Encuesta Nacional de la SEFH-2019: características generales, recursos humanos, materiales y sistemas de información en los Servicios de Farmacia Hospitalaria en España / SEFH National Survey-2019: general characteristics, staffing, material resources and information systems in Spain's hospital pharmacy departments

OBJETIVO: Dar a conocer los resultados referentes a características generales, recursos humanos, materiales y sistemas de información de la encuesta nacional de la Sociedad Española de Farmacia Hospitalaria (SEFH) 2019 sobre la situación de los Servicios de Farmacia Hospitalaria españoles. MÉTODO: Se envió un cuestionario on line a los responsables de los 368 Servicios de Farmacia Hospitalaria españoles registrados en el directorio de socios de la SEFH. El cuestionario incluía 77 preguntas agrupadas en ocho dimensiones. La información se recogió entre marzo y septiembre de 2019. RESULTADOS: La tasa global de respuesta fue del 54,3%. El 69% de los hospitales eran de titularidad pública y el tamaño más representado de 101-250 camas. El 9% permanecía abierto durante las 24 horas y el 57,5% no disponía de ninguna modalidad de atención continuada. La dispensación a pacientes externos durante la tarde se realizaba en el 41,9% de los centros. El 52,7% de los Servicios de Farmacia estaban acreditados por una norma de calidad. La media de farmacéuticos especialistas por Servicio de Farmacia fue 5,34 (desviación estándar [DE]: 6,22). El 47% de los farmacéuticos trabajaban al menos media jornada en las unidades clínicas. En cuanto a los sistemas automatizados rotativos de almacenamiento y dispensación, de media los Servicios de Farmacia disponían de 0,3 (DE: 0,7) y 0,9 (DE: 1,4) según fueran de tipo horizontal o vertical, respectivamente. El 16,1% de las camas hospitalarias estaban asistidas por sistemas automatizados de dispensación, llegando al 33,5% en hospitales con > 1.000 camas. El 3% de los Servicios de Farmacia Hospitalaria disponía de un sistema robotizado para la preparación de quimioterapia y el 24,8% de un sistema de trazabilidad y seguridad. Las bombas de infusión inteligentes se utilizaban en el 21,4% de los centros. La prescripción electrónica estaba implantada en el 98,8% de los hospitales para pacientes ingresados y en el 62% para pacientes ambulantes. CONCLUSIONES: En los Servicios de Farmacia Hospitalaria españoles existe una infradotación de farmacéuticos especialistas, a pesar de haberse duplicado su incorporación a las unidades clínicas. Destaca un crecimiento en la automatización de las actividades logísticas de dispensación, pero existe un importante margen de mejora en sistemas robotizados y de trazabilidad de las preparaciones. Conocer estos resultados puede resultar de gran utilidad para establecer planes de actuación

OBJECTIVE: To publicize the results regarding the general characteristics, human resources, materials and information systems of Spanish hospital pharmacy departments arising from SEFH's 2019 Survey on the Situation of Spanish Hospital Pharmacy Departments. METHOD: An online questionnaire was sent to the heads of the 368 hospital pharmacy departments affiliated to SEFH. The questionnaire included 77 questions grouped into 8 dimensions. The information was collected between March and September 2019. RESULTS: The overall response rate was 54.3%. Sixty-nine percent of hospitals were public and the most commonly reported hospital size was 101-250 beds. Nine percent of responding hospitals remained open round the clock and 57.5% did not offer a continued care service. A total of 41.9% of hospitals dispensed medications to outpatients in the afternoon and 52.7% of hospital pharmacy departments were accredited to some quality standard. The mean number of specialist pharmacists per pharmacy Department was 5.34 (SD: 6.22); 47% of pharmacists spent at least half their working day in a clinical unit. Hospital pharmacy departments had a mean of 0.3 (SD: 0.7) or 0:9 (SD: 1.4) automated storage and dispensing carousels, depending on whether they were horizontal or vertical, respectively. A total of 16.1% of beds were assisted by automated dispensing systems, a figure that reached 33.5% in hospitals with more than 1,000 beds. Three percent of hospital pharmacy departments had a robotized system for compounding chemotherapy medications and 24.8% had a traceability and safety system. Smart infusion pumps were used by 21.4% of hospitals. Electronic prescriptions were implemented in 98.8% of hospitals for inpatients and in 62% for outpatients. CONCLUSIONS: Spanish hospital pharmacy departments face a shortage of specialist pharmacists, although incorporation of such professionals to clinical units has doubled in the last few years. There has been an increase in the level of automation of the logistic processes involved in medication dispensing, but there is still significant room for improvement in the area of robotized dispensing and compounding traceability systems. This data could play an invaluable role in the design of future action plans

