某三甲妇儿医院抽动障碍超说明书用药回顾性调查分析

目的 分析某三甲妇儿医院抽动障碍超说明书用药现状,以促进临床安全合理用药。方法 通过医院信息系统,抽取该院2019年7月—2020年8月诊断为抽动障碍的儿科门诊处方,以2020年超说明书用药管理规定为标准,评定处方的超说明书用药情况。结果 共收集到诊断为抽动障碍的儿科处方1251张,超说明书用药发生率为29.58%;超说明书用药的主要类型为超适应证和超年龄;超说明书用药的主要品种是利培酮片(47.84%)、阿立哌唑片(43.78%)。结论 该院儿科门诊抽动障碍超说明书用药比较普遍,需对超说明书用药进行规范化管理,保障合理用药。     

吉林大学第一医院小儿风湿免疫科住院患者超说明书用药分析

目的：回顾性调查小儿风湿免疫科住院患者超说明书用药情况,为规范儿科用药提供依据。方法：随机抽取吉林大学第一医院2014年9月-2015年9月小儿风湿免疫科300例住院患者病历,根据药品说明书判断是否为超说明书用药,并对超说明书用药的数量及类型分别进行统计分析。结果：随机抽取的300例住院患者超说明书用药发生率为96%。其中,用药医嘱超说明书用药发生率28.79%;涉及药品212种,超说明书用药发生率44.81%。超说明书用药类型以超适应人群（78.21%）所占比例最大。结论：我院小儿风湿免疫科存在超说明书用药现象,应加强超说明书用药的规范管理,促进儿科安全合理用药。     

超说明书用药法律释读及应对策略分析

目的 解读超说明书用药的法律属性，促进超说明书用药的规范性和合法性使用。方法 通过分析药品注册流程，明确药品说明书的法律地位。根据民法基本原则和相关法律规定，界定超说明书用药行为的合法性。对当前文献报道的超说明书用药管理策略进行推荐等级和法律效力评价，进而提出建议。结果 药品说明书并非规范性法律文件，其法律效力仅为医务人员临床用药的参考。超说明书用药行为本身并不违反我国相关法律法规，但其合法性在业内外仍缺乏共识。为应对风险，部分学者建议并采取了一系列措施。考虑到临床实际和法律效应，部分措施的适用性有待商榷。结论 为规避执业风险，结合我国国情，建议摸索建立高效的医患沟通机制、呼吁政府不断完善药品监管体系和提请最高人民法院发布指导性案例，为合理合规的超说明书用药正名。     

超说明书用药临床应用的法律现实困境及对策研究

目的 对新修订的《中华人民共和国医师法》中有关超说明书用药的法律条款进行梳理与分析，为建构适应中国国情的超说明书用药法律机制提供借鉴和参考。方法 梳理超说明书用药的立法现状，分析中国超说明书用药在临床应用中存在的法律治理困境，借鉴美国超说明书用药法律制度，并针对问题提出相应的解决措施。结果 相关立法亟待完善、循证医学体系研究不足、患者知情同意权落实不全、超说明书风险控制措施不完备、临床用药管理不严等是中国超说明书用药在临床应用中面临的法律现实困境。结论 破解中国超说明书用药在临床应用中的法律困境需要通过立足实践完善立法、加强循证医学证据体系建设、落实患者知情同意权、完备超说明书用药风险防范机制、健全超说明书用药监管机制等多种途径来建构中国超说明书用药法律治理机制。     

2019年某部医院超说明书用药现状及管理策略分析

目的 调查武警河北省总队医院超药品说明书用药现状,对存在的安全隐患进行分析,提出防范建议,为降低用药风险,规范管理提供理论依据。方法 对本院2019年1～12月门诊处方、住院医嘱超说明书用药情况进行回顾性统计分析。结果 本院超说明书用药主要表现在超适应证、超适应人群和给药途径等方面,90%以上超说明书用药有证据支持,但也有部分超说明书用药没有指南推荐和文献支持,药品说明书之外的用法值得进一步商榷。结论 超药品说明书用药现象客观存在且不可避免,它涉及到药品有效性、医疗执业风险和安全隐患,因此制定合理的管理策略,强化超说明书用药管理的规范化、制度化是当前亟待解决的问题。     

