Saiyed Mohd Masnoon, Lalwani Tarachand, Rana Devang
Department of Pharmacology and Clinical Pharmacy, K.B. Institute of Pharmaceutical Education and Research, GH 6, Sector 23, Gandhinagar, Gujarat 382024, India.
Department of Pharmacology, Smt. N.H.L. Municipal Medical College, Sheth V.S. General Hospital, Ellisbridge, Ahmedabad, Gujarat 380006, India.
Int J Pediatr. 2014;2014:415815. doi: 10.1155/2014/415815. Epub 2014 Nov 25.
Background. In the absence of standard pediatric prescribing information, clinicians often use medicines in an off-label way. Many studies have been published across the globe reporting different rates of off-label use. There is currently no study based on Indian drug formulary. Methods. The prospective observational study included pediatric patients in ages between 0 and 12 years admitted in a tertiary care hospital. Off-label use was assessed using the National Formulary of India (NFI). Predictors of off-label use were determined by logistic regression. Results. Of the 1645 medications prescribed, 1152 (70%) were off-label based on 14 possible off-label categories. Off-label medicines were mainly due to dose difference and use in restricted age limits as indicated in NFI. Respiratory medicines (82%), anti-infectives (73%), and nervous system medicines (53%) had higher off-label use. Important predictors of off-label prescribing were pediatric patients in age of 0 to 2 years (OR 1.68, 95% CI; P < 0.001) and hospital stay of six to 10 days (OR 1.91, 95% CI; P < 0.001). Conclusion. Off-label prescribing is common among pediatric patients. There is need to generate more quality data on the safety and efficacy of off-label medicines to rationalize pediatric pharmacotherapy.
背景。在缺乏标准的儿科处方信息的情况下，临床医生经常以超说明书用药的方式使用药物。全球已发表了许多研究报告了不同的超说明书用药率。目前尚无基于印度药品处方集的研究。方法。这项前瞻性观察性研究纳入了一家三级护理医院收治的0至12岁儿科患者。使用印度国家处方集（NFI）评估超说明书用药情况。通过逻辑回归确定超说明书用药的预测因素。结果。在开出的1645种药物中，根据14种可能的超说明书类别，有1152种（70%）属于超说明书用药。超说明书用药主要是由于剂量差异以及在NFI中规定的受限年龄范围内使用。呼吸系统药物（82%）、抗感染药物（73%）和神经系统药物（53%）的超说明书用药率较高。超说明书处方的重要预测因素是0至2岁的儿科患者（比值比1.68，95%置信区间；P<0.001）以及住院6至10天（比值比1.91，95%置信区间；P<0.001）。结论。超说明书处方在儿科患者中很常见。需要生成更多关于超说明书用药安全性和有效性的高质量数据，以使儿科药物治疗合理化。
