Jobanputra Neha, Save Sushma U, Bavdekar Sandeep B
Int J Risk Saf Med. 2015;27(3):113-21. doi: 10.3233/JRS-150653.
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).
To determine prevalence of OL- and UL-drug use in children admitted to PICU.
Prospective observational study.
PICU in Mumbai (formerly Bombay), India.
Consecutive patients aged 28 d-12 yr admitted over 12-mo period.
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.
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.
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.
关于儿科重症监护病房（PICU）收治儿童使用超说明书（OL）和未获许可药物（UL）的数据较少。
确定入住PICU儿童中OL和UL药物的使用情况。
前瞻性观察研究。
印度孟买（原称 Bombay）的PICU。
连续12个月内收治的年龄在28天至12岁的患者。
对PICU患者的处方进行调查，并记录人口统计学数据、诊断以及所用药物的详细信息（剂量、频率、给药途径、适应症和UL使用情况）。使用描述性统计来提供OL药物（包括类别）和UL使用情况的患病率。使用Fisher-Pearson检验来确定年龄、机械通气以及涉及的系统数量与OL和UL药物使用之间的相关性。
482名参与者共收到1789份药物处方[OL：738份（41.25%），UL：376份（21.01%）]；OL药物使用在婴儿中最高（56.52%），超出许可适应症的使用（32.37%）是所有年龄组中最常见的OL药物使用类别。未获许可药物的使用完全归因于临时配制药物（EPD）的使用。OL药物和EPD的使用与婴儿期和通气治疗显著相关。
入住PICU的儿童中OL和UL药物的高使用率严重损害了他们获得安全药物的权利。由于大多数OL药物使用涉及已在儿童中使用数年的药物；需要立法和监管举措来确保积累的证据和经验纳入许可范围。
