Search

Preventing crimes related to counterfeit drugs, due to the technologies used in the production and distribution of these drugs, will not have a bright outlook with traditional methods such as field surveillance. Therefore, adopting appropriate preventive measures requires the use of innovative technologies capable of detecting these crimes on a large scale and with high accuracy. In this regard, artificial neural networks such as recurrent neural networks, generative adversarial networks, and convolutional neural networks, inspired by the structure of the human brain, are capable of detecting these crimes. However, each of these networks has its drawbacks, ignoring which makes the legal system face difficulties in preventing these crimes. Therefore, the present study, through a case study method, seeks to identify the most efficient neural network for preventing these crimes. The outcome of this research indicates that the legislature has paid special attention to the monitoring technique in the prevention domain but has not defined the tools for this monitoring. Nevertheless, the Food and Drug Administration, using the Titac system (tracking code), identifies the discovery of crimes in this area. However, due to the non-intelligence of the system, it will not be able to detect all forms of fraud. Therefore, simultaneous use of three networks (recurrent neural networks, generative adversarial networks, and convolutional neural networks) in the form of a composite neural network seems to improve the detection of drug crimes on a large scale.

The development of new methods of identification of active pharmaceutical ingredients (API) is a subject of paramount importance for research centers, the pharmaceutical industry, and law enforcement agencies. Here, a system for identifying and classifying pharmaceutical tablets containing acetaminophen (AAP) by brand has been developed. In total, 15 tablets of 11 brands for a total of 165 samples were analyzed. Mid-infrared vibrational spectroscopy with multivariate analysis was employed. Quantum cascade lasers (QCLs) were used as mid-infrared sources. IR spectra in the spectral range 980–1600 cm−1 were recorded. Five different classification methods were used. First, a spectral search through correlation indices. Second, machine learning algorithms such as principal component analysis (PCA), support vector classification (SVC), decision tree classifier (DTC), and artificial neural network (ANN) were employed to classify tablets by brands. SNV and first derivative were used as preprocessing to improve the spectral information. Precision, recall, specificity, F1-score, and accuracy were used as criteria to evaluate the best SVC, DEE, and ANN classification models obtained. The IR spectra of the tablets show characteristic vibrational signals of AAP and other APIs present. Spectral classification by spectral search and PCA showed limitations in differentiating between brands, particularly for tablets containing AAP as the only API. Machine learning models, specifically SVC, achieved high accuracy in classifying AAP tablets according to their brand, even for brands containing only AAP. [ABSTRACT FROM AUTHOR]

This paper explores problems of pharmaceutical supply chains, such as drug counterfeiting, and the opportunities of using digital technologies to overcome them. It also evaluates the risks associated with the use of digital technologies. Expert interviews were conducted with pharmaceutical supply chain stakeholders in the first step. The data obtained was assessed through qualitative content analysis. In addition to the lack of transparency, strong individual interests of the supply chain actors and different implementation levels of digitisation were revealed. It is also noticeable that the industry is still paper-oriented. Nevertheless, the chosen experts are optimistic about the increased use of digital technologies. Combining blockchain with other technologies, such as IoT and AI, can improve efficiency, traceability, and trust in pharmaceutical supply chains. A digitalised supply chain concept is developed based on these technologies, enhancing transparency and information availability in the supply chain. In addition, communication and processes along the entire pharmaceutical supply chain are optimised. [ABSTRACT FROM AUTHOR]

Background: The increasing prevalence of falsified and counterfeit medicines globally poses risks to international travellers. This narrative literature review examines the global challenge of falsified and counterfeit medicines, with a specific focus on risks for travellers. The aim is to provide a comprehensive understanding of this multidimensional issue, exploring potential solutions for effective intervention. Methods: A comprehensive search of databases, including PubMed, MEDLINE, and Scopus, as well as relevant reports from international organisations, was undertaken. There was a focus on extracting information pertaining to the prevalence, types, and geographical patterns of falsified and counterfeit medicines encountered by international travellers. Synthesising this information helped to identify overarching trends and patterns. This narrative review utilised a thematic analysis approach to synthesise the findings. Results: The findings revealed a diverse range of counterfeit drug categories, spanning from antibiotics to lifestyle medications, posing unique risks to travellers navigating the global pharmaceutical landscape. The review emphasises the geographical distribution of these drugs, with varying consequences for both high- and low-income nations. The inadequate formulations and inconsistent drug release arising from these practices pose severe threats to public health, especially for individuals travelling abroad. The review also highlights the significance of international collaboration in addressing this global challenge, as pharmaceutical supply chains seamlessly cross borders, necessitating a collaborative approach for effective regulation and enforcement. Conclusions: This review underscores the need for targeted research, collaborative interventions, and technological innovations to address the complexities associated with falsified and counterfeit medicines, ensuring the safety and well-being of international travellers.

Introduction: Counterfeit medicines are a significant problem globally. In a developing country like Nepal, community pharmacists play an important role in dispensing medicines. The study was done to assess community pharmacists’ perceived prevalence, awareness and attitude towards counterfeit medicines in Kathmandu valley. Methods: A cross-sectional study design was used. Data was collected conveniently from Kathmandu, Bhaktapur, and Lalitpur districts in March 2022 after obtaining ethical clearance from Nepal Health Research Council (reference no. 2200) and taking written informed consent from Community Pharmacists. Results: Among the 343 pharmacists who participated, 250 (72.89%) were from Kathmandu, 57 (16.62%) were from Lalitpur, and 36 (10.50%) from Bhaktapur. Most 252 (73.47%) were aged between 20 to 30 years, 222 (64.72%) were male, 239 (69.68%) had done a Diploma in Pharmacy, 201 (58.60%) had working experience of more than 5 years and 342 (99.71%) had done their education in Nepal. Their median perceived prevalence of counterfeit drugs was 10.00% but only 2.30% had clear knowledge of such practice. 332 (96.79%) believed that actions should be taken against community pharmacists dispensing counterfeit drugs, 325 (94.75%) believed that pharmacists who dispense counterfeit medicines are unprofessional; 338 (98.54%) stated that there should be strong law against counterfeit medicine sales. Conclusions: Median perceived prevalence of counterfeit medicines was 10.00% but only 2.30% were aware of counterfeit medicine dispensing. Out of 343 pharmacists, 332 (96.79%) mentioned that action should be taken against those pharmacists knowingly dispensing counterfeit medicines and 338 (98.54%) stated that there should be strong law against counterfeit medicines.

