药品说明书标准化模式的探讨

目的:了解我国目前药品说明书现状,为制定规范化、标准化的药品说明书提供参考。方法:根据《中华人民共和国药品管理法》(以下简称《药品管理法》)、《药品说明书和标签管理规定》(以下简称《规定》),利用万方数据库从1998～2012年以《药品说明书》为关键词搜索的关于《药品说明书》相关的论文314篇,对相关内容进行汇总和分析。结果:药品说明书在内容和形式上都不规范。结论:现行我国的药品说明书真是五花八门,有必要制定规范化、标准化的药品说明书。     

建立药品基本信息标准数据库的探讨

目的:为我国建立药品基本信息标准数据库提供参考。方法:从药品基本信息标准数据库在医药卫生保健事业(特别是药品监督管理)信息化中的作用和意义入手,分析其定义、特点和内容,提出建立药品基本信息标准数据库的基本思路及其结构和层次。结果与结论:药品基本信息标准数据库主要由成分、药物名称、剂型、规格、包装等几项内容构成,可划分为5个层次。药品基本信息标准数据库的建立需要国家食品药品监督管理局的领导,并实现维护工作的日常化以及社会资源的充分利用。     

浅析当前药品说明书存在的问题及建议

目的:促进药品说明书的规范,为合理用药提供依据。方法:根据《中华人民共和国药品管理法》和《药品说明书规范细则》对我院常用药品说明书存在的问题进行统计分析。结果与结论:部分药品说明书存在基本项目不齐、安全性信息缺失、服用时间不明确等问题,应采取增加警示标志、明确服药时间、列出变质提示等相应措施对当前药品说明书进行规范。     

常用口服药品说明书中老年人用药说明的调查分析

目的：了解口服药品说明书中老年人用药内容的标注情况,为老年人的合理用药提供参考。方法：采用逐张阅读的方法,对我院门诊老年患者常用的182种口服药说明书中＂老年人用药＂内容进行统计、分析。结果：32份（占17.58%,32/182）说明书标注了老年人用药剂量或标注了老年人无需调整用药剂量;21份（占11.54%,21/182）说明书标注了老年人需要根据肝肾功能或肝功能或肾功能适当调整剂量,但是并没有说明需要调整的具体剂量及调整方法;16份（占8.79%,16/182）说明书标注了老年人要慎重用药;22份（占12.09%,22/182）说明书没有标注＂老年人用药＂项。结论：应根据老年患者疾病特点完善口服药品说明书,保障老年人的用药安全。     

美国药品标识监管体系研究

目的：通过研究和分析美国药品说明书和标签监管体系,重点阐述现有监管制度上的环节要求,以期为完善我国药品说明书和标签监管体系提供较为全面的参考和借鉴,进一步提高用药安全水平。方法：采用非接触性研究中的内容分析方法,广泛查询FDA及美国联邦政府的官方网站、中国知网数据库等,收集整理与美国标识监管体系相关的资料,包括法律文件8个、指南36个及50余个FDA官网网页资料和报告文件等。结果与结论：围绕上市前、上市后和信息公开管理,并通过不断修订加强法律法规,美国药品标识逐步形成了法律、法规及指南3个层面的逻辑清晰的完整监管体系。我国药品说明书和标签监管体系建设工作相差明显,应尽快建立我国药品说明书和标签功能定位监管认识的新视角,完善上市前、上市后和信息公开管理制度机制,抓住《药品管理法》修订的契机,系统性安排药品说明书和标签立法工作计划,开展全国调研,为全面规范药品说明书和标签管理提供科学保障。     

The product label: how pharmacokinetics and pharmacodynamics reach the prescriber

The product label, or package insert, is the 'manual' for the safe and effective use of a drug. Important pharmacokinetic and pharmacodynamic properties of a drug product should appear in the label under specific sections, as required in the Code of Federal Regulations (CFR), using a format and language recommended by the Food and Drug Administration (FDA) in various guidances to the industry. The relevant regulations and guidance documents impacting on how this information is conveyed to the healthcare professional are discussed, with special emphasis on how the new proposed rule will impact upon how information is to be conveyed. With the availability of new clinical pharmacology information not available at the time of approval, package inserts for older drugs should be updated to reflect the new data and recommend the proper dosage regimen, enabling prescribers to optimise drug therapy and minimise possible adverse events.     

Bioequivalence of racemic drugs.

