The Role of ISoP in the Advancement of Pharmacovigilance in Low-and Middle-Income Countries (LMICs)
(Source: Drug Safety)
Source: Drug Safety - October 24, 2023 Category: Drugs & Pharmacology Source Type: research
Industry Review of Best Practices for Risk Management of Drug-Induced Liver Injury from Development to Real-World Use
AbstractThe relative treatment benefit of a drug for patients during development, marketing authorization review, or after approval includes an assessment of the risk of drug-induced liver injury (DILI). In this article, the Pharmacovigilance and Risk Mitigation Working Group of the IQ-DILI Initiative launched in June 2016 within the International Consortium for Innovation and Quality in Pharmaceutical Development presents and reviews three key topics for essential risk management activities to identify, characterize, monitor, mitigate, and communicate DILI risk associated with small molecules during drug development. The ...
Source: Drug Safety - October 24, 2023 Category: Drugs & Pharmacology Source Type: research
The Role of ISoP in the Advancement of Pharmacovigilance in Low-and Middle-Income Countries (LMICs)
(Source: Drug Safety)
Source: Drug Safety - October 24, 2023 Category: Drugs & Pharmacology Source Type: research
Industry Review of Best Practices for Risk Management of Drug-Induced Liver Injury from Development to Real-World Use
AbstractThe relative treatment benefit of a drug for patients during development, marketing authorization review, or after approval includes an assessment of the risk of drug-induced liver injury (DILI). In this article, the Pharmacovigilance and Risk Mitigation Working Group of the IQ-DILI Initiative launched in June 2016 within the International Consortium for Innovation and Quality in Pharmaceutical Development presents and reviews three key topics for essential risk management activities to identify, characterize, monitor, mitigate, and communicate DILI risk associated with small molecules during drug development. The ...
Source: Drug Safety - October 24, 2023 Category: Drugs & Pharmacology Source Type: research
Sodium-Glucose Cotransporter 2 Inhibitor-Associated “Ketoacidosis” Versus “Diabetic Ketoacidosis”: The Importance of Accurate Terminology
(Source: Drug Safety)
Source: Drug Safety - October 17, 2023 Category: Drugs & Pharmacology Source Type: research
Levothyroxine Treatment Among Pregnant Women and Risk of Seizure in Children: A Population-Based Cohort Study
ConclusionThe observed increased risk of seizure in children born from mothers exposed to levothyroxine during pregnancy might be due to residual confounding by maternal thyroid disease. The findings support the current guidelines on the safe use of levothyroxine treatment during pregnancy. (Source: Drug Safety)
Source: Drug Safety - October 16, 2023 Category: Drugs & Pharmacology Source Type: research
Adverse Drug Reactions to Opioids: A Study in a National Pharmacovigilance Database
ConclusionPatients treated with opioids experienced ADRs, primarily nausea, dizziness, and vomiting. For those groups of drugs, no significant differences were found between the sexes, except for the vomiting associated with tramadol. In general, ADRs related to opioids presented higher RORs when uncorrected and corrected for sexes and expenditure than other drugs. There was more disproportionate reporting for ADRs concerning abuse, misuse, and medication errors for opioids than other drugs in the Dutch SRS. (Source: Drug Safety)
Source: Drug Safety - October 12, 2023 Category: Drugs & Pharmacology Source Type: research
A Multi-method Exploratory Evaluation of a Service Designed to Improve Medication Safety for Patients with Monitored Dosage Systems Following Hospital Discharge
ConclusionsThe TCAM service facilitated a number of community pharmacy services offered to patients with monitored dosage systems; but the impact of the intervention on unintentional medication discrepancies and adverse drug event rates post-hospital discharge for this patient group was uncertain. The results of this exploratory study can inform the ongoing implementation of the TCAM service at hospital discharge and highlight the need to understand service implementation in different contexts, which may influence its impact on medication safety. (Source: Drug Safety)
Source: Drug Safety - October 11, 2023 Category: Drugs & Pharmacology Source Type: research
Supporting Pharmacovigilance Signal Validation and Prioritization with Analyses of Routinely Collected Health Data: Lessons Learned from an EHDEN Network Study
ConclusionsAnalyses of routine health data from a distributed network to support signal validation and prioritization are feasible in the given time limits and can inform decision making. The cost –benefit of integrating these analyses at this stage of signal management requires further research. (Source: Drug Safety)
Source: Drug Safety - October 7, 2023 Category: Drugs & Pharmacology Source Type: research
