如何用英文表达‘药物不良反应监测’？

Adverse Drug Reaction Monitoring: An Overview

Introduction

The use of medications is a common practice in healthcare to treat various diseases and improve patients' quality of life. However, medications can also cause adverse effects, which may range from mild to severe. Adverse drug reaction (ADR) monitoring is a crucial process that ensures the safety of patients receiving medication therapy. This article aims to provide an overview of ADR monitoring, including its definition, importance, methods, and challenges.

Definition

Adverse drug reaction (ADR) refers to any noxious, unintended, and dose-related effect of a drug that occurs at doses used in humans for prophylaxis, diagnosis, therapy, or to modify physiological function (WHO, 2002). In simpler terms, ADRs are unwanted effects that occur when a person takes a medication. These effects can be harmful and may range from mild, such as a skin rash, to severe, such as a life-threatening allergic reaction.

Importance of ADR Monitoring

Ensuring patient safety: ADR monitoring helps healthcare professionals identify and prevent potential harm to patients receiving medication therapy. By monitoring ADRs, healthcare providers can make informed decisions about the use of medications, thereby minimizing the risk of adverse effects.
Improving medication safety: ADR monitoring contributes to the continuous improvement of medication safety by identifying new ADRs, updating drug information, and revising dosages or contraindications. This process helps healthcare professionals and pharmaceutical companies to ensure that medications are used safely and effectively.
Enhancing drug development: ADR monitoring provides valuable information for drug developers and regulatory agencies. This information can help identify potential safety concerns, improve drug labeling, and facilitate the approval of new medications.

Methods of ADR Monitoring

Passive surveillance: This method relies on spontaneous reports from healthcare professionals, patients, and pharmaceutical companies. These reports are often submitted to national or international databases, such as the World Health Organization's (WHO) VigiBase or the Food and Drug Administration's (FDA) Adverse Event Reporting System (AERS).
Active surveillance: Active surveillance involves systematic collection of ADR data from various sources, such as electronic health records, registries, and clinical trials. This method allows for more comprehensive and detailed information on ADRs.
Spontaneous reporting systems: These systems encourage healthcare professionals and patients to report ADRs without any specific incentives. Spontaneous reporting systems are widely used in many countries and are an essential tool for ADR monitoring.
Enhanced reporting systems: Enhanced reporting systems provide incentives for healthcare professionals and patients to report ADRs. These incentives may include financial rewards, recognition, or improved patient care.

Challenges in ADR Monitoring

Underreporting: One of the main challenges in ADR monitoring is underreporting, which occurs when healthcare professionals and patients fail to report ADRs. Factors contributing to underreporting include lack of awareness, fear of legal consequences, and the belief that ADRs are not serious.
Data quality: Ensuring data quality is another challenge in ADR monitoring. Incomplete or inaccurate reports can lead to incorrect conclusions about the safety of a medication.
Identifying causal relationships: Determining the causal relationship between an ADR and a medication can be challenging. This is because ADRs can have multiple causes, and it is often difficult to establish a direct link between the medication and the adverse effect.
Resource limitations: ADR monitoring requires significant resources, including personnel, time, and funding. Limited resources can hinder the effectiveness of ADR monitoring programs.

Conclusion

Adverse drug reaction monitoring is a vital process that ensures the safety of patients receiving medication therapy. By employing various methods and addressing the challenges associated with ADR monitoring, healthcare professionals, pharmaceutical companies, and regulatory agencies can work together to improve medication safety and enhance the quality of healthcare.