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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 （1675）      PDF（pc） （3455KB）（1310）       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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Standards for Drug Safety Signal Detection Using Individual Case Safety Reports in Pharmacovigilance LIANG Jizhou, CHEN Chenxin, BAI Wangyang, GUO Xiaojing, XU Jinfang, HE Jia, YE Xiaofei Chinese Journal of Pharmacovigilance    2024, 21 (11): 1280-1283.   DOI: 10.19803/j.1672-8629.20240471 Abstract （756）      PDF（pc） （1223KB）（775）       Knowledge map    Save Objective To analyze and interpret the READUS-PV standard for drug safety signal detection based on individual safety reports in pharmacovigilance so as to provide references for related research in China. Methods The reporting of a disproportionality analysis for drug safety signal detection using individual case safety reports in pharmacovigilance (READUS-PV) jointly delivered by experts in pharmacovigilance worldwide was analyzed and interpreted. Results READUS-PV included 14 items concerning the title, introduction, methods, results, discussion, declaration and abstracts. Conclusion In actual drug safety signal detection research, READUS-PV can be consulted to improve research quality. 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 （749）      PDF（pc） （1327KB）（801）       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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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 （723）      PDF（pc） （1293KB）（228）       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）

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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 （699）      PDF（pc） （1411KB）（366）       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）

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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 （633）      PDF（pc） （1185KB）（847）       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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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 （607）      PDF（pc） （671KB）（594）       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）

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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 （596）      PDF（pc） （1263KB）（724）       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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Methods for signal management using the global safety database VigiBase HJELMSTRÖM Peter, BOWRING Geoffrey, YUE Qun-Ying, NORÉN G. Niklas Chinese Journal of Pharmacovigilance    2024, 21 (7): 836-840.   DOI: 10.19803/j.1672-8629.20240373 Abstract （596）      PDF（pc） （1584KB）（534）       Knowledge map    Save The WHO database of adverse event reports for medicines and vaccines, VigiBase, has been developed and maintained by UMC since 1978. VigiBase now holds over 39 million anonymised reports of suspected adverse effects of medicines and vaccines suffered by patients (as of June 2024). To support of members of the WHO Programme for International Drug Monitoring (WHO PIDM) in developing, implementing, and strengthening safety surveillance programmes, UMC has developed several systems, tools and methods to facilitate the use of VigiBase. This paper describes six such vigi Methods; vigiGrade, vigiMatch, vigiRank, vigiPoint, vigiGroup, vigiVec. VigiBase depends on unsolicited reporting of adverse drug effects and, regretfully, underreporting of adverse drug effects continues to be a major issue. Artificial intelligence methods for augmentation to increase efficiency, quality, and capability of case processing in the large databases such as VigiBase are evolving to meet the higher demands to manage the increasing volume of safety data. Continued development of existing and new methods to translate the information in the reports in VigiBase and other databases into valuable knowledge will be paramount for safer use of medicines and vaccines for patients in all countries globally. Reference | Related Articles | Metrics | Comments（0）

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Methods for Assessment of MAH Compliance with GVP LIU Ying, XIONG Shunyu, XIONG Huiyu, CAI Fei, XU Mengdan, WANG Qing, REN Wei, XU Yan Chinese Journal of Pharmacovigilance    2025, 22 (3): 282-285.   DOI: 10.19803/j.1672-8629.20240394 Abstract （596）      PDF（pc） （1207KB）（584）       Knowledge map    Save Objective To explore the methods for assessment of marketing authorization holders’ (MAHs) compliance with Good Pharmacovigilance Practice (GVP) and to design an informatized assessment tool according to applications in businesses so as to provide a reference for regulators’ efficient assessment of pharmacovigilance and for self-assessment by MAHs. Methods A system of indexes for assessment of MAHs’ compliance with GVP was developed as required by pharmacovigilance and related assessment. An informatized profiling model for MAHs’ pharmacovigilance was established via data analysis technology before the assessment methods were developed that were to be designed into assessment tools used across the province on a trial basis. Results Two hundred and ninety-nine key points of indexes for assessment and rating standards were identified, so the system and methods for assessment evaluation were established. Based on the actual operations, an informazed tool was devised and an informatized profiling model for assessment was established. Conclusion The establishment of methods for assessment of GVP compliance and informatized tools provides an innovative approach by which MAHs can improve their pharmacovigilance. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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Comparative research on active post-marketing drug safety surveillance systems worldwide based on real-world data SUN Yixin, NIE Xiaolu, WANG Xiaoling, GUO Peng Chinese Journal of Pharmacovigilance    2024, 21 (8): 892-899.   DOI: 10.19803/j.1672-8629.20240376 Abstract （582）      PDF（pc） （1301KB）（540）       Knowledge map    Save Objective s To compare and analyze the active post-marketing safety surveillance practices based on real-world data (RWD) worldwide, in order to provide the reference for establishing an effective and feasible nationwide active surveillance system in China. Methods The literature on active surveillance systems around the world were searched and reviewed. The framework synthesis was used to determine the analytical framework, coding and mapping the information related to organizational structure, data characteristics, and operation mechanism. The similarities and differences of the active surveillance model were summarized. Results A total of 12 systems/organizations that conduct active surveillance based on RWD were included in this study, 9 of which are located in Europe and the United States, and in Asia. There are two Chinese systems, the China Hospital Pharmacovigilance System (CHPS) and the Adverse Drug Event Active Surveillance and Assessment System-Ⅱ (ADE-ASAS-Ⅱ). After integrating the information, the active monitoring model was summarized in six dimensions: (i) The organizational model was divided into three categories, including the government (with academia and pharmaceutical companies) led consortium, the direct government management, and the academic alliance consultation; (ii) The data integration and sharing model included the common data model, the common study protocol, and the centralized database; (iii) The data collection model could be divided into two forms: automatic collection from databases, and manual collection for target populations or specialized studies; (iv) The data management model included anonymizing, structuring and standardizing processes; (v) The data storage and transmission model can be categorized into the distributed data networks and the central database storage; (vi) Correspondingly, the data analysis model was divided into two categories: distributed computing and centralized analysis. Conclusion At present, the pattern of active surveillance for drug safety based on RWD are relatively mature in developed countries. While learning from those advanced experiences, we should also explore the active surveillance in line with the actual situation of China, to protect the medication safety of patients. Reference | Related Articles | Metrics | Comments（0）

