Significant ADR
Significant ADR
1. Requires discontinuing the drug (therapeutic or diagnostic).
2. Requires changing the drug therapy.
3. Requires modifying the dose (except for minor dosage adjustments).
4. Necessitates admission to a hospital.
5. Prolongs stay in a health care facility.
6. Necessitates supportive treatment.
7. Significantly complicates diagnosis.
8. Negatively affects prognosis.
9. Results in temporary or permanent harm, disability, or death.