Nuevo marco legal para la erradicación de los medicamentos falsificados: los nuevos dispositivos de seguridad / New legal framework for the eradication of falsified medicines: the new safety devices

INTRODUCCIÓN: Los medicamentos falsificados son un problema emergente en la sociedad actual. Una de las principales estrategias para poder combatirlos es el empleo del Derecho. Por ello se promulgó, por parte de las instituciones europeas legalmente competentes para ello, el Reglamento Delegado de la Unión Europea 2016/161 de la Comisión de 2 de octubre de 2015, que completa la Directiva 2001/83/CE del Parlamento Europeo y del Consejo estableciendo disposiciones detalladas relativas a los dispositivos de seguridad que figuran en el envase de los medicamentos de uso humano (de fabricación industrial). MÉTODO: Se realizó una revisión bibliográfica de esta nueva normativa, promulgada por diversas instituciones comunitarias, con el objetivo de analizar las novedades existentes en el ámbito del medicamento. RESULTADOS: La norma comunitaria, objeto de nuestro estudio, establece las directrices para verificar aquellos medicamentos con mayor riesgo de falsificación, mediante unos dispositivos de seguridad compuestos de dos partes. Un dispositivo anti-manipulación que permite visualizar que el envase no ha sido alterado y un código identificador único, que será reconocido en todos los países comunitarios y que posee información sobre el medicamento. Desde las oficinas de farmacia se autentifica cada medicamento mediante la verificación y desactivación del código identificador en el momento de la dispensación del mismo. CONCLUSIONES: Esta nueva normativa pretende evitar la posible entrada de medicamentos falsificados en la cadena de suministro legal de medicamentos. Sus principales ventajas son, garantizar al paciente la veracidad del medicamento dispensado en las oficinas de farmacia y mejorar la trazabilidad de los mismos

INTRODUCTION: Falsified medicines are an emerging problem in today's society. One of the main strategies to combat them is the use of law. That is why the Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 was enacted by the relevant European institutions, which supplements Directive 2001/83/ EC of the European Parliament and of the Council by laying down detailed provisions relating to safety features appearing on the external packaging of medicinal products for human use (industrial manufacturing). METHOD: A literature review of this new legislation enacted by various Community institutions has been carried out with the aim of analyzing developments in the scope of the medicinal product. RESULTS: The Community regulation sets out the guidelines for verifying those medicinal products which have an increased risk of been falsified, using safety features consist of two parts: an anti-tampering device that allows to view that the packaging has not been altered, and a unique identifier code, which will be recognized in all Community countries and it has information on the medicinal product. Each drug is authenticated from the Pharmacies by verifying and deactivating the identifier code at the time of dispensing it. CONCLUSIONS: This new regulation aims to avoid the possible entry of falsified medicines into the legal supply chain of medicinal products. Its main advantages are ensuring to the patient the veracity of the drugs dispensed in the Pharmacy and improving the traceability of them

La otra pandemia / The other pandemic

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A nationwide web-based survey of a sample of Italian community pharmacists' perceptions and opinions about online sales of medicines and falsified drugs

BACKGROUND: Throughout Europe, legal online pharmacies increasingly sell online drugs as well as other products such as dietary supplements. Online sale of pharmaceuticals however is closely connected to the phenomenon of drug falsification. OBJECTIVE: The aim of this study was to assess the opinions of a sample of Italian community pharmacists towards the sale of pharmaceuticals on the web, as well as their knowledge and experience with falsified drugs. METHODS: A self-administered questionnaire was distributed by means of an online platform between October 2016 and January 2017. Collected information included: demographics, workplace and role, opinions towards the online sale of pharmaceuticals, whether the pharmacy has a website, knowledge and opinions about falsified drugs. RESULTS: A total of 668 community pharmacists completed the questionnaire (mean age: 48.5, SD 12.4 years, 52.3% women). Favourable opinions about online sale of pharmaceuticals were expressed by 4.9% of participants for prescription drugs, 25.4% for nonprescription drugs, and 51.6% for other products. Favourable opinions occurred more often among males and owners/directors of pharmacies in comparison to females and employees, and among pharmacists working in pharmacies with websites doing e-commerce. Knowledge about falsified drugs was limited, with 24.5% of respondents failing to indicate that falsified drugs may contain less or different ingredients, 46.4% less and/or different excipients, and 72.3% ignoring that falsified drugs may be lethal. One in 3 respondents didn't know about falsified drugs in Italy, however 51 participants had previous experience with falsified drugs and 21 provided specific information. CONCLUSIONS: Italian community pharmacists have low confidence in the online sale of pharmaceuticals, as well as alarmingly limited knowledge about falsified drugs, even if many of them reported previous experiences. Results may support targeted interventions to increase pharmacists' knowledge about pharmaceuticals and the web, as well as concerning falsified drugs, and suggest community pharmacies as key components of integrated systems aimed at monitoring falsified drugs

