Data sources for drug utilization research in Latin American countries-A cross-national study: DASDUR-LATAM study.

PURPOSE: Drug utilization research (DUR) contributes to inform policymaking and to strengthen health systems. The availability of data sources is the first step for conducting DUR. However, documents that systematize these data sources in Latin American (LatAm) countries are not known. We compiled the potential data sources for DUR in the LatAm region. METHODS: A network of DUR experts from nine LatAm countries was assembled and experts conducted: (i) a website search of the government, academic, and private health institutions; (ii) screening of eligible data sources, and (iii) liaising with national experts in pharmacoepidemiology (via an online survey). The data sources were characterized by accessibility, geographic granularity, setting, sector of the data, sources and type of the data. Descriptive analyses were performed. RESULTS: We identified 125 data sources for DUR in nine LatAm countries. Thirty-eight (30%) of them were publicly and conveniently available; 89 (71%) were accessible with limitations, and 18 (14%) were not accessible or lacked clear rules for data access. From the 125 data sources, 76 (61%) were from the public sector only; 46 (37%) were from pharmacy records; 43 (34%) came from ambulatory settings and; 85 (68%) gave access to individual patient-level data. CONCLUSIONS: Although multiple sources for DUR are available in LatAm countries, the accessibility is a major challenge. The procedures for accessing DUR data should be transparent, feasible, affordable, and protocol-driven. This inventory could permit a comparison of drug utilization between countries identifying potential medication-related problems that need further exploration.

Data Sources for Drug Utilization Research in Brazil-DUR-BRA Study.

Background: In Brazil, studies that map electronic healthcare databases in order to assess their suitability for use in pharmacoepidemiologic research are lacking. We aimed to identify, catalogue, and characterize Brazilian data sources for Drug Utilization Research (DUR). Methods: The present study is part of the project entitled, "Publicly Available Data Sources for Drug Utilization Research in Latin American (LatAm) Countries." A network of Brazilian health experts was assembled to map secondary administrative data from healthcare organizations that might provide information related to medication use. A multi-phase approach including internet search of institutional government websites, traditional bibliographic databases, and experts' input was used for mapping the data sources. The reviewers searched, screened and selected the data sources independently; disagreements were resolved by consensus. Data sources were grouped into the following categories: 1) automated databases; 2) Electronic Medical Records (EMR); 3) national surveys or datasets; 4) adverse event reporting systems; and 5) others. Each data source was characterized by accessibility, geographic granularity, setting, type of data (aggregate or individual-level), and years of coverage. We also searched for publications related to each data source. Results: A total of 62 data sources were identified and screened; 38 met the eligibility criteria for inclusion and were fully characterized. We grouped 23 (60%) as automated databases, four (11%) as adverse event reporting systems, four (11%) as EMRs, three (8%) as national surveys or datasets, and four (11%) as other types. Eighteen (47%) were classified as publicly and conveniently accessible online; providing information at national level. Most of them offered more than 5 years of comprehensive data coverage, and presented data at both the individual and aggregated levels. No information about population coverage was found. Drug coding is not uniform; each data source has its own coding system, depending on the purpose of the data. At least one scientific publication was found for each publicly available data source. Conclusions: There are several types of data sources for DUR in Brazil, but a uniform system for drug classification and data quality evaluation does not exist. The extent of population covered by year is unknown. Our comprehensive and structured inventory reveals a need for full characterization of these data sources.

Hipoglicemiantes Orais Para Diabetes Mellitus Tipo 2: Comparação de Preços no Brasil e em Outros Sistemas Universais de Saúde.

OBJECTIVES: To estimate the average price of oral hypoglycemic agents provided by the Brazilian health system (SUS) and to compare them to other public health systems. METHODS: Cross-sectional study about drug prices purchased by Belo Horizonte (municipal level), Minas Gerais (state level) and federal institutions in January and February of 2014. Average prices were calculated by defined daily dosage (DDD) and were compared to the management levels and the program "Aqui Tem Farmácia Popular" (ATFP). For international comparison, reimbursement values from Spain, Portugal, the United Kingdom and Canada (Province of Quebec) were used. RESULTS: Belo Horizonte had higher average prices than Minas Gerais. In general, essential oral hypoglycemic agents purchased by the SUS had lower prices than ATFP. For example, glibenclamide 5 mg was 1.023% more expensive. Metformin purchased by ATFP was more expensive than by SUS. Eight drugs purchased by SUS had average values above the respective Brazilian price ceiling. As an international comparison, SUS had lower average prices for glibenclamide and metformin. In ATFP, metformin was more expensive than in other countries, while glibenclamide was cheaper than Portugal only. CONCLUSION: The municipal management level had higher average prices than state level. Oral hypoglycemic agents purchased by SUS are predominantly cheaper than ATFP. Average prices paid by SUS are lower, while the prices paid by ATFP are higher than the reimbursed amounts from other countries.

Healthcare financing, decentralization and regional health planning: federal transfers and the healthcare networks in Minas Gerais, Brazil. / Financiamento, descentralização e regionalização: transferências federais e as redes de atenção em Minas Gerais, Brasil.

The Decrees 4279/10 and 7508/11 established norms to guide health politics, with impacts on funding of the Middle and High Complexity Hospital and Outpatient. To verify the effects on the consolidation of care networks in Minas Gerais, we performed an analytical-descriptive study of the National Health Fund from 2006 to 2014. We observed decentralization of responsibilities, accompanied of resources and innovative financing mechanisms, resulting expansion of the network care model. The federal government definitions suggest reduction of the autonomy and limitation of regional solutions.

