Acta Pædiatrica ISSN 0803-5253
REGULAR ARTICLE
Unlicensed and off-label drug use in an Irish neonatal intensive care unit: a prospective cohort study Emily A Kieran ([email protected])1,2,3, Noreen O’Callaghan4, Colm PF O’Donnell1,2,3 1.Department of Neonatology, The National Maternity Hospital, Dublin, Ireland 2.National Children’s Research Centre, Dublin, Ireland 3.School of Medicine and Medical Science, University College Dublin, Dublin, Ireland 4.Department of Pharmacy, The National Maternity Hospital, Dublin, Ireland
Keywords Drug, Infant, Neonatal Intensive Care Unit, Newborn, Off-label, Unlicensed Correspondence Emily Kieran, Department of Neonatology, The National Maternity Hospital, Holles Street, Dublin 2, Ireland. Tel: +353 1 6373100 | Fax: +353 1 6614623 | Email: [email protected] Received 18 June 2013; revised 29 October 2013; accepted 11 December 2013. DOI:10.1111/apa.12541
ABSTRACT Aim: Many drugs are not licensed for use in children and drugs that are licensed may be given to them in an unapproved manner. We wanted to determine the extent of unlicensed and off-label prescribing in our neonatal intensive care unit (NICU). Methods: All infants admitted to our tertiary-level NICU over 2 months were prospectively studied. We recorded demographic data, and all the drugs prescribed and compared the use of each drug to the licensed indications in the Summary of Product Characteristics. Results: All the 110 infants admitted received a prescribed drug, with 69 different drugs prescribed, a median (IQR) of four (range: 3–11) drugs each. Just less than a fifth (19%) were unlicensed and 39% were off-label, with 45 infants (44%) receiving both an unlicensed and off-label drug, three (3%) receiving an unlicensed drug and 35 (32%) receiving just an off-label drug. Most infants
REGULAR ARTICLE
Unlicensed and off-label drug use in an Irish neonatal intensive care unit: a prospective cohort study Emily A Kieran ([email protected])1,2,3, Noreen O’Callaghan4, Colm PF O’Donnell1,2,3 1.Department of Neonatology, The National Maternity Hospital, Dublin, Ireland 2.National Children’s Research Centre, Dublin, Ireland 3.School of Medicine and Medical Science, University College Dublin, Dublin, Ireland 4.Department of Pharmacy, The National Maternity Hospital, Dublin, Ireland
Keywords Drug, Infant, Neonatal Intensive Care Unit, Newborn, Off-label, Unlicensed Correspondence Emily Kieran, Department of Neonatology, The National Maternity Hospital, Holles Street, Dublin 2, Ireland. Tel: +353 1 6373100 | Fax: +353 1 6614623 | Email: [email protected] Received 18 June 2013; revised 29 October 2013; accepted 11 December 2013. DOI:10.1111/apa.12541
ABSTRACT Aim: Many drugs are not licensed for use in children and drugs that are licensed may be given to them in an unapproved manner. We wanted to determine the extent of unlicensed and off-label prescribing in our neonatal intensive care unit (NICU). Methods: All infants admitted to our tertiary-level NICU over 2 months were prospectively studied. We recorded demographic data, and all the drugs prescribed and compared the use of each drug to the licensed indications in the Summary of Product Characteristics. Results: All the 110 infants admitted received a prescribed drug, with 69 different drugs prescribed, a median (IQR) of four (range: 3–11) drugs each. Just less than a fifth (19%) were unlicensed and 39% were off-label, with 45 infants (44%) receiving both an unlicensed and off-label drug, three (3%) receiving an unlicensed drug and 35 (32%) receiving just an off-label drug. Most infants
