Arcabouço normativo relacionado à indicação e prescrição de medicamentos fitoterápicos por farmacêuticos no Brasil

O objetivo do presente estudo foi analisar a literatura acerca do uso de fitoterápicos na odontologia. Trata-se de uma revisão integrativa da literatura que utilizou os descritores: cirurgião-dentista, etnofarmacologia, medicamentos fitoterápicos, separadamente e posteriormente cruzando-os através do operador boleano AND. As bases de dados consultadas foram o Scientific Electronic Library Online (SciELO) e Medical Literature Analysis and Retrievel System online (MEDLINE). Foram analisados 13 artigos indexados na íntegra. Os resultados apontam que os fitoterápicos têm ganhado espaço no setor odontológico, principalmente após a aprovação da Política Nacional de Práticas Integrativas e Complementares (PNPIC) no SUS e do Conselho Federal de Odontologia, e mesmo com comprovação científica da eficácia farmacológica dessa terapêutica, existe uma resistência quanto à indicação e prescrição de fitoterápicos por alguns cirurgiões-dentistas, justificado na maioria das vezes por falta de conhecimento técnico dessa terapêutica. O uso dessa prática pelo cirurgião-dentista tem sido realizada principalmente em metrópoles, com ênfase na região sul do Brasil e mesmo que alguns profissionais afirmem não praticar a fitoterapia por desconhecimento técnico, percebe-se que esta vem sendo bastante utilizada por profissionais que atuam na Estratégia de Saúde da Família.

Objectives: The use of herbal medicine is one of the most widely used methods of complementary medicine around the world. Studies have shown that the elderly use a variety of herbal medicines and believe that these products are harmless due to being natural. This study aims to evaluate the amount of herbal medicines prescribed by physicians for the elderly in Iran. Methods & Materials: This is a secondary analysis study with a cross-sectional design. The study population consist of the paper prescriptions for all older adults in Tehran, Iran in 2020. Of these, 1591 paper prescriptions for older people aged >60 years referred to pharmacies in Tehran were selected by a cluster random sampling method. The data were analyzed using descriptive statistics (Mean, No. [%]) and inferential statistics (Chi-square test, independent t-test) in SPSS software, version 24. Results: Out of 1591 prescriptions, 79(5%) contained herbal medicines. Laxatives, ginkgo, and ginseng were the most prescribed medicines. Chi-square test results showed the statistically significant relationship of the educational level of the elderly (P=0.018), having insurance (P=0.004) and polypharmacy (P=0.000) with the prescription of herbal medicines, but the gender and marital status of the elderly and the gender, age and work experience of the physicians had no significant relationship with the prescription of herbal medicines. The rate of herbal medicine prescription by general practitioners was 5.7% and by specialized physicians was 4.7%, but no significant relationship was found between them. Among the specialized physicians, infectious disease specialists prescribed the most herbal medicines (14%) followed by physical medicine specialists (12%) and orthopedics (9.2%). Chi-square test results showed a significant relationship between the expertise of physicians and prescription of herbal medicines (P=0.042). Conclusion: The rate of herbal medicine prescription in Tehran city is low, but due to the interest of the elderly in herbal medicines, producing various herbal medicines with suitable forms and dosages and increasing the knowledge of physicians about these medicines can help increase the prescription of herbal medicines.

