Off-label use: what it means in HOF
Quick facts
- Definition
- Use of a medication or product for an indication, area, dose, route or age group different from the one approved in its registration.
- Where the approved indication is
- In the medication's label or the device's instructions for use, approved by ANVISA (Brazil's health regulator).
- Is it prohibited?
- Not in itself. It is a clinical decision, under the responsibility of the professional who prescribes it.
- Important difference
- Off-label means using a regularized product outside the label; a product without ANVISA registration is a different, irregular situation.
- Relevance in HOF
- Many usual applications of toxin and fillers are outside the label indication and should be stated in the consent form.
Off-label use is the use of a registered medication or product for an indication, area, dose, route of administration or age group different from the one approved in its registration, that is, outside what is in the label or the instructions for use. The term means "outside the label". It is not prohibited in itself: it is a clinical decision that stays under the responsibility of the professional who prescribes it. In HOF the topic is frequent, because many usual applications go beyond the registered indications.
Why is it so common in HOF?
A product's registration describes the indications that the manufacturer proved and submitted. Clinical practice tends to expand faster than those registrations:
| Situation | Example of why it may be off-label |
|---|---|
| Botulinum toxin | The label lists specific aesthetic indications, such as glabellar lines; other areas of the face may not appear |
| Hyaluronic acid filler | The instructions for use indicate areas; an area different from the one described falls outside them |
| Hyaluronidase | Use to break down filler may not be among the indications of the product's registration |
| Age group | Use at an age outside the range studied by the manufacturer |
To find out what is approved, check the label or instructions for use of the specific product, not of another in the same class. Injectable fillers are generally registered as class IV medical devices, and the registration can be looked up on the ANVISA website: see how to check an injectable's registration with ANVISA.
Is off-label the same as an irregular product?
No. Off-label means using a regularized product outside the label. A product without ANVISA registration, counterfeit, imported without authorization or compounded outside the rules is a different, irregular situation. The two must not be confused, either in the conversation with the patient or in the patient record.
Who is responsible for off-label use?
The recurring guidance from health authorities and professional councils is that use outside the label is done at the risk of the professional who prescribes it, who answers for the decision and for any harm. In practice, this calls for:
- Technical basis: literature and consensus statements that support the use.
- Council rules: each professional council has its own rules on the procedures and products its members may use. Check your council's rules.
- Information to the patient: the informed consent must say, in plain language, that the use is not in the label indication.
- Recording: product, lot, area and justification in the patient record.
How does it show up in the clinic's routine?
- Consent form: include a field for use outside the label indication. Templates are in botulinum toxin informed consent template.
- Traceability: keep the lot number and the product label, which helps with any adverse event report.
- Advertising: do not advertise off-label use as if it were an approved indication. The rules are in what you may advertise.
Also called: use outside the label, unlabeled use, extra-label use.
Frequently asked questions
What does off-label mean?
It means using a registered medication or product in a way different from what is approved in the label or instructions for use: another indication, another area, another dose, another route or another age group. The term means outside the label.
Is off-label use illegal?
Not in itself. It is a clinical decision that stays under the responsibility of the professional who prescribes it, and it must have a technical basis and be explained to the patient. What is irregular is using a product without ANVISA registration or outside the professional council's rules.