Factors Contributing to Negative Outcomes Associated with Medications and Drug-Related Problems in Kidney Replacement Therapy-A Hospital-Based Prospective Observational Study.

BACKGROUND: Negative outcomes associated with medications (NOM) and drug-related problems (DRP) significantly impact individuals with kidney replacement therapy (KRT) given the complexities of managing kidney disease and associated comorbidities. The present study aims to assess the frequency of NOMs/DRPs among KRT patients and identify contributing factors. METHODS: A cross-sectional study was conducted at Virgen de las Nieves University Hospital (Granada, Spain), involving 117 outpatient adults with KRT. Data were collected from February 2021 to July 2023 using electronic records, semi-structured interviews (Dáder Method), and discussions with nephrology specialists. NOMs/DRPs were identified following treatment guidelines. Binary logistic regression was used to determine associated factors (p-value < 0.05). RESULTS: Across 117 patients, 2436 NOMs and 3303 DRPs were identified, averaging 20.82 NOMs and 28.23 DRPs per patient. Prevalent NOMs included untreated conditions (58.95%), quantitative ineffectiveness (35.43%), and non-quantitative safety problems (5.13%). Dominant DRPs were undertreated conditions (37.63%), wrong dose/posology/length (33.00%), risk of adverse drug reactions (ADR) (16.14%), and non-adherence (6.87%). Patients with ADR, undertreated conditions, and anemia were associated with quantitative ineffectiveness. Risk of ADR and vitamin D deficiency/insufficiency correlated with non-quantitative safety problems. CONCLUSIONS: KRT patients exhibited a substantial prevalence of NOMs/DRPs. Further research is needed to deepen our understanding of these complexities for improved patient care.

Mapping the concept of health care integration: A lexicographic analysis of scientific literature.

BACKGROUND: Systems fragmentation is a major challenge for an efficient organization, integration being a potential solution also proposed in health care field, including pharmacy as a player. However, the use of different terms and definitions in the literature hinders the comparison of different integration initiatives. OBJECTIVE: To identify and map the terms used in scientific literature regarding integration in health care and to characterize each emerging topic. METHODS: A lexicographic analysis of the integration of healthcare systems literature indexed in PubMed was conducted. Ten different systematic searches, four using only Medical Subject Headings (MeSH) and six using text words, were conducted in March 2023. Journal scattering was analyzed following Bradford's distribution using the Leimkuhler model. An overall text corpus was created with titles and abstracts of all the records retrieved. The corpus was lemmatized, and the most used bigrams were tokenized as single strings. To perform a topic modeling, the lemmatized corpus text was analyzed using IRaMuTeQ, producing descending hierarchic classification and a correspondence analysis. The 50 words with higher chi-square statistics in each class were considered as representative of the class. RESULTS: A total of 42,479 articles published from 1943 to 2023 in 4469 different journals were retrieved. The MeSH "Delivery of Health Care, Integrated", created in the 1996 MeSH update, was the most productive retrieving 33.7 % of the total articles but also retrieving 22.6 % of articles not retrieved in any other search. The text word "Integration" appeared in 15,357 (36.2 %) records. The lexicographic analysis resulted in 7 classes, named as: Evidence and implementation, Quantitative research, Professional education, Qualitative research, Governance and leadership, Clinical research, and Financial resources. Association between the classes and the searches or the text-words used ranged from moderate to weak demonstrating the lack of a standard pattern of use of terms in literature regarding healthcare integration. CONCLUSIONS: The term "integration" and the MeSH "Delivery of Health Care, Integrated" are the most used to represent the concept of integration in healthcare and should be the preferred terms in the literature.

