Prescription patterns of somatostatin analogs in patients with acromegaly and neuroendocrine tumors.

PURPOSE: Acromegaly and neuroendocrine tumors are rare diseases that, under certain conditions, can be treated with somatostatin analogs. The aim was to determine the prescription patterns of somatostatin analogs in a group of patients with acromegaly and neuroendocrine tumors affiliated with the Colombian Health System. METHODS: A retrospective study. A cohort of patients from a drug dispensing database that collected all prescriptions of long-acting somatostatin analogs (octreotide, lanreotide, pasireotide). Sociodemographic variables, clinical variables (diagnosis and comorbidities) and pharmacological therapy variables (dose, changes, persistence of use, comedications) were considered. RESULTS: A total of 213 patients were identified, including 139 (65.3%) with acromegaly and 74 (34.7%) with neuroendocrine tumors. There was a predominance of women (58.7%) and a mean age of 59.7 ± 14.5 years. The most commonly used medications were lanreotide autogel (n = 107; 50.2%), octreotide LAR (n = 102; 47.9%) and pasireotide LAR (n = 4; 1.9%). During follow-up, 11.3% of patients experienced modifications of therapy, with a mean duration from the beginning of treatment to the change in medication of 25 ± 15.9 months. A total of 48.9% of the patients with acromegaly and 87.1% of individuals with neuroendocrine tumors received maximum approved doses of the drug. CONCLUSION: Patients with acromegaly and neuroendocrine tumors in Colombia are mainly women and are most frequently treated with lanreotide autogel for acromegaly and with octreotide LAR for neuroendocrine tumors. In addition, a high proportion are managed with maximum doses of long-acting somatostatin analogs.

Fármaco-seguridad al uso de antihipertensivos por adultos mayores de un programa para la salud psicofísica / Drug-safety to the use of antihypertensive drugs by older adults in a program for psychophysical health / Fármaco-segurança uso de anti-hipertensivos por adultos maiores de um programa para a saúde psicofísica

Resumen Introducción: la promoción de la salud psicofísica y la seguridad del uso responsable de los antihipertensivos es una necesidad para mejorar la calidad y esperanza de vida del paciente. Objetivo: indagar la relación de factores de riesgo que influyen en la farmacoseguridad del uso de antihipertensivos en un grupo de adultos mayores con enfermedad cardiovascular. Metodología: estudio cuantitativo exploratorio transversal descriptivo. Se aplicó el instrumento Sistema de Dispensación para usuarios Crónicos en validación a 45 adultos mayores entre 50 y 88 años con diagnóstico clínico de enfermedad cardiovascular durante 2015. Resultados: el ANOVA multifactorial con el paquete estadístico IBM SPSS 2016, evidenció relación estadística alta F (1) = 27,43; p< 0,001 entre los factores de riesgo, la no adherencia e ineficacia del uso antihipertensivo. El análisis comparativo de la diferencia de media entre la no adherencia al tratamiento y la media de la farmacoterapia eficaz e ineficaz, reveló una diferencia muy alta t (1) = 421.59, p< 0,001. Conclusiones: Este estudio muestra la necesidad de fomentar la práctica cotidiana de la promoción de la salud al adulto mayor, a fin de lograr una presión arterial estable y la prevención de algún evento y/o problema relacionado al uso del antihipertensivo que pueda incidir en el efecto terapéutico y en el bienestar del paciente.

Abstract Introduction: The promotion of psychophysical health and the safety of the responsible use of antihypertensive drugs, is a necessity to improve the quality and life expectancy of the patient. Objective: To explore the relationship of risk factors that influence the pharma security for the use of antihypertensive drugs by a group of older adults with cardiovascular disease. Methodology: Descriptive cross-sectional exploratory quantitative study. The Dispensing System for Chronic Users instrument was applied during 2015 in validation to 45 older adults with a clinical diagnosis of cardiovascular disease aged between 50 and 88 years old. Results: The multifactorial ANOVA with the statistical package IBM SPSS 2016, showed a high statistical relationship F (1) = 27.43; p< 0.001 between risk factors, non-adherence and ineffectiveness of antihypertensive use. The comparative analysis of the mean difference between non-adherence to treatment and the mean of effective and ineffective pharmacotherapy, revealed a very high difference t (1) = 421.59, p< 0.001. Conclusions: This study shows the need to encourage the daily practice of health promotion in the elderly, in order to achieve a stable blood pressure and the prevention of any event and/or problem related to the use of anti-hypertensive drugs that may affect the therapeutic effect and on the well-being of the patient.

Resumo Introdução: a promoção da saúde psicofísica e a segurança do uso responsável dos anti-hipertensivos é uma necessidade para melhorar a qualidade e esperança de vida do paciente. Objetivo: achar a relação de fatores de risco que influem na confiança nos fármacos dos pacientes que usam anti-hipertensivos em um grupo de adultos maiores com doença cardiovascular. Metodologia: estudo quantitativo exploratório transversal descritivo. Aplicou-se o instrumento Sistema de Dispensação para usuários Crónicos em validação a 45 adultos maiores entre 50 e 88 anos com diagnóstico clínico de doença cardiovascular durante 2015. Resultados: o ANOVA multifatorial com o pacote estatístico IBM SPSS 2016, evidenciou relação estatística alta F (1) = 27,43; p< 0,001 entre os fatores de risco, a não aderência e ineficácia o uso anti-hipertensivo. A análise comparativa da diferença de média entre a não aderência ao tratamento e a média da farmacoterapia eficaz e ineficaz, revelou uma diferença muito alta t (1) = 421.59, p< 0,001. Conclusões: Este estudo amostra a necessidade de fomentar a prática cotidiana da promoção da saúde ao adulto maior, a fim de obter uma pressão arterial estável e a prevenção de algum evento e/ou problema relacionado ao uso do anti-hipertensivo que possa incidir no efeito terapêutico e no bem-estar do paciente.

