Promoting Collaboration of Regulators and Patients in Improving Drug Safety and Regulatory Decision Making
AbstractPharmacovigilance involves a continuous process of evaluating, monitoring and communicating the safety profile of a medicine throughout its life cycle. This process involves a range of stakeholders, including national regulatory authorities, industry, health organisations, healthcare providers and patients. Although patients are the end users of medicines and experts in their medical conditions, patient involvement is still nascent in the Asia-Pacific region. While there are positive examples and encouraging trends, several key challenges currently hinder systemic patient involvement in drug safety and regulatory d...
Source: Drug Safety - December 11, 2023 Category: Drugs & Pharmacology Source Type: research
SGLT2 Inhibitor Use and Risk of Breast Cancer Among Adult Women with Type 2 Diabetes
ConclusionOur findings suggest SGLT2 inhibitors use was not associated with breast cancer risk compared with DPP4 inhibitors use. Studies with longer follow-up and better adjustments are needed to confirm the finding. (Source: Drug Safety)
Source: Drug Safety - December 9, 2023 Category: Drugs & Pharmacology Source Type: research
Optimizing Signal Management in a Vaccine Adverse Event Reporting System: A Proof-of-Concept with COVID-19 Vaccines Using Signs, Symptoms, and Natural Language Processing
ConclusionOur approach reduced the need for manual exclusion of disproportionality signals related to listed AEFIs and may lead to better optimization of time and resources in signal management. (Source: Drug Safety)
Source: Drug Safety - December 7, 2023 Category: Drugs & Pharmacology Source Type: research
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 - December 1, 2023 Category: Drugs & Pharmacology Source Type: research
The Unseen Hand: AI-Based Prescribing Decision Support Tools and the Evaluation of Drug Safety and Effectiveness
AbstractThe use of artificial intelligence (AI)-based tools to guide prescribing decisions is full of promise and may enhance patient outcomes. These tools can perform actions such as choosing the ‘safest’ medication, choosing between competing medications, promoting de-prescribing or even predicting non-adherence. These tools can exist in a variety of formats; for example, they may be directly integrated into electronic medical records or they may exist in a stand-alone website accessi ble by a web browser. One potential impact of these tools is that they could manipulate our understanding of the benefit-risk of med...
Source: Drug Safety - November 29, 2023 Category: Drugs & Pharmacology Source Type: research
An Overview of Regression Models for Adverse Events Analysis
This article is an overview of the existing regression models that may be considered to compare adverse events and to discuss model choice regarding the characteristics of the adverse events of interest. Many dimensions may be relevant to compare the adverse events between patients, (e.g., timing, recurrence, and severity). Recent efforts have been made to cover all of them. For chronic treatments, the occurrence of intercurrent events during the patient follow-up usually needs the modeling approach to be adapted (at least with regard to their interpretation). Moreover, analysis based on regression models should not be lim...
Source: Drug Safety - November 25, 2023 Category: Drugs & Pharmacology Source Type: research
Patient-Reported Reasons for Antihypertensive Medication Change: A Quantitative Study Using Social Media
ConclusionMusculoskeletal and respiratory symptoms were the most commonly reported adverse effects in social media postings associated with drug discontinuation. Managing such symptoms is a potential target of interventions seeking to improve medication persistence. (Source: Drug Safety)
Source: Drug Safety - November 23, 2023 Category: Drugs & Pharmacology Source Type: research
Chronic Obstructive Pulmonary Disease Adverse Event Signals Associated with Potential Inhibitors of Glutathione Peroxidase 1: A Sequence Symmetry Analysis
ConclusionADE signals were generated for several potential GPx1 inhibitors; however, further validation of signals is required in large well-controlled observational studies. (Source: Drug Safety)
Source: Drug Safety - November 23, 2023 Category: Drugs & Pharmacology Source Type: research
A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry
ConclusionNo new safety concerns were identified relative to the published literature, although notable differences in AE profile between modes of administration and cannabinoid content ratios should be considered by health professionals. Further work identifying and managing risk factors for AEs is warranted to maintain a favorable benefit-risk balance for MC. (Source: Drug Safety)
Source: Drug Safety - November 23, 2023 Category: Drugs & Pharmacology Source Type: research