The development of new methods of identification of active pharmaceutical ingredients (API) is a subject of paramount importance for research centers, the pharmaceutical industry, and law enforcement agencies. Here, a system for identifying and classifying pharmaceutical tablets containing acetaminophen (AAP) by brand has been developed. In total, 15 tablets of 11 brands for a total of 165 samples were analyzed. Mid-infrared vibrational spectroscopy with multivariate analysis was employed. Quantum cascade lasers (QCLs) were used as mid-infrared sources. IR spectra in the spectral range 980–1600 cm−1 were recorded. Five different classification methods were used. First, a spectral search through correlation indices. Second, machine learning algorithms such as principal component analysis (PCA), support vector classification (SVC), decision tree classifier (DTC), and artificial neural network (ANN) were employed to classify tablets by brands. SNV and first derivative were used as preprocessing to improve the spectral information. Precision, recall, specificity, F1-score, and accuracy were used as criteria to evaluate the best SVC, DEE, and ANN classification models obtained. The IR spectra of the tablets show characteristic vibrational signals of AAP and other APIs present. Spectral classification by spectral search and PCA showed limitations in differentiating between brands, particularly for tablets containing AAP as the only API. Machine learning models, specifically SVC, achieved high accuracy in classifying AAP tablets according to their brand, even for brands containing only AAP.

The pharmaceutical industry's profitability has attracted attention, but it faces challenges from counterfeiters exploiting vulnerabilities worsened by globalization and complex supply chains. In 2019, European authorities introduced regulation EU 2016/161 to enhance drug supply chain security and traceability. By conducting a systematic literature review, this study assesses the effectiveness of the European Drug Serialization system, examining its implementation and the potential benefits of integrating digital technologies like RFID and Blockchain. The aim is to investigate and identify measures contributing to the strengthening of pharmaceutical supply chains against counterfeiting. The research suggests that while serialization is crucial, it may not provide foolproof security, emphasizing the need for additional digital technology integration.

A mathematical model is developed for describing malaria transmission in a population consisting of infants and adults and in which there are users of counterfeit antimalarial drugs. Three distinct control mechanisms, namely, effective malarial drugs for treatment and insecticide-treated bednets (ITNs) and indoor residual spraying (IRS) for prevention, are incorporated in the model which is then analyzed to gain an understanding of the disease dynamics in the population and to identify the optimal control strategy. We show that the basic reproduction number, $ R_{0} $, is a decreasing function of all three controls and that a locally asymptotically stable disease-free equilibrium exists when $ R_{0} < 1 $. Moreover, under certain circumstances, the model exhibits backward bifurcation. The results we establish support a multi-control strategy in which either a combination of ITNs, IRS and highly effective drugs or a combination of IRS and highly effective drugs is used as the optimal strategy for controlling and eliminating malaria. In addition, our analysis indicates that the control strategies primarily benefit the infant population and further reveals that a high use of counterfeit drugs and low recrudescence can compromise the optimal strategy.

This Paper seeks to review the articles published in the Journal of Intellectual Property Rights (JIPR) in the first half of the second decade of the twenty-first century from Volume 15 (1) (2010) to Volume 19 (6) (2014). This is the fourth paper on the theme 'JIPR in IPR Research' and proceeds with the same argument and method as developed and used in the previous three papers published on the theme 'JIPR in IPR Research'. In this decade, two Special Issues on the themes 'IPR and Agriculture' and 'Leveraging IP for Business Advantage' were published with their separate guest editors. Compared to the previous decades, the articles published between 2010-2014 are maximum. Out of the total articles published between 1996-2014, the number of articles (251) published in this decade between 2010-2014 constitute 37.24 (point two four) compared to 32.64 (point six four) percent in 2005-2009, 19.58 (point five eight) percent in 2000-2004 and 10.53 (point five three) in 1996-1999. [ABSTRACT FROM AUTHOR]

Aim: The main objective of this study was to explore community pharmacists' knowledge of substandard and falsified medicines (SFs). Method: A descriptive cross-sectional study was conducted with community pharmacists in the Kingdom of Saudi Arabia using a pre-validated electronic survey. Key findings: Ninety-two community pharmacists participated in this study. Many of the respondents (68.5%) had no experience with identifying SFs. We identified a concerning trend of under-reporting SFs (P < 0.003). Respondents reported that SFs constitutes 1–5% of medicines, with weight loss medicines being the most targeted for falsification. Most of the respondents had a low level of awareness about the newly implemented anti-counterfeit system in Saudi Arabia called the 'Drug Track and Trace System' (28.3% not really, 23.1% not at all). Respondents showed low levels of knowledge about technologies available to detect SFs (P < 0.01). Conclusions: Community pharmacists' self-reported awareness and knowledge of SFs in Saudi Arabia was inadequate; this deficiency may affect their ability to protect their patients from potential harm by combating SFs. As a regulatory body responsible for issues related to SFs, the Saudi Food and Drug Authority should develop an action plan to equip community pharmacists with training in SFs to enhance their ability to respond to SFs. [ABSTRACT FROM AUTHOR]

