Department of Environmental and Occupational Health, Toho University School of Medicine, 5-21-16 Omori-nishi, Ota-ku, Tokyo, 143-8540, Japan.
Environ Health Prev Med. 2010 Jul;15(4):244-51. doi: 10.1007/s12199-010-0134-5. Epub 2010 Feb 9.
The size of the market for counterfeit drugs throughout the world is considerable. Many cases of health impairment due to counterfeits have been reported. The market share of counterfeits in drug markets in developed countries is smaller than that in developing countries. However, the size of the market for counterfeits of phosphodiesterase type 5 inhibitors (PDE5Is) used as anti-erectile-dysfunction drugs is not small. The purpose of the present study was to analyze the health impairment risk of taking the counterfeit PDE5Is and the convenience of obtaining the counterfeits in Japan, using an economic methodology in order to work out countermeasures for reducing the health impairment risk.
Information was obtained by interviewing employees of pharmaceutical and chemical corporations in Japan.
The size of the market for counterfeit PDE5Is in Japan was recently estimated to be about 2.5 times larger than that of genuine PDE5Is. The price of the counterfeits in their market is reported to be nearly equal to that of the genuine PDE5Is. An outbreak of severe hypoglycemia among users of counterfeit PDE5Is containing an antidiabetic drug in Singapore was reported in 2008, and seven patients remained comatose as a result of prolonged neuroglycopenia. Four of them subsequently died, so the health impairment risk due to counterfeit PDE5Is should not be ignored. In order to obtain a genuine PDE5I in Japan, a patient must be examined and have a prescription written at a medical institution, and buy it at a dispensing pharmacy. Focusing on the health impairment risk due to counterfeit PDE5Is and the convenience of obtaining the counterfeits in Japan, we analyzed the effects on the prices and quantities of PDE5Is in the market from demand and supply curves, using an economic methodology. From the analysis, it was shown that the health impairment risk due to the counterfeits is underestimated in the market in Japan. Physicians should warn their patients not to buy counterfeit PDE5Is, and when they write a prescription for purchasing genuine PDE5Is, should inform their patients of the severe health problems that occurred in Singapore.
The present economic analysis indicates that the health impairment risk due to counterfeit PDE5Is is underestimated in the market in Japan. Clarification of the underestimation of the severe health impairment risk due to counterfeits is important.
全球假药市场规模相当可观。已有许多因假药而导致健康受损的案例报告。在发达国家的药品市场中，假药的市场份额小于发展中国家。然而，作为治疗勃起功能障碍药物的磷酸二酯酶 5 抑制剂（PDE5Is）的假药市场规模不小。本研究的目的是通过经济方法分析服用假冒 PDE5Is 的健康损害风险以及在日本获得这些假药的便利性，以便制定降低健康损害风险的对策。
通过采访日本制药和化工公司的员工获取信息。
最近估计日本的假冒 PDE5Is 市场规模大约是正品 PDE5Is 的 2.5 倍。据称，他们市场上的假药价格与正品 PDE5Is 相近。2008 年，新加坡报道了一起使用含有抗糖尿病药物的假冒 PDE5Is 的使用者发生严重低血糖事件，7 名患者因长时间的神经低血糖而昏迷。其中 4 人随后死亡，因此不应忽视假冒 PDE5Is 带来的健康损害风险。在日本，患者必须在医疗机构接受检查并开具处方，然后在配药药房购买正品 PDE5Is，才能获得 PDE5Is。鉴于假冒 PDE5Is 带来的健康损害风险以及在日本获得这些假药的便利性，我们使用经济方法从需求和供应曲线分析了对市场上 PDE5Is 价格和数量的影响。分析表明，日本市场对假药的健康损害风险估计不足。医生应该警告他们的患者不要购买假冒 PDE5Is，并且在为购买正品 PDE5Is 开具处方时，应告知患者在新加坡发生的严重健康问题。
本经济分析表明，日本市场对假冒 PDE5Is 带来的健康损害风险估计不足。明确对假冒药品严重健康损害风险的低估非常重要。
