Research On The Safety Of Drugs

A drug is a substance, a natural substance or a man made substance. But there has never been any substance that is a drug constitutionally. A substance can be called a drug only if the medical value of the substance has been found and recognized and used for medical purposes. But the recognition of a drug is not always reliable. Our ancestors made their findings and recognitions by experience and trials on human body. We feel that was not reliable. The reliability of systematic study of modern pharmaceutical research in laboratories is also questionable. Modern drug research system dominated by pharmaceutical companies emphasizes particularly on the discovery and certification of the effectiveness of a drug. The finding and improving of defects of a drug is more likely to be neglected. The lack of safety has always been a great threat to patients.The major study methods applied by this paper are methods of literature research, comparative research, survey research, cases study, induction and illation, historical research of Marxism and so on, The paper systemically explores the issue of drug safety, by way of manufacturing defects, designing defects and usage defects of drugs. And make the issue of drug safety into three aspects which are manufacturing defects and drug quality, designing defects and ADRs, usage defects and irrational drug use. The paper analyzes the essential core and every aspect of drug safety, and uses the theory and practice of drug monitoring for reference, sums up the innovations and problems of pharmacovigilance, brings forward a unitive theory of pharmacovigilance of drug safety.The paper starts from general analysis of production defects, then analyzes the meanings, types and judging criteria etc. After that it studies the meanings and characteristics of designing defects, manufacturing defects and specification defects.The study of the three aspects of drug safety makes the main part of the paper. The three aspects are manufacturing defects and drug quality, designing defects and ADRs, usage defects and irrational drug use. It studies the meanings, nature, judging criteria, proving rules, legal liabilities, control and prevention of the three aspects. The paper also investigates some complex administrative issues of drug safety control, and puts forward some legislative proposals to perfect the regulations in related areas.This study investigates the requirements of the organization system, technical system and legislative system needed to make the theory of pharmacovigilance of drug safety into practice. By reviewing the events of Xinfu and Qi-eryao, the paper demonstrates the feasibility and luciferous prospect of drug monitoring system providing pharmacovigilance for issues other than ADRs after being adjusted and consolidated.The objective of present theory of pharmacovigilance has not been very clear, and find difficult to move forward. The theory of pharmacovigilance of drug safety which is brought forward by this paper, provides a solution to this problem. The study has also provided a theoretic basis for the present theory of pharmacovigilance to gain more perspicuity and get into pratice.