scholarly journals USA Criminal and Civil Prosecutions Associated with Illicit Online Pharmacies: Legal Analysis and Global Implications

2017 ◽  
Vol 1 ◽  
pp. maapoc.0000020 ◽  
Author(s):  
Camille Guerra ◽  
Timothy K. Mackey
Keyword(s):  
Patient Safety ◽  
Prescription Drug ◽  
Drug Distribution ◽  
Criminal Activity ◽  
Public Access ◽  
Legal Analysis ◽  
Policy Coherence ◽  
Regulatory Policies ◽  
Online Pharmacies ◽  
Google Search

The rise of digital technologies has created a complex online environment that now includes illicit Internet pharmacies, online facilitators, advertising sites, and foreign entities. Collectively, these networks create significant patient safety risks, including acting as unregulated access points encouraging prescription drug abuse. Although law enforcement is active in combating this form of cybercrime, there are several difficulties in prosecuting individuals involved in online prescription drug distribution. We characterize these challenges by conducting a comprehensive legal review and analysis of USA civil and criminal cases associated with online pharmacies. This is accomplished by reviewing legal documents/filings available via the Public Access to Court Electronic Records (PACER) database, the Drug Enforcement Agency's website, and structured search queries using the Google search engine. We found more than 100 cases, including criminal indictments, sentencing documents, judgments, forfeiture orders, motions, civil complaints, and restitution documents. Our review indicates that current legal tools and regulatory policies do not effectively deter this highly profitable criminal activity. Hence, we issue a “Call to Action,” advocating the need for more robust legal remedies and criminal penalties, and greater legal and policy coherence at the domestic, regional, and global level aimed at improving patient safety and ensuring the integrity of the drug supply chain.

scholarly journals Differences between the European Union and United States of America in Drug Regulatory Affairs Affect Global Patient Safety Standards and Public Health Awareness: The Case of Deferasirox and Other Iron Chelating Drugs

Medicines ◽  
2021 ◽  
Vol 8 (7) ◽  
pp. 36
Author(s):  
George J. Kontoghiorghes
Keyword(s):  
Patient Safety ◽  
Generic Drugs ◽  
Benefit Assessment ◽  
Regulatory Control ◽  
Pharmaceutical Companies ◽  
The European Union ◽  
Regulatory Policies ◽  
Regulatory Affairs ◽  
Risk Benefit Assessment ◽  
The Eu

Regulatory policies on drugs have a major impact on patient safety and survival. Some pharmaceutical companies employ all possible methods to achieve maximum sales in relation to the monopoly of their patented drugs, leading sometimes to irregularities and illegal activities. Misinformation on the orphan drug deferasirox has reached the stage of criminal investigations and fines exceeding USD 100 million. Additional lawsuits of USD 3.5 billion for damages and civil fines were also filed by the FBI of the USA involving deferasirox and mycophenolic acid, which were later settled with an additional fine of USD 390 million. Furthermore, a USD 345 million fine was also settled for bribes and other illegal overseas operations including an EU country. However, no similar fines for illegal practises or regulatory control violations have been issued in the EU. Misconceptions and a lack of clear guidelines for the use of deferasirox in comparison to deferiprone and deferoxamine appear to reduce the effective treatment prospects and to increase the toxicity risks for thalassaemia and other iron loaded patients. Similar issues have been raised for the activities of other pharmaceutical companies promoting the use of new patented versus generic drugs. Treatments for different categories of patients using new patented drugs are mostly market driven with no clear safeguards or guidelines for risk/benefit assessment indications or for individualised effective and safe optimum therapies. There is a need for the establishment of an international organisation, which can monitor and assess the risk/benefit assessment and marketing of drugs in the EU and globally for the benefit of patients. The pivotal role of the regulatory drug authorities and the prescribing physicians for identifying individualised optimum therapies is essential for improving the survival and safety of millions of patients worldwide.

Nursing Perception of the Impact of Medication Carts on Patient Safety and Ergonomics in a Teaching Health Care Center

2012 ◽  
Vol 26 (2) ◽  
pp. 131-137 ◽  
Author(s):  
Élise Rochais ◽  
Suzanne Atkinson ◽  
Jean-François Bussières
Keyword(s):  
Health Care ◽  
Patient Safety ◽  
Focus Group ◽  
Point Of Care ◽  
Care Center ◽  
Drug Distribution ◽  
University Hospital ◽  
Cross Sectional ◽  
Health Care Center ◽  
The Impact

