ArticleLiterature Review

Oncology drugs in the crosshairs of pharmaceutical crime

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Abstract

Oncology drugs clearly have become a target for pharmaceutical crime. In 2016, falsified oncology drugs ranked fifth in the most commonly falsified drug category among the reports received by the Pharmaceutical Security Institute. Although the prevalence of illicit oncology drugs in the legal supply chains appears to be small, these drugs are difficult to detect, particularly in clinical practice. Forthcoming countermeasures to detect illicit drugs in high-income countries include compulsory antitampering devices and product verification technology for a risk-based selection of medicines. Health-care professionals must implement these new procedures into their workflow and remain vigilant about those medicines that are not selected. Although countermeasures should firmly tighten supply chain security, there are concerns about how quickly pharmaceutical crime will adapt to these protections. Because patients and health-care professionals have shown a lenient attitude towards purchasing medicines from unreliable sources, measures against the highly accessible illegal medicine supply chain remain necessary. To improve detectability in clinical practice, reporting of ineffectiveness and unusual drug effects as adverse events or adverse drug reactions is essential.

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... The ineffective management of supply chains by manufacturers and distributors has allowed counterfeiters and smugglers to evolve rapidly and become very creative, and excel in producing counterfeit medicines and inserting them into the legitimate supply chains, meaning that many fake medicines go undetected [1]. To counter this issue, global organizations, such as the World Health Organization (WHO), the European Union (EU), and the US Food and Drug Administration (FDA), work together to reduce the spread of this frightening crime to protect the safety and security of patients [2]. ...
... Gautam et al. [47] discussed using simple barcode technologies by packagers to tag drug packages and prove product authenticity. Venhuis et al. [2] suggested using unique 2D barcodes on all medication packages to simplify the scanning and reveal the history and other critical information related to the medications. ...
... Improper rules and regulations, unstable policies, and a lack of common codes will eventually affect the safety of the PSC and patients [2,7,9,44,[58][59][60]. ...
Article
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Drug counterfeits have been an international issue for almost two decades, and the latest statistics show that fake medications will continue to penetrate legitimate pharmaceutical supply chains (PSCs). Therefore, identifying the issues faced by PSCs is essential to combat the counterfeit drug problem, which will require the implementation of technologies in various phases of the PSC to gain better visibility. In this regard, a literature review was conducted to fulfill the following objectives: (i) review the application of traceability technologies in various PSC phases to detect counterfeits; (ii) analyze the various barriers affecting the establishment of a safe PSC and the critical success factors used to overcome those barriers; and (iii) develop a conceptual framework and guidelines to demonstrate the influence of traceability technologies and success factors on overcoming the various barriers in different phases of the PSC. The major finding of this review was that traceability technologies and the critical success factors have a significant influence on overcoming the barriers to establishing a safe PSC.
... Recently, expensive medicines such as therapeutic proteins/peptides (e.g. antibodies) have become prone to falsification as well, mainly in HICs [9][10][11]. ...
... Falsified products are introduced on the market at different stages of production and inter-and intranational distribution and each of these stages has its challenges [10] (Table 1). ...
... Costly medicines are an attractive target for falsifications. Protein and peptide-based medicines, for instance, have become more prone to falsification as they are both expensive and falsifications are harder to detect [10,36]. Detection is harder because these medicines are generally colorless fluids and require complex detection methods. ...
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Falsified medicines affect public health all around the globe. Complex distribution routes, illegal online webshops and reuse of packaging materials make them hard to detect. In order to tackle this problem, detection methods for the recognition of suspicious medicines and subsequent confirmation of falsification by analytical techniques is required. In this review, we focus on the developments and challenges that existed in the last five years (2015-2020) in the detection and analysis of falsified medicines. These challenges might have not been solved yet or arisen with new types of falsifications, new analytical techniques or detection strategies. Detection of suspicious medicines starts with visual inspection of packaging materials. However, re-use of packaging materials and high-quality imitations complicate visual inspection. Recent developments in the analysis of packaging by microscopic and spectroscopic techniques such as optical microscopy, X-ray fluorescence, infrared spectroscopy and Raman spectroscopy or microscopy, in combination with multivariate analysis show promising results in the detection of falsified medicines. An ongoing big challenge in the analysis of falsified medicines is the affordability of analytical devices. Yet, recent reports showed that lower cost devices, such as Counterfeit Drug Indicator or Counterfeit Detection device version 3 show promising use in the detection of falsified medicines. Furthermore, combining the outcomes of different low-cost analytical techniques, such as Minilab, colorimetry and Counterfeit Drug Indicator significantly increased selectivity and sensitivity in the detection of falsified medicines. Also, recent developments make it possible to link a low-cost technique, such as TLC, to mobile phones. Proper training of personnel has shown room for improvement and remains a challenge, even for relatively simple techniques. With an increased use of analytical fingerprints, an upcoming challenge is the accessibility of the growing pool of data. There is also the need of validated reference libraries on both national and international levels. Developments of the last few years bring us a step closer in the fight against falsified medicines, however challenges remain in the worldwide accessibility of affordable, easily operable and sensitive techniques.
... The SF medicine problem cannot be narrowed down just to sexual-and other performance-enhancing medications. Several other therapeutic categories and even life-saving medicines are affected (e.g., antibiotics and antimalarials, oncotherapeutics, biological drugs, and cardiovascular medicines) (Kelesidis and Falagas, 2015;Janvier et al., 2018;Ozawa et al., 2018;Venhuis et al., 2018;Eberle et al., 2020;Tesfaye et al., 2020;Świeczkowski et al., 2022). Therefore, the health effects or harms associated with SF medicines are also showing a wide range of possibilities, such as treatment failure, toxicity, and antimicrobial resistance, making it even harder to identify. ...
... The SF medicine watchlist was developed based on Medicrime drug seizures and national Official Medicines Control Laboratories (OMCL) working actively in the market surveillance programs. Medicines such as antibiotics, antiobesity medicines, lifestyle products, anabolics, products against erectile dysfunction, and psychoanaleptics were included in the questionnaire (Anđelković et al., 2017;Venhuis et al., 2018). ...
Article
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Introduction: The public health threat of substandard and falsified medicines has been well known in the last two decades, and several studies focusing on the identification of products affected and preventing consumption have been published. However, the number of these products reaching patients and causing health consequences and adverse drug reactions is not a well-researched area. Objectives: Our aim was to identify and describe the characteristics of cases that are related to adverse drug reactions potentially originating from counterfeit medication using publicly available pharmacovigilance data. Methods: A descriptive study was performed based on pharmacovigilance data retrieved from Individual Case Safety Reports (ICSRs) identified in the European Medicines Agency’s EudraVigilance and FDA Adverse Event Reporting System (FAERS) databases in April 2022 using selected MedDRA preferred terms: counterfeit product administered, product counterfeit, product label counterfeit, product packaging counterfeit, suspected counterfeit product, adulterated product, product tampering, and suspected product tampering. ICSRs were analyzed by age and gender, by year of reporting, region of origin, reporter’s profession, and severity of the outcome. The disproportionality method was used to calculate pharmacovigilance signal measures. Results: A total of 5,253 cases in the FAERS and 1,049 cases in the EudraVigilance database were identified, generally affecting middle-aged men with a mean age of 51.055 (±19.62) in the FAERS and 64.18% of the cases between 18 and 65 years, while the male to female ratios were 1.18 and 1.5. In the FAERS database, we identified 138 signals with 95% confidence interval including sildenafil ( n = 314; PRR, 12.99; ROR, 13.04; RRR, 11.97), tadalafil ( n = 200; PRR, 11.51; ROR, 11.55; RRR, 10.94), and oxycodone ( n = 190; PRR, 2.47; ROR, 2.14; RRR, 2.47). While in the EV data 31, led by vardenafil ( n = 16, PRR = 167.19; 101.71–274.84; 95% CI, RRR = 164.66; 100.17–270.66; 95% CI, ROR = 169.47; 103.09–278.60; 95% CI, p < 0.001), entecavir ( n = 46, PRR = 161.26, RRR = 154.24, ROR = 163.32, p < 0.001), and tenofovir ( n = 20, PRR = 142.10, RRR = 139.42, ROR = 143.74, p < 0.001). Conclusion: The application of pharmacovigilance datasets to identify potential counterfeit medicine ADRs can be a valuable tool in recognition of potential risk groups of consumers and the affected active pharmaceutical ingredients and products. However, the further development and standardization of ADR reporting, pharmacovigilance database analysis, and prospective and real-time collection of potential patients with health consequences are warranted in the future.
... [4] According to WHO and the United Nations Office on Drugs and Crime, counterfeit drugs account for approximately 10% of the global pharmaceutical trade and 20-30% of all medicines in Africa, Asia, and the Middle East. [5] Furthermore, counterfeit medicines pertaining to both lifestyle and lifesaving drugs appear increasingly common in the U.S. [6] Counterfeit opioids have caused deaths in almost all states of the U.S. [7] The bolstered distribution of counterfeit medicines and pharmaceutical products can be attributed to the increased use of online pharmacies in recent years [8] and the ongoing COVID-19 pandemic scenario. Approximately 40 000 online pharmacies are currently active worldwide, with an increase of 600 every month. ...
... Fixeddesign regression with polynomial (or root-polynomial) expansions is an effective machine learning approach in the machine vision. To maximize the accuracy of color correction by taking nonlinearity into account, the authors expanded M 3 × m to M p × m that can be expressed explicitly: (5) where R, G, and B are three color intensity values in the red (R), green (G), and blue (B) channels. Among numerous combinations, polynomial expansions of the 2nd degree were used. ...
