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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 （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）

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Comparative Analysis of Adverse Drug Reactions of Evolocumab and Alirocumab Based on OpenFDA LI Jiangfan, HU Ye, PANG Hongxian, ZHAO Dan, LI Xinru, WANG Xuhong Chinese Journal of Pharmacovigilance    2021, 18 (10): 965-968.   DOI: 10.19803/j.1672-8629.2021.10.15 Abstract （1439）      PDF（pc） （1215KB）（179）       Knowledge map    Save Objective To search the database of the US Food and Drug Administration public data open project (OpenFDA) for adverse drug reactions (ADR) of PCSK9 inhibitors evolocumab and alirocumab, and to compare and analyze the related ADR so as to provide reference for clinical rational use. Methods Using the API module in the interactive chart section of the ADR endpoint in OpenFDA database, the data on ADR reports of evolocumab and alirocumab harvested between January 1, 2004 and January 18, 2021 was retrieved. Results The number of ADR reports of evolocumab and alirocumab was 71 676 and 8 006, respectively. ADR reports of evolocumab mostly came from doctors, consumers and non-health professionals, compared with consumers, non-health professionals and other health professionals for alirocumab. Most of the ADR occurred in the United States. Female patients outnumbered male ones. Adults and the elderly made up the majority of the patients. The main indications for the drug were cardiovascular diseases. The dominating ADR related to elouzumab was pain at the injection site, and myalgia for alirocumab. The outcomes of most of these patients were unknown. Conclusion In the process of using evolocumab and alirocumab clinically, clinicians should be alert to the related ADR so as to promote the rational use of drugs. Reference | Related Articles | Metrics | Comments（0）

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Efficacy and safety of sintilimab in patients with advanced colorectal cancer CAI Jiangxia, CHEN Siying, DONG Kai, QIN Jianpin, ZHANG Yue, QI Ruifeng, YE Yinmei Chinese Journal of Pharmacovigilance    2022, 19 (2): 164-168.   DOI: 10.19803/j.1672-8629.2022.02.11 Abstract （1258）      PDF（pc） （1378KB）（134）       Knowledge map    Save Objective To study the efficacy and adverse reaction of sintilimab combined with chemotherapy in patients with advanced colorectal cancer. Methods 82 patients with advanced colorectal cancer who had failed first-line chemotherapy with oxaliplatin in Bayinguoleng Mongolian Autonomous Prefecture Hospital between January 1, 2018 and July 31, 2020 were randomly divided into group A and group B. Patients in group A underwent second-line chemotherapy involving irinotecan and capecitabine (referred to as XELIRI regimen), while those in group B were given sintilimab combined with XELIRI chemotherapy. The short-term efficacy, long-term efficacy and adverse reactions were compared between the two groups. Results As of February 28, 2021, the clinical efficacy among the 82 patients with advanced colorectal cancer could be evaluated. The Objective response rate (ORR) was 20.00% in group A and 21.42% in group B. The disease control rate (DCR) was 65.00% in group A and 71.43% in group B. There was no significant difference in ORR or DCR between the two groups (P>0.05). The median PFS of group B was superior to that of group A, with statistically significant significance (P<0.05). As for adverse reactions, there was no significant difference between the two groups in blood toxicity, gastrointestinal tract reactions (nausea/vomiting), diarrhea or elevation of transaminase (P > 0.05). However, the incidence of such adverse reactions (mainly mild reactions of grade I to II) as rash, hypothyroidism and proteinuria was higher in group B than in group A, which were considered to be related to sintilimab. One patient developed grade III rash reaction, but the rash was completely relieved one month after withdrawal and after one week of symptomatic treatment. Overall adverse reactions were tolerable in both groups. Conclusions intilimab combined with second-line XELIRI chemotherapy is of potential benefit for patients with advanced colorectal cancer, with generally tolerable adverse reactions and controllable safety. Reference | Related Articles | Metrics | Comments（0）

