Pharmacoepidemiology and Social pharmacy Course and Research Unit, School of Pharmacy, College of Health Sciences, Mekelle University, Mekelle, Ethiopia.
Department of Clinical Pharmacy School of Pharmacy, College of Health Sciences, Mekelle University, Mekelle, Ethiopia.
Ital J Pediatr. 2020 Apr 3;46(1):41. doi: 10.1186/s13052-020-0809-5.
Off- label drug use refers to the use of medicines outside of their marketing authorization with respect to dose, dosage form, route of administration, indication or age. Off-label/unlicensed drug use significantly associated with adverse drug reactions and medication errors in neonates and critically ill neonates are more vulnerable to these problems.
To assess the prevalence and associated factors with off-label and unlicensed drug use in neonatal intensive care unit of Ayder Comprehensive Specialized Hospital.
A cross-sectional study was conducted from March 01,2019 to April 30, 2019 in neonatal intensive care unit of Ayder Comprehensive Specialized Hospital. Neonates admitted for 24 h and took at least one medicine were included in the study. Data was collected from prescription and medical charts. The off-label and license status of the medicine was verified based on European medicine Agency electronic medicine compendium. Data was analyzed by SPSS version 21.0. Binary and multivariate logistic regression was done to assess the predictors of off-label/unlicensed medicine use at p-value ≤0.05 significance level.
A total of 364 medicines prescribed for 122 neonates were analyzed. The prevalence of off-label and unlicensed drug use was 246 (67.58%), and 86 (23.63%) respectively. Of the total 122 neonates, 114(93.44%), and 57(46.72%) of them were exposed to at least one off-label and unlicensed drug respectively. Antibiotics were the most commonly prescribed off-label and unlicensed drugs. No statistically significant association was found between demographic as well as health related variables with off-label/unlicensed medicine use at p-value of ≤0.05 significance level.
Off-label and unlicensed medicine use was high among neonates admitted to intensive care unit of the hospital. Selecting the safest medicines for such vulnerable patients is crucial to promote rational prescribing and better therapeutic benefit.
药品标签外使用是指在剂量、剂型、给药途径、适应证或年龄方面超出药品上市许可的使用。标签外/未注册药品的使用与新生儿和重症新生儿的不良反应和用药错误显著相关，这些新生儿更容易出现这些问题。
评估亚的斯亚贝巴综合专科医院新生儿重症监护病房（NICU）标签外和未注册药品使用的流行情况及其相关因素。
2019 年 3 月 1 日至 2019 年 4 月 30 日在亚的斯亚贝巴综合专科医院新生儿重症监护病房进行了横断面研究。纳入在 24 小时内入院并至少使用一种药物的新生儿。数据从处方和病历中收集。根据欧洲药品管理局电子药品汇编，验证药品的标签外和许可证状态。使用 SPSS 版本 21.0 进行数据分析。采用二元和多变量逻辑回归分析，p 值≤0.05 为有统计学意义。
共分析了 122 名新生儿开具的 364 种药物。标签外和未注册药物的使用率分别为 246（67.58%）和 86（23.63%）。在 122 名新生儿中，有 114 名（93.44%）和 57 名（46.72%）至少使用了一种标签外和未注册药物。抗生素是最常开的标签外和未注册药物。在 p 值≤0.05 的统计学意义水平上，人口统计学和健康相关变量与标签外/未注册药物的使用之间没有发现统计学意义上的关联。
在医院重症监护病房住院的新生儿中，标签外和未注册药物的使用比例很高。为了促进合理用药和更好的治疗效果，为这些脆弱的患者选择最安全的药物至关重要。
