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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 （1657）      PDF（pc） （3455KB）（1266）       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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Chinese Journal of Pharmacovigilance    2024, 21 (2): 0-0.   Abstract （236）      PDF（pc） （430KB）（1190）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Applicability of evaluation standards for use of traditional Chinese medicine injections for promoting blood circulation and removing blood stasis ZHANG Jian, FANG Huihua Chinese Journal of Pharmacovigilance    2024, 21 (2): 185-189.   DOI: 10.19803/j.1672-8629.20230140 Abstract （113）      PDF（pc） （1543KB）（1072）       Knowledge map    Save Objective To establish the standard for evaluation of clinical use of traditional Chinese medicine injections for promoting blood circulation and removing blood stasis. Methods According to the National Pharmacopoeia of the People’s Republic of China (2020 edition), the Drug Catalogues for National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance (2021), the Guidelines for Clinical Application of Proprietary Chinese Medicine for Coronary Heart Disease (2020 edition) and the Guidelines for Clinical Application of Proprietary Chinese Medicine for Heart Failure (2021), all TCM injections for promoting blood circulation and removing blood stasis were sorted out. According to drug instructions, guidelines and clinical use, the indicators for evaluation were identified, and the standard for evaluation was established using the Delphi method. Data on TCM injections for promoting blood circulation and removing blood stasis used in the Department of Cardiology between January 1 and June 30, 2022 was collected. The Technique for Order Preference by Similarity to an Ideal Solution was used for evaluation. Results A total of 21 indications of TCM injections for promoting blood circulation and removing blood stasis were included before primary and secondary evaluation indexes were established in terms of indications, solvents, usage and dosage, excipients, compatibility and special populations. According to the results of evaluation, 107 patients (89.17%) with Ci≥60% were identified from among 120 patients receiving TCM injections for promoting blood circulation and removing blood stasis, indicating that the usage of these TCM injections in the Department of Cardiology was generally proper. Conclusion The establishment of a standard for evaluation can help improve the rationality of the way in which TCM injections for promoting blood circulation and removing blood stasis are used. Reference | Related Articles | Metrics | Comments（0）

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Chinese patent medicines for recurrent spontaneous abortion: a scoping review of clinical evidence YU Xin, GONG Leilei, YAO Weijie, YUAN Sisi, FENG Xin Chinese Journal of Pharmacovigilance    2024, 21 (4): 361-365.   DOI: 10.19803/j.1672-8629.20240057 Abstract （221）      PDF（pc） （2126KB）（774）       Knowledge map    Save Objective To systematically sort out the drug information and current status of clinical research on the treatment of Recurrent Spontaneous Abortion (RSA) with Chinese patent medicines, so as to provide reference evidence for the rational use of medicines in the clinic, and a basis for the decision-making in the clinical practice and healthcare. Methods We carried out Chinese and English database document retrieval to review the clinical studies on Chinese patent medicines for the treatment of RSA. Relevant software was used to manage the literature, extract the basic information of the drugs and studies, and carry out visual comparative analyses in the form of textual descriptions and charts. Results A total of 95 research articles on Chinese patent medicines were screened out, including 2 systematic reviews and 93 clinical studies. 11 types of Chinese patent medicines were involved, including 1 Chinese medicine injection. The drugs with a higher number of clinical studies were Zishenyutai pills, Gushenantai pills, and Baotailing preparation. Since 2005, the number of related studies has been on an overall elevated trend, and has been carried out in 24 regions of China, the largest number of studies with sample sizes of 51~100 cases included 67 (72.04%); the type of comparison with the largest number of studies was the comparison of Chinese patent medicines in combination with Western medicines versus Western medicines, with a total number of studies amounted to 75 (80.65%). At present, there is no uniform clinical treatment protocol and efficacy judgement standard, and some studies (43.01%) recorded the occurrence of adverse reactions during drug administration in patients. Conclusion Chinese patent medicines have good suitability for the treatment of RSA, and their effectiveness in combination with western medicines is clear. However, there are problems such as lack of content in the drug instruction, timing and duration of medication and outcome evaluation indexes are not standardised, insufficient attention to medication safety, insufficient embodiment of Chinese medicine characteristics , which needs to be improved in the future. 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）（760）       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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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 （309）      PDF（pc） （1550KB）（736）       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）

