의약품에서의 결함의 개념과 그 증명 = A Study on the Concepts of Defect in Ethical Drug and Its Attestation

다국어 초록 (Multilingual Abstract)

All matters concerning ethical drug was not recent ones but already began to occur as pharmaceutical drugs became commercialized on large scale and thereby administered to patients owing to the advancement of pharmaceutical technology. There are some critical harmful aspects behind ethical drugs, although they consist of synthetic chemical substances to induce chemical reactions in our body so that they can help heal certain diseases and keep health. In other words, ethical drugs may still have any unknown side effect, and resulting harms may bring considerable damages even within shorter time than we think, because the drugs are often widely used among many populations around the nation or world.
In the inherent characteristics of pharmaceutical drugs, they are generally approved as ethical drug mainly by the judgment of pharmaceutical values about the final result of comparing their effectiveness for certain diseases and the properties or extent of accompanying side effects respectively. However, there are still some limitations in perfectly estimating any side effect after marketing mainly through preclinical(physiochemical and animal experiment) and clinical study(human experiment). Besides, ethical drugs are typically subject to strict regulations throughout all relevant processes including preclinical and post-marketing process. Medical drugs are often used by practitioners and generic drugs are sold under the control of apothecary around pharmacy, drugstore, etc. On the other hand, the existence of ethical drug is approved with a combination of commodity and information in one. In particular, some information such as directions and warning is essential above all. Here, any pharmaceutical effectiveness and safety are confirmed and approved on the basis of certain conditions such as dosage, duration or method of administration and the like. Yet, if any violation of these prerequisites causes more or less damages in health care, it is unavoidable to bear any damage resulting from medical malpractice and pharmaceutical side effects.
Therefore, we cannot help considering legal liabilities of pharmaceutical manufacturer that produces drugs causing any harmful side effects. Unfortunately, in Korea, there has been not yet any case of directly uncovering and pointing out the liabilities of pharmaceutical manufacturer in terms of pharmaceutical defect of ethical drugs, although there are a few literatures referring to the harmful risks inherent m pharmaceutical manufacturing.
In the regard of these considerations, this study focuses on the necessity of suggesting any alternative or solutions for domestic pharmaceutical administration and relevant social problems even somewhat lately - in terms of latest marketing of cold remedy or tablets that contain phenylpropanolamine.

목차 (Table of Contents)

• Ⅰ. 들어가는 글
• Ⅱ. 의약품 결함의 개념과 결함의 유형
• Ⅲ. 의약품의 개발에 따른 위험과 항변
• Ⅳ. 맺는 글
• 필자소개
• Abstract