Shofuda Ken-ichi, Aragane Katsumi, Igari Yasutaka, Matsumoto Kinya, Ito Kazuya
Global Quality Assurance Department, Takeda Pharmaceutical Company Limited.
Yakugaku Zasshi. 2014;134(2):203-11. doi: 10.1248/yakushi.13-00230-2.
Global spread of counterfeit medicines is an imminent threat for the patients' safety. Although major targets of counterfeits are still erectile dysfunction (ED) drugs in the industrialized countries, including Japan, anti-cancer agents and some medicines for metabolic syndromes are also being counterfeited and circulated to the market mainly through the Internet. Due to the global expansion of the business, pharmaceutical companies based in Japan are suffering from the damage of counterfeits, illegal sales including diversion, and thefts, which have never been experienced in the conventional domestic market. We, pharmaceutical companies, must be responsible for the prevention of the prevalence because our mission is to deliver effective and safe medicine to patients. For this end, we are taking necessary actions including, 1. Forestalling counterfeit, falsification and illicit trade: Measures to prevent counterfeiting are taken by introducing anti-counterfeit technologies to the packaging and tablets on a risk basis. It is also important to establish supply chain security on a global scale. 2. Finding out counterfeits and cooperating crackdown: We are conducting market and internet surveillances when high risk products are sold in high risk markets. The outcome of the criminal investigation is reported to authorities and police if necessary. 3. Conducting educational campaign to medical staff or patients: For example, four companies which manufacture and sell ED drug in Japan are collaboratively continuing activities to raise the awareness of the danger of Internet purchase. To deliver effective and safe medicines stably and globally, pharmaceutical companies extend comprehensive measures against counterfeit and illicit trading.
假药的全球传播对患者安全构成了迫在眉睫的威胁。尽管在包括日本在内的工业化国家,假药的主要目标仍然是勃起功能障碍(ED)药物,但抗癌药物和一些治疗代谢综合征的药物也在被伪造,并主要通过互联网流入市场。由于业务的全球扩张,总部位于日本的制药公司正遭受假药、包括药品转移在内的非法销售以及盗窃行为的损害,而这些在传统国内市场从未发生过。我们制药公司必须对预防假药流行负责,因为我们的使命是为患者提供有效且安全的药物。为此,我们正在采取必要行动,包括:1. 预防假冒、伪造和非法贸易:在有风险的基础上,通过在包装和片剂上引入防伪技术来采取防伪措施。在全球范围内建立供应链安全也很重要。2. 查出假药并配合打击:当高风险产品在高风险市场销售时,我们会进行市场和互联网监测。如有必要,会将刑事调查结果报告给当局和警方。3. 对医务人员或患者开展教育活动:例如,日本四家生产和销售ED药物的公司正在合作开展活动,以提高人们对网上购买药物危险性的认识。为了在全球范围内稳定地提供有效且安全的药物,制药公司采取了全面的措施来打击假冒和非法交易。