Past, present, and future of pharmacovigilance in Korea

Abstract

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.

Severe Cutaneous Adverse Reactions to Anti-tuberculosis Drugs in Korean Patients

“…Established in 2014, the Korean registry of SCARs includes 36 referral hospitals and enrolled SCAR cases (indicated by allergy specialists) occurring between 2010 and 2015. 9 Clinical information, causative drugs, and the causal relationship between offending drug and the reactions were assessed by allergy specialists at each hospital, and pharmacovigilant nurses reported information on affected patients to the online registry. 10 A diagnosis of SJS and TEN was based on the diagnostic criteria proposed by the RegiSCAR study group.…”

Severe Cutaneous Adverse Reactions to Antiepileptic Drugs: A Nationwide Registry-Based Study in Korea

“…A web-based Korean SCARs registry was built in 2014. This registry was based on the Regional Pharmacovigilance Center (RPVC) pilot project of the Korean Food and Drug Administration (KFDA) which has played a crucial role in the Korean Pharmacovigilance System Administration 16. Thirty-six general hospitals, including 27 RPVC, participated in the Korean SCARs registry, which was opened for enrollment of the SCAR cases occurring between 2010 and 2015.…”

Exploration of Perception, Need and Barriers against Pharmacovigilance and Adverse Drug Reactions Reporting: Healthcare Professionals’ Insight

“…China has developed online spontaneous self-reporting Adverse Drug Reaction (ADR) Monitoring System in 2003. Although still the ADR reporting is not mandatory but even though extensive improvement in practicing ADRs monitoring and PV has shown great progress [17,18]. Similarly many countries have started active pharmacovigilance programs at their national level and also in collaboration with international authorities of WHO for drug safety and risk management [19].…”