The importance of COVID-19 vaccination during lactation.

The World Health Organization strongly supports breastfeeding as the main source of infant feeding to ensure maternal and child health. Since its emergence, COVID-19 has become a disease affecting the health of the world's population, and vaccines have been developed to prevent it. However, the decision to license COVID-19 vaccines for infants under 6 months of age has been delayed. Different studies have shown that during the breastfeeding period, the benefit-risk balance is much higher in favor of the benefit, at the immunological level for the infant, due to its low perception of adverse effects and the low transmission of products such as mRNA from the mother to the child. Different organizations and societies recommend vaccination in breastfeeding women. COVID-19 vaccines have been shown to be safe and effective.

Uso de Anticonceptivos Orales y Percepción del Papel del Farmacéutico Comunitario entre Adolescentes: un estudio observacional / Oral Contraceptive Use and Perception of the Role of the Community Pharmacist among Adolescents: an observational study

Introducción: Los embarazos no deseados en adolescentes tienen graves consecuencias tanto para las propias adolescentes y sus bebés como para el uso de los recursos del sistema sanitario. Una de las razones es el escaso uso de píldoras anticonceptivas orales (ACO) entre esta población, debido principalmente a la falta de información o a la no adherencia a los medicamentos. El objetivo de este estudio fue describir la información que reciben las adolescentes sobre los ACO y su uso, así como su percepción del papel del farmacéutico comunitario en este campo. Método: Se realizó un estudio observacional transversal mediante encuesta, aplicada a mujeres entre 12-19 años residentes en España, independientemente de si habían utilizado o no ACO, durante abril de 2021. Para la difusión de esta encuesta se utilizaron diferentes redes sociales. Asimismo, se contactó con diferentes asociaciones españolas dedicadas a la orientación de la planificación familiar y la salud sexual en adolescentes. Resultados: El 81,7% (n=76) de los encuestados no había tomado ACO, aunque el 35,5% (n=33) sí había mantenido relaciones sexuales. El 6% (n=1) que tomaba o había tomado ACO informó que eran adherentes. El 88% (n=82) pensaba que el farmacéutico tiene conocimientos sobre medicamentos; sin embargo, sólo el 19,4% (n=18) les consultaría para resolver dudas sobre ACO. Conclusiones: Para resolver los problemas de falta de información sobre ACO y de adherencia en mujeres adolescentes, el farmacéutico comunitario es un profesional accesible que puede contribuir a ello adoptando una actitud activa y utilizando diferentes formas de material educativo. (AU)

Introduction: Unintended pregnancies in adolescents have serious consequences both for the adolescents themselves and their babies and for the use of health system resources. One of the reasons is the low use of oral contraceptive pills (OCPs) among this population, mainly due to lack of information or non-adherence to the medication. The aim of this study was to describe the information adolescents receive about OCPs and their use, as well as their perception of the role of the community pharmacist in this field. Method: A cross-sectional observational study was carried out by means of a survey applied to women aged 12-19 years living in Spain, regardless of whether or not they had used OCPs, during April 2021. Different social networks were used to disseminate the survey. Different Spanish associations dedicated to family planning and adolescent sexual health counselling were also contacted. Results: 81.7% (n=76) of respondents had not taken OCPs, although 35.5% (n=33) had had sex. The 6% (n=1) who were taking or had taken OCPs reported adherence. 88% (n=82) thought that the pharmacist is knowledgeable about medicines; however, only 19.4% (n=18) would consult them for OCP questions. Conclusions: To solve the problems of lack of information about OCPs and adherence in adolescent women, the community pharmacist is an accessible professional who can contribute to this by taking an active role and using different forms of educational materials. (AU)

Protocolo de autocuidado para pacientes con psoriasis desde la farmacia comunitaria / Self-care protocol for patients with psoriasis from community pharmacy

Introducción: Debido a la baja calidad de vida y ad-herencia al tratamiento de los pacientes con psoria-sis se plantea desarrollar un protocolo de empode-ramiento que conduzca a un mayor conocimiento del autocuidado en pacientes con esta patología, acorde a sus necesidades, siendo importante el papel del farmacéutico para la mejora de ambos. Método: Se administró el test Morisky Green-4 items y el cuestionario Dermatology Life Quality Index a 40 pacientes con psoriasis que acudían a una farmacia comunitaria. Con estos datos, la información de las guías clínicas y la colaboración con un dermatólogo, se diseñó un protocolo de autocuidado.Resultados: Se observó falta de adherencia en el 100% de los pacientes y una calidad de vida leve/moderada (5,3±4,2), en las preguntas relacionadas con: los síntomas cutáneos afectan mucho/muy al 50% de los pacientes y la sensación de vergüenza y dificultad con su tratamiento entre poco y mucho en el 60%. Con estos resultados se diseñaron dos dípticos. A los 3 meses la calidad de vida mejoró a 3,98±2,05, p=0,048, y se observó falta de adheren-cia en el 70% de los pacientes.Conclusiones: Los protocolos de autocuidado son necesarios para mejorar la calidad de vida de los pacientes crónicos. El papel del farmacéutico es importante a través de un protocolo de autocuida-do en pacientes con psoriasis, ayudando a mejorar la adherencia al tratamiento y la calidad de vida. (AU)