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Significance of Good Pharmacovigilance Practice in the Construction of China Pharmacovigilance System WANG Dan, REN Jingtian, WU Guizhi, XIONG Weiyi, TANG Ren, PANG Yu, FAN Rong, YANG Le Chinese Journal of Pharmacovigilance    2021, 18 (6): 501-503.   DOI: 10.19803/j.1672-8629.2021.06.01 Abstract （1129）      PDF（pc） （1089KB）（1060）       Knowledge map    Save Objective To explore the significance of Good Pharmacovigilance Pracetice (GVP)in constructing the Pharmacovigilance System of China. Methods review the background of GVP, study its status in the field of drug safety supervision, summarize its core and gist, discuss its role in the Pharmacovigilance System, and analyze the significance of its introduction. Results and Conclusion the promulgation and implementation of GVP is the first step in the construction of China Pharmacovigilance System, which has great significance and far-reaching influence. Reference | Related Articles | Metrics | Comments（0）

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Problems with and suggestions about expedited reporting of suspected unexpected serious adverse reactions during clinical trials of drugs in China LIU Min, PEI Xiaojing, WANG Haixue Chinese Journal of Pharmacovigilance    2022, 19 (2): 176-179.   DOI: 10.19803/j.1672-8629.2022.02.13 Abstract （969）      PDF（pc） （1261KB）（1048）       Knowledge map    Save Objective To improve the quality of expedited reporting of suspected unexpected serious adverse reactions during clinical trials of drugs. Methods This article was based on the questions of safety reports received by regulators over the past two years combined with the current requirements and developments of expedited reporting at home and, screened several common problems. Results Some common problems about expedited reporting of suspected unexpected serious adverse reactions during clinical trials of drugs in China were analyzed and suggestions were offered. Conclusion Personnel engaged in expedited reporting during clinical trials of drugs should have accurate understanding of the requirements of guidelines and regulations related to pharmacovigilance at home and abroad so as to better protect the safety of subjects. Reference | Related Articles | Metrics | Comments（0）

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An introduction to the Medical Dictionary for Regulatory Activities and its use Anna C Zhao-Wong, ZHU Lilin Chinese Journal of Pharmacovigilance    2022, 19 (1): 74-78.   DOI: 10.19803/j.1672-8629.2022.01.16 Abstract （904）      PDF（pc） （1733KB）（1295）       Knowledge map    Save Objective To introduce the Medical Dictionary for Regulatory Activities (MedDRA) Terminology, a medical terminology developed under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the use of MedDRA in the regulatory area. Methods The need for an international standard terminology in the 1990s was traced, the structure and maintenance of MedDRA were illustrated, the milestones of MedDRA's growth and development were listed, including its recent actions to meet the challenges of the COVID-19 pandemic, and the future developments of MedDRA were outlined. Results and Conclusion MedDRA by ICH resulted from the need for an international standard terminology that could meet the regulatory needs in pharmaceutical research and development. MedDRA has been used in the registration, documentation, safety monitoring and oversight of medicinal products through each phase of the pipeline, from clinical trials to post-marketing surveillance. The structure and maintenance model of MedDRA can facilitate its use. Since its inception as a user-driven terminology, MedDRA has grown in volume and expanded in scope under the care of the Maintenance and Support Services Organization (MSSO) to meet the needs of users and of evolving regulatory reporting and to keep up with the advances of medicine. Reference | Related Articles | Metrics | Comments（0）

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Research progress in human serum albumin injections LU Song, YANG Ping, YANG Li, DONG Xianzhe, ZHANG Lan Chinese Journal of Pharmacovigilance    2022, 19 (2): 228-232.   DOI: 10.19803/j.1672-8629.2022.02.27 Abstract （726）      PDF（pc） （1260KB）（316）       Knowledge map    Save Human serum albumin (HSA) injections based on the “Guidelines for Comprehensive Evaluation of Chinese Drugs”were evaluated. The guidelines for diagnosis and treatment, pharmacopoeias, drug inserts, literature and official data related to HSA injections were consulted, while the safety, efficacy, compliance, cost, and clinical value of HSA were assessed. HSA injections are widely used in clinical practice and are quite safe, but they are too expensive and have not yet entered the national medical insurance catalogue. HSA injections have been recommended by guidelines in many countries for the treatment of such diseases as liver cirrhosis and hypovolemic shock, but there are still cases of inappropriate medication. Reference | Related Articles | Metrics | Comments（0）

