Medicamentos sujetos a seguimiento adicional en la Unión Europea / Medicines under additional monitoring in the European Union

Objetivo: El objetivo de nuestro estudio fue analizar las características de los medicamentos sujetos a seguimiento adicional. Para ello, estudiamos: los criterios aplicados para su designación, los criterios de dispensación autorizados, los grupos farmacológicos a los que pertenecen y su seguridad postcomercialización. Método: Se analizó la lista publicada por la Agencia Europea de Medicamentos en enero de 2017 (EMA/245297/2013 Rev.41). La información para el análisis se extrajo de las páginas web de la Agencia Europea de Medicamentos y la Agencia Española de Medicamentos y Productos Sanitarios. Resultados: Se estudiaron 316 medicamentos sujetos a seguimiento adicional. El criterio de designación más común fue ser un nuevo principio activo (n = 197 [62,3%]). Otros criterios de designación comunes fueron: requerir un estudio postautorización de seguridad (n = 52 [16,5%]) y ser un medicamento biológico, aunque no un nuevo principio activo (n = 49 [15,5%]). Con respecto a las condiciones de dispensación, casi el 66% de estos medicamentos se autorizaron con criterios de dispensación restringidos. Hasta enero de 2017, la Agencia Española de Medicamentos y Productos Sanitarios había publicado 14 notas informativas de seguridad referidas a los medicamentos sujetos a seguimiento adicional. Conclusiones: Los medicamentos sujetos a seguimiento adicional incluyen mayoritariamente nuevas sustancias activas. El grupo farmacológico más frecuente es el de los fármacos antineoplásicos e inmunomoduladores. La revisión postcomercialización de su seguridad ha generado ya alguna información publicada por la Agencia Española de Medicamentos y Productos Sanitarios

Objective: The objective of this study was to analyse the characteristics of medicines subject to additional monitoring. We assessed the following aspects: the criteria applied to approve a medicine as being subject to additional monitoring; the authorized dispensing conditions; the pharmacological groups to which they belong; and their post-authorisation safety. Method: We analysed the list published by the European Medicines Agency in January 2017 (EMA/245297/2013 Rev.41). Information for the analysis was obtained from the web sites of the European Medicines Agency and the Spanish Agency of Medicines and Medical Devices. Results: We assessed 316 medicines subject to additional monitoring. The most common criterion used to assign a medicine as being subject to additional monitoring was it being a new active substance (n = 197 [62.3%]). Other common criteria were requiring a post-authorisation safety study (n = 52 [16.5%]) and being a biologic medicine but not a new active substance (n = 49 [15.5%]). Regarding dispensing conditions, nearly 66% of these medicines were authorized under restricted conditions. Until January 2017, the Spanish Agency of Medicines and Medical Device published 14 safety reports related to medicines subject to additional monitoring. Conclusions: The group of medicines subject to additional monitoring mainly includes new active substances. The most common pharmacological group is antineoplastic and immunomodulating agents. The postauthorisation safety study has already produced information published by the Spanish Agency of Medicines and Medical Devices

Medicines under additional monitoring in the European Union.

OBJECTIVE: The objective of this study was to analyse the characteristics of  medicines subject to additional monitoring. We assessed the following aspects:  the criteria applied to approve a medicine as being subject to additional  monitoring; the authorized dispensing conditions; the pharmacological groups to which they belong; and their post-authorisation safety. METHOD: We analysed the list published by the European Medicines Agency in  January 2017 (EMA/245297/2013 Rev.41). Information for the analysis was  obtained from the web sites of the European Medicines Agency and the Spanish  Agency of Medicines and Medical Devices. RESULTS: We assessed 316 medicines subject to additional monitoring. The most  common criterion used to assign a medicine as being subject to additional  monitoring was it being a new active substance (n = 197 [62.3%]). Other  common criteria were requiring a post-authorisation safety study (n = 52  [16.5%]) and being a biologic medicine but not a new active substance (n = 49  [15.5%]). Regarding dispensing conditions, nearly 66% of these medicines were authorized under restricted conditions. Until January 2017, the Spanish Agency  of Medicines and Medical Device published 14 safety reports related to medicines subject to additional monitoring. CONCLUSIONS: The group of medicines subject to additional monitoring mainly  includes new active substances. The most common pharmacological group is antineoplastic and immunomodulating agents. The postauthorisation safety  study has already produced information published by the Spanish Agency of  Medicines and Medical Devices.

