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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Objective To analyze clinical feature and information of medication to explore the risk signals of preparations containing Psoraleae Fructus(BGZP)related with hepatobiliary adverse drug reactions(ADR),in order to rein...Objective To analyze clinical feature and information of medication to explore the risk signals of preparations containing Psoraleae Fructus(BGZP)related with hepatobiliary adverse drug reactions(ADR),in order to reinforce pharmacovigilance.Methods A retrospective study was conducted based on hepatobiliary ADR related with BGZP from the China Adverse Drug Reaction Monitoring System in years from January 2012 to December 2016.Serious and general ADRs were analyzed and assessed.Results There were 355 cases of hepatobiliary ADR related to BGZP.Both the amount of cases and the proportion of serious ADR showed an increasing growth by years(P<0.05).It was found that 10.43%of 355 cases may be involved with irrational drug use,including overdose,repeated medication,and combination of multiple drugs.There were 190 cases which used BGZP(non-combination),and they were mainly for common in diseases caused by abnormal immune activation(accounting for 40.53%of the total cases).Especially at the age group with the most cases with age of 41–50 years,the cases associated with immunological diseases of female were obviously more than that of male(P<0.05).The latency of hepatobiliary ADR related to BGZP ranged from 1 to 386 days,and the median latency was 27.5 days,along with the range of cumulative dose(0.45–520.02 g)as well as the daily dose(0.09–2.64 g/d)after the conversion.Conclusions Cases of hepatobiliary ADR related to BGZP showed significant individual differences,and there was no correlation between drug usage duration and dosage and the occurrence of hepatobiliary ADR.It may be similar with idiosyncratic drug-induced liver injury,and recommended that BGZP should be used with more caution under monitoring liver function,especially in female patients with immunological diseases.展开更多
Background:Adverse effects of antileishmanial drugs can affect patients’quality of life and adherence to therapy for visceral leishmaniasis(VL)and post-kala-azar dermal leishmaniasis(PKDL).In Bangladesh,there are 26 ...Background:Adverse effects of antileishmanial drugs can affect patients’quality of life and adherence to therapy for visceral leishmaniasis(VL)and post-kala-azar dermal leishmaniasis(PKDL).In Bangladesh,there are 26 treatment centers that manage leishmaniasis cases coming from 100 endemic upazilas(subdistricts)of 26 districts(these include VL,PKDL,treatment failure,and relapse VL and cutaneous leishmaniasis cases).This study aimed to investigate the feasibility of using focused pharmacovigilance for VL(VLPV)in Bangladesh’s National Kala-azar Elimination Programme for the early detection and prevention of expected and unexpected adverse drug reactions(ADRs).Methods:This activity has been going on since December 2014.Activity area includes secondary public hospital or Upazila health complex(UHC)in hundred sub districts and Surya Kanta Kala-azar Research Center(SKKRC)in Mymensingh District,a specialized center for management of complicated VL and PKDL cases.Communicable Disease Control(CDC)of the Directorate General of Health Services(DGHS)assigned twenty five of hundred UHCs and SKKRC(total 26)as treatment centers depending on their suitable geographical location.This was implemented for better management of VL cases with Liposomal Amphotericin B(AmBisome®)to ensure patient convenience and proper utilization of this expensive donated drug.A VLPV expert committee and a UHC VLPV team were established,an operational manual and pharmacovigilance report forms were developed,training and refresher training of health personnel took place at UHCs and at the central level,collected information such as patient data including demographics,treatment history and response,adverse events were analyzed.This report includes information for the period from December 2014 to December 2016.Results:From December 2014 to December 2016,1327 leishmaniasis patients were treated and 1066(80%)were available for VLPV.Out of these,57,33,9,and 1%were new VL,PKDL,VL relapse,and other cases,respectively.Liposomal amphotericin B was mostly used(82%)for case management,followed by miltefosine(20%)and paromomycin(3%).Out of the 1066 patients,26%experienced ADRs.The most frequent ADR was fever(17%,176/1066),followed by vomiting(5%,51/1066).Thirteen serious adverse events(SAEs)(eight deaths and five unexpected SAEs)were observed.The expert committee assessed that three of the deaths and all unexpected SAEs were possibly related to treatment.Out of the five unexpected SAEs,four were miltefosine-induced ophthalmic complications and the other was an AmBisome^(■)-induced avascular necrosis of the nasal alae.The Directorate General of the Drug Administration entered the ADRs into the World Health Organization Uppsala Monitoring Centre(WHO-UMC)VigiFlow database.Conclusions:This study found that VLPV through NKEP is feasible and should be continued as a routine activity into the public health system of Bangladesh to ensure patient safety against anti-leishmanial drugs.展开更多
