Reasons for and frequency of off-label drug use

Abstract

INTRODUCTION: 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. MATERIAL AND METHODS: The sources of information used are articles published in scientific journals and information from the official websites of regulatory agencies. RESULTS AND DISCUSSION: 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. CONCLUSION: 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.