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Annual report of national adverse drug reaction monitoring (2022) Chinese Journal of Pharmacovigilance    2023, 20 (6): 712-719.   DOI: 10.19803/j.1672-8629.20230168 Abstract （1547）      PDF（pc） （3455KB）（1142）       Knowledge map    Save Objective To analyze the amount of monitoring of adverse drug reactions/events(ADR/AE) in depth in China in 2022, and to remind the public of the need to use drugs safely and properly. Methods Work related to nation-wide monitoring of adverse drug reactions in 2022 was summarized. Reports of ADRs/AEs received by the National Adverse Drug Reaction Monitoring System in 2022 were statistically analyzed and interpreted. Results A total of 2.023 million reports of ADR/AE were received in 2022, 642 000 of which were new and serious reports. 2.185 million reports involved suspected drugs, 82.3% of which were chemical drugs, 2.6% were biological products, and 12.8% were Chinese medicines. There were 942 000 reports of ADR/AE that involved essential drugs. The risks of adverse reactions of anti-infective drugs, cardiovascular system drugs, anti-metabolic drugs, and drugs for children were given much attention. Conclusion Adverse drug reaction monitoring should continue to be strengthened to ensure safe use of drugs and offer better protection for the public. Related Articles | Metrics | Comments（0）

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Management of individual adverse drug reaction reports LI Xiaozhu, WANG Qiang, PANG Yu, ZHANG Yijing Chinese Journal of Pharmacovigilance    2023, 20 (9): 975-977.   DOI: 10.19803/j.1672-8629.20230264 Abstract （552）      PDF（pc） （1185KB）（666）       Knowledge map    Save Objective To summarize and analyze the key points of ways in which individual case safety reports (ICSRs) are managed by referring to domestic and overseas laws and regulations in order to assist marketing authorization holders (MAHs) in handling ICSRs. Methods Based on a review of related literature and regulations at home and abroad, the whole process of ICSR management was introduced. Speaking from experience, we discussed the problems that were worthy of attention in the course of ICSR management. Results and Conclusion ICSRs underline pharmacovigilance by MAHs, who should collect, process, and submit ICSRs in accordance with related laws and regulations. Reference | Related Articles | Metrics | Comments（0）

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Discovery and identification strategy for drug safety risks based on big data monitoring of adverse reactions GAO Yunjuan, ZHAO Xu, BAI Tiankai, BAI Zhaofang, WANG Jiabo, SONG Haibo, XIAO Xiaohe Chinese Journal of Pharmacovigilance    2024, 21 (1): 1-5.   DOI: 10.19803/j.1672-8629.20230772 Abstract （512）      PDF（pc） （1327KB）（532）       Knowledge map    Save Objective To explore how to quickly discover and accurately identify drug safety risks from a vast number of adverse reaction reports from domestic and foreign Chinese and Western medicines. The aim is also to make scientific and effective predictions and control measures for these risks. Methods Drug-induced liver injury data was taken as an example, and the process of discovering, evaluating, confirming, and controlling risks associated with drugs were discussed. Results A preliminary exploration was conducted, leading to the establishment of an integrated strategy and method system for “large-scale adverse reaction monitoring and discovery - multi-model recognition and analysis- disease-symptom-toxicology verification.” This system has been successfully applied in identifying and analyzing drug-induced liver injury. Conclusion This strategy offers a fresh perspective for the continuous development and innovation of drug safety evaluation. It also provides technical support for ensuring public safety in medication and promoting the healthy development of the Chinese and Western medicine industry. Reference | Related Articles | Metrics | Comments（0）