In several countries, counterfeit and substandard pharmaceuticals are a severe public health concern. This is a global issue, but it is especially prevalent in African countries, where more than 30 % of the pharmaceuticals supplied are counterfeit or substandard. Many reasons contribute to the emergence of this issue, which differ from country to country. Online business, light sanctions for drug infringers, ignorance, and an absence of meaningful collaboration amongst players are all variables involved. The Tanzania Food and Drugs Authority (TFDA), Tanzania Police Force, Weights and Measures Agency Tanzania Fair Competition Commission (FCC), Tanzania Bureau of Standards (TBS) and Tanzania Revenue Authority (TRA) Customs are all involved in the fight against counterfeit drugs in Tanzania. Despite this, more work needs to be done to control the supply of counterfeit and substandard pharmaceuticals, which have major health and economic effects. Based on the public health and economic consequences of these low-quality pharmaceuticals, strong international cooperation is required to address the issue. This includes tighter state licensing oversight of pharmaceutical suppliers. In order to identify these products at various supply chain stages, advanced technologies should be used. Finally, consumers must be educated on how to recognize counterfeit pharmaceuticals and their effects.

BackgroundIllicitly manufactured fentanyl and its analogues are appearing in countries throughout the world, often disguised as heroin or counterfeit prescription pills, with resulting high overdose mortality. Possible explanations for this phenomenon include reduced costs and risks to heroin suppliers, heroin shortages, user preferences for a strong, fast-acting opioid and the emergence of Dark Web cryptomarkets. This paper addresses these potential causes and asks three questions: (1) can users identify fentanyl; (2) do users desire fentanyl; and (3) if users want fentanyl, can they express this demand in a way that influences the supply?Argument/analysisExisting evidence, while limited, suggests that some users can identify fentanyl, although not reliably, and some desire it, but because fentanyl is frequently marketed deceptively as other drugs, users lack information and choice to express demand effectively. Even when aware of fentanyl's presence, drug users may lack fentanyl-free alternatives. Cryptomarkets, while difficult to quantify, appear to offer buyers greater information and competition than offline markets. However, access barriers and patterns of fentanyl-related health consequences make cryptomarkets unlikely sources of user influence on the fentanyl supply. Market condition data indicate heroin supply shocks and shortages prior to the introduction of fentanyl in the United States and parts of Europe, but the much lower production cost of fentanyl compared with heroin may be a more significant factor CONCLUSION: Current evidence points to a supply-led addition of fentanyl to the drug market in response to heroin supply shocks and shortages, changing prescription opioid availability and/or reduced costs and risks to suppliers. Current drug users in affected regions of the United States, Canada and Europe appear largely to lack both concrete knowledge of fentanyl's presence in the drugs they buy and access to fentanyl-free alternatives.

Counterfeit or substandard drugs are pharmaceutical formulations in which the active pharmaceutical ingredients (APIs) have been replaced or ingredients do not comply with the drug leaflet. With the outbreak of the COVID-19 pandemic, fraud associated with the preparation of substandard or counterfeit drugs is expected to grow, undermining health systems already weakened by the state of emergency. Analytical chemistry plays a key role in tackling this problem, and in implementing strategies that permit the recognition of uncompliant drugs. In light of this, the present work represents a feasibility study for the development of a NIR-based tool for the quantification of dexamethasone in mixtures of excipients (starch and lactose). Two different regression strategies were tested. The first, based on the coupling of NIR spectra and Partial Least Squares (PLS) provided good results (root mean square error in prediction (RMSEP) of 720 mg/kg), but the most accurate was the second, a strategy exploiting sequential preprocessing through orthogonalization (SPORT), which led (on the external set of mixtures) to an R2pred of 0.9044, and an RMSEP of 450 mg/kg. Eventually, Variable Importance in Projection (VIP) was applied to interpret the obtained results and determine which spectral regions contribute most to the SPORT model. [ABSTRACT FROM AUTHOR]

The objective of this special report is to present the advances in Latin America on regulation of the online sale of medical products and to offer guidance to national regulatory authorities (NRAs) on planning and implementing strategies to regulate and oversee the e-commerce of medical products. The regulatory advances and the programs and initiatives implemented in four Latin American countries to control the online sale of medical products are presented, including complementary reviews of the literature and reviews of e-commerce control programs of agencies of reference. Based on this review, the following strategies are proposed: strengthening the regulatory and policy framework; strengthening the capacity for oversight; collaboration with national and international authorities and other key players; and communication and awareness-raising with the community and health care professionals. Each of these strategies should be accompanied by specific actions that can serve as guidelines for NRAs in the Americas and in countries with similar contexts, to strengthen their regulatory frameworks and patient and consumer protections. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to describe law enforcement oversight of counterfeit drugs by the Food and Drug Administration (FDA) in the United States from 2016 through 2021. Methods: The FDA Office of Criminal Investigation database with hyperlinked press releases of enforcement actions was used to identify legal action against drug counterfeiters. Incidences of counterfeit drugs sold via Internet, how often they were obtained without a prescription, the most prevalent counterfeit drugs, the countries where counterfeit operations occurred, and the scale of counterfeit operations were assessed. Results: There were 130 unique enforcement actions against counterfeiting organizations and individuals. Overall, 64.6% of enforcement actions involved counterfeit products sold over the Internet, in 84.6% of actions counterfeit medications could be obtained without a prescription, and in 33.1% of actions the products were sold as dietary supplements. Sexual dysfunction, opioid, stimulant, anabolic muscle building, benzodiazepine, and dermatologic drugs were most counterfeited. China was the most prevalent country to produce counterfeit drugs followed by India, Turkey, Pakistan, and Russia. Counterfeiting operations were large with tens of millions of pills and hundreds of millions of dollars in sales. Health outcomes for counterfeit drugs were rarely discussed in the press releases and not all press releases had data for each parameter of interest. Conclusion and Relevance: This is the first report assessing enforcement actions against drug counterfeiters from the FDA Office of Criminal Investigation. The FDA is actively involved in identifying and prosecuting counterfeit drug rings, but the number of enforcement actions is smaller than the size of the problem. [ABSTRACT FROM AUTHOR]

