Relies on the holistic judgment of experienced clinicians who evaluate the case based on their medical knowledge, clinical experience, and the totality of the evidence.
A structured questionnaire-based method that assigns a numerical score to the likelihood of an adverse drug reaction, producing a standardized output.
| # | Question | Yes | No | Don't Know |
|---|---|---|---|---|
| 1 | Are there previous conclusive reports on this reaction? | +1 | 0 | 0 |
| 2 | Did the adverse event appear after the suspected drug was given? | +2 | -1 | 0 |
| 3 | Did the adverse reaction improve when the drug was discontinued or a specific antagonist given? | +1 | 0 | 0 |
| 4 | Did the adverse reaction reappear when the drug was readministered? | +2 | -1 | 0 |
| 5 | Are there alternative causes that could have caused the reaction? | -1 | +2 | 0 |
| 6 | Did the reaction reappear when a placebo was given? | -1 | +1 | 0 |
| 7 | Was the drug detected in blood (or other fluids) in toxic concentration? | +1 | 0 | 0 |
| 8 | Was the reaction more severe when the dose was increased, or less severe when decreased? | +1 | 0 | 0 |
| 9 | Did the patient have a similar reaction to the same or similar drug in any previous exposure? | +1 | 0 | 0 |
| 10 | Was the adverse event confirmed by any objective evidence? | +1 | 0 | 0 |
Determined by combining two sub-scores from the specific case:
Time to onset (C1 to C3), evolution after dechallenge, and response to rechallenge. Evaluates whether the temporal pattern is consistent with causation.
Clinical and extra-clinical signs (S1 to S3), and the exclusion of alternative causes. Evaluates the clinical plausibility of the drug-event relationship.
Benchmarks the case against the state of published medical literature:
Reaction listed in standard reference books (e.g., VIDAL, Martindale)
Reported in the literature but not yet "notorious"
Reported only once or twice in the literature
Completely new reaction — no prior reports found
By separating intrinsic (case-specific) from extrinsic (literature-based) accountability, the French method prevents well-known reactions from receiving automatic high scores without proper case-level evidence. It is mandatory for spontaneous reporting in France.