Objectives: In our Quebec (Canada) University Hospital Center, 68 medication carts have been implemented as part of a nationally funded project on drug distribution technologies. There are limited data published about the impact of medication carts in point-of-care units. Our main objective was to assess nursing staff’s perception and satisfaction of medication carts on patient safety and ergonomics. Method: Quantitative and qualitative cross-sectional study. Data were gathered from a printed questionnaire administered to nurses and an organized focus group composed of nurses and pharmacists. Results: A total of 195 nurses completed the questionnaire. Eighty percent of the nurses agreed that medication carts made health care staff’s work easier and 64% agreed that it helped to reduce medication incidents/accidents. Only 27% and 43% agreed that carts’ location reduces the risk of patients’ interruptions and colleagues’ interruptions, respectively. A total of 17 suggestions were extracted from the focus group (n = 7 nurses; n = 3 pharmacist) and will be implemented in the next year. Conclusions: This descriptive study confirms the positive perception and satisfaction of nurses exposed to medication carts. However, interruptions are a major concern and source of dissatisfaction. The focus group has revealed many issues which will be improved.

scholarly journals Criminal policy in the legal security system

2021 ◽  
Vol 136 (3) ◽  
pp. 105-112
Author(s):  
E.A. Ongarbayev ◽  
◽  
B.R. Sembekova ◽  
Keyword(s):  
Criminal Law ◽  
Criminal Policy ◽  
Criminal Activity ◽  
Theoretical Research ◽  
Legal Analysis ◽  
Complex Approach ◽  
Comparative Aspect ◽  
The Republic ◽  
Legal Security ◽  
Analysis System

The article considers issues of legal security through the modernization of criminal law, criminal procedure and criminal execution norms aimed at improving the criminal policy of the Republic of Kazakhstan. The authors carried out an analysis of norms of criminal law, criminal procedural, and criminal executive legislation of the Republic of Kazakhstan. The article highlights some innovations in a comparative aspect, indicating promising directions, ensuring the effectiveness of their application and implementation in law enforcement activity of the subjects of proof. The article reveals mechanisms of criminal policy improvement based on the system-complex approach and application of comparative-legal analysis. System-complex approach has been considered in terms of disclosure of material and procedural norms, determining comprehensiveness, completeness, and objectivity of regular processes of interaction, reflection, and manifestation of objective-subjective factors of formation and development of criminal activity. The mechanism of criminal activity has been disclosed in terms of regulation and management of the process of detection, investigation and prevention based on the principles of legality, objectivity and completeness in the pre-trial and trial processes that determine the factors of implementation of the classification basis of criminal offenses. Comparative legal analysis determined the effectiveness and efficiency of mechanisms to improve criminal policy based on the analysis of theoretical research and practice of foreign countries.

scholarly journals The Coordination of Activities of the Law Enforcement Agencies in the Fight Against Crime

Legal Concept ◽  
2021 ◽  
pp. 26-32
Author(s):  
Ekaterina Azarova ◽  
Vyacheslav Vnukov
Keyword(s):  
Law Enforcement ◽  
Organizational Support ◽  
System Analysis ◽  
Criminal Activity ◽  
Point Of View ◽  
Theory And Practice ◽  
Russian Society ◽  
Legal Analysis ◽  
Law Enforcement Agencies ◽  
The Law

Introduction: in modern Russian society, the fight against crime requires the legislative regulation. Crime is a multifaceted phenomenon that is becoming more complex in parallel with the development of society. Its growth makes it necessary to research the fundamentals of the theory and practice of coordinating the activities of the law enforcement agencies in the fight against crime. The important factors from the point of view of the state of coordination activities are their proper organizational support, the development of the right strategies and tactics when performing the necessary actions, as well as their effective use by the law enforcement agencies to curb criminal activity. The authors of the paper set the goal of the study, which is to analyze the coordination activities of the law enforcement agencies in the fight against crime. Methods: the methodological framework for the research is the dialectical-materialistic method of cognition, which includes the elements of system analysis, and the specific scientific methods, such as the logical and legal one. Results: based on the legal analysis, the content of coordination activities as the effective coordinated actions in the fight against crime is revealed. Conclusions: it is revealed that there is a need to adopt a special law aimed at improving the status of prosecutors in the framework of these coordination activities.

scholarly journals Segurança do paciente em hospitais de grande porte

2020 ◽  
Vol 14 ◽  
Author(s):  
Eliana Auxiliadora Magalhães Costa ◽  
William Mendes Lobão ◽  
Camila Lapa Matos Riba ◽  
Nathália Muraiviechi Passos
Keyword(s):  
Patient Safety ◽  
Patient Harm ◽  
Patient Identification ◽  
Regulatory Policies ◽  
Evaluative Study ◽  
Safety Plan ◽  
Politica Publica ◽  
National Patient ◽  
Pressure Injury ◽  
Quantitative Descriptive

