Science topic

Pharmacovigilance - Science topic

Explore the latest publications in Pharmacovigilance, and find Pharmacovigilance experts.
Filters
All publications are displayed by default. Use this filter to view only publications with full-texts.
Publications related to Pharmacovigilance (10,000)
Sorted by most recent
Research
Full-text available
Objectives: How to communicate vaccine-related safety issues; Policy making and regulations related to vaccine safety; How to report vaccine-related pharmacovigilance; How to manage vaccine side effects and adverse reactions; Companies versus labs versus government communications regarding vaccine safety. Examples of special populations: Elderly; i...
Article
Full-text available
Cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors are a recent targeted therapy approved for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2−) advanced breast cancer. Abemaciclib, palbociclib and ribociclib demonstrated great efficacy and safety during clinical studies. However, differences...
Article
Full-text available
We used the information component (IC), a disproportionate Bayesian analysis comparing the number of observed versus expected adverse drug reactions, to determine the potential association between anti‐neoplastic agents and thrombotic microangiopathy (TMA). The IC025 indicates the lower end of 95% of IC, in which a value >0 suggests a disproportion...
Article
Full-text available
Objective To assess the quality of reporting of adverse events in clinical trials of covid-19 drugs based on the CONSORT (Consolidated Standards of Reporting Trials) harms extension and according to clinical trial design, and to examine reporting of serious adverse events in drug trials published on PubMed versus clinical trial summaries on Clinica...
Article
Full-text available
Cefoperazone/sulbactam-induced hypoprothrombinaemia is associated with longer hospital stays and increased risk of death. The aim of this study was to develop and validate a nomogram for predicting the occurrence of cefoperazone/sulbactam-induced hypoprothrombinaemia in hospitalized adult patients. This retrospective cohort study involved hospitali...
Article
Full-text available
Background: Unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) are commonly used anticoagulants for the management of arterial and venous thromboses. However, it is crucial to be aware that LMWH can, in rare cases, lead to a dangerous complication known as heparin-induced thrombocytopenia (HIT). The objective of this study was to...
Article
Full-text available
The use of information and communication technologies (ICTs) has revolutionized the provision of health services, often referred to as eHealth, benefiting community pharmacies that can offer new services in innovative formats, namely through telepharmacy. This study aimed to explore the perceptions of pharmacy professionals (i.e., pharmacists and p...
Preprint
Full-text available
Recent media reports commented about a possible antidiabetics’ misuse issue related to molecules promoted as a weight-loss treatment in non-obese people. We evaluated here available pharmacovigilance misuse/abuse signals related to semaglutide, a glucagon-like peptide-1 (GLP-1) analogue, in comparison to other GLP-1 receptor agonists (albiglutide;...
Article
Full-text available
DrugCentral, accessible at https://drugcentral.org, is an open-access online drug information repository. It covers over 4950 drugs, incorporating structural, physicochemical, and pharmacological details to support drug discovery, development, and repositioning. With around 20,000 bioactivity data points, manual curation enhances information from s...
Article
Full-text available
Objectives The slow progress of pharmacovigilance (PV) in low-income and middle-income countries (LMIC) raises questions about core challenges on the growth of PV, and the appropriateness of strategies used so far to develop PV. Therefore, this scoping review aims to describe strategies and interventions to strengthen PV in LMIC and to propose reco...
Preprint
Full-text available
Background Clinical decision support systems (CDSS) have become an integral part of clinical software management systems in Australian general practices. These systems encompass a range of tools that support patient data management, medication management, patient diagnosis, decision support, pharmacovigilance, drug control, and clinical guidance. T...
Preprint
Full-text available
We tested the possibility of using “adverse events count” (AEC) as a drug-risk indicator and side-effect severity indicator. Data from 3938 adverse event (AE) reports for COVID-19 vaccines (Comirnaty, Moderna, Vaxzevria, and Janssen) and 6869 AE reports for other medicines were collected from the Bulgarian Drug Agency database (01.01.2018–31.03.202...
