1.Analysis of the Legislative Evolution and Causes of Biologics Data Protection System in the United States
Xuefang YAO ; Jinxi DING ; Hongye REN
China Pharmacy 2017;28(10):1302-1306
OBJECTIVE:To study the legislative evolution and causes of biologics data protection system in the United States, and provide reference for designing biologics data protection system in China. METHODS:Started from analyzing the features of biologics data protection in the United States,through analyzing the legislative struggle of biologics data protection in the United States,the caused and its enlightenment to China were explored. RESULTS & CONCLUSIONS:After legislative discussion evolu-tion and struggle,the United States enacted the Biologics Price Competition and Innovation Act in 2010,established the world's firststrong protectionstandard of biologics data protection system,and determined the 12-year data protection period. The legisla-tive basis was to stimulate the strategic needs of innovation,the direct cause was that a biological analogue simplified application was established in the United States,and the key factors included biologics technical attributes and patent protection features. Cur-rently,biologics data protection system is not suitable for China,and China should implement the system from nothing,from weak to strong when the national condition matches or strategic choice needs. Meanwhile,a mature registration approval system is the ba-sis of establishing data protection system.
2.Information commons concept-based stereoscopic resources support system for academic library and its application
Tiantian SHAN ; Hao CHEN ; Qin YAO ; Xuefang MEI ; Hongxin CAO
Chinese Journal of Medical Library and Information Science 2017;26(4):34-39
The information commons concept-based stereoscopic resources support system for academic library with brand-new connotations and its application were proposed according to the increasing development and expansion of informationization, networking and digitization in different social fields, the significant change in disseminating methods of information resources, and the need of readers for library service.
3.Trend analysis of ANDA after the implementation of the drug patent linkage system in China
China Pharmacy 2024;35(21):2577-2581
OBJECTIVE To provide a reference for improving the drug patent linkage system. METHODS Data on drug names, drug types, abbreviated new drug application (ANDA) acceptance numbers, registration classifications, and applicant names were obtained from the patent certifications and patent information disclosure modules of China’s patent information registration platform for marketed drugs. The data collection period was from July 4, 2021, to September 30, 2023. The analysis focused on the annual distribution of patent certifications for the ANDA varieties included in the statistics, the proportion of different registration classifications, the details of the type Ⅳ certifications, the remaining validity periods of the corresponding patents for the type Ⅲ certifications, and the number of manufacturers for the same variety. RESULTS Among the ANDA varieties analyzed, type Ⅰ certifications predominated (accounting for 86.53%), while types Ⅱ, Ⅲ and Ⅳ certifications each accounted for approximately 4% to 5%. In the three registration classifications, type Ⅰ certifications in registration classification 3 accounted for as high as 98.55%, and in registration classification 4, type Ⅰ certifications accounted for 79.65%, while types Ⅱ, Ⅲ and Ⅳ certifications each accounted for around 7%. In terms of the detailed type of the Ⅳ certifications, type Ⅳ of article 2 certifications had a large proportion (79.23%) and showed a slight upward trend, whereas the challenges of type Ⅳ of article 1 certifications were few. The remaining validity period of the patents corresponding to type Ⅲ certifications was excessively long, with a median of 18 months. The proportion of the same variety with fewer than 5 manufacturers was 36.44%, while those with more than or equal to 20 manufacturers accounted for 14.75%. CONCLUSIONS The ANDA system in China has been orderly integrated with the drug patent linkage system in practice. It is recommended to optimize aspects such as patent certifications registration and objection mechanisms, the effective approval dates for ANDA with type Ⅲ certifications, and incentive measures for type Ⅳ of article 1 certifications, thereby further standardizing the ANDA process and guiding the high-quality development of generic drugs.
