2015-12-13-世界卫生组织-Recommendations_from_the_38th_Annual_Meeting,_New_Delhi_2015_5页_348kb

38th Annual Meeting Summary: National Pharmacovigilance Centres Meeting (New Delhi, 4-6 Nov 2015)

Key Outcomes and Recommendations by Working Group

WG1: Pregnancy Register Practicalities

• WHO/WHO CCs: Lareb provides technical support (with WHO lead) for standardized tools (guidelines, training materials). Support model centers.
• National Centers: Integrate pregnancy PV into public health; start small registries.

WG2: Medication Errors Reporting & Learning

• National Centers: Build ME capacity (identify barriers, document procedures, fund use); optimize case forms; focus on reporting/publishing; adapt definitions locally; improve record-keeping; pursue collaborations; consider accreditation criteria; train pharmacists; validate 'P method'.
• WHO/CCs: Propose CIOMS working group for definition clarification.

WG3: National Data Mining/Signal Detection

• National Centers: Integrate data mining/signal detection into PH programs; obtain software tools.
• WHO/CCs: Support capacity building, training (e-learning), develop standardized tools (incorporating VigiLyze), SOP templates, fund-raising support; increase awareness of tools like VigiLyze.

WG4: Collaboration with Associations/Programmes

• National Centers: Collaborate mutually beneficially with PH programs (clear roles, agreements) & patient orgs (ambassadors, awareness). Raise PV awareness via media.
• WHO/CCs: Create a platform for sharing experience stories, modify existing platforms (VigiMed etc.), include collaboration topics in training.

WG5: Future of PV

• All: Promote PV education/training; raise public awareness; implement WHO PV indicators; explore new data sources/disciplines.
• WHO UMC CC: Seek solution for non-internet reporting, improve Vigimed portal usability, promote database tools.

WG6: Quantitative Benefit-Risk Assessment (B-R)

• All PV Centers (with support): Request regulators (FDA/EMA) share their B-R methodologies.

WG7: Revisiting Minimum PV Requirements

• WHO: Draft new minimum requirements and detailed guidelines for 2016 NPC meeting approval.

WG8: Capturing Adverse Events from OTC/IP/NMD

• Recommendations: Establish accredited online seller list; develop AE detection tools (social media); improve Vigimed usability.