The implementation of the bioequivalence certification policy in Chile: an analysis of market authorization data

Affordability is a key barrier to access to medicines. Generic medicines policies can address this barrier and promote access. Successful uptake of generic medicines depends, in part, on ensuring that these products are interchangeable with reference products. Typically, bioequivalence certification is established in order to demonstrate such interchangeability. To study the implementation of the bioequivalence certification policy in Chile. We used Chilean Market Regulatory Authority data for analysis to study the number of products that obtained bioequivalence certification, the time until bioequivalence certification and associated factors to obtain bioequivalence. As of January 2017, out of 2,336 products with a valid market authorization containing at least one of the 167 APIs that required BE certification, 1,026 products actually have BE certification (1,026/2,336, 43.9% compliance). Where data were available, the time between submission of the market authorization as a bioequivalent product to final authorization by the national medicine regulatory authority for most products varied between 4-6 months. The fraction of all BE products containing a given API out of the total marketed products containing that API varies considerably, e.g. for the API olmesartan there was only a single BE product marketed, the API diclofenac had none. Although the implementation of Chile's bioequivalence policy increased the number of bioequivalent products, over 50% of generic products requiring bioequivalence that did not obtain this certification. Also for some of the API none or very few BE products are marketed which limits the success of a substitution policy. Further studies are required to identify the apparent lack of incentives to obtain bioequivalence certification. Studies of sales volumes and prices of the products are needed to identify whether generic products without bioequivalence certification either become bioequivalent or eventually exit the market.

A decade of Food Safety Management System based on ISO 22000: a global overview / Una década del Sistema de gestión de la seguridad alimentaria basado en ISO 22000: visión general

The worldwide implementation and certification of food safety management systems (FSMS) have significantly increased during the last decade, reflecting the importance of assuming these standards in activity sectors involved in the food chain. Companies of all types and sizes worldwide have made several efforts for implementing a FSMS based on International Organization for Standardization (ISO) 22000. Certification system and quality management tools development in international context, are analyzed in food processing and food service sectors. Studies of food safety, performance of ISO 22000 implemented in food companies and hurdles of context characteristics wherein operate were reviewed. To summarize, improved product quality and safety has been identified as the major benefit of implementing ISO 22000. Other benefits highlighted include enhanced employee skills, improved company image, increased product sales, increased market share and access to new markets (AU)

La implementación y certificación mundial de los sistemas de gestión de la seguridad alimentaria (SGSA) se han incrementado significativamente durante la última década, lo que refleja la importancia de asumir estos estándares en los sectores de actividad involucrados en la cadena alimentaria. Empresas de todos los tipos y tamaños han realizado esfuerzos para implementar un SGSA basado en la Organización Internacional de Normalización (ISO) 22000. El sistema de certificación y el desarrollo de herramientas de gestión de calidad en el contexto internacional se analizan en los sectores de procesamiento de alimentos y servicios de alimentos. Se revisaron los estudios de inocuidad de los alimentos, el desarrollo de ISO 22000 implementado en las empresas de alimentos y los problemas según las características del contexto en donde opera. En resumen, la mejora en la calidad y seguridad del producto ha sido identificada como el principal beneficio de implementar ISO 22000. Otros beneficios destacados incluyen mejoras en las habilidades de los empleados, en la imagen de la compañía, mayores ventas de productos, mayor participación de mercado y acceso a nuevos mercados (AU)

Fatores socioeconômicos que influenciam na disposição de consumidores em adquirir carne bovina com certificação de origem em Belo Horizonte, Minas Gerais, Brasil / Socio-economic factors affecting the consumer provision in meat with certification of origin Belo Horizonte, Minas Gerais, Brazil

Objetivou-se verificar a influência dos fatores socioeconômicos na disposição de 407 consumidores em hipermercados do município de Belo Horizonte, Minas Gerais, em adquirir carne bovina com certificação de origem e verificar as características inerentes ao produto que auxiliam o consumidor no momento da compra, considerando o seu conhecimento prévio sobre rastreabilidade e certificação de origem. Foi realizada uma análise descritiva de todas as variáveis e, posteriormente, realizada a análise univariada pelo teste do qui-quadrado ou exato de Fischer. As variáveis foram adicionadas no modelo múltiplo da regressão logística Generalized Estimating Equations (GEE) e para todas as variáveis presentes no modelo final (p ≤ 0,05) foi calculado o risco por meio da odds ratio (OR) ajustada a um intervalo de confiança de 95%. Todos os fatores socioeconômicos analisados (sexo, idade, renda e escolaridade) influenciaram na disposição de consumidores em adquirir carne bovina com certificação de origem. Os atributos intrínsecos mais importantes na tomada de decisão no momento da compra da carne foram cor, maciez, odor e a pouca quantidade de gordura; enquanto que os atributos extrínsecos foram preço, selo de qualidade e carimbo do SIF. A maioria dos consumidores conhece o conceito correto de rastreabilidade e acreditam que o maior benefício da carne rastreada é oferecer mais segurança e evitar riscos de doenças transmitidas pelos alimentos; e a desvantagem é ser um produto mais caro do que o convencional.(AU)

