Frequency of off-label drug use in medicine

Abstract

Over the past 10-15 years, the use of drugs off-label (outside the label) has become common. Many authors of such publications believe that the practice of using drugs off-label has become so widespread that almost every drug is prescribed off-label. An analysis of the 10-year use of off-label drugs in the EU countries made it possible to estimate the frequency of such use, the number of leading drugs, the frequency of off-label use of original and generic drugs, depending on the frequency of their use for licensed indications and depending on their use in various areas of medicine. On average, off-label drugs were prescribed in 20% of cases, while in pediatrics, geriatrics, obstetrics and oncology, off-label drug prescription was more than 50%. At the same time, it is also worrying that almost three quarters of off-label prescriptions for drugs did not have convincing scientific support. Thus, the above data on the use of off-label drugs indicate: • an increase in the frequency of off-label drugs use; • about the widespread use of this type of therapy in such areas of medicine as pediatrics, oncology and psychiatry. All of the above obliges to analyze and systematize both the positive experience of using off-label drugs and the negative consequences of such use, as well as present the results of the analysis of the frequency of use and the effectiveness of off label therapy to the medical community.