Regulamentação Sanitária de Medicamentos

A regulamentação sanitária de medicamentos é uma das oito diretrizes da Política Nacional de Medicamentos. Trata-se da fiscalização e regulamentação de registro de medicamentos e da autorização de funcionamento desde os produtores até o varejo de medicamentos, bem como das restrições àqueles sujeitos a controle especial. A regulamentação sanitária de medicamentos tem como objetivo garantir eficácia, segurança, qualidade e custo aos produtos farmacêuticos. Os estudos clínicos dos medicamentos de Referência, a bioequivalência ou biodisponibilidade relativa e testes de equivalência dos medicamentos similares e genéricos são meios de avaliar a eficácia e a segurança. A qualidade é garantida lote a lote pelas Boas Práticas de Fabricação e Controle dos produtos farmacêuticos e a certificação da empresa pela ANVISA. O custo é avaliado pela câmara técnica de medicamento (CMED), que estabelece os critérios para fixação e ajuste de preços dos produtos farmacêuticos. No pós-registro, a efetividade, segurança e qualidade dos produtos são avaliadas por meio das comprovações exigidas na renovação do registro e, principalmente, pelo programa de farmacovigilância. Palavras-chave: Registro de Produtos. Medicamentos de Referência. Medicamentos Similares. Medicamentos Genéricos. Alteração de Registro de Produtos. ABSTRACT Health Regulations for Drugs The health regulation of drugs is one of eight guidelines issued within the National Drug Policy. It refers to the supervision and regulation of drug registration and the approval of operations, from the manufacturers to the retailers of medicines, as well as the restrictions that apply to drugs under special control. The health regulation of medicines is aimed at controlling the effectiveness, safety, quality and cost of pharmaceutical products. Clinical studies of brand-name (innovator) medicines, bioequivalence or relative bioavailability and the equivalence tests of generic and ‘similar’ brand-name drugs are means used to assess efficacy and safety. Quality is assured on a batch-to-batch basis by compliance with the Good Manufacturing Practices and Control of pharmaceutical products and by the certification of companies offered by ANVISA. The cost of a medicine is assessed by the Technical Chamber of Medicine (CMED), which establishes the criteria for setting and adjusting the prices of pharmaceutical products. After registration, the effectiveness, safety and quality of products are monitored by means of the tests required on renewal of registration and especially by the pharmacovigilance program. Keywords: Product Registration. Original Brand-name Drugs. Similar Drugs. Generic Drugs. Modification of Product Registration.

Environmental isolation, biochemical identification, and antifungal drug susceptibility of Cryptococcus species

Introduction The incidence of opportunistic fungal infections has increased in recent years and is considered an important public health problem. Among systemic and opportunistic mycoses, cryptococcosis is distinguished by its clinical importance due to the increased risk of infection in individuals infected by human immunodeficiency virus. Methods To determine the occurrence of pathogenic Cryptococcus in pigeon excrement in the City of Araraquara, samples were collected from nine environments, including state and municipal schools, abandoned buildings, parks, and a hospital. The isolates were identified using classical tests, and susceptibility testing for the antifungal drugs (fluconazole, itraconazole, voriconazole, and amphotericin B) independently was also performed. After collection, the excrement samples were plated on Niger agar and incubated at room temperature. Results A total of 87 bird dropping samples were collected, and 66.6% were positive for the genus Cryptococcus. The following species were identified: Cryptococcus neoformans (17.2%), Cryptococcus gattii (5.2%), Cryptococcus ater (3.5%), Cryptococcus laurentti (1.7%), and Cryptococcus luteolus (1.7%). A total of 70.7% of the isolates were not identified to the species level and are referred to as Cryptococcus spp. throughout the manuscript. Conclusions Although none of the isolates demonstrated resistance to antifungal drugs, the identification of infested areas, the proper control of birds, and the disinfection of these environments are essential for the epidemiological control of cryptococcosis.

