VigiFlow, developed and maintained by the Uppsala Monitoring Centre (UMC), is the world’s most widely used individual case safety report (ICSR) management system, deployed by over 50 countries worldwide. While the platform is designed for intuitive use, mastering its advanced coding features—particularly WHODrug Global for drug coding and MedDRA for adverse event coding—can dramatically improve data quality, searchability, and analytical capabilities.
This article provides a comprehensive practical guide to essential VigiFlow tips and tricks, including the rationale for coding both drug and reaction, handling dosing intervals and durations, using trade names and active ingredients effectively, leveraging the WHODrug search icon, managing multiple dosages within the same drug tab, and applying advanced search strategies such as “All Names” and “Any Names.” Drawing on official UMC documentation and regulatory guidance, this article equips pharmacovigilance professionals with the knowledge to optimise their VigiFlow workflows and enhance the quality of their pharmacovigilance data.
1. Introduction: Why Accurate Coding Matters
VigiFlow is a complete ICSR management system used by national pharmacovigilance authorities and vaccine units worldwide. Built-in coding with UMC’s Drug Dictionary (WHODrug Global) for medications and MedDRA for adverse events harmonises and improves data quality and usability. International standards for coding and structuring data are fully integrated across all applications.
Accurate coding is not merely an administrative exercise—it is the foundation of effective pharmacovigilance. Correctly coded data enables:
- Efficient signal detection: Disproportionality analyses and other statistical methods rely on consistent, standardised coding.
- Reliable data retrieval: Searches and queries can only return accurate results if the underlying data is correctly coded.
- Regulatory compliance: ICH E2B(R3) compliance requires standardised coding of drugs and reactions.
- Global data sharing: Standardised terminology facilitates comparison and aggregation across countries and regions.
2. Why We Code Drug and Reaction in VigiFlow
A fundamental principle in VigiFlow is that both the drug and the reaction must be coded to enable meaningful analysis.
2.1 The Rationale
| Aspect | Drug Coding (WHODrug) | Reaction Coding (MedDRA) |
|---|---|---|
| Purpose | Standardises drug names across trade names, active ingredients, and formulations | Standardises adverse event terms across synonyms and lexical variants |
| Enables | Disproportionality analyses, drug-event combination searches, identification of safety signals | Signal detection, causality assessment, regulatory reporting |
| Searchability | Users can find reports by drug name, active ingredient, ATC code, or batch number | Users can find reports by reaction term, SOC, or SMQ |
Coding both enables the system to perform computer processing of cases, such as calculations of disproportionality. Without coding, VigiFlow cannot identify patterns or perform statistical analyses that are essential for signal detection.
2.2 The Practical Benefit
When both drug and reaction are coded, users can:
- Search for all reports involving a specific drug and a specific reaction
- Perform quantitative signal detection (e.g., information component, reporting odds ratio)
- Generate aggregate analyses for periodic safety update reports (PSURs)
- Share data with VigiBase, the WHO global database, in a standardised format
For reports to be included in certain analyses, only reports where all reactions are coded with MedDRA and all drugs (Suspect, Interacting, Not Administered) are coded with WHODrug will be included. This underscores the critical importance of complete coding.
3. Essential VigiFlow Tips and Tricks
3.1 Use Both Trade Names and Active Ingredients
When coding to WHODrug in VigiFlow, you can search for both trade names and active substances in the Drug name field. A drop-down list appears with results matching your search.
Practical tip: If a reporter provides a trade name (e.g., “Perfalgan”), you can search for it directly. If they provide an active ingredient (e.g., “paracetamol”), that search will also work. VigiFlow is designed to accommodate both.
Why this matters: Searching by active ingredient retrieves all reports with that ingredient, regardless of whether coding was done on trade name or active ingredient. This is particularly useful for drugs with multiple brand names or for active ingredients used in combination products.
3.2 Leverage the WHODrug Search Icon
You can click the icon on the right of the Drug name field to access the more detailed WHODrug search. This advanced search interface allows you to see additional information such as:
- Marketing Authorisation Holder (MAH)
- Dose forms
- Pharmaceutical Product ID (PhPID)
- Record Identifier (RID)
Practical tip: Use the WHODrug search icon when:
- You need to verify the exact product formulation
- Multiple products share the same trade name but differ by MAH or dose form
- You want to code at the most specific level possible (e.g., trade name level rather than generic level)
Coding level guidance: Tradename level is best; generic level is good. You can also add an ATC group to describe concomitant medication.
3.3 Use “Drug Name as Reported” When Coding Fails
If you are unable to find the correct match for your search, or if you have information to add, use the field “Drug name as reported by initial reporter.” This free-text field captures the drug name exactly as reported, ensuring that no information is lost even when a specific WHODrug code cannot be assigned.
