Adecuación de la seguridad del metamizol y agranulocitosis / Adequacy of the safety of metamizole and agranulocytosis

Objetivo: Analizar si la nota informativa de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), de 30 de octubre del 2018, sobre agranulocitosis y metamizol contiene la información precisa y necesaria para proteger a los pacientes de la aparición de esta reacción adversa (RA) y si la documentación oficial de los medicamentos con metamizol para médicos, farmacéuticos y población general está adaptada a las directrices de la AEMPS para disminuir el riesgo. Emplazamiento y participantes: Nota informativa, búsqueda bibliográfica, información sobre los medicamentos con metamizol comercializados en España en la Agencia Europea del Medicamento, fichas técnicas, prospectos, base de datos de información sanitaria Bot PLUS y Catálogo de Especialidades Farmacéuticas. Notificación de 4casos de agranulocitosis por metamizol posteriores a la fecha de la nota informativa. Intervenciones y mediciones principales: Comparación de los puntos clave de la nota informativa y de los documentos oficiales sobre metamizol con la bibliografía. Descripción de 4casos de agranulocitosis por metamizol y aplicación del algoritmo de causalidad y gravedad. Resultados: La nota informativa presenta ausencias y dudas respecto a la bibliografía y al uso de metamizol en la práctica asistencial. Los documentos oficiales presentan faltas de actualización, indicaciones no aprobadas y dosis superiores a las recomendadas. La nota informativa no ha frenado la presentación de casos de agranulocitosis por metamizol. Conclusiones: La nota informativa de la AEMPS es mejorable y es necesario actualizar los documentos oficiales de información sobre el metamizol para profesionales sanitarios y pacientes para disminuir el riesgo de agranulocitosis.(AU)

Objective: To analyze whether the drug safety update issued by the Spanish Agency of Medicines and Healthcare Products (AEMPS), dated October 30, 2018, on agranulocytosis and metamizole contains accurate and necessary information to protect patients from the presentation of this adverse reaction (AR) and if the official documentation of medicines containing metamizole for doctors, pharmacists and the general population conforms to the guidelines of the AEMPS to reduce this risk. Setting and participants: Drug safety update, bibliographic search, information at the European Medicines Agency on metamizole drugs marketed in Spain, technical datasheets, leaflets, Bot PLUS Health Information Database and Catalog of Pharmaceutical Specialties. Notification of 4cases of agranulocytosis due to metamizole after the drug safety update was issued. Main interventions and measurements: Comparison of the key points of the drug safety update and official documents on metamizole with the bibliography. Description of the 4cases of agranulocytosis due to metamizole and application of the causality and severity algorithm. Results: The drug safety update contains omissions and contradiction in respect to the bibliography and the actual use of metamizole in healthcare practice. The official documents show a lack of updating, unapproved indications and doses higher than those recommended. The drug safety update has not stopped the presentation of cases of agranulocytosis due to metamizole. Conclusions: The AEMPS drug safety update can be improved and it is necessary to update the official information documents on metamizole for health professionals and patients in order to decrease the risk of agranulocytosis.(AU)

Drug Prescription Profiles in Patients with Polypharmacy in Spain: A Large-Scale Pharmacoepidemiologic Study Using Real-World Data.

We aimed to identify and compare medication profiles in populations with polypharmacy between 2005 and 2015. We conducted a cross-sectional study using information from the Computerized Database for Pharmacoepidemiologic Studies in Primary Care (BIFAP, Spain). We estimated the prevalence of therapeutic subgroups in all individuals 15 years of age and older with polypharmacy (≥5 drugs during ≥6 months) using the Anatomical Therapeutic Chemical classification system level 4, by sex and age group, for both calendar years. The most prescribed drugs were proton-pump inhibitors (PPIs), statins, antiplatelet agents, benzodiazepine derivatives, and angiotensin-converting enzyme inhibitors. The greatest increases between 2005 and 2015 were observed in PPIs, statins, other antidepressants, and ß-blockers, while the prevalence of antiepileptics was almost tripled. We observed increases in psychotropic drugs in women and cardiovascular medications in men. By patient´s age groups, there were notable increases in antipsychotics, antidepressants, and antiepileptics (15-44 years); antidepressants, PPIs, and selective ß-blockers (45-64 years); selective ß-blockers, biguanides, PPIs, and statins (65-79 years); and in statins, selective ß-blockers, and PPIs (80 years and older). Our results revealed important increases in the use of specific therapeutic subgroups, like PPIs, statins, and psychotropic drugs, highlighting opportunities to design and implement strategies to analyze such prescriptions' appropriateness.

