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Forensic Intelligence for Medicine Anti-Counterfeiting

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Forensic Intelligence for Medicine Anti-Counterfeiting

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... With the use of a pure melamine standard and known literature values, [24][25][26][43][44][45][46] the target wavelengths for Raman imaging of the FDA supplied test samples were acquired and used to complete the imaging scan for all compounds: sibutramine, phenolphthalein, and melamine. The Raman spectra and resulting images of the scanned areas are provided in Fig. 4 along with a bright-field comparison image. ...
... Melamine has current widespread use in plastics, dyes and fertilizers, and textiles, but its inclusion in food products causes renal toxicity and other nephrological detriments. [40][41][42][43][44][45][46][47][48][49][50][51] Previous outbreaks have been attributed to mainland China and are still a present concern for the United States and the European Union, influencing the food safety policy. 52,53 Melamine toxicity in humans, especially in infants, results in the development of kidney stones, especially when ingested with adjuvant chemicals such as cyanuric acid. ...
... Using the TE2000 inverted microscope and the iHR550 Raman Imaging Spectrometer with a Synapse detector. Top (a): Raman spectra of the purposed sibutramine, collected from the mixed sample A (b) Raman image after the major peak 1600 cm −1 of sibutramine from the literature [44][45][46] is scanned, pink/yellow indicates the possible sibutramine contaminant and (c) bright-field, 10× objective view of the desired particle(s) of sample A-run 1. Middle (d): ...
Article
In the United States, all food products have to be regulated to inform the consumers of the ingredients contained within. Some ingredients are not included on the label and yet are still found in the products. Presented is a Raman imaging technique for rapid, nondestructive, and spatially relevant localization of adulterants in powders. Raman spectroscopy followed by direct analyte-probed nanoextraction coupled to nanospray ionization-mass spectrometry allows rapid determination of the presence of each adulterant, leading to positive identifications such as melamine. The location and identification of these trace particles can then be extracted using a nanomanipulator. The nanomanipulation technique uses a solvent filled capillary tip which can be positioned on the particle of interest. Direct mass spectrometric analysis via nanospray of the particulate of interest eliminates time consuming chromatographic techniques prior to mass spectrometry analysis. This coupled technique combines rapid Raman spectroscopy techniques with direct mass spectrometry to confirm the presence of an adulterant. This technique was applied to an FDA supplied test sample, in which sibutramine, phenolphthalein, and melamine were confirmed to be present.
... Counterfeit pharmacological agents are a threat to the drug supply and are estimated to be found in the marketplace at greater than 20%, especially in developing markets [1,2,3]. Present methods to verify real versus counterfeit drug in the field, rely on packaging verification and serialized barcoding [3,4]. ...
... Counterfeit pharmacological agents are a threat to the drug supply and are estimated to be found in the marketplace at greater than 20%, especially in developing markets [1,2,3]. Present methods to verify real versus counterfeit drug in the field, rely on packaging verification and serialized barcoding [3,4]. More recently, field deployable analytical methods have been described, based on the use of hand-held Raman spectroscopy and the like. ...
... More recently, field deployable analytical methods have been described, based on the use of hand-held Raman spectroscopy and the like. However, the Raman approach reveals only the principle components (generally the excipients) of the dosage formulation and in most cases, cannot detect the active agent, nor can it identify the quality of the components of the drug formulation [3,4,5]. ...
Article
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A small PCR-generated DNA fragment was introduced into a pharmaceutical grade ink as a molecular taggant, and the DNA tagged ink was delivered onto the surface of capsules by standard high-speed offset printing. The amount of DNA in the ink on each capsule is roughly 10-12 fold lower than that allowed as safe by the United States Food and Drug Administration (FDA) and the WHO with regards to acceptable limits of residual DNA. The printed ink on the capsule surface was sampled by swabbing, followed by direct analysis of the DNA-swab complex, without subsequent DNA purification. It was shown that DNA recovered from the ink by swabbing was suitable for PCR-CE analysis-a widely used method in forensic science and was also suitable for qPCR and isothermal DNA amplification, when coupled with portable devices similar to those used for environmental sampling and food safety testing. The data set a precedent: A small DNA fragment could be introduced as an excipient into a pharmaceutical application, and thereafter tracked through the pharmaceutical supply chain via forensic DNA authentication.
... Illegal pharmaceutical products or dietary supplements have often been found with ingredient dose-to-dose variations. [17,18] Thus it is important to assess the homogeneity of a seizure or a population of samples. When a low quantity of sample is available for lab analysis, it is relevant to use non-destructive techniques for unknown products analysis. ...
... A sampling was necessary to assess a number of tablets statistically representative of the seizure. The sampling strategy was based on the approach recommended by the United Nations Office on Drugs and Crime [22] and also described by Degardin et al. [18] When the sample contained fewer than 10 tablets, all of them were measured by NIR spectroscopy. For a number of tablets between 10 and 100, 10 tablets were randomly selected and analyzed. ...
... One hyperspectral image per tablet was recorded on one tablet per NIR profile. [18] Figure 6. Raman chemical images of the samples. ...
Article
The use of performance enhancing drugs is a widespread phenomenon in professional and leisure sports. A spectroscopic study was carried out on anabolic tablets labelled as 5 mg methandienone tablets provided by police departments. The analytical approach was based on a two-step methodology: a fast analysis of tablets using near infrared (NIR) spectroscopy to assess sample homogeneity based on their global composition, followed by Raman chemical imaging of one sample per NIR profile to obtain information on sample formulation. NIR spectroscopy assisted by a principal components analysis (PCA) enabled fast discrimination of different profiles based on the excipient formulation. Raman hyperspectral imaging and multivariate curve resolution - alternating least square (MCR-ALS) provided chemical images of the distribution of the active substance and excipients within tablets and facilitated identification of the active compounds. The combination of NIR spectroscopy and Raman chemical imaging highlighted dose-to-dose variations and succeeded in the discrimination of four different formulations out of eight similar samples of anabolic tablets. Some samples contained either methandienone or methyltestosterone whereas one sample did not contain an active substance. Other ingredients were sucrose, lactose, starch or talc. Both techniques were fast and non-destructive and therefore can be carried out as exploratory methods prior to destructive screening methods. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
... The interpretation of the chemical and packaging links together with the seizure information can enable a better comprehension of the modus operandi of the counterfeiters. [5][6][7] The retrieved forensic intelligence can provide valuable information on counterfeit trafficking and then trigger efficient initiatives. [8] Many methods are available nowadays for a reliable analysis [9][10][11][12][13][14][15] and valuable data that can provide links between counterfeits can be revealed with chemical and packaging data. ...
... [8] Many methods are available nowadays for a reliable analysis [9][10][11][12][13][14][15] and valuable data that can provide links between counterfeits can be revealed with chemical and packaging data. [5] An example of counterfeits that emerged last year across Europe will illustrate the proposed analytical strategy. The described cases had to be handled quickly since the counterfeits were actually stolen genuine products which had been manipulated and had illegally entered the supply chain. ...
... The hypothesis can be made that a few variables are sufficient to classify the counterfeits within a production. [5] The variables were chosen among the ones previously generated, and likely to reveal reliable links between cases of counterfeits at several analytical levels. Indeed at each manufacturing step, counterfeiters leave traces of their crime (Figure 3a). ...
Article
Medicine counterfeiting is a current problem that the whole pharmaceutical field has to deal with. In 2014, counterfeits entered the legitimate supply chain in Europe. Quick and efficient action had to be taken. The aim of this paper is to explain which analytical strategy was chosen to deal with six of the cases concerned and which criteria have to be considered to provide quick and thorough information about the counterfeits. The evaluation of the packaging was performed in a first step, based on a comparison with genuine samples and evaluation of manipulation signs. Chemical methods were then used, consisting of near infrared and infrared spectroscopy, capillary zone electrophoresis and ultraviolet-visible spectrophotometry, in order to authenticate the samples and provide the chemical composition of the confirmed counterfeits. Among the 20 samples analyzed, 17 were confirmed as counterfeits. The counterfeits were the results of the manipulation of genuine samples, and one contained totally counterfeited parts. Several manipulation signs were asserted, like the addition of glue on the boxes and the vials. Genuine stolen goods had been diluted with water, while for an isolated case, a different active ingredient had been introduced in a vial. The analytical data generated were further investigated from a forensic intelligence perspective. Links could be revealed between the analyzed counterfeits, together with some interesting information about the modus operandi of the counterfeiters. The study was performed on a limited number of cases, and therefore encourages chemical and packaging profiling of counterfeits at a bigger scale. Copyright © 2015 John Wiley & Sons, Ltd.
... However, the majority of techniques are time consuming and require extensive pattern planning or sample destruction. On this account, improving an analytical approach to simultaneously distinguish legitimate and counterfeit medicine samples from blister packaging tests is critical, as it enables the tablet to remain intact in its physical form [13]. ...
... Polymers 2021,13, 2185 ...
