Yakhak Hoeji最新文献

Analysis of the Time Interval Between IND Approval and Clinical Trial Initiation IND批准和临床试验启动之间的时间间隔分析

Yakhak Hoeji Pub Date : 2025-06-30 DOI: 10.17480/psk.2025.69.3.256

The Pharmaceutical Society Of Korea, Saemi Cho, Sang-Won Lee

引用次数: 0

Association of Osteoporosis-related Healthcare Costs with the Use of Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide in Chronic Hepatitis B Patients: a Population-based National Cohort Study in Korea 慢性乙型肝炎患者使用富马酸替诺福韦二吡呋酯和替诺福韦阿拉非那胺与骨质疏松症相关医疗费用的关系：韩国一项基于人口的全国队列研究

Yakhak Hoeji Pub Date : 2024-02-28 DOI: 10.17480/psk.2024.68.1.26

You Ran Noh, Hae Sun Suh

{"title":"Association of Osteoporosis-related Healthcare Costs with the Use of Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide in Chronic Hepatitis B Patients: a Population-based National Cohort Study in Korea","authors":"You Ran Noh, Hae Sun Suh","doi":"10.17480/psk.2024.68.1.26","DOIUrl":"https://doi.org/10.17480/psk.2024.68.1.26","url":null,"abstract":"Long-term administration of tenofovir disoproxil fumarate (TDF) for chronic hepatitis B (CHB) may lead to bone mineral density loss. Tenofovir alafenamide (TAF) developed to address these concerns. This study aimed to investigate whether there is a significant difference in osteoporosis-related healthcare costs between CHB patients treated with TDF and TAF. This study is a retrospective cohort study using claims data from the Health Insurance Review and Assessment Service (HIRA) covering the entire population in Korea. The cohort included CHB patients treated with TDF or TAF from November 2017 to April 2022. We applied inverse probability of treatment weighting (IPTW) to balance baseline characteristics observed for one-year preceding prescription date. Osteoporosis-related costs per patient per year (PPPY) included all healthcare costs with an osteoporosis diagnosis code including outpatient and hospitalization costs. 7,172 and 3,837 patients were administered TDF and TAF respectively. After IPTW, TDF group had higher outpatient costs ($11.2) compared to TAF group ($6.1), but the difference was not statistically significant (p=0.1001). The total hospitalization cost was $24.6 in TDF group and $9.8 in TAF group, not statistically significant (p=0.1633). This largescale population-based study found no significant difference in osteoporosis-related healthcare costs between CHB patients treated with TDF and TAF.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"113 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140418428","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Comparative Review of Added Health Benefits of the Drugs Listed through Economic Evaluation Exemption Procedure in Korea: Cases of France, Germany, and Canada 对韩国通过经济评估豁免程序上市的药品的附加健康益处进行比较审查：法国、德国和加拿大的案例

Yakhak Hoeji Pub Date : 2024-02-28 DOI: 10.17480/psk.2024.68.1.62

Eun-Young Bae, Sohee Cha, Hwa-Ryeong Lim, Hyejin Lee, Jihyung Hong

{"title":"Comparative Review of Added Health Benefits of the Drugs Listed through Economic Evaluation Exemption Procedure in Korea: Cases of France, Germany, and Canada","authors":"Eun-Young Bae, Sohee Cha, Hwa-Ryeong Lim, Hyejin Lee, Jihyung Hong","doi":"10.17480/psk.2024.68.1.62","DOIUrl":"https://doi.org/10.17480/psk.2024.68.1.62","url":null,"abstract":"This study assessed the additional health benefits of the drugs listed through the Economic Evaluation Exemption Procedure (EEEP) in Korea. We conducted a comparative review of 32 EEEP drugs listed between May 2015 and July 2022, comparing how they were assessed in France, Germany, and Canada. To collect the data, we reviewed the evaluations conducted by the relevant agency in each country and identified if the additional benefit exists and how significant it is. Additionally, the size of the benefit gains assessed by each agency was categorized as “High” or “Low,” allowing us to evaluate the consistency among these countries. In France, only 38% of the 34 drugs compared demonstrated moderate or higher levels of additional benefit. Germany acknowledged substantial benefit improvement in 27% of the 30 drugs assessed, while 73% showed minor, unquantifiable, or no additional benefits. In Canada, 5 out of 22 cases have been identified as providing significant additional benefit. The level of inter-country consistency in the assessment results from these three countries was somewhat limited. Based on the evaluation results in France, Germany, and Canada, the additional benefits of EEEP drugs over existing treatments were not substantial in many cases. Even though the EEEP was introduced to improve accessibility to high-cost drugs for medical conditions with unmet needs, it is necessary to reconsider whether to allow exceptions for drugs with low therapeutic value.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"57 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140420717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Effect of Oleanolic Acid on the Gene Expression of Pulmonary MUC5AC Mucin through IKK/IκBα/NF-κB p65 in Human Airway Epithelial Cells 齐墩果酸通过IKK/ i -κB α/NF-κB p65对人气道上皮细胞肺MUC5AC粘蛋白基因表达的影响