Many older adults in Nigeria live with chronic illnesses and regularly need drugs to manage them, however, procuring genuine drugs is a challenge given the proliferation of counterfeit drugs in Nigeria. Older adults in rural Nigeria who are largely poor with lower educational status may be disproportionately affected by this high proliferation of counterfeit drugs in Nigeria. With qualitative interviews from purposefully sampled 24 rural older adults in Southeast Nigeria, we explored the problem of widespread counterfeit drugs and how rural older adults with chronic illnesses navigate this problem in Nigeria. The collected data were inductively coded with NVivo 12 and analysed thematically. Findings revealed that most of the sampled participants reported having had experiences procuring counterfeit drugs from chemists (drug stores) and doggermans (street vendors) with women more predisposed to the risk of using counterfeit drugs. This has greatly impacted their health, economic status, and has led them to the use of alternative medicines. The study thus recommended stricter regulations for drug distribution and provision of health insurance to give rural older adults access to drugs at hospital pharmacies where genuine drugs are guaranteed. [ABSTRACT FROM AUTHOR]

The increasing prevalence of falsified and counterfeit medicines globally poses risks to international travellers. This narrative literature review examines the global challenge of falsified and counterfeit medicines, with a specific focus on risks for travellers. The aim is to provide a comprehensive understanding of this multidimensional issue, exploring potential solutions for effective intervention. A comprehensive search of databases, including PubMed, MEDLINE, and Scopus, as well as relevant reports from international organisations, was undertaken. There was a focus on extracting information pertaining to the prevalence, types, and geographical patterns of falsified and counterfeit medicines encountered by international travellers. Synthesising this information helped to identify overarching trends and patterns. This narrative review utilised a thematic analysis approach to synthesise the findings. The findings revealed a diverse range of counterfeit drug categories, spanning from antibiotics to lifestyle medications, posing unique risks to travellers navigating the global pharmaceutical landscape. The review emphasises the geographical distribution of these drugs, with varying consequences for both high- and low-income nations. The inadequate formulations and inconsistent drug release arising from these practices pose severe threats to public health, especially for individuals travelling abroad. The review also highlights the significance of international collaboration in addressing this global challenge, as pharmaceutical supply chains seamlessly cross borders, necessitating a collaborative approach for effective regulation and enforcement. This review underscores the need for targeted research, collaborative interventions, and technological innovations to address the complexities associated with falsified and counterfeit medicines, ensuring the safety and well-being of international travellers. [ABSTRACT FROM AUTHOR]

Counterfeit drugs are forgery-tagged medicines that are considered to be drugs without vigorous active pharmaceutical ingredients (API). India, being the world's largest producer of drugs, faces a crucial issue of counterfeits. Moreover, counterfeits identify their path into the pharmaceutical supply chain (PSC) effortlessly owing to the dearth of security and traceability in the prevailing system. This is because the software applications currently in use stockpile the information about drugs on centralized servers and are accessed by manufacturers, distributors and retailers via the internet. The security of such systems is found to be weak. To address these issues, in this work, a novel method called Supersingular Isogeny and Hosmer–Lemeshow Logistic Regression-based (SI-HLLR) secured information sharing for the pharmaceutical supply chain is proposed. The SI-HLLR method is split into two sections, block validation and authentication. First, with the pharmaceutical sales data provided as input, the supersingular isogeny Diffie–Hellman key exchange model is applied for block validation and then is implemented using a blockchain. Next, with the validated blocks, the authentication mechanism is performed using Hosmer–Lemeshow logistic regression-based authentication that in turn eliminates the counterfeit drugs from the pharmaceutical supply chain. The hyperledger fabric blockchain solution using SI-HLLR leads to improved security ensuring data integrity and better authentication accuracy in the proposed method. [ABSTRACT FROM AUTHOR]

The increasing use of expensive oral anticancer medicines (OAM) comes with the downside of a financial and environmental burden, partially caused by unused medication. Current initiatives to reduce medication waste face challenges and legal barriers like the EU Falsified Medicines Directive. We propose an easy to implement, practical method which provides guaranteed quality of redispensed OAM. Returned OAM are assessed by the pharmacy on the basis of standardized quality criteria covering suitability, physical condition, authentication and additional aspects. Implementation of this approach in our institute resulted in 79% of returned OAM eligibility for redispensing, saving €483,301 and 1.1 kg of highly potent pharmaceutical waste over a 1 year period. We therefore advocate for removing any legal barriers for redispensing and broad adoption of this method to reduce unnecessary financial and medication waste while maintaining quality for our patients.

Introduction: Women who use drugs, particularly those using anabolic-androgenic steroids (AAS), encounter heightened social risks influenced by the legal status of AAS, varying regionally. In jurisdictions where AAS are legal, medical guidance and prescription are common, while in illegal regions, there are challenges associated with acquisition and safer usage. Therefore, we aimed to explore the experiences of women who use AAS in Australia, where these substances are criminalised, with a focus on the challenges they encounter in acquiring and using these drugs., Methods: We focused on data from six women in a broader study interviewing 15 AAS users. The data were subjected to iterative inductive analysis, resulting in two theme-categories., Results: Women who use AAS face distinct challenges in accessing reliable suppliers, with men seemingly having 'easier' access. Women experience this disparity as increasing their vulnerability to unsafe products, further compounded by their lack of knowledge regarding these substances. Moreover, mislabelling and counterfeiting of female-specific AAS substances is described to further compound these risks, reflecting the participants' expressed need for enhanced intervention and quality control in the AAS market., Discussion and Conclusions: Ensuring product reliability, transparency and accountability are perceived as essential for the health and safety of women who use AAS. To address these issues, interventions should provide women with comprehensive drug checking services tailored to their health needs. 'Steroid literacy' must be an integral component, equipping women with knowledge to make informed decisions in the gendered AAS market., (© 2024 The Author(s). Drug and Alcohol Review published by John Wiley & Sons Australia, Ltd on behalf of Australasian Professional Society on Alcohol and other Drugs.)