Use of live oocyst vaccine in the control of turkey coccidiosis: Effect on performance and intestinal morphology

An experiment was conducted to determine the effects of different coccidiosis-preventing programs on performance and intestinal morphology of commercial turkeys. Three hundred fifteen1-d-old female commercial cross turkey poults (British United Turkeys, BUT Big 9) were distributed into 3 treatments with 5 replicates of 21 birds each. Three programs were evaluated from 1 to 70 d of age, where program 1 had no anticoccidial drug and no vaccination against coccidiosis; program 2 had an anticoccidial drug (maduramycin 1%, 5 ppm); and program 3 had a vaccination (commercial vaccine, 4 species of Eimeria). All the groups were challenged with a dose of oocysts sporulated (20,000/bird) of 2 species of Eimeria at 21 d of age. In the growing phase (d 0-28), BW, BW gain, and FCR were significantly greater in treated groups compared with control group. In the fattening phase, the performance was not affected by treatments. Treatments and coccidiosis challenge had no significant effects on intestinal villus height. These observations support other reports that confirm live oocyst vaccination can be used effectively as a preventive against avian coccidiosis in commercially reared turkeys.

Ivabradine: Just another New Pharmacological Option for Heart Rate Control?

Ivabradine (IVB) is a heart rate lowering agent that acts via selective inhibition of the pacemaker funny current in sinoatrial nodal P cells, thus, reducing heart rate at rest and during exercise with minimal effect on myocardial contractility, blood pressure, and intracardiac conduction. IVB exerts no effect on external respiratory function parameters and it may also play a role in patients with concurrent chronic obstructive pulmonary disease. This property constitutes an important advantage over β-blockers. IVB acts by reducing the heart rate in a mechanism different from β-blockers, calcium channel blockers or late sodium channel blockers, three commonly prescribed antianginal drugs. As clinical trials have shown, it is remarkably well-tolerated and offers an alternative for patients who cannot take β-blockers. The combination of IVB and atenolol at commonly used doses in patients with chronic stable angina produced additional efficacy with no untoward effect on safety or tolerability. Additionally, side effects are rare and largely limited to a luminous phenomenon or phosphenes. This sensation is thought to be due to a block of Ih in the retina, a current very similar to cardiac If channels. IVB is contraindicated in patients with sick sinus syndrome or sinus node dysfunction and in patients taking hepatic inhibitors of Cytochrome P450 family 3, subfamily A, polypeptide 4 (abbreviated CYP3A4), with exception of omeprazole or lansoprazole. This review briefly summarizes the main studies regarding this drug.

Application of Cymbopogon winterianus Jowitt and Azadirachta indica A. Juss in the control of Rhipicephalus (Boophilus) microplus

Parasitism constitutes one of the main problems that affect livestock. Commercial acaricides have been used to control tick, but these chemicals have been responsible for the development of drug resistance and residues in the environment. Changes in the concept of production determined the search for natural measures, which guarantees animal sanity along with safety of the produced food. This assay had as objective to evaluate the citronella oil and neem oil in the control of bovine ticks. By the technique of adult ticks immersion, 280 ticks were evaluated, distributed in equal number throughout four treatments: negative control group, positive control (ivermectin), neem oil and citronella oil. It was analyzed the mortality index, estimated reproduction, product efficiency, index of eggs production and the hatchability rate. The efficiency of the product was verified by the mortality index just for the positive control group (100%) and citronella oil (97.14%). Also, the citronella oil inhibited the eclosion of eggs in 100%. The other treatments did not presented the minimum eclosion inhibition level of 95%. Under the conditions of the present assay citronella oil was efficient against Rhipicephalus (Boophilus) microplus. This result was not observed in relation to the neem oil.

