Off-label and unlicensed drug use in children admitted to Pediatric Intensive Care Units (PICU).

Background: There is paucity of data regarding the use of off-label (OL) and unlicensed drug (UL) use in children admitted to the Pediatric Intensive Care Units (PICUs).

Objective: To determine prevalence of OL- and UL-drug use in children admitted to PICU.

Design: Prospective observational study.

Setting: PICU in Mumbai (formerly Bombay), India.

Participants: Consecutive patients aged 28 d-12 yr admitted over 12-mo period.

Methods: Prescriptions issued to PICU patients were surveyed and demographic data, diagnosis and details of drugs used (dose, frequency, route of administration, indication, and UL use) were noted. Descriptive statistics was used for providing prevalence of OL drug (including category) and UL use. Fisher-Pearson test was used to determine the significance of age, mechanical ventilation and number of systems involved with reference to OL- and UL-drug use.

Results: 482 participants received 1789 [OL: 738(41.25%) and UL: 376(21.01%)] drug prescriptions; OL-drug use was highest in infants (56.52%) with indication outside the license (32.37%) being the commonest category of OL-drug use across all age-groups. Unlicensed drug use was entirely due to extemporaneously-prepared drug (EPD) use. The OL drug- and EPD-use were significantly associated with infancy and ventilation therapy.

Conclusions: The high prevalence of OL- and UL-drug use in children admitted in the PICU significantly compromises their right to safe drugs. As most of the OL drug use is related to drugs used in children for several years; legislative and regulatory initiatives are required to ensure that accumulated evidence and experience gets incorporated in the license.