Top Read

Published in last 1 year |

In last 2 years |

In last 3 years |

All

Please wait a minute...


For Selected: Download Citations EndNote Ris BibTeX Toggle Thumbnails

Select

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 （1558）      PDF（pc） （3455KB）（1167）       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）

Select

Chinese medicine pharmacovigilance and pharmaceutical care for progestational, pregnant and post-partum women based on ancient literature LYU Jintao, ZHANG Xiaomeng, ZHANG Bing, JIANG Hao, LIN Zhijian Chinese Journal of Pharmacovigilance    2022, 19 (6): 585-590.   DOI: 10.19803/j.1672-8629.2022.06.01 Abstract （615）      PDF（pc） （1392KB）（284）       Knowledge map    Save Objective To explore ancient theories about pharmacovigilance for progestational, pregnant and post-partum women in Chinese medicine, and provide reference for clinical pharmaceutical care and safe use of Chinese medicine. Methods Statements about pharmacovigilance were collected from 20 books on gynaecology and obstetrics published from the Tang Dynasty to the Qing Dynasty. Such information as phases, diseases, drugs, contraindications and precautions was retrieved. Notions of pharmacovigilance in Chinese medicine were ultimately collected via comparisons and summaries. Results In such phases as pregnancy preparation, pregnancy, perinatal and post-partum periods, pharmacovigilance measures for Chinese medicine included contraindications based on syndromes/ symptoms/ diseases, those based on people and time, control of dosage and courses of treatment, and dietary incompatibility. Such factors as drugs, patients and medications should be taken into consideration in pharmaceutical care according to the characteristics of different phases. Conclusion Pharmacovigilance measures for progestational, pregnant and post-partum women vary. Pharmaceutical care and guidance for rational use of Chinese medicine should be delivered based on physiological and pathological characteristics. Reference | Related Articles | Metrics | Comments（0）

Select

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 （581）      PDF（pc） （1327KB）（555）       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）

Select

The practice and consideration of pharmacovigilance during clinical trials in China CUI Huanhuan, PEI Xiaojing, LI Yanrong, LIU Wendong, WANG Haixue, LAN Gongtao, WANG Tao Chinese Journal of Pharmacovigilance    2022, 19 (10): 1050-1054.   DOI: 10.19803/j.1672-8629.20220242 Abstract （579）      PDF（pc） （671KB）（543）       Knowledge map    Save Objective To compare the construction of pharmacovigilance between United States and European Union, especially on the monitoring and managing of the safety signal; to meditating the future development direction of pharmacovigilance of China during the clinical trial. Methods The organizational framework, law and regulation system, the concept and management of safety signal for the implementation of pharmacovigilance between United States and European Union were compared, combined with the implementation experience of relevant work in China, suggestions for improving the level of pharmacovigilance during clinical trials in China were put forward. Results and Conclusion The pharmacovigilance system of United States and European Union are relatively perfect, the monitoring of safety information and mechanism of risk management are relatively mature. The pharmacovigilance system of clinical trial of China has been basically in place. The advance foreign experience can be referenced and through strengthening the law and regulation and organization system, carrying out focusing monitoring to improve the level of informationization to improve the level of pharmacovigilance of clinical trial in China. Reference | Related Articles | Metrics | Comments（0）

Select

Pharmaceutical care for a case of severe myelosuppression induced by meropenem injection combined with vancomycin injection LIU Baohua, SHEN Aizong, SU Dan Chinese Journal of Pharmacovigilance    2023, 20 (3): 339-342.   DOI: 10.19803/j.1672-8629.20220160 Abstract （579）      PDF（pc） （1293KB）（184）       Knowledge map    Save Objective To remind clinicians of possible adverse reactions of granulocytic myelosuppression induced by meropenem and vancomycin injections in clinical use. Methods One case of severe granulocytic myelosuppression was reported in a patient after cerebral hemorrhage surgery. Correlation analysis of the adverse reactions was conducted to identify the possible drug responsible for the occurrence of granulocytic myelosuppression in the patient. Results The severity of the adverse reactions was grade IV myelosuppression. The patient's condition and concomitant medication were excluded before the cause of severe myelosuppression was determined to be the combined use of antibacterial meropenem and vancomycin injections. The relevance of adverse reactions was evaluated as “probable”. The drug was immediately discontinued and the patient was improved after symptomatic treatment. Conclusion Adverse reactions of grade IV myelosuppression induced by the combined use of antibacterial meropenem and vancomycin injections are rarely reported and should be identified during clinical drug treatment. Reference | Related Articles | Metrics | Comments（0）