Article
Full-text available
Background Adverse Drug Reactions (ADRs) can occur with all medicines even after successful extensive clinical trials. ADRs result in more than 10% of hospital admissions worldwide. In Ghana, there has been an increase of 13 to 126 ADR reports per million population from 2012 to 2018. ADR Surveillance System (ADRSS) also known as pharmacovigilance...
Preprint
Full-text available
Background: no reports have examined the profile of drug-induced dysphagia in detail. The goal of this study was to investigate if there are any differences in the profiles of drug-induced dysphagia. Methods: This study used the Japanese Adverse Drug Event Report (JADER) database. Further, reported odds ratios (RORs) were used to analyze data on ad...
Article
Full-text available
Infigratinib is a fibroblast growth factor receptor (FGFR)-specifc tyrosine kinase inhibitor indicated for the treatment of patients with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma. However, few studies have been conducted to evaluated the safety of infigratinib in the real world. In this study, we conducted...
Conference Paper
Full-text available
Introduction: Immune checkpoint inhibitors (ICIs) have revolutionized the treatment of cancer. However, these agents can lead to immune-related adverse events (irAEs), which can be severe and potentially fatal. Real-world data on the incidence and characteristics of fatal irAEs are limited. This study aims to investigate the incidence and character...
Article
Full-text available
Effective spontaneous AEFI reporting is the first step to ensuring vaccine safety. Half of the global population lives in countries with weak vaccine safety monitoring systems, especially in the African, Eastern Mediterranean, and Western Pacific regions. Further, Immunisation services have been upscaled without commensurate effective AEFI surveill...
Research
Full-text available
ABSTRACT: Medicated Brain booster oil drug Raughan-e-Muqawwi-e-Dimagh a classical formulation used in the treatment of Brain Weakness, Insomnia, Amnesia and other Neurological disorders from since ancient time. Three drugs samples of REMED taken into these studies which 3 Batches were prepared B1,B2 and B3. and developed from applied SOP. on the b...
Article
Full-text available
Introduction: Pharmacovigilance on the African continent has developed over time, with 50 of the 54 countries currently being members of the WHO Programme for international drug monitoring. However, there are still challenges, such as weak regulation, insufficient resources, and differing policies. This expert opinion provides unique insights from...
Article
Full-text available
Contrary to the famous quote from Voltaire, “The art of medicine consists in amusing the patient, while nature cures the disease”, medicine has evolved since the 17th century into a multi-faceted scientific field facilitating healing and improving overall wellbeing. One rapidly evolving area within this field is drug safety, also known as pharmacov...
Preprint
Full-text available
Introduction: Real-world safety studies can provide important evidence on the thromboembolic risk associated with COVID-19 vaccines, considering that millions of people have been already vaccinated against COVID-19. In this study, we aimed to estimate the incidence of thromboembolic events after COVID-19 vaccination and to compare the Oxford–AstraZ...
Article
Full-text available
Introduction: In studies evaluating the effectiveness of additional risk minimisation measures (aRMMs), the need for speed must be properly balanced with the quality of the study. We assessed the duration of aRMM effectiveness evaluations, using additional pharmacovigilance activities, for centrally authorised medicinal products in the European Un...
Article
Full-text available
Adverse drug reactions (ADRs) represent a significant threat to patients’ safety in dentistry, necessitating proactive measures for prevention and treatment. However, identifying ADRs of dental and oral interest can be challenging, and underreporting remains a persistent issue globally. This paper illustrates a smart system to help Italian healthca...
Article
Full-text available
Background: The novel coronavirus SARS-CoV-2 pandemic, impacted health systems around the world resulting in a surge in demand for medicines and therapeutic interventions to combat the pandemic. Medicine regulatory agencies played a crucial role in ensuring the safety, quality, and efficacy of medicines. Regulatory agencies streamlined regulatory p...
Article
Full-text available
Purpose A key feature of human rights in health is access to safe, effective and affordable medicines. Pharmacovigilance is advocated for monitoring intended/unintended effects of medicines to assure their safety. The purpose of this paper is to synthesize knowledge about supply chain impediments to safe medicines in developing nations and contribu...
Conference Paper
Full-text available
Concept of Pharmacovigilance in Homoeopathy texts. Need and Scope of Pharmacovigilance for ASU& H drugs. Impediments of Pharmacovigilance programme for ASU& H drugs. Suggestions for better execution of the programme.
