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Extending the evidence on ustekinumab safety in Crohn’s disease:A pharmacovigilance disproportionality analysis of FAERS data 认领 引用
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作者 Qiu-Han Yao Wei-Yu Yang 《World Journal of Gastroenterology》 SCIE CAS 2026年第29期15-26,共12页
A previous retrospective study reported that most postoperative Crohn’s disease(CD)patients achieved clinical remission after ustekinumab therapy,with few adverse events(AEs)observed.While their findings were clinica... A previous retrospective study reported that most postoperative Crohn’s disease(CD)patients achieved clinical remission after ustekinumab therapy,with few adverse events(AEs)observed.While their findings were clinically significant,some limitations warrant consideration.First,the authors acknowledged that the small cohort size(n=71)may limit the reliability.Second,their study examined only a narrow spectrum of AEs.Third,their analysis presented only AE incidence counts without assessing crucial safety parameters,including temporal patterns,strength characteristics,or clinical risk mitigation strategies.To address these limitations,we conducted a pharmacovigilance analysis using the United States Food and Drug Administration Adverse Event Reporting System(FAERS)database from 2004(Q1)to 2025(Q2).Disproportionality analyses were performed using the reporting odds ratio(ROR)and proportional reporting ratio to characterize ustekinumab-associated AEs in CD.A total of 21441 AE reports were identified.Our results indicated that infections remain the predominant AE category reported with ustekinumab[lower respiratory tract infection(ROR=7.26,95%CI:6.7-7.87),clostridium difficile infection(ROR=3,95%CI:2.71-3.31),and abscess(ROR=2.01,95%CI:1.82-2.21)],consistent with its established safety profile.In addition,several cardiovascular and neuropsychiatric disproportionality signals were detected,including left ventricular dysfunction,dilated cardiomyopathy,acute coronary syndrome,pulseless electrical activity,suicide,abnormal dreams,obsessive-compulsive disorder,and autoscopy.Early monitoring within the first two months and continued surveillance beyond six months may be warranted,particularly in high-risk populations.These findings complement and extend those of previous study.However,FAERS has some limitations,including underreporting,reporting bias,and the inability to determine causality;therefore,these findings require confirmation in further studies. 展开更多
关键词 Crohn’s disease Ustekinumab Safety Pharmacovigilance Adverse event
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Toxicities Associated with Sacituzumab Govitecan:Data from Clinical Trials and a Real-World Pharmacovigilance Database 认领 引用 被引量：1
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作者 Qiao-yun Tan Xiang-ping Mei +4 位作者 Yue Hu Hong-ge Wu Lin-ka Xie Jie Xiong Jing Yao 《Current Medical Science》 SCIE CAS CSCD 2025年第2期301-313,共13页
Objective This study aimed to analyze the adverse effects(AEs)of sacituzumab govitecan(SG)through multiple sources of data to provide a reference for clinical safety management.Methods Clinical trials of SG with avail... Objective This study aimed to analyze the adverse effects(AEs)of sacituzumab govitecan(SG)through multiple sources of data to provide a reference for clinical safety management.Methods Clinical trials of SG with available safety data were retrieved and included in the pooled analysis.The adverse drug reaction(ADR)signals of SG were collected from the FDA Adverse Event Reporting System(FAERS)database.Drug interactions with SG in the DDInter database were summarized.Results A total of 6 clinical trials involving 1737 patients were included in the pooled analysis,and the most common AEs of≥grade 3 were neutropenia(46%),leukopenia(13%),and anemia(8%).In the pharmacovigilance study,1024 AE reports were extracted,and the most common toxicities of SG were hematologic and gastrointestinal.AEs not included in the drug instructions also presented high signals,such as meningitis,colitis and lymphedema.A total of 40 drugs identified could induce drug–drug interactions when they were concomitantly administered with SG.Conclusions This study provides the most comprehensive profile of SG toxicity on the basis of data from clinical trials and the FRAES and DDInter databases.Attention should be given not only to common ADRs but also to ADRs not reported in drug instructions,and potential drugs that can induce drug–drug interactions. 展开更多
关键词 Toxicity Sacituzumab govitecan Clinical trial Pharmacovigilance
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A real-world pharmacovigilance study of Food and Drug Administration Adverse Event Reporting System events for lenvatinib 认领 引用
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作者 Juan-Juan Xie Qiu-Lan Mo +1 位作者 Rong-Hui Wang Qiu-Gui Wei 《Medical Data Mining》 CAS 2025年第1期28-40,共13页
