O contributo do farmacovigilância para o uso racional do medicamento e o papel do farmacêutico

O âmbito deste trabalho reside no contributo da Farmacovigilância para um Uso Racional do Medicamento, focando o relevante papel do farmacêutico nestes dois campos. A Farmacovigilância tem uma actuação a nível mundial, com um objectivo bem claro, o uso seguro do medicamento. Tem-se verificado uma evolução ao longo dos séculos, tendo sido a ocorrência de tragédias o impulso para a implementação de Sistemas de Farmacovigilância, a tragédia que ocorreu com a administração de talidomida a mulheres grávidas foi um dos grandes marcos para a criação do Sistema Internacional de Farmacovigilância. A Reacção Adversa a Medicamento(s) (RAM) é uma consequência do risco subjacente à utilização de fármacos, estando por isso a Notificação Espontânea (NE) de RAMs na base da Farmacovigilância. Todos os que contactam com tratamentos terapêuticos devem notificar, falamos portanto de profissionais de saúde, da indústria e dos utentes. Não menosprezando qualquer efeito adverso que decorra da utilização de um medicamento, deve-se notificar todas as RAMs estando elas já reconhecidas ou não. O Uso Racional do Medicamento pressupõe a intervenção do médico, do farmacêutico e do utente, havendo o objectivo bem claro através de várias medidas implementadas e do apoio dos Estudos de Utilização de Medicamentos (EUM) de uma prescrição, uma dispensa e um uso correctos. O farmacêutico é parte activa da Farmacovigilância e do Uso Racional do Medicamento. O farmacêutico tem contacto não só com a prescrição como com a dispensa e com o evoluir do tratamento terapêutico, sendo portanto um monitorizador. Devido à proximidade do dia-a-dia entre farmacêutico e doente cabe a este profissional de saúde educar para um uso correcto e seguro do medicamento, transmitindo sempre um elevado nível de confiança e fiabilidade.

A influência da personalização dos serviços na satisfação do consumidor de remédios de uso contínuo nas farmácias do município de Vila Velha - ES

Este estudo procura identificar como o marketing de personalização pode ser desenvolvido, quais suas vantagens e quais os cuidados a serem tomados antes de seu uso. Analisa até que ponto a personalização gera satisfação a consumidores de medicamentos de uso contínuo em farmácias do município de Vila Velha, ES. Para a obtenção dos dados, faz uso de uma pesquisa bibliográfica e, em seguida, de uma pesquisa de campo, que envolve uma amostra de 90 sujeitos, selecionados intencionalmente por meio de abordagem técnica nãoprobabilística. Coleta os dados sobre esses sujeitos por meio de uma entrevista. Mostra os resultados de maneira descritiva, analisando-os à luz do estudo teórico feito. Conclui que a personalização de atendimento, neste caso, geraria satisfação e/ou o aumento considerável do grau de satisfação já existente.

Estratégia institucional no contexto empresarial : o setor farmacêutico e a regulamentação dos medicamentos genéricos no Brasil

Este trabalho procurou desenvolver o conceito de estratégia institucional, ilustrando sua aplicação no contexto específico da disputa de mercado pelas empresas farmacêuticas por ocasião da regulamentação dos medicamentos genéricos no Brasil. Estratégia institucional implica uma compreensão combinada das facetas técnica e institucional do ambiente e das organizações, e o reconhecimento da condição e das possibilidades de agência como socialmente construídas, sendo pertinente e relevante para aqueles que desejam formular e executar estratégias empresariais. O conceito apóia-se em elementos amplamente discutidos em Teoria Institucional em estudos organizacionais, porém negligenciados nas abordagens predominantes no campo da Estratégia Empresarial, ancoradas em pressupostos da economia neoclássica. Através de análise documental e análise de conteúdo, em perspectiva longitudinal, buscou-se caracterizar estratégias institucionais empregadas pelos laboratórios farmacêuticos, verificando-se a influência que tiveram sobre a regulamentação do setor, e o conseqüente impacto sobre o desempenho econômico das empresas. Os resultados encontrados, em linha com o referencial teórico desenvolvido, sugerem que as empresas empreenderam manobras institucionais, influenciando mudanças nas ¿regras do jogo¿ ou fazendo uso delas para obter ou manter fontes de rendas econômicas, restringidas pela condição de legitimidade que lhes foi atribuída pelos outros atores. Diversas mudanças na regulamentação puderam ser associadas às manobras estratégicas, e o impacto do novo arranjo institucional sobre o desempenho das empresas pode ser observado. O estudo aponta a necessidade de incorporação de novos elementos aos processos e análises convencionais de estratégia de empresas, notadamente uma reflexão crítica sobre as pressões institucionais e a avaliação de respostas estratégicas que possam ser percebidas como legítimas pelos outros atores sociais envolvidos.

