Table 2.
Question | Answer
|
|||
---|---|---|---|---|
Yes | No | Do not know | ||
1 | Are there previous conclusive reports on this reaction? | +1 | 0 | 0 |
2 | Did the adverse event appear after the suspected drug was administered? | +2 | –1 | 0 |
3 | Did the adverse event improve when the drug was discontinued or a specific antagonist was administered? | +1 | 0 | 0 |
4 | Did the adverse event reappear when the drug was readministered? | +2 | –1 | 0 |
5 | Are there alternative causes that could on their own 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 concentrations known to be toxic? | +1 | 0 | 0 |
8 | Was the reaction more severe when the dose was increased or less severe when the dose was decreased? | +1 | 0 | 0 |
9 | Did the patient have a similar reaction to the same or similar drugs in any previous exposure? | +1 | 0 | 0 |
10 | Was the adverse event confirmed by any objective evidence? | +1 | 0 | 0 |
Total score | Interpretation: probability of an adverse drug reaction | |||
≥9 | Definite | |||
5–8 | Probable | |||
1–4 | Possible | |||
≤0 | Doubtful |
Note: Reproduced with permission from Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239–245.16 © 1981 American Society for Clinical Pharmacology and Therapeutics.