Uso de fitoterápicos no controle das alterações bucais pós-tratamento oncológico: novas alternativas na odontologia / Use of Herbal Medicines to Control Oral Changes Post-Oncological Treatment: New Alternatives in Dentistry

O tratamento oncológico pode ocasionar diversas alterações orais durante e após o processo que podem acarretar déficit de mastigação, fonação, deglutição, além de dor e nutrição deficiente. Nesse contexto, ainda existe uma busca na comprovação do uso de fitoterápicos na oncologia com presença de lesões na cavidade oral ocasionadas pela oncoterapia, para tratamento destas. Assim, o trabalho em questão se trata de uma revisão de literatura, com objetivo de relatar, a partir da análise de periódicos, a observação de efeitos favoráveis para o tratamento das lesões orais por consequência da quimioterapia e radioterapia, através do uso dos fitoterápicos: Camomila (Matricaria chamomilla), Romã (Punica granatum) e extrato de Própolis (Apis mellifera L.). Realizou-se busca eletrônica de dados através do Scholar Google e PubMed, utilizando os Descritores em Ciências da Saúde (Medicamentos Fitoterápicos, Neoplasias, Protocolos Antineoplásicos). Os estudos apresentados neste trabalho evidenciam que o uso destes fitoterápicos pode auxiliar no tratamento das lesões decorrentes da quimioterapia e radioterapia, por possuírem diversas ações anti-inflamatórias, antimicrobianos, antitumorais, entre outras. Por fim, os fitoterápicos apresentados podem ser considerados como uma nova alternativa sendo assim uma escolha favorável de tratamento em relação aos medicamentos convencionais (alopatia), tanto pelo fato de serem naturais e não reduzirem mais ainda a imunidade do paciente, como também pelo seu baixo custo.

The cancer treatment can cause several oral changes during and after the process that can lead to deficits in chewing, phonation, swallowing, in addition to pain and poor nutrition. In this context, there is still a search to prove the use of herbal medicines in oncology with lesions in the oral cavity caused by oncotherapy. Thus, the work in question is a literature review, with the objective of reporting, from the analysis of journals, the observation of favorable effects for the treatment of oral lesions as a result of chemotherapy and radiotherapy, through the use of herbal medicines: Chamomile (Matricaria chamomilla), Pomegranate (Punica granatum) and Propolis extract (Apis mellifera L.). Electronic data search was carried out through Scholar Google and PubMed, using the Health Sciences Descriptors (Phytotherapic Drugs, Neoplasms, Antineoplastic Protocols). The studies presented in this work show that the use of these herbal medicines can help in the treatment of injuries resulting from chemotherapy and radiotherapy, as they have several anti-inflammatory, antimicrobial and anti-tumor actions, among others. Finally, the herbal medicines presented can be considered as a new alternative, thus being a favorable treatment choice in relation to conventional medicines (allopathy), both because they are natural and do not further reduce the patient's immunity, but also because of their low cost.

Ação Direta de Inconstitucionalidade nº 5.779: a preponderância da efetividade do direito à saúde sobre a hierarquia das normas jurídicas / Direct Action of Unconstitutionality No. 5.779: the preponderance of the effectiveness of the right to health over the hierarchy of legal norms / Acción Directa de Inconstitucionalidad nº 5.779: la preponderancia de la efectividad del derecho a la salud sobre la jerarquía de las normas jurídicas

Objetivo: refletir se a hierarquia das normas jurídicas deve ser usada como método de solução infalível mesmo quando um conflito aparente entre normas jurídicas que envolva o direito à saúde e, sobretudo, a sua efetividade, puder ser melhor resolvido mediante decisão técnica do órgão regulador competente. Metodologia: estudo descritivo de abordagem qualitativa e análise documental. Foram analisadas as Resolução de Diretoria Colegiada nº 52/2011, Lei nº 13.454/2017 e Ação Direta de Inconstitucionalidade nº 5.779-DF. Buscou-se doutrina jurídica especializada sobre os temas central e periféricos. Para análise dos dados utilizou-se a técnica da revisão crítico-narrativa. Resultados: no Brasil, a adoção das agências reguladoras como agente normativo e regulador de atividades econômicas viabilizou a tomada de decisões pautadas menos em critérios políticos que em critérios técnicos. O legislador, ancorado em critérios políticos, segundo o entendimento do Judiciário, não pode ultrapassar os critérios técnicos. Conclusão: do julgamento da Ação Direta de Inconstitucionalidade nº 5.779 se extrai que o conceito hodierno e a natureza jurídica do direito à saúde impõem novos paradigmas jurídicos que validam o papel das agências reguladoras (tomada de decisões técnicas em prol da máxima efetividade do direito à saúde), ainda que em detrimento de decisões do legislador, legitimadas politicamente. O paradigma formal não pode obstar a materialização do direito.

Objective: To reflect on whether the hierarchy of legal norms should be used as an infallible method of solution even when an apparent conflict between legal norms involving health law can be better resolved through a technical decision by the competent regulatory agency. Methodology: data was collected. In particular, Resolução de Diretoria Colegiada nº 52/2011, Law nº 13.454/2017 and Ação Direta de Inconstitucionalidade nº 5.779-DF. Specialized legal doctrine was sought on the central and peripheral themes. The data collected was analyzed using the critical-narrative review technique. Results: In Brazil, the adoption of regulatory agencies as normative agents and regulators of economic activities has made it possible to make decisions based less on political criteria than on technical criteria. The legislator, anchored in political criteria, according to the judiciary, cannot go beyond technical criteria. Conclusion: the judgment in Ação Direta de Inconstitucionalidade nº 5.779 shows that today's concept and the legal nature of the right to health impose new legal paradigms that validate the role of regulatory agencies (making technical decisions in favor of maximum effectiveness of the right to health), even to the detriment of politically legitimized decisions by the legislature. The formal paradigm cannot prevent the materialization of the right.

