Comercio ilegal de medicamentos, problemática enfocada en puntos de distribución y destrucción: unidades de eliminación de medicamentos e insumos / Illegal trade in medicines, problems focused on points of distribution and destruction: units for the disposal of medicines and supplies

Introducción: La falsificación y/o adulteración de medicamentos es un problema de salud pública el cual cada día se ve más reflejado en el país; una forma de evitarlo ya sea en mínima escala, es la correcta utilización de las unidades de eliminación de medicamentos e insumos, ayudando así a una eficaz desnaturalización y destrucción de estos.Objetivo General:Reconocer la importancia de la prevención del comercio ilegal de medicamentos mediante la utilización de las unidades de eliminación de medicamentos e insumos, en las etapas de comercialización y destrucción del producto, en los municipios de Santiago de Cali, La Unión y Jamundí en el Departamento del Valle del Cauca.Objetivos Específicos:•Medir el grado de conocimiento de las unidades de eliminación de medicamentos e insumos en cuanto a su funcionalidad e impacto en la población de Santiago Cali y en el municipio de La Unión Valle.•Analizar la incidencia de hallazgos de medicamentos en el material de reciclaje y su nivel de comercialización en Santiago de Cali y Jamundí.Método:Se realizó un estudio descriptivo- comparativo, de corte transversal, con enfoque cuantitativo que incluyó una muestra de 171 personas del municipio de Santiago de Cali y 89 personas en el municipio de La Unión Valle; una muestra de 21 recicladores del municipio de Santiago de Cali y 20 recicladores del municipio de Jamundí. El estudio fue realizado entre octubre y noviembre del 2022. Se utilizaron dos cuestionarios validados, diligenciados uno de forma virtual (grupo A) y otro de forma presencial (grupo B), el cual fue desarrollado de forma voluntaria.Resultados: Respecto al grupo de personas encuestadas en el grupo A, 45 que equivalen al 26.3% del universo de la población encuestada en Cali tienen conocimiento de las unidades de eliminación de medicamentos e insumos, 126 personas que equivalen al 73.7% no tienen conocimiento acerca del mismo.(AU)

Introduction: Counterfeiting and/or adulteration of medicines is a public health problem which is increasingly reflected in the country; One way to avoid it, whether on a small scale, is the correct use of the blue dot, thus helping to effectively denature and destroy them.General Objective: Recognize the importance of preventing the illegal trade of medicines using the blue point, in the stages of commercialization and destruction of the product, in the municipalities of Santiago de Cali, La Unión and Jamundí in the Department of Valle del Cauca.Specific Objectives: Measure the degree of knowledge of the blue dot in terms of its functionality and impact on the population of Santiago Cali and the municipality of La Uniòn Valle.Analyze the incidence of drug display in recycling material and its level of commercialization in Santiago de Cali and Jamundi.Method: A descriptive-comparative, cross-sectional study was conducted, with a quantitative approach that included a sample of 171 people from the municipality of Santiago de Cali and eighty-nine people from the municipality of La Union Valle, a sample of twenty-one recyclers from the municipality of Santiago de Cali and twenty recyclers from the municipality of Jamundí. The study was conducted between October and November 2022. Two validated questionnaires were used, one completed online (group A) and the other in person (group B), which was developed voluntarily.Results: Regarding the group of people surveyed in group A, 45, equivalent to 26.3% of the universe of the population surveyed in Cali, are aware of the blue dot, while 126 people, equivalent to 73.7%, are unaware of it. In Unión Valle, 14 people, equivalent to 15.7%, know about the blue dot, while 75 people, equivalent to 84.3%, are unaware of it.(AU)

Evaluación positiva de medicamentos: julio, septiembre y octubre de 2022 / Positive assessment of drugs: July, September and October of 2022

Se reseñan los medicamentos evaluados y con dictamen positivo por comisión de expertos de la Agencia Europea del Medicamento, hechos públicos en julio, septiembre y octubre de 2022 y considerados de mayor interés para el profesional sanitario. Se trata de opiniones técnicas positivas que son previas a la autorización y puesta en el mercado del medicamento.(AU)

The drugs assessed by the European Medicines Agency made public in July, September and October of 2022, and considered of interest to the healthcare professional, are reviewed. These are positive technical reports prior to the authorization and placing on the market of the product.(AU)

Consideraciones sobre la innovación incremental en medicamentos / Considerations regarding Incremental Drug Innovation