Pharmacological Chemolysis of Uric Acid Lithiasis in A Patient with Crohn’s Disease

Patients with chronic diarrhoea or ileostomies suffer from electrolyte and urinary disorders and are prone to developing uricacid or calcium oxalate stones. Evidence is lacking regarding the management of uric acid stones in patients with inflammatorybowel diseases. We present the case of a male patient with Crohn’s disease and carrying an ileostomy. He was diagnosed with uricacid urolithiasis (stone size of 11 mm located in the left pyeloureteral junction) after presenting to the emergency room during anepisode of left renal colic. Results of the 24-hour urinalysis showed an acidic pH (pH <5), consistent with hyperuricosuria. Thesuspicion of uric acid lithiasis was confirmed after performing an X-ray diffraction analysis of a lithiasic fragment that passedduring acute renal colic. The patient was prescribed with urinary alkalinisers (medical treatment) and dietary recommendations.After 12 months of treatment and urine pH monitoring, the patient achieved complete chemolysis while maintaining the stabilityof his underlying Crohn’s disease. The patient had no complications during follow-up, referring adequate gastrointestinal toleranceto treatment and denying side effects. The patient remains asymptomatic and is being followed-up on an outpatient basis.He continues on prophylactic treatment (Lit-Control® pH Up) to maintain the pH in the non-acidic range. (AU)

Association of Single-Nucleotide Polymorphisms in Capecitabine Bioactivation Pathway with Adjuvant Therapy Safety in Colorectal Cancer Patients.

Capecitabine, an oral prodrug of 5-fluorouracil (5-FU), is part of the standard treatment of colorectal cancer (CRC). Severe adverse dose limiting reactions that impair treatment safety and lead to treatment suspension remain a relevant concern. Single-nucleotide polymorphisms (SNPs) in genes involved in the activation of capecitabine may alter the bioavailability of 5-FU and thereby affect therapy outcomes. The aim of this study was to evaluate the association of these SNPs with severe toxicity and treatment suspension in patients with CRC treated with capecitabine-based therapy. An ambispective cohort study was conducted, including 161 patients with CRC. SNPs were analyzed using real-time PCR with TaqMan® probes. Toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events v.5.0. CES1 rs71647871-A was associated with a severe hand-foot syndrome (p = 0.030; OR = 11.92; 95% CI = 1.46-73.47; GG vs. A). CDA rs1048977-CC (p = 0.030; OR = 2.30; 95% CI 1.09-5.00; T vs. CC) and capecitabine monotherapy (p = 0.003; OR = 3.13; 95% CI 1.49-6.81) were associated with treatment suspension due to toxicity. SNPs CES1 rs71647871 and CDA rs1048977 may act as potential predictive biomarkers of safety in patients with CRC under capecitabine-based adjuvant therapy.

Effect of Pharmaceutical Intervention in Pharmacologically Treated Hypertensive Patients-A Cluster-Randomized Clinical Trial: AFPRES-CLM Study.

BACKGROUND: Evaluate the effect of a community pharmaceutical intervention on the control of blood pressure in hypertensive patients treated pharmacologically. METHODS: A cluster-randomized clinical trial of 6 months was carried out. It was conducted in the Autonomous Community of Castilla-La Mancha (Spain). Sixty-three community pharmacies and 347 patients completed the study. Intervention patients received the community pharmaceutical intervention based on a protocol that addresses the individual needs of each patient related to the control of their blood pressure, which included Health Education, Pharmacotherapy Follow-up and 24 h Ambulatory Blood Pressure Measurement. Control patients received usual care in the community pharmacy. RESULTS: The pharmaceutical intervention resulted in better control of blood pressure (85.8% vs. 66.3% p < 0.001), lower use of emergencies (p = 0.002) and improvement trends in the physical components of quality of life, measured by SF-36 questionnaire, after 6 months of pharmaceutical intervention. No significant changes were observed for any of these variables in the control group. There were also detected 354 negative medication-related outcomes that were satisfactorily resolved in a 74.9% of the cases and 330 healthcare education interventions and 29 Ambulatory Blood Pressure Monitorings were performed in order to increase adherence to pharmacological treatment and minimize Negative Outcomes associated with Medication and prevent medication-related problems. CONCLUSIONS: Community pharmaceutical intervention can increase hypertensive patients with controlled blood pressure, after 6 months, compared with usual care.