Objetivo: El objetivo de nuestro estudio fue analizar las características de los  medicamentos sujetos a seguimiento adicional. Para ello, estudiamos: los  criterios aplicados para su designación, los criterios de dispensación autorizados,  los grupos farmacológicos a los que pertenecen y su seguridad postcomercialización.Método: Se analizó la lista publicada por la Agencia Europea de Medicamentos en enero de 2017 (EMA/245297/2013 Rev.41). La información para el análisis se extrajo de las páginas web de la Agencia Europea  de Medicamentos y la Agencia Española de Medicamentos y Productos  Sanitarios.Resultados: Se estudiaron 316 medicamentos sujetos a seguimiento adicional.  El criterio de designación más común fue ser un nuevo principio activo (n = 197  [62,3%]). Otros criterios de designación comunes fueron: requerir un estudio  postautorización de seguridad (n = 52 [16,5%]) y ser un medicamento  biológico, aunque no un nuevo principio activo (n = 49 [15,5%]). Con respecto a las condiciones de dispensación, casi el 66% de estos medicamentos se  autorizaron con criterios de dispensación restringidos. Hasta enero de 2017, la  Agencia Española de Medicamentos y Productos Sanitarios había publicado 14  notas informativas de seguridad referidas a los medicamentos sujetos a  seguimiento adicional.Conclusiones: Los medicamentos sujetos a seguimiento adicional incluyen mayoritariamente nuevas sustancias activas. El grupo farmacológico más frecuente es el de los fármacos antineoplásicos e  nmunomoduladores. La revisión postcomercialización de su seguridad ha  generado ya alguna información publicada por la Agencia Española de  Medicamentos y Productos Sanitarios.

What can we learn from the public's understanding of drug information and safety? A population survey.

OBJECTIVE: The aim of our study was to analyse the perceptions of the public on medicine information and safety and on consumer reporting of suspected adverse drug reactions (ADR). METHODS: A voluntary survey was conducted in a population ≥18 years of age in Asturias, a region in northern Spain. The survey was designed to be completed in a face-to-face street interview or completed independently by the public. The survey consisted of structured questions organised in four sections: (1) demographic data, (2) use of medicines, (3) reading and understanding of the patient information leaflet (PIL) and (4) awareness and perception about consumer reporting of ADR. KEY FINDINGS: A total of 402 surveys were given and analysed; 295 were completed independently and 107 were completed in street interviews. Of the population surveyed, 82.3% had taken some drug(s) in the previous 3 months, although only 62.4% had performed so by medical prescription. A quarter of respondents claimed that they never read the PIL of medicines, 12.7% that they sometimes read it, and 61.4% that they always read this information. A high percentage (82.8%) of respondents reported that they were not aware of consumer reporting of ADR, and 86.1% stated their agreement with this option. CONCLUSIONS: The public has great interest in useful information about all aspects involved in the use of medicines. This includes consumer reporting of suspected ADR, which is still unknown to many people.

Los criterios STOPP/START más frecuentes en España. Una revisión de la literatura / The most common STOPP/START criteria in Spain. A review of the literature

Objetivo: Analizar los criterios STOPP/START encontrados con más frecuencia en los estudios llevados a cabo en España, con el fin de identificar las áreas principales de prescripción potencialmente inadecuada. Métodos: Revisión de la literatura de los estudios originales realizados en España que aplicaron los criterios STOPP/START, versión 2008, y que describían los criterios STOPP o START más comunes. En cada estudio, se realizó un análisis ponderado de los criterios encontrados, asignando una puntuación 5 al criterio encontrado en la primera posición, 4 al criterio en segunda posición y así sucesivamente hasta el quinto criterio. Posteriormente se obtuvieron las puntuaciones totales para cada criterio analizado. Resultados: Se seleccionaron 19 estudios originales que analizaban los criterios STOPP, de los cuales 14 analizaban también todos los criterios START. Del total de estudios, 11 se desarrollaron en atención extrahospitalaria y 8 en atención hospitalaria. El criterio STOPP con la valoración ponderada más alta fue el B7 (uso prolongado de benzodiacepinas de vida media larga), seguido del J (cualquier prescripción regular de 2fármacos de la misma clase). El criterio START con la valoración ponderada más alta fue el F4 (estatinas en la diabetes mellitus si coexisten uno o más factores mayores de riesgo cardiovascular), seguido del E3 (suplementos de calcio y vitamina D en pacientes con osteoporosis conocida [con evidencia radiológica o fractura por fragilidad previa o cifosis dorsal adquirida]). Conclusiones: Las áreas de prescripción potencialmente inadecuada están bien definidas y sañalan la pertinencia de intervención en algunos puntos terapéuticos concretos