Although pharmacokinetic and pharmacodynamic differences between the enantiomers of a chiral drug have been known or suspected for many years, racemate drugs have frequently been developed and approved without clinical pharmacologic consideration of their chiral components. In the late 1970s, the technology to isolate, manufacture, and detect pure enantiomers of racemate drugs became generally available. This availability has created new demands on both pharmaceutical firms and regulatory agencies. To prepare for this new technology, the Center for Drug Evaluation and Research at the Food and Drug Administration is formulating a policy statement to guide evaluation of new chiral drugs. At this time, it appears that whatever new policies are developed will not necessarily be applied retroactively to previously approved racemate drugs. Additional policies to guide the development and approval of generic and OTC chiral drugs may be required. In the Office of Generic Drugs in the Center, abbreviated new drug or antibiotic applications are approved on the basis of adequate chemistry, manufacturing, and control procedures and comparative pharmacokinetics (bioequivalence). The generic drug must be a racemate or single enantiomer if the corresponding innovator drug is a racemate or single enantiomer respectively. Whether a generic firm will be required to provide bioequivalence information on enantiomers of a racemate is determined on a case-by-case basis. Although it might be claimed that a generic drug product should be required only to undergo the same general kind of pharmaceutical evaluation as did the innovator, there may be instances when the approval of a generic drug or antibiotic will require measurement of specific enantiomers of a chiral drug.     

某三甲医院门诊抗高血压药利用分析

目的调查分析临床抗高血压药的应用状况和合理性。方法利用医院信息系统门诊药房管理子系统,对某综合医院门诊抗高血压药处方进行回顾性分析。以药品说明书、新编药物学（2005版）、2007年欧洲高血压治疗指南为标准,采用世界卫生组织推荐的限定日剂量方法、用药频度法对抗高血压药处方的使用情况进行统计、分析。结果该院门诊抗高血压药使用情况基本合理,但还存在一些问题,如利尿药的应用偏少,存在药物联用不适宜、用药间隔不合理现象。结论临床医师和药师应遵循药物治疗指南,掌握各类降压药的降压机制,进行合理的联合用药,提高合理用药水平。     

药品英文说明书的语言特点与翻译

目的:掌握药品英文说明书的基本结构、语言特点及翻译技巧,以指导临床合理用药。方法:根据药品名称、性状、药理作用、适应证、剂量和用法、注意事项、副作用和禁忌证等项目分析药品英文说明书的语言特点与翻译技巧。结果与结论:药品英文说明书大多使用被动语态,常用省略句和祈使句等,读者在理解和翻译药品英文说明书时对其应加以注意。     

Looking for a solution for drug addiction in China: Exploring the challenges and opportunities in the way of China's new Drug Control Law

In the wake of the deteriorating situation of drug addiction and related infectious diseases among injecting drug users (IDUs) in China in recent years, the Standing Committee of the National People's Congress of China adopted the new Drug Control Law which came into force in June 1, 2008. This law is part of a broad reform movement in China where drug addiction is no longer understood as simply a legal or moral issue but rather, as a complicated medical condition requiring comprehensive therapeutic strategies. Although the Drug Control Law draws a distinct line from previous Drug Control regulations in the country, there have still been dilemmas along the implementation process. This paper is intended to elaborate on the general principles of China's latest Drug Control Law from the point of view of scholars who are involved in the field of drug addiction research and treatment in China. This paper will also discuss the challenges we are currently facing, based on the observations and practical experiences the authors have obtained in China. It is hoped that by addressing these issues, we will be able to implement the new Drug Control Law more successfully and ensure that we deal more effectively with drug addiction in China.     

Analysis of German package inserts

OBJECTIVE: Package inserts have an important impact on patients compliance and thus on the effectiveness of drug use. Despite efforts of the European or national regulatory authorities and manufacturers to improve the readability and comprehensiveness of package inserts, they are still the subject of critical discussion. MATERIAL AND METHODS: 68 German package inserts were chosen for a detailed analysis of their quality and suitability based on a set of 104 quality criteria developed prior to the survey. RESULTS: In many cases package inserts available on the German drug market did not include important information or were difficult to read or understand. In 73.5% of cases, the daily maximum dose was missing and 63.2% gave no information on the measures to take for each of the interactions. 66.2% of package inserts provided no instructions about the correct storage and 58.8% gave no instructions on the appropriate storage temperature. In 13 cases, dosage instructions were provided only in milligrams of active substance instead of a number of tablets or volume of liquid. 98.5% of the 68 package inserts included non-quantifiable statements such as "high dosage" or "take 2 - 4 tablets, 1 - 3 times daily". 97.1% contained repetitious information, 83.8% included advertising elements and 8.8% contained contradictory information. CONCLUSION: Package inserts must be optimized and tested by selected groups of patients prior to approval of the drug. This will avoid misunderstandings and lack of information and ensure that use of the drug will give the best possible outcome and avoid safety risks.     