Abstract: Introduction: Following the introduction in 2006 of the National Policy on Integrative and Complementary Practices, and The National Policy on Medicinal Plants and Herbal Medicines, the Municipal Secretariat for the Environment of the City Hall of Sao Paulo initiated the Medicinal Plants Course, later expanded to The Medicinal Plants and Herbal Medicines Course for the training of health professionals. This study aimed to evaluate the impact of the 2014 and 2015 edition of the course “Medicinal Plants and Herbal Medicines” on health professional practices. Methods: An exploratory and descriptive study was conducted with a qualitative-quantitative approach. The quantitative process (Phase I) consisted of a questionnaire being emailed to health professionals who were involved in the course, divided into seven categories: biomedical professional, dental surgeon, nurse, pharmacist, physiotherapist, physician and nutritionist; and, out of 165 questionnaires, 114 responses were received (69.1%). The Qualitative and Quantitative process (Phase II), comprised semi-structured, in-person individual interviews to obtain detailed information on Phytotherapy practices, with 73 health professionals being interviewed, before and after the training, comparing their practices afterwards. Results: The course had a positive impact on the acceptance and application of Phytotherapy by health professionals with a significant increase (p<0.001) in the expansion of activities related to Phytotherapy (herbal tea “meetings”, medicinal herb gardens and capacity training), regarding the use of herbal products, such as Matricaria chamomilla (chamomile), Maytenus ilicifolia (espinheira-santa), Valeriana officinalis (valeriana). An increase in the knowledge of Phytotherapy risks was also observed, although there was no increase in the reporting of adverse reactions. The study confirmed the importance of the inclusion of Medicinal Plants and Herbal Medicines Courses as part of undergraduate and postgraduate school, as well as the technical training and continuing education for SUS health professionals. Conclusion: The positive impact found out in almost all evaluated aspects, such as the increase in the knowledge and in the prescription of herbal medicines, confirms the importance of such courses. The results suggest the training promoted a positive impact on the Phytotherapy practice of the Public Health System professionals in São Paulo.

Abstract: Introduction: Following the introduction in 2006 of the National Policy on Integrative and Complementary Practices, and The National Policy on Medicinal Plants and Herbal Medicines, the Municipal Secretariat for the Environment of the City Hall of Sao Paulo initiated the Medicinal Plants Course, later expanded to The Medicinal Plants and Herbal Medicines Course for the training of health professionals. This study aimed to evaluate the impact of the 2014 and 2015 edition of the course “Medicinal Plants and Herbal Medicines” on health professional practices. Methods: An exploratory and descriptive study was conducted with a qualitative-quantitative approach. The quantitative process (Phase I) consisted of a questionnaire being emailed to health professionals who were involved in the course, divided into seven categories: biomedical professional, dental surgeon, nurse, pharmacist, physiotherapist, physician and nutritionist; and, out of 165 questionnaires, 114 responses were received (69.1%). The Qualitative and Quantitative process (Phase II), comprised semi-structured, in-person individual interviews to obtain detailed information on Phytotherapy practices, with 73 health professionals being interviewed, before and after the training, comparing their practices afterwards. Results: The course had a positive impact on the acceptance and application of Phytotherapy by health professionals with a significant increase (p<0.001) in the expansion of activities related to Phytotherapy (herbal tea “meetings”, medicinal herb gardens and capacity training), regarding the use of herbal products, such as Matricaria chamomilla (chamomile), Maytenus ilicifolia (espinheira-santa), Valeriana officinalis (valeriana). An increase in the knowledge of Phytotherapy risks was also observed, although there was no increase in the reporting of adverse reactions. The study confirmed the importance of the inclusion of Medicinal Plants and Herbal Medicines Courses as part of undergraduate and postgraduate school, as well as the technical training and continuing education for SUS health professionals. Conclusion: The positive impact found out in almost all evaluated aspects, such as the increase in the knowledge and in the prescription of herbal medicines, confirms the importance of such courses. The results suggest the training promoted a positive impact on the Phytotherapy practice of the Public Health System professionals in São Paulo.

Despite the well-known influence of social determinants on access to health services, it is still being determined whether there are differences in the user profile regarding access to guidelines and prescriptions for medicinal plants and herbal medicines in Brazil. Given this context, the present study aimed to investigate the prevalence of professional guidelines and prescriptions on phytotherapy and associated factors among Brazilian practice users. The research is cross-sectional, analytical, and with a quantitative approach. In total, 1,396 individuals were questioned about access to guidance on phytotherapy, and of these, 664 (47.6%) received such guidance. Likewise, 1,421 participants were asked about the prescription for this use, among which 510 (35.9%) received a prescription for medicinal plants and/or herbal medicines. Phytotherapy guidelines and prescriptions in Brazil proved to be infrequent. There must be professional training, investments in continuing education, and readjustment of public policies among health professionals to encourage the use of herbal medicines.

