A new era in pharmacovigilance: toward real‐world data and digital monitoring

A Lavertu, B Vora, KM Giacomini… - Clinical …, 2021 - Wiley Online Library
Adverse drug reactions (ADRs) are a major concern for patients, clinicians, and regulatory
agencies. The discovery of serious ADRs leading to substantial morbidity and mortality has …

Digital health, big data and smart technologies for the care of patients with systemic autoimmune diseases: where do we stand?

H Bergier, L Duron, C Sordet, L Kawka… - Autoimmunity …, 2021 - Elsevier
The past decade has seen tremendous development in digital health, including in innovative
new technologies such as Electronic Health Records, telemedicine, virtual visits, wearable …

Integrating real-world evidence in the regulatory decision-making process: a systematic analysis of experiences in the US, EU, and China using a logic model

M Li, S Chen, Y Lai, Z Liang, J Wang, J Shi… - Frontiers in …, 2021 - frontiersin.org
Real world evidence (RWE) and real-world data (RWD) are drawing ever-increasing
attention in the pharmaceutical industry and drug regulatory authorities (DRAs) all over the …

The evolving role of disproportionality analysis in pharmacovigilance

M Fusaroli, E Raschi, E Poluzzi… - Expert opinion on drug …, 2024 - Taylor & Francis
Introduction From 2009 to 2015, the IMI PROTECT conducted rigorous studies addressing
questions about optimal implementation and significance of disproportionality analyses …

Insights from the Twittersphere: a cross-sectional study of public perceptions, usage patterns, and geographical differences of tweets discussing cocaine

C Castillo-Toledo, O Fraile-Martínez… - Frontiers in …, 2024 - frontiersin.org
Introduction Cocaine abuse represents a major public health concern. The social perception
of cocaine has been changing over the decades, a phenomenon closely tied to its patterns …

Intelligent telehealth in pharmacovigilance: a future perspective

H Edrees, W Song, A Syrowatka, A Simona, MG Amato… - Drug safety, 2022 - Springer
Pharmacovigilance improves patient safety by detecting and preventing adverse drug
events. However, challenges exist that limit adverse drug event detection, resulting in many …

Barriers to opioid use disorder treatment: a comparison of self-reported information from social media with barriers found in literature

W Bremer, K Plaisance, D Walker, M Bonn… - Frontiers in public …, 2023 - frontiersin.org
Introduction Medications such as buprenorphine and methadone are effective for treating
opioid use disorder (OUD), but many patients face barriers related to treatment and access …

Artificial intelligence, real-world automation and the safety of medicines

A Bate, SF Hobbiger - Drug Safety, 2021 - Springer
Despite huge technological advances in the capabilities to capture, store, link and analyse
data electronically, there has been some but limited impact on routine pharmacovigilance …

WHODrug: a global, validated and updated dictionary for medicinal information

O Lagerlund, S Strese, M Fladvad… - Therapeutic innovation & …, 2020 - Springer
The WHODrug medicinal information dictionary is a worldwide source of global medicinal
information with the aim to facilitate the coding of medications in clinical trials as well as …

[HTML][HTML] Complementing the US Food and Drug Administration adverse event reporting system with adverse drug reaction reporting from social media: comparative …

Z Zhou, KE Hultgren - JMIR public health and surveillance, 2020 - publichealth.jmir.org
Background: Adverse drug reactions (ADRs) can occur any time someone uses a
medication. ADRs are systematically tracked and cataloged, with varying degrees of …