Tomić Sinisa, Milcić Neven, Sokolić Milenko, Sucić Anita Filipović, Martinac Adrijana Ilić
Agencija za lijekove i medicinske proizvode, Zagreb.
Lijec Vjesn. 2010 Mar-Apr;132(3-4):81-6.
Counterfeit medicines are a growing problem in the world, for their use may endanger patient's health and therefore they pose an enormous public health risk. The manufacture of counterfeit medicines usually involves organised crime groups which place the counterfeit medicines on the market for reasons of profit. Detection and prevention of trade in counterfeit medicines requires close cooperation between medicine regulatory authorities, police, customs, judiciary and pharmaceutical industry. To this day, there have been no recorded cases of counterfeit medicines in the legal supply chain in Croatia. However, medicines without marketing authorisation in Croatia, originating from different countries, could be found on the illegal market. Most frequently, this includes medicines for the treatment of erectile dysfunction such as: sildenafil, tadalafil, vardenafil. In this study, 26 medicines for the treatment of erectile dysfunction, seized in illegal supply chain, were tested. High performance liquid chromatography (HPLC) was used for identification and quantification of active substances in the tested samples. It was determined that 13 out of 26 samples did not comply with declared composition of medicine and quality specification. Furthermore, two samples did not contain declared active substance vardenafil and that may indicate that these medicines are counterfeit.
假药问题在全球日益严重，因为使用假药可能危及患者健康，从而构成巨大的公共卫生风险。假药的制造通常涉及有组织犯罪集团，这些集团出于利润目的将假药投放市场。假药贸易的检测和预防需要药品监管当局、警方、海关、司法机构和制药行业密切合作。迄今为止，克罗地亚合法供应链中尚未有假药记录案例。然而，在非法市场上可以找到原产于不同国家但在克罗地亚没有销售许可的药品。最常见的是治疗勃起功能障碍的药物，如：西地那非、他达拉非、伐地那非。在本研究中，对在非法供应链中查获的26种治疗勃起功能障碍的药物进行了检测。采用高效液相色谱法（HPLC）对测试样品中的活性物质进行鉴定和定量。结果确定，26个样品中有13个不符合申报的药品成分和质量规范。此外，有两个样品不含申报的活性物质伐地那非，这可能表明这些药品是假药。