El concepto de innovación incremental abarca las adaptaciones resultantes del análisis de la utilización de los medicamentos existentes, con el fin de incorporar una modificación o proponer un nuevo uso diseñado para beneficiar a los pacientes. Puede clasificarse en 6 distintas categorías, en función de la naturaleza o del objetivo de la innovación realizada. La innovación incremental puede resultar muy interesantes para los profesionales sanitarios porque estas variaciones aportan mejoras en el tratamiento, en la continuación de los tratamientos, en la disminución de efectos adversos o en la adherencia. La innovación incremental tiene también una excelente acogida desde la perspectiva del paciente, puesto que facilita el tratamiento y en muchos casos abre una expectativa terapéutica a determinados subgrupos, inexistente antes de la comercialización del medicamento. Es interesante asimismo para el Sistema Nacional de Salud, ya que determinados pacientes tratados con innovaciones incrementales obtienen mejores resultados en salud y requieren con menor frecuencia hacer uso de otros servicios sanitarios. Desde una perspectiva económica, muchas empresas farmacéuticas radicadas en nuestro país relevantes desde un punto de vista estratégico, podrían asimismo mejorar con este tipo de innovaciones el arsenal terapéutico aportando productos necesarios que, lamentablemente, no tienen en la actualidad las condiciones idóneas de viabilidad. Por todo ello, la promulgación de una normativa española que ampare y aporte seguridad jurídica a los titulares de la autorización de comercialización de este tipo de innovaciones parece necesaria. Esta futura normativa debería incluir un procedimiento para calificar las innovaciones incrementales de interés para el Sistema Nacional de Salud y tener efectos económicos para garantizar su comercialización efectiva.(AU)

The concept of incremental innovation encompasses adaptations resulting from the analysis of the use of existing medicinal products, in order to incorporate a modification or propose a new use designed to benefit patients. It can be classified into 6 different categories, depending on the nature or objective of the innovation carried out. Incremental innovation can be very interesting for health professionals because these variations provide improvements in treatment, in the continuation of treatments, in the reduction of adverse effects or in adherence. Incremental innovation is also very well received from the patient’s perspective, since it facilitates treatment and in many cases opens up a therapeutic expectation for certain subgroups that did not exist before the medicinal product was marketed. It is also interesting for the National Health System, since certain patients treated with incremental innovations obtain better health results and require less frequent use of other health services. From an economic perspective, many pharmaceutical companies established in our country and relevant from a strategic point of view, could also improve the therapeutic arsenal with this type of innovations by providing products of therapeutic interest that, unfortunately, do not currently have the ideal conditions for viability. For all these reasons, the promulgation of a Spanish regulation that protects and provides legal certainty to the marketing authorization holders of this type of innovations seems necessary. This future regulation should include a procedure to qualify incremental innovations of interest to the National Health System and have economic effects to guarantee their effective commercialization.(AU)

Análisis de la evolución en el acceso a los medicamentos huérfanos en España / Analysis of the evolution in the access to orphan medicines in Spain

OBJETIVO: Evaluar el acceso al mercado de los medicamentos huérfanos en España que a fecha de 31 de diciembre de 2017 tuvieran vigente su designación, y para aquellos comercializados en España estimar los tiempos entre la asignación de código nacional (CN) por parte de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) y la fecha de comercialización efectiva. MÉTODO: La base de datos para identificar los medicamentos huérfanos autorizados por la Agencia Europea de Medicamentos (EMA), a fecha 31 de diciembre de 2017 (n = 142), es su Registro Comunitario publicado por la Comisión Europea. La EMA publica los medicamentos huérfanos que han perdido la designación. Las fechas de asignación de CN provienen de la AEMPS, y las de comercialización, de Bot PLUS. Se llevó a cabo un análisis descriptivo de las variables de estudio. Las variables cuantitativas se describieron utilizando la media y mediana, así como la desviación estándar y su rango. Las variables cualitativas se describieron según frecuencias absolutas y relativas. La comparación de resultados se realizó mediante contrastes paramétricos y no paramétricos en función de la aplicabilidad, con un nivel de significación del 5%. RESULTADOS: Entre 2002 y 2017, la EMA autorizó (con designación vigente a 31 de diciembre de 2017) 100 medicamentos huérfanos. De ellos, 86 tienen CN asignado, y de estos, 54 se han comercializado en España (54% de los medicamentos huérfanos vigentes y 63% de aquellos con CN). Para todos los medicamentos huérfanos con fecha de comercialización (53), el tiempo (mediana) desde la asignación del CN hasta su comercialización en España es de 13,4 meses (desviación estándar: 17,0; mínimo: 2,1; máximo: 91,7). La mediana para los comercializados en 2002-2013 y 2014-2017 es de 12,4 meses y 14,0 meses, respectivamente (p = 0,46). Esta diferencia no es estadísticamente significativa, lo que cabría esperar dado el número limitado de medicamentos huérfanos en nuestra «población». CONCLUSIÓN: Numerosos factores determinan el acceso a los medicamentos huérfanos. La autorización centralizada de comercialización en Europa es un éxito; su acceso es más limitado, dadas las complejidades de evaluación de la evidencia disponible en los procesos de financiación y precio. Es necesario implementar nuevas políticas que reduzcan las desigualdades en el acceso y permitan la sostenibilidad del sistema. Para conseguir estos objetivos, podrían contemplar un proceso acelerado en la decisión de financiación y precio, y el pago por resultados con incertidumbre alta

