Analysis of notifications of technical complaints and preventive health inspection measures applied during the COVID-19 pandemic in Brazil
Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02067 | Published on: 11/08/2023
DOI:
https://doi.org/10.22239/2317-269x.02067Keywords:
Post-Market Product Surveillance, Pharmacovigilance, Health Surveillance, Products RetentionAbstract
Introduction: The consumptio of falsified, unregistered, and substandard medicines is a serious public health problem, and it is essential to know the legal enforcement actions related that were taken during the pandemic in Brazil. Objective: To Analyze notifications of technical complaints and preventive health measures applied during the Covid-19 pandemic in Brazil. Method: Descriptive, quantitative, retrospective study with data from notifications of technical complaints and measures determined by the National Health Surveillance Agency (Anvisa), from 2019 to June 2021. Results: 25,088 notifications of technical complaints about medicines and
562 measures were identified. 314 were classified as class I risk, with high potential to cause serious injury to health, including death. Most unregistered products claim pharmaceutical properties regarding body image, immunity, or information as being “natural” or Traditional Chinese Medicine (TCM). There were 63.3% of actions for advertising and irregular commerce of medicines on the internet. There were 333 measures (59.3%) with an unknown/non-existent company associated, making it impossible to legally hold the offender responsible. The type of enforcement activities the most frequent were: seizure (322), destruction (305) and prohibition (376). The most cited stages of the chain related to post-production, included distribution, commercialization and use. It was observed that the frequency of risk classification of medicines is significantly different with enforcement actions (p < 0.001). Conclusions: It is important to: develop strategies aimed at preventing, detecting, and responding to irregular/illegal practices, by reviewing the legal regulatory and the framework; and have greater corporate accountability, traceability mechanisms, effective inspection actions and improvement of the measures adopted by Anvisa to protect the population’s health.
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Author Biographies
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Josivan Lima Padro, Universidade de Brasília (UnB), Brasília, DF, Brasil
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Dayani Galato, Faculdade de Ceilândia (FCE), Universidade de Brasília (UnB), Brasília, DF, Brasil
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Camila Alves Areda, Faculdade de Ceilândia (FCE), Universidade de Brasília (UnB), Brasília, DF, Brasil
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Mary Anne Fontenele Martins, Agência Nacional de Vigilância Sanitária (Anvisa), Brasília, DF, Brasil / Programa de Pós-Graduação em Saúde Coletiva, Universidade de Brasília (UnB), Brasília, DF, Brasil
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Copyright (c) 2023 Josivan Lima Padro, Dayani Galato, Camila Alves Areda, Mary Anne Fontenele Martins (Autor)
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