Financiamento, descentralização e regionalização: transferências federais e as redes de atenção em Minas Gerais, Brasil / Healthcare financing, decentralization and regional health planning: federal transfers and the healthcare networks in Minas Gerais, Brazil

Resumo A Portaria 4279/10 e o Decreto 7508/11 normatizaram o funcionamento político-institucional do sistema, com impactos no financiamento da Média e Alta Complexidade Hospitalar e Ambulatorial (MAC). Para verificar as consequências das diretrizes na consolidação das redes de atenção em Minas Gerais, realizou-se estudo analítico-descritivo do custeio federal do Bloco MAC nos anos de 2006 a 2014. Observa-se descentralização de responsabilidades, aporte de recursos e novos critérios de financiamento, com expansão do modelo de rede. Os repasses de recursos pré-definidos pelo governo federal sugerem redução a autonomia e limitação de soluções loco-regionais.

Abstract The Decrees 4279/10 and 7508/11 established norms to guide health politics, with impacts on funding of the Middle and High Complexity Hospital and Outpatient. To verify the effects on the consolidation of care networks in Minas Gerais, we performed an analytical-descriptive study of the National Health Fund from 2006 to 2014. We observed decentralization of responsibilities, accompanied of resources and innovative financing mechanisms, resulting expansion of the network care model. The federal government definitions suggest reduction of the autonomy and limitation of regional solutions.

Costs of Drug Therapy in Patients with Ankylosing Spondylitis in Brazil.

INTRODUCTION: The Brazilian Public Health System offers free-of-charge drug treatment for ankylosing spondylitis (AS) to all Brazilian citizens. We report here the first population-based cohort study on patients with AS in Brazil. The aim of this study was to evaluate the costs of the tumour necrosis factor (anti-TNF) blockers and disease-modifying antirheumatic drugs (DMARDs) that were used in the treatments of patients with AS in Brazil between March 2010 and September 2013. METHODS: A retrospective cohort study was performed using administrative databases. All patients with a diagnosis of AS who were aged 18 years or older and had been dispensed anti-TNF or DMARDs were included in the analysis. The cost analysis was carried out from the health system perspective, and the results were described as median monthly cost per capita and the annual cost over the study period. RESULTS: A search of the databases identified 1251 patients with AS who were treated during the study period, of whom 63.3% were male; the median age was 41 years. During the study period, 78.0% of patients initiated treatment with anti-TNF drugs and 22.0% with DMARDs. The median monthly cost per capita was US$ 1650 for anti-TNF therapy and US$ 25 for treatment with DMARDs. Among the anti-TNF drugs, therapy with etanercept was associated with the lowest cost per patient, followed by adalimumab and infliximab. No difference in monthly cost was observed in relation to gender and age. CONCLUSION: The cost per patient of treating AS in this study cohort was lower with etanercept than with adalimumab and infliximab. These results highlights the economic burden of treating patients with AS.

Treatment persistence in patients with rheumatoid arthritis and ankylosing spondylitis.

OBJECTIVE: To evaluate treatment persistence in patients with rheumatoid arthritis and ankylosing spondylitis who started therapies with disease-modifying antirheumatic drugs (DMARD) and tumor necrosis factor blockers (anti-TNF drugs). METHODS: This retrospective cohort study from July 2008 to September 2013 evaluated therapy persistence, which is defined as the period between the start of treatment until it is discontinued, allowing for an interval of up to 30 days between the prescription end and the start of the next prescription. Odds ratio (OR) with 95% confidence intervals (95%CI) were calculated by logistic regression models to estimate the patients' chances of persisting in their therapies after the first and after the two first years of follow-up. RESULTS: The study included 11,642 patients with rheumatoid arthritis - 2,241 of these started on anti-TNF drugs (+/-DMARD) and 9,401 patients started on DMARD - and 1,251 patients with ankylosing spondylitis - 976 of them were started on anti-TNF drugs (+/-DMARD) and 275 were started on DMARD. In the first year of follow-up, 63.5% of the patients persisted in their therapies with anti-TNF drugs (+/-DMARD) and 54.1% remained using DMARD in the group with rheumatoid arthritis. In regards to ankylosing spondylitis, 79.0% of the subjects in anti-TNF (+/-DMARD) group and 41.1% of the subjects in the DMARD group persisted with their treatments. The OR (95%CI) for therapy persistence was 1.50 (1.34-1.67) for the anti-TNF (+/-DMARD) group as compared with the DMARD group in the first year for the patients with rheumatoid arthritis, and 2.33 (1.74-3.11) for the patients with ankylosing spondylitis. A similar trend was observed at the end of the second year. CONCLUSIONS: A general trend of higher rates of therapy persistence with anti-TNF drugs (+/-DMARD) was observed as compared to DMARD in the study period. We observed higher persistence rates for anti-TNF drugs (+/-DMARD) in patients with ankylosing spondylitis as compared to rheumatoid arthritis; and a higher persistence for DMARD in patients with rheumatoid arthritis as compared to ankylosing spondylitis. OBJETIVO: Avaliar a persistência do tratamento em pacientes com artrite reumatoide e espondilite anquilosante que iniciaram terapia com medicamentos modificadores do curso da doença (MMCD) e agentes bloqueadores do fator de necrose tumoral (anti-TNF). MÉTODOS: Este estudo de coorte retrospectiva de julho de 2008 a setembro de 2013 avaliou a persistência na terapia, definida como o tempo do início até a descontinuação, permitindo-se um intervalo de até 30 dias entre o fim da prescrição e o início da prescrição seguinte. Odds ratio (OR) com intervalos de confiança de 95% (IC95%) foram calculados por meio de modelos de regressão logística para estimar a chance de apresentar persistência na terapia após o primeiro e os dois primeiros anos de seguimento. RESULTADOS: Foram incluídos 11.642 pacientes com artrite reumatoide - 2.241 iniciaram uso de agentes anti-TNF (+/-MMCD) e 9.401 iniciaram MMCD - e 1.251 pacientes com espondilite anquilosante - 976 iniciaram uso de agentes anti-TNF (+/-MMCD) e 275 iniciaram MMCD. No primeiro ano de acompanhamento, 63,5% persistiram em terapia com anti-TNF (+/-MMCD) e 54,1% em uso de MMCD do grupo com artrite reumatoide. Em relação à espondilite anquilosante, 79,0% do grupo anti-TNF (+/-MMCD) e 41,1% do grupo MMCD persistiram no tratamento. O OR (IC95%) para persistência na terapia foi de 1,50 (1,34-1,67) para o grupo anti-TNF (+/-MMCD) comparado com MMCD no primeiro ano em pacientes com artrite reumatoide, e de 2,33 (1,74-3,11) em pacientes com espondilite anquilosante. Foi observada tendência semelhante ao final do segundo ano. CONCLUSÕES: Observou-se uma tendência geral de taxas mais elevadas de persistência na terapia com anti-TNF (+/-MMCD) em relação a MMCD no período estudado. Foram observadas taxas de persistência mais elevadas para os usuários de anti-TNF (+/-MMCD) em pacientes com espondilite anquilosante em relação a artrite reumatoide, e maior persistência para MMCD em pacientes com artrite reumatoide em relação à espondilite anquilosante.

