Counterfeit Drug

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Bryan A Liang - One of the best experts on this subject based on the ideXlab platform.

  • Counterfeit Drug penetration into global legitimate medicine supply chains a global assessment
    American Journal of Tropical Medicine and Hygiene, 2015
    Co-Authors: Tim K Mackey, Bryan A Liang, Peter York, Thomas Kubic
    Abstract:

    Abstract. Counterfeit medicines are a global public health risk. We assess Counterfeit reports involving the legitimate supply chain using 2009–2011 data from the Pharmaceutical Security Institute Counterfeit Incident System (PSI CIS) database that uses both open and nonpublic data sources. Of the 1,510 identified CIS reports involving Counterfeits, 27.6% reported China as the source country of the incident/detection. Further, 51.3% were reported as Counterfeit but the specific Counterfeit subcategory was not known or verifiable. The most prevalent therapeutic category was anti-infectives (21.1%) with most reports originating from health-related government agencies. Geographically, Asian and Latin American regions and, economically, middle-income markets were most represented. A total of 127 (64.8%) of a total of 196 countries had no legitimate supply chain CIS Counterfeit reports. Improvements in surveillance, including detection of security breaches, data collection, analysis, and dissemination are urgently needed to address public health needs to combat the global Counterfeit medicines trade.

  • the global Counterfeit Drug trade patient safety and public health risks
    Journal of Pharmaceutical Sciences, 2011
    Co-Authors: Tim K Mackey, Bryan A Liang
    Abstract:

    Counterfeit Drugs are a global problem with significant and well-documented consequences for global health and patient safety, including Drug resistance and patient deaths. This multibillion-dollar industry does not respect geopolitical borders, and threatens public health in both rich and resource-poor nations alike. The epidemiology of Counterfeits is also wide in breadth and scope, including thousands of Counterfeit incidents per year, encompassing all types of therapeutic classes, and employing a complex global supply chain network enabling this illegal activity. In addition, information technologies available through the Internet and sales via online pharmacies have allowed the criminal element to thrive in an unregulated environment of anonymity, deception, and lack of adequate enforcement. Though recent global enforcement efforts have led to arrests of online Counterfeit sellers, such actions have not stemmed supplies from illegal online sellers or kept up with their creativity in illegally selling their products. To address this issue, we propose a global policy framework utilizing public-private partnership models with centralized surveillance reporting that would enable cooperation and coordination to combat this global health crisis.

  • global health commentary the global Counterfeit Drug trade patient safety and public health risks
    2011
    Co-Authors: Tim K Mackey, Bryan A Liang
    Abstract:

    Counterfeit Drugs are a global problem with significant and well-documented consequences for global health and patient safety, including Drug resistance and patient deaths. This multibillion-dollar industry does not respect geopolitical borders, and threatens public health in both rich and resource-poor nations alike. The epidemiology of Counterfeits is also wide in breadth and scope, including thousands of Counterfeit incidents per year, encompassing all types of therapeutic classes, and employing a complex global supply chain network enabling this illegalactivity.Inaddition,informationtechnologiesavailablethroughtheInternetandsalesvia online pharmacies have allowed the criminal element to thrive in an unregulated environment of anonymity, deception, and lack of adequate enforcement. Though recent global enforcement efforts have led to arrests of online Counterfeit sellers, such actions have not stemmed supplies from illegal online sellers or kept up with their creativity in illegally selling their products. To address this issue, we propose a global policy framework utilizing public-private partnership models with centralized surveillance reporting that would enable cooperation and coordination to combat this global health crisis. © 2011 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 100:4571-4579, 2011

Tim K Mackey - One of the best experts on this subject based on the ideXlab platform.

  • Counterfeit Drug penetration into global legitimate medicine supply chains a global assessment
    American Journal of Tropical Medicine and Hygiene, 2015
    Co-Authors: Tim K Mackey, Bryan A Liang, Peter York, Thomas Kubic
    Abstract:

    Abstract. Counterfeit medicines are a global public health risk. We assess Counterfeit reports involving the legitimate supply chain using 2009–2011 data from the Pharmaceutical Security Institute Counterfeit Incident System (PSI CIS) database that uses both open and nonpublic data sources. Of the 1,510 identified CIS reports involving Counterfeits, 27.6% reported China as the source country of the incident/detection. Further, 51.3% were reported as Counterfeit but the specific Counterfeit subcategory was not known or verifiable. The most prevalent therapeutic category was anti-infectives (21.1%) with most reports originating from health-related government agencies. Geographically, Asian and Latin American regions and, economically, middle-income markets were most represented. A total of 127 (64.8%) of a total of 196 countries had no legitimate supply chain CIS Counterfeit reports. Improvements in surveillance, including detection of security breaches, data collection, analysis, and dissemination are urgently needed to address public health needs to combat the global Counterfeit medicines trade.

