Developing an Artificial Intelligence-Guided Signal Detection in the Food and Drug Administration Adverse Event Reporting System (FAERS): A Proof-of-Concept Study Using Galcanezumab and Simulated Data
ConclusionAI could significantly ease some of the most time-consuming and labor-intensive steps of signal detection and validation. The AI-based approach showed promising results, however, future work is needed to validate the framework. (Source: Drug Safety)
Source: Drug Safety - June 10, 2023 Category: Drugs & Pharmacology Source Type: research
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 9, 2023 Category: Drugs & Pharmacology Source Type: research
Factors Associated with Underreporting of Adverse Drug Reactions by Health Care Professionals: A Systematic Review Update
ConclusionsAttitudes regarding the reporting of adverse reactions continue to be the main determinants of underreporting. Even though these are potentially modifiable factors through educational interventions, minimal changes have been observed since 2009.Clinical Trials RegistrationPROSPERO registration number CRD42021227944. (Source: Drug Safety)
Source: Drug Safety - June 6, 2023 Category: Drugs & Pharmacology Source Type: research
Sustained Decline of Direct General Practitioner Reporting of Adverse Drug Reactions in Australia and Paucity in Details of Australian Reports in Safety Advisories
ConclusionIt is our contention that the decline in GP reporting in Australia and the current paucity in details of Australian reports in safety advisories are closely linked. (Source: Drug Safety)
Source: Drug Safety - June 2, 2023 Category: Drugs & Pharmacology Source Type: research
Development and Application of an Active Pharmacovigilance Framework Based on Electronic Healthcare Records from Multiple Centers in Korea
ConclusionThese results are similar to those from previous studies and are conducive for new research, thereby demonstrating the feasibility of K-CDM for pharmacovigilance. However, the low quality of original EMR data, incomplete mapping, and heterogeneity between institutions reduced the validity of the analysis, thus necessitating continuous calibration among researchers, clinicians, and the government. (Source: Drug Safety)
Source: Drug Safety - May 27, 2023 Category: Drugs & Pharmacology Source Type: research
Authors ’ Reply to Juergen O Kirchner’s Comment on “Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project”
(Source: Drug Safety)
Source: Drug Safety - May 27, 2023 Category: Drugs & Pharmacology Source Type: research
Comment on “Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project”
(Source: Drug Safety)
Source: Drug Safety - May 27, 2023 Category: Drugs & Pharmacology Source Type: research
Development and Application of an Active Pharmacovigilance Framework Based on Electronic Healthcare Records from Multiple Centers in Korea
ConclusionThese results are similar to those from previous studies and are conducive for new research, thereby demonstrating the feasibility of K-CDM for pharmacovigilance. However, the low quality of original EMR data, incomplete mapping, and heterogeneity between institutions reduced the validity of the analysis, thus necessitating continuous calibration among researchers, clinicians, and the government. (Source: Drug Safety)
Source: Drug Safety - May 27, 2023 Category: Drugs & Pharmacology Source Type: research
Authors ’ Reply to Juergen O Kirchner’s Comment on “Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project”
(Source: Drug Safety)
Source: Drug Safety - May 27, 2023 Category: Drugs & Pharmacology Source Type: research
Comment on “Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project”
(Source: Drug Safety)
Source: Drug Safety - May 27, 2023 Category: Drugs & Pharmacology Source Type: research
The ISoP PatEG-SIG for Promoting Patient Engagement in Pharmacovigilance: A Change of Paradigm is Needed
(Source: Drug Safety)
Source: Drug Safety - May 25, 2023 Category: Drugs & Pharmacology Source Type: research
