Off-label use of medicines for COVID-19. Scientific brief, 31 March 2020

Abstract

No pharmaceutical products have yet been shown to be safe and effective for the treatment of COVID-19. However, a number of medicines have been suggested as potential investigational therapies, many of which are now being or will soon be studied in clinical trials, including the SOLIDARITY trial co-sponsored by WHO and participating countries. In many countries, doctors are giving COVID-19 patients medicines that have not been approved for this disease. The use of licensed medicines for indications that have not been approved by a national medicines regulatory authority is considered “off-label” use. The prescription of medicines for off-label use by doctors may be subject to national laws and regulations. All health care workers should be aware of and comply with the laws and regulations governing their practice. Further, such prescribing should be done on a case-by-case basis. Unnecessary stockpiling and the creation of shortages of approved medicines that are required to treat other diseases should be avoided...