Article
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Counterfeit medicines are a fundamental healthcare problem, threatening patient safety and public health as well as causing economic damage. Online pharmacies and the ongoing pandemic have promoted medicine counterfeiting. However, the existing anticounterfeit methods are limited because of material toxicity, low security, and complicated fabrication. Here a dosage‐level security method is introduced that combines digital watermarking and physical printing at the material level. A set of requirements is designed to ensure the edibility, printability, imperceptibility, and robustness of cyber‐physical watermarking. An inkjet printer using safe food coloring is adapted to print a watermarked image on a recombinant luminescent silk protein taggant to enhance attack resistance. Machine learning of color accuracy recovers unavoidable color distortions during printing and acquisition, allowing robust smartphone readability. An edible watermarked taggant affixed to each individual medicine can offer anticounterfeit and authentication features at the dosage level, empowering every patient to aid in abating illicit medicines.
... Authorities in numerous regions, including Asia and Europe, noticed the emergence of illegal erectile dysfunction drug trade online. 13 Despite SFMs being a worldwide problem, legal implications vary among countries. In the majority of highincome countries (HICs), SFMs are less likely to infiltrate the supply chain, due to laws regarding medicine manufacture, distribution and dispensing. ...
Article
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Simultaneous expansion of the Internet and increased globalisation of the pharmaceutical industry have meant medication can be accessed transnationally from both legal and illicit sources. This has coincided with the rise of substandard and falsified medicines (SFMs) online. These products fail to meet regulatory or quality standards and/or are constituted with substandard ingredients, causing undesired pharmacological effects, including possible injury and death. This review aimed to identify original research studies that examined characteristics of SFM online sales, attitudes towards purchasing medicines online and strategies to address this drug safety challenge. Keywords of 'Substandard' and 'Falsified'/'Counterfeit' and 'Medicines'/'Drugs' and 'Online'/'Internet' were searched using Web of Knowledge and PubMed databases. Resulting literature, which satisfied the study's inclusion criteria, was included in the review, and the findings from each paper were assessed. From an initial 185 literature articles, 7 were eligible according to the inclusion criteria to be reviewed. These articles identified studies testing SFMs purchased online, surveys of attitudes and knowledge about SFMs online, and website content analysis to detect illegal online sales. Challenges identified were lack of knowledge and awareness among consumers and physicians, in addition to the use of direct-to-consumer-advertising, via Internet platforms and social media, providing easy access to SFMs. Despite this, medicine authentication technology, website verification approaches and new detection methods were identified as potential solutions specific to online SFM sales. To address online sales of SFMs, more robust research, greater awareness/educational programmes, analytical detection methods and more stringent online global governance are required.
... Ponadto podczas procesu fałszowania dochodzi do naruszenia sterylności wytwarzanych produktów, co jest szczególnie niebezpieczne w chorobach przebiegających ze znacznym obniżeniem odporności organizmu, takich jak choroba nowotworowa. Pacjenci narażeni są tym samym na infekcje oraz poważne powikłania [36]. ...
Article
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We współczesnym świecie fałszowanie produktów leczniczych stanowi poważne zagrożenie dla zdrowia i życia pacjentów. Zjawisko to występuje w wielu krajach, na wszystkich kontynentach. Światowa Organizacja Zdrowia przedstawia dane, z których wynika, iż najczęściej fałszowanymi produktami leczniczymi są leki przeciwmalaryczne oraz antybiotyki. Inną grupą fałszowanych farmaceutyków są produkty lecznicze stosowane w leczeniu zaburzeń potencji, leki odchudzające oraz steroidy anaboliczne. Niebezpieczeństwo dla zdrowia i życia związane ze stosowaniem sfałszowanych produktów leczniczych jest znaczne. Używanie takich produktów uniemożliwia zapewnienie bezpiecznej i skutecznej terapii, a ponadto powoduje wystąpienie ciężkich działań niepożądanych. Pacjenci stosujący leki sfałszowane wymagają często hospitalizacji lub dodatkowych interwencji medycznych, które negatywnie wpływają na sytuację ekonomiczną kraju. Fałszowanie produktów leczniczych powoduje naruszenie własności intelektualnej dotyczącej praw autorskich, znaków towarowych oraz patentów.
... [92][93][94][95][96][97] investigate how counterfeit drugs are introduced and their impact on health and economics. Law enforcement, strict surveillance, and awareness are the most common solutions for counterfeit medicines [98][99][100][101][102][103][104][105]. ...
Chapter
Detecting termites in wood structures is complex, and the most available detection methods are potentially damaging to property. The goal of this study is to develop a proof-of-concept termite detection system for an indoor environment. Thermal imaging and microwave radar sensors are used to detect the presence of termites, while a mobile application is used to view the termites’ status using a heat map and a wave pattern. Testing is carried out based on the reliability and efficiency of the two methods for detecting termites. The results show that the thermal camera can detect hot and cold spots on the wooden surface up to 15 cm, while the microwave radar sensor can detect termite movement inside the wood up to 3 cm.
... [92][93][94][95][96][97] investigate how counterfeit drugs are introduced and their impact on health and economics. Law enforcement, strict surveillance, and awareness are the most common solutions for counterfeit medicines [98][99][100][101][102][103][104][105]. ...
Chapter
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Rendering animations into 2D or 3D involves sequential proceeding of inputs. This causes operational bottleneck, resulting in expensive and lengthy inefficient processes. In this paper, an efficient Blender-based software for creating 3D animations from related sources is proposed. It introduces a horizontally scaled and concurrent rendering of multiple Blender-based projects. It runs in three modes that combine to accomplish its task: Master, Client, and Slave. A single Master instance exposes a web GUI to the user, maintains the master list of render job states, and controls Slave instances. Client instances are launched on demand to provide users with a GUI to submit render jobs to the Master instance. Slave instances run on rendering machines and will, in turn, launch subprocesses of Blender to render individual frames when instructed to by the Master instance. Test implementation of our solutions indicate improvements over vertical scaling (increasing the power of a single rendering machine) and greatly reduces the overall time taken to render a complex animation project.
... [92][93][94][95][96][97] investigate how counterfeit drugs are introduced and their impact on health and economics. Law enforcement, strict surveillance, and awareness are the most common solutions for counterfeit medicines [98][99][100][101][102][103][104][105]. ...
Chapter
Full-text available
Agro-allied supply chain management (ASCM) presents unique issues ranging from dependence on climate, the engagement of many actors, to the bulk of the personnel’s lack of literacy, all of which need the use of communication and information technologies (IT). The purpose of the research is to present technologies centered on the Internet of things (IoT) and describe their applicability within the agro-allied industrial supply chain of a developing nation like Nigeria. The study recognized IoT-developed technologies in the framework of ASCM based on literature. In line with the study findings, the application of IoT in the food and agro-allied sector in Nigeria may help boost the growth of the agro-allied supply chain through significant reduction of waste as well as serving users’ needs in a long-term manner. In a developing country like Nigeria, IoT-based technology can integrate multiple ASCM tasks in an industrial setting.
... The rate of counterfeit drug production has increased due to the disruption that COVID-19 has caused to all supply chains, a lack of business resilience, and the rapid misuse of technologies [8] Implementing Digital traceability of pharmaceutical drugs in supply chain has been proving a very impactful process to minimize the risk of counterfeit and illicit drugs in the market. Venhuis et al. [9] suggested using unique 2D barcodes on all medication packages to simplify the scanning and reveal the history and other critical information related to the medications. ...
Article
Full-text available
The purpose of this paper is to focus on the need of Digital traceability of pharmaceutical drugs in the supply chain so that it can ensure the optimal safety of public health. Supply chain process in the pharmaceutical industry is a critical part. It secures medicine authenticity by mitigating the risk of counterfeit drugs supply, shortage of authentic drugs in the market. This paper makes an honest attempt to assess the need for digital traceability in the pharma supply chain due to potential threat of counterfeit and illicit drugs. This perspective highlights the need for implementing blockchain traceability technology for secure track and trace systems. It further explains the advantages of implementing digital traceability with blockchain technology, in the area of pharma supply chain and how vital it is for future adoption.
... The high cost of anticancer drugs has added oncology products to the list of highly counterfeited drugs. Many LMICs lack drug quality testing infrastructure with weak regulatory systems, which make counterfeit oncology drugs difficult to detect [10,11,12,13,14]. ...
Article
Cancer is one of the leading causes of death with 9.6 million deaths registered in 2018, of which 70% occur in Africa, Asia and Central and South America, the low-and middle-income countries (LMICs). The global annual expenditure on anticancer medicines increased from $96 billion in 2013 to $133 billion in 2017. This growth rate is several folds that of newly diagnosed cancer cases and therefore estimated to reach up to $200 billion by 2022. The Uganda Cancer Institute, Uganda's national referral cancer center, has increased access to cancer medicines through an efficient and cost-saving procurement system. The system has achieved cost savings of more than USD 2,000,000 on a total of 37 of 42 essential cancer medicines. This has resulted in 85.8% availability superseding the WHO's 80% target. All selected products were procured from manufacturers with stringent regulatory authority approval or a proven track record of quality products.
... In 2016, the Pharmaceutical Security Institute ranked oncology drugs as the fifth most commonly falsified drug class. 13 More than 1,500 products have been reported to the WHO Global Surveillance and Monitoring System for substandard and falsified medical products, but , 6.3% were cancer medicines, and only 19 member states reported in this category. 14 There was no information available about how these drugs were tested or which member states reported them. ...
... In 2016, the Pharmaceutical Security Institute ranked oncology drugs as the fifth most commonly falsified drug class. 13 More than 1,500 products have been reported to the WHO Global Surveillance and Monitoring System for substandard and falsified medical products, but , 6.3% were cancer medicines, and only 19 member states reported in this category. 14 There was no information available about how these drugs were tested or which member states reported them. ...