Objetivo: reflexionar si la jerarquía de las normas jurídicas debe utilizarse como método infalible de solución, incluso cuando un conflicto aparente entre normas jurídicas que impliquen al Derecho sanitario pueda resolverse mejor mediante una decisión técnica del órgano regulador competente. Metodología: se recopilaron datos. En particular, RDC nº 52/2011, Ley nº 13.454/2017 y ADI nº 5.779-DF. Se buscó doctrina jurídica especializada sobre los temas centrales y periféricos. Los datos recogidos se analizaron mediante la técnica de revisión crítico-narrativa. Resultados: En Brasil, la adopción de las agencias reguladoras como agentes normativos y reguladores de las actividades económicas ha permitido tomar decisiones basadas menos en criterios políticos que en criterios técnicos. El legislador, anclado en criterios políticos, según el poder judicial, no puede ir más allá de los criterios técnicos. Conclusión: la sentencia en el asunto ADI 5.779 demuestra que el concepto actual y la naturaleza jurídica del derecho a la salud imponen nuevos paradigmas jurídicos que validan el papel de las agencias reguladoras (que adoptan decisiones técnicas en favor de la máxima efectividad del derecho a la salud), incluso en detrimento de las decisiones políticamente legitimadas del poder legislativo. El paradigma formal no puede impedir la materialización del derecho.

The scenario of household pharmaceutical products: consumption, wastes, and disposal practices from a case study in Chile.

Concerns about the increasing consumption of medicines have been raised due to their contribution to waste pollution and environmental impacts. However, limited research addresses the profile and disposal practices of household medicines, particularly in Latin America. Therefore, this study analyzes the consumption, waste, and disposal of medicines within households in the commune of La Serena, Chile. Primary data were gathered through a semi-structured survey administered directly to a random sample of 430 households. The results indicate that women play a central role in managing medicines within households, with four therapeutic groups being most frequently used in medicines and generating waste: anti-inflammatory/analgesics, antihypertensives, lowering cholesterol, and antidiabetics. Ninety-six% of respondents were unaware of the collection points for this waste, and they disposed of it mainly in household garbage (78%) and sewage (13%). However, over 70% of them considered storing or disposing of medicines in household garbage or sewage to be "dangerous or very dangerous." Furthermore, 97% expressed support for collection campaigns. These results indicate the need for public policies to establish collection points for this waste and to inform consumers about the responsible use and proper disposal of medicines, particularly for women and patients with chronic illnesses.

Evaluation of drug litigation against the Campinas municipal health system from 2017 to 2021.

In Brazil, the judicialization of public health for access to medications has resulted in significant challenges to the management of public policies, especially at the municipal level. To evaluate the profile of drug litigations against the Campinas municipal health system from 2017 to 2021, this study analyzed the characteristics of litigants, medicine dispensation, and the timing of court decisions. A quantitative, analytical, and comparative cross-sectional study was conducted using data on the dispensation of 506 types of medications and 493 court cases. The analysis included sociodemographic, procedural, medical-sanitary, and pharmaceutical assistance management variables. The time of court decisions was assessed using the Kruskal‒Wallis test complemented by the Dunn test. The plaintiffs were predominantly adults, females, and self-declared students, and some cases involved nonresidents. Most of the lawsuits were represented by private lawyers, gratuitousness of justice and with decisions favorable to the plaintiff. However, only 43% of the patients obtained a preliminary injunction or early tutelage. The median time needed for a court decision from the date of case filing was 12 days until the granting of a preliminary injunction or early tutelage and 6.5 months until a judgment or dismissal without a decision on the merits. Approximately 32.4% of the medications dispensed by the judicial pharmacy already belonged to the list of the Brazil's Unified Health System in 2020; 46.3% were prescribed by their generic name; 75.5% had therapeutic equivalents, and 94.9% had marketing authorization from the Brazilian National Health Surveillance Agency. Judicialization in Campinas is an alternative way of accessing medications, but it is time-consuming and benefits only a small portion of the population (0.068%). The characteristics of the plaintiffs and judicialized medicines highlight the need to review health policies to promote equitable and efficient access to essential treatments for the population.

New Oncologic Drugs from 2008 to 2023-Differences in Approval and Access between the United States, Europe and Brazil.

INTRODUCTION: Advancements in oncology have revolutionized cancer treatment, with new drugs being approved at different rates worldwide. Our objective was to evaluate the approval of new oncological drugs for solid tumors by the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Brazilian Health Regulatory Agency (ANVISA) since 2008. METHODS: Data were collected from public and online databases by searching for the date of submission, the date of the procedure, the date of approval, clinical indication, and drug characteristics. The distribution was tested using the Shapiro-Wilk, test and comparisons were made using the Mann-Whitney U test; the data are reported using median days and interquartile range (IQR1-IQR3). RESULTS: In total, 104 new oncologic drugs for the treatment of solid tumors were approved by the three agencies: 98 by the FDA, 90 by the EMA, and 68 by ANVISA. The cancer types with the highest number of first indications were lung cancer (n = 24), breast cancer (n = 15), and melanoma (n = 15). Most approvals were for oral medications (n = 63) and tyrosine-kinase inhibitors or other small-molecule inhibitors (n = 54). Time to approval after submission was as follows: the FDA-224 days (167-285); the EMA-364 days (330-418); and ANVISA-403 days (276-636) (p < 0.00001 for the FDA to the EMA and the FDA to ANVISA). The difference between submission dates among the agencies was as follows: EMA-FDA: 24 days (0-85); ANVISA-FDA: 255 (114-632); and ANVISA-EMA: 260 (109-645). The difference in approval dates between the agencies was as follows: EMA-FDA: 185 days (59-319); ANVISA-FDA: 558 (278-957); and ANVISA-EMA: 435 days (158-918). CONCLUSIONS: New oncologic drugs are submitted to the FDA and EMA for approval on similar dates; however, the longer appraisal period by the EMA pushes the approval date for Europe to approximately 6 months later. The same steps at ANVISA delay the approval by 1.5 years. Such procedures cause a significant difference in available medications between these regions.