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El Convenio Europeo contra la falsificación de medicamentos (Convenio Medicrime) y el crimen transnacional organizado / The European Convention against counterfeit medical products (Medicrime Convention) and the transnational organised crime

El presente estudio tiene por objeto examinar el Convenio sobre la falsificación de productos médicos y delitos similares que supongan una amenaza para la salud pública (Medicrime). Los estados miembros, conscientes de la amenaza que representa para la salud pública el comercio internacional de medicamentos falsificados, han aprobado diversos instrumentos para controlar la elaboración, distribución y venta de medicamentos para el consumo humano en la Unión Europea, entre los que se destaca el aprobado por el Consejo de Europa, esto es, el Convenio Medicrime, hecho en Moscú el 28 de octubre de 2011, y que entró en vigor a partir del 1 de enero de 2016. Este instrumento ha contado, desde entonces, con la firma de más de 23 países de Europa, África y Asia para quienes supone un recurso indispensable en materia penal para los estados miembros que les permitirá proteger en mejor medida la salud pública de los ciudadanos de la venta ilegal de medicamentos

The purpose of this study is to examine the Convention on Counterfeiting of Medical Products and Similar Crimes Which pose a Threat to Public Health (Medicrime). The member states, aware of the threat to public health posed by the international trade in counterfeit medicines, have adopted various instruments to control the manufacture, distribution and sale of medicines for human consumption in the European Union, including the one approved by the Council of Europe, i.e. the Medicrime Convention, done in Moscow on 28 October 2011, which entered into force on 1 January 2016. This instrument has since been signed by more than 23 countries in Europe, Africa and Asia, for which it is an indispensable resource in criminal matters for member states that will allow them to better protect the public health of citizens from the illegal sale of medicines

Mobile authentication service in Nigeria: An assessment of community pharmacists' acceptance and providers' views of successes and challenges of deployment

Background: Mobile Authentication Service (MAS) is a mobile health technology deployed to hinder the retailing of falsified medicines to consumers in Nigeria. But, some community pharmacists reported that points of failures of MAS have negatively impacted their practices. Objectives: The objectives of this study were (1) to assess the acceptance of MAS by community pharmacists; (2) to explore the views of MAS providers on the challenges and successes of MAS deployment in Nigeria. Methods: A quantitative cross sectional survey was used to investigate community pharmacists' acceptance of MAS. A validated structured questionnaire, based on Technology Acceptance Model, was distributed to 326 community pharmacists. In addition, a structured interview guide was employed to explore MAS providers' views of challenges and successes of MAS deployment in Nigeria. Results: Just about half (53%) of responding community pharmacists were keen on using MAS. In addition, 51% of them would recommend the service to other practitioners and 54% would encourage their clients to use it. The results of the study indicated that both awareness and perceived reliability played important role in the behavioural intention to use the MAS. The findings from the exploration of MAS providers' views showed that the problems encountered with MAS (no response and wrong response) were mainly due to contextual challenges in the Nigerian setting. These contextual challenges like the Global System Mobile downtime, incessant power outages and limited ability of consumers to use the Short Message Service, all contributed to the limited success of MAS in Nigeria. Conclusions: Acceptance of mobile authentication service by community pharmacists is moderate. Perceived reliability and awareness are important factors that affect behavioural intention to use MAS. The limited success of MAS deployment appeared to be as a result of its interaction with the local context, where it has been deployed

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Directiva Europea de Medicamentos Falsificados: luces y sombras para la Farmacia Hospitalaria / European Directive on Falsified Medicines: Lights and shadows for the Hospital Pharmacy

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Dispensación de medicamentos de prescripción y resolución de incidencias a partir de la entrada en vigor de la directiva 2011/62/UE / No disponible

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Awareness of the implementation of the Falsified Medicines Directive among pharmaceutical companies' professionals in the European Economic Area

