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Implication of EU Pharmacovigilance System to China ZHANG Gui-ju, CHU Xiao-yi, TIAN Yue-jie, HUANG Lin, LI Yu-ji Chinese Journal of Pharmacovigilance    2015, 12 (10): 593-596.   Abstract （1208）      PDF（pc） （568KB）（47746）       Knowledge map    Save Objective To draw experience from pharmacovigilance system construction in EU, provide reference for pharmacovigilance system in China. Methods Introduce the organization structure and pharmacovigilance processes of EU pharmacovigilance system, compare the differences in regulations, directives and pharmacovigilance processes between China and EU, and provide advice on the improvement of drug adverse reaction monitoring and reporting in China. Results and Conclusion There are many differences between the drug adverse reaction monitoring and reporting system in China and EU pharmacovigilance system, such as the basement of regulation, the system design and the working mechanism. It is helpful for us to reform the drug adverse reaction monitoring and reporting in China borrowing the EU pharmacovigilance and enhance the interaction between drug administration and drug safety monitoring after drug approval. It would encourage the pharmaceutical enterprises taking responsibility of drug safety, promote the policy coordination of drug regulation, and improve the administration efficiency. Reference | Related Articles | Metrics | Comments（0）

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Research on the Differences and Correlation Between‘Serious’ and ‘Severe’ Adverse Drug Reactions/Events YUAN Li, YANG Yue Chinese Journal of Pharmacovigilance    2016, 13 (8): 484-488.   Abstract （1646）      PDF（pc） （1045KB）（3376）       Knowledge map    Save Objective To ravel out the concept,connotation and significance of ‘serious’ and ‘severe’ adverse drug reactions (ADRs) /adverse events (AEs), clear out the differences and correlation between the two concepts, and lay a foundation for accurate use in the actual work. Methods Literature research and comparative analysis were introduced to compare and summarize the differences and relationship between the concepts and connotation. Results ‘Serious’ ADR/AE is based on outcome, it is a guidance in determining responsibility in drug safety monitoring, ‘severe’ adverse drug reaction/event is a class of ADR/ADE marked as ‘severe’. Conclusion ‘Serious’ and ‘severe’ ADRs/AEs are not the same and often confused in use, the former is more likely a concept of administration, and the latter is more likely a technical concept. The existence of the two plays a different role, it should be paid attention when use. Reference | Related Articles | Metrics | Comments（0）

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Analysis of Ketoacidosis Induced by Dapagliflozin Tablets YUAN Menghu, QIAN Fengdan Chinese Journal of Pharmacovigilance    2020, 17 (3): 157-160.   DOI: 10.19803/j.1672-8629.2020.03.06 Abstract （2212）      PDF（pc） （781KB）（3108）       Knowledge map    Save Objective To explore the safety of dapagliflozin tablets in clinical application. Methods This article summarizes two cases which have been diagnosed with ketoacidosis after using dapagliflozin tablets from Shanghai General Hospital in November 2018. In addition, relevant literatures at home and abroad are reviewed. Results The two diabetic patients began to show symptoms of tolerance, nausea and vomiting without obvious inducement on the 6th and 1st day after taking dapagliflozin tablets respectively. On the 7th and 6th day after taking the tablets, they were diagnosed with ketoacidosis through laboratory examination. Their symptoms improved after drug withdrawal, fluid rehydration, low-dose insulin intravenous drip, electrolyte correction and other treatments. Conclusion Dapagliflozin tablets may cause ketoacidosis. Medical personnel should pay attention and use carefully in high-risk groups. Reference | Related Articles | Metrics | Comments（0）

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Common Signal Detection Methods of Adverse Drug Reaction REN Jing-tian, WANG Sheng-feng, HOU Yong-fang, DU Xiao-xi, LI Li-ming Chinese Journal of Pharmacovigilance    2011, 8 (5): 294-298.   Abstract （1286）      PDF（pc） （667KB）（2538）       Knowledge map    Save This paper aims to give some references for adverse drug reaction(ADR) signal detection in China, by summarizing the common used signal detection Methods and rationale, such as the Reporting Odd Ratio, Proportional Reporting Ratio, Information Component and Gamma-Poisson Shrinker. Reference | Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2014, 11 (2): 122-122.   Abstract （480）      PDF（pc） （560KB）（2359）       Knowledge map    Save Reference | Related Articles | Metrics | Comments（0）

