Rapid assessment of enhanced safety surveillance for influenza vaccine.

OBJECTIVES: The enhanced safety surveillance for seasonal influenza vaccines established by the European Medicines Agency is required each season. Therefore, a registry capable of rapidly detecting and evaluating potential new safety concerns is needed. The aim of the study is to demonstrate the effectiveness of the vaccine information system of the Valencia region to make a rapid assessment of the influenza vaccine safety and describe the safety of the two vaccine types used in the 2017/2018 season. STUDY DESIGN: It is a population-based descriptive study. METHODS: Adverse events following immunization reports collected from 23rd October 2017 to 15th March 2018 were analyzed. RESULTS: A total of 55 adverse events for influenza vaccine were reported in season 2017/2018 with a reporting rate (RR) of 0.77 per 10,000 administered doses. Injection site reactions had a RR of 0.30 and 0.47 per 10,000 for subunit and adjuvanted vaccines, respectively. Differences per vaccine, sex, and risk group did not reach statistical significance. CONCLUSIONS: Reported events of the two influenza vaccine types used were similar than in other seasons and consistent with their safety profiles.

Surveillance for adverse events following immunization (AEFI) for 7 years using a computerised vaccination system.

OBJECTIVES: The surveillance of vaccine safety is an essential requirement in vaccination programmes. Computerized immunization registries such as the Vaccination Information System (SIV) of Valencian Community (Spain) offer the opportunity to estimate the incidence of adverse events according to individual information. The aim of the study was to analyze adverse events following immunization reported through SIV from 2005 to 2011 by age, sex, type of vaccine and dose, and adverse event, and highlight the advantages of this type of reporting. STUDY DESIGN: A retrospective cohort study of subjects vaccinated in the Valencian Community using population health databases was carried out. METHODS: Analysis of vaccinations and reported AEFI via SIV in Valencian Community was carried out. RESULTS: More than 13 million vaccines doses were administered during 2005 through 2011, the reporting rate of adverse events was 12.4/100,000 doses administered with the highest value in 2009 (27.4), with differences by age and sex. DTaP vaccine had the highest reporting in children (96.6/100,000) while influenza A(H1N1)pdm09 in adults (87.7/100,000). An increased reporting of adverse events was seen with DTaP in children 5-6 years of age, detected in real time, drove to swap this vaccine to a low dose Tdap which was followed by a decrease in administration site events. CONCLUSIONS: SIV demonstrates advantages for passive surveillance. Reporting rates by individual characteristics are calculated accurately and it also allows detecting shifts in reporting rate on real time for specific vaccines. The study shows that vaccines included in the routine vaccination schedule for children and adult vaccination programs are safe.

Utilización de fármacos antipsicóticos atípicos en ancianos institucionalizados y prevalencia de alteraciones metabólicas / Utilisation of atypical antipsychotic drugs in institutionalised elderly persons and prevalence of metabolic alterations

Objetivos Describir y evaluar la utilización de antipsicóticos atípicos en la población anciana institucionalizada de la Comunidad Valenciana y la prevalencia de alteraciones metabólicas asociadas. Material y métodos Estudio multicéntrico, descriptivo y transversal de utilización de medicamentos y caso-control de la prevalencia de las alteraciones de la glucemia, colesterol y triglicéridos. El análisis estadístico de las alteraciones metabólicas se realiza a partir de la diferencia de prevalencia y su significación estadística entre el grupo control y estudio. Resultados Se incluyen 681 pacientes (grupo estudio: 344; grupo control: 337) de 20 centros sociosanitarios. El 18,5% de los pacientes institucionalizados está en tratamiento con antipsicóticos atípicos. Los diagnósticos más frecuentes son alteraciones de conducta asociada a la demencia (63,6%) y a la esquizofrenia (18,4%). La risperidona es el fármaco antipsicótico más utilizado (66,0%). En general, para todos los fármacos, las dosis utilizadas se ajustan a las recomendadas en el paciente anciano. La prevalencia de alteraciones en el metabolismo de la glucosa, el colesterol y los triglicéridos en el grupo de estudio es del 23,96, el 34,83 y el 26,29%, respectivamente, no encontrándose diferencias estadísticamente significativas con respecto al grupo control. El análisis por tipo de fármaco no muestra diferencias significativas. Conclusiones Los resultados obtenidos muestran que la utilización de antipsicóticos atípicos en el paciente anciano sigue en líneas generales las recomendaciones establecidas. Las dosis utilizadas en el paciente anciano con alteraciones de conducta asociadas a la demencia, mayoritariamente tratado con risperidona, no tienen un impacto significativo sobre el aumento de la prevalencia de alteraciones metabólicas (AU)

