Despite extensive researches and pre-market clinical trials, only limited information on the adverse drug reactions (ADRs) of a drug can be collected at the time of market approval from regulatory agency. ADRs constitute a major public health problem. Post-marketing surveillance of drugs is important to detect signals for ADR. In Korea, one of the main methods for monitoring the safety of marketed drugs is spontaneous reporting system of suspected ADRs. Re-examination and re-evaluation system are in force for monitoring safety of new market approval drugs and currently under marketing drugs, respectively. Recently, regional pharmacovigilance centers were designated from Korean Food and Drug Administration for facilitating ADR surveillance. Over recent years, with the development of information technology, there has been an increased interest in establishing data mining system for detecting signals from Health Insurance Review Agency database. The purpose of this paper is to review the current status of Korean ADR surveillance system and suggest the possible solutions for developing active pharmacovigilance system in Korea.
Adverse Drug Reaction Reporting Systems/*organization & administration ; Humans ; Information Systems/organization & administration ; Korea/epidemiology ; Product Surveillance, Postmarketing ; Public Health Informatics/organization & administration

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

As an essential part of patient safety, pharmacovigilance is of worldwide interest and should expand its scope and focus on new emerging issues. South Korea has been making continuous efforts in the field of pharmacovigilance for the last 3 decades since voluntary adverse drug reaction (ADR) reporting system was first launched in 1988. Korea joined the World Health Organization Program for International Drug Monitoring in 1992, and the activities of Pharmacovigilance Research Network, Korean Society for Pharmacoepidemiology and Risk Management, and Regional Pharmacovigilance Center (RPVC) have contributed to the remarkable progress in the pharmacovigilance area and global status. RPVCs have played pivotal roles in establishment of pharmacovigilance system in Korea by monitoring voluntary ADR reports. RPVCs started with 3 hospitals in 2006 and have now expanded to 27 hospitals nationwide. The Korea Institute of Drug Safety & Risk Management was established in 2012 and in charge of operating the decentralized national pharmacovigilance system. The voluntary report of ADR, which is the basis of current pharmacovigilance system, has various limitations and an active surveillance system can be the overarching alternative. This change in pharmacovigilance paradigm is a global trend and Korea has excellent infrastructure such as broad distribution of electronic medical recording systems and a nationwide single healthcare insurance. As a result, the pharmacovigilance in Korea is now expected to progress to a new active surveillance system from traditional spontaneous reporting system.
Adverse Drug Reaction Reporting Systems ; Delivery of Health Care ; Drug Monitoring ; Drug-Related Side Effects and Adverse Reactions ; Electronic Health Records ; Insurance ; Korea ; Patient Safety ; Pharmacoepidemiology ; Pharmacovigilance ; Risk Management ; World Health Organization

OBJECTIVE: To examine the characteristics of drug-induced fatal adverse effects in the United States from 1999 to 2004 and put forward suggestions for China's control of drug-induced adverse effects. METHODS: The data came from the compressed mortality file of Centers for Disease Control and Prevention (CDC) of the United States. Drug-induced mortality was used to analyze the effects of gender, race, age, and drug on drug-induced fatal adverse effects. RESULTS: During 1999-2004, 1 700 persons died of drug-induced adverse effects (mortality, 0.10/100,000). No difference was found in mortality between males and females. The drug-induced mortalities of whites, blacks and Native Americans, and other racial groups were respectively 0.10, 0.12, and 0.04 per 100,000 persons. The mortality increased quickly with the increase of age since the age group of 5-9. In this period, the 5 most common drugs that led to deaths were: (1) agents primarily affecting blood constituents; (2) analgesics, antipyretics, and anti-inflammatory drugs; (3) primarily systemic agents; (4) systemic antibiotics; and (5) hormones and their synthetic substitutes and antagonists, not elsewhere classified. At the age group of 20-84, 3 most common drugs leading to deaths for whites were: anticoagulants,opioids and related analgesics, and insulin and oral hypoglycaemic drugs. For blacks and Native Americans, they were: hydantoin derivatives, anticoagulants, and anaesthetic, unspecified. For people ages older than 84, anticoagulants, opioids and related analgesics, and drug or medicament, unspecified, were the 3 most common drugs resulting in deaths. For the rest of racial groups, the number of deaths caused by all kinds of drugs was less than 3. CONCLUSION Obvious differences on race, gender, age, and drug were found for drug-induced fatal adverse effects in the United States during 1999-2004, and these differences should be considered by the government when interventions are developed. China can learn something from the United States in controlling drug adverse effects, and improve its surveillance system of drug adverse effects as soon as possible.
Adolescent ; Adult ; Adverse Drug Reaction Reporting Systems ; organization & administration ; Aged ; Aged, 80 and over ; Analgesia ; adverse effects ; Anticoagulants ; adverse effects ; Child ; Child, Preschool ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; etiology ; mortality ; Female ; Humans ; Male ; Middle Aged ; United States ; epidemiology ; Young Adult