Deficiencies of Product Labeling Directions for the Preparation of Radiopharmaceuticals

ObjectiveTo identify potential deficiencies in product labeling (package insert) instructions for the preparation of radiopharmaceuticals.MethodsPreparation instructions, which include both reconstitution and quality control (QC) directions, as stated in the package inserts were evaluated for all commercially available reconstituted radiopharmaceuticals. Reviews of the package inserts were initially performed by each author, and then all identified deficiencies were compiled and evaluated by all authors. The preparation scenario for each package insert evaluated was based on a centralized nuclear pharmacy operation assuming typical support personnel, standard operating equipment, and workload.Main Outcome MeasureThe instructions as stated in each package insert for the preparation (including QC) were rated as inadequate if a satisfactory preparation could not be prepared by a nuclear pharmacist or physician when instructions were followed exactly.ResultsIdentified deficiencies in package insert instructions for the preparation of radiopharmaceuticals fell into the following five categories: (1) absent or incomplete directions (especially with regard to QC procedures); (2) restrictive directions (e.g., specific requirement to use designated needles, chromatography solvents, counting devices), (3) inconsistent directions (e.g., different reconstituted volumes for the same final drug product, unworkable expiration times); (4) impractical directions (e.g., unrealistically low reconstituted activity limits, dangerously high number of radiolabeled particles); and (5) vague directions (e.g., use of the words “should,” “may,” “recommend”).ConclusionManufacturers’ directions for the preparation of radiopharmaceuticals often contain deficiencies and should be viewed as standard guidance rather than as requirements. Just as physicians are permitted to use U.S. Food and Drug Administration (FDA)-approved drugs for off-label indications, nuclear pharmacists should be allowed to use alternative methods for preparing radiopharmaceuticals, provided those methods have been validated to be as good as the stated directions and that the nuclear pharmacists do not engage in activities that fall outside the normal practice of pharmacy. Manufacturers, FDA, nuclear pharmacists, and nuclear physicians should work together to address identified deficiencies in package insert directions.     

在实际工作中遇到的药品包装问题与建议

目的:为促进药品包装的逐步规范化提供参考。方法:以《中华人民共和国药品管理法》为依据,对2008、2009年黑龙江省20家大型医院和药店经营的1000余种药品的中包装从材料、装量等及小包装从标签、数量、说明书等进行实地调研,分析在实际工作中遇到的问题并提出建议。结果与结论:部分中包装选用材料材质不方便调剂,有可能导致药品污染,装量各异易致发药差错,市场监督码与国家药品编码易混淆;部分小包装的标签粘贴不牢,药品数量过多易致药品过期或二次包装造成药品污染,需避光保存的特殊药品包装后无法检查药品完好程度,药品说明书所示的使用剂量与规格标识不一致,个体较小的药品过度包装致资源浪费。建议使用可进行生物降解和再生使用的材料进行包装,根据剂量、疗程和不同用药人群来确定药品装量数,小包装数量应设置合理,药品说明书内容应客观真实等。     

我国临床用药参考资料中的问题

我国临床用药参考资料主要为药品说明书、参考书和论文。但药品说明书存在信息缺失，其与参考书存在适应证标注矛盾、用药剂量矛盾、药物相互作用矛盾和论文结论可信度低等问题，需引起重视。本文对我国临床用药主要参考资料中的部分问题作简单介绍。     

由一起行政诉讼案引发的对我国药品立法的再思考

目的:为修订《药品管理法》中与药品定义以及非药品冒充药品有关的规定提供参考。方法:通过笔者亲自参与的一起行政诉讼案件的法律适用中遭遇的尴尬入手,分析存在的相关法律瑕疵。结果与结论:我国《药品管理法》中有关药品定义的规定不够精确、规范,且不利于将非药品冒充药品的情形界定为假药,应借鉴其他国家立法经验,在新一轮修订中予以完善。     

药品包装标准化的意义和作用

目的 了解目前我国药品销售包装的现状,为制定统一标准化的药品销售包装提供参考.方法 根据<中华人民共和国药品管理法>(以下简称<药品管理法>)、<药品说明书和标签管理规定>(以下简称<规定>)对我国目前药品包装存在的问题进行归纳和总结.结果 目前药品的销售包装可以说是五花八门,我行我素,结论为保证药品产、供、用等各个环节的安全有效,有必要对药品销售包装(六个面的药盒)进行统一标准化管理.     