Objective:Despite established associations between certain medications and urticaria,the risk profiles of most pharmaceutical agents remain poorly characterized.This investigation aimed to identify risk factors for me...Objective:Despite established associations between certain medications and urticaria,the risk profiles of most pharmaceutical agents remain poorly characterized.This investigation aimed to identify risk factors for medication-induced urticaria through comprehensive analysis of the FDA Adverse Event Reporting System(FAERS)database.Methods:We employed reporting odds ratios(ROR)to evaluate drug-urticaria associations using FAERS data spanning from Q12004 to Q32024.Analytical approaches included univariate screening,LASSO regression,and multivariate logistic regression to identify potential risk factors.Multiple comparison adjustments were implemented using the Bonferroni method.Results:The study identified 1807 pharmaceutical agents potentially associated with urticaria development.Univariate analysis categorized these agents into several therapeutic classes:antimicrobials(19/85),biologics(16/85),analgesics(8/85),dermatologicals(3/85),anti-rheumatic agents(4/85),hormonal preparations(3/85),antihypertensives(2/85),neuropsychiatric medications(2/85),uric acid-lowering drugs(2/85),multiple sclerosis therapies(2/85),and miscellaneous agents(17/85).Multivariate analysis identified three significant risk determinants:middle-aged individuals(36-53 years),female gender,and exposure to any of 82 specific medications.Conclusion:These evidence-based findings provide valuable insights for early clinical recognition of drug-induced urticaria and establish a foundation for subsequent mechanistic investigations into medication-related hypersensitivity reactions.展开更多
基金supported by grants from the National Natural Science Foundation of China(82200212)and(81902934).
文摘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.
文摘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.
基金The 2022 Educational Teaching Reform and Research Project of Guangxi University of Traditional Chinese Medicine(2022C032).
文摘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.
文摘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.
文摘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.
基金Integration Application Status and Problems Investigation of ICH Q8,Q9,Q10 across the Product Life Cycle(No.20210605).
文摘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.
文摘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.
文摘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.
文摘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.
文摘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.
文摘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.
文摘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.
文摘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.
文摘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.
文摘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.
基金funded by General Program of National Natural Science Foundation of China(NO.81473798):Study on allergic reaction mechanism of post-marketing Chinese medicine injections with active monitoring and network target monitoringNational Science and Technology Major Project of"Development Program of Significant New Drug"(2015ZX09501004-001-002/009)Entrusted Project of China Center for Food and Drug International Exchange,The State Food and Drug Administration:International promotion of Chinese medicine safety
文摘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.
文摘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.
基金Supported by the National Natural Science Foundation of China(No.81630100)Beijing Nova Program(No.Z181100006218001)Project of China PLA General Hospital(No.2019MBD-023)。
文摘Objective To analyze clinical feature and information of medication to explore the risk signals of preparations containing Psoraleae Fructus(BGZP)related with hepatobiliary adverse drug reactions(ADR),in order to reinforce pharmacovigilance.Methods A retrospective study was conducted based on hepatobiliary ADR related with BGZP from the China Adverse Drug Reaction Monitoring System in years from January 2012 to December 2016.Serious and general ADRs were analyzed and assessed.Results There were 355 cases of hepatobiliary ADR related to BGZP.Both the amount of cases and the proportion of serious ADR showed an increasing growth by years(P<0.05).It was found that 10.43%of 355 cases may be involved with irrational drug use,including overdose,repeated medication,and combination of multiple drugs.There were 190 cases which used BGZP(non-combination),and they were mainly for common in diseases caused by abnormal immune activation(accounting for 40.53%of the total cases).Especially at the age group with the most cases with age of 41–50 years,the cases associated with immunological diseases of female were obviously more than that of male(P<0.05).The latency of hepatobiliary ADR related to BGZP ranged from 1 to 386 days,and the median latency was 27.5 days,along with the range of cumulative dose(0.45–520.02 g)as well as the daily dose(0.09–2.64 g/d)after the conversion.Conclusions Cases of hepatobiliary ADR related to BGZP showed significant individual differences,and there was no correlation between drug usage duration and dosage and the occurrence of hepatobiliary ADR.It may be similar with idiosyncratic drug-induced liver injury,and recommended that BGZP should be used with more caution under monitoring liver function,especially in female patients with immunological diseases.
