Falsified tadalafil tablets distributed in Japan via the internet

Sanada, T.; Yoshida, Naoko; Matsushita, Ryo; Kimura, Kazuko; Tsuboi, Hirohito

doi:10.1016/j.forsciint.2020.110143

Cited by 24 publications

(21 citation statements)

References 6 publications

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“…We tested products obtained by purchasing over the internet in previous studies [7][8][9]. These products were previously judged as genuine or falsified.…”

Section: Methodsmentioning

confidence: 99%

“…The WHO Global Surveillance and Monitoring System for substandard and falsified medical products reported that up to 2017, there were 1500 reports of substandard and falsified medical products [4]. These products include not only pharmaceuticals, such as antibiotics, antidiabetic agents, and antimalarial drugs, but also lifestyle medicines for beauty, diet, and erectile dysfunction (ED) [4][5][6][7][8][9]. The World-Wide Antimalarial Resistance Network (WWARN) published the data of falsified medicines from across the world [10].…”

Section: Introductionmentioning

confidence: 99%

“…Portable analyzers can be used in the field and reduce the number of samples that need to be tested in the laboratory [14,44,45]. Several handheld Raman scattering analyzers with different functions, sizes, and prices have been developed, and there are several reports that have evaluated their usefulness [7,8,14,[44][45][46][47][48][49][50][51]. The handheld Raman spectrometer is expected to be used in customs, warehouses, medical institutions, and pharmacies, and is cheaper than fixed Raman spectrometers installed in laboratories.…”

Section: Introductionmentioning

confidence: 99%

“…Compared with the handheld Raman scattering spectrometers that have already been reported, the advantages of the ultra-compact Raman scattering spectrometer are its price and size. Its size is similar to a smartphone, and it weighs only 90 g. In addition to its small size, the cost of the ultra-compact Raman scattering spectrometer is low enough to be affordable in many places and is one-tenth the price of the analyzer that we used in previous studies [7,8]. However, it needs to be modified for application because it is an Original Equipment Manufacturing (OEM) Raman spectroscopic module.…”

Section: Introductionmentioning

confidence: 99%

“…In this study, we examined the usefulness of the ultra-compact Raman spectrometer as a non-destructive detection method. The method was applied to detect falsified ED medicines that were in distribution; the authentic products were: tadalafil (Cialis), varde-nafil (Levitra), and sildenafil (Viagra) [7][8][9]. In addition to the confirmation of the Raman spectra, principal component analysis (PCA) was also performed to classify products.…”

Section: Introductionmentioning

confidence: 99%

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Discrimination of Falsified Erectile Dysfunction Medicines by Use of an Ultra-Compact Raman Scattering Spectrometer

et al. 2020

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Substandard and falsified medicines are often reported worldwide. An accurate and rapid detection method for falsified medicines is needed to prevent human health hazards. Raman scattering spectroscopy has emerged as a non-destructive analysis method for the detection of falsified medicines. In this laboratory study, Raman spectroscopy was performed to evaluate the applicability of the ultra-compact Raman scattering spectrometer (C13560). Principal component analysis (PCA) was also performed on the Raman spectra. This study analyzed tadalafil (Cialis), vardenafil (Levitra), and sildenafil (Viagra) tablets. We tested the standard product and products purchased from the internet (genuine or falsified). For Cialis and Levitra, all falsified tablets were identified by the Raman spectra and PCA score plot. For Viagra, the Raman spectra of some falsified tablets were almost comparable to the standard tablet. The PCA score plots of falsified tablets were dispersed, and some plots of falsified tablets were close to the standard tablet. In conclusion, C13560 was useful for the discrimination of falsified Cialis and Levitra tablets, whereas some falsified Viagra tablets had Raman spectra similar to that of the standard tablet. The development of detection methods that can be introduced in various settings may help prevent the spread of falsified products.