Estoque domiciliar de medicamentos na comunidade ibiaense acompanhada pelo Programa Saúde da Família

É grande o uso e a disponibilidade de medicamentos no meio doméstico. Um estoque domiciliar de medicamentos pode influenciar nos hábitos de consumo dos moradores, favorecendo a automedicação e a reutilização de prescrições. Este estudo objetivou estudar o estoque de medicamentos na comunidade Ibiaense acompanhada pelo Programa Saúde da Família (PSF). Buscou-se descrever as características dos usuários, as condições de armazenamento, as classes terapêuticas e formas farmacêuticas, a procedência dos medicamentos e o custo dos medicamentos provenientes do Sistema Público de Saúde. Foram visitados 285 domicílios, no período de julho a setembro de 2004. Verificou-se que a média de medicamentos por domicílio foi de 8,4 e que 93,5% das famílias entrevistadas apresentaram pelo menos um medicamento em estoque. Os medicamentos estocados em maior número foram: analgésicos (11,15%), seguidos dos diuréticos (6,42%), antibacterianos para uso sistêmico (5,82%), antiinflamatórios (5,08%) e os antiácidos (4,10%). Embora seja considerável o número de medicamentos estocados nos domicílios, foi pequeno o número de medicamentos sem prescrição médica procedentes do Sistema Público de Saúde , sendo este um reflexo favorável dos serviços de Assistência Farmacêutica do Município. Por outro lado, foi verificado um elevado percentual de medicamentos adquiridos em farmácias sem a devida prescrição médica, 41,6%. Este percentual sugere uma inserção de medicamentos adquiridos por automedicação. Foi encontrado um percentual de 18,5% de medicamentos vencidos. O estoque domiciliar resulta de prescrições com quantidades superiores ao necessário para o tratamento (20%) , não cumprimento do tratamento prescrito (17%), aquisição por conta própria (9%) no Sistema Público de Saúde. O estudo sugere a necessidade de orientação dos usuários em relação a utilização e armazenamento dos medicamentos, de sistematização dos registros de dados com perspectiva de auxílio na gestão dos recursos, além de oferecer subsídios para adoção de decisões vinculadas ao processo de planejamento e execução das ações na Assistência Farmacêutica.

Estudo da qualidade da informação constante nas bulas dos principais medicamentos fitoterápicos registrados no Brasil

