Efectividad y seguridad de los nuevos anticuerpos monoclonales en la profilaxis de la migraña / Effectiveness and safety of new monoclonal antibodies in migraine prophylaxis

Objetivos: Analizar la efectividad y seguridad en vida real de los nuevos anticuerpos monoclonales subcutáneos para la profilaxis de la migraña. Métodos: Estudio observacional retrospectivo llevado a cabo desde enero de 2020 hasta abril de 2021 con pacientes diagnosticados de migraña crónica o episódica. Las variables de interés se analizaron por el personal facultativo farmacéutico en una base de datos anonimizada. Esta base se completa como práctica clínica habitual durante la entrevista clínica en la consulta de pacientes externos. Resultados: Se analizaron 53 pacientes. Se observó una reducción del número de crisis respecto al valor basal a los 3, a los 6 y a los 12 meses de tratamiento, así como de otros fármacos para el tratamiento de la migraña. La mayoría de reacciones adversas descritas fueron de tipo leve, obligando a la suspensión del tratamiento de solo uno de los pacientes. Se describió un aumento de la tensión arterial en varios pacientes, así como una incidencia de estreñimiento superior a los ensayos pivotales. Conclusiones: Este estudio muestra una disminución del número de crisis de migraña y del uso de otros fármacos antimigrañosos tras el uso de anticuerpos monoclonales. Los tratamientos se pueden considerar seguros, observándose una baja incidencia de reacciones adversas graves. La mayoría de pacientes fueron tratados con erenumab. Se dispone de menos datos a medida que avanza del tiempo de estudio, por lo que resulta necesario recopilar más información para conocer el perfil de efectividad y seguridad de estos fármacos a largo plazo.(AU)

Objectives: To analyse the effectiveness and safety in real life of new subcutaneous monoclonal antibodies for the prophylaxis of migraine. Methods: Retrospective observational study conducted from January 2020 to April 2021 with patients diagnosed with chronic or episodic migraine. The variables of interest were collected by the pharmacist in an anonymised database during the clinical interview in the outpatient clinic. This databased is completed as standard clinical practice during the clinical interview in the outpatient clinic. Results: 53 patients were analysed. A reduction in the number of attacks from baseline was observed at 3, 6 and 12 months of treatment, as well as for other migraine treatment drugs. Most of the adverse reactions described were mild, leading to discontinuation of treatment in only one patient. An increase in blood pressure was reported in several patients, as well as a higher incidence of constipation than in pivotal trials. Conclusions: This study shows a decrease in the number of migraine attacks and in the use of other anti-migraine drugs after the use of monoclonal antibodies. The treatments can be considered safe, with a low incidence of serious adverse reactions. Most patients were treated with erenumab. Less information is available as the study time progresses, so more information needs to be collected to understand the long-term effectiveness and safety profile of these drugs.(AU)

Isavuconazole-tacrolimus drug-drug interactions in HSCT patients.

OBJECTIVES: Because tacrolimus has a narrow therapeutic window and exhibits both intraindividual and interindividual variability, we attempted to establish the percentage of calcineurin inhibitor (CNI) dose reduction to prevent toxicity and ensure stem cell engraftment when using this immunosuppressant with the antifungal isavuconazole (ISA). By calculating the tacrolimus concentration/dose (C/D) ratio, we expected to demonstrate the magnitude of change in the C/D ratio from baseline after ISA administration. METHODS: We evaluated the interaction between ISA, a new triazole antifungal used in prophylaxis for invasive fungal infections, and the CNI class of immunosuppressive drugs, specifically tacrolimus, in 11 blood samples from HSCT recipients. RESULTS: The mean tacrolimus C/D ratio increased 1.44-fold from baseline 48 h after ISA administration (P = 0.001). CONCLUSIONS: Although further investigation is needed, the results of this study suggest that a reduction of 18% in tacrolimus may be recommended.

Bezlotoxumab en la profilaxis de la infección recurrente por Clostridium difficile. Resultados en una serie de 4 casos / Bezlotoxumab in the prophylaxis of recurrent Clostridium difficile infection. Results in a series of 4 patients

Bezlotoxumab es un fármaco usado en la prevención de recurrencias de infección por Clostridium difficile, actuando mediante su unión a la toxina B de la bacteria, produciendo su inactivación. Este tipo de infección es muy frecuente en pacientes inmunodeprimidos, los cuales suelen presentar varias recurrencias que, junto con su enfermedad de base, pueden poner en compromiso la salud e incluso la vida del paciente. El objetivo de este trabajo es evaluar la efectividad de bezlotoxumab en la prevención de recaídas de infección por Clostridium difficile en una serie de cuatro pacientes. Para ello, se recopiló la información clínica necesaria y se anonimizó la base de datos antes de su análisis. Tras el análisis de nuestra serie de datos, obtuvimos resultados positivos ya que tres de los cuatro pacientes no sufrieron episodios de recurrencias en los cuatro meses posteriores a la administración de bezlotoxumab y ninguno presentó efectos adversos o intolerancias. Un paciente falleció un mes después de la administración de bezlotoxumab debido a la situación de inmunosupresión causada por su enfermedad de base y la infección no curada de Clostridium difficile. (AU)

