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Objectives: Budget Impact Analyses (BIA) of medicines helps managers in promoting health systems’ sustainability when assessing the role and value of new medicines. However, it is not clear whether BIAs typically underestimate or overestimate the impact on real-world budgets. This retroactive analysis seeks to compare estimated values obtained by a BIA and Real-World Evidence (RWE) to guide discussions. Methods: The estimated values were obtained through a BIA concerning the incorporation of adalimumab for the treatment of Rheumatoid Arthritis into the Brazilian Unified Health System (SUS) carried out retroactively and per international guidelines. RWE data was extracted from SUS computerized systems. We subsequently compared the number of treatments, costs, and Incremental Budget Impact (IBI). Results–The total number of treatments was underestimated by 10% (6,243) and the total expenditure was overestimated by 463% (US$ 4.7 billion). In five years, the total difference between the estimated values and real IBI reached US$ 1.1 billion. A current expenditure of US$ 1.0 was observed for every US$ 5.60 of estimated expenditure. Conclusion–The higher estimates from the BIA might cause decision makers to be more cautious with the introduction of a new medicine to reduce the opportunity costs for other interventions.

Objectives The study aim was to identify key factors associated with the health-related quality of life (HRQOL) of patients with type 1 diabetes mellitus (T1DM) treated with neutral protamine Hagedorn (NPH) insulin or human insulin analog glargine (IGLA). Methods We conducted two cross-sectional studies in Minas Gerais State, Brazil. One with 401 patients treated with IGLA, and the other with 179 T1DM patients treated with NPH. HRQOL was measured by Euroqol (EQ-5D-3L). Key findings Most participants were male (51%), aged between 18 and 40 years (47%), non-black (58%) and from the highest economic strata (A1-B2) (74%). Participants perceived their health as good/very good (51%), had one to three medical consultations in the previous year (51%), were not hospitalized in the previous year (74%), did not report angina (96%), diabetic neuropathy (90%), hearing loss (94%) or kidney disease (89%). Non-severe hypoglycaemia episodes in the last 30 days were reported by 17% of participants. Conclusions Higher HRQOL was associated with younger age (18–40 years), good/very good health self-perception, having had up to three medical consultations in the last year, not being hospitalized in the last year, having none to three comorbidities, not reporting angina, diabetic neuropathy, hearing loss or kidney disease and having had episodes of non-severe hypoglycaemia. In addition, the findings of our study demonstrated inequalities in access to treatment, which will be the subject of future research projects.

Aim: Access to essential medicines is a key component of managing patients in ambulatory care. In 2008, the State of Minas Gerais, Brazil, created the Pharmacy Network of Minas (Rede Farmácia de Minas [RFM]) program to improve access to medicines, increasing availability and restructuring the infrastructures. The aim was to assess the current situation, comparing municipalities with and without RFM. Materials & methods: Descriptive survey study, data collected from 2014 July to May 2015. Availability was verified by stock levels. Results: The drug availability index was 61.0%, higher in municipalities with RFM. Most physicians considered the pharmaceutical services as good/very good. The main reasons for medicines shortage were ‘financial transference problems’, ‘insufficient financial resources’ and ‘budget’. Conclusion: Strategies, such as the RFM can promote improvements in medicine availability.

Objectives The aim of this study was to evaluate the federal government expenditures with oncological care, for the most incident cancer types among the Brazilian population, using registries of all patients treated by the Brazilian National Health Service (SUS) between 2001 and 2015. We adopted the formal healthcare sector perspective in this study, with the costs per patient estimated by the reimbursement price paid by the Ministry of Health to service providers. Methods The costs were adjusted by the follow-up time for each patient. We performed multivariate regression analysis using ordinary least squares. We analyzed 952 960 patients aged ≥19 years who underwent cancer treatment, between 2001 and 2015, for breast, prostate, colorectal, cervix, lung, and stomach cancers. Results The annual mean costs per patient (in USD purchasing power parity) was $9572.30, varying from $5782.10 for breast cancer to $16 656 for cervical cancer. Several variables predicted higher costs of cancer treatment, namely: to be male (+14%), with younger age ranges at treatment initiation, resident in the Northeast region (+26%), treated for colorectal cancer (+482%), with treatment initiation from 2010 to 2014, tumor stages III and IV (III: +182%; IV: +165%), hospitalization for other reasons besides the cancer treatment, and suffering from some a comorbidity. Conclusions Given the forthcoming Brazilian demographic changes, which strongly suggest that the economic burden of cancer is about to increase in the near future, our estimates provide relevant information to produce useful projections about future cancer-related costs.