Objective: To analyse STOPP/START criteria found most frequently in the studies carried out in Spain, in order to identify the main areas of potentially inappropriate prescribing. Methods: A literature review was carried out on the original studies performed in Spain that applied the original version of the STOPP/START criteria and that described the most common STOPP and/or START criteria found. In each study, a weighted analysis was performed on the criteria found, by assigning 5 points to the criterion in first position, 4 points to the criterion in second position, and so on to fifth criterion. The total points of each analysed criterion were then obtained. Results: A total of 19 original studies analysing STOPP criteria were selected, 14 of them also studying all START criteria. From the total of studies, 11 were developed in out-of-hospital care, and 8 in hospital care. The STOPP criterion with the highest weighted assessment was B7 (long-term, long-acting benzodiazepines), followed by J (any duplicate drug class prescription). The START criterion with the highest weighted assessment was F4 (statin therapy in diabetes mellitus if coexisting major cardiovascular risk factors present), followed by E3 (calcium and vitamin D supplement in patients with known osteoporosis: previous fragility fracture, acquired dorsal kyphosis). Conclusions: The most common areas of potentially inappropriate prescribing are well defined, and suggest a particular intervention in some specific therapeutic points

[The most common STOPP/START criteria in Spain. A review of the literature]. / Los criterios STOPP/START más frecuentes en España. Una revisión de la literatura.

OBJECTIVE: To analyse STOPP/START criteria found most frequently in the studies carried out in Spain, in order to identify the main areas of potentially inappropriate prescribing. METHODS: A literature review was carried out on the original studies performed in Spain that applied the original version of the STOPP/START criteria and that described the most common STOPP and/or START criteria found. In each study, a weighted analysis was performed on the criteria found, by assigning 5 points to the criterion in first position, 4 points to the criterion in second position, and so on to fifth criterion. The total points of each analysed criterion were then obtained. RESULTS: A total of 19 original studies analysing STOPP criteria were selected, 14 of them also studying all START criteria. From the total of studies, 11 were developed in out-of-hospital care, and 8 in hospital care. The STOPP criterion with the highest weighted assessment was B7 (long-term, long-acting benzodiazepines), followed by J (any duplicate drug class prescription). The START criterion with the highest weighted assessment was F4 (statin therapy in diabetes mellitus if coexisting major cardiovascular risk factors present), followed by E3 (calcium and vitamin D supplement in patients with known osteoporosis: previous fragility fracture, acquired dorsal kyphosis). CONCLUSIONS: The most common areas of potentially inappropriate prescribing are well defined, and suggest a particular intervention in some specific therapeutic points.

Updated 2014 STOPP criteria to identify potentially inappropriate prescribing in community-dwelling elderly patients
.

OBJECTIVE: To analyze potentially inappropriate prescribing (PIP) using the 2014 version of STOPP criteria. MATERIALS AND METHODS: Prescriptions were analyzed by using invoicing data and electronic medical records. RESULTS: At least one STOPP criterion was observed in 9 out of every 10 patients. The most common STOPP criteria found were: "any drug prescribed without an evidence-based clinical indication" and "any drug prescribed beyond the recommended duration, where treatment duration is well defined". CONCLUSION: The high prevalence of PIP found seems to be due to the inclusion of new criteria related to indication of medication and duration of treatments.
.

Beers versus STOPP criteria in polyharmacy community-dwelling older patients / Criterios de Beers versus STOPP en pacientes mayores, polimedicados y residentes en la comunidad

Objective: To assess potentially inappropriate prescribing (PIP) using Beers (2012 version) and STOPP (2008 version) criteria in polypharmacy, community-dwelling, older patients. Methods: From the information collected in the invoicing data of the prescriptions and the electronic medical records, a sample was selected of 223 greater than or equal to 65-year-old patients who were taking simultaneously 10 or more drugs per day. Beers and STOPP criteria were separately applied, and the results obtained with the two methods were compared. Results: A total of 141 (63.2%) patients presented at least one Beers criterion. The two most frequently observed Beers criteria independent of diagnosis were the use of benzodiazepines and the use of non-COX-2-selective non-steroidal anti-inflammatory drugs. With regard to Beers criteria considering diagnosis, the most frequent were the use of anticholinergic drugs in patients with lower urinary tract symptoms or benign prostatic hyperplasia, and the use of benzodiazepines, antipsychotics, zolpidem or H2 -antihistamines, in patients with dementia or cognitive impairment. A total of 165 (73.9%) patients had at least one PIP according to the STOPP criteria. Duplicate drug classes and long-term use of long-acting benzodiazepines were the two most frequent STOPP criteria. Discussion: Our study identified a high frequency of PIP in polymedicated community-dwelling older patients. Simultaneous application of Beers and STOPP criteria represents a useful tool to improve prescribing in this population group (AU))