Medication Persistence of Disease-Modifying Antirheumatic Drugs and Anti-Tumor Necrosis Factor Agents in a Cohort of Patients With Rheumatoid Arthritis in Brazil.

OBJECTIVE: To assess the use and persistence of anti-tumor necrosis factor (anti-TNF) versus disease-modifying antirheumatic drug (DMARD) therapies in patients with rheumatoid arthritis (RA) in Brazil. METHODS: This was a new-user cohort study of RA patients from 2003 to 2010, using administrative data. Individuals were classified as being persistent using a drug at the first year and the first 2 years after cohort entry, if they did not discontinue that drug during that period. Cox regression was used to identify potential determinants of discontinuation of therapy in each medication group. RESULTS: Among 76,351 patients, 14,313 were using anti-TNF (+/- DMARD) therapy. At the end of the first year of followup, 48.2% continued using anti-TNF (+/- DMARD) therapy compared to 42.6% who persisted with DMARDs only. At the end of the second year, 23.1% of anti-TNF (+/- DMARD) users and 19.3% of DMARD-only users continued with therapy. Infliximab users had the lowest persistence rates. Multivariate Cox regression analysis showed that among anti-TNF (+/- DMARD) users, higher discontinuation rates were observed in female patients, in patients with lower income (only at the first 2 years of followup), in nonresidents of the region with the highest Human Development Index (HDI) rates, in those with a higher comorbidity score, and in those enrolled in the 2003-2006 period. Among DMARD-only users, younger patients, patients with lower income, nonresidents in regions with high HDI, those with a higher comorbidity score, and those enrolled in the 2003-2006 period were also more likely to discontinue therapy. CONCLUSION: Brazilian patients with RA showed low rates of medication persistence for DMARDs and anti-TNF agents, particularly at the first 2 years of followup. Future work could determine what other factors might contribute to drug persistence in RA.

Treatment persistence in patients with rheumatoid arthritis and ankylosing spondylitis / Persistência do tratamento em pacientes com artrite reumatoide e espondilite anquilosante

ABSTRACT OBJECTIVE To evaluate treatment persistence in patients with rheumatoid arthritis and ankylosing spondylitis who started therapies with disease-modifying antirheumatic drugs (DMARD) and tumor necrosis factor blockers (anti-TNF drugs). METHODS This retrospective cohort study from July 2008 to September 2013 evaluated therapy persistence, which is defined as the period between the start of treatment until it is discontinued, allowing for an interval of up to 30 days between the prescription end and the start of the next prescription. Odds ratio (OR) with 95% confidence intervals (95%CI) were calculated by logistic regression models to estimate the patients' chances of persisting in their therapies after the first and after the two first years of follow-up. RESULTS The study included 11,642 patients with rheumatoid arthritis - 2,241 of these started on anti-TNF drugs (+/-DMARD) and 9,401 patients started on DMARD - and 1,251 patients with ankylosing spondylitis - 976 of them were started on anti-TNF drugs (+/-DMARD) and 275 were started on DMARD. In the first year of follow-up, 63.5% of the patients persisted in their therapies with anti-TNF drugs (+/-DMARD) and 54.1% remained using DMARD in the group with rheumatoid arthritis. In regards to ankylosing spondylitis, 79.0% of the subjects in anti-TNF (+/-DMARD) group and 41.1% of the subjects in the DMARD group persisted with their treatments. The OR (95%CI) for therapy persistence was 1.50 (1.34-1.67) for the anti-TNF (+/-DMARD) group as compared with the DMARD group in the first year for the patients with rheumatoid arthritis, and 2.33 (1.74-3.11) for the patients with ankylosing spondylitis. A similar trend was observed at the end of the second year. CONCLUSIONS A general trend of higher rates of therapy persistence with anti-TNF drugs (+/-DMARD) was observed as compared to DMARD in the study period. We observed higher persistence rates for anti-TNF drugs (+/-DMARD) in patients with ankylosing spondylitis as compared to rheumatoid arthritis; and a higher persistence for DMARD in patients with rheumatoid arthritis as compared to ankylosing spondylitis.