Background: The Falsified Medicines Directive (FMD) is a response of the European Union to the increasing number of falsified medicines present in the legal supply chain within the Member States of the community. Effective implementation of the new regulations will depend on the effective cooperation of all parties involved in the distribution of medicinal products including the managers of pharmaceutical companies. Objective: The objective of the study was to examine awareness of the Implementation of the FMD among pharmaceutical company professionals in the European Economic Area. Methods: Sampling was conducted using a method called purposive sampling. An appropriate research tool in the form of an original questionnaire was made available to the respondents in electronic form. During the period from January 2016 to June 2016, 1,496 e-mail messages were sent. The response rate was 17.37%. Results: The study included 99 women (39.3%) and 153 men (60.7%). In the study group, 95.7% of people had heard of FMD. Doctors had rarely heard about the falsified medicine directive when compared to pharmacists (p=0.0063), people working in the pharmaceutical industry (p=0.0014), and respondents with a different professional profile (p=0.0114). In the study group, 89.6% of people were aware of the role of National Medicines Verification Organization in the process of implementing the provisions of FMD into the national system of distribution of medicinal products. The number of the respondents who knew the deadline for the implementation of FMD was significantly higher in the study population, i.e. 91.9% (p=0.0001). Both the younger respondents and those with lower level of education were less aware of the time requirements posed to national regulators (p=0.0003, p=0.0023, respectively). Conclusions: Awareness of the regulations related to the implementation of the FMD, although relatively high among pharmaceutical company professionals in the EEA, is still insufficient (AU)

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Analisis del comercio on-line de medicamentos falsificados / Analysis of on line marketing of counterfeit medicines

Los cambios tecnológicos por su naturaleza disruptiva y dinámica han supuesto socialmente un cambio en el modo de adquirir cualquier bien de consumo. Los medicamentos, no están ajenos a esta tendencia y en los últimos años se ha registrado un aumento significativo de la adquisición de éstos a través de canales no oficiales, como internet. Sin embargo, estas nuevas formas de comercialización están íntimamente relacionadas con la falsificación de los medicamentos. Los medicamentos falsificados son realmente productos nocivos, que pueden ocasionar graves problemas de salud a sus consumidores. Sin embargo, esta comercialización fraudulenta y legalmente poco castigada, reporta un gran beneficio económico a las redes distribuidoras. Por ello, la incidencia de este mercado es cada vez mayor, así como la perfección y variedad de los medicamentos falsificados. En el siguiente artículo, realizaremos un análisis descriptivo cualitativo y cuantitativo de un muestreo aleatorio de páginas web, que por sus características comercializan con falsificaciones de medicamentos. Así mismo, analizaremos las normas jurídicas y no jurídicas de ámbito europeo y nacional y los planes estratégicos nacionales e internacionales que se han establecido para luchar contra el fraude de los medicamentos espurios utilizadas por autoridades y profesionales de la salud para intentar erradicar la proliferación estos canales de distribución y proteger la salud de los pacientes impidiéndoles consumir medicamentos falsificados (AU)

Technological changes, because of their disruptive and dynamic nature, have implied a social change in the way to acquire any consumer product. Medicines are not excluded from this tendency, and in recent years a significant increase has been recorded in their acquisition through unofficial channels such as the internet. These new forms of marketing are closely linked, however, to the counterfeiting of drugs. Counterfeit drugs are truly nasty products which can cause serious problems in those taking them. This fraudulent and legally largely unpunished business, however, generates a large in come for the counterfeit drugs networks. This is why this market is constantly increasing, as are the perfection and variety of the counterfeit drugs marketed. In the following article we shall make a descriptive analysis, both qualitative websites which characteristically deal in counterfeit medicines. We shall also analyse the legal and non-legal rules (both national and international), as also the strategic plans (both national and international), which have been established by medical authorities and individuals to oppose the use of spurious medication and to eradicate the spread of the distribution channels and, thereby, to safegnard the health of patients by preventing them from taking counterfeit medicines (AU)

Los medicamentos falsificados en internet y el proyecto europeo Fakeshare: experiencias y actuaciones en España / Counterfeit medicines in internet and the Fakeshare european project: experiences and activities in Spain

