我国药师立法问题研究

发布时间：2018-01-09 14:12

  本文关键词：我国药师立法问题研究　出处：《南京中医药大学》2016年博士论文　论文类型：学位论文

  更多相关文章： 药师 职称药师 执业药师 药师立法

【摘要】：目前,我国医疗机构和社会零售药店的药品使用中,不合理用药问题普遍存在,涉药安全事件屡有发生。由于我国现行药师专门法的缺失,药师在用药安全方面的作用亟待发挥。根据2016年国务院最新的立法计划,药师法被列为第四类研究项目。加强药师的立法工作,推动药师向药学服务的角色转型,成为我国当前药学和法学领域亟需解决的重要问题。关于药师立法的现有研究,多直接提出法律框架与立法建议,或是思辨和认识论阶段的可行性与必要性分析,在药师的角色演化、药师立法所调整的法律关系、药师立法的基本理念、药师立法中存在的争议问题以及立法建议所依据的具体理由等方面有待进一步论证。本研究采取理论与实践相结合、逻辑推理与归纳总结相结合的方法,具体包括文献研究法、比较分析法、专家座谈法、定性访谈法等方法,对我国的药师立法问题进行全面、系统的研究,尝试提出适合我国国情的药师法律制度。本研究首先分析了国内外药师职业的溯源及其角色演化,认为国际上的药师职业自正式产生之后,角色演化历经以药品为中心的传统药学发展阶段、以安全用药为中心的临床药学发展阶段、以患者为中心的药学服务发展阶段。与国外相比,我国目前整体上仍处于传统药学向临床药学的过渡时期,我国迫切需要通过药师立法推动药师角色向药学服务转型。国际上药师角色之所以得到认可,其根本在于法律制度的保障。本研究比较分析了目前国际上药师法律制度,并将其立法模式归纳为三类：第一类为药房法模式,以美国为代表,特点在于可以清晰界定药师的执业领域以及药师的角色定位；第二类为药师法模式,以日本以及我国台湾地区为代表,特点在于通常按照药师管理主体、资格考试、注册制度、药师职责、继续教育、法律责任的立法体例来设计法律条款；第三类为药师注册法模式,以英国、新加坡为代表,特点在于主要体现药师注册的内容,且将药师资格考试称为“注册适任考试”或“注册评估考试”。与国际上药师法律制度相比,我国专门的药师法始终尚付阙如。目前我国药学技术人员主要分为职称药师和执业药师两类。前者实行专业技术职务任职资格,由国家卫生行政部门进行管理；后者实行职业资格准入制度,由国家药品监督管理部门进行管理。两类药学技术人员在法律制度、管理主体、资格准入、执业注册、职责权限等方面存在着双轨制问题。本研究认为,应通过药师立法构建一元化的药师法律制度。本研究认为推进我国的药师立法,首先需要明确药师立法的理论基础。药师法属于行政法的范畴,其立法的法理学基础在于保障公民健康权的实现,伦理学基础在于推进药师职业道德法制化,法社会学基础在于解决民众日益增长的安全用药的社会需求与药师人力资源短缺以及药学服务胜任力不够之间的冲突。此外,平衡论的基本理念应贯穿于我国药师立法的始终。在上述理论分析的基础上,本研究系统提出我国药师立法的具体建议：药师立法应采取《药师法》的立法名称；药师的角色应定位在药品零售和使用领域中为患者提供药学服务；设立专门的药师委员会,其中包括相应的考试委员会、专科药师委员会、注册委员会、继续教育委员会等；充分发挥药师协会的作用,其中药师必须加入药师协会；实行药师助理制度,明确其不得替代药师配备；提高药师准入门槛,并加强现行药学技术人员的资格认定以及民族药师的资格准入工作：实行执业注册和非执业备案制度；推行药师兼职制度,暂不宜推行药师多点执业；突出药师的特殊权利和特殊义务,其中药师的核心权利在于药事服务费的明确,药师的核心义务在于职责的明确；药师立法可仅规定药师职责的基本原则,再由中国药师协会制定系统、详细的业务实施细则；对继续教育机构进行认证,并提高继续教育的学分要求；规定行政相对人和行政主体违反药师法所应承担的法律责任等。
[Abstract]:At present, China's medical institutions and retail pharmacy drug use, generally irrational drug problem, drug safety incidents occurred frequently. Due to the lack of China's current pharmacist law specifically, in the role of pharmacists on medication safety. According to the State Council in 2016 to be the latest legislative plan, is listed as a pharmacist law fourth types of research. To strengthen the legislative work of pharmacist, pharmacist pharmacy services to promote the transformation of the role, has become an important issue in the field of law and the need to solve the pharmacy in China. The existing research on pharmacist legislation, directly put forward legal framework and legislative proposals, or speculative and epistemological necessity and feasibility analysis stage. The role of pharmacists in evolution, legal relation of pharmacist legislation, the basic concept of pharmacist legislation, specific and controversial issues in the legislation of pharmacists and legislative suggestions on the basis of From the aspects of further demonstration. This research adopts the combination of theory and practice, the method of logical reasoning and summarizing combination, including literature research, comparative analysis, expert interview method, qualitative interviews and other methods, comprehensive problems of pharmacist legislation, system research, tries to put forward the suitable for me China pharmacist legal system. This paper first analyzes the origin of domestic and foreign occupation pharmacist and its role in evolution, believe that the international community pharmacists occupation since the official after the role, after evolution stage of traditional pharmacy development in medicine as the center of the stage, the development of clinical pharmacy in drug safety as the center, take the patient as the pharmacy service development stage center. Compared with foreign countries, China's current overall is still in the transition period to the traditional pharmaceutical clinical pharmacy in China, the urgent need to promote the role of pharmacists to pharmacist legislation The pharmacy service transformation. The international role of pharmacists are accepted, which lies in the protection of the legal system. This study analyzes the current international legal system and the pharmacists, the legislative mode is divided into three