Background:Lenvatinib is primarily utilized for the treatment of inoperable or advanced hepatocellular carcinoma,radioiodine-refractory differentiated thyroid cancer,and advanced renal cell carcinoma.Primary informati... Background:Lenvatinib is primarily utilized for the treatment of inoperable or advanced hepatocellular carcinoma,radioiodine-refractory differentiated thyroid cancer,and advanced renal cell carcinoma.Primary information about adverse reactions is principally derived from clinical trials;however,there is a notable dearth of substantial real-world studies.Methods:In this research,an examination of the U.S.Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)database was performed to evaluate the potential side effects of lenvatinib.The FAERS database revealed a total of 20,290 reported adverse events associated with lenvatinib.Different algorithms for repeated measure analysis were employed to ascertain the significance of these adverse reactions.Results:The study identified 170 instances of adverse events(AEs)induced by lenvatinib,incorporating several significant adverse reactions that the product label does not mention.The investigation also evaluated the onset periods of the adverse reactions,pinpointing a median time of 43 days.The majority of adverse reactions manifested within the initial month of lenvatinib use.Sex-specific analysis revealed disparities in high risk adverse reactions between females(vascular and lymphatic diseases,and neuronal organ diseases)and males(death and infectious diseases).Our data mining has unveiled adverse reactions beyond those mentioned within the instructions,such as osteonecrosis of the jaw,cholecystitis,cholangitis,dehydration,tumor lysis syndrome,type 1 diabetes,hyperammonemia,liver abscess,interstitial lung disease,pneumothorax,sudden death,and aortic dissection.Conclusion:The insights derived from these findings contribute significant nuances for optimizing lenvatinib use,enhancing its efficacy,and substantially mitigating potential side effects.These data elements will substantially enhance the implementation of the drug in a clinical environment. 展开更多
关键词 pharmacovigilance study Food and Drug Administration FDA Adverse Event Reporting System lenvatinib
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Pharmacovigilance study on cardiac involvement associated with calcineurin inhibitors:focus on ventricular hypertrophy 认领 引用
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作者 Xin Yu Xinrui Wang +2 位作者 Zhuoling An Xin Feng Hui Yang 《Journal of Chinese Pharmaceutical Sciences》 CAS CSCD 2025年第8期732-740,共9页
Calcineurin inhibitors(CNIs)have significantly enhanced both organ and patient survival rates following transplantation.However,their safety profile remains a concern due to the heightened risk of ventricular hypertro... Calcineurin inhibitors(CNIs)have significantly enhanced both organ and patient survival rates following transplantation.However,their safety profile remains a concern due to the heightened risk of ventricular hypertrophy,a condition that can be life-threatening.This study aimed to evaluate the clinical characteristics,population-specific risks,and contributing factors to fatal outcomes associated with CNI-induced ventricular hypertrophy.We conducted an observational,retrospective pharmacovigilance analysis utilizing real-world data from the U.S.Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)database,spanning from its inception until the third quarter of 2023.A total of 131 cases of CNI-related ventricular hypertrophy were identified,with our findings demonstrating a significant correlation between CNIs and ventricular hypertrophy[ROR=3.03(2.54–3.61),IC=1.55(1.29–1.81)].Male patients were found to have an increased risk of fatal outcomes in CNI-associated ventricular hypertrophy(P=0.005).Given these findings,clinicians are urged to maintain heightened vigilance regarding this severe complication.Regular and comprehensive cardiac function assessments,including both global and regional cardiac evaluations,are particularly recommended for patients on long-term CNI therapy,with a specific focus on older male individuals. 展开更多
关键词 Calcineurin inhibitors Ventricular hypertrophy Hypertrophic cardiomyopathy FDA Adverse Events Reporting System Pharmacovigilance Disproportionality analysis Real-world study
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Research on the Optimization of Pharmacovigilance Laws and Regulations in China 认领 引用 被引量：1
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作者 Zhang Zhi Zhang Linlin +3 位作者 Feng Yuguo Huang Jiaxin Wang Huiyan Sun Lihua 《Asian Journal of Social Pharmacy》 CAS 2025年第2期116-125,共10页
Objective To analyze the problems of China’s pharmacovigilance legislation,and to provide some suggestions for improving it.Methods Relevant literature at home and abroad were studied to compare the laws and regulati... Objective To analyze the problems of China’s pharmacovigilance legislation,and to provide some suggestions for improving it.Methods Relevant literature at home and abroad were studied to compare the laws and regulations of the United States,the European Union,Japan and China.Then,the problems of China’s pharmacovigilance legislation were analyzed.Results and Conclusion The Chinese pharmacovigilance legislation has such problems as nontransparent formulation process,poor dynamic adaptability,insufficient use of the attention mechanism,fragmentation of laws and regulations,and poor connection of laws and regulations,which should be optimized.It is recommended to carry out theoretical and methodological research on pharmacovigilance legislation to provide practical guidance for optimizing pharmacovigilance legislation with Chinese characteristics. 展开更多