Objectives Describe and evaluate atypical antipsychotics utilisation on the institutionalized elderly population of the Valencian Community and prevalence of associated metabolic alterations. Material and methods Multicentre transversal descriptive study on medication utilisation and prevalence case-control of alterations of glycaemia, cholesterol and triglycerides. The statistical analysis of metabolic alterations is performed from the difference in prevalence and its statistical signification between the control group and the study group.Results681 patients were included (study group, 344; control group, 337) from 20 social-health-care centres. 18.5% of the institutionalised patients are being treated with atypical antipsychotics. The most frequent diagnoses are: behavioural alterations associated with dementia (63.6%) and schizophrenia (18.4%). Risperidone is the most frequently used antipsychotic (66.0%). For all the drugs in general the doses used adjust to those recommended for elderly patients. The prevalence of alterations in glycaemia, cholesterol and triglycerides metabolism in the group under study is 23.96%, 34.83%, and 26.29%, respectively, with no statistically significant differences against the control group. The analysis by type of drug did not show significant differences. Conclusions The results obtained show that utilisation of atypical antipsychotics in elderly patients complies with the established general recommendations. The doses used in elderly patients with behavioural alterations associated with dementia, mostly treated with risperidone, do not have a significant impact over prevalence increase of metabolic alterations (AU)

[Utilisation of atypical antipsychotic drugs in institutionalised elderly persons and prevalence of metabolic alterations]. / Utilización de fármacos antipsicóticos atípicos en ancianos institucionalizados y prevalencia de alteraciones metabólicas.

OBJECTIVES: Describe and evaluate atypical antipsychotics utilisation on the institutionalized elderly population of the Valencian Community and prevalence of associated metabolic alterations. MATERIAL AND METHODS: Multicentre transversal descriptive study on medication utilisation and prevalence case-control of alterations of glycaemia, cholesterol and triglycerides. The statistical analysis of metabolic alterations is performed from the difference in prevalence and its statistical signification between the control group and the study group. RESULTS: 681 patients were included (study group, 344; control group, 337) from 20 social-health-care centres. 18.5% of the institutionalised patients are being treated with atypical antipsychotics. The most frequent diagnoses are: behavioural alterations associated with dementia (63.6%) and schizophrenia (18.4%). Risperidone is the most frequently used antipsychotic (66.0%). For all the drugs in general the doses used adjust to those recommended for elderly patients. The prevalence of alterations in glycaemia, cholesterol and triglycerides metabolism in the group under study is 23.96%, 34.83%, and 26.29%, respectively, with no statistically significant differences against the control group. The analysis by type of drug did not show significant differences. CONCLUSIONS: The results obtained show that utilisation of atypical antipsychotics in elderly patients complies with the established general recommendations. The doses used in elderly patients with behavioural alterations associated with dementia, mostly treated with risperidone, do not have a significant impact over prevalence increase of metabolic alterations.

La cadena del frío de los medicamentostermolábiles en el domicilio del paciente / Cold chain for the storage of heat-labile drugs in the home