某院儿科住院患者盐酸氨溴索注射液使用分析

摘 要 目的:调查某院儿科住院患者盐酸氨溴索注射液（AHI）的使用情况,为促进临床合理用药提供参考。方法：回顾性随机抽查某院2014年1～6月191例使用了AHI的儿科住院患者住院病历,对用药适应证、用法用量等进行统计并分析。结果：AHI在191例病历中,用药适应证合理率为99.48%,但在给药途径、用法用量上均存在超说明书情况。结论：临床在儿科患者中使用AHI存在诸多超说明书用药的情况,应加强其规范使用的管理。     

基于前置处方审核系统的儿童专科医院心内科门急诊超说明书用药合理性分析

目的 对儿童专科医院心内科的全年度门急诊处方进行点评，分析超说明书的合理用药现状。方法 采用回顾性分析方法，汇总2021年度心内科门急诊处方在每日经前置处方审核系统审核后的所有阳性不合理处方，经药师、医师联合复审判定出假阳性不合理用药处方，再根据循证医学证据进一步判定超说明书用药情况，并用Excel软件进行统计分析。结果 抽取2021年度心内科门急诊所有处方共计84 821张，经合理用药软件点评得到不合理阳性处方335张，包含360条药品信息条目。经儿童心血管专科临床药师、医师联合复审前置审核系统筛出的阳性不合理处方后，判定假阳性不合理处方169张，涉及医嘱条目189条，其主要原因为儿科超说明书用药情况未在系统中完善以及系统无法审核处方医嘱的临床特殊事宜备注而导致的系统误判。排除系统误判，累积超说明书用药条目144条，其中超说明书适应证用药81条(56.25%)、超说明书用法用量45条(31.25%)、超说明书重复用药8条(5.56%)、超说明书药物相互作用用药8条(5.56%)和超说明书给药途径用药2条(1.39%)。结论 儿童心内科门急诊存在一定的超说明书用药情况，主要表现为超适应证用药和超用法用量。医院可通过不断完善超说明书用药规范化管理和系统规则进一步规范儿童心内科门急诊的合理用药，以期全方位提升临床的合理、规范用药。     

老年住院患者注射用红花黄色素超说明书用药分析及干预

目的 分析老年住院患者注射用红花黄色素超说明书用药情况并干预,降低老年人用药风险,促进临床合理使用。方法 分析老年住院患者注射用红花黄色素超说明书用药现状,通过对其超说明书用药的临床研究和文献进行检索评价后,制定注射用红花黄色素超说明书用药规则,采取软件智能审核与临床药师审核互补的方式对超说明书用药情况进行点评干预。随机抽取2018年1-6月（干预前）和2018年7~12月（干预后）老年住院患者使用注射用红花黄色素病历各480份,评价超说明书用药干预效果。结果 老年住院患者超说明书使用注射用红花黄色素问题严重。涉及的超说明书用药类型主要有超适应症用药、超溶媒、配伍禁忌和超注意事项,干预后各类型超说明书用药例数均明显下降,超说明书用药医嘱比例由干预前的56.61%下降至16.21%,不良反应上报数量由干预前的8例降至干预后的3例。结论 老年住院患者注射用红花黄色素超说明书用药情况普遍存在,利用合理用药软件实时监测与临床药师审核互补的方式可以显著减少超说明书用药。     

新生儿常见超说明书用药的合理性探讨

目的 分析新生儿科常见超说明书用药的合理性,为保障新生儿安全合理用药提供依据。方法 收集2016年8月-2017年7月新生儿科住院患儿用药医嘱,对其中常见的超说明书用药情况进行合理性分析与评价。结果 超说明书用药的存在不可避免,应根据循证医学证据强度对超说明书用药合理性进行评价。结论 临床药师应参与药物超说明书用药的规范化管理,积极寻找医学证据,为临床医师提供科学合理的用药参考。     

某院生殖中心门诊超说明书用药调查分析

摘 要 目的：分析某院生殖中心门诊超说明书用药情况,为临床合理用药提供科学依据,并进一步规范医师的超说明书用药行为。方法: 抽取某院2016年1～12月生殖中心的门诊处方,根据药品说明书内容,对超说明书用药处方进行统计分析,并查询相关文献对超说明书药品进行合理性评价。结果: 共收集到超说明书用药处方4 176张,超说明书用药类型包括超适应证用药、超剂量用药和超给药途径用药。超说明书用药比例排名前3位的药品是阿司匹林肠溶片(42.05%)、地屈孕酮片(27.37%)、左卡尼汀口服溶液(16.02%)。超说明书用药中多数有循证医学证据支持, 但也存在不合理用药现象。结论: 该院生殖中心超说明书用药现象普遍存在,医院应重视超说明书用药情况,并建立相关管理制度予以规范,从而降低超说明书用药的法律风险,促进医院合理用药水平。     

