Prescrição farmacêutica de fitoterápicos: aspectos regulatórios

Abstract

According to The Collegiate Board Resolution (RDC) N°26/2014 of the Brazilian Health Regulatory Agency (Anvisa), herbal medicines are industrialized products made exclusively from the active raw materials of plants, whose efficacy and safety are supported by clinical evidence, ensuring consistent product quality. In Brazil, phytotherapy was integrated into the Brazilian National Health System (SUS) in 2006 through the National Policy on Integrative and Complementary Practices (PNPIC). The development of phytotherapy has favored the regulation of pharmaceutical prescription by the Brazilian Federal Pharmacy Council (CFF) through the resolutions CFF 546/2011, 585/2013, and 586/2013. The study aimed to analyze the regulatory aspects related to the pharmaceutical prescription of herbal medicines. In order to analyze these aspects, an integrative review, a gray literature search and a document analysis were carried out. The databases used for the integrative review were Medline, Lilacs and SciELO, covering the period from January/2008 to December/2023. The gray literature search was undertaken on Google Academic with different combinations of keywords, but only “prescription”, “pharmaceutical” and “herbal medicines” provided pertinent results. The document analysis was conducted on websites of institutions relevant to the pharmaceutical practice: Brazilian National Association of Magistral Pharmacists (Anfarmag), Anvisa, Brazilian Ministry of Health (MS), CFF, Goiás State Health Department, Goiânia City Council, General Secretariat of Government (SGG), Superintendence of Health Surveillance (Suvisa) and Goiânia Health Surveillance Department. The integrative review identified 55 studies, but after reading the title and abstract, none of the results answered the research question. The gray literature search resulted in 13 articles, but only two focused on the regulatory aspects. Sixteen regulations were identified, including one federal law, one state law, one Brazilian Ministry of Health ordinance, five CFF resolutions, five Anvisa RDCs, and three normative instructions. No specific regulations were found in other institutions analyzed, such as SGG, Suvisa, and the Health Surveillance Department of Goiânia. Although the pharmaceutical prescription of herbal medicines requires specific training, the regulation allows the pharmacist to dispense these medicines, highlighting a normative discrepancy that raises concerns about safety and effectivity, as dispensing also affects the patient.