Prevalence of substandard, falsified, unlicensed and unregistered medicine and its associated factors in Africa: a systematic review.

Background: Substandard, falsified, unlicensed, and unregistered medicines pose significant risks to public health in developed and developing countries. This systematic review provides an overview of the prevalence of substandard, falsified, unlicensed, and unregistered medicine and its associated factors in Africa. Methods: Articles published from April 2014 to March 2024 were searched in Google Scholar, Science Direct, PubMed, MEDLINE, and Embase. The search strategy focused on open-access articles published in peer-reviewed scientific journals and studies exclusively conducted in African countries. The quality of the studies was assessed according to the Medicine Quality Assessment Reporting Guidelines (MEDQUARG). This systematic review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). Results: Of the 27 studies, 26 had good methodological quality after a quality assessment. Of the 7508 medicine samples, 1639 failed at least one quality test and were confirmed to be substandard/falsified medicines. The overall estimated prevalence of substandard/falsified medicines in Africa was 22.6% (1718/7592). The average prevalence of unregistered medicines was 34.6% (108/312). Antibiotics, antimalarial, and antihypertensive medicines accounted for 44.6% (712/1596), 15.6% (530/3530), 16.3% (249/1530), and 16.3% (249/1530), respectively. Approximately 60.7% (91/150) were antihelmintic and antiprotozoal medicines. Poor market regulatory permission, Free trade zones, poor registration, high demand, and poor importation standards contribute to the prevalence of these problems. Conclusion/Recommendations: Substandard, falsified, and unregistered medicines are highly prevalent in Africa, and attention has not been paid to the problem. Antibiotics, antimalarial, anthelmintic, and antiprotozoal are the most commonly reported substandard, falsified, and unregistered medicines. A consistent supply of high-quality products, enhancement of registration, market regulatory permission, and importation standards are essential to counter the problems in Africa. Preventing these problems is the primary duty of every responsible nation to save lives.

Assessment of knowledge, attitude, and practice on substandard and counterfeit pharmaceutical products among pharmacy professionals in Gondar City, North-West Ethiopia.

INTRODUCTION: The circulation of substandard and counterfeit pharmaceutical products on the national and international markets has increased. Different studies revealed that there is limited information about pharmacy professionals' awareness of substandard and counterfeit pharmaceutical products. Therefore; the aim of the present study was to assess the pharmacy professionals' knowledge, attitude, and practice of substandard and counterfeit pharmaceutical products. METHODS: A cross-sectional study was conducted to assess the knowledge, attitude, and practice of pharmacy professionals about substandard and counterfeited pharmaceutical products in Gondar City, North-West Ethiopia. Data were collected through a self-administered, structured questionnaire using the Kobo tool. SPSS version 27 was used for the analysis. To assess the association of factors with pharmacy professionals' practice towards substandard and counterfeit medicines, we conducted univariate and multivariate logistic regression analysis. RESULTS: A total of 170 respondents participated in the study. The highest numbers of participants (71.8%) were in the age group of 18-30 years. Only 10.6% of them reported purchasing medicines regularly. Of total, 31 (18.24%) of respondents had a good knowledge and more than one-third 60 (35.29%) of the respondents had a good level of practice. Multivariate logistic regression analysis results revealed that some socio-demography and attitude (AOR = 0.473 (0.225-0.995) were associated with the practice of pharmacy professionals towards substandard and counterfeit medicines. CONCLUSION: In general, less than one-quarters of the respondents had a good knowledge and more than one-thirds of the respondents had a good level of practice. However, half of the respondents had a positive attitude.

The challenges associated with the prevention of smuggling and counterfeiting health goods in Iran.

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.

Rare-Earth-Metal-Free Solid-State Fluorescent Carbonized-Polymer Microspheres for Unclonable Anti-Counterfeit Whispering-Gallery Emissions from Red to Near-Infrared Wavelengths.

