Recall of substandard medicines in Brazil during the period 2010–2018

Abstract

Background: Even with all the care taken during the production process, the pharmaceutical industries are still subject to manufacturing medicines with quality deviations, generating commercialized products without the required quality and necessitating their subsequent recall from the market. The objective of this study was to evaluate the reasons that led to the recall of medicines in Brazil in the period evaluated. Methods: This is a descriptive study (using document analysis), on the recall of substandard medicines registered on the website of the National Health Surveillance Agency (ANVISA), from 2010 to 2018. The variables studied were the type of medicine (reference, generic, similar, specific, biological, herbal, simplified notification, new and radiopharmaceutical), type of pharmaceutical dosage form (solid, liquid, semi-solid and parenteral preparation), and reason for recall (Good manufacturing practices, quality and quality/good manufacturing practices). Results: A total of n = 3,056 recalls of substandard medicine were recorded. Similar medicines had a higher recall index (30.1%), followed by generics (21.3%), simplified notification (20.7%) and reference (12.2%). Different dosage forms had similar recalls: solids (35.2%), liquids (31.2%) and parenteral preparations (30.0%), with the exception of semi-solids (3.4%). The reasons for the highest occurrences were related to good manufacturing practices (58.4%) and quality (40.4%). Conclusion: The probable cause for this high number of recalls is the fact that, even with all the quality controls and processes in accordance with good manufacturing practices, errors can occur, both human and in automated processes, thus causing the release of batches that should not have been approved. In summary, it is necessary for manufacturers to implement a robust and well structured quality system in order to avoid such deviations, and it is up to ANVISA to apply greater oversight in the post marketing of these products.