Eventos adversos del nimotuzumab en pacientes con tumor cerebral primario / Adverse events to the nimotuzumab in patients with primary cerebral tumor

Introducción: El nimotuzumab es un anticuerpo monoclonal empleado en el tratamiento de pacientes con tumor cerebral. Dada su novedad se justifica la realización de estudios de farmacovigilancia que avalen su seguridad. Objetivo: Caracterizar los eventos adversos relacionados con este medicamento en la práctica médica habitual. Métodos: Se realizó un estudio descriptivo y transversal de 41 pacientes con tumor cerebral primario tratados con nimotuzumab en el Departamento de Ensayos Clínicos del Hospital Provincial Docente Saturnino Lora Torres de Santiago de Cuba, desde mayo de 2017 hasta abril de 2019. Resultados: En la serie se identificaron 31 eventos adversos, de los cuales 17 eran conocidos y 14 desconocidos. Predominaron la cefalea (80,5 %), la debilidad en miembros inferiores (48,8 %) y la fosfatasa alcalina elevada (41,5 %). Cabe destacar que el total de los efectos no deseados se consideraron ligeros, según su intensidad; reversibles, según sus resultados y sin cambios, según la actitud respecto al medicamento. Conclusiones: Las características de los eventos adversos encontrados se asemejan a las descritas en otros estudios que también avalan la seguridad del fármaco.

Introduction: The nimotuzumab is a monoclonal antibody used in the treatment of patients with cerebral tumor. The realization of pharmaco surveillance studies that guaranteed its security is justified given its new features. Objective: To characterize the adverse events related to this medicine in the habitual medical practice. Methods: A descriptive and cross-sectional study of 41 patients with primary cerebral tumor treated with nimotuzumab in the Clinical Trial Department of Saturnino Lora Torres Teaching Provincial Hospital was carried out in Santiago de Cuba, from May, 2017 to April, 2019. Results: In the series 31 adverse events were identified, of which 17 were known and 14 were unknown. There was a prevalence of the headache (80.5 %), weakness in lower members (48.8 %) and the high alcaline phosphatase (41.5 %). It is necessary to highlight that all the non wanted effects were considered light according to the intensity; reversible, according to the results and without changes, according to the attitude regarding the medicine. Conclusions: The characteristics of the adverse events that were found resemble to those described in other studies that also guarantee the security of the drug.

Prognostic role of neutrophil-to-lymphocyte ratio in patients with ST-elevation myocardial infarction undergoing to pharmaco-invasive strategy.

OBJECTIVES: We sought to determine the relationship between in-hospital mortality and the neutrophil-to-lymphocyte ratio (NLR) in patients with ST-elevation myocardial infarction (STEMI) undergoing with pharmaco-invasive strategy (PIS). BACKGROUND: Increased levels of white blood cells have been associated with adverse clinical outcomes in patients with (STEMI). NLR has recently emerged as a potent and more specific prognostic marker in predicting short- and long-term mortalityin patients undergoing primary percutaneous coronary intervention. This association has never been reported in patients managed with PIS. METHODS: Between March 2010 and October 2016, 1860 STEMI patients managed with PIS were consecutively included in a dedicated database. The study population was divided into tertiles based on the admission NLR values (lower: <4.0, intermediate: 4.0 to <7.3, and upper: ≥7.3). Co-primary endpoints were in-hospital mortality and MACE (death, non-fatal reinfarction or stent thrombosis). RESULTS: Patients in the upper NLR tertile had significantly higher in-hospital mortality (9.0% vs. 4.8% versus. 1.8%, p < 0.001) and MACE (11.6% vs. 8.0% versus 2.9%, p < 0.001) than patients with intermediate or low NLR. By multivariable logistic regression analysis, the upper NLR tertile was an independent predictor of MACE (odds radio [OR] 4.19, 95% confidence interval [95% CI] 2.23-7.88, p < 0.001) and in-hospital mortality [OR 3.32, 95% CI 1.19-9.28, p = 0.02]. CONCLUSION: High NLR values were independently associated with in-hospital MACE and death in STEMI patients submitted to a PIS. NLR might be a simple and useful risk stratification tool in this high-risk population.

Variantes genéticas del SARS-CoV-2 y sus implicaciones clínicas / Genetic variants of SARS-CoV-2 and its clinical implications

El SARS-CoV-2, agente causal de la actual pandemia de la COVID-19, va sufriendo mutaciones como consecuencia de su ciclo evolutivo, lo que ha originado diferentes variantes genéticas, que han sido agrupadas en dos categorías: preocupante (alfa o británica, beta o sudafricana, gamma o brasileña y delta o india) y de interés (lamdba, mu, épsilon, eta, iota, kappa, zeta, theta); estas conllevan implicaciones clínicas en la transmisibilidad, virulencia y resistencia del SARS-CoV-2 a la inmunidad natural y adquirida, lo que representa un serio desafío para los servicios de salud en todo el mundo. En este artículo se describen dichas variantes genéticas, con énfasis en su probable impacto clínico, y además se plantea la posibilidad de que aparezcan otras, como fenómeno natural en la evolución de los virus.