A Survey of Availability and Affordability of Polypills for Cardiovascular Disease in Selected Countries.

Background: The recent inclusion of polypills-fixed-dose combinations of antihypertensive medicines and a statin with or without aspirin-in the World Health Organization's Essential Medicines List (EML) reiterates the potential of this approach to improve global treatment coverage for cardiovascular diseases (CVDs). Although there exists extensive evidence on the effectiveness, safety and acceptability of polypills, there has been no research to date assessing the real-world availability and affordability of polypills globally. Methods: We conducted a cross-sectional survey, based on the WHO/Health Action International methodology, in 13 countries around the world. In the surveyed countries, we first ascertained whether any polypill was authorised for marketing and/or included in EMLs and clinical guidelines. In each country, we collected retail and price data for polypills from at least one public-sector facility and three private pharmacies using convenience sampling. Polypills were considered unaffordable if the lowest-paid worker spent more than a day's wage to purchase a monthly supply. Results: Polypills were approved for marketing in four of the 13 surveyed countries: Spain, India, Mauritius and Argentina. None of these countries included polypills in national guidelines, formularies, or EMLs. In the four countries, no surveyed public pharmacies stocked polypills. In the private sector, we identified seven unique polypill combinations, marketed by eight different companies. Private sector availability was 100% in Argentina and Spain. Most combinations (n = 5) identified were in India. Combinations found in India and Spain were affordable in the local context. A lowest-paid government worker would spend between 0.2 (India) and 2.8 (Mauritius) days' wages to pay the price for one month's supply of the polypills. Polypills were likely to be affordable if they were manufactured in the same country. Conclusion: Low availability and affordability of polypills in the public sector suggest that implementation remains poor globally. Context-specific multi-disciplinary health system research is required to understand factors affecting polypill implementation and to design and evaluate appropriate implementation strategies.

The politics and governance of drug production in public-private partnerships: Brazil's response to hepatitis C.

The local manufacture of advanced pharmaceutical products has been a long-standing objective of health and industry policy in many developing countries, including in Latin America. This strategy has been applied to fight epidemics such as HIV/AIDS, malaria, and the COVID-19 pandemic. However, we still know little about the politics and governance that enable such arrangements, especially when there is no consent from the originator company. This study focuses on the case of Brazil, a country that is well-known for its health-industry policy, which includes the local production of direct-acting antivirals (DAAs), a new treatment for hepatitis C. We seek to explain the factors that have contributed to Brazil's successful production of generic versions of DAAs, and, later, to the decision by the Ministry of Health (MoH) to procure drugs from multinational pharmaceutical companies rather than from local laboratories. A lack of support for domestic production by important stakeholders, the patent holder's attempt to block domestic production and the MoH's adoption of more modern treatment guidelines under a different procurement logic all created an unfavourable environment for local production and procurement of DAAs. Our study draws implications for middle-income countries that wish to produce drugs domestically without voluntary license agreements.

An Agile and Accurate Approach for N-Nitrosamines Detection and Quantification in Medicines by DART-MS.

N-nitrosamines (NAs) are prevalent mutagenic impurities in various consumer products. Their discovery in valsartan-containing medicines in 2018 prompted global regulatory agencies to set guidelines on their presence and permissible levels in pharmaceuticals. In order to determine the NAs content in medicines, efficient and sensitive analytical methods have been developed based on mass spectrometry techniques. Direct analysis in real time-mass spectrometry (DART-MS) has emerged as a prominent ambient ionization technique for pharmaceutical analysis due to its high-throughput capability, simplicity, and minimal sample preparation requirements. Thus, in this study DART-MS was evaluated for the screening and quantification of NAs in medicines. DART-MS analyses were conducted in positive ion mode, for both direct tablet analysis and solution analysis. The analytical performance was evaluated regarding linearity, precision, accuracy, limits of detection, and quantification. The DART-MS proved to be suitable for the determination of NAs in medicines, whether through direct tablet analysis or solution analysis. The analytical performance demonstrated linearity in the range from 1.00 to 200.00 ng mL-1, limits of quantification about 1.00 ng mL-1, precision and accuracy lower than 15%, and no significant matrix effect for six drug-related NAs. In conclusion, the DART-MS technique demonstrated to be an alternative method to determine NAs in medicines, aligning with the principles of green chemistry.

Importance of phytotherapy for oral health care and quality of life in adults: A scoping review.

Medicinal plants and herbal medicines are used as integrative and complementary practices to provide comprehensive care, disease prevention, health promotion, and to improve quality of life (QoL). This scoping review aimed to identify and describe the use of phytotherapy in oral health care by adults and their outcomes, with a focus on perceptions of oral health-related QoL, healthcare access, and costs. A systematic search was conducted in six databases and supplemented in grey literature. According to a PRISMA-ScR protocol and eligibility criteria, publications were assessed for final inclusion, data charting, and narrative synthesis. Out of 4124 records, 542 publications were selected for full-text reading. A total of 32 studies were included: 21 studies assessed QoL, 7 reported access issues, and 11 reported costs issues. Herbal mouthwashes to prevent or treat non-infectious oral conditions were the most frequent treatment. Efficacy of phytotherapy was usually better than placebo or control treatment. Most studies reported QoL improvement, but several instruments were used with heterogeneous results. Limited healthcare access and high costs favoured traditional folk herbal medicine in underserved populations. It can be concluded that phytotherapy for oral health is used by adults worldwide, following modern clinical pharmacology and traditional knowledge concepts. Further studies should incorporate assessment of QoL, access, and costs in addition to clinical efficacy and safety, which are complementary aspects for delivering a comprehensive and efficient health care for all people.