Objetivo: Evaluar la prescripción potencialmente inapropiada (PPI) mediante la aplicación de los criterios Beers (versión 2012) y STOPP (versión 2008) en pacientes mayores, polimedicados y residentes en la comunidad. Métodos: A partir de la información recogida en los datos de facturación de recetas y de las historias clínicas electrónicas se seleccionó una muestra de 223 pacientes de 65 o más años, que tomaban simultáneamente 10 o más medicamentos/día. Se aplicaron separadamente los criterios de Beers y STOPP y se compararon los resultados obtenidos con ambos métodos. Resultados: Un total de 141 pacientes (63,2%) presentaban al menos un criterio de Beers. Los dos criterios de Beers independientes del diagnóstico observados con más frecuencia fueron el uso de benzodiazepinas y el uso de antiinflamatorios no esteroideos no selectivos de ciclooxigenasa-2. Con respecto a los criterios de Beers considerando el diagnóstico, los más frecuentes fueron el uso de anticolinérgicos en pacientes con síntomas del tracto urinario inferior o con hiperplasia benigna de próstata y el uso de benzodiazepinas, antipsicóticos, zolpidem o antihistamí- nicos H2 , en pacientes con demencia o deterioro cognitivo. Un total de 165 (73,9%) pacientes tenían al menos una PPI según los criterios STOPP. La duplicidad terapéutica y el uso prolongado de benzodiazepinas de vida media larga fueron los dos criterios STOPP más comunes. Discusión: Nuestro estudio identificó una alta frecuencia de PPI en pacientes mayores, polimedicados y residentes en la comunidad. La aplicación simultánea de los criterios de Beers y STOPP constituye una herramienta útil para mejorar la prescripción en este grupo de población (AU)

Beers versus STOPP criteria in polyharmacy community-dwelling older patients.

OBJECTIVE: To assess potentially inappropriate prescribing (PIP) using Beers (2012 version) and STOPP (2008 version) criteria in polypharmacy, community-dwelling, older patients. METHODS: From the information collected in the invoicing data of the prescriptions and the electronic medical records, a sample was selected of 223 ≥ 65-year-old patients who were taking simultaneously 10 or more drugs per day. Beers and STOPP criteria were separately applied, and the results obtained with the two methods were compared. RESULTS: A total of 141 (63.2%) patients presented at least one Beers criterion. The two most frequently observed Beers criteria independent of diagnosis were the use of benzodiazepines and the use of non-COX-2-selective non-steroidal anti-inflammatory drugs. With regard to Beers criteria considering diagnosis, the most frequent were the use of anticholinergic drugs in patients with lower urinary tract symptoms or benign prostatic hyperplasia, and the use of benzodiazepines, antipsychotics, zolpidem or H2-antihistamines, in patients with dementia or cognitive impairment. A total of 165 (73.9%) patients had at least one PIP according to the STOPP criteria. Duplicate drug classes and long-term use of long-acting benzodiazepines were the two most frequent STOPP criteria. DISCUSSION: Our study identified a high frequency of PIP in polymedicated community-dwelling older patients. Simultaneous application of Beers and STOPP criteria represents a useful tool to improve prescribing in this population group.

Objetivo: Evaluar la prescripcion potencialmente inapropiada (PPI) mediante la aplicacion de los criterios Beers (version 2012) y STOPP (version 2008) en pacientes mayores, polimedicados y residentes en la comunidad. Metodos: A partir de la informacion recogida en los datos de facturacion de recetas y de las historias clinicas electronicas se selecciono una muestra de 223 pacientes de 65 o mas anos, que tomaban simultaneamente 10 o mas medicamentos/dia. Se aplicaron separadamente los criterios de Beers y STOPP y se compararon los resultados obtenidos con ambos metodos. Resultados: Un total de 141 pacientes (63,2%) presentaban al menos un criterio de Beers. Los dos criterios de Beers independientes del diagnostico observados con mas frecuencia fueron el uso de benzodiazepinas y el uso de antiinflamatorios no esteroideos no selectivos de ciclooxigenasa-2. Con respecto a los criterios de Beers considerando el diagnostico, los mas frecuentes fueron el uso de anticolinergicos en pacientes con sintomas del tracto urinario inferior o con hiperplasia benigna de prostata y el uso de benzodiazepinas, antipsicoticos, zolpidem o antihistaminicos H2, en pacientes con demencia o deterioro cognitivo. Un total de 165 (73,9%) pacientes tenian al menos una PPI segun los criterios STOPP. La duplicidad terapeutica y el uso prolongado de benzodiazepinas de vida media larga fueron los dos criterios STOPP mas comunes. Discusion: Nuestro estudio identifico una alta frecuencia de PPI en pacientes mayores, polimedicados y residentes en la comunidad. La aplicacion simultanea de los criterios de Beers y STOPP constituye una herramienta util para mejorar la prescripcion en este grupo de poblacion.

