Potentially harmful excipients in neonatal medicines: a pan-European observational study
Potentially harmful excipients in neonatal medicines: a pan-European observational study
复制标题
DOI：
10.1136/archdischild-2014-307793
复制
发表时间：
2015-07-01
影响因子：
5.2
通讯作者：
Lutsar, Irja
中科院分区：
文献类型：
--
作者：
Nellis, Georgi;Metsvaht, Tuuli;Lutsar, Irja
目的我们的目的是描述八种潜在有害的相关辅料（EOI）的给药--对羟基苯甲酸酯、聚山梨醇酯80、丙二醇、苯甲酸酯、糖精钠、山梨醇，方法将所有新生儿在1天内服用的药物与个人处方和人口统计学数据一起登记在一个网络上，点流行率研究。根据产品特性总结鉴别辅料。EOI管理（地理区域，胎龄（GA），活性药物成分，单位水平和医院的教学状态）的决定因素进行了确定使用多变量逻辑回归analysis.Results总体89新生儿单位来自21个国家参加。共记录了2095张处方，用于726名新生儿的530种产品。在638份（31%）处方中发现EOI，并通过相对较少的产品（n=142; 27%）对456名（63%）新生儿进行了给药。对羟基苯甲酸酯，发现在71（13%）的产品给予313（43%）的新生儿，使用最频繁。EOI给药因地理区域、GA和给药途径而异。地理区域仍然是一个重要的决定因素，使用对羟基苯甲酸酯，聚山梨酯80，丙二醇和糖精钠调整后的潜在协变量，包括解剖学治疗化学类的活性成分。结论欧洲新生儿收到一些潜在的有害药用辅料。EOI给药的地区差异表明，不含EOI的产品是可用的，并提供了替代的可能性，以避免某些辅料的副作用。
Objectives We aimed to describe administration of eight potentially harmful excipients of interest (EOI)-parabens, polysorbate 80, propylene glycol, benzoates, saccharin sodium, sorbitol, ethanol and benzalkonium chloride-to hospitalised neonates in Europe and to identify risk factors for exposure.Methods All medicines administered to neonates during 1 day with individual prescription and demographic data were registered in a web-based point prevalence study. Excipients were identified from the Summaries of Product Characteristics. Determinants of EOI administration (geographical region, gestational age (GA), active pharmaceutical ingredient, unit level and hospital teaching status) were identified using multivariable logistical regression analysis.Results Overall 89 neonatal units from 21 countries participated. Altogether 2095 prescriptions for 530 products administered to 726 neonates were recorded. EOI were found in 638 (31%) prescriptions and were administered to 456 (63%) neonates through a relatively small number of products (n=142; 27%). Parabens, found in 71 (13%) products administered to 313 (43%) neonates, were used most frequently. EOI administration varied by geographical region, GA and route of administration. Geographical region remained a significant determinant of the use of parabens, polysorbate 80, propylene glycol and saccharin sodium after adjustment for the potential covariates including anatomical therapeutic chemical class of the active ingredient.Conclusions European neonates receive a number of potentially harmful pharmaceutical excipients. Regional differences in EOI administration suggest that EOI-free products are available and provide the potential for substitution to avoid side effects of some excipients.