Objectives In Brazil, specialty medicines for rheumatoid arthritis (RA) treatment are provided by the national health system (NHS) according to mandatory protocols. Knowing the rules for prescription of these biological agents is crucial to ensuring patient access to treatment. This study aims to evaluate the feasibility of an academic detailing strategy to promote the quality use of the medicines available in NHS among prescribers. Methods Forty-three specialists and general practitioners were visited by researchers to perform an academic detailing of the Clinical Protocols and Therapeutic Guidelines (PCDT) for RA adopted by NHS. After the visits, a survey was performed with prescribers to measure their perception in terms of satisfaction and information reliability with the academic visits. At the end, we perform a cost analysis to permit comparisons of this strategy with other educational activities. Key findings From 43 physicians that were visited, 28 responded to the telephone survey. Of these, 68% were very satisfied with the visit, 50% rated the content of the visit relevant to their practice, 64.3% agreed the duration of the visit did not affect their work, 60.7% agreed the distributed material would be useful for their professional practice, and 57.1% agreed that the visits added to their knowledge. A total of USDPPP 162.96 per prescriber (USDPPP 7,007.20, BRL14,185.00) were spent on the program. Conclusion The prescribers visited represent a large number of deferrals for the Specialized Component of Pharmaceutical Care (CEAF) drug applications. Therefore, the total amount spent on the implementation of this program and its potential for improving access to these medicines has the possibility to have a positive impact on the targeting of public expenditures and avoiding litigation against NHS. Academic detailing has the capability to become an effective strategy for PCDT dissemination and implementation.

Background The bioethical debate in the world on who should pay for the continuity of post-trials treatment of patients that have medical indication remains obscure and introduces uncertainties to the patients involved in the trials. The continuity of post-trial treatment was only incorporated in the 2000s by the Helsinki Declaration. The Universal Declaration on Bioethics and Human Rights, published in 2006, points out that post-trial continuity may present a broader scope than just the availability of the investigated medicine. In the latest version of this Declaration, in 2013, it was stated that “prior to the start of the clinical trial, funders, researchers and governments of the countries participating in the research should provide post-trial access for all participants who still require an intervention that was identified as beneficial. This information should also be disclosed to participants during the informed consent process”. However, a systematic review on the registration of phase III and IV clinical trials, from the clinical trials website, demonstrated that the understanding of the various guidelines and resolutions is conflicting, generating edges in the post-trial setting. For the health authorities of countries where clinical trials take place, the uncertainties about the continuity of the treatments generate gaps in care and legal proceedings against health systems, which are forced to pay for the treatments, even if they are not included in the list of medicines available to the population. Methods Fifty-one representatives from the health, judicial, legislative, patient and academic organizations of eight countries of Latin American and South Korea took part in a meeting in Chile, in 2017, to discuss the responsibility of the treatment continuation after clinical trials. From a hypothetical case of development of a new drug and its studies of efficacy and safety, the participants, divided in groups, proposed recommendations for the problem and pointed out the pros and cons of adopting each recommendation. The groups were, afterwards, confronted by a simulated jury and, finally, issued a final recommendation for the problem. Then, an analysis was made on the content of the recommendations and the pros and cons in adopting conservative or liberal positions, besides the possible impacts of a restrictive regulation regarding the conduction of clinical trials, pointed out by the groups, before and after the simulated jury. Results The theme was widely discussed and about 12 recommendations were proposed by the participants. The main ones took into account aspects related to patients’ rights, economic factors and the development of new technologies, above the position of industry and research institutes, as well as the legislation in force in each country. Conclusion The countries of Latin America and South Korea, currently, do not have laws that address patients’ rights, moreover, there is no definition on who should be responsible for post-trial treatments. It is suggested that the World Health Organization issue a resolution recommending that all associated countries determine that the pharmaceutical and medical device industries, or those that sponsored it, should continue to provide treatment to all patients who participated in clinical trials and have medical indication to the continuity.

