Brazilian Drug Research Articles

Brazilian Drug Information Centre: descriptive study on the quality of information 2010-2015

ObjectiveTo define the activities of the Drug Information Centre of the Federal Council of Pharmacy (Cebrim/FCP), to describe the passive information and the satisfaction of its users. MethodThe centre has a computerized system for recording and storing the received questions and their answers: the Sistema de Informação Farmacoterapêutica SIFAR (Pharmacotherapeutical Information System) that generates management reports; out of these, the reports from the period 2010 to 2015 were analyzed. ResultsThe main activity carried out by the centre was the passive information provided to pharmacists and undergraduate Pharmacy students. The most frequent subjects were: administration and way of use of medicines and indication and drug interactions, which were answered in less than 24 hours in most cases. Approximately 80% of those users who completed the satisfaction survey rated the service provided as good and optimal. ConclusionsCebrim/FCP provides objective, updated and timely information (passive information) on medicines for pharmacists, with administration and way of use as the most recurrent subjects, and the majority of applicants were satisfied with the service.

Cannabis sativa L. from Seized Drug Material: In Vitro Germination and Establishment.

Background: With the expansion of the cannabis-derived product market, there is a growing need for seedling development to produce raw material for pharmaceutical applications and medicinal research. However, cannabis cultivation is illegal in many countries, and legal producers do not sell cannabis seeds in these countries. In Brazil, cannabis is still illegal, and the only way to obtain access to cannabis plants for research or as medicine is through importation, which is costly and requires authorization from the National Health Surveillance Agency (ANVISA), or from material seized by the police from drug trafficking. Methods: Therefore, since cannabis seeds obtained from drug trafficking have never been tested regarding their viability and use in in vitro cultivation, the aim of this study was to analyze the in vitro establishment of cannabis from seeds derived from Brazilian drug trafficking seizures that were provided by the police to investigate seed disinfestation procedures and further multiplication of nodal segments, with the purpose of obtaining material for medicinal research in the country. Seeds were subjected to four disinfestation treatments. Results: The best disinfestation treatment consisted in submerging the seeds in a 2 g·L-1 Captan® solution for 30 min before following the standard procedure with 70% ethanol for 30 sec and then 20 min in 2.5% sodium hypochlorite. The in vitro establishment of cannabis from seeds originating from Brazilian drug trafficking seizures was successful. The germination rate ranged from 10% to 90% according to the sample material. Non-brick weed, which consisted of dry leaves, stalks, and flowers, was more suitable for seed extraction and germination. Clones originating from BW4b showed the best development results compared with others. Conclusions: This is the first report of in vitro cannabis use in Brazil and opens great prospects for future work on its cultivation and research for medicinal applications in the country without relying on seed importation.

Budgetary impact of new label indications after initial drug registration in Brazil: A case study of pembrolizumab and trastuzumab deruxtecan

The pharmaceutical landscape has undergone a transformative shift due to emerging technologies, leading to a projected value of USD 405.52 billion for the global pharmaceutical manufacturing market in 2020. Brazil, representing 2% of the global pharmaceutical market, boasts a comprehensive public health system called Sistema Único de Saúde (SUS), ensuring universal health coverage. However, the public and private health sectors in Brazil operate independently, with 23% of Brazilians possessing private health insurance plans. Regulated by the Brazilian Drug Market Regulation Chamber (CMED), which controls drug prices based on international retail prices and other factors, the pharmaceutical market in Brazil faces significant challenges in maintaining the sustainability of the Brazilian health-care system, particularly due to the high costs of cancer medications, such as pembrolizumab and trastuzumab deruxtecan. This study aims to assess the budgetary impact of expanding indications for pembrolizumab and trastuzumab deruxtecan in Brazil after their initial registration by the Brazilian Health Regulatory Agency. Utilizing epidemiological data from the National Cancer Institute (INCA) and clinical trial data, we estimated the eligible patient populations and associated costs for these medications. Trastuzumab deruxtecan’s eligible patient population increased from 383 to 23,000 across various indications, resulting in a total cost increase from USD 90.6 million to USD 5.0 billion. Similarly, pembrolizumab’s eligible patient population expanded from 1796 to 99,544 for multiple indications, causing the total cost increase from USD 121.1 million to USD 6.7 billion. The study highlights the substantial expansions in indications and patient eligibility for trastuzumab deruxtecan and pembrolizumab in Brazil, with significant budgetary implications potentially jeopardizing the health-care system’s sustainability. To ensure the long-term sustainability of health-care systems and to provide equitable access to optimal treatments, it is crucial for policymakers to monitor and adjust drug prices following their initial registration. Policymakers must be aware of these challenges and consider them in health-care policy development and decision-making processes.

