Paola Zucchi

Distorções causadas pelas ações judiciais à política de medicamentos no Brasil

OBJECTIVE: To describe how lawsuits, which demand the supply of drugs, impact on elements of the national drug policy. METHODS: This is a desk-based study using qualitative and quantitative methods. All legal proceedings brought by citizens against the Municipal Secretary of State of Sao Paulo, relating to the supply of drugs in 2005 were analyzed. A standardized form was used to collect data, with a view to carrying out an exploratory analysis. RESULTS: A total of 170 cases relating to the supply of drugs were brought against the Municipal Secretary of State. The National Health System (SUS) was the source for 59% of the prescriptions: 26% from the municipal level, 33% from other levels. Cancer and diabetes were the diseases most commonly involved (59%). About 62% of drugs requested are on the lists of SUS services. Total expenditure was R

Medicamentos de dispensação excepcional: histórico e gastos do Ministério da Saúde do Brasil

876,000 (Brazilian Reais), covering only non-selected items (i.e. those which are not included in the Municipal Register of Essential Medicines), 73% of which could be substituted. Of the total expenditure, 75% was spent on purchasing anticancer drugs, for which further clinical trials are required to prove their effectiveness. Two of these medicines were not registered in Brazil. CONCLUSIONS: The majority of demands for drugs that have led to legal proceedings could be avoided if two SUS directives were followed, namely the organization of oncology services and the observance of reporting on essential medicines. Failure to do so causes a breakdown in the National Drug Policy, in equality of access and in the rational use of drugs within the National Health System.

Diferenças de preços entre medicamentos genéricos e de referência no Brasil

OBJECTIVE To describe the technical aspects of the Exceptional Circumstance Drug Dispensing Program of the Brazilian Ministry of Health, especially with respect to the cost of dispensed medication. METHODS Technical information was obtained from the ordinances that regulate the Program. Expenditure from 2000 to 2007 was obtained from the Sistema Único de Saúdes (Unified Healthcare System) Outpatient Information System. All drugs dispensed between 1993 and 2009 and the amount and cost of each procedure were evaluated, based on information from the high-complexity procedure authorization of each of the countrys states. RESULTS The Program changed with the increase in the number of pharmacological agents and presentations distributed by, and the number of diseases contemplated in the program. In 1993, the program distributed 15 pharmacological agents in 31 distinct presentations. This number increased to 109 agents in 243 presentations in 2009. Total Ministry of Health expenditure with medications was R

Comissões farmacoterapêuticas no Brasil: aquém das diretrizes internacionais

1,410,181,600.74 in 2007, almost twice the amount spent in 2000, R

Demandas judiciais e assistência terapêutica no Sistema Único de Saúde

684,975,404.43. Diseases whose expenditure increased in the period included chronic renal insufficiency, transplantation, and hepatitis C. CONCLUSIONS The Exceptional Circumstance Drug Dispensing Program is in constant transformation, aimed at building instruments and strategies that can ensure and expand access to medication among the population. Alternatives should be sought to decrease the financial impact of the Program to a level that does not impact other sectors of the health care system, given the high cost associated with novel interventions.OBJETIVO: Descrever aspectos tecnicos do Programa de Medicamentos de Dispensacao em Carater Excepcional do Ministerio de Saude do Brasil, especialmente em relacao aos gastos com os medicamentos distribuidos. METODOS: Os aspectos tecnicos foram obtidos por meio de consulta a todas as portarias que regulamentaram o Programa. Gastos no periodo de 2000 a 2007 foram obtidos do Sistema de Informacoes Ambulatoriais do Sistema Unico de Saude. Foram analisados os medicamentos dispensados de 1993 a 2009, quantidades e valor de cada procedimento informados nas autorizacoes de procedimentos de alta complexidade para cada estado. RESULTADOS: O Programa mudou, com aumento do numero de farmacos e apresentacoes farmaceuticas distribuidas e de doencas contempladas. Eram distribuidos 15 farmacos em 31 diferentes apresentacoes farmaceuticas em 1993, passando para 109 farmacos em 243 apresentacoes em 2009. Os gastos totais do Ministerio da Saude com medicamentos somaram, em 2007, R

Financiamento da assistência farmacêutica no sistema único de saúde

1.410.181.600,74, quase o dobro do valor gasto em 2000: R

Custos diretos do programa de prevenção e controle da dengue no Município de São Paulo em 2005

684.975.404,43. Algumas das doencas que representaram maiores gastos nesse periodo foram: insuficiencia renal cronica, transplante e hepatite C. CONCLUSOES: O Programa de Medicamentos de Dispensacao em Carater Excepcional esta em constante transformacao, visando aprimorar os instrumentos e estrategias que assegurem e ampliem o acesso da populacao aos medicamentos. Devem-se buscar alternativas para reduzir o impacto financeiro do Programa para que nao haja prejuizos as outras areas do sistema de saude, dado o custo elevado das novas tecnologias.