Research
Full-text available
ABSTRACT : Raughan-e-Mukhtara a classical Unani formulated medicated oil used in the treatment of Arthritis, Anti-Inflammatory, Analgesic, relief in Nervine Pain, and other Neurological disorders from since ancient time. In these studies which 3 Batches of formulated drug were prepared B1,B2 and B3, applied and developed SOP on the basis of auth...
Article
Full-text available
Purpose of Review The treatment of multiple sclerosis has been revolutionised by disease-modifying therapies including fingolimod. However, these treatments are immunosuppressive and may be associated with increased risk and severity of skin cancer including melanoma. The aim of this review was to identify and evaluate the existing evidence regardi...
Preprint
Full-text available
Purpose Some of the COX-2 inhibitors are now clinically recognized as candidates for the treatment of various neurological disorders and cancers, especially celecoxib. We performed this pharmacovigilance analysis using the Food and Drug Administration Adverse Event Reporting System (FAERS) database to explore the mechanisms associated with Celecoxi...
Article
Full-text available
Multisystem inflammatory syndrome in children (MIS-c) is an uncommon, but serious, inflammatory response that occurs after SARS-CoV-2 infection. As time went by, MIS-c was also reported as a potential adverse event following COVID-19 vaccination. A descriptive analysis was performed of Individual Case Safety Reports (ICSRs) associated with anti COV...
Chapter
Full-text available
This chapter considered as a guidance to driving pharmacovigilance duties and medication safety practices. It provides HCPs and students with the technical information necessary to support drug therapy decision-making and the regulatory actions for the most commonly faced diseases and disorders and best hospital pharmacy practices. ISBN: 979-8-8869...
Article
Full-text available
Objectives The clinical features of aseptic meningitis associated with amoxicillin are unknown. The main objective of this study was to investigate the clinical characteristics of amoxicillin-induced aseptic meningitis (AIAM) and provide a reference for clinical diagnosis and treatment. Methods AIAM-related studies were collected by searching the...
Preprint
Full-text available
Background Sphingosine-1-phosphate receptor (S1PR) modulators have been proposed as therapeutic agents for various diseases. However, the presence of S1PR in multiple tissues may lead to numerous off-target effects of S1PR modulators, potentially limiting their use. There are no real-world reports on adverse effects of S1PR modulators. Aim This stu...
Preprint
Full-text available
Clozapine is effective at reducing symptoms of treatment-resistant schizophrenia, but it can also induce several adverse outcomes including neutropenia and agranulocytosis. We used linear mixed-effect models and structural equation modelling to determine whether pharmacokinetic and genetic variables influence absolute neutrophil count in a longitud...
Article
Full-text available
The arrival of COVID-19 pandemic in March 2020 adversely affected every aspect of human life, including the management of asthma. The pandemic has forced clinicians to revisit the application of high-risk aerosol-generating procedures in asthma management, including spirometry and nebuliser therapy. The use of commercial spacers with pressurised me...
Article
Full-text available
Adverse Drug Reactions (ADRs) have a direct impact on human health. As continuous pharmacovigilance and drug monitoring prove to be costly and time-consuming, computational methods have emerged as promising alternatives. However, most existing computational methods primarily focus on predicting whether or not the drug is associated with an adverse...
Book
Full-text available
This report discusses the importance of pharmacovigilance (PV) in contributing to building up resilient health systems. It is based on and summarizes the findings of a review of available literature on the topic and relevant case studies focusing on a set of country and regional experiences. Although indispensable in improving health outcomes, the...
Article
Full-text available
Background: Drug-associated acute kidney injury (D-AKI) accounts for 19-26% of acute kidney injury (AKI) events in hospitalized patients and results in outcomes similar to patients with AKI from other etiologies. Diagnosing D-AKI is complex and various criteria have been used. Summary: To highlight the variability in D-AKI determination, a revie...
Article
Full-text available
Real-world evidence (RWE) plays an important role in the management of type 2 diabetes (T2D). It provides data about the effectiveness and safety of an intervention from outside the randomised controlled trial (RCT) setting and allows healthcare professionals (HCPs) to determine if RCT data are applicable to their patients in routine clinical pract...