Bezlotoxumab is a drug used in the treatment of recurrences of Clostridium difficile infection, acting by binding to the toxin B of the bacterium, producing its inactivation. This type of infection is very common in immunocompromised patients, who usually present several recurrences that, together with their underlying disease, can compromise the health and even the patient’s life. The aim of this study is to evaluate the effectiveness of bezlotoxumab in the prevention of four patients admitted for relapses of Clostridium difficile infection after the previous therapeutic failure of other drugs such as vancomycin, metronidazole or fidaxomycin. To do this, the necessary clinical information was collected and the database was anonymized before analysis. After analyzing our data series, we obtained positive results as three of the four patients did not suffer relapse episodes in the four months after bezlotoxumab administration and none had adverse effects or intolerances. One patient died one month after administration of bezlotozumab due to immunosuppression caused by his underlying disease and uncured Clostridium difficile infection. (AU)

[Improvement of the knowledge on allergic cross-reactions between two drug groups: beta-lactams and NSAIDS]. / Mejora del conocimiento sobre reacciones alérgicas cruzadas en dos grupos de medicamentos: ß-lactámicos y AINEs.

OBJECTIVES: To identify opportunities for improving the available knowledge of health care professionals (particularly, physicians, pharmacists, and nurses) on crossed allergic reactions (CAR) to penicillins and NSAIDs. METHOD: Quasi-experimental prospective pre-exposure study at a 412-beds hospital. An assessment of the knowledge on CAR to penicillins and NSAIDs was performed by means of anonymous questionnaires before (1st questionnaire) and after (2d questionnaire) the implementation of a series of improvement measures: protocol of "patient allergic to drugs", pocket card, poster with summarized information, and informative talks. The questionnaires served as the CRF and the statistical analysis was done with the SPSS v18.0 software. RESULTS: The mean number of errors in the first questionnaire on CARs of penicillin allergic patient and on CARs of NSAIDs allergic patients was 20.53 and 27.62, respectively. The mean number of errors in the second questionnaire on CARs of penicillin allergic patient and on CARs of NSAIDs allergic patients was 2.27 and 7.26, respectively. All the results were significant for a p level < 0.005. CONCLUSIONS: - There is insufficient knowledge on CARs to penicillins and NSAIDS, which justifies improvement measures. - After the implementation of improvement measures, there is an increased knowledge on CARs to penicillins and NSAIDs in the study groups.

Objetivos: Identificar oportunidades de mejora, sobre el conocimiento disponible del personal sanitario (en concreto a personal médico, farmacéutico y de enfermería), sobre reacciones alérgicas cruzadas (RAC) de penicilinas y AINEs. Método: Estudio prospectivo cuasiexperimental pre-exposición en un hospital de 412 camas. Se realizó una valoración del conocimiento sobre RAC de penicilinas y AINEs, a través de encuestas anónimas, antes (1a encuesta) y después (2a encuesta) de la implantación de una serie de medidas de mejora: protocolo "paciente alérgico a medicamentos", tarjeta de bolsillo, póster resumen de información y charlas divulgativas. Las propias encuestas sirvieron de hoja de recogida de datos y el análisis estadístico se llevó a cabo con el programa SPSS v18.0. Resultados: La media de errores en las 1as encuestas sobre "RAC en paciente alérgico a penicilinas" y sobre "RAC en paciente alérgico a AINEs", fue de 20,53 y 27,62, respectivamente. La media de errores en las 2as encuestas sobre "RAC en paciente alérgico a penicilinas" y sobre "RAC en paciente alérgico a AINEs", fue de 2,27 y 7,26, respectivamente. Todos los resultados se consideraron significativos para un nivel 945;< 0,05. Conclusiones: - No se dispone de un nivel adecuado de conocimiento sobre RAC de penicilinas y AINEs, lo que justifica la realización de un ciclo de mejora. - Tras la implantación de las medidas de mejora se aprecia un aumento en el nivel de conocimiento sobre RAC en penicilinas y AINEs, en los grupos de estudio.

