Exploring the impact of pharmacogenetics on personalized medicine: A systematic review. / [Artículo traducido] Exploración del impacto de la farmacogenética en la medicina personalizada: una revisión sistemática.

INTRODUCTION: Pharmacogenetics evaluates how genetic variations influence drug responses. Nowadays, genetic tests have advanced, becoming more affordable, and its integration is supported by stronger clinical evidence. Guidelines such as those from CPIC (Clinical Pharmacogenetics Implementation Consortium) and resources like PharmGKB facilitate genotype-based prescribing; and organizations like the FDA promote genetic testing before initiating certain medications. Preventive pharmacogenetic panels seem promising, but further research on biomarkers and diverse populations is needed. The aim of this review is to analyze recent evidence on the genotype-drug response relationship to examine how the genetic profile of patients influences the clinical response to treatments, and analyze the areas of research that need further study to advance towards a genetic-based precision medicine. MATERIALS AND METHODS: A systematic search was conducted on PubMed to identify articles investigating the genotype-drug response relationship. The search strategy included terms such as "pharmacogenetics", "personalized treatment", "precision medicine", "dose adjustment", "individualized dosing", "clinical routine" and "clinical practice." Clinical trials, observational studies, and meta-analyses published in English or Spanish between 2013 and 2023 were included. The initial search resulted in a total of 136 articles for analysis. RESULTS: 49 articles were included for the final analysis following review by two investigators. A relationship between genetic polymorphisms and drug response or toxicity was found for drugs such as opioids, GLP-1 agonists, tacrolimus, oral anticoagulants, antineoplastics, atypical antipsychotics, efavirenz, clopidogrel, lamotrigine, anti-TNF-α agents, voriconazole, antidepressants, or statins. However, for drugs like metformin, quetiapine, irinotecan, bisoprolol, and anti-VEGF agents, no statistically significant association between genotype and response was found. CONCLUSION: The studies analyzed in this review suggest a strong correlation between genetic variability and individual drug responses, supporting the use of pharmacogenetics for treatment optimization. However, for certain drugs like metformin or quetiapine, the influence of genotype on their response remains unclear. More studies with larger sample sizes, greater ethnic diversity, and consideration of non-genetic factors are needed. The lack of standardization in analysis methods and accessibility to genetic testing are significant challenges in this field. As a conclusion, pharmacogenetics shows immense potential in personalized medicine, but further research is required.

Exploring the impact of pharmacogenetics on personalized medicine: A systematic review.

INTRODUCTION: Pharmacogenetics evaluates how genetic variations influence drug responses. Nowadays, genetic tests have advanced, becoming more affordable, and its integration is supported by stronger clinical evidence. Guidelines such as those from CPIC (Clinical Pharmacogenetics Implementation Consortium) and resources like PharmGKB facilitate genotype-based prescribing; and organizations like the FDA promote genetic testing before initiating certain medications. Preventive pharmacogenetic panels seem promising, but further research on biomarkers and diverse populations is needed. The aim of this review is to analyze recent evidence on the genotype-drug response relationship to examine how the genetic profile of patients influences the clinical response to treatments, and analyze the areas of research that need further study to advance towards a genetic-based precision medicine. MATERIALS AND METHODS: A systematic search was conducted on PubMed to identify articles investigating the genotype-drug response relationship. The search strategy included terms such as "pharmacogenetics", "personalized treatment", "precision medicine", "dose adjustment", "individualizing dosing", "clinical routine", and "clinical practice." Clinical trials, observational studies, and meta-analyses published in English or Spanish between 2013 and 2023 were included. The initial search resulted in a total of 136 articles for analysis. RESULTS: 49 articles were included for the final analysis following review by 2 investigators. A relationship between genetic polymorphisms and drug response or toxicity was found for drugs such as opioids, GLP-1 agonists, tacrolimus, oral anticoagulants, antineoplastics, atypical antipsychotics, efavirenz, clopidogrel, lamotrigine, anti-TNFα agents, voriconazole, antidepressants, or statins. However, for drugs like metformin, quetiapine, irinotecan, bisoprolol, and anti-VEGF agents, no statistically significant association between genotype and response was found. CONCLUSION: The studies analyzed in this review suggest a strong correlation between genetic variability and individual drug responses, supporting the use of pharmacogenetics for treatment optimization. However, for certain drugs like metformin or quetiapine, the influence of genotype on their response remains unclear. More studies with larger sample sizes, greater ethnic diversity, and consideration of non-genetic factors are needed. The lack of standardization in analysis methods and accessibility to genetic testing are significant challenges in this field. As a conclusion, pharmacogenetics shows immense potential in personalized medicine, but further research is required.

Trastornos en la calidad del sueñoasociados a los inhibidores dela integrasa en el tratamiento del VIH / Sleep disorders related to HIV treatment

FUNDAMENTOS: Los inhibidores de la integrasa se han posicionado recientemente en todas las Guías Clínicas de VIH como tratamiento antirretroviral de primera línea para el VIH. Sin embargo, dos de estos fármacos se han asociado también a efectos adversos a nivel del sistema nervioso central, concretamente con alteraciones del sueño. El objetivo del trabajo fue analizar la influencia de bictegravir y dolutegravir en la calidad del sueño en personas que viven con VIH (PVIH). MÉTODOS: Se realizó un estudio observacional y transversal entre los meses de diciembre de 2020 y enero de 2021 en las PVIH de las consultas de atención farmacéutica del hospital. Se recogieron variables demográficas y de adherencia. La calidad del sueño se midió mediante el Cuestionario de Pittsburgh o PSQI. Las PVIH se clasificaron en 2 grupos: el grupo estudio, constituido por participantes con bictegravir o dolutegravir en su tratamiento, y el grupo control, integrado por el resto de PVIH. Se analizó la influencia de las variables recogidas sobre el resultado del PSQI mediante la prueba de chi cuadrado/odds ratio para variables categóricas y el de t de Student o U de Mann Whitney para variables continuas. RESULTADOS: Se incluyeron 119 PVIH, de las cuales un 64% en el grupo estudio y un 67% en el grupo control sufrían trastornos del sueño según el PSQI (p=0,788). Tampoco hubo diferencias estadísticamente significativas cuando se compararon los diferentes componentes del sueño entre los dos grupos. CONCLUSIONES: Un elevado porcentaje de PVIH, independientemente de si el TAR incluye bictegravir o dolutegravir, tienen problemas relacionados con la calidad del sueño. No se encuentra correlación entre la calidad del sueño y el tratamiento con bictegravir o dolutegravir comparado con el resto de tratamientos.(AU)

