Uso de psicofármacos durante la gestación: necesidad vs seguridad / Use of psychotropic drugs during pregnancy: necessity vs Safety

Resumen La seguridad de los psicofármacos durante el embarazo es un tema crucial en la práctica clínica. En esta revisión, se hace un breve recorrido sobre los cambios en el embarazo que impactan en la farmacodinamia de los medicamentos, además, se analizan los principales grupos farmacológicos en psiquiatría y sus efectos durante el embarazo. Se identifican tres períodos críticos durante el embarazo. El período de las primeras dos semanas se asocia con un mayor riesgo de aborto espontáneo. El período de la segunda a la décima semana es el más riesgoso, ya que pueden ocurrir alteraciones teratogénicas que afectan el desarrollo fetal. El período posterior a la décima semana se caracteriza por alteraciones en el crecimiento y desarrollo funcional del feto, pero suelen ser menos graves. Los antidepresivos, especialmente los inhibidores selectivos de la receptación de serotonina (ISRS) y los antipsicóticos de segunda generación se consideran los más seguros, pero estos últimos pueden estar asociados con síndrome metabólico, cardiopatías congénitas y trastornos del neurodesarrollo. El litio se ha asociado con efectos teratogénicos y malformaciones cardíacas, mientras que el valproato está relacionado con defectos congénitos importantes. Las benzodiacepinas pueden tener efectos tóxicos y causar síndrome de abstinencia en el recién nacido. La seguridad de los psicofármacos durante el embarazo requiere una evaluación individualizada de los beneficios y riesgos. Aunque algunos grupos de psicofármacos se consideran relativamente seguros, es necesario tener precaución y considerar las posibles complicaciones asociadas con su uso durante el embarazo.

Abstract: The safety of psychoactive drugs during pregnancy is a crucial issue in clinical practice. In this review, a brief overview of the changes in pregnancy that impact the pharmacodynamics of drugs is made; in addition, the main pharmacological groups in psychiatry and their effects during pregnancy are analyzed. Three critical periods during pregnancy are identified. The period of the first two weeks is associated with an increased risk of miscarriage. The period from the second to the tenth week is the most at risk , since teratogenic effects that affect fetal development can take place. The period after the tenth week is characterized by alterations in fetal growth and functional development , however ,less severe defects. Antidepressants, especially selective serotonin reuptake inhibitors (SSRIs), and second-generation antipsychotics are considered the safest, but the latter may be associated with metabolic syndrome, congenital heart disease, and neurodevelopmental disorders. Lithium has been associated with teratogenic effects and cardiac malformations, while valproate is associated with major birth defects. Benzodiazepines can have toxic effects and cause Neonatal Withdrawal Syndrome . The safety of psychotropic drugs during pregnancy requires an individualized assesment of the benefits and risks. Although some groups of psychiatric drugs are considered relatively safe, caution is needed when considering the potential complications associated with their use during pregnancy.

Judicialización de medicamentos de alto precio en Argentina: estudio cuali-cuantitativo / Judicialization of high priced medications in Argentina: quali-quantitative study

Resumen Introducción : Las consecuencias económicas de la cobertura obligatoria, vía judicial, de medicamentos de alto precio constituye un problema creciente, que amerita conocer sus características locales para aportar posibles soluciones. Objetivo : Identificar medicamentos, enfermedades, impacto económico y factores contextuales de la ju dicialización de medicamentos de alto precio (MEP) Argentina. Métodos : Estudio descriptivo cuali-cuantitativo que analizó retrospectivamente recursos de amparos legales por MEP de tres bases de datos nacionales y provinciales durante 4 años, evaluando relación existente entre am paros con aprobación regulatoria, inclusión de los MEP al paquete de beneficios y relación con notas periodísticas. Resultados : Se incluyeron 405 amparos provenientes principalmente del Ministerio de Salud Nacional. Los tres medicamentos más judicializados fueron nusiner sen (21.7%), palbociclib (5.9%) y agalsidasa-alfa (4.7%). Solo el 69.4% de los medicamentos se encontraban aprobados para la comercialización en Argentina al momento del amparo; el 45.7% se encontraban incorpo rados al Sistema Único de Reintegros y el 16.8% contaban con informe de la Comisión Nacional de Evaluación de Tecnologías Sanitarias y Excelencia Clínica (CONETEC), negativa en el 87.1% de casos. El tiempo promedio des de la solicitud hasta la provisión del medicamento fue de 150 días. Se observó una correlación temporal entre la aparición del MEP en la prensa nacional gráfica y la presentación de amparos de dicho MEP. Conclusiones : La judicialización se concentró en medicamentos de altísimo precio para enfermedades poco frecuentes u oncológicas. Los fallos fueron mayo ritariamente a favor del demandante, siendo los tiempos de acceso al medicamento prolongados. Los medios de comunicación anticiparon los procesos judiciales.

Abstract Introduction : The economic consequences of manda tory coverage, through judicial means, of high-priced medications constitutes a growing problem, which mer its knowing its local characteristics to provide possible solutions. Objective : To identify medications, diseases involved, economic impact and contextual factors of the judi cialization of high-priced medications in the Argentine Health System(MEP). Methods : Quali-quantitative descriptive study that retrospectively analyzed legal protection resources by MEP from three national and provincial databases from January 2017 to December 2020, evaluating the exist ing relationship between lawsuits with regulatory ap proval, inclusion in benefit packages and relationship with journalistic articles for the three most frequently prosecuted drugs. Results : 405 lawsuits were included, mainly from the Ministry of National Health. The three most prosecuted medications were nusinersen (21.7%), palbociclib (5.9%) and agalsidase-alfa (4.7%). Only 69.4% of medications were approved for marketing in Argentina at the time of the protection; 45.7% were incorporated into the Single Reimbursement System, and 16.8% had a report from the National Commission for the Evaluation of Health Technologies and Clinical Excellence (CONETEC), which was negative in 87.1% of cases. The average time from request to provision of the medication was 150 days. A temporal correlation was observed between the appear ance of the MEP in the national graphic press and the appeals occurrence. Conclusions : Judicialization focused on very high-priced medications for rare or oncological diseases. The rulings were mostly in favor of the plaintiff, and access times to the medication took a long time. The mass media anticipated the judicial processes.

Análisis comparativo entre regiones del mundo relacionado con el consumo de sustancias psicoactivas en las últimas tres décadas / Comparative analysis between regions of the world related to the consumption of psychoactive substances in the last three decades

Resumen El consumo de sustancias psicoactivas (SPA) trae efectos de adicción que modifican el pensamiento, la mente y el espíritu del adicto, no solo está generando un riesgo latente que afecta la salud de las personas, también trae consecuencias negativas para la sociedad misma, como mayor inversión económica en salud, presencia de habitantes de calle, aumento de delincuencia, entre otros aspectos. El objetivo del presente estudio consistió en evaluar las estadísticas relacionadas con el consumo de sustancias psicoactivas a nivel mundial en las últimas tres décadas. Para el análisis de la información se utilizó la técnica multivariada de la varianza MANOVA con contraste canónica ortogonal, se empleó el paquete estadístico SAS University en el proceso de la información. Como resultado destacado, se encontró divergencia estadística entre regiones, donde Norteamérica ocupa el primer lugar seguido de Asia y Oceanía. El mayor número de muertes por trastornos relacionados por el consumo de SPA se da en personas menores a los 49 años. El acelerado incremento y abuso en el consumo de SPA está generando altos índices de morbilidad y mortalidad a nivel global. Es una prioridad actuar con urgencia desde todos los frentes, profesionales de la salud, líderes políticos y comunitarios, entes educativos y núcleo familiar, para controlar esta problemática y tratar de disminuir el consumo y abuso de SPA.