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Key points of investigation and report of suspected death of adverse drug reaction LIU Saiyue, LYU Xiaoqin, ZHOU Yun Chinese Journal of Pharmacovigilance    2023, 20 (9): 971-974.   DOI: 10.19803/j.1672-8629.20230307 Abstract （504）      PDF（pc） （1263KB）（609）       Knowledge map    Save Objective To guide the drug marketing authorization holder (MAH) to standardize the investigation and report of death cases, so as to provide a basis for in-depth evaluation of drug safety. Methods This paper refers to the requirements of domestic and foreign regulatory guidelines, elaborated the key points of field investigation and internal investigation of suspected death cases of adverse drug reactions known to MAH, as well as the comprehensive analysis of death cases. Results Field investigation includes basic information of cases, drug use, adverse reactions, diagnosis and treatment of patients, and medical institutions. Internal investigation and evaluation can be carried out from the whole process of production and quality control. In addition to the investigation and disposal, the investigation report can provide comprehensive analysis and evaluation combined with the previous safety analysis of the variety. Within the prescribed time limit, the investigation content should be summarized and analyzed to form the investigation report, and submitted as required. Conclusion To standardize the investigation and report of death cases, MAH needs to improve the pharmacovigilance system, and multi-department interaction and efficient disposal, so as to provide reliable basis for risk assessment and risk control, and better guide clinical safe drug use. Reference | Related Articles | Metrics | Comments（0）

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Evaluation index system of MAH pharmacovigilance work JIA Jinsheng, WANG Qing, LIU Hongliang, HOU Yongfang Chinese Journal of Pharmacovigilance    2023, 20 (10): 1090-1094.   DOI: 10.19803/j.1672-8629.20230508 Abstract （488）      PDF（pc） （2882KB）（606）       Knowledge map    Save Objective To explore methods to quantitatively evaluate the pharmacovigilance evaluation work of marketing authorization holder(MAH) and support the development of scientific supervision work based on big data. Methods The analytic hierarchy process(AHP) method was used to decompose and detail ADR/ADE monitoring and reporting, risk identification and evaluation, post-market safety research, drug safety risk control and other related aspects, forming the MAH pharmacovigilance work evaluation index system. A data analysis information platform based on this index system was designed. Results 6 indicators of the criterion layer, 25 indicators of the sub-criterion layer and 85 indicators of the lowest layer are selected, and the weight values of each indicator of the evaluation system are determined. Based on the actual business situation and real world data, an information platform for MAH pharmacovigilance work evaluation was explored and designed. Conclusion The evaluation index system and information platform of holder pharmacovigilance laid the foundation for the intelligent evaluation of MAH pharmacovigilance work. Reference | Related Articles | Metrics | Comments（0）

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Characterization of adverse reactions associated with drug-induced liver injury in 448 inpatients CHEN Chongze, LI Jie, KUANG Lian, TAN Xuewen, LIU Minhui, LIU Xi, ZHENG Yanchai, JIN Hongtao Chinese Journal of Pharmacovigilance    2023, 20 (6): 697-704.   DOI: 10.19803/j.1672-8629.20220648 Abstract （481）      PDF（pc） （2556KB）（237）       Knowledge map    Save Objective To investigate the occurrence and outcomes of drug-induced liver injury in hospitalized patients and provide evidence for rational drug use in the clinic. Methods Drug-induced liver injury (DILI) reported between January 1, 2014 and July 31, 2022 was analyzed retrospectively. Cases of DILI adverse reactions were screened by setting inclusion and exclusion criteria before they were analyzed in terms of age, gender, clinical typing, RUCAM scores severity, regression, and drugs involved. Results A total of 201 268 hospitalizations were collected, and 448 inpatients with DILI adverse reactions were screened. The incidence of DILI adverse reactions was 0.22%. The male-to-female ratio was 1: 0.56. The mean age was (59.24±18.22) years old, and there was a significant difference between males and females in age (P< 0.05). The diseases were mostly infectious diseases (28.35%) and cerebrovascular diseases (27.46%), and the clinical manifestations were primarily non-specific. As for clinical types, the dominating type was hepatocyte injury (218 cases, 48.46%), followed by the mixed type (161 cases, 35.93%), and the cholestasis type (69 cases,15.40%). The RUCAM scale score averaged above 3 points, with 264 cases (58.93%) ≥6 points. There were significant differences in RUCAM scores and severity between the three clinical types. The levels of ALT, AST, ALP, GGT, TBIL and ALB were also significantly different between. The top three suspected types of drugs were cardio-cerebrovascular and lipid-regulating drugs, antibiotics and antipyretic analgesics. The top three suspected drugs were atorvastatin, rosuvastatin and moxifloxacin. There were 387 cases (86.38%) of mild liver injury according to the grading of severity. There were of 36 cases of moderate liver injury (8.04%), compared with 25 cases of severe liver injury (5.58%). The clinical outcomes were generally good after drug withdrawal/reduction and liver-protecting and symptomatic treatment. Conclusion Male, middle-aged and elderly patients are prone to DILI adverse reactions, especially mild to moderate liver injury. Clinical use of cardio-cerebrovascular and lipid-regulating drugs, antibiotics, antipyretic analgesics requires alertness to DILI adverse reactions. Reference | Related Articles | Metrics | Comments（0）