Practical tip: If you can’t find a specific pharmaceutical product in WHODrug, contact UMC to suggest its inclusion in the dictionary. This contributes to the ongoing improvement of the global drug dictionary.
3.4 Code the “Drug Role” Correctly
The “Drug role” field is used to indicate the role of each reported medication. The available roles are:
| Drug Role | Definition |
|---|---|
| Suspect | The drug suspected of causing the adverse reaction |
| Concomitant | A drug taken at the same time but not suspected of causing the reaction |
| Interacting | A drug that may have interacted with the suspect drug |
| Not Administered | A drug that was prescribed but not actually taken |
Why this matters: The drug role is one of the minimum requirements for sending a copy of the report to VigiBase. Incorrect role assignment can lead to inaccurate signal detection and misclassification of causal relationships.
3.5 Handle Dosing Intervals Correctly
The dosing interval field captures how often a drug is administered. VigiFlow uses structured fields for this information.
Example: For “500 mg every 6 hours”:
- Dose: 500 mg
- Number of doses in the interval: 6
- Dosing interval unit: Hour
Practical tip: When a prescription indicates a dose of less than one unit (e.g., “half a tablet”), enter the full tablet strength in the “Dose” field and enter 0.5 as the “Number of doses in the interval.”
Recent update: With further adaptation to ICH E2B(R3), the “Dosing interval” unit and “Time interval between administration and reaction onset” unit have been updated to include the value “Decade”. The “Duration” unit has been updated to include “Second” and “Decade.”
3.6 Use the “Calculate” Button for Duration
When entering start and end dates for drug administration or reaction onset, VigiFlow includes a “Calculate” button that automatically computes the duration based on the dates entered.
Practical tip: Always use the Calculate button to ensure consistent duration calculations. This reduces manual errors and ensures that duration data is captured in a structured, analysable format.
Increased precision for “Time”: Start and end of administration/reaction, and time for date of reconstitution, can now be specified with increased precision down to seconds.
3.7 Include Time for Infusion Reactions
For infusion-related reactions, it is essential to capture the time of infusion start and the time of reaction onset. VigiFlow allows entry of start and end times for both drug administration and reactions.
Why this matters: Infusion reactions are often rate-dependent, and the time interval between administration and reaction onset is critical for causality assessment and for identifying rate-related adverse effects.
Practical tip: Use the structured time fields (with precision down to seconds) to document the exact timing of infusion and reaction onset.
3.8 Handle Multiple Dosages Within the Same Drug Tab
VigiFlow supports entering multiple dosage information for the same drug or vaccine within the same drug tab. This is particularly useful when:
- A patient received different doses during the course of treatment
- A dose was adjusted (e.g., increased or decreased)
- A loading dose was followed by a maintenance dose
Practical tip: Use the “Add another dose” function within the drug tab to capture all dosage information without creating separate drug entries. This preserves the integrity of the data and ensures that all dose-related information is linked to the correct drug.
Feature highlight: VigiFlow offers 2 viewing modes for data entry, allowing users to choose the mode that best suits their workflow.
3.9 Use “All Names” and “Any Names” for Multi-Drug Searches
When applying advanced filters in VigiFlow, you can search for multiple drugs/vaccines simultaneously by selecting two or more drugs in the Drug name (WHODrug) field and then selecting either “All names” or “Any names” in the adjacent field.
| Option | Search Logic | Example |
|---|---|---|
| “All names” | AND logic – returns reports where all selected drugs are present | Find reports with Paracetamol AND Perfalgan |
| “Any names” | OR logic – returns reports where at least one selected drug is present | Find reports with Paracetamol OR Perfalgan |
Practical tip: Use “All names” when you want to find reports involving a specific combination of drugs (e.g., drug-drug interaction reports). Use “Any names” when you want to find reports involving any of a group of related drugs (e.g., all statins).
Note: Existing saved filters will continue to use AND logic.
3.10 Filter by Active Ingredient for Broader Search
The Active ingredient(s) (WHODrug) filter allows you to search for reports based on the active ingredient, regardless of whether the drug was coded at the trade name or active ingredient level.
Why this matters: This provides a broader search than searching by drug name alone, ensuring that you capture all reports involving a specific active ingredient, even if reporters used different trade names.
Practical tip: Use this filter when:
- You want to identify all reports for a drug class (e.g., all SSRIs)
- You are performing a class-wide safety review
- You want to ensure comprehensive capture of all relevant reports
3.11 Search by ATC Code for Broader Coverage
For an even broader search, you can enter the ATC code of interest. ATC (Anatomical Therapeutic Chemical) codes classify drugs by their therapeutic, pharmacological, and chemical properties.
