevalence and quality

BackgroundMedication plans are instruments used to document drug therapies, guide patients, and ensure medication safety. In Germany, patients who take at least 3 long-term medications are eligible to receive a medication plan. It has been statutory to use the federal standard layout (German: “Bundeseinheitlicher Medikationsplan”) since April 2017.ObjectivesThis study explores the prevalence, availability, medication discrepancies, and conformance with statutory regulations of medication plans since the introduction of the format of the federal standard medication plan in Germany.MethodsMedication reconciliation was performed for hospitalized patients according to the Best Possible Medication History principle. The collected medication lists were analyzed for medication discrepancies and conformance with the statutory regulations. The medication discrepancies were (1) omitted drugs, (2) additional drugs, and (3) dosing errors.ResultsAfter hospitalization, 524 patients taking drugs were included. The majority (n = 424 patients) were eligible for a medication plan. While 241 medication lists were present, only 24.1% (n = 58) matched the federal standard format. The mean number of drugs was 6.3 ± 3.6, with 3315 medications (3046 long-term and 269 as needed) reconciled totally. The 84 medication lists with omitted or additional drugs included 166 medication discrepancies upon 774 drugs listed. Of the 253 patients with dosing errors, 146 had a medication list. Inappropriate dosages were due to single dose (n = 195), daily dose (n = 225) or frequency of application (n = 255).ConclusionMedication plans are valuable tools for patients and health care providers. This study shows that the introduced paper-based federal standard medication plan in Germany falls short of its expectations regarding availability and correctness. Switching to an electronic patient record system may overcome some of the current pitfalls.     

口服缓控释制剂研究概况

本文综述了口服缓控释制剂研究概况。缓控释制剂有三种释药类型：定时、定速、定位释药。有多种剂型：包括骨架缓控释制剂、薄膜包衣缓控释制剂、渗透泵型缓控释制剂、胃内漂浮缓控释制剂、缓控释微丸、缓控释液体制剂等。口服缓控释释放系统的迅猛发展，为新药物的研制、老药新用途的开发提供了更为广阔的前景。     

Pharmacist-led medication reviews in pre-dialysis and dialysis patients

BackgroundPre-dialysis and dialysis patients are at risk for drug related problems (DRPs) due to a high incidence of comorbidities. Pharmacist-led medication reviews might reduce the number of DRPs.ObjectivesThe aim of this study was to evaluate pharmacist-led medication reviews in pre-dialysis and dialysis patients by determining the number and type of DRPs, nephrologist acceptance of pharmacist interventions and time investment.MethodsFrom September 2017 until December 2018, pharmacist-led medication reviews were performed on pre-dialysis and dialysis patients. DRPs (medication discrepancies, prescribing issues related to drug and dose selection, drug use problems) were identified using the pharmacists’ expert opinion and the STOPP/START criteria. Number and type of accepted pharmacist interventions, sustainability of interventions after at least 1 month and time investment were determined. Practical barriers in the process were appraised.ResultsOne-hundred twenty five patients were reviewed: 37 pre-dialysis and 88 dialysis patients. In 100 (80%) patients 277 medication discrepancies were identified of which 224 (81%) were accepted by the nephrologist. Pharmacists suggested 422 interventions concerning drug or dose selection for 115 patients; 106 interventions were accepted by the nephrologist, which resulted in 60 patients having medication changed. Ninety percent of those changes remained implemented on follow-up after at least 1 month. In 46 (37%) patients, the clinical pharmacist detected DRPs concerning the drug use process and performed patient counseling. The average time investment was 85 min per patient for the clinical pharmacist and 15 min for the nephrologist. Besides time investment, unclear responsibility for medication management due to multiple prescribers was an important barrier in the process and the main reason for nephrologists to reject pharmacist interventions.ConclusionPharmacist-led medication reviews in pre-dialysis and dialysis patients led to medication changes in half of the patients. However, efficiency should be improved before adopting pharmacist-led medication reviews into clinical practice.     

The medication discrepancy taxonomy (MedTax): The development and validation of a classification system for medication discrepancies identified through medication reconciliation

BackgroundMedication discrepancies directly impact patient safety and can adversely impact quality of care and resource utilization at transitions of care.ObjectivesTo develop a common nomenclature and taxonomy for classifying and reporting medication discrepancies and to assess the content validity and reliability of the taxonomy.MethodsThe taxonomy was developed following a multi-stage process. The content of the taxonomy was then assessed using expert opinion through a two-round modified Delphi process. The expert panel comprised 10 experts who were selected based on pre-defined selection criteria. Six experienced pharmacists were then invited to classify medication discrepancies from a number of fictitious cases (adapted from authentic cases) using the taxonomy.ResultsThe medication discrepancy taxonomy (MedTax) comprises 12 main types and 28 sub-types of discrepancies. A set of operational instructions and definitions to aid the use of the taxonomy was formulated. The overall Average content validity index (Ave-CVI) was 0.93 and interrater reliability was 0.67 (multirater κfree), indicating substantial agreement. An excellent internal consistency of the taxonomy was established (Kuder–Richardson Formula 20 (KR-20) = 0.92).ConclusionsA content valid and reliable taxonomy for classifying medication discrepancies was developed. The MedTax may be used to classify medication discrepancies identified following medication reconciliation services. The clear and consistent reporting of medication discrepancies arising from medication reconciliation services may be of value to policy makers, healthcare professionals and researchers, when evaluating such services. The MedTax was designed to fill an essential void in global endeavors to reinforce standardization of medication reconciliation practices and to improve medication safety across transitions of care.     

高血压患者的药物重整服务与药学监护

目的探讨药师参与药物重整服务的工作模式及其在防范用药差错中的作用与实践。方法对我院心内科收治的400例高血压患者实施药物重整服务,建立药师参与药物重整服务的工作模式,分析此期间发现的常见问题及其在防范用药差错中的作用与实践。结果初步建立了药师参与药物重整服务的工作模式。药物重整服务可减少重复用药、漏服药物、药物选择不适宜、用法用量不适宜、给药时间不适宜、停药时间不适宜、药物相互作用等现象。结论药物重整服务在减少用药差错中具有重要作用,为药师参与临床治疗提供了一个新的突破口。     

智能化患者服药提醒App的调研与开发

目的：通过移动互联网帮助患者进行个性化精准用药,保障药物安全、有效、合理使用,减少药物不良反应及药源性疾病的发生。方法：收集某院药学门诊信息,根据药房840余种药品制作用药数据库,搭建云服务器,连接医院HIS系统,开发具有自主知识产权的智能化患者用药教育APP"服药管家"。以问卷调查方式调研湖南省不同医院患者对APP的接受程度。结果：共收集1 146条患者药学咨询信息,咨询信息排名前三位的是：用法用量38%（435次）、适应证23.4%（102次）、不良反应18.2%（208次）。共发放问卷414份,有效回收388份。全部受调查的人群当中有77.6%的人群有智能手机,43.9%的人群愿意接受包括智能手机APP在内的有偿药学服务。结论：湖南省范围内,住院门诊患者对药学咨询服务需求迫切。以互联网为媒介的有偿药学咨询服务具有一定的市场潜力。智能化患者服药提醒APP"服药管家"功能设计合理,将精准化提升患者用药。在患者人群中有一定认可度,具有扩大推广的价值。     

三例精准用药门诊药物治疗管理案例分析

药物重整是药物治疗管理的一个重要部分,也是精准用药门诊的工作重点。专业药师运用专业知识为患者重整并优化药物治疗方案,开展用药教育并进行随访。本文主要分析3例在精准用药门诊实践中临床药师开展以药物重整为重点的药物治疗管理的案例。