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Analysis of 327 reports of new adverse drug reactions ZHANG Luxin, MENG Lu, ZHANG Hong Chinese Journal of Pharmacovigilance    2023, 20 (10): 1159-1162.   DOI: 10.19803/j.1672-8629.20230062 Abstract （468）      PDF（pc） （1600KB）（491）       Knowledge map    Save Objective To study the characteristics of new adverse drug reactions so as to provide reference for effective prevention of new adverse drug reactions. Methods Three hundred and twenty-seven reports of new adverse drug reactions were screened from 856 reports submitted by a hospital between 2019 and 2022. Results Among the 327 new ADR, 245 cases (74.92%) involved people aged 41 or older. In terms of types of drugs, 241 cases (73.70%) were associated with Western drugs and 86 cases (26.30%) with proprietary Chinese medicines. The top three drugs responsible for new ADR were Ginkgo Biloba injection, compound thromboxane tablets, and levofloxacin hydrochloride injection. There were twenty-one drug dosage forms involved, and the top three were injection, powder injection and tablets. Thirteen routes of administration were involved, including 195 cases of intravenous injection (59.63%) and 90 cases of oral administration (27.52%). The systems-organs involved were mainly skin and its accessory injury, followed by injuries to the digestive system and nervous system. Conclusion New adverse drug reactions have their own patterns of occurrence, and targeted monitoring of new adverse drug reactions can improve the level of rational clinical use of drugs and effectively avoid the risk that arises from drug use. Reference | Related Articles | Metrics | Comments（0）

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Pharmacovigilance Newsletter Chinese Journal of Pharmacovigilance    2023, 20 (6): 720-720.   Abstract （460）      PDF（pc） （700KB）（525）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Processes of remote inspection of pharmacovigilance for marketing authorization holders XIA Xudong, LI Meixia, SUN Yang, YANG Shengya Chinese Journal of Pharmacovigilance    2023, 20 (9): 967-970.   DOI: 10.19803/j.1672-8629.20220582 Abstract （419）      PDF（pc） （1241KB）（481）       Knowledge map    Save Objective To explore the normal processes of and considerations for remote inspection of pharmacovigilance for marketing authorization holders licensed by China's drug regulatory authorities. Methods The application of information tools and instruments in a particular part of remote inspection was discussed according to the on-site inspection workflow. Results and Conclusion Based on current information network technology, remote inspection of pharmacovigilance can achieve its purpose and help to improve efficiency, save time and costs, and identify and address drug safety issues earlier. Reference | Related Articles | Metrics | Comments（0）

