2012-05-01-世界卫生组织-2012_ACSoMP_recommendations_6页_240kb

WHO ACSoMP Ninth Meeting Summary

Pharmacovigilance (PV) Toolkit

• The PV Toolkit serves as a resource for low/middle-income countries.
• Based on previous feedback, ACSoMP recommends including links to relevant guidelines (e.g., European GVP) and translating content into other languages to increase usage.

Procedures for Reviewing Safety Concerns

• Established processes for safety concerns referral and handling.
• Recommended creating a list of PV experts and engaging committee members in investigations when required.

EU PV Legislation and Collaboration

• Discussed the impacts of new EU PV legislation on the WHO Programme for International Drug Monitoring.
• Recommended enhancing collaboration with EU Member States for timely signal detection and data sharing through the EMA.

Detecting/Preventing Medication Errors (MEs)

• Draft publication on reporting/learning systems for medication errors within PV centers is proposed.
• Noted varying approaches across countries (e.g., US integrates ME prevention into development, China separates responsibility)
• Called for mapping the impact of ME-related harms and further development of learning tools for HIV treatment managers.

International Agency Drug Supply and PV

• Reviewed draft agreement for PV responsibilities in drug procurement/supply chains.
• Recommended clearer roles for national authorities, legal provisions, and stronger risk communication regarding serious AEs.

Definitions in PV

• Endorsed WHO's role in defining PV terminology and continues developing them, including incorporating industry perspectives via CIOMS consultations.

Sub-Saharan Africa Drug Safety

• Survey by USAID/SPS highlighted capacity gaps and recommended collaboration on PV infrastructure, training, integrating PV into guidelines, and regulatory use of safety data.

TB Medicines Safety

• Underlines the need for careful monitoring as new drugs are implemented.
• TSR is recommended for integrating PV in low-resource settings but acknowledged limitations in detecting unexpected events.
• Recommended optimizing spontaneous reporting data analysis for local toxicity assessments.

Monitoring Medicines (MM) Project

• EC-funded initiative (11 countries) to strengthen consumer reporting and widen PV centers' role to include MEs.
• Includes analysis of VigiBase for dependence medicines and developing detection methods for substandard medicines.
• Advocated sharing of web-based patient ADR reporting tool with EMA and wider dissemination at upcoming WHA.

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