BACKGROUND: HIV Clinical Guidelines have positioned integrase inhibitors recently as first-line treatment. However, two of these drugs have also been associated with adverse side effects on the central nervous system, especially with sleep disturbances. The objective was to analyse the influence of bictegravir and dolutegravir on the sleep quality in HIV patients. METHODS: An observational, cross-sectional study was carried out between December 2020 and January 2021 in HIV patients attended in a pharmacy care clinic. Demographic and adherence variables were collected. Sleep quality was measured using the Pittsburgh questionnaire or PSQI. We classified patients into two groups: patients with bictegravir or dolutegravir in their treatment (study group) and the rest (control group). The influence of the variables collected on the PSQI result was analysed using the Chi-Square test for categorical variables and the student t-test or Mann-Whitney U test for continuous variables. RESULTS: One hundred and nineteen patients were included. 64% in the study group and 67% in the control group suffered from sleep disorders according to the PSQI questionnaire (p=0.788). Neither were statistical differences found when the different components of sleep were analysed between the two groups. CONCLUSIONS: A high percentage of patients, regardless of whether their treatment includes bictegravir or dolutegravir, have problems with their sleep quality. We didn’t find a correlation between sleep quality and treatment with bictegravir or dolutegravir compared to the other treatments.(AU)

Atrial fibrillation and QT prolongation after a single dose of hydroxychloroquine / Fibrilación auricular y prolongación del QT después de una dosis única de hidroxicloroquina

Non-antiarrhythmic drugs may induce QT-prolongation and increase the risk of arrhythmias. Recent studies have determined that there is a risk of atrial fibrillation (AF) due to QT prolongation. We report a case of FA associated to QT prolongation secondary to a single dose of hydroxychloroquine (HCQ) in an 83-years-old polymedicated patient admitted to our hospital due to SARS-CoV-2 infection. Quetiapine was prescribed as regular medicine after admission and a 5-days oral HCQ regimen was started for COVID-19. Thirty minutes after HCQ loading dose, FA was reported on electrocardiogram (EKG). COVID-19 treatment is leading to use off-label drugs that may generate adverse effects. It should be considered that drugs that induce QT prolongation may be triggers for atrial arrhythmias. There is not any report of sudden onset of increased QT interval with associated arrythmia after a single dose of HCQ, even in a short course treatment. (AU)

Los fármacos no antiarrítmicos pueden inducir la prolongación del intervalo QT y aumentar el riesgo de arritmias. Estudios recientes han determinado que existe riesgo de desarrollar fibrilación auricular (FA) asociada a la prolongación del intervalo QT. Presentamos un caso de FA asociado a prolongación del QT secundario a una dosis única de hidroxicloroquina (HCQ) en una paciente polimedicada de 83 años ingresada en nuestro hospital por infección por SARS-CoV-2. A la paciente se le prescribió quetiapina como parte de su medicamento habitual al ingreso y se inició tratamiento frente a COVID-19 basado en HCQ oral. Treinta minutos tras la dosis de carga de HCQ, se informó FA en el electrocardiograma (ECG). El tratamiento de COVID-19 está llevando al uso de medicamentos no aprobados que pueden generar efectos adversos. Además, debe considerarse que los fármacos que inducen la prolongación del QT pueden desencadenar arritmias auriculares. No se han reportado casos de aparición repentina de aumento del intervalo QT con arritmia asociada después de una dosis única de HCQ. (AU)

DRESS, una reacción alérgica no mediada por IgE / DRESS, a Non-IgE Mediated Allergic Reaction

Resumen El síndrome de reacción a medicamentos con eosinofilia y síntomas sistémicos (DRESS, por sus siglas en inglés) es una respuesta de hipersensibilidad multisistémica poco frecuente inducida por uno o varios medicamentos que puede inducir una reacción adversa cutánea grave, la cual es difícil de diagnosticar y pone en peligro la vida del paciente si no es identificada y no se recibe tratamiento. Frecuentemente, se manifiesta como una erupción cutánea amplia, linfadenopatía, signos de afectación de órganos viscerales y alteraciones hematológicas, como leucocitosis, eosinofilia y, en ocasiones, linfocitosis atípica que se presentan de 2 a 8 semanas posterior a la administración del fármaco responsable. Los medicamentos responsables con mayor número de reportes son la fenitoína, la carbamazepina, el alopurinol y el abacavir. Se han identificado algunos alelos específicos del antígeno leucocitario humano (HLA) que se asocian a la hipersensibilidad de estos fármacos. La fisiopatología del síndrome de DRESS aún no se conoce por completo, generalmente se trata de una respuesta de hipersensibilidad mediada por células T, al interactuar con el receptor del complejo principal de histocompatibilidad en individuos con factores de susceptibilidad genética, como ocurre en otros cuadros de reacciones graves secundarias a la ingesta de fármacos. Los criterios del European Registry of Severe Cutaneous Adverse Reactions to Drugs (RegiSCAR) son los más utilizados para su diagnóstico. El síndrome de hipersensibilidad inducido por fármacos (DiHS), el síndrome de Stevens-Johnson (SSJ), la necrólisis epidérmica tóxica (NET), y la pustulosis exantemática generalizada aguda (PEGA) deben considerarse ante cualquier exantema que aparezca posterior a la administración de cualquier fármaco. La terapia incluye la eliminación del agente causal lo antes posible, así como los corticosteroides sistémicos, los cuales son los pilares del tratamiento.. Los agentes ahorradores de esteroides, como la ciclosporina, las inmunoglobulinas intravenosas (IVIGs) y otros agentes inmunosupresores, se han utilizado con éxito para contribuir al tratamiento.

Abstract DRESS (drug reaction syndrome with eosinophilia and systemic symptoms) is a rare drug-induced multisystemic hypersensitivity response that can induce a severe cutaneous adverse reaction that is difficult to diagnose and treat. It frequently manifests as an extensive skin rash, systemic symptoms, lymphadenopathy, visceral organ involvement, and hematological alterations, mainly leukocytosis, eosinophilia, and sometimes atypical lymphocytosis that manifest 2 to 8 weeks after continuous administration of the responsible drug. The most prevalent drugs related with this syndrome are phenytoin, carbamazepine, allopurinol, and abacavir. Some specific human leukocyte antigen (HLA) alleles have been identified that are associated with hypersensitivity to these drugs. The pathophysiology of DRESS syndrome is not yet fully understood; the main hypothesis is a T-cell mediated hypersensitivity response when interacting with the major histocompatibility complex receptor in individuals with genetic susceptibility factors. The criteria of the European Registry of Severe Cutaneous Adverse Reactions to Drugs (RegiSCAR) are the most commonly used for the diagnosis of DRESS syndrome. Drug-induced hypersensitivity syndrome (DiHS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) should be considered for any rash that appears following the administration of any drug. Therapy of DRESS includes the elimination of the causative agent as soon as possible, as well as systemic corticosteroids which are the cornerstones of treatment. Steroid-sparing agents such as cyclosporine, intravenous immunoglobulins (IVIGs), and other immunosuppressive agents have been used successfully to contribute to treatment.