Introduction: Due to the low quality of life and adherence to treatment of patients with psoriasis, it is proposed to develop an empowerment protocol that leads to greater knowledge of self-care in pa-tients with this pathology, according to their needs, with the role of the pharmacist being important for the improvement of both.Method: The Morisky Green-4 items test and the Dermatology Life Quality Index questionnaire were administered to 40 patients with psoriasis who attended a community pharmacy. With these data, information from clinical guidelines and collabora-tion with a dermatologist, a self-care protocol was designed.Results: Lack of adherence was observed in 100% of the patients and a mild/moderate quality of life (5.3±4.2), in questions related to: skin symptoms af-fect a lot/very much 50% of the patients and feeling of embarrassment and difficulty with their treat-ment between a little and a lot in 60%. With these results, two diptychs were designed. Three months later, the quality of life improved to 3.98±2.05, p=0.048, and non-adherence was observed in 70% of the patients.Conclusions: Self-care protocols are necessary to improve quality of life of chronic patients. The role of the pharmacist is important through a self-care protocol in patients with psoriasis, helping to im-prove adherence to treatment and quality of life. (AU)

Polymorphisms in VDR, CYP27B1, CYP2R1, GC and CYP24A1 Genes as Biomarkers of Survival in Non-Small Cell Lung Cancer: A Systematic Review.

The objective of this systematic review was to provide a compilation of all the literature available on the association between single-nucleotide polymorphisms (SNPs) in the genes involved in the metabolic pathway of vitamin D and overall survival (OS) and progression-free survival (PFS) in patients with non-small cell lung cancer (NSCLC). This systematic review was conducted in accordance with the PRISMA guidelines. It included all the literature published up to 1 November 2022 and was carried out in four databases (Medline [PubMed], Scopus, Web of Science, and Embase), using the PICO strategy, with relevant keywords related to the objective. The quality of the studies included was evaluated with an assessment tool derived from the Strengthening the Reporting of Genetic Association Studies (STREGA) statement. Six studies were included in this systematic review. Our findings showed that the BsmI (rs1544410), Cdx-2 (rs11568820), FokI (rs2228570), ApaI (rs7975232), TaqI (rs731236), rs4646536, rs6068816, rs7041, and rs10741657 SNPs in the genes that play a part in vitamin D synthesis (CYP2R1, CYP27B1), transport (GC), and metabolism (CYP24A1), as well as in the vitamin D receptor (VDR), are associated with OS and/or PFS in patients with NSCLC. The SNPs in VDR have been the most extensively analyzed. This systematic review summed up the available evidence concerning the association between 13 SNPs in the main genes involved in the vitamin D metabolic pathway and prognosis in NSCLC. It revealed that SNPs in the VDR, CYP27B1, CYP24A1, GC, and CYP2R1 genes could have an impact on survival in this disease. These findings suggest the identification of prognostic biomarkers in NSCLC patients. However, evidence remains sparse for each of the polymorphisms examined, so these findings should be treated with caution.

Influence of Single-Nucleotide Polymorphisms on Clinical Outcomes of Capecitabine-Based Chemotherapy in Colorectal Cancer Patients: A Systematic Review.

The aim of this systematic review was to provide a comprehensive overview of the literature published in the last decade on the association of single-nucleotide polymorphisms in genes involved in the pharmacodynamic and pharmacokinetic pathways of capecitabine with treatment outcomes among colorectal cancer patients. A systematic search of the literature published in the last 10 years was carried out in two databases (Medline and Scopus) using keywords related to the objective. Quality assessment of the studies included was performed using an assessment tool derived from the Strengthening the Reporting of Genetic Association (STREGA) statement. Thirteen studies were included in this systematic review. Genes involved in bioactivation, metabolism, transport, mechanism of action of capecitabine, DNA repair, and folate cycle were associated with toxicity. Meanwhile, genes related to DNA repair were associated with therapy effectiveness. This systematic review reveals that several SNPs other than the four DPYD variants that are screened in clinical practice could have an impact on treatment outcomes. These findings suggest the identification of future predictive biomarkers of effectiveness and toxicity in colorectal cancer patients treated with capecitabine. However, the evidence is sparse and requires further validation.