El tráfico ilícito de medicamentos a través de Internet es un problema en auge que afecta a la salud pública. Desde el año 2013, la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) participa en el proyecto europeo Fakeshare, cofinanciado por la Comisión Europea y coordinado por la Agenzia Italiana del Farmaco (AIFA). Este proyecto tiene el propósito de coordinar iniciativas desarrolladas contra el suministro ilegal de medicamentos, incluyendo la compraventa a través de sitios web que realizan una actividad ilegal a los robos y otros desvíos de medicamentos al tráfico ilícito. Este artículo presenta las actividades desarrolladas en este ámbito a nivel nacional así como las estrategias y materiales elaborados. Las claves para combatir o hacer frente a la venta ilegal de medicamentos a través de Internet son la colaboración coordinada con todos los agentes implicados, a difusión de campañas de comunicación para concienciar y sensibilizar a consumidores, profesionales sanitarios y organizaciones del sector sobre los riesgos que supone la compra de medicamentos en sitios web ilegales, la creación de bases de datos para compartir la información sobre robos y otros desvíos al mercado ilícito, así como la difusión de las prácticas nacionales a nivel europeo e internacional (AU)

The illicit trafficking of medicines over the Internet is a growing problem that affects public health. Since 2013, the Spanish Agency of Medicines and Medical Devices (AEMPS) participates in the European project Fakeshare, co-funded by the European Commission and coordinated by the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA). This project aims to coordinate initiatives against the illegal supply of medicines, including from purchases through websites engaged in illegal activity, to thefts and other diversions of medicines to the illicit trafficking. This paper presents the activities in that area as well as strategies and elaborated materials at the national level. The keys to fight or face the illegal sale of medicines over the internet are coordinated cooperation with all the stakeholders, development of communication campaigns to raise awareness and sensitize consumers, health professionals and industry organizations about the risks of buying medicines on illegal websites, creating databases to share information on thefts and other deviations to the illegal market and disseminate national practices to combat illicit medicines trafficking at European and international levels (AU)

Resultados de una metodología para la identificación de distribución inversa de medicamentos en oficinas de farmacia / Methodology for identification of inverse drug distribution, Spain

FUNDAMENTOS: El fenómeno del tráfico inverso en la cadena legal de suministro de medicamentos es una práctica ilícita con graves riesgos para la Salud Pública. El objetivo de este trabajo fue identificar de forma proactiva, oficinas de farmacia que realizan estas conductas ilegales. MÉTODOS: Se cruzaron los datos de facturación al SAS de 52 millones de envases de medicamentos con los de las 496 farmacias de la provincia en un periodo de 29 meses (abril de 2012 a agosto de 2014). Junto con la aplicación del indicador específico definido denominado "porcentaje de sobrecompra", permitió identificar los establecimientos farmacéuticos con alto riesgo de estar implicados en el comercio ilícito. RESULTADOS: Se comprobó que hubo desvío en dos oficinas de farmacia, una rural (de 5.130 envases de medicamentos y beneficio ilícito obtenido de 9.591,78 €) y otra urbana (9.982 envases y 26.885,11 €), los cuales habían pasado desapercibidos en anteriores actuaciones inspectoras. CONCLUSIONES: La metodología implantada permite definir un perfil de oficina de farmacia infractora de alto riesgo en estas prácticas ilícitas, identificarlas, ponderar los fármacos destinados a este comercio ilegal y determinar nuevos medicamentos objeto de desvío. Ayuda a ajustar de forma precisa el cálculo del beneficio ilícito obtenido

BACKGROUND: The phenomenon of reverse drug trafficking in the legal supply chain is an unlawful practice to serious risks to public health. The aims was to identify proactively pharmacies that carry out these illegal activities. METHODS: An analysis was performed through the crossing billing data to SAS of 52 million packs of medicines for the 496 pharmacies in the province over a period of 29 months with the drug packaging data supplied by the distribution entities of the provincewith the implementation of specific indicator defined called 'percentage overbought' allows us to detect those pharmacies at high risk of being involved in this illicit trade. RESULTS: It was tested in two pharmacies one rural and other urban a detour of 5.130 medicine containers and an illicit profit obtained from € 9,591.78 for the first and 9.982 packaging and € 26,885.11 for the second; they had gone unnoticed in previous inspections. CONCLUSIONS: The methodology implemented to define a profile of infringing pharmacies high risk in these illicit practices, identify new ones that had not been sanctioned, weigh the drugs for illegal trade and to identify new drugs subject to diversion; also added as a challenge, it helps to adjust accurately and effectively calculate the illicit profit obtained

Counterfeit medicine. A threat to health. Legal situation / El medicamento falsificado. Una amenaza para la salud. Situación legal

