Severity and seriousness assessment: BP805T Pharmacovigilance Notes
Definitions
Adverse Drug Reaction:
According to WHO Adverse drug reaction is defined as ”A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.”
Adverse Event:
Adverse event is defined as ” Any medical occurrence temporally associated with the use of a medicinal product, but not necessarily causally related.”
Severity:
It describes the extent to which the ADRs influence the everyday life of patients.
Seriousness:
It is of an ADR is related to its life-threatening nature and is defined as any untoward reaction to the medicinal product that may result in death and requires patient hospitalization
Severity Assessment:
1. Karch and Lasagna classify severity into minor, moderate, severe and lethal.
- Mild(Minor)
- Moderate
- Severe
- Lethal
2. Hartwig et al categorized ADRs into seven levels as per their severity.
- Level 1 & 2 fall under mild category,
- Level 3 & 4 under moderate and
- level 5, 6 & 7 fall under severe category.
Seriousness assessment
The seriousness of the reaction according to FDA criteria on the basis of their life-threatening nature.
- Death
- Life-threatening
- Hospitalization (initial or prolonged)
- Disability or Permanent Damage
- Congenital Anomaly/Birth Defect
- Required Intervention to Prevent Permanent Impairment or Damage (Devices)
- Naranjo Algorithm: It is used to determine adverse drug reaction probability