Optimización de la información sobre la medicación de personas polimedicadas en atención primaria / Optimization of information on the medication of polypharmacy patients in primary care

Dentro del protocolo de pacientes polimedicados/as elaborado por el Servicio de Salud del Principado de Asturias, los/las médicos/as de atención primaria reciben periódicamente los listados de los tratamientos de pacientes de cualquier edad que consumen 10 o más medicamentos/día durante un período de 6 meses. Actualmente, el Servicio de Salud del Principado de Asturias está desarrollando un proyecto orientado a evaluar las medicaciones de pacientes polimedicados/as, con el fin de identificar: 1) el consumo de medicamentos de utilidad terapéutica baja, 2) el consumo de fármacos potencialmente nefrotóxicos en pacientes con filtrado glomerular disminuido, y 3) la posible prescripción inadecuada en pacientes mayores de 65 años. El proyecto se inició con una primera fase llevada a cabo en el Área Sanitaria II y actualmente se pretende extenderlo a las áreas sanitarias restantes. Consideramos que su automatización y aplicación generalizada podrían ser útiles para optimizar la prescripción de medicamentos (AU)

As part of the protocol of the Health Service of the Principality of Asturias (Spain), primary care physicians periodically receive listings of the treatments of patients of any age taking 10 or more drugs/day for 6 months. Currently, the Health Service of the Principality of Asturias is developing a project that aims to assess the medications of polypharmacy patients. The aim is to identify: 1) the consumption of medicines of low therapeutic usefulness, 2) the consumption of potentially nephrotoxic drugs in patients with a low glomerular filtration rate, and 3) potentially inappropriate prescribing in patients aged 65 years or older. The project was started in Health Area II and the aim is to extend it to the remaining health areas. In our opinion, its automation and general implementation could be useful to optimize drug prescription (AU)

Inappropriate prescribing in polypharmacy elderly outpatients taking multiple medications. Are the STOPP criteria useful?

OBJECTIVE: To assess potentially inappropriate medications (PIMs) in elderly outpatients taking multiple medications. METHODS: Invoicing data of the prescriptions and electronic medical records were used to apply the STOPP (screening tool of older people's prescriptions) criteria. RESULTS: Three out of 4 patients included in the study received PIMs. The most common criteria found were: duplicate drug class prescriptions (n = 58 (17.4%)), long-term long-acting benzodiazepines (n = 54 (16.2%)), and acetylsalicylic acid with no history of coronary, cerebral, or peripheral vascular symptoms or occlusive event (n = 32 (9.6%)). CONCLUSION: Our results highlight the relevance of the systematic review of the pharmacological treatments in these patients.

[Optimization of information on the medication of polypharmacy patients in primary care]. / Optimización de la información sobre la medicación de personas polimedicadas en atención primaria.

As part of the protocol of the Health Service of the Principality of Asturias (Spain), primary care physicians periodically receive listings of the treatments of patients of any age taking 10 or more drugs/day for 6 months. Currently, the Health Service of the Principality of Asturias is developing a project that aims to assess the medications of polypharmacy patients. The aim is to identify: 1) the consumption of medicines of low therapeutic usefulness, 2) the consumption of potentially nephrotoxic drugs in patients with a low glomerular filtration rate, and 3) potentially inappropriate prescribing in patients aged 65 years or older. The project was started in Health Area II and the aim is to extend it to the remaining health areas. In our opinion, its automation and general implementation could be useful to optimize drug prescription.

[Direct reporting by patients of adverse drug reactions in Spain]. / La notificación directa por los pacientes de reacciones adversas a medicamentos en España.

The Spanish Pharmacovigilance System for Medicinal Products for Human Use, integrated by regional centers of pharmacovigilance coordinated by the Spanish Agency for Medicines and Health Products, is responsible for developing the Program of Spontaneous Reporting of Suspected Adverse Drug Reactions in our country. Although, until now, reports were only requesting to health professionals, the current understanding of the role of patients in the clinical setting and the experience gained in other countries of our environment, have demonstrated the convenience of developing active participation systems to patients in the reporting of suspected adverse drug reactions. In addition, this is taking into account in the new European legislation on pharmacovigilance.