The existence of substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products is an unacceptable risk to public health, becoming an emerging problem in recent years. However, we should be aware that the phenomenon of counterfeiting is not a novelty since such practice coexists with human beings since time immemorial. In the present work we will do a partial analysis of counterfeiting situation from a legislative point of view and will analyze how various legal and non-legal instruments have been used trying to resolve this issue in the European context

La existencia de medicamentos falsificados es una realidad. Se trata de un problema emergente en los últimos años. Sin embargo, hemos de ser conscientes que el fenómeno de la falsificación no es un hecho novedoso ya que tal práctica convive con el ser humano desde tiempos pretéritos. En el siguiente texto se realizará un análisis parcial de la situación de los mismos desde su punto de vista legislativo y se analizará cómo se han utilizado diversas herramientas jurídicas y no jurídicas para intentar solventar esta problemática existente a nivel comunitario

Desoxipipradrol. Fármacos antiguos, problemas nuevos / Desoxypipradrol. Old drugs, new problems

A través de Internet recientemente se han comercializado algunas sustancias estimulantes estructuralmente parecidas a neurotransmisores derivadas de medicamentos ya retirados, que potencialmente pueden causar cuadros clínicos de diversa gravedad. Su efecto estimulante y el hecho de que aparecen antes de prohibirse su consumo explican la denominación genérica de legal highs. La exposición a estas sustancias se manifiesta como cuadros parecidos a los del consumo de productos como fenciclidina, anfetaminas o cocaína, ya que muy probablemente compartan mecanismos de acción sobre la recaptación de dopamina en los núcleos cerebrales implicados en el comportamiento de gratificación. La escasez de información médica contrastada, y las dificultades para disponer de material de calibración constituyen un reto diagnóstico. El desoxipipradol, sintetizado hace más de 6 décadas para el tratamiento del trastorno hipercinético, fue relegado por el metilfenidato, un compuesto análogo. En 2009 reapareció como droga recreativa responsable de algunos cuadros clínicos de intoxicación (AU)

Stimulant substances previously used for therapeutic purposes, and are currently banned, have recently been marketed through the Internet. These drugs, structurally similar to neurotransmitters, can potentially cause severe clinical conditions. Exposure to these 'legal highs' results in symptoms similar to those of well-known substances such as phencyclidine, amphetamines or cocaine, probably because they share mechanisms of action related to dopamine reuptake in brain nuclei involved in the regulation of reward behavior. The limitations of medical evidence, as well as difficulties in obtaining calibration material, constitute an analytical challenge. Desoxypipradol was synthesized more than six decades ago for the treatment of hyperkinetic disorder, but was surpassed by methylphenidate, a similar compound with a better pharmacokinetic performance. In 2009 desoxypipradol appeared as a recreational drug involved in several cases of clinical intoxication (AU)

Equívoca quintaesencia. Alquimia espiritual y moneda falsa en la España del siglo XVI / Equivocal quintessence. Spiritual Alchemy and counterfeit money in 16th-century Spain

Una de las principales obsesiones de la Edad Moderna consistió en determinar las nociones de verdadero y falso para aplicarlas a los distintos campos del saber y, de ese modo, fundamentar la separación entre lo lícito y lo prohibido. Dicha tendencia iba a afectar especialmente a los terrenos de la religión y la ciencia, haciéndose necesario distinguir no sólo verdaderos y falsos espíritus, reliquias o milagros, sino también verdaderos y falsos astrólogos y alquimistas. Situada a caballo entre el idealismo y el materialismo, la alquimia ejemplificaba especialmente dichas tensiones, como se comprobará a través del proceso incoado en 1593 contra un fraile del monasterio jerónimo de Santa Engracia de Zaragoza, a quien su prior acusó de fabricar «plata de humo y joyas de trasgos» (AU)

One of the main obsessions of the Early Modern Era was that of determining the notions of true and false, in order to apply them to various fields of knowledge and thus establish the divide between the lawful and the unlawful. This trend was to have a particular impact on the fields of religion and science, where it became necessary to distinguish not only between true and false spirits, relics or miracles, but also between genuine and fake astrologers and alchemists. Situated in the middle ground between idealism and materialism, alchemy was prime territory for such tensions, as was demonstrated by a trial held in 1593 at the Jeronymite monastery of Santa Engracia in Saragossa, whose prior accused a friar of making «silver out of smoke and jewels from goblins» (AU)