  • the global Counterfeit Drug trade patient safety and public health risks
    Journal of Pharmaceutical Sciences, 2011
    Co-Authors: Tim K Mackey, Bryan A Liang
    Abstract:

    Counterfeit Drugs are a global problem with significant and well-documented consequences for global health and patient safety, including Drug resistance and patient deaths. This multibillion-dollar industry does not respect geopolitical borders, and threatens public health in both rich and resource-poor nations alike. The epidemiology of Counterfeits is also wide in breadth and scope, including thousands of Counterfeit incidents per year, encompassing all types of therapeutic classes, and employing a complex global supply chain network enabling this illegal activity. In addition, information technologies available through the Internet and sales via online pharmacies have allowed the criminal element to thrive in an unregulated environment of anonymity, deception, and lack of adequate enforcement. Though recent global enforcement efforts have led to arrests of online Counterfeit sellers, such actions have not stemmed supplies from illegal online sellers or kept up with their creativity in illegally selling their products. To address this issue, we propose a global policy framework utilizing public-private partnership models with centralized surveillance reporting that would enable cooperation and coordination to combat this global health crisis.

  • global health commentary the global Counterfeit Drug trade patient safety and public health risks
    2011
    Co-Authors: Tim K Mackey, Bryan A Liang
    Abstract:

    Counterfeit Drugs are a global problem with significant and well-documented consequences for global health and patient safety, including Drug resistance and patient deaths. This multibillion-dollar industry does not respect geopolitical borders, and threatens public health in both rich and resource-poor nations alike. The epidemiology of Counterfeits is also wide in breadth and scope, including thousands of Counterfeit incidents per year, encompassing all types of therapeutic classes, and employing a complex global supply chain network enabling this illegalactivity.Inaddition,informationtechnologiesavailablethroughtheInternetandsalesvia online pharmacies have allowed the criminal element to thrive in an unregulated environment of anonymity, deception, and lack of adequate enforcement. Though recent global enforcement efforts have led to arrests of online Counterfeit sellers, such actions have not stemmed supplies from illegal online sellers or kept up with their creativity in illegally selling their products. To address this issue, we propose a global policy framework utilizing public-private partnership models with centralized surveillance reporting that would enable cooperation and coordination to combat this global health crisis. © 2011 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 100:4571-4579, 2011

Thomas Kubic - One of the best experts on this subject based on the ideXlab platform.

  • Counterfeit Drug penetration into global legitimate medicine supply chains a global assessment
    American Journal of Tropical Medicine and Hygiene, 2015
    Co-Authors: Tim K Mackey, Bryan A Liang, Peter York, Thomas Kubic
    Abstract:

    Abstract. Counterfeit medicines are a global public health risk. We assess Counterfeit reports involving the legitimate supply chain using 2009–2011 data from the Pharmaceutical Security Institute Counterfeit Incident System (PSI CIS) database that uses both open and nonpublic data sources. Of the 1,510 identified CIS reports involving Counterfeits, 27.6% reported China as the source country of the incident/detection. Further, 51.3% were reported as Counterfeit but the specific Counterfeit subcategory was not known or verifiable. The most prevalent therapeutic category was anti-infectives (21.1%) with most reports originating from health-related government agencies. Geographically, Asian and Latin American regions and, economically, middle-income markets were most represented. A total of 127 (64.8%) of a total of 196 countries had no legitimate supply chain CIS Counterfeit reports. Improvements in surveillance, including detection of security breaches, data collection, analysis, and dissemination are urgently needed to address public health needs to combat the global Counterfeit medicines trade.

Christine Eckers - One of the best experts on this subject based on the ideXlab platform.

  • identification of the wrong active pharmaceutical ingredient in a Counterfeit halfan Drug product using accurate mass electrospray ionisation mass spectrometry accurate mass tandem mass spectrometry and liquid chromatography mass spectrometry
    Rapid Communications in Mass Spectrometry, 2003
    Co-Authors: Jeanclaude Wolff, Linda A Thomson, Christine Eckers
    Abstract:

    Methodology is presented for identifying an unknown active (pharmaceutical) ingredient (AI) in a Counterfeit Drug product. A range of mass spectrometric techniques, i.e., accurate mass mass spectrometry, tandem mass spectrometry (MS/MS) and liquid chromatography/mass spectrometry (LC/MS), has been employed to determine the AI in a Counterfeit Halfan™ suspension, an antimalarial Drug. In particular, use of LockSpray accurate mass MS/MS allowed identification of parts of the molecule from fragments, hence limiting the number of possible elemental compositions for the nominal mass of 278 found for the AI in the Counterfeit product. The analysis of the isotope pattern observed for the protonated molecule further reduced the number of possible elemental compositions. A literature search for readily commercially available compounds of molecular formula C12H14N4O2S suggested that the AI was either sulfamethazine or sulfisomidine. An LC/MS separation of those two compounds and reference MS/MS spectra obtained for sulfamethazine and sulfisomidine led to the conclusion that the AI in the Counterfeit Halfan™ suspension is sulfamethazine, which is an antibacterial agent. Copyright © 2002 John Wiley & Sons, Ltd.

Nicholas J. White - One of the best experts on this subject based on the ideXlab platform.