Abstract The consumption of psychoactive substances (PAS) has addictive effects that modify the addict's thinking, mind and spirit, and not only generates a latent risk that affects people's health, but also has negative consequences for society itself, such as greater economic investment in health, the presence of street dwellers, and an increase in crime, among other aspects. The objective of this study was to evaluate the statistics related to the consumption of psychoactive substances worldwide in the last three decades. For the analysis of the information, the multivariate technique of variance MANOVA with orthogonal canonical contrast was used, and the SAS University statistical package was used to process the information. As an outstanding result, statistical divergence was found between regions, with North America occupying the first place followed by Asia and Oceania. The highest number of deaths due to disorders related to PAS consumption occurs in people under 49 years of age. The accelerated increase and abuse of PAS is generating high rates of morbidity and mortality globally. It is a priority to act urgently from all fronts, health professionals, political and community leaders, educational entities and the family nucleus, to control this problem and try to reduce the consumption and abuse of PAS.

Shortage of perioperative supplies and drugs: Theory and practical implications / Desabastecimiento de insumos y medicamentos de uso perioperatorio: teoría e implicaciones prácticas

Abstract During the past three decades the world has been witness to an alarming increase in the shortage of drugs and biomedical products in the field of anesthesia and surgical care. This situation can be particularly challenging when there are no therapeutic alternatives available, as is the case with some supplies and drugs for perioperative use. Anesthesiologists, who play a crucial role in the preparation of the drugs they administer, are particularly aware of these shortages. The reasons for these shortages are diverse and involve problems in supply, demand and government regulation. Among the causes identified are the increase in demand, bidding systems and the sustainability challenges faced by pharmaceutical companies. It is essential to understand these causes in order to seek strategies to reduce the risk of shortages of medicines and supplies. Addressing this challenge requires improving supply chain management, fostering transparency in information on stock-outs, promoting local production of medicines, and strengthening procurement and distribution regulations and policies. The solution to this problem requires a comprehensive and collaborative approach, with multiple stakeholders working together to ensure adequate access to needed medications in the anesthesia and surgical care setting.

Resumen Durante las últimas tres décadas, en el mundo se ha observado un alarmante aumento en el desabastecimiento de medicamentos y productos biomédicos en el ámbito de la atención anestésica y quirúrgica. Esta situación puede resultar especialmente problemática cuando no existen alternativas terapéuticas disponibles, como ocurre en algunos casos de insumos y medicamentos de uso perioperatorio. Los anestesiólogos, quienes desempeñan un papel crucial en la preparación de los medicamentos que administran, son particularmente conscientes de estos fenómenos de desabastecimiento. Las causas de estos desabastecimientos son diversas e involucran problemas en la oferta, la demanda y la regulación estatal. Entre las causas identificadas se encuentran el aumento en la demanda, los sistemas de licitación y los desafíos de sostenibilidad que enfrentan las empresas farmacéuticas. Es fundamental comprender estas causas para buscar estrategias que reduzcan el riesgo de desabastecimiento de medicamentos e insumos. Para abordar este desafío se requiere mejorar la gestión de la cadena de suministro, fomentar la transparencia en la información sobre desabastecimientos, promover la producción local de medicamentos y fortalecer las regulaciones y políticas de adquisición y distribución. La solución a este problema exige un enfoque integral y colaborativo, en el que múltiples partes interesadas trabajen conjuntamente para garantizar un acceso adecuado a los medicamentos necesarios en el ámbito de la atención anestésica y quirúrgica.

Vivencias y estrategias comunitarias de manejo del riesgo dentro de las prácticas chemsex: un estudio cualitativo / Community experiences and strategies of risk management within chemsex practices: a qualitative study

Resumen El auge en el estudio del uso sexualizado de drogas entre hombres gais, bisexuales u otros hombres que tienen sexo con hombres (HSH), conocido como chemsex, ha generado una multiplicidad de datos que contribuyen a su problematización en tanto cuestión de salud pública a través del vínculo con el VIH y las adicciones. El estudio de estas prácticas, desde un paradigma biomédico, se ha centrado en el riesgo y ha contribuido a su reducción como fenómeno único y cuantificable. Este estudio tiene como objetivo explorar la vivencia del riesgo en el transcurso de las prácticas, para conocer qué estrategias de manejo emplean frente a éste y de qué manera son generadas. Se realizaron entrevistas semiestructuradas a cinco practicantes de chemsex en el Área Metropolitana de Barcelona y, posteriormente se aplicó un análisis temático. Los hallazgos muestran cómo estos hombres detectan, asumen y enfrentan los riesgos presentes en estas prácticas, donde toman relevancia el tipo de relaciones que allí se dan y el círculo social del que disponen. Este estudio destaca también la creación de estrategias basadas en la experiencia y cómo la transmisión de estos saberes entre participantes facilita la toma de decisiones y el manejo del riesgo.

Abstract The rise in the study of sexualised drug use among gay, bisexual and other men who have sex with men (MSM), known as chemsex, has generated a multiplicity of data that contribute to its problematisation as a public health issue through the link with HIV and addictions. The study of these practices, from a biomedical paradigm, has focused on risk and has contributed to its reduction as a unique and quantifiable phenomenon. This study aims to explore the experience of risk in the course of the practices, to find out what management strategies they employ in the face of risk and how they are generated. Semi-structured interviews were conducted with five chemsex practitioners in the Metropolitan Area of Barcelona and, subsequently, a thematic analysis was applied. The findings show how these men detect, assume and confront the risks present in these practices, where the type of relationships that take place and the social circle available to them are relevant. This study also highlights the creation of strategies based on experience and how the transmission of this knowledge among participants facilitates decision-making and risk management.

Prescrição de benzodiazepínicos em Unidades Básicas de Saúde em uma comunidade com alta vulnerabilidade social / Prescription of benzodiazepines in Health Centers in a community with high social vulnerability

RESUMO Os benzodiazepínicos, medicamentos mais prescritos no mundo, são extremamente úteis no manejo de patologias relativas ao sistema nervoso central, porém, nem sempre sua prescrição está relacionada com uma patologia. Este estudo buscou identificar os fatores influenciadores na prescrição de benzodiazepínicos na Atenção Básica do Sistema Único de Saúde e suas consequências, em uma região com alta vulnerabilidade social. Foram utilizados os princípios de um estudo qualitativo com amostra intencional de médicos prescritores construída com a ajuda dos Informantes-Chave e com tamanho (n = 10) definido pelo princípio da saturação teórica. A coleta de dados ocorreu mediante entrevistas semiestruturadas nas unidades básicas onde os profissionais atuavam. Os temas identificados relativos aos motivos da prescrição foram: relativos ao paciente (demanda do paciente; problemas sociais); relativos ao medicamento (dependência); relativos ao prescritor (uso irracional). A prescrição do benzodiazepínico deu-se devido às baixas condições sociais dos usuários nessa região e as consequências dessa conjuntura (vulnerabilidade social, problemas angustiantes de difícil resolução). Educação permanente para profissionais, ações interprofissionais e integralidade do cuidado foram demandas dos profissionais. O problema extrapola a ação do médico, e são sugeridas políticas públicas que garantam, às populações com essas características, acesso a saúde, trabalho e educação.