Objetivo: Valorar, de forma preliminar, las condiciones de conservación de los medicamentos termolábiles dispensados a pacientes externos, con el fin de ampliar el control de la cadena de frío al ámbito domiciliario. Métodos: El Servicio de Farmacia ofrece a los pacientes la posibilidad de validar la capacidad de la correcta conservación domiciliaria de los medicamentos termolábiles que le son dispensados. El procedimiento permite registrar la temperatura de conservación durante el transporte y en el frigorífico del paciente. A tal fin se utilizan tarjetas registradoras VarioSens(R), que se colocan en la parte externa del material de acondicionamiento del medicamento y que son programadas para hacer registros de temperatura cada 10 minutos, si ésta se encuentra fuera del rango 2-8 ºC. Resultados: En ninguno de los casos (n= 36) se mantuvo la temperatura dentro del rango establecido durante todo el periodo registrado. La temperatura media durante el transporte fue de 21,3 ± 7,0 ºC, alcanzándose más de 25 ºC en el 50% de los casos. La temperatura media de las neveras fue de 8,4 ± 3,7 ºC. En 18 casos sus temperaturas medias estaban dentro del intervalo establecido, en 16 por encima de 8 ºC y en 2 casos estuvieron por debajo de 2 ºC. Conclusiones: Los resultados obtenidos indican que hay que desarrollar medidas para mejorar las condiciones de conservación de los medicamentos termolábiles en el domicilio de los pacientes ambulatorios, para poder garantizar la efectividad terapéutica de éstos. Las nuevas tecnologías permiten ampliar el control de la cadena del frío hasta la administración del medicamento (AU)

Objective: A preliminary evaluation of the conditions in which the heat-labile drugs provided to outpatients are stored, in the attempt to extend the control of the cold chain to the home setting. Methods: The Pharmacy Service offers patients the possibility of validating the proper storage of the heat-labile drugs provided to them in their homes. The procedure makes it possible to record the storage temperature during transport and in the patient's refrigerator at home. This is achieved using VarioSens(R) data loggers, placed on the outer surface of the packaging of the medication. These recording cards were programmed to measure the temperature every 10 minutes if it was outside the range of 2 to 8 ºC. Results: In no case (n= 36) was the temperature maintained with in the established range for the entire recording period. The mean temperature during transport was 21.3 ± 7.0 ºC, with temperatures of over 25 ºC in 50% of the cases. The mean temperature of the refrigerators was 8.4 ± 3.7 ºC. In 18 cases, the mean temperatures were within the established range, in16 cases, they were over 8 ºC and in two cases, they were under 2 ºC. Conclusions: The results obtained indicate that measures must be introduced to improve the storage conditions of heat-labile drugs in the homes of outpatients in order to ensure their therapeutic efficacy. New technologies make it possible to control the cold chain until the medication is administered (AU)

Concursos de traslado y apertura: una opción peculiar en la Comunidad Autónoma Canaria / Move procedure of the pharmacies and new establishment in the Canary Island

El presente artículo describe la regulación del peculiar concurso de traslados de oficinas de farmacia en la Comunidad Autónoma de Canarias. Se comenta asimismo el concurso de aperturas, por su conexión con el anterior. Se investigan las razones justificativas de la normativa canaria y, se comparan las alternativas similares de otras comunidades, como el baremo para el concurso de aperturas de la Comunidad Valenciana. Finalmente se enumeran los principales inconvenientes de este sistema

The present paper describes in detail the peculiar move procedure of the chemist shops that takes place in the Canary Island. It can be performed in any place of the Community. The paper also comments the procedure for new establishment installation, as it is clearly related. The reasons justifying the regulation are investigated and some other possibilities used by different autonomic governments are compared, as the merit scale used by the Valenciana Community. The disadvantages of the move procedure are also pointed out

Desabastecimiento y suministro irregular de medicamentos: problemas urgentes / Shortages and irregular supply of medicines: an urgent problem

Actualmente en el Estado español se están produciendo problemas en el suministro de medicamentos a los serviciosfarmacéuticos. En el presente artículo se revisa la normativa vigente acerca de la distribución de medicamentos.Se comentan además las posibles causas del problema. También se analizan los medios que desarrolla el Estadopara evitar esta problemática y la postura de la Comunidad Valenciana que, de manera pionera, quiere regular enmateria de distribución farmacéutica, mediante una normativa con rango de Ley, para evitar los problemas quese suscitan

In this paper, we discuss the problems arising from the current supply problems of medicines to pharmacy outlets inSpain, as well as a revision of present regulations governing their distribution. In addition to the possible causes, ananalysis of the measures developed by the state to combat these problems has been made, as well as an assessment ofthe impact of new pioneering legislation passed by the regional government of Valencia, aimed at finding a solution

