WHOART

WHOART (World Health Organization Adverse Reaction Terminology) is a system developed by the World Health Organization (WHO) to standardize the terminology used in the reporting and monitoring of adverse drug reactions (ADRs). WHOART is used globally by regulatory authorities and the pharmaceutical industry to ensure consistency in the classification and communication of ADR data.

Overview

WHOART was first introduced in 1968 by the World Health Organization as a tool to facilitate the international exchange of information on drug safety. It provides a standardized language for describing adverse events, allowing for more effective communication and collaboration between different stakeholders in the field of pharmacovigilance.

The terminology is organized into system organ classes (SOCs), which are further divided into high level group terms (HLGTs), high level terms (HLTs), preferred terms (PTs), and lowest level terms (LLTs). This hierarchical structure allows for a detailed and precise description of adverse events.

Use in Pharmacovigilance

In the field of pharmacovigilance, WHOART is used to classify adverse events reported in post-marketing surveillance and clinical trials. This allows for the identification of potential safety signals and the assessment of the risk-benefit balance of drugs.

The use of a standardized terminology like WHOART facilitates the exchange of information between different regulatory authorities and the pharmaceutical industry. It also allows for the pooling and analysis of data from different sources, contributing to a more comprehensive understanding of drug safety.

Comparison with Other Terminologies

WHOART is one of several terminologies used in pharmacovigilance. Others include the Medical Dictionary for Regulatory Activities (MedDRA) and the Systematized Nomenclature of Medicine – Clinical Terms (SNOMED CT). While these terminologies have their own strengths and weaknesses, WHOART is recognized for its comprehensive coverage of adverse events and its hierarchical structure, which allows for a detailed and precise description of adverse events.

See Also

• Pharmacovigilance
• Adverse drug reaction
• MedDRA
• SNOMED CT