Lopes Sarah Gomes Pitta, Luiza Vera Lúcia, Silva Rondineli Mendes da
Conselho Regional de Farmácia do Estado do Rio de Janeiro. R. Afonso Pena 115, Tijuca. 20270-244 Rio de Janeiro RJ Brasil.
Escola Nacional de Saúde Pública Sérgio Arouca, Fundação Oswaldo Cruz. Rio de Janeiro RJ Brasil.
Cien Saude Colet. 2023 Feb;28(2):561-573. doi: 10.1590/1413-81232023282.10382022. Epub 2022 Sep 2.
The work analyzed the effect of Public Consultations (PC) and their contributions to the recommendations of the National Commission for the Incorporation of Technologies (CONITEC). This is a descriptive and retrospective study with a qualitative-quantitative approach using a secondary data source of public access, between 2012 and 2017. A database was developed to characterize the PC of medications and their contributions, which allowed the identification of cases of reversals between the preliminary and final recommendation of CONITEC. We analyzed the contributions in cases of reversal for characterization of argumentative axes and type of basis. Of the 307 demands for incorporation of medications, 205 went through PC, with 23,894 contributions. The reversal of the recommendations occurred in 9% of the open PC (15 medications), all in the sense of non-incorporation for incorporation. Main argumentative axes dealt with clinical benefits and minor adverse events, with prevalence of the submission of clinical experiences and opinions. Advances in the processes of incorporation of technologies in the SUS by performing PC were found and the challenge that decision makers face in institutional spaces for the improvement of social participation to strengthen the public benefit was clear.
该研究分析了公众咨询（PC）的效果及其对国家技术纳入委员会（CONITEC）建议的贡献。这是一项描述性回顾性研究，采用定性定量方法，利用2012年至2017年期间可公开获取的二手数据源。开发了一个数据库来描述药物的公众咨询情况及其贡献，从而能够识别CONITEC初步建议和最终建议之间的反转案例。我们分析了反转案例中的贡献，以确定论证轴和依据类型。在307项药物纳入申请中，205项经过了公众咨询，收到了23894份意见。公开的公众咨询中有9%（15种药物）的建议发生了反转，均是从不纳入转为纳入。主要论证轴涉及临床益处和轻微不良事件，提交的临床经验和意见占多数。通过开展公众咨询，发现了统一卫生系统（SUS）技术纳入流程中的进展，并且明确了决策者在机构层面提高社会参与度以增强公共利益时所面临的挑战。
