AIMC Topic: Adverse Drug Reaction Reporting Systems

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Signal detection in pharmacovigilance: Methods, tools, and workflows from case identification to adverse drug reaction database entry.

Przeglad epidemiologiczny
Adverse drug reactions (ADRs) remain a major, yet largely preventable, global public health challenge, causing significant morbidity, mortality, and healthcare costs. This review synthesises evidence on the global burden, pharmacovigilance systems, a...

The need for guardrails with large language models in pharmacovigilance and other medical safety critical settings.

Scientific reports
Large language models (LLMs) are useful tools with the capacity for performing specific types of knowledge work at an effective scale. However, LLM deployments in high-risk and safety-critical domains pose unique challenges, notably the issue of "hal...

Assessment of drug induced hyperuricemia and gout risk using the FDA adverse event reporting system.

Scientific reports
Hyperuricemia, the key pathological basis of gout, is increasingly prevalent worldwide. While lifestyle factors contribute, various medications also play a role. However, their specific risks and mechanisms remain inadequately studied. Disproportiona...

Pharmacovigilance in the digital age: gaining insight from social media data.

Experimental biology and medicine (Maywood, N.J.)
Pharmacovigilance is essential for protecting patient health by monitoring and managing medication-related risks. Traditional methods like spontaneous reporting systems and clinical trials are valuable for identifying adverse drug events, but face de...

Artificial Intelligence: Applications in Pharmacovigilance Signal Management.

Pharmaceutical medicine
Pharmacovigilance is the science of collection, detection, and assessment of adverse events associated with pharmaceutical products for the ongoing monitoring and understanding of those products' safety profiles. Part of this process, signal manageme...

Interplay of Spontaneous Reporting and Longitudinal Healthcare Databases for Signal Management: Position Statement from the Real-World Evidence and Big Data Special Interest Group of the International Society of Pharmacovigilance.

Drug safety
Signal management, defined as the set of activities from signal detection to recommendations for action, is conducted using different data sources and leveraging data from spontaneous reporting databases (SRDs), which represent the cornerstone of pha...

Narrative Search Engine for Case Series Assessment Supported by Artificial Intelligence Query Suggestions.

Drug safety
INTRODUCTION: Manual identification of case narratives with specific relevant information can be challenging when working with large numbers of adverse event reports (case series). The process can be supported with a search engine, but building searc...

Effectiveness of Transformer-Based Large Language Models in Identifying Adverse Drug Reaction Relations from Unstructured Discharge Summaries in Singapore.

Drug safety
INTRODUCTION: Transformer-based large language models (LLMs) have transformed the field of natural language processing and led to significant advancements in various text processing tasks. However, the applicability of these LLMs in identifying relat...

ADR-DQPU: A Novel ADR Signal Detection Using Deep Reinforcement and Positive-Unlabeled Learning.

IEEE journal of biomedical and health informatics
The medical community has grappled with the challenge of analysis and early detection of severe and unknown adverse drug reactions (ADRs) from Spontaneous Reporting Systems (SRSs) like the FDA Adverse Event Reporting System (FAERS), which often lack ...