Newly developed anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) drugs are being rapidly approved in countries worldwide. These new drugs are being approved after testing with a limited number of cases, and in real-world clinical practice, unknown and potentially serious adverse events that could not be detected in clinical trials may emerge. Accordingly, in the event of an adverse drug reaction for which a causal relationship with these new drugs cannot be ruled out, it is vital to promptly report the details of the case to the regulatory authorities. To date, through close cooperation between physicians and pharmacists, we have reported four cases of adverse drug reactions for which a causal relationship to anti-SARS-CoV-2 drugs cannot be ruled out. Herein, we introduce safety measures taken by pharmacists when using these new drugs in the hospital, and a system for reporting to the regulatory authorities when adverse events occur.
Keywords: Japan; adverse events; regulatory authorities; safety.
2022, National Center for Global Health and Medicine.