categories: the first category is the pharmacy law model, represented by the United States, especially in areas of practice can be clearly defined by the pharmacist and the role of pharmacists; second for pharmacists to model, Japan and Taiwan of China as the representative, is usually in accordance with the pharmacist management subject, qualification examination, registration system, pharmacist responsibilities, continuing education, legislation of legal responsibility to design legal provisions; third for pharmacists registered in Britain, France mode. Singapore as the representative, is mainly registered pharmacist qualification examination content, and will be called the "registration certificate examination" or "registration assessment" and international medicine. Compared with the normal legal system, our country specialized pharmacists method always still lack. At present the pharmaceutical technical personnel in China is mainly divided into two types of professional pharmacists and licensed pharmacists. The implementation of professional and technical qualifications, managed by the national health administrative departments; the implementation of occupation qualification system, the management of the drug supervision and Administration Department of state two types of pharmaceutical technical personnel in the legal system, management subject, qualification, registration, aspects of responsibilities is two pronged problem. This study suggests that, by constructing the legal system of medicine master pharmacist legislation unified. This dissertation argues that promoting China's pharmacist legislation, first need to clear the theoretical basis of pharmacists in legislation. Pharmacist Law of administrative law, the legislative basis of jurisprudence is to realize the protection of citizens the right to health, to promote the basic ethics of pharmacists occupation moral legalization And the foundation of the sociology of law is to solve the drug safety in the people's growing demand of society and human resources shortage and pharmacist pharmacy service competency is not between the conflict. In addition, the basic concept of the theory of balance should be throughout our pharmacist legislation always. Based on the above theoretical analysis, put forward specific suggestions of legislation of pharmacists this study system: the pharmacist legislation should take "legislative law" name of pharmacists; the role of pharmacists should provide pharmaceutical care for patients in the field of pharmaceutical retail and use; the establishment of specialized pharmacists Committee, including the corresponding examination committee, the registration committee specialized pharmacist Committee, continuing Education Committee; give full play to the role of Pharmacists Association the role of the pharmacist must join the Pharmacists Association; the pharmacist assistant system, the pharmacist shall not replace with; improve access threshold and pharmacists. To strengthen the existing pharmaceutical technical personnel qualification and national pharmacists qualification work: the implementation of registration and non practicing filing system; the implementation of system of part-time pharmacist, pharmacists more practice will not carry out; outstanding pharmacists special rights and special duty, which is the core right pharmacist pharmacy service fee is clear, is the core duty of pharmacists the basic principle of clear responsibilities; pharmacist legislation can be only stipulated by the clinical pharmacist, Pharmacists Association China formulation system, detailed rules for the implementation of business; certification of continuing education institutions, and improve the continuing education credits; provisions of the administrative relative person and the violation of administrative subject should bear the legal responsibility of Pharmacist Law.

【学位授予单位】：南京中医药大学
【学位级别】：博士
【学位授予年份】：2016
【分类号】：R95;D922.16
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本文编号：1401707