Prevalence of adverse drug reactions associated with emergency department visits and risk factors for hospitalization. / [Artículo traducido] Prevalencia de reacciones adversas a medicamentos asociadas a visitas al servicio de urgencias y factores de riesgo de hospitalización.

OBJECTIVE: Adverse drug reactions increase morbidity and mortality, prolong hospital stay and increase healthcare costs. The primary objective of this study was to determine the prevalence of emergency department visits for adverse drug reactions and to describe their characteristics. The secondary objective was to determine the predictor variables of hospitalization for adverse drug reactions associated with emergency department visits. METHODS: Observational and retrospective study of adverse drug reactions registered in an emergency department, carried out from November 15th to December 15th, 2021. The demographic and clinical characteristics of the patients, the drugs involved and the adverse drug reactions were described. Logistic regression was performed to identify factors related to hospitalization for adverse drug reactions. RESULTS: 10,799 patients visited the ED and 216 (2%) patients with adverse drug reactions were included. The mean age was 70 ± 17.5 (18-98) years and 47.7% of the patients were male. A total of 54.6% of patients required hospitalization and 1.6% died from adverse drug reactions. The total number of drugs involved was 315 with 149 different drugs. The pharmacological group corresponding to the nervous system constituted the most representative group (n = 81). High-risk medications, such as antithrombotic agents (n = 53), were the subgroup of medications that caused the most emergency department visits and hospitalization. Acenocumarol (n = 20) was the main drug involved. Gastrointestinal (n = 62) disorders were the most common. Diarrhea (n = 16) was the most frequent adverse drug reaction, while gastrointestinal bleeding (n = 13) caused the highest number of hospitalizations. Charlson comorbidity index behaved as an independent risk factor for hospitalization (aOR 3.24; 95% CI: 1.47-7.13; p=0.003, in Charlson comorbidity index 4-6, and aOR 20.07; 95% CI: 6.87-58.64; p = 0.000, in Charlson comorbidity index ≥ 10). CONCLUSIONS: The prevalence of emergency department visits for adverse drug reactions continues to be a non-negligible health problem. High-risk drugs such as antithrombotic agents were the main therapeutic subgroup involved. Charlson comorbidity index was an independent factor in hospitalization, while gastrointestinal bleeding was the adverse drug reaction with the highest number of hospital admissions.

Definición y caracterización del fenómeno “Diagnóstico Lastre Generado por Medicamentos” / Definition and characterization of the phenomenon "Diagnosis of Drug-Generated Ballast"

Proponemos el presente estudio para la identifica-ción del fenómeno "Diagnóstico Lastre Generado por Medicamentos" (DLGM), que es la traducción farmacéutica de la interpretación médica de un problema de salud generado por medicamentos y atribuido a causas clínicas con la consiguiente pérdida de identidad que limita su identificación y manejo. No habrá mejoría de la enfermedad si no se corrige la causa del problema, por lo que cabe esperar un empeoramiento y persistencia de la enfermedad marcados por el fracaso farmacote-rapéutico, convirtiendo el problema de salud en un verdadero lastre para los pacientes a la espera de ser identificado.La propuesta de un algoritmo de caracterización del problema como herramienta de cribado se ha aplicado a 10 pacientes en el servicio de segui-miento farmacoterapéutico, confirmando la sospe-cha de DLGM, y demostrando que las reacciones adversas a medicamentos habían adquirido la identidad de una enfermedad. Un DLGM podría defi-nirse como la entidad que surge al diagnosticar una enfermedad sobre un resultado negativo asociado al uso del medicamento y que, por tanto, no recibe el tratamiento adecuado.La identificación del fenómeno DLGM permite detectar muchos resultados negativos asociados a la medicación (RNM) y contribuye a su adecuado tratamiento.No identificar un DLGM complica el estado clínico del paciente y limita su recuperación. (AU)

The present study was proposed for the identifica-tion the phenomenon "Diagnosis load Generated by Medications" (DLGM), which is the pharmaceutical translation to the medical interpretation of a health problem generated by medications and attributed to clinical causes with the consequent loss of iden-tity limiting its identification and handling. There will be no improvement of the desease if the cause of the problem is not corrected, so worsening and persistence of the disease marked by pharmaco-therapeutic failure is to be expected, making the health problem a real burden for patients to waiting to be identified.The proposal of an algorithm characterising the problem as a screening tool has been applied to 10 patients in the pharmacotherapeutic monitoring service, confirming the suspicion of DLGM, and demonstrating that adverse drugs reactions had acquired the identity of a disease. DLGM could be defined as the entity that arises from diagnosing a disease on a negative results associated to medici-ne use and that therefore does not receive adequa-te treatment.The identification of the DLGM phenomenon allows the detection of many Negative Outcomes Relea-ted to Mediccines (NOMs) and contributes to their adequate treatment.Not identifying DLGM complicates the clinical con-dition of the patient and his/her recovery. (AU)

Reações adversas medicamentosas em pacientes em quimioterapia e estratégias de intervenções / Adverse drug reactions in chemotherapy patients and intervention strategies / Reacciones adversas a medicamentos en pacientes quimioterápicos y estrategias de intervención

A quimioterapia do câncer pode ocasionar reações adversas medicamentosas (RAM), podendo resultar de interações medicamentosas (IM) e impactar na adesão. O presente estudo relatou as RAM apresentadas por pacientes em quimioterapia (QT) e propôs estratégias de intervenções. Este trabalho foi aprovado em comité de ética (5.160.503), sendo incluídos 23 pacientes em quimioterapia (oral- VO e/ou endovenosa- EV) e todos foram entrevistados. Recebiam apenas o QTEV, 20 pacientes e 2 QTEV e VO, a maioria em tratamento paliativo (50%), predomínio de estadiamento IV, sendo as doenças mais presentes de pâncreas (27,3%), estômago (22,7%) e mama (18,2%) e esquema mais usado foi Carboplatina + Paclitaxel. As principais comorbidades foram diabetes e hipertensão arterial. As interações medicamentosas foram classificadas em graves (45%), moderadas (55%) e intencional (75%), sendo necessário introdução de medicamentos de suporte (61%). Houve RAM de maior gravidade, neutropenia, sendo necessário a suspensão temporária, e de menor gravidade náuseas. Houve um óbito relacionado a evolução de doença e, talvez, o tratamento possa ter contribuído. Ao final, foram feitas as intervenções para cada caso e validado o formulário para a consulta farmacêutica a pacientes oncológicos.

