Off-label and unlicensed drug use in a Spanish Neonatal Intensive Care Unit
<p><strong>Objetive:</strong> To describe off-label and unlicensed drugs in clinical practice in a Neonatal Intensive Care Unit (NICU).</p><p><strong>Method:</strong> The design of the study was a descriptive and retrospective three months research in a N...
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| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2017-05-01
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| Series: | Farmacia Hospitalaria |
| Subjects: | |
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| Summary: | <p><strong>Objetive:</strong> To describe off-label and unlicensed drugs in clinical practice in a Neonatal Intensive Care Unit
(NICU).</p><p><strong>Method:</strong> 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.</p><p><strong>Results:</strong> 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.</p><p><strong>Conclusion:</strong> 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.</p><p> </p> |
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| ISSN: | 1130-6343 2171-8695 |