Assessing Adverse Drug Reactions

Once this assessment has been completed as below, document as per the Adverse Drug Reaction (ADR) reporting guidelines.
A definite causal relationship between a drug and an ADR is hard to establish.
The following is a formal approach to establish the probability of causality.

Answer the following questions. Add up the score. Make sure that the patient was given the drug before assessing.


Question		Yes	No	Do not know
1.	Did the ADR appear after the suspected drug was administered?	+2	-1	0
2.	Did the ADR improve when the drug was discontinued or a specific antagonist was administered?	+1	0	0
3.	Did the ADR reappear when the drug was re-administered?	+2	-1	0
4.	Was the ADR more severe when the dose was increased, or less severe when the dose was decreased?	+1	0	0
5.	Are there alternative causes that could, on their own, have caused the reaction?	-1	+2	0
6.	Are there previous conclusive reports of this reaction?	+1	0	0
7.	Did the patient have a similar ADR to the same or similar drug in any previous exposure?	+1	0	0
8.	Was the drug detected in the blood or other fluids in toxic concentrations?	+1	0	0
9.	Did the ADR reappear when a placebo was given?	-1	+1	0
10.	Was the ADR confirmed by any objective evidence?	+1	0	0

Assign the ADR to a probability category from the total score as follows:

Derived from Naranjo CA et al. 'Method for estimating probability of adverse drug reactions'.
Clin Pharmacol Ther 1981; 30: 239-245

Topic Code: 93323