关键词 pharmacovigilance laws and regulations system optimization policy recommendations
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A Quantitative Analysis of China’s Pharmacovigilance Policy Based on the PMC Index Model 认领 引用
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作者 Yao Tingzhen Wang Shuling 《Asian Journal of Social Pharmacy》 CAS 2025年第4期387-401,共15页
Objective To study the current situation of China’s pharmacovigilance system,and to provide some suggestions for the improvement of related policies.Methods A policy modeling consistency(PMC)index model of pharmacovi... Objective To study the current situation of China’s pharmacovigilance system,and to provide some suggestions for the improvement of related policies.Methods A policy modeling consistency(PMC)index model of pharmacovigilance policy was constructed to quantitatively assess the samples of policies combining text mining.Then,the PMC surface was established to obtain the visualization results of China’s pharmacovigilance policy samples,and their shortcomings were clearly analyzed by comparison.Results and Conclusion Forty-one percent of China’s pharmacovigilance policies were rated as excellent,54%as acceptable,and the overall evaluation was acceptable.But there is still some room for improvement.On the whole,there are problems of insufficient policy synergy,lack of policy incentives and constraints,and incomplete coverage of policy functions.It is recommended that China’s pharmacovigilance policy system should be optimized by strengthening policy coordination,increasing policy incentives and constraints,and guiding multi-subjects to participate in coordination.These findings and recommendations can provide operational ideas for the system of China’s pharmacovigilance policy. 展开更多
关键词 pharmacovigilance PMC index model policy evaluation adverse drug reaction
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Research on the Optimization of China’s Pharmacovigilance Organization Management 认领 引用
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作者 Zhang Zhi Sun Lihua 《Asian Journal of Social Pharmacy》 CAS 2025年第1期10-19,共10页
Objective To analyze the problems of China’s pharmacovigilance organization system,and to provide targeted suggestions for improving it.Methods The relevant literature at home and abroad was reviewed to compared the ... Objective To analyze the problems of China’s pharmacovigilance organization system,and to provide targeted suggestions for improving it.Methods The relevant literature at home and abroad was reviewed to compared the differences in pharmacovigilance organizations in the United States,the European Union,Japan and China.Then,the problems of China’s pharmacovigilance organization management were found out.Results and Conclusion China’s pharmacovigilance organizational system has problems such as inadequate organizational setup,immature institutional construction,no coordination mechanism for pharmacovigilance practice,and industry associations of third-party organizations having no role to play.It is recommended to carry out theoretical and methodological research on the pharmacovigilance organizational system to provide practical guidance for optimizing the system with Chinese characteristics. 展开更多
关键词 pharmacovigilance organization system optimization policy suggestion
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Familiarity, Knowledge and Practices of Healthcare Professionals Regarding the Pharmacovigilance of Biological Medicines in Lusaka, Zambia: A Multi-Facility Cross-Sectional Study 认领 引用 被引量：1
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作者 Michelo Banda Katia Verhamme +7 位作者 Webrod Mufwambi Steward Mudenda Billy Chabalenge Scott Kaba Matafwali Ronald Kampamba Mutati Christabel Nang’andu Hikaambo Martin Kampamba Lavina Prashar 《Pharmacology & Pharmacy》 2022年第7期230-251,共22页
Background: Pharmacovigilance of biological medicines is crucial because it ensures that medicines meet the World Health Organization (WHO) standards. In Zambia, there is little information on healthcare professionals... Background: Pharmacovigilance of biological medicines is crucial because it ensures that medicines meet the World Health Organization (WHO) standards. In Zambia, there is little information on healthcare professionals’ familiarity, knowledge and practices on the pharmacovigilance of biological and biosimilar medicines. Therefore, this study investigated the familiarity, knowledge, and practices related to the pharmacovigilance (PV) of biological and biosimilar medicines at selected hospitals in Lusaka, Zambia. Methods: The study was an analytical questionnaire-based cross-sectional study