Evidence-based medicines for children: Important implications for new therapies at all ages

European Respiratory Journal

Volumn 28, Issue 6, 2006, Pages 1069-1072

  Bush, A ^a  

^a ROYAL BROMPTON HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIPYRETIC AGENT; BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; CORTICOSTEROID; DRUG; NEW DRUG; STEROID; TGN 1412;

CLINICAL TRIAL; DRUG FATALITY; DRUG LEGISLATION; DRUG OVERDOSE; DRUG USE; EDITORIAL; EUROPEAN UNION; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE FACILITY; HEALTH PRACTITIONER; HUMAN; MEDICAL ETHICS; MEDICAL RESEARCH; MEDICAL SOCIETY; PATENT; PEDIATRICS; PRESCRIPTION; PRIORITY JOURNAL; RESEARCH ETHICS; SAMPLE SIZE; WHEEZING;

CHILD; EVIDENCE-BASED MEDICINE; HUMANS; LUNG DISEASES; PHARMACEUTICAL PREPARATIONS; PRACTICE GUIDELINES;

EID: 33845353293     PISSN: 09031936     EISSN: None     Source Type: Journal    
DOI: 10.1183/09031936.00116306     Document Type: Editorial

References (41)

1. Turner S, Nunn AJ, Fielding K, Choonara I. Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: a prospective study. Acta Pediatr 1999; 88: 965-968.
2. Conroy S, Choonara I, Impicciatore P, et al. Survev 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. McIntyre J, Conroy S, Avery A, Corns H, Choonara I. Unlicensed and off label prescribing of drugs in general practice. Arch Dis Child 2000; 83: 498-501.
4. Lifshitz M, Gavrilov Y, Gorodischer R. Off-label and unlicensed use of antidotes in paediatric patients. Eur J Cin Pharmacol 2001; 56: 839-841.
5. 't Jong GW, Yulto AG, de Hoog M, et al. A survey of the use of off-label and unlicensed drugs in a Dutch children's hospital. Pediatrics 2001; 108: 1089-1093.
6. Craig JS, Henderson CR, Magee FA. The extent of unlicensed and off-label drug use in the paediatric ward of a district general hospital in Northern Ireland. Ir Med J 2001; 94: 237-240.
7. Pandolfini C, Impicciatore P, Provasi D, et al. Off-label use of drugs in Italy: a prospective, observational and multi-centre study. Acta Paediatr 2002; 91: 339-347.
8. 't Jong GW, van der Linden PD, Bakker EM, et al. Unlicensed and off-label drug use in a paediatric ward of a general hospital in the Netherlands. Eur J Clin Pharmacol 2002; 58: 293-297.
9. O'Donnell CP, Stone RJ, Morley CJ. Unlicensed and off-label drug use in an Australian neonatal intensive care unit. Pediatrics 2002; 110: e52.
10. Horen B, Montastruc JL, Lapeyre-Mestre M. Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol 2002; 54: 665-670.
11. Schirm E, Tobi H, de Jong-van den Berg LT. Risk factors for unlicensed and off-label drug use in children outside the hospital. Pediatrics 2003; 111: 291-295.
12. 't Jong GW, Eland IA, Sturkenboorn MC,van den Anker JN, Stricker BH. Determinants for drug prescribing to children below the minimum licensed age. Eur J Clin Pharmacol 2003; 58: 701-705.
13. Dick A, Keady S, Mohamed F, et al. Use of unlicensed and off-label medications in paediatric gastroenterology with a review of the commonly used formularies in the UK. Aliment Pharmacol Ther 2003; 15: 571-575.
14. Neubert A, Dormann H, Weiss J, et al. The impact of unlicensed and off-label drug use on adverse drug reactions in paediatric patients. Drug Saf 2004; 27: 1059-1067.
15. Hay AD, Redmond M, Fletcher M. Antipyretic drugs for children. BMJ 2006; 333: 4-5.
16. Doull IJ, Freezer NJ, Holgate ST. Growth of prepubertal children with mild asthma treated with inhaled beclo-methasone dipropionate. Am J Respir Crit Care Med. 1995; 151: 1715-1719.