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Literature Analysis of Clinical Application and Adverse Drug Reaction/Event of Lianhua Qingwen Capsule PENG Li-li, LI Lan, SHEN Lu, LI Xing-ling Chinese Journal of Pharmacovigilance    2015, 12 (12): 753-755.   Abstract （9022）      PDF（pc） （642KB）（2225）       Knowledge map    Save ObjectiveTo investigate and analyze the literatures on clinical application and ADR/ADE induced by Lianhua Qingwen Capsule to provide reference for its rational use in clinic. MethodsThe literatures for ADR/ADE of Lianhua Qingwen Capsule were retrieved in the databases of CNKI、Wangfang data for the last 10 years, which were screened out and analyzed by evidence-based medicine method and bibliometric statistical method. ResultsThirty-eight literatures were included and toltal 122 adverse drug reaction cases were collected. Most drug adverse reactions occurred after first use, primarily involved gastrointestinal system(73.9%), skin and its appendaes (9.6%), including nausea, vomiting, abdominal distention, diarrhea, skin rashes, itching, etc. ConclusionWe should reinforce the clinical application of Lianhua Qingwen Capsule, standardize and improve the drug package inserts, promote the rational use of drug and guarantee the safety of patients. Reference | Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2020, 17 (8): 548-548.   DOI: 10.19803/j.1672-8629.2020.08.21 Abstract （711）      PDF（pc） （845KB）（2071）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Hypothyroidism Caused by Terepril and Literature Analysis ZHAO Shuang, MIAO Qiuli, SONG Yanqing, LI Yue Chinese Journal of Pharmacovigilance    2021, 18 (7): 697-699.   DOI: 10.19803/j.1672-8629.2021.07.22 Abstract （300）      PDF（pc） （874KB）（1993）       Knowledge map    Save Objective To analyze the clinical characteristics, risk factors, diagnosis and therapeutic strategy of hypothyroidism caused by terepril monoclonal antibody based on the cases. Methods A case of hypothyroidism induced by rectal cancer treated with terepril monoclonal antibody was analyzed, and the related literature was summarized. Results In this case, a 44 year old male patient with multiple metastases of rectal cancer after two or three lines of chemotherapy was treated with terepril monoclonal antibody 240 mg intravenously. This patient presented with symptoms such as decreased levels of FT3 and FT4 and elevated levels of TSH . Left thyroxine sodium tablet was given 12.5 μg orally once a day. Blood routine showed that there was no significant abnormality in the three normal values of thyroid function. The patient did not stop the treatment of terepril monoclonal antibody. Conclusion During the treatment of terepril monoclonal antibody, we should pay attention to the clinical symptoms and imaging characteristics of the patients, identify the immune-related hypothyroidism that may be caused by terepril monoclonal antibody. The patients with immune-related adverse reactions should be given corresponding treatment according to their severity, and at the same time, we should be alert to the risk of recurrence after re administration. Reference | Related Articles | Metrics | Comments（0）