The present study aimed to verify the influence of socioeconomic factors in the provision of 407 consumers in supermarkets in the city of Belo Horizonte, Minas Gerais, Brazil, in purchasing beef with certification of origin and to verify the inherent characteristics of the product that help the consumer at the time of purchase, considering their prior knowledge about traceability and certification of origin. A descriptive analysis of all variables was performed and a univariate analysis was subsequently conducted by chi-square test. The variables were added in the multiple logistic regression model Generalized Estimating Equations (GEE), and for all variables in the final model (p ≤ 0.05) the risk was calculated by the adjusted odds ratio (OR) to a range of 95% confidence. All socioeconomic factors examined (gender, age, income and education) influence the willingness of consumers to purchase beef with certification of origin. The most important intrinsic attributes in decision making when buying meat were the color, softness, odor and little amount of fat, whereas the extrinsic attributes were price, quality seal and stamp of the SIF. Most of the consumers know the correct concept of traceability and believe that the greatest benefit of the traced meat is to be safer and to avoid the risk of foodborne illness; and the disadvantage is to be a more expensive product than the conventional.(AU)

Registro Español de Marcapasos. XI Informe Oficial de la Sección de Estimulación Cardiaca de la Sociedad Española de Cardiología (2013) / Spanish Pacemaker Registry. Eleventh Official Report of the Spanish Society of Cardiology Working Group on Cardiac Pacing (2013)

Introducción y objetivos. Se describe el resultado del análisis de los implantes y recambios de marcapasos remitidos al Registro Español de Marcapasos en 2013, con especial referencia a selección de los modos de estimulación. Métodos. Se basa en el procesado de la información que aporta la Tarjeta Europea del Paciente Portador de Marcapasos. Resultados. Se recibió información de 118 centros hospitalarios, con un total de 12.831 tarjetas, el 35% de la actividad estimada. El consumo de generadores convencionales y dispositivos de resincronización fue de 755 y 58,1 unidades por millón de habitantes respectivamente. La media de edad de los pacientes que recibieron un implante era 77,4 años. El 59,5% de los implantes y el 56,6% de los recambios se realizaron en varones. La mayoría de los implantes y recambios de generadores se produjeron en la franja de los 80 años. Los cables endocavitarios utilizados son bipolares, el 78,7% con sistema de fijación activa. Se estimula en modo VVI/R pese a estar en ritmo sinusal al 24% de los pacientes con enfermedad del nódulo sinusal y el 25% de aquellos con bloqueo auriculoventricular. Conclusiones. Persiste la tendencia a aumentar del consumo de generadores marcapasos y dispositivos de resincronización por millón de habitantes. El sistema de fijación activa de los cables es mayoritario y un 20%, específico de protección de resonancia magnética. La edad y, en menor grado, el tipo de bloqueo auriculoventricular y el sexo son los factores que influyen en la adecuación del modo de estimulación. La monitorización domiciliaria de marcapasos aún dista mucho de generalizarse (AU)

Introduction and objectives. The present report summarizes the analysis of pacemaker implantation and replacement data sent to the Spanish Pacemaker Registry in 2013, with specific discussion of pacing mode selection. Methods. This study was based on information obtained from the European Pacemaker Patient Identification Card. Results. Information was received on 118 hospital centers, with a total of 12 831 cards, or 35% of the estimated activity. There were 755 and 58.1 conventional and resynchronization devices per million population, respectively. The mean age of patients receiving an implant was 77.4 years. Men received 59.5% of first implantations and 56.6% of replacements. Most implantations and generator replacements were performed in patients older than 80 years. Almost all endocardial leads used were bipolar, and 78.7% of leads had an active fixation mechanism. Despite being in sinus rhythm, 24% of patients with sick sinus syndrome and 25% of those with atrioventricular block were paced in VVIR mode. Conclusions. The use of pacemaker generators and resynchronization devices per million population continues to increase in Spain. Active fixation mechanisms predominate for leads but just 20% of leads are compatible with magnetic resonance imaging. The factors influencing the correct selection of pacing mode were age and, to a lesser extent, the type of atrioventricular block, and sex. Implementation of home monitoring of pacemakers remains low (AU)

Fatores associados à percepção e atitude de consumidores de carne bovina com certificação de origem / Factors associated with perceptions and attitude of consumers of meat with certification of origin

