Adverse drug reactions and off-label and unlicensed medicines in children: a nested case-control study of inpatients in a paediatric hospital
نویسندگان
چکیده
1 Department of Women’s and Children’s Health, University of Liverpool, First Floor, Liverpool Women's Hospital, Crown Street, Liverpool, L8 7SS, UK 2 Department of Biostatistics, University of Liverpool, Shelley's Cottage, Brownlow Street, Liverpool, L69 3GS, UK 3 Research and Development, Alder Hey Children’s NHS Foundation Trust, Eaton Road, Liverpool, L12 2AP, UK, 4 Oncology Unit, Alder Hey Children’s NHS Foundation Trust, Eaton Road, Liverpool, L12 2AP, UK 5 Institute of Child Health, University College London, 30 Guilford Street, London, WC1N 1EH, UK 6 Department of Molecular and Clinical Pharmacology, Ashton Street, Liverpool, L69 3GE, UK
منابع مشابه
European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use
Very few publications specifically address the issue of off label and/or unlicensed medicines. Underreporting is the case for paediatric adverse drug reactions (ADR’s) as for adults, but may be even more common for unlicensed, off-label medicines. In contrast to spontaneous reporting, prospective monitoring of ADR’s indicates higher incidence and in particular shows up to double incidence when ...
متن کاملAdverse drug reactions and off-label and unlicensed medicines in children: a nested case?control study of inpatients in a pediatric hospital
BACKGROUND Off-label and unlicensed (OLUL) prescribing has been prevalent in pediatric practice. Using data from a prospective cohort study of adverse drug reactions (ADRs) among pediatric inpatients, we aimed to test the hypothesis that OLUL status is a risk factor for ADRs. METHODS A nested case?control study was conducted within a prospective cohort study. Details of all medicines administ...
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OBJECTIVE To determine the extent of use in children in hospital of drugs that are not specifically licensed for use in children (unlicensed) and of drugs that are used outside the terms of their product licence that apply to indication, age, dose, or route of administration (off label). DESIGN Prospective study of drugs administered on paediatric medical and surgical wards for 13 weeks. SE...
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I Hill P. Ofl'Iicense and oil label prescribing in children: litigation fears for physicians. Arch Do Child 2005;90:17-5. 2 Conroy S. Choonara 1, Impicciatore P, Mohn A, Arnell H, Rane A, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries BAf/ 2000; 320:7 9-52. 3 McIntyre I, Conroy 5, Avery A, Corns H, Choonara I Unlicensed and off lapel prescribing of ...
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