Article
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The detection of counterfeit pharmaceuticals is always a major challenge, but the early detection of counterfeit medicine in a country will reduce the fatal risk among consumers. Technically, fast laboratory testing is vital to develop an effective surveillance and monitoring system of counterfeit medicines. This study proposed the combination of Attenuated Total Reflectance Fourier Transform Infrared (ATR-FTIR) and Differential Scanning Calorimetry (DSC) for the quick detection of counterfeit medicines, through the polymer analysis of blister packaging materials. A sample set containing three sets of original and counterfeit medicine was analyzed using ATR-FTIR and DSC, while the spectra from ATR-FTIR were employed as a fingerprint for the polymer characterization. Intending to analyze the polymeric material of each sample, DSC was set at a heating rate of 10 °C min−l and within a temperature range of 0–400 °C, with nitrogen as a purge gas at a flow rate of 20 mL min−1. The ATR-FTIR spectra revealed the chemical characteristics of the plastic packaging of fake and original medicines. Further analysis of the counterfeit medicine’s packaging with DSC exhibited a distinct difference from the original due to the composition of polymers in the packaging material used. Overall, this study confirmed that the rapid analysis of polymeric materials through ATR-FTIR and comparing DSC thermograms of the plastic in their packaging effectively distinguished counterfeit drug products.
... In the past 15 years drug counterfeiting has become a global phenomenon that is constantly burgeoning [1][2][3][4][5]. According to the WHO, a counterfeit medicine is defined as: "one which is deliberately and fraudulently mislabeled with respect to identity and/or source. ...
... The use of these advanced laboratory methods enables to determine the composition of counterfeit products, and on this basis, their possible adverse effects on patients who have taken a counterfeit drug. However, the first step in the fight against drug counterfeiting should be the fastest possi- ble withdrawal of the falsified drug from the market [3]. For this purpose, it is necessary to develop a reliable and simple tool to distinguish between genuine and counterfeit drugs. ...
Article
The WHO estimates that up to 10% of drugs on the market may be counterfeit. In order to prevent intensification of the phenomenon of drug counterfeiting, the methods for distinguishing genuine medicines from fake ones need to be developed. The aim of this study was to try to develop simple, reproducible and inexpensive method for distinguishing between original and counterfeit medicines based on the measurement of directional reflectance. The directional reflectance of 6 original Viagra(®) tablets (Pfizer) and 24 (4 different batches) counterfeit tablets (imitating Viagra(®)) was examined in six spectral bands: from 0.9 to 1.1μm, from 1.9 to 2.6μm, from 3.0 to 4.0μm, from 3.0 to 5.0μm, from 4.0 to 5.0μm, from 8.0 to 12.0μm, and for two angles of incidence, 20° and 60°. Directional hemispherical reflectometer was applied to measure directional reflectance. Significant statistical differences between the directional reflectance of the original Viagra(®) and counterfeit tablets were registered. Any difference in the value of directional reflectance for any spectral band or angle of incidence identifies the drug as a fake one. The proposed method of directional reflectance analysis enables to differentiate between the real Viagra(®) and fake tablets. Directional reflectance analysis is a fast (measurement time under 5s), cheap and reproducible method which does not require expensive equipment or specialized laboratory staff. It also seems to be an effective method, however, the effectiveness will be assessed after the extension of research.
... Nowadays, lifesaving products like cancer or antimalarial medicines are however largely impacted and no therapeutic area is immune. Contrary to what is commonly assumed, also all regions of the world are impacted (Pharmaceutical Security Institute 2018; WHO 2010; SafeMedicines 2018; Degardin et al. 2015;Bate 2012b;Deisingh 2005;del Castillo Rodriguez 2015;Medina et al. 2016). Complex manufacturing and delivery chains involving several countries complicate scientific and legal investigations. ...
... Performing a full characterization of the chemical composition of counterfeits is primarily necessary for drug safety and detailed information may be supportive in the event of legal action. The more detailed the characterization of the composition is, the easier it is to detect links between different counterfeit cases (Degardin et al. 2015). Such evidence, used in a forensic intelligence context, enables to deliver additional information for law enforcement (Ribaux 2003). ...
Article
Full-text available
Application of NMR spectroscopy to derive in-depth characterization of structure and dynamical properties of biomolecules is well established nowadays in many laboratories. Most of these methods rest on the availability of protein labeled with stable isotopes like 13C and 15N. In this report examples are presented on the application of NMR spectroscopic methods to characterize biopharmaceutical proteins in cases no isotope labeled material are available. This is typically found in protein samples used in the development of formulations and production processes. Another important focus of this report is the application of NMR methodology in the field of counterfeit drugs of biologicals and biosimilars. Especially here, NMR does offer relevant structural and quantitative data due to the high versatility of the NMR equipment. An excurse regarding the high medical relevance for a detailed spectroscopic analysis of counterfeits will be presented.
... This enables links between the counterfeits to be detected at the bulk medicine and/or packaging levels. Combined with seizure information, such as the country and date of seizure, such information can even lead to the detection and analysis of counterfeit networks (8). ...
Article
Currently, counterfeit medicine is a significant issue for the pharmaceutical world, and it targets all types of therapeutic areas. The health consequences are appalling, since counterfeit medicines can contain impurities and the wrong chemical composition, and can be manufactured and/or stored in dreadful conditions. The provision of fast and reliable analytical tools can contribute to an efficient fight against this phenomenon. In this paper, an analytical strategy based on mobile and forensic laboratories is presented. The mobile equipment, composed of handheld x-ray fluorescence, Raman, infrared, and near-infrared spectrometers, and a handheld microscope, can be used as a first screening tool to detect counterfeits. The counterfeits can then be confirmed in a forensic-dedicated lab in which the chemical composition of the counterfeits is determined to evaluate the danger encountered by the patients. Relevant links with former counterfeit cases then can be revealed based on the analytical data, and can be interpreted from a forensic intelligence perspective in order to provide additional information for law enforcement.
... For example, people that have the same level of formal education could have different perspectives on health due to different cultural backgrounds. 19,20 These perspectives at times lead to incorrect conclusions about the relationship between socioeconomic indicators and health outcomes or health perspectives in general. The aim of this study was to determine whether or not the type of medicines (medicine for lifestyle or disease treatment) related to the socioeconomic factors based on the human development index (HDI) in eight selected countries of the world. ...
Article
Full-text available
Counterfeit medicines potentially reach 70% of the global drug markets, and the largest proportion is found in developing countries. Increasing public awareness of counterfeit medicines will automatically affect the demand for counterfeit medical products that will finally reduce counterfeit medicine activities. However, raising awareness of the dangers of counterfeit medicines is a challenging task because public health professionals need to consider diversity of social, economic and educational factors. This study examined peer-reviewed journal articles, media reports, official government and non-government reports. As many as 179 papers (1990 to 2014) were retrieved to identify the relationship between Human Development Index (HDI) of the USA, Japan, Brazil, Iran, Vietnam, Indonesia, Pakistan and Nigeria, and the type of counterfeit medicines. An electronic search was conducted using the following databases, such as Medline, Scopus, CINAHL, Embase, Google Scholar. Counterfeit disease curing medicines are found in high varieties most likely in countries with low HDI. At the same time, medicines for lifestyle are not solely found in countries with high HDI, but also exist in low to medium HDI. Abstrak Obat-obatan palsu berpotensi mencapai 70% dari pasaran obat internasional dengan proporsi terbanyak ditemukan di negara berkembang. Meningkatkan kesadaran masyarakat akan adanya obat-obatan palsu akan secara langsung memengaruhi permintaan produk obat palsu yang akhirnya akan mengurangi kegiatan pemalsuan obat. Akan tetapi, meningkatkan pengetahuan masyarakat akan bahaya obat-obatan palsu tidaklah mudah sebab profesi kesehatan masyarakat harus juga mempertimbangkan keberagaman faktor-faktor sosial, ekonomi dan pendidikan. Laporan ini menelaah artikel jurnal yang ditelaah oleh kelompok seminat, laporan media, laporan resmi pemerintah dan non-pemerintah. Sebanyak 179 artikel (dari 1990 sampai 2014) ditelaah untuk mengetahui hubungan antara indeks pembangunan manusia (IPM) dari USA, Jepang, Brasil, Iran, Vietnam, Indonesia, Pakistan dan Nigeria, dan tipe pemalsuan obat. Pencarian elektronik menggunakan pangkalan data seperti Medline, Scopus, CINAHL, Embase, Google Scholar. Obat-obatan palsu untuk pengobatan ditemukan dalam banyak ragam terutama di negara dengan IPM rendah. Pada saat yang sama, obat-obatan untuk keperluan gaya hidup tidak hanya ditemukan di negara dengan IPM tinggi, akan tetapi juga beredar di negara dengan IPM rendah dan sedang.
... This could definitely be an effective way to combat counterfeits and a good addition to special tokens, overt or covert, which are already used by various pharmaceutical companies. A complex approach to the analysis of a suspicious medicine is very important [4], a special workflow for the complex analysis is presented in [5]. However, the most reliable way to get evidence that a medicine is not a counterfeit is testing the drug itself. ...
