Severity assessment of
ADRs: The term severity is often used to describe the intensity
of a medical event, as in grading ‘mild’, ‘moderate’ and ‘severe’. Severity
assessment categorizes the ADRs as mild, moderate, or severe based on the based
on the steps taken for the management of the ADRs.
Karch and Lasagna classified severity into minor, moderate,
severe and lethal as defined below:
i. Minor: no antidote, therapy or prolongation of
hospitalization required.
ii. Moderate: requires a change in drug therapy, specific
treatment or an increase in hospitalization by at least 1 day.
iii. Severe: potentially life threatening, causing permanent
damage or requiring intensive medical care.
iv. Lethal: directly or indirectly contributes to the death
of the patient.
The USFDA classifies an ADR as serious when it results in
death, life- threatening causes, or prolongs hospitalization, causes a
significant persistent disability, results in a congenital anomaly, or requires
intervention to prevent permanent damage.
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 category severe. (See below)
ADR
severity assessment scale
(Modified Hartwig and
Siegel)
Mild
Level 1:
The ADR requires no change in treatment with the suspected drug.
OR
Level
2: The ADR requires that the suspected
drug be withheld, discontinued or otherwise changed. No antidote or other
treatment is required, and there is no increase in lenght of stay.
Moderate
Level 3:
The ADR requires that the suspected drug be withheld, discontinued or otherwise
changed, and/ or an antidote or other treatment is required. There is no
increase in lenght of stay.
OR
Level 4
(a): Any level 3 ADR that increases lenght of stay by at least one day.
OR
Level 4
(b): The ADR is the reason for admission.
Severe
Level 5:
Any level 4 ADR that requires intensive medical care.
OR
Level 6:
The ADR causes parmanent harm to the patient.
OR
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