La notificación directa por los pacientes de reacciones adversas a medicamentos en España / Direct reporting by patients of adverse drug reactions in Spain

El Sistema Español de Farmacovigilancia de medicamentos de uso humano, integrado por los centros autonómicos de farmacovigilancia coordinados por la Agencia Española de Medicamentos y Productos Sanitarios, se encarga del desarrollo en nuestro país del Programa de Notificación Espontánea de Sospechas de Reacciones Adversas a Medicamentos. Aunque hasta ahora se solicitaba la notificación únicamente a los profesionales sanitarios, el entendimiento actual del papel de los pacientes en la relación clínica y la experiencia obtenida ya en otros países de nuestro entorno, han puesto de manifiesto la conveniencia de desarrollar sistemas de participación activa de los pacientes en la notificación de sospechas de reacciones adversas a medicamentos. Así lo recoge además la nueva normativa europea en materia de Farmacovigilancia (AU)

The Spanish Pharmacovigilance System for Medicinal Products for Human Use, integrated by regional centers of pharmacovigilance coordinated by the Spanish Agency for Medicines and Health Products, is responsible for developing the Program of Spontaneous Reporting of Suspected Adverse Drug Reactions in our country. Although, until now, reports were only requesting to health professionals, the current understanding of the role of patients in the clinical setting and the experience gained in other countries of our environment, have demonstrated the convenience of developing active participation systems to patients in the reporting of suspected adverse drug reactions. In addition, this is taking into account in the new European legislation on pharmacovigilance (AU)

Trends in the pharmacological treatment of osteoporosis in Spain from 2000 to 2008.

AIM: To analyze the time trends in anti-osteoporosis medications consumption in Spain between 2000 and 2008 and the influence on such consumption induced by the Information Sheets related to the safety of menopausal hormone therapy and strontium ranelate published by the Spanish Agency of Medicines and Health Products (AEMPS). METHODS: Purchase data of anti-osteoporosis medications from 2000 to 2008 were obtained from the Spanish Ministry of Health. This information includes the pharmacy sales data of medicinal products reimbursed by the Spanish National Health Service. Anti-osteoporosis medications consumption data were expressed as defined daily dose per 1 000 inhabitants per day in women aged 50 or more. RESULTS: During the study period, anti-osteoporosis medications consumption showed a continuous increase. The greatest increase was observed with bisphosphonates, particularly alendronate and risedronate in their weekly formulations. Strontium ranelate consumption was low but continuously increased and new information concerning its safety in 2007 had no effect on its consumption. The use of menopausal hormone therapy remained stable until 2003, and from then presented a continuous decrease until 2008. Raloxifene utilization increased from 2000 to 2004 and decreased thereafter. Calcitonin utilization decreased uninterruptedly and teriparatide was infrequently used. CONCLUSION: This study reports a marked change in osteoporosis treatment in Spain, which includes an important increase in anti-osteoporosis medication use, particularly of bisphosphonates and a decrease in menopausal hormone therapy use secondary to the new information about their safety.

Proporción divina en pacientes con síndrome de clase II división 1 / Divine proportion in patients with Class II Division I Syndrome

La belleza y la armonía facial desempeñan una función decisiva en las relaciones sociales del hombre. La afectación estética es el principal motivo de consulta de los pacientes de Ortodoncia. La Proporción Divina está siendo estudiada cada día más, con fines diagnósticos y terapéuticos relacionados con la estética facial. Con el objetivo de evaluar el comportamiento de la Proporción Divina en mediciones faciales en pacientes con Síndrome de Clase II división 1 y su relación con el sexo se realizó un estudio descriptivo transversal durante los años 2008-2010 en el Departamento de Ortodoncia de la Facultad de Estomatología de la Habana. La muestra estuvo formada por 30 pacientes que cumplieron con los criterios de inclusión y se estudiaron las mediciones faciales mediante fotografías de frente y perfil. El estudio arrojó que los mayores porcentajes se encontraron en los pares que relacionaban la distancia entre el canto lateral de los ojos y el margen lateral de la nariz (66,7 por ciento); la base del tragus y el canto lateral del ojo y de este a la punta de la nariz (66,7 por ciento); de trichion al ala de la nariz y de esta al mentón (63,3 por ciento). Pocos pacientes mostraron la Proporción Divina en las mediciones faciales estudiadas, sin diferencias significativas en su comportamiento en relación con el sexo(AU)

