Prácticas tuteladas y/o estancias de farmacia: ¿penúltima ocasión perdida?

Se pretende hacer, de la manera más objetiva posible, un recorrido histórico de lo que fue y está siendo la asignatura de mayor carga lectiva de los estudios de farmacia en los prácticamente últimos 30 años, con inclusión, en ocasiones, de la opinión personal por haber sido muy directa la experiencia en este tema. De igual manera se pretende recordar también la esencia misma de esta asignatura existente por imperativo de la Unión Europea, así como cuáles fueron también y son sus razones de ser, explicando algunos conceptos que a pesar de ser antiguos aún siguen suscitando cierta polémica. De esta manera superando incluso lo que actualmente es la realidad diversa y variada de esta asignatura a nivel de España, se contempla la propia evolución de las directivas europeas, desde las iniciales del año 1985 hasta las actuales del 2013 y las modificaciones que estas últimas incluyen, que esperamos se tengan en cuenta para su posterior implementación en los cambios de los planes de estudios del graduado en Farmacia que normativamente deben actualizarse tras el proceso de renovación de la acreditación

Trabajo de Fin de Grado en farmacia clínica, atención farmacéutica y farmacia asistencial: ¿consiguen los alumnos integrar los contenidos y las competencias?

Podeu consultar la Vuitena trobada de professorat de Ciències de la Salut completa a: http://hdl.handle.net/2445/66524El Trabajo de Fin de Grado (TFG) consiste en la elaboración, presentación y defensa de un proyecto o estudio que suponga la integración de la formación recibida por el estudiante a lo largo de la titulación. En el Grado en Farmacia, se puede optar por su realización en uno de los 27 ámbitos docentes que han sido establecidos, entre los que se encuentra el de Farmacia Clínica, Atención Farmacéutica y Farmacia Asistencial (FC, AF y FA). En esta comunicación se pretende realizar un análisis sobre los TFG realizados en este ámbito, para establecer diferentes aspectos sobre el objetivo final de integrar los contenidos formativos recibidos y las competencias adquiridas por el estudiante. Se analiza, entre otros aspectos, el lugar donde se ha desarrollado el trabajo, de que tipo ha sido y el nivel alcanzado..

Nuevo máster oficial en medicamentos, salud y sistema sanitario

Podeu consultar la Vuitena trobada de professorat de Ciències de la Salut completa a: http://hdl.handle.net/2445/66524Introducción Diferentes institucionales universitarias internacionales han abogado por avanzar en la armonización de programas formativos interprofesionales y de investigación que faciliten vínculos entre la formación y la práctica profesional. El objetivo es la difusión del nuevo Máster oficial “Medicamentos, Salud y Sistema Sanitario” dentro del sistema universitario de Cataluña, que surge como consecuencia de la demanda de nuestra sociedad y entorno laboral...

Turn back crime: medicamentos ilegales y papel del farmacéutico comunitario

El objetivo del presente trabajo fue describir y analizar la situación en España de los productos de venta ilícita, tanto medicamentos como complementos alimenticios, poniendo en conocimiento las principales acciones realizadas en los últimos meses y su contextualización a nivel mundial. Asimismo, servir de alerta sobre la magnitud del problema y la importancia del papel del farmacéutico comunitario.Se realizó una búsqueda de información tanto a nivel nacional como internacional y se realizó un análisis descriptivo de las Notas Informativas de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) (medicamentos ilegales, uso humano, 2015).Los productos de venta ilícita representan un problema grave para la salud pública que no ha parado de aumentar. En España, en 2015 se publicaron 20 notas donde se prohibió y retiró un total de 35 productos. Dichos productos estaban comercializados como complemento alimenticio y presentaban un principio activo en cantidad suficiente para conferirle legalmente la condición de medicamento. El 86% se dirigía a la disfunción eréctil.Para minimizar este problema, es imprescindible la colaboración internacional, siendo la última y más importante operación PANGEA VIII, en junio del 2015, implicando a 115 países. En enero del 2016 entró en vigor la Convención Medicrime, tratado internacional sobre la falsificación de productos médicos y delitos similares. Por otro lado, también es necesario concienciar a la ciudadanía y dotarla de mecanismos para identificar el riesgo potencial. Los productos adquiridos fuera de los canales legales de distribución no aseguran el cumplimiento de las normas de correcta fabricación, distribución, ni posterior conservación y carecen de la información adecuada

Readability analysis of the package leaflets for biological medicines available on the Internet between 2007 and 2013: an analitycal longitudinal study