Colloidal carbon dots (CDs) have garnered much attention as metal-free photoluminescent nanomaterials, yet creation of solid-state fluorescent (SSF) materials emitting in the deep red (DR) to near-infrared (NIR) range poses a significant challenge with practical implications. To address this challenge and to engineer photonic functionalities, a micro-resonator architecture is developed using carbonized polymer microspheres (CPMs), evolved from conventional colloidal nanodots. Gram-scale production of CPMs utilizes controlled microscopic phase separation facilitated by natural peptide cross-linking during hydrothermal processing. The resulting microstructure effectively suppresses aggregation-induced quenching (AIQ), enabling strong solid-state light emission. Both experimental and theoretical analysis support a role for extended π-conjugated polycyclic aromatic hydrocarbons (PAHs) trapped within these microstructures, which exhibit a progressive red shift in light absorption/emission toward the NIR range. Moreover, the highly spherical shape of CPMs endows them with innate photonic functionalities in combination with their intrinsic CD-based attributes. Harnessing their excitation wavelength-dependent photoluminescent (PL) property, a single CPM exhibits whispering-gallery modes (WGMs) that are emission-tunable from the DR to the NIR. This type of newly developed microresonator can serve as, for example, unclonable anti-counterfeiting labels. This innovative cross-cutting approach, combining photonics and chemistry, offers robust, bottom-up, built-in photonic functionality with diverse NIR applications.

Utilizing experimental design and desirability function in optimizing RP-HPLC method for simultaneous determination of some skeletal muscle relaxants and analgesics.

An experimental design and response surface methodologies using Plackett-Burman and Box-Behnken designs were applied for selecting and optimizing the most appropriate parameters which significantly affect the separation and quantitative estimation of five skeletal muscle relaxants and four analgesic drugs (baclofen, methocarbamol, dantrolene sodium, orphenadrine citrate, cyclobenzaprine hydrochloride, ketoprofen, etoricoxib, ibuprofen, and mefenamic acid) with a relatively short duration of analysis in a single run. For the separation of the nine drugs, an INERTSIL ODS-V3-5 µm C18 column (250 × 4.6 mm I.D.) was used with the optimum mobile phase conditions (45.15 mM ammonium acetate buffer pH 5.56 adjusted with acetic acid, acetonitrile, and methanol in a ratio of 30.5:29.5:40, v/v/v with a flow rate of 1.5 mL/min) and UV-detection at 220 nm. The optimized method was successfully subjected to the validation steps as described in ICH guidelines for linearity, precision, accuracy, robustness, and sensitivity. The optimized and validated method was effectively applied to determine the content of the studied drugs in their pharmaceutical preparations and to expand its applicability to the counterfeit estimation of etoricoxib in different brands of tablet dosage forms.

Fake Xanax: Designer Emerging Benzodiazepine Epidemic Linked to Morbidity and Mortality a Narrative Review.

Etizolam is a thienodiazepine derivative which produces an anxiolytic effect similar to benzodiazepines such as alprazolam (Xanax). Like classic benzodiazepines, etizolam has a high affinity towards the GABAA receptor, and allosterically potentiates the effects of GABA resulting in neuronal hyperpolarization related to chloride influx. When taken in therapeutic doses, etizolam produces a similar effect to Xanax. Counterfeit Xanax tablets contain variable amounts of etizolam. Tablets with high amounts of etizolam can cause toxicity if ingested, especially when combined with other substances. When toxic symptoms occur in patients, they may include severe sedation, unconsciousness, and depression of the medullary respiratory center. In this regard, there is the potential for death. Additionally, the rise in fake Xanax tablets containing etizolam and other counterfeit medications has been exacerbated by the difference in regulations regarding these substances in different countries as well as the illegal drug trade. Healthcare providers may also play a role through the over- or underprescribing of certain medications. Thus, in order to combat the rise in counterfeit medications such as fake Xanax, international cooperation, regulation, and enforcement of laws pertaining to the manufacture, prescription, and distribution of these substances are needed.

Evaluating the Knowledge, Practice, and Regulatory Situation of Veterinary Experts Regarding Counterfeit Veterinary Medications in the Selected Districts of Central Gondar Zone, Ethiopia.

