Identificación de reacciones adversas a medicamentos en pacientes adultos con prescripción de psicotrópicos atendidos en el hospital general IESS Machala

Abstract

Pharmacovigilance is the science responsible for detecting, evaluating, and preventing adverse effects associated with the use of medications. Within this field, adverse drug reactions (ADRs) are defined as harmful and unintended responses that occur at therapeutic doses. In this context, psychotropic drugs are those that act on the central nervous system, causing changes in behavior, alertness, mood, and consciousness in patients. The objective of this study was to identify ADRs in adult patients prescribed psychotropic drugs at the IESS Machala General Hospital, characterizing their pathophysiological conditions, analyzing side effects, and determining the prevalence and type of ADRs, in order to contribute to a more efficient pharmacovigilance system. The research was cross-sectional, non-experimental, and observational. A sample of 46 patients over the age of 18, undergoing psychotropic treatment for more than three months, was included. Structured surveys, the yellow card, and the Naranjo algorithm, a tool used to classify the causality of ADRs, were used for data collection. A higher prevalence was observed among females (60.87%), with predominant diagnoses such as mild depression (34.78%) and mixed anxiety-depressive disorder (28.26%). Among the results, 102 clinical manifestations were identified, with the most relevant adverse reaction being parasomnia classified as type A, present in 15.69% of cases. Side effects such as insomnia (13.73%), dry mouth (11.76%), and headache (10.78%) were also reported, with clonazepam (50%) and alprazolam (19.6%) being the most commonly prescribed medications. Pharmacovigilance is an essential element in health and pharmaceutical services, as it allows for the identification, evaluation, and prevention of the most common adverse reactions associated with the use of psychotropic drugs. This process not only strengthens patient safety but also contributes to improving the quality of medical care and, consequently, the quality of life of those receiving these treatments.