Incidence of prescriptions without product licence in a neonatal intensive care unit.
Incidence of prescriptions without product licence in a neonatal intensive care unit.
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DOI：
10.1016/s0929-693x(00)88083-5
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发表时间：
2000-02-01
影响因子：
1.8
通讯作者：
Danan, C
中科院分区：
文献类型：
--
作者：
Avenel, S;Bomkratz, A;Danan, C
新生儿重症监护病房中无产品许可证处方的发生率。儿科单位开的大多数药物没有产品许可证。缺乏儿童临床研究和适当的药物配方降低了其安全性：缺乏法律的框架使开处方者不安全。即使这场辩论不是最近的，在这一领域也很少进行研究。本研究的目的是评估在新生儿重症监护病房的无证和标签外药物的处方率。- 本研究于1998年1月12日至2月12日在我们的新生儿重症监护室进行。纳入40例0 ~ 128天的婴儿（90%为新生儿），胎龄在25 ~ 40周之间（88%为早产儿，出生体重低于1000 g）。- 在此期间，共开出了257张处方，使用了55种不同类型的药物。百分之十的处方药没有产品许可证。早产儿和新生儿分别有62%和64%的标签外使用：90%是由于年龄，9.3%是由于剂量，0.7%是由于给药方法。在少数几种获得许可的药物中，没有发现这些处方的治疗替代品。- 新生儿重症监护病房无证和超说明书用药处方是日常和重复发生的事件。开处方者通常不知道药物的确切状态，也没有意识到问题的重要性以及法律的和潜在的后果。儿科临床研究的缺乏在很大程度上是儿科药物注册缺失的原因。制药业没有什么动力来开发儿科产品许可证。(C)2000年，Elsevier SAS科学与医学版。
Incidence of prescriptions without product licence in a neonatal intensive care unit. Most of the drugs prescribed in pediatric units have no product licence. The lack of clinical studies in children and appropriate drug formulations decrease their safety: The lack of a legal framework makes the prescriber insecure. Even if the debate is not recent, few studies have been carried out in this field. The aim of the present study was to evaluate the rate of prescriptions of unlicensed and off-label drugs in a neonatal intensive care unit.Patients and methods. - The present study was carried out in our neonatal intensive care unit, from January 12 to February 12, 1998. Forty babies aged 0 to 128 days were included (90% newborns), with a gestational age between 25 to 40 weeks (88% were premature, with a birth weight lower than 1000 g).Results. - Two hundred and fifty-seven prescriptions were administered with 55 different types of drugs during this period. Ten percent of the prescribed drugs had no product licence. Sixty-two percent were off-label for premature infants and 64% for newborns: 90% due to age, 9.3% due to dose and 0.7% to method of administration. No therapeutic alternatives to these prescriptions were found among the few available licensed drugs.Conclusion. - The prescriptions of unlicensed and off-label drugs in neonatal intensive care units are daily and repeated events. The prescribers are usually not aware of the exact status of the drug and do not realize neither he importance of the problem nor the legal and potential consequences. The lack of pediatric clinical studies is to a large extent responsible for the absence of drug registration in pediatrics. The pharmaceutical industry has few incentives to develop the pediatric product licences. (C) 2000 Editions scientifiques et medicales Elsevier SAS.