Farmacoriflessioni
Farmaci e utilizzo “wrong-label” in pediatria. L’esempio del paracetamolo, del salbutamolo e dell’amoxicillina
WRONG-LABEL DRUG USE IN PAEDIATRICS: THE EXAMPLES OF ACETAMINOPHEN, SALBUTAMOL AND AMOXICILLIN
INES L’ERARIO, ANNA DI BENEDETTO, JENNY BUA, STEFANIA NORBEDO, EGIDIO BARBI, FEDERICO MARCHETTI
Clinica Pediatrica, IRCCS “Burlo Garofolo”, Trieste
Novembre 2007 - pagg. 580 -585
Abstract
Two thirds of the drugs prescribed for children are off-label. However, off-label is not synonymous with incorrect, since it often represents the most rational, evidence-based therapy. One aspect of the off-label problem in paediatrics depends on the lack of updating the drugs specific Summary Product Characteristics (SPC). This is a frequent problem in Italy. The Authors give the example of three of the most commonly prescribed drugs in paediatrics (acetaminophen, salbutamol and amoxicillin), the SPC which recommends wrong dosages compared to those based on the to-date evidence and recommended by clinical guidelines (“wrong-label”). Reviewing and updating of SPC should be one of the priorities to tackle the off-label problem in the Italian reality.
Classificazione MeSH
Bibliografia
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30. Hazir T, Qazi SA, Bin Nisar Y, et al. Comparison of standard versus double dose of amoxicillin in the treatment of non-severe pneumonia in children aged 2-59 months: a multi-centre, double blind, randomised controlled trial in Pakistan. Arch Dis Child 2007; 2(4):291-7.
31. AIFA. Fogli illustrativi dei farmaci. Bif 2006;3:134-5.
32. Regolamento (CE) n. 1901/2006 del Parlamento Europeo e del Consiglio 12/12/2006 relativo ai medicinali per uso pediatrico e che modifica il regolamento (CEE) n. 1768/92, la direttiva 2001/20/CE, la direttiva 2001/83/CE e il regolamento (CE) n. 726/2004. Gazzetta Ufficiale dell’Unione Europea 27/12/2006 (accessibile dal sito http://eur-lex.europa.eu/ LexUriServ/site/it/oj/2006/l_378/l_3782006 1227it00010019.pdf)
33. Marchetti F, Bua J, Demarini S, et al. Le prioritŕ associate all’uso dei farmaci “off-label”. Il punto di vista del pediatra ospedaliero. Medico e Bambino 2005;24:527-31.
2. Waller DG. Off-label and unlicensed prescribing for children: have we made any progress? Br J Clin Pharmacol 2007;64(1):1-2.
3. Conroy S, Choonara I, Impacciatore P, et al. Survey of unlicensed and off label drugs use in pae-diatric wards in European countries. BMJ 2000;320:79-82.
4. Pandolfini C, Bonati M. A literature review on off-label drug use in children. Eur J Pediatr 2005;164:552-58.
5. Pandolfini C, Impicciatore P, Provasi D, Rocchi F, Campi R, Bonati M and the Italian Paediatric Off-label Collaborative Group. Off-label use of drugs in Italy: a prospective, observational and multicentre study. Acta Paediatr 2002;91:339-47.
6. Hill P. Off licence and off label prescribing in children: litigation fears for physicians. Arch Dis Child 2005;90 Suppl 1:i17-8.
7. AIFA. Il foglietto illustrativo: tra strumento comunicativo e documento regolatorio. Bif 2004;2:51-6.
8. Ministero della Salute. Guida all’uso dei farmaci per i bambini. Roma: Istituto Poligrafico e Zecca dello Stato, 2003.
9. BNF for Children. London: BMJ Publishing Group, 2006.
10. Marchetti F, Bua J, Maschio M, Barbi E. Il trattamento sintomatico della febbre e del dolore nella pratica ambulatoriale. Medico e Bambino 2004;24:47-54.
11. Mahadenevan SD. McKiernan PJ, Kelly DA. Paracetamol induced epatotoxicity. Arch Dis Child 2006;91:598-603.
12. Davanzo F, Settimi L, Sesana F, et al. Esposizioni a paracetamolo nei bambini: i dati del Centro Antiveleni di Milano. Bif 2007;2:69-73.
13. Berde CB, Sethna NF. Analgesics for the treatment of pain in children. N Engl J Med 2002;347(14):1094-103.
14. Heubi JE, Barbacci MB, Zimmerman HJ. Therapeutic misadventures with acetaminophen: he-patotoxicity after multiple doses in children. J Pediatr 1998;132(1):22-7.