ABSTRACT Benzodiazepines, the most prescribed medications in the world, are extremely useful in managing conditions related to the central nervous system, however, their prescription is not always related to a pathology. This study sought to identify the factors influencing the prescription of benzodiazepines in Primary Care of the Unified Health System and their consequences, in a region with high social vulnerability. The principles of a qualitative study with intentional sampling of prescribing physicians were used, constructed with the help of Key Informants and with a size (N=10) defined by the principle of theoretical saturation. Collection took place through semi-structured interviews in the basic units where the professionals worked. The themes identified regarding the reasons for prescription were Patient-related (patient demand; social problems); Relating to medication (dependence); Relative to the prescriber (irrational use). The prescription of benzodiazepine was due to the low social conditions of users in this region and the consequences of this situation (social vulnerability, distressing problems with difficult resolution). Continuous education for professionals, interprofessional actions, and comprehensive care were demands of the professionals. The problem goes beyond the doctor's scope of action, and public policies that guarantee such populations access to health, work, and education are suggested.

Prevalencia de la automedicación en odontología en adultos de Macas, Ecuador / Prevalence of self-medication in dentistry in adults in Macas, Ecuador

Introducción: el hecho de que una persona no puede acceder a un servicio de salud puede favorecer la automedicación, que es la administración de fármacos según la autopercepción del individuo sobre su posible diagnóstico y solución. Aunque es una situación considerada como problema de salud pública, por medio de la educación o futuras investigaciones que generen propuestas, se podrá erradicar las barreras al acceso de la salud oral. Objetivo: determinar la prevalencia de la automedicación en odontología en adultos de Macas, Ecuador, durante el año 2021. Material y métodos: estudio descriptivo, cuantitativo, documental, comunicacional y transversal actual, donde se trabajó sobre la población de edad adulta de Macas, Ecuador; los datos se recolectaron mediante una encuesta online, para luego ser analizados en prevalencia, frecuencia y chi cuadrado. Resultados: 49% de los encuestados respondió que se automedican, los analgésicos fueron el tipo de medicamento más consumido (44.2%); 27% de los individuos respondió que el dolor dental era una causa para tomar medicamentos sin receta, el principal motivo para automedicarse y no acudir al odontólogo fue por indicación del técnico de farmacia (26%). Conclusiones: los datos epidemiológicos obtenidos en esta investigación demuestran la marcada tendencia de las personas a consumir medicinas sin receta médica, por lo que, se deduce que existe una barrera para acceder a los servicios de salud oral; por ello, debería darse la importancia y atención oportuna (AU)

Introduction: the fact that a person cannot access a health service, may favor self-medication, which is the administration of drugs according to the individual's self-perception about their possible diagnosis and solution. Although, it is a situation considered as a public health problem, through education or future research that generates proposals, it will be possible to eradicate the barriers to oral health access. Objective: to determine the prevalence of self-medication in dentistry in adults in Macas, Ecuador, during the year 2021. Material and methods: a descriptive, quantitative, documentary, communicational and current cross-sectional study was carried out on the adult population of Macas, Ecuador; data were collected by means of an online survey and then analyzed in terms of prevalence, frequency and chi-square. Results: 49% of those surveyed responded that they self-medicate, analgesics were the most consumed type of medicine (44.2%), 27% of the individuals responded that dental pain was a cause for taking medicines without prescription, the main reason for self-medicating and not going to the dentist was because of the indication of the pharmacy technician (26%). Conclusions: the epidemiological data obtained in this investigation show us the marked tendency of people to take medicines without a medical prescription; therefore, it can be deduced that there is a barrier to accessing oral health services, and for this reason it should be given importance and timely attention (AU)

Consumo de drogas: percepción de padres y adolescentes / Drug use: perception of parents and adolescents

Resumen Objetivo: Comparar la percepción de padres y adolescentes sobre el papel de la familia en la prevención del consumo de drogas. Materiales y métodos: Investigación de tipo cualitativa, realizada en mayo de 2022 en la ciudad de Xalapa Veracruz (México): se realizaron dos grupos focales de personas ligadas a una escuela preparatoria -uno con adolescentes (cinco varones y seis mujeres) y otro con padres (un varón y ocho mujeres)- sin relación parental entre los grupos, reclutados de manera aleatoria. Las personas accedieron a participar después de haber conocido los objetivos y alcances del proyecto, por lo que firmaron una carta de consentimiento informado, en el caso de los padres, y de asentimiento informado en el caso de los adolescentes. Para el análisis de la información recogida en la entrevista grupal se utilizó el análisis de discurso, técnica que analiza lo dicho de acuerdo con el contexto en que se dice, lo que permitió comparar lo expresado en ambos grupos. Resultados: Los padres consideran que ellos brindan confianza a sus hijos, mientras que los adolescentes perciben que esto no es así. Asimismo, los adultos perciben que sus hijos tienen los conocimientos necesarios sobre el consumo de drogas por lo que no consideran necesario ahondar en el tema: en contraste, los adolescentes se muestran preocupados al conocer sobre sus riesgos. Finalmente, los padres perciben que sus hijos no tienen carencias ni necesidad de mejorar la relación con ellos, mientras que los adolescentes manifiestan insuficiente amor y atención por parte de sus padres. Conclusiones: Los padres y los hijos tienen una percepción distinta sobre el consumo de drogas y sobre el papel de la familia en la prevención. Se identificó la necesidad de generar espacios de reflexión que permitan una mayor comunicación entre padres e hijos.

Abstract Objective: To know and compare the perception of parents and adolescents on the role of the family in the prevention of drug use. Materials and methods: Qualitative research, conducted in May 2022, in which group interviews were applied through the instrument called focus group, two groups were integrated, one with adolescents (five boys and six girls) and another with parents (one boy and eight girls), with no parental relationship between the groups, randomly recruited, belonging to the same high school in the city of Xalapa, Veracruz. After reading and signing the informed consent, answers were given to the nine questions of the questionnaire. Results: For the analysis of the information, discourse analysis was used, which technique studies what was said according to the context, which allowed us to compare what was expressed in both groups. Parents perceive that they provide trust, while adolescents perceive that they do not; parents perceive that their children have the necessary knowledge about drug use, while adolescents are concerned to know about the risks, parents perceive that their children have no lacks, no needs, while adolescents manifest insufficient love and attention from their parents. Conclusions: Parents and children have a different view on drug use and on the role of the family in prevention. The need to generate spaces for reflection that allow for greater communication between parents and children was identified.