Practical tip: ATC code searches are useful for:
- Class-wide safety assessments
- Identifying all drugs within a therapeutic subgroup
- Pharmacoepidemiological studies
Note: A WHODrug search includes all reports coded to “child” products, ensuring comprehensive retrieval.
3.12 Use the “Drug Name as Reported” Field for Incomplete Coding
If a specific product cannot be coded to WHODrug, the “Drug name as reported by initial reporter” field captures the verbatim drug name. This ensures that the information is preserved for manual review and future coding.
Practical tip: When using this field, also enter as much structured information as possible (e.g., active ingredient, dose form, route of administration) to facilitate future coding and analysis.
4. Summary of VigiFlow Coding Tips
| Tip | Key Action | Benefit |
|---|---|---|
| 1. Code both drug and reaction | Complete WHODrug and MedDRA coding | Enables signal detection, disproportionality analysis, and VigiBase submission |
| 2. Use trade names and active ingredients | Search by either in the Drug name field | Ensures comprehensive retrieval |
| 3. Leverage the WHODrug search icon | Access detailed search for MAH, dose forms, PhPID | Improves coding precision |
| 4. Use “Drug name as reported” | Capture verbatim name when coding fails | Preserves information for future coding |
| 5. Code drug role correctly | Suspect, Concomitant, Interacting, Not Administered | Minimum requirement for VigiBase; ensures accurate causality assessment |
| 6. Handle dosing intervals correctly | Use structured fields for dose, number of doses, interval | Enables accurate dose-response analysis |
| 7. Use the “Calculate” button | Automatically compute duration from dates | Reduces manual errors |
| 8. Include time for infusion reactions | Capture exact timing of infusion and reaction onset | Critical for rate-dependent reactions |
| 9. Handle multiple dosages | Use “Add another dose” within the same drug tab | Preserves data integrity |
| 10. Use “All Names” and “Any Names” | AND/OR logic for multi-drug searches | Flexible search strategies |
| 11. Filter by active ingredient | Broader search across trade names | Comprehensive capture |
| 12. Search by ATC code | Class-wide searches | Pharmacoepidemiological studies |
Conclusion
Mastering VigiFlow’s coding and data entry features is essential for pharmacovigilance professionals seeking to maximise the quality and utility of their safety data. The tips and tricks outlined in this article—from coding both drug and reaction, to leveraging the WHODrug search icon, to using “All Names” and “Any Names” for multi-drug searches—provide a practical roadmap for efficient and accurate data entry.
Key takeaways:
- Complete coding is non-negotiable. Both drug (WHODrug) and reaction (MedDRA) must be coded for reports to be included in analyses and submitted to VigiBase.
- Precision matters. Use the WHODrug search icon to access detailed product information and code at the most specific level possible.
- Structured data enables analysis. Correctly enter dosing intervals, durations, and timing information to support signal detection and causality assessment.
- Search strategies are powerful. Use “All Names” and “Any Names” for multi-drug searches, filter by active ingredient for broader coverage, and search by ATC code for class-wide assessments.
- When in doubt, capture the verbatim. The “Drug name as reported” field ensures that no information is lost, even when a specific WHODrug code cannot be assigned.
By applying these tips in daily practice, pharmacovigilance professionals can enhance the quality of their data, improve signal detection capabilities, and contribute to the global effort to ensure medication safety.
References
- Uppsala Monitoring Centre. Coding drug information with WHODrug. VigiFlow Support Documentation. 2026. Available from: https://support.who-umc.org/vigiflow/entering-and-structuring-data-in-reports/coding-drug-information-with-whodrug
- Uppsala Monitoring Centre. Search for multiple drugs/vaccines. VigiFlow Support Documentation. 2026. Available from: https://support.who-umc.org/vigiflow/find-relevant-reports-using-filters/search-for-multiple-drugs-vaccines
- Uppsala Monitoring Centre. Searching for drugs/vaccines with WHODrug. VigiFlow Support Documentation. 2026. Available from: https://support.who-umc.org/vigiflow/find-relevant-reports-using-filters/searching-for-drugs-vaccines-with-whodrug
- Uppsala Monitoring Centre. Entering and structuring data in reports. VigiFlow Support Documentation. 2026. Available from: https://support.who-umc.org/vigiflow/entering-and-structuring-data-in-reports
- Uppsala Monitoring Centre. VigiFlow Release 02 March 2022. UMC; 2022.
- Uppsala Monitoring Centre. VigiFlow Release 25 October 2023. UMC; 2023.
- Control Sanitario Ecuador. Guía para uso de VIGIFLOW. ANEXO 3. 2025.
- Uppsala Monitoring Centre. Manage your data with VigiFlow. UMC; 2025.
