Potentialities and limitations of the Sentinel Network to improve the post-marketing/post-use monitoring of products subject to health surveillance adopted by Anvisa

Abstract

Introduction: Hospitals are essential for the universal coverage of any health system, as well as sources of  valuable information on adverse events and technical complaints of products subjects to health surveillance. Objective: To identify the potentialities and limitations of the Sentinel Network to improve post-marketing/post-use monitoring of products subject to health surveillance adopted by Anvisa. Method: A descriptive quantitative study that used data from a national administrative survey applied to the Sentinel Network, which was conducted between August 4 and September 2, 2021, by the Anvisa. Data were collected using an electronic structured  questionnaire. Statistical analyzes were performed in the Gretl-2022a software, including the calculation of absolute and relative frequencies, medians, and interquartile ranges. Results: A response rate of 69.1% (181/262) was obtained. Among the potentialities, the following stand out: acting as a center for study, teaching, and research of health establishments (n = 145; 80.1%), presence of implanted electronic medical records (n = 142; 78.4%) and the development of initiatives focused on innovation involving risk management of health products (n = 94; 52.0%). As one of the limitations, health establishments that do not have any current excellence/quality certifications predominate (n = 104; 57.5%). Conclusions: The Sentinel Network has  several potentialities and limitations that affect the post-marketing/post-use monitoring of products subject to  health surveillance. Identifying them, as was the objective of this study, demonstrates the need to promote actions that offer the possibility of expanding the potentialities and mitigate the limiting factors to the improvement of post-marketing/post-use monitoring adopted by Anvisa.