Number of Drug Ingredients Providing Side Effect Information Expanded from 66 to 113

MFDS, Preventing Recurrence of Patient Harm

The Ministry of Food and Drug Safety, the Korea Institute of Drug Safety & Risk Management, and the Health Insurance Review & Assessment Service announced on the 24th that the number of drug ingredients subject to adverse reaction history information for patients in the 'Drug Utilization Review (DUR)' service, which is provided to medical staff in real time, has been expanded from the existing 66 to 113.

DUR (Drug Utilization Review) is a service that provides doctors and pharmacists with real-time drug safety information, such as drugs that cause adverse reactions when taken together. If a patient who has experienced adverse drug reactions is exposed again to the same or similar class of drugs, severe adverse reactions may occur.

Previously, since December 2020, the Ministry of Food and Drug Safety, the Korea Institute of Drug Safety & Risk Management, and the Health Insurance Review & Assessment Service have built a patient-specific adverse reaction database (DB) within the DUR system and provided medical staff with pop-up alerts containing adverse reaction information for patients who have received damage relief. However, because information on patients who received damage relief had to be exchanged through official documents between the Korea Institute of Drug Safety & Risk Management and the Health Insurance Review & Assessment Service, work efficiency was low, and there were difficulties in expanding the service, such as requiring patients to submit consent forms for providing personal information only in writing.

With this measure, from now on, adverse reaction information for all patients who have received damage relief will be managed and filtered within the DUR system, and information transmission and reception between institutions will be possible electronically, enabling more efficient provision of patients' adverse reaction information. Currently, there are a total of 113 drug ingredients for which the occurrence of adverse reactions and causality have been clearly recognized.

Oh Yu-kyung, Commissioner of the Ministry of Food and Drug Safety, said, "The types and degrees of adverse reactions that may occur after drug use can vary depending on an individual's underlying diseases and health conditions, so building and providing personalized adverse reaction information is very important," adding, "We will continue to improve and develop related systems and policies to ensure that drugs that caused adverse reactions are not prescribed again to patients who have received damage relief for drug adverse reactions."

This content was produced with the assistance of AI translation services.