Background: The package leaflet included in the packaging of all medicinal products plays an important role in the transmission of medicine-related information to patients. Therefore, in 2009, the European Commission published readability guidelines to try to ensure that the information contained in the package leaflet is understood by patients. Objective: The main objective of this study was to calculate and compare the readability levels and length (number of words) of the package leaflets for biological medicines in 2007, 2010, and 2013. Methods: Thesampleofthisstudyincluded36biologicalmedicinepackageleafletsthatweredownloadedfromtheEuropean Medicines Agency website in three different years: 2007, 2010, and 2013. The readability of the selected package leaflets was obtained using the following readability formulas: SMOG grade, Flesch-Kincaid grade level, and Szigriszt's perspicuity index. The length (number of words) of the package leaflets was also measured. Afterwards, the relationship between these quantitative variables (three readability indexes and length) and categorical (or qualitative) variables were analyzed. The categorical variables were the year when the package leaflet was downloaded, the package leaflet section, type of medicine, year of authorization of biological medicine, and marketing authorization holder. Results: The readability values of all the package leaflets exceeded the sixth-grade reading level, which is the recommended value for health-related written materials. No statistically significant differences were found between the three years of study in the readability indexes, although differences were observed in the case of the length (P=.002), which increased over the study period. When the relationship between readability indexes and length and the other variables was analyzed, statistically significant differences were found between package leaflet sections (P<.001) and between the groups of medicine only with regard to the length over the three studied years (P=.002 in 2007, P=.007 in 2010, P=.009 in 2013). Linear correlation was observed between the readability indexes (SMOG grade and Flesch-Kincaid grade level: r2=.92; SMOG grade and Szigriszt's perspicuity index: r2=.81; Flesch-Kincaid grade level and Szigriszt's perspicuity index: r2=.95), but not between the readability indexes and the length (length and SMOG grade: r2=.05; length and Flesch-Kincaid grade level: r2=.03; length and Szigriszt's perspicuity index: r2=.02). Conclusions: There was no improvement in the readability of the package leaflets studied between 2007 and 2013 despite the European Commission's 2009 guideline on the readability of package leaflets. The results obtained from the different readability formulas coincided from a qualitative point of view. Efforts to improve the readability of package leaflets for biological medicines are required to promote the understandability and accessibility of this online health information by patients and thereby contribute to the appropriate use of medicines and medicine safety

Radiofàrmacs: leucòcits marcats amb radionúclids

L'estratègia de l'exploració consisteix a aprofitar la localització dels leucòcits en el lloc on hi ha el procés inflamatori o infecciós. Amb aquesta característica fisiopatològica, els leucòcits del pacient queden marcats amb un radionúclid emissor de radiació gamma i s'introdueixen de nou al pacient amb la finalitat que s'acumulin al lloc patològic i detectar-los des de l'exterior

Adverse drug events in patients with dementia and neuropsychiatric/behavioral, and psychological symptoms, a one-year prospective study

Older people usually present with adverse drug events (ADEs) with nonspecific symptoms such as cognitive decline, recurrent falls, reduced mobility, and/or major deterioration. The aims of this study were to assess the ADEs of patients with dementia and presenting neuropsychiatric/behavioral, and psychological symptoms in dementia (BPSD) and to categorize and identify the principal factors that allow to prevent ADEs, and separately ADEs that result in falls. To that end, a one-year prospective study in a psychogeriatric ward (July 2015 to July 2016) was performed. All patients admitted to this ward were eligible for enrolment. Patients who met any of the following criteria were excluded from the study: Patients without cognitive impairment, a length of stay under 7 days, and palliative or previous psychiatric pathology. We included 65 patients (60% women, 84.9 years ± 6.7) with mild to moderate cognitive impairment, moderate to severe functional dependence, and a high prevalence of geriatric syndromes and comorbidity. A total of 87.7% were taking five or more drugs (mean 9.0 ± 3.1). ADEs were identified during the interdisciplinary meeting and the follow up by clinical record. Sixty-eight ADEs (81.5% patients) were identified, of which 73.5% were not related to falls. From these, 80% were related to drugs of the nervous system. The Naranjo algorithm determined that 90% of ADEs were probable. The severity of the ADEs was Category E in 34 patients (68%). The number of preventable ADE according to the Schumork⁻Thornton test was 58%. The main ADE was drowsiness/somnolence (27.7%). ADEs related to falls represented a 26.5%. The balance between effective treatment and safety is complex in these patients. A medication review in interdisciplinary teams is an essential component to optimize safety prevention

