Systematically analyze the composition of post-marketing adverse drug reaction data and the open mode in the EU, and summarize its characteristics. EU post-marketing ADR data is open to six categories of stakeholders:...Systematically analyze the composition of post-marketing adverse drug reaction data and the open mode in the EU, and summarize its characteristics. EU post-marketing ADR data is open to six categories of stakeholders: EMA, EC, medicines regulatory authorities in EEA member states, healthcare professionals and the public, Marketing Authorization Holders, academia, WHO and medicines regulatory authorities in third countries. The EU has implemented hierarchical opening for ADRs, with different levels containing different data and facing different stakeholders. Openness is divided into active and passive openness. In opening up data, the EU complies with relevant personal data protection laws to protect the privacy of individuals. The EU’s post-marketing adverse drug reaction data openness is characterized by a combination of data openness and privacy protection, active and passive openness, and a hierarchy of data openness. It is hoped that this can provide a reference for the opening up of post-marketing adverse drug reaction data in China.展开更多
Objective: To systematically review the rate of patient delay of pulmonary tuberculosis (PTB) patients among students in China. Methods: Databases including Web of Science Core Collection, PubMed, The Cochrane Library...Objective: To systematically review the rate of patient delay of pulmonary tuberculosis (PTB) patients among students in China. Methods: Databases including Web of Science Core Collection, PubMed, The Cochrane Library, CBM, CNKI, VIP, and WANFANG DATA were electronically searched to collect cross-sectional studies on the incidence of delayed consultation in students with PTB in China from January 1, 2000, to November 15, 2022. Two researchers independently screened studies, extracted data, and assessed the risk of bias of the included studies. Meta-analysis was then performed by Stata 16.0 software. Results: In total, 60 cross-sectional studies with 260,707 cases involving 136,701 delayed consultation PTB patients were included. The results of meta-analysis showed that the rate of patient delay was 46.4% (95% CI 44.3% to 48.4%) among students with PTB in China. Results of subgroup analyses showed that: 1) The rates were 46.8% and 50.4% for male and female students, respectively. 2) The rates for the East, Central and West parts of China were 42.3%, 45.6% and 50.5%, respectively. 3) The rates were increased first and then decreased during 2007 to 2020. 4) The rates of students from primary school, junior high school, senior high school and university were 50.3%, 49.8%, 40.7% and 44.9%, respectively. 5) The rates for the Han and the other nationalities were 50.3% and 53.9%, respectively. 6) The rates for local and non-local students were 47.2% and 50.5%, respectively. 7) The rates of patients detected by consultation due to symptoms, recommendation due to symptoms, referral, tracking and healthy physical examination were 50.5%, 51.6%, 46.6%, 55.6% and 16.2%, respectively. 8) The rates of patients with initial PTB and retreatment PTB were 53.1% and 59.6%, respectively. 9) The rates of patients with positive etiology, negative etiology and without etiological results were 55.9%, 47.0% and 51.6%, respectively. 10) The rates of severe and non-severe patients were 59.4% and 52.9%, respectively. Conclusion: The patient d展开更多
Objective: To evaluate the cost-effectiveness of atezolizumab plus pemetrexed and platinum-based (APP) in the first-line treatment of non-squamous non- small cell lung cancer (NSCLC). Methods: A partitioned survival m...Objective: To evaluate the cost-effectiveness of atezolizumab plus pemetrexed and platinum-based (APP) in the first-line treatment of non-squamous non- small cell lung cancer (NSCLC). Methods: A partitioned survival model (PSM) was constructed based on the IMpower132 clinical trial. Total cost, quality- adjusted life years (QALY), and incremental cost-effectiveness ratio (ICER) were the main outputs of the model. Deterministic sensitivity analysis and probabilistic sensitivity analysis were adopted to test the uncertainty of the parameters. Results: The results of the base-case analysis illustrated that compared with PP, the incremental cost of APP was CNY 591040.94, the incremental utility was 0.46 QALY, and the ICER was CNY 1291414.83/QALY. Deterministic sensitivity analysis results illustrated that atezolizumab and other parameters have a greater impact on ICER. Probabilistic sensitivity analysis results show that no matter how each parameter changes, under the willingness to pay threshold of 3-times Chinese per capita GDP, the probability of APP has cost-effectiveness is 0. Conclusion: From the perspective of the Chinese health system, APP is not cost-effective for first-line treatment of non-squamous non-small cell lung cancer without sensitizing EGFR or ALK genetic alterations.展开更多