Cancer chemotherapy can cause adverse drug reactions (ADRs), which can result from drug interactions (IM) and impact adherence. The present study reported the ADRs presented by patients undergoing chemotherapy (CT) and proposed intervention strategies. This work was approved by the ethics committee (5,160,503), and 23 patients on chemotherapy (oral-VO and/or intravenous-IV) were included and all were interviewed. Only received CTIV, 20 patients and 2 CTIV and VO, most in palliative treatment (50%), predominance of stage IV, being the most common diseases of pancreas (27.3%), stomach (22.7%) and breast (18.2%) and the most used regimen was Carboplatin + Paclitaxel. The main comorbidities were diabetes and arterial hypertension. Drug interactions were classified as severe (45%), moderate (55%) and intentional (75%), requiring the introduction of supportive drugs (61%). There were more severe ADRs, neutropenia, requiring temporary suspension, and less severe nausea. There was one death related to the evolution of the disease and, perhaps, the treatment may have contributed. At the end, interventions were made for each case and the form for the pharmaceutical consultation to cancer patients was validated.

La quimioterapia contra el cáncer puede causar reacciones adversas a los medicamentos (RAM), que pueden ser consecuencia de interacciones farmacológicas (IM) y repercutir en la adherencia. El presente estudio reportó las RAM presentadas por pacientes en quimioterapia (QT) y propuso estrategias de intervención. Este trabajo fue aprobado en comité de ética (5.160.503), se incluyeron 23 pacientes en quimioterapia (oral- VO y/o endovenosa-EV) y todos fueron entrevistados. Recibieron sólo QTEV, 20 pacientes y 2 QTEV y VO, la mayoría en tratamiento paliativo (50%), predominio de estadiaje IV, siendo las enfermedades más presentes las de páncreas (27,3%), estómago (22,7%) y mama (18,2%) y el esquema más utilizado fue Carboplatino + Paclitaxel. Las principales comorbilidades fueron la diabetes y la hipertensión arterial. Las interacciones farmacológicas se clasificaron como graves (45%), moderadas (55%) e intencionadas (75%), requiriendo la introducción de fármacos de apoyo (61%). La RAM más grave fue la neutropenia, que requirió la suspensión temporal, y la menos grave las náuseas. Hubo una muerte relacionada con la evolución de la enfermedad y, tal vez, el tratamiento pudo haber contribuido. Al final, se realizaron intervenciones para cada caso y se validó el formulario de consulta farmacéutica a pacientes oncológicos.

Prevalencia de reacciones adversas a medicamentos asociadas a visitas al servicio de urgencias y factores de riesgo de hospitalización / Prevalence of adverse drug reactions associated with emergency department visits and risk factors for hospitalization

Objetivos: las reacciones adversas a medicamentos aumentan la morbimortalidad, prolongan la estancia hospitalaria y aumentan los costes sanitarios. El objetivo principal de este estudio fue determinar la prevalencia de visitas por reacciones adversas a medicamentos al servicio de urgencias y describir sus características. El objetivo secundario fue determinar las variables predictoras de hospitalización por reacciones adversas a medicamentos asociadas a visitas al servicio de urgencias.Métodosestudio observacional y retrospectivo de las reacciones adversas a medicamentos registradas en un servicio de urgencias, realizado del 15 de noviembre al 15 de diciembre de 2021. Se describieron las características demográficas y clínicas de los pacientes, los medicamentos involucrados y las reacciones adversas a medicamentos. Se realizó una regresión logística para identificar los factores relacionados con la hospitalización por reacciones adversas a medicamentos.Resultados10.799 pacientes visitaron el servicio de urgencias, de los que 216 (2%) presentaban reacciones adversas a medicamentos. La edad media fue de 70 ± 17,5 (18-98) años y el 47,7% de los pacientes fueron hombres. Un 54,6% de los pacientes requirieron hospitalización y el 1,6% fallecieron a causa de una reacción adversa a medicamentos. El número total de fármacos involucrados fue de 315, con 149 fármacos diferentes. El grupo farmacológico correspondiente al sistema nervioso constituyó el grupo más representativo (n = 81). Medicamentos de alto riesgo, como los antitrombóticos (n = 53), fueron el subgrupo de medicamentos que causó más visitas a urgencias y hospitalizaciones. El acenocumarol (n = 20) fue el principal fármaco implicado. Los trastornos gastrointestinales (n = 62) fueron mayoritarios. (AU)

Objective: Adverse drug reactions increase morbidity and mortality, prolong hospital stay and increase healthcare costs. The primary objective of this study was to determine the prevalence of emergency department visits for adverse drug reactions and to describe their characteristics. The secondary objective was to determine the predictor variables of hospitalization for adverse drug reactions associated with emergency department visits.MethodsObservational and retrospective study of adverse drug reactions registered in an emergency department, carried out from November 15th to December 15th, 2021. The demographic and clinical characteristics of the patients, the drugs involved and the adverse drug reactions were described. Logistic regression was performed to identify factors related to hospitalization for adverse drug reactions.Results10,799 patients visited the ED and 216 (2%) patients with adverse drug reactions were included. The mean age was 70 ± 17.5 (18-98) years and 47.7% of the patients were male. A total of 54.6% of patients required hospitalization and 1.6% died from adverse drug reactions. The total number of drugs involved was 315 with 149 different drugs. The pharmacological group corresponding to the nervous system constituted the most representative group (n = 81). High-risk medications, such as antithrombotic agents (n = 53), were the subgroup of medications that caused the most emergency department visits and hospitalization. Acenocumarol (n = 20) was the main drug involved. Gastrointestinal (n = 62) disorders were the most common. Diarrhea (n = 16) was the most frequent adverse drug reaction, while gastrointestinal bleeding (n = 13) caused the highest number of hospitalizations. Charlson comorbidity index behaved as an independent risk factor for hospitalization (aOR 3.24; 95% CI: 1.47-7.13; p=0.003, in Charlson comorbidity index 4-6, and aOR 20.07; 95% CI: 6.87–58.64; p = 0.000, in Charlson comorbidity index ≥ 10). (AU)

Utilidad estadística de los estudios de farmacovigilancia para evaluar reacciones adversas a medicamentos

Introducción: la detección oportuna y la evaluación de las reacciones adversas de los medicamentos es cada vez más importante. En Cuba existe la necesidad de profundizar y extender con alcance nacional los estudios de Farmacovigilancia, por tal motivo se expone como objetivo fundamentar sustentados en la estadística el uso de estudios de farmacovigilancia para la detección, registro, notificación y evaluación de las sospechas de las reacciones adversas de los medicamentos valorando su seguridad. Desarrollo: se brinda un resumen de tipos de estudios de farmacovigilancia con ejemplos de objetivos de investigaciones realizadas y publicadas en revistas científicas posibles a considerar y aplicar a las condiciones reales que tenga cada investigador, se presentan variables que ya han sido establecidas en otros estudios que se deben tener en cuenta para estudiar seguridad de los medicamentos y técnicas estadísticas teniendo en cuenta los tipos de variables a relacionar. Conclusiones: se concluye que resulta un logro científico conocer formas de profundizar y extender los estudios de Farmacovigilancia para tomar conocimiento de la seguridad de los fármacos y promover un uso racional, científico y adecuado de los mismos, en beneficio de la comunidad.

