Modern medical and pharmaceutical problems of off label drug use: literature review

Abstract

The off-label use of drugs (beyond the instructions) is an important part of modern medicine and pharmacy, especially in the pharmacotherapy of pediatric, oncological, psychiatric patients. The term was established in the United States in 1997. Off-label therapy is one of the ways to identify new drug indications, i.e. innovation in modern pharmacotherapy. However, the off-label use of drugs does not have the same degree of scientific control and information as drugs for approved indications (on-label). The lack of an adequate and generalized informative database of off-label therapy in the world is one of the main problems associated with the assessment of such drug use. As a result, no matter from what angle the off-label use of drugs is viewed, problems arise. However, this use of drugs has gained momentum: one drug in five is prescribed off-label, so this is not a trivial problem. In addition, side effects from off-label drugs are about two to three times more likely than from on-label drugs. All of the above is the reason and necessity for professional, ethical, and legal control over the regulation of the use of off-label drugs. Official medicine can use existing clinical evidence regarding the use of offlabel drugs, and should also monitor their safety in the framework of harmacovigilance. Today, the use of off-label drugs has become a reality of pharmacotherapy, so it must be properly regulated at the legislative level.