Pharmacists' practices for non-prescribed antibiotic dispensing in Mozambique

BACKGROUND: Antibiotics are the most frequently used medicines worldwide with most of the countries defining these as prescription-only medicines. Though, dispensing non-prescribed antibiotics represent one of the chief causal factors to the irrational use of antibiotics that paves the way to the development of antimicrobial resistance. OBJECTIVE: We aimed at describing the practices and the enablers for non-prescribed antibiotic dispensing in Maputo city, Mozambique. METHODS: A qualitative study was conducted, between October 2018 and March 2019, in nine private pharmacies randomly selected across Maputo city. Eighteen pharmacists were contacted and seventeen enrolled through snowball sampling. In-depth interviews were conducted, audiotaped, and transcribed verbatim. Transcripts were coded and analysed though thematic analysis with guidelines from Braun and Clark. The Consolidated Criteria for Reporting Qualitative Studies (COREQ) checklist by (Tong, 2007) was performed. RESULTS: Out of seventeen, fifteen pharmacists admitted non-prescribed dispensing of antibiotics. Common antibiotic dispensing practices included; dispensing without prescription, without asking for a brief clinical history of patients, without clear explanation of the appropriate way of administering, without advising on the side effects. Reasons for non-prescribed antibiotic dispensing are linked to patients' behaviour of demanding for non-prescribed antibiotics, to the patients expectations and beliefs on the healing power of antibiotics, to the physicians' prescribing practices. Other reasons included the pressure for profits from the pharmacy owners, the fragile law enforcement, and absence of accountability mechanisms. CONCLUSIONS: The practices of non-prescribed antibiotic dispensing characterize the 'daily life' of the pharmacists. On the one hand, the patient's demand for antibiotics without valid prescriptions, and pharmacist's wish to assist based on their role in the pharmacy, the pressure for profits and on the understanding of the larger forces driving the practices of self-medication with antibiotics - rock. On the other hand, pharmacists are aware of the legal status of antibiotics and the public health consequences of their inappropriate dispensing practices and their professional and ethical responsibility for upholding the law - hard place. Highlighting the role of pharmacists and their skills as health promotion professionals is needed to optimizing antibiotic dispensing and better conservancy in Mozambique

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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

Non-prescription dispensing of emergency oral contraceptives: recommendations from the German Federal Chamber of Pharmacists [Bundesapothekerkammer]

Background: Emergency hormonal contraceptives (EHC) are contraceptives used to prevent unintended pregnancy following unprotected sexual intercourse (USI) or contraceptive failure. The EHCs available without a prescription include medicines containing levonorgestrel (LNG) in more than 80 countries and, recently, based on an EU-switch ellaOne®, which contains ulipristal acetate (UPA). EHCs work by stopping or delaying ovulation. Those containing LNG can be used up to 72 hours after USI or contraceptive failure, while UPA can be used up to 120 hours. In the context of the UPA implementation process, Germany switched LNG to non-prescription status as well. Objectives: To develop recommendations, a protocol, and a continuing education program for pharmacists to assure quality when giving advice and dispensing EHCs in community pharmacies without a medical prescription. Methods: The recommendations were developed by an iterative process of drafting, recognizing, and discussing comments and proposals for amendments as well a seeking agreement with a number of stakeholders such as the Federal Ministry of Health (BMG), Federal Institute for Drugs and Medical Devices (BfArM), Federal Chamber of Physicians (BÄK), Drug Commission of German Physicians (AkdÄ), professional organizations/associations of gynaecologists, pharmaceutical OTC-industry as well as government-controlled, private, and church-based organizations and centres providing advice on sex education and family planning. Results: The recommendations were eventually endorsed by the BMG in consultation with the BfArM. Conclusions: The recommendations were made public, published in the professional journal and used in an uncounted number of continuing education programs based on the curriculum and provided by the State Chambers of Pharmacists (AU)