Introduction: timely detection and evaluation of adverse drug reactions is increasingly important. In Cuba there is a need to deepen and extend pharmacovigilance studies nationwide. That is why it is stated, based on statistics, the use of studies for the detection, registration, notification and evaluation of suspected adverse drug events, assessing their safety. Development: a summary of types of pharmacovigilance studies is provided with examples of objectives of research works already done and published in scientific magazines likely to consider and use in actual conditions each researcher has, and there are also presented variables that have already been established in other studies, which must be taken into account to study drug safety and statistical techniques considering the types of variables to be related. Conclusion: it is concluded that knowing ways to deepen and spread the Pharmacovigilance studies in order to be aware of drug safety and foster their rational, scientific and adequate use in the interests of the community is indeed a scientific accomplishment.

Introdução: a detecção e avaliação oportunas de reações adversas a medicamentos está se tornando cada vez mais importante. Em Cuba há uma necessida de de aprofundar e ampliar os estudos de farmacovigilância com âmbito nacional, por esta razão é declarado como um objetivo fundamentar com base em estatísticas o uso de estudos de farmacovigilância para a detecção, registro, notificação e avaliação de suspeitas de reações adversas de medicamentos que avaliam sua segurança. Desenvolvimento: um resumo dos tipos de estudos de farmacovigilância é fornecido com exemplos de objetivos de pesquisa realizados e publicados em possíveis revistas científicas a serem consideradas e aplicadas às condições reais que cada pesquisador possui, variáveis que já foram estabelecidas em outros estudos que devem ser levadas em conta para estudar a segurança de medicamentos e técnicas estatísticas levando em conta os tipos de variáveis a serem relacionadas. Conclusões: conclui-se que é uma conquista científica conhecer formas de aprofundar e ampliar os estudos de farmacovigilância para tomar conhecimento da segurança dos medicamentos e promover um uso racional, científico e adequado dos mesmos, em benefício da comunidade.

Implantación y evaluación de un modelo de atención farmacéutica domiciliaria mediante Telefarmacia / Implementation and evaluation of a home pharmaceutical care model through Telepharmacy

Objetivo: Describir el impacto de un modelo de atención farmacéutica especializada que incluye el seguimiento farmacoterapéutico de lospacientes mediante una plataforma de Telefarmacia y la dispensación dela medicación en el domicilio.Método: Estudio descriptivo, retrospectivo, llevado a cabo en un serviciode farmacia de un hospital terciario entre el 23 marzo de 2020 y el 31de diciembre de 2021. Se desarrolló un nuevo modelo de atención farmacéutica para la atención de los pacientes crónicos ambulatorios, queincluye: i) definición de los criterios de selección de los pacientes candidatos a Telefarmacia, ii) estratificación de los pacientes según el nivel deriesgo, iii) definición del seguimiento farmacoterapéutico individualizado,iv) adaptación de la plataforma de apps del servicio de farmacia paragarantizar el seguimiento farmacoterapéutico continuo y la monitorizaciónde los pacientes (e-Oncosalud, e-Midcare y farMcuida), v) implantación deun sistema de citación, y vi) el desarrollo de un módulo informático para lagestión de la dispensación y entrega de la medicación en el domicilio. Elimpacto de este modelo de atención se evaluó mediante el análisis deindicadores de actividad, seguridad, adherencia y calidad percibida. Asimismo, se incluyó un estudio adicional sobre el impacto de la COVID-19 en la accesibilidad de la atención médica y la continuidad de los tratamientos,mediante una encuesta a una muestra aleatoria de 100 pacientes.Resultados: Durante el periodo de estudio, 2.737 pacientes se hanbeneficiado del nuevo modelo de atención farmacéutica a distancia. Elnúmero de consultas de Telefarmacia realizadas fue 7.758. (AU)

Objective: To describe the impact of a Specialized PharmaceuticalCare model that includes pharmacotherapeutic monitoring of patientsthrough an Telepharmacy platform and home medication dispensing.Method: A descriptive and retrospective study conducted in the Pharmacy Service of a tertiary hospital, between 23 March 2020 and31 December 2021. A new pharmaceutical care model for chronicambulatory patients was developed, including: (i) definition of criteria forselecting Telepharmacy candidate patients; (ii) stratification of patients byrisk level; (iii) definition of individualized pharmacotherapeutic monitoring;(iv) adaptation of the Pharmacy Service app platform to ensure continuouspharmacotherapeutic monitoring and patient monitoring (e-Oncohealth,e-Midcare and farMcuida), (v) implementation of an appointment system;and (vi) development of a software module for the management of homemedication delivery. The impact of this pharmaceutical care model wasassessed by analyzing indicators of activity, safety, adherence and perceived quality. Moreover, an additional study on the impact of COVID-19was developed in order to assess the accessibility of medical care andcontinuity of treatment through a survey conducted on a random sampleof 100 patients. Results: During the study period, 2,737 patients benefited from thenew remote pharmaceutical care model. A total of 7,758 Telepharmacyconsultations were performed. Pharmacotherapeutic monitoring prevented 1,043 adverse drug reactions, which affected 10.4% of patients(3.6 adverse drug reactions/patient). Mean adherence to treatment was95.2%. Overall satisfaction with the new model was 9.8/10. (AU)

Evaluación del perfil de seguridad del medicamento lopinavir/ritonavir (Lpv/r) en los pacientes sospechosos o confirmados por COVID-19 / Evaluation of the safety profile of the drug lopinavir/ritonavir (Lpv/r) in suspected or confirmed COVID-19 patients