Medication Review with Follow-Up for End-Stage Renal Disease: Drug-Related Problems and Negative Outcomes Associated with Medication-A Systematic Review.

BACKGROUND: This article reviews the available scientific literature on drug-related problems and negative outcomes associated with medications identified by medication review with follow-up for end-stage renal disease and discussed with the physicians. METHODS: A systematic review was conducted of the scientific literature retrieved from the following databases: MEDLINE (via PubMed), Web of Science, SCOPUS, Cochrane Library: The Cochrane Central Register and Control Trials (CENTRAL) and Literatura Latinoamericana y del Caribe (LILACS), Medicina en Español (MEDES), and the SciELO bibliographic database (a collection of scientific journals). The following terms were used as descriptors and searched in free text: "end-stage renal disease", "medication review", "drug-related problems", and "negative outcomes associated with medication". The following limits were applied: "humans" and "adults (more than 18 years)". RESULTS: A total of 59 references were recovered and, after applying inclusion/exclusion criteria, 16 articles were selected. Of these selected articles, 15 provided information on drug-related problems and only 1 on negative outcomes associated with medications. CONCLUSIONS: It can be concluded that drug-related problems and negative outcomes associated with medications affect patients with end-stage renal disease, mainly those receiving renal replacement therapy. More evidence is needed, especially on negative outcomes associated with medication.

Identification of high-risk patients for referral through machine learning assisting the decision making to manage minor ailments in community pharmacies.

Background: Data analysis techniques such as machine learning have been used for assisting in triage and the diagnosis of health problems. Nevertheless, it has not been used yet to assist community pharmacists with services such as the Minor Ailment Services These services have been implemented to reduce the burden of primary care consultations in general medical practitioners (GPs) and to allow a better utilization of community pharmacists' skills. However, there is a need to refer high-risk patients to GPs. Aim: To develop a predictive model for high-risk patients that need referral assisting community pharmacists' triage through a minor ailment service. Method: An ongoing pragmatic type 3 effectiveness-implementation hybrid study was undertaken at a national level in Spanish community pharmacies since October 2020. Pharmacists recruited patients presenting with minor ailments and followed them 10 days after the consultation. The main outcome measured was appropriate medical referral (in accordance with previously co-designed protocols). Nine machine learning models were tested (three statistical, three black box and three tree models) to assist pharmacists in the detection of high-risk individuals in need of referral. Results: Over 14'000 patients were included in the study. Most patients were female (68.1%). With no previous treatment for the specific minor ailment (68.0%) presented. A percentage of patients had referral criteria (13.8%) however, not all of these patients were referred by the pharmacist to the GP (8.5%). The pharmacists were using their clinical expertise not to refer these patients. The primary prediction model was the radial support vector machine (RSVM) with an accuracy of 0.934 (CI95 = [0.926,0.942]), Cohen's kappa of 0.630, recall equal to 0.975 and an area under the curve of 0.897. Twenty variables (out of 61 evaluated) were included in the model. radial support vector machine could predict 95.2% of the true negatives and 74.8% of the true positives. When evaluating the performance for the 25 patient's profiles most frequent in the study, the model was considered appropriate for 56% of them. Conclusion: A RSVM model was obtained to assist in the differentiation of patients that can be managed in community pharmacy from those who are at risk and should be evaluated by GPs. This tool potentially increases patients' safety by increasing pharmacists' ability to differentiate minor ailments from other medical conditions.

Suitability of indexing terms in the MEDLINE bibliographic database on drug-related problems.