Background: Pentobarbital is a Schedule II/III short-acting barbiturate with limited medical use in humans. Veterinary professionals use pentobarbital to euthanize dogs, cats, and other companion animals. Pentobarbital is also utilized in capital punishment and small amounts are illegally shipped or diverted to assist in suicides. However, five kilograms of pentobarbital smuggled in from Mexico was recently seized by an organized crime drug enforcement task force (along with fentanyl, heroin, and cocaine), which may suggest a shift in illicit supply. We investigated potential indicators of illicit pentobarbital use or availability in the US to help determine whether this drug is becoming an emerging public health concern., Methods: The National Drug Early Warning System requested information on pentobarbital from its sentinel surveillance sites and collaborators and conducted a search of current literature., Results: In early 2024, multiple batches of counterfeit pills (e.g., pressed as "M30s" to represent oxycodone) confiscated near the Southwest border tested positive for pentobarbital plus combinations of fentanyl, fentanyl analogs, and xylazine. Other indicators suggest pentobarbital is being smuggled in powder form and possibly sold as another drug such as heroin. One national drug analysis program detected pentobarbital in 217 drug submissions from 2020 to 2023, and there were at least 12 fatal exposures linked to use from 2020 to 2022., Conclusion: Continued monitoring of illicit use and availability is needed as pentobarbital may continue to appear on the illicit market. Unknown exposure can occur if the drug is mixed into counterfeit pills or sold in powder form represented to be another drug., Competing Interests: Declaration of Competing Interest J. Palamar has consulted for the Washington-Baltimore High Intensity Drug Trafficking Area program. The authors have no other potential conflicts to declare., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Substandard and falsified medical products for treating COVID-19 have spread worldwide. These medicines have entered Japan through personal importation of products purchased via the Internet. In this study, we investigated the circulation of 19 COVID-19-related medicines on the Internet in Japan and evaluated the pharmaceutical quality and authenticity of 2 medicines (dexamethasone tablets and ivermectin tablets) obtained online. We purchased 23 samples of 0.5-mg dexamethasone tablets and 13 samples of 3-mg ivermectin tablets from the Internet in December 2020 and July 2022. We investigated the quality and authenticity of the obtained samples through visual observation and tested their authenticity. We conducted pharmacopoeia compliance testing (quantitative assay, content uniformity tests, and dissolution tests) using the high-performance liquid chromatography-photodiode array detector method. No prescription was ever required at the time of purchase. Visual observation revealed that most samples lacked a package insert and some samples had packaging deficiencies. In terms of authenticity, eight ivermectin samples were genuine; the authenticity of the other samples remained uncertain. Four dexamethasone samples and three ivermectin samples failed quality testing based on pharmacopeia validation standards. Our findings illustrate that dexamethasone and ivermectin tablets of poor quality are available online. It is important to increase consumer awareness and provide information about these medicines to prevent the purchase of substandard medicines via the Internet.

Abstract Objective Substandard and falsified (SF) medical products are a global public health threat. The presence and spread of SF drugs negatively affect (1) patients’ safety and health outcomes, (2) national economy, (3) public trust in the healthcare system, and (4) the international fight against serious health challenges such as malaria and antimicrobial resistance. The objective of the current study was to investigate and provide a snapshot analysis of the evolution and developmental patterns of global research publications on SF products. Methods A bibliometric approach was adopted using terms such as fake, falsified, counterfeit, substandard, and others. No language restriction was made. The study period was from 1900 up to 2020. The search strategy was validated and implemented using Scopus database. Results The search strategy retrieved 978 documents authored by 2861 researchers from 100 different countries and published in 421 different journals. The retrieved documents received 11,237 citations (11.5 citations per document) with an H-index of 53. The 978 documents retrieved from Scopus were published from 1961 to 2020, giving an average of 16.6 publications per year. The present study indicated that research on SF medical products: (a) has experienced a steep growth from 2001 to 2012 followed by a steady-state growth; (b) was disseminated in a wide range of journals, mainly in the fields of the pharmaceutical industry, analytical chemistry, public health, infectious diseases, and internal medicine; (c) was published by scholars with diverse and distant geographical backgrounds; (d) was mainly produced in the United States, United Kingdom, and Germany; (d) has fragmented research networks and a limited number of researchers per network; (e) has limited cross-country collaboration except for that between the US and the UK in one hand and countries in the Mekong region in the other hand; (f) emphasized on medications related to malaria and sexual stimulants; and (g) received relatively inadequate funding. Conclusions Research on SF medical products is important and should remain a priority to ensure good quality of medications. Research activity in the field needs to be encouraged in world regions such as Africa and the Middle East where drug regulations are unsatisfactory and cross-border trade of illegal medications is common.