Introducción: El nuevo SARS-CoV-2, es el agente causal de la enfermedad COVID-19. La Organización Mundial de la Salud (OMS) ha referenciado el uso del lopinavir/ritonavir (Lpv/r), es un inhibidor de la proteasa del virus de inmunodeficiencia humana adquirida (VIH-1). El estudio clínico de Cao et al., identificó que el uso de Lpv/r no se asociaron con un mayor número de eventos adversos en comparación con el tratamiento estándar.Materiales y métodos: Estudio retrospectivo de farmacovigilancia en una cohorte en pacientes sospechosos o confirmados de COVID-19 en un hospital de tercer Nivel de la Ciudad de México en el periodo 01 abril 2020 al 30 julio 2020. Resultados: El tratamiento de Lpv/r incluyó 140 pacientes, de los cuales 91 pacientes completaron el tratamiento, mientras que 50 pacientes no terminaron el esquema. Los principales motivos de la suspensión del esquema del medicamento fueron: alta por mejoría (11 casos), defunciones (10 casos) y por inicio de ruxolitinib (9 casos). Además, se identificaron 8 reacciones adversas al medicamento, de las cuales 5 son reacciones asociadas a los trastornos gastrointestinales (diarreas) y las otras 3 reacciones asociadas a trastornos hepatobiliares (hipertransaminasemia).Conclusión: El perfil de seguridad del medicamento Lpv/r demostró una coherencia con las observaciones de estudios previos en relación en los eventos adversos presentados de tipo gastrointestinales y hepáticos, estos últimos se encuentran relacionados a interacción fármaco-fármaco, por lo que sugerimos un seguimiento farmacoterapéutico para identificar las interacciones y las reacciones adversas durante el uso Lpv/r. (AU)

Abstract: The new SARS-CoV-2 is the causal agent for COVID-19. The World Health Organization (WHO) referenced the use of lopinavir/ritonavir (Lpv/r), which is a protease inhibitor of human inmunodeficiency virus (HIV-1). The Clinical trial by Cao et al. identified that the use of Lpv/r has not been associated with any increase of adverse drug reactions within compared to the standard of care.Materials and methods: Pharmacovigilance retrospective study of patients suspected or confirmed with COVID-19 in a 3rd level hospital in Mexico City from April, 01 2020 to July, 30 2020.Results: Lopinavir/ritonavir treatment was prescribed 140 patients from which 91 patients completed the treatment, while 50 patients did not completed the treatment. The cause suspensions were: patient discharge for improvement (11 cases), deaths (10 cases) and start of ruxolitinib (9 cases). In addition, were identify 8 adverse drug reaction from which 5 were associated to gastrointestinal disorders (diarrhea) and 3 hepatobiliary disorders (hypertransaminasemia).Conclusion: The safety profile of the Lpv/r demonstrated consistency with the observations of previous studies in relation to gastrointestinal and hepatic adverse events, which were related to drug-drug interaction, so we suggest a pharmacotherapeutic monitoring to identify them as well as adverse drug reactions due to Lpv/r. (AU)

La notificación espontánea de las reacciones adversas a medicamentos

RESUMEN Introducción: El uso adecuado de medicamentos elimina o controla numerosas enfermedades, contribuye al bienestar de la población y al incremento de la esperanza de vida; pero también puede generar reacciones adversas, las cuales deben ser reportadas para identificar nuevos riegos y construir el verdadero perfil de seguridad de cualquier medicamento. Se realiza una revisión de artículos publicados en las bases de datos LILACS, PAHO, SciELO, EMBASE, PubMed e Infomed, relacionados con el tema. Objetivos: Analizar el proceso de notificación espontánea de las reacciones adversas a medicamentos en Cuba. Desarrollo: El Centro de Monitoreo Internacional de Medicamentos, analiza los patrones de presuntos daños que causan en todo el mundo, a partir de los informes enviados por los países miembros, entre ellos Cuba, que a través de la Unidad Coordinadora Nacional de Farmacovigilancia, armoniza la actividad a nivel nacional. Este proceso tiene como piedra angular a la persona que reporta, ya sea profesional sanitario o paciente y es la notificación espontánea la forma más frecuente, pero que puede encontrar limitantes en su desarrollo, sobre las que se debe accionar, para adquirir los conocimientos y habilidades necesarias en la búsqueda, diagnóstico, reporte, tratamiento, la concientización de su necesidad y motivación. Conclusiones: El sistema cubano de farmacovigilancia tiene normalizadas sus acciones y métodos de trabajo, la notificación espontanea de reacciones adversas a medicamentos es su fuente de información más importante. Están identificadas sus limitaciones y la manera de erradicarlas de manera sistemática.

ABSTRACT Introduction: The proper use of medications eliminates or controls numerous diseases, contributes to the well-being of the population and increases life expectancy; but it can also generate adverse reactions, which must be reported to identify new risks and build the true safety profile of any drug. A review of articles published in the databases LILACS, PAHO, SciELO, EMBASE, PubMed and Infomed, related to the subject is carried out. Objectives: To analyze the spontaneous notification process of adverse drug reactions in Cuba. Development: The Center for International Drug Monitoring, analyzes the patterns of alleged damage they cause throughout the world, based on reports sent by member countries, including Cuba, which, through the National Coordinating Unit of Pharmacovigilance, harmonizes activity at the national level. This process has as its cornerstone the person who reports, whether he is a healthcare professional or a patient, and spontaneous notification is the most frequent way, but which may find limitations in its development, on which it must be acted upon, to acquire knowledge and skills. necessary in the search, diagnosis, report, treatment, awareness of their need and motivation. Conclusions: The Cuban pharmacovigilance system has standardized its actions and working methods, spontaneous notification of adverse drug reactions is its most important source of information. Its limitations and the way to systematically eradicate them have been identified.

Notificación de sospechas de reacciones adversas a medicamentos por enfermeras en España. Un estudio observacional descriptivo retrospectivo / Reporting of suspected adverse drug reactions by nursing in Spain. An observational-descriptive retrospective study

Objetivo: Conocer el grado de participación de las enfermeras en la notificación espontánea de sospechas de reacciones adversas a medicamentos (RAM) al Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano (SEFV-H), describir las características principales de los casos notificados e identificar puntos de mejora. Método: Estudio observacional descriptivo retrospectivo a partir de la información contenida en la base de datos FEDRA del SEFV-H. Se tomaron como muestra las notificaciones espontáneas de las RAM realizadas por enfermeras durante los seis primeros meses del 2018. Resultados: De las 6.370 sospechas de RAM notificadas por profesionales sanitarios en el periodo considerado, tan solo un 4,8% fueron realizadas por enfermeras. El 62,7% procede de centros extrahospitalarios y la mayoría de las RAM son consideradas no graves (78%). Las reacciones notificadas con más frecuencia son las reacciones locales. Los pacientes más implicados son los niños y las vacunas los medicamentos más notificados (58,3%), seguidas de los contrastes intravenosos para la realización de pruebas diagnósticas. Conclusiones: Las enfermeras notifican muy pocos casos al SEFV-H y están en su mayoría relacionados con la administración de vacunas y son enviados por enfermeras que trabajan en el medio extrahospitalario. La mayoría de los casos no presentan gravedad y suelen referir reacciones adversas conocidas para el fármaco sospechoso. Esta infranotificación observada plantea la necesidad de promover la formación en materia de farmacovigilancia entre estas enfermeras notificadoras para que continúen notificando, y también a las que no lo hacen en su práctica diaria, para que puedan comenzar a hacerlo.(AU)