Revisión de la estabilidad de los medicamentos fotosensibles / Review of the Stability of Photosensitive Medications

Objetivo Identificar los medicamentos fotosensibles incluidos en la guía farmacoterapéutica del hospital y realizar una búsqueda de datos de estabilidad durante el almacenamiento, reconstitución y dilución de los mismos. Método La búsqueda de datos fue a través de las fichas técnicas, información aportada por los laboratorios fabricantes y en algunos casos se recurrió a una búsqueda bibliográfica más extensa (fuentes terciarias y comunicaciones a congresos) que se especifica junto a cada medicamento. También se realizó una búsqueda en la base informática Pubmed (del 2004 al 2009).Los medicamentos han sido ordenados alfabéticamente por marca comercial ya que la estabilidad frente a la luz no depende exclusivamente del principio activo. Ocho columnas describen las características principales: nombre comercial, principio activo, laboratorio, condiciones de almacenamiento, reconstituido y diluido, observaciones y bibliografía. Resultados El listado recoge 139 especialidades farmacéuticas fotosensibles, de las 1954 especialidades incluidas en la GFT (tabla 1).Conclusiones La carencia de estudios publicados sobre estabilidad de medicamentos fotosensibles, planteó la necesidad de realizar una revisión interna en nuestro hospital. Es importante que los laboratorios realicen estudios de fotosensibilidad de sus productos y los resultados consten en la fichas técnicas, para así disponer de información más accesible y fiable y para ello resaltamos la necesidad de que la ley lo exija (AU)

Objectives Identify the photosensitive drugs included in the hospital pharmacotherapeutic guide and search for stability data on the storage, reconstitution, and dilution of these compounds. Methods The data were obtained by referencing technical specifications, information provided by drug laboratories, and in some cases, we performed a more extensive bibliographic search (tertiary sources and conference lectures) for each particular medication. We also performed a data search on the PubMed information database (from 2004 to 2009).The drugs were placed in alphabetical order by brand since the stability of each drug when exposed to light does not depend exclusively on the primary active ingredient. Eight columns describe the principal characteristics of the drugs: brand name, active ingredient, laboratory, storage, reconstitution and dilution conditions, observations, and references. Results The listing comprised of 139 of the 1954 photosensitive medicines included in the pharmacotherapeutical guide (Table 1).Conclusions The lack of studies published on the stability of photosensitive medications provided the need for an internal review at our hospital. It is important for drug-producing laboratories to perform photosensitivity tests on their products, with the results presented in the technical specifications in order to provide more accessible and reliable information. We believe that this should be required by law (AU)

[Review of the stabitlity of photosensitive medications]. / Revisión de la estabilidad de los medicamentos fotosensibles.

OBJECTIVES: Identify the photosensitive drugs included in the hospital pharmacotherapeutic guide and search for stability data on the storage, reconstitution, and dilution of these compounds. METHODS: The data were obtained by referencing technical specifications, information provided by drug laboratories, and in some cases, we performed a more extensive bibliographic search (tertiary sources and conference lectures) for each particular medication. We also performed a data search on the PubMed information database (from 2004 to 2009). The drugs were placed in alphabetical order by brand since the stability of each drug when exposed to light does not depend exclusively on the primary active ingredient. Eight columns describe the principal characteristics of the drugs: brand name, active ingredient, laboratory, storage, reconstitution and dilution conditions, observations, and references. RESULTS: The listing was comprised of 139 photosensitive medicines, of the 1,954 included in the pharmacotherapeutical guide (table 1). CONCLUSIONS: The lack of studies published on the stability of photosensitive medications provided the need for an internal review at our hospital. It is important for drug-producing laboratories to perform photo-sensitivity tests on their products, with the results presented in the technical specifications in order to provide more accessible and reliable information. We believe that this should be required by law.

Enfermedad del suero-like asociada a clopidogrel / No disponible

No disponible

[Effectiveness of an intervention to improve medical prescription quality in specialized care]. / Efectividad de una intervención en la mejora de la calidad de prescripción con receta médica en atención especializada.

OBJECTIVE: The study was designed to research whether providing doctors with customized reports on prescription indicators,plus a presentation of the project to clinical departments and hospital boards, would improve prescription quality in specialized care. MATERIAL AND METHODS: Quasi experimental intervention study. During three periods of time we observed whether any differences between physicians receiving said reports (intervention group) and physicians not receiving said reports (control group)occurred in three overall quality markers (94 physicians)--generic drugs, low therapeutic value drugs, and irrelevant novel drugs-and two specific indicators--angiotensin converting enzyme inhibitors (109 physicians) and omeprazole (169 physicians). Indicators were assessed using mean values (95% Cl) and differences between groups with the z test. RESULTS: Prior to the intervention, indicators had no significant differences. At 4-6 months after delivering the report, generic drug prescription improved in the intervention group - 3.13%(1.79-4.47) versus 1.81% (1.08-2.54) in the control group,p = 0.041. After 10-12 months the intervention group had significantly improved versus the control group regarding: generic drugs, 4.01% (2.28-5.73) versus 2.22% (1.56-2.87), p = 0.025;ACE inhibitors, 58.89% (47.56-70.21) versus 45.91% (36.03-55.79), p = 0.042; and low therapeutic utility drugs, 8.57%(5.56-11.6) versus 12.35% (8.96-15.74), p = 0.047. Improvement regarding omeprazole did not reach statistical significance,and novel medications remained virtually unchanged. CONCLUSION: The intervention proved effective for the improvement of qualitative prescription indicators in specialized care.