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Thoughts on the Establishment of Pharmacovigilance Systems in Pharmaceutical Group Companies under Pharmacovigilance Systems JIANG Danna, LAI Wenjian, ZHAO Xiping, LIU Ying, XU Yan Chinese Journal of Pharmacovigilance    2021, 18 (6): 504-506.   DOI: 10.19803/j.1672-8629.2021.06.02 Abstract （693）      PDF（pc） （1154KB）（859）       Knowledge map    Save Objective To provide a reference for pharmaceutical groups to build a group pharmacovigilance system through reflecting on the key issues in building a group pharmacovigilance system. Methods Based on the good pharmacovigilance practices (GVP) and the experience of marketing authorization holders in establishing pharmacovigilance systems, the advantages, conditions and possible problems of a group pharmacovigilance system were discussed and suggestions on how to build a group pharmacovigilance system were made. Results The construction of a group pharmacovigilance system is conducive to maximizing resource utilization and improving the professional level of the group pharmacovigilance. Conclusion To meet the challenges brought by the implementation of GVP, pharmaceutical groups may consider establishing a group pharmacovigilance system based on their own situation. Reference | Related Articles | Metrics | Comments（0）

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Discussion on the Monitoring and Analysis of Cluster Adverse Drug Events by Drug Marketing Authorization Holders YANG Le, TIAN Chunhua, XIA Dongsheng, DON Duo, FAN Rong, ZHANG Meiling Chinese Journal of Pharmacovigilance    2021, 18 (10): 940-943.   DOI: 10.19803/j.1672-8629.2021.10.09 Abstract （676）      PDF（pc） （1134KB）（742）       Knowledge map    Save Objective To provide reference for drug marketing authorization holders (MAH) to monitor and analyze cluster adverse drug events (referred to as "cluster events"). Methods The main characteristics and causes of cluster risks/events were analyzed, introduces Monitoring methods of cluster risks, setting rules for early warning signals, key points of on-site investigation, cluster risks/event analysis were introduced. Results and Conclusion MAH can identify and judge cluster risk signals in the adverse drug reaction(ADR) database by establishing monitoring methods, to confirm and control potential drug quality risks or use risks in advance, and maximize the protection of public medication safety. Reference | Related Articles | Metrics | Comments（0）

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Current Adverse Drug Reaction Reporting and Monitoring of Essential Medicines in China YU Hongli, PANG Yu, SHAO Bo, XIAO Aili, YU Dongmei Chinese Journal of Pharmacovigilance    2021, 18 (8): 766-768.   DOI: 10.19803/j.1672-8629.2021.08.14 Abstract （674）      PDF（pc） （1080KB）（674）       Knowledge map    Save Objective To analyze the levels of reporting and monitoring of adverse drug reactions of essential medicines in recent years in China so as to provide reference for clinical safe use. Methods The Annual Reports on National ADR Monitoring issued by the National Medical Products Administration between 2015 and 2019 were collected while those on ADR/ADE involving national essential medicines were summarized and analyzed. Results From 2015 to 2019, reports of ADR/ADE caused by essential medicines in China kept increasing, which was consistent with the overall trend of reports in China. Conclusion With the improvement of regulations on essential medicines in China, ADR related to essential medicines deserve attention in order to promote the safe clinical use. Reference | Related Articles | Metrics | Comments（0）

