Frequency of the off-label use of antibiotics in clinical practice: A systematic review

Expert Review of Anti-Infective Therapy

Volumn 10, Issue 12, 2012, Pages 1383-1392

  Tansarli, Giannoula S ^a   Rafailidis, Petros I ^a,b   Kapaskelis, Anastasios ^a   Falagas, Matthew E ^a,b,c  

^a ALFA INSTITUTE OF BIOMEDICAL SCIENCES AIBS   (Greece)

^b HENRY DUNANT HOSPITAL   (Greece)

^c TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

anti infective; antibacterial; antibiotic; antimicrobial; clinical; frequency; off label; unapproved; unlicensed

Indexed keywords

AMIKACIN; AMOXICILLIN; AMOXICILLIN PLUS CLAVULANIC ACID; AMPICILLIN; ANTIBIOTIC AGENT; AZITHROMYCIN; CEFOTAXIME; CEFTAZIDIME; CEFTRIAXONE; CLARITHROMYCIN; COTRIMOXAZOLE; FLUCLOXACILLIN; GENTAMICIN; LINEZOLID; NITROFURANTOIN; OFLOXACIN; PENICILLIN G; TELITHROMYCIN; TIGECYCLINE; TOBRAMYCIN; TRIMETHOPRIM; VANCOMYCIN;

AGE; CHILD CARE; CLINICAL PRACTICE; COHORT ANALYSIS; CROSS-SECTIONAL STUDY; DRUG EFFICACY; DRUG SAFETY; EVIDENCE BASED MEDICINE; GASTROINTESTINAL DISEASE; HUMAN; INFECTION; INTENSIVE CARE; LUNG TUBERCULOSIS; OFF LABEL DRUG USE; OUTPATIENT CARE; PHYSICIAN ATTITUDE; PRESCRIPTION; PROSPECTIVE STUDY; RETROSPECTIVE STUDY; REVIEW; SYSTEMATIC REVIEW; VENTILATOR ASSOCIATED PNEUMONIA;

ANTI-BACTERIAL AGENTS; DATABASES, BIBLIOGRAPHIC; DRUG UTILIZATION; HUMANS; OFF-LABEL USE; PHYSICIAN'S PRACTICE PATTERNS;

EID: 84871416002     PISSN: 14787210     EISSN: 17448336     Source Type: Journal    
DOI: 10.1586/eri.12.137     Document Type: Review

References (43)

