Table 3. Number and proportion of the three most frequent off-label indications for drugs with at least 5,000 prescriptions (year 2008, multiple counting of off-label indications per prescription).
Compound class | Compound | All prescriptions (n) | Off-label due to ‘indication’ or ‘age&indication’ (n,% of all prescriptions) | Three most frequent off-label indications* (n, % of all off-label prescriptions due to ‘indication’ and ‘age&indication’) |
Inhaled SABA | Salbutamol | 159,655 | 67,084 (42.0%) | Acute bronchitis: 29,989 (44.7%), Acute upper respiratory infections: 23,827 (35.5%), Other diseases of upper respiratory tract: 13,267 (19.8%) |
Inhaled SABA combination | Reproterol/CGA (fixed combination) | 8,729 | 2,538 (29.1%) | Other disease of upper respiratory tract: 999 (39.4%), Acute upper respiratory tract infections: 402 (15.8%), Bronchitis nec: 259 (10.2%) |
Inhaled LABA/ICS | Salmeterol/Fluticasone (fixed combination) | 27,600 | 3,910 (14.2%) | Other diseases of upper respiratory tract: 1,066 (27.3%), Acute bronchitis: 751 (19.2%), Acute upper respiratory infections: 679 (17.4%) |
Formoterol/Budesonide (fixed combination) | 13,833 | 2,471 (17.9%) | Other diseases of upper respiratory tract: 621 (25.1%), Acute upper respiratory infections: 456 (18.5%), Bronchitis nec: 428 (17.3%) | |
Inhaled SAMA | Ipratropium | 21,822 | 10,910 (50.0%) | Acute bronchitis: 5,779 (53.0%), Acute upper respiratory infections: 4,124 (37.8%), Bronchitis nec: 2,033 (18.6%) |
ICS | Fluticasone | 17,097 | 3,443 (20.1%) | Acute bronchitis: 1,096 (31.8%), Acute upper respiratory infections: 977 (28.4%), Other diseases of upper respiratory tract: 847 (24.6%) |
Oral B2A | Oral Salbutamol | 19,475 | 5,544 (28.5%) | Acute upper respiratory infections: 2,431 (43.8%), Bronchitis nec: 2,020 (36.4%), Other diseases of upper respiratory tract: 1,001 (18.1%) |
Oral Terbutaline | 6,940 | 2,012 (29.0%) | Acute upper respiratory infections: 880 (43.7%), Bronchitis nec: 773 (38.4%), Other diseases of upper respiratory tract: 348 (17.3%) | |
Oral B2A combination | Oral Clenbuterol/Ambroxol (fixed combination) | 91,385 | 18,897 (20.7%) | Acute upper respiratory infections: 9,131 (48.3%), Other diseases of upper respiratory tract: 2,767 (14.6%), Other respiratory diseases: 2,228 (11.8%) |
Others | Montelukast | 33,501 | 12,522 (37.4%) | Acute bronchitis: 3,868 (30.9%), Acute upper respiratory infections: 3,850 (30.7%), Other diseases of upper respiratory tract: 3,014 (24.1%) |
Cromoglicic acid | 5,087 | 3,137 (61.7%) | Acute upper respiratory infections: 1,151 (36.7%), Acute bronchitis: 1,101 (35.1%), Other diseases of upper respiratory tract: 789 (25.2%) |
SABA: Short-acting beta-2-agonist, CGA: Cromoglicic acid, LABA: Long-acting beta-2-agonist, ICS: Inhaled corticosteroid, SAMA: Short-acting muscarinic antagonist, B2A: Beta-2-agonist, nec: not elsewhere classified.
*Exclusive missing indications.