In 2008, the Programa Rede Farmácia de Minas (RFM, literally translated: ‘Minas Gerais Pharmacy Network’ program) was created as a strategy to expand access to medicines. Aim: Measure access to medicines in public pharmacies through comparison between municipalities that joined or not the RFM. Materials & methods: Cross-sectional, evaluative study, gathering information from a representative sample of the municipalities in Minas Gerais between July 2014 and May 2015. The Poisson regression results were obtained by calculating the prevalence ratios. Results: Adequate access to medicines in Minas Gerais was 69.9%, being 75.8% in municipalities with and 69.2% without the RFM. The municipalities with the RFM showed statistically higher percentages in the Availability, Adequacy/Accommodation, and Acceptability dimensions. Conclusion: RFM appears an efficient strategy for promoting access to medicines.

Introduction: The new coronavirus pandemic has appreciably impacted on morbidity and mortality as well as having appreciable economic impact worldwide. New vaccines are a potential way forward to reduce transmission rates and their subsequent impact. In Brazil vaccines are being distributed via the public sector. In the future, vaccines will be available in the private market. Information about consumers' willingness to pay (WTP) for a hypothetical vaccine against SARS CoV-2 can help future price setting discussions. Methods: A cross-sectional study was conducted with consumers in the five regions of Brazil regarding the willingness to pay (WTP) for a hypothetical vaccine against SARS CoV-2 with a 50% efficacy. Results: A total of 1402 individuals over 18 years of age who declared not having COVID-19 at the time of the survey were interviewed. The acceptability for this hypothetical vaccine was 80.7%. In addition, the amount of WTP by Brazilian consumers for a hypothetical SARS CoV-2 vaccine was estimated at US$ 22.18(120.00 BRL). Conclusion: This study can contribute to decision-making to inform potential pricing for a hypothetical SARS CoV-2 vaccine.

Objective: To evaluate the influence of organizational structure and technical-management activities on the availability of essential medicines in the primary healthcare. Materials & methods: Cross-sectional, exploratory and evaluative study. The availability was evaluated according to parameters established by the WHO. Results: The average availability of standardized essential medicines was 83.3 and 73.3% for medicines purchased centrally by the Brazilian government. Among the therapeutic groups evaluated, the lowest average availability were for the tuberculostatics (24.1%) and psychotropic/special control medicines (30.3%). Conclusion: The availability of essential medicines was positively influenced by the presence of the pharmacist and by the computerized system deployed, and negatively associated with essential medicines purchased centrally by the federal government, especially in the smaller municipalities.