[Adequacy of the safety of metamizole and agranulocytosis]. / Adecuación de la seguridad del metamizol y agranulocitosis.

OBJECTIVE: To analyze whether the drug safety update issued by the Spanish Agency of Medicines and Healthcare Products (AEMPS), dated October 30, 2018, on agranulocytosis and metamizole contains accurate and necessary information to protect patients from the presentation of this adverse reaction (AR) and if the official documentation of medicines containing metamizole for doctors, pharmacists and the general population conforms to the guidelines of the AEMPS to reduce this risk. SETTING AND PARTICIPANTS: Drug safety update, bibliographic search, information at the European Medicines Agency on metamizole drugs marketed in Spain, technical datasheets, leaflets, Bot PLUS Health Information Database and Catalog of Pharmaceutical Specialties. Notification of 4cases of agranulocytosis due to metamizole after the drug safety update was issued. MAIN INTERVENTIONS AND MEASUREMENTS: Comparison of the key points of the drug safety update and official documents on metamizole with the bibliography. Description of the 4cases of agranulocytosis due to metamizole and application of the causality and severity algorithm. RESULTS: The drug safety update contains omissions and contradiction in respect to the bibliography and the actual use of metamizole in healthcare practice. The official documents show a lack of updating, unapproved indications and doses higher than those recommended. The drug safety update has not stopped the presentation of cases of agranulocytosis due to metamizole. CONCLUSIONS: The AEMPS drug safety update can be improved and it is necessary to update the official information documents on metamizole for health professionals and patients in order to decrease the risk of agranulocytosis.

Hiponatremia grave y uso velado de oxcarbazepina / Severe hyponatremia and oxcarbazepina hidden use

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Utilización de antisépticos orales para la infección por SARS-CoV-2 / Use of oral antiseptics for SARS-CoV-2 infection

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Evolution of polypharmacy in a spanish population (2005-2015): A database study.

PURPOSE: To analyze the evolution of the prevalence of polypharmacy and excessive polypharmacy in a Spanish population, and to improve the identification of patients with polypharmacy. METHODS: A descriptive, annual cross-sectional observational study was carried out. PATIENTS: individuals over 14 years of age included in a multiregional primary care database of the Spanish population (BIFAP). ANALYSIS: prescription data. Period 2005-2015. VARIABLES: proportion of patients with polypharmacy (simultaneous prescription of ≥5 drugs) and excessive polypharmacy (≥10 drugs) for at least 6 months, according to sex and age groups. A trend analysis of the studied period was performed (overall, and by sex and age groups). RESULTS: The data are reported on a comparative basis (2005 vs 2015). Number of patients analyzed: 2664743 vs 4 002 877. The prevalence of polypharmacy increased significantly (2.5% vs 8.9%, P-value for trend <0.001), being greater in females throughout the study period and in the group aged ≥80 years (P-value for trends <0.001). The prevalence of excessive polypharmacy also increased significantly (0.1% vs 1%, P-value for trend <0.001), being higher in the group aged ≥80 years (P-value for trend <0.001). The proportion of patients with no chronic treatment decreased (80.2% vs 63.1%). CONCLUSIONS: The prevalence of polypharmacy in this Spanish population has tripled in the period 2005-2015, while excessive polypharmacy has increased 10-fold. These increments are seen in both sexes and in all age groups, particularly in individuals over 80 years of age. The proportion of patients without chronic treatments has decreased.

Efficacy and cost-effectiveness of a blended cognitive behavioral therapy for depression in Spanish primary health care: study protocol for a randomised non-inferiority trial.