Objective: to identify how professionals who work with Family Health Strategy in the city of Rio de Janeiro, a common integrative and complementary practice in the Public Health System in Brazil, have incorporated phytotherapy into their practice, highlighting the limits of this use from the perspective of the right to an integral health. Methodology: using a qualitative exploratory methodology, a cross-sectional study was conducted to identify the use and prescription of herbal medicines and medicinal plants by physicians, nurses, and community health agents from December 2016 to March 2018. Results: the professionals surveyed have not incorporated phytotherapy into their practice. The results show that 66.6% of physicians and 41.6% of nurses prescribe herbal medicines, however, most claimed to have had no instruction on the subject. 76.9% of community health workers and 54% of nurses observed at home visits that the population cultivates medicinal plants and 83.3% of nurses and 80.9% of doctors reported the use by the population. Conclusion: phytotherapy remains marginal in the Family Health Strategy. Promoting and expanding the use of phytotherapy in Primary Health Care can result in innovative experiences involving users, health professionals, and managers to transform the population's health conditions.

ABSTRACTOBJECTIVES This study examined the purchases of eculizumab, a high-cost monoclonal antibody used in the treatment of rare diseases by Brazilian federal agencies, in terms of purchased quantities, expenditures, and prices.METHODS Eculizumab purchases made between March 2007 and December 2018 were analyzed, using secondary data extracted from the Federal Government Purchasing System (SIASG in Portuguese). The following aspects were assessed: number of purchases, purchased quantities, number of daily doses defined per 1,000 inhabitants per year, annual expenditures, and prices. The prices were adjusted by the National Broad Consumer Price Index for December 2018. Linear regression was used for trend analysis.RESULTS All acquisitions by federal agencies were made by the Brazilian Ministry of Health. The purchases began in 2009 with tender waiver to comply with legal demand. There was an increasing trend in the number of purchases and quantities acquired over time. Two hundred and eighty-three purchases were made, totaling 116,792 units purchased, 28.2% of them in 2018. The adjusted total expenses summed more than R$ 2.44 billion. After market approval by the Brazilian Health Regulatory Agency, the weighted average price fell approximately 35%, to values under the Medicines Market Chamber of Regulation established prices.CONCLUSION Eculizumab represented extremely significant expenditures for the Brazilian Ministry of Health during the period. All purchases were made to meet demands from lawsuits, outside the competitive environment. The market approval of eculizumab promoted an important price reduction. This study indicates the relevance of licensing and the need for permanent monitoring and auditing of drug purchases to meet legal demands.

A prescription of Chinese herbal medicine, tentatively named P-19, was examined for its inhibitory effect and its mechanism using an experimental model of nephropathy induced by purified snake venom proteinase, Ac(1)-proteinase (Ac(1)-P). The treated mice were injected with 0.1 ml of crude extract of P-19 intraperitoneally every other day beginning 2 d before to 1 week after the injection of Ac(1)-P. The non-treated mice were injected with saline instead of the medicine P-19. The physiological condition and histopathological observation of the mice at one week after Ac(1)-P injection were better in the treated group than in the non-treated group. This indicates that P-19 inhibited the production of glomerular lesions induced in mice by Ac(1)-P. The physiological condition and histopathological changes in the mice were better with P-19 treatment than with P-3 treatment. Differences in the mechanism of action between the crude extract of P-3 and P-19 are not only in diuretic action but also in the changes in the glomerular basement membrane. On the basis of spectrophotometric studies, phenolic carboxylates were confirmed to be contained in the crude extract of P-19, having a different chemical structure of caffeic acid, which is the effective component in P-3. Immunohistochemical observation revealed a difference between the groups. In the non-treated mice, deposits of the venom were clearly observed in the glomerular tuft and Bowman's capsule, corresponding to the histopathological changes, within 2.5 min after the injection of Ac(1)-P. In the treated mice, the deposits were indistinct in the Bowman's capsule. The difference was considered to be caused by changes in the glomerular basement membrane after P-19 treatment.