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Risk Signal Mining of Adverse Events Related to Levothyroxine Sodium Tablets Based on FAERS CHEN Chongze, ZHOU Tianyu, SUN Siman, GUO Shushu, JIN Hongtao Chinese Journal of Pharmacovigilance    2024, 21 (12): 1425-1431.   DOI: 10.19803/j.1672-8629.20240036 Abstract （577）      PDF（pc） （1426KB）（256）       Knowledge map    Save Objective To analyze the adverse drug events (ADE) caused by levothyroxine sodium tablets to provide a reference for rational and safe clinical use. Methods The U. S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) was searched to retrieve the ADE data on the primarily suspected drug collected from the first quarter of 2015 to the second quarter of 2023. The reporting odds ratio (ROR)、proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCNPP) and multi-item gamma poisson shrinker (MGPS) methods were used to screen for effective signals of ADEs of drugs. Results A total of 271 356 ADEs related to levothyroxine tablets as the primary suspect were reported. Most of the people involved were women (198 219, 73.05%) and the patients ranged from 18 to 85 in age (62.46%). A total of 5 991 adverse events of levothyroxine sodium tablets were mined, 3 371 signals were obtained after excluding non-drug adverse event signals, and 20 organ systems were found to be involved. Fatigue (22 511 items), nausea (17 591 items), diarrhea (16 400 items), headache (15 043 items) and dyspnea (12 866 items)were the top five ADEs reported.Analysis showed that neonatal gangrene (ROR=267.57, IC025=4.66), bronchiolithiasis (ROR=187.30, IC025=267.57), homophonic association (ROR=107.03, IC025=267.57), increased trans-triiodothyronine (ROR=89.19, IC025=4.42), and decreased free thyroxine indexes (ROR=80.27, IC025=4.38）were the top five ADEs in terms of intensities of signals. Based on secondary screening, the top three PTs related to the neonatal risk signal intensity were neonatal gangrene, neonatal intestinal dilation, and neonatal thyrotoxicosis. The top three PTs regarding the stone risk signal intensity were bronchial stones, cerebral stones, and staghorn stones. A total of 146 signals that were not recorded in the instructions were found, which were mostly manifested in various examinations, gastrointestinal system diseases, infections and invasive diseases, nervous system diseases, benign and malignant tumors of unknown nature. Conclusion Levothyroxine sodium tablets can potentially cause such ADRs as calculuses, infections and secondary tumors in patients with hypothyroidism. Clinical multidisciplinary follow-up is recommended for patients taking levothyroxine sodium tablets. Reference | Related Articles | Metrics | Comments（0）