Ageratum conyzoides: A Potential Source for Medicinal and Agricultural Products

Ageratum conyzoides is a widely spread weed, especially in the tropical and subtropical regions. It has been reported to be used as folk medicine in different countries for treating burns, wounds, skin disorders, headaches, fever, pneumonia, gynecological diseases, leprosy, snakebites, rheumatism, inflammations, stomach ailments like parasites, colic, diarrhea, dysentery, used as a painkiller during childbirth, and many more. It has been reported to contain active secondary metabolites such as alkaloids, tannins, phenols, saponins, coumarins, essential oils, and flavonoids, which support its medicinal uses in disease treatment and prevention. It can be a potential source of drugs for various diseases. In fact, pharmaceutical companies are being run in Brazil using A. conyzoides as raw material with recommendations from the Brazilian Drug Centre. It is also used for agricultural purposes as manure, insecticide, pesticide, herbicide, nematicide, fodder, etc. In China, it is widely intercropped in the citrus orchard to control pests and weeds. The review attempts to bring together medicinal and agricultural usage of Ageratum conyzoides with scientific evidence to demonstrate its efficacy. This weed has a negative influence in agriculture and the ecosystem but after studying about its potential medical and agricultural uses, we now have a different viewpoint on this weed, and we believe that further harnessing it for such positive uses might be a management strategy for this weed.

Implementation fidelity of a Brazilian drug use prevention program and its effect among adolescents: a mixed-methods study

BackgroundBased on the US DARE-kiR, a version of the Keepin’ it REAL program, the Drug and Violence Resistance Educational Program (PROERD) is the most widely implemented Brazilian prevention program. It originates from the translation of the DARE-kiR, a version of the Keepin’ it REAL program. Previous results suggest its inefficiency in preventing drug use among Brazilian adolescents. Since kiR fidelity can impact program outcomes, this mixed-methods study evaluates the PROERD implementation fidelity and its effects on preventing drug use among adolescents.MethodsData from two cluster randomized controlled trials (cRCTs) with 4,030 students from 30 public schools in São Paulo (1,727 fifth graders and 2,303 seventh graders), assessed at two-time points, were analyzed quantitatively. After implementing each lesson during the cRCT, 19 PROERD instructors answered fidelity forms. The effect of PROERD fidelity on alcohol, cigarettes, marijuana, inhalant, and cocaine use (the last two only among seventh graders) in the six months prior to follow-up assessment was analyzed by logistic regressions for fifth grade and mixed effect models for seventh graders. For qualitative analysis, semi-structured interviews were conducted with PROERD instructors and investigated by thematic analysis.ResultsQuantitative analysis showed that PROERD implementation fidelity had no impact on drug use among fifth and seventh graders. Conversely, the qualitative analysis revealed important aspects that may influence implementation fidelity and consequently program effectiveness, such as adaptations made by instructors, school infrastructure, among others, besides program application.ConclusionPROERD requires cultural adaptation to improve its implementation in Brazilian public schools.

