New initiatives for pharmacovigilance in South Korea: introducing the Korea Institute of Drug Safety and Risk Management (KIDS)

Shin, Ju‐Young; Jung, Soyoung; Ahn, So-Hyeon; Lee, Shin Haeng; Kim, Sujin; Seong, Jong-Mi; Chung, Sang-Min; Park, Byung Joo

doi:10.1002/pds.3715

Cited by 34 publications

(30 citation statements)

References 22 publications

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“…The public announcement defined age‐contraindicated drugs as drugs that should not be prescribed or dispensed for patients in a certain age group because of the lack of proof of safety and their potential effects on the growth of children and adolescents. Criteria for age contraindication were established based on the label information from eight countries including Korea, Japan, USA, and the UK, literature review, and expert review …”

Section: Methodscontrasting

confidence: 74%

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Decrease in use of contraindicated drugs with automated alerts in children

Song

Shin

2017

Pediatrics International

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Section: Methodscontrasting

confidence: 74%

“…Criteria for age contraindication were established based on the label information from eight countries including Korea, Japan, USA, and the UK, literature review, and expert review. 14…”

Section: Subjectsmentioning

confidence: 99%

Decrease in use of contraindicated drugs with automated alerts in children

Song

Shin

2017

Pediatrics International

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“…Every medical institution and pharmacy in Korea has a computer system linked to the DUR system of the Health Insurance Review and Assessment (HIRA) for real‐time transmission of prescribing and dispensing information. The system generates alerts according to predefined DUR criteria at the time of prescription and dispensing (11). Until 2012, the system was concerned with drug‐drug interactions, contraindications in specific populations, and duplication of the same drug.…”

Section: Introductionmentioning

confidence: 99%

Effect of a Nationwide Real‐Time Drug Utilization Review System on Duplicated Nonsteroidal Antiinflammatory Drug Prescriptions in Korea

Jung

Jang

Choi

et al. 2020

Arthritis Care & Research

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Objective Since January 2013, a nationwide drug utilization review (DUR) system for therapeutic duplication (TD) of nonsteroidal antiinflammatory drugs (NSAIDs) has been implemented in Korea. Our objective was to perform an interrupted time series study to assess changes in the pattern of NSAIDs use in knee osteoarthritis patients after implementation of the regulations. Methods We compared the prescribing patterns in 2012 and 2013 by means of an interrupted time series study, using the Health Insurance Review and Assessment Service database. TD was defined as use of concurrent NSAIDs either on the same or on different prescriptions for >3 days in a patient. Level change and trend change (with 95% confidence intervals [95% CIs]), and absolute and relative changes in the proportion of TDs, were estimated using segmented regression models. Multivariable logistic regression models were used to explore patient and provider characteristics associated with the TDs. Results Approximately 2.5 million patients were prescribed NSAIDs in both 2012 and 2013. The proportion of TDs before and after introduction of the DUR system was 7.4% and 5.6%, respectively. Overall, an absolute reduction of 89% and a relative reduction of 30% in TDs were observed. In the postregulation period, older patients, medical aid subscribers (odds ratio [OR] 1.87 [95% CI 1.84, 1.90]), and veterans (OR 3.28 [95% CI 3.10, 3.46]) were most likely to receive NSAID TDs. Conclusion The prescription of NSAID TDs decreased with the introduction of the nationwide DUR system. Continuous adherence to the DUR regulations and safety monitoring are needed, especially with the elderly, medical aid subscribers, and veterans.

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“…On July 28, 2015, the Ministry of Food and Drug Safety (MFDS) in South Korea announced a list of medicines that should be used with caution for the elderly aged 65 years or more; the list included all the TCAs used to treat depression in South Korea. Since October 1, 2015, nearly every prescriber who prescribes TCAs to the outpatients aged 65 years or more receives the following real-time pop-up window by a nationwide computerized drug utilization review (DUR) monitoring system [ 9 ]: “TCAs should be cautiously administered at low doses to the elderly because of adverse events such as orthostatic hypotension, stagger, dry mouth, dysuria, constipation, and increased intraocular pressure due to an anticholinergic effect.”…”

Section: Introductionmentioning

confidence: 99%

Effect of providing drug utilization review information on tricyclic antidepressant prescription in the elderly

et al. 2018

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Tricyclic antidepressants are known as potentially inappropriate medications in the elderly. A notification issued in July 2015 in South Korea recommended caution while prescribing tricyclic antidepressants to the elderly. Further, since October 2015, the nationwide computerized drug utilization review monitoring system provides a pop-up window, on a real-time basis, whenever tricyclic antidepressants are prescribed to elderly outpatients. Therefore, we evaluated whether providing drug utilization review information was effective in reducing tricyclic antidepressant prescription to elderly outpatients. We used the Health Insurance Review and Assessment Service-Adult Patient Sample data from 2014 to 2016. Data related to the prescription of tricyclic antidepressants to outpatients aged 65 years or more were extracted. We determined the number of prescriptions per day per 100,000 elderly patients in each month, compared the average number of prescriptions before and after the drug utilization review information was provided, and evaluated the changes in the number of prescriptions by using an interrupted time series analysis. The average number of tricyclic antidepressant prescriptions per day per 100,000 elderly patients decreased from 76.6 (75.5 to 77.6) to 65.7 (64.5 to 66.9), a 14.2% reduction after the provision of drug utilization review information started. Following initiation of provision of drug utilization review information, there was an immediate drop of 9.2 tricyclic antidepressant prescriptions per day per 100,000 elderly patients, whereas there was no statistically significant change in trends. Providing the drug utilization review information on tricyclic antidepressant prescription for the elderly contributed to the reduction in tricyclic antidepressant prescriptions.

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New initiatives for pharmacovigilance in South Korea: introducing the Korea Institute of Drug Safety and Risk Management (KIDS)

Abstract: The KIDS will continue to contribute to the improvement of Korean pharmacovigilance by collecting, managing, and analyzing consumer-centered drug safety information.

Cited by 34 publications

References 22 publications

Decrease in use of contraindicated drugs with automated alerts in children

Decrease in use of contraindicated drugs with automated alerts in children

Effect of a Nationwide Real‐Time Drug Utilization Review System on Duplicated Nonsteroidal Antiinflammatory Drug Prescriptions in Korea

Effect of providing drug utilization review information on tricyclic antidepressant prescription in the elderly

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