[Analysis of the legal framework on food supplements for menopause in Spanish community pharmacies]. / Análisis del marco legal sobre complementos alimenticios para la menopausia en farmacias comunitarias españolas.

OBJECTIVE: To analyze the legal framework for the marketing of specific food supplements prescribed and indicated for menopause symptoms, so that it is verified if according to the effects on health that they produce, should be considered in the category of food supplements, or in others included in our legal system. METHOD: An exhaustive review of the legal frameworks applicable to food supplements used both in Spain and in Europe, collecting those aspects that are related to legal concepts such as the definition of medicine for human use, medicine based on medicinal plants, or the so-called "frontier products". RESULTS: There is a large number of products that can be called "frontier products", they can fit into different product categories, they can fit into different product categories, since some of the plants in their formulation are also authorized for use as industrial medicines or medicines based on traditional medicinal plants. CONCLUSIONS: There are currently specific food supplements for menopause that raise reasonable doubts about their inclusion in other legal categories, both as medicines for human use, or as herbal medicines, so the legislator would need to enable more agile mechanisms and more frequent reviews of the new certainties that science finds, and that can change the status of these products.

Análisis del marco legal sobre complementos alimenticios para la menopausia en farmacias comunitarias españolas / Analysis of the legal framework on food supplements for menopause in Spanish community pharmacies

Objetivo: Realizar un análisis sobre el marco legal de los complementos alimenticios prescritos e indicados para la sintomatología de la menopausia, verificando si de acuerdo con los efectos sobre la salud que producen deben ser considerados como complementos alimenticios o bien en otras categorías recogidas en el ordenamiento jurídico español. Método: Se realiza una revisión de los marcos jurídicos aplicables a los complementos alimenticios utilizados en España y Europa, recogiendo aquellos aspectos que resulten aplicables o relevantes para los utilizados durante la menopausia, y la relación que guarden con conceptos jurídicos como la definición de medicamento de uso humano, medicamento a base de plantas medicinales o los denominados «productos frontera». Resultados: Existe una gran cantidad de productos que pueden ser considerados «productos frontera» y pueden encajar en categorías de productos diferentes, ya que algunas de las plantas en su formulación también se encuentran autorizadas para su uso como medicamentos industriales o medicamentos de plantas medicinales tradicionales. Conclusiones: Existen complementos alimenticios para la menopausia que suscitan dudas razonables sobre su inclusión en otras categorías legales, tanto como medicamentos de uso humano o como medicamentos a base de plantas, por lo que el legislador necesitaría habilitar mecanismos más agiles y revisiones más frecuentes de las nuevas certezas que la ciencia encuentre, y que pueda cambiar la consideración de estos productos. (AU)

Objective: To analyze the legal framework for the marketing of specific food supplements prescribed and indicated for menopause symptoms, so that it is verified if according to the effects on health that they produce, should be considered in the category of food supplements, or in others included in our legal system. Method: An exhaustive review of the legal frameworks applicable to food supplements used both in Spain and in Europe, collecting those aspects that are related to legal concepts such as the definition of medicine for human use, medicine based on medicinal plants, or the so-called “frontier products”. Results: There is a large number of products that can be called “frontier products”, they can fit into different product categories, they can fit into different product categories, since some of the plants in their formulation are also authorized for use as industrial medicines or medicines based on traditional medicinal plants. Conclusions: There are currently specific food supplements for menopause that raise reasonable doubts about their inclusion in other legal categories, both as medicines for human use, or as herbal medicines, so the legislator would need to enable more agile mechanisms and more frequent reviews of the new certainties that science finds, and that can change the status of these products. (AU)

Un nuevo camino en la Atención Farmacéutica: la idoneidad de la Evaluación Clínica Objetiva Estructurada / A new path in Pharmaceutical Care: the fitness of Objective Structured Clinical Evaluation