Deprescribing psychotropic drugs in a geriatric psychiatry outpatient clinic

Objective: To describe the psychotropic drug deprescription process in older patients of a geriatric psychiatry outpatient clinic. Methods: We conducted a quasi-experimental study of people aged ≥ 60 years who were treated at Hospital São Lucas' Geriatric Psychiatry Outpatient Clinic, which is affiliated with Pontifícia Universidade Católica do Rio Grande do Sul, Brazil. Data on 150 older people were collected from March 2021 to August 2022 and were evaluated by the pharmacists. The inclusion criteria were age ≥ 60 years, being a patient of the hospital's Geriatric Psychiatry Outpatient Clinic, use of at least one psychotropic drug, and agreeing to participate in the study. Those unable to report their medications and those who only came to the first appointment were excluded. Results: Overall, deprescription of at least one psychotropic drug was indicated in 61.3% (n = 92) of the participants, and it was effectively implemented in 68.5% (n = 63) of this group. Deprescribing, which was more frequent in the youngest age group (60­69 years) (p = 0.049), was indicated for 37.4% (n = 136) of psychotropic drugs, 67.6% (n = 92) of which were effectively deprescribed. The main classes indicated for deprescription were hypnotics and sedatives (90.0%; n = 18) and anxiolytics (73.3%; n = 11). Conclusions: At least 1 psychotropic drug was indicated for deprescription in the majority of the patients, and in most cases it was effectively implemented. One-third of the prescribed psychotropic drugs were indicated for deprescription, and more than half were successfully deprescribed. (AU)

O uso de drogas e seus efeitos na cavidade oral

Objetivos: Descrever as principais manifestações bucais associadas ao uso das drogas lícitas e ilícitas mais utilizadas atualmente, bem como os cuidados que devem ser tomados durante o atendimento odontológico desses pacientes. Revisão de literatura: Na revisão foi abordada a classificação das substâncias químicas, as principais manifestações orais e os cuidados que o cirurgião-dentista deve ter durante o atendimento odontológico. As substâncias descritas foram álcool, tabaco, benzodiazepínicos, maconha, anfetaminas e cocaína/crack. As complicações de saúde bucal associadas ao abuso de drogas podem resultar da exposição direta dos tecidos orais às drogas durante o fumo ou ingestão, da interação biológica das drogas com a fisiologia normal da cavidade oral e dos efeitos das drogas na função cerebral que resultam em um espectro de comportamentos de dependência, como comportamento de risco, falta de higiene e descuido. Considerações finais: O consumo de substâncias psicoativas, seja a curto ou longo prazo, pode desencadear consequências, tanto na saúde geral como na saúde bucal do usuário. Sob essa perspectiva, o cirurgião-dentista deve estar ciente das manifestações orais e sistêmicas causadas pelas substâncias psicoativas e estar capacitado para diagnosticar, tratar ou também encaminhar o usuário, se necessário, visando um cuidado integral e multiprofissional.

Objective: to describe the main oral manifestations associated with the use of the most commonly used licit and illicit drugs today, as well as the care that should be taken during the dental care of these patients. Literature review: The review covered the classification of chemical substances, the main oral manifestations and the care that dentist should take during dental care. The substances described were alcohol, tobacco, benzodiazepines, marijuana, amphetamines and cocaine/crack. Oral health complications associated with drug abuse can result from direct exposure of oral tissues to drugs during smoking or ingestion, from the biological interaction of drugs with the normal physiology of the oral cavity, and from the effects of drugs on brain function that result in a spectrum of addictive behaviors, such as risk behavior, poor hygiene and carelessness. Final considerations: The consumption of psychoactive substances, whether in the short or long term, can have consequences for both the general health and the oral health of the user. From this perspective, the dentist must be aware of the oral and systemic manifestations caused by psychoactive substances and be able to diagnose, treat or also refer the user, if necessary, aiming for comprehensive, multi-professional care.

Relación entre el consumo de sustancias psicoactivas, alcohol y cigarrillo en estudiantes de Enfermería. Un estudio de corte transversal / Relationship Between Psychoactive Substance, Alcohol and Cigarette use in Nursing Students. A Cross-Sectional Study

RESUMEN Introducción: El incremento del consumo de sustancias psicoactivas (SPA), alcohol y cigarrillo en población joven se ha convertido en un problema de salud pública. La identificación de los factores que aumentan o disminuyen el riesgo de la exposición a estas sustancias y la relación que puede haber entre ellas resulta fundamental para la planificación de estrategias con enfoque de riesgo, razón por la cual se planteó el presente estudio. El objetivo es establecer el perfil de consumo de SPA, alcohol y cigarrillo y los factores asociados con dicho consumo en estudiantes del programa de Enfermería de una institución de educación superior. Métodos: Estudio cuantitativo, observacional y analítico de tipo corte transversal. Resultados: Se incluyó a 310 estudiantes de los semestres I a IX de un programa de Enfermería de una institución privada de educación superior de Bogotá. La prevalencia de consumo de SPA en el último ario fue del 2,96% (IC95%, 1,36-5,54); la marihuana es la sustancia de mayor consumo (55,55%). Las prevalencias de consumo de alcohol y cigarrillo durante los últimos 12 meses se estimaron en el 86,64% (IC95%, 83,24-91,0) y el 12,16% (IC95%, 8,4315,88) respectivamente. Se encontró una asociación estadísticamente significativa entre los consumos: tomar alcohol se asoció con el consumo de cigarrillo (OR = 3,22; p = 0,006) y fumar se asoció con el consumo de SPA (OR = 15,4; p <0,001). Conclusiones: En esta población universitaria, el consumo de alcohol aumenta la posibilidad de consumo de cigarrillo, y este a su vez aumenta la posibilidad del consumo de SPA.

ABSTRACT Background: The increase in the use of psychoactive substances, alcohol and cigarettes in young people has become a public health problem. The identification of factors that increase or reduce the risk of exposure to these substances and the possible relationship between them is essential for planning strategies with a risk approach, hence the reason for this study. The objective was to establish the profile of use of psychoactive substances, alcohol and cigarettes and the factors associated with such use in nursing students of a higher education institution. Methods: Quantitative, observational, analytical cross-sectional study. Results: We included 310 students from 1st to 9th semester of a Nursing programme from a prívate higher education institution in Bogotá. The prevalence of psychoactive substance use in the last year was 2.96% (95%CI, 1.36-5.54), with marijuana being the substance most used (55.55%). The prevalence of alcohol and cigarette use during the last 12 months was estimated at 86.64% (95%CI, 83.24-91.0) and 12.16% (95%CI, 8.43-15.88) respectively. A statistically significant association was found between the use of these substances: alcohol use was associated with cigarette use (OR = 3.22; P = 0.006) and smoking was associated with psychoactive substance use (OR = 15.4; P < 0.001). Conclusions: Alcohol use increases the likelihood of smoking cigarettes, and this in turn increases the likelihood of psychoactive substance use, in this university population.

Perfil de las víctimas mortales por intoxicaciones agudas en Costa Rica del 2012 al 2021 asociadas al consumo de sustancias psicoactivas y drogas de abuso: etanol, metanol, benzodiacepinas, anfetaminas, heroína, cocaína y mixto / Profile of fatalities due to acute intoxications in Costa Rica from 2012 to 2021 associated with the consumption of psychoactive substances and drugs of abuse: ethanol, methanol, benzodiazepines, amphetamines, heroin, cocaine and mixed

Resumen Introducción: La mortalidad por intoxicaciones agudas de sustancias psicoactivas representa un problema de salud pública, especialmente en personas jóvenes. El objetivo del estudio fue crear un perfil de las víctimas mortales por intoxicación aguda en Costa Rica entre los años 2012 y 2021 asociado al consumo de sustancias psicoactivas y drogas de abuso. Materiales y métodos: Se recopilaron datos de Sección de Patología Forense del Departamento de Medicina Legal en Costa Rica, con los cuales se realizó una revisión de las víctimas mortales por intoxicaciones agudas a partir del 1 de enero de 2012 hasta el 31 de diciembre de 2021. La revisión incluyó las siguientes variables: variables epidemiológicas: sexo, edad, nacionalidad, ocupación, estado civil, provincia, consumo frecuente asociado, manera de muerte, tipo de sustancia y lugar de intoxicación. Resultados: De los 456 casos de muertes asociados a intoxicaciones agudas por etanol, metanol, benzodiacepinas, anfetaminas, heroína, cocaína y mixtas; reportados entre el 1 de enero de 2012 y el 31 de diciembre de 2021: el año que más casos reportó fue 2020; 82% de las víctimas fueron hombres y 18% mujeres; las principales edades de las personas reportadas abarcan entre 41 y 60 años. 80% de las personas eran costarricenses; San José fue la provincia con mayor número de casos de intoxicación letal, siendo el domicilio el sitio más frecuente. 14% de las víctimas eran desempleadas; 77% de las personas presentaban algún trastorno de la adicción o consumo frecuente de alguna de las sustancias estudiadas. La mayoría de muertes fueron de manera accidental. Conclusiones: El perfil predominante de las víctimas fue: masculino, entre 41 y 60 años, costarricense, de estado civil indeterminado o soltero, desempleado, que muere de manera accidental, en su domicilio, por intoxicación aguda con alcohol o mixta (alcohol y cocaína).