conducted among healthcare professionals (HCPs) at the Adult hospital, Cancer Diseases hospital, Paediatrics hospital and Women and New Born Hospital in Lusaka. Data were collected over four weeks in May and June 2021 and subsequently analysed using IBM SPSS version 21. The statistical significance was set at a 95% confidence interval. Results: Of 245 participants, only 115 (48.9%) of the HCPs were familiar with biological medicines to a basic understanding. Regarding the term biosimilars, most of the HCPs (40.9%) never heard of this word. The mean score for knowledge regarding the PV considerations of biological medicines was 4.1 out of 8 questions. Most HCPs used non-proprietary names (44.2%) when prescribing, dispensing, or administering biological medicines. Additionally, more than half (57.3%) of HCPs did not record batch numbers when dispensing or administering biological medicines. Conclusion: Healthcare professionals were more familiar with the term biological medicines than biosimilars. Healthcare professionals generally scored poorly when their knowledge regarding the PV considerations of biological medicines was assessed. Thus, there is a need to provide adequate training and continuous professional development among healthcare professionals on the pharmacovigilance of biological and biosimilar medicines. 展开更多
关键词 Pharmacovigilance Biological Medicines Biosimilars Brand Batch Zambia
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Research on Construction of Pharmacovigilance System for Marketing Authorization Holders in China 认领 引用
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作者 Zhao Jiai Tian Lijuan 《Asian Journal of Social Pharmacy》 2024年第2期106-116,共11页
Objective To provide suggestions for helping marketing authorization holders(MAHs)to develop an effective and compliant pharmacovigilance system.Methods The construction strategies of pharmacovigilance system of the m... Objective To provide suggestions for helping marketing authorization holders(MAHs)to develop an effective and compliant pharmacovigilance system.Methods The construction strategies of pharmacovigilance system of the multinational pharmaceutical companies were analyzed based on the requirements of regulations and laws.Results and Conclusion There are some gaps between local and multinational pharmaceutical companies in the construction of pharmacovigilance system.We can learn from the experience of multinational pharmaceutical companies to improve the pharmacovigilance system,which includes building a sound pharmacovigilance organizational structure,establishing a series of operational system files and cultivating professional talents.MAHs of China should improve the structure of enterprise pharmacovigilance system.Besides,members of Drug Safety Committee should be department managers with higher position so that they can fulfil the responsibilities of risk assessment.If MAHs possess a large variety and quantity of products,a Drug Safety Committee should be established to ensure the timely discovery of risks.In addition,MAHs should pay attention to the implementation of related regulations and laws on pharmacovigilance and establish compliant,effective and operatable files combing with the actual operation of pharmacovigilance system.Finally,MAHs should introduce and train pharmacovigilance talents,and hire pharmacovigilance experts as consultants to solve the problem of talent shortage. 展开更多
关键词 marketing authorization holder(MAH) pharmacovigilance system good pharmacovigilance practice
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Defining the awareness and attitude of the clinicians through pharmacovigilance in Turkey 认领 引用
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作者 Ozlem Celik Aydin Sonay Aydin Hakki Zafer Guney 《World Journal of Clinical Cases》 SCIE 2023年第20期4865-4873,共9页
BACKGROUND Pharmacovigilance(PV)is the activities and scientific studies conducted to detect,evaluate,understand or prevent adverse reactions and other drug-related problems.AIM To define the awareness and experiences... BACKGROUND Pharmacovigilance(PV)is the activities and scientific studies conducted to detect,evaluate,understand or prevent adverse reactions and other drug-related problems.AIM To define the awareness and experiences of the clinicians on PV and adverse drug reactions(ADRs)in Turkey.METHODS The study was cross-sectional and analytical.Data were obtained through a questionnaire.The questionnaire was sent via e-mail.The survey was sent to 2030 physicians and 670 participated.RESULTS The most appropriate definition of PV was correctly defined by 53.9%of the participants.The most important goal of PV was correctly defined by 54.9%of the participants,and 27.3%of the participants were aware of the Turkish Pharmacovigilance Center.Nonsurgical physicians had better PV knowledge than surgical physicians.A total of 80.9%of the physicians who encountered ADRs,filled in the ADR notification form,and 8.8%received training on how to fill in the form.PV knowledge of the clinicians was not sufficient.Although half of the physicians encountered ADRs,the rates of seeing and filling in the ADR form were low.CONCLUSION Few of the physicians followed the current information about PV.The results provide more comprehensive data on PV practices and ADR reporting at a national level. 展开更多
