不良反应术语使用指南 英文版

不良反应术语使用指南英文版英文回答：

Guidance on the Use of Adverse Reaction Terminology.

1. Introduction.

Adverse reaction terminology is a critical tool for the accurate and consistent reporting, evaluation, and management of adverse reactions to drugs and medical devices. A standardized approach to adverse reaction terminology is essential to ensure clear communication among healthcare professionals, researchers, and regulators.

2. Standard Terminology.

The World Health Organization (WHO) Adverse Reaction Terminology (ART) is the international standard for adverse reaction terminology. ART provides a comprehensive and structured list of terms for describing adverse reactions.

It is intended to be used in conjunction with the International Classification of Diseases (ICD) to provide a complete picture of a patient's health status and any associated adverse reactions.

3. Preferred Terms.

The WHO ART specifies preferred terms for describing adverse reactions. These terms are based on the clinical manifestations of the reaction and are intended to be unambiguous and specific. Preferred terms should be used consistently in all documentation and reporting related to adverse reactions.

4. Modifying Terms.

In addition to preferred terms, WHO ART also includes a number of modifying terms that can be used to further specify the characteristics of an adverse reaction. These terms include:

Severity: Mild, moderate, severe, life-threatening,

fatal.

Duration: Acute, subacute, chronic, intermittent, persistent.

Onset: Sudden, gradual, delayed, unspecified.

Causality: Probable, possible, unlikely, unrelated, unknown.

Other: Serious, unexpected, suspected.

5. Reporting Adverse Reactions.

Healthcare professionals are responsible for reporting all suspected adverse reactions to drugs and medical devices. Adverse reactions should be reported using the WHO ART terminology and should include as much detailed information as possible, including:

The patient's demographics and medical history.

The drug or device involved.

The dose and route of administration.

The time of onset and duration of the reaction.

The severity and outcome of the reaction.

Any suspected causality between the drug or device and the reaction.

6. Conclusion.

The use of standardized adverse reaction terminology is essential for the accurate and consistent reporting, evaluation, and management of adverse reactions. The WHO ART provides a comprehensive and structured list of terms for describing adverse reactions and is the international standard for adverse reaction terminology.

中文回答：