4.Hospital-acquired pressure ulcers cause analysis and preventive measures
Xuefang YANG ; Jianqin YAO ; Qixia JIANG ; Zujing WANG ; Shasha SONG
Chinese Journal of Modern Nursing 2016;22(27):3857-3860,3861
Objective To analysis the causes and preventive measures of acquired pressure ulcers in hospitalized patients, and to provide evidences and references for strengthening hospital management of pressure ulcers.Methods We took a retrospective study to collect relevant information of 201 patients with hospital-acquired pressure ulcers from January 2012 to December 2014, and conducted a descriptive statistical analysis on the cause of the developed, high-risk departments and high-risk areas, then came up with preventive suggestions.Results The high incidence of 201 hospital-acquired pressure ulcers was oncology department, which accounted for 33.83%;the most common part was the sacrococcygeal region, which accounted for 59.2%;stage II was the most common stage of pressure ulcer, which accounted for 76. 12%; 64. 67% of the pressure ulcers happens within the first two weeks in hospital. Braden scoring less than 12 points that accounted for 58. 21%;anemia accounted for 72. 14%; hypoalbuminemia accounted for 75. 62%; forced postures caused by pain or hydrothorax and ascite accounted for 26.87%; medical equipment pressure accounted for 10.95%. The use of vacuum pad accounted for 87.56%;turning over once every 2 hours accounted for 41.79%. Skin nursing according to the guide accounted for 62. 19%; nutritional support through the mouth or vein accounted for 38.81%. Reporting to the nursing department timely after the occurrence accounted for 95.52%; found in ward rounds accounted for 1.99%; reported by patients or their families accounted for 1.49%; failure to report and found in the medical records accounted for 1.00%,the patient or family members to report accounted for 1.49%. Conclusions Cancer patients are high-risk groups of nosocomial pressure ulcers. The sacrococcygeal region is the high-risk area;stage II is the most common stage, and most of them happens within the first 2 weeks in hospital. Main reasons are hypoalbuminemia, anemia, forced postures, unable to turn over periodically, and the preventive care implementation is not enough. For cancer patients, preventive care is recommended, especially those patients with cancer pain, malnutrition and forced postures.
5.Study on the production efficiency of platelet components in 24 prefecture-level blood stations in China
Minyu HUA ; Wei NIU ; Jian YAO ; Shouguang XU ; Yuxia QIU ; Li LI ; Dongmei ZHAO ; JiaYu WAN ; Feng YAN ; Hongzhi JIA ; Hao LI ; Jiaqi QIIAN ; Peng WANG ; Zhenxing WANG ; Lin BAO ; Shan WEN ; Sheng YE ; Xuefang FENG ; Man ZHANG ; Xiaobo CAI ; Wei ZHANG ; Dexu CHU ; Youhua SHEN ; Peifang CONG ; Hui ZHANG ; Yan QIU
Chinese Journal of Blood Transfusion 2022;35(9):937-942
【Objective】 To learn the production efficient of platelet components among prefecture-level blood stations in China, to provide supporting data for those blood stations to optimize the production mode of platelet components and continuously improve production efficiency and supply capacity. 【Methods】 The data from 2017 to 2020 was obtained from 24 prefecture-level blood stations who were the members of the practice comparison network for blood institutes in China. The collection units of apheresis platelets, the number of dual-collections of apheresis platelets and plasma, the average apheresis units of one platelet apheresis procedure, the discarded rate of apheresis platelets, the amount of expired apheresis platelets and the amount of apheresis platelets issued were collected. For concentrated platelets, the prepared amount of platelet concentrates and the amount of expired platelet concentrates were collected; both the quantity of qualified and issued concentrated platelets were submitted for statistical analysis.The total output and efficiency of platelet components were calculated based on the collected data. 【Results】 The average annual growth rate of apheresis platelets collection in 24 prefecture-level blood stations was 12.23%, accounting for 99.80% of the total platelet output; the average collection unit of one platelets apheresis procedure was 1.75; from 2019 to 2020, only 5 blood stations performed dual-collection of platelet and plasma during one apheresis procedure; the discarded rate of apheresis platelets was 0.28%, of which 0.007% was due to expiration. A total of 1 621.2 therapeutic units of concentrated platelets were prepared, and 13.03% of them was discarded due to the expiration. The production efficiency of platelet components was 97.56%, of which the production efficiency of apheresis platelets was 97.61% and the production efficiency of concentrated platelets was 74.43%. 【Conclusion】 There are large regional differences in the supply capacity of platelet components in prefecture-level blood stations. Apheresis platelets are the main resource of platelet components product, and the collection capacity is increasing over the years with the characteristics of high production efficiency and low expiration scrapping rate. However, the preparation of concentrated platelets are still limited with relatively low production and high expiration discarded rate.