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Analysis of Granulocytopenia Induced by Thiamazole WEN Xiaoling, GAO Yunjuan, ZHANG Hailang, YANG Jie, LAN Shan, LI Yamei, LI Lan Chinese Journal of Pharmacovigilance    2018, 15 (7): 398-403.   Abstract （691）      PDF（pc） （819KB）（1951）       Knowledge map    Save Objective To analyze the characteristics of granulocytopenia induced by thiamazole, so as to provide reference for clinical safe and rational drug use. Methods Retrospective study was conducted on the statistical analysis of granulocytopenia induced by thiamazole that received by the national adverse drug reactions monitoring database from January 1, 2004 to June 30, 2016. Results Among 1 358 cases of granulocytopenia induced by thiamazole, the proporation of the serious adverse drug reactions(ADRs) was 48.53%, female patients were 3.93 times that of male patients, the most of patients were 15 to 44 years old, it occurred within 12 weeks accounting for 87.56%, and there may be a dose correlation in the occurrence of ADRs. Clinical manifestations were mainly the blood system damage, systemic damage and respiratory damage. Conclusion Granulocytopenia induced by thiamazole can't be ignored. The clinic should pay attention to usage and dosage. The education of patients, the blood monitoring before and after treatment should be strengthened. Doctors should actively take treatment measures to reduce the injury if it happened, so as to prevent or reduce the occurrence of serious adverse drug reactions. 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 （663）      PDF（pc） （1105KB）（1904）       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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Detection and Evaluation of Post-marketing Safety Alert Signals for Human Papillomavirus 9-valent Vaccine Based on US Vaccine Adverse Event Reporting System (VAERS) GONG Li, PAN Lingyun, LIU Yan, JI Huanhuan, TANG Xuewen, JIA Yuntao Chinese Journal of Pharmacovigilance    2019, 16 (8): 478-486.   Abstract （718）      PDF（pc） （938KB）（1784）       Knowledge map    Save Objective To detect and evaluate the post-marketing safety warning signals of separate vaccination of human papillomavirus 9-valent vaccine (9vHPV), so as to provide references for follow-up studies and vaccinations. Methods 9vHPV-related (alone) AE reports from January 2015 to December 2018 were collected from the VAERS and comprehensive standard method was adopted to detect and evaluate the safety warning signals. Results A total of 39 safety warning signals were obtained through detection, involving 14 SOCs in total, the first three signals in each class were nervous system diseases, reproductive system diseases and breast diseases, and investigations, among which, the new signals of clinical concern included irregular menstruation (PRR=12.11,χ2=48.94), amenorrhea (PRR=4.43,χ2=14.41), infertility (PRR=8.86,χ2=32.54), ovarian cyst (PRR=7.85,χ2=16.31), opsomenorrhea (PRR=8.56,χ2=17.81), menorrhagia (PRR=4.96, χ2=9.42), premature menopause (PRR=4.43,χ2=5.93), alopecia (PRR=3.02,χ2=19.27). Conclusion In this paper, comprehensive standard method was adopted to mine relevant data from VAERS and many new safety signals were detected at last, which lays a foundation for the follow-up safety studies on 9vHPV. Reference | Related Articles | Metrics | Comments（0）

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The Establishing and Running of Pre-warning System on Adverse Event Cluster Signals FENG Hong-yun, HOU Yong-fang, WU Gui-zhi, CHENG Gang Chinese Journal of Pharmacovigilance    2012, 9 (12): 745-747.   Abstract （767）      PDF（pc） （630KB）（1777）       Knowledge map    Save To discovery the adverse event cluster signals earlier, a pre-warning system was established and running in national adverse drug reaction monitoring system. Related processes, including background, pre-warning regulations, all problems during pre-warning system running and adjustments were introduced. In order to test the sensitivity and accuracy of pre-warning regulations, the three important historical drug hazards were pre-warned by hand. Reference | Related Articles | Metrics | Comments（0）

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Implementation of Pharmacovigilance System in Drug Administration Law and Application of ICH E2 Guideline YANG Yue Chinese Journal of Pharmacovigilance    2020, 17 (2): 65-71.   DOI: 10.19803/j.1672-8629.2020.02.01 Abstract （1753）      PDF（pc） （1079KB）（1684）       Knowledge map    Save This paper is intended to analyze the difference in adverse reaction reporting and monitoring systems between the previous Drug Administration Law and the pharmacovigilance system specified in the newly revised Drug Administration Law. Starting with the meaning of pharmacovigilance and combined with the macro background of acceleration of new drug authorization since the reform of drug review and approval in China, this paper points out that the pharmacovigilance system can be compared to the braking mechanism for new drug review to enter the “expressway”. Combined with the transformation and application of ICH E2 series guidelines, this paper makes recommendations for the implementation of pharmacovigilance requirements according to the revised Drug Administration Law, such as changing notions about the monitoring and reporting of drugs, improving the efficiency and ability of signal detection, carrying out cumulative risk benefit evaluation, and exploring the requirements of risk management plans suited to China. Reference | Related Articles | Metrics | Comments（0）