Based on the perspective of professional knowledge and professional technology, this paper focuses on the path to improve the technological innovation ability on the technical level, and provides advice and reference ...Based on the perspective of professional knowledge and professional technology, this paper focuses on the path to improve the technological innovation ability on the technical level, and provides advice and reference for promoting the pharmaceutical industry to achieve the improvement of technological innovation ability and the structural upgrading of the entire industry. It is found that in the project approval process of innovation subject, the key is to realize the guiding role of market demand on the project approval process of scientific research. In the research and development of innovative drugs, it is necessary to focus on the adaptation and transformation of laboratory technology in scale-up production. In the process of innovation achievement delivery and transformation, the focus is to truly complete the extension from the patent application stage to the product launch stage.展开更多
Pharmaceutical technology innovation process needs a lot of human, material and financial support, so the government must give full play to its financial support function. Specifically, the government should improve t...Pharmaceutical technology innovation process needs a lot of human, material and financial support, so the government must give full play to its financial support function. Specifically, the government should improve the fund investment mechanism of the pharmaceutical industry, improve the financial investment management system of pharmaceutical technology innovation, strengthen the function and mechanism of the capital market, improve the risk investment system, focus on cultivating a good credit environment, and increase the support of national policy-based financial institutions. Through direct investment, financial subsidies, tax incentives and low-interest financing and other means, vigorously promote the improvement of pharmaceutical innovation capacity.展开更多
<span style="font-family:Verdana;">In order to achieve the goal of drug safety, effectiveness and quality control, corporate compliance management construction is significant. Therefore, this paper sys...<span style="font-family:Verdana;">In order to achieve the goal of drug safety, effectiveness and quality control, corporate compliance management construction is significant. Therefore, this paper systematically analyzes the seven elements of compliance management for </span><span style="font-family:Verdana;">U.S. pharmaceutical manufacturers</span><span style="font-family:""><span style="font-family:Verdana;"> as described in the </span><i><span style="font-family:Verdana;">Compliance Program Guidance for Pharmaceutical Manufacturers</span></i><span style="font-family:Verdana;"> issued by the HHS-Office of Inspector General, as well as further analyzes the implementation of the guidance by representative multinational companies in different drug regis</span><span style="font-family:Verdana;">tration stages. Finally, some suggestions and implications are proposed to </span><span style="font-family:Verdana;">strengthen the construction of compliance management for Chinese drug</span><span style="font-family:Verdana;"> registration applicants based on the former practical experience.展开更多
Objective: To evaluate the cost-utility of nivolumab plus chemotherapy compared with chemotherapy alone as the first-line treatment for advanced gastric, gastro-oesophageal junction, and esophageal adenocarcinoma in C...Objective: To evaluate the cost-utility of nivolumab plus chemotherapy compared with chemotherapy alone as the first-line treatment for advanced gastric, gastro-oesophageal junction, and esophageal adenocarcinoma in China. Methods: Based on CheckMate649, a partitioned survival model was carried out with a circulation cycle of 6 weeks to simulate the patient’s lifetime. Sensitivity analysis were adopted to verify the robustness of the results. Results: The results of the base-case analysis showed that both the total cost and utility of the nivolumab group were higher, and the ICUR value was CNY 267498.67/QALY, more than 3 times the GDP per capita of China in 2020. The results of deterministic sensitivity analysis indicated that the three most influential factors were the utility value of PFS state, the cost of nivolumab and the discount rate. The results of probabilistic sensitivity analysis were consistent with those of base-case analysis, proving that the results were robust. The scenario analysis illustrated that economical price of nivolumab was CNY 3652.71. Conclusions: Under the willing-to-pay threshold of three times the GDP per capita of China in 2020, compared with chemotherapy alone, nivolumab plus chemotherapy is not a cost-effective option in China.展开更多