关键词 Pharmacovigilance Physicians Knowledge level Attitude Behavior Adverse drug reaction
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Why pharmacovigilance of traditional medicines used as analgesics is important? 认领 引用
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作者 Subhransu Dash Neha Bajwa +1 位作者 Abinash Choudhury Preet Amol Singh 《Traditional Medicine Research》 2023年第10期47-55,共9页
Traditional remedies have gained recognition for their effectiveness in treating various conditions such as diabetes,arthritic pain,liver disease,cough and cold,memory enhancement,and immunological stimulation.Their p... Traditional remedies have gained recognition for their effectiveness in treating various conditions such as diabetes,arthritic pain,liver disease,cough and cold,memory enhancement,and immunological stimulation.Their perceived safety has led to the increasing use of herbs by people without prescriptions.These therapies remain significant in areas with limited access to modern drugs or cultural preferences for traditional treatments.With a long history of use,traditional medicines have been the primary method of pain management.This review article explores natural and herb-based analgesics,their origins,and potential benefits,along with the growing scientific evidence supporting their effectiveness.Studies have examined their efficacy in treating musculoskeletal pain,neuropathic pain,and migraines.Rather than being seen as separate therapies,traditional medicines should be considered supplementary or alternative options that can be integrated into comprehensive pain management regimens.However,some studies have reported adverse drug reactions associated with herbal formulations and plants.Therefore,there is a need for pharmacovigilance in traditional medicine to ensure patient safety and promote evidence-based practices.Although pharmacovigilance in this field is still developing,it faces challenges due to the wide availability of herbal medicines without on-site medical supervision.This paper discusses the complex challenges of herbal pharmacovigilance,provides insights on recent advancements,and offers recommendations for improving the safety monitoring of traditional medications in the future. 展开更多
关键词 herbal medicine pharmacovigilance regulatory framework traditional medicine
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Does educational intervention change knowledge,attitude,and practice regarding pharmacovigilance among nursing officers in Central India?An interventional study 认领 引用
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作者 Chaitali Ashish CHINDHALORE Ganesh Natthuji DAKHALE Ashish Vijay GUPTA 《Journal of Integrative Nursing》 2022年第3期114-119,共6页
Objectives:To evaluate the impact of educational intervention on knowledge,attitude,and practice(KAP)regarding pharmacovigilance(PV)and adverse drug reaction(ADR)reporting among nursing officers.Materials and Methods:... Objectives:To evaluate the impact of educational intervention on knowledge,attitude,and practice(KAP)regarding pharmacovigilance(PV)and adverse drug reaction(ADR)reporting among nursing officers.Materials and Methods:A pre-and post-single-arm interventional study was conducted at All India Institute of Medical Sciences(AIIMS),Nagpur from May 2021 to October 2021 among 48 nursing officers.Data related to KAP were obtained through validated questionnaires before and after 3 months of educational intervention.Results:The mean knowledge score among nursing officers significantly improved from 11.05±3.09 to 16.77±2.07 after training session(P<0.001).The mean score regarding attitude was significantly upgraded from 21.16±5.6 to 23.79±2.97(P<0.001).At baseline,the mean practice score was poor(2.41±2.89),which was improved after training session,but the difference is not significant.Conclusion:Educational intervention had a significant impact on knowledge and attitude toward ADR reporting.The practice of detecting and reporting an ADR to the treating consultant is improved,but it is not transformed into reporting an ADR to the PV center to a significant extent.Hence,it is recommended to streamline ADR reporting process by implementing such training modules more frequently. 展开更多
关键词 Adverse drug reaction attitude knowledge nursing staff pharmacovigilance practice
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Antibiotics’ Prescribing and Pharmacovigilance Attitudes among Pediatricians and Pediatric Residents in Cyprus 认领 引用 被引量：1
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作者 Mary Geitona Aikaterini Toska +3 位作者 Dimitra Latsou Maria Saridi Andri Evripidou Iliada Evripidou 《Pharmacology & Pharmacy》 2017年第3期75-84,共10页