Background Herbal medicine is widely used for the treatment of functional dyspepsia (FD) in East Asian countries. We aimed to analyze the prescription patterns of herbal medicine for patients with FD in Korean medicine clinical settings through the analysis of national health insurance claims data over the past 10 years and to check how herbal medicine has been used for FD within the scope of national health insurance. Methods All prescription data claimed to the Health Insurance Review and Assessment Service with the diagnosis of FD and herbal medicine prescriptions in 2010–2019 were reviewed. We estimated the demographics, clinical characteristics, and annual prescription amount and cost of each herbal medicine. Frequent comorbidities of FD were investigated by analyzing the frequency of the Korean standard classification of diseases codes used together with FD. Results In total, 19,388,248 herbal medicine prescriptions were identified. Herbal medicine prescriptions were mostly claimed by women, the elderly, outpatients at Korean medicine clinics, and national health insurance; the number increased every year. The most frequently prescribed herbal medicine was Pingwei-san (Pyeongwi-san) (31.12%), followed by Xiangshapingwei-san (Hyangsapyeongwi-san) (23.20%), Qiongxia-tang (Gungha-tang) (6.31%), and Banxiaxiexin-tang (Banhasasim-tang) (6.25%). The total cost of herbal medicine prescriptions increased every year, and it was highest for Xiangshapingwei-san (Hyangsapyeongwi-san) (19.37%), followed by Banxiaxiexin-tang (Banhasasim-tang) (17.50%) and then Pingwei-san (Pyeongwi-san) (15.63%). Musculoskeletal and connective tissue diseases including low back pain and myalgia were the commonest comorbidities associated with FD. Conclusion This is the first study to investigate the disease burden and actual prescription pattern of herbal medicine for FD using claim data. Future clinical research and related healthcare policies should be established based on our study.

Objetivo: analisar a utilização das Práticas Integrativas e Complementares (PICS) na atenção integral à Saúde da Mulher. Método: Revisão narrativa da literatura, realizada nas bases Scientific Electronic Library Online (SciELO), Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS) e PubMed. Utilizando os descritores: “Terapias Complementares” AND “Saúde da Mulher”, sem recorte temporal. Foram selecionados dez artigos, submetidos à análise de conteúdo de Bardin. Resultados: A primeira publicação foi no ano de 2010, e 80% dos estudos foram desenvolvidos pela Enfermagem. Emergiram três categorias: as práticas integrativas e complementares em saúde, os impactos na saúde da mulher e os profissionais da saúde. As evidências mostraram que o modelo de saúde continua centrado na doença. No entanto, dentre as PICS destacam-se a musicoterapia, a hidroterapia, a aromaterapia, reflexologia podálica, escalda-pés, uso de plantas medicinais, entre outras. As PICS foram empregadas para o alívio de sintomas físicos, dores em geral, com benefícios emocionais e psicológicos, no processo de parturição, durante o pré-natal, neoplasias e nos sinais de climatério. Os profissionais da saúde que frequentemente utilizam essas práticas no cuidado à saúde da mulher são médicos, enfermeiros, fisioterapeutas e doulas. Conclusão: As práticas Integrativas e Complementares em Saúde podem ser utilizadas em todos os ciclos e fases da saúde da mulher, portanto, integrar os conhecimentos das PICS na formação e qualificação são essenciais para que seja prestada assistência integral à saúde da mulher.

