Reasons for and frequency of off-label drug use

The application of drugs in accordance with the marketing authorization issued by the regulatory authority is considered on-label use, while off-label drug use frequently occurs in medical practice. It includes the application of drugs beyond approved indications; for unapproved age group, with different dosage regimens or different administration route. Medical specialists frequently prescribe an off-label drug in pediatrics, neonatology, geriatrics, psychiatry and oncology. Some countries have established registers of off-label drugs and guidelines for their prescribing and administration. The aim of the paper is to review practices in off-label drug use in order to satisfy the attitude of regulatory bodies and professional associations regarding the off-label use of drugs.

The sources of information used are articles published in scientific journals and information from the official websites of regulatory agencies.

The most common reasons why physicians decide to prescribe off-label drugs are primarily the absence of drugs for a particular indication or those for a particular age group. In their daily work, doctors prescribe drugs for an off-label use based on their own or other colleague's experience. There is no general agreement on off-label use of drugs at the national or international level, but more and more doctors' associations and regulatory bodies approve off-label drug use in compliance with certain scientific and legal requirements.

Off-label drug use has its place in practice and it has been widely accepted by the medical community and by itself it is not a violation of the standards of healthcare. Off-label use is common in our country and worldwide, and it is necessary to establish a registry for off-label drug use.