Pharmacovigilance of compounded drugs - Part 2: Adverse event notifications and technical complaints in Brazil
DOI:
https://doi.org/10.22239/2317-269x.01996Keywords:
Pharmacovigilance, Compounded Drug, Pharmaceutical Compounding ServiceAbstract
Introduction: Compounded drug is a pharmaceutical preparation obtained by a pharmacotechnical procedure from a prescription of a qualified professional intended for an individualized patient, or whose formula is registered in the National or International Form. Objective: To describe the profile of notifications related to compounded drugs, reported to the National Health Surveillance Notification System (Notivisa). Method: Descriptive exploratory study, retrospective to the period 2006-2016, of the notifications of compounded drugs reported to Notivisa. Data were recorded and analyzed using the Excel program, version for Windows 3.5.4. Results: Of a total of 108,400 notifications referring to medicines in the studied period, 335 (0.32%) were related to reports of compounded drugs. Technical complaints (QT) obtained 90.40% of the notifications, while adverse events (AE) obtained 9.60%. The Southeast region was the main notifier (66.00%), and the state of São Paulo was responsible for 54.00% of the total notifications. Hospitals were the institutions with the highest frequency of notification (81.00%). It was possible to evaluate the reasons that generated the notifications, of which the changes related to the aspect of the pharmaceutical preparation were the predominant among the QT, while for the AEs, the adverse drug reactions stood out. Conclusions: The occurrences observed in the pharmacovigilance of compounded drugs are specific to each product with its particularities, although, what is sought is a pattern. In this way, such observation can prevent the occurrence of damages to the population exposed to similar situations, if it is duly notified and widely disseminated.
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Author Biographies
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Márcia Maria Barros dos Passos, Faculdade de Farmácia, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brasil
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Thamires Lemos Pimenta, Faculdade de Farmácia, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brasil
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Danilo Ribeiro de Oliveira, Faculdade de Farmácia, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brasil
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Zaida Maria Faria de Freitas, Faculdade de Farmácia, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brasil
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Mariana Sato de Souza Bustamante Monteiro, Faculdade de Farmácia, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brasil
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Copyright (c) 2022 Márcia Maria Barros dos Passos, Thamires Lemos Pimenta, Danilo Ribeiro de Oliveira, Zaida Maria Faria de Freitas, Mariana Sato de Souza Bustamante Monteiro
This work is licensed under a Creative Commons Attribution 4.0 International License.
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