1. Garazzino S, Tovo PA. Clinical experience with linezolid in infants and children. J. Antimicrob. Chemother. 66(Suppl. 4), iv23-iv41 (2011).
2. van Rappard DC, Limpens J, Mekkes Jr. The off-label treatment of severe hidradenitis suppurativa with TNF-α inhibitors: A systematic review. J. Dermatolog. Treat. doi:10.3109/09546634.2012.674193 (2012) (Epub ahead of print).
3. Turner S, Nunn AJ, Fielding K, Choonara I. Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: A prospective study. Acta Paediatr. 88(9), 965-968 (1999). (Pubitemid 29448261)
4. Ufer M, Kimland E, Bergman U. Adverse drug reactions and off-label prescribing for paediatric outpatients: A one-year survey of spontaneous reports in Sweden. Pharmacoepidemiol. Drug Saf. 13(3), 147-152 (2004). (Pubitemid 38332047)
5. Conroy S, Choonara I, Impicciatore P et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children. BMJ 320(7227), 79-82 (2000). (Pubitemid 30173044)
6. de Jong J, van den Berg PB, Visser ST, de Vries TW, de Jong-van den Berg LT. Antibiotic usage, dosage and course length in children between 0 and 4 years. Acta Paediatr. 98(7), 1142-1148 (2009).
7. Jain SS, Bavdekar SB, Gogtay NJ, Sadawarte PA. Off-label drug use in children. Indian J. Pediatr. 75(11), 1133-1136 (2008).
8. Lass J, Käär R, Jõgi K, Varendi H, Metsvaht T, Lutsar I. Drug utilisation pattern and off-label use of medicines in Estonian neonatal units. Eur. J. Clin. Pharmacol. 67(12), 1263-1271 (2011).
9. McIntyre J, Conroy S, Avery A, Corns H, Choonara I. Unlicensed and off label prescribing of drugs in general practice. Arch. Dis. Child. 83(6), 498-501 (2000).
10. Pandolfini C, Impicciatore P, Provasi D, Rocchi F, Campi R, Bonati M; Italian Paediatric Off-label Collaborative Group. Off-label use of drugs in Italy: A prospective, observational and multicentre study. Acta Paediatr. 91(3), 339-347 (2002). (Pubitemid 34270876)
11. Brosgart CL, Mitchell T, Charlebois E et al. Off-label drug use in human immunodeficiency virus disease. J. Acquir. Immune Defic. Syndr. Hum. Retrovirol. 12(1), 56-62 (1996).
12. Herring C, McManus A, Weeks A. Off-label prescribing during pregnancy in the UK: An analysis of 18,000 prescriptions in Liverpool Women's Hospital. Int. J. Pharm. Pract. 18(4), 226-229 (2010).
13. Rayburn WF, Turnbull GL. Off-label drug prescribing on a state university obstetric service. J. Reprod. Med. 40(3), 186-188 (1995).
14. Stone KJ, Viera AJ, Parman CL. Off-label applications for SSRIs. Am. Fam. Physician 68(3), 498-504 (2003). (Pubitemid 36962063)
15. Albaladejo P, Caillet B, Moine P, Vigué B, Decorps-Declère A, Benhamou D. [Off-label prescriptions in an adult surgical intensive care unit]. Presse Med. 30(30), 1484-1488 (2001). (Pubitemid 32999612)
16. Barr J, Brenner-Zada G, Heiman E et al. Unlicensed and off-label medication use in a neonatal intensive care unit: A prospective study. Am. J. Perinatol. 19(2), 67-72 (2002). (Pubitemid 34229581)
17. Conde-Estévez D, Grau S, Horcajada JP, Luque S. Off-label prescription of tigecycline: Clinical and microbiological characteristics and outcomes. Int. J. Antimicrob. Agents 36(5), 471-472 (2010).
18. Conroy S, McIntyre J, Choonara I. Unlicensed and off label drug use in neonates. Arch. Dis. Child. Fetal Neonatal Ed. 80(2), F142-F144; discussion F144 (1999).
19. Curcio D. Off-label use of antibiotics in hospitalized patients: Focus on tigecycline. J. Antimicrob. Chemother. 64(6), 1344-1346 (2009).
20. Curcio D, Fernández F, Cané A, Barcelona L, Stamboulian D. Indications of a new antibiotic in clinical practice: Results of the tigecycline initial use registry. Braz. J. Infect. Dis. 12(3), 198-201 (2008).
21. Curcio D, Fernández F, Duret F. [Initial use of tigecycline in Argentina]. Rev. Chilena Infectol. 24(6), 497-499 (2007).
