Public awareness and views on unlicensed use of medicines in children

British Journal of Clinical Pharmacology

Volumn 66, Issue 6, 2008, Pages 838-845

  Mukattash, T L ^a   Millership, J S ^a   Collier, P S ^a   McElnay, J C ^a  

^a QUEEN'S UNIVERSITY BELFAST   (United Kingdom)

Author keywords

Children; Clinical trials; Consent; Off label medicines; Unlicensed medicines

Indexed keywords

ARTICLE; AWARENESS; CHILD CARE; CHILD HEALTH; CLINICAL RESEARCH; DRUG USE; HEALTH STATUS; HUMAN; INFORMED CONSENT; INTERVIEW; LICENSING; MEDICAL PRACTICE; OFF LABEL DRUG USE; OUTCOME ASSESSMENT; PATIENT PARTICIPATION; PRESCRIPTION; PRIORITY JOURNAL; QUESTIONNAIRE;

ADOLESCENT; ADULT; BIOMEDICAL RESEARCH; CHILD; CHILD WELFARE; DRUG MONITORING; FEMALE; HEALTH CARE SURVEYS; HUMANS; MALE; MIDDLE AGED; NORTHERN IRELAND; PARENTS; PHARMACEUTICAL PREPARATIONS; PILOT PROJECTS; QUESTIONNAIRES; YOUNG ADULT;

EID: 56549105528     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2008.03290.x     Document Type: Article

References (31)

1. Shirkey H. Editorial comment: identification of prescribed drugs on the label of the container. J Pediatr 1967 71 : 592 4.
2. Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A, Knoeppel C, Seyberth H, Pandolfini C, Raffaelli M, Rocchi F, Bonati M, Jong T, Anker J. Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children. BMJ 2000 320 : 79 82.
3. Conroy S, Newman C, Gudka S. Unlicensed and off label drug use in acute lymphoblastic leukaemia and other malignancies in children. Ann Oncol 2003 14 : 42 7.
4. Conroy S, McIntyre J, Choonara I. Unlicensed and off label drug use in neonates. Arch Dis Child Fetal Neonatal Ed 1999 80 : 142 5.
5. Conroy S, McIntyre J. The use of unlicensed and off-label medicines in the neonate. Semin Fetal Neonatal Med 2005 10 : 115 22.
6. Royal College of Paediatrics. Medicines for Children. London : RCPCH, 1999.
7. Joint Formulary Committee. British National Formulary for Children, 1st edn. London : British Medical Association and Royal Pharmaceutical Society of Great Britain, 2005.
8. Fernandez CV, Gillis-Ring J. Strategies for the prevention of medical errors in pediatrics. J Pediatr 2003 143 : 155 62.
9. Fortescue EB, Kaushal R, Landrigan PC, McKenna KJ, Clapp MD, Federico F, Goldmann DA, Bates DW. Prioritizing strategies for preventing medication errors and adverse drug events in pediatric inpatients. Pediatrics 2003 111 : 722 9.
10. Collier J. Paediatric prescribing: using unlicensed drugs and medicines outside their licensed indications. Br J Clin Pharmacol 1999 48 : 5 8.
11. Essex C, Rylance G. Children have rights to medicines. BMJ 1997 316 : 62.
12. Wong I, Sweis D, Cope J, Florence A. Paediatric medicines research in the UK: how to move forward? Drug Saf 2003 26 : 529 37.
13. Horen B, Montastruc JL, Lapeyre-Mestre M. Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol 2002 54 : 665 70.
14. Impicciatore P, Choonara I, Clarkson A, Provasi D, Pandolfini C, Bonati M. Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. Br J Clin Pharmacol 2001 52 : 77 83.
15. Turner S, Longworth A, Nunn AJ, Choonara I. Unlicensed and off label drug use in paediatric wards: prospective study. BMJ 1998 316 : 343 5.
16. Impicciatore P, Choonara I. Status of new medicines approved by the European Medicines Evaluation Agency regarding paediatric use. Br J Clin Pharmacol 1999 48 : 15 8.
17. Aynsley-Green A, Barker M, Burr S, Macfarlane A, Morgan J, Sibert J, Turner T, Viner R, Waterston V, Hall D. Who is speaking for children and adolescents and for their health at the policy level? BMJ 2000 321 : 229 32.
18. Parliament UK. Medicines (Children). House Commons Hansard Debate 1999 329 : 329.
19. Kmietowicz Z. Drug industry is unwilling to run trials in children. BMJ 2000 320 : 1362.
20. Zachry WM III., Ginsburg DB. Patient autonomy and the regulation of direct-to-consumer advertising. Clin Ther 2001 2024 : 2022 3.
21. Sweis D, Wong IC. Giving medicines to children: understanding the parents' views. Paediatr Drugs 2004 6 : 67 9.
22. Wazaify M, Shields E, Hughes CM, McElnay JC. Societal perspectives on over-the-counter (OTC) medicines. Fam Pract 2005 22 : 170 6.
23. Bell H, Hughes C, McElnay JC. Societal perspectives on the role of the community pharmacist and community-based pharmaceutical services. J Soc Adm Pharm 2000 17 : 119 28.
24. Ekins-Daukes S, Helms PJ, Taylor MW, McLay JS. Off-label prescribing to children: attitudes and experience of general practitioners. Br J Clin Pharmacol 2005 60 : 145 9.
25. Stewart D, Rouf A, Snaith A, Elliott K, Helms PJ, McLay JS. Attitudes and experiences of community pharmacists towards paediatric off-label prescribing: a prospective survey. Br J Clin Pharmacol 2007 60 : 90 5.
26. Fraenkel L, McGraw S. Participation in medical decision making: the patients' perspective. Med Decis Making 2007 27 : 553 8.
27. St Clair EW. The calm after the cytokine storm: lessons from the TGN1412 trial. J Clin Invest 2008 118 : 1344 7.
28. Bluebond-Langner M, Belasco JB, Goldman A. Understanding parents' approaches to care and treatment of children with cancer when standard therapy has failed. J Clin Oncol 2007 25 : 2414 9.
29. Clinical trials are proven to offer children with cancer the best chance of survival. Available at http://www.seattlecca.org/patientsandfamilies/ WhatAreClinicalTrials/ChildrenClinicalTrials/ (last accessed: 29 September 2007).
30. Peden V, Choonara I, Gennery B, Done H. Recruiting children to a clinical trial. Paediatric and Perinatal Drug Therapy 2000 4 : 75 8.
31. Sammons HM, Atkinson M, Choonara I, Stephenson T. What motivates British parents to consent for research? A questionnaire study. BMC Pediatr 2007 7 : 12.