Criminal Action Against Drug Counterfeiters: Assessment of the FDA Office of Criminal Investigation Database 2016 Through 2021.

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.

Edible unclonable functions.

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.

Illicit fentanyls in the opioid street market: desired or imposed?

BACKGROUND: Illicitly 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/ANALYSIS: Existing 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.

The Global Wicked Problem of Corruption and Its Risks for Access to HIV/AIDS Medicines.

We discuss how corruption affects access to antiretroviral therapies (ARVs) globally. Recent cases of theft of ARVs, collusion, and manipulation in procurement found in countries such as Central African Republic, Bangladesh, Malawi, and Guinea, show there is still much work to be done to reduce the risk of corruption. This includes addressing the structural weaknesses in procurement mechanisms and supply chain management systems of health commodities and medicines.

Fentanyl: A Whole New World?

This article seeks to document the latest danger in the opioid crisis: fentanyl and related synthetic opioids. Fifty times more potent than pure heroin, cheaper to manufacture in laboratories worldwide, and easily distributed by mail and couriers, fentanyl is flooding the illicit opioid markets throughout the country.

An insight into the deep web; why it matters for addiction psychiatry?

OBJECTIVE: Nowadays, the web is rapidly spreading, playing a significant role in the marketing or sale or distribution of "quasi" legal drugs, hence facilitating continuous changes in drug scenarios. The easily renewable and anarchic online drug-market is gradually transforming indeed the drug market itself, from a "street" to a "virtual" one, with customers being able to shop with a relative anonymity in a 24-hr marketplace. The hidden "deep web" is facilitating this phenomenon. The paper aims at providing an overview to mental health's and addiction's professionals on current knowledge about prodrug activities on the deep web. METHODS: A nonparticipant netnographic qualitative study of a list of prodrug websites (blogs, fora, and drug marketplaces) located into the surface web was here carried out. A systematic Internet search was conducted on Duckduckgo® and Google® whilst including the following keywords: "drugs" or "legal highs" or "Novel Psychoactive Substances" or "NPS" combined with the word deep web. RESULTS: Four themes (e.g., "How to access into the deepweb"; "Darknet and the online drug trading sites"; "Grams-search engine for the deep web"; and "Cryptocurrencies") and 14 categories were here generated and properly discussed. CONCLUSIONS: This paper represents a complete or systematical guideline about the deep web, specifically focusing on practical information on online drug marketplaces, useful for addiction's professionals.

Poor-Quality and Counterfeit Drugs: A Systematic Assessment of Prevalence and Risks Based on Data Published From 2007 to 2016.

Counterfeit drugs can hurt patients and harm the pharmaceutical industry. In 2006, the International Medical Products Anti-Counterfeiting Taskforce expressed a need to generate more and better data to calculate a worldwide prevalence of counterfeiting. This review analyzes field test data that were published in the time frame January 2007 to December 2016, were accessible via Pubmed, and which addressed the prevalence of counterfeit drugs. Based on the 41 studies identified, it is still not possible to make a reliable statement about the prevalence of counterfeit drugs due to the heterogeneity of the results. To make further progress in this area, both the quantity and quality of documented field tests should be increased. Without a differentiated analysis considering therapeutic class, source, and country of counterfeit drugs, it will remain difficult to identify the root causes of market infiltration and useful points of attack to combat them. Studies with high sample power and randomized sampling, packaging inspection, and detailed chemical analysis will be necessary to correctly identify (especially professional) counterfeit samples. The classification system presented in this review should help to calculate not only the prevalence of counterfeit drugs but also the risks to the patient associated with different types of counterfeited medicines.

Captagon: use and trade in the Middle East.

BACKGROUND: Fenetheylline, a psychostimulant drug, often branded as Captagon, is a combination of amphetamine and theophylline. Since the cessation of its legal production in 1986, counterfeited products have been produced illicitly in south-east Europe and far-east Asia. Its profitable trade has been linked to terrorist organizations, including Islamic State of Iraq and the Levant. This study aims to reach up-to-date data, concerning the Captagon e-commerce and use in the Middle East. METHODS: A multi-staged and multi-lingual literature search was carried out. A list of prespecified keywords was applied across medical and paramedical databases, web and Dark web, search engines, social communication media, electronic commerce websites, media networks, and the Global Public Health Intelligence Network database. RESULTS: The use of Captagon as a stimulant in terrorist settings has been marginally covered in the literature. Data can widely be retrieved from Google and AOL search engines, YouTube, and Amazon e-commerce websites, and to a lesser extent from Alibaba and eBay. On the contrary, Middle Eastern e-commerce websites yielded almost no results. Interestingly, the Dark web generated original data for Captagon e-commerce in the Middle East. CONCLUSION: Further investigations are needed on the role that psychoactive drugs play in terrorist attacks and civil war zones. Unless a comprehensive methodological strategy, inclusive of unconventional methods of research, is implemented, it will not be feasible to face such a threat to humanity.

The Challenge of Counterfeit Drugs: A Comprehensive Review on Prevalence, Detection and Preventive Measures.

Counterfeit drugs are a worldwide concern. This organized crime has deterrent effect on public health and on pharmaceutical business across the globe. Lack of comprehensive standardized definition of counterfeit drugs with global acceptance, higher benefits of cost ratio and intercomplexity of market and globalized network are the major reasons behind this. Unawareness among the stakeholders lack of intellectual property protection and social-economic factor also resulted in flourished market of fake drugs. Despite of several attempts made by global regulatory agencies, inefficient regulations, lax enforcement of existing legislation and lack of commitment by involved authorities still remain major loopholes, aggravating the serious problem of counterfeiting. Although use of techniques based on interference pattern, encryption, spectroscopy and chromatographic principles by pharmaceutical industries to authenticate genuine products has curtailed the problem to a limited extent. In order to efficiently control the organized crime of medicine counterfeiting, collective efforts of 'National Counterfeit Control Agencies', pharmaceutical industries, law regulatory agencies and public are essential. Strict legal enforcement, applications of comprehensive database, interlinked network and technological advancement are need of the hour. The purpose of this article is to overview all aspects of drug counterfeiting including current status and magnitude, effectiveness and limitation of existing technologies available to counter with particular attention to suggest possible roadmap to overcome the problem through uni-directional and focus global co-operation.

