Departamento de Ciencias Básicas de la Salud, Facultad de Ciencias de la Salud, Universidad Rey Juan Carlos, Alcorcón, Spain.
Unidad Asociada al Instituto de Química Medica (IQM) del Consejo Superior de Investigaciones Científicas (CSIC), Universidad Rey Juan Carlos, Alcorcón, Spain.
High Performance Research Group in Experimental Pharmacology (Pharmakom-URJC), URJC, Alcorcón, Spain.
Departamento de Ciencias Básicas de la Salud, Facultad de Ciencias de la Salud, Universidad Rey Juan Carlos, Alcorcón, Spain.
Unidad Asociada al Instituto de Química Medica (IQM) del Consejo Superior de Investigaciones Científicas (CSIC), Universidad Rey Juan Carlos, Alcorcón, Spain.
High Performance Research Group in Experimental Pharmacology (Pharmakom-URJC), URJC, Alcorcón, Spain.
Department of Psychiatry, The Second Xiangya Hospital, Central South University, Changsha, Hunan 410011, China; Mental Health Institute of the Second Xiangya Hospital, Central South University, Chinese National Clinical Research Center on Mental Disorders (xiangya), Chinese National Technology Institute on Mental Disorders, Hunan Key Laboratory of Psychiatry and Mental Health, Changsha, Hunan 410011, China.
Evidence highlights the allergenic potential of PEGylated drugs because of the production of anti-polyethylene glycol immunoglobulins. We investigated the risk of hypersensitivity reactions of PEGylat...
We selected adverse drug reaction reports attributed to medicinal products containing PEGylated active substances and/or PEGylated liposomes from the Italian Spontaneous Reporting System in the period...
Overall, 3865 adverse drug reaction reports were related to PEGylated medicinal products and 11,961 to their non-PEGylated comparators. Around two-thirds of patients were female and reports mostly con...
The findings of this analysis of the Italian spontaneous adverse drug reaction database suggest a potential involvement for PEGylation in triggering drug-related hypersensitivity reactions, especially...
Adverse Drug Reactions (ADR) add a significant clinical and economic burden to the healthcare system of a country. We present an overview of the different approaches of ADR reporting systems worldwide...
A systematic review of the literature was made based on PubMed and the Cochrane database of systematic reviews. The articles searched for included original articles, WHO and FDA reports and institute ...
Development and acquisition of newer technologies to promote ADR monitoring and reporting is a necessity for an effective pharmacovigilance system in a country....
Amyotrophic lateral sclerosis is a fatal progressive disease with a still unclear multi-factorial etiology. This study focused on the potential relationship between drug exposure and the development o...
The FDA Adverse Event Reporting System quarterly data (January 2004-June 2020) were downloaded and deduplicated. The reporting odds ratios and their 95% confidence intervals were calculated as a dispr...
We retained 1188 amyotrophic lateral sclerosis cases. Sixty-two drugs showed significant disproportionality for amyotrophic lateral sclerosis onset in at least one analysis, and 31 had consistent repo...
For each drug emerging as possibly associated with amyotrophic lateral sclerosis onset, biological plausibility, underlying disease, and reverse causality could be argued. Our findings strengthened th...
Antibiotics are commonly used in both outpatient and inpatient settings and are responsible for the majority of adverse drug reaction (ADR) reports. We aimed to characterize spontaneously reported ADR...
We conducted a retrospective descriptive study based on ADRs related to antibiotics spontaneously reported by healthcare workers to the National Pharmacovigilance Database of Vietnam (NPDV) between Ju...
We included 6385 antibiotic-related reports from a total of 12,056 reports submitted to the NPDV during the study period. Beta-lactam antibiotics, mostly broad-spectrum with parenteral route, were sus...
ADRs related to antibiotic use represent more than half of ADRs spontaneously reported in Vietnam. Approximately one in every ten reported cases is associated with pADRs. The majority pADRs can be pre...