Objective: To analyze cancer-specific mortality (CSM) and other-cause mortality (OCM) among patients with prostate cancer that initiated treatment in the Brazilian Unified Health System (SUS), between 2002 and 2010, in Brazil. Methods: Retrospective observational study that used the National Oncological Database, which was developed by record-linkage techniques used to integrate data from SUS Information Systems, namely: Outpatient (SIA-SUS), Hospital (SIH-SUS), and Mortality (SIM-SUS). Cancer-specific and other-cause survival probabilities were estimated by the time elapsed between the date of the first treatment until the patients’ deaths or the end of the study, from 2002 until 2015. The Fine-Gray model for competing risk was used to estimate factors associated with patients’ risk of death. Results: Of the 112,856 studied patients, the average age was 70.5 years, 21% died due to prostate cancer, and 25% due to other causes. Specific survival in 160 months was 75%, and other-cause survival was 67%. For CSM, the main factors associated with patients’ risk of death were: stage IV (AHR = 2.91; 95%CI 2.73 - 3.11), systemic treatment (AHR = 2.10; 95%CI 2.00 - 2.22), and combined surgery (AHR = 2.30, 95%CI 2.18 - 2.42). As for OCM, the main factors associated with patients’ risk of death were age and comorbidities. Conclusion: The analyzed patients with prostate cancer were older and died mainly from other causes, probably due to the presence of comorbidities associated with the tumor. RESUMO: Objetivo: Analisar a mortalidade câncer-específica (MCE) e a mortalidade por outras causas (MOC) em pacientes diagnosticados com câncer da próstata que iniciaram tratamento no Sistema Único de Saúde (SUS) entre 2002 e 2010, no Brasil. Métodos: Estudo observacional retrospectivo utilizando a “Base Nacional em Oncologia”, desenvolvida por meio de pareamento determinístico-probabilístico dos sistemas de informação do SUS: Ambulatorial (SIA), Hospitalar (SIH) e de Mortalidade (SIM). Probabilidades de sobrevivência específicas do câncer e por outras causas foram estimadas pelo tempo decorrido entre a data do primeiro tratamento até a morte do paciente ou o final do estudo, de 2002 a 2015. O modelo de riscos competitivos de Fine & Gray foi utilizado para estimar os fatores associados ao risco de morte do paciente. Resultados: Dos 112.856 pacientes estudados, a idade média foi de 70,5 anos, 21% foi a óbito devido ao câncer de próstata e 25% por outras causas. A probabilidade de sobrevida específica em160 meses foi de 75% e a por outras causas de 67%. Na CSM, os principais fatores associados ao risco de óbito dos pacientes foram: estágio IV (AHR = 2,91; IC95% 2,73 - 311), tratamento sistêmico (AHR = 2,10; IC95% 2,00 - 2,22) e cirurgia combinada (AHR = 2,30; IC95% 2,18 - 2,42). Na MOC, os principais fatores associados ao risco de óbito do paciente foram idade e comorbidades. Conclusão: Os pacientes com câncer da próstata analisados mostraram-se mais velhos e faleceram principalmente por outras causas, provavelmente devido às comorbidades associadas ao tumor.

Introduction: Antipsychotics are widely prescribed for patients with schizophrenia. The Brazilian public health system provides these patients free of charge to patients and it is pertinent to evaluate their benefits. Objective: To evaluate the effectiveness of olanzapine and risperidone in the treatment of patients with schizophrenia in the real world and assessing risk factors for their discontinuation through a national non-concurrent cohort with 16 years of follow-up. Methods: Three SUS administrative databases were integrated by deterministic-probabilistic linkage. After, patients were matched (1:1) for psychiatric hospitalization, year of receiving the antipsychotic, sex and age, considering either olanzapine or risperidone at study entry. Kaplan-Meier was used to estimate the cumulative probabilities of discontinuation of treatment and associated factors were identified. Sensitivity analyzes were performed. Results: 3416 pairs of patients were included. Olanzapine had a longer time until discontinuation of treatment (p = 0.021), and risperidone had a higher risk of discontinuation (p = 0.021). Among patients persistent for at least 24 months, there was no statistically significant difference. Conclusion: Olanzapine demonstrated superior real-world effectiveness over risperidone, in terms of survival and psychiatric hospitalization. This superiority was not sustained in all analyzes.

