't Jong G W, Vulto A G, de Hoog M, Schimmel K J, Tibboel D, van den Anker J N
Department of Pediatrics, Sophia Children's Hospital, Erasmus Medical Center Rotterdam (EMCR), Rotterdam, The Netherlands.
Pediatrics. 2001 Nov;108(5):1089-93. doi: 10.1542/peds.108.5.1089.
The treatment of pediatric patients with drugs in hospitals is being impeded by a shortage in the availability of licensed drugs in an appropriate formulation. We have studied the extent of use of drugs that are not licensed for use in children (unlicensed) and drugs that are used outside the terms of the product license (off-label). We conducted this study in a Dutch academic children's hospital.
In a prospective study of 5 weeks' duration, we reviewed drug prescriptions in a pediatric ward and 3 intensive care units. We classified the prescribed drugs in 3 main categories-licensed, unlicensed, and off-label-and determined the nature of their unlicensed and off-label use.
Two thousand one hundred thirty-nine courses of drugs were administered to 237 patients in 442 patient-days. Of 2139 prescriptions, 725 (34%) were licensed, 1024 (48%) were unlicensed, and 390 (18%) were off-label. In 392 (90%) of 435 patient-days, children received 1 or more courses of an unlicensed or off-label drug prescription in hospital.
With regard to the availability of drugs of proven quality and adequate license for pediatric patients in hospital, dramatic shortcomings exist. As a result, drug legislation originally designed to protect patients and prescribing physicians against unsafe drug use and unjustified claims has turned into an insurmountable threshold to make proper drugs available for a vulnerable minority of patients.
医院中儿童用药的治疗因缺乏合适剂型的获批药物而受到阻碍。我们研究了未获儿童用药许可（未获批）的药物以及超出产品许可范围使用（超说明书用药）的药物的使用程度。我们在一家荷兰学术儿童医院开展了这项研究。
在一项为期5周的前瞻性研究中，我们审查了儿科病房和3个重症监护病房的药物处方。我们将所开药物分为三大类——获批、未获批和超说明书用药——并确定其未获批和超说明书用药的性质。
在442个患者日里，共对237名患者使用了2139个疗程的药物。在2139份处方中，725份（34%）是获批的，1024份（48%）是未获批的，390份（18%）是超说明书用药。在435个患者日中的392个（90%）里，儿童在医院接受了1个或更多疗程的未获批或超说明书用药处方。
在为住院儿科患者提供经证实质量可靠且有充分许可的药物方面，存在严重不足。因此，原本旨在保护患者和开处方医生免受不安全用药和不合理索赔影响的药品立法，已成为为少数弱势患者提供合适药物的不可逾越的障碍。