Perceptions and attitudes of Jordanian paediatricians towards off-label paediatric prescribing

Objective To assess current experiences and attitudes of hospital based paediatricians towards off-label medicine prescribing. Setting Paediatric hospital wards and out-patient clinics. Design A prospective, questionnaire based study. Results A 30 item questionnaire was sent to 300 hospital based paediatricians and 250 (83%) were returned completed. Over 69% of responders were familiar with the term off-label medicines. However, only 28% were knowingly prescribing off-label medicines to children. The majority of respondents (90%) expressed concerns about the safety and efficacy of off-label medicines. Only 15% had observed Adverse Drug Reactions, and 31% a treatment failure. The vast majority of respondents (83%) did not obtain informed consent or tell parents they were prescribing off label medicines to their children. Conclusions Off-label prescribing of medicines to children is a familiar concept to the majority of paediatricians in Jordan although only a smaller number are aware that it is common in their practice. Respondents showed concern about off label prescribing, although the majority do not consider it necessary to inform parents. More comprehensive research is needed in this area in Jordan and other Middle Eastern countries.     

基于门急诊处方分析和评价儿童患者超说明书用药情况

目的基于门急诊处方点评,调查和分析门急诊儿童处方药品超说明书用药情况,评价其相关危险因素,为促进儿童合理用药提供基数数据。方法抽取2012~2014年玉林市第一人民医院门急诊儿童处方,以药品说明书为依据,判断超说明书用药情况,分析超说明书用药类型、以及各年龄段超说明书用药发生率等情况。结果共抽取1 883张处方,含4 962条用药记录,其中超说明书用药处方737张(39.14%);超说明书用药记录960条(19.35%)。超说明书用药类型中居前3位的分别为未提及儿童用药信息(53.13%)、给药剂量(16.04%)和给药频次(11.14%)。变态反应性疾病、神经系统疾病和全身感染性疾病居前3位。超说明书用药高发生率前3位的单品种药品为注射用单磷酸阿糖腺苷(18.85%)、注射用乳糖酸阿奇霉素(9.27%)和注射用头孢呋辛钠(4.79%)。处方数和用药记录方面的超说明书用药情况发生率在各年龄阶段均有显著性差异(P<0.01),发生率不同或不全相同。超说明书用药发生的风险与使用非基本药物有关(P<0.01)。结论门急诊中儿童处方超说明书用药情况普遍,药品说明书中儿童用药信息严重缺乏,需要国家规范可能日趋严重的超说明书用药行为,为儿童用药提供更多科学的循证依据。     

某三甲妇儿医院2016年来曲唑门诊超说明书用药回顾性调查分析

目的：了解某三甲妇儿医院门诊来曲唑超说明书用药现状,为规范医疗机构超说明书用药管理。方法：通过医院信息系统收集来曲唑处方,制定标准,按标准分析处方中超说明书用药情况。结果：共汇门诊来曲唑处方3 451张,超说明书用药处方2 937张,来曲唑超说明书用药的发生率为85.11%;超说明书用药类型为超适应证用药和超剂量用药;超适应证用药前3的疾病诊断为女性不孕症、女性原发性不育症、女性继发性不育症;年龄、性别、处方开具科室均是超说明书用药的风险因素。结论：某三甲妇儿医院2016年门诊来曲唑超说明书用药情况普遍,需对来曲唑超说明书用药进行规范管理,保障来曲唑的用药安全和规避相关医疗风险。     

我院肾病综合征超说明书用药分析

摘 要 目的： 分析我院治疗肾病综合征超说明书用药的合理性,为临床合理用药提供科学依据,并进一步规范我院超说明书用药行为。方法: 选取本院2014年11月～2015年4月诊断为肾病综合征的门诊处方1 908张,列出所有超说明书药品;通过查阅相关指南、文献等对其用药合理性进行分析评价。结果: 超说明书用药中他克莫司胶囊、吗替麦考酚酯胶囊、注射用环磷酰胺、环孢素软胶囊、双嘧达莫片、硫酸羟氯喹片、华法林钠片等均有国内外指南推荐,有较高循证医学证据级别;雷公藤多苷片、来氟米特片有大量临床文献支持;以上9种药符合用药合理性。蚓激酶肠溶胶囊、丹参川芎嗪注射液、匹多莫德分散片仅有少数期刊报道;细菌溶解产物胶囊、硼酸粉无相关资料支持,属医师经验用药;以上5种药属于不合理用药。 结论:肾病综合征超说明书用药现象普遍存在,用药情况大部分合理,临床医师应当谨慎用药。我院需对有较高循证医学证据的超说明书用药行为进一步规范化管理,以提高临床合理用药水平以及处方的合理率。     

