TABLE 4

Absolute Prevalence of Off-Label Systemic Drug Orders by Drug Class and Age for Children in US Ambulatory Settings (2006–2015)

Drug ClassaOff-Label Orders per 1000 Ambulatory Visits (95% CIs)
Age <1 moAge 1 mo to <2 yAge 2–5 yAge 6–11 yAge 12–17 yAll Children
Anti-infective 13.7b (6.8–20.5) 60.1 (52.9–67.2) 88.6 (80.7–96.6) 78.3 (70.3–86.2) 79.8 (70.1–89.5) 74.8 (69.6–79.9) 
Respiratory 0.5b (0–1.6) 48.0 (40.6–55.4) 63.5 (56.5–70.6) 61.0 (53.8–68.2) 50.1 (43.8–56.5) 53.8 (49.8–57.9) 
Nervous 9.0b (1.2–16.7) 8.6 (4.3–12.9) 16.0 (12.8–19.1) 62.6 (54.2–71.0) 123.0 (108.9–137.2) 53.7 (47.8–59.5) 
Alimentary 27.5 (15.8–39.2) 26.3 (21.9–30.8) 26.9 (22.1–31.8) 27.8 (23.5–32.1) 22.1 (18.8–25.5) 25.8 (23.2–28.4) 
Hormonal NDb 13.4 (10.5–16.3) 15.8 (12.8–18.7) 12.2 (9.1–15.2) 10.3 (7.8–12.9) 12.4 (10.9–13.9) 
Cardiovascular 0b (0–0.1) 1.6b (0.8–2.4) 3.4 (2.2–4.6) 6.4 (4.5–8.4) 8.3 (6.2–10.4) 4.9 (4.0–5.9) 
Musculoskeletal 1.3b (0–3.4) 3.8 (2.5–5.1) 3.3 (1.8–4.8) 3.4 (2.2–4.5) 8.5 (6.4–10.5) 4.7 (3.9–5.6) 
Genitourinary NDb 0.2b (0–0.5) 0.3b (0–0.5) 0.6b (0.1–1.2) 15.7 (12.8–18.6) 4.4 (3.6–5.2) 
Drug ClassaOff-Label Orders per 1000 Ambulatory Visits (95% CIs)
Age <1 moAge 1 mo to <2 yAge 2–5 yAge 6–11 yAge 12–17 yAll Children
Anti-infective 13.7b (6.8–20.5) 60.1 (52.9–67.2) 88.6 (80.7–96.6) 78.3 (70.3–86.2) 79.8 (70.1–89.5) 74.8 (69.6–79.9) 
Respiratory 0.5b (0–1.6) 48.0 (40.6–55.4) 63.5 (56.5–70.6) 61.0 (53.8–68.2) 50.1 (43.8–56.5) 53.8 (49.8–57.9) 
Nervous 9.0b (1.2–16.7) 8.6 (4.3–12.9) 16.0 (12.8–19.1) 62.6 (54.2–71.0) 123.0 (108.9–137.2) 53.7 (47.8–59.5) 
Alimentary 27.5 (15.8–39.2) 26.3 (21.9–30.8) 26.9 (22.1–31.8) 27.8 (23.5–32.1) 22.1 (18.8–25.5) 25.8 (23.2–28.4) 
Hormonal NDb 13.4 (10.5–16.3) 15.8 (12.8–18.7) 12.2 (9.1–15.2) 10.3 (7.8–12.9) 12.4 (10.9–13.9) 
Cardiovascular 0b (0–0.1) 1.6b (0.8–2.4) 3.4 (2.2–4.6) 6.4 (4.5–8.4) 8.3 (6.2–10.4) 4.9 (4.0–5.9) 
Musculoskeletal 1.3b (0–3.4) 3.8 (2.5–5.1) 3.3 (1.8–4.8) 3.4 (2.2–4.5) 8.5 (6.4–10.5) 4.7 (3.9–5.6) 
Genitourinary NDb 0.2b (0–0.5) 0.3b (0–0.5) 0.6b (0.1–1.2) 15.7 (12.8–18.6) 4.4 (3.6–5.2) 

ND, not defined.

a

Drug class according to ATC level 1 classification.

b

Values are based on <30 observations.

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