2015-06-29-世界卫生组织-Guidelines_on_the_conduct_of_surveys_of_the_quality_of_medicines_-_QAS_15.630_29页_734kb

Summary of WHO Guidelines on Conducting Surveys of Medicine Quality

Introduction

This document outlines guidelines for conducting surveys to assess medicine quality, emphasizing their role in ensuring patient safety and improving healthcare outcomes. Based on drafts prepared by the WHO in 2015, it provides a framework for planning, methodology, and implementation to address issues like substandard or falsified medicines. The guidelines are designed for national medicine regulatory authorities (NMRA) and international organizations.

Key Objectives

• Conduct surveys to evaluate medicine quality, identify risks to patient health, and support regulatory actions.
• Examples include: assessing exposure to poor-quality medicines, comparing domestic vs. imported products, finding counterfeit items, and informing public health policies.
• Surveys should focus on high-risk medicines, prioritize vulnerable populations, and optimize resource use through risk-based planning.

Methodology

• Initial Planning: Define specific objectives, clarify limitations, analyze existing knowledge, understand distribution chains, and engage stakeholders early.
• Sampling Designs: Use probability or non-probability methods like convenience sampling (judgment-based, simple but prone to bias), random sampling (for reliable estimates), LQAS (for binary decisions on quality thresholds), and sentinel site monitoring (for longitudinal tracking).
• Sample Collection: Collect intact, unopened samples with proper labeling; use overt or mystery-shopper approaches based on context; ensure chain-of-custody for storage and transport.
• Testing: Utilize qualified laboratories for analysis, perform tests like identity verification, assay, and dissolution studies; handle out-of-specification results confidentially.
• Data Management: Summarize and analyze data carefully; publish reports widely but responsibly to avoid misinformation and address safety concerns.

Conclusion

The guidelines recommend a systematic, risk-focused approach to ensure surveys provide actionable data for improving medicine quality and public health, while adhering to ethical and logistical standards.