Objetivo: analisar a implementação da política nacional de segurança do paciente. Método: trata-se de um estudo quantitativo, descritivo e avaliativo de casos múltiplos em hospitais de grande porte. Informa-se que a coleta de dados constou de uma entrevista com o profissional responsável pelos Núcleos de Segurança do Paciente por meio de um formulário semiestruturado. Analisaram-se os dados pela estatística simples. Resultados: detalha-se que, dos 20 hospitais elegíveis, 12 (60%) participaram do estudo; todos os hospitais (100%) possuem núcleos constituídos, (91,7%) com Plano de Segurança do Paciente e (50%) contam com profissional com dedicação exclusiva. Implementaram-se, por mais da metade dos núcleos (58,3%), todos os protocolos obrigatórios, sendo identificação do paciente (83,3%) e higienização das mãos (83,3%) os mais frequentes. Revela-se que os percentuais de eventos adversos notificados foram: lesão por pressão (88,9%); queda do leito (77,8%) e erros de medicamentos (75%). Conclusão: conclui-se que os núcleos estudados não atendem totalmente às políticas regulatórias vigentes no país, merecendo, portanto, de adequações e de controle sanitário efetivo. Descritores: Segurança do Paciente; Legislação Hospitalar; Dano ao Paciente; Doença Iatrogênica; Política Pública; Assistência à Saúde.AbstractObjective: to analyze the implementation of the national patient safety policy. Method: this is a quantitative, descriptive and evaluative study of multiple cases in large hospitals. Please be informed that the data collection consisted of an interview with the professional responsible for the Patient Safety Centers using a semi-structured form. Data were analyzed using simple statistics. Results: it is detailed that, of the 20 eligible hospitals, 12 (60%) participated in the study; all hospitals (100%) have centers, (91.7%) have a Patient Safety Plan and (50%) have a professional with exclusive dedication. All mandatory protocols were implemented in more than half of the centers (58.3%), with patient identification (83.3%) and hand hygiene (83.3%) being the most frequent. It is revealed that the percentages of adverse events reported were: pressure injury (88.9%); bed falls (77.8%) and medication errors (75%). Conclusion: it is concluded that the centers studied do not fully comply with the regulatory policies in force in the country, therefore deserving adjustments and effective sanitary control. Descriptors: Patient Safety; Hospital Legislation; Patient Harm; Iatrogenic Disease; Public Policy; Delivery of Health Care.ResumenObjetivo: analizar la implementación de la política nacional de seguridad del paciente. Método: se trata de un estudio cuantitativo, descriptivo y evaluativo de casos múltiples en grandes hospitales. Tenga en cuenta que la recopilación de datos consistió en una entrevista con el profesional responsable de los Centros de Seguridad del Paciente utilizando un formulario semiestructurado. Los datos se analizaron mediante estadísticas simples. Resultados: se observa que de los 20 hospitales elegibles, 12 (60%) participaron en el estudio. Se dice que todos los hospitales (100%) tienen centros constituidos, (91.7%) con un Plan de Seguridad del Paciente y (50%) tienen un profesional con dedicación exclusiva. Es de destacar que más de la mitad de los centros (58.3%) implementan todos los protocolos obligatorios, siendo la identificación del paciente (83.3%) y la higiene de manos (83.3%) las más frecuentes. Se observa que los porcentajes de eventos adversos informados fueron: lesión por presión (88,9%), caída de la cama (77,8%) y errores de medicación (75%). Conclusión: se informa que los centros estudiados no cumplen plenamente con las políticas regulatorias vigentes en el país, por lo que merecen ajustes y un control sanitario efectivo. Descriptores: Seguridad del Paciente; Legislación Hospitalaria; Daño del Paciente; Enfermedad Iatrogénica; Política Pública; Prestación de Atención de Salud. 

scholarly journals Features of Terrorist-Oriented Criminality in the Socialist Republic of Vietnam and Measures of Legal Response to Fight it at the Present Stage

2020 ◽  
Vol 14 (3) ◽  
pp. 400-410
Author(s):  
Alexander Korobeev ◽  
Dmitriy Lobach ◽  
Nguyen Hung
Keyword(s):  
Political Violence ◽  
Criminal Liability ◽  
Criminal Activity ◽  
Criminal Code ◽  
Islamic State ◽  
Legal Analysis ◽  
Socialist Republic ◽  
Terrorist Organizations ◽  
Wide Range ◽  
Global Terrorism