A mudança discursiva na assistência ao usuário ou dependente de drogas: análise de discurso crítica de uma lei federal

Abstract Brazilian drug policies have undergone changes over time, bearing marks for each historical period and experienced sanitary-political interests. Nowadays, an anti-reformist character was perceived in changes concentrated on Law no. 13,840, of June 5, 2019. The aim of this study is to analyze the key elements of a normative document on drugs based on the Critical Discourse Analysis. We analyzed the Law no. 13,840 using Fairclough’s method for three-dimensional analysis and then discussed it with Foucault’s notions of Biopower and Biopolitics. We consider that the emphasis on involuntary hospitalization, therapeutic communities and abstinence opposes the Brazilian psychiatric reform movement. The development of oppressive care practices are hidden by the so-called ideological neutrality and scientific evidence.

The discourse change in drugs users or addicts care: critical discourse analysis of a federal Act.

Brazilian drug policies have undergone changes over time, bearing marks for each historical period and experienced sanitary-political interests. Nowadays, an anti-reformist character was perceived in changes concentrated on Law no. 13,840, of June 5, 2019. The aim of this study is to analyze the key elements of a normative document on drugs based on the Critical Discourse Analysis. We analyzed the Law no. 13,840 using Fairclough's method for three-dimensional analysis and then discussed it with Foucault's notions of Biopower and Biopolitics. We consider that the emphasis on involuntary hospitalization, therapeutic communities and abstinence opposes the Brazilian psychiatric reform movement. The development of oppressive care practices are hidden by the so-called ideological neutrality and scientific evidence.

Mediating Factors of a Brazilian School-Based Drug Prevention Program

Mediating Factors of a Brazilian School-Based Drug Prevention Program

Establishing a genomic database for the medicinal plants in the Brazilian Pharmacopoeia

BackgroundBrazil is exceptionally abundant in medicinal plant resources and has a rich ethnopharmacological history. Brazilian Pharmacopoeia (BP) acts as a national standard that regulates drug quality and has six published editions. Recent genomic approaches have led to a resurgence of interest in herbal drugs. The genomic data of plants has been used for pharmaceutical applications, protecting natural resources, and efficiently regulating the market. However, there are few genomic databases specifically for medicinal plants, and the establishment of a database that focuses on the herbs contained in the BP is urgently required.MethodsThe medicinal plant species included in each edition of the BP were analyzed to understand the evolution of the Brazilian herbal drugs. The data of 82 plants in the BP were collected and categorized into four sections: DNA barcodes, super-barcodes, genomes, and sequencing data. A typical web server architecture pattern was used to build the database and website. Furthermore, the cp-Gs of the Aloe genus in the database were analyzed as an illustration.ResultsA new database, the Brazilian Pharmacopoeia Genomic Database (BPGD) was constructed and is now publicly accessible. A BLAST server for species identification and sequence searching with the internal transcribed spacer 2 (ITS2), the intergenic region (psbA-trnH), and the chloroplast genome (cp-G) of Brazilian medicinal plants was also embedded in the BPGD. The database has 753 ITS2 of 76 species, 553 psbA-trnH and 190 genomes (whole genome and chloroplast genome) of 57 species. In addition, it contains 37 genome sequence data sets of 24 species and 616 transcriptome sequence data sets of 34 species and also includes 187 cp-Gs representing 57 medicinal species in the BP. Analyses of the six cp-Gs of three Aloe species identified the variable regions in the cp-Gs. These can be used to identify species and understand the intraspecific relationships.ConclusionsThis study presents the first genomic database of medicinal plants listed in the latest BP. It serves as an efficient platform to obtain and analyze genomic data, accelerate studies regarding Brazilian medicinal plants and facilitate the rational development on their market regulation.