Background: The intentional and illegal misrepresentation of fake medications involves falsely indicating their source. These fraudulent medications can include products that contain either accurate or incorrect ingredients, lack proper labeling, have insufficient quantities of ingredients, and are packaged with counterfeit packaging. This unlawful activity has led to treatment failures, the development of antibiotic resistance, adverse effects, and even deaths. Hence, the objective of this study was to assess the knowledge, practice, and regulatory status of veterinary drug experts in the central Gondar zone of Ethiopia regarding counterfeit veterinary medications. Methods: From January 2023 to July 2023, a self-administered structured questionnaire was utilized to conduct a cross-sectional study in Central Gondar Zone, Ethiopia. The analysis of the data involved the application of descriptive and chi-square tests. Results: The study revealed that the majority of professionals possessed a work experience ranging from 5 to 9 years (23; 56.1%). Additionally, a total of 25 individuals (61.0%) who participated in the research had not undergone any kind of training. It was observed that a significant proportion of participants (82.9%) possessed knowledge about counterfeit veterinary drugs. Only about 63% and 36% of respondents had high knowledge and good practice concerning veterinary counterfeit drugs, respectively. Only 29.3% of participants have reported practices. Furthermore, a poor regulatory level of coordination was detected (85.4%). The study revealed a significant (χ2 =7.6165; p = 0.022) disparity between the respondents' practice levels and training. Respondents' regulatory levels were also significantly associated (p < 0.05) with their sex (χ2 = 13.34; p = 0.001) and work experience (χ2 = 13.64; p = 0.033). The research findings also revealed a noteworthy correlation between practice and regulatory activity (χ2 = 15.0463; p = 0.005). Conclusion: The study outlines the necessity of awareness initiatives, with a focus on the significance of veterinary experts' knowledge, practice, and regulatory efforts in addressing the issue of counterfeit veterinary medications.

Cross-border forensic profiling of fraudulent identity and travel documents: A pilot project between France and Switzerland.

The serial character of document fraud and its connection to organised crime groups who produce, sell and/or use fraudulent documents is a challenge for security and crime fighting. As a response, the added value of forensic intelligence is increasingly recognised. Using a forensic profiling method and a dedicated system deployed in Switzerland, document examiners can detect series (i.e., documents that share a common source) of fraudulent documents conveniently and efficiently. This detection can trigger or orientate investigations, supports crime intelligence efforts, and facilitates cross-jurisdictional cooperation. This study aims to assess the suitability of the forensic profiling system for international purpose and the efficiency of the method to detect cross-border series. The forensic profiling system has been deployed in France in the framework of a cross-border pilot project conducted by the School of Criminal Justice from the University of Lausanne and the French National Police (Division Nationale de Lutte contre la Fraude Documentaire et à l'Identité) over the period July 2019-May 2020. Data from the Swiss and French forensic profiling systems were compared to each other to detect cross-border series. The study sought to create operating conditions as close as possible to the real-life conditions of the profiling systems. The results are extremely positive both quantitatively and qualitatively. They demonstrate the benefit of setting up a systematic exchange of forensic data issued from profiling systems for fraudulent identity documents between France and Switzerland, let alone between any other countries. The results open up a very promising prospect for a sustained operational implementation by the police services of both countries and the extension of the exchanges internationally.

From inspection to analysis: A combined approach to identifying counterfeit whiskeys using HS-GC-FID and bottle integrity.

Counterfeiting of alcoholic beverages, particularly high-value spirits such as whiskey, presents significant challenges for regulators, manufacturers, and consumers. In this study, we introduce and validate a novel application of headspace extraction (HS) followed by gas chromatography with flame ionization detection (GC-FID) for the quantitative determination of ethanol content in 42 suspected counterfeit brazilian samples of whiskeys. This method, in conjunction with visual inspection of material inconsistencies, offers a combined approach to identify potential cases of fraud. The HS-GC-FID findings revealed that only 19% of the analyzed samples had ethanol content in the limits declared on the label, emphasizing the role of ethanol content as a chemical marker for suspected beverage fraud.

Uncovering the Counterfeit: A study of whiskey authenticity through volatile organic compound fingerprinting, aroma and color sensory analysis.

This study presents a method employing gas chromatography coupled with mass spectrometry and headspace solid-phase microextraction (HS-SPME-GC-MS), supplemented with chemometrics (Soft independent modelling of class analogies - SIMCA), to analyze volatile organic compound (VOCs) profiles in suspect whiskey samples. Furthermore, a sensory analysis of aroma and color was conducted with a panel of 52 non-trained volunteers to evaluate their ability to discriminate and preference for counterfeit whiskeys. The HS-SPME-GC-MS method successfully distinguished 41 seized samples from authentic beverages. Interestingly, sensory analysis revealed that panelists could differentiate between counterfeit and authentic samples with a reference standard but did not consistently show a preference for aroma. In some cases, there was even a preference for the color of counterfeit whiskeys. The findings suggest that sensorial tests alone may not effectively distinguish counterfeit from authentic whiskeys, especially for non-expert consumers, highlighting the need for analytical instrumentation methods in fraud detection.