This article examines distinguishing features of terrorist-oriented criminality in the Socialist Republic of Vietnam, exploring quantitative indicators of certain types of crimes. It is concluded that the current level of political violence in Vietnam is low. Using a wide range of data sources on composite indicators (Global Terrorism Index, Global Terrorism Database and Global Peace Index), it is concluded that to date Vietnam has recorded a low level of political violence. The research explores basic «criminogenic» conditions or factors that lead to relevant risk of growth of political violence. It should be noted that to some extent ethnic tensions still exist in Vietnam. There is also a great concern about criminal activity of a number of domestic and international terrorist organizations, which, in the short or long term, could disrupt domestic political situation and escalate terrorism. The researchers argue that although political and religious motives (e.g. establishing an Islamic state) underlie certain terrorist activities of international terrorist organizations and the fact that Muslims in Vietnam make up about 0,1 % of the countrys population, Vietnams international commitment to counter-terrorism is likely to make it a target of retaliation by these organizations. In addition, there is a possibility that these organizations may commit terrorist acts within the territory of the Socialist Republic of Vietnam to support and fund terrorist activities in the future. We summarized that as at present in force Criminal Code of the Socialist Republic of Vietnam includes special provisions that carry liability for individual acts showing signs of terrorism (arts. 113, 299, 300 CC SRV) and norms within international obligations that cover criminal liability for other crimes of terrorist nature (crimes with indicators of terrorization). The comparative legal analysis of anti-terrorist statutes presented in the 2015 version of the Criminal Code of the Socialist Republic of Vietnam reveals legal and technical defects in certain material elements of terrorist offences. It is noted that Vietnamese legislator distinguishes two forms of terrorism: «traditional» terrorism, which pursues political aims (criminal acts against the peoples government, committed for the purpose of combating it) and terrorism aimed at creating a climate of fear in society.

scholarly journals Managing Illicit Online Pharmacies: Web Analytics and Predictive Models Study

10.2196/17239 ◽  
2020 ◽  
Vol 22 (8) ◽  
pp. e17239
Author(s):  
Hui Zhao ◽  
Sowmyasri Muthupandi ◽  
Soundar Kumara
Keyword(s):  
Prescription Drugs ◽  
Performance Metrics ◽  
Prediction Models ◽  
Future Research ◽  
K Nearest Neighbor ◽  
Data Set ◽  
Specificity And Sensitivity ◽  
The Status ◽  
Online Pharmacies ◽  
Google Search

Background Online pharmacies have grown significantly in recent years, from US $29.35 billion in 2014 to an expected US $128 billion in 2023 worldwide. Although legitimate online pharmacies (LOPs) provide a channel of convenience and potentially lower costs for patients, illicit online pharmacies (IOPs) open the doors to unfettered access to prescription drugs, controlled substances (eg, opioids), and potentially counterfeits, posing a dramatic risk to the drug supply chain and the health of the patient. Unfortunately, we know little about IOPs, and even identifying and monitoring IOPs is challenging because of the large number of online pharmacies (at least 30,000-35,000) and the dynamic nature of the online channel (online pharmacies open and shut down easily). Objective This study aims to increase our understanding of IOPs through web data traffic analysis and propose a novel framework using referral links to predict and identify IOPs, the first step in fighting IOPs. Methods We first collected web traffic and engagement data to study and compare how consumers access and engage with LOPs and IOPs. We then proposed a simple but novel framework for predicting the status of online pharmacies (legitimate or illicit) through the referral links between websites. Under this framework, we developed 2 prediction models, the reference rating prediction method (RRPM) and the reference-based K-nearest neighbor. Results We found that direct (typing URL), search, and referral are the 3 major traffic sources, representing more than 95% traffic to both LOPs and IOPs. It is alarming to see that direct represents the second-highest traffic source (34.32%) to IOPs. When tested on a data set with 763 online pharmacies, both RRPM and R2NN performed well, achieving an accuracy above 95% in their predictions of the status for the online pharmacies. R2NN outperformed RRPM in full performance metrics (accuracy, kappa, specificity, and sensitivity). On implementing the 2 models on Google search results for popular drugs (Xanax [alprazolam], OxyContin, and opioids), they produced an error rate of only 7.96% (R2NN) and 6.20% (RRPM). Conclusions Our prediction models use what we know (referral links) to tackle the many unknown aspects of IOPs. They have many potential applications for patients, search engines, social media, payment companies, policy makers or government agencies, and drug manufacturers to help fight IOPs. With scarce work in this area, we hope to help address the current opioid crisis from this perspective and inspire future research in the critical area of drug safety.

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