Monday, June 18, 2007
WHO Causality Classification
WHO Causality Classification
Term Definition Source
Certain A clinical event, including laboratory test abnormality, occurring in a plausible time relationship to drug administration, and which cannot be explained by concurrent disease or other drugs or chemicals. The response to withdrawal of the drug (dechallenge) should be clinically plausible. The event must be definitive pharmacologically or phenomenologically, using a satisfactory rechallenge procedure if necessary. WHO letter ref.: M1O/372/2 (A) (1991)
Probable A clinical event, including laboratory test abnormality, with a reasonable time sequence to administration of the drug, unlikely to be attributed to concurrent disease or other drugs or chemicals, and which follows a clinically reasonable response on withdrawal (dechallenge). Rechallenge information is not required to fulfill this definition.
Possible A clinical event, including laboratory test abnormality, with a reasonable time sequence to administration of the drug but which could also be explained by concurrent disease or other drugs or chemicals. Information on drug withdrawal may be lacking or unclear.
Unlikely A clinical event, including laboratory test abnormality, with a temporal relationship to drug administration which makes a casual relationship improbable, and in which other drugs, chemicals or underlying disease provide plausible explanations. Would be not reportable
Not Related Any reaction that does not meet the criteria above. Add on . Not reportable
Term Definition Source
Certain A clinical event, including laboratory test abnormality, occurring in a plausible time relationship to drug administration, and which cannot be explained by concurrent disease or other drugs or chemicals. The response to withdrawal of the drug (dechallenge) should be clinically plausible. The event must be definitive pharmacologically or phenomenologically, using a satisfactory rechallenge procedure if necessary. WHO letter ref.: M1O/372/2 (A) (1991)
Probable A clinical event, including laboratory test abnormality, with a reasonable time sequence to administration of the drug, unlikely to be attributed to concurrent disease or other drugs or chemicals, and which follows a clinically reasonable response on withdrawal (dechallenge). Rechallenge information is not required to fulfill this definition.
Possible A clinical event, including laboratory test abnormality, with a reasonable time sequence to administration of the drug but which could also be explained by concurrent disease or other drugs or chemicals. Information on drug withdrawal may be lacking or unclear.
Unlikely A clinical event, including laboratory test abnormality, with a temporal relationship to drug administration which makes a casual relationship improbable, and in which other drugs, chemicals or underlying disease provide plausible explanations. Would be not reportable
Not Related Any reaction that does not meet the criteria above. Add on . Not reportable
Causality
Causality reportable
Verbatim causality by To be entered
Health professional
Related - Certainly
Likely - Probable
Very likely - Probable
Dubious - Possible
Cannot be excluded - Possible
Unknown - Unable to determine
Remote - Not likely
Doubtful - Not likely
Excluded - Not related
Verbatim causality by To be entered
Health professional
Related - Certainly
Likely - Probable
Very likely - Probable
Dubious - Possible
Cannot be excluded - Possible
Unknown - Unable to determine
Remote - Not likely
Doubtful - Not likely
Excluded - Not related
Naranjo Algorithm
The Naranjo algorithm can be used to assess the liklihood that a change in clinical status is the result of an ADR rather than the result of other factors such as progression of disease. Answer each of the ten items in the assessment and enter the value of the answer in the column labelled Score. Sum the scores of the ten items to determine the total score, and apply the interpretation rules that appear at the bottom of the page.
Interpretation of the Total Score
Total scores of 9 or more mean that an ADR is highly probable.
Scores from 5 to 8 mean that an ADR is probable.
Scores from 1 to 4 that an ADR is possible.
Scores of zero or less mean that an ADR is doubtful.
Interpretation of the Total Score
Total scores of 9 or more mean that an ADR is highly probable.
Scores from 5 to 8 mean that an ADR is probable.
Scores from 1 to 4 that an ADR is possible.
Scores of zero or less mean that an ADR is doubtful.
Friday, June 15, 2007
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