The SARS-CoV-2, causal agent of the COVID-19 current pandemic, is suffering mutations as a consequence of its evolutive cycle, what has originated different genetic variants that have been grouped in two categories: worrying (alpha or British, beta or South African, gamma or Brazilian and delta or Indian) and of interest (lamdba, mu, epsilon, eta, iota, kappa, zed, theta); these categories bear clinical implications in the transmissibility, virulence and resistance from SARS-CoV-2 to the natural and acquired immunity, what represents a serious challenge in health services worldwide. These genetic variants are described in this work, with emphasis in its probable clinical impact, and the possibility that other variants could appear is also explained, as natural phenomenon in the evolution of viruses.

Estudio de utilización de fármacos antigotosos en población colombiana, 2016 / Patterns of anti-gout drug use in a Colombian population: 2016

RESUMEN Objetivo: Identificar las características clínicas de los pacientes con gota y la forma de utilización de los medicamentos antigotosos en Colombia. Métodos: Estudio de corte transversal en el que se analizaron 310 historias clínicas de pacientes atendidos en el último trimestre del 2016 y que recibieron un medicamento antigotoso. Se identificaron variables sociodemográficas, clínicas, farmacológicas, comorbilidades y paraclínicas. Para cada medicamento antigotoso se determinó si el uso fue según las recomendaciones aprobadas por la Federal Drug Administration (FDA). Se realizaron análisis descriptivos, bivariados y multivariados. Resultados: Se evaluaron pacientes de 14 diferentes ciudades de Colombia, con un predominio masculino del 70,3% (n = 218) y una mediana de edad de 64 arios (RIC: 26-94 arios). El antigotoso más frecuentemente utilizado fue alopurinol (n = 255; 82,3%), seguido de colchicina (n = 54; 17,4%). Los diagnósticos hallados como indicación fueron: hiperuricemia (n = 181; 58,4%), gota (n = 34; 11%), artritis gotosa (n = 28; 9%). El 74,5% (n = 231) de las prescripciones tenía un uso aprobado según la FDA, especialmente alopurinol en el manejo de gota e hiperuricemias, mientras que colchicina se encontró siendo utilizada en indicaciones no aprobadas (n = 44; 81,4%). Las comorbilidades más frecuentes fueron hipertensión (68,4%) y dislipidemia (55,8%). Conclusiones: Los pacientes con gota en tratamiento farmacológico tienen una elevada frecuencia de comorbilidades cardiovasculares, y están siendo tratados con alopurinol para la prevención a largo plazo, mientras que una menor proporción recibe colchicina que comúnmente es utilizada para indicaciones no aprobadas por las agencias reguladoras.

ABSTRACT Objective: To identify the clinical characteristics of patients with gout, and the prescription patterns of anti-gout medications in Colombia. Methods: Cross-sectional study, that analysed the data from 310 medical records of patients treated in the last quarter of 2016, and who received an anti-gout medication. Sociodemographic, clinical, pharmacological, comorbidities, and paraclinical variables were identified. For each anti-gout drug used, it was determined whether the use was in accordance with Federal Drug Administration (FDA) approved recommendations. Descriptive, bivariate and multivariate analyses were performed. Results: Patients from 14 different cities in Colombia were evaluated, with a male predominance of 70.3% (n = 218) and a median age of 64 years (RIC: 26-94 years). The most frequently used anti-gout medication was allopurinol (n = 255; 82.3%), followed by colchicine (n = 54; 17.4%). The main diagnoses found as an indication were: hyperuricaemia (n=181, 58.4%), gout (n = 34; 11.0%), and gouty arthritis (n = 28; 9.0%). Almost three-quarters (74.5%; n = 231) of the prescriptions had an approved use according to the FDA, especially allopurinol in the management of gout and hyperuricaemia, while colchicine was found to be used in unapproved indications (n = 44, 81.4%). The most frequent comorbidities were hypertension (68.4%) and dyslipidaemia (55.8%). Conclusions: Patients with gout who are under pharmacological treatment have a high frequency of cardiovascular comorbidities. They were being treated with allopurinol for long-term prevention, while a smaller proportion received colchicine, which is often used for indications not approved by regulatory agencies.

Criterios de medicación potencialmente inapropiada para el anciano: una propuesta cubana / Medication approaches potentially inappropriate for the elderly: a Cuban proposal

Introducción: El impacto de la prescripción inapropiada de fármacos en el anciano ha llevado al desarrollo de métodos para su reducción en varias partes del mundo. Objetivo: Diseñar y validar los criterios de medicación potencialmente inapropiada en el anciano, adaptados al entorno sociosanitario de Cuba. Métodos: Se realizó una investigación cualitativa, en la cual los criterios fueron validados por medio de la metodología Delphi, por un comité de expertos (especialistas en medicina geriátrica y clínica de diferentes zonas geográficas del país), y se les calculó la consistencia interna mediante el coeficiente alfa de Cronbach. Resultados: Los criterios quedaron estructurados en tres listas: 1) medicación potencialmente inapropiada, medicamento indicado no prescripto, cuando no existe contraindicación para su uso; 2) medicación potencialmente inapropiada independiente del diagnóstico o la condición clínica; 3) medicación potencialmente inapropiada dependiente del diagnóstico o la condición clínica. Conclusiones: Se demostró la validez del contenido y la adecuada consistencia interna de los criterios diseñados para la identificación de medicación potencialmente inapropiada en el anciano.