[Assessment of prescription in discharge reports at a university hospital]. / Evaluación de la prescripción de medicamentos en los informes de alta en un hospital universitario.

OBJECTIVE: To determine and analyze drug prescription at hospital discharge, mainly regarding generic drug use, use of novel but irrelevant therapeutic agents and use of low therapeutic value drugs (LTVD). MATERIAL AND METHODS: In a retrospective study 195 discharge reports from 11 different departments in a 450-bed general hospital were analyzed for a monthly period. An Access database allowed us to record the number of prescriptions, each drugs therapeutic group according to the Anatomical Therapeutic Chemical (ATC) Classification System, prescribed drugs for which generics are available, prescribed C-group drugs, LTVD drugs, etc. RESULTS: Following an analysis of results, only 6.17% of all drugs were prescribed according to their generic name, when this would have been possible in 22.8%. If only the most efficient agents had been prescribed, savings would have amounted to 589.3 Euros. In all, 1.28% of prescribed drugs were LTVD, and 1.15% had irrelevant therapeutic value. CONCLUSION: Although specialized medical prescription represents a minimum of total prescriptions in a healthcare area, measures intended to improve quality will have a positive impact on primary care prescriptions. These measures include information to physicians on more efficient preparations, plus the design of a Pharmacotherapeutic Guide to unify pharmacologic criteria in the Area.

[Literature review on the stability of diluted mixtures of cytostatic agents]. / Revisión bibliográfica de la estabilidad de las mezclas diluidas de citostáticos.

Up-to-date, evidence-based consensus protocols are an increasingly incorporated tool in health care. These protocols, clinical pathways, etc., represent a major support of health-care quality, namely scientific-technical quality. Compliance with these protocols by all team members guarantees that all patients be provided with an adequate level of health-care quality in the light of current knowledge and using available means. This principle of uniformity and quality in health care is essential for all, no matter the level of health care delivered or the activity being developed. In the Pharmacy Department and, more specifically, in the Unit of Cytostatic Agent Reconstitution and Dosing, knowledge and consensus on stability conditions and timing for diluted mixtures are essential to reach area-related quality standards. From literature references that are most relevant to or most widely used by in-hospital pharmacy departments, we designed a documented stabilities protocol to be used as a tool to: Augment preparation quality by including a documented expiry date within labels, optimize management on the basis of scientific criteria for mixtures not administered to patients and returned to the Pharmacy Department and design alternatives to hospitalization and outpatient delivery programs to improve end-user satisfaction and, therefore, health-care quality.

[Alternatives to solid pharmacutical forms usually given by enteral nutrition tubes]. / Alternativas a las formas farmacéuticas sólidas administradas habitualmente por sondas de nutrición enteral.

We analyze which drugs of those administered through an enteral nutrition tube, present problems which are inherent to the pharmaceutical forms. The study is conducted with a sample of 40 patients who have a feeding tube, who received a total of 48 different medications. 38 (78.3%) were in a solid pharmaceutical form, and 10 (21.7%) were liquid. Among the most used medications, ranitidine stands out in 12 patients, paracetamol in 8, and phenytoin in 7. We note the use of the solid forms of phenytoin, nifedipine, and controlled release morphine, as having the greatest interest due to their contraindication. For all the studied cases, we propose alternatives and we note those drugs for which we did not find any. The hospitalary pharmaceutical guides should include liquid pharmaceutical forms of those drugs which should not be ground up. There is little information on the wards about the administration of drugs through feeding tubes.

[Cystic fibrosis: nutritional aspects and recommendations]. / Fibrosis quística: aspectos y recomendaciones nutricionales.

Given the high numbers of nutritional supplements and enteral diets which are supplied for patients suffering from cystic fibrosis, by the departments of hospital pharmacy, the present study aims to review which are the characteristics of this disease which determine the appearance of malnutrition in these patients. Also, their nutritional treatment has been reviewed. On one hand, considering the general dietary measures, keeping in mind the composition of the diets, their characteristics according to age, and the supplementation with vitamins and with pancreatic enzymes. On the other hand, there is a review of the special dietary measures which should be applied in case of failure to thrive of the child, which goes from the modification of the oral diet, to the administration of parenteral nutrition.