Identification of liquor adulteration by Raman spectroscopy method based on ICNAFS.

The health of consumers can be impacted by the additives placed into the liquor. To address the issues of poor accuracy, low reliability, and complex operational procedures in identifying adulteration in existing liquor, an improved convex non-negative matrix factorization (ICNAFS) with an adaptive graph constraint for unsupervised feature extraction is proposed in this paper, with the goal of achieving rapid identification of adulteration in liquor by Raman spectroscopy through dimensionality reduction. For the sake to streamline the calculation process for effective feature extraction and increase the accuracy of the analyzed model, the proposed ICNAFS method incorporates two fundamental models, such as ridge regression and convex non-negative matrix factorization (NMF). In particular, dimensionality reduction of the original spectrum is initially conducted using Principal Component Analysis (PCA), Sequential Projection Algorithm (SPA), Convex Non-Negative Matrix Factorization with an Adaptive Graph Constraint (CNAFS), and ICNAFS respectively. k-means is subsequently employed to merge the four models for clustering analysis. The results suggest that the accuracy of the presented ICNAFS-assisted k-means model is higher than the other techniques, with a clustering accuracy of 98.67%, exhibiting a 4% improvement over the existing CNAFS, through examination of 150 sets of tainted liquor data from five categories of samples. This demonstrates the potency of the proposed ICNAFS-assisted k-means clustering model in conjunction with Raman spectroscopy as a method for detecting tainted liquor.

[Health alerts for substandard, falsified, and unregistered medical products at the onset of the COVID-19 pandemic in the AmericasAlertas de saúde para produtos médicos abaixo do padrão, falsificados e não registrados no início da pandemia de COVID-19 nas Américas]. / Alertas sanitarias de productos médicos subestándares, falsificados y no registrados al inicio de la pandemia de COVID-19 en las Américas.

Objective: Identify and analyze incidents of substandard, falsified, unregistered, and stolen medical products at the onset of the COVID-19 pandemic. Methods: Detailed search of the websites of regulatory authorities in the Americas. Identification of incidents of substandard, falsified, unregistered, and stolen medicines and medical devices (including in vitro diagnostics). The types of products were determined, as were the stages in the supply chain where they were detected, and the actions taken by authorities. Results: A total of 1 273 incidents were identified in 15 countries (1 087 substandard, 44 falsified, 123 unregistered, and 19 stolen products). The largest number of incidents involved medical devices, disinfectants, and antiseptics. The most frequently reported point in the supply chain was online purchasing. The principal measures taken by the regulatory authorities were: alerts, prohibition of use, prohibition of advertising and manufacture, recall, and monitoring of adverse events. Conclusions: A substantial number of incidents involving substandard, falsified, unregistered, and stolen medical products at the onset of the COVID-19 pandemic were identified. Shortages of supplies, easing of regulatory requirements, and increased demand are factors that may have led to an increase in the number of incidents. The national regulatory authorities of reference reported more frequent detection of incidents and more frequent application of health measures. A regulatory strategy is needed in order to address online sales and ensure the safe distribution of medical products.

Objetivo: Identificar e analisar incidentes de produtos médicos abaixo do padrão, falsificados, não registrados e roubados no início da pandemia de COVID-19. Métodos: Foi realizada uma busca detalhada nos sites das autoridades reguladoras das Américas. Foram identificados incidentes envolvendo medicamentos e dispositivos médicos (incluindo para diagnóstico in vitro) abaixo do padrão, falsificados, não registrados e roubados. Foram determinados os tipos de produtos, os estágios da cadeia de abastecimento em que foram detectados e as medidas tomadas pelas autoridades. Resultados: Foram identificados 1 273 incidentes em 15 países (1 087 produtos abaixo do padrão, 44 falsificados, 123 não registrados e 19 roubados). O maior número de incidentes estava relacionado a dispositivos médicos, desinfetantes e antissépticos. O ponto na cadeia de abastecimento com a maior frequência de relatos foi a de aquisição pela internet. As medidas tomadas pelas autoridades reguladoras foram principalmente alertas, proibições de uso, proibições de publicidade e fabricação, recolhimento de produtos do mercado e monitoramento de eventos adversos. Conclusões: Houve um número significativo de incidentes envolvendo produtos médicos abaixo do padrão falsificados, não registrados e roubados no início da pandemia de COVID-19. A escassez de insumos, a flexibilização das exigências regulatórias e o aumento da demanda são fatores que podem levar a um maior número de incidentes. As autoridades reguladoras nacionais de referência informaram um aumento na frequência de detecção de incidentes e implementação de medidas sanitárias. O canal de vendas pela internet precisa ser abordado com alguma estratégia regulatória para garantir a distribuição segura de produtos médicos.