Objective To evaluate factors related to liver graft survival with a focus on immunosuppressive schemes based on calcineurin inhibitors (tacrolimus or cyclosporine). Methodology This study was carried out through an open cohort constructed by deterministic and probabilistic matching through three databases of the SUS with assessment of liver graft survival from 2000 to 2015 in Brazil. From this first cohort, a second cohort was constructed by pairing 1: 1 to more precisely assess the effect of the immunosuppressive scheme on graft survival. The Kaplan-Meier method and was used to estimate the probability of survival. Cox's model of proportional risks was used to assess factors related to graft loss. Result We found 12,687 patients in the Full cohort and 470 patients in the Matched cohort. The overall graft survival rates at 1, 5, 10, and 16 years were 72.6, 63.3, 52.8, and 45.3%, respectively. Patients younger had a longer graft survival than older ones. In the Full cohort, male patients had a higher survival rate than female ones. Therapeutic schemes based on tacrolimus were more prevalent and had a better survival rate when compared to schemes that used cyclosporine. Tacrolimus without association with antiproliferative agents or rapamycin inhibitors was the therapeutic scheme associated with greater survival rate in both cohorts (HR = 0.81, 95% CI = 0.72-0.91), (HR = 0.50, 95% CI = 0.30-0.85). In addition, white-skinned patients had longer survival rate in both cohorts (HR = 0.55, 95% CI = 0.50-0.61 and HR = 0.50, 95% CI = 0.34-0.75). On the other hand, patients who a greater time ratio without using an immunosuppressant had lower graft survival rate (HR = 6.46, 95% CI = 5.05-8.27 and HR = 6.57, 95% CI = 2.66-16.22). Conclusion This 16-year cohort showed that the older age and the greater time ratio without using an immunosuppressant are risk factors for liver graft loss. White-skinned patients and tacrolimus-based regimens, especially tacrolimus without other immunosuppressants, are factors of better prognosis to the graft.

BackgroundRelapsing-remitting multiple sclerosis (RRMM) is a chronic, progressive, inflammatory and immune-mediated disease that affects the central nervous system and is characterized by episodes of neurological dysfunction followed by a period of remission. The pharmacological strategy aims to delay the progression of the disease and prevent relapse. Interferon beta and glatiramer are commonly used in the Brazilian public health system and are available to patients who meet the guideline criteria. The scenario of multiple treatments available and in development brings the need for discussion and evaluation of the technologies already available before the incorporation of new drugs. This study analyses the effectiveness of first-line treatment of RRMS measured by real-world evidence data, from the Brazilian National Health System (SUS).Methods and findingsWe conducted a non-concurrent national cohort between 2000 and 2015. The study population consisted of 22,722 patients with RRMS using one of the following first-line drugs of interest: glatiramer or one of three presentations of interferon beta. Kaplan-Meier analysis was used to estimate the time to treatment failure. A univariate and multivariate Cox proportional hazard model was used to evaluate factors associated with treatment failure. In addition, patients were propensity score-matched (1:1) in six groups of comparative first-line treatments to evaluate the effectiveness among them. The analysis indicated a higher risk of treatment failure in female patients (HR = 1.08; P = 0,01), those with comorbidities at baseline (HR = 1.20; PConclusionsThis retrospective cohort suggests that glatiramer is associated with greater effectiveness compared to the three presentations of interferon beta. When evaluating beta interferons, the results suggest that the intramuscular presentation is not effective in the treatment of multiple sclerosis.

Healthcare is receiving many improvements from real world evidence. The advances in data management and machine learning models are driving better resources to support decision making. One of the most common techniques to develop recommendations and guidelines to physicians is through systematic reviews. To evaluate the quality of the evidence, among other methods, the researchers uses the Risk of Bias Assessment. Besides, that method is widely used and provides good results it has been done manually by researchers. This work provides the MCRB a multiclassifier tool for the risk of bias assessment using machine learning techniques. The software was tested with four machine learning models: Logistic Regression, SVM, Naive Bayes, and XGBoost. The results show that is quite possible to classify well the seven dimensions of the problem with a macro average AUC Score of 75%