Background: The inappropriate, irrational use or misuse of antibiotics is observed in all health systems and in all patients’ groups worldwide, especially for children, where antibiotics continue to be the drugs most... Background: The inappropriate, irrational use or misuse of antibiotics is observed in all health systems and in all patients’ groups worldwide, especially for children, where antibiotics continue to be the drugs most commonly prescribed. Methods: A cross-sectional study was conducted in all public pediatric clinics in the Republic of Cyprus, from April to May 2015. A questionnaire was distributed to pediatricians in order to identify the antibiotic prescription practices in common childhood diseases and attitudes towards Pharmacovigilance. The SPSS 19.0 was used for the statistical analysis. In total 42 pediatricians and pediatric residents filled out the questionnaire. Results: A significant percentage of the respondents administered empirical therapy for possible group A streptococcus infection (59.5%), they implemented the “watchful waiting” tactic in acute otitis media (66.7%), whereas 11.9% of them administered antibiotics for the prevention of secondary respiratory tract infections. The majority of physicians did not feel diagnostic uncertainty leading to antibiotics prescribing (90.2%) and their prescribing habits were not influenced by parental demand (80.5%). Although 23.1% of physicians observed often/very often Adverse Drug Reactions (ADRs) after antibiotic administration during their clinical practice, however, 47.6% of the pediatricians declared that they did not report them. Conclusion: Health professionals’ continuing education on the use of therapeutic guidelines and protocols and the development of Pharmacovigilance programs could significantly contribute to the avoidance of the misuse of antibiotics in hospital care as well as to health professionals’ awareness on rational prescribing. 展开更多
关键词 Antibiotics’ Prescribing Pharmacovigilance Pediatricians Adverse Drug Reactions
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Enlightenment from WHO Pharmacovigilance in Construction of Chinese Materia Medica Pharmacovigilance System 认领 引用
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作者 Wei Ruili Xie Yanming Wang Lianxin 《World Journal of Integrated Traditional and Western Medicine》 2018年第3期40-47,共8页
With the widespread concern about the safety of Chinese materia medica, China urgently needs to build a Chinese materia medica pharmacovigilance system that conforms to the national development policy and has the char... With the widespread concern about the safety of Chinese materia medica, China urgently needs to build a Chinese materia medica pharmacovigilance system that conforms to the national development policy and has the characteristics of traditional Chinese medicine(TCM). A good job of pharmacovigilance of Chinese materia medica not only helps Chinese pharmaceutical companies to control their risks, but also guides them to use drugs safely and rationally. And it is also of great significance to the national drug regulatory work. Based on the monitoring of herbal safety in WHO pharmacovigilance system, the establishment of a Chinese materia medica pharmacovigilance system was explored in order to provide a valuable reference for the risk control of Chinese pharmaceutical companies, the clinical use of Chinese materia medica, and the national drug regulatory work. 展开更多
关键词 WHO pharmacovigilance Chinese materia medica pharmacovigilance Adverse drug reaction
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Analysis of Adverse Reactions Related to Drugs and Vaccines Received at the National Centre for Pharmacovigilance from 2009 to 2016 in Togo 认领 引用
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作者 Yao Potchoo Mouhoudine Yerima +5 位作者 Tante T. Gnandi Mounerou Mounerou Salou Aboudoulatif Diallo Batoyema Bakoma Atani T. Nyansa Mireille Prince-David 《Pharmacology & Pharmacy》 2018年第8期344-356,共13页
Objectives: To assess the received suspected adverse events occurring upon treatment with drugs and vaccines, at National Centre for Pharmacovigilance, in Togo, from 2009 to 2016. Methods: A crossover study was conduc... Objectives: To assess the received suspected adverse events occurring upon treatment with drugs and vaccines, at National Centre for Pharmacovigilance, in Togo, from 2009 to 2016. Methods: A crossover study was conducted in order to collect data about patients, drugs, suspected adverse events and notifiers. Suspected adverse events were classified using Med DRA 19.1. Notification’s circumstances were classified into Public Health Programs’ campaigns and routine practice. Data were collated into Excel spreadsheet and processed with SPSS software. Key Findings: Regional distribution is irregular. Of the 322 collected report forms, paramedics have notified 60.8% of the cases. Adult patients were the most represented (70.2%). Public Health Programs campaigns provided 72.6% versus 27.4% for routine practice including Neglected Tropical Diseases (41.4%), immunization (27.7%), tuberculosis (25.9%) and 4.5% for HIV. Skin disorders were the most prevalent suspected adverse events (147 sheets;45.7%) followed by general disorders and administration site disorders (29.8%) and gastro-intestinal disorders (12.7%). General anti-infective drugs for systemic use, antiparasites, and insecticides were the most reported class of medications (161 sheets;44.7%). Conclusions: A thorough follow-up of pharmacovigilance launched activities is needed to build a sustainable adverse effect’s surveillance system and routine practice has to be strengthened. 展开更多