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“…We tested products obtained by purchasing over the internet in previous studies [7][8][9]. These products were previously judged as genuine or falsified.…”

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Discrimination of Falsified Erectile Dysfunction Medicines by Use of an Ultra-Compact Raman Scattering Spectrometer

et al. 2020

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Quality and Authenticity of Metformin Tablets Circulating on Japanese Websites

Zhu

Yoshida

Tsuboi

et al. 2021

Ther Innov Regul Sci

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Background Low-quality medicines and falsified medicines represent long-standing problems in developing countries. In Southeast Asia, the circulation of low-quality diabetes drugs (metformin) has been confirmed. It is possible that low-quality metformin has entered Japan via personal import through the Internet. This study evaluated the pharmaceutical quality and authenticity of metformin tablets obtained via the Internet in Japan. Methods In total, 33 samples of 500-mg metformin tablets and 7 samples of extended-release/sustained-release tablets (500, 750, and 1,000 mg) were purchased via personal import in January 2017. Confirmation of a prescription was never requested purchase. The obtained samples were subjected to visual observations and authenticity investigations. Additionally, quantitative analysis, content uniformity and dissolution tests were performed using HPLC–PDA. Results Our authenticity investigations revealed that seven samples were genuine products, whereas the authenticity of the remaining 33 samples was unclear. Referring to United States Pharmacopeia 2014 for validation, four samples failed quality testing, five samples failed content uniformity testing, and two samples failed dissolution testing. Conclusions Our findings illustrate that metformin tablets of poor-quantity and unregistered/unlicensed doses are available online and that it is important to increase consumer awareness about the presence of these medicines on the Internet to prevent the purchase of substandard medicines.

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Facing Counterfeit Medications in Sexual Medicine. A Systematic Scoping Review on Social Strategies and Technological Solutions

2021

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Introduction:The counterfeit phenomenon is a largely under-reported issue, with potentially large burden for healthcare. The market for counterfeit drugs used in sexual medicine, most notably type 5 phosphodiesterase inhibitors (PDE5i), is rapidly growing. Aims: To report the health risks associated with the use of counterfeit medications, the reasons driving their use, and the strategies enacted to contain this phenomenon. Methods: A systematic scoping review of the literature regarding counterfeit PDE5i was carried between January and June 2021, then updated in August 2021. Main Outcome Measure: We primarily aimed to clarify the main drivers for counterfeit PDE5i use, the health risks associated, and the currently available strategies to fight counterfeiters. Results: One hundred thirty-one records were considered for the present scoping review. Production of fake PDE5i is highly lucrative and the lacking awareness of the potential health risks makes it a largely exploitable market by counterfeiters. Adulteration with other drugs, microbial contamination and unreliable dosages make counterfeit medications a cause of worry also outside of the sexual medicine scope. Several laboratory techniques have been devised to identify and quantify the presence of other compounds in counterfeit medications. Strategies aimed at improving awareness, providing antitampering packaging and producing non-falsifiable products, such as the orodispersible formulations, are also described. Clinical implications: Improving our understanding of the PDE5i counterfeit phenomenon can be helpful to promote awareness of this issue and to improve patient care. Strengths & Limitations: Despite the systematic approach, few clinical studies were retrieved, and data concerning the prevalence of counterfeit PDE5i use is not available on a global scale. Conclusion:The counterfeit phenomenon is a steadily growing issue, with PDE5i being the most counterfeited medication with potentially large harmful effects on unaware consumers. Sansone A, Cuzin B, and Jannini EA.

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Falsified tadalafil tablets distributed in Japan via the internet

Cited by 24 publications

References 6 publications

Discrimination of Falsified Erectile Dysfunction Medicines by Use of an Ultra-Compact Raman Scattering Spectrometer

Discrimination of Falsified Erectile Dysfunction Medicines by Use of an Ultra-Compact Raman Scattering Spectrometer

Quality and Authenticity of Metformin Tablets Circulating on Japanese Websites

Facing Counterfeit Medications in Sexual Medicine. A Systematic Scoping Review on Social Strategies and Technological Solutions

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