RESUMO OBJETIVO Avaliar a persistência do tratamento em pacientes com artrite reumatoide e espondilite anquilosante que iniciaram terapia com medicamentos modificadores do curso da doença (MMCD) e agentes bloqueadores do fator de necrose tumoral (anti-TNF). MÉTODOS Este estudo de coorte retrospectiva de julho de 2008 a setembro de 2013 avaliou a persistência na terapia, definida como o tempo do início até a descontinuação, permitindo-se um intervalo de até 30 dias entre o fim da prescrição e o início da prescrição seguinte. Odds ratio (OR) com intervalos de confiança de 95% (IC95%) foram calculados por meio de modelos de regressão logística para estimar a chance de apresentar persistência na terapia após o primeiro e os dois primeiros anos de seguimento. RESULTADOS Foram incluídos 11.642 pacientes com artrite reumatoide - 2.241 iniciaram uso de agentes anti-TNF (+/-MMCD) e 9.401 iniciaram MMCD - e 1.251 pacientes com espondilite anquilosante - 976 iniciaram uso de agentes anti-TNF (+/-MMCD) e 275 iniciaram MMCD. No primeiro ano de acompanhamento, 63,5% persistiram em terapia com anti-TNF (+/-MMCD) e 54,1% em uso de MMCD do grupo com artrite reumatoide. Em relação à espondilite anquilosante, 79,0% do grupo anti-TNF (+/-MMCD) e 41,1% do grupo MMCD persistiram no tratamento. O OR (IC95%) para persistência na terapia foi de 1,50 (1,34-1,67) para o grupo anti-TNF (+/-MMCD) comparado com MMCD no primeiro ano em pacientes com artrite reumatoide, e de 2,33 (1,74-3,11) em pacientes com espondilite anquilosante. Foi observada tendência semelhante ao final do segundo ano. CONCLUSÕES Observou-se uma tendência geral de taxas mais elevadas de persistência na terapia com anti-TNF (+/-MMCD) em relação a MMCD no período estudado. Foram observadas taxas de persistência mais elevadas para os usuários de anti-TNF (+/-MMCD) em pacientes com espondilite anquilosante em relação a artrite reumatoide, e maior persistência para MMCD em pacientes com artrite reumatoide em relação à espondilite anquilosante.

Legal and health variations in drug litigation injunctions granted in Minas Gerais.

OBJECTIVE: To investigate the factors related to the granting of preliminary court orders [injunctions] in drug litigations. METHODS: A retrospective descriptive study of drug lawsuits in the State of Minas Gerais, Southeastern Brazil, was conducted from October 1999 to 2009. The database consists of 6,112 lawsuits, out of which 6,044 had motions for injunctions and 5,167 included the requisition of drugs. Those with more than one beneficiary were excluded, which totaled 5,072 examined suits. The variables for complete, partial, and suppressed motions were treated as dependent and assessed in relation to those that were independent--lawsuits (year, type, legal representation, defendant, court in which it was filed, adjudication time), drugs (level five of the anatomical therapeutic chemical classification), and diseases (chapter of the International Classification of Diseases). Statistical analyses were performed using the Chi-square test. RESULTS: Out of the 5,072 lawsuits with injunctions, 4,184 (82.5%) had the injunctions granted. Granting varied from 95.8% of the total lawsuits in 2004 to 76.9% in 2008. Where there was legal representation, granting exceeded 80.0% and in lawsuits without representation, it did not exceed 66.9%. In public civil actions (89.1%), granting was higher relative to ordinary lawsuits (82.8%) and injunctions (80.1%). Federal courts granted only 68.6% of the injunctions, while the state courts granted 84.8%. Diseases of the digestive system and neoplasms received up to 87.0% in granting, while diseases of the nervous system, mental and behavioral disorders, and diseases of the skin and subcutaneous tissue received granting below 78.6% and showed a high proportion of suspended injunctions (10.9%). Injunctions involving paroxetine, somatropin, and ferrous sulfate drugs were all granted, while less than 54.0% of those involving escitalopram, sodium diclofenac, and nortriptyline were granted. CONCLUSIONS: There are significant differences in the granting of injunctions, depending on the procedural and clinical variances. Important trends in the pattern of judicial action were observed, particularly, in the reduced granting [of injunctions] over the period.

Legal and health variations in drug litigation injunctions granted in Minas Gerais / Variáveis jurídicas e de saúde no deferimento de liminares por medicamentos em Minas Gerais

