From: Off-label use and harmful potential of drugs in a NICU in Brazil: A descriptive study
Extremely preterm neonates (EPN) | Preterm neonates (PN) | Term neonates (TN) | |||||
---|---|---|---|---|---|---|---|
<28 weeks | 28–30 weeks | 31–33 weeks | 34–36 weeks | ≥37 weeks | Total (n) | p-value* | |
N | 23 | 34 | 48 | 39 | 48 | 192 | -- |
Male (%) | 43.5 | 50.0 | 58.3 | 53.8 | 50.0 | 52.0 | 0.804a |
Cesarean delivery (%) | 43.5 | 67.6 | 79.2 | 79.5 | 64.6 | 69.2 | 0.019a |
Discharge (%) | 17.4 | 38.2 | 56.3 | 59.0 | 66.7 | 51.5 | <0.001a |
Transfer (%) | 17.4 | 14.7 | 27.1 | 23.1 | 22.9 | 21.8 | <0.001a |
Deaths (%) | 65.2 | 47.1 | 16.7 | 17.9 | 10.4 | 26.5 | <0.001a |
Survivors (%) | 34.8 | 52.9 | 83.3 | 82.1 | 89.6 | 73.4 | <0.001a |
APGAR 1’ (mean, SD) | 6.0 ± 2.7 | 5.9 ± 2.0 | 6.5 ± 1.8 | 7.0 ± 1.6 | 6.8 ± 2.0 | 6.5 ± 2.0 | 0.139 b |
APGAR 5’ (mean, SD) | 7.7 ± 2.2 | 7.9 ± 1.3 | 8.1 ± 1.1 | 8.5 ± 1.0 | 8.2 ± 1.3 | 8.1 ± 1.3 | 0.100b |
Resuscitation (%) | 69.6 | 79.4 | 68.8 | 64.1 | 56.3 | 66.6 | 0.275a |
Birth weight (mean, SD- g) | 804.0 ± 164.0 | 1078.4 ± 268.6 | 1681.4 ± 276.1 | 2244.5 ± 594.1 | 2983.7 ± 585.6 | 1909.5 ± 886.0 | <0.001c |
NICU stay (days) | 24.0 ± 25.1 | 24.2 ± 19.5 | 14.7 ± 13.1 | 18.0 ± 15.0 | 17.3 ± 19.3 | 18.8 ± 18.2 | 0.203b |
Neonate-days | 552 | 824 | 706 | 705 | 730 | 3617 | -- |
Prescriptions (mean, SD) | 23.6 ± 24.4 | 22.5 ± 19.2 | 13.3 ± 12.3 | 16.6 ± 15.7 | 14.1 ± 18.6 | 17.0 ± 17.9 | 0.019b |
Drugs (mean, SD) | 11.5 ± 6.0 | 11.9 ± 5.3 | 6.9 ± 4.9 | 9.0 ± 5.8 | 7.1 ± 6.9 | 8.8 ± 6.1 | <0.001c |
Drugs/prescription (mean, SD) | 4.1 ± 1.5 | 4.2 ± 1.4 | 2.8 ± 1.4 | 3.8 ± 1.8 | 3.0 ± 2.0 | 3.4 ± 1.7 | <0.001c |
>6 drugs (%) | 73.9 | 85.3 | 41.7 | 53.8 | 37.5 | 54.7 | <0.001a |
Exposure to UL (%) | 26.1 | 20.5 | 10.4 | 2.6 | 8.3 | 11.9 | 0.030a |
Exposure to OL (%) | 100 | 100 | 100 | 100 | 97.9 | 99.5 | 0.555a |
UL and OL/prescription (mean, SD) | 3.6 ± 1.3 | 3.5 ± 1.3 | 2.5 ± 1.2 | 3.3 ± 1.5 | 2.5 ± 1.8 | 3.0 ± 1.5 | <0.001c |
Exposure to high-alert medications (%) | 82.6 | 97.0 | 60.4 | 69.2 | 64.5 | 72.4 | 0.002a |
Number of high-alert medications (mean, SD) | 2.6 ± 1.4 | 2.4 ± 1.5 | 2.1 ± 1.1 | 2.7 ± 1.5 | 2.7 ± 1.5 | 2.5 ± 1.4 | 0.561b |
Exposure to harmful excipients (%) | 91.3 | 100.0 | 93.7 | 92.3 | 83.3 | 91.6 | 0.101a |
Formulations with harmful excipients (mean, SD) | 4.5 ± 2.1 | 4.5 ± 2.0 | 3.2 ± 1.6 | 4.1 ± 1.7 | 3.8 ± 2.2 | 3.4 ± 2.1 | 0.001b |