Los principios bioéticos de los médicos generales integrales en la prescripción de medicamentos

Introducción: Durante el acto de la prescripción se deben relacionar los conocimientos de la terapéutica con los principios de la bioética para contribuir al uso racional de medicamentos. En el artículo se analiza el cumplimiento de los principios bioéticos relacionados con las prescripciones de medicamentos por los médicos generales integrales del municipio Santiago de Cuba. Métodos: Se realizó un estudio descriptivo transversal con una muestra de médicos generales integrales en el que se emplearon métodos teóricos, empíricos y matemáticos estadísticos, así como la triangulación metodológica. Se consideró como variable el cumplimiento de los principios bioéticos relacionados con las prescripciones de medicamentos y cinco indicadores que fueron valorados mediante encuesta, entrevista y observación del desempeño. Resultados: Se encontró que los médicos generales integrales alcanzaron un nivel alto de cumplimiento de los principios bioéticos relacionados con las prescripciones de medicamentos con un valor de media ponderada de 2,94. La valoración de la frecuencia de realización de los indicadores evidenció que tres de ellos fueron considerados del nivel alto, dos de nivel medio y ninguno de nivel bajo. Discusión: los resultados fueron confrontados con otros estudios y se confirma que los médicos generales integrales en Cuba por su formación humanista cumplen con la mayoría de los principios bioéticos en su desempeño profesional.

Introduction: During the act of prescription, therapeutic knowledge must be related to the principles of bioethics to contribute to the rational use of medications. The article analyzes compliance with bioethical principles related to medication prescriptions by comprehensive general practitioners of the Santiago de Cuba municipality. Methods: A cross-sectional descriptive study was carried out with a sample of comprehensive general practitioners in which theoretical, empirical and mathematical statistical methods were used, as well as methodological triangulation. Compliance with bioethical principles related to medication prescriptions and five indicators that were assessed through a survey, interview and performance observation were considered as variables. Results: It was found that comprehensive general practitioners reached a high level of compliance with bioethical principles related to medication prescriptions with a weighted mean value of 2.94. The assessment of the frequency of carrying out the indicators showed that three of them were considered high level, two medium level and none low level. Discussion: the results were compared with con studies and it is confirmed that comprehensive general practitioners in Cuba, due to their humanistic training, comply with most of the bioethical principles in their professional performance.

Evaluation of marketing authorization and labels of medicines in 2021 WHO Model List of Essential Medicines for Children in China, the Russian Federation and Brazil.

OBJECTIVE: This work compares the marketing authorization, labels and dosage forms of medicines in the WHO Model List of Essential Medicines for Children (EMLc) in China, the Russian Federation and Brazil to urge policymakers to pay more attention to paediatric medication. METHODS: Medicines were selected from the 8th EMLc. By searching relevant databases, which include different types of medical information in China, the Russian Federation and Brazil, the marketing authorization, labels and dosage forms of paediatric medicines in the three countries were evaluated. RESULTS: A total of 485 drug products containing 312 active pharmaceutical ingredients listed in the WHO EMLc were evaluated. Among them, 344 products were approved for use in China, 286 in the Russian Federation and 264 in Brazil. Out of the 344 approved medicines, 317 (92.15%) were authorized for paediatric use in China, 224 (78.32%) in the Russian Federation and 218 (82.58%) in Brazil. In terms of guidance information labelling on drug labels, 75.08%, 83.04% and 88.07% of paediatric drugs approved in China, the Russian Federation and Brazil, respectively, clearly indicated the usage and dosage for paediatric use. Additionally, injections and tablets were the most prevalent dosage forms in these three countries. CONCLUSION: There is still scope for enhancing the marketing authorization and development of dosage forms for paediatric medicines in the three countries. Furthermore, additional measures are being implemented to enhance the information provided on drug labels for children, particularly in China.

Effectiveness and safety of biological and target synthetic drugs treatment for psoriatic arthritis: a systematic review with network meta-analysis.

BACKGROUND: Psoriatic arthritis (PA) is a chronic inflammatory systemic arthritis that can result in loss of functional capacity and joint deformation. This systematic review assessed the effectiveness and safety of biological and target synthetic drugs for treating PA. METHODS: We searched for randomized clinical trials (RCTs) that evaluated the use of Adalimumab, Etanercept, Infliximab, Golimumab, Secukinumab, Certolizumab Pegol and Tofacitinib in the main general databases and clinical trial registers databases. The primary outcomes were ACR 50, PsARC, and serious adverse events. Two independent reviewers performed study selection and data extraction. Network meta-analyses were conducted using a random effects model and frequentist approach. The CINeMA software was used to assess the certainty of evidence. RESULTS: We included 33 RCTs (n = 11,034). The results from the network meta-analysis for the ACR 50 at 6-months follow-up showed that all drugs were superior to placebo, with Secukinumab (high certainty of evidence), Infliximab (very low certainty of evidence) and Adalimumab (high certainty of evidence) ranking the highest. Regarding the PsARC (at 6-months follow-up), all drugs, except for Golimumab (very low certainty of evidence), were superior to placebo, with Etanercept (low certainty of evidence), Infliximab (low certainty of evidence) and Certolizumab Pegol (low certainty of evidence) being the most effective drugs. There were no significant differences in the risk of serious adverse events between the drugs and placebo. Golimumab (very low certainty of evidence), Secukinumab (low certainty of evidence), and Adalimumab (very low certainty of evidence) ranked the highest for safety. CONCLUSIONS: In conclusion, based on the balance between efficacy and safety, Secukinumab and Adalimumab may be the preferred options among the evaluated drugs for treating patients with PsA. However, caution is necessary when interpreting the safety findings, as they are supported by evidence of low to very low certainty. Consequently, the balance between benefits and potential risks may change as new safety evaluation studies become available. PROTOCOL REGISTRATION: PROSPERO: CRD42022315577.

STOPP-START Criteria Used to Identify the Elderly Population Prone to Potentially Inadequate Prescribing in a Colombian Cohort.