Select

Comparison and interpretation of guidelines for the application of bacterial endotoxin tests in Chinese and American Pharmacopoeia PEI Yusheng, CHEN Chen, CAI Tong, ZHAO Xiaoyan, GAO Hua Chinese Journal of Pharmacovigilance    2023, 20 (3): 317-320.   DOI: 10.19803/j.1672-8629.20211190 Abstract （565）      PDF（pc） （1411KB）（301）       Knowledge map    Save Objective To provide reference for the detection, research and pharmacovigilance related to bacterial endotoxin in China. Methods USP 1085 and Chinese Pharmacopoeia 9251 were studied, and the similarities and differences in endotoxin reference material management, quality management and sections prone to misinterpretation in the guidelines were introduced and interpreted. Results USP 1085 and Chinese Pharmacopoeia 9251 were included in 2020 for the first time. Practitioners were given detailed guidance and descriptions on the background, testing, working standard calibration, quality management, limit calculation, and alternative methods. Conclusion USP 1085 and Chinese Pharmacopoeia 9251, as an authoritative guideline for bacterial endotoxin detection, is quite helpful for personnel engaged in endotoxin testing and for revision of Chinese Pharmacopoeia. It will be constantly revised and improved in the process of practice. Reference | Related Articles | Metrics | Comments（0）

Select

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 （560）      PDF（pc） （1185KB）（673）       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）

Select

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 （512）      PDF（pc） （1263KB）（615）       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）

Select

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 （492）      PDF（pc） （2882KB）（610）       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）

Select

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 （487）      PDF（pc） （2556KB）（242）       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）

Select

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 （481）      PDF（pc） （1600KB）（498）       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）

Select

Pharmacovigilance Newsletter Chinese Journal of Pharmacovigilance    2023, 20 (6): 720-720.   Abstract （463）      PDF（pc） （700KB）（531）       Knowledge map    Save Related Articles | Metrics | Comments（0）

Select

Chinese Journal of Pharmacovigilance    2022, 19 (9): 1044-1044.   Abstract （453）      PDF（pc） （857KB）（560）       Knowledge map    Save Related Articles | Metrics | Comments（0）

Select

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 （423）      PDF（pc） （1241KB）（485）       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）

Select

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 （419）      PDF（pc） （1254KB）（507）       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）

Select

Thoughts on constructing vigilance system of Chinese medical device in the new era SHEN Chuanyong, SONG Yana, ZHAO Yan, ZHENG Lijia, ZHAO Yifei, LI Dong Chinese Journal of Pharmacovigilance    2022, 19 (7): 697-701.   DOI: 10.19803/j.1672-8629.2022.07.01 Abstract （417）      PDF（pc） （1422KB）（403）       Knowledge map    Save Objective To analyze the current status as well as the opportunities and challenges facing post-marketing surveillance and evaluation of medical devices in my country, this paper puts forward the thinking of constructing vigilance system of Chinese medical device in the new era. Methods Based on China's national conditions, combined with the development status of my country's medical device industry and the reform of medical device supervision concepts brought about by deepening the review and approval system, this article analyzes the opportunities and challenges facing post-marketing surveillance and evaluation of medical devices in China by reviewing literature, data comparison and other method. Results Combined with the current situation of domestic and foreign regulatory regulations, ideas are offered as to how to improve the regulatory system of surveillance and evaluation quickly, enhance the capabilities of risk control of post-marketing medical device products, and construct vigilance system of Chinese medical device. Conclusion Exploring and promoting the construction of medical device vigilance system is an important subject of medical device supervision in the new era, new situation and new system under the guidance of regulatory science. Reference | Related Articles | Metrics | Comments（0）

Select

107 cases of liver injury caused by traditional Chinese medicines WANG Guanjie, DU Shifang, LIU Baosheng, HAN Jiayan, WANG Zhenhua, LU Changfei Chinese Journal of Pharmacovigilance    2023, 20 (3): 331-333.   DOI: 10.19803/j.1672-8629.20220330 Abstract （415）      PDF（pc） （1366KB）（414）       Knowledge map    Save Objective To analyze the characteristics of liver injury caused by traditional Chinese medicines in order to provide data for clinical medication. Methods The Pareto diagram was used to analyze 107 cases of liver injury caused by traditional Chinese medicines, which were recorded by Shandong Adverse Drug Reaction Monitoring System between 2018 and 2020. Results Among the 107 cases reported, males accounted for 57.94%. People aged 51 to 60 made up 29.91%. There were 11 types of traditional Chinese medicines that were found to cause liver injury. Desiccating formulas (34.59%) accounted for the largest proportion, followed by blood-regulating agents (25.24%) and heat-clearing agents (14.96%). Elevated levels of alanine aminotransferase and aspartate aminotransferase were the most common clinical symptoms. The shortest duration of medication was only one day (2 cases), and the longest was 2 years. The overall prognosis of liver injury was good, and no permanent liver injury or death was found in these reports. Conclusion Such ADR as liver injury induced by traditional Chinese medicines should be subject to more vigorous monitoring in order to reduce the incidence of liver injury and ensure the safety of medications. Reference | Related Articles | Metrics | Comments（0）

Select

Chinese Journal of Pharmacovigilance    2023, 20 (8): 0-0.   Abstract （401）      PDF（pc） （448KB）（351）       Knowledge map    Save Related Articles | Metrics | Comments（0）

Select

Chinese Journal of Pharmacovigilance    2023, 20 (5): 0-0.   Abstract （391）      PDF（pc） （456KB）（163）       Knowledge map    Save Related Articles | Metrics | Comments（0）

Select

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 （386）      PDF（pc） （1257KB）（312）       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）