OBJECTIVE: To assess the access to orphan medicines in Spain, focusing on those with an active "orphan" designation, as of 31st December 2017; and for those orphan medicines in the Spanish market, estimate the time between being assigned a National Code (NC) by the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) and being approved for launch. METHOD: We used the European Commission's Public Register of orphan medicines to identify the orphan medicines authorised by the European Medicines Agency (EMA), as of 31 December 2017, while we sourced expired orphan indications from the EMA's website. Dates when NCs were assigned were sourced from the AEMPS, and commercialisation dates from Bot PLUS. A descriptive analysis of the study variables was done. The quantitative variables were described using means and medians, as well as standard deviations and ranges. The qualitative variables were described according to absolute and relative frequencies. The comparison of results was performed by parametric and non-parametric contrasts according to the applicability, at a 5% significance level. RESULTS: The EMA has approved 100 orphan medicines (with designation as of 31/12/2017) between 2002-2017. Eighty-six have a NC assigned by the AEMPS. Fifty-four have been launched in Spain (representing 54% of the full sample; 63% with NC). For the 53 orphan drugs with launch date in Spain, the median time between receiving its NC and its launch is 13.4 months (standard deviation: 17.0; minimum: 2.1; maximum: 91,7). The median time is 12.4 months and 14.0 months for those medicines launched in Spain between 2002-2013 and 2014-2017 respectively (p = 0.46). This difference is not statistically significant, which is what could be expected given the low numbers of orphan medicines in the "population". CONCLUSION: Complex factors determine the access to orphan drugs in Europe. The centralised procedure to obtain marketing authorisation at European level is a success. However, access is more limited, given the complexities of the evaluation of the available evidence for pricing and reimbursement decisions. It is therefore necessary to implement new policies that reduce inequalities in access and help achieve sustainable healthcare systems. To achieve this, they will need to offer the possibility of allowing earlier access, and using payment by results when there is high uncertainty

Desenvolvimento de uma ferramenta para avaliação do desempenho de fornecedores de medicamentos na divisão de farmácia de um hospital universitário brasileiro / Development of a tool for drug supplier performance evaluation in a pharmacy division of a Brazilian University Hospital

OBJETIVO: O presente estudo tem como objetivo desenvolver uma ferramenta para avaliação do desempenho dos fornecedores capaz de gerar indicadores que possam ser utilizados como critério de qualificação dos mesmos na divisão de farmácia de um hospital universitário brasileiro com intuito de garantir a aquisição de medicamentos seguros e eficazes, dentro dos prazos adequados e a custo reduzido, assegurando a prestação de um serviço de qualidade ao paciente. MÉTODOS: O trabalho foi desenvolvido por meio das seguintes etapas: pesquisa bibliográfica, desenvolvimento da ferramenta por meio da elaboração de critérios e estabelecimento de um sistema de pontuação e avaliação do fornecedor mediante um score final. Em seguida foi realizado um estudo para validação e análise dos resultados e posterior definição de ações de melhoria. RESULTADO: O balanced scorecard (BSC) foi a ferramenta selecionada após levantamento bibliográfico por ter uma estrutura abrangente e simples na medição de desempenho. Em seguida foi elaborada a ferramenta a partir da seleção de quatro critérios alinhados com a visão da divisão de farmácia e baseados nas perspectivas financeiras, nos processos internos, no cliente e na inovação e aprendizagem do BSC. Para o estudo foi selecionado 10 fornecedores homologados em processos licitatórios no período de abril a junho de 2018 aos quais foi aplicada a ferramenta com objetivo de planejar ações futuras de melhoria. Conlusão: Pode-se observar ao final deste trabalho que o objetivo pretendido foi alcançado

