Understanding Severity assessment, predictability and preventability assessment of an ADR

1. SEVERITY AND SERIOUSNESS
ASSESSMENT OF ADR
Dr. Ramesh Bhandari
Asst. Professor
Department of Pharmacy Practice,
KLE College of Pharmacy, Belagavi

2. SEVERITY
•The term severity is often used to describe the
intensity of a medical event.
•Severity assessment categorizes the ADRs as
mild, moderate or severe based on the steps taken
for the management of the ADRs.

3. SEVERITY
• KARCH AND LASAGNA classified severity into minor, moderate,
severe and lethal as defined below:
 Minor: No antidote, treatment or prolongation of hospitalization
required.
 Moderate: A change in drug therapy (e.g.: modified dosage, addition
of a drug), but not necessarily discontinuation of the drug is required;
hospitalization may be prolonged, or specific treatment may be
required.
 Severe: Potentially life threatening, causing permanent damage or
requiring intensive medical care. Requires drug discontinuation.
 Lethal: Directly or indirectly contributes to the death of the patient.

4. MODIFIED HARTWIG’S AND SIEGELASSESSMENT SCALE
• Hartwig et. al robustly categorized ADR severity into seven
levels according to clinical consequence, including resultant
harm and intensity of medical intervention required.
oLevel 1 and 2 fall under mild category
oLevel 3 and 4 fall under moderate category
oLevel 5, 6 and 7 fall under category severe category.

5. Modified Hartwig and Siegel
• Mild:
Level 1: The ADR requires no change in treatment with the
suspected drug
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 length of stay.

6. Modified Hartwig and Siegel
• 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 length of
stay
Level 4 (a): Any level 3 ADR that increases length of stay by at
least one day
Level 4 (b): The ADR is the reason for admission.

7. Modified Hartwig and Siegel
• Severe:
Level 5: Any level 4 ADR that requires intensive medical care.
Level 6: The ADR causes permanent harm to the patient
Level 7: The ADR either directly or indirectly leads to the death
of the patient.

8. SERIOUSNESS CLASSIFICATION
• A serious adverse event or reaction is any untoward medical
occurrence that at any dose:
 Results in death
 Is life threatening
 Requires inpatient hospitalization or prolong hospitalization
 Results in persistent or significant disability
 Is a congenital anomaly/birth defect

9. PREVENTABILITY AND
PREDICTABILITY OF ADRs

10. PREVENTABILITY OFADRs
• Schumock and Thornton criteria:
• It has three sections namely definitely preventable, probably preventable and not-preventable.
• Section A comprises of five questions while section B has four questions.
• All the answers are categorized as “yes” or “no”.
• ADRs are “definitely preventable” if answer was “yes” to one or more questions in section A.
• If answers are all negative (“no”), then proceed to section B
• ADRs are “probably preventable” if answer was “yes” to one or more questions in section B.
• If answers were all negative then proceed to section C.
• In section C, the ADRs are not-preventable.

12. PREDICTABILITY Of ADRs
• Type A (Predictable):
Extension of pharmacological effect
Often predictable and dose dependent
Example: Dry mouth induced by anti-cholinergics.
• Type B (Non-predictable):
Idiosyncratic or immunologic reactions
Rare and unpredictable
Example: Penicillin induced anaphylactic shock.

13. REFERENCES
1. Karch FE, Lasagna L. Adverse drug reactions. JAMA. 1975;
234(12):1236
2. S. K. Gupta. Textbook of Pharmacovigilance. 2nd Edition. Jaypee
Brothers Medical Publishers. 2019.

14. THANK YOU