The beauty and the facial harmony have a decisive function in social relationships of man. The esthetic affection is the leading cause of consultation of patients to Orthodontics. Divine Proportion is being more and more studied having diagnostic and therapeutical aims related to the facial aesthetics. To assess the behavior of Divine Proportion in facial measurements in patients presenting with Class II Division I syndrome and its relation to sex a cross-sectional and descriptive study was conducted for 2008-2010 in the Orthodontics Department of the Stomatology Faculty of La Habana. The sample included 30 patients who fulfilled the inclusion criteria studying the facial measurements by frontal and in profile photos. Study demonstrated that the greater percentages were in the pairs related to the distance between the lateral edge of eyes and the lateral margin of the nose (66.7 percent); the tragus basement ahd the lateral side of eye and from this one to nose tip and from this one to chin (63.3 percent). Few patients showed the Divine Proportion in the study facial measurements without significant differences in its behavior in relation to sex.(AU)

Proporción divina en pacientes con síndrome de clase II división 1 / Divine proportion in patients with Class II Division I Syndrome

La belleza y la armonía facial desempeñan una función decisiva en las relaciones sociales del hombre. La afectación estética es el principal motivo de consulta de los pacientes de Ortodoncia. La Proporción Divina está siendo estudiada cada día más, con fines diagnósticos y terapéuticos relacionados con la estética facial. Con el objetivo de evaluar el comportamiento de la Proporción Divina en mediciones faciales en pacientes con Síndrome de Clase II división 1 y su relación con el sexo se realizó un estudio descriptivo transversal durante los años 2008-2010 en el Departamento de Ortodoncia de la Facultad de Estomatología de la Habana. La muestra estuvo formada por 30 pacientes que cumplieron con los criterios de inclusión y se estudiaron las mediciones faciales mediante fotografías de frente y perfil. El estudio arrojó que los mayores porcentajes se encontraron en los pares que relacionaban la distancia entre el canto lateral de los ojos y el margen lateral de la nariz (66,7 por ciento); la base del tragus y el canto lateral del ojo y de este a la punta de la nariz (66,7 por ciento); de trichion al ala de la nariz y de esta al mentón (63,3 por ciento). Pocos pacientes mostraron la Proporción Divina en las mediciones faciales estudiadas, sin diferencias significativas en su comportamiento en relación con el sexo(AU)

The beauty and the facial harmony have a decisive function in social relationships of man. The esthetic affection is the leading cause of consultation of patients to Orthodontics. Divine Proportion is being more and more studied having diagnostic and therapeutical aims related to the facial aesthetics. To assess the behavior of Divine Proportion in facial measurements in patients presenting with Class II Division I syndrome and its relation to sex a cross-sectional and descriptive study was conducted for 2008-2010 in the Orthodontics Department of the Stomatology Faculty of La Habana. The sample included 30 patients who fulfilled the inclusion criteria studying the facial measurements by frontal and in profile photos. Study demonstrated that the greater percentages were in the pairs related to the distance between the lateral edge of eyes and the lateral margin of the nose (66.7 percent); the tragus basement ahd the lateral side of eye and from this one to nose tip and from this one to chin (63.3 percent). Few patients showed the Divine Proportion in the study facial measurements without significant differences in its behavior in relation to sex(AU)

Continuous reporting of new cases in Spain supports the relationship between Herbalife® products and liver injury.

PURPOSE: Previous publications have linked Herbalife® products to hepatotoxicity. The identification of earlier cases in which the culprit agent could not be established raised the hypothesis of a possible contamination of some specific batches of Herbalife products. METHODS: We searched the Spanish Pharmacovigilance Centres' database of adverse reactions for reports of liver injury associated with the use of Herbalife products from 2003, when the first case was submitted, through September 2010. RESULTS: The search resulted in 20 reports of liver damage (mean age, 49 years; 16 women), with 12 patients (60%) requiring hospitalization. Hepatocellular damage predominated, and nine (53%) of the hepatocellular cases with bilirubin values were jaundiced, fulfilling the Hy's law criteria, which increases the risk for serious outcomes. Two patients experienced a positive rechallenge. One patient developed cirrhosis, whereas all the others recovered. Causality assessment by the Karch and Lasagna modified algorithm showed a category of definite in 1 case, probable in 14, and possible in 5. Analysis of the different Herbalife products that each patient had taken did not enable us to identify any commonly known hepatotoxic ingredient. CONCLUSIONS: Our results support the relationship between the consumption of Herbalife products and hepatotoxicity, underscore the concern regarding the liver-related safety of this dietary supplement, and emphasize the need to establish further regulatory measures.