  • characterization of solid Counterfeit Drug samples by desorption electrospray ionization and direct analysis in real time coupled to time of flight mass spectrometry
    ChemMedChem, 2006
    Co-Authors: Facundo M Fernandez, Sivong Sengaloundeth, Christina Y Hampton, Robert B Cody, Michael D. Green, Rose Mcgready, Nicholas J. White, Paul N. Newton
    Abstract:

    The search for more versatile, sensitive, and robust ionization methods is a recurring theme in mass spectrometry (MS). Since the discovery of electrospray ionization (ESI) and matrix-assisted laser desorption/ionization (MALDI), many developments such as atmospheric pressure MALDI, nanospray ionization, Venturi-assisted electrospray, and ion-funnel atmospheric pressure interfaces, have paved the way to improved characterization of small molecules and biomolecules. One of the bottlenecks in achieving high sample throughput with both ESI and MALDI is the need to dissolve, extract, and/or filter the sample prior to analysis. Moreover, vacuum-incompatible materials cannot be easily investigated by MS without disturbing their innate structure. Recently, two novel methods for the direct ionization of solid samples under atmospheric pressure by MS were reported: desorption electrospray ionization (DESI) and direct analysis in real time (DART). More recently, McEwen et al. described a modified atmospheric pressure chemical ionization (APCI) technique for the direct analysis of solids which they named atmospheric pressure solids analysis probe (ASAP). DESI makes use of a high-speed liquid spray directed at a sample held or deposited on a surface at atmospheric pressure. Ions generated during this process are sampled by a mass spectrometer. Several DESI applications such as the mapping of analytes separated by thin-layer chromatography, the detection of explosives, and the screening of pharmaceutical tablets and illicit Drugs quickly followed the proof-of-principle description of the method. DART involves an ionizing beam of metastable He atoms (S1, 19.8 eV) generated by a corona discharge. The DART ionization mechanism is still not completely understood. In negative ion mode, the metastable He atoms generate electrons that produce negatively charged oxygen–water clusters, which then form the corresponding adducts. In positive ion mode, metastable He atoms generate protonated gaseous water clusters by Penning ionization. Then, by proton exchange, these clusters form [M+H] ions, which are generally the predominant species. DART’s high throughput coupled with the high mass accuracy now attainable with modern time-of-flight mass (TOF) analyzers and accurate isotopic abundance measurements make it especially suitable for the rapid identification of unknown species in solid materials. One particularly relevant example is Counterfeit Drug samples. Counterfeit Drugs are defined as those that are “deliberately and fraudulently mislabeled with respect to identity and/or source”. They may include products with the “wrong” ingredient(s), without active ingredient(s), or with an insufficient amount of active ingredient(s). In recent years, a particularly alarming case of Drug Counterfeiting has been reported by field researchers who have detected Counterfeit products that mimic the vital antimalarial, artesunate. The consumption of fake antimalarials has resulted in the death of many patients. Evidence suggests that the production of Counterfeit artesunate tablets is on an industrial scale. For example, one health care organization in southeast Asia unwittingly purchased 100,000 artesunate tablets which were later shown to be Counterfeit. Classic hyphenated analysis methods, such as liquid chromatography–mass spectrometry (LC–MS), lack the required sample throughput to survey such large numbers of samples in a reasonable amount of time. Figure 1a shows a schematic of the DART TOF MS setup used to screen 52 representative samples of a database containing more than 400 artesunate-based antimalarial tablets. Figure 1b and 1c show the negative ion mode DART TOF MS data of genuine and Counterfeit artesunate (M) tablets, respectively. The spectrum shown in Figure 1b has signals corresponding to the diagnostic [M H] artesunate anion (experimental m/z=383.1702, calculated m/z=383.1711) and palmitic acid, a ubiquitous contaminant. Artesunate fragment ions due to dissociation of the highly labile artesunate carboxylic acid side [a] Prof. Dr. F. M. Fern ndez, C. Y. Hampton School of Chemistry and Biochemistry Georgia Institute of Technology 770 State St. Atlanta, GA 30332 (USA) Fax: (+1)404-385-6447 E-mail : facundo.fernandez@chemistry.gatech.edu [b] Dr. R. B. Cody JEOL USA, Inc. 11 Dearborn Road, Peabody, MA 01960 (USA) [c] Dr. M. D. Green Division of Parasitic Diseases, National Center for Infectious Diseases Center for Disease Control and Prevention 1600 Clifton Road, Mailstop F12, Atlanta, GA 30333 (USA) [d] Dr. R. McGready Shoklo Malaria Research Unit Mae Sot Tak (Thailand) [e] Dr. S. Sengaloundeth Food and Drug Department Ministry of Health, Government of the Lao PDR Vientiane (Lao PDR) [f] Prof. N. J. White, Dr. P. N. Newton Microbiology Laboratory, Mahosot Hospital Wellcome Trust–Mahosot Hospital–Oxford Tropical Medicine Research Collaboration, Vientiane (Lao PDR) and Centre for Clinical Vaccinology and Tropical Medicine Churchill Hospital, Oxford University, Oxford, OX37LJ (UK) [] Prof. White is also affiliated with: Wellcome Trust–Mahidol University–Oxford Tropical Medicine Research Programme, Faculty of Tropical Medicine Mahidol University, Bangkok, 10400 (Thailand)