OBJECTIVE To investigate the factors related to the granting of preliminary court orders [injunctions] in drug litigations. METHODS A retrospective descriptive study of drug lawsuits in the State of Minas Gerais, Southeastern Brazil, was conducted from October 1999 to 2009. The database consists of 6,112 lawsuits, out of which 6,044 had motions for injunctions and 5,167 included the requisition of drugs. Those with more than one beneficiary were excluded, which totaled 5,072 examined suits. The variables for complete, partial, and suppressed motions were treated as dependent and assessed in relation to those that were independent – lawsuits (year, type, legal representation, defendant, court in which it was filed, adjudication time), drugs (level five of the anatomical therapeutic chemical classification), and diseases (chapter of the International Classification of Diseases). Statistical analyses were performed using the Chi-square test. RESULTS Out of the 5,072 lawsuits with injunctions, 4,184 (82.5%) had the injunctions granted. Granting varied from 95.8% of the total lawsuits in 2004 to 76.9% in 2008. Where there was legal representation, granting exceeded 80.0% and in lawsuits without representation, it did not exceed 66.9%. In public civil actions (89.1%), granting was higher relative to ordinary lawsuits (82.8%) and injunctions (80.1%). Federal courts granted only 68.6% of the injunctions, while the state courts granted 84.8%. Diseases of the digestive system and neoplasms received up to 87.0% in granting, while diseases of the nervous system, mental and behavioral disorders, and diseases of the skin and subcutaneous tissue received granting below 78.6% and showed a high proportion of suspended injunctions (10.9%). Injunctions involving paroxetine, somatropin, and ferrous sulfate drugs were all granted, while less than 54.0% of those involving escitalopram, sodium diclofenac, and nortriptyline were granted. CONCLUSIONS ...

OBJETIVO Investigar fatores relacionados ao deferimento de liminares por medicamentos. MÉTODOS Estudo descritivo retrospectivo dos processos judiciais por medicamentos em Minas Gerais, de outubro de 1999 a 2009. A base de dados, constituída por 6.112 ações judiciais, teve 6.044 com pedido de liminar e 5.167 com requisição de medicamentos. Foram excluídas as ações que continham mais de um beneficiário, totalizando 5.072 ações analisadas. As variáveis deferimento total, parcial e suspensão foram tratadas como dependentes e avaliadas em relação às independentes: processo (ano, tipo de ação, representação judicial, réu, justiça de ajuizamento, tempo de decisão judicial), medicamentos (nível 5 da Anatomical Therapeutic Chemical) e doença (por capítulo da Classificação Internacional de Doenças. As análises estatísticas foram realizadas pelo teste Qui-quadrado. RESULTADOS Dentre as 5.072 ações com liminares, 4.184 (82,5%) foram deferidas. O deferimento variou de 95,8% em 2004 a 76,9% em 2008. Quando houve representação judicial, o deferimento superou 80,0%; nas ações sem representação, não ultrapassou 66,9%. Nas ações civis públicas (89,1%) o deferimento foi superior ao verificado em ações ordinárias (82,8%) e nos mandados de segurança (80,1%). A Justiça Federal deferiu apenas 68,6% das liminares, contra 84,8% da Justiça Estadual. Doenças do aparelho digestivo e neoplasias apresentaram deferimento acima de 87,0%, enquanto doenças do sistema nervoso, transtornos mentais e comportamentais e doenças da pele e do tecido celular subcutâneo tiveram deferimento inferior a 78,6% e apresentaram elevada proporção de liminares suspensas (10,9%). Os fármacos paroxetina, ...

[Public spending on drugs for the treatment of osteoporosis in post-menopause]. / Gastos públicos com medicamentos para o tratamento da osteoporose na pós-menopausa.

OBJECTIVE: To analyze expenditure on treatment for postmenopausal osteoporosis and associated factors on mean per capita expenditure. METHODS: A probabilistic-deterministic linkage between the database of Authorizations for Highly Complex Procedures and the mortality information system was constructed, resulting in a historical cohort of patients using high-cost medications for the treatment of postmenopausal osteoporosis, between 2000-2006. Mean monthly spending on medicines was stratified by age group and described according to demographic and clinical characteristics and the type of drug used. A linear regression model was used to assess the impact of demographic and clinical characteristics on per capita mean monthly expenditure on medicines. RESULTS: We identified 72,265 women who received drugs for the treatment of postmenopausal osteoporosis. The average monthly expenditure per capita in the first year of treatment was $ 54.02 (sd $ 86.72). The population was predominantly composed of women aged 60-69 years old, who had started treatment in 2000, resident in the Southeast of Brazil, who had previously suffered osteoporotic fractures, and Alendronate sodium was the drug most commonly used at baseline. For most of the patients, the same active ingredient remained in use throughout the treatment period. During the program, 6,429 deaths were identified among participants. More than a third of women remained in treatment for up to 12 months. Raloxifen and calcitonin were the therapeutic alternatives with the greatest impact on the average monthly expenditure on medicine using alendronate sodium as a reference standard. CONCLUSIONS: Due to the high impact of the type of drug used on expenditure on medication, it is recommended that criteria for prescribing and dispensing be established by prioritizing those with lower costs and greater effectiveness in order to optimize the process of pharmaceutical care and provide the population with a greater number of pharmaceutical units.

Gastos publicos com medicamentos para o tratamento da osteoporose na pos-menopausa / Public spending on drugs for the treatment of osteoporosis in post-menopause / Gastos con medicamentos en el Sistema Unico de Salud para el tratamiento de la osteoporosis en la post-menopausia

