Table 1.
Prevalence rates of off-label systemic drug orders in ambulatory pediatric visits in the United States (2006–2015)1
| 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/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 | 1,801 | 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 | 2,079 | 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 | 3,501 | 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 weight | 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 weight | 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 (where applicable) weight2 | 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) |
1
All rates account for sampling, clustering, and strata, reflecting nationally representative estimates
2
Drugs that were ordered for an approved indication, an approved age (and, where applicable, weight) for a different indication, but an unapproved age or weight for the documented diagnoses and symptoms