BACKGROUND: For years, there has been controversy about the meaning of medication-related problems (MRPs). This has led several authors to attempt to redefine and classify this term with the aim of using it correctly in the healthcare setting. So far without achieving the desired objective, resulting in erroneous results in the sources of information and thus in malpractice in the sector. OBJECTIVE: To describe and analyze the appropriateness of the existing indexing of scientific publications in the MEDLINE bibliographical database with respect to drug-related problems (DRPs) and to determine whether the descriptors used fulfilled the function of suitably representing this concept. METHODS: A descriptive study was conducted, using the following search terms: Medication Errors; Drug Interactions; Drug Overdose; Drug-Related Side Effects and Adverse Reactions; Contraindications, Drug. The sample size was calculated by estimating population parameters in an infinite population (expected value = 0.05; precision of interval = 0.05; level of confidence = 0.95) and the selection method was simple random sampling without replacement, taking the total number of bibliographical references in the database as the basis. The agreement of the indexing with DRPs was evaluated with the coefficient of determination (R2), and the Cohen kappa coefficient was used for the association between the definition of the descriptors and the objective of the article. RESULTS: The 1930 records analyzed showed a total of 2888 different major topics. These major topics were present, with at least one of the five descriptors studied, in 482 (25.0%; 95% CI 23.0-27.0) documentary files, with statistically significant differences between the two phases analyzed (χ2 = 183.8; degrees of freedom (df) = 1; p < 0.001): 1st phase, 295 (13.3%; 95% CI 13.7-16.9) and 2nd phase, 187 (9.7%; 95% CI 8.4-11.0). Overall scientific output with the five descriptors showed a coefficient of determination (R2) of 0.9 (p < 0.001) and the relationship between the objective of the study and the definitions of the five descriptors was 0.9 (p < 0.001). CONCLUSIONS: There was a very good direct exponential trend of the overall scientific output retrieved with the terms associated with DRPs, although the progression of the five descriptors separately did not show a growth model conforming to expectations. There was a moderate agreement between the objective of the study and the definition of each of the five descriptors used and a low relationship between the objective of the study and the concept of DRPs used for this investigation. It is essential to have a descriptor that unifies the terminological diffusion that has existed up till now, since process (causes) and effects (outcomes) have been mixed together under the various definitions and classifications of DRPs found in the studies.

Spanish translation of the ABC taxonomy for medication adherence.

BACKGROUND: The Ascertaining Barriers to Compliance (ABC) taxonomy was developed aiming at systematizing definitions and operationalizations of medication adherence. Its translation is crucial to improve the generalizability, application and comparison of study findings. OBJECTIVE: To provide a consensus translation of the ABC taxonomy from English to Spanish. METHODS: A two-phased approach was used, according to the Preferred Methods for the Translation of the ABC Taxonomy for Medication Adherence. Two literature reviews were conducted: to identify Spanish synonyms and definitions of the ABC taxonomy, and to identify a panel of Spanish-speaking experts in medication adherence. A Delphi survey was designed based on the synonyms and definitions found. The experts previously identified were invited to participate in the Delphi. A consensus of ≥85% was established for the first round. A moderate consensus (50-75%), a consensus (75-95%) or a strong consensus (>95%) were considered to be necessary in the second round. RESULTS: Forty potential synonyms of the ABC taxonomy terms were identified from a total of 270 papers. The response rate during the first Delphi round was 32% (63/197) and in the second round 86% (54/63). A strong consensus was reached for the term "inicio del tratamiento" (96%) and consensus for the term "implementación" (83%). A moderate consensus was obtained for "adherencia a la medicación" (70%), "interrupción del tratamiento" (52%), "manejo de la adherencia" (54%) and "disciplinas relacionadas con la adherencia" (74%). No consensus was reached for the term persistence. Five out of the seven definitions reached a consensus in the first round, and two definitions a moderate consensus after the second round. CONCLUSION: The adoption of the Spanish taxonomy will increase transparency, comparability and transferability of results in the field of medication adherence. This may facilitate benchmarking of adherence strategies between Spanish-speaking researchers and practitioners, and other language speakers.