Introducción: la Evaluación Clínica Objetiva Estructurada (ECOE) es una de las herramientas más novedosas y con mejores resultados en la evaluación de competencias clínicas. Su uso en Farmacia constituye una oportunidad para innovar y mejorar el proceso de enseñanza-aprendizaje. Método: el proceso de implementación se estructuró en dos etapas: 1) Fase de preparación, que incluyó el diseño teórico de la prueba ECOE con tres componentes clave (Comité Organizador, Mapa de Competencias y Tabla de Especificaciones y Selección de Casos y Diseño de Estaciones) y la planificación práctica con el montaje de la prueba; 2) Fase de ejecución y evaluación de resultados. Resultados: el estudio piloto se desarrolló en la Facultad de Farmacia de la Universidad de Granada, España en el curso 2018-2019, y participaron 33 estudiantes de AF de Grado y 14 estudiantes de Máster en AF. Se evaluaron cinco competencias: Clínica, Técnica, Servicios Farmacéuticos Asistenciales, Comunicación y Actividades Educativas, distribuidas en cinco estaciones, tres de paciente simulado estandarizado y dos estaciones escritas. Se identificaron los recursos materiales, humanos y económicos necesarios, se elaboraron los documentos de cada estación y se seleccionaron y entrenaron los participantes. Conclusiones: la prueba ECOE es una herramienta útil e idónea para evaluar las competencias específicas de Atención Farmacéutica. El procedimiento descrito y los elementos clave identificados facilitan la implantación de este tipo de pruebas innovadoras en Farmacia. (AU)

Introduction: Objective Structured Clinical Evaluation (OSCE) is a novel and best-performing tool in the evaluation of clinical competencies. Its use in Pharmacy represents an opportunity to innovate and improve the teaching-learning process. Method: The implementation process was structured in two stages: 1) Preparation phase, which included the theoretical design and practical planning of the OSCE test with three key components (Organizing Committee, Map of Competencies and Table of Specifications and Selection of Cases and Design of Stations) and the practical planning with the assembly of the test; 2) Phase of execution and evaluation of results. Results: The pilot study was carried out at the School of Pharmacy (University of Granada, Spain) in the 2018-2019 academic year, and 33 undergraduate students and 14 Master students participated. Five competencies were evaluated: Clinical, Technical, Pharmaceutical Services, Communication and Educational activities, delivered in five stations, three with simulated standardized patients and two written stations. Material, human and economic resources were identified. The necessary material, human and economic resources were identified, the documents for each station were prepared and the participants were selected and trained. Conclusions: OSCE is a suitable and great tool for evaluating the specific competencies of Pharmaceutical Care. The procedure and key elements identified facilitate the implementation of this type of innovative tests in Pharmacy. (AU)

Intervention model for detection, prevention and control of COVID-19 in community pharmacy

Abstract The announcement by the WHO of the characterization of the new Coronavirus 2019 disease (COVID-19) as a pandemic, entails an adaptation by the community pharmacy in carrying out its care activity in general, with particular emphasis on "Minor Ailments Service" in particular. The measures taken by the different health administrations in which patient telephone care by primary care offices is prioritized have left more consultations on symptoms in the community pharmacist health-related problems as pharmacies are the closest health facilities to the patient. The similarity between the symptomatology caused by the new Coronavirus with that of some Enteroviruses that cause mild respiratory and gastrointestinal tables (dry cough, fever, sore throat, vomiting, diarrhoea, etc.) makes community pharmacies highly capable places for contagion detection and prevention. A model of protocolized intervention is needed to facilitate the pharmacist's work in discriminating during the indication between minor symptoms and symptoms of referral for possible cases of COVID-19 so that in conjunction with the rest of the staff we help control the disease and make better use of primary care consultations.

Adaptation of practical classes of clinical subjects in the COVID-19 era

Abstract Pharmaceutical Care is a subject within the Pharmacy Degree that is taught using theoretical and practical classes. When COVID-19 appeared, Faculty of Pharmacy had to change its way of teaching and learning to online classes. Our aim is to assess the impact of COVID-19 situation on practical classes in Pharmaceutical Care. A prospective study was performed by undergraduate students from Pharmaceutical Care subject. Students attended to 2-day practical classes and were assessed through an evaluative workbook. Undergraduate students (n=390) obtained a score of 8.4±0.8 in practical classes, being higher in face-to-face sessions than online sessions, but not significant differences among both methodologies. The higher score was for the session of minor ailment services (9.3±1.3) and the lower for Personalized Medication Dosage (7.0±1.6) and similar in both scenarios. 59% of students obtained more than 8 score in the global punctuation, being higher in in-face-to-face practical classes. This study showed that learning in health care can be guided and evaluated through an online method. Adapt to new technologies, prevent vulnerable students from being left behind, as well as working on cross-cutting skills at a distance, are some of the challenges of higher education in times of COVID-19.