Cannabis Consumption Onset and Addiction: Data from the Second Brazilian Drugs and Alcohol Survey (BNADS)

ABSTRACT The objective of this study was to provide rates of cannabis use and dependence and risk factors, proposing a conditional path model for cannabis addiction. A subsample of adult participants from a Brazilian household survey was analyzed to estimate cannabis dependence. Estimation of prevalence rates and association between dependence and age of cannabis use initiation were performed. The conditional model was applied to investigate the mediation of depressive symptoms and alcohol consumption in the association of early cannabis use and dependence. Lifetime and last year cannabis use were 6.47% and 2.81%, respectively. Moderate and severe cannabis dependence were 0.74% and 0.18% in the population, and 26.47% and 6.38% among last year’s cannabis users. A Parallel Multiple Mediator Model revealed strong association between cannabis use initiation age and dependence, when depressive symptoms or alcohol consumption mediate this association. The proportion of cannabis users displaying dependence symptoms is elevated and it is associated with the age of cannabis use initiation. The results show the importance of primary prevention interventions, prioritizing the delay of cannabis and alcohol experimentation. Our findings can enrich the debate on drugs policies and legislation, reinforcing the need for stronger restrictions of adolescent drug access and ensuring its enforcement.

Effect of eight common Brazilian drugs on Lemna minor and Salvinia auriculata growth.

The growth of two species of macrophytes (Lemna minor and Salvinia auriculata) under the effect of a mixture of amoxicillin, caffeine, carbamazepine, dipyrone, ibuprofen, losartan, omeprazole, and tenivastatin was investigated by bioassay. Three concentration levels were utilized in this study (10, 200, and 500 μg L-1) using a growth inhibition test based on the OECD 221/2006 guidelines. The frond number, total area, and chlorophyll a level were selected as suitable end points. For L. minor, at all concentrations, a significant difference in the total frond number was observed and the growth inhibition varied from 30 to 70% at the low and high concentrations, respectively. No significant growth change was observed to S. auriculata exposed to the mixture of drugs. Thus, individual drug tests were performed for L. minor which demonstrated stimulation in growth, when exposed to most drugs individually, except tenivastatin which was identified as the drug responsible for the significant growth inhibition seen in the mixture. The L. minor enhanced growth was probably caused by N molecule transformation to ammonium and nitrate, essential nutrients for plants.

Supportive housing for homeless people in the context of the Brazilian drug policy: implementation evaluation

Abstract Supportive housing interventions based on the Housing First approach have been implemented in Brazil as part of drug policy. It is relevant to analyze the influence of local characteristics on the implementation degree of this kind of intervention in this national context. We conducted an implementation evaluation case study of a supportive housing Project, in Brasília/DF. To describe the initiative we used official documents, participant observation of real and virtual environments, systematization of the perception of project workers/managers and logic model. The project description was then compared with criteria based on the HF proposal parameters. The results indicate the appropriateness of the intervention to the fundamental principle of putting housing in the first place, using local solutions and adaptations. However, shortcomings in the management of comprehensive care and disintegration of the social policy network challenge the implementation of the social integration component of the proposal. Health and Social Care interface needs to be better analyzed and the original model better known in its context of origin.

Investigation of factors associated with low adherence to treatment of codependency in family members of psychoactive substance users

Abstract The aim of this study was to investigate possible factors that prevent adherence to the treatment of codependent family members of problem drug use individuals. A quasi-experimental study was carried out with 133 relatives of psychoactive substances users who called the Brazilian drug hotline (Ligue 132) between 2013 and 2015, from the five regions of Brazil. The following instruments were used: General service protocol; Family assistance protocol; Holyoake Codependency Index; Behavioral Adherence Scale; and Adherence Factor Questionnaire. Univariate analysis of data was performed for categorical variables and Chi-square test for comparison between variables, with p < 0.05. The sample showed a predominance of women (91.7%), especially mothers (82.7%). Among the investigated factors, alcohol as the substance involved in the problem showed a significant association with the non-adherence to treatment through teleintervention of family members.

