Martins Mary Anne Fontenele, Scherer Magda Duarte Dos Anjos, Lucchese Geraldo
Universidade de Brasília (UnB) Programa de Pós-Graduação em Saúde Coletiva Brasília (DF) Brasil Universidade de Brasília (UnB), Programa de Pós-Graduação em Saúde Coletiva, Brasília (DF), Brasil.
Universidade de Brasília (UnB) Faculdade de Ciências da Saúde Brasília (DF) Brasil Universidade de Brasília (UnB), Faculdade de Ciências da Saúde, Brasília (DF), Brasil.
Rev Panam Salud Publica. 2022 May 3;46:e36. doi: 10.26633/RPSP.2022.36. eCollection 2022.
To identify the strategies employed by regulatory systems for the market surveillance and control of substandard, falsified, and unregistered medicines at the regional-global levels, especially regarding drug recall procedures.
An integrative literature review was performed. Searches were performed in MEDLINE via PubMed, Embase, and SciELO to select articles published from 2007 to 2019 in English, Portuguese, and Spanish, covering national regulatory system initiatives, with a focus on the recall of substandard, falsified, and unregistered medicines.
Of 483 articles initially identified, 21 global, regional, or national scope studies were selected. Prevention, detection, and response strategies, including drug recall, were grouped according to two broad market surveillance and control models (passive-reactive and proactive) used by regulatory systems. These models seem to combine passive and proactive, complementary or concurring actions that varied according to country development level and regulatory capacity. Although considered the most effective response for protection of populations, medicine recall was not implemented in a uniform manner in different regulatory systems as indicated by the studies.
Addressing the complexity and magnitude of the problem of substandard, falsified, and unregistered medicines will demand effort, investment, and profound changes in the approaches, processes, and capacity of regulatory systems, with market surveillance and control strategies possibly converging toward a hybrid, multisectoral, multidisciplinary, global, and systemic model of human health protection.
确定监管系统在区域和全球层面针对不合格、伪造和未注册药品进行市场监督和控制所采用的策略，特别是关于药品召回程序的策略。
进行了一项综合文献综述。通过PubMed、Embase和SciELO在MEDLINE中进行检索，以选择2007年至2019年期间以英文、葡萄牙文和西班牙文发表的文章，涵盖国家监管系统举措，重点是不合格、伪造和未注册药品的召回。
在最初识别的483篇文章中，选择了21项全球、区域或国家范围的研究。预防、检测和应对策略，包括药品召回，根据监管系统使用的两种广泛的市场监督和控制模式（被动-反应型和主动型）进行了分组。这些模式似乎结合了被动和主动、互补或协同的行动，这些行动因国家发展水平和监管能力而异。尽管药品召回被认为是保护公众最有效的应对措施，但研究表明，在不同的监管系统中，药品召回的实施方式并不统一。
应对不合格、伪造和未注册药品问题的复杂性和规模需要付出努力、投入资金，并在监管系统的方法、流程和能力方面进行深刻变革，市场监督和控制策略可能会趋向于一种混合、多部门、多学科、全球和系统性的人类健康保护模式。