Preprint
Full-text available
Increased sales of natural products (NPs) in the US and growing safety concerns highlight the need for NP pharmacovigilance. A challenge for NP pharmacovigilance is ambiguity when referring to NPs in spontaneous reporting systems. We used a combination of fuzzy string-matching and a neural network to reduce this ambiguity. We aim to increase the ca...
Article
Full-text available
The evaluation of dolutegravir based on available preclinical and clinical studies reveals a risk of central nervous system (CNS) disorders associated with long-term use of the drug. The available literature on the pharmacokinetics of the drug, including its penetration of the blood–brain barrier, was reviewed, as well as clinical trials assessing...
Article
Full-text available
Background: this study assessed the nephrotoxicity of regorafenib (REG) and encorafenib (ENC) in metastatic colorectal cancer (mCRC) through an analysis of reports from the US Food and Drug Administration's Adverse Event Reporting System (FAERS) database. Methods: descriptive and disproportional analyses were performed for all reports using ENC...
Book
Full-text available
About the Book This book deals with the deep concepts of Pharmacovigilance as per PCI (Pharmacy Council of India) Education Regulation, 2020 for Pharmacy students covering entire syllabus. It contains a comprehensive description an overview of existing knowledge of Pharmacovigilance and making it appropriate for introductory and institutional purp...
Article
Full-text available
A farmácia hospitalar é um setor que engloba diversas funções, dentre elas a gestão de órteses, próteses e materiais especiais (OPME). Estes materiais possuem custo elevado e representam uma parcela significativa nos gastos financeiros de uma unidade hospitalar. Dentro desse contexto o profissional farmacêutico mostra-se indispensável para a garant...
Article
Full-text available
Introduction Immune checkpoint inhibitors (ICIs) have revolutionized cancer therapeutics. However, immune-related adverse events (irAEs) increase morbidity and mortality and thereby limit therapeutic utility. The real-world incidence of the entire spectrum of pulmonary irAEs has not been systematically described. The objective of this study is to a...
Article
Full-text available
Almost a year after the declaration of the pandemic due to the SARS-CoV-2 virus which causes the COVID-19 disease and the need to contain the progression and treatment, the promising option was designing an effective and safe vaccine to reach a state of massive immunity. The first vaccine approved was the one produced by Pfizer-BioNTech, and its ap...
Article
Full-text available
Remdesivir (Veklury®), a nucleotide analogue prodrug with broad-spectrum antiviral activity, is approved for the treatment of coronavirus disease 2019 (COVID-19), the illness caused by severe acute respiratory syndrome coronavirus 2 infection. Unlike some antivirals, remdesivir has a low potential for drug-drug interactions. In the pivotal ACTT-1 t...
Article
Full-text available
Introduction: Ibrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, is authorized for the treatment of chronic lymphocytic leukemia (CLL). This study aims to explore the cardiac safety profile of ibrutinib in comparison with obinutuzumab. Methods: A retrospective pharmacovigilance study was conducted on data retrieved from the European pharmacovig...
Preprint
Full-text available
Background Lowering low-density lipoprotein cholesterol (LDL-C) through PCSK9 inhibition represents a new therapeutic approach to preventing and treating cardiovascular disease (CVD). Phenome-wide analyses of PCSK9 genetic variants in large prospective biobanks can help to identify unexpected effects of PCSK9 inhibition. Methods The prospective Ch...
Book
Full-text available
Medicines, vaccines, medical devices, and blood are commonly used to treat disease. Medicines deserve a special focus because almost any medical visit ends with at least one prescription. So, monitoring the safety and effectiveness of therapeutic treatments and procedures is crucial at both the individual and community levels. In the case of medici...
Article
Full-text available
This study aimed to determine the type of drugs reported as suspected of causing severe supraventricular arrhythmias from the Spanish Human Pharmacovigilance System database. A total of 1053 reports were analysed, of which 526 (50%) were on men and 516 (49%) were on women. The most affected age group was the over-65s, with 593 reports (56%). Of the...