基金This activity was supported by funds from PATH,USA.The funders had no role in the study’s design,data collection and analysis,decision to publish,or preparation of the paper.
文摘Background:Adverse effects of antileishmanial drugs can affect patients’quality of life and adherence to therapy for visceral leishmaniasis(VL)and post-kala-azar dermal leishmaniasis(PKDL).In Bangladesh,there are 26 treatment centers that manage leishmaniasis cases coming from 100 endemic upazilas(subdistricts)of 26 districts(these include VL,PKDL,treatment failure,and relapse VL and cutaneous leishmaniasis cases).This study aimed to investigate the feasibility of using focused pharmacovigilance for VL(VLPV)in Bangladesh’s National Kala-azar Elimination Programme for the early detection and prevention of expected and unexpected adverse drug reactions(ADRs).Methods:This activity has been going on since December 2014.Activity area includes secondary public hospital or Upazila health complex(UHC)in hundred sub districts and Surya Kanta Kala-azar Research Center(SKKRC)in Mymensingh District,a specialized center for management of complicated VL and PKDL cases.Communicable Disease Control(CDC)of the Directorate General of Health Services(DGHS)assigned twenty five of hundred UHCs and SKKRC(total 26)as treatment centers depending on their suitable geographical location.This was implemented for better management of VL cases with Liposomal Amphotericin B(AmBisome®)to ensure patient convenience and proper utilization of this expensive donated drug.A VLPV expert committee and a UHC VLPV team were established,an operational manual and pharmacovigilance report forms were developed,training and refresher training of health personnel took place at UHCs and at the central level,collected information such as patient data including demographics,treatment history and response,adverse events were analyzed.This report includes information for the period from December 2014 to December 2016.Results:From December 2014 to December 2016,1327 leishmaniasis patients were treated and 1066(80%)were available for VLPV.Out of these,57,33,9,and 1%were new VL,PKDL,VL relapse,and other cases,respectively.Liposomal amphotericin B was mostly used(82%)for case management,followed by miltefosine(20%)and paromomycin(3%).Out of the 1066 patients,26%experienced ADRs.The most frequent ADR was fever(17%,176/1066),followed by vomiting(5%,51/1066).Thirteen serious adverse events(SAEs)(eight deaths and five unexpected SAEs)were observed.The expert committee assessed that three of the deaths and all unexpected SAEs were possibly related to treatment.Out of the five unexpected SAEs,four were miltefosine-induced ophthalmic complications and the other was an AmBisome^(■)-induced avascular necrosis of the nasal alae.The Directorate General of the Drug Administration entered the ADRs into the World Health Organization Uppsala Monitoring Centre(WHO-UMC)VigiFlow database.Conclusions:This study found that VLPV through NKEP is feasible and should be continued as a routine activity into the public health system of Bangladesh to ensure patient safety against anti-leishmanial drugs.
文摘Objective:Despite established associations between certain medications and urticaria,the risk profiles of most pharmaceutical agents remain poorly characterized.This investigation aimed to identify risk factors for medication-induced urticaria through comprehensive analysis of the FDA Adverse Event Reporting System(FAERS)database.Methods:We employed reporting odds ratios(ROR)to evaluate drug-urticaria associations using FAERS data spanning from Q12004 to Q32024.Analytical approaches included univariate screening,LASSO regression,and multivariate logistic regression to identify potential risk factors.Multiple comparison adjustments were implemented using the Bonferroni method.Results:The study identified 1807 pharmaceutical agents potentially associated with urticaria development.Univariate analysis categorized these agents into several therapeutic classes:antimicrobials(19/85),biologics(16/85),analgesics(8/85),dermatologicals(3/85),anti-rheumatic agents(4/85),hormonal preparations(3/85),antihypertensives(2/85),neuropsychiatric medications(2/85),uric acid-lowering drugs(2/85),multiple sclerosis therapies(2/85),and miscellaneous agents(17/85).Multivariate analysis identified three significant risk determinants:middle-aged individuals(36-53 years),female gender,and exposure to any of 82 specific medications.Conclusion:These evidence-based findings provide valuable insights for early clinical recognition of drug-induced urticaria and establish a foundation for subsequent mechanistic investigations into medication-related hypersensitivity reactions.
