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Table 1 Incident severity classification system recommended by the National University Hospital Council of Japan

From: Patient safety incident reports related to traditional Japanese Kampo medicines: medication errors and adverse drug events in a university hospital for a ten-year period

Level

Continuity of injury

Severity of injury

Outcome/Treatment of injury

Level 5

Death

–

Death (excluding those due to the natural course of the underlying disease)

Level 4b

Permanent

Moderate–severe

Permanent disability or subsequent complication remained, accompanied with significant dysfunction or an aesthetic problem

Level 4a

Permanent

Mild–moderate

Permanent disability or subsequent complication remained, but was not accompanied by significant dysfunction or an aesthetic problem

Level 3b

Transient

Severe

Substantial treatment was required (significant change in vital signs, use of artificial respirator, surgery, prolongation of hospitalization, hospitalization, fracture, etc.)

Level 3a

Transient

Moderate

Simple treatment was required (disinfection, poultice, skin suture, administration of analgesics, etc.)

Level 2

Transient

Mild

Treatment was not necessary (mild change in vital signs, need for increased patient observation, examination for confirmation of safety, etc.)

Level 1

None

–

There was no harm to the patient (but there was a possibility of some influence)

Level 0

–

–

Error or trouble with a pharmaceutical or medical device was found, but did not affect the patient