The annual ConV2X is a leading international health tech symposium driving real world evidence, strategy, research, operations and trends to create a blueprint for a new digital health era. The 2021 symposium featured a scientific program of academic/research presentations in addition to business and industry talks. The research track focused on exploring and sharing developments in blockchain and emerging technologies in health and clinical medicine. Submissions were based on original research, conceptual frameworks, proposed applications, position papers, case studies, and real-world implementation. Selection was based on a peer-review process. Faculty, students, and industry researchers were encouraged to submit abstracts to present ideas before an informed and knowledgeable audience of industry leaders, policy makers, funders, and researchers. This presentation was selected by the scientific review committee. Submission Review Committee • Dave Kochalko, CEO of ARTiFACTS • Anjum Khurshid, UT Austin • Carlos Caldas, UT Engineering • Gil Alterovitz, Harvard Medical School • Kayo Fujimoto, UT Health Houston • Lei Zhang, University of Glasglow • Sean Manion, CSciO of ConsenSys Health • Vijayakuman Varadarajan, University of South Wales • Vikram Dhillon, Wayne State University • Yuichi Ikeda, Kyoto University

• An electrochemical sensor for Xanax is presented to tackle counterfeit pills. • The active ingredient, alprazolam, is identified via electrochemical fingerprinting and data analysis. • Adulterants and illicit drugs are integrated in the automated electrochemical strategy. • The counterfeit testing is based on real on-site scenarios, i.e. affordable and user-friendly. • The protocol can be expanded to other counterfeit medicines. The illicit drug market has been constantly evolving in the last decades, with a significant rise in counterfeit medicines posing serious public health risks. Benzodiazepines (BZDs) such as alprazolam (generally sold under the brand name Xanax), have particularly become the target of counterfeiting efforts due to their addictive nature and upsurge of unregulated designer BZDs. These counterfeit versions frequently resemble legitimate products but contain harmful adulterants or other potent illicit substances. Few methods have been developed to tackle counterfeit pills, usually limited to accurate and sophisticated laboratory equipment. This study explores the feasibility of combining electrochemical fingerprinting with data analysis to overcome the limitations of traditional methods. First, the electrochemical behavior of selected BZDs is studied, and analytical parameters such as pH are optimized. Then, the electroanalysis of common adulterants and illicit drugs is addressed and integrated into a user-friendly app, including a flowchart system. The proposed electrochemical strategy enables the detection of counterfeit Xanax by identifying the presence or absence of alprazolam. It also allows determination of the alprazolam content within a pill while meeting the fundamental requirements of the end users. This study represents an on-site methodology to address the growing challenges posed by BZDs, easily transferable to counterfeit medicines from other drug groups. [Display omitted] [ABSTRACT FROM AUTHOR]

Counterfeit drugs are rife across developing nations, production, and trade of these substandard and fake drugs for monetary benefit imperils thousands of innocent lives and puts extra stress on the already struggling health-care system of populous countries. Methods like printing of anti-counterfeit labels with holograms and QR codes partially solve the issue by tracking and eliminating forged packagings. However, ingredient-based testing is inevitable for quality checks, especially when the contents and their respective concentrations are to be analyzed. Ingredient analysis mostly includes techniques like infrared and Raman spectroscopy, isotope characterization, and mass spectrometry. We used microwave cavity perturbation with 3-D printed sample holders for instant detection of counterfeits in a variety of drugs. The method is based on the screening of samples through dielectric measurements. The applicability of the proposed method was tested and verified on the genuine and counterfeited samples of capsulated oral drugs, tablets, gel-based antibiotics, and pain relief tubes. [ABSTRACT FROM AUTHOR]

Background: WHO report of 2017 estimates that the rates of substandard and falsified medical products in low- and middle-income countries is approximately 10.5% with an estimated spend of US$ 30.5 billion.Objective: The purpose of the study is to assess the quality of different brands of metronidazole available in Jimma town, Oromia region, South West Ethiopia.Methods: Cross-sectional study was conducted in Jimma town, Oromia regional state, Ethiopia. The study was conducted from May 03 – July 30, 2018. Samples were collected using convenience sampling technique. The samples were analyzed using methods specified in British Pharmacopoeia 2013 and United States Pharmacopoeia 2015.Results: All the seven brands of Metronidazole analyzed for quality passed identity test specification of BP 2013. The three brands of Metronidazole capsules passed weight uniformity and dissolution test specification of USP 2015. The seven brands of Metronidazole passed assay (i.e. drug content) test specification of USP 2015. The highest percentage of drug content, 107.81% and 105.56%, obtained for Metronidazole (generic)(capsule) and Nirmet(injection) respectively. However, statistical comparison of assay of respective brands of the respectivedosage forms at 95% confidence interval indicates that there exists significant difference in assay within and among the brands of the respective dosage forms (p

Blockchain technology is accelerating digital transformation across multiple industries, including the pharmaceutical industry. The pharmaceutical industry suffers from a lack of transparency, difficulty tracking products, lack of trust, and the shipment of expired products. Blockchain technology has been applied to solve several of these problems. In this paper, we present a systematic review of the literature focusing on the adoption of blockchain technology in the pharmaceutical industry. We collected, analyzed, qualified, and discussed studies retrieved from seven databases. The initial search yielded 2,185 papers, which were screened, discussed, voted on, critically appraised, and collected by a snowball workflow that finally yielded 38 papers. The blockchain application areas covered in the papers were classified as counterfeit drug prevention, drug distribution, tracking and tracing, and safety and security. The most frequent category was counterfeit drug prevention, which is consistent with the primary objective of the pharmaceutical industry. The newer topics discussed in this study were data governance, data quality, pharmaceutical turnover, and prescription drug monitoring. We discuss issues surrounding each of these topics and research studies, along with their limitations and solutions. We also examine the challenges and future research directions of applying blockchain technology in the pharmaceutical industry.