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)

Intervención farmacéutica en el manejo de inhaladores con pacientes EPOC citados para una espirometría en un centro de salud / Pharmaceutical intervention in the usage of inhalers with COPD patients that have an appointment in a health center to do an spirometry

Antecedentes: el uso de los inhaladores es algo complejo, con este trabajo en pacientes con EPOC debido a su complejidad, lo que se pretende es que tras la intervención de un farmacéutico se garanti-ce el uso adecuado de dichos medicamentos con el fin de mejorar la calidad de vida.Métodos: se citaba a los pacientes para la realiza-ción de una espirometría por parte de la enfermera y por otro lado la farmacéutica en una consulta valoraba el uso de los inhaladores y realizaba los test de adherencia y calidad de vida. A los tres meses los pacientes acudían a la segunda visita y la farmacéutica repetía el mismo el proceso para detectar los posibles cambios tras la intervención.Resultados: en aquellos pacientes que acudieron a las dos visitas se observó que había cambios estadísticamente significativos entre las puntuacio-nes de adherencia en la primera visita respecto a la segunda. La media de puntuaciones es mayor en la segunda visita (49,09) respecto a la primera (46,45), diferencia significativa con una p<0,05. La calidad de vida era igual en ambas visitas y la media de errores en el uso de inhaladores en la segunda visi-ta (1,773) se reduce de forma significativa respecto a la media de errores en la primera visita (4,727).Conclusiones: la intervención de un farmacéutico en un equipo multidisciplinar para el seguimiento de pacientes EPOC ha resultado beneficiosa para dichos pacientes, sobre todo en cuanto al manejo de los inhaladores y la adherencia al tratamiento. (AU)

Background: the usage of inhalers is something complex. This work with COPD patients pretends that, after the pharmacist intervention, the correct usage of these drugs is guaranteed so as to im-prove the quality of life. Methods: the nurse set a date to do an spirometry to the patients. On the other hand, the pharmacist assessed the usage of the inhalers and carried out the adherence and quality of life tests. Three months after, the patients came back to the con-sultation and the pharmacist repeated the same procedure to detect any possible change after the intervention.Results: on those patients that attended both ap-pointments, it was seen that there were statistically significant changes between the adherence punc-tuation regarding both appointments. The average of punctuation is higher in the second appointment (49.09) in respect to the first one (46.45), this is a significant difference with a p<0.05. The quality of life was the same in both appointments and the errors average in the usage of inhalators in the second appointment decreased (1773) significantly in respect to the errors average in the first appoint-ment (4727).Conclusion: the intervention of a pharmacist in a multidisciplinary team to the following of COPD pa-tients is advantageous to these patients, mainly in relation to the usage of inhalers and the adherence to treatment. (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.

[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.

Community pharmacy and primary health care - Types of integration and their applicability: A narrative review.

BACKGROUND: There is an urgent need for health care systems to be more efficient and efficacious. An approach to integrate public and private provider organizations such as community pharmacies and public primary health care (PHC) merits consideration. The objective of this review was to identify the types of integration in health care settings and discuss their applicability to the potential integration of community pharmacy and PHC. METHODS: A narrative review using Medline, Scopus and SciELO databases was performed in which terms related to health were combined with terms related to integration. Levels and Types of integration: 14 types of integration were identified (two in breadth, seven as enablers and five in system levels). A model was created which classifies and assigns the types of integration to the different levels of the health system and to the breadth, intensity, and enablers of the integration process. Due to the nature of community pharmacy and PHC system, a horizontal integration at the micro level, supported by meso and macro levels policy, is suggested. The different elements of intensity and enablers can significantly influence the process. CONCLUSION: The application of principles, concepts and types of integration suggest that it might be feasible and practical to integrate community pharmacies and PHC. However, the conflictive historical context would need to be overcome with appropriate policy and incentives.

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)

Pharmacological Chemolysis of Uric Acid Lithiasis in A Patient with Crohn's Disease.