A realidade das informações da política de medicamentos especializados nos websites das Secretarias Estaduais de Saúde

O objetivo desse artigo é analisar como os sites das Secretarias Estaduais de Saúde da Paraíba, Bahia, Santa Catarina e Rio Grande do Sul disponibilizam informações sobre a política de medicamentos brasileira para os usuários do SUS. Com base em uma metodologia qualitativa, observa-se uma variedade de formas de organização e apresentação das informações estruturadas em uma linguagem predominantemente técnica, em desacordo com o nível de instrução da população, em oposição à uma comunicação pública que deve ser, segundo a norma legal, acessível e compreensível por gestores, profisionais e atores da sociedade civil, superando o linguajar do corpo técnico-burocrático para que a política pública seja apropriada pela sociedade. Ao identifiar uma distância existente entre lei e realidade, conclui-se enunciando limites e desafis a serem superados pelos agentes políticos no aprofundamento e desenvolvimento de metodologias voltadas para a qualidade do acesso às informações da política pública de medicamentos pela população.

Cannabis plantations as an aspect of population survival and as a public policy and security issue in the northeast region of Brazil

Based on historical and structural data, this article aims to discuss the cultivation of cannabis as a social and political issue in Brazil. The objective was to analyze the genesis of the issue of illegal plantations, its evolution, the governmental response and its consequences for public security and agricultural policies in the São Francisco Valley region, in the Northeast of Brazil. Qualitative methodologies were used with emphasis on the descriptive analysis of the phenomenon. The result is that the state steps that affected the environment, the Brazilian drug policy, the inefficient agricultural policy for the semi-arid region and the plantation eradication measures are directly and indirectly related to the continuation of the plantations as relevant economic and criminal activities.

Assessment of Knowledge, Attitude, and Practice of Pharmacovigilance among Healthcare Professionals in Brazil

Background: Adverse Drug Events represent a public health problem with high morbidity and mortality rates around the world. Knowledge, attitudes and practices of health professionals toward pharmacovigilance and reporting these events are important factors to promote safe drug therapy use. Objectives: The aim of this study was to evaluate Knowledge, attitudes and practices of health professionals and reporting of Adverse Drug Events by health professionals in Brazil. Methods: across-sectional study with a pretested questionnaire available online on the website of the Brazilian drug regulatory agency. Pharmacovigilance related Knowledge, attitudes and practices and Adverse Drug Events reporting were evaluated and correlations were estimated. Results: In total, 761health professionals responded to the survey. The overall knowledge, attitudes and practices was of 57.7% for pharmacists, 56.9% for nurses and 40% for physicians 40% (considered to be a poor level). When evaluating performance by region, one physician (100%) from the South region and one nurse from the Central-West (83.3%) performed well on this indicator. Professionals in the age group older than 45 years and those with postgraduate degrees had the best performance in knowledge, attitudes and practices. The statistical analysis was performed with the software State version 15. Conclusion: The study identified knowledge, attitudes and practices deficiencies in pharmacovigilance and mapped its main weaknesses, which makes it possible to better delineate measures to address these challenges and improve the Brazilian national pharmacovigilance system. Key words: Adverse Drug Reaction Reporting Systems, Health Knowledge, Attitudes, Practice, Patient Safety, Pharmaco epidemiology, Product Surveillance, Post marketing.

A (im)prescindibilidade do laudo toxicológico definitivo, na condenação pelos crimes de tráfico de drogas, no Tribunal de Justiça do Estado do Pará

O objetivo deste trabalho é analisar o posicionamento do Tribunal de Justiça do Estado do Pará em relação à possibilidade de condenação nos crimes de tráfico de drogas em que o laudo toxicológico definitivo está ausente no processo. Para tanto, será realizada uma pesquisa jurisprudencial nos acórdãos do tribunal, a partir do método dedutivo, considerando o disposto na Lei 11.343/2006 (Lei de Drogas). A hipótese central é a de que o tribunal tem condenado pessoas sem o laudo, como resquício de uma política inquisitorial e proibicionista. No decorrer do artigo serão analisados a moldura inquisitorial do sistema processual penal, os delineamentos da noção de materialidade e verdade e a história da legislação brasileira sobre drogas, em especial a Lei 11.343/2006. Essa pesquisa se apresenta como relevante, ao se considerar que ela diz respeito ao maior tribunal da Região Norte do País e que se está a analisar uma das provas fundamentais para julgamento de um dos crimes que mais aprisiona no Brasil.