OBJECTIVE: The objective of this study was to develop a tool for drug suppliers' performance evaluation that was able to generate indicators to be used as a qualification criterion in a pharmacy division of a Brazilian teaching hospital, ensuring the purchase of efficacious and safe drugs, within estimated delivery time and at reduced cost, thus providing a quality care for patients. METHODS: The work was carried out in the following steps: bibliographical research on the theme, development of a tool based on criteria for supplier performance assessment and the establishment of a scoring system and the supplier evaluation trough a final score. A study was conducted for validation and analysis of the results for further definition of actions for improvement. RESULTS: After the bibliographical survey, the Balanced Scorecard (BSC) was the chosen tool as it had a more comprehensive and simple structure for performance measuring. The tool was developed according to selected criteria compliant with the vision statement of the pharmacy division, based on: financial perspective, internal processes, costumer and innovation and BSC learning. For the study it was selected 10 of the approved suppliers in bidding processes from April to June 2018 to which was applied the tool in order to plan future actions of improvement

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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Estudio comparativo de divisibilidad de diferentes formulaciones de prednisona / Comparative study on the divisibility of different prednisone formulations

El objetivo de este trabajo fue estudiar la influencia de la divisibilidad en comprimidos de prednisona 30 mg. La división de comprimidos se utiliza a menudo en la práctica farmacéutica para ajustar las dosis administradas. La prednisona es un corticoesteroide (glucocorticoide) utilizado en el tratamiento de sustitución en la insuficiencia adrenal incluyendo entre otras la enfermedad de Addison. Como medicamento de referencia se utilizó Dacortin 30 mg, el cual se comparó con dos medicamentos genéricos. Se estudiaron diferentes características farmacotécnicas para evaluar la calidad de los comprimidos estudiados, tales como la disgregación y la resistencia a la rotura. Atendiendo al estudio de fraccionamiento de comprimidos, se determinó la diferencia sobre el peso teórico esperado (pérdida de masa media tras el fraccionamiento de cada marca comercial). La liberación del principio activo se estudió mediante el ensayo de velocidad de disolución en fracciones de comprimidos. Los resultados de las tres presentaciones comerciales fueron estudiados y analizados estadísticamente con un nivel de confianza de un 95 %

The objective of this work was to study the influence of the division in prednisone tablets 30 mg. The division of tablets is often used in pharmaceutical practice to adjust the administered doses. Prednisone is a corticosteroid (glucocorticoid) used in the substitution treatment in adrenal insufficiency including, among others, Addison's disease. As a reference drug, Dacortin 30 mg was used, and compared with two generic drugs. Different pharmacotechnic characteristics were studied to evaluate the quality of the tablets studied, such as disintegration, and the resistance to crushing. Based on the study of tablet fractionation, the difference over the expected theoretical weight was determined (loss of average mass after the fractionation of each trademark). The release of the active substance was carried out with dissolution rate study in fractions of tablets. The results of the three commercial formulations were studied and statistically analyzed with a confidence level of 95 %

Analysing criteria for price and reimbursement of orphan drugs in Spain / Análisis de los criterios sobre precio y financiación de los medicamentos huérfanos en España

Objective: There are differences between countries regarding data requirements for orphan drug evaluation and it is also unknown which criteria might determine the price and reimbursement decision. This study aimed to identify the key criteria for price and reimbursement of orphan drugs in Spain, approved by the European Commission, between January 2012 and June 2018. Method: A descriptive analysis of the orphan drugs and its characteristics was performed. Outcomes criteria assessed were: therapeutic area, existence of alternative treatment, rarity of the disease, clinical trial outcomes and therapeutic positioning report assessment. Hypotheses for each variable regarding Spanish pricing and reimbursement were made and tested with two regression analyses. Results: Out of 78 orphan drugs approved by the European Commission, 82.1% asked pricing and reimbursement in Spain. From this, 43.8% had pricing and reimbursement approved and 20.3% rejected. Mean time from Spanish marketing authorisation approval to pricing and reimbursement approval was 12.1 ± 5.1 months. Having a positive therapeutic positioning report and no therapeutic alternatives would be associated with a positive pricing and reimbursement in Spain. Conclusions: It remains challenging to establish which are the driving criteria for pricing and reimbursement approval of orphan drugs in Spain. Further research should be done including other variables that might influence the pricing and reimbursement final decision in Spain

