Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Medicinal Products Containing Valproate: An Interrupted Time Series Study
ConclusionThere was a small impact of the 2018 RMMs on valproate use in the studied European countries/regions. The substantial number of concurrent pregnancies with valproate exposure warrants a careful monitoring of implementation of the existing PPP for valproate in clinical practice in Europe, to see if there is any need for additional measures in the future. (Source: Drug Safety)
Source: Drug Safety - June 20, 2023 Category: Drugs & Pharmacology Source Type: research
Use of Electronic Health Record Data for Drug Safety Signal Identification: A Scoping Review
ConclusionDespite broad interest in utilizing EHRs for safety signal identification, current efforts fail to leverage the full breadth and depth of available data or to rigorously control for confounding. The development of best practices and application of common data models would promote the expansion of EHR-based pharmacovigilance. (Source: Drug Safety)
Source: Drug Safety - June 20, 2023 Category: Drugs & Pharmacology Source Type: research
Provision and Characterization of a Corpus for Pharmaceutical, Biomedical Named Entity Recognition for Pharmacovigilance: Evaluation of Language Registers and Training Data Sufficiency
ConclusionsA manually annotated dataset with a variety of different pharmaceutical and biomedical entities was created and is made available to the research community. Our results show that models that combine different registers provide better maintainability, have higher robustness, and have similar or higher performance. Fractional stratified k-fold cross-validation allows the evaluation of training data sufficiency on the entity level. (Source: Drug Safety)
Source: Drug Safety - June 20, 2023 Category: Drugs & Pharmacology Source Type: research
Use of Electronic Health Record Data for Drug Safety Signal Identification: A Scoping Review
ConclusionDespite broad interest in utilizing EHRs for safety signal identification, current efforts fail to leverage the full breadth and depth of available data or to rigorously control for confounding. The development of best practices and application of common data models would promote the expansion of EHR-based pharmacovigilance. (Source: Drug Safety)
Source: Drug Safety - June 20, 2023 Category: Drugs & Pharmacology Source Type: research
Provision and Characterization of a Corpus for Pharmaceutical, Biomedical Named Entity Recognition for Pharmacovigilance: Evaluation of Language Registers and Training Data Sufficiency
ConclusionsA manually annotated dataset with a variety of different pharmaceutical and biomedical entities was created and is made available to the research community. Our results show that models that combine different registers provide better maintainability, have higher robustness, and have similar or higher performance. Fractional stratified k-fold cross-validation allows the evaluation of training data sufficiency on the entity level. (Source: Drug Safety)
Source: Drug Safety - June 20, 2023 Category: Drugs & Pharmacology Source Type: research
Hospitalisations Related to Adverse Drug Reactions in Switzerland in 2012 –2019: Characteristics, In-Hospital Mortality, and Spontaneous Reporting Rate
ConclusionsThis 8-year observation in Switzerland revealed that 2.3%, or roughly 32,000 admissions per year, were caused by ADRs. The majority of ADR-related admissions were not reported to the regulatory authorities, despite legal obligations. (Source: Drug Safety)
Source: Drug Safety - June 19, 2023 Category: Drugs & Pharmacology Source Type: research
Automatic Extraction of Comprehensive Drug Safety Information from Adverse Drug Event Narratives in the Korea Adverse Event Reporting System Using Natural Language Processing Techniques
ConclusionsWe formulated the extraction of comprehensive drug safety information from ADE narratives as NLP tasks and developed the annotated corpus and strong baseline models for the tasks. The annotated corpus and models for extracting comprehensive drug safety information can improve the data quality of an SRS database. (Source: Drug Safety)
Source: Drug Safety - June 17, 2023 Category: Drugs & Pharmacology Source Type: research
Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance
ConclusionWhile serial combination produced fewer false-positive signals compared with the most specific method, it generated more false-negative signals compared with the most sensitive method. Using a historical comparator design followed by an SCCS analysis yielded decreased sensitivity in evaluating safety signals relative to a one-stage SCCS approach. While the current use of serial testing in vaccine surveillance may provide a practical paradigm for signal identification and triage, single epidemiological designs should be explored as valuable approaches to detecting signals. (Source: Drug Safety)
Source: Drug Safety - June 16, 2023 Category: Drugs & Pharmacology Source Type: research
Nephrotoxicity of Amoxicillin and Third-Generation Cephalosporins: An Updated Review
AbstractBecause of their broad-spectrum bactericidal activity, amoxicillin (AMX) and third-generation cephalosporins (TGC) are widely used for the prophylaxis and treatment of established infections. They are considered relatively safe, but several recent reports have suggested substantial nephrotoxicity, especially with AMX use. Considering the importance of AMX and TGC for clinical practice, we conducted this up-to-date review, using the PubMed database, which focuses specifically on the nephrotoxicity of these molecules. We also briefly review the pharmacology of AMX and TGC. Nephrotoxicity of AMX may be driven by sever...
Source: Drug Safety - June 13, 2023 Category: Drugs & Pharmacology Source Type: research
Future of ChatGPT in Pharmacovigilance
(Source: Drug Safety)
Source: Drug Safety - June 12, 2023 Category: Drugs & Pharmacology Source Type: research