Article
Counterfeit medicines of ‘high quality’ are the most difficult to detect as they have the same chemical composition as the genuine ones, but they are produced by underground manufacturers who violate technological regulations. Our approach is to consider a remedy as a whole object, taking into account the complex composition of APIs, excipients and manufacturing conditions. For rapid testing, the Near Infrared (NIR)-based approach is applied. It entails the acquisition of NIR spectra and processing of the collected data using a modern one-class classifier method called data driven soft independent modeling by class analogy (DD-SIMCA). We present an exemplary analysis of the suspected drugs, which have the same designation and a very similar chemical composition to the brand of a widely used medication used to treat allergies. We recognized the counterfeits using a model that had been previously developed and stored in a library for everyday monitoring in drugstores. We also describe the steps taken in development and validation of DD-SIMCA library models. In the case under consideration, the NIR-based analysis reveals 100% of counterfeits, and this result surpasses the results of the routine compedial tests. Additionally, we present a new instrument, VisCam, that is used in visual analysis of the primary and secondary packages. This instrument combines a tenfold web-camera with different light sources. It is shown that VisCam helps to reveal hidden violations in the primary and secondary packages.
... Dégardin et al. [23] propose a rational approach based on an arbitrary sampling supported by the United Nations Office on Drugs and Crime (UNODC) [24]: -if n (number of units available) <10: all units are analysed, -if 10 < n < 100: 10 units are selected randomly and analysed, -if n > 100: ...
Article
Given the harm to human health, the fight against falsified medicines has become a priority issue that involves numerous actors. Analytical laboratories contribute by performing analyses to chemically characterise falsified samples and assess their hazards for patients. A wide range of techniques can be used to obtain individual information on the organic and inorganic composition, the presence of an active substance or impurities, or the crystalline arrangement of the formulation’s compound. After a presentation of these individual techniques, this review puts forward a methodology to combine them. In order to illustrate this approach, examples from the scientific literature (products used for erectile dysfunction treatment, weight loss and malaria) are placed in the centre of the proposed methodology. Combining analytical techniques allows the analyst to conclude on the falsification of a sample, on its compliance in terms of pharmaceutical quality and finally on the safety for patients.
... The extent of occurrences of and damage caused by counterfeit medicines is difficult to evaluate, however, reports, academic papers (Newton, Green, Fernández, day & white, 2006;Chaudhry & Stumpf, 2013;dégardin, Roggo & Margot, 2014;Jack, 2016) and investigative efforts (who, 2010) indicate that these are highly profitable and severely damaging activities. Apart from health-related problems and loss of revenue, there are also concerns about terrorist acts (Cannon, 2015;dégardin et al. , 2014) and organised crime (Mackey & Liang, 2011;dégardin et al. , 2014;dégardin, Roggo & Margot, 2015) being funded through medicine counterfeiting. ...
Conference Paper
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Purpose: The purpose of this paper is to present internet sales of counterfeit medicines and list some indicators that may be used to detect rogue pharmacies and adverts for counterfeit medicines. Methods: The paper is based on a substantial literature review and analysis of websites in the Slovene language, where the purchase of medicines is (supposedly) possible. Findings: Counterfeit medicines are often sold online. Such impersonal sales provide anonymity for sellers and buyers, and easy communication with a wide range of users, especially via spam advertising and the social media. This makes illicit online pharmacies a very lucrative business. Due to the high-risk to the health of users, law enforcement, customs and regulatory authorities around the globe are combating counterfeit medicines available online. Rogue pharmacies may be identified mainly due to the lack of a postal address and telephone number, the possibility to buy prescription-only medicines without an actual medical prescription, suspiciously low prices of medicines, etc. The legitimate online pharmacies of Slovene origin, however, may be identified by a special logo. Research limitations: The research only included the analysis of web pages in the Slovene language where the purchase of medicines is (supposedly) possible. It must be also stated, that no purchase from such online pharmacies was actually made. Originality: The paper presents the situation in Slovenia with respect to a global problem of counterfeit medicines and aims to stimulate in-depth discussions on the subject among the interested stakeholders.
... The growing problem of substandard and falsified pharmaceuticals presents a serious and increasing threat to international public health and patient safety [1][2][3]. Substandard medicines result from poor manufacturing and quality assurance processes and reach the public due to lax control measures whereas falsified (counterfeit) medicines are deliberately and fraudulently labelled [4]. In reality, both falsified and substandard medicines claim to be PLOS something that they are not. ...
Article
Full-text available
The World Health Organization suggests that approximately 10% of medicines worldwide are either falsified or substandard with higher figures in low and middle income countries. Such poor quality medicines can seriously harm patients and pose a threat to the economy worldwide. This study investigates attenuated total reflectance-fourier transform infrared (ATR-FTIR) spectroscopy as a simple and rapid method for determination of drug content in tablet dosage forms. Paracetamol was used as the model pharmaceutical ingredient. Spectra of standard mixtures of paracetamol with different excipients formed the basis for multivariate PLS based quantitative analysis of simulated tablet content using different selected infrared absorbance bands. Calibration methods using ATR-FTIR were compared with the ATR-FTIR and conventional ultraviolet spectroscopic analyses of real tablet samples and showed that the paracetamol/microcrystalline cellulose mixtures gave optimum results for all spectral bands tested. The quantitative data for band 1524–1493cm⁻¹ was linear (R² ˃ 0.98; LOQ ≥ 10%w/w tablet). Global examples of paracetamol tablets were tested using this protocol and 12% of the tablet samples examined was identified as substandard. Each sample analysis was completed in just a few minutes. ATR-FTIR can therefore be used in the rapid screening of tablet formulations. The simplicity of the proposed method makes it appropriate for use in low and middle income countries where analytical facilities are not available.
... 22 Whenever counterfeit products are seized they should be examined from a forensic intelligence perspective, with all data obtained being stored into a database which will help law enforcement tackle illicit manufacture and trafficking of these items. 14 The chemical profile should be mapped along with a general physical examination of the medication and packaging. Batch numbers, best before dates and any other relevant information should be entered which, after time, will allow for quick searching of seized products against known counterfeit batches. ...
... Thus, drawing on the repetitive nature of some types of deliberate fires, and successes with other repetitive crime types [2][3][4][5][6], we advocate using an intelligence-led approach to support a more effective approach to deliberate fires [1], based on the application of the intelligence process cycle [7,8]. ...
Article
Deliberate fires are a very common problem affecting all countries around the world. They create a high sense of insecurity within communities, consuming and straining many resources (human and financial). Yet, despite various attempts, significantly tackling and reducing deliberate fires has remained largely ineffective, mainly due to the case-by-case approach implemented in responding to these incidents. Drawing on the repetitive nature of some types of deliberate fires, it was shown that adopting an intelligence-based approach is promising in tackling and reducing repetitive deliberate fires. This paper presents a two-fold procedure developed to produce intelligence on a dataset of fire events that were either deliberate or unknown in origin. Firstly, through the creation of a relevant dataset (which is a peculiar problem due to the specificities of the event of fire) and secondly through the application of specific analyses. This procedure was implemented on a dataset of fire events collated from a nine-year period in the State of Geneva, Switzerland. Results show that rudimentary data and simple processing can already generate valuable intelligence, often unsuspected until then. These results provide responding agencies with a clearer understanding of the problem, which can also support their decision-making process. This study proposes the basis for the development of an integrated real-time intelligence process. Such a process would allow the systematic and real-time monitoring of fire events in general and deliberate fires in particular by providing an immediate view of the problem, detecting recurrent events and revealing linkages between cases indicating repetitions. In terms of policies and governance, such a study should encourage institutions that deal with fires to collectively reshape their objectives, share data and analyses, and coordinate their actions to reduce harm.
... Moreover using chemometric tools, a profiling of the counterfeits can be quickly made with NIRS. The grouping of counterfeits of similar chemical composition can then be observed,providing valuable data for forensic intelligence and law enforcement[27,54,55]. Furthermore NIR devices can be miniaturized and the market has recently been spread with new portable and handheld spectrometers that allow an even faster identification on the field[21,37]. ...
... Counterfeiting of valuable certificates, banknotes, medicines, and high-end products has become a serious issue and threat worldwide while bringing forth a surge of interest in the areas of anti-counterfeiting and tracking [1][2][3]. Motivated by the ever-growing demand, much of the recent work has focused on alternatives to already existing ones including watermarks, holograms, barcodes, etc. [4][5][6]. Plenty of technologies based on plasmonic security tags [7], electromagnetic responses labels [8][9], and biomimetic micro fingerprints [10] have emerged and could achieve increased levels of security against forgery. ...
... Independently from the composition of the samples, another risk coming from the counterfeits is the appalling conditions in which they are produced and stored [9][10][11]. Organized crime has been proved to be behind the trafficking of counterfeits, thus requiring fast investigation of the cases [12][13][14][15]. Quick and efficient analytical tools are essential for the authentication of suspect samples and the detection of the compounds present in the confirmed counterfeits [16,17]. ...
... Such a limit might be added on almost all the supervised methods. The [27,54,55]. Furthermore NIR devices can be miniaturized and the market has recently been spread with new portable and handheld spectrometers that allow an even faster identification on the field [21,37]. ...