Readability assessment of package leaflets of biosimilars

Objectives: To assess the degree of readability and the length of the package leaflets of biosimilars. Setting: The package leaflets analysed were downloaded from the European Medicines Agency (EMA) website. Participants The study sample included the package leaflets written in English of all the biosimilars that were authorised by the EMA on 31 August 2017, and whose content was available via the internet on that date (n=35). Design This was a cross-sectional analytical study. The readability of the package leaflets of all biosimilars authorised by the EMA in August 2017 was determined applying the Flesch and Flesch-Kincaid formulas. The influence of the following variables on the readability and length was also analysed: package leaflet section, type of biosimilar, date of first authorisation of the biosimilar and type of medicine. Results: A considerable variation of the package leaflets length was found (3154±803). The readability of all the package leaflets overtook the recommended value for health-related written materials taking into account Flesch-Kincaid Index, and none of the package leaflets were easy to understand according to the Flesch Index. Statistically significant differences (p<0.05) were observed between the sections of package leaflets in readability indices and length. The most difficult sections to understand were those related with the therapeutic indication of medicine and the possible side effects. Conclusions: Package leaflets for authorised biosimilars may not fulfil the function for which they were designed. The competent organisations could be informed about the possible negative effect on the use of this type of medicines

Sex-Divergent Clinical Outcomes and Precision Medicine: An Important New Role for Institutional Review Boards and Research Ethics Committees

The efforts toward individualized medicine have constantly increased in an attempt to improve treatment options. These efforts have led to the development of small molecules which target specific molecular pathways involved in cancer progression. We have reviewed preclinical studies of sunitinib that incorporate sex as a covariate to explore possible sex-based differences in pharmacokinetics and drug-drug interactions (DDI) to attempt a relationship with published clinical outputs. We observed that covariate sex is lacking in most clinical outcome reports and suggest a series of ethic-based proposals to improve research activities and identify relevant different sex outcomes. We propose a deeper integration of preclinical, clinical, and translational research addressing statistical and clinical significance jointly; to embed specific sexdivergent endpoints to evaluate possible gender differences objectively during all stages of research; to pay greater attention to sex-divergent outcomes in polypharmacy scenarios, DDI and bioequivalence studies; the clear reporting of preclinical and clinical findings regarding sex-divergent outcomes; as well as to encourage the active role of scientists and the pharmaceutical industry to foster a new scientific culture through their research programs, practice, and participation in editorial boards and Institutional Ethics Review Boards (IRBs) and Research Ethics Committees (RECs). We establish the IRB/REC as the centerpiece for the implementation of these proposals. We suggest the expansion of its competence to follow up clinical trials to ensure that sex differences are addressed and recognized; to engage in data monitoring committees to improve clinical research cooperation and ethically address those potential clinical outcome differences between male and female patients to analyze their social and clinical implications in research and healthcare policies. Keywords: sunitinib, sex-divergent pharmacokinetics, clinical outcomes, covariate sex, research ethics, IRB, ELS

Effects of the Off-Label Drug Prescription in the Paediatric Population in Spain from the Adoption of the Latest European Regulation: A Pre-Post Study

The year 2021 marks the 15th anniversary of the Paediatric Regulation (1901/2006/EC) in Europe. The main aim of the study was to conduct a pre-post comparison on the annual off-label prescription rates in the under-18 population in Spain and assess the potential influence of the Paediatric Regulation adoption. An observational study in the paediatric population was performed. Four cross-sectional annual periods, one before and the three latest periods after the adoption of the Regulation, were compared. Prescriptions in the primary health care setting were sorted by age group and drug and off-label status were determined. The number of off-label prescriptions issued by paediatricians was over two million per year. Prior to the adoption of the Paediatric Regulation, the off-label prescription rate was estimated at 7% of total prescriptions. Although the increase in the off-label rate over the study periods was mild, it was statistically significant (OR: 1.045; 95% CI: 1.043-1.046; p < 0.05). One of the most vulnerable population groups was neonates and infants up to 1 year, in which the off-label prescription rates showed the highest increase during the post follow-up period, which was statistically significant (OR: 4.270; 95% CI: 4.253-4.287; p < 0.05). The findings can help raise awareness and advocate for the development and authorization of medicines for children in the primary health care setting. Keywords: off-label prescription, paediatrics, paediatric regulation, pharmaceutical products, prescription drugs, primary health car