O objetivo deste estudo foi verificar quais fatores socioeconômicos estão relacionados com a decisão de compra de carne comcertificação de origem, além de levantar o perfil de percepção e atitude dos consumidores de carne bovina em São Luís/MA.Foi realizada a descrição das variáveis e construído um modelo múltiplo Generalized Estimating Equations (GEE) de regressãologística visando a identificar possíveis associações entre as características socioeconômicas dos consumidores e os principaisatributos da carne que influenciam a decisão para sua compra levantada por meio das entrevistas entre 400 entrevistados no mêsde março de 2012. O selo de qualidade na aquisição da carne foi o atributo que mais influenciou (32,5%) a decisão de comprados consumidores. A maioria dos entrevistados (68,7%) nunca ouviu falar sobre rastreabilidade bovina. Dentre os que já ouviramfalar, a maior parte (71,2%) está disposta a pagar mais pela carne com certificação de origem, apesar de considerar que hádesvantagens associadas à rastreabilidade, principalmente em relação ao aumento no preço da carne. Consumidores com maiorgrau de escolaridade apresentam 2,62 mais chances de já terem ouvido falar em carne rastreada e 1,90 mais chances de considerarque o principal benefício da carne rastreada é oferecer mais segurança alimentar; enquanto os com maior renda apresentam3,23 mais chances de aceitar pagar mais pela certificação da carne. Ou seja, pessoas com maior escolaridade apresentarammelhor conhecimento sobre esse tipo de certificação, enquanto aqueles com maior renda mostraram maior aceitação em pagarmais caro pela carne bovina rastreada.

The aim of this study was to verify which socioeconomic factors are related to the decision to purchase meat with certification oforigin, as well as raising the profile of perception and attitude of consumers of meat in São Luís/MA. The description of the variableswere performed and constructed a multiple model Generalized Estimating Equations (GEE) of logistic regression model using thestatistical package SPSS 18.0, to identify possible associations between socio-demographic characteristics of the consumers andthe main attributes of the meat that influence the decision for its purchase raised through interviews among 400 respondents inMarch 2012. The seal of quality for acquisition of the meat was the attribute that most influences (32,5%) the purchasing decisionsof consumers. Most respondents (68,7%) never heard about bovine traceability. Amongst these who had heard about traceability,most (71,2%) would be willing to pay more for meat with certification of origin, although considering that there are disadvantagesassociated with traceability, especially in relation to the increase in the price of meat. Consumers with greater levels of schoolingpresent 2,62 more chances of having already heard of traced meat and 1,90 more chances of considering that the main benefitof traced meat is to offer more food security, while the ones with bigger income present 3,23 more chances of accepting to paymore for the certification of the meat. This means that people with greater schooling present better knowledge about this type ofcertification, while those with bigger income show bigger acceptance to spend more money on traced meat.

Una década de trabajo del Registro Sanitario de Juguetes en Cuba / Ten years of work related to the health registry of toys in Cuba

Los juguetes son un instrumento vital para el desarrollo de los niños y las niñas, por lo que es una prioridad el cumplimiento de los requisitos de su seguridad para evitar así riesgos de daño a la salud. Una herramienta eficaz para verificar y controlar la seguridad de los juguetes, es su certificación sanitaria. En Cuba, previo a su comercialización, los juguetes se someten al proceso de registro sanitario, el cual culmina con el otorgamiento del certificado sanitario que avala su inocuidad. El objetivo de este artículo es brindar una síntesis del trabajo realizado por el Registro Sanitario de Juguetes en Cuba en el período 1999-2009 y brindar algunas consideraciones para mejorar esta actividad. En una década de trabajo se aprobaron 1993 certificados, se rechazaron 79 referencias de juguetes por diferentes causas, entre ellas, deficiencias en la terminación del producto, etiquetado inexistente o incorrecto y problemas en el diseño. Se ha brindado asesoría técnica a las empresas que forman parte de la cadena de distribución, impartido conferencias y cursos y participado en talleres que permitieron el intercambio entre los especialistas. En la actualidad se trabaja en el fortalecimiento de los requisitos de seguridad para los juguetes en concordancia con los progresos científicos, la evolución del mercado y el mayor conocimiento acerca de cuestiones de salud y seguridad(AU)

Toys are a vital tool for the development of children, thus, it is a priority the fulfillment of requirement of its safe to avoid the risks of health damage. An effective tool to verify and to control the toys' safe is its safe. In Cuba, prior to its marketing, the toys underwent a health registry process, which end with the granting of a health certification endorsing its safe. The objective of present paper is to offer a synthesis of the work performed by the Toy's Health Registry in Cuba from 1999 to 2009 and also some considerations to improve this activity. During ten years of work 1993 certificates were approved, rejecting 79 toy's references by different causes including the deficiencies in the finished product, lack of labeling or a incorrectness of it and design problems. A technical consultancy to enterprises that are part of the distribution and production line, lecturer and courses have been given and the participation in workshops allowing the exchange among the specialists. At present times it is working in the strengthen of safe requirements for toys in agreement with the scientific progresses, the market evolution and a great knowledge on health and safe matters(AU)

Análisis de los productos farmacéuticos con registro sanitario vigente al mes de diciembre de 1997: Una aproximación al estudio de la oferta de medicamentos en el Perú / Analysis of veterinary pharmaceuticals current as of December 1997: An approach to the study of the supply of medicines in Peru

El presente documento describe los aspectos cuantitativos de la disponibilidad de los medicamentos en el mercado nacional, asi como el valor sanitario de los mismos(AU)