El derecho de continuidad en la propiedad de las oficinas de farmacia / Continuity right on the pharmacy community property

En la Ley 16/1997, de 25 de abril, de Regulación de Servicios de las Oficinas de Farmacia, se establece el derecho de transmisión de dichas oficinas a favor únicamente de farmacéuticos. Por otra parte, la normativa define el derecho de continuidad que se erige como la única excepción prevista reglamentariamente a este precepto. Este derecho de continuidad puede contemplar también el concepto de reserva de titularidad que puede considerarse como una especificidad dentro del mismo. Se hace un breve resumen de los orígenes de este precepto y se analiza la situación actual, que presenta una amplia variabilidad debido a las discrepancias de la normativa autonómica en materia de ordenación farmacéutica

Community pharmacies can only be owned by pharmacists, as enforced in the Law 16/1997, 25th April (Regulation of Community Pharmacy Services). Nevertheless, the continuity right allows a unique exception, which can also comprise the titular reservation (a special situation). A concise summary of the origin and development of this rule is presented. The situation in Spain nowadays is characterized as highly variable mainly due to the fact that autonomic governments are responsible for the pharmacy ordinance

Consideraciones acerca de la propiedad de oficinas de farmacia: doble titularidad / Considerations about property of the pharmacy: double titularty

Se revisa la normativa relativa a la propiedadde las farmacias respecto a la disposición deque únicamente puede ostentar la propiedadde una farmacia (Reales Ordenanzas -derogadas-,leyes autonómicas de ordenación farmacéutica).Se alude asimismo a la normativa que contemplalos procedimientos de autorización (Ordende 21 de noviembre de 1979 y Orden de17 de enero de 1980 del Ministerio de Sanidady Seguridad Social) que representaron una garantíadel cumplimiento de este requisito. Secomentan algunas sentencias que ponen demanifiesto la problemática que ha surgido endeterminados momentos

The ruIes applying to the owners of the Spanishpharmacy establishments that restrict thepossibility to one establishment are reviewed.The procedures to obtain an authorization(Order of 21st November 1979 and Order of17th January 1980 from the Social Insuranceand Health Ministry) are also cited as theyconstituted a guarantee of requirement accomplishment.Some sentences considering illegalsituations are commented in order to point outthe importance of the rules

Medicamentos extranjeros en atención primaria / No disponible

La incorporación de la gestión de medicamentos extranjeros a la cartera de servicios de la Farmacia de atención primaria representa una interesante oportunidad para desarrollar nuevas perspectivas profesionales enel entorno de la atención farmacéutica.Objetivo. Analizar la actividad realizada por el servicio de farmacia de atención primaria, respecto a lagestión de medicamentos extranjeros, revisando las posibilidades que ofrece y planteando líneas estratégicaspara la optimización del proceso.Metodología. Se describe el procedimiento de gestión llevado a cabo por el servicio de farmacia de un áreade salud (162.261 habitantes) durante el primer periodo de funcionamiento. Se realiza un análisis DAFO del proceso.Análisis DAFO. Fortalezas: Gran accesibilidad del paciente, simplificación de trámites, existencia de unprocedimiento normalizado de trabajo. Debilidades: Escasez de recursos, falta de experiencia. Oportunidades:Requerimientos de información continua, de coordinación entre niveles, necesidad de atención farmacéuticaal paciente. Amenazas: Escasa relevancia fuera del contexto, dificultad en el mantenimiento de lacalidad.Líneas estratégicas de actuación. 1. Establecimiento de directrices respecto a la atención al paciente,información y seguimiento. 2. Establecimiento de un sistema de coordinación entre los distintos nivelesimplicados. 3. Establecimiento de indicadores y registros de actividad. 4. Adaptación del PNT base. 5. Resolución de los problemas de recursos.Discusión. La atención farmacéutica por parte de los servicios de farmacia de atención primaria puedeofrecer una alta calidad en la atención integral del paciente, dando soporte a sus necesidades (disponibilidadde medicamentos, control, coordinación e información)

