Análise da utilização do registro nacional de preços de medicamentos como instrumento para aumento da oferta de medicamentos no Sistema Único de Saúde

Trata-se de uma pesquisa avaliativa, que tem como objetivo a análise do Registro Nacional de Preços - RNP, para compras de medicamentos e insumos médicohospitalares do Ministério da Saúde. Esse sistema permite a utilização via eletrônica pelos gestores estaduais e municipais. O período avaliado compreende os anos de 2001 e 2002. Como fonte, foi utilizado um modelo lógico para avaliação de programas de saúde do Center for Disease Control and Prevention – dos Estados Unidos da América. Uma base de dados foi especialmente elaborada a partir dos processos de licitação do RNP e dos registros de aquisição medicamentos disponíveis no Departamento de Programas Estratégicos do Ministério da Saúde. Os eixos principais da avaliação foram os tempos dos trâmites burocráticos dos processos; as aquisições realizadas pelos gestores municipais, estaduais e federais através do sistema; os recursos financeiros envolvidos nas compras e disponibilizados pelo estado para a atenção básica e a viabilidade econômica dos preços obtidos nos medicamentos registrados em comparação com as fontes disponíveis no mercado. Os resultados evidenciaram morosidade no processo administrativo com prejuízo à disponibilidade dos produtos no sistema em tempo ideal e baixa adesão na utilização do RNP para aquisição de medicamentos, evidenciando-se a desarticulação do gestor federal, estadual e municipal. A movimentação financeira de estados e municípios foi baixa se comparada com os recursos circulantes no período provenientes do Incentivo à Assistência Farmacêutica – IAFB e outros. Os preços unitários de um grupo de medicamentos obtidos através do RNP comparados com: os preços dos laboratórios estatais; outras licitações dos gestores estaduais e municipais; fornecedores privados e valores da prestação de contas municipais dos recursos do IAFB, mostraram-se muito competitivos reforçando a viabilidade financeira do programa. Contraditoriamente, o RNP apresenta deficiências e algumas falhas de base como lentidão, burocracia, baixa adesão, pouca publicidade, associada a excelências como a tecnologia, pois todo o sistema é informatizado e possui recursos financeiros disponíveis na área estatal com preços competitivos em todos os segmentos do mercado.

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

Análise Microbiológica de Embalagens para o Acondicionamento de Medicamentos e Cosméticos

Microbiological Control of Packaging Materials for Medicines and Cosmetics. Several consumers and official agencies, associated with the necessity of more efficient, safety and good microbiological quality packaging materials, conducted to the challenge of having packages which assure both the integrity of products and consumer's health. However, the packaging material can be an important source of microorganisms when does not fulfill the microbiological quality requirements. The objective of this work was to study the microbiological quality of different types of packaging materials for medicines and cosmetics. The microbial quality studies were conducted by analyzing representative samples by bioassay. The packing materials were analyzed for microbiological quality to verify presence of viable microorganisms. They showed the analyzed packaging materials for medicines are in agreement with RDC # 481 on 23/9/1999 of ANVISA. However, the packages to store cosmetic material are not fulfilling this RDC. The microbiological quality control of packing materials has fundamental importance for public health.

A intervenção do poder judiciário no acesso a medicamentos no Rio Grande do Norte: uma análise sob a ótica das políticas nacionais de medicamento e de assistência farmacêutica

The present study aimed to evaluate the inclusion of the principles of the National Medicines Policy - PNM and the Pharmaceutical assistance - PNAF in the prosecution of lawsuits involving medicines. To fulfill this necessity , data collection was performed on the website by the Tribunal Rio Grande do Norte - TJ RN ( Rio Grande do Norte Court) , in 2012 . It was obtained 115 judgments, which were analyzed in order to generate Monitoring Indicators from lawsuits and conduct content analysis proposed by Bardin (2006). The results showed that : a) 100 % of the decisions were favorable to the author , b) 76 % of decisions were requests by the trade name of the drug , c) only one drug (eculizumabe) had not granted by ANVISA , d) 36 % of drugs were present in the list of standard medicines in SUS , 16 % of primary care block and 20 % of specialized component , e) 76 % of the decisions presented the request of at least 01 non-standard medicine. With regard to decentralization of PNM and PNAF we observed a commitment to this principle at judicial decisions, to see that municipalities and states are often forced to buy medicines of responsibility from another federal entity or other tertiary units as CACONs and UNACONS. The content analysis revealed that the argument from the judges used when you utter their decisions was that the right to health is recognized by Brazilian law as a fundamental right and should be guaranteed by the State for all its citizens. So, health is more than budgetary constraints of federal entities, which are severally liable for lawsuits , regardless the medication requested belongs or not to a particular block of a pharmaceutical assistance funding. Given these data, it is observed that there are gaps in the judgment when it comes to the insertion of the words and principles of PNM and PNAF, creating then the need for greater dialogue between the executive and judicial, so that they may consider relevant the effectiveness and application of such principles to minimize the negative consequences of the phenomenon of health judicialisation. Keywords: Judicialisation, Medicines, Public Policy, Pharmaceutical Care

