Off-label and unlicensed drug use in neonatal intensive care units in Turkey: the old-inn study
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Background Recently several developed countries have improved the safety and efficacy of drugs used in infants and pediatric patients. Most drugs administered to adults have licensed approvals outlining indications, doses, and the recommended route of administration. However, many drugs that are given to children are unlicensed or used off-label. Objectives To assess the extent and nature of unregistered and off-label drug use in neonatal intensive care units (NICUs) in Turkey, and to explore awareness and views of the general public on the unlicensed use of medicine in preterm and term infants in developing countries. Study Design A prospective observational study of a dynamic cohort of 464 neonates from 17 NICUs in Turkey. All medications administered to neonates who were hospitalized and admitted to the NICU over a 24-h period were recorded. The prescriptions were analyzed to determine whether the medicines were used in a licensed or unlicensed manner. Results In total, 1,315 prescriptions comprising 93 different medicines were written. We found that 62.3% of the drugs prescribed to the neonates over the 24-h period were unlicensed or off-labeled. Conclusions The present study indicates that unlicensed and off-label medicines are frequently used in preterm and term infants in Turkish NICUs. This finding is consistent and reported in other countries. We believe that the needs of the neonatal population must be a priority and access to safe and appropriate medicines requires urgent attention.
KeywordsNeonates Off-label drug Turkey Unlicensed drug
Special thanks to Esra Arun Ozer from Tepecik Training and Research Hospital, Güner Karatekin from Zeynep Kamil Maternity and Children’s Education and Training Hospital, Nurullah Okumus from Dr. Sami Ulus Maternity and Children’s Hospital, Nihal Demirel from Etlik Zubeyde Hanım Maternity and Children’s Education and Training Hospital, Seyhan Erişir Oygucu from Diyarbakır Children’s Hospital, Gokhan Buyukkale from Sanlıurfa Children’s Hospital, Murat Saygili from Urfa Maternity Hospital, Sevim Ünal from Ankara Children’s Hematology and Oncology Research Hospital,Neonatology Department, Erdal Peker from Yuzuncu Yil University School of Medicine, Department of Pediatrics, Division of Neonatology, Bilge Tanyeri from Gaziantep Children’s Hospital, Sinan Uslu from Sisli Etfal Children’s Hospital, Ahmet Karadag from İnonu University, School of Medicine Turgut Ozal Medical Center, Department of Pediatrics, Division of Neonatology, Rahmi Örs from Selcuk University, School of Medicine Meram Medical Center, Department of Pediatrics, Division of Neonatology, Esat Köklü from Trabzon Maternal and Child Health State Hospital, Hasan Kahveci from Nenehatun Maternity State Hospital, Yaşar Bildirici from Eskişehir Maternal Child Health State Hospital for their collaboration to the study, sharing information and kind support.
Conflicts of interest
All authors declare that they have no conflict of interest.
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