Appeal for Increasing the Impact of Pharmacovigilance
(Source: Drug Safety)
Source: Drug Safety - December 20, 2023 Category: Drugs & Pharmacology Source Type: research
Improving Data Collection in Pregnancy Safety Studies: Towards Standardisation of Data Elements in Pregnancy Reports from Public and Private Partners, A Contribution from the ConcePTION Project
ConclusionsData access providers participating in this study presented a very high proportion of variables matching the CDE items, indicating that alignment of definitions and harmonisation of data analysis by different stakeholders to accelerate and strengthen pregnancy pharmacovigilance safety data analyses could be feasible. (Source: Drug Safety)
Source: Drug Safety - December 19, 2023 Category: Drugs & Pharmacology Source Type: research
The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments
This article aims to identify the challenges faced by regulators and HTA agencies today, emphasizing the sig nificance of conducting regulatory reviews and health technology assessments throughout a technology's lifecycle, underlining the value of utilizing real-world data and evidence, and emphasizing the necessity of enhancing collaboration between regulatory authorities and HTA agencies, all within the overarching context of drug safety. (Source: Drug Safety)
Source: Drug Safety - December 19, 2023 Category: Drugs & Pharmacology Source Type: research
Improving Data Collection in Pregnancy Safety Studies: Towards Standardisation of Data Elements in Pregnancy Reports from Public and Private Partners, A Contribution from the ConcePTION Project
ConclusionsData access providers participating in this study presented a very high proportion of variables matching the CDE items, indicating that alignment of definitions and harmonisation of data analysis by different stakeholders to accelerate and strengthen pregnancy pharmacovigilance safety data analyses could be feasible. (Source: Drug Safety)
Source: Drug Safety - December 19, 2023 Category: Drugs & Pharmacology Source Type: research
The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments
This article aims to identify the challenges faced by regulators and HTA agencies today, emphasizing the sig nificance of conducting regulatory reviews and health technology assessments throughout a technology's lifecycle, underlining the value of utilizing real-world data and evidence, and emphasizing the necessity of enhancing collaboration between regulatory authorities and HTA agencies, all within the overarching context of drug safety. (Source: Drug Safety)
Source: Drug Safety - December 19, 2023 Category: Drugs & Pharmacology Source Type: research
Implementation of a Taxonomy-Based Framework for the Selection of Appropriate Drugs and Outcomes for Real-World Data Signal Detection Studies
ConclusionsWe proposed and applied a framework for the selection of drugs and outcomes for both drug safety signal detection and method assessment used in signal detection to optimise their performance given a study design. This framework will eliminate part of the bias relating to drugs and outcomes not being suited to the method or database. The main difficulty lies in the choice of the criteria and their application to ensure systematic selection, especially as some information remains unknown in signal detection, and clinical judgement was needed on occasions. The same framework could be adapted for other methods. (Source: Drug Safety)
Source: Drug Safety - December 13, 2023 Category: Drugs & Pharmacology Source Type: research
Effectiveness and Respiratory Adverse Events Following Inactivated and mRNA COVID-19 Vaccines in Patients with COPD and Asthma: A Chinese Population-Based Study
ConclusionsAmong people with COPD and asthma, the COVID-19 vaccines CoronaVac and BNT162b2 did not increase severe exacerbations and achieved moderate-to-high effectiveness against COVID-related outcomes. COVID-19 vaccination remains essential and should be encouraged to protect this vulnerable population in future epidemic waves. (Source: Drug Safety)
Source: Drug Safety - December 12, 2023 Category: Drugs & Pharmacology Source Type: research
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