Awareness,knowledge and views of off‐label prescribing in children: a systematic review

AimThe aim of this review was to provide an updated overview of awareness, knowledge and views of off‐label prescribing in children.MethodA literature search using electronic databases including PubMed, Medline, Scopus, Science Direct, Springer Link, Proquest, Ebsco Host and Google Scholar was conducted. Additional articles were identified by reviewing the bibliography of retrieved articles. The articles were searched with any of the following medical subject headings (MeSH) terms in the title: attitude, awareness, knowledge, experience, view, off‐label, pediatric, paediatric and children. The inclusion criteria were full text articles published in English between January 2004 and February 2015 and reported outcome related to awareness, knowledge and views regarding off‐label prescribing in children. Editorials, reviews, notes, conference proceedings, letters and studies reporting prevalence of off‐label prescribing were excluded. The articles were scrutinized using thematic analysis.ResultsEleven studies conducted among doctors, community pharmacists, paediatric nurses, parents and children met the inclusion criteria. Nine themes were developed through document analysis which included main domains such as knowledge, awareness and views on off‐label drug use in children, choice of information sources, reasons and suggestions to reduce off‐label prescribing, concern regarding obtaining consent and participation in clinical trials.ConclusionThe studies reviewed reported that the majority of doctors and community pharmacists were familiar with the term off‐label prescribing but knowledge among parents was low. Awareness on off‐label prescribing in children remains low among all study participants. There is a mismatch between views on off‐label prescribing in children of study participants and the finding of previous studies.     

Unlicensed and off-label drug use: issues and recommendations

Most adult patients would expect to receive only medicines which have been shown to be well tolerated, effective, and of a high quality. The licensing process to which most drugs are subjected gives the best assurance available that these criteria are met. However, every day, children are required to take medicines which are either not licensed, or are being used outside the terms of their license. Consequently, we cannot be sure that they meet the high standards we require for adult patients. This situation exists wherever children are treated across the world, and when they are in hospital or treated at home. The drugs involved are not obscure; they are routinely used drugs, and many are the mainstay of pediatric therapeutics. The terms 'unlicensed' and 'off-label' should not be taken to imply disapproval, nor incorrect or improper use of drugs, as such prescribing is a vital part of everyday pediatric drug therapy. It is essential because the gold-standard randomized clinical trials supporting adult medicine are often unavailable for children's treatments. Adequate information is not available to ensure that children have timely access to well tolerated and effective medicines with accurate, scientifically justified prescribing information. Many problems arise from this situation, including the lack of availability of appropriate pediatric drug formulations, poor prescribing information, and increased risk of medication errors and unanticipated adverse drug reactions. This situation is unacceptable. The US has taken the lead to change this situation by providing legislation and incentives to the pharmaceutical industry to perform pediatric clinical trials. Funding has been provided to set up research facilities where trials can be conducted by experienced pediatric investigators using imaginative, innovative, and noninvasive testing methods. The rest of the world should learn from these experiences and follow this lead to ensure that children have the same rights as adults to well tolerated and effective medicines.     

儿科药品临床试验中的相关问题探讨

由于缺药、超标签用药以及药品不良反应等导致的儿童死亡和疾病屡见不鲜,但这些都是可以通过恰当使用儿科药物而有效避免。我国儿童数量众多,但有儿童临床证据的药品却十分少。儿科临床试验的开展一直是儿科药品研究中的主要阻碍,这其中存在方方面面的问题,其中包括家长对知情同意书的理解、受试儿童的招募、经济补偿、伦理道德以及儿童的依从性等各个方面。本文将围绕这些方面的问题进行分析,借鉴国外学者的研究成果并提出相应建议。     

Pharmacological research in pediatrics: From neonates to adolescents

The data guiding the dosing, efficacy and safety of medicines for children have lagged substantially as compared to the information available for adults. As a consequence, pediatricians faced with the prospect of confining their practice to medicines with adequate information have frequently resorted to prescribing medicines for unapproved uses (different dose, frequency, age group, route, indication or formulation). Although a long time in coming, the past decade, have witnessed a new era in drug development for children--an era that is still in its infancy, but which is currently showing signs of maturation. This review will give some of the history and current progress in pharmacological research and pediatric drug development.