Objetivo: Los requisitos para la evaluación de los medicamentos huérfanos difieren entre los países miembros de la Unión Europea y tampoco se sabe qué criterios influyen en la decisión final sobre precio y financiación. Este estudio ha tenido como objetivo identificar los criterios clave para establecer el precio y la financiación de los medicamentos huérfanos en España, una vez aprobados por la Comisión Europea, entre enero de 2012 hasta junio de 2018. Método: Se realizó un análisis descriptivo de los medicamentos huérfanos y sus características. Los criterios evaluados fueron: área terapéutica, existencia de tratamientos alternativos, rareza de la enfermedad, tipo de resultados de los ensayos clínicos e informe de posicionamiento terapéutico. Para cada variable se estableció una hipótesis con respecto a la aprobación de precio y financiación y se analizaron con dos análisis de regresión. Resultados: De las 78 aprobaciones de medicamentos huérfanos realizadas por la Comisión Europea, el 82,1% solicitaron precio y financiación en España. De estas, el 43,8% fueron aprobadas y el 20,3% fueron rechazadas. El tiempo medio desde la aprobación de la autorización de comercialización en España hasta la aprobación del precio y la financiación fue de 12,1 ± 5,1 meses. Un informe de posicionamiento positivo y la falta de alternativas terapéuticas se asociaría con una aprobación de precio y financiación. Conclusiones: Sigue siendo un reto establecer cuáles son los criterios clave para la aprobación de los medicamentos huérfanos en España. Los próximos estudios deberían incluir un mayor número de variables que puedan influir en el precio y la decisión de financiación

Evaluación positiva de medicamentos: mayo, junio y julio 2018 / Positive assessment of drugs: May, June and July 2018

Se reseñan los medicamentos evaluados y con dictamen positivo por comisión de expertos de la Agencia Española de Medicamentos y Productos Sanitarios o de la Agencia Europea del Medicamento hechos públicos en mayo, junio y julio de 2018, y considerados de mayor interés para el profesional sanitario. Se trata de opiniones técnicas positivas que son previas a la autorización y puesta en el mercado del medicamento

The drugs assessed by the Spanish Agency for Medicines and Health Products or European Medicines Agency made public in May, June and July of 2018, and considered of interest to the healthcare professional, are reviewed here. These are positive technical reports prior to the authorization and placing on the market of the product

La farmacia española y el comercio electrónico / Spanish pharmacies and e-commerce

La utilización de las nuevas tecnologías, de manera asidua, por parte de la sociedad como herramienta para la obtención de diferentes tipos de servicios es innegable en la actualidad. Esta nueva manera de actuación, ha exigido a las distintas formas de negocio y a los mercados, que se transformen y adapten a los nuevos procesos comunicativos. Las farmacias en su vertiente empresarial no podía dejar pasar esta oportunidad de contemporización, por ello se promulgo el Real Decreto 870/2013, con el objetivo de coordinar la actuación sanitaria del farmacéutico y su actividad comercial realizada a través de internet, ya que esta nueva forma de servicio de las farmacias es una extensión virtual de la propia farmacia física. La farmacia digital puede suponer una oportunidad para incrementar el volumen de ventas, crear marca y actualizar la imagen de un negocio tan tradicional como éste. Sin embargo, para los profesionales de la farmacia la transformación de su negocio en un servicio digital es un nuevo reto al que se aproxima con desconocimiento, manifestando sus dudas sobre cómo montar una página web y que servicios ofertar. Por lo que, antes de iniciar el esfuerzo, que supone la implantación del negocio digital en la farmacia, debe hacer un análisis de los riesgos y oportunidades, que le supone su instauración. El objetivo de esta investigación fue facilitar a los farmacéuticos, una herramienta para conocer las características de este mercado y ayudarle a implantar y gestionar los contenidos de su farmacia on-line