Objective: This study aimed to gain knowledge of the nurses’ involvement in the spontaneous report of suspected adverse drug reactions (ADR) in the Spanish Pharmacovigilance System for Medicinal Products for Human Use (SEFV-H), describing the principal characteristics of the reported cases, identifying points of improvement. Methods: A descriptive observational retrospective study was based on the data from FEDRA, the database created by the SEFV-H. The sample taken was the spontaneous adverse drug reactions reported to SEFV-H by nurses during the first 6 months of the 2018. Results: Complete data was provided by 6,370 suspicions of ADR reported to SEFV-H by all healthcare professionals. Only 4,8% of the samples were taken by nurses, 62,7% came from medical centers. The majority of the ADR were not considered a serious disease (78%). The most frequently adverse drug reactions reported by nurses were local reactions. The patients most involved were children and vaccines were the most reported drugs (58,3%), followed by the intravenous contrast agents used in diagnostic tests. Conclusions: Nurses report very few cases to SEFV-H and are mostly related to the administration of vaccines and are sent by nurses working in the out-of-hospital setting. Most cases are not serious and usually report known adverse reactions to the suspected drug. This observed under-notification raises the need to promote increased pharmacovigilance training among these notifying nurses so that they can continue to report, and also for those who do not do so in their daily practice, so that they can begin to do so.(AU)

Reporting of suspected adverse drug reactions by nursing in Spain. An observational-descriptive retrospective study.

OBJECTIVE: This study aimed to gain knowledge of the nurses' involvement in the spontaneous report of suspected adverse drug reactions (ADR) in the Spanish Pharmacovigilance System for Medicinal Products for Human Use (SEFV-H), describing the principal characteristics of the reported cases, identifying points of improvement. METHODS: A descriptive observational retrospective study was based on the data from FEDRA, the database created by the SEFV-H. The sample taken was the spontaneous adverse drug reactions reported to SEFV-H by nurses during the first 6 months of the 2018. RESULTS: Complete data was provided by 6,370 suspicions of ADR reported to SEFV-H by all healthcare professionals. Only 4,8% of the samples were taken by nurses, 62,7% came from medical centers. The majority of the ADR were not considered a serious disease (78%). The most frequently adverse drug reactions reported by nurses were local reactions. The patients most involved were children and vaccines were the most reported drugs (58,3%), followed by the intravenous contrast agents used in diagnostic tests. CONCLUSIONS: Nurses report very few cases to SEFV-H and are mostly related to the administration of vaccines and are sent by nurses working in the out-of-hospital setting. Most cases are not serious and usually report known adverse reactions to the suspected drug. This observed under-notification raises the need to promote increased pharmacovigilance training among these notifying nurses so that they can continue to report, and also for those who do not do so in their daily practice, so that they can begin to do so.

Manejo del angiodema inducido por inhibidores de la enzima convertidora de angiotensina con icatibant / Management of angiotensin-converting enzyme inhibitors-related angioedema with icatibant

Objetivo: Evaluar la efectividad de icatibant en el tratamiento del angioedema inducido por IECA (AII), en un centro sin protocolización previa del manejo.Método: Estudio observacional retrospectivo y descriptivo. Se incluyeron pacientes diagnosticados de AII y tratados con icatibant 30 mg entre mayo 2015-diciembre 2017. Las variables de resultado principal y secundaria fueron: tiempo hasta resolución completa y tiempo hasta primera mejoría; respectivamente.Resultados: Cinco pacientes, mediana de edad 76 años (46-81); cuatro mujeres y un varón. Todos caucásicos. Medianas de tiempo hasta resolución completa y hasta primera mejoría: 23 horas (IQR 20,0-25,0) y 3 horas (IQR 3,0-6,0); respectivamente.Conclusiones. El inicio temprano del tratamiento anti-bradicinérgico puede resultar clave para la evolución del cuadro. Para alcanzar la máxima efectividad, se reduzcan las morbilidades asociadas, los ingresos en UCI y el tiempo de estancia hospitalaria, resulta primordial la elaboración de protocolos locales que tengan en cuenta las particularidades de cada centro. (AU)

Objetive: To assess the effectiveness of icatibant in the management of angiotensin-converting enzyme inhibitor-induced angioedema (AII) in a hospital without a treatment guidance.Methods: Observational, retrospective and descriptive study. All patients diagnossed with AII and treated with icatibant 30 mg between May 2015-December 2017 were included. The primary and secondary end-points were: time to total resolution and time to first improvement; respectively.Results: Five patients, median age 76 years (46-81). Four women and a man. All of them Caucasian. Median time to total resolution and to first improvement: 23 hours (IQR 20.0-25.0) and 3 hours (IQR 3.0-6.0); respectively.Conclusion: The early start with the anti-bradicinergic therapy may be key to the AII evolution. To achieve the maximum effectiveness and to get reduced the associated morbidity, the ICU admission and the time to discharge, the development of local protocols considering the particularities of each center is highly necessary. (AU)

Reporting of suspected adverse drug reactions by nursing in Spain. An observational-descriptive retrospective study. / Notificación de sospechas de reacciones adversas a medicamentos por enfermeras en España. Un estudio observacional descriptivo retrospectivo.

OBJECTIVE: This study aimed to gain knowledge of the nurses' involvement in the spontaneous report of suspected adverse drug reactions (ADR) in the Spanish Pharmacovigilance System for Medicinal Products for Human Use (SEFV-H), describing the principal characteristics of the reported cases, identifying points of improvement. METHODS: A descriptive observational retrospective study was based on the data from FEDRA, the database created by the SEFV-H. The sample taken was the spontaneous adverse drug reactions reported to SEFV-H by nurses during the first 6 months of the 2018. RESULTS: Complete data was provided by 6,370 suspicions of ADR reported to SEFV-H by all healthcare professionals. Only 4,8% of the samples were taken by nurses, 62,7% came from medical centers. The majority of the ADR were not considered a serious disease (78%). The most frequently adverse drug reactions reported by nurses were local reactions. The patients most involved were children and vaccines were the most reported drugs (58,3%), followed by the intravenous contrast agents used in diagnostic tests. CONCLUSIONS: Nurses report very few cases to SEFV-H and are mostly related to the administration of vaccines and are sent by nurses working in the out-of-hospital setting. Most cases are not serious and usually report known adverse reactions to the suspected drug. This observed under-notification raises the need to promote increased pharmacovigilance training among these notifying nurses so that they can continue to report, and also for those who do not do so in their daily practice, so that they can begin to do so.