BACKGROUND: Data from primary health care in Spain show a high prevalence of the major depressive disorder. Blended treatment (combination of face-to-face and online components) seems to be a very promising tool for the optimization and dissemination of psychological treatments in a cost-effective form. Although there is growing data that confirm the advantages of blended therapies, few studies have analyzed their application in regular clinical practice. The objective of the present paper is to describe the protocol for a clinical study aimed at exploring the clinical and cost-effectiveness of a blended cognitive behavioral therapy (b-CBT) for depression, compared to treatment as usual (TAU) in a primary health care setting. METHODS: A two-arm randomised controlled non-inferiority trial will be carried out, with repeated measures (baseline, 3 months, 6 months, and 12 months) under two conditions: b-CBT and TAU. The b-CBT program will consist in three face-to-face sessions and eight online sessions. The TAU is defined as the routine care delivered by the general practitioner for the treatment of depression in primary care. The primary outcome is a symptomatic change of depressive symptoms on the patient-health questionnaire (PHQ-9). Other secondary outcomes will be considered (e.g., quality of life, treatment preference). All participants must be 18 years of age or older and meet the diagnostic criteria for major depressive disorder according to the Diagnostic and Statistical Manual of Mental disorders 4th edition. 156 participants will be recruited (78 per arm). DISCUSSION: It is expected that b-CBT is clinically non-inferior when compared to TAU. This is the first study in Spain to use a b-CBT format in primary and specialized care, and this format could be an efficacious and cost-effective therapeutic strategy for the treatment of depression. TRIAL REGISTRATION: ClinicalTrials.gov NCT02361684. Registered on 8 January 2015. Currently recruiting participants.

Fibromialgia y empatía: un camino hacia el bienestar / Fibromyalgia and empathy: A path towards well-being

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Brote comunitario de leishmaniasis cutánea en la comarca de La Ribera: a propósito de las medidas de Salud Pública / Community outbreak of cutaneous leishmaniasis in La Ribera region of Valencia, Spain: Public Health measures

Introducción: Los brotes de leishmaniasis humana no son muy frecuentes en España, a pesar de ser considerada una enfermedad con carácter endémico. A través del presente estudio se comunica un brote nuevo detectado en la Comunidad Valenciana, con el objetivo principal de describir las características clinicoepidemiológicas y de referir las principales medidas, en materia de Salud Pública, instauradas para la contención del brote. Métodos: Se consideró caso a toda persona con domicilio en la localidad de Tous (en la Comunidad Valenciana), diagnóstico de leishmaniasis según los criterios clínicos y de laboratorio definidos por la Red de Vigilancia Epidemiológica, y fecha de inicio de síntomas entre el 1 de enero de 2012 y el 31 de diciembre de 2015. Se realizó un análisis descriptivo de las distintas variables epidemiológicas recogidas. Resultados: Desde la semana 28ª del año 2012 hasta la semana 30ª del 2013 se notificaron un total de 19 casos. La edad adulta fue la más afectada (73%). La forma clínica más frecuente fue la leishmaniasis de tipo cutáneo (89%). Un 79% de los casos se confirmaron mediante técnica de PCR; en 7 muestras pudo realizarse la tipificación, siendo el parásito identificado como Leishmania infantum. La evolución de los pacientes fue favorable tras el tratamiento físico (31%) o farmacológico (69%). El 37% presentaron algún tipo de lesión residual. Se aplicaron diversas medidas dirigidas a los profesionales sanitarios y al control del vector y del reservorio, así como recomendaciones generales a la población para la contención del brote. Conclusiones: Este brote de leishmaniasis cutánea confirma el carácter endémico y la elevada prevalencia de la enfermedad en la cuenca mediterránea. El tratamiento más utilizado fue el antimoniato de meglumina intralesional. Para el control del brote fue necesario desarrollar un plan integral de actuación (AU)

Introduction: Outbreaks of human leishmaniasis are not very common in Spain, despite being considered an endemic disease. In this study, a new outbreak in the Valencian Community is presented. Its principal objective is to describe the clinical-epidemiological characteristics and to present the main Public Health measures established to contain the outbreak. Methods: A case was defined as anyone residing in the village of Tous (in Valencian Community), diagnosed with leishmaniasis according to clinical and laboratory criteria, defined by the Epidemiological Surveillance Network, and date of symptoms onset between 1 January 2012 and 31 December 2013. A descriptive analysis was performed on the epidemiological variables collected. Results: A total of 19 cases were reported from the 28th week of 2012 to the 30th week of 2013. Adults were most affected by the disease (73%). The most common clinical form was cutaneous leishmaniasis (89%). More than three-quarters (79%) of cases were confirmed by PCR. Species typing was performed on seven samples, with the parasite Leishmania infantum being identified. Patient outcome was favourable after physical (31%), or pharmacological (69%) treatment. Some kind of residual damage was observed in 37% of cases. Different measures were applied, aimed at health professionals, and vector and reservoir control, as well as general recommendations to the population for the containment of the outbreak. Conclusions: This cutaneous leishmaniasis outbreak confirms the endemic nature and the high prevalence of the disease in the Mediterranean area. The most commonly used treatment was intralesional meglumine antimoniate. A comprehensive plan of action had to be developed in order to control the outbreak (AU)