22. Gleason PP, Walters C, Heaton AH, Schafer JA. Telithromycin: The perils of hasty adoption and persistence of off-label prescribing. J. Manag. Care Pharm. 13(5), 420-425 (2007). (Pubitemid 47162416)
23. Lat I, Micek S, Janzen J, Cohen H, Olsen K, Haas C. Off-label medication use in adult critical care patients. J. Crit. Care 26(1), 89-94 (2011).
24. Manfredi R, Nanetti A, Dal Monte P, Calza L. Increasing pathomorphism of pulmonary tuberculosis: An observational study of slow clinical, microbiological and imaging response of lung tuberculosis to specific treatment. Which role for linezolid? Braz. J. Infect. Dis. 13(4), 297-303 (2009).
25. Neubert A, Lukas K, Leis T, Dormann H, Brune K, Rascher W. Drug utilisation on a preterm and neonatal intensive care unit in Germany: A prospective, cohort-based analysis. Eur. J. Clin. Pharmacol. 66(1), 87-95 (2010).
26. Porta A, Esposito S, Menson E et al. Off-label antibiotic use in children in three European countries. Eur. J. Clin. Pharmacol. 66(9), 919-927 (2010).
27. Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch. Intern. Med. 166(9), 1021-1026 (2006).
28. Santos DB, Clavenna A, Bonati M, Coelho HL. Off-label and unlicensed drug utilization in hospitalized children in Fortaleza, Brazil. Eur. J. Clin. Pharmacol. 64(11), 1111-1118 (2008).
29. '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. 58(4), 293-297 (2002).
30. Zhou Q, Zhu LL, Yan XF, Pan WS, Zeng S. Drug utilization of clarithromycin for gastrointestinal disease treatment. World J. Gastroenterol. 14(39), 6065-6071 (2008).
31. Lifshitz M, Gavrilov V, Grossman Z et al. Unapproved prescription practices in primary pediatric clinics in Israel: A prospective analysis. Curr. Ther. Res. Clin. Exp. 63(12), 830-837 (2002). (Pubitemid 36092344)
32. 't Jong GW, Eland IA, de Hoog M, Sturkenboom M, van den Anker JN, Stricker BH. Unlicensed and off-label prescription of systemic anti-infective agents to children. Pediatr. Perinatal Drug Ther. 5(2), 71-77 (2002).
33. Gavrilov V, Lifshitz M, Levy J, Gorodischer R. Unlicensed and off-label medication use in a general pediatrics ambulatory hospital unit in Israel. Isr. Med. Assoc. J. 2(8), 595-597 (2000).
34. Dell'Aera M, Gasbarro AR, Padovano M et al. Unlicensed and off-label use of medicines at a neonatology clinic in Italy. Pharm. World Sci. 29(4), 361-367 (2007). (Pubitemid 47196657)
35. Fridkin SK, Gaynes RP. Antimicrobial resistance in intensive care units. Clin. Chest Med. 20(2), 303-16, viii (1999). (Pubitemid 29283545)
36. Rose K, Della Pasqua O. Development of paediatric medicines: Concepts and principles. Handb. Exp. Pharmacol. 205, 111-124 (2011).
37. Ceci A, Felisi M, Baiardi P et al. Medicines for children licensed by the European Medicines Agency (EMEA): The balance after 10 years. Eur. J. Clin. Pharmacol. 62(11), 947-952 (2006). (Pubitemid 44657629)
38. d'Aloja E, Paribello F, Demontis R, Müller M. Off-label drugs prescription in neonatology: A physician's duty or a medical hazardous attitude? J. Matern. Fetal. Neonatal. Med. 24(Suppl. 1), 99-100 (2011).
39. Tobin Jr. Use of pharmaceuticals 'off-label' in the neonate. Best Pract. Res. Clin. Anaesthesiol. 24(3), 451-460 (2010).
40. Davies EH, Ollivier CM, Saint Raymond A. Paediatric investigation plans for pain: Painfully slow! Eur. J. Clin. Pharmacol. 66(11), 1091-1097 (2010).
41. Giamarellou H, Poulakou G Multidrug-resistant Gram-negative infections: What are the treatment options? Drugs 69(14), 1879-1901 (2009).
42. Giménez MJ, García-Rey C, Barberán J, Aguilar L. [Clinical experience with tigecycline in the treatment of nosocomial infections caused by isolates exhibiting prevalent resistance mechanisms]. Rev. Esp. Quimioter. 22(1), 48-56 (2009).
43. Bonati M, Pandolfini C. Off-label drug use in children should be rational. Arch. Dis. Child. 96(9), 870-871 (2011).