Os objetivos deste trabalho foram: fazer um levantamento das dez espécies vegetais que compõem o maior número de apresentações farmacêuticas de fitoterápicos simples registradas na ANVISA; realizar o diagnóstico da oferta e da qualidade das informações contidas nas bulas das apresentações contendo as cinco espécies vegetais mais utilizadas; e definir as informações técnicas que devem estar contidas na bula de especialidades farmacêuticas que contenham como ingredientes ativos unicamente extratos preparados a partir destas espécies. O levantamento das dez espécies vegetais abrangeu o período de 01/01/1998 a 30/06/2003 e foi realizado através de consulta ao OPTLINE (www.i-helps.com). Os medicamentos fitoterápicos representam 7,76% (1888) das apresentações de registro de medicamentos no Brasil, sendo 1311 (5,38 %) apresentações de medicamentos fitoterápicos simples. Cinqüenta e oito espécies vegetais constituíam os registros de medicamentos fitoterápicos simples, sendo as dez com maior número de apresentações Ginkgo biloba L.: 302 (23,04%); Hypericum perforatum L.: 126 (9,61%); Piper methysticum F.: 87 (6,64%); Cimicifuga racemosa Nutt: 79 (6,03%); Valeriana officinalis L.: 76 (5,80%); Vitis vinifera L.: 69 (5,26%); Echinacea purpurea L.: 58 (4,42%); Aesculus hippocastanum L.: 53 (4,04%); Panax ginseng C. A Mayer: 48 (3,66%) e Cynara scolymus L.: 31 (2,36%). O diagnóstico da oferta e da qualidade das informações contidas nos textos das bulas foi realizado comparando-se estas informações com aquelas apresentadas na base de dados Medline (PubMed - www.ncbi.nhm.nhi.gov) dos últimos 5 anos e em obras bibliográficas de referência aceitas pela ANVISA, além de outras, clássicas na área de farmacognosia e fitoterapia . Foram avaliadas vinte e oito bulas. As informações de todas as bulas apresentavam incompatibilidades com as informações da literatura consultada. Os problemas mais freqüentemente encontrados foram relativos à sinonímia popular, eficácia, via de administração, contra-indicações, uso em idosos, crianças e grupos de risco, reações adversas e interações medicamentosas. Para cada uma das cinco espécies mais citadas, as informações científicas e técnicas compiladas foram organizadas como uma proposta de bula para o Profissional de Saúde a ser incluída no Compêndio de Bulas de Medicamentos (CBM), conforme previsto na Resolução-RDC nº 140/03, o qual consiste em um conjunto de bulas de medicamentos comercializados, editado pelo órgão regulador e com conteúdo da bula para o paciente e da bula para o profissional de saúde.

Concorrência e acesso a medicamentos: evergreening em perspectiva comparada

Este trabalho estuda o fenômeno do evergreening, definido como o uso de patenteamento secundário para a obtenção de extensão indevida na proteção patentária sobre uma criação, sob a perspectiva do direito da concorrência no Brasil, União Europeia, Estados Unidos e Índia. Baseia-se em suas experiências com esta prática para determinar a aplicabilidade do direito da concorrência brasileiro e mais alternativas institucionais para abordar o problema.

Centro de Informação sobre Medicamentos - CIM: avaliação da informação prestada

Providing information about medication, an essential function of pharmaceutical practice to ensure rational drug use, is an important activity of hospital pharmacy services. The Drug Information Center of Onofre Lopes University Hospital (DIC-HUOL) initiated its activities in 1979 with the first Clinical Pharmacy Service in Brazil. The aim of this study was to assess information provided by DIC-HUOL, describing the profile of passive information offered by the center. A retrospective cross-sectional study was conducted to identify the profile of information requests (IR). One hundred percent of the IR received by the DIC between January 2008 and December 2009 were used. The results were divided by year to determine the influence of the restructuring process that occurred in 2008 and 2009. The study at DIC-HUOL showed a mean of 5.5 IR/month in 2008 and 20.3 IR/month in 2009; the mean of the last year is comparable to that of other Brazilian DIC. Most of the IR were made by medical residents (22.7%) in 2008 and by pharmacists (32.5%) in 2009. The significant use of the DIC by medical residents may be due to its location in a university hospital. The most recurrent types of IR concerned issues related to pathway/mode of administration (16.8%) and drug stability (13.1%) in 2008 and 2009, respectively. Requests were made verbally in 100% of the cases in 2008 and 78.8% in 2009, owing to the fact that most of the DIC users were professionals from the hospital itself. Time elapsed between request and response was not reported in 83.3% and 21.3% of the cases in 2008 and 2009, respectively. The most widely used bibliographic source during the two years was MICROMEDEX®, with 41.9% and 39.2%, respectively. The restructuring process had a positive influence on the DIC-HUOL, exhibiting similar parameters to those of other Brazilian DIC, but some of these parameters must be improved to achieve international standards

Investigação farmacoepidemiológica do uso do clonazepam no distrito sanitário leste em Natal-RN