Article
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PURPOSE A postmarket evaluation of chemotherapy dosage forms in Ethiopia was conducted to test the accuracy of the chemoPAD, a paper analytical device for drug quality screening. MATERIALS AND METHODS In September of 2018 in Addis Ababa, Ethiopia, 41 anticancer drug dosage forms (representing 4 active ingredients, 5 brands, and 7 lot numbers) were collected and were rapidly screened for quality using a chemotherapy paper analytical device (chemoPAD). Confirmatory analysis via high performance liquid chromatography was conducted. RESULTS The chemoPAD showed that the correct active pharmaceutical ingredient was present in doxorubicin, methotrexate, and oxaliplatin injectable dosage forms. However, 11 of 20 cisplatin samples failed the screening test. Confirmatory assay by high-performance liquid chromatography showed that all 20 cisplatin samples—comprising three lot numbers of a product stated to be Cisteen—were substandard, containing on average 54% ± 6% of the stated cisplatin content. Inductively coupled plasma optical emission spectroscopy analysis of five representative samples found 57% to 71% of the platinum that should have been present. The sensitivity of the chemoPAD for detection of falsified products could not be measured (as none were present in these samples), but the selectivity was 100% (no false positives). The sensitivity for detection of substandard products was 55%, and the selectivity was 100% (no false positives). CONCLUSION Although instrumental analysis by pharmacopeia methods must remain the gold standard for assessing overall drug quality, these methods are time consuming and patients could be exposed to a bad-quality drug while clinical workers wait for testing to be performed. The chemoPAD technology could allow clinicians to check at the point of use for serious problems in the quality of chemotherapy drugs on a weekly or monthly schedule.
... The health and economic consequences of counterfeit medicines are far more serious in low-income and middle-income countries. It is estimated that counterfeit medicines account for 10% of the global pharmaceutical trade and more than 20-30% of all medicines in Africa, Asia, and the Middle East 6,9 . ...
Article
Full-text available
Counterfeit medicines are a fundamental security problem. Counterfeiting medication poses a tremendous threat to patient safety, public health, and the economy in developed and less developed countries. Current solutions are often vulnerable due to the limited security levels. We propose that the highest protection against counterfeit medicines would be a combination of a physically unclonable function (PUF) with on-dose authentication. A PUF can provide a digital fingerprint with multiple pairs of input challenges and output responses. On-dose authentication can verify every individual pill without removing the identification tag. Here, we report on-dose PUFs that can be directly attached onto the surface of medicines, be swallowed, and digested. Fluorescent proteins and silk proteins serve as edible photonic biomaterials and the photoluminescent properties provide parametric support of challenge-response pairs. Such edible cryptographic primitives can play an important role in pharmaceutical anti-counterfeiting and other security applications requiring immediate destruction or vanishing features. Counterfeit medicines are a threat to patient health and public safety. Here, the authors use random patterns formed by fluorescent silk microparticles with various excitation and emission pairs as an edible physical unclonable function that can directly be attached onto the surface of medicines.
... 4 In addition to such deliberate falsification, improper storage of medications can lead to drug degradation and result in a medication of lower potency than expected. 5 Demand is increasing for chemotherapy drugs in LMICs because of increasing efforts to diagnose cancer and innovations such as the collaboration between the American Cancer Society and the Clinton Health Access Initiative to provide lower prices on 16 chemotherapy drugs in six African countries. 6 From 2012 to 2025, the cancer incidence is estimated to increase by 77%, 7 from 14.1 million to 20 million new cases diagnosed annually, and most of those cases will be diagnosed in LMICs. ...
Article
A paper analytic device, the chemoPAD, was developed and validated to visually detect methotrexate, doxorubicin, cisplatin, and oxaliplatin at concentrations commonly found in injectable dosage forms. By testing residual solution after patient treatment, the chemoPAD can be used to monitor drug quality without restriction of patient access to medication. The chemoPAD is produced by wax printing on Ahlstrom paper to create separate reaction areas and deposits small amounts of chemicals to create color changes in response to different active pharmaceutical ingredients (APIs). This creates a unique color bar code to identify each medication. Internal validation studies show that the chemoPAD has excellent sensitivity and specificity to differentiate between samples of 100% and 0% API, which is the distinction relevant to the majority of reported falsified chemotherapy cases. The platinum-containing drugs, cisplatin and oxaliplatin, can be detected semiquantitatively. The cards can be read either visually by comparison with a standard image or by using computer image analysis. Dosage forms were collected from the Ethiopian health care system and analyzed with the chemoPAD followed by high-performance liquid chromatography. A substandard sample was discovered and reported to the Ethiopian Food Medicine and Healthcare Administration and Control Authority.
... 4 In addition to such deliberate falsification, improper storage of medications can lead to drug degradation and result in a medication of lower potency than expected. 5 Demand is increasing for chemotherapy drugs in LMICs because of increasing efforts to diagnose cancer and innovations such as the collaboration between the American Cancer Society and the Clinton Health Access Initiative to provide lower prices on 16 chemotherapy drugs in six African countries. 6 From 2012 to 2025, the cancer incidence is estimated to increase by 77%, 7 from 14.1 million to 20 million new cases diagnosed annually, and most of those cases will be diagnosed in LMICs. ...
Article
Full-text available
A paper analytic device, the chemoPAD, was developed and validated to visually detect methotrexate, doxorubicin, cisplatin, and oxaliplatin at concentrations commonly found in injectable dosage forms. By testing residual solution after patient treatment, the chemoPAD can be used to monitor drug quality without restriction of patient access to medication. The chemoPAD is produced by wax printing on Ahlstrom paper to create separate reaction areas and deposits small amounts of chemicals to create color changes in response to different active pharmaceutical ingredients (APIs). This creates a unique color bar code to identify each medication. Internal validation studies show that the chemoPAD has excellent sensitivity and specificity to differentiate between samples of 100% and 0% API, which is the distinction relevant to the majority of reported falsified chemotherapy cases. The platinum-containing drugs, cisplatin and oxaliplatin, can be detected semiquantitatively. The cards can be read either visually by comparison with a standard image or by using computer image analysis. Dosage forms were collected from the Ethiopian health care system and analyzed with the chemoPAD followed by high-performance liquid chromatography. A substandard sample was discovered and reported to the Ethiopian Food Medicine and Healthcare Administration and Control Authority.
... As mentioned before, in the last decade more advanced biologicals such as different blockbuster monoclonal antibodies have been falsified. Major oncology drugs such as adalimumab, trastuzumab, rituximab and bevacizumab are prone to falsifications and have been found in the legal supply chains in the USA, Western Europe, India, Western Africa, Northern-Cyprus and Turkey [18,92,[130][131][132][133]. Analysis of the seized samples however showed that, in contrast to the earlier mentioned anabolic proteins, in most cases no API was found to be present. ...
Chapter
One of the major threats to the information and communications technology (ICT) supply chain is the introduction of counterfeit parts and components. Global efforts have been intensified to defend against counterfeiters and counterfeit products due to their detrimental impact on the economy, safety, and security. Among the extensive literature of papers, reviews, books, and articles, this review attempts to include a detailed selection of most significant research work done in the intersection of ICT, supply chains, and counterfeits to provide a reference source for researchers. Citation network and global citation scores have been used to extract and analyze papers and discuss them in different types of clusters (electronic, medical, food, and anti-counterfeiting technologies and approaches). Our review approaches the clustered papers by focusing on (1) their contribution in documenting and modeling the intrusion of counterfeit electronic parts in the ICT supply chain, (2) the proposed counterfeits’ detection and avoidance techniques in the ICT supply chain, and (3) the contribution of ICT in thwarting counterfeits in medical, pharmaceutical, and food supply chains. This review provides a better understanding of the global efforts to address counterfeits in the ICT supply chain, as well as the role of ICT in thwarting counterfeits in other supply chains, which can guide future research to minimize the impact of counterfeits on supply chains.
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Counterfeit medicines are a healthcare security problem, posing not only a direct threat to patient safety and public health but also causing heavy economic losses. Current anticounterfeiting methods are limited due to the toxicity of the constituent materials and the focus of secondary packaging level protections. We introduce an edible, imperceptible, and scalable matrix code of information representation and data storage for pharmaceutical products. This matrix code is digestible as it is composed of silk fibroin genetically encoded with fluorescent proteins produced by ecofriendly, sustainable silkworm farming. Three distinct fluorescence emission colors are incorporated into a multidimensional parameter space with a variable encoding capacity in a format of matrix arrays. This code is smartphone-readable to extract a digitized security key augmented by a deep neural network for overcoming fabrication imperfections and a cryptographic hash function for enhanced security. The biocompatibility, photostability, thermal stability, long-term reliability, and low bit error ratio of the code support the immediate feasibility for dosage-level anticounterfeit measures and authentication features. The edible code affixed to each medicine can serve as serialization, track and trace, and authentication at the dosage level, empowering every patient to play a role in combating illicit pharmaceuticals.
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Typical of most industries, digitisation of healthcare products, services and models of E-Commerce is democratizing the current healthcare system in China while unlocking new previously inaccessible healthcare segments. This monumental convergence of healthcare industry with IT is part of a larger evolution and growth of E-Commerce from simple search portals for purchasing goods and services to more integrated digital marketplace that incorporates personalized experience and informed purchase decision making into online behaviours. The result is the manifestation of a new era of healthcare consumerism, as healthcare customers demand retail-like buying experience. We performed a comprehensive systematic scoping review of published data to identify how E-Commerce is complementing the traditional healthcare delivery system in China. We note that healthcare E-Commerce is facilitating the reconstruction of the healthcare value chain in China and at the same time is helping health facilities to reengineer operations and service processes. Our study highlights the important role E-commerce is playing in the healthcare industry in China.
