The use of an off-label medicinal product (from English off – outside, label – label, instruction) means that the doctor prescribes it to the patient not as mentioned in the description: for unregistered indications or for another age category, outside the established dosage, zone or routes of administration, with a different frequency, that is, as not directly indicated in the approved instructions that come with the drug.
Eroshkin Evgeniy Yuryevich
Candidate of Medical Sciences, Dermatovenereologist
Clinic of Dermatology and Cosmetology "Evgeniy Eroshkin MD"
The use of medicines outside of approved indications presents a dilemma of sorts. On the one hand – Regulatory authorities try to keep patients away from ineffective and sometimes dangerous drugs with detailed instructions for their use.
On the other hand – medical science is developing rapidly, and many interesting discoveries regarding the use of a number of drugs for new indications require time to go through all the important stages of research, without which such indications cannot be officially included in the instructions.
In this case, the doctor, prescribing off-label drugs to the patient, is guided by his experience and professional knowledge.
Why is this being done?
Е.Е. In aesthetic medicine, for example, there are no standards of therapy for skin rehabilitation after minimally invasive cosmetic procedures, hardware effects, plastic surgery. A trichologist has the right to resort to off-label preparations if, in case of hair loss, the patient has exhausted all the means prescribed by the standards.
In dermatology, the number of discoveries that help to understand the causes of the development and exacerbation of a number of skin diseases is increasing every year, and, accordingly, the list of drugs that can be used to treat these diseases is expanding.
At the same time, pharmaceutical companies do not have time to conduct proper research and therefore are not entitled to amend the current instructions. In this case, the basis for the use of off-label drugs are publications in medical journals that show the effectiveness of certain drugs in a new situation. It is to be hoped that, under such circumstances, the use of a specific drug outside its approved indications may even determine what should be the standard of care for patients with certain diseases.
Here are some examples from my own experience with the successful use of certain drugs for indications not listed in the instructions
I would like to note that the use of drugs for non-officially approved indications always carries a certain risk. The fact that a drug has been found to be completely safe and effective in one patient does not mean that it will be equally effective and safe in any other patient. Therefore, a physician should only use off-label drugs if he is fully convinced that the potential benefits will far outweigh the possible risks.
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