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Implementation of periodic benefit risk evaluation reports in China TIAN Chunhua, WU Guizhi Chinese Journal of Pharmacovigilance    2023, 20 (12): 1382-1384.   DOI: 10.19803/j.1672-8629.20230579 Abstract （412）      PDF（pc） （1254KB）（496）       Knowledge map    Save Objective To elaborate on the revision of PSUR in the Adverse Drug Reaction Reporting and Monitoring Management(Order 81) in combination with the current regulation of drugs in China. Methods The revision and implementation of the ICH E2C guideline system and related requirements in China were introduced. The status quo, problems and challenges related to the transformation and implementation of ICH E2C were outlined before recommendations were offered. Results Compared with PSUR, PBRER was more comprehensive and detailed, which could better reflect the overall situation of product benefits and risks. However, the adoption of PBRER also faced many challenges, such as a lack of knowledge of PBRER on the part of drug marketing authorization holders, the need for more professional participation in PBRER writing, and the difficulty in obtaining complete data for mature products. Conclusion The full adoption of PBRER can promote the accountability of holders and help the national and provincial adverse drug reaction monitoring agencies to supervise holders. It is recommended that PBRER be fully adopted following the revision of Order 81. Reference | Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2023, 20 (8): 0-0.   Abstract （401）      PDF（pc） （448KB）（350）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2023, 20 (5): 0-0.   Abstract （391）      PDF（pc） （456KB）（162）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Research progress in pharmacogenic cardiotoxicity ZHANG Bing, SA Rina, ZHANG Xiaomeng, ZHANG Dan, LIN Zhijian, WANG Yu Chinese Journal of Pharmacovigilance    2023, 20 (8): 841-847.   DOI: 10.19803/j.1672-8629.20230293 Abstract （382）      PDF（pc） （1257KB）（308）       Knowledge map    Save Pharmacogenic cardiotoxicity is one of the severe adverse reactions triggered by drugs, the severity of which ranges from mild electrocardiographic changes to fatal arrhythmias. Pharmacogenic cardiotoxicity is characterized by multiple sources, high incidence, insidiousness, susceptibility to special populations, diversity of clinical manifestations, and complexity of mechanisms. In recent years, research on pharmacogenic cardiotoxicity has received much attention. This paper reviews the research progress in pharmacogenic cardiotoxicity in terms of its clinical manifestations, mechanisms of occurrence and preventive measures to provide reference for clinical prevention of pharmacogenic cardiotoxicity. Reference | Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2023, 20 (5): 543-543.   Abstract （369）      PDF（pc） （584KB）（448）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Interpretations of reporting recommendations intended for pharmaceutical risk minimization evaluation studies(RIMES) statement NIE Xiaolu, TANG Shaowen, YU Jinyang, SONG Haibo, FU Zhu, SUN Feng Chinese Journal of Pharmacovigilance    2023, 20 (5): 524-529.   DOI: 10.19803/j.1672-8629.20220527 Abstract （368）      PDF（pc） （1286KB）（449）       Knowledge map    Save Objective To help implementers and readers better understand and apply the reporting recommendations intended for pharmaceutical risk minimization evaluation studies(RIMES) statements by introducing the checklist of RIMES statements and interpreting them. Methods The characteristics and current research of RIMES were summarized. Meanwhile, the checklist of RIMES statements was translated based on the translation integrity procedure (TIP) through forward and backward translation. Results There were 43 items in the RIMES checklist in four dimensions, including key information, research design, implementation and evaluation. Conclusion With the increasing regulators of global pharmacovigilance, RIMES statements will provide an important framework for RIMES. Reference | Related Articles | Metrics | Comments（0）