Introduction: The impact of inappropriate prescription of medication in the elderly has led to the development of methods for its reduction in several parts of the world. Objective: To design and validate the medication approaches potentially inappropriate in the elderly, adapted to the socio-sanitary environment of Cuba. Methods: A qualitative investigation was carried out, in which the approaches were validated by means of the Delphi methodology, by an experts committee (specialists in geriatrics medicine and clinic from different geographical areas of the country), and the internal consistency was calculated by means of the alpha coefficient of Cronbach. Results: The approaches were structured in three lists: 1) potentially inappropriate medication, advised medication non prescribed, when contraindication doesn't exist for its use; 2) medication potentially inappropriate, independent from the diagnosis or clinical condition; 3) potentially inappropriate medication, depending on the diagnosis or clinical condition. Conclusions: The validity of the content and the appropriate internal consistency of the designed approaches for the medication identification potentially inappropriate in the elderly were demonstrated.

Enfermedad celíaca, epilepsia y calcificaciones cerebrales / Celiac disease, epilepsy and cerebral calcifications

Resumen Varón de 33 años con antecedentes de convulsiones febriles y discapacidad intelectual moderada grave, inició a los 2 años convulsiones tanto focales como generalizadas atónicas diarias, que ocasionaron traumas faciales. Debido a la farmacorresistencia se implantó un estimulador del nervio vago, con respuesta parcial al mismo. Durante su seguimiento, se hizo diagnóstico de enfermedad celíaca. Al realizar una tomografía de encéfalo se evidenciaron calcificaciones piriformes occipitales bilaterales, estableciéndose el diagnostico de enfermedad celiaca, epilepsia y calcificaciones cerebrales. Se le indicó dieta libre de gluten y continuar el tratamiento farmacológico, logrando de esta manera una reducción de las crisis.

Abstract A 33-year-old man with a history of febrile seizures and moderate-severe intellectual disability began, at 2 years, both focal and generalized daily atonic seizures, which caused facial trauma. Due to drug resistance, a vagus nerve stimulator was implanted, with partial response to it. During his follow-up, he was diagnosed with celiac disease. When performing a brain tomography, bilateral occipital pyriform calcifications were evidenced, establishing the diagnosis of celiac disease, epilepsy and cerebral calcifications. A gluten-free diet was indicated and pharmacological treatment continued, thus achieving a reduction in seizures.

[Celiac disease, epilepsy and cerebral calcifications]. / Enfermedad celíaca, epilepsia y calcificaciones cerebrales.

A 33-year-old man with a history of febrile seizures and moderate-severe intellectual disability began, at 2 years, both focal and generalized daily atonic seizures, which caused facial trauma. Due to drug resistance, a vagus nerve stimulator was implanted, with partial response to it. During his follow-up, he was diagnosed with celiac disease. When performing a brain tomography, bilateral occipital pyriform calcifications were evidenced, establishing the diagnosis of celiac disease, epilepsy and cerebral calcifications. A gluten-free diet was indicated and pharmacological treatment continued, thus achieving a reduction in seizures.

Varón de 33 años con antecedentes de convulsiones febriles y discapacidad intelectual moderada grave, inició a los 2 años convulsiones tanto focales como generalizadas atónicas diarias, que ocasionaron traumas faciales. Debido a la farmacorresistencia se implantó un estimulador del nervio vago, con respuesta parcial al mismo. Durante su seguimiento, se hizo diagnóstico de enfermedad celíaca. Al realizar una tomografía de encéfalo se evidenciaron calcificaciones piriformes occipitales bilaterales, estableciéndose el diagnostico de enfermedad celiaca, epilepsia y calcificaciones cerebrales. Se le indicó dieta libre de gluten y continuar el tratamiento farmacológico, logrando de esta manera una reducción de las crisis.

Cost-minimization Analysis of Ranibizumab versus Aflibercept in the Treatment of Neovascular Age-related Macular Degeneration in Colombia.

BACKGROUND: In 2020 Colombia may expect to have close to 231,700 patients with neovascular age-related macular degeneration (ARMD). Treatment of neovascular ARMD involves the sequential Intra-vitreal injections of anti-vascular endothelial growth factor (anti-VEGF therapy) medications. The efficacy and safety of anti-VEGF therapy on a treat-and-extend (T&E) dosing scheme are similar when ranibizumab or aflibercept are administered. Objective : A cost-minimization analysis from the payer`s perspective in Colombia projects treatment expenses of anti-VEGF therapy using aflibercept or ranibizumab on T&E regimens for the treatment of neovascular ARMD. Methods : A model projects the expenses of the compared treatment regimens for two and five-year periods beginning on February 2020. The model used information from clinical trials, case series and meta-analyses on the compared treatment regimens, demographic, epidemiologic and economic data originated from the Colombian government sources. A 3% discount rate was applied. Results : Projected cost differences in favor of ranibizumab after two and five-year treatment periods beginning February 2020 could be close to U.S. $ 4,861 and U.S $ 7,241 per treated eye, respectively. If all patients with unilateral and bilateral neovascular ARMD in Colombia were to receive appropriate anti-VEGF therapy for two years, the projected expected cost difference in favor of ranibizumab could be close to U.S. $ 462,717,092 dollars. Conclusion : Within the Colombian healthcare setting anti-VEGF therapy on a T&E regimen utilizing ranibizumab for neovascular ARMD may be cost-saving compared with employing aflibercept. Despite cost favorability, ranibizumab should not be the only therapeutic option since in clinical practice alternatives are required.