Article
Medicine counterfeiting is one of the current burdens of the pharmaceutical world. Reliable technologies have become available for the chemical analysis of suspect medicines. Near infrared spectroscopy (NIRS) allows for instance fast, specific and non-destructive authentication of pharmaceutical products. In this paper, a NIRS method is presented for the identification of 29 different pharmaceutical product families of tablets, one family containing one or more formulation (s), e.g. different dosages. This selection represents the whole tablet portfolio of our firm. The high number of product families constituted a challenge, given that the measurement of the samples, made on two similar instruments, generated a dataset of 7120 spectra. Several chemometric tools proved efficient for the identification of these medicines. The dataset was first investigated with a Principal Component Analysis (PCA) in order to provide an overview of the distribution of the samples. The K-Nearest Neighbors (KNN), the Support Vector Machines (SVM) and the Discriminant Analysis (DA) supervised classification tools were successfully applied and generated an outstanding classification rate of 100% of correct answer. The methods were then fully validated with an independent set of spectra. The DA was selected as the method for the routine analysis of suspect tablets with the Mahalanobis distance as acceptance criterion for identification. Counterfeits, generics and placebos samples, constituting a second validation set, were tested and rejected by the method. NIRS has thus been demonstrated as an efficient tool for the quick identification of a large dataset of pharmaceutical tablets and the detection of counterfeit medicines.
... Investigations and analyses of counterfeit medicines have been rising in recent years following the growing of medicines falsification worldwide [1,2]. Chemical profiling of counterfeit medicines plays an important role in forensic intelligence in order to identify the different types of falsification and illicit producers [3]. Several methods have been employed for chemical analysis of counterfeit medicines, being most common the chromatographic and spectroscopic [2]. ...
Article
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Gas chromatography (GC) is a gold standard technique used in forensic laboratories, including for the characterization of counterfeit medicines. When coupled simultaneously to flame ionization (FID) and mass detector (MS) allow the identification and quantification of medicines and drugs employing a single method, besides permitting the application of chemometric tools for forensic intelligence purposes. Here is presented a pilot study that developed and applied a simple qualitative method for the analysis of irregular medicines using a simple extraction procedure followed by GC-FID/MS analysis, with application of chemometric tools. The main purpose was to identify similarities between the all compounds detected in the irregular medicines allowing the traceability of illicit producers with the creation of a common data base. Seized medicines obtained from different producers were extracted with methanol and submitted to ultrasound and centrifugation. 1mL was then injected into the GC through simultaneous detection by FID and MS. Through the analyses it was verified that different producers of counterfeit medicines labeled as Sibutramine, added a mixture of Caffeine and Benzocaine to its formulation, respecting the same ratio of 2.2:1. Hierarchical Cluster Analysis (HCA) was able to confirm these results, showing the presence of both falsifications in the same cluster, representing the best tool to identify similar characteristics among the samples. Other interesting finding was the use of Fluoxetine as a falsification of counterfeit medicines labeled as Sibutramine and Diethylpropion. Another seized sample labeled as "Nobésio Forte", marketed as a mix of stimulants, showed mainly Caffeine and Lidocaine in its formulation. The pilot project applied primarily to 45 samples of counterfeit medicines containing amphetamine-type stimulants and antidepressants, showed the capability of perform the chemical profiling of counterfeit medicines in the solid form-powder, capsules and tablets. Further analysis can be performed for different types of medicines in solid form using the developed method, allowing the construction of a single database to perform the chemical profiling of counterfeit medicines, helping forensic intelligence to track the illicit producers.
... However, established intelligence cells within forensic science facilities are realizing the benefits to be gained from this approach. The latter is clearly demonstrated by the various examples Ribaux and Margot 2003;Esseiva et al. 2007;Baechler et al. 2012;Morelato et al. 2013;Pazos et al. 2013;D egardin 2015;Marclay 2014). Including forensic intelligence in a broad intelligence-led policing strategy adds value at many levels of law enforcement and public perceptions of safety. ...
Article
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For the past decade, the National Institute of Forensic Science (NIFS) has been involved in and committed to raising the awareness of forensic intelligence in Australia. In this context, a discussion paper was written and distributed across Australia and New Zealand covering forensic intelligence principles and offering a ‘quick reference’ guide. In addition, NIFS jointly facilitated a set of papers on forensic intelligence that was published in the Australian Journal of Forensic Sciences. The implementation of forensic intelligence requires substantial planning and adaptation within an organization. There must be commitment within an agency to refocus outcomes so that crime prevention and disruption become priorities along with the traditional focus on the court. This implies many changes including a shift from a single case focus to a multi-case focus and a breaking down of existing interdisciplinary silos. At a time of budget restrictions, the resources to implement these changes are often difficult to identify. However, established intelligence cells within forensic science facilities are realizing the benefits to be gained from this approach. The primary aim of this paper is to raise awareness on the principles and practice of forensic intelligence through the collation and integration of recently published findings and observations. It is intended to provide introductory principles to personnel of various levels and disciplines involved in law enforcement, including forensic scientists, police officers, and those involved in administering the criminal justice system.
... Developed countries have more advanced laboratory infrastructure and technology. For example, in the EU, the European Directorate for Quality Medicines (EDQM) has developed a fingerprint database of active ingredients used in the manufacture of medicines which can be identified by analytical methods, such as chromatography and spectrophotometry [42,43]. The information generated by the analytical process can be used by regulators to provide evidence and, therefore, pursue appropriate legal action. ...
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Background Substandard and Falsified (SF) medical products are a growing global concern. They harm the individual patient, the healthcare system and the economy. The World Health Organisation (WHO) has highlighted contributing factors globally: insufficient national medicine regulation, poor enforcement of existing legislation, weak stakeholder collaboration and the rise of novel viruses, such as the COVID-19. The study aimed to assess the legislative and policy framework and institutional relationships governing pharmaceuticals and anti-counterfeiting strategies. Methods The study was explorative and consisted of two phases. The first phase was between 2016 and 2017. It looked at document analysis (annual reports and press releases from 2011 to 2016) from government institutions involved in medicines regulation and law enforcement for SF seizure reports between 2004 and 2017. The second phase was between 2016 and 2018 through in-depth semi-structured interviews (seven in total) with selected stakeholders. Results First Phase—the data collected and reported by various departments was sporadic and did not always correlate for the same periods indicating, a lack of a central reporting system and stakeholder collaboration. In South Africa, counterfeiting of medicines mainly involves the smuggling of non-registered goods. The most common counterfeit items were painkillers, herbal teas, herbal ointments, while some were medical devices. Furthermore, Customs identified South Africa as a transhipment point for SF infiltration to neighbouring countries with less robust regulatory systems. Second phase—interview transcripts were analysed by thematic coding. These were identified as the adequacy of legislation, institutional capacity, enforcement and post-market surveillance, stakeholder collaboration and information sharing, and public education and awareness. Conclusion Document analysis and interviews indicate that South Africa already has a national drug policy and legislative framework consistent with international law. However, there is no specific pharmaceutical legislation addressing the counterfeiting of medicines. Law enforcement has also been complicated by poor stakeholder engagement and information sharing.
... shoemarks, DNA profiles, chemical profiles of substances, projectiles, images) to monitor various types of repetitive crime (e.g. high volume crimes, the use of false identity documents, the distribution of counterfeit medicine), have demonstrated the potential of the approach (Baechler et al., 2012;Lammers, 2013;Rossy et al., 2013;Dégardin et al., 2015;. ...
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Counterfeits are now world-wide issue. An anti-counterfeit technology with high security level (unclonable), high through-put rate of authentication, and low cost is desirable. Nanotag of plasmonic nanostructure with surface enhanced Raman scattering (SERS) activity is promised for the ideal authentication. The gold nanoparticle (AuNP) self-assemblies were applied to SERS active “stealth nanobeacon” for authentication. Mild deposition of aqueous dispersion of self-assembled AuNP was used. 10 ng AuNP assemblies deposited on a commercial medicine tablet were almost invisible to the eye. Distinguishable SERS signals of reporting molecules was produced by 1s irradiation of 785 nm laser over the nanobeacon, while Raman spectrum of the ingredients was observed on the tablet without the nanobeacon. Rapid authentication of tablets stocked for 60 days was sufficiently carried out. It is considered that the presence of discrete AuNP assemblies allows excellent performances of stealth nanobeacon
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Counterfeit, fake, adulterated or falsified drugs and pharmaceuticals, could be branded or generic drugs, excipients and active substances (in drugs and vaccines), medical supplies and devices, etc, intended to pass as the original. Counterfeits are always inferior in terms of quality, safety and efficacy compared to the original pharmaceuticals, and subsequently, they pose an unpredictable risk to public health and lead to loss of confidence in medicines, healthcare providers, and health systems. In the decades before the outbreak of the COVID-19 pandemic, a constant trend of increased trafficking was reported. However, the pandemic created a combination of public health emergency, economic distress, and misinformation-driven panic that made problematic the access and supply of high quality essential medicines and health products, and pushed consumers and vendors even more towards counterfeit pharmaceuticals. This contribution aims to review the trends in counterfeit drugs and pharmaceuticals trafficking, the health impact of their use, as well as, measures and actions implemented to restrict their proliferation, before and during COVID-19 pandemic; the relative recommendations, the expressed perspectives and the existing limitations are thoroughly discussed.