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Management of adverse events during clinical trials SHEN Yanjie, WU Yiqing Chinese Journal of Pharmacovigilance    2023, 20 (9): 982-986.   DOI: 10.19803/j.1672-8629.20230310 Abstract （357）      PDF（pc） （1248KB）（465）       Knowledge map    Save Objective To give advice about drug safety during clinical trials by introducing ways to manage adverse events(AE). Methods By summarizing the laws and regulations in China, reviewing the related literature, and outlining the sponsors' current practices, the time and ways to collect AE, the content to be collected, means of reporting of safety information and analysis of reports of AE were described. Results With the successive enforcement of laws and regulations in China, the collection and reporting of adverse events during clinical trials became increasingly standardized, but there was still a lack of uniform standards in some specific areas (e.g. start-end time or causality judgment). Conclusion Management of safety in clinical trials underlies the establishment of safety profiles in the product label as well as post-marketing safety surveillance. Therefore, close collaboration and active communication between health authorities, sponsors, and investigators are critical. Reference | Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2023, 20 (11): 0-0.   Abstract （340）      PDF（pc） （474KB）（342）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2023, 20 (9): 0-0.   Abstract （322）      PDF（pc） （469KB）（352）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Exploring the significance of collecting patient reports based on international pharmacovigilance experience PANG Yu, LIU Bo, LYU Shaoli, WANG Tao, XING Ying, QIN Xingyu, TIAN Yuejie, WU Wenyu Chinese Journal of Pharmacovigilance    2023, 20 (9): 978-981.   DOI: 10.19803/j.1672-8629.20230247 Abstract （291）      PDF（pc） （1192KB）（370）       Knowledge map    Save Objective To explore the significance of enterprises collecting patient reports as stated in Good Pharmacovigilance Practice (GVP). Methods Review the literature about the research findings from various nations and discuss the value of patient reports to reveal the importance of collecting patient reports. Results and Conclusion Patient reports are a beneficial supplement to doctor reports and are conducive to signal detection. Enterprises should take patient reports seriously, establish paths for collecting patient reports, and ensure the paths work efficiently. Reference | Related Articles | Metrics | Comments（0）

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Safe doses of Lingyang Ganmao oral liquid for children based on the multi-animal model SUN Qiyue, ZHAO Ronghua, BAO Lei, GUO Shanshan, GENG Zihan, LI Shuran, XU Yingli, ZHANG Jingsheng, CUI Xiaolan, SUN Jing Chinese Journal of Pharmacovigilance    2024, 21 (2): 121-126.   DOI: 10.19803/j.1672-8629.20230388 Abstract （286）      PDF（pc） （1550KB）（708）       Knowledge map    Save Objective To determine the effectiveness and range of optimal dosages of Lingyang Ganmao oral liquid for children, and to provide reference for medication in children. Methods Based on multi-animal models, five corresponding young animal models that targeted the major properties were used, including the mouse pneumonia model caused by influenza A (H1N1) virus infection, the mouse acute inflammation model for increased permeability of abdominal capillaries caused by glacial acetic acid, the mouse cough model caused by ammonia nebulization, the mouse pain model caused by glacial acetic acid and the rabbit fever model caused by lipopolysaccharide (LPS). To observe the antiviral, anti-inflammatory, antitussive, analgesic and antipyretic efficacy of Lingyang Ganmao oral liquid in six dosage groups, namely 0.1, 0.2, 0.4, 0.6, 0.8 and 1.0 mL·kg-1·d-1 for human use (children's dosage).The animal dosages were calculated using the body surface area conversion formula, based on the human dose. For mice, the dosages were 1, 2, 4, 6, 8, and 10 mL·kg-1·d-1, while for rabbits, the dosages were 0.3, 0.6, 1.2, 1.8, 2.4, and 3.0 mL·kg-1·d-1. The results are used to determine the optimal dose range for children. Results Lingyang Ganmao oral liquid could reduce lung indexes, inhibit capillary permeability, reduce the number of times mice coughed and writhed and help lower the body temperature of rabbits. The doses of stable efficacy ranged from 4.0 to 8.0 mL·kg-1·d-1 and from 1.2 to 2.4 mL·kg-1·d-1, respectively, which were equivalent to 0.4-0.8 mL·kg-1·d-1 for human use. Conclusion Lingyang Ganmao oral liquid produces stable and effective antiviral, anti-inflammatory, anti-cough, analgesic and antipyretic effects within the dose range of 0.4 to 0.8 mL·kg-1·d-1. The recommended dosage is 5mL each time and 1-2 times daily for children ages 1 to 3, 5mL each time and 1-3 times daily for those ages 4 to 6, and 5mL each time and 2-4 times daily for those between 7 and 12. Reference | Related Articles | Metrics | Comments（0）