Dataset Information

Analysis of Issues and Future Trends Impacting Drug Safety in South Korea.

ABSTRACT: New drug safety issues are emerging that are beyond the existing medication safety management system. To pre-empt these problems, forecasting future drug safety trends and issues is a necessity. The objective of this study was to identify issues and future trends impacting drug safety using foresight methodologies. The study started by identifying global megatrends, trends in safety management of medicines, and key issues in drug safety. A total of 25 global megatrends were selected by extracting and clustering keywords from 26 reports concerning the future. Using the text-mining method, 10 trends in drug safety were identified from 3593 news articles. This study derived 60 issues which can arise from the trends, and finally, the 20 key issues with the highest urgency and impact scores were selected. Some examples of issues with high scores were as follows: illegal distribution of medicines, lack of technology for managing and utilizing big data, change in the pharmaceutical trade environment, lack of education and safety management for specific populations, lack of artificial intelligence-based technology for the safety management of medicines, and the prevalence of drug advertisements through social network services. The key issues could be used to establish plans for medication safety management.

SUBMITTER: Kim MG

PROVIDER: S-EPMC6765849 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Analysis of Issues and Future Trends Impacting Drug Safety in South Korea.

Kim Myeong Gyu MG Huh Seungyeon S Han Nayoung N Kim Jae Hyun JH Kim Kyungim K Lee Euni E Kim In-Wha IW Oh Jung Mi JM

International journal of environmental research and public health 20190912 18

New drug safety issues are emerging that are beyond the existing medication safety management system. To pre-empt these problems, forecasting future drug safety trends and issues is a necessity. The objective of this study was to identify issues and future trends impacting drug safety using foresight methodologies. The study started by identifying global megatrends, trends in safety management of medicines, and key issues in drug safety. A total of 25 global megatrends were selected by extractin ...[more]

PMID: 31547245

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Project description:Europe, the United States (U.S), and Korea each maintain post-marketing surveillance (PMS) systems to monitor rare or unexpected adverse events. Korea's PMS mainly involves a re-examination system to identify new adverse events not seen in pre-market trials during the early stages of post-marketing drug use, along with the risk management plan (RMP), a comprehensive strategy using methods like signal detection to regularly assess safety and benefit-risk throughout the drug's lifecycle. This study compares the post-marketing safety issues associated with dapagliflozin as identified by the European Medicines Agency (EMA), the U.S Food and Drug Administration (FDA), and in Korea. To identify these safety issues, we reviewed the safety concerns listed in the European Union RMP (EU-RMP), adverse events noted in the Warnings and Precautions section of the U.S FDA drug label, and use-result surveillance results detailed in the Korean Ministry of Food and Drug Safety drug label. Additionally, we used Korean Adverse Event Reporting System (KAERS) data to detect safety signals. We manually matched and compared safety issues identified by the EMA and FDA with those recognized in Korea. For safety issues unique to Korea, we compared KAERS signals with the results from use-result surveillance. We compared 17 EMA/FDA safety issues with 38 KAERS signals and 231 results from use-result surveillance. While there was a significant concordance (71%) between the safety issues identified by the EMA/FDA and those in Korea, Korean safety issues had limitations in capturing long-term outcomes and laboratory results. Some safety issues that were initially recognized in the EU-RMP and FDA drug labels were no longer found in the latest documents. To enhance PMS in Korea, it is necessary to establish more specific laws and regulations and develop detailed guidelines that utilize a variety of real-world data and research methodologies to continuously assess causality throughout the product lifecycle.

Dataset Information

Analysis of Issues and Future Trends Impacting Drug Safety in South Korea.

Publications

Analysis of Issues and Future Trends Impacting Drug Safety in South Korea.

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