Nitrosamine Impurities in Angiotensin Receptor Blockers.

Nitrosamines are known carcinogens which have been recently discovered in several angiotensin receptor blockers (ARBs). This led to the recall of valsartan in the United States in 2018, and afterward, the recall of other ARBs as well as unrelated medications (e.g., ranitidine). The presence of nitrosamine in ARBs was likely a result of changes in the manufacturing process, although nitrosamine contamination is believed to occur by different mechanisms with other medications. The United States Food and Drug Administration has since taken steps to identify products affected by nitrosamine contamination and mitigate this concern going forward. Despite the contamination of some drug products, studies estimate that the overall risk to patients is low enough to not necessitate changes in prescribing patterns at this time.

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

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

Tianeptina: ¿por qué en España no ha sido catalogada como estupefaciente? / Tineptine: why has not been classified as a narcotic in Spain?

No disponible

Seguridad cardiovascular de los antidiabéticos no insulínicos. Posicionamiento científico SEMERGEN / Cardiovascular safety of non-insulin anti-diabetic drugs. Scientific position statement of SEMERGEN

La diabetes mellitus (DM) incrementa el riesgo de presentar complicaciones tanto microvasculares como macrovasculares. Aunque reducir la glucemia hasta los objetivos recomendados reduce el riesgo de complicaciones microvasculares, el efecto de los antidiabéticos sobre las complicaciones macrovasculares y la muerte cardiovascular es motivo de preocupación. Es más, algunos antidiabéticos podrían ser hasta perjudiciales desde el punto de vista de seguridad cardiovascular. En este contexto, las diferentes agencias reguladoras han establecido la necesidad de realizar estudios específicamente diseñados acerca de la seguridad cardiovascular de los antidiabéticos. Recientemente se han publicado los resultados de 2 ensayos clínicos que aportan información relevante acerca de la seguridad cardiovascular de los inhibidores de la dipeptidil peptidasa-4 (DPP-4). El objetivo del presente artículo es revisar la evidencia científica disponible acerca de la seguridad cardiovascular de los diferentes antidiabéticos no insulínicos y realizar unas recomendaciones prácticas sobre su uso en este contexto (AU)

Diabetes increases the risk of both microvascular and macrovascular complications. Although reducing plasma glucose levels to recommended targets decreases the risk of microvascular outcomes, the effects of anti-diabetic drugs on macrovascular complications and cardiovascular death are of concern. In fact, it has been suggested that some anti-diabetic agents could even be harmful for cardiovascular outcomes. In this context, several health care regulatory agencies have established the need for performing clinical trials specifically designed to assess the cardiovascular safety of anti-diabetic drugs. The results of 2 clinical trials have recently been published that provide important information on the cardiovascular safety of dipeptidyl peptidase 4 (DPP-4) inhibitors. The aim of this document was to review the available evidence on the cardiovascular safety of non-insulin anti-diabetic drugs and provide practical recommendations on their use in this context (AU)

An analysis of Australia's legal regime for imposing liability on manufacturers of pharmaceutical drugs.

Following a trial in June 2009 where the Federal Court heard submissions regarding whether Merck Sharpe and Dohme Australia should be held liable for an increased risk of cardiovascular conditions noted in patients who had taken the anti-inflammatory drug Vioxx, a judgment was handed down against MSDA in March 2010. MSDA then appealed to the Full Federal Court, where it was successful. A subsequent special leave to appeal application to the High Court of Australia was rejected in May 2012. This article examines the themes raised in the trial judgment and the appropriateness of Australia's statutory consumer protection regime through the lens of pharmaceutical drug injuries and side effects.

Trials and tribulations in the removal of dextropropoxyphene from the Australian Register of Therapeutic Goods.

• The Therapeutic Goods Administration determined in November 2011 that dextropropoxyphene should be removed from the Australian Register of Therapeutic Goods. This is consistent with this drug's removal from the market in many other developed countries. • However, dextropropoxyphene is still on the market in Australia owing to a series of appeals made to the Administrative Appeals Tribunal (AAT) by the drug's manufacturer. • There is a difference between the standards by which the AAT judges the safety and efficacy of medicines and the standards used for registering therapeutic goods by regulatory agencies worldwide. • This raises the question as to whether the appeal process against TGA decisions appropriately serves the Australian public interest.