本文關鍵詞：我國藥師立法問題研究　出處：《南京中醫(yī)藥大學》2016年博士論文　論文類型：學位論文

  更多相關文章： 藥師 職稱藥師 執(zhí)業(yè)藥師 藥師立法

【摘要】：目前,我國醫(yī)療機構和社會零售藥店的藥品使用中,不合理用藥問題普遍存在,涉藥安全事件屢有發(fā)生。由于我國現(xiàn)行藥師專門法的缺失,藥師在用藥安全方面的作用亟待發(fā)揮。根據(jù)2016年國務院最新的立法計劃,藥師法被列為第四類研究項目。加強藥師的立法工作,推動藥師向藥學服務的角色轉型,成為我國當前藥學和法學領域亟需解決的重要問題。關于藥師立法的現(xiàn)有研究,多直接提出法律框架與立法建議,或是思辨和認識論階段的可行性與必要性分析,在藥師的角色演化、藥師立法所調(diào)整的法律關系、藥師立法的基本理念、藥師立法中存在的爭議問題以及立法建議所依據(jù)的具體理由等方面有待進一步論證。本研究采取理論與實踐相結合、邏輯推理與歸納總結相結合的方法,具體包括文獻研究法、比較分析法、專家座談法、定性訪談法等方法,對我國的藥師立法問題進行全面、系統(tǒng)的研究,嘗試提出適合我國國情的藥師法律制度。本研究首先分析了國內(nèi)外藥師職業(yè)的溯源及其角色演化,認為國際上的藥師職業(yè)自正式產(chǎn)生之后,角色演化歷經(jīng)以藥品為中心的傳統(tǒng)藥學發(fā)展階段、以安全用藥為中心的臨床藥學發(fā)展階段、以患者為中心的藥學服務發(fā)展階段。與國外相比,我國目前整體上仍處于傳統(tǒng)藥學向臨床藥學的過渡時期,我國迫切需要通過藥師立法推動藥師角色向藥學服務轉型。國際上藥師角色之所以得到認可,其根本在于法律制度的保障。本研究比較分析了目前國際上藥師法律制度,并將其立法模式歸納為三類：第一類為藥房法模式,以美國為代表,特點在于可以清晰界定藥師的執(zhí)業(yè)領域以及藥師的角色定位；第二類為藥師法模式,以日本以及我國臺灣地區(qū)為代表,特點在于通常按照藥師管理主體、資格考試、注冊制度、藥師職責、繼續(xù)教育、法律責任的立法體例來設計法律條款；第三類為藥師注冊法模式,以英國、新加坡為代表,特點在于主要體現(xiàn)藥師注冊的內(nèi)容,且將藥師資格考試稱為“注冊適任考試”或“注冊評估考試”。與國際上藥師法律制度相比,我國專門的藥師法始終尚付闕如。目前我國藥學技術人員主要分為職稱藥師和執(zhí)業(yè)藥師兩類。前者實行專業(yè)技術職務任職資格,由國家衛(wèi)生行政部門進行管理；后者實行職業(yè)資格準入制度,由國家藥品監(jiān)督管理部門進行管理。兩類藥學技術人員在法律制度、管理主體、資格準入、執(zhí)業(yè)注冊、職責權限等方面存在著雙軌制問題。本研究認為,應通過藥師立法構建一元化的藥師法律制度。本研究認為推進我國的藥師立法,首先需要明確藥師立法的理論基礎。藥師法屬于行政法的范疇,其立法的法理學基礎在于保障公民健康權的實現(xiàn),倫理學基礎在于推進藥師職業(yè)道德法制化,法社會學基礎在于解決民眾日益增長的安全用藥的社會需求與藥師人力資源短缺以及藥學服務勝任力不夠之間的沖突。此外,平衡論的基本理念應貫穿于我國藥師立法的始終。在上述理論分析的基礎上,本研究系統(tǒng)提出我國藥師立法的具體建議：藥師立法應采取《藥師法》的立法名稱；藥師的角色應定位在藥品零售和使用領域中為患者提供藥學服務；設立專門的藥師委員會,其中包括相應的考試委員會、專科藥師委員會、注冊委員會、繼續(xù)教育委員會等；充分發(fā)揮藥師協(xié)會的作用,其中藥師必須加入藥師協(xié)會；實行藥師助理制度,明確其不得替代藥師配備；提高藥師準入門檻,并加強現(xiàn)行藥學技術人員的資格認定以及民族藥師的資格準入工作：實行執(zhí)業(yè)注冊和非執(zhí)業(yè)備案制度；推行藥師兼職制度,暫不宜推行藥師多點執(zhí)業(yè)；突出藥師的特殊權利和特殊義務,其中藥師的核心權利在于藥事服務費的明確,藥師的核心義務在于職責的明確；藥師立法可僅規(guī)定藥師職責的基本原則,再由中國藥師協(xié)會制定系統(tǒng)、詳細的業(yè)務實施細則；對繼續(xù)教育機構進行認證,并提高繼續(xù)教育的學分要求；規(guī)定行政相對人和行政主體違反藥師法所應承擔的法律責任等。
[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.

【學位授予單位】：南京中醫(yī)藥大學
【學位級別】：博士
【學位授予年份】：2016
【分類號】：R95;D922.16
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本文編號：1401707