Off-label therapy is a decision to start a medical experiment

The use of a medicinal product in the off-label procedure is a biomedical experiment.

Change in the therapeutic procedure in terms of indications for use, dosage, route of administration without further specification:

1/contraindications,

2/special warnings and precautions,

3/interactions with other drugs or other forms of interaction,

4/side effects

is creating additional risk for the patient.

That's why we invented:

• PASS post authorization safety study/
• PAES post authorization efficasy study/effectiveness/

The same active substance used in a different therapeutic indication may show different: contraindications, interactions, side effects.

The lack of appropriate clinical trials conducted on a separate cohort of clinical trial participants is a safety risk for a patient treated off-label.

The new indication is determined in an interventional or non-interventional post-registration clinical trial.

When making a decision to use an off-label drug, the doctor usually bases his or her professional group on current medical knowledge/amantadine in the treatment of COVID-19/.

The physician who decides to use an off-label drug is responsible for it even when

Health Minister winks at the lewd acquiescence of his order.

Whether the doctor will be punished depends on an independent court.

The general ethical principle of primum non nocere should not be marginalized.

I meant well but the bridge collapsed.

I agree that making the right decision results from a good diagnosis of the clinical situation, knowledge of scientific data and the use of only reliable reports, knowledge of the patient's condition, including the emotional one.

The most popular reasons for limiting: indications, dosage and route of administration in the summary of the medicinal product approved by the competent authority are:

- lack of sufficient reliable/strong/statistical EBM data,

- no decision of the MAH to extend the indication in relation to the one originally described,

- other, e.g. economic, strategic, etc.

Any decision to use off-label mode is a risk to physician liability and patient safety.

P.S.

SmPC is not a narrower concept than EBM.

The SmPC is the quintessence of the EBM on the date of the decision on the marketing authorization of the medicinal product.