Abstract Introduction. Mortality from acute poisoning of psychoactive substances represents a public health problem, especially in young adults. The purpose of the study was to create a profile of fatalities due to acute poisoning in Costa Rica between 2012 and 2021 associated with the consumption of psychoactive substances and drugs of abuse. Materials and methods. Data were collected from the Forensic Pathology Section of the Legal Medicine Department in Costa Rica, then a review of fatalities due to acute poisoning was carried out from January 1, 2012 to December 31, 2021. The review included the following epidemiological variables: sex, age, nationality, occupation, marital status, province, consumption associated, manner of death, type of substance, and place of intoxication. Results. Out of the 456 reported cases of deaths associated with acute intoxication with ethanol, methanol, benzodiazepines, amphetamines, heroin, cocaine, and mixed substances between January 1, 2012, and December 31, 2021: the year with the highest number of cases reported was 2020; 82% of the victims were male, and 18% were female; the main age group of reported victims ranged from 41 to 60 years old. 80% of the victims were Costa Rican, and San Jose was the province with the highest number of lethal intoxication cases, with the home being the most frequent site. 14% of the victims were unemployed, and 77% of the individuals had some addiction disorder or frequent consumption of one of the studied substances. The majority of deaths were accidental. Conclusion. The main profile of the victims was male, between 41 and 60 years old, Costa Rican, of indeterminate or single marital status, unemployed, who died accidentally, at home, due to acute intoxication with alcohol or a mixture of substances (alcohol and cocaine).

Asociación del consumo de drogas ilícitas en mujeres embarazadas y sífilis congénita en un Hospital Público de México / Association of illicit drug use in pregnant women and congenital syphilis in a public hospital in Mexico

Resumen Realizamos un estudio de casos y controles anidado en una cohorte con el objetivo de estudiar la asociación del consumo de drogas ilícitas y sífilis congénita (SC). Los casos se diagnosticaron mediante pruebas treponémicas y no treponémicas en la madre y el recién nacido (RN). Se realizó un análisis multivariado con regresión logística. Se registraron 6.171 nacimientos con edad gestacional promedio 37,8 semanas y se diagnosticaron 62 eventos de SC (incidencia: 10,5 eventos/1.000 RN). Los factores maternos asociados fueron el uso de drogas ilícitas (OR = 14,08; IC 95% = 1,19-166,6), menos de cinco consultas en el control prenatal (OR = 2,9; IC 95% = 1,12-7,53), más de dos parejas sexuales (OR = 3,76; IC 95% = 1,62-8,71) y estudios universitarios (OR = 0,06; IC 95% = 0,005-0,85). Entre las madres de los casos, la prevalencia del consumo de drogas ilícitas fue de 22,6% y las más frecuentes fueron las metanfetaminas y la marihuana.

Abstract We conducted a nested case-control study within a cohort with the aim of studying the association between illicit drug use and congenital syphilis (CS). Cases were diagnosed based on treponemal and non-treponemal tests conducted both in the mother and the newborn (NB). Multivariate analysis with logistic regression was performed. A total of 6171 births with a mean gestational age of 37.8 weeks were recorded and 62 CS events were diagnosed (incidence 10.5 events/1000 NB). Associated maternal factors were illicit drug use (OR 14.08, 95% CI 1.19-166.6), <5 prenatal visits (OR 2.9, 95% CI 1.12-7.53), more than two sexual partners (OR 3.76, 95% CI 1.62-8.71) and professional education level (OR 0.06, 95% CI 0.005-0.85). Among the mothers of the cases presented, the prevalence of illicit drug use was 22.6% and the most frequent drugs were methamphetamines and cannabis.

Caracterização do perfil sociodemográfico dos usuários de profilaxia pré-exposição ao HIV (PrEP) no Ceará / Characterization of the sociodemographic profile of users of hiv pre-exposure prophylaxis (PrEP) in Ceará

Introdução: a PrEP é uma estratégia de prevenção biomédica que consiste no uso de antirretrovirais (ARV) orais com o objetivo de mitigar o risco de adquirir o HIV e, consequentemente, de desenvolver a AIDS. O presente estudo tem como objetivo descrever o perfil sociodemográfico dos usuários com dispensação da PrEP no Ceará, no período de 2018 a 2023. Métodos: trata-se de um estudo transversal descritivo. Os dados foram obtidos por meio do Departamento de HIV/Aids, Tuberculose, Hepatites Virais e Infecções Sexualmente Transmissíveis (DATHI) do Ministério da Saúde por meio do Painel de monitoramento da PrEP. Resultados: observou-se um predomínio de usuários gays e homens que fazem sexo com homens, mas não se consideram gays; autodeclarados como pardos, com alta escolaridade e com faixa etária entre 30 e 39 anos. As dispensações da PrEP apresentaram progressão no período analisado, apesar dos anos de pandemia. Conclusão: embora a PrEP tenha-se mostrado eficaz no controle e declínio no número de infecções pelo HIV, esses dados demonstram que há uma lacuna entre quem se beneficia dela. É um desafio fazer com que a PrEP chegue a quem se pode beneficiar dela e com maior probabilidade de exposição ao HIV indivíduos de baixa escolaridade, pessoas trans, travestis, jovens adultos /adolescentes e não brancos.

Introduction: PrEP is a biomedical prevention strategy that consists of the use of oral antiretrovirals (ARV) to mitigate the risk of acquiring HIV and, consequently, of developing AIDS. The present study aims to describe the sociodemographic profile of users dispensed with PrEP in Ceará from 2018 to 2023. Methods: this is a descriptive cross-sectional study. The data was obtained from the Department of HIV/Aids, Tuberculosis, Viral Hepatitis, and Sexually Transmitted Infections (DATHI) of the Ministry of Health through the PrEP Monitoring Panel. Results: there was a predominance of Gay users and Men who have Sex with Men but do not consider themselves gay; they self-declared as mixed race, highly educated, and aged between 30 and 39 years old. PrEP dispensations showed progression in the period analyzed despite years of pandemic. Conclusion: although PrEP is effective in controlling and declining the number of HIV infections, these data demonstrate that there is a gap between who benefits from it. It is a challenge to make PrEP reach those who can most benefit from it and who are most likely to be exposed to HIV, individuals with low education, trans people, transvestites, young adults/adolescents, and non-whites.

