Pub Date : 2024-02-28DOI: 10.17480/psk.2024.68.1.26
You Ran Noh, Hae Sun Suh
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.
{"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}
Pub Date : 2024-02-28DOI: 10.17480/psk.2024.68.1.62
Eun-Young Bae, Sohee Cha, Hwa-Ryeong Lim, Hyejin Lee, Jihyung Hong
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.
{"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}
Pub Date : 2023-08-31DOI: 10.17480/psk.2023.67.4.277
Jeong Ah Kim, Heehyun Won, Na-Young Jeong, Nam-Kyong Choi
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.
{"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}
Pub Date : 2023-08-31DOI: 10.17480/psk.2023.67.4.244
Eun Joo Lee, Hyun Soon Sohn
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.
{"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}
Pub Date : 2023-08-31DOI: 10.17480/psk.2023.67.4.224
Seongmi Jeon, Mi-Hai Park
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.
{"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}
Pub Date : 2023-08-31DOI: 10.17480/psk.2023.67.4.215
Woung Choi, Min Kim, Dong Hee Na
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.
{"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}
Pub Date : 2023-08-31DOI: 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
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.
在最近的destiny - breast - 03试验中，在人表皮生长因子2阳性转移性乳腺癌(HER2+ MBC)患者中，曲妥珠单抗德鲁西替康(T-DXd)与曲妥珠单抗恩坦辛(T-DM1)相比，显示出显著延长无进展生存期(PFS)。虽然有明确的证据表明T-DXd的临床益处，但除了这些临床益处之外，关于社会影响的证据还有待探索。因此，我们估计了HER2+ MBC患者中T-DXd与T-DM1相比的社会经济效益。我们首先计算了在延长PFS方面，与T-DM1相比，T-DXd产生的增量健康益处。然后，我们将增量PFS转换为花在有偿工作和无偿工作上的时间。最后，T-DXd的总体社会影响是通过汇总有偿和无偿工作时间可能产生的潜在国内生产总值得出的。我们确定了2212例符合分析条件的患者。总的来说，延长T-DXd的PFS产生了约2600亿韩元的社会经济效益，相当于每位患者1.1亿韩元。总之，我们观察到使用新型药物T-DXd带来了可观的社会经济效益，这将有助于医疗保健决策者做出决策。
{"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}
Pub Date : 2023-08-31DOI: 10.17480/psk.2023.67.4.268
Seung Won Yun, Pusoon Chun
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.
{"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}
Pub Date : 2023-08-31DOI: 10.17480/psk.2023.67.4.231
Daesung Lee, Kyenghee Kwon
Education in regulatory affairs for pharmaceuticals is crucial in order to equip experts with the necessary competency and knowledge to navigate the legal and scientific regulations involved in managing the drug lifecycle. In order to develop the framework which ensures the competency and knowledge, 6 competency requirements and 48 knowledge items were derived from the previous studies. These were then reviewed by 16 experts in three rounds of a Delphi process to assess their validity and reliability in terms of both present and required levels. The Wilcoxon Signed Ranked Test was subsequently conducted to determine whether there was a statistically significant difference between the required and present levels. and Borich's educational needs and the Locus for Focus Model were used to confirm the 12 knowledge and 1 competency areas that were identified as having high priority. Based on the findings of this study, a systematic educational program focusing on the necessary competencies and knowledge required for professionals in regulatory affairs of pharmaceuticals should be developed and established.
{"title":"The Assessment of Educational Needs in the Industry for Training Professionals in the Regulatory Affairs of Pharmaceuticals on the Competency and Knowledge","authors":"Daesung Lee, Kyenghee Kwon","doi":"10.17480/psk.2023.67.4.231","DOIUrl":"https://doi.org/10.17480/psk.2023.67.4.231","url":null,"abstract":"Education in regulatory affairs for pharmaceuticals is crucial in order to equip experts with the necessary competency and knowledge to navigate the legal and scientific regulations involved in managing the drug lifecycle. In order to develop the framework which ensures the competency and knowledge, 6 competency requirements and 48 knowledge items were derived from the previous studies. These were then reviewed by 16 experts in three rounds of a Delphi process to assess their validity and reliability in terms of both present and required levels. The Wilcoxon Signed Ranked Test was subsequently conducted to determine whether there was a statistically significant difference between the required and present levels. and Borich's educational needs and the Locus for Focus Model were used to confirm the 12 knowledge and 1 competency areas that were identified as having high priority. Based on the findings of this study, a systematic educational program focusing on the necessary competencies and knowledge required for professionals in regulatory affairs of pharmaceuticals should be developed and established.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"60 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82081056","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}
Pub Date : 2023-08-31DOI: 10.17480/psk.2023.67.4.261
Min Seok Kim, In Ho Im, Yun Hwa Jeong, Seung Hyun Kim, Young-Chang Cho, Jeong Uk Choi
In this study, we identified whether atorvastatin could induce ferroptosis or not in B16F10.OVA cells, which is being used to treat hypercholesterolemia. To demonstrate this, we treated the mouse melanoma cell line B16F10.OVA with atorvastatin at varying concentrations, spanning from low to high, followed by a 24-hour culture period. In the group treated with atorvastatin in our experiment, we observed a decrease in cell viability that was dependent on the concentration of the treatment, when compared to the control group. The IC50 value of atorvastatin in B16F10.OVA cells was determined to be 49.89 μM. Compared to the control group, treatment with atorvastatin resulted in a concentrationdependent increase in the generation of reactive oxygen species and the accumulation of iron ions. Moreover, atorvastatin treatment exhibited a concentration-dependent increase in the population of apoptotic cells and the expression of calreticulin, significantly surpassing that of the control group. The analysis of ferroptosis-related protein expression levels revealed a notable decrease in the expression of GPX4 in the group treated with atorvastatin, as compared to the control group. These findings strongly suggest that atorvastatin holds promise as a potent anti-cancer agent capable of inducing ferroptosis in melanoma cells.
{"title":"Identification of Ferroptosis Induction by Treating Atorvastatin in B16F10.OVA Cells","authors":"Min Seok Kim, In Ho Im, Yun Hwa Jeong, Seung Hyun Kim, Young-Chang Cho, Jeong Uk Choi","doi":"10.17480/psk.2023.67.4.261","DOIUrl":"https://doi.org/10.17480/psk.2023.67.4.261","url":null,"abstract":"In this study, we identified whether atorvastatin could induce ferroptosis or not in B16F10.OVA cells, which is being used to treat hypercholesterolemia. To demonstrate this, we treated the mouse melanoma cell line B16F10.OVA with atorvastatin at varying concentrations, spanning from low to high, followed by a 24-hour culture period. In the group treated with atorvastatin in our experiment, we observed a decrease in cell viability that was dependent on the concentration of the treatment, when compared to the control group. The IC50 value of atorvastatin in B16F10.OVA cells was determined to be 49.89 μM. Compared to the control group, treatment with atorvastatin resulted in a concentrationdependent increase in the generation of reactive oxygen species and the accumulation of iron ions. Moreover, atorvastatin treatment exhibited a concentration-dependent increase in the population of apoptotic cells and the expression of calreticulin, significantly surpassing that of the control group. The analysis of ferroptosis-related protein expression levels revealed a notable decrease in the expression of GPX4 in the group treated with atorvastatin, as compared to the control group. These findings strongly suggest that atorvastatin holds promise as a potent anti-cancer agent capable of inducing ferroptosis in melanoma cells.","PeriodicalId":23923,"journal":{"name":"Yakhak Hoeji","volume":"73 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89815595","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}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：