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Medicamentos como posible factor asociado a la infertilidad masculina / Medicines as a possible factor associated with male infertility

Revisión sistemática de las fichas técnicas (apartados 4.6 y 5.3) de los medicamentos más consumidos en España, según el Sistema Nacional de Salud, y revisión bibliográfica a través de PubMed, según un patrón de búsqueda estándar, con respecto a la influencia de éstos sobre la fertilidad masculina. Como resultado a esto nos encontramos con que de 29 principios activos estudiados, 15 no presentan datos referentes a la fertilidad masculina en su ficha técnica, para 18 no se recuperó información al respecto en la búsqueda en PubMed y 9 no disponen de material de información que provenga de ninguna de las dos fuentes de las que utilizamos. En 3 medicamentos los resultados de las dos fuentes coinciden y en 2 encontramos discrepancias. En 13 de los 29 fármacos estudiados se ha encontrado información de efectos adversos sobre la fertilidad masculina en alguna de las 2 fuentes de información revisadas. Se demuestra con esto una falta de información clara, concisa y contrastada (AU)

Systematic review of the technical specifications (4.6 and 5.3 paragraph) of the most frequently used drugs in Spain, from NHS, and the information provided by PubMed according to a standard search pattern with respect to their influence on male fertility. As a result of this we find that 15 of 29 active substances studied have no data about male fertility in their technical data sheets, 18 of this 29 have no data about male fertility from PubMed and 9 don’t have any information coming from either source we used. 3 medicines have matching results from the two sources and other 2 found discrepancies. In 13 of the 29 drugs studied the information about adverse effects on male fertility was found in one of the two sources of information reviewed. It’s demonstrated that it’s necessary clear, concise and contrasted information (AU)

Farmacogenómica y el Profesional Farmacéutico. Qué es y por qué es importante para la profesión / Pharmacogenomics and the Professional Pharmacist. What it is and Why it is important for the Pharmacist

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Dispensación de benzodiacepinas y análogos en farmacias comunitarias de Valladolid / Dispensation of benzodiazepines and analogues in community pharmacies in Valladolid

Introducción: Las benzodiacepinas (BZD) son fármacos de consumo creciente, que se utilizan muy frecuentemente para los trastornos de ansiedad y del sueño, así como relajantes musculares. Muchos pacientes las usan de forma crónica a pesar de estar desaconsejadas y, en algunas ocasiones, de manera inadecuada, en especial la población anciana. Objetivos: Investigar las principales características de los usuarios, las BZD prescritas, si se tiene conocimiento y se hace un buen uso de ellas, las reacciones adversas, las posibles interacciones farmacológicas con la medicación y otros problemas relacionados con los medicamentos. Material y métodos: Se llevó a cabo un estudio transversal en 2 farmacias comunitarias de Valladolid desde septiembre de 2012 hasta febrero de 2013. Se utilizó un cuestionario cerrado y administrado por el farmacéutico. Se incluyeron todos los pacientes mayores de 16 años que solicitaron BZD prescritas por el médico. Resultados: En total, 104 pacientes consintieron ser entrevistados. La mayor parte utilizaba las BZD más tiempo del aconsejado. El 63,5% de los pacientes experimentó, al menos, una reacción adversa (dependencia, sedación, somnolencia, pérdida de memoria, etc.). El 13,2% de los usuarios mayores de 65 años estaba tomando dosis mayores de las recomendadas en la fi cha técnica, y el 27,7% de éstos utilizaba BZD de vida media larga. Conclusiones: Este estudio muestra un inadecuado uso de las BZD por parte de la población, en especial los ancianos. El farmacéutico comunitario junto con el médico desempeñan un papel clave en la mejora del uso de las BZD por parte de la población (AU)

Background: Benzodiazepines (BZD) are drugs of growing consumption, which are very often used for anxiety disorders, sleep and relaxing muscle. Many patients use them chronically despite being discouraged and sometimes misused, particularly in the elderly population. Aims: To investigate the main characteristics of the users, prescribed BZD, knowledge and if they make good use of them, adverse reactions, possible drug interactions with medication and other drug-related problems. Material and methods: A cross-sectional study in two community pharmacies in Valladolid was conducted during the months of September of 2012 through February of 2013. We used a closed questionnaire administered by the pharmacist. We included all patients older than sixteen years that requested BZD prescribed by the doctor. Results: In total, 104 patients consented to be interviewed. Most of the users took BZD longer than the recommended time. The 63.5% of the patients experienced at least one adverse reaction (dependence, sedation, sleepiness, loss of memory, etc.). The 13.2% of users over the age of 65 was taking doses higher than those recommended in the technical sheet and 27.7% of these used long half-life BZD. Conclusions: This study shows the inadequate use of BZD by the population, especially in the elderly population. The community pharmacist and the doctor play a key role in the improvement of the use of BZD by the population (AU)