Background: There are many health benefits since 31 years after the foundation of the National Health Service (NHS) in Brazil, especially the increase in life expectancy. However, family-income inequalities, insufficient funding, and suboptimal private sector–public sector collaboration are still areas for improvement. The efforts of Brazil to achieve universal health coverage (UHC) for medicines have resulted in increased public financing of medicines and their availability, reducing avoidable hospitalization and mortality. However, lack of access to medicines still remains. Due to historical reasons, pharmaceutical service organization in developing countries may have important differences from high-income countries. In some cases, developing countries finance and promote medicine access by using the public infrastructure of health care/medical units as dispensing sites and cover all costs of medicines dispensed. In contrast, many high-income countries use private community pharmacies and cover the costs of medicines dispensed plus a fee, which includes all logistic costs. In this study, we will undertake an economic evaluation to understand the funding needs of the Brazilian NHS to reduce inequalities in access to medicines through adopting a pharmaceutical service organization similar to that seen in many high-income countries with hiring/accrediting private pharmacies. Methods: We performed an economic evaluation of a model to provide access to medicines within public funds based on a decision tree model with two alternative scenarios public pharmacies (NHS, state-owned facilities) versus private pharmacies (NHS, agreements). The analysis assumed the perspective of the NHS. We identified the types of resources consumed, the amount, and costs in both scenarios. We also performed a budget impact forecast to estimate the incremental funding required to reduce inequalities in access to essential medicines in Brazil. Findings: The model without rebates for medicines estimated an incremental cost of US$3.1 billion in purchasing power parity (PPP) but with an increase in the average availability of medicines from 65% to 90% for citizens across the country irrespective of family income. This amount places the NHS in a very good position to negotiate extensive rebates without the need for external reference pricing for government purchases. Forecast scenarios above 35% rebates place the alternative of hiring private pharmacies as dominant. Higher rebate rates are feasible and may lead to savings of more than US$1.3 billion per year (30%). The impact of incremental funding is related to medicine access improvement of 25% in the second year when paying by dispensing fee. The estimate of the incremental budget in five years would be US$4.8 billion PPP. We have yet to explore the potential reduction in hospital and outpatient costs, as well as in lawsuits, with increased availability with the yearly expenses for these at US$9 billion and US$1.4 billion PPP respectively in 2017. Interpretation: The results of the economic evaluation demonstrate potential savings for the NHS and society. Achieving UHC for medicines reduces household expenses with health costs, health litigation, outpatient care, hospitalization, and mortality. An optimal private sector–public sector collaboration model with private community pharmacy accreditation is economically dominant with a feasible medicine price negotiation. The results show the potential to improve access to medicines by 25% for all income classes. This is most beneficial to the poorest families, whose medicines account for 76% of their total health expenses, with potential savings of lives and public resources.

The maintenance of patients with renal transplant typically involves two or more drugs to prevent rejection and prolong graft survival. The calcineurin inhibitors (CNI) are the most commonly recommended medicines in combinations with others. While immunosuppressive treatment regimens are well established, there is insufficient long-term effectiveness data to help guide future management decisions. The study analyzes the effectiveness of treatment regimens containing CNI after renal transplantation during 16 years of follow-up with real-world data from the Brazilian National Health System (SUS). This was a retrospective study of 2318 SUS patients after renal transplantion. Patients were propensity score-matched (1:1) by sex, age, type and year of transplantation. Kaplan&ndash, Meier analysis was used to estimate the cumulative probabilities of survival. A Cox proportional hazard model was used to evaluate factors associated with progression to graft loss. Multivariable analysis, adjusted for diabetes mellitus and race/color, showed a greater risk of graft loss for patients using tacrolimus plus mycophenolate compared to patients treated with cyclosporine plus azathioprine. In conclusion, this Brazilian real-world study, with a long follow-up period using matched analysis for relevant clinical features and the representativeness of the sample, demonstrated improved long-term effectiveness for therapeutic regimens containing cyclosporine plus azathioprine. Consequently, we recommend that protocols and clinical guidelines for renal transplantation should consider the cyclosporine plus azathioprine regimen as a potential first line option, along with others.