The Impact of Advanced Age on Major Cardiovascular Events and Mortality in Patients with ST-Elevation Myocardial Infarction Undergoing a Pharmaco-Invasive Strategy.

BACKGROUND: There is little research in the efficacy and safety of a pharmaco-invasive strategy (PIS) in patients ≥75 years versus <75 years of age. We aimed to evaluate and compare the influence of advanced age on the risk of death and major adverse cardiac events (MACE) in patients undergoing PIS. METHODS: Between January 2010 and November 2016, 14 municipal emergency rooms in São Paulo, Brazil, used full-dose tenecteplase to treat patients with STEMI as part of a pharmaco-invasive strategy for a local network implementation. RESULTS: A total of 1852 patients undergoing PIS were evaluated, of which 160 (9%) were ≥75 years of age. Compared to patients <75 years, those ≥75 years were more often female, had lower body mass index, higher rates of hypertension; higher incidence of hypothyroidism, chronic renal failure, prior stroke, and diabetes. Compared to patients <75 years of age, in-hospital MACE and mortality were higher in patients with ≥75 years (6.5% versus 19.4%; p<0.001; and 4.0% versus 18.2%; p<0.001, respectively). Patients ≥75 years had higher rates of in-hospital major bleeding (2.7% versus 5.6%; p=0.04) and higher incidence of cardiogenic shock (7.0% versus 19.6%; p<0.001). By multivariable analysis, age ≥75 years was independent predictor of MACE (OR 3.57, 95% CI 1.72 to 7.42, p=0.001) and death (OR 2.07, 95% CI 1.12-3.82, p=0.020). CONCLUSION: In patients with ST-segment elevation myocardial infarction undergoing PIS, age ≥75 years was an independent factor that entailed a 3.5-fold higher MACE and 2-fold higher mortality rate compared to patients <75 years of age.

The impact of ethnic density on dispensing of antipsychotic and antidepressant medication among immigrants in the Netherlands.

PURPOSE: A higher own-group ethnic density in the area of residence is often associated with a lower risk for psychotic disorder. For common mental disorders the evidence is less convincing. This study explores whether these findings are mirrored in data on dispensing of antipsychotics and antidepressants. METHODS: Health insurance data on dispensed medication among all adults living in the four largest Dutch cities were linked to demographic data from Statistics Netherlands. Dispensing of antipsychotics and antidepressants in 2013 was analyzed in relation to the proportion of the own ethnic group in the neighborhood. RESULTS: Higher own-group ethnic density was associated with lower dispensing of antipsychotics among the Moroccan-Dutch (N = 115,455), after adjusting for age, gender, and SES of the neighborhood (ORadj for the highest vs. the lowest density quintile = 0.72 [0.66-0.79]). However, this association vanished after adjustment for household composition (ORadj = 0.93 [0.85-1.03]). Similar results were found for the Turkish-Dutch (N = 105,460) (ORadj = 0.86 [0.76-0.96] and 1.05 [0.94-1.18]). For those of Surinamese (N = 147,123) and Antillean origin (N = 41,430), in contrast, the association between ethnic density and lower risk remained after each adjustment (P < 0.001). For antidepressants, a negative association with own-group ethnic density was consistently found for those of Antillean origin (ORadj = 0.62 [0.52-0.74]) only. CONCLUSION: These data on dispensing of psychomedication confirm the ethnic density hypothesis for psychosis alongside earlier equivocal findings for other mental disorders. The negative association between own-group ethnic density and dispensing of antipsychotics among the Moroccan- and Turkish-Dutch may be explained, at least in part, by a favourable household composition (i.e., living in a family) in high-density neighborhoods.

Successful Treatment of a Drug-Resistant Epilepsy by Long-term Transcranial Direct Current Stimulation: A Case Report.

Transcranial direct current stimulation (tDCS) is a reemerged noninvasive cerebral therapy used to treat patients with epilepsy, including focal cortical dysplasia, with controversial results. We present a case of a 28-year-old female with left frontal cortical dysplasia refractory to antiepileptic drugs, characterized by 10-15 daily right tonic hemi-body seizures. The patient received a total of seven sessions of cathodal tDCS (2 mA, 30 min). The first three sessions were applied over three consecutive days, and the remaining four sessions of tDCS were given each at 2-week intervals. At the 1-year follow-up, the patient reported to have a single seizure per month and only mild adverse events.

Pharmaco-parasitological evaluation of the ricobendazole plus levamisole nematodicidal combination in cattle.