关键词 Medicines Vaccines Routine Health Care Public Health Program Adverse Events Reporting Pharmacovigilance
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Perception of Pharmacovigilance by Nurses and Midwives of the Cocody University Teaching Hospital in Abidjan 认领 引用
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作者 Balayssac Eric Tadjo Jean +1 位作者 Adon Auguste Ehouman Mocket 《Pharmacology & Pharmacy》 2019年第11期474-483,共10页
Objective: To assess the perception on pharmacovigilance by the nurses and midwives at the University Teaching Hospital (CHU) of Cocody in 2017. Methodology: Descriptive and analytic cross-sectional study conducted in... Objective: To assess the perception on pharmacovigilance by the nurses and midwives at the University Teaching Hospital (CHU) of Cocody in 2017. Methodology: Descriptive and analytic cross-sectional study conducted in 17 services of the University Teaching Hospital (CHU) of Cocody using an anonymized and standardized questionnaire. Results: The response rate was 39.33% for the 86 nurses and 21 midwives with at least 10 years of professional experience (50.6%). 57.94% of the respondents (n = 62) have already heard about pharmacovigilance during their basic training (40.18%, n = 43). However, only 19.63% (21/107) of the respondents knew about the existence of a pharmacovigilance unit which they wrongly located to the pharmacy (11/21) of the CHU of Cocody. 40.18% of respondents (n = 43) had previously experienced an adverse drug reaction that was reported (76.74%, n = 33) to a hierarchical supervisor (60.60%, n = 20). The causes of non-reporting were either the frequent occurence (4/10) or the benign nature (2/10) of the adverse drug reaction. Specific actions to be taken (37.38%, n = 40) and a feedback (28.97%, n = 31) were the respondents’ main expectations for the stimulation of the reporting system. They also wanted the pharmacovigilance monitors to regularly visit their services (34.57%, n = 37) and to provide them with the reporting forms (30.84%, n = 33). Conclusion: Our study has allowed us to highlight the lack of knowledge of the pharmacovigilance and to identify certain factors that could improve the perception of the pharmacovigilance by the nurses and the midwives in Ivory Coast. 展开更多
关键词 Perception Pharmacovigilance Nurses Midwives Hospital
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Comparative Perception of Pharmacovigilance by Physicians versus Paramedical Professions in Ivory Coast 认领 引用
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作者 Balayssac Eric Adon Auguste +1 位作者 Tuo Mamadou Ehouman Mocket 《Pharmacology & Pharmacy》 2019年第10期416-426,共11页
Objective: To assess the perception of pharmacovigilance by healthcare professionals practicing at the University Teaching Hospital of Cocody (Ivory Coast) in 2017. Methodology: A descriptive and analytic cross-sectio... Objective: To assess the perception of pharmacovigilance by healthcare professionals practicing at the University Teaching Hospital of Cocody (Ivory Coast) in 2017. Methodology: A descriptive and analytic cross-sectional survey has been conducted in 2017 at the University Teaching Hospital of Cocody. This survey involved a sample of healthcare professionals practicing in 17 services who are prescribing medications and gave their oral consent. Results: A response rate of 54.08% (106/196) among physicians versus 43.87% (86/196) for the nurses and 27.61% (21/76) for the mid-wives. 57.94% (62/107) of paramedics versus 94.33% (100/106) of physicians had already heard about pharmacovigilance, during their basic training (40.18% of paramedics versus 73.58% of doctors). However, the main obstacles to the practice of pharmacovigilance were it teaching hours considered insufficient (94.39% of paramedics versus 75.47% of physicians), the lack of knowledge on the location of the pharmacovigilance unit (80.37% of paramedics versus, 40% of physicians) and the reporting of the adverse drug reactions to a hierarchical supervisor (60.60% of paramedics versus 37.25% of physicians). A regular visit of pharmacovigilance monitors in the hospital services (34.57% of paramedics versus 29.24% of physicians) and the availability of reporting forms (30.84% of paramedics versus 27.35% of physicians) could improve the perception of pharmacovigilance by the healthcare professionals. Conclusion: Our investigational survey has highlighted some factors that may influence the perception of pharmacovigilance by the healthcare professionals in Ivory Coast. 展开更多
关键词 Perception Pharmacovigilance Healthcare Professionals Hospital
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Importance of Pharmacoeconomics in the Pharmacovigilance for National Health Systems 认领 引用