Interactions of cobicistat and ritonavir in patients with HIV and its clinical consequences. / Interacciones de cobicistat y ritonavir en pacientes con VIH y sus consecuencias clínicas.

INTRODUCTION: The prescription of antiretroviral treatment (ART) that contains pharmacokinetic enhancers such as ritonavir and cobicistat is frequent. The objective of this stdy was to analyze the potential interactions of ART that include these molecules in their formulation with the patient's home medication, as well as the clinical management of those potentially serious. METHODS: Prospective study conducted in the pharmacy care clinic of a third level hospital between January and December of 2018. Those HIV+patients with an ART containing cobicistat or ritonavir were included in the study. Potential interactions between ART and concomitant medication were analysed in three databases (Micromedex®, Drugs.com and Liverpool), the interventions carried out were detailed, and adverse drug reactions analysed. RESULTS: 968 patients were included with a total of 2,148 prescriptions (274 different medications). A total of 86 interventions were performed regarding potential interactions in patients. The most frequent were substitutions of corticoid treatments, treatment suspensions and closer monitoring of treatments. A total of possible adverse drug reactions were analysed. The degree of agreement in the severity classification of the interactions for cobicistat and ritonavir was good among the three databases. It was remarkable Micromedex® as the most complete because it has more registered medications. CONCLUSION: The interactions between ART with pharmacokinetic enhancers in its composition and concomitant medication is frequent and requires a significant variety of interventions. The check of interactions in different databases is recommended since they can cause adverse drug reactions.

Eventos adversos relacionados à administração de medicamentos em um hospital do Vale do Taquari / Adverse events related to medication administration in a Taquari Valley hospital / Eventos adversos relacionados con la administración de medicamentos en un hospital del Valle del Taquari

Justificativa e Objetivos: O processo de medicação no ambiente hospitalar é uma das atividades de maior importância para assegurar a eficácia na terapêutica do paciente. Este estudo teve como objetivo conhecer a percepção da equipe de enfermagem sobre a ocorrência de eventos adversos relacionados a administração de medicamentos em um hospital do Vale do Taquari, Rio Grande do Sul. Métodos: Trata-se de um estudo exploratório descritivo, com abordagem quali-quantitativa. Os dados foram coletados por meio da aplicação de um questionário aos profissionais da enfermagem, constituindo uma amostra de cinquenta e oito entrevistados. A análise foi realizada por meio de estatística descritiva. Resultados: Dos participantes, 96,6% conheciam as etapas para evitar erros de medicação, 79,3% já cometeram algum erro, sendo mais frequente o erro de dose de administração 43,5%. Dos profissionais 97,3% já perceberam algum erro no processo de medicação e 30% consideram a sobrecarga de trabalho um fator para a ocorrência destes. Comunicavam verbalmente 80,4% e receberam orientação verbal, 78,3% das vezes. E 36,8% sentiram medo de prejudicar o paciente. Conclusão: Os achados apontam erros potenciais graves que prejudicam a segurança do paciente, no entanto, nota-se que orientações verbais são oferecidas evitando a punição, mas o incentivo para o registro de notificação do erro é precário, dificultando a equipe de identificar os erros potenciais e implementar barreiras para evitá-los.(AU)

Background and Objectives: The medication process in the hospital environment is one of the most important activities to ensure efficacy in the patient's therapy. The objective of this study was to know the perception of the nursing team about the occurrence of adverse events related to drug administration in a hospital in Vale do Taquari, Rio Grande do Sul. Methods: This is a descriptive exploratory study with a qualitative approach-quantitative. Data were collected through the application of a questionnaire to nursing professionals, constituting a sample of fifty-eight interviewees. The analysis was made through descriptive statistics. Results: Of the participants, 96.6% knew the steps to avoid medication errors, and 79.3% had already made some mistake in their professional practices in the institution. The most frequent error was the erroneous administration dose of 43.5%, with 97.3% of the professionals already perceived some error in the medication process and 30% considered the work overload to be an aggravating factor for the occurrence of errors. Regarding the professional's behavior regarding the error, 80.4% communicated verbally to the supervising professional and as a consequence received verbal guidance 78.3% of the time. As for feelings about the error 36.8% revealed to feel fear of harming the patient. Conclusion: These findings point to serious potential errors that impair patient safety; however, it is noted that verbal guidelines are offered avoiding punishment, but the incentive for reporting the error is precarious, making it difficult for the team to identify potential errors and implement barriers to avoid them.(AU)

Justificación y Objetivos: El proceso de medicación en el ambiente hospitalario es una de las actividades de mayor importancia para asegurar la eficacia en la terapéutica del paciente. El estudio tuvo como objetivo conocer la percepción del equipo de enfermería sobre la ocurrencia de eventos adversos relacionados con la administración de medicamentos en un hospital del Valle del Taquari, Rio Grande do Sul. Métodos: Se trata de un estudio exploratorio descriptivo, con abordaje cuali-quantitativo. Los datos fueron recolectados por medio de la aplicación de un cuestionario a los profesionales de la enfermería, constituyendo una muestra de cincuenta y ocho entrevistados. El análisis fue realizado por medio de estadística descriptiva. Resultados: De los participantes 96,6% conocían las etapas para evitar errores de medicación y el 79,3% ya cometieron algún error en sus prácticas profesionales en la institución. El error más frecuente fue la dosis de administración equivocada 43,5%, siendo que el 97,3% de los profesionales ya percibieron algún error en el proceso de medicación y el 30% considera la sobrecarga de trabajo un factor agravante para la ocurrencia de errores. En cuanto a la conducta del profesional frente al error 80,4% comunicaban verbalmente al profesional supervisor y como consecuencia recibieron orientación verbal el 78,3% de las veces. En cuanto a los sentimientos frente al error 36,8% revelaron sentir miedo de perjudicar al paciente. Conclusión: Tales hallazgos apuntan errores potenciales graves que perjudican la seguridad del paciente, pero se nota que las orientaciones verbales son ofrecidas evitando el castigo, pero el incentivo para el registro de notificación del error es precario, dificultando el equipo de identificar los errores potenciales e implementar barreras para evitarlos.(AU)