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Substandard and falsified (SF) medicines are a global issue contributing to antimicrobial resistance and causing economic and humanitarian harm. To direct law enforcement efficiently, halt the spread of SF medicines and antimicrobial resistance, academics, NGOs and government organisations use medicine quality sampling studies to estimate the prevalence of the problem. A systematic review of medicine quality studies was conducted to estimate how the methodological quality of these studies and SF prevalence has changed between 2013 and 2018. We also aimed to critique medicine sampling study methodologies, and the systematic review process which generates prevalence estimates. Based on 33 studies, the overall estimated median (Q1–Q3) prevalence of SF medicines appears to have remained high at 25% (7.7%–34%) compared with 28.5% in 2013. Furthermore, the methodological quality of prevalence studies has improved over the last 25 years. Definitive conclusions regarding the prevalence of SF medicines cannot be drawn due to the variability in sample sizes, consistency of design methods, and a lack of information concerning contextual factors affecting medicine quality studies. We contend that studies which present cumulative average prevalence figures are useful in a broad sense but could be improved to create more reliable estimates. We propose that medicine quality studies record the context of the study environment to allow systematic reviewers to compare like with like. Although, the academic rigour of medicine quality studies is improving, medicine sampling study limitations still exist. These limitations inhibit the accurate estimation of SF medicine prevalence which is needed to support detailed policy changes.
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Purpose of Review Breast cancer is becoming a significant burden to the healthcare system in Zimbabwe. The financial toxicity of breast cancer treatment is a significant problem for patients even in the developed world. This review looks at the management of breast cancer patients in Zimbabwe relating it to the other developed nations. Recent Findings Despite the tremendous progress made by science in the care of women with breast cancer over the past few decades, most of the women in Zimbabwe are yet to benefit from this progress. There is poor access to modern screening methods, quality chemotherapy drugs and reliable radiotherapy services and lack of evidence-based medicine derived from our own settings. Out-of-pocket payments for healthcare are still the major health-funding model, and it denies most women access to quality and appropriate healthcare services. Summary An increase in the number of medical specialists treating breast cancer over the past 10 years has resulted in a slight improvement in diagnostic and treatment capability of the country; however, resources for breast cancer management in Zimbabwe remain far from being adequate. Universal health coverage (UHC) if achieved through the drive to attain the 17 Sustainable Development Goals (SDGs) will improve care for breast cancer patients.
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Importance Substandard and falsified medicines burden health systems by diverting resources to ineffective or harmful therapies, causing medical complications and prolonging illnesses. However, the prevalence and economic impact of poor-quality medicines is unclear. Objective To conduct a systematic review and meta-analysis to assess the prevalence and estimated economic burden of substandard and falsified essential medicines in low- and middle-income countries. Data Sources Five databases (PubMed, EconLit, Global Health, Embase, and Scopus) were searched from inception until November 3, 2017. Study Selection Publications were assessed to determine whether they examined medicine quality and the prevalence and/or economic burden of substandard and falsified medicines in low- and middle-income countries. Studies with a sample size of 50 or more were included in the meta-analysis. Data Extraction and Synthesis The study is registered in PROSPERO and reported via the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines. Study quality was assessed using an adapted Medicine Quality Assessment Reporting Guidelines scoring metric. Multiple reviewers conducted the data extraction and quality assessment independently. Main Outcomes and Measures Prevalence and/or estimated economic impact of substandard and falsified medicines. Results Two hundred sixty-five studies that estimated the prevalence of poor-quality essential medicines in low- and middle-income countries were identified. Among 96 studies that tested 50 samples or more (67 839 total drug samples), overall prevalence of poor-quality medicines was 13.6% (95% CI, 11.0%-16.3%), with regional prevalence of 18.7% in Africa (95% CI, 12.9%-24.5%) and 13.7% in Asia (95% CI, 8.2%-19.1%). Of studies included in the meta-analysis, 19.1% (95% CI, 15.0%-23.3%) of antimalarials and 12.4% (95% CI, 7.1%-17.7%) of antibiotics were substandard or falsified. Eight approximations of the economic impact, focused primarily on market size, with poor or undisclosed methods in estimation were identified, ranging from $10 billion to $200 billion. Conclusions and Relevance Poor-quality essential medicines are a substantial and understudied problem. Methodological standards for prevalence and rigorous economic studies estimating the burden beyond market size are needed to accurately assess the scope of the issue and inform efforts to address it. Global collaborative efforts are needed to improve supply-chain management, surveillance, and regulatory capacity in low- and middle-income countries to reduce the threat of poor-quality medicines. Trial Registration PROSPERO Identifier: CRD42017080266
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In some low- and middle-income countries, the national stores and public-sector health facilities contain large stocks of pharmaceuticals that are past their expiry dates. In low-income countries like Uganda, many such stockpiles are the result of donations. If not adequately monitored or regulated, expired pharmaceuticals may be repackaged and sold as counterfeits or be dumped without any thought of the potential environmental damage. The rates of pharmaceutical expiry in the supply chain need to be reduced and the disposal of expired pharmaceuticals needs to be made both timely and safe. Many low- and middle-income countries need to: (i) strengthen public systems for medicines’ management, to improve inventory control and the reliability of procurement forecasts; (ii) reduce stress on central medical stores, through liberalization and reimbursement schemes; (iii) strengthen the regulation of drug donations; (iv) explore the salvage of officially expired pharmaceuticals, through re-analysis and possible shelf-life extension; (v) strengthen the enforcement of regulations on safe drug disposal; (vi) invest in an infrastructure for such disposal, perhaps based on ultra-high-temperature incinerators; and (vii) include user accountability for expired pharmaceuticals within the routine accountability regimes followed by the public health sector.
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In Europe, the use of falsified medical products (Medicrime products) is increasing. The unreliable quality of these products is expected to cause health damage. The nature and extent of this damage is difficult to determine because the expected symptoms are not sufficiently specific to be recognized in everyday practice. It is also unclear to health care professionals where and how they can report their suspicions about usage. This is shown in an exploratory study by RIVM. Medicrime products are rarely found at (family) doctors and official pharmacies. However, consumers receive these products when they purchase medical products from unreliable suppliers, mainly over the internet. Through this source they are increasingly exposed to Medicrime products. This study assesses Medicrime products that are seized throughout Europe and the associated health complaints expected. Six categories of Medicrime products are seized most: erectile dysfunction agents, psychoactive drugs (such as stimulants, and designer drugs), drugs (especially steroids), slimming agents, strong painkillers and medicines for heart disease. These categories represent about 40 per cent of the seized Medicrime products. The remaining 60 per cent comprises a large variety of drugs, including anti-cancer agents, antibiotics, and anti-retroviral drugs. Even though these are seized in smaller numbers, the health threat is not to be underestimated due to their nature. With respect to epidemics and the development of resistance, it is undesirable that unreliable anti-infective medicines are used. It is recommended to raise awareness among physicians of the phenomenon of Medicrime products through, for example publications in medical journals. It is also recommended to create an information exchange platform on suspect products and complaints. Finally, it is important to devise a simple registration procedure for suspected medical products to set, for example, by adding a tickbox to the international adverse events reporting form by WHO. The recommendations have been incorporated into a pilot study in several European countries that is currently being tested.
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Background Falsely labelled, falsified (counterfeit) medicines (FFCm’s) are produced or distributed illegally and can harm patients. Although the occurrence of FFCm’s is increasing in Europe, harm is rarely reported. The European Directorate for the Quality of Medicines & Health-Care (EDQM) has therefore coordinated the development and validation of a screening tool. Methods The tool consists of a questionnaire referring to a watch-list of FFCm’s identified in Europe, including symptoms of their use and individual risk factors, and a scoring form. To refine the questionnaire and reference method, a pilot-study was performed in 105 self-reported users of watch-list medicines. Subsequently, the tool was validated under “real-life conditions” in 371 patients in 5 ambulatory and in-patient care sites (“sub-studies”). The physicians participating in the study scored the patients and classified their risk of harm as “unlikely” or “probable” (cut-off level: presence of ≥2 of 5 risk factors). They assessed all medical records retrospectively (independent reference method) to validate the risk classification and documented their perception of the tool’s value. Results In 3 ambulatory care sites (180 patients), the tool correctly classified 5 patients as harmed by FFCm’s. The positive and negative likelihood ratios (LR+/LR-) and the discrimination power were calculated for two cut-off levels: a) 1 site (50 patients): presence of two risk factors (at 10% estimated health care system contamination with FFCm’s): LR + 4.9/LR-0, post-test probability: 35%; b) 2 sites (130 patients): presence of three risk factors (at 5% estimated prevalence of use of non-prescribed medicines (FFCm’s) by certain risk groups): LR + 9.7/LR-0, post-test probability: 33%. In 2 in-patient care sites (191 patients), no patient was confirmed as harmed by FFCm’s. The physicians perceived the tool as valuable for finding harm, and as an information source regarding risk factors. Conclusions This “decision aid” is a systematic tool which helps find in medical practice patients harmed by FFCm’s. This study supports its value in ambulatory care in regions with health care system contamination and in certain risk groups. The establishment of systematic communication between authorities and the medical community concerning FFCm’s, current patterns of use and case reports may sustain positive public health impacts. Electronic supplementary material The online version of this article (doi:10.1186/s12913-017-2235-y) contains supplementary material, which is available to authorized users.