Evaluación de las necesidades de actualización de conocimientos en materia de fitoterapia de los farmacéuticos de la ciudad de Madrid / Evaluation of the needs of updating knowledge in the field of phytotherapy for the pharmacists from madrid city

El consumo de productos de plantas medicinales, para la prevención y/o tratamiento de diversos problemas de salud, ha experimentado un notable incremento en el estado español, especialmente en las farmacias. Esto es debido entre otros factores a la constatación científica de su eficacia y seguridad y a la labor profesional realizada por parte de los farmacéuticos en la recomendación de estos preparados. En este trabajo se realiza una evaluación de las necesidades de formación de los farmacéuticos en la ciudad de Madrid como base fundamental para realizar una buena dispensación de plantas medicinales, en res- puesta a la demanda de los pacientes. Respecto a estudios anteriores, los resultados obtenidos indican un incremento en la demanda de preparados de plantas medicinales por parte de los pacientes, principalmente mujeres. Asimismo se aprecia una mayor tendencia a elegir la oficina de farmacia como lugar de adquisición, al reconocer la mejor cualificación del farmacéutico en esta materia. No se observa una modificación sustancial en cuanto a la demanda por grupos terapéuticos, si bien la crisis económica parece influir en un incremento de la dispensación de plantas para el tratamiento de la ansiedad. Los farmacéuticos encuestados muestran su interés por ampliar y actualizar los conocimientos en fitoterapia mediante acciones formativas directas y próximas (AU)

The consumption of herbal products for the prevention and / or treatment of various health problems, has seen a remarkable increase in the Spanish state, especially in pharmacies, this is due among other factors to the scientific findings of its effectiveness and safety and the great effort made by pharmacists in the recommendation of these preparations. This paper assesses the training needs of pharmacists in the city of Madrid as the foundation for a good dispensing of medicinal plants, in response to patient demand. The results we get indicate an increase in the demand of natural preparations on the part of patients, ainly women. Also there is a greater tendency to choose the pharmacy as a place to buy it, recognizing that the pharmacist is more qualified in this area. We do not find a substantial change in the demand for treatment groups, but the economic crisis seems to influence in the consume of phytotherapy plant ìs for the treatment of anxiety. The pharmacists of the study show their interest in increase and update their knowledge in herbal drug with compatible courses with their professional life’s (AU)

Seguimiento farmacoterapéutico y dispensación activa: diferencias y similitudes / Drug therapy follow up and active dispensing. Differences and similitudes

La publicación del Consenso sabre Atención Farmacéutica ha aclarado los términos Dispensación Activa, Indicación Farmacéutica y Seguimiento Farmacoterapéutico, describiéndolos como los servicios fundamentales dentro de la Atención Farmacéutica. Al tratar de llevar a la practica las lineas generales que aparecen en ese Consenso, se pueden estar cometiendo errores por falta de desarrollo conceptual, frecuentemente en relación al concepto de problemas relacionados con medicamentos (PRM). El objetivo del presente trabajo es analizar las diferencias existentes entre dos de los tres servicios citados: Seguimiento y Dispensación, basándose en las diferencias existentes entre los conceptos de proceso y resultados del paradigma SPO (structure-precess-outcomes) (AU)

Publishing of the Consensus on Pharmaceutical Care has clarified the terms Active Dispensing, Pharmacist Consultation, and Drug Therapy Follow-up, being described as the fundamental services within that Pharmaceutical Care. On treating to put into practice the general guidelines established on this Consensus, some errors due to the lack of conceptual development, frequently related to the concept of drug-related problems (DRP) may appear. The aim of the present study is to analyze differences existing between two of the three mentioned services: Follow-up and Dispensing, being supported by the differences existing between the concepts of process and outcomes resulting from the SPO (structure-process-outcomes) paradigm (AU)