The goals of the current study were to evaluate the potential pharmacokinetic (PK) interactions and the clinical efficacy occurring after the subcutaneous (s.c.) administration of ricobendazole (RBZ) and levamisole (LEV) given both separately and co-administered to calves naturally infected with susceptible gastrointestinal nematodes. The clinical efficacy was shown in two seasons, winter and spring, with predominance of different nematode populations. Groups of 15 calves were treated with RBZ alone, LEV alone and RBZ + LEV combination, and an untreated group was kept as a Control. RBZ and LEV plasma concentrations were quantified by HPLC. The clinical efficacy was determined by the faecal egg count reduction test. RBZ and LEV have similar plasma persistence, being detected in plasma over 24 hr post-treatment. No PK interactions were observed after the combined treatment, with similar PK parameters (p > .05) obtained for the single-drug and the combination-based strategy. In winter, the observed clinical efficacies were 96%, 99% and 100% for groups treated with RBZ, LEV and RBZ + LEV, respectively; however, in spring, the efficacies were 95%, 93% and 96% for the same groups. Remarkably, the combination was the only treatment that achieved 100% clinical efficacy against both Haemonchus spp and Ostertagia spp in winter; but the increased presence of Ostertagia spp. in spring (28% in untreated group) determined a tendency to reduced efficacies compared to winter time (only 10% of Ostertagia spp. in untreated group), even for the combined treatment. Overall, in a scenario where the nematode population is susceptible, the RBZ + LEV treatment may be a valid combination in cattle to delay the development of resistance, especially in winter when this combination achieved 100% of efficacy. Thus, selection of anthelmintic resistance will never occur. In fact, this is one of the greatest challenges for the whole cattle production system: to be one step ahead of anthelmintic resistance.

Seguridad de las fluoroquinolonas: riesgos habitualmente olvidados para el clínico / Safety of fluoroquinolones: risks usually forgotten for the clinician

Resumen Las quinolonas constituyen una familia de antimicrobianos de amplio uso y si bien son consideradas segura para los pacientes, el conocimiento del perfil de seguridad es necesario para que los profesionales estén alertas a lo que deben vigilar. Sobre el sistema músculo-esquelético, las quinolonas tienen el potencial de dañar cartílagos, provocando incluso muy excepcionalmente rotura de tendón. A nivel endocrino se ha observado hipoglicemia/hiperglicemia, por lo que en pacientes diabéticos se recomienda el control cuidadoso de la glicemia. Las reacciones adversas cardiovasculares son poco frecuentes, pero pueden ir desde alteraciones del ECG como prolongación del QT sin traducción clínica a graves arritmias que pueden ser de riesgo vital. En el sistema nervioso, destaca la aparición de alteraciones del sistema nervioso central y la neuropatía periférica. Durante la evaluación de la seguridad de las quinolonas es importante considerar las potenciales interacciones con otros medicamentos. En niños se prefiere no usar las fluoroquinolonas debido al potencial riesgo de daño a los cartílagos de crecimiento, efectos que no parecen ser tan dramáticos a la luz de la evidencia actual. A pesar del optimismo se debe evaluar la seguridad del tratamiento de estos antimicrobianos en todo paciente pediátrico.

Quinolones are a group of widely used antimicrobials. Although they are considered safe for patients, knowledge of the safety profile is necessary so that professionals become aware of what is necessary to monitor. At the musculoskeletal level, quinolones have the potential to damage cartilage, causing even tendon rupture in infrequent cases. Hypoglycemia / hyperglycemia has been observed at the endocrine level, thus, careful monitoring of glycemia in patients with quinolone is recommended in diabetic patients. At the cardiovascular level, arrhythmias induced by these antimicrobials are rare but severe. At the level of the nervous system, the appearance of alterations of the central nervous system and the peripheral neuropathy are emphasized. When assessing the safety of quinolones, it is important to consider potential interactions with other substances (medical products). In children it is preferred not to use fluoroquinolones because of the potential risk of cartilage damage and growth, effects that do not seem to be so dramatic in the face of new evidence. Despite optimism, the safety of the treatment of these antimicrobials should be evaluated in every pediatric patient.

Listado de medicamentos trazadores/señaladores como herramienta en programas de seguimiento farmacoterapéutico o de farmacoseguridad / List of drug tracers/ markers as a tool in pharmacotherapeutic follow-up or drug-safety programs

Resumen Introducción: los resultados negativos asociados a la medicación (RNM), incluyendo las reacciones adversas a medicamentos (RAM) o problemas de seguridad, son un problema clínico relevante, debido a su alta incidencia y a efectos nocivos en la salud. Un medicamento podría ser considerado como trazador/señalador, debido a: 1) una mayor probabilidad de causar RAM o problemas de seguridad; o 2) su utilización para tratar y por tanto identificar pacientes con RAM. Los listados de medicamentos trazadores podrían ser útiles en los programas de farmacoseguridad o seguimiento farmacoterapéutico (SFT). Objetivo: el objetivo de este trabajo fue estructurar un listado de medicamentos trazadores/ señaladores de los pacientes con mayor riesgo de presentar RNM, el cual podría ser útil para seleccionar pacientes para programas de SFT o farmacoseguridad. Obtención de datos: inicialmente, se realizó una revisión estructurada en PubMed/Medline para identificar medicamentos asociados a la presentación de RAM clasificadas como graves o moderadas y con una prevalencia igual o superior a 10%. Posteriormente, el listado de medicamentos identificados, fue comparado y complementado con medicamentos de alta alerta del Institute for Safe Medication Practices (ISMP) y con medicamentos utilizados para el tratamiento de RAM o antídotos. Resultados: se generó un listado general de 139 medicamentos trazadores/señaladores. Conclusiones: este listado podría ser una herramienta para detectar y seleccionar los pacientes que más se podrían beneficiar de los programas de SFT o farmacoseguridad. Se requiere de la realización de estudios diseñados para evaluar la utilidad práctica de dicho listado.