Access to 2,4-Disubstituted Pyrrole-Based Polymer with Long-Wavelength and Stimuli-Responsive Properties via Copper-Catalyzed [3+2] Polycycloaddition.

Pyrrole-based polymers (PBPs), a type of fascinating functional polymers, play a crucial role in materials science. However, efficient synthetic strategies of PBPs with diverse structures are mainly focused on conjugated polypyrroles and still remain challenging. Herein, an atom and step economy protocol is described to access various 2,4-disubstituted PBPs by in situ formation of pyrrole core structure via copper-catalyzed [3+2] polycycloaddition of dialkynones and diisocyanoacetates. A series of PBPs is prepared with high molecular weight (Mw up to 18 200 Da) and moderate to good yield (up to 87%), which possesses a fluorescent emission located in the green to yellow light region. Blending the PBPs with polyvinyl alcohol, the stretchable composite films exhibit a significant strengthening of the mechanical properties (tensile stress up to 59 MPa, elongation at break >400%) and an unprecedented stress-responsive luminescence enhancement that over fourfold fluorescent emission intensity is maintained upon stretching up to 100%. On the basis of computational studies, the unique photophysical and mechanical properties are attributed to the substitution of carbonyl chromophores on the pyrrole unit.

Causes and consequences of quack medicine in health care: a scoping review of global experience.

BACKGROUND: The field of health has been facing challenges with fraudulent practices and the prevalence of "quack medicine". Many cases have given rise to this issue. Therefore, this study aims to comprehensively investigate and categorize the causes and consequences of quack medicine in the healthcare. METHODS: A scoping review, using the 5 stages of Arksey and O'Malley's framework, was conducted to retrieve and analyze the literature. International databases including the PubMed, Scopus, Embase and Web of Science and also national Iranian databases were searched to find peer reviewed published literature in English and Persian languages. Grey literature was also included. Meta-Synthesis was applied to analyze the findings through an inductive approach. RESULTS: Out of 3794 initially identified studies, 30 were selected for this study. Based on the findings of this research, the causes of quackery in the health were divided into six categories: political, economic, socio-cultural, technical-organizational, legal and psychological. Additionally, the consequences of this issue were classified into three categories: health, economic and social. Economic and social factors were found to have a more significant impact on the prevalence of quackery in the health sector. Legal and technical-organizational factors played a crucial role in facilitating fraudulent practices, resulting in severe health consequences. CONCLUSION: It is evident that governing bodies and health systems must prioritize addressing economic and social factors in combating quackery in the health sector. Special attention should be paid to the issue of cultural development and community education to strengthen the mechanisms that lead to the society access to standard affordable services. Efforts should be made also to improve the efficiency of legislation, implementation and evaluation systems to effectively tackle this issue.

"Pressed OXY M30 Pills, Great Press, Potent, Fast Shipping!!!": Availability of Counterfeit and Pharmaceutical Oxycodone Pills on One Major Cryptomarket.

From 2018 to 2021, seizures of counterfeit oxycodone pills containing non-pharmaceutical fentanyl or other novel synthetic opioids increased significantly contributing to continuing increases in overdose mortality in Northern America. Evidence suggests that counterfeit pills are distributed through cryptomarkets. This article presents data regarding the availability and characteristics of oxycodone pills advertised on one major cryptomarket between January and March 2022. Collected data were processed using a dedicated Named Entity Recognition algorithm to identify oxycodone listings and categorized them as either counterfeit or pharmaceutical. Frequency of listings, average number of pills advertised, average prices per milligram, number of sales, and geographic indicators of shipment origin and destination were analyzed. In total, 2,665 listings were identified as oxycodone. 48.2% (1,285/2,665) of these listings were categorized as counterfeit oxycodone, advertising a total of 652,699 pills (93,242.7 pills per datapoint) offered at a lower price than pharmaceutical pills. Our data indicate the presence of a large volume of counterfeit oxycodone pills both in retail- and wholesale-level amounts mostly targeting US and Canadian customers. These exploratory findings call for more research to develop epidemiological surveillance systems to track counterfeit pill and other drug availability on the Dark web environment.