Desenvolvimento de metodologia simplificada para análise de hexametilenotetramina (hmt) em medicamentos contendo corantes em sua formulação

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

Análise do conteúdo de propagandas de medicamentos psicoativos

O objetivo do estudo foi descrever as figuras humanas retratadas nas propagandas de medicamentos psicoativos quanto ao gênero, a idade, a etnia e o contexto social. Foi realizada análise de conteúdo de 86 impressos publicitários inéditos divulgados em Araraquara (SP) no ano de 2005. A associação entre as categorias foi analisada usando o teste exato de Fisher. Houve predomínio de mulheres (62,8%), sendo quatro vezes mais freqüentes que os homens em propagandas de antidepressivos e ansiolíticos. A maioria era constituída de jovens adultos (72%), de etnia branca (98,8%). As pessoas estavam em lazer (46,5%), em suas casas (29%) ou em contato com a natureza (16,2%). A mensagem transmitida foi que os medicamentos tratam sintomatologias subjetivas de desconforto do dia-a-dia, induzindo a um apelo irracional que pode refletir na prescrição medicamentosa.

Análise retrospectiva da toxicidade de gotas otológicas, medicamentos tópicos nasais e orofaríngeos registrada na Grande São Paulo.

BACKGROUND: Retrospective analysis of human toxicity files involving topical medicines for treatment of upper airways diseases (eardrops, topical nasal medicines, lozenges, drops and sprays for oropharyngeal affections). METHODS: Thirty-four brands of eardrops, 48 of topical nasal medicines and 22 of tablets, lozenges and sprays for oropharyngeal affections were selected, from a total of 104 products available in Brazil. We analyzed the registries in the electronic database from the Poison Control Centre of São Paulo (CCI-Jabaquara), Brazil, for the period from January 1996 through December 2000. The cases related to selected pharmaceuticals were collected. RESULTS: 10,823 cases of human toxicity caused by medicines were voluntarily reported to CCI-Jabaquara. Topical medicines for treatment of upper airways diseases accounted for 291 cases (2.68%), from which 240 (82.5%) represented poisoning; 12 (4.1%) involved ear drops, 268 (92%), topical nasal medicines and 11 (3.9%), topical medicines for oropharyngeal affections. Among topical nasal medicines, vasoconstrictors predominated (233 cases), and among medicines for oropharyngeal affections, it was tetracaine (four cases). Considering age distribution, toxicity predominated significantly in children aged from 1 to 4 years (p=0.0003). The main causes of toxicity were: accidental intake of medicines (43%) and error in drug administration (14.8%). Hypereflexia and vomiting were the most frequent symptoms related to toxicity. CONCLUSIONS: There was significant incidence of systemic toxicity due to eardrops, topical nasal and oropharyngeal medicines in children 1 to 4 years-old, whose main cause was accidental intake of these medicines.

Estudo da bula de medicamentos: Uma análise da situação

This study was carried out in the city of Araraquara (SP, Brazil), where 1829 people selected randomly from 42 districts were interviewed with regard to their use of medicines, in particular whether and how they read the insert information sheet and the most frequently read items and problems encountered in the text. Surveys were performed in two stages, the first when package inserts were regulated in Brazil by Portaria SVS 110/1997 (Ministry of Health directive) and the second after the new regulation (RDC 140/2003) came into force. Out of 1829 people interviewed, 1597 reported using some medicine. The markedly similar results in both stages of the research pointed to the difficulties encounteved in reading the package inserts, due to the small letters, the obscure language and the massive amount of information. This paper shows that package inserts of medicines need to be simpler, so the patients have an idea of the importance of the medicine and are able to realize soon any problem that might appear due to the use of the medicine and what action they should take. Furthermore, it will be helpful to the evaluation of the package inserts of medicines, elaborated in conformity with RDC 140, if they work effectively as a source of information and guidance for the patient are not simply given a new layout, while maintaining items that impede their understanding and use.

