1.Regional PV Center
1) Introduction of Regional PV Center·
Decentralized Pharmacovigilance System is the operating system in South Korea. In this system, central center functions as a focal point for regional centers and collects data from each center. The regional center, such as a local teaching hospital, is called Regional Pharmacovigilance Center (RPVC).·
Each RPVC monitors AE reports within the center and also outside reports from local clinics and pharmacies. It performs an intensive monitoring on special populations(pediatrics, geriatrics, etc) or special medicinal products designated by MFDS(Ministry of Food and Drug Safety) and offers consultations to reporters and consumers as well. Finally, it puts emphasis on education and promotional campaign to stimulate the pharmacovigilance activities.·
Starting from 3 RPVCs designated from KFDA(now, MFDS) in 2006, the number of centers gradually increased to 6 in 2007 and to 9 in 2008. During 2009~2011, it increased to 20 centers through Pharmacovigilance Research Network(PVNet).·
Starting from 2012, the Korea Institute of Drug Safety and Risk Management(KIDS) has took the role of central center that manages RPVCs-22 RPVCs in 2013, 27 RPVCs in 2014.
2. Regional PV centers’ AE reporting system and current activities
1) RPVC AE reporting system·
Individual center of the RPVC has electronic AE reporting system. Each center builds collaborative relationships with local healthcare providers to stimulate voluntary AE reporting.
2) Current AE reporting collection, evaluation, and achievement·
The number of voluntary AE reports, around 1000 reports per year in 2005, has been significantly increased with initiation of RPVC in late 2006. Significant increase in the number of voluntary AE reports (more than 3,000 reports/year) within short period of regional PV center involvement testifies the importance of RPVCs in stimulating AE monitoring.
3) Drug-AE intensive monitoring·
RPVCs continuously conduct intensive monitoring in special medicines and special population, especially for pediatrics and geriatrics.·
➀ Special medicinal products designated by MFDS (oral contraceptives, appetite suppressant, NSAIDs, angiotensin II Receptor Antagonist, etc)·
➁ Special population (pediatrics, geriatrics, etc)
4) Surveillance of Drug-AEs and Education/Promotions·
In RPVCs, education and promotional campaigns regarding the importance of pharmacovigilance are done periodically.·
The activities are as follows: production and distribution of newsletters, press-release update in the bulletin.