AbuAlsaud Zainab, Alshayban Dhfer, Joseph Royes, Pottoo Faheem Hyder, Lucca Jisha Myalil
Department of Pharmacy Practice, College of Clinical Pharmacy, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.
Department of Pharmacology, College of Clinical Pharmacy, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.
Hosp Pharm. 2020 Feb;55(1):37-43. doi: 10.1177/0018578718817861. Epub 2018 Dec 7.
Off-label drug prescribing remains a major pediatric health concern worldwide. The lack of studies in this vulnerable population causes many practitioners to prescribe drugs outside their license. This study aims to investigate and compare the current knowledge and views of general practitioners, pediatricians, and other specialists toward off-label pediatric prescribing. A descriptive, cross-sectional-based study conducted on a random sample of physicians who work in three different hospitals in the Eastern Province of Saudi Arabia. Data were obtained from three hospitals, comprising a total of 160 practitioners. Overall, more than half of the participated practitioners (54%) were familiar with the definition of off-label prescribing. Thirty percentage of participated practitioners agreed that more than 10% of their prescribed medicines to children were off-labeled. A majority of participants expressed concerns over the efficacy (83%) and safety (92%) of off-label prescribing to children. Importantly, a noticeable proportion of the responders claimed that they sometimes observed an adverse drug reaction (n = 23; 20%) or treatment failure (n = 43; 37%) following off-label prescribing medicines to children. Only 46% participants have always informed the parents or guardian about the off-label prescription of medications to their children. A Large number of physicians are familiar with the concept of off-label prescribing of medicines to children in the Eastern Province of Saudi Arabia. Safety and efficacy are the main concerns of prescribing such medications. Policies toward improving pediatric clinical research and supporting the safety and efficacy of the drugs should be encouraged.
在全球范围内，药品的超说明书用药仍然是一个主要的儿科健康问题。由于缺乏针对这一弱势群体的研究，许多从业者在其执业范围外开药。本研究旨在调查和比较全科医生、儿科医生及其他专科医生对儿科超说明书用药的现有认知和看法。对沙特阿拉伯东部省三家不同医院工作的医生进行了一项基于描述性横断面的随机抽样研究。数据来自三家医院，共160名从业者。总体而言，超过半数的参与从业者（54%）熟悉超说明书用药的定义。30%的参与从业者同意他们给儿童开的药中超过10%是超说明书用药。大多数参与者对儿童超说明书用药的疗效（83%）和安全性（92%）表示担忧。重要的是，相当比例的受访者称，他们有时会观察到给儿童超说明书用药后出现药物不良反应（n = 23；20%）或治疗失败（n = 43；37%）。只有46%的参与者总是会告知家长或监护人其给孩子开的药是超说明书用药。沙特阿拉伯东部省的大量医生熟悉给儿童超说明书用药的概念。安全性和疗效是开具此类药物时的主要关注点。应鼓励制定改善儿科临床研究以及支持药物安全性和疗效的政策。