Background Schizophrenia is associated with significant economic burden. In Brazil, antipsychotic drugs and outpatient and hospital services are provided by the Brazilian National Health System (SUS) for patients with schizophrenia. However, few studies capture the cost of managing these patients within the Brazilian NHS. This is important to appraise different management approaches within universal healthcare systems. Objective Our objective was to use real-world data to describe the costs associated with the treatment of schizophrenia in adults receiving atypical antipsychotics in Brazil from 2000 to 2010. Methods We integrated three national databases for adult patients with schizophrenia receiving one or more atypical antipsychotics. We assessed only direct medical costs and the study was conducted from a public-payer perspective. A multivariate log-linear regression model was performed to evaluate associations between costs and clinical and demographic variables. Results We identified 174,310 patients with schizophrenia, with mean ± standard deviation (SD) annual costs of $US1811.92 ± 284.39 per patient. Atypical antipsychotics accounted for 79.7% of total costs, with a mean annual cost per patient of $US1578.74 ± 240.40. Mean annual costs per patient were $US2482.90 ± 302.92 for psychiatric hospitalization and $US862.96 ± 160.18 for outpatient psychiatric care. Olanzapine was used by 47.7% of patients and represented 62.8% of the total costs of atypical antipsychotics. Patients who used clozapine had the highest mean annual cost per patient for outpatient psychiatric care and psychiatric hospitalization. Conclusions Atypical antipsychotics were responsible for the majority of the schizophrenia treatment costs, and psychiatric hospitalization costs were the highest mean annual cost per patient. Authorities should ensure efficient use of atypical antipsychotics and encourage outpatient psychiatric care over psychiatric hospitalization where possible. Electronic supplementary material The online version of this article (10.1007/s40258-018-0408-4) contains supplementary material, which is available to authorized users.

Background: Diabetes mellitus type 1 (DM1) is an autoimmune disease characterized by metabolic destruction of pancreatic cells responsible for insulin production, with treatment based on replacing insulin. Long-acting insulin analogs are indicated for patients with DM1 who exhibit important oscillations of their daily glycemia, despite its higher cost. Our study objective was to evaluate the effectiveness and safety of two long-acting insulins, insulin glargine and detemir, in treating patients with DM1. Methods: We undertook a systematic review with meta-analysis of observational studies (cohort and registry) available in the databases and the gray literature, and a complementary search in the Diabetes Care journal. Outcomes assessed were: glycated hemoglobin concentration; fasting plasma or capillary glucose; occurrence of episodes of severe hypoglycemia and occurrence of nocturnal hypoglycemia. The assessment of methodological quality was performed using the Newcastle score. The meta-analyses were performed on software Review Manager® 5.2. Results: Out of 705 publications, 8 cohort studies were included. The quality of these studies was classified as high. In the meta-analysis, results regarding episodes of severe hypoglycemia ( p = 0.02) and fasting glucose ( p = 0.01) were in favor of detemir. The glycated hemoglobin ( p = 0.49; I2 = 89) showed high heterogeneity and no statistically significant difference between the two. The meta-analysis of total insulin dose favored glargine ( p = 0.006; I2 = 75). The rates of nocturnal hypoglycemia (NH) were evaluated only for one study and showed a significant reduction of NH after therapy with detemir, ( p < 0.0001). Conclusion: Although some outcomes were favorable to detemir insulin analog, it has not been possible to identify important differences of effectiveness and safety between the two analogs. These results can help in the current debate on the inclusion of long-acting analogs on the list of reimbursed medicines in Brazil, especially with the recent introduction of an insulin glargine biosimilar at a considerably lower price.