Optimizing information on drug exposure by collection of package code information in questionnaire surveys

PURPOSE: The thorough analysis of special drug characteristics requires information on the specific brand of a drug. This information is often not sought in pharmacoepidemiologic surveys although in many countries packages are labelled with an unequivocal code (in Germany called Pharmazentralnummer (PZN)). We aimed to assess the benefit and quality of PZN information collected in self-completed questionnaires. METHODS: We performed a survey in 905 ambulatory patients who were asked to list brand name, strength, and the PZN of all drugs they were taking. RESULTS: The medication list was completed by 97.5% (n = 882) of the responding patients (mean age 67.3 years). Altogether 5543 drugs (100%) were mentioned in the questionnaires and for 4230 (76.3%) the exact drug package could be allocated on the basis of the PZN. When PZN was considered in addition to the drug name the quality of drug coding was significantly improved (p < 0.001) with regard to the allocation of drug package (74% versus 2%), brand (90% versus 70%), and strength (96% versus 86%). The time needed for drug coding was three times shorter. CONCLUSIONS: The high response rate and high fraction of correct PZN indicate that the collection of package code information is a valuable method to achieve more accurate drug data in questionnaire surveys and to facilitate the drug coding procedure.     

Stimulant use among clients entering drug treatment in Europe

The aim of this article is to explore the prevalence of primary illicit stimulant use among people who enter drug treatment in Europe. Drawing on information provided by European Union treatment centres in 2009 (excluding Latvia, Lithuania, Portugal and Norway), the European Monitoring Centre for Drug and Drug Addiction showed data in relation to the analysis of two of the most problematic drugs: cocaine and stimulants other than cocaine. The analysis reached three conclusions: the primary use of stimulants (cocaine and amphetamines) among clients entering treatment appears to be widespread throughout Europe; stimulant use including different forms of stimulants varied from country to country and two geographical patterns emerge across Europe: North-Eastern European countries show high levels of prevalence of problematic use of amphetamines and methamphetamines, while South-Western countries report high levels of problematic use of cocaine.     

Optimization of antimicrobial therapy based on therapeutic drug monitoring

Recently, the pharmacokinetic (PK)-pharmacodynamic (PD) theory draws attention in the therapy of the infectious disease. Although the theory was only introduced into the field of antimicrobial therapy several years ago, the foundation was in the individualization of administering design by therapeutic drug monitoring (TDM) begun 30 years ago. Although, the main purpose of TDM that had been performed so far was assumption of the evasion of the side effects caused with antimicrobials, it is difficult to say that it has been used as a tool to improve the efficacies. Furthermore, although the information described in the package inserts of antimicrobials must be important grounds to use the agents properly, it was recently recognized that there were pitfalls in PK-PD region. In this review, the following three items are described; 1) problem of dosage regimen described in package insert of antimicrobials, such as aminoglycosides and vancomycin in our country, and findings accumulated through their TDM; 2) strategy for proper use of antimicrobials based on PK-PD theory; 3) finally, the role of the pharmacist expected in the area of the infectious disease treatment.     

Development and evaluation of an individuals-oriented information-provision system for outpatients--utility of "drug Usage sheets" and "Drug Information Cards" for patient consultation

We have implemented an information-provision system for outpatients at the department of pharmacy, University of Tokyo Hospital, in order to comply with the revised Pharmacists' Law by which pharmacists have been obliged to provide patients with information necessary for rational usage of medicine at the time they receive dispensed drugs. This system is linked on-line with the order entry system to print "Drug Usage Sheets" containing important drug information such as therapeutic effects and adverse reactions, as well as photographic color views of drugs. We prepared the sheets by extracting and classifying the original information, and by converting medical terms into lay expressions. Moreover, we developed "Drug Information Cards" to inform each patient of severe side effects and drug interactions, which should affect drug compliance, and implemented an individuals-oriented information system using both the "Drug Usage Sheets" and "Drug Information Cards." In this study, we evaluated the usefulness of this system from the viewpoint of patients' recognition and understanding on necessary drug information. It was indicated from questionnaires to patients that the "Drug Usage Sheets" help most patients understand the names, usage, effects, and general cautions including slight adverse reactions (i.e. grade 1), and that the use of colored letters for important parts and pictograms is a useful method to attract more attention from patients as compared with a conventional method using only letters. Most patients answered that the "Drug Usage Sheets" can be utilized in many ways and valuable in taking drugs with assurance. We formulated the "Drug Information Cards" by information processing: separation of early symptoms of adverse effects into subjective and objective ones and their classification into related organs. Moreover, the brand names of drugs which may cause drug interactions have been listed on the cards so that worsening of adverse reactions and drug interactions can be avoided. Although 14% of the patients answered that they became unsecured when informed on side effects, the percentage of such patients was significantly higher with those who received caution-required drugs for the first time or who have experienced drug side effects before, suggesting the need for combining oral explanation based on each patient's background and understanding on drug adverse effects. In conclusion, an efficient provision of drug information became possible through our integration of necessary drug information in this study, and the individuals-oriented system of drug information was established, which was demonstrated to contribute to the rational usage of medicine.