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E-Commerce evolved as a significant Business-to-Business (B2B), Business-to-Customer (B2C) marketing and selling approach. It provides many advantages over traditional retail sales such as geographical limitations, lower cost, fast go-to-market time, target direct customers, and wider reachability to customers. With digital transformation, pharmaceutical companies are taking a step back and revisiting everything they do, from internal systems to customer interactions both online and in person. E-Commerce are in many different formats such as branded website, mobile app, marketplaces like Amazon and eBay, and social media platforms like Facebook Marketplace, Instagram Shoppable Ads, and Pinterest Buyable Pins. Most of social media platforms have their own marketplace where traders can sell products directly to customer without following required guideline and mandate. These platforms do not have effective mechanisms to validate product source and authenticity. Criminals and counterfeiter take it as an opportunity to sell fake drugs to customer by offering attractive price and dispensing without doctors' prescriptions. Drug counterfeiters use many online tools to locate their customers based on online search history, trends, and health conditions. There is a need of powerful regulation on pharmaceutical sales in social media and dark web which can impose strong penalties on criminals and counterfeiters.
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Aggregation-induced emission (AIE) of 2D protein supramolecular nanofilm to exhibit multiple functions is achieved for the first time at the air/water interface or on a solid surface at a timescale of several minutes. The mixture of lysozyme, tris(2-carboxyethyl)phosphine (TCEP) and 9,10-distyrylanthracene with two ammonium groups (DSAI) results in the rapid synthesis of a phase-transited lysozyme (PTL) AIE nanofilm, coating or ink from a neutral aqueous solution at room temperature. The multifunctionality of these waterborne biocompatible DSAI@PTL AIE materials shows some potential applications such as anti-bacterial and anti-counterfeiting for edible items or living creatures. This strategy combines the advantages of AIE with 2D biopolymer suprastructure and provides an eco-friendly interfacial material with biological functions and applications. By introducing versatile AIE molecules with different functions and emissions, the development of optically active bio-mimic materials with a wide range of applications could be opened up, such as multi-colour polymer coatings.
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Plastic bottles are commonly encountered in drug cases where they are used as packaging materials and produced with polymers. However, to the best of our knowledge, systematic studies on the evidential values of medicine bottles have not been carried out. Therefore, it is difficult practically to determine if it is possible to identify whether the plastic bottles are manufactured with the same steel mold by comparing the manufacturing marks on plastic bottles. This paper reports the successful attempt of the authors in establishing a definite relationship between three different medicine bottles with a steel mold recovered from suspects. Fourier transform infrared spectroscopy (FT‐IR) was used to characterize the chemical composition of submitted medicine bottles, and then some physical characteristics (viz., total length, length, and diameter of different parts) and the manufactured marks on these bottles were examined. The results showed that the linkage of the medicine bottles to a steel mold was successfully established using the similarities in physical characteristics and manufacturing marks. In the process, the FT‐IR was only complementary in the identification process. The individual characteristics of plastic medicine bottles included the imperfections and striated impressions that were produced by the grinding patterns on the inner surface of a steel mold.
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Molecules exist in different isotopic compositions and most of the processes, physical or chemical, in living systems cause selection between heavy and light isotopes. Thus, knowing the isotopic fractionation of the common atoms, such as H, C, N, O or S, at each step during a metabolic pathway allows the construction of a unique isotope profile that reflects its past history. Having access to the isotope abundance gives valuable clues about the (bio)chemical origin of biological or synthetic molecules. Whereas the isotope ratio measured by mass spectrometry provides a global isotope composition, quantitative NMR measures isotope ratios at individual positions within a molecule. We present here the requirements and the corresponding experimental strategies to use quantitative NMR for measuring intramolecular isotope profiles. After an introduction showing the historical evolution of NMR for measuring isotope ratios, the vocabulary and symbols - for describing the isotope content and quantifying its change - are defined. Then, the theoretical framework of very accurate quantitative NMR is presented as the principle of Isotope Ratio Measurement by NMR spectroscopy, including the practical aspects with nuclei other than ²H, that have been developed and employed to date. Lastly, the most relevant applications covering three issues, tackling counterfeiting, authentication, and forensic investigation, are presented, before giving some perspectives combining technical improvements and methodological approaches.
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Counterfeiting and inverse engineering of security and confidential documents, such as banknotes, passports, national cards, certificates, and valuable products, has significantly been increased, which is a major challenge for governments, companies, and customers. From recent global reports published in 2017, the counterfeiting market was evaluated to be $107.26 billion in 2016 and forecasted to reach $206.57 billion by 2021 at a compound annual growth rate of 14.0%. Development of anticounterfeiting and authentication technologies with multilevel securities is a powerful solution to overcome this challenge. Stimuli-chromic (photochromic, hydrochromic, and thermochromic) and photoluminescent (fluorescent and phosphorescent) compounds are the most significant and applicable materials for development of complex anticounterfeiting inks with a high-security level and fast authentication. Highly efficient anticounterfeiting and authentication technologies have been developed to reach high security and efficiency. Applicable materials for anticounterfeiting applications are generally based on photochromic and photoluminescent compounds, for which hydrochromic and thermochromic materials have extensively been used in recent decades. A wide range of materials, such as organic and inorganic metal complexes, polymer nanoparticles, quantum dots, polymer dots, carbon dots, upconverting nanoparticles, and supramolecular structures, could display all of these phenomena depending on their physical and chemical characteristics. The polymeric anticounterfeiting inks have recently received significant attention because of their high stability for printing on confidential documents. In addition, the printing technologies including hand-writing, stamping, inkjet printing, screen printing, and anticounterfeiting labels are discussed for introduction of the most efficient methods for application of different anticounterfeiting inks. This review would help scientists to design and develop the most applicable encryption, authentication, and anticounterfeiting technologies with high security, fast detection, and potential applications in security marking and information encryption on various substrates.
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Purpose This paper examines the scope of anorectics in counterfeit weight-reducing formulations and provides insight into the present state of research in determining such adulterants. Analytical techniques utilised in profiling adulterants found in slimming products, including limitations and mitigation steps of these conventional methods are also discussed. The current legal status of the anorectics and analogues routinely encountered in non-prescription slimming formulations is also explored. Methods All reviewed literature was extracted from Scopus, Web of Science, PubMed, and Google Scholar databases using relevant search terms, such as, ‘counterfeit drugs’, ‘weight loss drugs’, ‘weight-reducing drugs’, ‘slimming drugs’, ‘anorectic agents’, and ‘counterfeit anorexics’. Legislation related to anorectics was obtained from the portals of various government and international agencies. Results Anorectics frequently profiled in counterfeit slimming formulations are mostly amphetamine derivatives or its analogues. Five routinely reported pharmacological classes of adulterants, namely anxiolytics, diuretics, antidepressants, laxatives, and stimulants, are mainly utilised as coadjuvants in fake weigh-reducing formulations to increase bioavailability or to minimise anticipated side effects. Liquid and gas chromatography coupled with mass spectrometric detectors are predominantly used techniques for anorectic analysis due to the possibility of obtaining detailed information of adulterants. However, interference from the complex sample matrices of these fake products limits the accuracy of these methods and requires robust sample preparation methods for enhanced sensitivity and selectivity. The most common anorectics found in counterfeit slimming medicines are either completely banned or available by prescription only, in many countries. Conclusions Slimming formulations doped with anorectic cocktails to boost their weight-reducing efficacy are not uncommon. Liquid chromatography combined with mass spectrometry remains the gold standard for counterfeit drug analysis, and requires improved preconcentration methods for rapid and quantitative identification of specific chemical constituents. Extensive method development and validation, targeted at refining existing techniques while developing new ones, is expected to improve the analytical profiling of counterfeit anorectics significantly.
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Analysis of illicit drugs and medicines in forensic laboratories requests a constant improvement and update of protocols and analytical techniques to follow the new trends employed by the illicit producers. Therefore, the application of reliable and fast techniques to identify the chemical profiling of seized samples, allowing the detection of the different types of adulteration performed, is urgent. In this study, Paper Spray Ionization (PSI) coupled to Fourier Transform Ion Cyclotron Resonance Mass Spectrometry (FT-ICR MS) was used for the determination of chemical profiling of 92 samples of counterfeit medicines and ecstasy tablets. Then, all the samples were evaluated by principal component analysis (PCA) to discriminate their chemical composition. By the results were identified different strategies of medicines counterfeiting, as the change of API and the employment of a mixture of substances to produce distinct medicines. A cross-contamination of the medicines with cocaine and 3,4-methylenedioxymethamphetamine (MDMA) was also detected. Moreover, were identified the compounds cassaidine and glyceryl nonivamide in the three classes of the seized medicines analyzed. Such compounds act as new markers of illicit production, not reported before in counterfeit samples. The majority of ecstasy tablets showed the main compound MDMA and some samples presented ethylone in its composition. By PSI-MS combined with chemometrics it was performed the identification of substances present in the seized medicines and ecstasy tablets, through a simple, fast and reliable procedure. Therefore, it was possible to connect the substances present in the seized material according to their chemical profiling, producing important evidences for police intelligence, constituting a great tool to be employed in forensic laboratories.