Objective. To identify the strategies employed by regulatory systems for the market surveillance and control of substandard, falsified, and unregistered medicines at the regional-global levels, especially regarding drug recall procedures. Method. An integrative literature review was performed. Searches were performed in MEDLINE via PubMed, Embase, and SciELO to select articles published from 2007 to 2019 in English, Portuguese, and Spanish, covering national regulatory system initiatives, with a focus on the recall of substandard, falsified, and unregistered medicines. Results. Of 483 articles initially identified, 21 global, regional, or national scope studies were selected. Prevention, detection, and response strategies, including drug recall, were grouped according to two broad market surveillance and control models (passive-reactive and proactive) used by regulatory systems. These models seem to combine passive and proactive, complementary or concurring actions that varied according to country development level and regulatory capacity. Although considered the most effective response for protection of populations, medicine recall was not implemented in a uniform manner in different regulatory systems as indicated by the studies. Conclusions. Addressing the complexity and magnitude of the problem of substandard, falsified, and unregistered medicines will demand effort, investment, and profound changes in the approaches, processes, and capacity of regulatory systems, with market surveillance and control strategies possibly converging toward a hybrid, multisectoral, multidisciplinary, global, and systemic model of human health protection. [ABSTRACT FROM AUTHOR]

The purpose of this research is to identify the determinants of the attitude towards counterfeit drugs and to analyze the effect of this attitude on the purchasing behavior of Cameroonian consumers. The purchase of illicit drugs requires a better understanding of consumer behavior if the authorities are to effectively combat the development of this scourge. Data were collected by questionnaire from 696 households in the cities of septentrional zone of Cameroun. The use of regression tests on the determinants of attitude towards counterfeit drugs. The results reveal that attitude towards counterfeit drugs depends on certain socio-demographic factors, product-related factors, and psychographic factors. However, product-related factors, such as perceived quality and the price differential between the original and the counterfeit drug, are the most important. These results are similar to those of Le Roux (2015). The counterfeit drug market is resistant to anti-counterfeiting campaigns mainly because patients find relief at a lower cost. [ABSTRACT FROM AUTHOR]

Objective. To assess all the incidents of substandard, falsified and unregistered medicines in 2017 and 2018 in Latin America, determining the types of products affected, stages of the supply chain in which incidents were detected, quality deviations identified in tested samples, and regulatory measures taken by authorities. Methods. A comprehensive search of the websites of the Latin American national regulatory authorities was conducted, identifying all eligible incidents during 2017-2018. Standardized values were collected from each incident for pre-determined variables: country, year, type of incident, therapeutic group, supply chain, regulatory measures and laboratory data. Results. A total of 596 incidents in 13 countries were included (236 substandard, 239 falsified, 116 unregistered and 5 stolen). The therapeutic categories with the highest incidents were: anti-infectives, medicines for pain/palliative care, hormones/contraceptives, medicines for the respiratory tract, and medicines for mental/ behavioural disorders. The most common places where incidents were detected were commercial establishment, pharmacies, health services and manufacturers. The most recurrent quality deviations were failure in parameters (appearance or physicochemical), incorrect labelling, different quantity of active pharmaceutical ingredient, presence of unknown particles, and microbiological contamination. The most frequent regulatory measures identified were alerts, withdrawals, seizures, and prohibition of marketing/distribution/use. Conclusions. In Latin America, substandard, falsified and unregistered medicines persist as a highly prevalent problem. An advanced degree of regulatory development in countries is associated with higher incident detection/reporting rates and a more comprehensive set of measures. The pharmaceutical supply chain is more vulnerable in its final node. Quality deviations identified in tested samples pose serious risks to public health.

Availability of counterfeit prescription pills (counterfeit pills) containing illegally made fentanyl, including counterfeit M-30 oxycodone (counterfeit M-30) pills, has risen sharply in the United States and has been increasingly linked to overdose deaths. In 2023, approximately 115 million counterfeit pills were seized in U.S. High Intensity Drug Trafficking Areas. However, clinical data on counterfeit pill-related overdoses are limited. Medical toxicology consultations during 2017-2022 from one U.S. Census Bureau Western Region hospital participating in the Toxicology Investigators Consortium Core Registry were analyzed. A total of 352 cases suspected to involve counterfeit M-30 pills, including 143 (40.6%) cases of fentanyl exposure and 209 (59.4%) cases of acute withdrawal were identified; consultations increased from three in 2017, to 209 in 2022. Patients aged 15-34 years accounted for 95 (67.4%) exposure cases. Among all patients with exposures, 81.1% were hospitalized, 69.0% of whom were admitted to an intensive care unit. Additional substances were detected in 131 (91.6%) exposures. Providing outreach to younger persons misusing prescription pills, improving access to and distribution of harm reduction tools including fentanyl test strips and naloxone, and promoting linkage of persons treated for overdose in hospitals to harm reduction and substance use treatment services are strategies to reduce morbidity associated with use of counterfeit M-30., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed.

Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Roisin McElroy reports payment from St. Joseph’s Health Centre/Unity Health Toronto, Toronto, Canada for provision of emergency medical clinical services. Mary-Margaret A. Fill reports receipt of travel funding from the Council of State and Territorial Epidemiologists (CSTE) for travel to CSTE Executive Board meetings and CSTE conference and unpaid service as member-at-large of CSTE’s Executive Board and the University of Tennessee’s One Health Committee. Catherine M. Brown reports receipt of travel support from CSTE for attendance at the CSTE annual conference and unpaid service as a CSTE Executive Board member. No other potential conflicts of interest were disclosed.