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In the framework of the EC supported Fakeshare project (www.fakeshare.eu), a comprehensive summary of the general features and of the recent developments in tackling pharmaceutical crime (IE counterfeiting, diversion, falsification of medicines) was developed, as an instrument for the Italian police forces. This English, updated version of the e-book was developed as a Fakeshare deliverable, with the goal of sharing the research in the field with all EU health authorities, police forces and scientists.
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Objectives This study aims to establish expert opinion and potential improvements for the Falsified Medicines Directive mandated medicines authentication technology. Design and intervention A two-round Delphi method study using an online questionnaire. Setting Large National Health Service (NHS) foundation trust teaching hospital. Participants Secondary care pharmacists and accredited checking technicians. Primary outcome measures Seven-point rating scale answers which reached a consensus of 70–80% with a standard deviation (SD) of <1.0. Likert scale questions which reached a consensus of 70–80%, a SD of <1.0 and classified as important according to study criteria. Results Consensus expert opinion has described database cross-checking technology as quick and user friendly and suggested the inclusion of an audio signal to further support the detection of counterfeit medicines in secondary care (70% consensus, 0.9 SD); other important consensus with a SD of <1.0 included reviewing the colour and information in warning pop up screens to ensure they were not mistaken for the ‘already dispensed here’ pop up, encouraging the dispenser/checker to act on the warnings and making it mandatory to complete an ‘action taken’ documentation process to improve the quarantine of potentially counterfeit, expired or recalled medicines. Conclusions This paper informs key opinion leaders and decision makers as to the positives and negatives of medicines authentication technology from an operator's perspective and suggests the adjustments which may be required to improve operator compliance and the detection of counterfeit medicines in the secondary care sector.
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The rapid growth of technology has transformed many brick-and-mortar businesses into online businesses, and medicines are now being sold over the internet. Influenced by the notions that online purchases are economical and do not require a prescription, the general public are keen to purchase medicine online through websites, social media and mobile apps. Online medicine purchase is presumed to be convenient and confidential, free from embarrassment of sharing personal and sensitive health information to a healthcare professional. Public in United States, Europe, Australia is generally aware that internet sales form part of the official medicines distribution channels, often a valid prescription is required for controlled medicine. However, unlicensed, substandard and falsified medicines with various dubious medical claims are advertised and sold illegally in many rogue online pharmacies (Jack, 2016). These include medications for weight loss, hair growth, and treatment of erectile dysfunction. Such medicines are termed as substandard, spurious, falsely labelled, falsified and counterfeit medical products by the World Health Organisation (WHO). Similarly, the European Commission defines such products as falsified medicines or fake medicines that pass themselves off as real, authorised medicines (European Commission, 2016). These medicines may contain substandard active ingredients, which are low quality and/or an incorrect amount, either too high or too low, and have not been properly evaluated by authorities in terms of quality, safety and efficacy. It must be noted that falsified medicines are often confused with counterfeit medicines. According to European Commission, counterfeit medicines refers to medicines that do not comply with European Union law on intellectual and industrial property rights, for example, unregistered medicines sourced from parallel import (European Medicines Agency). In this article, the illegal sales of both counterfeit and falsified medicines (CFMs) will be discussed. In 2012, the World Health Organisation estimated the falsified and counterfeit medicines industry to be worth USD 431 billion a year, but further estimates has not been reported in the recent years due to the fast growing, widespread practice of this industry, making it impractical to estimate on a global scale (Garrett, 2012). Authorities are finding it difficult to curb CFMs due to the lack of governance over the internet. Furthermore, fragmented cybercrime legislation leads to large substantive and procedural lacunae in law, rendering law enforcement efforts useless.
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Poor-quality medicines are a major problem for health-care systems in resource-poor settings as identifying falsified medicines requires a complex laboratory infrastructure such as a Medicines Quality Control Laboratory. We report here an evaluation of a low-cost, handheld near-infrared spectrometer (NIRS) device by analyzing a library of artemisinin-based combination therapy (ACT) medicines to determine its usefulness as a drug-screening tool. The "SCiO" research prototype device was used to collect NIR spectra of a library of ACT and artesunate monotherapy medicine samples previously collected in Bioko Island and Equatorial Guinea and Kintampo, Ghana. The quality of these samples had been categorized as falsified, substandard, and quality assured based on the amount of stated active pharmaceutical ingredients detected using high-performance liquid chromatography photodiode array. Numerical analyses were performed on the NIR spectra to assess the usefulness of NIR to identify falsified and substandard medicines. The NIRS device was successful at detecting falsified medicines in all cases where the library contained both quality assured and falsified medicines of the same stated brand of medicines. The NIRS device was successful at identifying substandard amounts of artesunate but not amodiaquine in the ACT samples (N = 15) of artesunate-amodiaquine. This work reveals that this low-cost, portable NIRS device is promising for screening ACTs for falsified samples and could enable widespread drug screening at all points of the health system.
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Background: Promoting access to medicines requires concurrent efforts to strengthen quality assurance for sustained impact. Although problems of substandard and falsified medicines have been documented in low- and middle-income countries, reliable information on quality is rarely available. Objective: The aim of this study was to validate an alternative post-market surveillance model to complement existing models. Methods: The study used standardized patients or mystery clients (people recruited from the local community and trained to pose as real patients) to collect medicine samples after presenting a pre-specified condition. The patients presented four standardized conditions to 42 blinded facilities in Nairobi, Kenya, resulting in 166 patient-clinician interactions and dispensing of 300 medicines at facilities or nearby retail pharmacies. The medicine samples obtained thus resemble those that would be given to real patients. Results: Sixty samples were selected from the 300, and sent for analysis at the Kenya National Quality Control Laboratory. Of these, ten (17%) did not comply with monograph specifications (three ibuprofen, two cetirizine, two amoxicillin/clavulanic acid combinations, and one each for prednisone, salbutamol and zinc). Five of the ten samples that failed had been inappropriately prescribed to patients who had presented symptoms of unstable angina. There was no association between medicine quality and ownership, size or location of the facilities. Conclusion: The study shows that the standardized patient model can provide insights into multiple dimensions of care, thus helping to link primary care encounters with medicine quality. Furthermore, it makes it possible to obtain medicines from blinded sellers, thus minimizing the risk of obtaining biased samples.
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In an era when the number of expedited and conditional review pathways for newly available brand-name drugs and biosimilar medicines to treat serious and life-threatening diseases is increasing, defining pharmacovigilance has never been more crucial. 21st century pharmacovigilance is not merely about uncovering, reporting, and addressing adverse events associated with already approved and marketed agents, but can be described as the systematic monitoring of the process of pre-market review and post-market surveillance, which includes the use of medicines in everyday practice. Pharmacovigilance identifies previously unrecognised adverse events or changes in the patterns of these effects, the quality and adequacy of drug supply, and should ensure effective communication with the public, health-care professionals, and patients about the optimum safety and effective use of medicines. In this paper, the first in a Series of three about drug safety in oncology, we discuss evolving challenges in the purview, roles, and responsibilities of the US Food and Drug Administration and the European Medicines Agency with respect to pharmacovigilance efforts, with a special emphasis on oncology treatment.
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Illicit erectile dysfunction (ED) products often contain experimental medicines. The acute health risks of using such illicit ED products, however, appear to be relatively low – at least to date. Less health damage has been reported than expected based on the presumed use of these products, although their long-term effects on human health are unknown. This report was compiled from the records of five national institutes in the Netherlands and is the third RIVM report to be published on illicit ED products. The investigated products were all confiscated outside the official distribution system. Illicit Illicit ED products are illegally produced or distributed without the necessary licences. There are three licensed ED products available on the Dutch market (Viagra®, Cialis® and Levitra®). All need to be prescribed by a physician. The use of illicit ED products has increased dramatically during the last decade, most likely due to the ease of purchasing via the Internet. Risks Risks that have been identified are overdosing, adverse combination(s) with alcohol or drugs and long-term use. Adulterated food supplements containing experimental medicines (analogues), counterfeit generics and ED products mixed with antidepressants are considered to represent the greatest health risks. Research This report describes the product characteristics and presents the chemical analysis data of 538 illicit ED products (containing PDE5 inhibitors) confiscated in the period 2007–2010. These products can be classified as counterfeit medicines (17%), illicit generics (unapproved medicines) (69%) and adulterated food supplements (13%). Most ED products contain an effective amount of the active substance, although many are fraudulently mislabelled in terms of the active drug substance and dose. The results of this study show that the composition of illicit ED products is usually unreliable. Surveillance Marketing surveillance of medicines is well organised in The Netherlands, but it does need to be improved for food supplements as current regulations and laws governing the composition of such products are too limited. According to the RIVM, improved measures aimed at safeguarding the veracity of food supplements are desirable. Although there appears to be a low incidence of health damage attributable to the use of ED products, it remains necessary to monitor these products for trends in new active drug substances and long-term health risks. It is also important to investigate user behaviour.
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Summary of the biggest investigation on pharmaceutical crime held in Europe in recent years: stolen and falsified medicines, sourced from Italian hospitals and from other illegal chains, were recycled in the EU distribution network. This White Paper was submitted to the EC and published by AIFA.