Situación legal de la atención farmacéutica en residencias de ancianos en España / Legal Situation of Pharmaceutical Care in Nursing Homes in Spain

ntroducción: La mayor esperanza de vida está pro-duciendo un aumento de la población de personas mayores de 65 años. Este grupo de población se caracteriza por un elevado consumo de medica-mentos y de asistencia sanitaria, permaneciendo muchos de ellos en centros residenciales donde son cubiertas todas sus necesidades. El perfil farmacoterapéutico de estos pacientes suele ser complejo debido a la polimedicación y a las pato-logías crónicas que padecen. Es aquí donde entra en juego el papel del farmacéutico a través de servicios asistenciales. El objetivo de esta revisión es analizar la situación legal, a través del estudio de la normativa específica española que regula la atención farmacéutica en centros sociosanitarios.Método: Revisión de la situación legal de la aten-ción farmacéutica en centros sociosanitarios en EspañaResultados: En España, el marco legal básico se encuentra en el Real Decreto Ley 16/2012 que esta-blece la obligación de tener un servicio de farmacia para los centros sociosanitarios que tengan cien o más camas en régimen de asistidos, mientras que aquellos con menos camas tendrán que tener-lo vinculado a un hospital o a una farmacia. Sin embargo, cada Comunidad Autónoma establece un régimen propio de funcionamiento, a través de su normativa específica.Conclusiones: Existen diferencias en la regulación de los centros sociosanitarios en cuanto a presta-ciones, funciones y servicios farmacéuticos corres-pondiente a cada Comunidad Autónoma (AU)

Introduction: Longer life expectancy is producing an increase among the population of people over the age of 65. This population group is charac-terized by a high consumption of medicines and healthcare, living many of them in residential facili-ties where all their needs are covered.The pharmacotherapeutic profile of these patients is usually complex due to their polymedication and the chronic pathologies they suffer. Here is where the role of the pharmacist comes into play with healthcare services. The aim of this review is to analyze the legal situation by studying the specific Spanish regulations that rule the pharmaceutical care in social and health care centers.Method: Review of the legal situation of pharma-ceutical care in social-health centers in Spain.Results: In Spain, the basic legal framework is found in Royal Decree Law 16/2012, which estab-lishes the obligation to have a pharmacy service for social care centers with one hundred beds or more in assisted care, while those with fewer beds must be linked to a hospital or pharmacy. However, each Autonomous Community establishes its own oper-ating regime through its specific regulations.Conclusions: There are differences in the regula-tion of social and healthcare centers in terms of benefits, functions and pharmaceutical services corresponding to each Autonomous Community (AU)

Cost-Utility Analysis of a Medication Adherence Management Service Alongside a Cluster Randomized Control Trial in Community Pharmacy.

BACKGROUND: It is necessary to determine the cost utility of adherence interventions in chronic diseases due to humanistic and economic burden of non-adherence. PURPOSE: To evaluate, alongside a cluster-randomized controlled trial, the cost-utility of a pharmacist-led medication adherence management service (MAMS) compared with usual care in community pharmacies. MATERIALS AND METHODS: The trial was conducted over six months. Patients with treatments for hypertension, asthma or chronic obstructive pulmonary disease (COPD) were included. Patients in the intervention group (IG) received a MAMS based on a brief complex intervention, whilst patients in the control group (CG) received usual care. The cost-utility analysis adopted a health system perspective. Costs related to medications, healthcare resources and adherence intervention were included. The effectiveness was estimated as quality-adjusted life years (QALYs), using a multiple imputation missing data model. The incremental cost-utility ratio (ICUR) was calculated on the total sample of patients. RESULTS: A total of 1186 patients were enrolled (IG: 633; CG: 553). The total intervention cost was estimated to be €27.33 ± 0.43 per patient for six months. There was no statistically significant difference in total cost of medications and healthcare resources per patient between IG and CG. The values of EQ-5D-5L at 6 months were significantly higher in the IG [IG: 0.881 ± 0.005 vs CG: 0.833 ± 0.006; p = 0.000]. In the base case, the service was more expensive and more effective than usual care, resulting in an ICUR of €1,494.82/QALY. In the complete case, the service resulted in an ICUR of €2,086.30/QALY, positioned between the north-east and south-east quadrants of the cost-utility plane. Using a threshold value of €20,000/QALY gained, there is a 99% probability that the intervention is cost-effective. CONCLUSION: The medication adherence management service resulted in an improvement in the quality of life of the population with chronic disease, with similar costs compared to usual care. The service is cost-effective.