Phytotherapy in the control of helminthiasis in production animals

Parasitic diseases constitute one of the main problems affecting livestock; however the use of chemical medicaments provides drug resistance residues in animal and environmental contamination. Changes in production concepts require that food must be produced in hygienic conditions, per healthy animals and that are not eliminating antibiotic residues, pesticides or other drugs. This scenario has favored organic production and the use of medicinal plants. For the control of endoparasites, several studies have published the benefits of Azadirachta indica A. Juss., Punica granatum Linn., Musa sp., Operculina hamiltonii G. DON., propolis, among others. However, despite the existence in- vitro studies that demonstrate the pharmacological properties of phytotherapics, there is still need for clinical trials to determine dosage and its effects in- vivo. Investigations of new bioactive natural substances can be of great value for the control of animal health and food safety, which is particularly important for organic production systems in which the use of chemical drugs is a limiting factor for certification.

Fiscal policy contradiction: a perspective on Brazil and Mexico

The aim of this paper is to discuss the quality of fiscal policy in Brazil and Mexico and investigate whether fiscal policy influence is favorable to reduce the unemployment rate. Public spending, which has a positive effect on the level of employment when results in additional aggregate demand, may cause a negative effect on employment, if its financing depends on persistent high interest rates. Brazil and Mexico have engaged in a long effort to control public spending and to reduce the public deficit to zero. Does this policy bring a positive result to the economic activity no matter how actual public deficit has been financed? We select variables related to public budget as public sector borrowing requirements, taxes, public debt and others to form a data base. The fiscal institutional arrangement and the data allow us to evaluate the fiscal policy as a who leand to discuss the importance of credibility and reputation of the government.

Drug addictions and sexual violence in childhood and adolescence: analyzing life stories

The sexual abuse suffered in childhood and adolescence, in addition to damage to physical and psychological health of the victim, is considered as an important risk factor for alcohol and drugs addiction, development of psychopathology and psychosocial damage in adulthood. In addition to the pain and humiliation that are submitted by the abuse, children and adolescents also experience shame and guilt which require them to adopt coping strategies to endure those feelings. The use of psychoactive substances is a recognized way of dealing with the pains of living. This work, which is of narrative style, analyses and discusses, through five case reports, chemical dependency as a result of sexual abuse suffered in childhood and/or adolescence. The eight subjects in this study are male and have suffered sexual violence in this age period of life. Their ages range from 23 years to 39 years, and all are admitted to a therapeutic community in a city in the interior of Sao Paulo state, in Brazil, for treatment of chemical dependency, being met by the Department of Psychology. The reasons for the choice of the participants for treatment modality for patients are: difficult to stop using drugs, even unwilling to take it, they have easy access to it; the feeling of losing control over their lives; by successive losses as a result of drug use, and for fear that their lives had a tragic ending. With the exception of two participants, the others do not classify that as a child suffered sexual violence. However, all attribute that facilitated their entry into the world of drugs. Seven participants experienced such violence in childhood (between 7 years and 9 years) and adolescence (age 14). The attackers were people closed to the victims—in the case of two victims, their families, with the exception of one participant who was raped by a stranger. Six participants declared themselves as homosexual. Another participant does not claim to be homosexual, but presents difficulties in terms of sexuality. Two participants are HIV positive. The start of psychoactive substances use occurred during adolescence (12 years to 17 years). The participants see drugs as an anesthetic to the pain of the soul, a way to get pleasure, but they get charged expensively, as it increases the feeling of emptiness, guilt, helplessness, worthlessness and hopelessness. Although participants have sought help to deal with addiction, it is noted that throughout the life course the issue of sexual violence was not treated. It was noted that the patients have a double stigma in society: the issue of drugs addiction and the orientation of sexual desire, because the majority of participants are homosexual. The results reinforce the need for effective action geared to accommodate the victims of sexual violence and effective preventive measures to prevent children and adolescents from being abused.