The assiduous use of new technologies as a way for societies to achieve different services is undeniable in today’s day and age. This new way of carrying out tasks has demanded a transformation and adaption in communication processes from different types of businesses and markets. The business side of pharmacies could not miss this opportunity and, therefore, the promulgation of the Royal Decree 870/2013 came into effect. The objective of this decree is to coordinate the healthcare actions taken by pharmacists as well as their commercial activity carried out via the internet, considering that this new form of service is a virtual extension of the physical pharmacy. The digital pharmacy can create an opportunity to increase the number of sales, the creation of a brand, and update the traditional image that this business has. However, for the pharmacists themselves, the transformation of their businesses to a digital one is a new challenge that starts with the unknown, and continues with doubts about how to create a webpage and deciding what services to offer. Therefore, before starting the process, which implies implanting a digital business within the pharmacy, it is important to carry out an analysis of the risks and opportunities that come along with the establishment of such a venture. The objective of this research project was to provide pharmacists with a tool to help them understand the characteristics of this market, and help them implement and manage the contents of their online pharmacy

Resource-based theory of competitive advantage - a framework for pharmacy practice innovation research

Background: Community pharmacists have a key role to play in the management of allergic rhinitis (AR). Their role is especially important because the majority of medications used to treat AR are available for purchase over-the-counter (OTC), allowing patients to self-select their own medications and bypass the pharmacists. Patients' self-selection often results in suboptimal treatment selection, undertreated AR and poor clinical outcomes. In order for pharmacists to optimise the care for AR patients in the pharmacy, pharmacists need to be able to identify patient cohorts who self-select and are at high risk of mismanagement. Objectives: This study aimed to compare the demographics, clinical characteristics and medication selected, between pharmacy customers who choose to self-select and those who speak with a pharmacist when purchasing medication for their AR in a community pharmacy and identify factors associated with AR patients' medication(s) self-selection behaviour. Methods: A cross-sectional observational study was conducted in a convenience sample of community pharmacies from the Sydney metropolitan area. Demographics, pattern of AR symptoms, their impact on quality of life (QOL) and medication(s) selected, were collected. Logistic regressions were used to identify factors associated with participants' medication self-selection behaviour. Results: Of the 296 recruited participants, 202 were identified with AR; 67.8% were female, 54.5% were >40 years of age, 64.9% had a doctor's diagnosis of AR, and 69.3% self-selected medication(s). Participants with AR who self-select were 4 times more likely to experience moderate-severe wheeze (OR 4.047, 95% CI 1.155-14.188) and almost 0.4 times less likely to experience an impact of AR symptoms on their QOL (OR 0.369, 95% CI 0.188-0.727). Conclusions: The factors associated with AR patients' self-selecting medication(s) are the presence of wheeze and the absence of impact on their QOL due to AR symptoms. By identifying this cohort of patients, our study highlights an opportunity for pharmacists to engage these patients and encourage discussion about their AR and asthma management

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Spanish Society of Hospital Pharmacy position paper on biosimilar medicines / Documento de posicionamiento de la Sociedad Española de Farmacia Hospitalaria sobre los medicamentos biosimilares

Biological medicines nowadays have a great impact, as they offer treatment for diverse diseases and suppose a high cost for health system. Biosimilar medicines contain a version of an active substance already authorized as an original biotechnological medicine, whose patent has expired, and they comply with the guidelines published by the European Medicines Agency. These guidelines, where biosimilarity criteria are established, guarantee comparability between biosimilar product and reference one. Biosimilars’ authorization is carried out through a centralized procedure based on clinical, non-clinical and quality studies. These studies allow the extrapolation of indications, frequently, without carrying out additional analyses. In several European countries, switching between original and biosimilar medicine is considered safe. In Spain, Pharmacy and Therapeutic Committee of hospitals, as consensus bodies among health professionals, are the most suitable bodies to establish the interchangeability criteria in each center. Biosimilar drugs contribute to sustainability and to improvement of the accessibility to medicines. Faced with this situation, Spanish Society of Hospital Pharmacy considers interesting to express its position about biosimilar medicines’ strategies. Spanish Society of Hospital Pharmacy, in September 2015, published an information note about biosimilar medicines, in which its role as medicines similar in quality, safety and efficacy to the originals, but at lower cost, was highlighted. Likewise, it was stressed the role of hospital pharmacists within the Pharmacy and Therapeutic Committee of hospitals, where their knowledge for the selection, evaluation and use of medicines could be useful, in coordination and permanent collaboration with other units or clinical services of hospitals

