Reports of Symptoms Associated with Supraventricular Arrhythmias as a Serious Adverse Drug Reaction in the Spanish Pharmacovigilance Database.

This study aimed to determine the type of drugs reported as suspected of causing severe supraventricular arrhythmias from the Spanish Human Pharmacovigilance System database. A total of 1053 reports were analysed, of which 526 (50%) were on men and 516 (49%) were on women. The most affected age group was the over-65s, with 593 reports (56%). Of the 1613 drugs, those belonging to the cardiovascular system (ATC Group C) were the most numerous (414 reports, 26%), with digoxin being the most frequent drug (49 reports, 12%). Other common groups were antiinfectives for systemic use (ATC Group J; 306 reports, 19%), antineoplastic and immunomodulating agents (ATC Group L; 198 reports, 12%), and nervous system drugs (ATC Group N; 185 reports, 11%). The most common supraventricular arrhythmia was atrial fibrillation (561 reports, 51%). Regarding outcomes, 730 (66%) patients recovered, 76 (7%) did not recover, 25 (3%) recovered but with sequelae, and 23 (2%) resulted in death. This study revealed that certain drugs have reported to be associated more frequently to supraventricular arrhythmias as serious adverse reactions, especially in the older population. Proper clinical management and effective strategies to ensure medication appropriateness should always be considered to improve patient safety when prescribing drugs.

Prescribed Drugs and Self-Directed Violence: A Descriptive Study in the Spanish Pharmacovigilance Database.

Self-inflicted violence is a major and growing public health problem and its prediction and prevention is challenging for healthcare systems worldwide. Our aim was to identify prescribed drugs associated with self-directed violent behaviors in Spain. A descriptive, longitudinal and retrospective study of spontaneous reports of adverse drug reactions corresponding to self-directed violence was recorded in the Spanish Pharmacovigilance Database (FEDRA®) from 1984 to 31 March 2021. A total of 710 cases were reported in the study period. The mean age was 45.52 years (range 1-94). There were no gender differences except in children, where most reports were of male children. The main therapeutic groups that were involved included drugs for the nervous system (64.5%) and anti-infectives for systemic use (13.2%). The most commonly reported drugs were varenicline, fluoxetine, lorazepam, escitalopram, venlafaxine, veralipride, pregabalin, roflumilast and bupropion. There were reports of montelukast, hydroxychloroquine, isotretinoin, methylphenidate, infliximab, natalizumab, ribavirin and efavirenz, which were less known to be involved in self-directed violence. This study shows that self-directed violence is a rare adverse drug reaction, and can be related to the use of some medicines. It is important for healthcare professionals to consider this risk in their clinical praxis, implementing person-centred approaches. Further studies are needed, considering comorbidities and potential interactions.

[A study of incidence and clinical characteristics of adverse drug reactions in hospitalized patients.] / Análisis de la incidencia y de las características clínicas de las reacciones adversas a medicamentos de uso humano en el medio hospitalario.

OBJECTIVE: Adverse drug reactions (ADR) are one of the ten main causes of mortality in the world, as a cause of hospital admissions or prolongation hospitalizations days created an important health and economic impact. This study aimed to detect incidence and characterize ADRs that occurred during hospitalization and associated with admission in Internal Medicine service. METHODS: Observational and prospective study of intensive RAM monitoring patients admitted in Internal Medicine services in a third level hospital over a twelve months period in 2014. The assessment consisted of a complete and protocol collecting information about the patients and related to suspected ADRs during hospitalization. Statistical analysis was performed using SPSS v.20.0. RESULTS: The study included 253 patients and in 54 (21,34%) ADR were detected, the risk of experiencing an ADR was associated with the age (p=0.012). ADR-related hospitalizations incidence were 7,11%, and fatal ADR incidence were 1,97%. With regard to severity 81,2% were severe. Gastrointestinal disorders represented the most common ADRs followed by metabolism and nutrition disorders and vascular disorders. The drugs most frequently associated with ADRs were cardiovascular agents, antiinfective drugs and central nervous system agents. 72.2% of the patients who suffered ADR had polypharmacy. CONCLUSIONS: In our study incidence of adverse drug reactions in hospitalized patients was 21,34%, this data and ADR´s related to admission to hospital or fatal ADR´s are mainly suffered by pluripathology and polymedicated elderly patients with worst renal function values. In these patients a more careful prescription should be made.

