藥師調劑之注意義務與民事責任

The Duty and Civil Liability of Pharmacist

劉又禎(Yu-Chen Liu)

指導教授 ： 劉宗榮

共同指導教授 ： 陳聰富(Tsung-Fu Chen)

國立臺灣大學/法律學院/法律學研究所/碩士(2011年)

https://doi.org/10.6342/NTU.2011.01657

摘要

「藥師」在醫藥服務流程中，負責處方箋調劑之工作，不僅藉由處方成為醫師與病患間之橋樑，更是病患取得藥品的最後關卡，扮演重要的角色。然由於我國醫療體系與民眾觀念，向來視藥師為單純之「包藥機器」，因此國內探討藥師注意義務與民事責任之相關文獻，付之闕如。惟本文認為，隨著「醫藥分業」政策之推動與發展，藥師之重要性日漸提升，因此有必要明確化藥師在醫藥體系中所扮演之角色與職責，並具體化藥師調劑之各項注意義務及內涵，以進一步探究藥師依法應負之民事責任。

本文首先就「醫藥服務」為簡單之說明，包含醫藥服務之流程、藥品與藥事人員之種類及規範等，並簡述我國醫藥制度之現況，特別是醫藥分業之推動過程及困境。對藥師處方箋調劑之「法律關係」，本文認為儘管藥師本人經常非契約當事人，但基於其與機構間之僱傭關係，仍必須先探究藥師之注意義務為何。又本文認為藥師基於契約關係與侵權行為所生之注意義務，並無不同，故將一併討論之。

就藥師調劑流程中之各項注意義務，本文援引美、日兩國之法院判決、案例與學說見解，確定藥師調劑時之注意義務，並具體化各項義務之內涵。本文認為藥師調劑時有下列七項義務：於藥師有依照處方調劑時，尚有「受理處方之注意義務」、「用藥適當性評估義務」與「用藥指導義務」；若藥師未依照處方調劑，則可能是違反「不得無處方給藥之義務」或「不得調劑錯誤之義務」；除此之外，藥師仍應負「親自調劑之義務」與「保密義務」。

當藥師違反其注意義務時，自須負擔一定之民事責任，然由於「藥品調劑服務」包含藥品交付與調劑服務提供二者，具有相當之特殊性，故本文分析其責任類型，除討論藥師調劑服務瑕疵時所負擔之責任外，更進一步探討藥品瑕疵時，藥師基於藥品經銷商之地位所負擔之責任。就前者而言，本文主張藥師雖為藥事專業人員，然其注意義務標準仍應為「善良管理人之注意」；就後者而言，本文透過比較美國侵權行為法整編之規定，與法院判決理由之分析，認為在我國法的架構下，藥品製造人就藥品之設計瑕疵，仍得負擔消費者保護法第7條第1項之無過失責任，而藥品經銷商亦應依消費者保護法第8條負連帶賠償責任，方為妥當。

本論文之研究，主要欲喚起我國對於藥師調劑之相關法律問題之注意，儘管此議題現今重要性仍不高，但觀察美、日兩國之發展，可想見在不久之將來，必將成為重要之議題。儘管因藥品傷害案件之高度複雜性、國內文獻缺乏及研究能力與時間之限制，本文僅能提出一些可供判斷之標準與規則，描繪出一個模糊的框架，惟希望能以本文作為開端，激發更多相關研究，並期待健全藥師之義務與責任後，能對國內荒蕪之藥師法律責任研究領域，能有微薄之貢獻。

關鍵字

藥師 ； 藥品 ； 醫藥分業 ； 處方箋調劑 ； 藥事服務 ； 注意義務

並列摘要

In the medical service process, “Pharmacist” is responsible for dispensing prescriptions. Pharmacist plays an important role as a bridge between physicians and patients, and also patients’ access to pharmaceuticals. However, due to our medical system and people’s traditional point of view, they mostly regard pharmacist as a “machine” to package drugs. Therefore, no one pays much attention to the duty and civil liability of pharmacists. However, the development of “Separation of Dispensing Practice from Medical Practice Policy” enhances the importance role of a pharmacist. For this reason, it is necessary to find out the role and responsibilities of pharmacists, and concretize their duty and civil liability.

This paper begins with the definition of "pharmaceutical services", and a brief description of Taiwan’s medical system. Then, it lays out the “legal relationship between pharmacist and other medical participants of dispensing prescriptions. This paper also discusses the Contractual Liabilities and Tortious Liabilities of pharmacists, and concludes that it should make no difference to the pharmacists’ duty.

This paper analyzes pharmacists’ duty from case studies in the US and Japan to understand the duty of care within the pharmacist dispensing process, and concludes that a pharmacist should follow seven duties: when the pharmacist dispenses drug by prescription, there are three duties to assure the accuracy and appropriateness: ” duty to confirm the prescription when s/he receives it”, “duty to access medication’s appropriation”, and “duty to instruct patients” ; when the pharmacist does not distribute the drugs by the prescription, he violate the “can not dispense without prescription” duty and “no dispensing errors” duty; In addition, a pharmacist is also responsible for “dispense by himself” and “confidentiality “.

When a pharmacist violates the duties above, s/he also violates the civil liabilities of a pharmacist. Due to the characteristic of “pharmaceutical services,” this paper discuses not only “dispensing errors”, but also “product defects”. For the former, this paper argues that a pharmacist should possess a “reasonable man” standard. For the latter, this paper argues that drug manufacturers and drug dealers should be subjected to the Consumer Protection Law Article 7 and Article 8.

The purpose of this paper is mainly to raise the awareness of the legal issues associated with pharmacists. Although the importance of this issue is not high today, from the observation of the US and Japan case, there is no doubt that pharmacists’ liability will become an important issue in the near future. This paper aims to serve as an engine in this area of legal study, and to inspire more research in the coming future.

並列關鍵字

Pharmacist ； Pharmaceuticals ； the Separation of Dispensing Practice from Medical Practice ； Dispensing Prescription ； Pharmaceutical Care Service ； Duty of Care

參考文獻

朱懷祖（1997）。《藥物責任與消費者保護》。台北：五南。

行政院消費者保護委員會（1994）。《消費者保護法立法目的與條文說明》。台北：行政院消費者保護委員會。

行政院消費者保護委員會（1995）。《消費者保護法施行細則研訂資料》。台北：自版。

行政院消費者保護委員會編印（1998），《消費者保護法判決函釋彙編（一）》。臺北市 : 行政院消費者保護委員會。

劉春堂（2000）。《消費者保護與消費者法》。台北：行政院消費者保護委員會。