Prescription errors are the most serious type of medication errors found in the health system. The main purpose of this study was to evaluate the quality of clonazepam prescriptions. A descriptive and observational study with retrospective data collection was conducted at 30 community pharmacies in Natal/RN, Brazil, after informed consent was obtained from the pharmacists. A sample of 313 prescription notifications was randomly collected in October 2009. They were analyzed for legible handwriting and completeness. During the study, one researcher, two pharmacists, and one pharmacy undergraduate student evaluated patient and purchaser identification, pharmaceutical form, dosing regimen, administration route, and prescription by generic name. This research was approved by the institutional Ethics Committee. Among the 313 collected notifications, only 44.1% were legible. A total of 55.91% (175/313) had at least one illegible item, 100% contained incomplete information, and 97.12% (304/313) contained one or more abbreviations. The proportion of illegible handwriting related to the patient s identification (p=0.0001) was statistically significantly greater than that related to the drug purchaser s identification (p=0.0004). Contrary to legal requirements, prescriptions with the generic name accounted for 13.42% (42/313) of the total. All the examined notifications were handwritten. Prescription errors, which potentially can have serious consequences, have been evaluated worldwide, although little is known about this subject as it relates to community pharmacies. This study showed high percentages of prescribing problems, which justifies the development of future research about medication errors in community pharmacies and education activities for prescribers

Avaliação da publicidade de medicamentos veiculada nas principais emissoras de rádio de Natal-RN

Drugs advertising is one of the most important marketing resources used by the pharmaceutical industry to induce people to buy these products although they do not have the real necessity to use them. The purpose of this article is to evaluate drugs advertisings transmitted on radio stations in Natal/RN, from October 2007 to September 2008. Were collected 228 advertising pieces, where, 21 were different among themselves and corresponded to 15 drugs. The results showed that 73,3% of the drugs ads were announced on AM station and 26,7% on FM station. The majority of the drugs were constituted of analgesics (26%), following by antiacids, vitamins, phitotherapics (13% each). The legal analysis showed that each advertising had some kind of infraction. The omission of the registration number happened in each advertising, following by the totally lack of contraindications (95,2%) and contraindications DCB/DCI (76,2%). In 42,9% advertisements were observed the relation between drugs use and physique/intellectual/emotional/sexual performance and/or beauty and 33% of them had abusive exploration of illnesses. The obligatory warning was omitted in 28,6% and the offer of financial bonus happened in 9,5% cases. The content analysis demonstrated that the most persuasion and convincing elements observed were indicatives of consumption appeal (34,2%). The study indicates the necessity of the topic drugs advertisements to be treated in a wide context, that is, to be discussed as a public health concern. Although the advertising regulation and inspection is the State responsibility , this should be shared with the advertising agency, pharmaceutical industry and media. Furthermore, it is indispensable to inform and to conscience the population of their rights in such mistaken situation

Desenvolvimento de emulsões contendo óleos vegetais para uso cosmético

The fat acid esters and tocopherolic derivatives are of great economic interest in many industries. The sunflower oil, which had its rich constitution in these composites, is a very interesting raw material source for the job in some sectors as bio-carburants, bio-lubrificants, bio-surfactants, dispersing agents, food industries, medicines and cosmetics. A system emulsified steady from this oil can wide be used in the therapeutical one, therefore it is of easy acceptance for the patient, for being pharmaceutical forms that allow a better medicine administration. The chemical composition characteristics, rich in unsaturad fat acid and tocopherolic derivatives, the sunflower oil, make of the emulsified systems contend this oil a proposal promising for formularizations of pharmaceutical and cosmetic use with antirust and photoprotection. The general objective of this work was to apply the HLB beddings to determine the sunflower oil critical HLB and, from this, to be able to evaluate the ideal mixture of the constituent of this system through the study of the ternary diagrams for the determination of the ratio of constituent that will generate the emulsion most steady

A propaganda de medicamentos voltados à clínica obstétrica e/ou ginecológica e sua influência sobre a prescrição