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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 （744）      PDF（pc） （1327KB）（713）       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 （595）      PDF（pc） （1263KB）（682）       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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Chinese Journal of Pharmacovigilance    2024, 21 (4): 0-0.   Abstract （324）      PDF（pc） （473KB）（669）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2024, 21 (6): 0-0.   Abstract （292）      PDF（pc） （482KB）（664）       Knowledge map    Save 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 （527）      PDF（pc） （2882KB）（662）       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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Determination of bactericidal sodium benzoate and potassium sorbate in pediatric oral liquid preparations by HPLC ZHOU Yuanhua, WU Liangyong, ZHANG Liwen, DONG Shunling, YAO Shangchen, XU Mingzhe, ZHANG Xianhua Chinese Journal of Pharmacovigilance    2023, 20 (4): 365-369.   DOI: 10.19803/j.1672-8629.20230094 Abstract （114）      PDF（pc） （1350KB）（577）       Knowledge map    Save Objective To establish an HPLC method for screening analysis of sodium benzoate and potassium sorbate in pediatric oral liquid preparations. Methods The chromatography was performed on Ecosil C18 column(250 mm×4.6 mm, 5μm) using. 0.02 mL·min-1 ammonium acetate solution-acetonitrile(95∶5, V/V) as mobile phase at a flow rate of 1.0 mL·min-1, and detected at 225 nm. Results Sodium benzoate and potassium sorbate showed a good linear relationship with the peak area in the range of 1.140~114.0 μg·mL-1（r=1.000 0）and 1.082~108.2 μg·mL-1（r=1.000 0）, respectively.The limit of quantification (LOD) were 0.220 9 ng and 0.202 1 ng, and the limit of quantification (LOQ) were 0.673 8 and 0.736 4 ng. The average recoveries were 100.4% with an RSD of 0.4% (n=9) and 100.7% with an RSD of 0.5% (n=9) .In 21 samples of 15 species, the sodium benzoate and potassium sorbate detected were within the reference limits. Conclusion The proposed HPLC method is specificity, accuracy and serviceability. It can be successfully applied in quality control of different types of pediatric oral liquid preparations. 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 （460）      PDF（pc） （1254KB）（576）       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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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）（564）       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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Pharmacovigilance Newsletter Chinese Journal of Pharmacovigilance    2023, 20 (6): 720-720.   Abstract （482）      PDF（pc） （700KB）（555）       Knowledge map    Save 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 （558）      PDF（pc） （1600KB）（541）       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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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 （456）      PDF（pc） （1241KB）（525）       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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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 （399）      PDF（pc） （1248KB）（517）       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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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 （393）      PDF（pc） （1286KB）（482）       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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Updates and reflections on expedited reporting of safety information during drug clinical trials LIU Min, CHEN Yan, LIU Wendong, WANG Haixue Chinese Journal of Pharmacovigilance    2024, 21 (1): 98-101.   DOI: 10.19803/j.1672-8629.20230624 Abstract （331）      PDF（pc） （1324KB）（469）       Knowledge map    Save Objective To advance our understanding of the requirements on implementation of expedited reporting of safety information. Methods The background and changes of FAQ 2.0, including the scope, time limit, and method of expedited reporting, were interpreted and analyzed. Results and Conclusion In order to improve the quality of safety information reports, the applicant, as the main responsible person, should fulfil his responsibility, communicate willingly with all the parties involved in the clinical trial, and collect as much information as possible. The drug regulatory authority should continue to elevate the level of pharmacovigilance during the clinical trial, improve the system of standards and codes for practice, enhance the ability to assess risks, and upgrade informatization so as to protect the safety, rights and interests of the subjects. Reference | Related Articles | Metrics | Comments（0）