Papers

Unlicensed and off label drug use in paediatric wards: prospective study

^a Department of Pharmacy, Alder Hey Children’s Hospital, Liverpool L12 2AP, ^b Institute of Child Health, Alder Hey Children’s Hospital

Correspondence to: Professor Imti Choonara Academic Division of Child Health, Derbyshire Children’s Hospital, Derby DE22 3NE imti.choonara@nottingham.ac.uk

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.
Setting: Regional children’s hospital.
Subjects: Paediatric inpatients in medical and surgical wards.
Main outcome measures: Comparison of the use of each drug with its product licence to determine whether the drug was used in an unlicensed or off label manner.
Results: 2013 courses of drugs were administered to 609 paediatric patients in 707 admissions. 506 (25%) of the drug courses (prescriptions) were either unlicensed (139) or off label (367) uses. In 256 (36%) of the 707 admissions patients received one or more courses of an unlicensed or off label treatment in hospital.
Conclusions: Use of drugs in an off label or unlicensed manner to treat children is widespread. Drugs are more likely to be used in an off label manner than in an unlicensed manner.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    StumbleUpon    Technorati    What's this?

Relevant Articles

Underdosing of antiretrovirals in UK and Irish children with HIV as an example of problems in prescribing medicines to children, 1997-2005: cohort study

Esse N Menson, A Sarah Walker, Mike Sharland, Carole Wells, Gareth Tudor-Williams, F Andrew I Riordan, E G Hermione Lyall, Diana M Gibb collaborative HIV paediatric study steering committee
BMJ 2006 332: 1183-1187. [Abstract] [Full Text] [PDF]

Unlicensed and off label drug use for paediatric patients

Richard M Martin, Lynda V Wilton, Ronald D Mann, Paul Steventon, Sean R Hilton, and Sharon Conroy
BMJ 1998 317: 204. [Extract] [Full Text] [PDF]

This article has been cited by other articles:

• Sammons, H (2009). Ethical issues of clinical trials in children: a European perspective. Arch. Dis. Child. 94: 474-477 [Abstract] [Full text]  
• Thomson, S. A., Tuleu, C., Wong, I. C. K., Keady, S., Pitt, K. G., Sutcliffe, A. G. (2009). Minitablets: New Modality to Deliver Medicines to Preschool-Aged Children. Pediatrics 123: e235-e238 [Abstract] [Full text]  
• Cheng, K, Masters, S, Stephenson, T, Cooke, R, Ferner, R, Ashworth, M, Nunn, A J (2008). Identification of suspected fatal adverse drug reactions by paediatricians: a UK surveillance study. Arch. Dis. Child. 93: 609-611 [Abstract] [Full text]  
• Thornton, J., Beresford, M. W., Clayton, P. (2008). Improving the evidence base for treatment of juvenile idiopathic arthritis: the challenge and opportunity facing the MCRN/ARC Paediatric Rheumatology Clinical Studies Group. Rheumatology (Oxford) 47: 563-566 [Full text]  
• Stephenson, T (2007). "Bonne Annee", "Gutes Neues Jahr"? Will 2007 be a "Happy New Year" for children's medicines in Europe?. Arch. Dis. Child. 92: 661-663 [Full text]  
• Shah, S. S., Hall, M., Goodman, D. M., Feuer, P., Sharma, V., Fargason, C. Jr, Hyman, D., Jenkins, K., White, M. L., Levy, F. H., Levin, J. E., Bertoch, D., Slonim, A. D. (2007). Off-label Drug Use in Hospitalized Children. Arch Pediatr Adolesc Med 161: 282-290 [Abstract] [Full text]  
• Balakrishnan, K., Grieve, J., Tordoff, J., Norris, P., Reith, D. (2006). Pediatric licensing status and the availability of suitable formulations for new medical entities approved in the United States between 1998 and 2002.. J Clin Pharmacol 46: 1038-1043 [Abstract] [Full text]  
• Choonara, I (2006). Improving children's medicines. Arch. Dis. Child. 91: 550-551 [Full text]  
• McLay, J S, Tanaka, M, Ekins-Daukes, S, Helms, P J (2006). A prospective questionnaire assessment of attitudes and experiences of off label prescribing among hospital based paediatricians. Arch. Dis. Child. 91: 584-587 [Abstract] [Full text]  
• Kunac, D L, Reith, D M, Kennedy, J, Austin, N C, Williams, S M (2006). Inter- and intra-rater reliability for classification of medication related events in paediatric inpatients.. Qual Saf Health Care 15: 196-201 [Abstract] [Full text]  
• Eiland, L. S., Knight, P. (2006). Evaluating the off-label use of medications in children.. Am J Health Syst Pharm 63: 1062-1065 [Full text]  
• Menson, E. N, Walker, A S., Sharland, M., Wells, C., Tudor-Williams, G., Riordan, F A. I, Lyall, E G H., Gibb, D. M, collaborative HIV paediatric study steering commit, (2006). Underdosing of antiretrovirals in UK and Irish children with HIV as an example of problems in prescribing medicines to children, 1997-2005: cohort study.. BMJ 332: 1183-1187 [Abstract] [Full text]  
• Smyth, R L, Edwards, A D (2006). A major new initiative to improve treatment for children.. Arch. Dis. Child. 91: 212-213 [Full text]  
• Zuppa, A. F., Adamson, P. C., Mondick, J. T., Davis, L. A., Maka, D. A., Narayan, M., Nicholson, C., Patel, D., Collison, K. R., Barrett, J. S. (2005). Drug Utilization in the Pediatric Intensive Care Unit: Monitoring Prescribing Trends and Establishing Prioritization of Pharmacotherapeutic Evaluation of Critically Ill Children. J Clin Pharmacol 45: 1305-1312 [Abstract] [Full text]  
• Prot, S., Fontan, J. E., Alberti, C., Bourdon, O., Farnoux, C., Macher, M. A., Foureau, A., Faye, A., Beaufils, F., Gottot, S., Brion, F. (2005). Drug administration errors and their determinants in pediatric in-patients. Int J Qual Health Care 17: 381-389 [Abstract] [Full text]  
• Sammons, H M, Naylor, C, Choonara, I, Pandolfini, C, Bonati, M (2005). Should paediatricians support the European Paediatric Clinical Trials Register?. Arch. Dis. Child. 90: 559-560 [Full text]  
• Voirol, P., Kayser, S. R, Chang, C. Y, Chang, Q L., Youmans, S. L (2004). Impact of Pharmacists' Interventions on the Pediatric Discharge Medication Process. The Annals of Pharmacotherapy 38: 1597-1602 [Abstract] [Full text]  
• 't Jong, G.W., Eland, I.A., Sturkenboom, M.C.J.M., van den Anker, J.N., Stricker, B.H.C. (2004). Unlicensed and off-label prescription of respiratory drugs to children. Eur Respir J 23: 310-313 [Abstract] [Full text]  
• Nunn, A J (2003). Making medicines that children can take. Arch. Dis. Child. 88: 369-371 [Full text]  
• Sutcliffe, A. G (2003). Testing new pharmaceutical products in children. BMJ 326: 64-65 [Full text]  
• Boos, J. (2003). Off label use--label off use?. Ann Oncol 14: 1-5 [Full text]  
• Conroy, S., Newman, C., Gudka, S. (2003). Unlicensed and off label drug use in acute lymphoblastic leukaemia and other malignancies in children. Ann Oncol 14: 42-47 [Abstract] [Full text]  
• Guiton, S, Reith, D. M, Isitt, V. L (2002). Off label prescribing in children. BMJ 325: 338-338 [Full text]  
• 't Jong, G. W., Vulto, A. G., de Hoog, M., Schimmel, K. J. M., Tibboel, D., van den Anker, J. N. (2001). A Survey of the Use of Off-Label and Unlicensed Drugs in a Dutch Children's Hospital. Pediatrics 108: 1089-1093 [Abstract] [Full text]  
• Padkin, A., Rowan, K., Black, N. (2001). Using high quality clinical databases to complement the results of randomised controlled trials: the case of recombinant human activated protein C. BMJ 323: 923-926 [Full text]  
• Stephenson, T (2001). Current topic: Medicines for children{---}the last century and the next. Arch. Dis. Child. 85: 177-179 [Full text]  
• (2001). . Arch. Dis. Child. 84: 0-0 [Full text]  
• Clarkson, A, Ingleby, E, Choonara, I, Bryan, P, Arlett, P (2001). A novel scheme for the reporting of adverse drug reactions. Arch. Dis. Child. 84: 337-339 [Abstract] [Full text]  
• McIntyre, J, Conroy, S, Avery, A, Corns, H, Choonara, I (2000). Unlicensed and off label prescribing of drugs in general practice. Arch. Dis. Child. 83: 498-501 [Abstract] [Full text]  
• Chalumeau, M, Tréluyer, J M, Salanave, B, Assathiany, R, Chéron, G, Crocheton, N, Rougeron, C, Mares, M, Bréart, G, Pons, G (2000). Off label and unlicensed drug use among French office based paediatricians. Arch. Dis. Child. 83: 502-505 [Abstract] [Full text]  
• Stephenson, T. (2000). Current topic: Implications of the Crown Report and nurse prescribing. Arch. Dis. Child. 83: 199-202 [Full text]  
• Conroy, S., Choonara, I., Impicciatore, P., Mohn, A., Arnell, H., Rane, A., Knoeppel, C., Seyberth, H., Pandolfini, C., Raffaelli, M. P., Rocchi, F., Bonati, M., Jong, G.`t, de Hoog, M., van den Anker, J. (2000). Survey of unlicensed and off label drug use in paediatric wards in European countries. BMJ 320: 79-82 [Abstract] [Full text]  
• HEY, E (2000). Unlicensed and off label drug use in neonates • Editors' comments. Arch. Dis. Child. Fetal Neonatal Ed. 82: 77F-77 [Full text]  
• Sutcliffe, A. G (1999). Prescribing medicines for children. BMJ 319: 70-71 [Full text]  
• Conroy, S., McIntyre, J., Choonara;, I., HULL, P. S. D. (1999). Unlicensed and off label drug use in neonates • Commentary. Arch. Dis. Child. Fetal Neonatal Ed. 80: 142F-145 [Abstract] [Full text]  
• Martin, R. M, Wilton, L. V, Mann, R. D, Steventon, P., Hilton, S. R, Conroy, S. (1998). Unlicensed and off label drug use for paediatric patients. BMJ 317: 204-204 [Full text]