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PP-28 Unlicensed and off-label medication use in a paediatric and neonatal intensive care units at a single medical centre: no change over a decade
  1. Berkovitch1,
  2. Abu-Kishk2,
  3. Heyman3,
  4. Nir4
  1. 1Assaf Harofeh Medical Centre, MOSHAV BEIT OVED, Israel
  2. 2Assaf Harofeh Medical Centre, Paediatric Intensive Care Unit, ZERIFIN, Israel
  3. 3Assaf Harofeh Medical Centre, Neonatal Intensive Care Unit, ZERIFIN, Israel
  4. 4Assaf Harofeh Medical Centre, Clinical Pharmacology Unit, ZERIFIN, Israel


Background Many of the prescribed medications to hospitalised children are off-label and/or unlicensed. To determine the extent of unlicensed and off-label medi-cation use in the NICU and PICU at one medical centre and to compare it to a study performed in the same units thirteen years ago.

Methods All drugs prescribed to patients admitted to the NICU/PICU, during 2 months of observation, were prospectively recorded and classified as licensed, un-licensed or off-label, according to their license status, indication, age, prescribed dose, frequency and way of administration specified in each specific marketing au-thorization.

Results NICU: 134 patients were included. 1069 prescrip-tions for 49 medications were prescribed: 312 (29.2%)-li-censed. 63 (5.9%)-unlicensed and 693 (64.8%)-off-label. 23.9% of the patients received at least one unlicensed medication and 96.3% received at least one off-label medication. thirteen years ago, 16% of the prescription were unlicensed, 63% off-label and 93% of the patients received at least one unlicensed/off-label medication.

PICU: 56 patients were included. 388 prescriptions for 75 medications were prescribed. 205 (52%)-licensed, 13 (3.4%)-unlicensed, 170 (43.8%)-off-label. 86.8% of patients received at least one off-label medication, and 88.7% received at least one unlicensed/off-label medi-cation. 13 years ago, none of the medication prescribed were unlicensed, 41% were off-label and 90.5% of the pa-tients received at least one off-label medication.

Conclusion There is high prevalence of unlicensed and off-label drug use in a PICU and NICU. After thirteen years, despite regulatory efforts, the prevalence of unapproved medications is still high.

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