Table 3.
Classification of the adverse drug events detected in the intensive care unit of a tertiary hospital in the Brazilian Midwest. Brazil, 2016.
| Trigger Tool | Non-targeted chart review | p | |
|---|---|---|---|
| Adverse drug events | 98 | 122 | – |
| Patients experiencing adverse drug events (%) | 65 (40.12%) | 73 (43,19%) | 0.321a |
| Cumulative incidence (ADE/patient) | 0.60 | 0.72 | – |
| Incidence density rate (ADE/1000 patient-days) | 61.09 | 64.04 | – |
| Causality: Naranjo algorithm (Naranjo et al., 1981) | 0.001a | ||
| <0 points: Doubtful | – | – | |
| 1–4 points: Possible | 28 (28.57%) | 12 (9.84%) | |
| 5–8 points: Probable | 63 (64.29%) | 95 (77.87%) | |
| >9 points: Definite | 7 (7.14%) | 15 (12.29%) | |
| Severity: CTCAE v4.0 (National Cancer Institute, 2010) | 0.029 a | ||
| Grade 1: Mild, asymptomatic, intervention not indicated | 7 (7.14%) | 17 (13.93%) | |
| Grade 2: Moderate, requires local or noninvasive intervention | 36 (36.74%) | 48 (39.34%) | |
| Grade 3: Severe, not immediately life-threatening, prolongs hospitalization | 32 (32.65%) | 45 (36.89%) | |
| Grade 4: Life-threatening, requires urgent intervention | 23 (23.47%) | 12 (9.84%) | |
| Grade 5: Death related to adverse event | – | – | |
| Predictability: (Rawlins and Thompson, 1991) | 0.991a | ||
| Type A: Dosing-dependent, predictable | 86 (87.76%) | 107 (87.70%) | |
| Type B: Pharmacologically unexpected, idiosyncratic | 12 (12.24%) | 15 (12.30%) | |
| Damage: NCC MERP Index for Categorizing Medication Errors (National Coordinating Council for Medication Error Reporting, 2001) | 0.099a | ||
| Category E: Temporary harm to the patient and required intervention | 55 (56.12%) | 62 (50.82%) | |
| Category F: Temporary harm to the patient and prolonged hospitalization | 24 (24.49%) | 46 (37.70%) | |
| Category G: Permanent patient harm | 2 (2.04%) | 3 (2.46%) | |
| Category H: Intervention necessary to sustain life | 17 (17.35%) | 11 (9.02%) | |
| Category I: Patient death | – | – | |
CTCAE: Common Terminology Criteria for Adverse Events version 4.0.
a
Pearson's chi-square test for independence.