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.

Estabilidade, polimorfismo, dissolução e correlação in vivo-in vitro de Darunavir comprimidos

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Caracterização de poliformos em comprimidos distribuídos pela Secretaria de Saúde de Araraquara por difração de raios X

Pós-graduação em Química - IQ

Embalagens de medicamentos: diretrizes para o desenvolvimento

Pós-graduação em Design - FAAC

Depression and Cognitive Decline: Factors Related to Demographics and Psycho Pharmacotherapy on Elderly in Nursing Homes

Objectives: To identify the prevalence of neuropsychiatric disorders, especially DP and CD, on a sample of nursing home residents, relating this prevalence with some aspects of the demographics and psycho pharmacotherapy. Methods: 48 elders from two different nursing homes were selected. The collection of demographic and pharmacological data was made utilizing medical records. The medication was classified according to the Anatomical Therapeutic Chemical Code (ATC) criteria. The Geriatric Depression Scale (GDS 30) and the Mini Mental State Examination (MMSE) tests were utilized to determine the prevalence of DP and CD. Results: It was observed in the sample a high incidence of DP and CD among the researched elders. More schooling individuals tend to present less CD. Individuals with less CD indicatives present less symptomatology for DP. Of all the researched elders, 54,2% are submitted to psycho pharmacotherapy. Of all the consumed medicine, 16,5% belonged to the class of neuropsychiatric medicine. The medicated elders present, in average, a larger symptomatology for DP (12 points/average/GDS) than the non-medicated elders (9,9 points/average/GDS). The inverse occurs in relation to the CD indicatives. The use of psychotropics, especially in association, can have negative effects related to depression and cognition. Discussion: The pharmacotherapy, characterized for the polymedication and chronicity, especially of neuropsychiatric medicines, deserves special attention among elders, because the data suggest a significant relation between the utilization of medicines, singly or in association, and the increase of CD and DP. In addition, the data suggest that DP is a risk factor for CD and DM.

Atividade antimicrobiana de plantas medicinais e aromáticas pertencentes à CPMA - Coleção de Plantas Medicinais e Aromáticas do CPQBA - UNICAMP

The increase of the antimicrobial resistance and its propagation around the world are the biggest threats to the public health care and to the treatment of diseases caused by microorganisms. Nowadays the antimicrobial resistance has increased abruptly. The essential oils are volatile and aromatic compounds derived from parts of plants as flowers, leafs, fruits, seeds, roots, sprouts, among others. The activity of extracts and essential oils of several plant species have been recognized and studied by empirical methods since a long time, but its antimicrobial activities were confirmed recently. Medicinal plants are used in folk medicine as medicines, antibiotic, analgesic, sedative and anti-inflammatory. The use of medicinal plants like source of medicines is an alternative of therapeutics for diseases treatment. In Brazil, studies with this goal are very important, once medicinal plants have been used as a choice of treatment and prevention of infections and diseases in health areas. Considering the fact that some products from medicinal plants have antimicrobial properties it is expected that using screening programs, new potential medicaments could be developed. Otherwise, scientific researches focused on determining therapeutic potential of plants are limited, there are lack of scientific studies which confirms the potential antibiotics properties of a large number of plants. The aim of the present study is determinate the antimicrobial activity of 10 medicinal species belonging to CPMA - Collection of Medicinal and Aromatic Plants from CPQBA/UNICAMP. The minimal inhibitory (MIC) and minimal bactericidal or fungicidal concentration (MBC) will be determined against the bacteria Escherichia coli, Pseudomonas aeruginosa, Salmonella choleraesuis, Staphylococcus aureus and the yeast Candida albicans. Furthermore, will be conducted chemical identification and fractionation of essential oils and extract with better activity

Avaliação de fatores preditivos de estresse oxidativo em pessoas saudáveis

Evaluation of predictive factors for oxidative stress in healthy people. This study aimed to evaluate the inÀuence of factors such as smoNing, alcohol consumption, use of medicines, contact Zith chemicals, as Zell as age and gender on marNers of oxidative stress, in healthy subMects. :e checNed the effect of age on the antioxidant capacity, Zith decreased values in older individuals, Zhich may be the cause of increased oxidative stress, associated Zith aging. Regarding the other factors, no differences Zere found in the values of the marNer of lipid peroxidation and the antioxidant capacity.

