Pharmacy Department, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Rua Pastor Samuel Munguba, 1210, Rodolfo Teófilo, Fortaleza, 60430-372, Ceará, Brazil.
Lato Sensu post-graduation in pharmaceutical industry, Pharmacy Department, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Rua Pastor Samuel Munguba, 1210, Rodoldo Teófilo, Fortaleza, Ceará, Brazil.
BMC Health Serv Res. 2023 Mar 10;23(1):238. doi: 10.1186/s12913-023-09225-w.
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.
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).
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%).
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.
即使在生产过程中采取了所有措施，制药行业仍然存在生产质量偏差的药品的风险，导致商业化产品不符合质量要求，需要从市场召回。本研究的目的是评估导致巴西在评估期间召回药品的原因。
这是一项描述性研究（使用文件分析），研究了 2010 年至 2018 年期间在巴西国家卫生监督局（ANVISA）网站上注册的不合格药品召回情况。研究的变量包括药品类型（参考、通用、相似、特定、生物、草药、简化通知、新药和放射性药品）、药品剂型（固体、液体、半固体和注射制剂）和召回原因（良好生产规范、质量和质量/良好生产规范）。
共记录了 3056 次不合格药品召回。相似药品的召回指数（30.1%）最高，其次是通用药品（21.3%）、简化通知药品（20.7%）和参考药品（12.2%）。不同剂型的召回率相似：固体（35.2%）、液体（31.2%）和注射制剂（30.0%），半固体除外（3.4%）。召回率最高的原因与良好生产规范（58.4%）和质量（40.4%）有关。
召回数量高的可能原因是，即使所有质量控制和生产过程都符合良好生产规范，也可能会出现错误，无论是人为错误还是自动化过程中的错误，从而导致不应批准的批次放行。总之，制造商有必要实施强大且结构良好的质量体系，以避免此类偏差，而 ANVISA 则需要在这些产品的上市后加强监督。