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Background The US FDA recently developed CD3+, a counterfeit detection tool that is based on sample illumination at specific wavelengths of light and visual comparison of suspect sample and packaging materials to an authentic sample. To test performance of the CD3+ in field conditions, a study was conducted in Ghana which compared the CD3+ side-by-side with two existing medicine quality screening technologies—TruScan™ Portable Raman spectrometer and GPHF Minilab®. Methods A total of 84 anti-malarial test samples comprising artemether–lumefantrine tablets and artesunate–amodiaquine tablets were used. The technologies were evaluated for sensitivity in determining counterfeit/substandard (The term counterfeit or falsified is used in this article to refer to medicines that carry a false representation of identity or source or both. The term substandard is used to refer to medicines that do not meet the quality specifications given in the accepted pharmacopeia.) medicines, specificity in determining authentic products, and reliability of the results. Authentic samples obtained from manufacturers were used as reference standards. HPLC analysis data was used as the “gold standard” for decisions regarding a sample being authentic or substandard/counterfeit. Results CD3+ had a sensitivity of 1.00 in detecting counterfeit/substandard products compared to Minilab (0.79) and TruScan (0.79). CD3+ had a lower specificity (0.53) in determining authentic products compared to the specificities reached by Minilab (0.99) and TruScan (1.00). High sensitivity in this context means that the technology is effective in identifying substandard/counterfeit products whereas the low specificity means that the technique can sometimes mischaracterize good products as substandard/counterfeit. Examination of dosage units only (and not packaging) using CD3+ yielded improved specificity 0.64. When only assessment of sample identification was done, the TruScan provided sensitivity (1.00) and specificity (0.99); and the Minilab provided sensitivity (1.00) and specificity (1.00). All three technologies demonstrated 100 % reliability when used to analyse the same set of samples over 3 days by a single analyst and also when used to determine the same set of samples by three different analysts. Eight of the field samples were confirmed to be counterfeits with no active pharmaceutical ingredient content. All three technologies identified these samples as counterfeits. Conclusions The study revealed the relative effectiveness of the technologies as quality control tools. Using a combination of CD3+, with either the Minilab or TruScan, to screen for medicine quality will allow for complete examination of both the dosage units and the packaging to decide whether it is authentic or counterfeit.
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This meeting report presents the key findings and discussion points of a 1-day meeting entitled 'Fake anti-malarials: start with the facts' held on 28th May 2015, in Geneva, Switzerland, to disseminate the findings of the artemisinin combination therapy consortium's drug quality programme. The teams purchased over 10,000 samples, using representative sampling approaches, from six malaria endemic countries: Equatorial Guinea (Bioko Island), Cambodia, Ghana, Nigeria, Rwanda and Tanzania. Laboratory analyses of these samples showed that falsified anti-malarials (<8 %) were found in just two of the countries, whilst substandard artemisinin-based combinations were present in all six countries and, artemisinin-based monotherapy tablets are still available in some places despite the fact that the WHO has urged regulatory authorities in malaria-endemic countries to take measures to halt the production and marketing of these oral monotherapies since 2007. This report summarizes the presentations that reviewed the public health impact of falsified and substandard drugs, sampling strategies, techniques for drug quality analysis, approaches to strengthen health systems capacity for the surveillance of drug quality, and the ensuing discussion points from the dissemination meeting.
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Three years have passed since the FDA announced that it had detected counterfeit versions of the injectable anticancer drug bevacizumab (Avastin®, Genentech, USA) in the US drug-supply chain. Following this discovery, almost 1,000 FDA warning letters were sent to physicians and medical practices in 48 different states and two US territories, as more batches of counterfeit Avastin were uncovered. In response, criminal prosecutions have been pursued against certain distributors and clinicians, and other individuals who trafficked, sold, purchased, and/or administered an unsafe and ineffective treatment while also defrauding the government. Although limited and targeted legal action has been taken, patients potentially affected by this seminal patient safety event have not been appropriately identified. Hence, despite the clear and documented patient-safety and public-health risks posed by the transnational criminal trade in counterfeit medicines, the case study of counterfeit bevacizumab detection in the USA demonstrates the continued lack of information, knowledge, and solutions that would be necessary to protect those who are most affected—the patients. In response, we call for greater investment in multisector, multistakeholder strategies to enhance surveillance for counterfeit medicines and enable improvements in communication of risk information, to better protect patients with cancer.
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Objective To explore healthcare policy and system improvements that would more proactively respond to future penetration of counterfeit cancer medications in the USA drug supply chain using geospatial analysis. Design A statistical and geospatial analysis of areas that received notices from the Food and Drug Administration (FDA) about the possibility of counterfeit Avastin penetrating the US drug supply chain. Data from FDA warning notices were compared to data from 44 demographic variables available from the US Census Bureau via correlation, means testing and geospatial visualisation. Results were interpreted in light of existing literature in order to recommend improvements to surveillance of counterfeit medicines. Setting/participants This study analysed 791 distinct healthcare provider addresses that received FDA warning notices across 30 431 zip codes in the USA. Outcomes Statistical outputs were Pearson's correlation coefficients and t values. Geospatial outputs were cartographic visualisations. These data were used to generate the overarching study outcome, which was a recommendation for a strategy for drug safety surveillance congruent with existing literature on counterfeit medication. Results Zip codes with greater numbers of individuals age 65+ and greater numbers of ethnic white individuals were most correlated with receipt of a counterfeit Avastin notice. Geospatial visualisations designed in conjunction with statistical analysis of demographic variables appeared more capable of suggesting areas and populations that may be at risk for undetected counterfeit Avastin penetration. Conclusions This study suggests that dual incorporation of statistical and geospatial analysis in surveillance of counterfeit medicine may be helpful in guiding efforts to prevent, detect and visualise counterfeit medicines penetrations in the US drug supply chain and other settings. Importantly, the information generated by these analyses could be utilised to identify at-risk populations associated with demographic characteristics. Stakeholders should explore these results as another tool to improve on counterfeit medicine surveillance.
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This publication is a part of a more widespread project - developed by AIFA and EDQM with the help of experts from various institutions who daily confront the problem, in the framework of the EDQM/Council of Europe “Committee of Experts on Minimising Public Health Risks posed by Counterfeiting of Medical Products and Related Crimes” (CD-P-PH/CMED) activities - which is aimed at increasing knowledge and awareness about a phenomenon which is often the object of unreliable information and data. This book is a good example of the international collaboration which has been established with the deep conviction that communication with both the public and health workers represents an indispensable aspect in the fight against counterfeit medicine. The book examines, through real case studies, the various aspects of pharmaceutical counterfeiting: the root causes of the phenomenon, the types of counterfeit products, their distribution through uncontrolled channels such as the Internet, current legislation, the role of national and international institutions and their initiatives.
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Biologics play an integral role in the treatment of cancer not only for their therapeutic effects and ability to improve outcomes, but also as supportive care agents. Biologics are more complex to manufacture and take longer to bring to market. Because biologics are considerably more costly than small-molecule drugs, their use has placed an increasing economic demand on healthcare systems worldwide. Biosimilars are designed to be highly similar to existing branded biologics, but because biologics cannot be exactly copied, biosimilars should not be referred to as generic, exact versions of the innovator biologic. Biosimilars have the potential to increase access and provide lower cost options for cancer care as patent protection for some of the most widely used biologics begins to expire. Regulatory requirements for biosimilars are evolving, as are global harmonization and/or standardization strategies that can facilitate their robust clinical development. This review highlights critical factors involved with the integration of biosimilars into oncology treatment paradigms and practices. Clinicians will likely seek out practice guidelines and position statements from established scientific societies to help evaluate key information regarding biosimilars, such as efficacy, safety, comparability, and interchangeability with the reference biologic. Automatic substitution, nomenclature, extrapolation of clinical data from one indication to another, as well as parameters for ongoing pharmacovigilance are evolving considerations. Education of physicians and other healthcare providers, payers, and patients about biosimilars may facilitate informed decision making, promote acceptance of biosimilars into clinical practice, increase accessibility, and expedite associated health and economic benefits.
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To determine the extent of substandard and falsified medicines in the UK. A retrospective review of drug alerts and company-led recalls. The Medicines and Healthcare Products Regulatory Agency (MHRA) website search for drug alerts issued between 2001 and 2011. Drug alerts related to quality defect in medicinal products. Relevant data about defective medicines reported in drug alerts and company-led recalls, including description of the defect, type of formulation, year of the alert and category of the alert. There were 280 substandard medicines of which 222 were recalled. The two most frequent problems were contamination (74 incidents) and issues related to packaging (98 incidents). Formulations for parenteral administration (117 incidents) were the formulation most frequently affected. There were 11 falsified medicines, as defined by the MHRA, reported over the 11-year period. The number of defective medicines reported by the MHRA increased 10-fold from 5 in 2001 to 50 in 2011. Substandard medicines are a significant problem in the UK. It is uncertain whether the increasing number of reports relates to improved detection or an increase in the number of substandard medicines.
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Objective. Counterfeit medicines are a global, multi-faceted, and complex public health problem. Global health diplomacy and cooperative efforts relying on governance systems have been limited in effectively addressing proliferation of this dangerous trade. Methods. This review conducts a comprehensive mapping exercise of governance efforts by international organizations to address counterfeit medicines, including analysis of related international treaties and conventions that may be applicable to anticounterfeit efforts. This work also reviews governance and global health diplomacy proposals from the literature that addresses counterfeit medicines. Summary of Findings. A number of international organizations have become active in addressing the global trade of counterfeit medicines. However, governance approaches by international organizations, including the World Health Organization (WHO), the United Nations Office on Drugs and Crime (UNODC), Interpol and the World Customs Organization (WCO), have varied in scope and effectiveness. Treaty instruments with applicability to counterfeit medicines have also not been fully leveraged to combat this issue. Results indicate that a formalized and multi-stakeholder governance mechanism is needed to address the issue. The UNODC is uniquely situated to act as a forum for such a proposal in partnership with other international organizations. Implications of Findings. Global health diplomacy efforts to combat counterfeit medicines require multi-stakeholder and formalized governance structures that can leverage stakeholder participation and resources. Through cooperative arrangements leveraging the strengths of partners such as UNODC (combating transnational crime), Interpol (law enforcement purposes), the WCO (customs and border control), and the WHO (for public health science and analysis), the international community can mobilize a coordinated, inclusionary, health diplomacy response to the crisis of global counterfeit medicines.