Acute kidney injury and hypercalcemia associated with veterinary supplements applications in adult man / Injúria renal aguda e hipercalcemia associadas a aplicações de suplementos veterinários em homem adulto

The compound "ADE" is an injectable oil for veterinary use which contains large amounts of vitamins A, D and E. The parenteral application in humans leads to a granuloma reaction which triggers hypercalcemia. A 42-year-old man was admitted with lower limb pain, nephrolithiasis and nephrocalcinosis. Laboratory tests revealed creatinine 4.59 mg/dl, calcium 13.3 mg/dl and parathormone 13.8 pg/ml. He underwent an ureterolithotripsy, stent placement, intravenous crystalloid fluids, and corticosteroid. He improved symptoms, kidney function and normalized serum calcium. The "ADE"-induced hypercalcemia diagnosis can be challenging. The early diagnosis may avoid negative outcomes.

O composto "ADE'' é um óleo veterinário injetável que contém grandes quantidades de vitaminas A, D e E. A aplicação parenteral causa reação granulomatosa e hipercalcemia. Um homem de 42 anos foi admitido com dor no membro inferior, nódulos musculares endurecidos, nefrolitíase e nefrocalcinose. O laboratório revelou creatinina 4,59 mg/dl, cálcio 13,3 mg/dl e paratormônio 13,8 pg/ml. Foi tratado com ureterolitotripsia, cateter duplo-J, cristaloide intravenoso e corticoterapia. Ele apresentou melhora dos sintomas, função renal e normalizou cálcio. O diagnóstico da hipercalcemia pelo "ADE'' pode ser desafiador. O diagnóstico precoce pode evitar desfechos negativos.

Understanding local reactions induced by Bothrops jararaca venom: the role of inflammatory mediators in Leukocyte–Endothelium interactions

In recent years, extensive research has delved into the pathophysiology of local reactions triggered by Bothrops snake venoms. Even though antivenom works well at reducing death and systemic effects, it is still not very effective in treating local reactions because it cannot counteract damage that has already been triggered. This limitation might be attributed to certain molecules that amplify the venom-induced innate response. While evidence suggests endogenous mediators at the venom site play a role in this envenomation, in Brazil, the concurrent use of anti-inflammatory agents or other drugs alongside antivenom remains uncommon. This study evaluated the pharmacological mediation of alterations in leukocyte–endothelium interactions following the experimental envenomation of mice with Bothrops jararaca venom, the main culprit of snake-related accidents in Southeast Brazil. We treated envenomed mice with inhibitors of different pharmacological pathways and observed the cremaster muscle microcirculation with intravital microscopy. We found that eicosanoids related to cyclooxygenase pathways and nitric oxide significantly contributed to B. jararaca venom-induced alterations in leukocyte–endothelium interactions. Conversely, lipoxygenase-mediated eicosanoids, histamine, and serotonin had minimal participation. Notably, dexamethasone and antivenom treatment diminished B. jararaca venom–induced alterations in leukocyte–endothelium interactions. The limited efficacy of the antivenom in managing Bothrops venom-induced local reactions emphasizes the critical need for supplementary treatments to enhance therapeutic outcomes.

Retrospective review of medicine utilization for noncommunicable diseases in three public sector pharmacies in Jamaica / Revisión retrospectiva del uso de medicamentos para enfermedades no transmisibles en tres farmacias del sector público de Jamaica / Revisão retrospectiva do uso de medicamentos para doenças não transmissíveis em três farmácias da rede pública na Jamaica

ABSTRACT Objective. The rational use of medicines offers a cost-saving strategy to maximize therapeutic outcomes for developing and developed countries. The aim of this study was to evaluate the rational use of medicines for selected noncommunicable diseases (NCDs) at three pharmacies at public hospitals in Jamaica using the World Health Organization's (WHO's) prescribing indicators. Methods. In this retrospective cross-sectional study, prescriptions for adult outpatients containing at least one medicine for cardiovascular disease, diabetes, cancer, chronic obstructive pulmonary disease or asthma that were filled between January and July 2019 were reviewed using WHO's prescribing indicators for the rational use of medicines. Data were analyzed and expressed as descriptive and inferential statistics. For all analyses conducted, significance was determined at P < 0.05. Results. A total of 1 500 prescriptions covering 5 979 medicines were reviewed; prescriptions were mostly written for female patients aged 42-60 years. Polypharmacy was observed in 35.6% (534) of prescriptions, and there was an average of 4 medicines per prescription, with a maximum of 17. Most of the prescriptions at each site were filled, with the main reason for not dispensing a medicine being that it was out of stock. Generic prescribing was high for all sites, accounting for more than 95% (5 722) of prescribed medicines. There was full compliance with prescribing according to the WHO Model List of Essential Medicines at two of the sites, but it was just off the target at Site 1, by 1.4%. Conclusions. The WHO guidelines for the rational use of medicines were followed with respect to the proportion of medicines prescribed from the WHO Model List and the proportion of antibiotics prescribed. The number of medicines per prescription and the proportion of medicines prescribed by generic name did not meet the WHO criteria. However, prescribing was aligned with treatment guidelines for the selected NCDs.

RESUMEN Objetivo. El uso racional de los medicamentos proporciona una estrategia de ahorro de costos para maximizar los resultados terapéuticos tanto en los países en desarrollo como en los países desarrollados. El objetivo de este estudio fue evaluar el uso racional de medicamentos para algunas enfermedades no transmisibles (ENT) seleccionadas en tres farmacias de hospitales públicos de Jamaica, usando los indicadores de prescripción de la Organización Mundial de la Salud (OMS). Métodos. En este estudio transversal retrospectivo se examinaron las prescripciones realizadas a pacientes ambulatorios adultos que incluían al menos un medicamento para enfermedades cardiovasculares, diabetes, cáncer, enfermedad pulmonar obstructiva crónica o asma, dispensadas entre enero y julio del 2019, utilizando los indicadores de prescripción para el uso racional de medicamentos de la OMS. Los datos se analizaron y expresaron mediante estadística descriptiva e inferencial. Para todos los análisis realizados se estableció un nivel de significación de p <0,05. Resultados. Se examinó un total de 1 500 prescripciones que incluían 5 979 medicamentos; la mayor parte de ellas correspondían a pacientes de sexo femenino de 42 a 60 años. Se observó que había polimedicación en el 35,6% (534) de las prescripciones, con un promedio de 4 y un máximo de 17 medicamentos por receta. En todos los centros se dispensó la mayor parte de los medicamentos prescritos, y el motivo principal para no hacerlo fue la falta de existencias del medicamento en cuestión. La prescripción de genéricos fue elevada en todos los centros y supuso más del 95% (5 722) de los medicamentos prescritos. En dos centros la prescripción se realizó en su totalidad de acuerdo con la Lista Modelo de Medicamentos Esenciales de la OMS, pero en el centro 1 no se alcanzó el objetivo por un 1,4%. Conclusiones. Se siguieron las directrices de la OMS para el uso racional de medicamentos en cuanto a la proporción de medicamentos prescritos de la Lista Modelo de la OMS y la proporción de antibióticos prescritos. El número de medicamentos por receta y la proporción de medicamentos prescritos mediante su nombre genérico no cumplieron con los criterios de la OMS. Sin embargo, las prescripciones estaban en consonancia con las directrices de tratamiento de las enfermedades no transmisibles seleccionadas.