From prohibition to harm reduction? An analysis of the adoption of the Dutch harm reduction approach in Brazilian drug laws and practice

BackgroundBrazilian drugs law and policy used to focus on prohibition of drug use. In 2006, inspired by the Dutch harm reduction approach, Brazil adopted Law 11.343/06, a new drugs law focused at harm reduction. Dutch harm reduction is characterized by a distinction between users and traffickers of drugs, and by a distinction between drug markets (soft drugs and hard drugs). Notwithstanding the new drugs law, some Brazilian scholars claim that Brazil still favors prohibitionism towards drug use. The current study investigates the extent to which the Dutch harm reduction approach is reflected in Brazilian law and practice. MethodsFirst, a documentary analysis of the Brazilian law and policy documents is performed to see whether they incorporate the distinctions between actors and markets. Second, a case law analysis of 102 judicial decisions delivered by the Rio de Janeiro courts of appeal was conducted to investigate to what extent judges refer to aspects of the harm reduction approach. ResultsFindings of this study indicate that law and policy documents now indeed separate users from traffickers, but soft drugs are not separated from hard drugs. Moreover, where the distinction between users and traffickers in the Dutch law is solely based on the quantity of seized drugs, the Brazilian judge has large discretionary powers to decide whether the suspect is a user or a trafficker. ConclusionThe Brazilian legal system has partially incorporated the Dutch harm reduction approach. The law distinguishes users from traffickers, but does not prescribe criteria to make the distinction. The lack of objective criteria by Brazilian law and policy reflects in subjective and inconsistent decisions delivered by the courts, which impairs an approach of harm reduction towards drug users.

Rastreabilidade na cadeia de medicamentos brasileira

Falsification, theft and all the deviations related to drugs movimentation, commercialization and administration are responsible for several deaths and losses, not only in Brazil, but also around the world. Due to the severity of these problems, the World Health Organization (WHO) recommends government authorities to strengthen their drug supply chains, in order to ensure its integrity. In this sense, this TechnicalNote presents the Brazilian Drug Control System (SNCM – acronym for the Portuguese translation), in implementation by the Brazilian HealthRegulatory Agency (Anvisa - acronym for the Portuguese translation), which introduces the traceability concept in the Brazilian Drugs SupplyChain; and it also describes the operationalization and the results obtained with the tests taken at the SNCM Experimental Phase. The results achieved, shown in this Technical Note, indicated that the traceability is compatible with the drugs supply chain; besides that it is able to ensure the integrity recommended by WHO; and it also acts as an instrument for improving health communication.

High rates of incarceration due to drug trafficking in the last decade in southern Brazil.

Introduction Drug-related crimes, especially drug trafficking, account for a large part of incarcerations not only in Brazil, but also worldwide. It is not clear whether the change in the drug law has contributed to the increase in the number of drug trafficking prisoners. Few studies have investigated gender differences and the growth of drug trafficking offenses in the Brazilian southern state of Rio Grande do Sul. Objective To investigate the growth of the prison population in the state of Rio Grande do Sul, emphasizing incarcerations for drug trafficking and gender differences. Method This was an ecological study using secondary data collected from official databases of the Brazilian National Penitentiary Department (Departamento Penitenciário [DEPEN]), affiliated with the Brazilian Ministry of Justice. Results Between 2006 and 2015, incarcerations increased by 27% (25% men, 83% women). Incarcerations for drug trafficking accounted for 11% of total arrests in 2006 (11% men, 20% women) and 45% in 2015 (47% men, 91% women), corresponding to an increase of 427% (415% among men, 723% among women). Conclusions Imprisonment for drug trafficking has increased considerably, especially among women. This may be due to factors such as: increase of drug trafficking, increase in the numbers of gangs in the state, and changes in the Brazilian drug law. These results highlight an emerging challenge in public health from the perspective of human rights and gender.