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Brief Introduction on the Guideline for the Pharmacovigilance Delegation Agreement (Pilot Version) YANG Le, TIAN Chunhua, XIA Dongsheng, WANG Dan, LIU Cuili, TANG Ren, YU Hongli PENG Lili, WANG Gang Chinese Journal of Pharmacovigilance    2021, 18 (6): 510-513.   DOI: 10.19803/j.1672-8629.2021.06.04 Abstract （647）      PDF（pc） （1105KB）（1510）       Knowledge map    Save Objective To provide an important reference for drug marketing authorization holders and consignee to carry out pharmacovigilance commission. Methods From the perspective of drafters, the regulation is related with the drafting background, the status of post marketing pharmacovigilance Commission, guidelines and key points were introduced. Results and Conclusion The guidelines for the Pharmacovigilance delegation agreement (pilot version) has been officially released on June 4, 2020. As the first normative documentation on how to carry out pharmacovigilance delegation for drug marketing authorization holders in China in the new era, it aims to provide guide and enlightenment for relevant parties, and will be continuously adjusted and improved in practice. Reference | Related Articles | Metrics | Comments（0）

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The Mechanism of monitoring of adverse drug reaction cluster signals and disposal at the provincial level LU Changfei, CUI Xiaokang, LIU Wenwen, ZHANG Huaqi, GAO Wenzheng, WU Shifu Chinese Journal of Pharmacovigilance    2022, 19 (2): 180-184.   DOI: 10.19803/j.1672-8629.2022.02.14 Abstract （626）      PDF（pc） （1355KB）（627）       Knowledge map    Save Objective To explore the working mechanism of monitoring of adverse drug reaction cluster signals and disposal at the provincial level. Methods Based on ways of monitoring in Shandong Province, the patterns and characteristics of adverse drug reaction cluster signals were summarized, specific requirements were clarified and advice on improving the monitoring of ADR cluster signals was given. Results and Conclusion The monitoring and disposal of adverse drug reaction cluster signals requires that the main responsibilities of drug marketing authorization holders are fulfilled, risk control be given the top priority, multi-sided collaboration and closed-loop disposal be ensured. Reference | Related Articles | Metrics | Comments（0）

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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）

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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 （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）

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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 （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）

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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 （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）

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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 （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）

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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 （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）

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Common Problems with Post-marketing Adverse Drug Reaction Reports from Literature ZHU Lan, ZHU Yan, LIU Lihong, SHAO Bo, LIU Hongliang, XIONG weiyi Chinese Journal of Pharmacovigilance    2021, 18 (12): 1155-1158.   DOI: 10.19803/j.1672-8629.2021.12.12 Abstract （526）      PDF（pc） （1092KB）（622）       Knowledge map    Save Objective To summarize problems with post-marketing adverse drug reaction (ADR) reports collected from literature in China and give related advice to marketing authorization holders (MAHs).Methods The common problems with ADR reports from related literature were listed and analyzed. Suggestions for improvement were offered based on the requirements of relevant guidelines and documents issued by the NMPA after 2018 and the requirement of ICH E2D guideline. Results and Conclusion The ADR reports collected from related literature are imperfect in terms of compliance, completeness and timeliness, and MAHs need to make more efforts to improve the quality of such reports. Reference | Related Articles | Metrics | Comments（0）

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One case of hypokalemia caused by moxifloxacin injection and literature analysis YANG Guiling, ZHAO Mudan, GAO Yiling, WANG Bei, ZHU Minghui Chinese Journal of Pharmacovigilance    2022, 19 (3): 342-344.   DOI: 10.19803/j.1672-8629.2022.03.26 Abstract （525）      PDF（pc） （1115KB）（343）       Knowledge map    Save Objective To explore the mechanism by which hypokalemia is caused by moxifloxacin injection so as to provide reference for clinical rational and safe use of moxifloxacin. Methods The diagnosis and treatment process of one case of hypokalemia after moxifloxacin injection was analyzed. Results Symptoms of hypokalemia (2.78 mmol·L-1) occurred one week after intravenous injection of moxifloxacin. After moxifloxacin injection was withdrawn and intravenous and oral potassium supplementation was started, the level of potassium returned to normal (4.41 mmol·L-1). Conclusion Intravenous injection of moxifloxacin may lead to hypokalemia, which deserves more attention in clinic. Reference | Related Articles | Metrics | Comments（0）