Yakhak Hoeji Pub Date : 2023-12-31 DOI: 10.17480/psk.2023.67.6.335

The Pharmaceutical Society Of Korea, Hyun Jae Lee, Choong Jae Lee

{"title":"Effect of Oleanolic Acid on the Gene Expression of Pulmonary MUC5AC Mucin through IKK/IκBα/NF-κB p65 in Human Airway Epithelial Cells","authors":"The Pharmaceutical Society Of Korea, Hyun Jae Lee, Choong Jae Lee","doi":"10.17480/psk.2023.67.6.335","DOIUrl":"https://doi.org/10.17480/psk.2023.67.6.335","url":null,"abstract":"In the present study, we investigated whether oleanolic acid, an anti-inflammatory natural product, significantly affects the phorbol 12-myristate 13-acetate (PMA)-induced gene expression of airway MUC5AC mucin. Confluent NCIH292 cells were pretreated with oleanolic acid for 30 min and then stimulated with PMA for 24 h or the indicated periods. The MUC5AC mucin mRNA expression was measured by RT-PCR. Production of MUC5AC mucin protein was measured by ELISA. To elucidate the action mechanism of oleanolic acid, effect of oleanolic acid on PMA-induced NF-B signaling pathway was investigated by western blot analysis. The results were as follows: (1) Oleanolic acid significantly inhibited the production of MUC5AC mucin protein and down-regulated the expression of MUC5AC mucin mRNA; (2) Oleanolic acid inhibited PMA-induced activation (phosphorylation) of inhibitory kappa B kinase (IKK), and thus phosphorylation and degradation of inhibitory kappa Ba (IB); (3) Oleanolic acid inhibited PMA-induced nuclear translocation of nuclear factor kappa B (NF-B) p65, led to the down-regulation of MUC5AC mucin gene expression in NCI-H292 cells. These results suggest that oleanolic acid can regulate the gene expression of mucin by acting on airway epithelial cells through regulation of NF-B signaling pathway.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"67 6","pages":"335-341"},"PeriodicalIF":0.0,"publicationDate":"2023-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147898762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Immunization Status of the 23-Valent Pneumococcal Polysaccharide Vaccine among Elderly Aged 65 and Older in South Korea 韩国65岁及以上老年人23价肺炎球菌多糖疫苗免疫现状

Yakhak Hoeji Pub Date : 2023-08-31 DOI: 10.17480/psk.2023.67.4.277

Jeong Ah Kim, Heehyun Won, Na-Young Jeong, Nam-Kyong Choi

{"title":"Immunization Status of the 23-Valent Pneumococcal Polysaccharide Vaccine among Elderly Aged 65 and Older in South Korea","authors":"Jeong Ah Kim, Heehyun Won, Na-Young Jeong, Nam-Kyong Choi","doi":"10.17480/psk.2023.67.4.277","DOIUrl":"https://doi.org/10.17480/psk.2023.67.4.277","url":null,"abstract":"The 23-valent pneumococcal polysaccharide vaccine (PPSV23) was introduced as part of Korea's national immunization program (NIP) in May 2013 for people aged 65 years and older. We aimed to describe the immunization status of Korean elderly aged 65 years and older who had received a first dose of PPSV23 via the NIP and to analyze the cumulative PPSV23 vaccination coverage rates. A descriptive study was conducted using the Korea Immunization Registry Information System. The study included adults aged 65 years and older who received at least one dose of PPSV23 between May 1, 2013, and December 31, 2020. During the study period, 6,705,624 elderly individuals received PPSV23, with 198,236 receiving it concurrently with other vaccines on the same day, most commonly with the influenza vaccine (n=175,118, 88.3%). Although the cumulative PPSV23 vaccination coverage rates for people aged 65 years and older have been steadily increasing, instances of non-adherence to the minimum intervals between pneumococcal vaccines have been observed. Therefore, education and promotion programs aimed at healthcare providers and the general public are needed to increase awareness. Furthermore, ongoing research on PPSV23 vaccination status for individuals aged 65 years and older and people at high risk for pneumococcal infection should be conducted.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"12 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87745262","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Korean Elderly’s Demand for Supplying Elderly-friendly Dosage Forms Easy to Swallow 韩国老年人对提供易于吞咽的老年人友好剂型的需求