OBJETIVO: Analisar os gastos com medicamentos para o tratamento da osteoporose na pós-menopausa e os fatores associados ao gasto médio per capita . MÉTODOS: Pareamento probabilístico-determinístico a partir das bases das Autorizações de Procedimentos de Alta Complexidade com o Sistema de Informação sobre Mortalidade, resultando em coorte histórica de pacientes que utilizaram medicamentos de alto custo para o tratamento da osteoporose na pós-menopausa de 2000 a 2006. O gasto médio mensal com medicamentos foi estratificado por faixas etárias e descrito de acordo com as características demográficas, clínicas e tipo de medicamento utilizado. Foi utilizado modelo de regressão linear para avaliar o impacto de características demográficas e clínicas sobre o gasto médio mensal per capita com os medicamentos. RESULTADOS: Foram identificadas 72.265 mulheres que receberam medicamentos para o tratamento da osteoporose na pós-menopausa. O gasto médio mensal per capita no primeiro ano de tratamento foi de R$ 90,00 (dp R$ 144,49). A maioria das mulheres tinha de 60 a 69 anos de idade, iniciaram tratamento em 2000, eram residentes na região Sudeste, tinham fraturas osteoporóticas prévias e o alendronato de sódio foi o medicamento mais utilizado no início do tratamento. A maioria das pacientes permaneceu em uso do mesmo princípio ativo durante o tratamento. Foram identificados 6.429 óbitos entre as participantes. Mais de um terço das mulheres permaneceram no programa por até 12 meses. Raloxifeno e calcitonina sintética foram as alternativas com maior impacto sobre o gasto médio mensal com medicamentos, tendo como padrão de referência o ...

OBJECTIVE: To analyze expenditure on treatment for postmenopausal osteoporosis and associated factors on mean per capita expenditure. METHODS: A probabilistic-deterministic linkage between the database of Authorizations for Highly Complex Procedures and the mortality information system was constructed, resulting in a historical cohort of patients using high-cost medications for the treatment of postmenopausal osteoporosis, between 2000-2006. Mean monthly spending on medicines was stratified by age group and described according to demographic and clinical characteristics and the type of drug used. A linear regression model was used to assess the impact of demographic and clinical characteristics on per capita mean monthly expenditure on medicines. RESULTS: We identified 72,265 women who received drugs for the treatment of postmenopausal osteoporosis. The average monthly expenditure per capita in the first year of treatment was $ 54.02 (sd $ 86.72). The population was predominantly composed of women aged 60-69 years old, who had started treatment in 2000, resident in the Southeast of Brazil, who had previously suffered osteoporotic fractures, and Alendronate sodium was the drug most commonly used at baseline. For most of the patients, the same active ingredient remained in use throughout the treatment period. During the program, 6,429 deaths were identified among participants. More than a third of women remained in treatment for up to 12 months. Raloxifen and calcitonin were the therapeutic alternatives with the greatest impact on the average monthly expenditure on medicine using alendronate sodium as a reference standard. CONCLUSIONS: Due to the high impact of the type of drug used on expenditure on medication, it is recommended that criteria for prescribing and dispensing ...

OBJETIVO: Analizar los gastos con medicamentos para el tratamiento de la osteoporosis en la post-menopausia y los factores asociados al gasto promedio per cápita. MÉTODOS: Pareamiento probabilístico-deterministico a partir de las bases de las Autorizaciones de Procedimientos de Alta Complejidad con el Sistema de Información sobre Mortalidad, resultando en cohorte histórica de pacientes que utilizaron medicamentos de alto costo para el tratamiento de la osteoporosis en la post-menopausia de 2000 a 2006. El gasto promedio mensual con medicamentos fue estratificado por grupos etarios y descrito de acuerdo con las características demográficas, clínicas y tipo de medicamento usado. Se utilizó modelo de regresión linear para evaluar el impacto de las características socio demográficas y clínicas sobre el gasto promedio mensual per cápita con los medicamentos. RESULTADOS: Se identificaron 72.265 mujeres que recibieron medicamentos para el tratamiento de la osteoporosis en la post-menopausia. El gasto promedio mensual per cápita en el primer año de tratamiento fue de R$ 90,00 (de R$ 144,49). La mayoría de las mujeres tenía de 60 a 69 años de edad, iniciaron tratamiento en 2000, eran residentes en la región Sureste, tenían fracturas osteoporóticas previas, y el alendronato de sodio fue el medicamento más utilizado en el inicio del tratamiento. La mayoría de los pacientes permaneció en uso del mismo principio activo durante el tratamiento. Se identificaron 6.429 óbitos entre las participantes. Más de un tercio de las mujeres permanecieron en el programa por 12 meses. Raloxifeno y calcitonina sintética fueron las alternativas con mayor impacto sobre el gasto promedio mensual con medicamentos, teniendo como patrón de referencia ...

Potentially inappropriate medication use among institutionalized elderly individuals in southeastern Brazil

In recent decades, the elderly population in Brazil has grown rapidly, as has concern for the health of this population. Institutionalization in nursing homes has appeared as an alternative form of health care for frail elderly that live alone. The present study evaluated the pharmacotherapy and inappropriate drug prescriptions for institutionalized elderly patients living in long-term institutions in southeastern Brazil. This research was conducted at five institutions with a total sample of 151 individuals aged at least 60 years. Databases were used to identify drug interactions, defined daily dose and inappropriate prescriptions. The prevalence of drug intake among the elderly was 95.36%, and there were an average of 3.31 ± 1.80 drug prescriptions per individual. Based on Beers criteria, the prevalence of inappropriate prescriptions was 25.83%. In addition, 70.2% of prescriptions were prescribed at a higher dosage than the defined daily dose (ATC/WHO). Potential drug interactions were identified for 54.11% of prescriptions; 81.42% of these were of moderate severity. The main inappropriate drugs were prescribed for cardiovascular and nervous system problems. Institutionalized elderly individuals presented a high consumption and misuse of medications, requiring professional intervention to monitor prescriptions and improve the quality of service for this population.