Article
A case can be made that much common ground exists between pharmacovigilance and pharmaceutical manufacturing. Of the 8 major US statutes that shaped the pharmaceutical industry since early in the 20th Century, 7 followed fatally catastrophic events related to the use of a manufactured product, and 1 followed the discovery of a counterfeit product. To facilitate an understanding of the interplay between pharmacovigilance and manufacturing, it is convenient to divide manufacturing into 3 categories: (1) upstream sourcing of materials: pharmacovigilance plays an important role when adverse event clusters are seen during routine vigilance detection processes and the suspicion turns to possibly contaminated source material, (2) the manufacturing process itself: pharmacovigilance may be called on to conduct a health hazard evaluation if a manufacturing deviation is detected after product release (the assessment can inform the depth of a recall), and (3) downstream distribution and product use: there is only light regulation of the interval between product distribution after manufacturing release and just before administration to patients, a time during which product may be subject to an out-of-specification determination for environmental controls or subject to malfeasant activities, such as counterfeit substitution or product diversion. Recently introduced statutory remedies, including the FDA Safety and Innovation Act and the Drug Supply Chain Security Act in the United States and the Falsified Medicines Directive (directive 2011/62/EC) in the European Union, can provide capabilities to support pharmacovigilance signal management activities that have the potential to reduce the risk to patients of experiencing adverse events caused by counterfeit, diverted, or tampered product.
Article
Introduction: The globalization of the pharmaceutical supply chain has introduced new challenges, chief among them, fighting the international criminal trade in fake medicines. As the manufacture, supply, and distribution of drugs becomes more complex, so does the need for innovative technology-based solutions to protect patients globally. Areas covered: We conducted a multidisciplinary review of the science/health, information technology, computer science, and general academic literature with the aim of identifying cutting-edge existing and emerging “digital” solutions to combat fake medicines. Our review identified five distinct categories of technology including mobile, radio frequency identification, advanced computational methods, online verification, and block chain technology. Expert opinion: Digital fake medicine solutions are unifying platforms that integrate different types of anti-counterfeiting technologies as complementary solutions, improve information sharing and data collection, and are designed to overcome existing barriers of adoption and implementation. Investment in this next generation technology is essential to ensure the future security and integrity of the global drug supply chain.
Article
Introduction: The distribution and use of substandard medicines (SSMs) is a public health concern worldwide. The detection of SSMs is currently limited to expensive large-scale assay techniques such as high-performance liquid chromatography (HPLC). Since 2013, the Pharmacovigilance Department at Novartis Pharma AG has been analyzing drug-associated adverse events related to 'product quality issues' with the aim of detecting defective medicines using spontaneous reporting. The method of identifying SSMs with spontaneous reporting was pioneered by the Monitoring Medicines project in 2011. Methods: This retrospective review was based on data from the World Health Organization (WHO) Global individual case safety report (ICSR) database VigiBase® collected from January 2001 to December 2014. We conducted three different stratification analyses using the Multi-item Gamma Poisson Shrinker (MGPS) algorithm through the Oracle Empirica data-mining software. In total, 24 preferred terms (PTs) from the Medical Dictionary for Regulatory Activities (MedDRA®) were used to identify poor-quality medicines. To identify potential SSMs for further evaluation, a cutoff of 2.0 for EB05, the lower 95% interval of the empirical Bayes geometric mean (EBGM) was applied. We carried out a literature search for advisory letters related to defective medicinal products to validate our findings. Furthermore, we aimed to assess whether we could confirm two SSMs first identified by the Uppsala Monitoring Centre (UMC) with our stratification method. Results: The analysis of ICSRs based on the specified selection criteria and threshold yielded 2506 hits including medicinal products with an excess of reports of product quality defects relative to other medicines in the database. Further investigations and a pilot study in five authorized medicinal products (proprietary and generic) licensed by a single marketing authorization holder, containing valsartan, methylphenidate, rivastigmine, clozapine, or carbamazepine, were performed. This resulted in an output of 23 potential SSMs. The literature search identified two communications issued to health professionals concerning a substandard rivastigmine patch, which validated our initial findings. Furthermore, we identified excess reporting of product quality issues with an ethinyl estradiol/norgestrel combination and with salbutamol. These were categorized as confirmed clusters of substandard/spurious/falsely labelled/falsified/counterfeit (SSFFC) medical products by the UMC in 2014. Conclusion: This study illustrates the value of data mining of spontaneous adverse event reports and the applicability of disproportionality analysis to identify potential SSMs.
Article
Counterfeit medicines are, first and foremost, a matter of patient health and safety. Counterfeit medicines pose a threat to patients because of the conditions under which they are manufactured, in unlicensed, unregulated, uninspected and often unsanitary sites. The ''medicines'' themselves pose a threat to patient health and safety because their contents are not regulated and they may not contain the correct active pharmaceutical ingredient (API) to deliver the therapeutic benefit for which they were prescribed, or even ingredients that are themselves harmful such as heavy metals or pesticides. To mitigate that threat, and ensure that their patients receive safe and effective medicines, pharmaceutical companies have incorporated anti-counterfeiting technologies into their packaging and implemented campaigns to detect and disrupt those counterfeiters who place greed above patient safety. Although counterfeiting presents a global threat from which no company, therapeutic area, region or country is immune; gauging the true scope of the problem has remained a challenge. There are hopeful signs, however, as we have seen improved reporting and greater transparency by enforcement and regulatory agencies. © 2016 - Network of Centres for Study of Pharmaceutical Law. All rights reserved.
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There must be a large market for active pharmaceutical ingredients of illegal source to support the huge and lucrative business of trade in illegal medicines. The active substances found in illegal pharmaceuticals may differ from their legal counterparts concerning purity and associated risks for the health of the user. In this study we show two examples in which the active substance sildenafil, used in erectile dysfunction products, was not of European Pharmacopeia quality. In one case milligram-scale amounts of a 2-mercaptobenzothiazole contamination were found, in another case the mesylate salt rather than the monograph based citrate was used. For the user of products containing these active substances, the risks of side effects increase through the inherent properties of the impurity and the chance of overdosing. The fact that the users are most likely not aware of the poor quality of the products adds up to the health risk of using prescription medication without consulting medical professionals.
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Purpose: To report the recent controversy surrounding the intraocular use of bevacizumab in India and its relationship to the broader problems of off-label drug use, medication compounding, and drug counterfeiting. Design: Perspective METHODS: Data for this perspective was obtained from several sources. Literature reviews for compounding-related endophthalmitis and drug counterfeiting were performed. Supplemental information was obtained through targeted Google searches for related published manuscripts. First-hand accounts of negotiations between representatives of the Vitreoretinal Society of India (VRSI) and India's Central Drugs Standards Control Organization (CDSCO) were provided by two of the authors (RN, VG). Results: In December, 2015, 15 cases of intraocular inflammation following injections of counterfeit bevacizumab occurred in Gujarat, India. CDSCO reacted by prohibiting the use of intraocular bevacizumab throughout the country. Intense negotiations between the VRSI and CDSCO resulted in the permission to use bevacizumab in accordance with new safety guidelines. These include an enhanced informed consent process, the stamping of the Kezzler code on all bevacizumab vials, a real-time digital verification process between the end-user and Roche Pharmaceuticals, and mandatory destruction of empty drug vials. Conclusion: Counterfeit bevacizumab has caused outbreaks of sterile and infectious post-injection endophthalmitis in at least three countries during the past 5 years and has entered the supply-chain in other countries. Physicians and compounding pharmacists need to be aware that international counterfeiters have targeted bevacizumab.
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Counterfeit medicines pose a serious risk to public health around the world. The trade in fake drugs is considerable; according to Pfizer's own company records, more than 200 million counterfeit doses of Pfizer product have been intercepted since 2004. Meanwhile, the issue of counterfeits has no single or simple solution1 and cannot be eliminated by any one individual, organisation or government. It is a global problem that needs global, collaborative approach.
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Background: Permanently recalled drugs are a public health concern if they remain accessible in violation of applicable regulation. Illicit online pharmacies act as an alternative form of access and have been associated with the sale to patients of counterfeit/falsified/fraudulent/substandard drugs. We wished to determine if permanently recalled and significantly restricted drugs were illegally marketed for sale online. Objective: The study was conducted in two phases with two objectives. The first phase attempted to identify drugs subject to permanent recall in certain major pharmaceutical markets as well as those listed as recalled or significantly restricted by the United Nations. We also examined the market authorization status of identified drugs in China and India. The second phase used structured searches on the Internet to determine if identified drugs were marketed for sale online. Setting: The World Wide Web. Method: After identification of permanently recalled and restricted drugs we conducted Internet searches for illegal "no prescription" marketing events. We assessed the form of marketing, whether a site offered direct-to-patient sale, use of social media marketing, and the site's compliance status with external monitoring bodies. Main outcome: Number of recalled drugs marketed as available for purchase on the Internet. Results: We identified 16 class I equivalent permanently recalled or restricted drugs, 56.3 % (n = 9) of which maintained market authorization in either China or India. Half (n = 8) were marketed for sale online without a prescription direct-to-patient. Use of social media marketing was mixed, with only 18.8 % (n = 3) of recalled drugs having a presence on Facebook, though 50.0 % (n = 8) had content on Twitter. We also found the majority (68.8 %, n = 11) were available and marketed for sale by vendors on the wholesale/business-to-business website alibaba.com primarily as active pharmaceutical ingredient. Conclusion: Despite efforts in several countries to restrict access to these drugs or permanently remove them from the market, our study indicates that various sources actively market recalled drugs for sale online. Drug regulators, public health agencies, and law enforcement officials should act with urgency to appropriately restrict and regulate these sales to protect global patients and consumers.