17. Doull IJ, Campbell MJ, Holgate ST. Duration of growth suppressive effects of regular inhaled corticosteroids, Arch Dis Child 1998; 78: 172-173.
18. Thibeault DW, Heimes B, Rezaiekhaligh M, Mabry S. Chronic modification of lung and heart development in glucocorticoid treated newborn rats exposed to hyperoxia or room air. Pediatr Pulmonol 1993; 16: 81-88.
19. Tschanz SA, Damke BM, Burri PH. Influence of postnatally administered glucocorticoids on rat lung growth, Biol Neonate 1995; 68: 229-245.
20. Saglani S, Malmström K, Pelkonen AS, et al. Airway remodeling and inflammation in symptomatic infants with reversible airflow obstruction. Am J Respir Crit Care Med 2005; 171: 722-727.
21. Lodrup-Carlsen KC, Jaakkola JJ, Nafstad P, Carlsen KH. In utero exposure to cigarette smoking influences lung function at birth. Eur Respir J 1997; 10: 1774-1779.
22. Stick SM, Burton PR, Gurrin L, Sly PD, Le Souëf PN. Effects of maternal smoking during pregnancy and a family history of asthma on respiratory function in newborn infants. Lancet 1996; 348: 1060-1064,
23. Young S, Le Souëf PN, Geelhoed GC, Stick SM, Turner KJ, Landau LI. The influence of a family history of asthma and parental smoking on airway responsiveness in early infancy. N Engl J Med 1991; 324: 1166-1173.
24. Stevenson EC, Turner G, Heaney LG, et al. Bronchoalveolar lavage findings suggest two different forms of childhood asthma. Clin Exp Allergy 1997; 27: 1027-1035.
25. Stick S, Arnott J, Landau LI, Turner D, Sly S, Le Souëf P. Bronchial responsiveness and lung function in recurrently wheezy infants. Am Rev Respir Dis 1991; 144: 1012-1015.
26. Turner SW, Young S, Landau LI, Le Souëf PN. Reduced lung function both before bronchiolitis and at 11 years. Arch Dis Child 2002; 87: 417-420.
27. Stein RT, Sherrill D, Morgan WJ, et al. Respiratory syncytial virus in early life and risk of wheeze and allergy by age 13 years. Lancet 1999; 354: 541-545.
28. Pelkonen AS, Hakulinen AL, Turpeinen M. Bronchial lability and responsiveness in school children born very preterm. Am J Respir Crit Care Med 1997; 156: 1178-1184.
29. Gappa M, Berner MM, Hohenschild S, Dammann CE, Bartmann P. Pulmonary function at school-age in surfactant-treated preterm infants. Pediatr Pulmonol 1999; 27:191-198.
30. Medicines for Children. London, RCPCH, 2003.
31. BNF for Children. London, BMJ Publishing Group, 2005.
32. Morgan WJ, Stern DA, Sherrill DL, et al. Outcome of asthma and wheezing in the first 6 years of life: follow-up through adolescence. Am J Respir Crit Care Med 2005; 172: 1253-1258.
33. McIntosh N, Bates P, Brykczynska G, et al. Guidelines for the ethical conduct of medical research involving children. Arch Dis Child 2000; 82: 177-182.
34. US Food and Drug Aministration. The Pediatric Research Equity Act. Public Law 108-155 December 3 2003. www.fda.gov/cder/pediatric/ S-650-PREA.pdf.
35. Watson R. EU offers incentives to firms to produce medicines for children. BMJ 2006; 332: 1352.
36. Clinical trials in children for children, Lancet 2006; 367: 1953.
37. Smith R. Conflicts of interest: how money clouds objectivity. J Roy Soc Med 2006; 99: 292-297.
38. Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA 2003; 289: 454-465.
39. European Respiratory Society. European Lung White Book. Sheffield, ERSJ Ltd, 2003.
40. Bush A. Strategies for effective collaboration between investigator sites and the pharmaceutical industry in pediatrics. Pediatric Drugs 2006; (in press).
41. Paediatric research should take centre stage, Lancet 2004; 364: 732.