Cardiac therapy drugs are widely used in the treatment of heart disease. However, the concern regarding adverse events (AEs) of cardiac therapy drugs have been rising. This study aimed to analyse card...
Retrospective observational study....
In this study, cardiac therapy drug-related AEs were detected using the JAERS database from January 2000 to March 2022....
Reports of cardiac therapy drug-related AEs were extracted from JAERS database, and the basic information of patients, reports and common AEs were analysed. Four disproportionality analysis methods, p...
In total, 168 314 AEs were reported, of which 4788 were associated with cardiac therapy drugs. Using the PRR, ROR, MHRA and BCPNN method, we detected 52 signals, 52 signals, 33 signals and 43 signals,...
We identified 14 new cardiac therapy drug signals that did not appear on drug labels in China and 1 new signal that did not appear on drug labels in 3 counties. A causal link between cardiac therapy d...
Adverse drug reaction (ADR) under-reporting is highly prevalent internationally and interventions created to address this problem have only been temporarily successful. This review aims to investigate...
This review investigated the significance of ADR under-reporting, the barriers of reporting ADRs, and the magnitude of success of various interventions to improve ADR reporting by searching the EMBASE...
Digital transformation has presented a significant opportunity with vast quantities of patient health data becoming available in electronic formats. The application of artificial intelligence to detec...
Pharmacovigilance importance has increased in the last few decades and it has led to rise in awareness of adverse drug reaction reporting by both patients and health care professionals. Despite this, ...
We aimed to review literature on adverse drug reaction reporting applications and whether their introduction improved reporting practice in patients and health care professionals....
In this review, we have described several mobile application implementations in different countries. Moreover, we have illustrated some of the applications for particular patients, e.g. patients with ...
All of the included studies showed positive association between application use and ADR reporting. However, there is a great need for future high quality studies to confirm impact of mobile applicatio...
Spontaneous reporting of suspected adverse drug reactions (ADRs) is the cornerstone of pharmacovigilance. Despite this, it is believed that there is significant under-reporting in the veterinary setti...
We designed a survey to explore the perceptions, attitudes and experiences of UK veterinary professionals towards ADR reporting. The survey was advertised widely through conventional and social media ...
In total, 260 respondents completed the survey, including 210 veterinary surgeons, 49 veterinary nurses and one suitably qualified person. Respondents generally understood the need to report ADRs. The...
Our findings suggest that technological interventions to facilitate reporting and empowerment of veterinary nurses to report through a tailored training event should be explored further....
Adverse drug reactions (ADRs) are unintended consequences of medication use and may result in hospitalizations or deaths. Timely reporting of ADRs to regulators is essential for drug monitoring, resea...
We sought to explore the ways that ADRs are monitored or reported in Australia. We reviewed how consumers and health care professionals participate in ADR monitoring and reporting....
The Arksey and O'Malley framework provided a methodology to sort the data according to key themes and issues. Web of Science, Scopus, Embase, PubMed, CINAHL, and Computer & Applied Sciences Complete d...
Seven articles met the inclusion criteria. The Adverse Medicine Events Line (telephone reporting service) was introduced in 2003 to support consumer reporting of ADRs; however, only 10.4% of consumers...
Despite the existence of national and international guidelines for ADR reporting and management, there is substantial interinstitutional variability in the standards of ADR reporting among individual ...
Spontaneous notification systems are essential in a post-marketing safety context. However, using this method, only about 6% of all adverse drug reactions are notified. To overcome this sub-notificati...
The Joanna Briggs Institute guidelines were considered, and the framework proposed by Arksey and O'Malley was followed. All the articles that met the inclusion criteria were examined for this review. ...
A final number of five articles were included, revealing seven implemented mobile apps for adverse drug reaction report (Medwatcher, VigiBIP, Yellow Card, Bijwerking, Halmed, Med Safety, and ADR PvPi)...
Apps are easier and faster ways of reporting. The integration of such a tool in an individual care plan would allow to maintain a complete electronic health record at both individual and global level ...
