Comparative Analysis of Information Provided in German Adverse Drug Reaction Reports Sent by Physicians, Pharmacists and Consumers
ConclusionThe ADR reports from consumers were comparable with regard to the completeness score with those from physicians and pharmacists underlining their value. Differences in completeness of specific information between the reporter types were found, suggesting that a common reporting of interactions between the three reporters may further improve the completeness of ADR reports. Furthermore, stratified analysis of ADR reports per reporter type may be helpful for certain objectives in scientific research. (Source: Drug Safety)
Source: Drug Safety - November 21, 2023 Category: Drugs & Pharmacology Source Type: research
Cognitive Safety is Largely Ignored in Clinical Drug Trials: A Study of Registered Study Protocols
ConclusionsCognitive safety is largely ignored by recent controlled clinical trials. This applies even to trials assessing new drugs and trials assessing central nervous system drugs. There is an urgent need for drug manufacturers, regulatory authorities, and the medical profession to address the cognitive safety of drugs. (Source: Drug Safety)
Source: Drug Safety - November 16, 2023 Category: Drugs & Pharmacology Source Type: research
The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations
This study aims to assess the relative risk of obstetric, neonatal, and infant outcomes associated with the use of drugs specifically indicated for the treatment of COVID-19 compared with other drug treatment strategies. The purpose of this article is to present elements of the study protocol.MethodsThe COVID-19 International Drug Pregnancy Registry (COVID-PR) is a noninterventional, postmarketing cohort study. Pregnant women receiving treatment with monoclonal antibodies (mAbs) or antiviral drugs for mild, moderate, or severe COVID-19 are matched 1:1 with pregnant women not receiving these study-specific drugs, based on c...
Source: Drug Safety - November 16, 2023 Category: Drugs & Pharmacology Source Type: research
Cognitive Safety is Largely Ignored in Clinical Drug Trials: A Study of Registered Study Protocols
ConclusionsCognitive safety is largely ignored by recent controlled clinical trials. This applies even to trials assessing new drugs and trials assessing central nervous system drugs. There is an urgent need for drug manufacturers, regulatory authorities, and the medical profession to address the cognitive safety of drugs. (Source: Drug Safety)
Source: Drug Safety - November 16, 2023 Category: Drugs & Pharmacology Source Type: research
The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations
This study aims to assess the relative risk of obstetric, neonatal, and infant outcomes associated with the use of drugs specifically indicated for the treatment of COVID-19 compared with other drug treatment strategies. The purpose of this article is to present elements of the study protocol.MethodsThe COVID-19 International Drug Pregnancy Registry (COVID-PR) is a noninterventional, postmarketing cohort study. Pregnant women receiving treatment with monoclonal antibodies (mAbs) or antiviral drugs for mild, moderate, or severe COVID-19 are matched 1:1 with pregnant women not receiving these study-specific drugs, based on c...
Source: Drug Safety - November 16, 2023 Category: Drugs & Pharmacology Source Type: research
Enhancing Pharmacovigilance in C ôte d'Ivoire: Impact of GSK’s Training and Mentoring Pilot Project in the Abidjan Region
ConclusionRegular PV trainings and mentoring improved AE reporting in C ôte d’Ivoire but further enhancement is required to improve passive safety surveillance. (Source: Drug Safety)
Source: Drug Safety - November 15, 2023 Category: Drugs & Pharmacology Source Type: research
The Moroccan Experience of Implementing a University Curriculum for the Pharmacovigilance of Herbal Medicines (Phytovigilance)
(Source: Drug Safety)
Source: Drug Safety - November 15, 2023 Category: Drugs & Pharmacology Source Type: research
Enhancing Pharmacovigilance in C ôte d'Ivoire: Impact of GSK’s Training and Mentoring Pilot Project in the Abidjan Region
ConclusionRegular PV trainings and mentoring improved AE reporting in C ôte d’Ivoire but further enhancement is required to improve passive safety surveillance. (Source: Drug Safety)
Source: Drug Safety - November 15, 2023 Category: Drugs & Pharmacology Source Type: research
The Moroccan Experience of Implementing a University Curriculum for the Pharmacovigilance of Herbal Medicines (Phytovigilance)
(Source: Drug Safety)
Source: Drug Safety - November 15, 2023 Category: Drugs & Pharmacology Source Type: research
Validation of a Natural Language Machine Learning Model for Safety Literature Surveillance
ConclusionCharacterizing model performance prospectively, under real-world conditions, allows us to thoroughly examine model consistency and failure modes, qualifying it for use in our surveillance processes. We also identify potential future improvements and recognize the opportunity for the community to collaborate on this shared task. (Source: Drug Safety)
Source: Drug Safety - November 8, 2023 Category: Drugs & Pharmacology Source Type: research
Application of an Innovative Data Mining Approach Towards Safe Polypharmacy Practice in Older Adults
ConclusionsWe demonstrated the application of a data mining technique to discover high-order drug combinations associated with an increased risk of ADE. We identified high-risk, high-order drug combinations often have low-risk alternative drug combinations in similar therapeutic classes. (Source: Drug Safety)
Source: Drug Safety - November 7, 2023 Category: Drugs & Pharmacology Source Type: research
Pulmonary Toxicity Associated with Immune Checkpoint Inhibitors-Based Therapy: Current Perspectives and Future Directions
AbstractImmune checkpoint inhibitors (ICIs) have shown efficacy in tumor therapy. However, the risk of pulmonary toxicity from ICI-based treatment regimens remains unknown. We searched multiple databases and clinical trial websites from January 2015 to December 2021 and summarized the pulmonary toxicity profile and risk ranking of ICI-based treatments in cancer patients. We included a Phase III randomized clinical trial (RCT) in which the treatment group received at least one ICI and experienced pulmonary adverse events (PAEs). Our study, which included 104 RCTs, found the highest incidence of grades 1 –2 and 3–5 treat...
Source: Drug Safety - November 7, 2023 Category: Drugs & Pharmacology Source Type: research
Application of an Innovative Data Mining Approach Towards Safe Polypharmacy Practice in Older Adults
ConclusionsWe demonstrated the application of a data mining technique to discover high-order drug combinations associated with an increased risk of ADE. We identified high-risk, high-order drug combinations often have low-risk alternative drug combinations in similar therapeutic classes. (Source: Drug Safety)
Source: Drug Safety - November 7, 2023 Category: Drugs & Pharmacology Source Type: research
Pulmonary Toxicity Associated with Immune Checkpoint Inhibitors-Based Therapy: Current Perspectives and Future Directions
AbstractImmune checkpoint inhibitors (ICIs) have shown efficacy in tumor therapy. However, the risk of pulmonary toxicity from ICI-based treatment regimens remains unknown. We searched multiple databases and clinical trial websites from January 2015 to December 2021 and summarized the pulmonary toxicity profile and risk ranking of ICI-based treatments in cancer patients. We included a Phase III randomized clinical trial (RCT) in which the treatment group received at least one ICI and experienced pulmonary adverse events (PAEs). Our study, which included 104 RCTs, found the highest incidence of grades 1 –2 and 3–5 treat...
Source: Drug Safety - November 7, 2023 Category: Drugs & Pharmacology Source Type: research