Exceptional circumstance drug dispensing: history and expenditures of the Brazilian Ministry of Health

OBJETIVO: Verificar a magnitude da diferenca de preco entre os medicamentos genericos e os respectivos medicamentos de referencia, alem de avaliar o efeito da concorrencia entre eles quanto aos seus precos. METODOS: De janeiro de 2000 a junho de 2004, foram acompanhadas 135 apresentacoes de medicamentos genericos e seus respectivos medicamentos de referencia por um periodo de ate quatro anos. Os precos foram extraidos de publicacoes especificas voltadas para o comercio farmaceutico, e foram anotados os precos para ambos os medicamentos, desde o lancamento do generico e durante periodo de comercializacao posterior. RESULTADOS: Os genericos foram introduzidos, em media, com precos 40% menores do que os medicamentos de referencia e esta diferenca tendeu a aumentar ao longo do tempo. Comparando a diferenca de preco do generico em relacao ao seu medicamento de referencia observou-se aumento de 68% nos quatro anos seguintes ao seu lancamento. CONCLUSOES: A introducao de medicamentos genericos no mercado farmaceutico brasileiro contribuiu para a oferta de medicamentos a precos menores. Entretanto, a procura dos medicamentos genericos nao provocou reducao dos precos da maioria dos medicamentos de referencia.

Aplicações diretas para aquisição de medicamentos no Sistema Único de Saúde

The inadequate use of drugs leads to lack of therapeutic efficacy, adverse reactions, side effects, preventable drug interactions, increased bacterial resistance to antibiotics, and wasted resources. Changing this scenario is one of the most complex challenges facing health systems today. One approach used to rationalize the use of drugs lies in the creation of pharmacy and therapeutics committees, whose main role is to guide and assist health institutions at all levels in selecting drugs and monitoring their use, training professionals to use drugs rationally, and collecting systematized information to guide new strategies and actions. Brazil, unlike other parts of the world, does not make it compulsory to have pharmacy and therapeutics committees. Although committees for monitoring hospital infections are compulsory in that country, their action is restricted to hospitals and is not as broad as that proposed for pharmacy and therapeutics committees. Data from 2003 shows that among 250 public and private hospitals in Brazil, only 29 had pharmacy and therapeutics committees. It is essential that the need to make these committees compulsory at all levels of the Brazilian health system be discussed, and that the national Ministry of Health and other related agencies create the conditions necessary for the establishment of pharmacy and therapeutics committees, in accordance with other health policies currently in place.

Ouvidorias públicas de saúde: estudo de caso em ouvidoria municipal de saúde

OBJECTIVE To analyze the qualitative coverage of therapeutic policies at federal level in the Brazilian Public Health System (SUS) for diseases that were the subject of lawsuits. METHODS An exploratory research was performed, based on a sample of diseases referred to in lawsuits against the city of São Paulo Municipal Office for Health, in 2005. A search of the standards that set forth therapeutic policies, as well as recommended therapeutic resources (surgical procedures and drugs), was performed. The database Diseasedex, part of the Micromedex system, was used as the basis for therapeutic procedures used to treat those diseases. A reference summary table was prepared to facilitate comparison between recommendations in public policies and the Diseasedex database. RESULTS Therapeutic public policy covers the major part (n = 26) of the diseases analyzed, either by public policies for primary care or public policies for rare diseases and/or high cost treatment diseases. This represents 96% of the sample analyzed (n = 27). Only 3 of the 27 diseases in the sample are contemplated by limited therapeutic policies. This means that public policies do not offer full first-line therapy, which corresponds to 11% of the sample. There was only one disease that was not covered by public therapeutic policies: attention deficit hyperactivity disorder. CONCLUSION There were limitations in the qualitative coverage of treatment of some diseases from the sample analyzed, which may jeopardize the comprehensiveness of therapeutic assistance and health care in some cases.