INTRODUCTION: Drug advertisement stimulates self-medication and irrational use of medicines, especially when it starts to interfere in the prescription. Monitoring advertisements, as well as the observation of its influence on health professionals, prescriptions become necessary because of this public health problem. OBJECTIVE: The aim of this work was to analyze drug advertisements directed to gynecologists and/or obstetricians doctors relating them to the current legislation as well as its influence on prescription. METHODOLOGY: The sample was composed of drug advertisements divulged to the gynecologists and / or obstetricians doctors and was analyzed according to RDC96/2008. To evaluate the influence of advertisement on prescription, a questionnaire was administered to gynecologists / obstetricians doctors and prescriptions of a public maternity were also evaluated. RESULTS AND CONCLUSION: Concerning the advertisements analyzed, 48% complied fully with current legislation and 52% of the advertisements analyzed were in accordance to the RDC No. 96/2008 in most of the items evaluated. The doctors interviewed are used to receive the visits of propagandists, even in the public service, receiving gifts offered by the industry and believe that medicine advertisement tries to influence prescribing. Many of them use the material provided by the propagandist as a source for their prescription, although they present a critical view about them information. The use of trade name / mark on the prescription is a common practice among the doctors interviewed, even in the public service, suggesting there is an influence of medicine advertisement on the prescription

Avaliação da argila atapulgita para potencial uso como excipiente farmacêutico em formas sólidas

Clays are natural materials that have great potential for use as excipients for solid dosage forms. Palygorskite is a type of clay that has hydrophilic properties as well as a large surface area, which could contribute to the dissolution of drugs. Thus, the present study aims to evaluate the use of palygorskite clay, from Piaui (Northeast region of Brazil), as a pharmaceutical excipient for solid dosage forms, using rifampicin and isoniazid as the model drugs. The former is a poorly soluble drug often associated with isoniazid for tuberculosis treatment. Palygorskite was characterized by X-ray diffraction (XRD), X-ray fluorescence (XRF), particle size, transmission electron microscopy (TEM), scanning electron microscopy (SEM) and specific surface area (BET). The rheological and technological properties of palygorskite were determined and compared to those of talc, magnesium stearate and Aersosil 200. Mixtures between drugs and palygorskite were analyzed by differential scanning calorimetry (DSC), thermogravimetric analysis (TG) combined with thermal analysis (DTA) and Fourier Transform Infrared Spectroscopy (FT-IR), where the results were compared with those of the individual compounds. In addition, dissolution studies of solid dispersions and capsules containing the drugs, mixed with either palygorskite or a mixture of talc and magnesium stearate, were performed. The results showed that palygorskite has small particles with a high surface area. Its rheological characteristics were better than those of others commonly used glidants and lubricants. There was no interaction between palygorskite and the drugs (rifampicin and isoniazid). Among the dispersions studied, the mixture with palygorskite (5%) showed the highest drug dissolution when compared to other excipients. The dissolution of the rifampicin capsules containing palygosrkite was faster in higher concentrations. However, these differences were statistically different only in the first minutes of the dissolution experiment. The dissolution profile of isoniazid was also statistically different on the initial part of the experiment. The formulations prepared with isoniazid and palygorskite showed higher drug dissolution, but it was in descending order of concentration. According to these results, the palygorskite clay used in this study has great potential for application as an excipient for solid dosage forms

O direito à saúde e a política nacional de atenção oncológica: uma análise a partir da crescente judicialização dos medicamentos antineoplásicos

The 1988 Federal Constitution of Brazil by presenting the catalog of fundamental rights and guarantees (Title II) provides expressly that such rights reach the social, economic and cultural rights (art. 6 of CF/88) as a means not only to ratify the civil and political rights, but also to make them effective and practical in the life of the Brazilian people, particularly in the prediction of immediate application of those rights and guarantees. In this sense, health goes through condition of universal right and duty of the State, which should be guaranteed by social and economic policies aimed at reducing the risk of disease and other hazards, in addition to ensuring universal and equal access to actions and services for its promotion, protection and recovery (Article 196 by CF/88). Achieving the purposes aimed by the constituent to the area of health is the great challenge that requires the Health System and its managers. To this end, several policies have been structured in an attempt to establish actions and services for the promotion, protection and rehabilitation of diseases and disorders to health. In the mid-90s, in order to meet the guidelines and principles established by the SUS, it was established the Política Nacional de Atenção Oncológica PNAO, in an attempt to sketch out a public policy that sought to achieve maximum efficiency and to be able to give answers integral to effective care for patients with cancer, with emphasis on prevention, early detection, diagnosis, treatment, rehabilitation and palliative care. However, many lawsuits have been proposed with applications for anticancer drugs. These actions have become very complex, both in the procedural aspects and in all material ones, especially due to the highcost drugs more requested these demands, as well as need to be buoyed by the scientific evidence of these drugs in relation to proposed treatments. The jurisprudence in this area, although the orientations as outlined by the Parliament of Supreme Court is still in the process of construction, this study is thus placed in the perspective of contributing to the effective and efficient adjudication in these actions, with focus on achieving the fundamental social rights. Given this scenario and using research explanatory literature and documents were examined 108 lawsuits pending in the Federal Court in Rio Grande do Norte, trying to identify the organs of the Judiciary behave in the face of lawsuits that seeking oncology drugs (or antineoplastic), seeking to reconcile the principles and constitutional laws and infra constitutional involving the theme in an attempt to contribute to a rationalization of this judicial practice. Finally, considering the Rational Use of health demands and the idea of belonging to the Brazilian people SUS, it is concluded that the judicial power requires ballast parameters of their decisions on evidence-based medicine, aligning these decisions housing constitutional principles that the right to health and the scientific conclusions of efficacy, effectiveness and efficiency in oncology drugs, when compared to the treatments offered by SUS