Yakhak Hoeji Pub Date : 2023-08-31 DOI: 10.17480/psk.2023.67.4.244

Eun Joo Lee, Hyun Soon Sohn

{"title":"Korean Elderly’s Demand for Supplying Elderly-friendly Dosage Forms Easy to Swallow","authors":"Eun Joo Lee, Hyun Soon Sohn","doi":"10.17480/psk.2023.67.4.244","DOIUrl":"https://doi.org/10.17480/psk.2023.67.4.244","url":null,"abstract":"As the population ages, it has become increasingly important to provide elderly-friendly dosage forms (EFDF) that are easy to take and promote medication adherence to achieve treatment goals. This cross-sectional questionnaire study, conducted during October to November 2021, aimed to investigate the demand for EFDF among elderly individuals aged 65 years or older. Of the 421 respondents, 81.9% were prescription drug users, 34.9% experienced difficulty swallowing pills, and 26.8% had previous experience of not taking medication due to swallowing problems. 64.1% of respondents agreed to necessity of EFDF easy to swallow than oral solid form, their preferred dosage forms were powder (19.7%) and liquid (57.7%). Furthermore, 51.8% showed willingness to pay additional cost for EFDF. The demand for EFDF was significantly higher in women, facility residents such as nursing homes, elderly living alone, and elderly had difficulties in swallowing and experiences of not taking pills. Considering the elderly themselves personal preferences and improvement of medication adherence, we suggest that pharmaceutical industry and government begin further discussion on EFDF more positively.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"55 2 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78327380","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Analysis of Medical and Pharmaceutical Expenses for Lung Cancer Before and After the Introduction of Immunotherapy 肺癌引入免疫治疗前后的医疗药费分析

Yakhak Hoeji Pub Date : 2023-08-31 DOI: 10.17480/psk.2023.67.4.224

Seongmi Jeon, Mi-Hai Park

{"title":"Analysis of Medical and Pharmaceutical Expenses for Lung Cancer Before and After the Introduction of Immunotherapy","authors":"Seongmi Jeon, Mi-Hai Park","doi":"10.17480/psk.2023.67.4.224","DOIUrl":"https://doi.org/10.17480/psk.2023.67.4.224","url":null,"abstract":"Lung cancer has been the leading cause of cancer-related deaths in Korea and is considered one of the world’s most costly cancer to treat. Novel insights into the molecular biology of lung cancer discovered in recent years have facilitated the use of targeted therapy and immunotherapy, arousing concerns over the financial burden of patients due to high healthcare costs. Using HIRA-NPS (Health Insurance Review & Assessment Service-National Patient Sample) database from 2015 to 2020, we analyzed lung cancer patients’ both medical and pharmaceutical expenditures. This study focused on targeted therapies and immunotherapies and compared these expenditures before and after the introduction of immunotherapy. In our analysis, the number of patients prescribed targeted drugs and immunotherapies for lung cancer continues to increase yearly, and consequentially pharmaceutical expenses are also on the rise. An interrupted time series analysis showed pharmaceutical expenditures for lung cancer increased immediately after the introduction of immunotherapy and have continued to increase since then, while total medical expenses, medical and pharmaceutical expenses per patient have not shown any further increase after the immediate increase. The number of patients in immunotherapy has increased but there is little change in drug prices, such as drug price cuts or the entry of more expensive drugs, so the spending per patient has not consistently increased.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89620247","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Recent Issues and Regulatory Requirements of Data Integrity in Pharmaceutical Industry 制药行业数据完整性的最新问题和监管要求

Yakhak Hoeji Pub Date : 2023-08-31 DOI: 10.17480/psk.2023.67.4.215

Woung Choi, Min Kim, Dong Hee Na

{"title":"Recent Issues and Regulatory Requirements of Data Integrity in Pharmaceutical Industry","authors":"Woung Choi, Min Kim, Dong Hee Na","doi":"10.17480/psk.2023.67.4.215","DOIUrl":"https://doi.org/10.17480/psk.2023.67.4.215","url":null,"abstract":"Pharmaceutical manufacturers are responsible for providing safe and effective high-quality products to patients and consumers by assuring that decisions on production and distribution of products are based on accurate, reliable, truthful, and complete data. Nevertheless, in recent years, regulatory authorities have increasingly observed good manufacturing practice (GMP) violations related to data integrity during GMP inspections. This is problematic since ensuring data integrity is a mandatory requirement to assure the safety, efficacy, and quality of drug products. The breaches in data integrity found during inspections have set off the need to publish more detailed guidance documents that describe more clearly the regulatory expectations in GMP-related systems. With new awareness derived from recent regulatory restrictions, industry uses state-of-the-art technology to improve processes and establish systems for detection and mitigation of gaps that affect data integrity in paper and computerized systems. Recently issued guidances by regulatory agencies emphasize the importance of good laboratory and manufacturing documentation practices. The main purpose of regulatory requirements remains confident in the quality and integrity of the data generated to ensure patient safety and product quality. This review summarizes data integrity guidances and risk assessment that facilitate firms to develop robust data integrity management system with both manual processes with paper records and computerized systems.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"23 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80757719","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The Societal/economical Impact of Trastuzumab-deruxtecan in Patients with Human Epidermal Growth Factor Receptor2-positive Metastatic Breast Cancer 曲妥珠单抗-德鲁司替康对人表皮生长因子受体2阳性转移性乳腺癌患者的社会/经济影响

