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Sales of substandard and falsified medical products (SF) are rising rapidly everywhere around the globe. The wide and easy access to these products is an alarming issue to the global ...health systems and undermined the health of patients, especially with the thrive of online commerce. To tackle this threat to public health, new ways to access these products should be identified and detection technologies should be strengthened. The overarching aim of this study was to investigate if herbal supplements sold online claiming to be natural alternatives to Viagra® were amongst these SF medical products and how effective different analytical techniques are in providing information about these products. 3 products which claimed to be herbal supplements for men sexual performance were purchased from an e-commerce platform. Two products were received as unregistered generic sildenafil citrate tablets manufactured in India (and thus different to the products information on the website) while one product was received in the same packaging as shown on the website, claiming to be an herbal product. Nevertheless, all products were proven to contain sildenafil citrate, the active pharmaceutical ingredients in Viagra® after the comprehensive analytical tests. The results elucidated that the quality standards for the unregistered generic sildenafil citrate tablets were fulfilled according to the British Pharmacopeia, but the falsified product failed the quality tests and contained approximately 200 mg sildenafil citrate, which is equivalent to 2-fold of the daily maximum dose. Furthermore, physical characterisations, including powder x-ray diffraction and thermal analysis were performed and revealed that the polymorphic forms of sildenafil citrate were different, demonstrating the importance of employing thermal analysis in addition to the conventional analysis techniques for the substandard and falsified medical products. These techniques provided valuable insights into the physical form of the active ingredient in these products. What is more, the ease with which these SF products were obtained and confirmed to be misleading consumers emphasises the need for tighter regulation for e-commerce websites in line with those enforced on online pharmacies.
Counterfeit medicines (CFMs) is a catastrophic public health issue that encompasses all therapeutic classes in Indonesia. It is a consensus that community pharmacists in many countries could ...contribute to preventing the distribution of CFMs. Information on community pharmacists’ attitudes regarding CFMs is lacking. This study explores the attitudes of community pharmacists in Yogyakarta, Indonesia, regards to CFMs. The specific aim was to identify the perceived reason, the method used to identify CFMs, and complemented with recommendations on what aspects are lacking today. A crosssectional study involving 350 community pharmacists in Yogyakarta province was conducted. A semistructured questionnaire assessed the components of their attitude toward CFMs. The Likert-scale statements were implemented to best describe pharmacists’ attitudes in responding to specific questions. Most community pharmacists perceived a business profit induced by exceeded market demand and a medicine shortage as significant reasons for CFMs in Indonesia. They are confident in identifying CFMs through the medicine’s appearance, packaging, and noticeable price difference. This study captures the need for enforcing regulators to take more responsibility for specific CFMs regulations and build a centralized system for reporting the potential cases of CFMs, allowing for continuous country CFMs surveillance. Community pharmacists could be a crucial supporting function in preventing CFMs from reaching patients. To enhance their role, a robust reporting system is urged to be adopted and socialized in a massive way.
The globalization of the pharmaceutical supply chain has introduced new challenges, chief among them, fighting the international criminal trade in fake medicines. As the manufacture, supply, and ...distribution of drugs becomes more complex, so does the need for innovative technology-based solutions to protect patients globally. Areas covered: We conducted a multidisciplinary review of the science/health, information technology, computer science, and general academic literature with the aim of identifying cutting-edge existing and emerging 'digital' solutions to combat fake medicines. Our review identified five distinct categories of technology including mobile, radio frequency identification, advanced computational methods, online verification, and blockchain technology. Expert opinion: Digital fake medicine solutions are unifying platforms that integrate different types of anti-counterfeiting technologies as complementary solutions, improve information sharing and data collection, and are designed to overcome existing barriers of adoption and implementation. Investment in this next generation technology is essential to ensure the future security and integrity of the global drug supply chain.
•Challenges in falsified medicines – a review.•Focus on recent developments in analytical devices (2015–2020).•Methods and places for the detection of suspicious medicines.•Challenges and promising ...developments in chemical analysis.•Other challenges such as affordability of devices and accessible data.
