Serious Adverse Drug Events Account for 13% of Cases... Highest Rate in First Half of This Year

Park Heeseung's Office:
"Relief system exists, but public awareness remains low"

The proportion of "serious adverse events," such as shortness of breath, among drug side effects has reached its highest level so far this year. Although causal relationships in serious adverse events can be investigated through the drug side effect relief system, experts point out that the public's low awareness of the system limits the effectiveness of relief efforts.

According to data submitted by Park Heeseung, a member of the National Assembly's Health and Welfare Committee from the Democratic Party of Korea, to the Ministry of Food and Drug Safety on October 21, a total of 2,968,865 cases of drug adverse events were reported from 2015 to June of this year. Of these, 292,136 were serious adverse events, accounting for 9.8% of all reported cases.

Last year, a total of 253,486 drug adverse events were reported, with serious adverse events making up 12.1% (30,705 cases). From January to June this year, there were 132,826 reported adverse events, with serious adverse events accounting for 12.9% (17,160 cases), the highest proportion in the past 11 years.

Serious adverse events are defined under the "Regulations on the Safety of Drugs, etc." as cases that result in death or are life-threatening, require hospitalization or extension of hospitalization, cause persistent or significant disability or functional impairment, cause congenital anomalies or defects, lead to drug dependence or abuse, blood disorders, or any other medically significant situation requiring treatment.

The government operates a drug side effect relief system. This system compensates patients and their families who suffer serious harm such as death, disability, or hospitalization, even when drugs are used appropriately.

Accordingly, from 2015 to August of this year, a total of 1206 cases received relief payments amounting to 18.865 billion won. By type, there were 124 cases of death (12.03 billion won), 123 cases of funeral expenses (1.073 billion won), 38 cases of disability (2.913 billion won), and 921 cases of medical treatment (2.858 billion won).

During the same period, drug epidemiologists conducted a total of 1,443 causality assessments, with 1,207 cases recognized as having a causal relationship, resulting in a recognition rate of 83.6%.

However, a 2022 nationwide survey on public awareness by age group showed that awareness of the relief payment system among those in their 30s and 40s was only 42.2%, indicating that overall awareness remains low.

Park Heeseung stated, "Even when using approved and appropriate drugs, so-called adverse events that are unintended and undesirable can occur, but it is virtually impossible for patients or their families to directly prove causality. Therefore, it is essential to raise public awareness of the drug side effect relief payment system, and given the high recognition rate when causality is investigated, more active investigations should be conducted."

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