Table 1 Summary of the studies reporting off-label medicines use and specifying respiratory off-label use
From: Off-label prescribing for allergic diseases in children
| Â | Off-label% | ||||||||
|---|---|---|---|---|---|---|---|---|---|
Reference | Country | Setting | Study design* | Age | No patients | No Prescriptions | Off-label type | Total | Resp. |
Knopf, 2013 [17] | Germany | Population based sample (KiGGS) | Prospective; drug-use assessed by survey | 0 to 17 years | 8899 | 12667 | Age, dose, indication | 30 | 37 |
Morais-Almeida, 2013 [12] | Portugal | Allergy outpatient clinic | Retrospective; clinical files analysis in 2012 | 0 to 6 years | 500 | 1224 | Age, dose, indication | 35 | 77 |
Ribeiro, 2013 [18] | Portugal | ED; University Hospital | Retrospective; random sample of children attending to the ER for 9 months in 2010 | 0 to 17 years | 700 | 724 | Age, dose, indication, route | 32 | 28 |
Ballard, 2012 [19] | Australia | Pediatric general ward, acute-care university Hospital | Retrospective; two groups of 150 consecutive pediatric patients admitted in July 2009 and Jan. 2010 | 1Â day to 11 years | 300 | 887 | Age, dose, indication, route | 32 | 11 |
Kimland, 2012 [20] | Sweden | 34 Pediatric; 7 non-Pediatric Hospitals | Prospective; data collection of all prescriptions, in two separate 48 hour periods (May and October 2008) | 0 to 18 years | 2947 | 11 294 | Age, dose, indication, route | 34 | 11 |
Palcevski, 2012 [21] | Croatia | Pediatric Ward; University Hospital | Prospective; clinical files analysis on a pre-determined day of each month during 12 months (May 2010 to April 2011) | 0 to 19 years | 531 | 1643 | Age, indication, route | 13.3 | 5.1 |
Olsson, 2011 [22] | Sweden | Population based sample (Swedish Prescribed Drug Register) | Retrospective; analysis of all outpatient prescriptions performed in 2007 | 0 to 18 years | -- | 2.19 million | Age, dose, indication | 13.5 | 3.1 |
Phan, 2010 [23] | US | ED of a tertiary-care children’s Hospital | Retrospective; all medical records admissions analysis from January to May 2007 | 0 to 18 years | 2191 | 6675 | Age, dose, Indication, route | 25.6 | 31.8 |
Morales-Carpi, 2010 [24] | Spain | Outpatient prescriptions | Prospective; analysis of all prescriptions performed prior to the ED visit collected from June2005 to August 2006 (14Â months) | 0 to 14 years | 336 | 667 | Indication, dose, frequency and route | 50.7 | 31.4 |
| Â | Â | Join outpatient prescriptions to ER random sample; University Hospital | Â | Â | Â | Â | Â | Â | Â |
MuhlBauer 2009 [25] | Germany | German statutory health insurance provider | Retrospective; analysis of all prescriptions performed during 2002 | 0 to 16 years | -- | 1.5 million | Age, indication | 3.2 | 7 |
Bazzano, 2009 [26] | US | National Ambulatory Medical Care Surveys (NAMCS) | Retrospective; representative sample of outpatient visits from 2001 to 2004 | 0 to 18 years | 312 million | 484 million | Age, indication | 62# | 70# |
Jain, 2008 [27] | India | Tertiary care central Hospital | Prospective study, prescription survey applied to a consecutive sample of children admitted to the ward from May to July 2006 | 1 month to 12Â years | 600 | 2064 | Age, dose, frequency, indication | 51 | 53 |
Hsien, 2008 [28] | Germany | Pediatric ward in tertiary care Hospital | Prospective study of all patient files between January and June 2006 | 0 to 18 years | 417 | 1812 | Age, dose, indication | 31 | 30 |
Shah, 2007 [29] | US | 31 tertiary care pediatric hospitals (PHIS database) | Retrospective study of all children discharged from the Hospital during 2004 | 0 to 17 years | 355409 | --- | Age, indication | 78.7# | 11.2# |
Ufer, 2004 [30] | Sweden | Population based sample (Statistics Sweden and the National Corporation of Swedish Pharmacists) | Retrospective study of all drug register present in the database in 2000 | 0 to 15 years | -- | 2,8million | Age, dose, indication, formulation, route | 20.7 | 8.6 |
Schirm, 2003 [31] | Netherland | Pharmacies dispensing records in northern Netherland (Interaction database) | Retrospective study of all drugs dispensing records in the Interaction database in 2000 | 0-16Â years | 18493 | 66222 | Age | 20.6 | 15.1 |
Pandolfini, 2002 [32] | Italy | Nine general pediatric hospitals wards | Prospective; analysis of all prescriptions performed to children in 12 week period | 1Â month to 14 years | 1461 | 4255 | Dose, route, indication and duration | 60 | 33 |
McIntyre, 2000 [33] | England | Suburban general practice clinic | Retrospective; study of all prescriptions performed in 1998 | 0 to 12Â years | 1175 | 3347 | Age, dose, route | 10.5 | 28 |