Post mortem blood bromazolam concentrations and co-findings in 96 coronial cases within England and Wales.

Bromazolam is a newly emerging benzodiazepine drug which is not licensed for medicinal use. It may be sourced as a New Psychoactive Substance (NPS) for its desired effects or be consumed unknowingly via counterfeit Xanax® or Valium® preparations. As part of our Coronial workload, we observed an increase in the detection of bromazolam from September 2021 to November 2022. We report a series of 96 cases in which bromazolam was quantitated by high resolution accurate mass - mass spectrometry (HRAM - MS) in post-mortem blood. The mean (SD) post-mortem blood bromazolam concentration from our case series was 64.6 ( ± 79.4) µg/L (range <1-425 µg/L). Routine toxicological screening results have also been reported; the most commonly encountered drugs taken in combination with bromazolam were cocaine, gabapentinoids and diazepam. In 48% of cases at least one further designer benzodiazepine drug was also present (etizolam, flualprazolam, flubromazolam, flubromazepam). It is essential that laboratories providing toxicological investigations are aware of the limitations of their assays; and inclusion of bromazolam within targeted screening panels using LC-MS/MS is encouraged. Bromazolam has not been associated with death in isolation from resulting toxic concentrations; however, it is likely to enhance adverse clinical effects when taken in combination with stimulant and/or centrally-acting depressant drugs (poly-drug deaths). Bromazolam, similar to other benzodiazepines, may also impair cognition and decision making skills.

Alertas sanitarias de productos médicos subestándares, falsificados y no registrados al inicio de la pandemia de COVID-19 en las Américas / Health alerts for substandard, falsified, and unregistered medical products at the onset of the COVID-19 pandemic in the Americas / Alertas de saúde para produtos médicos abaixo do padrão, falsificados e não registrados no início da pandemia de COVID-19 nas Américas

RESUMEN Objetivo. Identificar y analizar los incidentes de productos médicos subestándares, falsificados, no registrados y robados al inicio de la pandemia de COVID-19. Métodos. Búsqueda detallada en los sitios web de las autoridades reguladoras de las Américas. Identificación de los incidentes de medicamentos y dispositivos médicos (incluidos los de diagnóstico in vitro) subestándares falsificados, no registrados y robados. Se determinaron los tipos de productos, las etapas de la cadena de suministro en las que se detectaron y las medidas tomadas por las autoridades. Resultados. Se identificaron 1 273 incidentes en 15 países (1 087 productos subestándares, 44 falsificados, 123 no registrados y 19 robados). La mayor cantidad de incidentes corresponden a dispositivos médicos, desinfectantes y antisépticos. El punto en la cadena de suministro con mayor frecuencia de informes fue la adquisición a través de internet. Las medidas tomadas por las autoridades reguladoras corresponden en su mayoría a: alerta, prohibición de uso, prohibición de publicidad y fabricación, retiro del mercado y seguimiento de eventos adversos. Conclusiones. Se evidenció un número destacable de incidentes de productos médicos subestándares, falsificados, no registrados y robados al inicio de la pandemia por COVID-19. La escasez de insumos, la flexibilización en los requisitos regulatorios y el aumento de la demanda son factores que pueden favorecer el incremento del número de incidentes. Las autoridades reguladoras nacionales de referencia presentaron mayores frecuencias de detección de incidentes y de aplicación de medidas sanitarias. Se observó que se debe abordar el canal de venta por internet con alguna estrategia reguladora para garantizar la distribución segura de productos médicos.

ABSTRACT Objective. Identify and analyze incidents of substandard, falsified, unregistered, and stolen medical products at the onset of the COVID-19 pandemic. Methods. Detailed search of the websites of regulatory authorities in the Americas. Identification of incidents of substandard, falsified, unregistered, and stolen medicines and medical devices (including in vitro diagnostics). The types of products were determined, as were the stages in the supply chain where they were detected, and the actions taken by authorities. Results. A total of 1 273 incidents were identified in 15 countries (1 087 substandard, 44 falsified, 123 unregistered, and 19 stolen products). The largest number of incidents involved medical devices, disinfectants, and antiseptics. The most frequently reported point in the supply chain was online purchasing. The principal measures taken by the regulatory authorities were: alerts, prohibition of use, prohibition of advertising and manufacture, recall, and monitoring of adverse events. Conclusions. A substantial number of incidents involving substandard, falsified, unregistered, and stolen medical products at the onset of the COVID-19 pandemic were identified. Shortages of supplies, easing of regulatory requirements, and increased demand are factors that may have led to an increase in the number of incidents. The national regulatory authorities of reference reported more frequent detection of incidents and more frequent application of health measures. A regulatory strategy is needed in order to address online sales and ensure the safe distribution of medical products.