RESUMO Objetivo. O uso racional de medicamentos é uma estratégia de contenção de custos para maximizar os resultados terapêuticos em países desenvolvidos e em desenvolvimento. O objetivo deste estudo foi avaliar o uso racional de medicamentos para algumas doenças não transmissíveis selecionadas em três farmácias de hospitais públicos na Jamaica a partir dos indicadores de prescrição preconizados pela Organização Mundial da Saúde (OMS). Métodos. Estudo transversal retrospectivo que avaliou receitas médicas de pacientes ambulatoriais adultos contendo pelo menos um medicamento prescrito para doença cardiovascular, diabetes, câncer, doença pulmonar obstrutiva crônica ou asma e dispensadas entre janeiro e julho de 2019. A avaliação foi realizada a partir dos indicadores de prescrição preconizados pela OMS para o uso racional de medicamentos. Os dados obtidos foram analisados por meio de estatísticas descritivas e inferenciais. O nível de significância de p <0,05 foi adotado em todas as análises. Resultados. Ao todo, foram analisadas 1 500 receitas médicas compreendendo 5 979 medicamentos. Em sua maioria, as receitas foram prescritas para pacientes do sexo feminino com idades entre 42 e 60 anos. A polifarmácia foi observada em 35,6% (534) das receitas; em média, foram prescritos 4 medicamentos, até um máximo de 17. As farmácias estudadas dispensaram a maior parte dos medicamentos receitados. O principal motivo para não fornecer algum medicamento foi o desabastecimento. O percentual de medicamentos genéricos foi alto em todos os locais, representando mais de 95% (5 722) do volume receitado. Houve plena observância da Lista Modelo de Medicamentos Essenciais da OMS nas receitas analisadas em dois dos locais estudos, e observância quase completa (diferença de 1,4%) no local 1. Conclusões. As diretrizes da OMS de uso racional de medicamentos foram cumpridas no que se refere ao percentual de medicamentos receitados de acordo com a Lista Modelo da OMS e o percentual de antibióticos receitados. Os critérios da OMS não foram cumpridos quanto ao número de medicamentos por receita e ao percentual receitado usando o nome genérico. Porém, os medicamentos foram receitados de acordo com as diretrizes terapêuticas para as doenças não transmissíveis selecionadas.

Alertas sanitarias de productos médicos subestándares, falsificados y no registrados al inicio de la pandemia de COVID-19 en las Américas / Health alerts for substandard, falsified, and unregistered medical products at the onset of the COVID-19 pandemic in the Americas / Alertas de saúde para produtos médicos abaixo do padrão, falsificados e não registrados no início da pandemia de COVID-19 nas Américas

RESUMEN Objetivo. Identificar y analizar los incidentes de productos médicos subestándares, falsificados, no registrados y robados al inicio de la pandemia de COVID-19. Métodos. Búsqueda detallada en los sitios web de las autoridades reguladoras de las Américas. Identificación de los incidentes de medicamentos y dispositivos médicos (incluidos los de diagnóstico in vitro) subestándares falsificados, no registrados y robados. Se determinaron los tipos de productos, las etapas de la cadena de suministro en las que se detectaron y las medidas tomadas por las autoridades. Resultados. Se identificaron 1 273 incidentes en 15 países (1 087 productos subestándares, 44 falsificados, 123 no registrados y 19 robados). La mayor cantidad de incidentes corresponden a dispositivos médicos, desinfectantes y antisépticos. El punto en la cadena de suministro con mayor frecuencia de informes fue la adquisición a través de internet. Las medidas tomadas por las autoridades reguladoras corresponden en su mayoría a: alerta, prohibición de uso, prohibición de publicidad y fabricación, retiro del mercado y seguimiento de eventos adversos. Conclusiones. Se evidenció un número destacable de incidentes de productos médicos subestándares, falsificados, no registrados y robados al inicio de la pandemia por COVID-19. La escasez de insumos, la flexibilización en los requisitos regulatorios y el aumento de la demanda son factores que pueden favorecer el incremento del número de incidentes. Las autoridades reguladoras nacionales de referencia presentaron mayores frecuencias de detección de incidentes y de aplicación de medidas sanitarias. Se observó que se debe abordar el canal de venta por internet con alguna estrategia reguladora para garantizar la distribución segura de productos médicos.

ABSTRACT Objective. Identify and analyze incidents of substandard, falsified, unregistered, and stolen medical products at the onset of the COVID-19 pandemic. Methods. Detailed search of the websites of regulatory authorities in the Americas. Identification of incidents of substandard, falsified, unregistered, and stolen medicines and medical devices (including in vitro diagnostics). The types of products were determined, as were the stages in the supply chain where they were detected, and the actions taken by authorities. Results. A total of 1 273 incidents were identified in 15 countries (1 087 substandard, 44 falsified, 123 unregistered, and 19 stolen products). The largest number of incidents involved medical devices, disinfectants, and antiseptics. The most frequently reported point in the supply chain was online purchasing. The principal measures taken by the regulatory authorities were: alerts, prohibition of use, prohibition of advertising and manufacture, recall, and monitoring of adverse events. Conclusions. A substantial number of incidents involving substandard, falsified, unregistered, and stolen medical products at the onset of the COVID-19 pandemic were identified. Shortages of supplies, easing of regulatory requirements, and increased demand are factors that may have led to an increase in the number of incidents. The national regulatory authorities of reference reported more frequent detection of incidents and more frequent application of health measures. A regulatory strategy is needed in order to address online sales and ensure the safe distribution of medical products.

RESUMO Objetivo. Identificar e analisar incidentes de produtos médicos abaixo do padrão, falsificados, não registrados e roubados no início da pandemia de COVID-19. Métodos. Foi realizada uma busca detalhada nos sites das autoridades reguladoras das Américas. Foram identificados incidentes envolvendo medicamentos e dispositivos médicos (incluindo para diagnóstico in vitro) abaixo do padrão, falsificados, não registrados e roubados. Foram determinados os tipos de produtos, os estágios da cadeia de abastecimento em que foram detectados e as medidas tomadas pelas autoridades. Resultados. Foram identificados 1 273 incidentes em 15 países (1 087 produtos abaixo do padrão, 44 falsificados, 123 não registrados e 19 roubados). O maior número de incidentes estava relacionado a dispositivos médicos, desinfetantes e antissépticos. O ponto na cadeia de abastecimento com a maior frequência de relatos foi a de aquisição pela internet. As medidas tomadas pelas autoridades reguladoras foram principalmente alertas, proibições de uso, proibições de publicidade e fabricação, recolhimento de produtos do mercado e monitoramento de eventos adversos. Conclusões. Houve um número significativo de incidentes envolvendo produtos médicos abaixo do padrão falsificados, não registrados e roubados no início da pandemia de COVID-19. A escassez de insumos, a flexibilização das exigências regulatórias e o aumento da demanda são fatores que podem levar a um maior número de incidentes. As autoridades reguladoras nacionais de referência informaram um aumento na frequência de detecção de incidentes e implementação de medidas sanitárias. O canal de vendas pela internet precisa ser abordado com alguma estratégia regulatória para garantir a distribuição segura de produtos médicos.

