Ações de vigilância sanitária na área de produtos e serviços farmacêuticos do município de Fortaleza, Ceará

Abstract

This exploratory study, of the retrospective survey type, presents a situational diagnosis of health actions in the area of pharmaceutical products and services in the city of Fortaleza - CE, registered in the Fiscalize System, from January 2018 to December 2019. The method work consisted of access to the Fiscalize system, search by registration group and registration date, with the viewing and copying of the content, individually, of each inspection. The data collected were categorized by type of establishment, number of inspections and non-conformities and stratified in notifications and fines, neighborhood of occurrence, non-conformities found and legislation used in the legal substantiation. They were compiled in an Excel 2016 spreadsheet from Microsoft®, using the “dynamic tables” resource, graphs and tables were elaborated and the results expressed in absolute and relative frequencies, followed by their descriptive and exploratory analysis. During the period, 614 establishments were inspected, 948 inspections were carried out and 2830 non-conformities were found, of which 385 (14%) were fines and 2445 (86%) were notified. The irregularities found varied according to the types of establishments inspected. Drugstore was the most frequent establishment (65.85%) and the lack of mandatory health documentation was the prevalent non-conformity (17.35%). The most used legislation to substantiate the irregularities was RDC Anvisa nº 44/2009, used in 45.19% of non-conformities. In the distribution by neighborhoods, downtown concentrated the largest number of inspected establishments (7.17%). The results showed that the vast majority of the inspected establishments followed the legally established sanitary standards, since only a minority of the verified non-conformities was a reason for fines, while the vast majority was only notified to show improvements.