Yakhak Hoeji Pub Date : 2023-08-31 DOI: 10.17480/psk.2023.67.4.252

Ahhyung Choi, Hwa Yeon Ko, Bin Hong, Ji-Hwan Bae, In-Sun Oh, Sun-Kyeong Park, Yeon Hee Park, Ju-Yong Shin

{"title":"The Societal/economical Impact of Trastuzumab-deruxtecan in Patients with Human Epidermal Growth Factor Receptor2-positive Metastatic Breast Cancer","authors":"Ahhyung Choi, Hwa Yeon Ko, Bin Hong, Ji-Hwan Bae, In-Sun Oh, Sun-Kyeong Park, Yeon Hee Park, Ju-Yong Shin","doi":"10.17480/psk.2023.67.4.252","DOIUrl":"https://doi.org/10.17480/psk.2023.67.4.252","url":null,"abstract":"In the recent DESTINY-Breast03 trial, trastuzumab deruxtecan (T-DXd) has shown significantly prolonged progression free survival (PFS) compared with trastuzumab emtansine (T-DM1) among human epidermal growth factor2- positive metastatic breast cancer (HER2+ MBC) patients. While there is clear evidence of the clinical benefits of T-DXd, evidence on societal effects that go beyond these clinical benefits is yet to be explored. Thus, we estimated the socioeconomic benefits of T-DXd compared to T-DM1 among HER2+ MBC patients. We first calculated the incremental health benefits that T-DXd generates compared to T-DM1 in terms of prolonged PFS. We then translated the incremental PFS into the time spent on paid work and unpaid work hours. Lastly, the overall societal impact of T-DXd was yielded by aggregating the potential gross domestic products that can be generated from both paid and unpaid work hours. We identified 2,212 patients who are eligible for the analyses. Overall, the prolonged PFS of T-DXd resulted in a socioeconomic benefit of approximately 260 billion KRW, which corresponded to 110 million KRW per patient. In conclusion, we observed considerable socioeconomic benefits that come along with the use of the novel drug, T-DXd, which will be helpful for healthcare policymakers in decision-making.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"3 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79338241","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Real world tablet-splitting prescription status of enteric-coated tablets of diclofenac sodium and aspirin 双氯芬酸钠和阿司匹林肠溶片的现实世界分片处方状况

Yakhak Hoeji Pub Date : 2023-08-31 DOI: 10.17480/psk.2023.67.4.268

Seung Won Yun, Pusoon Chun

{"title":"Real world tablet-splitting prescription status of enteric-coated tablets of diclofenac sodium and aspirin","authors":"Seung Won Yun, Pusoon Chun","doi":"10.17480/psk.2023.67.4.268","DOIUrl":"https://doi.org/10.17480/psk.2023.67.4.268","url":null,"abstract":"This study aimed to investigate tablet-splitting prescription of enteric-coated tablets of diclofenac sodium and aspirin. We conducted a retrospective cross-sectional study using claims data collected by the Health Insurance Review and Assessment Service (HIRA) of Korea during 2016-2020. Of the 1,227,666 prescriptions of aspirin 100 mg enteric-coated tablet, 941 tablet-splitting prescriptions were identified, accounting for 0.1%. Of the 941 prescriptions, 41.7% (392) were prescribed for the elderly individuals aged 65 years. Of the 334 tablet-splitting cases with 15 or more consecutive days of prescription, 58.7% (196) were found in the elderly. Furthermore, 37.0% (37/100), 37.1% (13/35), and 40.4% (36/89) of cases with consecutive days of prescription of 31-60, 61-90 days, and more than 90 days, respectively, gastrointestinal disorders were found. Of the 53,868 prescriptions of diclofenac sodium 25 mg enteric-coated tablet, 2,248 tablet-splitting prescriptions were identified, accounting for 4.2%. Furthermore, of the 2,248 prescriptions, 53.0% (1,192) were prescribed for children under 5 years old, and 33.1% (744) were prescribed for children aged 5-9 years, respectively. We found that tablet-splitting prescription rate of diclofenac sodium 25 mg was high, especially in children. Gastrointestinal disorders were common in the tablet-splitting prescriptions of aspirin 100 mg, especially in the cases with 15 or more consecutive days of prescription.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"34 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81331417","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0