The addition of the management of foreign drugs to the range of services of the primary care pharmacy representsan interesting opportunity for the development of new professional prospects in the pharmaceuticalcare setting.Objective. To analyze the activity of the primary care pharmaceutical service with regard to the managementof foreign drugs, examining the opportunities it offers and suggesting strategies for optimizing theprocess.Methods. The authors describe the management procedure carried out by the pharmacy service of a healthcare area (population 162,261) during its initial period of activity. A SWOT approach was employed for theanalysis.SWOT analysis. Strengths: Ready access on the part of the patient, simplification of the process, existenceof a standardized working procedure. Weaknesses: Scarcity of resources, lack of experience. Opportunities:To fulfill the needs for continuous information, coordination among levels of professionals and pharmaceutical care for the patient. Threats: Little relevance when taken out of context, difficulties in maintenance of quality.Strategies for action: 1) The drafting of guidelines concerning patient care, information and follow-up. 2) The establishment of a system of coordination among the different levels involved. 3) The establishment of indicators and records of the activity carried out. 4) Adaptation of the untreated patient base. 5) Solution of the problems of resources.Dicussion. High-quality pharmaceutical care on the part of primary care pharmacy services can be achieved.It involves offering integral care to patients and providing support for their needs (availability of medication, control, coordination and information)

Situación de la atención farmacéutica en los centros sociosanitarios públicos de la Comunidad Valenciana / No disponible

La actual ralentización del crecimiento demográfico junto con el envejecimiento progresivo de la poblaciónimplican la acumulación de problemas de salud a lo largo de la vida, tanto en la incidencia como en la prevalenciade muchas enfermedades, así como en las limitaciones del bienestar psíquico, físico y de la autonomía. Todo esto se traduce en una importante demanda de bienes y servicios que comienza a requerir la población y que se agudizará en los próximos años tanto en atención social como en atención sanitaria. La mejor expectativa es la adaptación para la mejora de la calidad de vida en este sector de la población, en la cual el farmacéutico tiene una participación activa muy importante, ofreciendo soluciones para garantizar el uso racional de los medicamentos e integrándose en un equipo multidisci-plinar en la atención farmacéutica en los centros sociosanitarios o de atención sociosanitaria.La Comunidad Valenciana ha sido la pionera en llevar a cabo un modelo eficaz en este tipo de prestación especiali-zada de atención farmacéutica en centros sociosani-tarios, ya que se han evidenciado numerosas mejoras, entre las que destacan los balances económicos positivos en cuanto a la adquisición de medicamentos y material sanitario, la disminución de errores en la dispensación, la implantación de un sistema de control de calidad, la atención farmacéutica especializada e individualizada que reciben los pacientes y la incorporación de la figura del farmacéutico en un nuevo ámbito de trabajo.La experiencia se inició en la provincia de Valencia, en el año 1990, con un botiquín farmacéutico en la Residencia Mixta de la Tercera Edad de Carlet, desde donde se llevó a cabo un modelo de asistencia farmacéutica que ha conseguido instaurarse en toda la Comunidad Valenciana y actualmente están funcionando cinco servicios de farmacia en los que se encuentra integrada la figura del farmacéutico especialista en farmacia hospitalaria. Debido a la distancia entre los servicios de farmacia y los centros sociosantiarios suministrados por éstos, se establece un depósito de medicamentos en cada centro sociosanitario en función de las necesidades del mismo, en los que se garantiza la disponibilidad de los medicamentos a través del sistema de dosis unitarias, así como la adaptación de los tratamientos a una guía pautada farmacoterapéutica sociosanitaria. Tanto los servicios de farmacia como los depósitos de medicamentos cuentan con los medios personales y materiales necesarios para el adecuado cumplimiento de sus funciones, así como la garantía dedisponibilidad de los medicamentos necesarios para la población asistida en los centros.Durante los últimos años se ha producido un notable incremento en la autorización por parte de la Conselleriade Sanidad de estos depósitos de medicamentos en los centros sociosanitarios y se prevé que vaya en aumento, ya que son la mejor herramienta para el crecimiento y desarrollo de una buena labor asistencialen el ámbito farmacéutico