OBJETIVO: Las reacciones adversas a medicamentos de uso humano (RAM) son una de las diez principales causas de mortalidad a nivel mundial, siendo las que causan ingreso o prolongan la estancia hospitalaria las de mayor impacto sanitario y económico. Los objetivos de este estudio fueron conocer la incidencia y las características de las RAM en pacientes hospitalizados en los servicios de Medicina Interna. METODOS: Estudio observacional y prospectivo de monitorización intensiva de RAM de los pacientes ingresados en los servicios de Medicina Interna en un hospital de tercer nivel durante el año 2014. Se protocolizó la recogida de datos relativos al paciente así como las características de las RAM. El análisis estadístico se realizó con el software SPSS v.20.0. RESULTADOS: Se monitorizaron 253 pacientes. Se detectaron RAM en 54 pacientes (21,34%), encontrándose una asociación positiva entre la edad y la presencia de RAM (p=0.012). La incidencia de ingresos causados por una RAM fue de 7,11% y las RAM mortales fueron un 1,97%. Las RAM fueron graves en el 81,2% de los casos. Los órganos más afectados fueron el gastrointestinal, trastornos del metabolismo y de la nutrición y el vascular. Los grupos terapéuticos causantes de RAM más frecuentes fueron los agentes cardiovasculares, los antinfecciosos y los del sistema nervioso. El 72,2% de los pacientes que sufrieron RAM presentaban polimedicación. CONCLUSIONES: La incidencia de RAM en nuestro estudio se sitúa en el 21,34%. La carga de ingresos o de mortalidad derivados de una RAM la sufren, fundamentalmente, pacientes ancianos, pluripatológicos, polimedicados y con peores valores de función renal por lo que es en ellos en quien fundamentalmente se debería realizar una prescripción más cuidadosa.

Análisis de la incidencia y de las características clínicas de las reacciones adversas a medicamentos de uso humano en el medio hospitalario / A study of incidence and clinical characteristics of adverse drug reactions in hospitalized patients

Fundamentos: Las reacciones adversas a medicamentos de uso humano (RAM) son una de las diez principales causas de mortalidad a nivel mundial, siendo las que causan ingreso o prolongan la estancia hospitalaria las de mayor impacto sanitario y económico. Los objetivos de este estudio fueron conocer la incidencia y las características de las RAM en pacientes hospitalizados en los servicios de Medicina Interna. Métodos: Estudio observacional y prospectivo de monitorización intensiva de RAM de los pacientes ingresados en los servicios de Medicina Interna en un hospital de tercer nivel durante el año 2014. Se protocolizó la recogida de datos relativos al paciente así como las características de las RAM. El análisis estadístico se realizó con el software SPSS v.20.0. Resultados: Se monitorizaron 253 pacientes. Se detectaron RAM en 54 pacientes (21,34%), encontrándose una asociación positiva entre la edad y la presencia de RAM (p=0.012). La incidencia de ingresos causados por una RAM fue de 7,11% y las RAM mortales fueron un 1,97%. Las RAM fueron graves en el 81,2% de los casos. Los órganos más afectados fueron el gastrointestinal, trastornos del metabolismo y de la nutrición y el vascular. Los grupos terapéuticos causantes de RAM más frecuentes fueron los agentes cardiovasculares, los antinfecciosos y los del sistema nervioso. El 72,2% de los pacientes que sufrieron RAM presentaban polimedicación. Conclusión: La incidencia de RAM en nuestro estudio se sitúa en el 21,34%. La carga de ingresos o de mortalidad derivados de una RAM la sufren, fundamentalmente, pacientes ancianos, pluripatológicos, polimedicados y con peores valores de función renal por lo que es en ellos en quien fundamentalmente se debería realizar una prescripción más cuidadosa (AU)

Objectives: Adverse drug reactions (ADR) are one of the ten main causes of mortality in the world, as a cause of hospital admissions or prolongation hospitalizations days created an important health and economic impact. This study aimed to detect incidence and characterize ADRs that occurred during hospitalization and associated with admission in Internal Medicine service. Methods: Observational and prospective study of intensive RAM monitoring patients admitted in Internal Medicine services in a third level hospital over a twelve months period in 2014. The assessment consisted of a complete and protocol collecting information about the patients and related to suspected ADRs during hospitalization. Statistical analysis was performed using SPSS v.20.0. Results: The study included 253 patients and in 54 (21,34%) ADR were detected, the risk of experiencing an ADR was associated with the age (p=0.012). ADR-related hospitalizations incidence were 7,11%, and fatal ADR incidence were 1,97%. With regard to severity 81,2% were severe. Gastrointestinal disorders represented the most common ADRs followed by metabolism and nutrition disorders and vascular disorders. The drugs most frequently associated with ADRs were cardiovascular agents, antiinfective drugs and central nervous system agents. 72.2% of the patients who suffered ADR had polypharmacy. Conclusion: In our study incidence of adverse drug reactions in hospitalized patients was 21,34%, this data and ADR´s related to admission to hospital or fatal ADR´s are mainly suffered by pluripathology and polymedicated elderly patients with worst renal function values. In these patients a more careful prescription should be made (AU)