Falsified medicines affect public health all around the globe. Complex distribution routes, illegal online webshops and reuse of packaging materials make them hard to detect. In order to tackle this problem, detection methods for the recognition of suspicious medicines and subsequent confirmation of falsification by analytical techniques is required. In this review, we focus on the developments and challenges that existed in the last five years (2015–2020) in the detection and analysis of falsified medicines. These challenges might have not been solved yet or arisen with new types of falsifications, new analytical techniques or detection strategies. Detection of suspicious medicines starts with visual inspection of packaging materials. However, re-use of packaging materials and high-quality imitations complicate visual inspection. Recent developments in the analysis of packaging by microscopic and spectroscopic techniques such as optical microscopy, X-ray fluorescence, infrared spectroscopy and Raman spectroscopy or microscopy, in combination with multivariate analysis show promising results in the detection of falsified medicines. An ongoing big challenge in the analysis of falsified medicines is the affordability of analytical devices. Yet, recent reports showed that lower cost devices, such as Counterfeit Drug Indicator or Counterfeit Detection device version 3 show promising use in the detection of falsified medicines. Furthermore, combining the outcomes of different low-cost analytical techniques, such as Minilab, colorimetry and Counterfeit Drug Indicator significantly increased selectivity and sensitivity in the detection of falsified medicines. Also, recent developments make it possible to link a low-cost technique, such as TLC, to mobile phones. Proper training of personnel has shown room for improvement and remains a challenge, even for relatively simple techniques. With an increased use of analytical fingerprints, an upcoming challenge is the accessibility of the growing pool of data. There is also the need of validated reference libraries on both national and international levels. Developments of the last few years bring us a step closer in the fight against falsified medicines, however challenges remain in the worldwide accessibility of affordable, easily operable and sensitive techniques.
Counterfeit medicines represent a global public health threat warranting the development of accurate, rapid, and nondestructive methods for their identification. Portable near-infrared (NIR) ...spectroscopy offers this advantage. This work sheds light on the potential of combining NIR spectroscopy with principal component analysis (PCA) and soft independent modelling of class analogy (SIMCA) for authenticating branded and generic antibiotics. A total of 23 antibiotics were measured “nondestructively” using a portable NIR spectrometer. The antibiotics corresponded to six different active pharmaceutical ingredients being: amoxicillin trihydrate and clavulanic acid, azithromycin dihydrate, ciprofloxacin hydrochloride, doxycycline hydrochloride, and ofloxacin. NIR spectra were exported into Matlab R2018b where data analysis was applied. The results showed that the NIR spectra of the medicines showed characteristic features that corresponded to the main excipient(s). When combined with PCA, NIR spectroscopy could distinguish between branded and generic medicines and could classify medicines according to their manufacturing sources. The PCA scores showed the distinct clusters corresponding to each group of antibiotics, whereas the loadings indicated which spectral features were significant. SIMCA provided more accurate classification over PCA for all antibiotics except ciprofloxacin which products shared many overlapping excipients. In summary, the findings of the study demonstrated the feasibility of portable NIR as an initial method for screening antibiotics.
The Knowledge about the use of counterfeit medicines in Lebanon is still very limited. Thus, the objective of this study was to evaluate the degree of awareness of counterfeit medicines among the ...Lebanese population and the harm associated with their consumption. A cross-sectional study based on a questionnaire survey has been applied where a semi-structured survey questionnaire was distributed, between June 2017 and May 2018, among 750 participants from 98 Lebanese areas to assess their awareness regarding counterfeit medicines. Seven hundred and four participants completed the questionnaire. 55.4% purchased medicines regularly. The main sources of medicines were pharmacies (52.6%), government clinics (16.3%) and private clinics (8.7%). The most common purchased medicines were lifesaving ones (80%). In the majority of cases (71.9%), participants could not identify the manufacturer country. Overall, 46.2% of the participants were aware of counterfeit medicines. 5.4% of the participants experienced self-reporting adverse effects, among which 89.5% of cases were reported to pharmacists or other authorities. Despite the risk, 4.7% of participants were willing to buy a potential counterfeit medicine. In fact, 56. 4% of the participants associated low harm level with the use of counterfeit medicines. Despite their awareness of counterfeit drugs-associated risks, the majority of participants tend to buy them again. Informative public health campaign and health professionals training, to prevent counterfeit medicines-associated harms, should be implemented.
•A novel image-based approach detects counterfeit medicines and identifies the most relevant regions of the tablet•Support vectors generate a heat map indicating tablet regions that contribute the ...most to the classification purpose•The framework is validated in two datasets of authentic and counterfeit tablets•The method outperformed a competing approach from the literature by yielding more robust explanations
This paper proposes a novel image-based approach to detect counterfeit medicines and identify the most relevant regions of the tablet in the task of classification. Images of medicine tablets undergo an initial pre-processing step which (i) removes the background to find the region of interest, (ii) clusters individual pixels into super-pixels, and (iii) extracts features containing color and texture information. The classification relying on Support Vector Machine (SVM) defines the class the respective image will be inserted into. The task of identifying the relevant regions of the tablets for counterfeiting detection is performed using the concept of support vectors, generating a heat map that indicates the regions that contribute the most to the classification purpose. Two datasets containing images of authentic and counterfeit tablets of Cialis and Viagra were used to validate our propositions, achieving correct classification rates of 100% on both datasets. Regarding the task of identifying the most relevant regions, our proposition outperformed the traditional LIME (Local Interpretable Model-agnostic Explanations) method by yielding more robust explanations.
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