Article
Full-text available
En este artículo de caso clínico, presentamos como el Farmacéutico Comunitario podría integrar durante la práctica farmacéutica asistencial los Servicios de Atención Farmacéutica orientados a evaluar y mejorar los resultados de medicamentos en salud. El Servicio Seguimiento Farmacoterapéutico que tiene como objetivo la detección de Problemas Relaci...
Article
Full-text available
Adverse drug reactions (ADRs) pose significant challenges to patient safety and require effective prediction and monitoring strategies. This study explores the potential of combining machine learning techniques with the FDA Adverse Event Reporting System (FAERS) data to revolutionize healthcare analytics for ADR prediction. FAERS, a comprehensive d...
Article
Full-text available
Postmarketing surveillance systems play a critical role in monitoring the safety and effectiveness of drugs in real-world settings. However, there is a growing need to enhance these systems to ensure early detection and effective management of adverse drug reactions (ADRs). This research provides a comprehensive review of strategies for improving p...
Book
Full-text available
El Salvador en Centroamérica, es el país más densamente poblado de la América Continental. Su historia da cuenta de un patrón constante de rebeldía contra las potencias colonizadoras, dictaduras y grupos oligárquicos que se han alternado y sucedido en el poder salpicando de masacres y represión a los pobladores originarios inicialmente y luego a lo...
Article
Full-text available
Background Rucaparib has been approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. However, the long-term safety of rucaparib in large sample population was unknown. The presented study aimed to evaluate rucaparib-associated adverse events (AEs) according to the re...
Article
Full-text available
Introdução: O consumo de medicamentos falsificados, não registrados e fora do padrão é um grave problema de saúde pública, sendo fundamental conhecer as ações legais de fiscalização sanitária durante a pandemia no Brasil. Objetivo: Analisar as notificações de queixas técnicas e as medidas preventivas de fiscalização sanitária, aplicadas durante a p...
Article
Full-text available
Purpose Recently, there has been a growing interest in using ChatGPT for various applications in Medicine. We evaluated the interest of OpenAI chatbot (GPT 4.0) for drug information activities at Toulouse Pharmacovigilance Center. Methods Based on a series of 50 randomly selected questions sent to our pharmacovigilance center by healthcare profess...
Article
Full-text available
Phytoestrogens (PEs) are plant-based compounds that can interact with estrogen receptors and are mainly used to treat menopausal complaints. However, the safety of products with assumed phytoestrogenic activity is not fully understood. This study aimed to identify plant species with assumed phytoestrogenic activity, review existing literature on th...
Poster
Full-text available
Pharmacovigilance Perspectives on Copper-Based Medicines in Siddha System of Medicine Dr.U.Kavitha1, Dr.S.Balamani2, Dr.S.Sulfin Nihar3, Dr.M.P.Abdul Kader Jeylani4 1Junior Research Fellow, Peripheral Pharmacovigilance Centre, Government Siddha Medical College, Palayamkottai 2Lecturer, Department of Nanju Maruthuvam, Government Siddha Medical Colle...
Article
Full-text available
Considerando a COVID-19, a terapia destinada em seu tratamento e os eventos adversos causados por medicamentos, com destaque para a lesão renal aguda, este estudo transversal, descritivo, retrospectivo e documental teve o objetivo de analisar o potencial nefrotóxico dos medicamentos utilizados em pacientes internados na Unidade de Terapia Intensiva...
Article
Full-text available
Os eventos adversos relacionados ao uso de medicamentos são muito frequentes, podendo causar desde danos leves até o óbito do paciente. Por isso, quando presentes devem ter um manejo rápido e efetivo. O tratamento com anticonvulsivantes deve ser cuidadosamente monitorado para o risco de hepatotoxicidade que pode resultar em DILI, levando a baixa ad...
Article
Full-text available
Background Use of direct oral anticoagulants (DOACs) in patients with cancer remains suboptimal due to the concern regarding potential drug-drug interactions (DDIs) with antineoplastic treatments. However, the clinical relevance of these DDIs is unknown. Methods We conducted a pharmacovigilance study of adverse event (AE) reports from the US Food...