Identificação das queixas técnicas como instrumento de farmacovigilância e controle de qualidade de medicamentos antidepressivos dispensados pela rede pública.

Abstract

Pharmacovigilance have a large role in the health regulation of each country. Through it is possible to have control of adverse effects and technical complaints, both problems related to medications. Monitoring the quality of medicines that are purchased in the public sector can be carried out with chemical and microbiological physical quality control, which requires specific laboratories, or through pharmacovigilance, which becomes a simple, accessible and important tool in the public sector. Quality control of medicinal products is intended to ensure product characteristics, stability and efficacy within the expiration date established by the manufacturer. Pharmacovigilance is a set of actions aimed at the promotion, protection and recovery of health, both individual and collective, taking the drug as an essential input and aiming for access and rational use. Psychotropic agents are those that act in the Central Nervous System generating changes in behavior, mood and cognition. The objective of this study was to evaluate the quality of the antidepressant medications Amitriptyline Hydrochloride 25 mg and Fluoxetine Hydrochloride 20 mg in the solid pharmaceutical form, dispensed at the Municipal Pharmacy of Santa Cruz do Sul, as well as to verify if users and employees of this same place had some technical complaint related to the drugs that are dispensed. The research was characterized as an observational, cross-sectional and experimental study, approved by the Ethics Committee of the UNISC, based on a consolidated opinion no. 2,699,255. The evaluation of the quality of the drugs was performed through tests such as weight determination, hardness, friability, disintegration and dosing, and the evaluation of technical complaints was done through a semi-structured questionnaire in interviews with health professionals, employees and users of the Municipal Pharmacy. The results obtained in the determination of average weight, hardness, friability, disintegration and dosing of the drugs were in accordance with the pharmacopoeial specifications. There were technical complaints regarding some classes of drugs such as antidepressants, antibiotics, antihypertensives and bronchodilators dispensed by the pharmacy, mainly by employees, especially the absence of tablets in the blister, tablets brittle and capsules with their contents outside the envelope. Pharmacovigilance and quality control actions are important tools in the identification of technical complaints and deviations of the quality of medicines, contributing to guarantee effectiveness and safety in their use.