Characterization and representation of substandard drugs in the area of pharmacovigilance scope: a narrative review
DOI:
https://doi.org/10.22239/2317-269x.01922Keywords:
Pharmacovigilance, Notification, Quality Control, Pharmaceutical PreparationsAbstract
Introduction: Substandard drugs (SD) present great relevance in the area of pharmacovigilance and should be investigated and monitored as they can lead to several clinical outcomes. Objective: To discuss the characteristics of SD in the area of pharmacovigilance through a narrative review. Method: A comprehensive search was performed on databases using the descriptors “pharmacovigilance”, “technical complaints (TC)”, “SD” and “notification systems” including studies directly concerning the subject conducted in Brazil and published between 2005 and 2020. Results: SD issues might be associated with drug product alterations, content and integrity of the package and labeling. Among the 18 selected studies (14 articles, two book chapters and two dissertations) regarding SD notifications reported as drug TC, two exclusively evaluated drug TC notifications (100.0%), while the rest showed that this type of notification represented 0.6% to 70.0% of the total of notifications made in national health establishments. The main SD issues found were: alterations on the product aspect; absence/reduction in the amount of drug product; and, package problems. Conclusions: Notifications involving SD issues are considered an excellent quality indicator for the drugs available in the market, which contributes to suppliers’ qualification and provision of consistent products for the population.
Downloads
Downloads
Published
Issue
Section
License
Copyright (c) 2022 Health Surveillance under Debate: Society, Science & Technology (Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnología) – “Visa em Debate”
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
COPYRIGHT ALLOWANCE The author (s) hereinafter designated as the ASSIGNOR hereby assign and transfer, free of charge, the ownership of the copyrights related to this ARTICLE to the Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debate, represented by FUNDAÇÃO OSWALDO CRUZ, established at Av. Brasil, nº 4365, Manguinhos, Rio de Janeiro, RJ, Brazil, CEP 21045-900, under the conditions set out below: (a) The terms and conditions set forth in this Agreement shall apply to the following: 1. The ASSIGNOR declares that they s(he) is (are) the author (s) and owner (s) of the copyrighted property of the ARTICLE submitted. 2. The ASSIGNOR declares that the ARTICLE does not infringe the copyrights and / or other property rights of third parties, that the disclosure of images (if any) has been authorized and that they s(he) assume(s) full moral and / or property liability for its content, before third parties. 3. THE ASSIGNOR assigns and transfers all copyrights relating to the ARTICLE to the ASSIGNEE, especially the rights of editing, publication, translation into another language and reproduction by any process or technique. The ASSIGNEE becomes the exclusive owner of the rights related to the ARTICLE, and any reproduction, totally or partially, is prohibited in any other means of publicity, printed or electronic, without prior written authorization from the ASSIGNEE. 4. The assignment is free and, therefore, there will be no remuneration for the use of the ARTICLE by the ASSIGNEE.