RESUMO Objetivo. Identificar e analisar incidentes de produtos médicos abaixo do padrão, falsificados, não registrados e roubados no início da pandemia de COVID-19. Métodos. Foi realizada uma busca detalhada nos sites das autoridades reguladoras das Américas. Foram identificados incidentes envolvendo medicamentos e dispositivos médicos (incluindo para diagnóstico in vitro) abaixo do padrão, falsificados, não registrados e roubados. Foram determinados os tipos de produtos, os estágios da cadeia de abastecimento em que foram detectados e as medidas tomadas pelas autoridades. Resultados. Foram identificados 1 273 incidentes em 15 países (1 087 produtos abaixo do padrão, 44 falsificados, 123 não registrados e 19 roubados). O maior número de incidentes estava relacionado a dispositivos médicos, desinfetantes e antissépticos. O ponto na cadeia de abastecimento com a maior frequência de relatos foi a de aquisição pela internet. As medidas tomadas pelas autoridades reguladoras foram principalmente alertas, proibições de uso, proibições de publicidade e fabricação, recolhimento de produtos do mercado e monitoramento de eventos adversos. Conclusões. Houve um número significativo de incidentes envolvendo produtos médicos abaixo do padrão falsificados, não registrados e roubados no início da pandemia de COVID-19. A escassez de insumos, a flexibilização das exigências regulatórias e o aumento da demanda são fatores que podem levar a um maior número de incidentes. As autoridades reguladoras nacionais de referência informaram um aumento na frequência de detecção de incidentes e implementação de medidas sanitárias. O canal de vendas pela internet precisa ser abordado com alguma estratégia regulatória para garantir a distribuição segura de produtos médicos.

A narrative review of illegal online pharmacies and contemporary issues with restricting FDA-approved medication access.

The rapid growth of technology has transformed the way the public purchases many products, including medications. Online medication purchasing has become a convenient and confidential route for patients to access healthcare without leaving their homes. Online pharmacies have many benefits but also present an increased risk for patient harm caused by unintentionally purchasing from illegal online pharmacies. Illegal online pharmacies are those that operate online without the requisite valid licenses or supply drugs not approved by the Food and Drug Administration (FDA). As obtaining certain medications has become restricted, either due to policy or drug shortages, more patients are relying on services provided by Internet pharmacies. The overturning of Roe versus Wade has caused an emerging drug restriction that may coerce the public to turn to Internet pharmacies for purchasing medications. A narrative review was conducted to analyze both the past and present effects of medications sold by illegal online pharmacies to help recognize the implications of restricting access to FDA-approved medications. Several large science and health literature databases were searched to find relevant references. Resulting resources, which referenced the connection between restricting access to FDA-approved medications and the increase in illegal online sales, were included in this review. The information evaluated in this article will help inform healthcare providers and policymakers of the inadvertent effects of restricting access to FDA-approved medications.

Background: Illegal online pharmacies target vulnerable patient populations such as patients affected by drug shortages or patients who require restricted access medications.Increased production of substandard or falsified medications is rampant during drug shortages or restricted access use and can lead to patient harm.The overturning of Roe versus Wade in the United States may illicit a response from the public to acquire their medications through illegal online pharmacies which may be providing substandard or falsified medications. Methods: A narrative review was conducted to understand the implications of restricting access to FDA-approved medications. Previous instances of drug shortages and restricted access use medications were analyzed to understand the effects the overturning of Roe versus Wade may have on patient harm. Results: Illegal online pharmacies continue to threaten patient harm by supplying substandard or falsified medications to patients.Patient harm from substandard and falsified medications has been observed through previous abortion bans. Conclusion: Purchasing abortive medications from illegal online pharmacies is correlated with an increase in the number of serious or fatal events.This phenomenon can continue to impact the healthcare system as legal implications surrounding abortion develop.Education and advocacy to safe and effective abortive medications are key in ensuring patient safety in reproductive care.

A Narrative Review of Illegal Online Pharmacies and Contemporary Issues with Restricting FDA-Approved Medication Access.