Propagandas de medicamentos psicoativos: Análise das informações científicas

Objective: According to the World Health Organization, medicinal drug promotion should be reliable, accurate, truthful, informative, balanced, up-to-date and capable of substantiation. The objective of the present study was to review psychoactive drug advertisements to physicians as for information consistency with the related references and accessibility of the cited references. Methods: Data was collected in the city of Araraquara, Southeastern Brazil, in 2005. There were collected and reviewed 152 drug advertisements, a total of 304 references. References were requested directly from pharmaceutical companies' customer services and searched in UNESP (Ibict, Athenas) and BIREME (SciELO, PubMed, free-access indexed journals) library network and CAPES journals. Advertisement statements were checked against references using content analysis. Results: Of all references cited in the advertisements studied, 66.7% were accessed. Of 639 promotional statements identified, 346 (54%) were analyzed. The analysis showed that 67.7% of promotional statements in the advertisements were consistent with their references, while the remaining was either partially consistent or inconsistent. Of the material analyzed, an average 2.5 (1-28) references was cited per advertisement. In the text body, there were identified 639 pieces of information clearly associated with at least one cited reference (average 3.5 pieces of information per advertisement). Conclusion: The study results evidenced difficult access to the references. Messages on efficacy, safety and cost, among others, are not always supported by scientific studies. There is a need for regulation changes and effective monitoring of drug promotional materials.

Análise da prescrição de medicamentos de pacientes hipertensos atendidos pelo SUS da rede municipal de saúde de Rincão - SP

The purpose of this study was to identify the drugs most often prescribed for hypertension at the Municipal Health Care Center of the town of Rincäo, State of São Paulo, Brazil, and the principal interactions arising from their association with other drugs, both anti-hypertensives and those in other classes. The study included 725 hypertensive patients registered at this health care center who were regularly seen by a physician every three months. Data were collected on age, sex, occurrence of diabetes, smoking, sedentary lifestyle and overweight, to obtain a profile of the hypertensive population of the area. Control records of all patients were available at the pharmacy in the health care center, where patients obtained their drugs once a month. Of the 725 patients, 38% were male and 62% female. Most (57%) were between 50 and 70 years of age, 21% used tobacco and 43% led a sedentary lifestyle. Single-drug therapy accounted for 33% of the prescriptions, multidrug therapy for 66%. In addition to anti-hypertensives, 50% of the patients took drugs of other therapeutic classes. Of those receiving multidrug therapy, 34% used three or more anti-hypertensives and 66% used only two of these drugs. Drug interactions were detected in as many as 47% of the prescriptions. Captopril was the drug that showed most interactions with others (54%), followed by hydrochlorothiazide (27%), furosemide (14%), propanolol (4%), and nifedipine (1%). The analysis revealed that drug consumption by the patients investigated is high, with a concomitantly high number of episodes of drug interaction.

Análise dos aspectos legais das prescrições de medicamentos

This article describes a survey of prescriptions dispensed in drugstores and pharmacies in the city of Araraquara in the state of São Paulo, Brazil, in May 2006. Their contents were assessed for compliance with the laws in force on drug prescription and dispensing. A total of 1,335 prescriptions were examined: 40 (3%) were unsigned, 212 (15.9%) did not contain the prescribing physician's stamp, 170 (12.7%) were undated. There were prescriptions containing corrections (4.6%), and written in code (4.4%). Only 58.8% were legible and easy to understand; nevertheless all of them were dispensed. Some did not specify the name of the patient (7.2%). On how to use the medication prescribed, not a single prescription contained all the information required by law. Specifically, 7.6% lacked information on dosage, 54.3% on presentation, 33.6% on how to take the drug, and 51.2% on duration of treatment. The data show a general failure to comply with the laws on drug prescription and dispensing. Incomplete information on the drugs and their correct use could lead to irrational use and errors in medication. The lack of prescribers' signature and stamp, date of emission and name of patient can lead to fraudulent and counterfeit prescriptions. Thus, the data found point to the need for capacitation of prescribing and dispensing professionals and the importance of the role of professional associations in guiding their members.

Análise das propagandas dos medicamentos isentos de prescrição veiculadas em revistas para prescritores na área médica

This article presents an analysis of the quality of advertisements for over-the-counter (OTC) drugs addressed to the medical profession, based on the new Anvisa resolution RDC 96 (17/12/2008). For this analysis, 16 volumes of the Brazilian Journal of Medicine (RBM) were collected, from August 2009 to December 2010. To investigate the quality of the adverts, we prepared a questionnaire divided into three parts. In total, 160 advertisements were found, of which 27 were related to drugs exempt from prescription, from 9 laboratories. It was observed that none of the advertisements complied fully with the new rules, as required by legislation (RDC 96/08), with violations ranging from identification of the advert to prohibitions of human figures and subjective messages. Therefore, it was concluded that there is a need to implement more effective monitoring, so as to improve the quality of the adverts, so they can be used as a reliable source of information and update by prescribers.

Análise de dispensação de medicamentos em uma farmácia hospitalar. -

Pós-graduação em Pesquisa e Desenvolvimento (Biotecnologia Médica) - FMB

Análise do sistema de distribuição de medicamentos em hospital oncológico do Estado de São Paulo

Pós-graduação em Ciências Farmacêuticas - FCFAR

Desenvolvimento de procedimento em fluxo com detecção espectrofotométrica para análise de bromoprida em medicamentos e/ou fluido biológico

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)