Abstract
Despite all efforts to improve the on-label use of licensed medicines for neonates, there is still high percentage and demands of offlabel and unlicensed medicines use in neonatal therapy. Therefore, the general objective of this survey is to provide a description of off-label and unlicensed medicines use within the neonatal therapeutic areas in a Department of Neonatology, University Clinic for Gynecology and Obstetrics, in Skopje, Republic of Macedonia. All analyzed prescriptions were given in accordance with the Evidence Based Guidelines applied in the Department. During the three months’ period in 2015, there were given 1595 prescriptions, comprising 3.99 prescriptions per newborn during the hospital stay. Out of them, 532 (33.3%) were on-label medicine uses, 1052 (66%) were off-label medicines, and 11 prescriptions (0.7%) were unlicensed medicines. The results from this study show the high level of off-label medicine use in neonatal therapy. These results present only the “top of the iceberg” and require more comprehensive analysis that will gradually evolve in a National Guideline on off-label use areas in pediatric medicine, especially for critically ill newborns who are prescribed much more life-saving medicines.
Highlights
The practice of off-label prescribing and use is a complex issue with advantages and weaknesses
The results from this study show the high level of off-label medicine use in neonatal therapy
It refer to prescription of a registered medicine for a use that is not included in the Summary of Product Characteristics (SPC), not listed in the product information, the uses outside the terms of their product license disclaimed in the SPC (Kimland et al, 2007)
Summary
The practice of off-label prescribing and use is a complex issue with advantages and weaknesses It refer to prescription of a registered medicine for a use that is not included in the Summary of Product Characteristics (SPC), not listed in the product information, the uses outside the terms of their product license (approval) disclaimed in the SPC (Kimland et al, 2007). This practice is a real challenge for any prescriber. Unlicensed or unregistered medicine use, is the use of a medicine or dosage form of a medicine that has not been evaluated nor approved by the regulatory authorities These include medicines whose formulation is modified, those that are imported before a li-. In practice, this approach is not different from what should ideally be done for the rational prescribing of any medicine
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