BACKGROUND: Elderly people have multiple comorbidities that often require treatment with multiple medications. Having strategies to lessen the risks associated with pharmacological interactions and potentially inadequate prescribing (PIP) is of major importance. The STOPP- START criteria are useful in identifying PIP along with other tools, such as LASA (look alike/sound alike) drugs and high-risk medications (HRM). OBJECTIVE: We aimed to clinically and sociodemographically characterize the population with PIP according to the STOPP-START criteria in hospitalized elderly patients over 6 months in a third-level hospital in Colombia, South America. We also aimed to calculate the prevalence of PIP, LASA drugs and HRM and to identify other problems related with medication. Finally, we proposed an algorithm for the identification of PIP in this population. METHODS AND MATERIALS: This was a descriptive, cross-sectional study in hospitalized patients older than 60 years during the first semester of 2021 to identify PIP according to STOPP- START criteria. An analysis of clinical and sociodemographic variables was conducted, as well as the construction of an algorithm to identify PIP in the elderly in a semiautomated way. Data were collected and analyzed using the software SPSS 2021, using descriptive statistics and measures of central tendency. RESULTS: The prevalence of PIP in the study population was 25%. Furthermore, 60% of patients had one problem related to medication, and 27% used at least one LASA drug or HRM. CONCLUSION: This study allows one to characterize, for the first time, the Colombian population prone to PIP, as well as the construction of an algorithm that identifies PIP in a semiautomated way.

Medicines policy, access and use in Mexico: a systematic literature review 2000-2022.

Background: Research on medicines access and use is heterogeneous and can be challenging for decision-makers to interpret. Pharmaceutical policy is an additional component for study and is the foundation for the promotion of access and use of medicines. This systematic review summarizes findings from the literature on medicines policy, access and use over the past two decades in Mexico and identifies research gaps that should be addressed. Methods: A systematic review of the literature published between 2000 and 2022 was conducted to identify publications on medicines policy, access and use in Mexico. The study followed PRISMA Statement guidelines 2020. A narrative review including content analysis was conducted. Results: A total of 5057 articles were reviewed, of which 77 fit the inclusion criteria. Studies described the lack of an explicit national policy, a misalignment between the legal framework and reinforcement incentives, deficient policy documentation at the national level, and the absence of necessary medicines regulation and transparency. In terms of access to medicines, challenges related to supply, selection, acquisition, distribution and expenditure were noted. Regarding medicine use, key study findings included a lack of adherence to standard treatment guidelines, dispensing, lack of reliable information on medicines, lack of treatment adherence and harmful self-medication. Conclusion: The appropriate use of medicines and adequate access to them are priority topics for the formulation of Mexican pharmaceutical policy. It is critical that further research includes longitudinal studies of medicine access and use, and the consideration of studying the private sector as well as new methodological approaches. Many reported challenges related to access to and use of medicines have persisted across decades, suggesting a lack of effective research-to-practice knowledge transfer and policy implementation.This article is part of the Hospital pharmacy, rational use of medicines and patient safety in Latin America Special Issue: https://www.drugsincontext.com/special_issues/hospital-pharmacy-rational-use-of-medicines-and-patient-safety-in-latin-america/.

Sedentary behavior, abdominal obesity and healthcare costs in Brazilian adults with cardiovascular diseases: a cross-sectional study

ABSTRACT BACKGROUND: Research on the economic burden of sedentary behavior and abdominal obesity on health expenses associated with cardiovascular diseases is scarce. OBJECTIVE: The objective of this study was to verify whether sedentary behavior, isolated and combined with abdominal obesity, influences the medication expenditure among adults with cardiovascular diseases. DESIGN AND SETTING: This cross-sectional study was conducted in the city of President Prudente, State of São Paulo, Brazil in 2018. METHODS: The study included adults with cardiovascular diseases, aged 30-65 years, who were treated by the Brazilian National Health Services. Sedentary behavior was assessed using a questionnaire. Abdominal obesity was defined by waist circumference. Medication expenditures were verified using the medical records of each patient. RESULTS: The study included a total of 307 adults. Individuals classified in the group with risk factor obesity combined (median [IQ] USD$ 29.39 [45.77]) or isolated (median [IQ] USD$ 27.17 [59.76]) to sedentary behavior had higher medication expenditures than those belonging to the non-obese with low sedentary behavior group (median [IQ] USD$ 13.51 [31.42]) (P = 0.01). The group with combined obesity and sedentary behavior was 2.4 (95%CI = 1.00; 5.79) times more likely to be hypertensive. CONCLUSION: Abdominal obesity was a determining factor for medication expenses, regardless of sedentary behavior, among adults with cardiovascular diseases.

Acesso a medicamentos para o tratamento de hipertensão arterial sistêmica e diabetes mellitus tipo 2 na população brasileira: dados da Pesquisa Nacional de Saúde de 2019 / Access to medicines for the treatment of systemic arterial hypertension and type 2 diabetes mellitus in the Brazilian population: data from the 2019 Brazilian National Health Survey / Acceso a medicamentos para el tratamiento de la hipertensión arterial sistémica y la diabetes mellitus tipo 2 en la población brasileña: datos de la Encuesta Nacional de Salud de 2019

Resumo: Este estudo objetivou mensurar o acesso aos medicamentos para o tratamento da hipertensão arterial sistêmica e diabetes mellitus tipo 2 no Brasil segundo a via de obtenção, bem como analisar os fatores associados a esse acesso, de acordo com os dados da Pesquisa Nacional de Saúde (PNS) de 2019. Foram analisados dados socioeconômicos e relacionados ao uso de medicamentos de pessoas de 15 anos ou mais, em relação ao acesso via Programa Farmácia Popular do Brasil (PFPB) e via serviço público. A maior parte dos brasileiros que participaram da PNS referiu fazer uso do medicamento para controle da hipertensão, nos últimos 15 dias (91,5%), assim como a maior parte referiu fazer uso de medicamento oral para diabetes (95,2%) e/ou uso da insulina (70%).Os medicamentos orais para hipertensão arterial sistêmica e diabetes mellitus tipo 2 foram obtidos majoritariamente via PFPB, sendo respectivamente (45,2% e 53,6%), e os fatores que mais influenciaram negativamente esse acesso foram maior faixa etária, menor renda, menor escolaridade, não ter plano de saúde e referir uma autoavaliação de saúde muito ruim. O acesso à insulina, por sua vez, se deu com maior frequência via serviço público de saúde (69,7%), e os fatores que mais influenciaram negativamente esse acesso foram raça preta/parda, menor renda, não ter plano de saúde e referir uma autoavaliação de saúde muito ruim. De forma geral, foi evidenciada a importância do PFPB como política de ampliação de acesso a medicamentos essenciais no Brasil, considerando a gratuidade dos anti-hipertensivos e antidiabéticos.

