ABSTRACT
Objective@#To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. @*Methods@#We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. @*Results@#All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. @*Conclusion@#All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission.Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.
ABSTRACT
Objective@#To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. @*Methods@#We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. @*Results@#All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. @*Conclusion@#All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission.Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.
ABSTRACT
OBJECTIVE: This study analyzed the national claims data of veterans to generate scientific evidence of the trends and appropriateness of their drug utilization in an outpatient setting. METHODS: The claims data were provided by the Health Insurance Review & Assessment (HIRA). Through sampling and matching data, we selected two comparable groups; Veterans vs. National Health Insurance (NHI) patients and Veterans vs. Medical Aid (MAID) patients. Drug use and costs were compared between groups by using multivariate gamma regression models to account for the skewed distribution, and therapeutic duplication was analyzed by using multivariate logistic regression models. RESULTS: In equivalent conditions, veteran patients made fewer visits to medical institutions (0.88 vs. 1), had 1.86 times more drug use, and paid 1.4 times more drug costs than NHI patients (p < 0.05); similarly, veteran patients made fewer visits to medical institutions (0.96 vs. 1), had 1.11 times more drug use, and paid 0.95 times less drug costs than MAID patients (p < 0.05). The risk of therapeutic duplication was 1.7 times higher (OR=1.657) in veteran patients than in NHI patients and 1.3 times higher (OR=1.311) than in MAID patients (p < 0.0001). CONCLUSION: Similar patterns of drug use were found in veteran patients and MAID patients. There were greater concerns about the drug use behavior in veteran patients, with longer prescribing days and a higher rate of therapeutic duplication, than in MAID patients. Efforts should be made to measure if any inefficiency exists in veterans' drug use behavior.