15. Global Iniziative for Asthma. Global strategy for asthma management and prevention (GINA). National Heart, Lung and Blood Institute/ WHO Workshop Report 2002.
16. Barbi E, Petaros P, Lenhardt A, Longo G. Salbutamolo e cortisonici nell’accesso acuto d’asma: tutto scontato ma non troppo. Medico e Bambino 2004;23:559-65.
17. Kelly AM, Powell C, Kerr D. Patients with a longer duration of symptoms of acute asthma are more likely to require admission to hospital. Emerg Med 2002;14(2):142-5.
18. Delgado A, Chou KJ, Silver EJ, Crain EF. Nebulizer vs metered-dose inhalers with spacers for bronchodilator therapy to treat wheezing in children aged 2 to 24 mounth in a pediatric emer-gengy department. Arch Pediatr Adolesc Med 2003;157(1):76-80.
19. Castro-Rodriguez JA, Rodrigo G. Beta-agonist through metered-dose inhaler with valved hold-ing chamber vs nebulizer for acute exacerbation of wheezing or asthma in children under 5 years of age: a systematic review with meta-analysis. J Pediatr 2004;145:172-7.
20. Bergamini M, Bussi R, Bozzetti R, et al. Una vecchia “conoscenza” (la faringotonsillite) e i nuovi dubbi: trattare o non trattare. Medico e Bambino 2006;25:570-5.
21. American Academy of Pediatrics. Clinical Practice Guideline: Management of Sinusitis. Pediat-rics 2001;108(3):798-808.
22. American Academy of Pediatrics Subcommittee on Management of Acute Otitis Media. Dia-gnosis and management of acute otitis media. Pediatrics 2004;113:1451–65.
23. Garrison GD, Sorum PC, Hioe W, Miller MM. High-dose versus standard-dose amoxicillin for acute otitis media. Ann Pharmacother 2004;38(1):15-9.
24. Garbutt J, Rosenbloom I, Wu J, Storch GA. Empiric first-line antibiotic treatment of acute oti-tis in the era of the heptavalent pneumococcal conjugate vaccine. Pediatrics 2006;117 (6):e1087-94.
25. Garbutt J, St Geme JW 3rd, May A, Storch GA, Shackelford PG. Developing communityspecific recommendations for first-line treatment of acute otitis media: is high-dose amoxicillin necessary? Pediatrics 2004;114(2):342-7.
26. Schrag SJ, Pena C, Fernandez J, et al. Effect of short-course, high-dose amoxicillin therapy on resistant pneumococcal carriage: a randomized trial. JAMA 2001;286(1):49-56.
27. Marchetti F, Ronfani L, Conti Nibali S, Tamburlini G. Delayed Prescription May Reduce the Use of Antibiotics for Acute Otitis Media. Arch Pediatr Adolesc Med 2005;159: 679-84.
28. Rovers MM, Glasziou P, Appelman CL, et al. Antibiotics for acute otitis media: a metaanalysis with individual patient data. Lancet 2006;368(9545):1429-35.
29. British Thoracic Society of Standards of Care Committee. BTS Guidelines for the Management of Community Acquired Pneumonia in Childhood. Thorax 2002;57:1-24.
30. Hazir T, Qazi SA, Bin Nisar Y, et al. Comparison of standard versus double dose of amoxicillin in the treatment of non-severe pneumonia in children aged 2-59 months: a multi-centre, double blind, randomised controlled trial in Pakistan. Arch Dis Child 2007; 2(4):291-7.
31. AIFA. Fogli illustrativi dei farmaci. Bif 2006;3:134-5.
32. Regolamento (CE) n. 1901/2006 del Parlamento Europeo e del Consiglio 12/12/2006 relativo ai medicinali per uso pediatrico e che modifica il regolamento (CEE) n. 1768/92, la direttiva 2001/20/CE, la direttiva 2001/83/CE e il regolamento (CE) n. 726/2004. Gazzetta Ufficiale dell’Unione Europea 27/12/2006 (accessibile dal sito http://eur-lex.europa.eu/ LexUriServ/site/it/oj/2006/l_378/l_3782006 1227it00010019.pdf)
33. Marchetti F, Bua J, Demarini S, et al. Le prioritŕ associate all’uso dei farmaci “off-label”. Il punto di vista del pediatra ospedaliero. Medico e Bambino 2005;24:527-31.
Corrispondenza: marchetti@burlo.trieste.it