2010-11-30-世界卫生组织-Recommendations_from_the_33rd_Annual_Meeting,_Accra_2010_4页_327kb

33rd Annual Meeting of National Pharmacovigilance Centres (WHO Programme for International Drug Monitoring)

Location: Accra, Ghana (1–3 November 2010)

Working Group 1: Preventing Medication Errors (WG1)

• Scope: Defined limits/pharmacist/recommendations for preventing medication errors.
• Recom.:
  • Incorporate medication error issues into national PV policies.
  • Standardize terminology for medication errors.
  • Modify tools to capture error details.
  • Advocate reporting even without adverse events.
  • Include medication errors in PV training.

WG2: Improving Individual Case Safety Report (ICSR) Quality

• Problem: Defining "good quality" ICSR and addressing incomplete reporting (e.g., missing lab results).
• Recom.:
  • Improve reporting form design.
  • Analyze national reporting practices.
  • Use Uppsala Monitoring Centre’s tool for completeness analysis.

WG3: Establishing/Strengthening Pharmacovigilance Centres

• Challenges: Underreporting, low ADR quality, staff shortages, funding constraints, legislative gaps, lack of coordination.
• Recom.:
  • Train healthcare professionals (physicians, pharmacists, nurses) in PV.
  • Integrate PV into public health programs (e.g., Global Fund).
  • Promote PV via media, conferences, and professional orgs.
  • Mandate reporting by HCWs and industry.
  • Explore funding sources (government, agencies, NGOs).

WG4: AEFIs (Adverse Events Following Immunization)

• Focus: Ensuring vaccine safety monitoring through reporting, causality assessment, and signal detection.
• Recom.:
  • Enhance collaboration between NRA, NIP, and PV centers.
  • Develop clear SOPs and guidelines for AEFI reporting.
  • Involve the public and media.

WG5: Fighting Substandard/Poor-Quality Medicines

• Goal: Prompt identification and withdrawal of unsafe/contaminated drugs.
• Recom.:
  • PV centers as reporting points for substandard drugs.
  • Redesign data tools to capture substandard issues.
  • Advocate/educate for integrated efforts.
  • Collaborate with various stakeholders.

WG6: Building Human Resource Capacity

• Issue: Limited PV focus in staff training, high turnover.
• Recom.:
  • Set minimum qualification profiles for PV staff.
  • Include PV awareness in health professional training.
  • Develop continuous training packages (with WHO/Collaborating Centers).
  • Allocate training budget for PV centers.

WG7: Improving Awareness of Drug Safety

• Strategy: Social marketing to promote PV and ADR reporting.
• Recom.:
  • Target behaviors for improved reporting (professionals & public).
  • Use media, public initiatives for marketing.
  • Measure impact through data analysis and behavioral changes.

WG8: Good Practice in Pharmacovigilance Inspections

• Context: Current limitations in PV inspections.
• Recom.:
  • NRA leads inspections; collaboration with PV centers as needed.
  • Develop guidelines/procedures (WHO-led with experienced countries).
  • Start with capacity-appropriate inspection targets.