Los medicamentos biológicos actualmente presentan un gran impacto, ya que ofrecen tratamiento para diversas enfermedades y suponen un elevado coste para el sistema sanitario. Los medicamentos biosimilares contienen una versión de una sustancia activa ya autorizada como medicamento biotecnológico original, cuya patente ha caducado, y cumplen con las guías publicadas por la European Medicines Agency, que establecen los criterios de biosimilitud para garantizar la comparabilidad entre el producto biosimilar y el de referencia. La autorización de los biosimilares se realiza mediante un procedimiento centralizado, a través de estudios comparativos clínicos, no-clínicos y de calidad, que permiten la extrapolación de indicaciones, frecuentemente sin realizar estudios adicionales. Algunos países europeos consideran seguro el intercambio entre medicamento original y biosimilar. En España, las Comisiones de Farmacia y Terapéutica hospitalarias, como órganos de consenso entre profesionales sanitarios, se consideran las más adecuadas para establecer los criterios de intercambiabilidad en cada centro. Los biosimilares contribuyen a la sostenibilidad y a la accesibilidad a los medicamentos. Ante esta situación, la Sociedad Española de Farmacia Hospitalaria considera de interés expresar su posicionamiento sobre las estrategias relacionadas con los medicamentos biosimilares. La Sociedad Española de Farmacia Hospitalaria, en septiembre de 2015, publicó una nota informativa sobre los medicamentos biosimilares, en la que destacó su similitud en calidad, seguridad y eficacia respecto a los originales, pero con menor coste. Igualmente, se recalcó el papel del farmacéutico hospitalario en las Comisiones de Farmacia y Terapéutica hospitalarias, donde sus conocimientos son útiles para la selección, evaluación y empleo de los medicamentos, en coordinación y colaboración permanente con los demás servicios clínicos del hospital

An assessment of the impact of entrepreneurial skills of community pharmacists on pharmaceutical business performance in Jos metropolis, Nigeria

Background: Community pharmacy has been a lucrative area of practice for pharmacists in Jos, Nigeria,until about the turn of the millennium where a decline in viability of the business has been observed. Objective: This study assessed the entrepreneurial skills of community pharmacists, the business performance of community pharmacies and the impactof their entrepreneurial skills on business performance. Methods: A cross sectional survey was conducted by administering a pretested questionnaire to 30 community pharmacists in Jos. An adaptation of the Bernelli model and the expanded Katz (1974)/Herron (1990) Skill Typology Model was used to assess nine entrepreneurial skills -product, organizational, industry, networking, leadership, executive, entrepreneurial, marketing and money skills; while sales growth, net profit and stock growth were used to assess business performance. Frequency distribution of results was presented, with further analysis done withthe Epi-Info software using the chi square test ofassociation. Result: The results from this study showed that community pharmacies in Jos do possess requisite entrepreneurial skills, but to varying extents. Product skills ranked highest while money skills and entrepreneurial skills ranked least, portraying a need for skills enhancement in these areas. Business performance was suboptimal, being rated as average or poor by 56.6% of respondents. However, most respondents (90%) still assessed their businesses as profitable. Money skills had a significant impact on business performance (P=0.03) and stock growth (P=0.04); while stock growth was significantly affected by leadership skills (P=0.002) and entrepreneurial skills (0.02). Net profit was significantly affected by industry skills (P=0.008). Conclusions: Community pharmacy business is still a profitable business venture in Jos though business performance is sub optimal. The entrepreneurial skills set of a community pharmacist set has an impact on business performance with money skills, leadership skills and entrepreneurial skills being most significant. This study recommended that entrepreneurial skills of community pharmacists in Nigeria are further developed to improve pharmaceutical business performance (AU)

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Proposals for harmonization of allergens regulation in the European Union

Allergen medicinal products in the European Union are regulated differently across the different Member States. Thus, whereas in some countries strict quality, safety and efficacy requirements are in place, in others, most allergens are on the market as Named Patient Products, without any regulatory oversight. This situation results on European allergic patients being exposed to totally different standards depending on where they live. Initiatives to correct this situation are needed (AU)

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Desabastecimientos de medicamentos en un hospital de tercer nivel en España / Shortages in medicinal products in a tertiary care hospital in Spain

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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)

Las compañías farmacéuticas británicas y el desarrollo de las ciencias de la vida tras el Brexit / British pharmaceutical companies and the development of the life sciences after the Brexit

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