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An isocratic reversed-phase high performance liquid chromatographic method has been developed and validated to simultaneously determine nicotinic acid, pravastatin sodium, rosuvastatin calcium, atorvastatin calcium, pitavastatin calcium, lovastatin sodium and simvastatin sodium in focus on counterfeit drug detection. Thin-layer chromatography, nuclear magnetic resonance and mass spectrometry have been additionally performed to verify the identification of adulterants of counterfeit herbal medicines. Chromatographic separation was carried out on Inertsil® ODS-3 C18 (4.6 × 150 mm, 5 μm) with isocratic mobile phase elution containing a mixture of acetonitrile: methanol: 25 mM potassium dihydrogen phosphate buffer, pH 2.86 adjusted with 0.1 M o-phosphoric acid (48: 30: 22, v/v/v), at a flow rate of 1 mL/min and with UV detection at 238 nm. The design of experiment methodology, Plackett–Burman and Box–Behnken designs, was used to screen and optimize the mobile phase composition. The validation of the method was also carried out under the International Conference on Harmonization guidelines. The developed method was sensitive, accurate, simple, economical and highly robust, in addition to the comprehensiveness and novelty of this method for separating the seven drugs. The results were statistically compared with the reference methods used Student’s t-test and variance ratio F-test at P < 0.05.
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For the last ten years, quantitative isotope ratio monitoring 13C NMR (irm-13C NMR) has been successfully tested and proved as an efficient tool for the determination of the position-specific determination of 13C/12C ratios. Several applications in different domains have shown its interest. In the context of origin assignment, the possibility to track the distribution network of illicit drugs or cutting agents is of prime importance. However irm-13C NMR still suffers from a relative lack of sensitivity limiting its dissemination among control laboratories. Improvements were proposed to reduce experiment time by using the INEPT sequence (“Insensitive Nuclei Enhanced by Polarization Transfer”) based on polarization transfer from highly sensitive 1H to less sensitive 13C. Several applications based on the use of the one bond scalar coupling between 1H and 13C (1JCH) have shown the potential of this methodology in terms of short experimental duration. However, the isotopic information given by quaternary carbons was lost. The aim of this study is to extend this approach by using short and long range coupling (1JCH, 2JCH and 3JCH) in order to have access to all 13C/12C position-specific ratios, i.e. acquisition of the full spectrum (FS-INEPT). It is shown that this innovative tool provides both sensitivity gain -thanks to the long-range polarization transfer- and appropriate repeatability. The relative isotopic profiles allowed the classification of two cutting agents, caffeine and paracetamol (acetaminophen), according to their origin, as it was previously observed with “classical” irm-13C NMR but consuming much less sample and/or reducing the experimental time.
Technical Report
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Organized crime, transnational criminal networks but also «white-collar» opportunists, there are multiple forms of crime taken by counterfeit medicines trafficking and decrypted for the first time in this report. This report was presented by the Institute of Research Against Counterfeit Medicines (IRACM).
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Researchers procured a range of antimalarial, antibiotic and antimycobacterial drugs from cities in six countries: Ghana, India, Kenya, Nigeria, Tanzania, and Uganda. Semi-quantitative thin-layer chromato-graphy (TLC) and disintegration tests, Raman spectrometry, and near-infrared (NIR) spectrometry were used to measure the concentration of active ingredients and excipients (spectrometry only) to deter-mine whether the tested samples were of good quality. Overall, 15% of tested samples failed TLC, 13% of tested samples failed disintegration tests, 41% of tested samples failed NIR spectrometry, and 47% of tested samples failed Raman spectrometry. The drug testing technologies were qualitatively compared in terms of time, cost, and reliability for identifying substandard drugs in the field. NIR and Raman spectrometry compared favorably to TLC in most respects except cost. If the indirect costs of TLC— including requirements for a climate controlled location and trained laboratory staff—are considered, the cost advantage of TLC may disappear in developing countries. Key words: Raman and near-infrared spectrometry, thin-layer chromatography, counterfeit and substandard drug production, regulation of drug quality.
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The article explores why — when the counterfeiting of medicines is so prevalent, hard to detect and quietly dangerous or fatal — it remains totally unaddressed and therefore legal in international criminal law. It is argued that criminalizing the counterfeiting of medicines on an international scale would present no legally insurmountable barriers, and would offer significant advantages over the current national-scale approaches. The authors propose a legal definition of ‘counterfeit’, canvass the current legal doctrines that could be arrayed to better criminalize medicine counterfeiting, including classifying the severest instances as crimes against humanity, and explain the mechanisms necessary to close the jurisdictional gaps that are currently exploited by organized criminals who trade in counterfeit medicines across borders. They suggest that a counterfeit medicine treaty should be drafted under the auspices of the World Health Organization, and illustrate the feasibility of doing so with existing and developing treaty law on another health danger, tobacco.
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Paul Newton and colleagues argue that public health, and not intellectual property or trade issues, should be the prime consideration in defining and combating counterfeit medicines, and that the World Health Organization (WHO) should take a more prominent role.
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The present article describes the profiling process developed at the Institute of Forensic Science of the School of Crime Sciences of the Faculty of Law at the University of Lausanne. The technique is oriented towards an operational approach that can be applied directly by drug units of local law enforcement authorities. The background of the development of that technique and issues relating to data sources are outlined. Analytical, statistical and computerized methods for detecting, managing and visualizing linkages are examined in the context of drug profiling. Harmonization of methods and operational use of links are discussed and explained using examples. Finally, adequate communication of forensic information/intelligence is explored as an area of development. This endeavour has helped demonstrate the enormous potential that linking seizures made in different regional markets has for police investigations. The next stage is to focus on implementing this model in a more systematic manner and, if possible, at the national level and even the international level. That harmonization of methods should be pursued in order to maximize the potential of the detected linkages. In conclusion, links established through profiling, combined with traditional information, can be utilized to better understand the market's structure and implement medium- and long-term investigation strategies.
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This paper considers the public health impacts of the income-generating activities of organised crime. These range from the traditional vice activities of running prostitution and supplying narcotics, to the newer growth areas of human trafficking in its various forms, from international supply of young people and children as sex workers through deceit, coercion or purchase from family, through to smuggling of migrants, forced labour and the theft of human tissues for transplant, and the sale of fake medications, foodstuffs and beverages, cigarettes and other counterfeit manufactures. It looks at the effect of globalisation on integrating supply chains from poorly-regulated and impoverished source regions through to their distant markets, often via disparate groups of organised criminals who have linked across their traditional territories for mutual benefit and enhanced profit, with both traditional and newly-created linkages between production, distribution and retail functions of cooperating criminal networks from different cultures. It discusses the interactions between criminals and the structures of the state which enable illegal and socially undesirable activities to proceed on a massive scale through corruption and subversion of regulatory mechanisms. It argues that conventional approaches to tackling organised crime often have deleterious consequences for public health, and calls for an evidence-based approach with a focus on outcomes rather than ideology.
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During this study, Fourier transform infrared spectroscopy (FT-IR), near infrared spectroscopy (NIR) and Raman spectroscopy were applied to 55 samples of counterfeit and imitations of Viagra and 39 samples of counterfeit and imitations of Cialis. The aim of the study was to investigate which of these techniques and associations of them were the best for discriminating genuine from counterfeit and imitation samples. Only the regions between 1800-400 cm(-1) and 7000-4000 cm(-1) were used for FT-IR and NIR spectroscopy respectively. Partial least square analysis has been used to allow the detection of counterfeit and imitation tablets. It is shown that for the Viagra samples, the best results were provided by a combination of FT-IR and NIR spectroscopy. On the other hand, the best results for the Cialis samples were provided by the combination of NIR and Raman spectroscopy (1400-1190 cm(-1)). These techniques not only permitted a clear discrimination between genuine and counterfeit or imitation samples but also the distinction of clusters among illegal samples. This might be interesting for forensic investigations by authorities.
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Counterfeit drugs are a menacing and deadly problem worldwide. The proliferation of fake drugs is astounding, with over 100 countries reporting incidents of fake drugs, according to a 2008 report from the Pharmaceutical Security Institute. And incidents of drug counterfeiting show no evidence of declining: some industry insiders suggest that the number of counterfeit medicines on the market has increased as much as 25% each year over the past several years.
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"Counterfeit Drugs Kill" is the slogan the World Health Organization (WHO) uses in its anti-counterfeiting campaign. International organizations, governments of developed and developing countries, and the pharmaceutical industry created the IMPACT initiative (International Medical Products Anti-Counterfeiting Taskforce) to take on the thriving illegal industry that makes profits by selling fake drugs. However, before committing resources, policy makers want to assess the burden caused by counterfeit drugs in comparison with other health problems that compete for the limited resources available.
