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Substandard and falsified medical products for treating COVID-19 have spread worldwide. These medicines have entered Japan through personal importation of products purchased via the Internet. In this study, we investigated the circulation of 19 COVID-19-related medicines on the Internet in Japan and evaluated the pharmaceutical quality and authenticity of 2 medicines (dexamethasone tablets and ivermectin tablets) obtained online. We purchased 23 samples of 0.5-mg dexamethasone tablets and 13 samples of 3-mg ivermectin tablets from the Internet in December 2020 and July 2022. We investigated the quality and authenticity of the obtained samples through visual observation and tested their authenticity. We conducted pharmacopoeia compliance testing (quantitative assay, content uniformity tests, and dissolution tests) using the high-performance liquid chromatography–photodiode array detector method. No prescription was ever required at the time of purchase. Visual observation revealed that most samples lacked a package insert and some samples had packaging deficiencies. In terms of authenticity, eight ivermectin samples were genuine; the authenticity of the other samples remained uncertain. Four dexamethasone samples and three ivermectin samples failed quality testing based on pharmacopeia validation standards. Our findings illustrate that dexamethasone and ivermectin tablets of poor quality are available online. It is important to increase consumer awareness and provide information about these medicines to prevent the purchase of substandard medicines via the Internet.
Financial support: This work was supported by the Ministry of Health, Labour and Welfare of the
Disclosure: This study did not require ethical review board approval because it did not involve any animal experimentation and/or human subject research.
Current contact information: Shu Zhu, Graduate School of Medical Sciences, Medi-Quality Security Institute, Kanazawa University, Kanazawa, Japan, Medicine Security Workshop, 4F Venture Business Laboratory, Kanazawa University, Kanazawa, Japan, and AI Hospital/Macro Signal Dynamics Research and Development Center, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Japan, E-mail: zhushu@staff.kanazawa-u.ac.jp. Naoko Yoshida, AI Hospital/Macro Signal Dynamics Research and Development Center, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Japan, and Japan and Medicine Security Workshop, 4F Venture Business Laboratory, Kanazawa University, Kanazawa, Japan, E-mail: naoko@p.kanazawa-u.ac.jp. Ryo Matsushita, Clinical Pharmacy and Healthcare Sciences, Faculty of Pharmacy, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Japan, E-mail: matusita@p.kanazawa-u.ac.jp. Mohammad Sofiqur Rahman, Department of Clinical Pharmacy, School of Pharmacy, University of California, San Francisco, San Francisco, CA, E-mail: rahmansofique@gmail.com. Kazuko Kimura, Graduate School of Medical Sciences, Medi-Quality Security Institute, Kanazawa University, Kanazawa, Japan, and Medicine Security Workshop, 4F Venture Business Laboratory, Kanazawa University, Kanazawa, Japan, E-mail: kimurak@staff.kanazawa-u.ac.jp.
Past two years | Past Year | Past 30 Days | |
---|---|---|---|
Abstract Views | 0 | 0 | 0 |
Full Text Views | 917 | 917 | 917 |
PDF Downloads | 182 | 182 | 182 |