Reliable attribution of a cause-effect relationship provides the biggest problem in this field. The following degrees of conviction assist in attributing adverse events to drugs:2
• Definite: time sequence from taking the drug is reasonable; event corresponds to what is known of the drug; event ceases on stopping the drug; event returns on restarting the drug (rarely advisable).
• Probable: time sequence is reasonable; event corresponds to what is known of the drug; event ceases on stopping the drug; event not reasonably explained by patient's disease.
• Possible: time sequence is reasonable; event corresponds to what is known of the drug; event could readily have been result of the patient's disease or other therapy.
• Conditional: time sequence is reasonable; event does not correspond to what is known of the drug; event could not reasonably be explained by the patient's disease.
• Doubtful: event not meeting the above criteria.
Recognition of adverse drug reactions. When an unexpected event, for which there is no obvious cause, occurs in a patient already taking a drug, the possibility that it is drug-caused must always
2 Journal of the American Medical Association 1975 234: 1236.
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