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Since 1998 the serious public health problem in South East Asia of counterfeit artesunate, containing no or subtherapeutic amounts of the active antimalarial ingredient, has led to deaths from untreated malaria, reduced confidence in this vital drug, large economic losses for the legitimate manufacturers, and concerns that artemisinin resistance might be engendered. With evidence of a deteriorating situation, a group of police, criminal analysts, chemists, palynologists, and health workers collaborated to determine the source of these counterfeits under the auspices of the International Criminal Police Organization (INTERPOL) and the Western Pacific World Health Organization Regional Office. A total of 391 samples of genuine and counterfeit artesunate collected in Vietnam (75), Cambodia (48), Lao PDR (115), Myanmar (Burma) (137) and the Thai/Myanmar border (16), were available for analysis. Sixteen different fake hologram types were identified. High-performance liquid chromatography and/or mass spectrometry confirmed that all specimens thought to be counterfeit (195/391, 49.9%) on the basis of packaging contained no or small quantities of artesunate (up to 12 mg per tablet as opposed to approximately 50 mg per genuine tablet). Chemical analysis demonstrated a wide diversity of wrong active ingredients, including banned pharmaceuticals, such as metamizole, and safrole, a carcinogen, and raw material for manufacture of methylenedioxymethamphetamine ('ecstasy'). Evidence from chemical, mineralogical, biological, and packaging analysis suggested that at least some of the counterfeits were manufactured in southeast People's Republic of China. This evidence prompted the Chinese Government to act quickly against the criminal traders with arrests and seizures. An international multi-disciplinary group obtained evidence that some of the counterfeit artesunate was manufactured in China, and this prompted a criminal investigation. International cross-disciplinary collaborations may be appropriate in the investigation of other serious counterfeit medicine public health problems elsewhere, but strengthening of international collaborations and forensic and drug regulatory authority capacity will be required.
Book
This study develops and applies a rigorous methodology to estimate the incidence of counterfeit and pirated items in world trade. This methodology can be used in the future to refine the assessment as the quality and quantity of data improve. The study also provides an analysis of the market for counterfeit and pirated goods and the effects on various affected parties, ranging from the owners of the intellectual property rights, to consumers and governments. The study also provides a number of in-depth snapshots of different industry sectors, highlighting how those sectors are affected by counterfeiting and piracy, and how they are responding.
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Forensic intelligence is a distinct dimension of forensic science. Forensic intelligence processes have mostly been developed to address either a specific type of trace or a specific problem. Even though these empirical developments have led to successes, they are trace-specific in nature and contribute to the generation of silos which hamper the establishment of a more general and transversal model. Forensic intelligence has shown some important perspectives but more general developments are required to address persistent challenges. This will ensure the progress of the discipline as well as its widespread implementation in the future. This paper demonstrates that the description of forensic intelligence processes, their architectures, and the methods for building them can, at a certain level, be abstracted from the type of traces considered. A comparative analysis is made between two forensic intelligence approaches developed independently in Australia and in Europe regarding the monitoring of apparently very different kind of problems: illicit drugs and false identity documents. An inductive effort is pursued to identify similarities and to outline a general model. Besides breaking barriers between apparently separate fields of study in forensic science and intelligence, this transversal model would assist in defining forensic intelligence, its role and place in policing, and in identifying its contributions and limitations. The model will facilitate the paradigm shift from the current case-by-case reactive attitude towards a proactive approach by serving as a guideline for the use of forensic case data in an intelligence-led perspective. A follow-up article will specifically address issues related to comparison processes, decision points and organisational issues regarding forensic intelligence (part II).
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Counterfeit medicine is a serious global problem. Vibrational spectroscopy combined with chemometric methods can be used to combat the pharmaceutical counterfeit problem. In this study, packages containing counterfeit tablets were analyzed using Raman microscopy and two-dimensional correlation spectroscopy. Two color regions were analyzed and different chemical origins from the color region could be resolved by two-dimensional correlation spectroscopy. Univariate Raman images were used to show the spatial distribution of the chemical components and confirm the findings of two-dimensional correlation analysis.
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With the increase of globalization in trading and online shopping, phony products are on the rise in the market. This article introduces a range of technologies that have been implemented in the supply chain to deter counterfeiters. Technology for both product authentication and tracing and tracking products in the supply chain will be discussed, along with the advantages and disadvantages of each solution. Additionally, success stories on combating counterfeits are introduced. Finally, issues related to rising anti-counterfeiting costs, collaborative efforts in fighting fakes, and a multi-pronged plan are explored.
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The purpose of this paper is to identify and clarify the issues facing our society resulting from the phenomenon of serial murder. It will be argued that the extent and prevalence of serial murders in our society today is an indirect effect of the almost total lack of sharing or coordination of investigative information relating to unsolved murders and to the lack of adequate networking among law enforcement agencies in this country. This lack of coordination and networking will be referred to as linkage blindness. This inability of law enforcement to link unsolved murders to a serial pattern greatly increases the probability that this serial sequence of murders will continue until the murderer makes a mistake.
Article
La contrefaçon de médicaments est un délit qui n'a cessé d'augmenter ces dernières années. Diff érents spectromètres portables ont été proposés sur le marché afi n de permettre une détection rapide des contrefaçons sur le terrain. Les spectroscopies Raman, Infrarouge et Proche Infrarouge présentent des caractéristiques intéressantes pour l'analyse de médicaments douteux, propriétés qui sont exposées dans cet article. Une comparaison des diff érents instruments portables permet de présenter l'intérêt d'utiliser ces spectromètres pour la détection de contrefaçons. MOTS-CLÉS Contrefaçons de médicaments; Spectromètres portables; Détection sur le terrain; Raman; Infrarouge; Proche Infrarouge. Evaluation of Raman, Infrared and Near Infrared handheld spectrometers for the detection of counterfeit medicines SUMMARY Medicine counterfeiting is a crime that has been spreading within the last few years. Various handheld spectrometers have been proposed on the market for a fast fi eld detection of counterfeits. Indeed Raman, Infrared and Near Infrared spectroscopies present interesting characteristics for the analysis of suspect medicines that are presented in this paper. A comparison of different handheld instruments allows to present the interest of using these spectrometers for counterfeit detection.
Article
Counterfeit drugs are a widespread, important public health problem. This mini review reports on the current status of the issue of drug counterfeiting, with special emphasis on our findings on counterfeit anti-infectives, and the new detection tools being developed to identify and characterize fake drugs.
Article
Raman spectroscopy combined with chemometrics has recently become a widespread technique for the analysis of pharmaceutical solid forms. The application presented in this paper is the investigation of counterfeit medicines. This increasingly serious issue involves networks that are an integral part of industrialized organized crime. Efficient analytical tools are consequently required to fight against it. Quick and reliable authentication means are needed to allow the deployment of measures from the company and the authorities. For this purpose a method in two steps has been implemented here. The first step enables the identification of pharmaceutical tablets and capsules and the detection of their counterfeits. A nonlinear classification method, the Support Vector Machines (SVM), is computed together with a correlation with the database and the detection of Active Pharmaceutical Ingredient (API) peaks in the suspect product. If a counterfeit is detected, the second step allows its chemical profiling among former counterfeits in a forensic intelligence perspective. For this second step a classification based on Principal Component Analysis (PCA) and correlation distance measurements is applied to the Raman spectra of the counterfeits.
Article
Counterfeit pharmaceutical products have become a widespread problem in the last decade. Various analytical techniques have been applied to discriminate between genuine and counterfeit products. Among these, Near-infrared (NIR) and Raman spectroscopy provided promising results. The present study offers a methodology allowing to provide more valuable information for organisations engaged in the fight against counterfeiting of medicines. A database was established by analyzing counterfeits of a particular pharmaceutical product using Near-infrared (NIR) and Raman spectroscopy. Unsupervised chemometric techniques (i.e. principal component analysis - PCA and hierarchical cluster analysis - HCA) were implemented to identify the classes within the datasets. Gas Chromatography coupled to Mass Spectrometry (GC-MS) and Fourier Transform Infrared Spectroscopy (FT-IR) were used to determine the number of different chemical profiles within the counterfeits. A comparison with the classes established by NIR and Raman spectroscopy allowed to evaluate the discriminating power provided by these techniques. Supervised classifiers (i.e. k-Nearest Neighbors, Partial Least Squares Discriminant Analysis, Probabilistic Neural Networks and Counterpropagation Artificial Neural Networks) were applied on the acquired NIR and Raman spectra and the results were compared to the ones provided by the unsupervised classifiers. The retained strategy for routine applications, founded on the classes identified by NIR and Raman spectroscopy, uses a classification algorithm based on distance measures and Receiver Operating Characteristics (ROC) curves. The model is able to compare the spectrum of a new counterfeit with that of previously analyzed products and to determine if a new specimen belongs to one of the existing classes, consequently allowing to establish a link with other counterfeits of the database.
