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Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 J+Pharm+Pharmacol 2017 ; 69 (4): 432-8 Nephropedia Template TP
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Off?label and unlicensed medicines to hospitalised children in Norway #MMPMID27334565
Teigen A; Wang S; Truong BT; Bjerknes K
J Pharm Pharmacol 2017[Apr]; 69 (4): 432-8 PMID27334565show ga
Objectives: The aim of this study was to investigate the use of off?label (OL) and unlicensed (UL) medicines to hospitalised children in Norway, to add to the current knowledge on use of medicines in this vulnerable patient group. Methods: The study was performed as a cross?sectional prospective study. Medication was classified as on? or off?label based on the comparison with the SmPC regarding age, indication, dosage, route of administration and handling of the product. UL products were classified as imported or pharmacy produced. Key findings: More than 90% of children receiving medicines in our study were given OL or UL medicines. More patients received OL (83%) than UL (59%). Route of administration was the most frequently observed OL category. The vast majority of the OL prescriptions were for ?off?patent? products. One?third of products prescribed were UL. Conclusions: The study confirms that medicines to children in hospital to a significant degree are being used outside or without authorisation, in spite of recent paediatric regulatory initiatives. More data are still needed on efficacy and safety of medicines used in children, data to be incorporated in the SmPC. In addition, suitable formulations are needed to ensure optimal dosing and adherence without risky manipulations.