Introduction: Counterfeit medications, sometimes referred to as "fake" or falsified drugs or pills, are drugs that are illicitly manufactured but designed to look like legitimate pharmaceuticals. Counterfeit medications are a growing public health concern. This study estimated the prevalence of self-reported use of suspected counterfeit medications by adults in the US and to assess what ingredients these individuals suspected were in the counterfeit medications., Methods: This general population survey, drawn from an online panel, was administered across 2 waves in 2022 (15 April 3 June and 9 September 21 October) to 59,041 adults aged 18 and older. Statistical calibration weighting was used to calculate estimates representative of the national adult population., Results: An estimated 1.8% (95% CI 1.7%-1.9%) of respondents, corresponding to approximately 4.6 million adults, suspected past 12-month use of counterfeit medications. Fentanyl was the most commonly suspected ingredient in the counterfeit product (16.1%, 95% CI 12.8%-19.3%). The next most prevalent response was "I don't know" (15.0%, 95% CI 11.0%-18.9%) followed by methamphetamine (14.9%, 95% CI 11.4%-18.4%)., Conclusions: These data show the scale of the issue in relation to other well established drug use data points in the US. System-level methods, such as drug scanning software, should be implemented to reduce the likelihood that counterfeit drugs end up in the hands of individuals., (Copyright © 2024 American Society of Addiction Medicine.)

Introduction: Counterfeit medicines are a significant problem globally. In a developing country like Nepal, community pharmacists play an important role in dispensing medicines. The study was done to assess community pharmacists' perceived prevalence, awareness and attitude towards counterfeit medicines in Kathmandu valley.  Methods: A cross-sectional study design was used. Data was collected conveniently from Kathmandu, Bhaktapur, and Lalitpur districts in March 2022 after obtaining ethical clearance from Nepal Health Research Council (reference no. 2200) and taking written informed consent from Community Pharmacists.  Results: Among the 343 pharmacists who participated, 250 (72.89%) were from Kathmandu, 57 (16.62%) were from Lalitpur, and 36 (10.50%) from Bhaktapur. Most 252 (73.47%) were aged between 20 to 30 years, 222 (64.72%) were male, 239 (69.68%) had done a Diploma in Pharmacy, 201 (58.60%) had working experience of more than 5 years and 342 (99.71%) had done their education in Nepal. Their median perceived prevalence of counterfeit drugs was 10.00% but only 2.30% had clear knowledge of such practice. 332 (96.79%) believed that actions should be taken against community pharmacists dispensing counterfeit drugs, 325 (94.75%) believed that pharmacists who dispense counterfeit medicines are unprofessional; 338 (98.54%) stated that there should be strong law against counterfeit medicine sales., Conclusions: Median perceived prevalence of counterfeit medicines was 10.00% but only 2.30% were aware of counterfeit medicine dispensing. Out of 343 pharmacists, 332 (96.79%) mentioned that  action should be taken against those pharmacists knowingly dispensing counterfeit medicines and 338 (98.54%) stated that there should be strong law against counterfeit medicines.

Background: Smuggling health goods given the importance and critical nature of health services should be undeniably addressed and controlled by all countries. This issue is especially more widespread in developing countries with more damaging consequences. This paper therefore aims to identify and analyze the challenges of preventing smuggling of health goods in Iran., Method: Within this qualitative study, we conducted face-to-face, semi-structured interviews with 30 purposefully recruited key informants and stakeholders in the detection, prevention, and combating of health goods smuggling. Each interview was analyzed thematically, using an inductive approach to generate codes, then categorized and presented in the form of main themes and sub-themes. Maxqda 11 assisted in coding, analysis, and data management., Results: Three main themes emerged representing the challenges of prevention of smuggling in Iran in the areas of anti-smuggling policy development, including categories of inefficient policy and plan, and failure to reach agenda; policy implementation; categorized into actors, resources and instruments, and implementation guarantee; and finally monitoring and evaluation; including, procedures and practices, and the role of surveyors., Conclusion: Prevention of smuggling health goods proves to be a highly complex, challenging, and multi-faceted practice. Therefore, strengthening policy-making, regulatory frameworks, and facilitation functions about smuggling, counterfeiting, and corruption should be promoted in parallel., (© 2024. The Author(s).)

Competing Interests: Disclosure of interest: The authors completed the ICMJE Disclosure of Interest Form (available upon request from the corresponding author) and disclose no relevant interests.

Objective: Substandard and falsified (SF) medical products are a global public health threat. The presence and spread of SF drugs negatively affect (1) patients' safety and health outcomes, (2) national economy, (3) public trust in the healthcare system, and (4) the international fight against serious health challenges such as malaria and antimicrobial resistance. The objective of the current study was to investigate and provide a snapshot analysis of the evolution and developmental patterns of global research publications on SF products.Methods: A bibliometric approach was adopted using terms such as fake, falsified, counterfeit, substandard, and others. No language restriction was made. The study period was from 1900 up to 2020. The search strategy was validated and implemented using Scopus database.Results: The search strategy retrieved 978 documents authored by 2861 researchers from 100 different countries and published in 421 different journals. The retrieved documents received 11,237 citations (11.5 citations per document) with an H-index of 53. The 978 documents retrieved from Scopus were published from 1961 to 2020, giving an average of 16.6 publications per year. The present study indicated that research on SF medical products: (a) has experienced a steep growth from 2001 to 2012 followed by a steady-state growth; (b) was disseminated in a wide range of journals, mainly in the fields of the pharmaceutical industry, analytical chemistry, public health, infectious diseases, and internal medicine; (c) was published by scholars with diverse and distant geographical backgrounds; (d) was mainly produced in the United States, United Kingdom, and Germany; (d) has fragmented research networks and a limited number of researchers per network; (e) has limited cross-country collaboration except for that between the US and the UK in one hand and countries in the Mekong region in the other hand; (f) emphasized on medications related to malaria and sexual stimulants; and (g) received relatively inadequate funding.Conclusions: Research on SF medical products is important and should remain a priority to ensure good quality of medications. Research activity in the field needs to be encouraged in world regions such as Africa and the Middle East where drug regulations are unsatisfactory and cross-border trade of illegal medications is common. [ABSTRACT FROM AUTHOR]