Off-label drug use in pediatric anesthesia and intensive care according to official and pediatric reference formularies

Abstract

Purpose: In pediatric practice, the official drug label often does not accurately reflect the contemporary use of many drugs prescribed to children. Therefore, clinicians frequently use contemporary drug references as a source of prescribing information instead of national formularies. The objective of this study was to compare drug prescriptions between two national formularies and two commonly used contemporary pediatric reference guidelines in the operating room/postanesthetic care unit (OR/PACU), pediatric intensive care unit (PICU), and neonatal intensive care unit (NICU).

Methods: We performed a retrospective chart review of patients admitted over a one-month period to the NICU and PICU, and for one week during the same month, we reviewed charts of patients in the OR/PACU. The data collected included patients' demographic information, drugs prescribed, and dosage information. We assessed conformity with two national formularies, the Canadian Compendium of Pharmaceuticals and Specialties (CPS) and France's 2009 Dictionnaire Vidal (Vidal), and two contemporary pediatric references, the Hospital for Sick Children Handbook and Formulary and the Lexi-Comp Pediatric Dosage Handbook.

Results: Across the three clinical units, 59.7% (95% confidence interval [CI] 57.1-62.1%) of prescriptions were identified as being off-label, as defined by the CPS formulary. The odds of having an off-label prescription would have been substantially lower if the contemporary pediatric references (odds ratio [OR] = 0.074; 95% CI 0.065-0.084) or Vidal (OR = 0.70; 95% CI 0.63-0.77) had been used to define the label (both P < 0.001 compared with the CPS).

Conclusion: Drugs are less likely to be off-label if prescribed according to a contemporary pediatric reference rather than according to national formularies. Methodologies used to compile contemporary references might serve as templates to inform a drug's official label.