Table 3.
Types of off‐label and unlicensed prescribing
| Category | Examples |
|---|---|
| Types of off‐label prescribing in which the medicine is not approved for the intended indication | |
| 1. The branded formulation is not approved for the intended indication, but other branded formulations of the same medicine are so approved | Inderal–propranolol is not approved for treatment of infantile haemangiomas, but Hemangiol–propranolol is so approved |
| 2. The medicine is not approved in any formulation for the intended indication, but other medicines of the same pharmacological class, which might be expected to be efficacious, are so approved | Licensed formulations of bisoprolol and celiprolol do not include the treatment of migraine among their approved indications, but licensed formulations of propranolol and oxprenolol do |
| 3. The medicine is not approved in any formulation for the intended indication, and no other medicine of the same pharmacological class is so approved either | Streptomycin is used to treat infection with Mycobacterium tuberculosis, but is not licensed for that indication in the UK; neither are other aminoglycoside antibiotics listed in the British National Formulary specifically licensed for the treatment of infection with M. tuberculosis |
| 4. The medicine is approved for an indication and can be used in cases where the indication is assumed but not known | Use of ampicillin, indicated for the treatment of a wide range of bacterial infections caused by ampicillin‐sensitive organisms, to treat infections whose cause is not known or when infecting bacteria are not known to be sensitive |
| Types of off‐label prescribing in which the medicine is approved for the intended indication but not in other respects, e.g. population, dose, or frequency of administration | |
| 5. For an unapproved age group | Many examples of prescribing for children, when the prescribed drug is approved for the relevant indication in adults but not children |
| 6. In an unapproved dosage regimen | Use of an oral contraceptive in twice the recommended dose to obviate reduced efficacy due to a drug–drug interaction |
| 7. By an unapproved route of administration | Giving bevacizumab intravitreously for age‐related macular degeneration (AMD); this is also an example of an off‐label indication, since the approved indications for bevacizumab do not include AMD |
| 8. With omission of therapy with a drug mandated in the SmPC for co‐administration | Prescribing infliximab without methotrexate in rheumatoid arthritis as a therapeutic trial in a patient who cannot tolerate methotrexate |
| 9. When monitoring that is mandated by the SmPC is omitted | Failing to monitor serum sodium concentrations in patients taking low‐dose diuretics for hypertension, taking into account evidence that it is of no therapeutic benefit to do so |
| Unlicensed products that can be prescribed but need to be imported or provided as specials | |
| Glycopyrronium bromide (available in the UK for injection) | Glycopyrronium bromide 0.05% topical solution |
| Hydroquinone (no licensed product marketed in the UK) | Hydroquinone 4% cream |
| Melatonin (available in the UK as a modified‐release formulation) | Melatonin oral solutions and oral suspensions 2–10 mg per 5 ml |