Perfil da farmacoterapia utilizada por idosos institucionalizados: uma análise dos problemas relacionados ao uso de medicamentos em instituições de longa permanência para idosos

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Sobre a promoção da saúde na contemporaneidade: um desafio ao farmacêutico educador

Pós-graduação em Educação - IBRC

Sports practice is related to parasympathetic activity in adolescents

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Avaliação da termociclagem sobre a estabilidade de cor de diferentes matizes de resina composta

The objective was to evaluate the effect of thermocycling on the color variation of three different composite resins . We studied was Resin Enamel on 3 levels : ( Esthetic X , Opallis and Venus ) ; Resin Dentin in three levels : ( Esthetic X , Opallis and Venus ) and Thermocycling on level 1 : ( 3,000 cycles ) ; variable was the change of color gauged by spectrophotometry . 60 specimens , subdivided into 6 groups were made : GI - Esthetic X Enamel ; GII - Esthetic X dentin ; GIII - Opallis Enamel ; GIV - Opallis dentin ; GV - Enamel and GVI Venus - Venus dentin . The specimens were prepared with a matrix to standardize samples . The inserts of incrementally resins and polymerized with a halogen light Ultralux unit ( Dabi Atlante , Brazil ) with a power of 450mW / cm ² . After fabrication , underwent color reading with a UV Visible Spectrophotometer reflection , UV -2450 ( Shimadzu , Kyoto , Japan ) , with the changes calculated by the system CIE L * a * b * . Then isolates were stored in artificial saliva at 35 ° C ± 2 ° C during 3 months containers being subjected to the effects of thermal cycling for 3000 cycles over the range of 5C to 55C . Again subjected to chromatic evaluation. For the analysis of the results of color change of the studied resins was applied ANOVA two factors at 5 % . The results showed a statistically equal resins enamel GI and GV ( p = 0.79 ) ; the same was not observed for GI and G III resins , where the color change was higher for resin G III ( p = 0.0000002 ) . The same was observed between G III and GV , where the resin enamel G III showed a statistically superior to the color change ( p = 0.0000005 ) Average . Resins to dentin was there a statistical equality between the materials studied . We conclude that the resins studied change in color and resin enamel G III was the most suffered major color changes after aging by thermocycling .

A importância da atenção farmacêutica após a verificação da qualidade microbiológica de medicamentos contendo paracetamol encontrados em algumas residências de Américo Brasiliense - SP

It is known that a high microbial count can compromise the stability of medicines, thus reducing their therapeutic efficacy. This work tried to demonstrate that the microbial contamination can be directly related to the inadequate handling of the medicines stored in homes, making it possible to draw strategies to reduce the possible risks of medical therapy offering correct information and advising. The objective of this work was to evaluate the quality of the medicines containing paracetamol found in the residences of Américo Brasiliense-SP, using the microbial analysis of non-sterile method described in the Brazilian Pharmacopoeia (1988). The medicine samples (30 samples) were obtained directly from the interviewed local residents, who had received new medicine bottles of the same product. An analysis of viable microorganisms (bacteria and fungus) was carried out to identify pathogens found in the collected samples. Although 90% of the analyzed samples have shown some microbial contamination, the results indicated the absence of pathogenic microorganisms, and the total count of viable microorganisms was below the maximum value for non-sterile (104 UFC/g or mL). It was also verified that the local residents stored the medicines in appropriate places, according to the orientations received when they bought the medicines in pharmacies and drugstores, showing the importance of information for the correct use and conservation of pharmaceuticals.

Regulatory issues on pharmacovigilance in Latin American countries

Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use andduring clinical trials. Legal requirements for pharmacovigilance in some Latin American countries (Argentina, Brazil, Chile, Paraguay and Uruguay) were reviewed. Disparities in the legal framework among the countries are observed being those for marketing authorization holders one of the most evident. Theactive rol of the universities and drug information centers for/of pharmacovilance seems to be a positivecommon point. Legal requirements regarding pharmacovigilance of biosimilar medicines, is still a pointto be developed.

Acesso, segurança e uso de medicamentos por usuários

The present study aims to identify families who have stock and are making use of medications, as well as assess the conditions of storage, security and use of these drugs. The study was conducted in a city of São Paulo, the interviews were conducted in households enrolled in one of ten units of the Estratégia de Saúde da Família (ESF) that the city provides and the sample was defined by means of stratified random sampling (134households, IC 95%). Data collection was conducted through interviews with a semistructured questionnaire during the first half of 2011. We interviewed 118 (88.0%) households, of which 112 (95.0%) had medications that were stored n insecure or inadequate places in 75.4% of households, non-prescription self-medication was a common practice in 46 (47 4%) households, and lack of identification and security of medications stored was observed in 60 (53.6%) households. Most households had stock of medicines, which were done improperly or unsecure, or have specialties with lack of identification and security, which can lead to poisoning or e ineffective therapy. The Pharmaceutical Assistance under SUS lacks social initiatives, with actions directed for medications users, which can be supplied by the presence of the pharmacist in the ESF, essential for the promotion of racional use of medicines, that, through the Pharmaceutical Care, can identify, correct and prevent possible problems related to drugs.

Tempos de barbante: declínio e revitalização da literatura de cordel. Da Primeira República à contemporaneidade

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)