Abstract: This study aimed to measure access to medicines for the treatment of systemic arterial hypertension and type 2 diabetes mellitus in Brazil according to the mode of acquisition, as well as to analyze the factors associated with this access, based on data from the 2019 Brazilian National Survey of Health (PNS, acronym in Portuguese). Socioeconomic data and data related to the use of medicines by people aged 15 and over were analyzed in relation to access via the Brazilian Popular Pharmacy Program (PFPB, acronym in Portuguese) and via public services. The majority of Brazilians who took part in the PNS reported using medication to control hypertension in the previous 15 days (91.5%) and using oral medication for diabetes (95.2%) and/or insulin (70%). Most participants obtained oral medication for hypertension and type 2 diabetes mellitus via PFPB (45.2% and 53.6%, respectively), and the factors that most negatively influenced this access were older age, lower income, lower schooling, very poor self-rated health and not having private health insurance. Access to insulin, on the other hand, was most often via the public health service (69.7%), and the factors that most negatively influenced this access were black/mixed-race skin color, lower income, very poor self-rated health and not having private health insurance. Generally, the importance of the PFPB as a policy to increase access to essential medicines in Brazil was highlighted, considering the free supply of antihypertensive and antidiabetic drugs.

Resumen: Este estudio tuvo como objetivo medir el acceso a los medicamentos para el tratamiento de la hipertensión arterial sistémica y de la diabetes mellitus tipo 2 en Brasil según la vía de obtención, además de analizar los factores asociados a este acceso, según datos de la Encuesta Nacional de Salud (PNS) de 2019. Se analizaron datos socioeconómicos y relacionados con el uso de medicamentos de personas de 15 años o más, con relación al acceso por medio del Programa Farmacia Popular de Brasil (PFPB) y por medio del servicio público. La mayor parte de los brasileños que participaron en la PNS refirió utilizar medicamentos para controlar la hipertensión, en los últimos 15 días (91,5%), así como la mayoría refirió el uso de medicamentos orales para la diabetes (95,2%) o uso de insulina (70%). Los medicamentos orales para hipertensión arterial sistémica y diabetes mellitus tipo 2 se obtuvieron en su mayoría por medio del PFPB, respectivamente (45,2% y 53,6%), y los factores que influyeron de forma más negativa en este acceso fueron mayor rango de edad, menores ingresos, menor escolaridad, no tener seguro de salud y reportar una autoevaluación de salud muy mala. El acceso a la insulina, a su vez, se produjo con mayor frecuencia por medio del servicio público de salud (69,7%), y los factores que influyeron de forma más negativa en este acceso fueron la raza negra/morena, menores ingresos, no tener plan de salud y reportar una autoevaluación de salud muy mala. En general, se destacó la importancia de la PFPB como política de ampliación del acceso a medicamentos esenciales en Brasil, considerando la gratuidad de los antihipertensivos y antidiabéticos.

Vinte anos da publicação da regulamentação de preços de medicamentos no Brasil: momento de atualizar? / Twenty years since the publication of medication price regulation in Brazil: time to update? / Veinte años desde la publicación de la regulación de precios de medicamentos en Brasil: ¿es hora de actualizarla?

Resumo: Os critérios para definir os preços de medicamentos no Brasil estão previstos na Resolução CMED nº 2/2004 da Câmara de Regulação do Mercado de Medicamentos. Os preços estipulados influenciam o mercado privado e público, o que torna desafiador a revisão de políticas de preços devido a necessidade de harmonizar interesses sociais e econômicos. Uma proposta de revisão dessa Resolução foi disponibilizada por meio da Consulta Pública SEAE nº 2/2021 da Secretaria de Advocacia da Concorrência e Competitividade/Ministério da Economia, porém, até o momento sem publicação dos resultados consolidados até o momento. Recomendações recentes da Organização Mundial da Saúde em relação à adoção de diferentes limiares para definição de preços de medicamentos são adotadas nessa Resolução, embora essa tenha sido publicada há 20 anos. Com o objetivo de interpretar e descrever o alinhamento e os possíveis avanços e retrocessos nos textos legais relacionados à regulação de preços de medicamentos, foi utilizado o método da pesquisa documental analítica-descritiva, de cunho exploratório. Como resultado, foram mantidas a lista de países referência para conferência de preço internacional e os limiares de referenciamento interno e externo de preços. As omissões normativas da Resolução permanecem na Consulta Pública, como a ausência de critérios para precificar radiofármacos, terapias avançadas e medicamentos sem preço internacional, e sem comparadores no mercado brasileiro para revisar preços e transpor preço provisório para definitivo. Um ponto crítico foi a criação de bônus de 35% acima do preço estipulado para medicamentos que apresentem benefício clínico adicional sem, contudo, definir contornos claros quanto às evidências científicas aceitáveis para a comprovação desse benefício. Em suma, poucos avanços foram percebidos na Consulta Pública.

