Following more and more new drugs are authorized into market, new, serious or unexpected adverse drug reactions appear frequently, which is a serious threat to people health and life. Through making laws and guidelines, governments of various countries aim to strengthen and standardize the surveillance and reporting of postmarketing drugs. The drugs management department of our country are doing related jobs positively, but there are some problems, such as drug risk-menagement is not emphasized well, and the management department lacks clarity on operating related regulations. This article tries to explore foreign countries' laws and regulations on the surveillance and reporting of postmarketing drugs, aiming to provide reference for our courtry.
Adverse Drug Reaction Reporting Systems ; legislation & jurisprudence ; organization & administration ; China ; Humans ; Internationality ; legislation & jurisprudence ; Legislation, Drug ; Marketing of Health Services

China ; Humans ; Occupational Diseases ; prevention & control ; Occupational Health ; legislation & jurisprudence ; Occupational Health Services ; organization & administration ; standards

OBJECTIVE: To investigate the basic principles and important rules of forensic identification of adverse drug events and to accumulate basic data and to provide references for forensic identification of similar cases. METHODS: Thirty-three cases of adverse drug events in our forensic identification files were retrospectively reviewed, analyzed, and summarized. RESULTS: There were 27 live and 6 dead victims included in this study. Our study showed a gradually increasing numbers of adverse drug cases in forensic identification year by year with a slight female predominance (20/33 cases, 60.6%). Of the 33 victims, nearly two-thirds (21/33, 63.6%) were due to hospital errors including only one case of drug overdose (1/21, 4.8%), whereas the rest were not related to the hospital errors. Eight cases (8/33, 24.2%) were caused by illegal medical practitioners due to improper use of medication. CONCLUSION Investigators need to pay more attention to the characteristics and complexities of adverse drug events on a case by case basis encountered in increasing numbers of more and more such forensic identification.
Adult ; Drug-Related Side Effects and Adverse Reactions ; Expert Testimony ; Female ; Forensic Medicine ; Health Services Administration/legislation & jurisprudence* ; Humans ; Male ; Malpractice/statistics & numerical data* ; Medical Errors/prevention & control* ; Middle Aged ; Retrospective Studies ; Risk Factors ; Sex Distribution ; Young Adult