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Regulation of cellular and gene therapies at home and abroad ZHAO Peipei, WEN Baoshu Chinese Journal of Pharmacovigilance    2024, 21 (9): 1019-1024.   DOI: 10.19803/j.1672-8629.20240160 Abstract （576）      PDF（pc） （1350KB）（678）       Knowledge map    Save Objective To give tips about how to improve the regulation of cellular and gene therapies in China and promote high-quality development of the industry. Methods The ways in which cellular and gene therapy products were regulated in the US, Japan and Europe were compared by reviewing regulations and literature. The implications for China were analyzed in the light of actual regulation in China and the needs of industrial development. Results and Conclusion Based on the current practices related to the review and approval of cellular and gene therapies in China and by learning from the regulatory models and review process designs of the United States, Japan and Europe, China's regulatory system can be upgraded by means of innovative regulatory concepts, integration of review resources, more international exchanges and cooperation as well as intensified efforts. 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 （560）      PDF（pc） （1600KB）（571）       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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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 （549）      PDF（pc） （2556KB）（285）       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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Brief introduction and inspiration to the WHO guidance on Ethics and Governance of Artificial Intelligence for Health WANG Tao, SONG Haibo, WANG Qing, HOU Yongfang, LIU Hongliang, ZHANG Lin Chinese Journal of Pharmacovigilance    2024, 21 (8): 906-909.   DOI: 10.19803/j.1672-8629.20230518 Abstract （533）      PDF（pc） （1244KB）（370）       Knowledge map    Save Objective To systematically introduce the WHO guidance on Ethics and Governance of Artificial Intelligence for Health, as well as the status of ethics and governance of AI in medicine and health in China, other major countries and regions in the world, in order to provide a reference for formulating AI-based ethical guidelines in drug regulation in our country in the future. Methods The formulation, main contents and ethical principles of the WHO guideline were introduced. The general situation of AI ethics and governance in the medical and health field of government departments and related organization in the United States, the European Union and China through literature review and the websites of regulatory agencies was also elucidated. Results The WHO guideline elaborated 6 core ethical principles for the healthy development and use of AI in the field of medicine and health. Government departments and related organization in the United States, the European Union and China have formulated a series of policies and regulations on AI ethics and governance around the principles of fairness and justice, respect for privacy, security and control, shared responsibility, openness and transparency. Conclusion Drawing on the experience of WHO and foreign countries, it is suggested that NMPA actively formulate and implement the regulatory standards or relevant guidelines of new AI technologies in the whole life cycle of products, strengthen the transparency of artificial intelligence drugs and medical device products and other aspects to strengthen the governance of AI ethics. 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 （528）      PDF（pc） （2882KB）（704）       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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Chinese Journal of Pharmacovigilance    2024, 21 (12): 0-0.   Abstract （525）      PDF（pc） （443KB）（483）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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A National Pharmacovigilance Management System in a New Era YANG Xuyun, SUN Yang, TIAN Chunhua, HU Zengyao Chinese Journal of Pharmacovigilance    2025, 22 (3): 276-281.   DOI: 10.19803/j.1672-8629.20240861 Abstract （524）      PDF（pc） （1478KB）（736）       Knowledge map    Save Objective To analyze what pharmacovigilance is about in the new era and under new circumstances and summarize related experience in order to provide a reference for the construction of a national pharmacovigilance management system. Methods Based on related laws and regulations as well as the construction of systems and mechanisms, the achievements and downsides of pharmacovigilance in China were analyzed in terms of the evolution of pharmacovigilance, and ways to improve pharmacovigilance were recommended. Results Pharmacovigilance runs through the whole life cycle of drugs and focuses on risk management, providing strong technical support for regulation of pharmaceuticals. Since the implementation of pharmacovigilance, the legal system, regulatory system, organizational system, and professionalism have been gradually established and improved, but there is also much room for improvement. Conclusion It is recommended that more efforts be made to make pharmacovigilance more scientific, standard and legalized, and that a solid bottom line for drug safety be established to promote the high-quality development of pharmacovigilance and the pharmaceutical industry. Reference | Related Articles | Metrics | Comments（0）

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One case of severe constipation caused by dapagliflozin LU Jing, YU Shanshan, TONG Fei, LIN Zhuohui, SONG Luyao Chinese Journal of Pharmacovigilance    2024, 21 (9): 1071-1074.   DOI: 10.19803/j.1672-8629.20240167 Abstract （503）      PDF（pc） （1269KB）（326）       Knowledge map    Save Objective To remind health care professionals to be more alert to the risk of severe constipation associated with dapagliflozin and to provide reference for safe use of this drug. Methods The clinical process of treating a patient who developed severe constipation after taking dapagliflozin tablets was analyzed. Based on related literature, the possible mechanisms and treatment regimens of severe constipation caused by sodium-glucose cotransporter 2 inhibitors (SGLT-2i) were studied. Results One patient developed severe constipation after taking dapagliflozin. After discontinuation of the drug, the patient's constipation improved. However, upon re-administration of dapagliflozin, the patient relapsed into constipation. Immediately after drug withdrawal and treatment with laxatives to moisten the intestines, the patient's conditions improved. The causal relationship of adverse reactions was defined as “definite”, so the severe constipation of this patient was considered to have been caused by dapagliflozin. Conclusion Constipation poses a significant threat to patients' quality of life and may potentially precipitate cardiovascular events. Therefore, it is imperative to enhance clinicians' awareness and pharmacological surveillance regarding the adverse effects of constipation associated with dapagliflozin and SGLT-2i. Reference | Related Articles | Metrics | Comments（0）