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Review of Adverse Drug Reaction Reports Causality Assessment Methods WEI Jing, WANG Yu-xin Chinese Journal of Pharmacovigilance    2011, 8 (10): 600-602.   Abstract （1414）      PDF（pc） （470KB）（1585）       Knowledge map    Save ADR causality assessment method is an important tool in the process of pharmacovigilance. The aim of this review is to provide an overview of these methods and discuss their strengths and weaknesses. The methods were found, falling into three broad categories: expert judgement/global introspection, algorithms and probabilistic methods(Bayesian approaches). Expert judgements are individual assessments based on previous knowledge and experience in the field using no standardized tool to arrive at conclusions regarding causality. Algorithms are sets of specific questions with associated scores for calculating the likelihood of a cause-effect relationship. Bayesian approaches use specific findings in a case to transform the prior estimate of probability into a posterior estimate of probability of drug causation. The prior probability is calculated from epidemiological information and the posterior probability combines this background information with the evidence in the individual case to come up with an estimate of causation. Different causality categories are adopted in each method, and the categories are assessed using different criteria. In conclusion, there is still no method universally accepted for causality assessment of ADRs. Reference | Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2013, 10 (7): 444-444.   Abstract （435）      PDF（pc） （564KB）（1560）       Knowledge map    Save Reference | Related Articles | Metrics | Comments（0）

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Analysis of Reports on Adverse Events of Surgical Suture Devices CHEN Xi, LONG Li-ping* Chinese Journal of Pharmacovigilance    2012, 9 (2): 114-116.   Abstract （341）      PDF（pc） （647KB）（1541）       Knowledge map    Save Objective By analyzing the reports on adverse events of surgical suture devices in Hunan province in 2010, provide technical support for the monitoring work of medical device adverse events. MethodsWith the description method, statistically analyze 409 reports collected in 2010 with the help of Microsoft Excel, primarily discuss the existing problems and present corresponding measures. ResultsThese surgical suture adverse events in Hunan province largely occurred in the patients between 20-30 years old. The reports mainly came from medical facility, and most events happened in November, in which the majority was absorbable surgical suture adverse events. The clinical manifestations of adverse events focused on suture reaction and poor wound healing, 80.20% of all the adverse events needed internal and surgical treatment to avoid the permanent injury. ConclusionWe should strengthen the training of surgical suture adverse event monitoring, promote the quality of reports to make them become effective information available for the safe use of medical devices. 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 （935）      PDF（pc） （1733KB）（1509）       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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Introduction of European Union Pharmacovigilance System facing New Regulation DONG Duo, WU Gui-zhi, CHENG Gang Chinese Journal of Pharmacovigilance    2012, 9 (11): 662-665.   Abstract （863）      PDF（pc） （520KB）（1447）       Knowledge map    Save By introducing the revision of European Union(EU) Pharmocovigilance regulation, it helped to know the structure of EU Pharmacovigilance system better. And it also clearly showed the contents of the system, such as Pharmacovigilance Systems and their Quality Systems, Pharmacovigilance System Master File, Pharmacovigilance Inspections, Risk Management Systems. It provided the example and reference for perfecting and developing Adverse Drug Reaction Reporting and Monitoring System of China. Reference | Related Articles | Metrics | Comments（0）

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Comparison of the Drug Package Inserts of Domestic and Foreign Compound Preparations Containing Narcotic Drugs LIU Wei, LUAN Rong, ZHAI Suo-di Chinese Journal of Pharmacovigilance    2011, 8 (10): 603-605.   Abstract （171）      PDF（pc） （495KB）（1437）       Knowledge map    Save Objective To regulate the drug package inserts of domestic compound preparations containing narcotic drugs and improve rational use of these drugs. Methods From the safe medication's angle, choose drug abuse and dependence, contraindications, precautions and so on from the drug package inserts, and then contrastively analyse the domestic and foreign part. Results The domestic drug package inserts are lack of warnings. Both the domestic and the foreign ones are not all-inclusive about contraindications. The Chinese and English drug package inserts do not correspond. Conclusion We can reference package inserts of the narcotic drugs unilaterally preparations and foreign compound preparations containing narcotic drugs to revise domestic ones. Reference | Related Articles | Metrics | Comments（0）

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Study on Comparative Application of the Materials of Heart Stents DONG Si-yuan Chinese Journal of Pharmacovigilance    2012, 9 (12): 728-730.   Abstract （478）      PDF（pc） （434KB）（1413）       Knowledge map    Save The coronary implantation of heart stents is one of the important methods for the treatment of coronary heart disease. With the advances of biomaterial technology, rapid development has been achieved in the application of heart stents materials. The author introduced the evolution of heart stents materials in terms of metal stents, drug-eluting stents and soluble stents, and that the application of novel material stents is the important rout to reduce the rate of cardiovascular restenosis. Additionally, the future of materials of stents was also looked into. Reference | Related Articles | Metrics | Comments（0）