Oil-in-water biocompatible microemulsion as a carrier for the antitumor drug compound methyl dihydrojasmonate

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Clinical and epidemiological profiles of individuals with drug-resistant tuberculosis

Drug-resistant tuberculosis (TB) is a growing global threat. Approximately 450,000 people developed multidrugresistant TB worldwide in 2012 and an estimated 170,000 people died from the disease. This paper describes the sociodemographic, clinical-epidemiological and bacteriological aspects of TB and correlates these features with the distribution of anti-TB drug resistance. Mycobacterium tuberculosis (MT) cultures and drug susceptibility testing were performed according to the BACTEC MGIT 960 method. The results demonstrated that MT strains from individuals who received treatment for TB and people who were infected with human immunodeficiency virus were more resistant to TB drugs compared to other individuals (p < 0.05). Approximately half of the individuals received supervised treatment, but most drug-resistant cases were positive for pulmonary TB and exhibited positive acid-fast bacilli smears, which are complicating factors for TB control programs. Primary healthcare is the ideal level for early disease detection, but tertiary healthcare is the most common entry point for patients into the system. These factors require special attention from healthcare managers and professionals to effectively control and monitor the spread of TB drug-resistant cases.

Teflubenzuron as a tool for control of trichodinids in freshwater fish: Acute toxicity and in vivo efficacy

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Role of cholinergic and adrenergic pathways of the medial septal area in the control of water intake and renal excretion in rats

In this study, we investigated an interaction between noradrenergic and cholinergic pathways of the medial septal area (MSA) on the control of water intake and urinary electrolyte excretion by means of injection of their respective agonists. Noradrenaline (a nonspecific α-adrenergic agonist) and clonidine (an α2-adrenergic agonist), but not phenylephrine (an α1-adrenergic agonist), induced natriuresis and kaliuresis. α-Adrenergic activation had no effect on the natriuresis and kaliuresis induced by carbachol (a cholinergic agonist) and it inhibited the antinatriuresis and antikaliuresis induced by isoproterenol (a ß-adrenergic agonist). Interactions related to volume excretion are complex. α-Adrenergic activation induced a mild diuresis and inhibited the antidiuresis induced by isoproterenol, but phenylephrine combined with carbachol induced antidiuresis. The water intake induced by carbachol was inhibited by clonidine and noradrenaline, but not phenylephrine. These results show an asymmetry in the interaction between α-adrenergic and cholinergic receptors concerning water intake and electrolyte excretion. © 1992.

The control of sodium chloride intake: Functional relationship between hypothalamic inhibitory areas and amygdaloid complex stimulating areas

Sodium chloride intake was studied in rats submitted to different neurosurgical procedures. Intake decreased in animals submitted to bilateral destruction of the basolateral amygdaloid complex, and increased after the same animals were submitted to destruction of the anterior lateral hypothalamus, a procedure which is known to cause increased intake in intact rats. In the reverse experiment, where the anterior lateral hypothalamus was destroyed before the basolateral amygdaloid complex, the effect of increased sodium chloride intake induced by destruction of the hypothalamus overcame the decreased expected upon destruction of the amygdaloid complex. These results permit us to conclude that the hypothalamic areas which inhibit sodium chloride intake predominate over the stimulating areas of the amygdaloid complex in the control of sodium chloride intake. © 1981 ANKHO International Inc.

Physico-chemical characterization and analytical development for sodium azumolene, a potential drug designed to fight malignant hyperthermia

Sodium azumolene is a drug designed to fight Malignant Hyperthermia (MH), which is characterized by genetic predisposition and triggered by the use of inhalational anesthetics. This drug is shown as a water-soluble analogue of dantrolene sodium, 30-folds more water soluble, which gives advantages for its emergency use. To our knowledge there is no analytical method for sodium zaumolene raw material or dosage form published so far. The objective of the present investigation was to develop and validate analytical methods to achieve sodium azumolene chemical identification and quantification. The sodium azumolene was characterized regarding its thermal behavior, by differential thermal analysis and thermogravimetric analysis; Visible, UV and infrared absorption. To accurately assess the sodium Azumolene content three different analytical methods (visible and UV spectrophotometry and high performance liquid chromatography) were developed and validated. All methods showed to be linear, accurate, precise and reliable. Azumolene has shown to be equipotent to dantrolene in the treatment and prevention of an MH crisis and the great advantage compared to dantrolene is better water solubility. This study has characterized the sodium azumolene and presents new analytical methods which have not been reported so far.

Insights into the swelling process and drug release mechanisms from cross-linked pectin/high amylose starch matrices

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)