Abstract Introduction: negative outcomes associated with medication (NOM), including adverse drug reactions (ADRs) or safety problems, are a relevant clinical problem due to their high incidence and harmful effects on health. A drug could be considered a tracer / marker because of: 1) an increased likelihood of causing ADR or safety problems; or 2) its use to treat and therefore identify patients with ADR. Tracer drug listings could be useful in pharmacological safety or pharmacotherapeutic monitoring programs. Objective: the objective of this study was to structure a list of drug tracer / markers of the patients with the highest risk of presenting NOM, which could be useful to select patients for FFT or pharmacological safety programs. Data collection: initially, a structured review was performed in PubMed / Medline to identify drugs associated with the presentation of ADRs classified as severe or moderate and with a prevalence of 10% or greater. Subsequently, the list of identified medications was compared and complemented with high alert medications of the Institute for Safe Medication Practices (ISMP) and medications used to treat ADRs or antidotes. Results: a general listing of 139 drug tracers / markers was generated. Conclusions: this listing could be a tool to detect and select the patients who could most benefit from the FTS or pharmacological safety programs. Studies designed to evaluate the practical usefulness of this listing are required.

Medication errors in outpatient care in Colombia, 2005-2013.

INTRODUCTION: Medication errors outside the hospital have been poorly studied despite representing an important threat to patient safety. OBJECTIVE: To describe the characteristics of medication errors in outpatient dispensing pharmacists reported in a pharmaco-surveillance system between 2005 and 2013 in Colombia. MATERIALS AND METHODS: We conducted a descriptive study by reviewing and categorizing medication error reports from outpatient pharmacy services to a national medication dispensing company between January, 2005 and September, 2013. Variables considered included: process involved (administration, dispensing, prescription and transcription), wrong drug, time delay for the report, error type, cause and severity. The analysis was conducted in the SPSS® software, version 22.0. RESULTS: A total of 14,873 medication errors were reviewed, of which 67.2% in fact occurred, 15.5% reached the patient and 0.7% caused harm. Administration (OR=93.61, CI 95%: 48.510-180.655, p<0.001), dispensing (OR=21.58, CI 95%: 16.139-28.870, p<0.001), transcription errors (OR=5.64; CI 95%: 3.488-9.142, p<0.001), medicines for sensory organs (OR=2.04, CI 95%: 1.519-2.756, p<0.001), anti-infective drugs for systemic use (OR=1.99, CI 95%: 1.574-2.525, p0.001), confusion generated with the name of the drug (OR=1.28, CI 95%: 1.051-1.560, p=0.014), and trouble interpreting prescriptions (OR=1.32, CI 95%: 1.037-1.702, p=0.025) increased the risk for error reaching the patient. CONCLUSIONS: It is necessary to develop surveillance systems for medication errors in ambulatory care, focusing on the prescription, transcription and dispensation processes. Special strategies are needed for the prevention of medication errors related to anti-infective drugs.

Medication errors in outpatient care in Colombia, 2005-2013 / Errores de medicación en pacientes atendidos en servicios ambulatorios de Colombia, 2005-2013

Introduction: Medication errors outside the hospital have been poorly studied despite representing an important threat to patient safety. Objective: To describe the characteristics of medication errors in outpatient dispensing pharmacists reported in a pharmaco-surveillance system between 2005 and 2013 in Colombia. Materials and methods: We conducted a descriptive study by reviewing and categorizing medication error reports from outpatient pharmacy services to a national medication dispensing company between January, 2005 and September, 2013. Variables considered included: process involved (administration, dispensing, prescription and transcription), wrong drug, time delay for the report, error type, cause and severity. The analysis was conducted in the SPSS ® software, version 22.0. Results: A total of 14,873 medication errors were reviewed, of which 67.2% in fact occurred, 15.5% reached the patient and 0.7% caused harm. Administration (OR=93.61, CI 95%: 48.510-180.655, p<0.001), dispensing (OR=21.58, CI 95%: 16.139-28.870, p<0.001), transcription errors (OR=5.64; CI 95%: 3.488-9.142, p<0.001), medicines for sensory organs (OR=2.04, CI 95%: 1.519-2.756, p<0.001), anti-infective drugs for systemic use (OR=1.99, CI 95%: 1.574-2.525, p<0.001), confusion generated with the name of the drug (OR=1.28, CI 95%: 1.051-1.560, p=0.014), and trouble interpreting prescriptions (OR=1.32, CI 95%: 1.037-1.702, p=0.025) increased the risk for error reaching the patient. Conclusions: It is necessary to develop surveillance systems for medication errors in ambulatory care, focusing on the prescription, transcription and dispensation processes. Special strategies are needed for the prevention of medication errors related to anti-infective drugs.