Patients with chronic diarrhoea or ileostomies suffer from electrolyte and urinary disorders and are prone to developing uric acid or calcium oxalate stones. Evidence is lacking regarding the management of uric acid stones in patients with inflammatory bowel diseases. We present the case of a male patient with Crohn's disease and carrying an ileostomy. He was diagnosed with uric acid urolithiasis (stone size of 11 mm located in the left pyeloureteral junction) after presenting to the emergency room during an episode of left renal colic. Results of the 24-hour urinalysis showed an acidic pH (pH <5), consistent with hyperuricosuria. The suspicion of uric acid lithiasis was confirmed after performing an X-ray diffraction analysis of a lithiasic fragment that passed during acute renal colic. The patient was prescribed with urinary alkalinisers (medical treatment) and dietary recommendations. After 12 months of treatment and urine pH monitoring, the patient achieved complete chemolysis while maintaining the stability of his underlying Crohn's disease. The patient had no complications during follow-up, referring adequate gastrointestinal tolerance to treatment and denying side effects. The patient remains asymptomatic and is being followed-up on an outpatient basis. He continues on prophylactic treatment (Lit-Control® pH Up) to maintain the pH in the non-acidic range.

Role of Single-Nucleotide Polymorphisms in Genes Implicated in Capecitabine Pharmacodynamics on the Effectiveness of Adjuvant Therapy in Colorectal Cancer.

Colorectal cancer (CRC) is a highly prevalent form of neoplasm worldwide. Capecitabine, an oral antimetabolite, is widely used for CRC treatment; however, there exists substantial variation in individual therapy response. This may be due to genetic variations in genes involved in capecitabine pharmacodynamics (PD). In this study, we investigated the role of single-nucleotide polymorphisms (SNPs) related to capecitabine's PD on disease-free survival (DFS) in CRC patients under adjuvant treatment. Thirteen SNPs in the TYMS, ENOSF1, MTHFR, ERCC1/2, and XRCC1/3 genes were genotyped in 142 CRC patients using real-time PCR with predesigned TaqMan® probes. A significant association was found between favorable DFS and the ENOSF1 rs2612091-T allele (p = 0.010; HR = 0.34; 95% CI = 0.14-0.83), as well as with the TYMS/ENOSF1 region ACT haplotype (p = 0.012; HR = 0.37; 95% CI = 0.17-0.80). Other factors such as low histological grade (p = 0.009; HR = 0.34; 95% CI = 0.14-0.79) and a family history of cancer (p = 0.040; HR = 0.48; 95% CI = 0.23-0.99) were also linked to improved DFS. Therefore, the SNP ENOSF1 rs2612091 could be considered as a predictive genetic biomarker for survival in CRC patients receiving capecitabine-based adjuvant regimens.

Effect of Single Nucleotide Polymorphisms in the Vitamin D Metabolic Pathway on Susceptibility to Non-Small-Cell Lung Cancer.

The pathogenesis of non-small-cell lung cancer (NSCLC) is complex, since many risk factors have been identified. Recent research indicates that polymorphisms in the metabolic pathway of vitamin D may be involved in both risk and survival of the disease. The objective of this study is to assess the effect of 13 genetic polymorphisms involved in the vitamin D metabolic pathway on the risk of suffering from NSCLC. We conducted an observational case-control study, which included 204 patients with NSCLC and 408 controls, of Caucasian origin, from southern Spain. The CYP27B1 (rs4646536, rs3782130, rs703842, rs10877012), CYP2R1 (rs10741657), GC (rs7041), CYP24A1, and VDR (BsmI, Cdx-2, FokI, ApaI, TaqI) gene polymorphisms were analyzed by real-time polymerase chain reaction. The logistic regression model, adjusted for smoking and family history of cancer, revealed that in the genotypic model, carriers of the VDR BsmI rs1544410-AA genotype were associated with a lower risk of developing NSCLC compared to the GG genotype (p = 0.0377; OR = 0.51; CI95% = 0.27-0.95; AA vs. GG). This association was maintained in the recessive model (p = 0.0140). Haplotype analysis revealed that the AACATGG and GACATGG haplotypes for the rs1544410, rs7975232, rs731236, rs4646536, rs703842, rs3782130, and rs10877012 polymorphisms were associated with a lower risk of NSCLC (p = 0.015 and p = 0.044 respectively). The remaining polymorphisms showed no effect on susceptibility to NSCLC. The BsmI rs1544410 polymorphism was significantly associated with lower risk of NSCLC and could be of considerable value as a predictive biomarker of the disease.