Adverse Reactions Medications French System | Medical Algorithm

Description

Begaud et al described a system in France for determining if a drug could be implicated as the cause for an adverse event in a patient based on clinical and temporal findings.

Elements to the evaluation:

(1) chronological imputation

(2) semeiological (symptomatologic) imputation

(3) intrinsic imputability based on the chronological and semeiological findings

Challenge	Dechallenge	Rechallenge	Chronology
very suggestive	suggestive	positive	C3 (suggestive)
very suggestive	suggestive	not done	C3 (suggestive)
very suggestive	suggestive	negative	C1 (dubious)
very suggestive	inconclusive	positive	C3 (suggestive)
very suggestive	inconclusive	not done	C2 (possible)
very suggestive	inconclusive	negative	C1 (dubious)
very suggestive	unsuggestive	positive	C1 (dubious)
very suggestive	unsuggestive	not done	C1 (dubious)
very suggestive	unsuggestive	negative	C1 (dubious)
compatible	suggestive	positive	C3 (suggestive)
compatible	suggestive	not done	C2 (possible)
compatible	suggestive	negative	C1 (dubious)
compatible	inconclusive	positive	C3 (suggestive)
compatible	inconclusive	not done	C1 (dubious)
compatible	inconclusive	negative	C1 (dubious)
compatible	unsuggestive	positive	C1 (dubious)
compatible	unsuggestive	not done	C1 (dubious)
compatible	unsuggestive	negative	C1 (dubious)
incompatible	suggestive	positive	C0 (incompatible)
incompatible	inconclusive	not done	C0 (incompatible)
incompatible	unsuggestive	negative	C0 (incompatible)

where:

• Suggestive dechallenge: event regressions seems linked to drug withdrawal

• Inconclusive dechallenge: (a) event regression spontaneous; (b) event regression induced by non-specific treatment known to be effective; (c) unknown evolution; (d) follow-up to short; (e) irreversible lesion; (f) drug not withdrawn

• Unsuggestive dechallenge: no regression of reversible event, or complete regression without drug withdrawal

Alternative Non-drug Related Explanation	Symptomatology or Other Factor Favoring Drug	Findings of a Reliable and Specific Test	Semeiological Criteria
none	present	positive	S3 (suggestive)
none	present	not done or not available	S3 (suggestive)
none	present	negative	S1 (dubious)
none	absent	positive	S3 (suggestive)
none	absent	not done or not available	S2 (possible)
none	absent	negative	S1 (dubious)
possible or present	present	positive	S3 (suggestive)
possible or present	present	not done or not available	S2 (possible)
possible or present	present	negative	S1 (dubious)
possible or present	absent	positive	S3 (suggestive)
possible or present	absent	not done or not available	S1 (dubious)
possible or present	absent	negative	S1 (dubious)

Chronology	Semeiology	Interpretation
C0	S1	unlikely (appears excluded)
C0	S2	unlikely (appears excluded)
C0	S3	unlikely (appears excluded)
C1	S1	dubious
C1	S2	dubious
C1	S3	possible
C2	S1	dubious
C2	S2	possible
C2	S3	likely
C3	S1	likely
C3	S2	likely
C3	S3	very likely

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Description

Specialty

Objective

ICD-10

French System for Monitoring Unexpected or Toxic Drug Reactions (UTDR)

Purpose: To evaluate a drug as a possible explanation for an adverse event in a patient using a method employed in France.

Description

Specialty

Objective

ICD-10