Nas últimas décadas, o número de idosos no Brasil cresceu rapidamente, bem como, a preocupação com a saúde desta parcela da população. Neste cenário, a institucionalização em casas de repouso aparece como uma alternativa para os cuidados com a saúde dos idosos debilitados ou que vivem sozinhos. O presente estudo avaliou a farmacoterapia e a prescrição inadequada para idosos que residem em instituições de longa permanência no sudeste do Brasil. Esta pesquisa foi realizada em cinco instituições, totalizando uma amostra de 151 indivíduos com idade a partir de 60 anos. O banco de dados foi analisado para identificação de interações medicamentosas, dose diária definida e critérios de Beers. Dentre os indivíduos avaliados, 95,36% consomem algum tipo de medicamento, sendo 3,31 ± 1,80 medicamentos prescritos por indivíduo. Com base nos critérios de Beers, a prevalência de prescrições inapropriadas foi de 25,83%, sendo também encontradas 70,2% das prescrições com doses superiores à dose diária definida (ATC/WHO). Interações medicamentosas potenciais estavam presentes em 54,11% das prescrições, sendo 81,42% com grau moderado de gravidade. Os principais medicamentos inapropriados foram prescritos para problemas cardiovasculares e do sistema nervoso. Os idosos institucionalizados apresentam alto consumo e uso inadequado de medicamentos, sendo necessária a intervenção profissional para monitorar as prescrições médicas e melhorar a qualidade do serviço de distribuição de medicamentos a esta parte da população.

[Doctors, lawyers and pharmaceutical industry on health lawsuits in Minas Gerais, Southeastern Brazil]. / Médicos, advogados e indústria farmacêutica na judicialização da saúde em Minas Gerais, Brasil.

OBJECTIVE: To describe the relationship between the prescribing doctor, lawyer and pharmaceutical industry in lawsuits against the state. METHODS: Retrospective descriptive study based on data from administrative files, relating to lawsuits involving medicine demands, in the state of Minas Gerais, Southeastern Brazil, from October 1999 to October 2009. RESULTS: A total of 2,412 lawsuits were analyzed with 2,880 medicine requests, including 18 different drugs, 12 of them provided through Pharmaceutical Policies of the Brazilian National Health System (SUS). The most frequent medicines requested included were adalimumab, etanercept, infliximab, insulin glargine and tiotropium bromide. The main diseases were rheumatoid arthritis, ankylosing spondylitis, diabetes mellitus, and chronic obstructive pulmonary disease. Private lawyers and doctors were predominant. The results revealed the association between doctors and law offices on drug requests. Among the lawsuits filed by the office A, 43.6% had a single prescriber to adalimumab, while 29 doctors were responsible for 40.2% of the same drug prescriptions. A single doctor was responsible for 16.5% of the adalimumab prescriptions, being requested through lawsuits filed by a single private law office in 44.8% of legal proceedings. CONCLUSIONS: A greater representation of doctors and lawyers from the private sector can hinder equity in health. The results revealed the association between doctors and law offices on drug requests. This is an indication that justice and medical practice have been used, at certain times, to serve the interests of the pharmaceutical industry.

Médicos, advogados e indústria farmacêutica na judicialização da saúde em Minas Gerais, Brasil / Doctors, lawyers and pharmaceutical industry on health lawsuits in Minas Gerais, Southeastern Brazil / Médicos, abogados e industria farmacéutica en la judicialización de la salud en Minas Gerais, Sudeste de Brasil

OBJETIVO: Descrever as relações entre médico prescritor, advogado e indústria farmacêutica em ações judiciais contra o Estado. MÉTODOS: Estudo descritivo retrospectivo com base nas informações dos expedientes administrativos dos processos judiciais com demandas por medicamentos contra o Estado de Minas Gerais movidos entre outubro de 1999 e outubro de 2009. As variáveis estudadas foram: sexo, idade e doença dos beneficiários das ações, origem do atendimento médico (público ou privado), médico prescritor, tipo de representação jurídica e medicamento solicitado. Foi realizada análise descritiva das variáveis com a distribuição de frequências. RESULTADOS: Foram analisadas 2.412 ações judiciais referentes a 2.880 medicamentos solicitados, com 18 fármacos diferentes. Entre esses, 12 são fornecidos pelas políticas de assistência farmacêutica do Sistema Único de Saúde (SUS). Os medicamentos mais solicitados foram adalimumabe, etanercepte, infliximabe e insulina glargina. As principais doenças dos beneficiários foram artrite reumatóide, espondilite anquilosante, diabetes mellitus e doenças pulmonares obstrutivas crônicas. Houve predomínio de representação por advogados particulares e atendimento por médicos do setor privado. Entre as ações representadas pelo escritório A, 43,6% tiveram um único médico prescritor para o adalimumabe e 29 médicos foram responsáveis por 40,2% dos pedidos do mesmo fármaco. Apenas um médico foi responsável por 16,5% das prescrições de adalimumabe, solicitado por apenas um escritório particular de advocacia, em 44,8% dos pedidos. CONCLUSÕES: A maior representatividade de médicos do setor privado e advogados particulares pode trazer prejuízo à equidade. Os dados sugerem associação entre médicos e escritórios de advocacia nas solicitações dos medicamentos. Esse quadro é um indício de que a Justiça e a medicina têm sido utilizadas para atender aos interesses da indústria farmacêutica.

