2011-11-09-世界卫生组织-Recommendations_from_the_34th_Annual_Meeting,_Dubrovnik_2011_4页_327kb

34th Annual Meeting Summary (Dubrovnik, Croatia, 30 Oct - 2 Nov 2011)

by National PV Centres in WHO Programme

This report summarizes discussions and recommendations from eight working groups:

WG1. Optimizing communications between national PV centres

• Communication methods: VigiMed (preferred), formal agreements, informal interaction, websites.
• VigiMed challenges: Learning curve, password access, lack of criteria (priority, repetition).
• Recommendations:
  • Easier official VigiMed access.
  • Information on unregistered/withdrawn drugs.
  • Search-friendly topic index.
  • Medical translator for documents.
  • UMC: Quick tips, "flag" function, linked PV reports, VigiMed monitoring.

WG2. Assessing the preventability of medicines-related problems

• Developed the 'P method' (20 criteria) to classify ADRs as preventable, non-preventable, or unassessable.
• Closely linked to Medication Errors (ME) prevention.
• Discussions focused on P method effectiveness, harmonization of terms, and need for guidelines.

WG3. Involving traditional medicine (TM) practitioners in pharmacovigilance

• Importance of TM use (esp. primary healthcare) and associated risks (adulteration, counterfeiting).
• Need to expand PV scope to include TM/ herbal medicines.
• Recommendations:
  • Task force for TM at national centres.
  • Train TM practitioners (e.g., herbalists) on ADR reporting.
  • Enhance physician-TM practitioner communication.
  • Develop national/regulatory measures.

WG4. How to demonstrate impact of pharmacovigilance activities

• Seek indicators to measure PV impact on public health and decision-making.
• Identified indicators from easier-to-measure (e.g., # ADR reports) to harder (e.g., patient outcome).
• Recommended potential impact-assessment approaches (e.g., signal-to-action ratio, communication effectiveness).

WG5. Improving safety information to patients and their carers

• Aim for effective risk/benefit communication and risk mitigation through patient/carer education.
• Recommendations:
  • Early age drug safety education.
  • Multi-media public information (radio, films).
  • Face-to-face practitioner-patient communication.
  • Develop tailored materials (information sheets, visual tools).

WG6. Experiences in using documentation grading statistics to improve data quality

• Documentation Grading measures completeness and relevance of Individual Case Safety Reports (ICSRs).
• Suggestions for improvement:
  • Add more criteria (causality, medical history, action taken, etc.).
  • Different criteria for vaccines (batch number).
  • Collect results semi-annually, integrate grading into VigiLyze.
  • Improve forms, feedback mechanisms, training, and target impact assessment.

WG7. Future role of Periodic Safety Update Reports (PSURs): requirements for generic manufacturers

• Discussed EU and other regulations on PSURs.
• Most countries studied require generic PSURs.
• Concerns: Increasing workload, resource constraints for generic versions. Quality and inspection resources vary.
• Generally agreed generics must submit PSURs.
• Recommended workload management models.
• Importance of a legal framework defining responsibilities.

WG8. Integrating national pharmacovigilance and public health programmes

• Benefits include preventing overlap, improving PV capacity via public health systems, and enhanced surveillance.
• Each country's legal framework and integration model is context-specific.
• Recommendations included clarifying roles, responsibilities, and mechanisms for information sharing, training, and feedback.