Introducción. Los errores de medicación en la atención ambulatoria se han estudiado poco, a pesar de que representan una amenaza importante para la seguridad del paciente. Objetivo. Describir las características de los errores de medicación en atención ambulatoria reportados por un sistema de farmacovigilancia de Colombia entre el 2005 y el 2013. Materiales y métodos. Se hizo un estudio descriptivo en el cual se recopilaron, revisaron y categorizaron los reportes de errores de medicación de pacientes atendidos en un servicio farmacéutico ambulatorio a cargo de una empresa nacional de dispensación de medicamentos, entre enero de 2005 y septiembre de 2013. Se consideraron variables que involucraban el proceso (administración, dispensación, prescripción y transcripción), el medicamento, el tiempo para elaborar el reporte, el tipo de error, su causa y su gravedad. El análisis se hizo con el programa SPSS ® , versión 22.0. Resultados. Se recopilaron 14.873 errores de medicación, de los cuales 67,2 % realmente ocurrió, 15,5 % afectó al paciente y 0,7 % causó daño. Los errores de administración (p<0,001; OR=93,614; IC 95% 48,510-180,655), de dispensación (p<0,001; OR=21,585; IC 95% 16,139-28,870), de transcripción (p<0,001; OR=5,647; IC 95% 3,488-9,142), los relacionados con medicamentos para los órganos de los sentidos (p<0,001; OR=2,046; IC 95% 1,519-2,756), y con los medicamentos de uso sistémico contra infecciones (p<0,001; OR=1,993; IC 95% 1,574-2,525), la confusión en el nombre del fármaco (p=0,014; OR=1,281; IC 95% 1,051-1,560) y los problemas en la interpretación de las prescripciones (p=0,025; OR=1,328; IC 95% 1,037-1,702), aumentaron el riesgo de que el error afectara al paciente. Discusión. Es necesario establecer sistemas de vigilancia específicos para errores de medicación en los servicios ambulatorios, que hagan énfasis en los procesos de prescripción, transcripción y dispensación. Se requieren estrategias específicas para la prevención de los errores de medicación relacionados con antibióticos.

Estudio de utilización de antibióticos en el servicio de consulta externa de un hospital público en Bogotá, D.C. / Study of the use of antibiotics in the outpatient service of a public hospital in Bogotá, D. C.

Se realizó un estudio de utilización de medicamentos sobre hábitos y calidad de la prescripción, con el fin de describir las características y potencial uso no adecuado de los antibióticos en el servicio de consulta externa de un hospital de segundo nivel de la ciudad de Bogotá, D.C. En las 8077 prescripciones analizadas se encontraron 613 (8%) con al menos un antibiótico de uso sistémico. Los antibióticos más dispensados fueron: Amoxicilina, Cefalexina, Ciprofloxacina, Dicloxacilina, Doxiciclina. Se prescribieron combinaciones de dos antibióticos en el 3% de las fórmulas, siendo la más frecuente macrólido-penicilina. Todas las prescripcion esanalizadas cumplieron con los requisitos de calidad y el 0,4% de los tratamientos no tenían el tiempo de duración del tratamiento. La frecuencia de uso de los antibióticos en el servicio de consulta externa fue más baja que en otros estudios. Se identificaron potenciales usos no adecuados como la falta de diagnóstico infeccioso, combinación de antibióticos no documentada, interacciones de medicamentos y falta de información adecuada en la administración de tetraciclinas.

A study on drug use habits and quality of prescribing was conducted to describe the characteristics and potential inadequate use of antibiotics in the outpatient service of one of the Bogota's second-level hospitals. In 8077 prescriptions analyzed it was found 613 (8%) with at least one antibiotic for systemic use. Amoxicillin, Cephalexin, Ciprofloxacin, Dicloxacillin, and Doxycycline were the most dispensed antibiotics. Combinations of two antibiotics were prescribed for 3% of the formulas; the most common of these was macrolide-penicillin. All prescriptions analyzed met the quality requirements and only 0.4% of the treatments did not have the time duration of treatment. The found frequency of use of antibiotics in outpatient services was lower than in other studies. Potential not suitable uses as the lack of infectious diagnosis, antibiotic combination unreported, drug interactions and lack of adequate information on the administration of tetracyclines were identified.

Increased expression of BDNF transcript with exon VI in hippocampi of patients with pharmaco-resistant temporal lobe epilepsy.

A putative role of the brain-derived neurotrophic factor (BDNF) in epilepsy has emerged from in vitro and animal models, but few studies have analyzed human samples. We assessed the BDNF expression of transcripts with exons I (BDNFI), II (BDNFII), IV (BDNFIV) and VI (BDNFVI) and methylation levels of promoters 4 and 6 in the hippocampi of patients with pharmaco-resistant temporal lobe epilepsy (TLE) (n=24). Hippocampal sclerosis (HS) and pre-surgical pharmacological treatment were considered as clinical independent variables. A statistical significant increase for the BDNFVI (p<0.05) was observed in TLE patients compared to the autopsy control group (n=8). BDNFVI was also increased in anxiety/depression TLE (N=4) when compared to autopsies or to the remaining group of patients (p<0.05). In contrast, the use of the antiepileptic drug Topiramate (TPM) (N=3) was associated to a decrease in BDNFVI expression (p<0.05) when compared to the remaining group of patients. Methylation levels at the BDNF promoters 4 and 6 were similar between TLE and autopsies and in relation to the use of either Sertraline (SRT) or TPM. These results suggest an up-regulated expression of a specific BDNF transcript in patients with TLE, an effect that seems to be dependent on the use of specific drugs.