Identificação Visual de Caixas de Medicamentos Usando Features Correspondentes

This work uses computer vision algorithms related to features in the identification of medicine boxes for the visually impaired. The system is for people who have a disease that compromises his vision, hindering the identification of the correct medicine to be ingested. We use the camera, available in several popular devices such as computers, televisions and phones, to identify the box of the correct medicine and audio through the image, showing the poor information about the medication, such: as the dosage, indication and contraindications of the medication. We utilize a model of object detection using algorithms to identify the features in the boxes of drugs and playing the audio at the time of detection of feauteres in those boxes. Experiments carried out with 15 people show that where 93 % think that the system is useful and very helpful in identifying drugs for boxes. So, it is necessary to make use of this technology to help several people with visual impairments to take the right medicine, at the time indicated in advance by the physician

Gestão de estoques: uma proposta de reposição contínua para material médico hospitalar e medicamentos em um hospital universitário federal do estado do Rio Grande do Norte

The inventory management in hospitals is of paramount importance, since the supply materials and drugs interruption can cause irreparable damage to human lives while excess inventories involves immobilization of capital. Hospitals should use techniques of inventory management to perform replenishment in shorter and shorter intervals, in order to reduce inventories and fixed assets and meet citizens requirements properly. The inventory management can be an even bigger problem for public hospitals, which have restrictions on the use of resources and decisionmaking structure more bureaucratized. Currently the University Hospital Onofre Lopes (HUOL) uses a periodic replacement policy for hospital medical supplies and medicines, which involves one moment surplus stock replenishment, the next out of stock items. This study aims to propose a system for continuous replenishment through order point for inventory of medical supplies and medicines to the hospital HUOL. Therefore, a literature review of Federal University Hospitals Management, Logistics, Inventory Management and Replenishment System in Hospitals was performed, emphasizing the demand forecast, classification or ABC curve and order point system. And also, policies of inventory management and the current proposal were described, dealing with profile of the mentioned institution, the current policy of inventory management and simulation for continuous replenishment order point. For the simulation, the sample consisted of 102 and 44 items of medical and hospital drugs, respectively, selected using the ABC classification of inventory, prioritizing items of Class A, which contains the most relevant items in added value, representing 80 % of the financial value in 2012 fiscal year. Considering that it is a public organization, subject to the laws, we performed two simulations: the first, following the signs for inventory management of Instruction No. 205 (IN 205 ), from Secretary of Public Administration of the Presidency ( SEDAP / PR ), and the second, based on the literature specializing in inventory management hospital. The results of two simulations were compared to the current policy of replenishment system. Among these results are: an indication that the system for continuous replenishment reorder point based on IN 205 provides lower levels of safety stock and maximum stock, enables a 17% reduction in the amount spent for the full replenishment of inventories, in other words, decreasing capital assets, as well as reduction in stock quantity, also the simulation made from the literature has indicated parameters that prevent the application of this technique to all items of the sample. Hence, a change in inventory management of HUOL, with the application of the continuous replenishment according to IN 205, provides a significant reduction in acquisition costs of medical and hospital medicine