An expert review of clozapine in Latin American countries: Use, monitoring, and pharmacovigilance.

There is growing interest in clozapine clinical use, monitoring, and research, particularly adverse drug reactions (ADRs) other than agranulocytosis. In this study we focused on clozapine pharmacovigilance. Hence, we contacted clinicians and researchers in Latin America and requested information about local psychiatric services, clozapine availability, clinical use, and ADR monitoring with the VigiBase system. Only two countries have the minimum recommended number of psychiatric beds (15 per 100,000 residents): Uruguay (N = 34.9) and Argentina (N = 17). Bolivia is the only country where clozapine is unavailable. Nine out of twenty countries (45 %) reported ADRs to VigiBase. Argentina, Brazil, Chile, Colombia, and Mexico published national guidelines for schizophrenia treatment. Chile is the sole country with clozapine clinics with drug serum monitoring. Ethnicity-related drug titration in not described in package inserts in any country. We examined in detail the 9 most frequent and important clozapine ADRs in the worldwide database (pneumonia, sudden death, cardiac arrest, agranulocytosis, myocarditis, constipation, arrhythmia, seizure, and syncope). These 9 ADRs led to 294 reports with fatal outcomes in Argentina (N = 3), Brazil (N = 3), Chile (N = 2), and Peru (N = 1). Agranulocytosis was reported from 7 countries: constipation or seizures from 8 countries. Only two countries reported pneumonia and one country reported myocarditis. The number of clozapine reports in VigiBase has no relationship to the country's population. All Latin American countries underreport clozapine associated ADRs. Latin American governments, along with clinicians, researchers, and educators, should optimize clozapine use and monitoring for the benefit of people with severe mental and some neurological disorders.

Validación al español del Self-Harm Questionnaire para detección de autolesionismo en adolescentes / Validation into Spanish language of the Self-Harm Questionnaire for detection of self-harming in adolescents

ANTECEDENTES: El autolesionismo comprende las conductas encaminadas al daño físico de la propia persona. Estas conductas son un fenómeno en aumento entre los adolescentes y pueden ser consideradas como predictores de muerte por suicidio, por lo que su identificación oportuna es una necesidad. El Cuestionario de autolesionismo permite identificar la presencia de pensamientos y conductas autolesivas.OBJETIVO: Validar el cuestionario de autolesionismo al español y determinar su valor diagnóstico para detectar autolesionismo en adolescentes mexicanos que reciben atención psiquiátrica.MÉTODO: Se realizó el procedimiento de traducción-retrotraducción para la adaptación de la escala al idioma español. Se seleccionó una muestra de 106 adolescentes de entre 11 y 17 años de edad en seguimiento por trastornos afectivos o ansiedad para la aplicación de la escala. Se evaluó la consistencia interna mediante el coeficiente de fiabilidad a de Cronbach y se determinó el coeficiente de correlación de Spearman por medio de una prueba test-retest tres meses después de la primera administración. Posteriormente, se realizó una revisión del expediente clínico para determinar la presencia de autolesionismo y realizar un análisis de la sensibilidad y especificidad del cuestionario para detectar el fenómeno.RESULTADOS: El cuestionario traducido presentó un a de Cronbach de 0.960 y una estabilidad temporal a tres meses de 0.9787. La sensibilidad para detectar autolesionismo fue de 97.96%, y la especificidad de 54.39%, comparadas con el expediente clínico.DISCUSIÓN Y CONCLUSIÓN: Los resultados de este estudio sugieren que la escala traducida es una herramienta válida y confiable para detectar autolesionismo en adolescentes mexicanos. La identificación rápida y oportuna de esta población es crucial para evitar suicidios. El uso de la escala puede ayudar a identificar a estos pacientes.

BACKGROUND: Self-injurious behaviour englobes conducts in which persons hurt or harm themselves. These conducts are an increasing phenomena among adolescents, and can be considered as predictors of death by suicide, making their opportune identification a necessity. The Self Harm Questionnaireallows the identification of thoughts and self-injurious conducts.OBJECTIVE: The objective of this study was to validate it into the Spanish language and to determine its diagnostic value for detecting self- injurious behaviour in Mexican adolescents under psychiatric follow up.METHOD: The translation-retrotranslation procedure was used for the adaptation of the questionnaire into Spanish. A sample of 106, 11 to 17 year-old adolescents under follow up because of affective disorders or anxiety was selected for the application of the questionnaire. Internal consistence was evaluated through the Cronbach a reliability coefficient, and the Spearman correlation coefficient was determined through a test-retest after 3 months of the first administration of the probe. Afterwards, an evaluation of the clinical records was performed to assess the sensitivity and specificity of the test to detect self-injurious behaviour.RESULTS: The translated questionnaire possess a Cronbach a of 0.960, and a 3 month temporal stability of 0.9787. The sensitivity to detect self-injurious behaviour was 97.96%, and its specificity was 54.39%, compared to the clinical records.DISCUSSION AND CONCLUSION: This study results suggest that the translated questionnaire is a valid and reliable tool to detect self-injurious behaviour in Mexican adolescents. Rapid and opportune identification of this population of patients is crucial to avoid suicides. The use of this questionnaire can help identify these patients.