治験薬の取り違え防止に関する治験薬包装への取り組み

抄録

One of the most common medical errors is the mix-up of drugs, and a suitable approach for drug packaging is an important preventive measure. However, packaging of investigational drugs, commonly known as “white boxes,” is often of a non-specific design and does not provide adequate measures to prevent drug mix-ups. At Tokyo Medical and Dental University Hospital (hereinafter, referred to as “our hospital”), pharmacists managing investigational drugs and clinical research coordinators have voluntarily taken measures such as underlining and adding necessary items to the labels of investigational drug packages. In this study, we conducted a retrospective survey of measures taken by sponsors and our hospital for investigational drug management by our hospital as of April 2022, and analyzed the problems and future measures. We found that sponsors took countermeasures by emphasizing labeling items on the investigational drug packaging or by using colors in 94.8％ of the cases. Labeling items are emphasized or additional descriptions are entered for 91.4％ of the cases at our hospital. These results suggested that medical institutions consider the current investigational drug packaging as insufficient to prevent mix-ups. Moreover, there is a concern that relying solely on each medical institution to prevent mix-ups in investigational drug packaging may adversely affect the homogeneity of clinical trial protocols. Thus, we believe that sponsors should exchange sufficient information and opinions with medical institutions and cooperate with the regulatory authorities to establish a more effective investigational drug packaging system from the viewpoints of both medical institutions and subjects.