[Counterfeit and Falsified Drugs: an Overview]. / Trafic de faux médicaments : panorama 2014.

If the traffic of fake medicines may represent an economic threat for the pharmaceutical industry, it can also be responsible of safety concerns for patients. Despite fake drugs represent a real threat for public health, the intended punishments are until now only based on intellectual property rights. Estimated to generate more than 55 billion euros per year, the traffic of falsified drugs varies from a country to another one. Indeed, the proportion of falsified drugs ranges from 1% in industrialized countries with a regulated and controlled distribution system to 60% of medicines in some developing countries. Currently, the measures developed to limit this traffic concern five main areas: legislation / regulation, cooperation, enforcement, technology and communication. Communication actions should be performed to inform health professionals as the populations about the risks of using drugs purchased outside the legal drug market.

Interventions to combat or prevent drug counterfeiting: a systematic review.

OBJECTIVE: Drug counterfeiting has serious public health and safety implications. The objective of this study was to systematically review the evidence on the effectiveness of interventions to combat or prevent drug counterfeiting. DATA SOURCES: We searched multiple electronic databases and the grey literature up to March 2014. Two reviewers completed, in duplicate and independently, the study selection, data abstraction and risk of bias assessment. STUDY ELIGIBILITY CRITERIA, PARTICIPANTS AND INTERVENTIONS: We included randomised trials, non-randomised studies, and case studies examining any intervention at the health system-level to combat or prevent drug counterfeiting. Outcomes of interest included changes in failure rates of tested drugs and changes in prevalence of counterfeit medicines. We excluded studies that focused exclusively on substandard, degraded or expired drugs, or that focused on medication errors. APPRAISAL AND SYNTHESIS: We assessed the risk of bias in each included study. We reported the results narratively and, where applicable, we conducted meta-analyses. RESULTS: We included 21 studies representing 25 units of analysis. Overall, we found low quality evidence suggesting positive effects of drug registration (OR=0.23; 95% CI 0.08 to 0.67), and WHO-prequalification of drugs (OR=0.06; 95% CI 0.01 to 0.35) in reducing the prevalence of counterfeit and substandard drugs. Low quality evidence suggests that licensing of drug outlets is probably ineffective (OR=0.66; 95% CI 0.41 to 1.05). For multifaceted interventions (including a mix of regulations, training of inspectors, public-private collaborations and legal actions), low quality evidence suggest they may be effective. The single RCT provided moderate quality evidence of no effect of 'two extra inspections' in improving drug quality. CONCLUSIONS: Policymakers and stakeholders would benefit from registration and WHO-prequalification of drugs and may also consider multifaceted interventions. Future effectiveness studies should address the methodological limitations of the available evidence. TRIAL REGISTRATION NUMBER: PROSPERO CRD42014009269.

Autonomy and paternalism in medical e-commerce.

One of the overriding interests of the literature on health care economics is to discover where personal choice in market economies end and corrective government intervention should begin. Our study addresses this question in the context of John Stuart Mill's utilitarian principle of harm. Our primary objective is to determine whether public policy interventions concerning more than 35,000 online pharmacies worldwide are necessary and efficient compared to traditional market-oriented approaches. Secondly, we seek to determine whether government interference could enhance personal  utility maximization, despite its direct and indirect (unintended) costs on medical e-commerce. This study finds that containing the negative externalities of medical e-commerce provides the most compelling raison d'etre of government interference. It asserts that autonomy and paternalism need not be mutually exclusive, despite their direct and indirect consequences on individual choice and decision-making processes. Valuable insights derived from Mill's principle should enrich theory-building in health care economics and policy.

Internet-ordered viagra (sildenafil citrate) is rarely genuine.

INTRODUCTION: Counterfeit medication is a growing problem. This study assessed the requirement for prescription, cost, origin, and content of medications sold via the Internet and purporting to be the phosphodiesterase type 5 inhibitor Viagra (sildenafil citrate). METHODS: Pfizer monitored top search results for the query "buy Viagra" on the two leading Internet search engines in March 2011. Orders were placed from 22 unique Web sites claiming to sell Viagra manufactured by Pfizer. Tablets received were assessed for chemical composition. RESULTS: No Web site examined required a prescription for purchase or a health screening survey; 90% offered illegal "generic Viagra." Cost per tablet ranged from $3.28-$33.00. Shipment origins of purchases were Hong Kong (N = 11), the United States (N = 6), and the United Kingdom (N = 2) as well as Canada, China, and India (N = 1 each). Notably, the four Internet pharmacies claiming to be Canadian did not ship medication from a Canadian address. Of 22 sample tablets examined, 17 (77%) were counterfeit, 4 (18%) were authentic, and 1 (5%) was an illegal generic. Counterfeit tablets were analyzed for sildenafil citrate, the active pharmaceutical ingredient (API) of Viagra, and contents varied between 30% and 50% of the label claim. Counterfeits lacked product information leaflets, including appropriate safety warnings, and genuine Viagra formulations. CONCLUSION: Internet sites claiming to sell authentic Viagra shipped counterfeit medication 77% of the time; counterfeits usually came from non-U.S. addresses and had 30% to 50% of the labeled API claim. Caution is warranted when purchasing Viagra via the Internet.