Abstract: Criteria for setting medication prices in Brazil are set forth in CMED Resolution n. 2/2004 of the (Medicines Market Regulation Chamber). The stipulated prices influence the private and public markets, which makes it challenging to review pricing policies due to the need to harmonize social and economic interests. A proposal for reviewing this Resolution was made available through the SEAE Public Consultation n. 2/2021 of the Competition and Competitiveness Advocacy Secretariat/Brazilian Ministry of Economy; however, so far without publication of the consolidated results. Recent recommendations from the World Health Organization regarding the adoption of different thresholds for setting medication prices are adopted in this Resolution, although it was published 20 years ago. To interpret and describe the alignment, possible advances and setbacks between the legal texts related to medication price regulation, we conducted an analytical-descriptive and exploratory documentary research. As a result, the list of reference countries for international price verification and the thresholds for internal and external price referencing were maintained. The normative omissions of the Resolution remain in the Public Consultation, such as the absence of criteria for pricing radiopharmaceuticals, advanced therapies and medication without international and comparator prices in the Brazilian market, to revise prices and transpose provisional to definitive prices. A critical point was the creation of a 35% bonus above the stipulated price for medication that present additional clinical benefit without, however, defining clear contours as to the acceptable scientific evidence to prove such benefit. In short, few advances were noticed in the Public Consultation.

Resumen: Los criterios para definir los precios de los medicamentos en Brasil están establecidos en la Resolución CMED nº 2/2004 de la Cámara de Regulación del Mercado de Medicamentos. Los precios estipulados influyen en el mercado público y privado, lo que dificulta la revisión de las políticas de precios debido a la necesidad de armonizar los intereses sociales y económicos. Una propuesta para revisar esta Resolución se puso a disposición mediante la Consulta Pública SEAE nº 2/2021 de la Secretaría de Competencia y Promoción de la Competitividad/Ministerio de Economía, sin embargo, hasta el momento no se han publicado los resultados consolidados. En esta Resolución se adoptan recomendaciones recientes de la Organización Mundial de la Salud sobre la adopción de diferentes umbrales para fijar los precios de los medicamentos, aunque fue publicada hace 20 años. Con el objetivo de interpretar y describir el alineamiento, posibles avances y retrocesos, entre los textos legales relacionados con la regulación de precios de medicamentos, se utilizó el método de investigación documental analítica-descriptiva, de carácter exploratorio. Como resultado, se mantuvieron la lista de países de referencia para la verificación de precio internacional y los umbrales para la referenciación interna y externa de precios. Quedan en Consulta Pública las omisiones normativas de la Resolución, como la ausencia de criterios de fijación de precios de radiofármacos, terapias avanzadas y medicamentos sin precio internacional y comparadores en el mercado brasileño, para revisar precios y transponer el precio provisional al definitivo. Un punto crítico fue la creación de una bonificación del 35% sobre el precio estipulado para los medicamentos que presenten un beneficio clínico adicional sin definir, sin embargo, contornos claros sobre las evidencias científicas aceptables para demostrar dicho beneficio. En definitiva, se percibieron pocos avances en la Consulta Pública.

Prescription of HIV Post-Exposure Prophylaxis in emergency care units and return for follow-up appointments in specialized services in Salvador, Brazil, 2018: a cross-sectional study / Prescripción de Profilaxis Post Exposición al VIH en unidades de emergencia y consulta de control en unidades de seguimiento y de acompañamiento, Salvador, 2018: un estudio transversal / Prescrição da profilaxia pós-exposição ao HIV em unidades de urgência e retorno às consultas de acompanhamento em serviços especializados, Salvador, 2018: um estudo transversal

Abstract Objective: To analyze HIV Post-Exposure Prophylaxis (PEP) prescription and return for follow-up appointments. Methods: This was a descriptive cross-sectional study using data on people who sought PEP in emergency care units (UPAs) and specialized medical services in Salvador, BA, Brazil, between January-December/2018. Results: Of the 1,525 people who sought PEP at UPAs, 1,273 (83.5%) met PEP eligibility criteria, while 252 (16.5%) did not; of the eligible group, 1,166 (91.6%) had antiretrovirals prescribed, while 107 (8.4%) eligible people did not; of the total number of people with PEP prescriptions, only 226 (19.4%) returned for the first follow-up appointment, 115 (9.9%) for the second, and 33 (2.8%) for the third in order to complete the protocol. Conclusion: We found a significant proportion of eligible users who did not have PEP prescribed at UPAs and a significant loss of return for specialized service follow-up appointments.

Resumen Objetivo: Analizar la prescripción de Profilaxis Post Exposición (PPE) al Virus de la Inmunodeficiencia Humana (VIH) y la concurrencia a las consultas de control y seguimiento. Método: Estudio de datos descriptivo transversal de personas que solicitaron la PPE en Unidades de Atención de Emergencia (UPA) y servicios médicos especializados en Salvador, BA, Brasil, durante los meses de enero a diciembre de 2018. Resultados: De las 1.525 personas que consultaron por PEP en las unidades hospitalarias de emergencia, 1.273 (83,5%) cumplieron criterios de elegibilidad para profilaxis y 252 (16,5%) no los cumplieron; entre los elegibles, a 1.166 (91,6%) personas se les recetaron antirretrovirales (ARVs), pero 107 (8,4%) no los recibieron. Del total de personas que recibieron prescripción de PPE, solamente 226 (19,4%) regresaron a la primera consulta; 115 (9,9%) a la segunda consulta y 33 (2,8%) a la tercera consulta para completar el protocolo. Conclusión: Hubo una proporción significativa de usuarios elegibles que no recibieron prescripción de PEP en las Unidades de Atención de Emergencia y una pérdida significativa en las consultas de control al servicio especializado.