Biotechnological sovereignty is not a mere nationalist concept, it is a necessity for Colombia and Latin America / Soberanía biotecnológica no es un mero concepto nacionalista, pero una necesidad para Colombia y América Latina / A soberania biotecnológica não é um mero conceito nacionalista, é uma necessidade para a Colômbia e a América Latina

Abstract: During the pandemic, Latin American countries suffered the collapse of their health systems. This was caused by the high demand for care of patients infected with SARS-CoV-2, which was added to the care of patients with other diseases. The significant increase in demand for health services caused medical and laboratory supplies to decline rapidly. The COVID-19 pandemic exacerbated a health crisis in several developing countries, mainly caused by insufficient systematic policies for integrating scientific knowledge. The current Colombian government must formulate a Biotechnological or Biosecurity Sovereignty Law that guarantees scientific autonomy, ensuring that Colombia is self-sufficient in Science, Technology, and Innovation. Colombian government should also focus on establishing and developing pharmaceutical chemical production by acquiring active chemical ingredients from other countries. This strategy could reduce the production costs and final prices of medicines, as well as generate high-level employment and wealth for the country. In this way, the Colombian government could prevent shortage of essential medicines and excessive price increases by commercial intermediation. In conclusion, the manuscript focuses on the lack of biotechnological sovereignty in Colombia. We propose a model of a Latin American Science and Technology ecosystem to achieve biotechnological sovereignty via state funding of research, strengthening universities, and fostering participation among private companies and Ministries of Science, Education, Trade, and Health. Scientific autonomy based on innovative processes that strengthen biotechnological independence can contribute to the economy by generating gross added value, creating high-quality employment, and facilitating the appropriation and social dissemination of knowledge, and cost reduction.

Resumen: Durante la pandemia, los países latinoamericanos vieron colapsar sus sistemas de salud. Esto se debió a la alta demanda de atención para las personas contagiadas con SARS-CoV-2 y a la atención de pacientes con otros tipos de enfermedades. El aumento significativo de la demanda de los servicios de salud llevó a la rápida disminución de los suministros médicos y de laboratorio. La pandemia de la COVID-19 intensificó la crisis sanitaria en los países en desarrollo, principalmente por una política sistemática e insuficiente de apropiación del conocimiento científico. Si el actual gobierno colombiano formulara una Ley de Soberanía Biotecnológica o de Bioseguridad por la cual se garantizaría la autonomía científica, esto conduciría a una autonomía de Colombia en Ciencia, Tecnología e Innovación. El Gobierno de Colombia también debería centrarse en fomentar y desarrollar la producción de productos químicos farmacéuticos mediante el abastecimiento de ingredientes químicos activos de otros países. Esta estrategia favorece la reducción de costos de producción y del precio final de los medicamentos, además de generar empleos de alto nivel y riqueza para el país. De esta manera, no habría escasez de medicamentos esenciales, ni alzas excesivas de precios en la intermediación comercial. Pero, la realidad es que hay una débil soberanía biotecnológica en Colombia. En este texto se propone un modelo de ecosistema basado en Ciencia y Tecnología para que Latinoamérica logre la soberanía biotecnológica mediante el financiamiento estatal a la investigación en universidades, con la participación de entidades privadas y Ministerios de Ciencia, Educación, Comercio y Salud. La autonomía científica se basa en procesos de innovación que implican el fortalecimiento de la autonomía biotecnológica.

Resumo: Durante a pandemia, os países latino-americanos sofreram o colapso de seus sistemas de saúde. Isso foi causado pela alta demanda de atendimento aos infectados pelo SARS-CoV-2, que somou-se, em paralelo, ao atendimento de pacientes com outros tipos de doenças. O aumento significativo na demanda por serviços de saúde levou à rápida diminuição dos suprimentos médicos e laboratoriais. A pandemia de COVID-19 acelerou, nos países em desenvolvimento, uma crise sanitária causada principalmente por uma política sistemática e insuficiente de apropriação do conhecimento científico. O atual governo colombiano deve formular uma Lei de Soberania Biotecnológica ou de Biossegurança que garanta a autonomia científica, o que leva à autonomia que garante que a Colômbia seja autossuficiente em Ciência, Tecnologia e Inovação. O governo da Colômbia também deve se concentrar em estabelecer e desenvolver a produção de produtos químicos farmacêuticos, adquirindo ingredientes químicos ativos de outros países. Essa estratégia reduz os custos de produção e o preço final dos medicamentos, além de gerar empregos de alto nível e riqueza para o país. Desta forma, não haveria escassez de medicamentos essenciais, nem estaríamos sujeitos a aumentos excessivos de preços por intermediação comercial. Em conclusão, o manuscrito foca na fracassada soberania biotecnológica na Colômbia. Propomos um modelo de ecossistema latino-americano de Ciência e Tecnologia para alcançar a soberania biotecnológica por meio do financiamento estatal do fortalecimento da pesquisa das universidades, com a participação de empresas privadas e Ministérios da Ciência, Educação, Comércio e Saúde. A autonomia científica é baseada em processos de inovação que fortalecem a autonomia biotecnológica.

Asociación entre el grado de consumo de alcohol, tabaco, sustancias ilícitas y el desenlace obstétrico adverso / Association between the degree of alcohol, tobacco, illicit of alcohol, tobacco, illicit substances and adverse obstetric outcome

Resumen OBJETIVO: Establecer la relación entre el grado de consumo de alcohol, tabaco y sustancias ilícitas con los desenlaces obstétricos adversos para que el personal encargado de la atención obstétrica evalúe los riesgos que implica el consumo de esas sustancias. MATERIALES Y MÉTODOS: Estudio retrospectivo, observacional, analítico y transversal de una serie de casos llevado a cabo en pacientes en el puerperio hospitalizadas en el servicio de Ginecología y Obstetricia del Hospital General de Saltillo entre marzo y junio del 2023 y que refirieron consumo de alcohol, tabaco o drogas durante el embarazo. Posterior al procedimiento obstétrico se aplicó la herramienta ASSIST o prueba de detección de consumo alcohol, tabaco y sustancias. Según el grado de consumo, se utilizó la prueba χ2 de Pearson y la prueba exacta de Fisher para evaluar su asociación con los desenlaces adversos. RESULTADOS: De 863 atenciones obstétricas, 47 pacientes 5.4% refirieron un consumo activo de diferentes sustancias durante el embarazo; de ellas, 22 consumían 2 sustancias, con una tendencia entre el consumo de tabaco y cannabis a un desenlace obstétrico adverso p = 0.16 y 0.17, respectivamente. El desenlace obstétrico adverso más frecuente fue el bajo peso al nacer en 22 de 47 pacientes. CONCLUSIONES: Las sustancias con mayor tendencia a un desenlace obstétrico adverso fueron el tabaco y la cannabis, y la consecuencia desfavorable más frecuente en los neonatos fue el bajo peso al nacer.

Abstract OBJECTIVE: To determine the relationship between the extent of alcohol, tobacco and illicit substance use and adverse obstetric outcomes to enable obstetric care providers to assess the risks of substance use. MATERIALS AND METHODS: Retrospective, observational, analytical and cross-sectional study of a case series of postpartum patients who were admitted to the Gynaecology and Obstetrics Service of the General Hospital of Saltillo between March and June 2023 and who reported alcohol, tobacco or drug use during pregnancy. After the obstetric procedure, the ASSIST tool or screening test for alcohol, tobacco and drug use was applied. Pearson's χ2 test and Fisher´s exact statistic were used to assess their association with adverse outcomes according to the level of use. RESULTS: Of 863 obstetric attendances, 47 patients 5.4% reported active use of different substances during pregnancy; of these, 22 used 2 substances, with a trend between tobacco and cannabis use for adverse obstetric outcomes p = 0.16 and 0.17, respectively. The most common adverse obstetric outcome was low birth weight in 22 of 47 patients. CONCLUSIONS: The substances with the highest tendency for adverse obstetric outcome were tobacco and cannabis, and the most common adverse neonatal outcome was low birthweight.