The present slow growth of the population in addition with the aging of the population implies an accumulationof health problems during life. This is reflected not only on the incidence and prevalence of many illnesses,but also in the limitations of the autonomy and physical and psychological welfare of the people.All this is translated into an important demand of goods and services that the population requires and thatwill be intensified in the years to come as much as in social care as in health care.The best hope for this sector of the population is the adaptation to improve their quality of life, in which pharmacists play an important active role, offering solutions that guarantee the rational use of medicines and, in so doing, being integrated in a multidisciplinary team in the social health-care centres.The Valencian community has had a pioneering role in carrying out an efficient model of specialized pharmaceutical care in health-care centres, as numerous improvements have been shown. The most important ofthese are maintaining positive economic balances related to the acquisition of medicines and health material,the decrease of dispensing errors, the establishment of a quality control system, a specialized and individualized pharmaceutical care received by patients and the incorporation of the pharmacist in a new workingenvironment.The experience was initiated in 1990 in the province of Valencia with the provision of a first-aid kit at theCarlet’s Mixed Elderly Residence, where a model of pharmaceutical care was carried out. This model has beenestablished within the regions of the Valencian community and, nowadays, five pharmacy departments arefunctioning, in which the hospital pharmacy specialist is integrated.Due to the distance between the departments of pharmacy and the health-care centres that they supply, a medicinesstore is created in each health-care centre depending on their requirements. The availability of the medicines is guaranteed by a system of single doses as well as by adjusting the treatments according to a pharmaceuticalformulary. Both, the departments of pharmacy and the medicines stores, include enough staff and resources in order to carry out their functions appropriately and to guarantee the availability of the medicinesrequired by the patients assisted in the centres.During recent years there has been an important increase in the creation of these medicines stores in thehealth-care centres by the «Conselleria de Sanidad». It is thought this rate is going to increase, as these medicines stores are the best tool for the growth and development of a good welfare work in the pharmaceutical environment (AU)

Formulación magistral: arte y calidad / Magistral formulation: art and quality

El artículo revisa la definición de formulación magistral y enuncia la normativa que le es de aplicación. Resume su actual función en relación al pasado. Comenta la oportunidad que genera la normativa, centrada en la mejora del servicio que oferta. También analiza la amenaza que puede derivarse para la profesión de la génesis de categorías entre las oficinas y de un coste social y económico muy elevado en relación al volumen de la formulación sobre la dispensación total (AU)

Tribunal Constitucional: transmisibilidad vs concesiones. Más vale tarde que nunca / Constitutional Court: transmission vs concession. Better late than never

No disponible

[Community health pharmacists' situation in the framework of the Spanish State. Analysis of their functions and competence in the matter of food hygiene in the Community of Valencia]. / Situación de los farmacéuticos titulares en el ámbito del Estado Español. Análisis de sus funciones y competencias en materia de Higiene del los Alimentos en la Comunidad Valenciana.

BACKGROUND: We intend to show the Community Health pharmacists's situation in the different Autonomous Communities of the State, independently from their health. With regard to the Community of Valencia, we propose to integrate the Community Health pharmacists in the health structures of Health Areas, so that they can better fulfil their duties: specially Food Hygiene. METHODS: The information provided by the Health Services of each Autonomous Community has been used. Data from the Community of Valencia come from the Public Health General Direction and from Valencia Health Service of Generalidad Valenciana. Official criteria of periodical inspection in order to study needs have been put into practice. Data process has been computerized. RESULTS: Two kinds of Autonomous Communities have been identified depending on wether they have carried out or not the reorganization and/or the reassignment of duties of Community Health pharmacists. The distribution of Community Health pharmacists in the Autonomous Community of Valencia is shown in its health map, as well as the needs of surveillance for industries and food establishments within a pharmaceutic scope. CONCLUSIONS: The necessity of adapting the figure of the Community Health pharmacist to the Health General Law appears evident, particularly to health structures in the Areas; as well as the convenience of not making the chemist's shop possession compatible with the rest of duties assigned to this pharmacist's Body.