Resumo Objetivo: Analisar a prescrição da profilaxia pós-exposição (PEP) ao vírus da imunodeficiência humana (HIV) e o retorno às consultas de acompanhamento. Métodos: Estudo transversal descritivo, sobre dados de pessoas que buscaram a PEP em unidades de pronto atendimento (UPAs) e serviço médico de atenção especializada em Salvador, BA, Brasil, entre janeiro e dezembro/2018. Resultados: Das 1.525 pessoas que buscaram a PEP nas UPAs, 1.273 (83,5%) apresentaram critérios de elegibilidade à profilaxia e 252 (16,5%) não os apresentaram; entre os elegíveis, 1.166 (91,6%) pessoas tiveram prescrição dos antirretrovirais (ARVs), mas 107 (8,4%) não os receberam; do total de pessoas com prescrição de PEP, apenas 226 (19,4%) retornaram à primeira consulta, 115 (9,9%) à segunda consulta e 33 (2,8%) à terceira consulta para conclusão do protocolo. Conclusão: Observou-se proporção importante de usuários elegíveis que não receberam prescrição de PEP nas UPAs e perda significativa nas consultas de retorno ao serviço especializado.

Listas de medicamentos disponíveis no sistema público de saúde da Inglaterra e do Brasil para enfrentamento da carga de doenças / Lists of medicines available in the public health system in England and Brazil to address the burden of disease

Resumo Objetivou-se comparar as listas de medicamentos oferecidos pelos sistemas públicos de saúde inglês e brasileiro, averiguando a amplitude das possibilidades terapêuticas em ambos os países. Na análise utilizou-se o subgrupo químico (4º nível) da classificação anatômica, terapêutica e química (Anatomic Therapeutic Chemical classification - ATC), com foco nas três principais causas de anos de vida perdidos ajustados pela incapacidade (Disability-Adjusted Life Years - DALYs) encontrados no estudo de Carga Global de Doenças de 2019, comuns a ambos os países: doenças cardiovasculares, músculo-esqueléticas e mentais. Da comparação entre a Drug Tariff de março de 2020 (Inglaterra) e a Relação Nacional de Medicamentos Essenciais (Rename) 2020 (Brasil) emergiu que a Drug Tariff contém 3.620 apresentações farmacêuticas e a Rename, 921, sendo que 3.158 e 796 são monofármacos, respectivamente; um número 3,9 vezes maior de apresentações farmacêuticas que a Rename e duas vezes maior de substâncias ativas. A Rename e a Drug Tariff possuem 281 substâncias químicas ativas em comum, considerando o 5º nível da ATC. A lista de medicamentos financiados pelo NHS apresenta-se mais ampla que a do Brasil, tanto para doenças em geral, quanto para as doenças prevalentes nos dois países, podendo-se constituir uma possibilidade de aprimoramento para a Rename.

Abstract This study aimed to compare the lists of medicines offered by the England (National Health Service -NHS) and Brazilian (Sistema Único de Saúde - SUS) health systems. The analysis was performed using the chemical subgroup (4th level) of the Anatomical Therapeutic Chemical classification (ATC), focusing on the main causes of disability-adjusted life years (DALYs) found in the 2019 Global Disease Burden study for both countries: cardiovascular, musculoskeletal and mental disorders. The comparison between the Drug Tariff of March 2020 (England) and the Relação Nacional de Medicamentos Essenciais (Rename) 2020 (Brazil) showed that the former contains 3,620 pharmaceutical presentations and Rename, 921, with 3,158 and 796 being monodrugs, respectively. Drug Tariff has 3.9 times more pharmaceutical presentations than Rename and 2 times more active substances in monodrugs than Rename. Rename and Drug Tariff have 281 active chemicals in common, considering the 5th level of the ATC. The list of medicines financed by the NHS is broader than that of Brazil, both for diseases in general and for diseases prevalent in both countries, which may constitute a possibility of improvement for Rename, keeping the need for more studies in-depth on the topic.

O fim da extensão das patentes e as Parcerias para Desenvolvimento Produtivo: reflexos no acesso a medicamentos no Brasil / The end of patent extensions and the Productive Development Partnerships: effects on access to medicines in Brazil

Resumo A covid-19 jogou luz sobre o impacto negativo da propriedade intelectual na saúde e deu nova relevância à Ação Direta de Inconstitucionalidade 5529/DF, que, acatada pelo Supremo Tribunal Federal em 2021, culminou na extinção da extensão automática de patentes no Brasil. Este estudo busca analisar o efeito do julgamento histórico da ADI 5529/DF sobre pedidos de patente e as patentes de interesse das Parcerias para Desenvolvimento Produtivo (PDP). Trata-se de um estudo com base em uma pesquisa documental de análise do andamento, até 31 de dezembro de 2020, de 90 pedidos de patente relacionados a 15 medicamentos objetos de PDP. Nos sites do Instituto Nacional de Propriedade Industrial, do Ministério da Saúde, da Anvisa e da Câmara de Regulação do Mercado de Medicamentos, foram pesquisadas variáveis para comparar o cenário patentário dos medicamentos com o das PDP. De 88 pedidos válidos, 28 patentes foram concedidas, das quais dezessete foram estendidas para mais de vinte anos (média de 24 anos e nove meses). A decisão do STF resultou em mais de 68 anos de monopólio perdidos, potencialmente desanuviando alternativas para a produção de genéricos no país. Neste momento de retomada das PDP, estratégias para a superação de barreiras patentárias deveriam ser incorporadas à política.

Abstract The COVID-19 pandemic has shed light on the negative impact of intellectual property on health and has given new relevance to the Direct Action of Unconstitutionality 5529/DF, which was ruled by the Supreme Court in 2021, resulting in the extinction of automatic patent extensions in Brazil. This documentary case study analyzes the effects of the judicial decision on patent applications and patents of interest for Productive Development Partnerships (PDP), investigating the progress of 90 patent applications related to 15 PDPs drugs of interest until Decembre 31, 2020. Variables for comparing the drug patent scenario with that of the PDPs were researched on the websites of the National Institute of Industrial Property, the Ministry of Health, ANVISA, and the Brazilian Medicines Market Regulation Chamber. Of 88 valid applications, 28 patents were granted, 17 of which had been extended to more than 20 years (24 years and 09 months average). The court decision resulted in a loss of over 68 years of monopoly, potentially opening alternatives for generic production. This resumption of the PDP policy should incorporate strategies to overcome patent barriers.