Article
The high prevalence of alprazolam abuse translates to an increased workload for crime laboratories in characterizing seized tablets. These tablets may originate as diverted pharmaceuticals or counterfeited mimics, so efficient analytical techniques should provide confirmatory data while minimizing destruction of evidence. We offer the first report of a validated forensic method for confirming alprazolam tablets by direct analysis in real time-time of flight (DART-TOF) mass spectrometric analysis. This technique provides rapid identification of target analytes with minimal sample preparation, allowing direct analysis in the atmospheric sample gap. Selectivity is achieved through high resolution and mass accuracy, unique ion fragments, and chlorine isotopic ratios. This method utilizes fragmentation in two separate voltage functions to observe the alprazolam pseudo molecular ion at 309.09070 using 40 V and major ion fragments of 281.07197 and 205.07657 at 120 V. These parameters allow our laboratory to confirm alprazolam tablets efficiently, without compromising quality forensic standards.
Article
On November 25, in Istanbul, Turkey, Ministers of Justice from Europe and around the world will meet. Many will attend to sign up to the Council of Europe’s MEDICRIME Convention, a proposed treaty to criminalise the manufacture and trade in counterfeited drugs and other medical products. The intent behind this treaty is good, but the wording creates serious difficulties, and European officials lack credibility to pursue this treaty globally as they would like. Only a treaty initiated by WHO will suffice.
Article
Acomplia was ordered over the internet resulting in the delivery of counterfeit Acomplia and imitation products. The tablets were analyzed for the presence of rimonabant. Using LC-DAD-MSn the presence of effective quantities of rimonabant was confirmed in samples A-D. Samples A and D also contained traces of the rimonabant analogue NIDA-41020. Furthermore, NIR spectroscopy on the tablets indicated the presence of an unapproved rimonabant polymorph in samples C and D which was confirmed by Raman spectroscopy and X-ray diffraction (XRD). In sample E a low dose of sibutramine was found as well traces of N-desmethylsibutramine and bis-N-desmethylsibutramine. Rimonabant was withdrawn from the market because of serious adverse events and lack of efficacy. The availability of poor quality products with rimonabant, impurities and unapproved polymorphs is worrying. Suspect weight-loss medicines should be screened for the presence of novel analogues.
Article
Thèse sc. forensiques Lausanne, 2004. Literaturverz. Université, Lausanne
Article
Ce travail de thèse décrit dans un premier volet le contexte historique et géopolitique de l'héroïne et de la cocaïne, ainsi que la composition chimique des produits et les étapes de leur fabrication. Le second volet est consacré à la description du concept du profilage et aux méthodes d'analyses chimiques et de comparaison de profils. Le troisième volet présente l’utilisation d’outils permettant une gestion et une visualisation des liens chimiques mis en évidence. L'ensemble de la démarche s'inscrit dans le but visant à cerner mieux les rouages de l’organisation du trafic de stupéfiants et de proposer une architecture cohérente et efficace de la gestion des analyses des produits stupéfiants. Le résultat permet de fournir une information opérationnelle utile aux forces de police actives dans la lutte contre le trafic de stupéfiant. Enfin une réflexion est menée sur l’interprétation des résultats et la valeur probante de ceux-ci, notamment lorsqu’une expertise est rédigée à l’attention d’un magistrat ou d’un tribunal.
Article
Counterfeiting and the sale of substandard pharmaceutical products can no longer be ignored. At 10% of global trade, counterfeiting is affecting many countries, causing serious downstream expenses and resource shortages. To describe the nature and impact of drug product counterfeiting and substandard product sale and to present strategies that may have value in ameliorating these phenomena. A literature review was conducted, supplemented by interviews of key leaders/experts in the field and the search of relevant web sites. All of the data were combined, integrated, and coordinated to present the complete picture of this problem. In addition to known corruption in some of the least developed countries, the trail through developed countries was detected. This report identifies means to detect faulty products and describes efforts toward resisting and ending these corrupt practices. Counterfeit drugs, if not stopped, can be responsible for a macroeconomic pandemic where major portions of some populations may be too ill to work and where the health sector resources are completely overwhelmed, as with the case of HIV/AIDS.
Article
Near infrared chemical imaging (NIR-CI) analysis was performed on 55 counterfeit Heptodin tablets obtained from a market survey and an additional 11 authentic Heptodin tablets for comparison. The aim of the study was to investigate whether NIR-CI can be used to detect the counterfeit tablets and to classify/source them so as to understand the possible number of origins to aid investigators and authorities to shut down counterfeiting operations. NIR-CI combined with multivariate analysis is particularly suited to compare chemical and physical properties of samples, since it is a quick and non-destructive method of analysis. Counterfeit tablets were easily distinguished from the authentic ones. Principal component analysis (PCA) and k-means clustering were performed on the data set. The results from both analyses grouped the counterfeit tablets in 13 main groups. The main groups found with both methods were quite consistent. Out of the 55 tablets only 18% contained the correct active pharmaceutical ingredient (API), i.e., the anti-viral drug lamivudine. The remaining 82% of counterfeit tablets contained talc and starch as main excipients. The API containing tablets classified into three main groups, based mainly on the amount of lamivudine present in the tablet. The group which had close to the correct amount of lamivudine sub-classified into three groups. From the analysis carried out, it is likely that the counterfeit tablets originate from as many as 15 different sources.
Article
Two isocratic liquid chromatography (LC) methods have been developed for the purity estimation and quantitative determination of sibutramine HCl, using 4-chloro aniline and lovastatin as internal standards, respectively. The precision has been checked in terms of F-test variance ratio using latter method as reference. The ratio of variances of the two methods is close to unity, confirming their good precision. The correlation coefficient for linear regression is more than 0.999. The inter and intra-day precision is found to be < 1.3% RSD. The accuracy determined as relative mean error (RME) for the intra-day assay is +/- 1.7%. The enantiomeric separation of sibutramine by chiral chromatography method has been described also. This method is capable of separating the two enantiomers with a selectivity of 1.4 and a resolution of 4.0. Both methods are found to be stability indicating and useful in the quality control of the bulk material.
Article
A model that is based on the knowledge of experienced investigators in the analysis of serial crime is suggested to bridge a gap between technology and methodology. Its purpose is to provide a solid methodology for the analysis of serial crimes that supports decision making in the deployment of resources, either by guiding proactive policing operations or helping the investigative process. Formalisation has helped to derive a computerised system that efficiently supports the reasoning processes in the analysis of serial crime. This novel approach fully integrates forensic science data.
Article
This article has no abstract; the first 100 words appear below. In May 2002, thousands of vials of Procrit (epoetin) labeled as containing 40,000 units were found to contain only 2000 units, and later that year, other vials of Procrit were found to contain nothing but Miami tap water. In the spring of 2003, there were reports that some Lipitor (atorvastatin) pills tasted bitter, caused a burning sensation on the tongue, and were too large. In February 2004, several Web sites sold unsuspecting consumers contraceptive patches, under the Ortho Evra brand name, that contained no active ingredient. These incidents were determined to involve counterfeit drugs, resulted in the recall of thousands . . . Source Information From the Food and Drug Administration, Rockville, Md.
Article
A Fast Chemical Identification System (FCIS) consisting of two colour reactions based on functional groups in molecules of macrolide antibiotics and two TLC methods was developed for screening of fake macrolide drugs. The active ingredients could be extracted from their oral preparations by absolute alcohol. Sulfuric acid reaction as a common reaction of macrolides was first used to distinguish the macrolides from other types of drugs and then 16-membered macrolides and 14-membered ones were distinguished by potassium permanganate reactions depending on the time of loss of colour in the test solution; after which a TLC method carried out on a GF(254) plate (5 cm x 10 cm) was chosen to further identification of the macrolides. The mobile phase A consisting of ethyl acetate, hexane and ammonia (100:15:15, v/v) was used for the identification of 14-membered macrolides, and the mobile phase B consisting of trichloromethane, methanol and ammonia (100:5:1, v/v) was used for the identification of 16-membered ones. A suspected counterfeit macrolide preparation can be identified within 40 min. The system can be used under different conditions and has the virtues of robustness, simplicity and speed.
Article
In support of the efforts to combat the illegal sale and distribution of counterfeit anti-malarial drugs, we evaluated a new analytical approach for the characterization and fast screening of fake and genuine artesunate tablets using a combination of Raman spectroscopy, Spatially Offset Raman Spectroscopy (SORS) and Attenuated Total Reflection-Fourier Transform Infrared (ATR-FTIR) imaging. Vibrational spectroscopy provided chemically specific information on the composition of the tablets; the complementary nature of Raman scattering and FTIR imaging allowed the characterization of both the overall and surface composition of the tablets. The depth-resolving power of the SORS approach provided chemically specific information on the overall composition of the tablets, non-invasively, through a variety of packaging types. Spatial imaging of the tablet surface (using ATR-FTIR) identified the location of domains of excipients and active ingredients with high sensitivity and enhanced spatial resolution. The advantages provided by a combination of SORS and ATR-FTIR imaging in this context confirm its potential for inclusion in the analytical protocol for forensic investigation of counterfeit medicines.
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