OBJECTIVE: To describe the relationship between the prescribing doctor, lawyer and pharmaceutical industry in lawsuits against the state. METHODS: Retrospective descriptive study based on data from administrative files, relating to lawsuits involving medicine demands, in the state of Minas Gerais, Southeastern Brazil, from October 1999 to October 2009. RESULTS: A total of 2,412 lawsuits were analyzed with 2,880 medicine requests, including 18 different drugs, 12 of them provided through Pharmaceutical Policies of the Brazilian National Health System (SUS). The most frequent medicines requested included were adalimumab, etanercept, infliximab, insulin glargine and tiotropium bromide. The main diseases were rheumatoid arthritis, ankylosing spondylitis, diabetes mellitus, and chronic obstructive pulmonary disease. Private lawyers and doctors were predominant. The results revealed the association between doctors and law offices on drug requests. Among the lawsuits filed by the office A, 43.6% had a single prescriber to adalimumab, while 29 doctors were responsible for 40.2% of the same drug prescriptions. A single doctor was responsible for 16.5% of the adalimumab prescriptions, being requested through lawsuits filed by a single private law office in 44.8% of legal proceedings. CONCLUSIONS: A greater representation of doctors and lawyers from the private sector can hinder equity in health. The results revealed the association between doctors and law offices on drug requests. This is an indication that justice and medical practice have been used, at certain times, to serve the interests of the pharmaceutical industry.

OBJETIVO: Describir las relaciones entre médico prescriptor, abogado e industria farmacéutica en acciones judiciales contra el Estado. MÉTODOS: Estudio descriptivo retrospectivo con base en las informaciones de los expedientes administrativos de los procesos judiciales con demandas por medicamentos contra el Estado de Minas Gerais, Sudeste de Brasil, movidos entre octubre de 1999 y octubre de 2009. Las variables estudiadas fueron: sexo, edad y enfermedad de los beneficiarios de las acciones, origen de la atención médica (público o privado), médico prescriptor, tipo de representación jurídica y medicamento solicitado. Se realizó análisis descriptivo de las variables con la distribución de frecuencias. RESULTADOS: Los medicamentos más solicitados fueron adalimumabe, etanercepte, infliximabe e insulina glargina. Las principales enfermedades de los beneficiarios fueron artritis reumatoide, espondilitis anquilosante, diabetes mellitus y enfermedades pulmonares obstructivas crónicas. Hubo predominio de representación por abogados particulares y atención por médicos del sector privado. Entre las acciones representadas por la oficina A, 43,6% tuvieron un único médico prescriptor para el adalimumabe, y 29 médicos fueron responsables por 40,2% de los pedidos del mismo fármaco. Sólo un médico fue responsable por 16,5% de las prescripciones de adalimumabe, solicitado por sólo una oficina particular de abogacía, en 44,8% de los pedidos. CONCLUSIONES: La mayor representatividad de médicos del sector privado y abogados particulares pudo traer perjuicio a la equidad. Los datos sugieren asociación entre médicos y oficinas de abogacía en las solicitudes de medicamentos. Este escenario es un indicio de que la justicia y la medicina han sido utilizadas para atender a los intereses de la industria farmacéutica.

Potentially inappropriate medication use in a city of Southeast Brazil

Potentially inappropriate medication use by the Diamantina (Minas Gerais State) population was investigated by analyzing medicine consumption, self-medication, polypharmacy and drug interactions of medicines prescribed among those interviewed. Level of knowledge about rational drug use and its relationship to socio-economic variables was also evaluated using a semi-structured questionnaire. This survey was based on stratified sampling of 423 individuals selected randomly. The prevalence of prescription drug consumption was 42.32% (n=179) and cardiovascular drugs were the most prescribed. Drug interactions were found in 45.81% (n=82) of prescriptions and 92.68% (n=76) of these interactions were moderate, with co-administration of cardiovascular drugs occurring in more than half of the cases. The inappropriate use of medication, according to Beers criteria, occurred in 44.73% of prescriptions to the elderly. The prevalence of self-medication was 63.34% (n=268) while 21.99% (n=91) of individuals administered medications to their children without formal prescriptions, where this practice was associated to analgesic/antipyretic consumption. The population showed a high prevalence of inappropriate use of drugs across all strata of society, representing an issue requiring effective actions to promote rational use of medicines.

O consumo inapropriado de medicamentos pela população de Diamantina-MG foi investigado através da análise do consumo de medicamentos, automedicação, polifarmácia e interações medicamentosas prescritas aos entrevistados. Também foi avaliado o nível de conhecimento sobre uso racional de medicamentos e sua relação com variáveis sócio-econômicas através de um questionário semi-estruturado. Este estudo transversal foi baseado em amostragem estratificada e contou com a participação de 423 indivíduos selecionados aleatoriamente. A prevalência do consumo de medicamentos prescritos foi de 42,32% (n=179), sendo os medicamentos cardiovasculares os mais prescritos. Entre as prescrições foram encontradas 45,81% (n=82) de interações medicamentosas, sendo 92,68% (n=76) destas interações moderadas e a co-administração de medicamentos cardiovasculares presente em mais da metade dos casos. O uso inadequado de medicamentos, segundo os critérios de Beers, esteve presente em 44,73% das prescrições de idosos. Com relação à automedicação, 63,34% (n=268) dos entrevistados admitem fazer uso de medicamento sem prescrição e 21,99% (n=91) administram medicamentos aos filhos sem prescrição profissional, sendo os analgésicos e antitérmicos os mais comumente administrados em ambas as situações. A população avaliada apresentou alta prevalência de uso inadequado de medicamentos observados em todas as camadas da sociedade, sendo necessário estabelecer medidas eficazes para promoção do uso racional de medicamentos.