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作者 Manuel Miguel Collazo Herrera Leslie Perez Ruiz 《Journal of Pharmacy and Pharmacology》 2017年第2期79-84,共6页
The objective of this study is to conduct a literature review to assess the importance of pharmacoeconomics in developing pharmacovigilance activities as a working tool to guide the process of decision making in the h... The objective of this study is to conduct a literature review to assess the importance of pharmacoeconomics in developing pharmacovigilance activities as a working tool to guide the process of decision making in the health field. The authors have done a literature review in order to find information about pharmacovigilance and their relationship with the pharmacoeconomics field, as an important element to assess the economic and health consequences because of the use of drugs in health systems. From this study, it can be found that pharmaeoeconomics applied to the pharmacovigilance activities should be considered as an aspect that contributes to improving the rational use of medicines, because it allows to compare the costs and consequences （beneficial and detrimental） with the use of different pharmacotberapeutic alternatives, in order to assess the negative effects due to ADRs （adverse drug reactions）, which directly increase the morbidity and mortality in patients, increase the direct health costs and indirectly decrease the productivity labors. It can be also concluded that pharmacoeconomics constitutes an important aspect to the pharmacovigilance activity in the health systems, in order to evaluate the negative impact of ADR, both on patient health as its economic implications, due to associated costs with these adverse effects. 展开更多
关键词 Pharmacoeconomics pharmacovigilance adverse drug reaction health costs.
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Discussion on How to Build a Pharmacovigilance System in Pharmaceutical Manufacturing Enterprises 认领 引用
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作者 WANG Le 《外文科技期刊数据库（文摘版）医药卫生》 2021年第4期225-229,共5页
Drugs are related to the public's life and health. The "Drug Administration Law of the People's Republic of China" implemented on December 1, 2019 officially specifies that the state establishes a ph... Drugs are related to the public's life and health. The "Drug Administration Law of the People's Republic of China" implemented on December 1, 2019 officially specifies that the state establishes a pharmacovigilance system. This paper analyzes and considers the current situation and main problems of developing the pharmacovigilance system from the perspective of pharmaceutical manufacturing enterprises, expounds the significance of constructing the pharmacovigilance system, and discusses the important contents related to the construction of the pharmacovigilance system combining with the practical experience of enterprises. 展开更多
关键词 pharmaceutical manufacturing enterprises pharmacovigilance system construction
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Bridging Traditional Medicine with Modern Technology:“Omics”-guided Herbal Pharmacovigilance for Integrative Liver Health 认领 引用 被引量：1
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作者 Anuradha Singh 《Future Integrative Medicine》 2026年第1期13-26,共14页
This review aims to advocate for a paradigm shift in herbal safety by proposing a cohesive molecular framework that integrates advanced“omics”technologies with artificial intelligence(AI)to address the clinical chal... This review aims to advocate for a paradigm shift in herbal safety by proposing a cohesive molecular framework that integrates advanced“omics”technologies with artificial intelligence(AI)to address the clinical challenges of herb-induced liver injury(HILI).Traditional herbal medicine constitutes a substantial,yet often unregulated,component of global healthcare,driving high patient exposure alongside a significant and escalating clinical burden of HILI.Current pharmacovigilance systems are critically undermined by fundamental deficits,including severe underreporting,unknown population denominators,and pervasive product quality failures.Furthermore,the complexity of multi-ingredient formulations and the frequency of herb-drug interactions complicate causality assessment,particularly for high-risk drugs.To bridge the gap between empirical practice and contemporary safety standards,this integrated“omics”-AI paradigm transforms herbal safety from a reactive,populationlevel assessment into an evidence-based,personalized system.By enabling precise risk mitigation,this approach establishes a scientifically rigorous foundation for the future of integrative liver health.In conclusion,the synergy of molecular profiling and computational intelligence provides the necessary tools to modernize herbal pharmacovigilance,ensuring that traditional wisdom is effectively harmonized with modern technological standards for enhanced patient safety. 展开更多
关键词 Traditional herbal medicine Pharmacovigilance Herb-induced liver injury Multi-omics Genomics Proteomics Metabolomics Artificial intelligence Adulteration Risk stratification
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