Table 2.
Classification
|
|||
---|---|---|---|
Criterion | Dose related | Time related | Susceptibility related |
Allows classification on basis of clinical features | No; dose dependency is not always clear from clinical observations and dose ranging studies are not always available | Yes; the time course of a reaction can be directly observed in individual cases or populations | Sometimes, depending on type of susceptibility |
Give insight into mechanism of reaction | No; only implies the range of doses at which it occurs | Yes; different mechanisms have different time courses | Yes; mechanism and susceptibility are often linked |
Avoids assigning a reaction to more than one category | No | Yes | No; an adverse drug reaction may be associated with multiple susceptibility factors |
Suggests how to monitor adverse reactions | Yes | Yes | Yes |
Suggests population strategies for pharmacovigilance | Yes | Yes; also tells the patient when to be alert for an adverse reaction | Yes (can identify patients at high risk or low risk) |
Helps in making decisions on treatment or avoiding adverse reactions | Only some types | Yes | Only some types |
Guides drug development and regulation | Yes; can help in defining the therapeutic dosage range | Yes; suggests strategies for monitoring during drug development and after marketing | Yes; defines subgroups at high risk or low risk |