Arocas Casañ Vicente, Cabezuelo Escribano Belén, Garrido-Corro Beatriz, De la Cruz Murie Pablo, Blázquez Álvarez Mª José, De la Rubia Nieto M ª Amelia
Pharmacy Department. Hospital Clínico Universitario Virgen de la Arrixaca, Murcia..
Universidad de Murcia (University of Murcia)..
Farm Hosp. 2017 May 1;41(3):371-381. doi: 10.7399/fh.2017.41.3.10691.
Objetive: To describe off-label and unlicensed drugs in clinical practice in a Neonatal Intensive Care Unit (NICU).
The design of the study was a descriptive and retrospective three months research in a NICU of a Spanish University Hospital. All prescriptions were classified as approved, off-label and unlicensed drug used, according to the information available on the Summary of Product Characteristics. Off-label drugs prescriptions were divided into four groups (dose, frecuency, age and indication of use) depending on the reason of disconformity.
Forty-one neonates were included (46.3% premature patients) and a total of 273 drug prescriptions were evaluated. Of them, 53.1% (145) were classified as an approved drug prescriptions, 41.4% (113) were off-label use and 5.5% (15) were unlicensed drugs. 90.2% of the patients (37/41) received at least one off label prescription, with a median of 3 (range 1-7). Age was the foremost reason for off-label use (42.5%), followed by dose (31.0%), frecuency (16.8%) and dose-frecuency off-label drug use (8.8%). The last place was reserved for off-label drug use by indication (0.9%). Group J (corresponding with antiinfectives for systemic use) was the most frecuently prescribed, with ampicillin (18.6%) and gentamicin (16.8%) as the drugs most commonly use as off-label prescriptions. Finally, caffeine citrate was the unlicensed drug most frecuently prescribed.
Off-label and unlicensed drug use prescriptions in our NICU clinical practice are highly frecuent as other authors have previously published in other countries where they were studied. Although there are few studies in newborn patients, both off-label and unlicensed drug prescriptions are commonly recomended in Paediatrics Guidelines.
目的：描述新生儿重症监护病房（NICU）临床实践中使用的超说明书用药和未获许可药物。
本研究设计为对西班牙一家大学医院的新生儿重症监护病房进行为期三个月的描述性回顾性研究。根据药品说明书上的可用信息，所有处方被分类为已批准用药、超说明书用药和未获许可药物。超说明书用药处方根据不符合规定的原因分为四组（剂量、频率、年龄和使用指征）。
纳入41例新生儿（46.3%为早产儿），共评估273份药物处方。其中，53.1%（145份）被分类为已批准药物处方，41.4%（113份）为超说明书用药，5.5%（15份）为未获许可药物。90.2%的患者（37/41）接受了至少一张超说明书处方，中位数为3张（范围1 - 7）。年龄是超说明书用药的首要原因（42.5%），其次是剂量（31.0%）、频率（16.8%）和剂量 - 频率超说明书用药（8.8%）。使用指征超说明书用药占比最低（0.9%）。J组（对应全身用抗感染药）是最常开具处方的组，氨苄西林（18.6%）和庆大霉素（16.8%）是最常作为超说明书处方使用的药物。最后，枸橼酸咖啡因是最常开具处方的未获许可药物。
与其他作者之前在其他国家发表的研究结果一样，我们新生儿重症监护病房临床实践中超说明书用药和未获许可药物的处方非常常见。虽然针对新生儿患者的研究较少，但超说明书用药和未获许可药物处方在儿科指南中都很常见。