Valoración de la ecuación de Tanaka-Johnston en estudiantes cubanos con oclusión normal / Assessment of Tanaka-Johnston equation in Cuban students presenting normal occlusion

El análisis de Tanaka-Johnston, mundialmente empleado para la predicción del espacio de caninos y premolares no brotados, ha sido muy cuestionado por la variabilidad en el tamaño dentario entre las diferentes poblaciones, y por haber sido realizado en un grupo étnico no aplicable a todos. Se realizó un estudio descriptivo transversal, con el objetivo de determinar el ancho mesiodistal de incisivos, caninos y premolares mandibulares, así como de caninos y premolares maxilares, y comparar la suma real de estos dientes con los estimados por Tanaka-Johnston, según el sexo y la arcada. El universo de esta investigación estuvo constituido por 50 estudiantes de la Facultad de Estomatología de La Habana, 25 del sexo femenino y 25 del sexo masculino, con oclusión normal, sin antecedentes de tratamiento ortodóncico; todos descendientes de cubanos. En los resultados se observó que los anchos mesiodistales de los incisivos, caninos y primeros premolares inferiores y de caninos y segundo premolar izquierdo superiores fueron significativamente mayores en el sexo masculino que en el femenino. La suma real de caninos y premolares superiores e inferiores fue mayor en el sexo masculino que en el femenino. Cuando se comparó la suma real de caninos y premolares, con lo estimado según la ecuación de Tanaka-Johnston, se halló que la esta sobrestimó los valores de caninos y premolares, ya que los resultados fueron significativamente menores(AU)

The Tanaka-Johnston analysis used at worldwide to predict the space of non-erupted canines and premolars has been questioned due to the variability in the teeth size among different populations and also to be carried out in non-applicable whole ethnic group. A cross-sectional and descriptive study was conducted to determine the mesiodistal width of mandibular incisives, canines and premolars, as well as of danines and premolar-maxillary and to compare the real sum of these theeth with the estimates by Tanaka-Johnston, according to sex and the arcade. Universe of this research included 50 students of Stomatology Faculty of havana (25 males and 25 females) presenting with normal occlusion, without a history of Orthodontics treatment all of them descendants of Cubans. In results it was noted that the mesiodistal widths of incisives, canines and first lower premolars and of canines and second left premolars upper are greater in male sex than in the female one. The real sum of upper and lower canines and premolars was greter in male sex than in the female one. Comparing the real sum of canines and premolars with that estimated according Tanaka-Johnston, it was noted that it overestimated the values of canines and premolar since the results were significantly lower(AU)

Valoración de la ecuación de Tanaka-Johnston en estudiantes cubanos con oclusión normal / Assessment of Tanaka-Johnston equation in Cuban students presenting normal occlusion

El análisis de Tanaka-Johnston, mundialmente empleado para la predicción del espacio de caninos y premolares no brotados, ha sido muy cuestionado por la variabilidad en el tamaño dentario entre las diferentes poblaciones, y por haber sido realizado en un grupo étnico no aplicable a todos. Se realizó un estudio descriptivo transversal, con el objetivo de determinar el ancho mesiodistal de incisivos, caninos y premolares mandibulares, así como de caninos y premolares maxilares, y comparar la suma real de estos dientes con los estimados por Tanaka-Johnston, según el sexo y la arcada. El universo de esta investigación estuvo constituido por 50 estudiantes de la Facultad de Estomatología de La Habana, 25 del sexo femenino y 25 del sexo masculino, con oclusión normal, sin antecedentes de tratamiento ortodóncico; todos descendientes de cubanos. En los resultados se observó que los anchos mesiodistales de los incisivos, caninos y primeros premolares inferiores y de caninos y segundo premolar izquierdo superiores fueron significativamente mayores en el sexo masculino que en el femenino. La suma real de caninos y premolares superiores e inferiores fue mayor en el sexo masculino que en el femenino. Cuando se comparó la suma real de caninos y premolares, con lo estimado según la ecuación de Tanaka-Johnston, se halló que la esta sobrestimó los valores de caninos y premolares, ya que los resultados fueron significativamente menores(AU)

The Tanaka-Johnston analysis used at worldwide to predict the space of non-erupted canines and premolars has been questioned due to the variability in the teeth size among different populations and also to be carried out in non-applicable whole ethnic group. A cross-sectional and descriptive study was conducted to determine the mesiodistal width of mandibular incisives, canines and premolars, as well as of danines and premolar-maxillary and to compare the real sum of these theeth with the estimates by Tanaka-Johnston, according to sex and the arcade. Universe of this research included 50 students of Stomatology Faculty of havana (25 males and 25 females) presenting with normal occlusion, without a history of Orthodontics treatment all of them descendants of Cubans. In results it was noted that the mesiodistal widths of incisives, canines and first lower premolars and of canines and second left premolars upper are greater in male sex than in the female one. The real sum of upper and lower canines and premolars was greter in male sex than in the female one. Comparing the real sum of canines and premolars with that estimated according Tanaka-Johnston, it was noted that it overestimated the values of canines and premolar since the results were significantly lower(AU)