This document is a training presentation from the Uppsala Monitoring Centre (UMC) about VigiFlow, which is an internet-based system for managing Individual Case Safety Reports (ICSRs). The primary focus is on how a country can implement a decentralised structure within VigiFlow to distribute pharmacovigilance (PV) activities beyond the national PV centre.
Key Concepts Explained
1. What is VigiFlow?
- It is the national database for pharmacovigilance.
- Its purpose is to manage the workflow of collecting, processing, and sharing safety reports.
- It structures data to facilitate analysis.
2. Centralised vs. Decentralised Systems
- Centralised: Only the national PV centre has access to VigiFlow.
- Decentralised: The national PV centre grants access to VigiFlow to other organisations within the country (e.g., regional centres, hospitals, specialized programs).
3. The Goal of Decentralisation
- To decrease the workload at the national PV centre by allowing other organisations to perform data entry and case assessment.
- The national PV centre always retains full oversight of all reports and is the only entity that can send reports to the WHO global database (VigiBase).
4. Hierarchical Structure
- VigiFlow allows the creation of a hierarchy with up to three levels:
- Level 1: National PV Centre (the top level).
- Level 2: Affiliated organisations (e.g., Regional PV Centres, State Centres).
- Level 3: Sub-organisations (e.g., individual Hospitals, Clinics reporting to a Level 2 centre).
- Default Viewing & Editing Rights:
- Each centre can only view and edit the ICSRs it created, plus all reports created by centres below it in the hierarchy.
- The National PV Centre (Level 1) can see and edit all reports in the entire country’s database.
5. Data Flow into VigiFlow
Data can enter the system from both outside and inside VigiFlow:
- “Outside VigiFlow”: Paper forms, E2B files from Marketing Authorisation Holders (MAHs), online reporting, mobile apps.
- “Inside VigiFlow”: Direct data entry by various decentralised organisations like hospitals, immunization programmes, and regional centres that have user accounts.
Workflow Support Features
The document highlights five key features in VigiFlow that help manage the workflow in a decentralised system:
- Delegate ICSRs: A centre can send a report to another organisation within the hierarchy (up or down, but not across) for review or further action. This indicates that the report is ready for the next step.
- “Created by” Filter: Allows users to search for reports based on which organisation originally entered them into the system.
- Assign ICSRs to Users: Within an organisation, reports can be assigned to specific individual users (e.g., to a specific assessor) to manage internal workload. This cannot be done across organisations.
- Change Status of Report: Each report can have one of three statuses to track its progress: Open, Under Assessment, or Closed.
- Add Comments: Users can add internal comments to a report to communicate with colleagues or document the assessment process. These comments are not exported with the report.
Practical Examples of Decentralised Structures
The PDF provides several models:
- Example 1 (Flat): Hospitals report directly to the National PV Centre.
- Example 2 (Two-Tier): Hospitals and Regional Centres all report directly to the National PV Centre.
- Example 3 (Three-Tier): Hospitals report to State Centres, which perform an initial assessment before sending the reports to the National PV Centre.
- Example 4 (Complex): A mix of different reporting streams, including state centres, a dedicated TB programme, a vaccine programme, and a poison centre, all feeding into the National PV Centre.
Conclusion
In summary, this presentation illustrates how VigiFlow’s decentralisation feature transforms a national pharmacovigilance centre from a sole data processor into a coordinating hub. It enables a collaborative national PV network where multiple stakeholders can contribute directly to the ICSR management process, improving efficiency and scalability while ensuring the national centre maintains ultimate control and oversight.