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Drug safety for the patients is of paramount importance for a medical professional. Pharmacovigilance attempts to ensure the safety of patients by keeping a close vigil on the pattern of adverse events secondary to drug use. Number of medicolegal cases is at rise since last few years. Forensic sciences and pharmacovigilance need to work hand in hand to unlock the mystery of many criminal and civil proceedings. Pharmacovigilance offers its wide scope in forensic sciences by putting forward its expertise on adverse profile of drugs which may be instrumental in solving the cases and bringing the justice forth. It may range from as simple affairs as defining the adverse drug reaction on one hand to putting expert advice in critical criminal cases on the other one. Pharmacovigilance experts have to abide by the ethics of the practice while executing their duties as expert else it may tarnish the justice and loosen its dependability. As a budding discipline of science, it is confronted with several hurdles and challenges which include reluctance of medical professionals for being involved in court proceedings, extrapolations of facts and data and variations in law across the globe etc. These challenges and hurdles call the medical fraternity come forward to work towards the momentous application of pharmacovigilance in the forensic sciences. Evidence based practice e.g. testing the biological samples for the presence of drugs may prove to be pivotal in the success of this collaboration of sciences. Copyright © 2015 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.
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Counterfeit and poor quality medicines threaten to undermine decades of progress in global health, particularly in the areas of HIV/AIDS, tuberculosis, and malaria, say papers published on 20 April in a special supplement of the American Journal of Tropical Medicine and Hygiene.1“The pandemic of falsified and substandard medicines is pervasive and underestimated, particularly in low and middle income countries where drug regulatory systems are weak or non-existent, as shown by field studies in the supplement,” said Jim Herrington, co-editor of the supplement and director of the Gillings Global Gateway at the University of North Carolina at Chapel Hill, NC, USA.The supplement, The Pandemic of Falsified Medicines: Laboratory and Field Innovations and Policy Perspectives, features 17 articles that detail the extent and impact of the problem, describe new counterfeit drug detection technologies, and outline policy responses. For example, seven surveys of quality described in the supplement that together tested more than 16 000 samples of malaria drugs, antituberculosis medicines, antibiotics, and antileishmaniasis medicines found that an estimated 9% to 41% of specimens failed quality specifications.In one of the articles on policy responses Amir Attaran, of the faculties of law and medicine at the Institute of Population Health, University of Ottawa, Canada, noted that in many countries the “law hardly punishes those who intentionally or recklessly deal in falsified or substandard medicine, when clearly it should criminalize these perpetrators in proportion to the grievous—even fatal—injury they inflict on public health.”To correct this, Attaran has proposed a new “model law on medicine crime” that countries can use as a template for strengthening their national laws. The model law would include criminal prohibitions against manufacturing, trafficking, or selling poor quality medicines, as well as principles for punishing offenders. The model law is offered free of charge under a Creative Commons license to any governments that want to implement it.NotesCite this as: BMJ 2015;350:h2137
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Sexual enhancement medication presents a large market for counterfeit versions. We report here a case of hypoglycemia caused by an illicit sexual enhancement medication containing an extremely large amount of the sulfonylurea drug glibenclamide together with a moderate amount sildenafil citrate. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
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If a biosimilar insulin is discovered postmarketing to be subpotent, superpotent, or contaminated or the contents mislabeled, it is an adulterated product and must be quarantined for removal including from a patient's home. Adulterated products could be considered "counterfeit" since they do not meet the original standards established by the FDA. The FDA must establish a method of regularly assaying samples of biosimilar insulin drawn directly from the supply pipeline to help ensure patient safety and evaluate clinical performance. Independent groups without conflict of interest would perform confidential comparison assay. For less than 5 cents per vial/pen, manufacturers could easily support an independent, FDA-recognized, random sample program and create a functional postmarket surveillance system that better protects the public and the manufacturer from undesired outcomes.
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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 database (CIS) that uses both open and non-public data sources. Of the 1510 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 sub-category 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.
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Food supplements are regularly found to contain pharmacologically active substances. Recently, the food supplement Dexaprine was removed from the Dutch market because it was associated with severe adverse events. Reports to the Dutch Poisons Information Center (DPIC) showed that ingestion of as little as half a tablet caused several cases of nausea, agitation, tachycardia, and palpitations and even one case of cardiac arrest. The remaining tablets of four patients were sent in by different healthcare professionals. Analysis by ultra-performance liquid chromatography quadrupole time of flight mass-spectrometry (UPLC-QTOF-MS) confirmed the presence of synephrine, oxilofrine, deterenol, yohimbine, caffeine, and theophylline. Two more compounds were found which were tentatively identified as β-methyl-β-phenylethylamines. This incident is only the next in a series of similar incidents involving dietary supplements with (undeclared) active substances that are either unsafe or have no known safety profile. Copyright © 2014 John Wiley & Sons, Ltd.
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In this report, we show three examples of how the variability in dose units in single packages of counterfeit medicines and adulterated dietary supplements may contribute to a false negative screening result and inaccurate health risk assessments. We describe a counterfeit Viagra 100mg blister pack and a box of an instant coffee both containing dose units with and without an active pharmaceutical ingredient (API). We also describe a purportedly herbal slimming product with capsules that mutually differed in API and impurities. The adulterated dietary supplements contained sibutramine, benzyl-sibutramine, N-desmethyl-sibutramine (DMS), N,N-didesmethyl-sibutramine (DDMS) and several other related impurities. Counterfeit medicines and adulterated dietary supplements are a health risk because their quality is unreliable. Health risks are even greater when such unreliability extends to fundamental differences between dose units in one package. Because dose-to-dose variability for these products is unpredictable, the confidence interval of a sample size is unknown. Consequently, the analyses of a selection of dose units may not be representative for the package. In the worst case, counterfeit or unauthorised medicines are not recognised as such or a health risk is not identified. In order to reduce erroneous results particular care should be taken when analysing a composite of dose units, when finding no API in a dietary supplement and when finding conformity in a suspect counterfeit medicine.
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Cancer cases are rising in developing countries which are already grappling with high levels of infectious diseases including human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), tuberculosis (TB) and malaria. The United Nations (UN) including the World Health Organisation (WHO) have called on member states to establish strategies to deal with the increasing burden of non-communicable diseases, including cancer, in developing countries. The complexity of cancer care and management calls for innovative approaches in low resource settings especially since these settings are already grappling with huge challenges in healthcare including lack of funds, weak human resource base and lack of treatment guidelines. Whilst the cost of medications is by no means the only high cost in cancer care, the availability of affordable anti-cancer generic drugs and biologically similar therapeutic agents (biosimilars) will go a long way to reduce overall cost of cancer care. The high cost of anticancer medicines has been cited among the reasons whilst patients default in treatment. Non-proprietary anti-cancer agents - generics and biosimilars -often cost several times lower than their innovator branded counterparts. They can reduce the cost of care significantly and their multi-source origin often provide guarantee in supply. The use of generic and biosimilar products is hinged on the assumption that they are of assured quality and of the same pharmaceutical integrity as their innovator counterparts. The use of these products however is associated with challenges that must be understood and addressed. The quality of all generics and biosimilars should be rigorously controlled and assured. Measures to prevent counterfeit and sub-standard generics and biosimilars should be developed and the cold-chain must be maintained for all biosimilars. In addition to these, the WHO is encouraged to develop a prequalification scheme to assist countries without strong regulatory systems to procure anticancer generics and biosimilars of assured quality.
Counterfeit pharmaceuticals have been discovered in the parallel supply chain in the UK, which may influence the Commission's consultation on ‘The Future of Pharmaceuticals for Human Use in Europe’ and the Office of Fair Trading's market study into distribution of medicines in the UK.
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Most Internet users receive unsolicited invitations to enhance their health through the purchase of online medications. Often these medications are illegal and may even be counterfeit. However, there are a few legitimate online pharmacies. The National Association of Boards of Pharmacy has established the Verified Internet Pharmacy Practice Sites program, which certifies the legitimacy of some Internet merchants. Also, there are hundreds of Canadian pharmacies online because of the rise in popularity of Canadian drugs. The actual number of online Canadian pharmacies is difficult to estimate, and many of the so-called Canadian pharmacies are not from Canada. Besides the few legitimate sites in the United States and Canada, most online pharmacies deal with unapproved, illegal, and counterfeit medication. It is hard to know the number of online pharmacies because of the complex structure of the Internet. Their rapid growth can mainly be attributed to huge profits, but online pharmacies are also used for money laundering and may be used for terrorism. Although the United States has been limited in its actions, it still has taken numerous measures. However, internationally, online pharmacies do not appear to be as much of a problem, so almost any action taken has been led by the United States.
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When Hippocrates advised physicians to never give a deadly drug, he assumed they would know for sure that the medicines they prescribed were safe. Today, criminals and unscrupulous manufacturers have permeated the global pharmaceutical market, calling into question this basic assumption of clinical practice. Between November 2012 and March 2013, an injectable drug compounded under unhygienic conditions at the New England Compounding Pharmacy was linked to more than 700 illnesses and 50 deaths.1 In poor countries, where drug regulatory oversight is weaker, the problem is worse, but blends with the background noise of high mortality and strained health systems. Only in rare cases, as when 120 Pakistanis died after taking a carelessly made batch of isosorbide mononitrate, do people in low- and middle-income countries learn of their vulnerability.2