Prevalence Rates of Off-Label Systemic Drug Orders in Ambulatory Pediatric Visits in the United States (2006–2015)
| Off-Label Characteristic . | Sample, n . | % of Total Visits (95% CI) . | % of Visits With Systemic Drugs (95% CI) . | % of Off-Label or Possibly Off-Label Drugs (95% CI) . | Estimated Orders, Millions per Year (95% CI) . |
|---|---|---|---|---|---|
| Off label for any reason | 17 064 | 18.5 (17.7–19.3) | 44.5 (43.3–45.8) | 90.6 (89.8–91.4) | 41.2 (39.9–42.4) |
| Possibly off label for any reason | 1801 | 1.6 (1.5–1.8) | 3.9 (3.5–4.4) | 9.4 (8.6–10.2) | 4.3 (3.9–4.7) |
| Off label by indication | 13 914 | 15.6 (15.0–16.3) | 37.6 (36.4–38.8) | 74.6 (73.2–75.9) | 33.9 (32.7–35.1) |
| Possibly off label by indication | 2079 | 1.8 (1.7–2.0) | 4.4 (4.0–4.9) | 10.2 (9.5–11.1) | 4.6 (4.3–5.1) |
| Off label by age | 3501 | 4.3 (3.9–4.6) | 10.3 (9.6–11.0) | 17.6 (16.5–18.7) | 8.0 (7.4–8.6) |
| Off label by wt | 131 | 0.2 (0.2–0.3) | 0.6 (0.4–0.8) | 0.6 (0.4–0.8) | 0.4 (0.3–0.6) |
| Possibly off label by wt | 419 | 0.5 (0.4–0.6) | 1.2 (1.0–1.5) | 1.2 (0.9–1.5) | 0.9 (0.7–1.1) |
| Off label by combination of age, indication, and (when applicable) wta | 893 | 1.2 (1.0–1.4) | 2.8 (2.5–3.3) | 4.6 (4.1–5.3) | 2.1 (1.8–2.4) |
| Off-Label Characteristic . | Sample, n . | % of Total Visits (95% CI) . | % of Visits With Systemic Drugs (95% CI) . | % of Off-Label or Possibly Off-Label Drugs (95% CI) . | Estimated Orders, Millions per Year (95% CI) . |
|---|---|---|---|---|---|
| Off label for any reason | 17 064 | 18.5 (17.7–19.3) | 44.5 (43.3–45.8) | 90.6 (89.8–91.4) | 41.2 (39.9–42.4) |
| Possibly off label for any reason | 1801 | 1.6 (1.5–1.8) | 3.9 (3.5–4.4) | 9.4 (8.6–10.2) | 4.3 (3.9–4.7) |
| Off label by indication | 13 914 | 15.6 (15.0–16.3) | 37.6 (36.4–38.8) | 74.6 (73.2–75.9) | 33.9 (32.7–35.1) |
| Possibly off label by indication | 2079 | 1.8 (1.7–2.0) | 4.4 (4.0–4.9) | 10.2 (9.5–11.1) | 4.6 (4.3–5.1) |
| Off label by age | 3501 | 4.3 (3.9–4.6) | 10.3 (9.6–11.0) | 17.6 (16.5–18.7) | 8.0 (7.4–8.6) |
| Off label by wt | 131 | 0.2 (0.2–0.3) | 0.6 (0.4–0.8) | 0.6 (0.4–0.8) | 0.4 (0.3–0.6) |
| Possibly off label by wt | 419 | 0.5 (0.4–0.6) | 1.2 (1.0–1.5) | 1.2 (0.9–1.5) | 0.9 (0.7–1.1) |
| Off label by combination of age, indication, and (when applicable) wta | 893 | 1.2 (1.0–1.4) | 2.8 (2.5–3.3) | 4.6 (4.1–5.3) | 2.1 (1.8–2.4) |
All rates account for sampling, clustering, and strata, reflecting nationally representative estimates.
Drugs that were ordered for an approved indication and an approved age (and, when applicable, wt) for a different indication but an unapproved age or wt for the documented diagnoses and symptoms.