Pharmacists are the implementers of clinical drug management, and they play an irreplaceable role in promoting the improvement of rational drug use. However, the current role of pharmacists in the supervision and prot...Pharmacists are the implementers of clinical drug management, and they play an irreplaceable role in promoting the improvement of rational drug use. However, the current role of pharmacists in the supervision and protection of rational drug use has not been fully exerted. This article is aimed to investigate the current situation of pharmacists’ work of rational drug use from the perspectives of pharmacists, physicians, and patients. It is found that the professional value of pharmacists in the rational drug use has not been valued by medical institutions, physicians, and patients. Pharmacists face problems such as workload, working conditions, and doctor-patient cooperation in the rational drug use. Suggestions are made for further exerting the professional value of pharmacists in promoting the level of rational drug use. Relevant managers should pay full attention to the professional value of pharmacists, and provide corresponding system and facility guarantees for pharmacists to carry out rational drug use.展开更多
文摘Systematically analyze the composition of post-marketing adverse drug reaction data and the open mode in the EU, and summarize its characteristics. EU post-marketing ADR data is open to six categories of stakeholders: EMA, EC, medicines regulatory authorities in EEA member states, healthcare professionals and the public, Marketing Authorization Holders, academia, WHO and medicines regulatory authorities in third countries. The EU has implemented hierarchical opening for ADRs, with different levels containing different data and facing different stakeholders. Openness is divided into active and passive openness. In opening up data, the EU complies with relevant personal data protection laws to protect the privacy of individuals. The EU’s post-marketing adverse drug reaction data openness is characterized by a combination of data openness and privacy protection, active and passive openness, and a hierarchy of data openness. It is hoped that this can provide a reference for the opening up of post-marketing adverse drug reaction data in China.
文摘Objective: To systematically review the rate of patient delay of pulmonary tuberculosis (PTB) patients among students in China. Methods: Databases including Web of Science Core Collection, PubMed, The Cochrane Library, CBM, CNKI, VIP, and WANFANG DATA were electronically searched to collect cross-sectional studies on the incidence of delayed consultation in students with PTB in China from January 1, 2000, to November 15, 2022. Two researchers independently screened studies, extracted data, and assessed the risk of bias of the included studies. Meta-analysis was then performed by Stata 16.0 software. Results: In total, 60 cross-sectional studies with 260,707 cases involving 136,701 delayed consultation PTB patients were included. The results of meta-analysis showed that the rate of patient delay was 46.4% (95% CI 44.3% to 48.4%) among students with PTB in China. Results of subgroup analyses showed that: 1) The rates were 46.8% and 50.4% for male and female students, respectively. 2) The rates for the East, Central and West parts of China were 42.3%, 45.6% and 50.5%, respectively. 3) The rates were increased first and then decreased during 2007 to 2020. 4) The rates of students from primary school, junior high school, senior high school and university were 50.3%, 49.8%, 40.7% and 44.9%, respectively. 5) The rates for the Han and the other nationalities were 50.3% and 53.9%, respectively. 6) The rates for local and non-local students were 47.2% and 50.5%, respectively. 7) The rates of patients detected by consultation due to symptoms, recommendation due to symptoms, referral, tracking and healthy physical examination were 50.5%, 51.6%, 46.6%, 55.6% and 16.2%, respectively. 8) The rates of patients with initial PTB and retreatment PTB were 53.1% and 59.6%, respectively. 9) The rates of patients with positive etiology, negative etiology and without etiological results were 55.9%, 47.0% and 51.6%, respectively. 10) The rates of severe and non-severe patients were 59.4% and 52.9%, respectively. Conclusion: The patient d
文摘Objective: To evaluate the cost-effectiveness of atezolizumab plus pemetrexed and platinum-based (APP) in the first-line treatment of non-squamous non- small cell lung cancer (NSCLC). Methods: A partitioned survival model (PSM) was constructed based on the IMpower132 clinical trial. Total cost, quality- adjusted life years (QALY), and incremental cost-effectiveness ratio (ICER) were the main outputs of the model. Deterministic sensitivity analysis and probabilistic sensitivity analysis were adopted to test the uncertainty of the parameters. Results: The results of the base-case analysis illustrated that compared with PP, the incremental cost of APP was CNY 591040.94, the incremental utility was 0.46 QALY, and the ICER was CNY 1291414.83/QALY. Deterministic sensitivity analysis results illustrated that atezolizumab and other parameters have a greater impact on ICER. Probabilistic sensitivity analysis results show that no matter how each parameter changes, under the willingness to pay threshold of 3-times Chinese per capita GDP, the probability of APP has cost-effectiveness is 0. Conclusion: From the perspective of the Chinese health system, APP is not cost-effective for first-line treatment of non-squamous non-small cell lung cancer without sensitizing EGFR or ALK genetic alterations.
