Department of Health Surveillance and Bioethics, Forensic Toxicology Laboratory, Università Cattolica del Sacro Cuore F. Policlinico Gemelli IRCCS, Rome, Italy.
Clin Toxicol (Phila). 2021 Jan;59(1):47-52. doi: 10.1080/15563650.2020.1770277. Epub 2020 Jun 1.
The illegal market of counterfeit and falsified medicines and supplements containing unlabeled pharmaceuticals is expanding worldwide. They are usually referred to by the term "performance and image enhancing drugs" (PIEDs) and are mainly steroids, stimulants, hormones, and drugs for erectile dysfunction. PIEDs are easily accessible through the online or black markets. We analyzed over 400 such medicines confiscated in Italy in the period 2017-2019, to determine their composition.
Confiscated products were analyzed by gas chromatography/mass spectrometry and liquid chromatography/high-resolution mass spectrometry, in order to ascertain their composition and to evaluate the correspondence between what was declared on the label and the actual content, or to identify unknown products.
The most commonly found substance was anabolic steroids, found in 64% of products, with 11% containing hormone modulators, 6% stimulants, 6% sexual enhancers (mainly sildenafil) and other drugs, including thyroid hormones, melanin stimulators, and vitamins. These substances were often in mixtures. The products were often mislabeled, containing contaminants in addition to the drug declared, or consisted of a drug completely different from the one reported on the label. Fifteen percent of products had a qualitative composition completely different from that declared, while 10% of products showed cross-contamination with other drugs, mainly testosterone esters, probably due to the presence of residues of other drugs in the production line. In addition, 11% of products were not labeled, so their purported composition was unknown.
PIEDs pose a threat to public health. The main risks are related to the intrinsic toxicity of the substances found, especially when taken without a therapeutic indication. Another issue is related to the mislabeling of the fake medicines, and the poor-quality standard of counterfeit product preparation, with additional risks of the presence of other toxic ingredients or microbial contamination.
The use of counterfeit products is a public health concern, as it constitutes a high risk for consumer health. It is mainly caused by the uncontrolled use of steroids, stimulants, sexual enhancers, and other medicaments, without medical indication or supervision, with variable and unknown compositions and doses, as well as other contaminants as a result of the absence of good manufacturing practices.
假冒伪劣药品和未经标注的医药补充剂的非法市场在全球范围内不断扩大。这些药品通常被称为“性能和形象增强药物”（PIEDs），主要包括类固醇、兴奋剂、激素和勃起功能障碍药物。PIEDs 可通过在线或黑市轻松获得。我们分析了 2017 年至 2019 年期间在意大利没收的 400 多种此类药品，以确定其成分。
通过气相色谱/质谱和液相色谱/高分辨率质谱对没收的产品进行分析，以确定其成分，并评估标签上声明的内容与实际含量之间的一致性，或识别未知产品。
最常见的物质是合成代谢类固醇，在 64%的产品中发现，11%的产品含有激素调节剂，6%的兴奋剂，6%的性增强剂（主要是西地那非）和其他药物，包括甲状腺激素、黑色素刺激剂和维生素。这些物质经常混合在一起。这些产品经常贴错标签，除了声明的药物外，还含有污染物，或者由与标签上报告的药物完全不同的药物组成。15%的产品的定性成分与声明的完全不同，而 10%的产品与其他药物发生交叉污染，主要是睾酮酯，可能是由于生产线中残留了其他药物。此外，11%的产品没有标签，因此其声称的成分未知。
PIEDs 对公共健康构成威胁。主要风险与所发现物质的内在毒性有关，尤其是在没有治疗指征的情况下服用时。另一个问题与假冒药品的标签错误以及假冒产品制备质量标准低有关，此外还存在其他有毒成分或微生物污染的额外风险。
假冒产品的使用是一个公共卫生问题，因为它对消费者健康构成了高风险。这主要是由于未经控制地使用类固醇、兴奋剂、性增强剂和其他药物引起的，没有医疗指示或监督，成分和剂量各不相同且未知，并且由于缺乏良好的生产规范，还存在其他污染物。
