INTRODUCTION: Recently, automated detection has been a new approach to address the risks posed by prescribing errors. This study focused on prescription errors and utilized real medical data to supplement the Drug Utilization Review (DUR)-based rules...
INTRODUCTION: Safety underreporting is a recurrent issue in clinical trials that can impact patient safety and data integrity. Clinical quality assurance (QA) practices used to detect underreporting rely on on-site audits; however, adverse events (AE...
INTRODUCTION: Substandard medicines are medicines that fail to meet their quality standards and/or specifications. Substandard medicines can lead to serious safety issues affecting public health. With the increasing number of pharmaceuticals and the ...
Pharmacovigilance is the science of monitoring the effects of medicinal products to identify and evaluate potential adverse reactions and provide necessary and timely risk mitigation measures. Intelligent automation technologies have a strong potenti...
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. We discuss emerging research in the use of artificial intelligence, ...
INTRODUCTION: Identification of adverse events and determination of their seriousness ensures timely detection of potential patient safety concerns. Adverse event seriousness is a key factor in defining reporting timelines and is often performed manu...
Research that makes secondary use of administrative and clinical healthcare databases is increasingly influential for regulatory, reimbursement, and other healthcare decision-making. Consequently, there are numerous guidance documents on reporting fo...
INTRODUCTION: Adverse event (AE) under-reporting has been a recurrent issue raised during health authorities Good Clinical Practices (GCP) inspections and audits. Moreover, safety under-reporting poses a risk to patient safety and data integrity. The...