An examination of the prescription and dispensing of medicines by Western herbal therapists: A national survey in Australia

Objectives: The purpose of this study is to analyze the current state of quantitative literature evidence for the prescription of 56 herbal medicines covered by health insurance that have been studied in Korea for the past 30 years, to evaluate the reliability of the evidence, and to find out the research direction of herbal medicine prescription in the future.Methods: 56 kinds of herbal medicine prescriptions were searched in domestic literature search databases OASIS, DBpia, and overseas PubMed, classified into chemistry, toxicity, cells, animals, clinical cases, and clinical trial studies, and built into an EBM pyramid structure.Results: When classified according to research contents, there were 61 cases (7.5%) of physicochemical analysis to identify constituent substances, 80 cases (9.8%) of toxicity evaluation, and 672 cases (82.7%) of efficacy evaluation. The efficacy evidence was classified according to the evidence-based medical pyramid structure: 196 cell trials (29.1%), 372 animal trials (55.4%), 89 case and case reporting series (13.3%), 7 comparative case studies (1.1%), and 8 randomized control clinical trials (1.2%). In the pyramid composition, the basis for the validity of 56 kinds of herbal medicines prescribed was 568 cases (84.5%) in cell and animal units, which could not be said to be highly reliable. There was no relationship between the ranking of quantitative literature evidence for herbal medicine prescriptions and the ranking of salary administration.Conclusions: In an era that continues to require scientific evidence for herbal medicine, traditional herbal medicine should secure the basis for safety validity even for the 10th most frequent prescription among 56 herbal medicine prescriptions for consumers. In particular, traditional herbal medicine should increase the quantitative and qualitative level of case reports on related herbal medicine prescriptions, focusing on each clinical society, and move toward comparative case studies and randomized clinical trial so that traditional herbal medicine is positioned as Evidence-based medicine.

This study sought to understand the use of herbal medicines as a therapeutic practice in dentistry in primary health care. A literature review was carried out using the databases National Library of Medicine - National Institutes of Health (PubMed), Latin American and Caribbean Literature in Health Sciences (LILACS), and Brazilian Dentistry Bibliography (BBO), using the descriptors found in DeCS (Health Sciences Descriptors) and MeSH (National Center for Biotechnology Information): “dentistry,” “primary health care” and “phytotherapy.” The results showed that dentists have a deficient theoretical-practical basis for training on herbal medicines in dentistry, which leads to the reduced prescription of herbal medicines in health services as auxiliary therapies for treating oral pathologies. The lack of knowledge of dental professionals and the low financial incentive of managers to use herbal medicines reflect the low adherence to herbal medicine in pharmaceutical care in health units. Professional qualification and financial investment are essential for consolidating phytotherapy in primary health care.

This study discusses actors and institution movements leading to the disclosure in 2014 of Resolution 199 by the Brazilian Ministry of Health, which establishes the National Policy for the Comprehensive Care of Persons with Rare Diseases. Taking as sources the mainstream newspapers, drafts law, and secondary literature on the subject, we begin our analysis in the early 1990s when the first patient associations were created in Brazil - mainly for claiming more funds for research on genetic diseases - and arrive at the late 2010s when negotiations for a national policy are taking place in the National Congress. Resolution 199 is part of an ongoing process and the path towards its disclosure and the complications that followed have given us elements to discuss contemporary aspects of the Brazilian public health. Based on the references of the history of the present time and the social studies of science, we argue that two aspects have been fundamental to creating a national policy: framing different illnesses within the terminology "rare diseases" and the construction of a public perception about the right of health which is guaranteed by the 1988 Brazilian Constitution.

The aim of this paper is to review the herbal registration regulations (RDC no. 26/14) and to evaluate the outlook for prescription of herbal medicine at SUS. For this purpose, we’ve tracked and analyzed the record of political measures related to herbal medicine within the Brazilian health system as well as herbal registration norms which existed prior to the publication of RDC no. 26/14. The classification of herbal medicine formulated by legislation (herbal medicine and traditional herbal product) allows immediate visualization of safety and efficacy, since not all medicinal plants have clinical studies to prove safety and efficacy. The new legislation and herbal medicine monographs presented in Brazilian Pharmacopeia have brought reliability and safety to prescribers and healthcare professionals regarding drug treatment through herbal medicine. The current herbal registration legislation reveals the unceasing concern from Brazilian authorities to develop legislation that corroborates with the National Policy on Integrative and Complementary Practices and with the National Policy of Herbal Medicine at SUS and in agreement with World Health Organization recommendations in order to foster the quality of health among the Brazilian population.