文摘Based on the perspective of professional knowledge and professional technology, this paper focuses on the path to improve the technological innovation ability on the technical level, and provides advice and reference for promoting the pharmaceutical industry to achieve the improvement of technological innovation ability and the structural upgrading of the entire industry. It is found that in the project approval process of innovation subject, the key is to realize the guiding role of market demand on the project approval process of scientific research. In the research and development of innovative drugs, it is necessary to focus on the adaptation and transformation of laboratory technology in scale-up production. In the process of innovation achievement delivery and transformation, the focus is to truly complete the extension from the patent application stage to the product launch stage.
文摘Pharmaceutical technology innovation process needs a lot of human, material and financial support, so the government must give full play to its financial support function. Specifically, the government should improve the fund investment mechanism of the pharmaceutical industry, improve the financial investment management system of pharmaceutical technology innovation, strengthen the function and mechanism of the capital market, improve the risk investment system, focus on cultivating a good credit environment, and increase the support of national policy-based financial institutions. Through direct investment, financial subsidies, tax incentives and low-interest financing and other means, vigorously promote the improvement of pharmaceutical innovation capacity.
文摘<span style="font-family:Verdana;">In order to achieve the goal of drug safety, effectiveness and quality control, corporate compliance management construction is significant. Therefore, this paper systematically analyzes the seven elements of compliance management for </span><span style="font-family:Verdana;">U.S. pharmaceutical manufacturers</span><span style="font-family:""><span style="font-family:Verdana;"> as described in the </span><i><span style="font-family:Verdana;">Compliance Program Guidance for Pharmaceutical Manufacturers</span></i><span style="font-family:Verdana;"> issued by the HHS-Office of Inspector General, as well as further analyzes the implementation of the guidance by representative multinational companies in different drug regis</span><span style="font-family:Verdana;">tration stages. Finally, some suggestions and implications are proposed to </span><span style="font-family:Verdana;">strengthen the construction of compliance management for Chinese drug</span><span style="font-family:Verdana;"> registration applicants based on the former practical experience.
文摘Objective: To evaluate the cost-utility of nivolumab plus chemotherapy compared with chemotherapy alone as the first-line treatment for advanced gastric, gastro-oesophageal junction, and esophageal adenocarcinoma in China. Methods: Based on CheckMate649, a partitioned survival model was carried out with a circulation cycle of 6 weeks to simulate the patient’s lifetime. Sensitivity analysis were adopted to verify the robustness of the results. Results: The results of the base-case analysis showed that both the total cost and utility of the nivolumab group were higher, and the ICUR value was CNY 267498.67/QALY, more than 3 times the GDP per capita of China in 2020. The results of deterministic sensitivity analysis indicated that the three most influential factors were the utility value of PFS state, the cost of nivolumab and the discount rate. The results of probabilistic sensitivity analysis were consistent with those of base-case analysis, proving that the results were robust. The scenario analysis illustrated that economical price of nivolumab was CNY 3652.71. Conclusions: Under the willing-to-pay threshold of three times the GDP per capita of China in 2020, compared with chemotherapy alone, nivolumab plus chemotherapy is not a cost-effective option in China.
文摘Pharmacists are the implementers of clinical drug management, and they play an irreplaceable role in promoting the improvement of rational drug use. However, the current role of pharmacists in the supervision and protection of rational drug use has not been fully exerted. This article is aimed to investigate the current situation of pharmacists’ work of rational drug use from the perspectives of pharmacists, physicians, and patients. It is found that the professional value of pharmacists in the rational drug use has not been valued by medical institutions, physicians, and patients. Pharmacists face problems such as workload, working conditions, and doctor-patient cooperation in the rational drug use. Suggestions are made for further exerting the professional value of pharmacists in promoting the level of rational drug use. Relevant managers should pay full attention to the professional value of pharmacists, and provide corresponding system and facility guarantees for pharmacists to carry out rational drug use.