Introduction and objectives: Stains have become an integral part of treatment to reduce cardiac events in patients with cardiovascular disease. However, their use within the public healthcare system in Brazil is unknown. Consequently, we sought to determine and characterize statin use in primary healthcare delivered by the public health system (SUS) in Brazil and evaluate associated patient factors to improve future use. Methods: Cross-sectional study with a national representative sample from five Brazilian regions, derived from the National Survey on Access, Use and Promotion of Rational Use of Medicines using a multi-stage complex sampling plan. Patients over 18 years old were interviewed from July/2014 to May/2015. Prevalence of statin use and statins’ self-reported adherence were determined amongst medicine users. The association between statin use and sociodemographic/health condition variables were assessed using logistic regression. Results: 8,803 patients were interviewed; of which, 6,511 were medicines users. The prevalence of statins use was 9.4% with simvastatin (90.3%), atorvastatin (4.7%) and rosuvastatin (1.9%) the most used statins. Poor adherence was described by 6.5% of patients. Statins use was significantly associated with age ≥65 years old, higher educational level, residence in the South, metabolic and heart diseases, alcohol consumption and polypharmacy. Conclusions: This is the first population based study in Brazil to assess statin use in SUS primary healthcare patients. Addressing inequalities in access and use of medicines including statins is an important step in achieving the full benefit of statins in Brazil, with the findings guiding future research and policies.

Introduction Insulin analog glargine (GLA) has been available as one of the therapeutic options for patients with type 1 diabetes mellitus to enhance glycemic control. Studies have shown that a decrease in the frequency of hypoglycemic episodes improves the quality of life (QoL) of diabetic patients. However, there are appreciable acquisition cost differences between different insulins. Consequently, there is a need to assess their impact on QoL to provide future guidance to health authorities. Method A systematic review of multiple databases including Medline, LILACS, Cochrane, and EMBASE databases with several combinations of agreed terms involving randomized controlled trials and cohorts, as well as manual searches and gray literature, was undertaken. The primary outcome measure was a change in QoL. The quality of the studies and the risk of bias was also assessed. Results Eight studies were eventually included in the systematic review out of 634 publications. Eight different QoL instruments were used (two generic, two mixed, and four specific), in which the Diabetes Treatment Satisfaction Questionnaire (DTSQ) was the most used. The systematic review did not consistently show any significant difference overall in QoL scores, whether as part of subsets or combined into a single score, with the use of GLA versus neutral protamine Hagedorn (NPH) insulin. Only in patient satisfaction measured by DTSQ was a better result consistently seen with GLA versus NPH insulin, but not using the Well-being Inquiry for Diabetics (WED) scale. However, none of the cohort studies scored a maximum on the Newcastle–Ottawa scale for quality, and they generally were of moderate quality with bias in the studies. Conclusion There was no consistent difference in QoL or patient-reported outcomes when the findings from the eight studies were collated. In view of this, we believe the current price differential between GLA and NPH insulin in Brazil cannot be justified by these findings. Electronic supplementary material The online version of this article (10.1007/s40271-017-0291-3) contains supplementary material, which is available to authorized users.

RESUMO: Introdução: O uso inadequado e o crescimento dos gastos em saúde reforçam a necessidade de ampliar o conhecimento sobre a qualidade de uso de medicamentos. Objetivos: Descrever e avaliar o perfil de utilização de medicamentos em uma amostra representativa de usuários adultos da atenção primária do Sistema Único de Saúde (SUS) de Minas Gerais. Método: Estudo transversal, com 1.159 entrevistados em 104 municípios e 253 serviços de saúde. Foram coletados dados sobre características sociodemográficas, condições de saúde e uso de medicamentos, sendo essas características estratificadas por faixas etárias. Análises univariada e multivariada, por meio de regressão logística, foram conduzidas para identificar preditores de automedicação. Para todos os testes, foi adotado o nível de significância de 5%. Resultados: A prevalência de uso de medicamentos foi de 81,8%, com média de 2,67 medicamentos por usuário, que aumenta com a faixa etária. Os medicamentos mais utilizados foram losartana, hidroclorotiazida e sinvastatina, com diferenças entre as faixas etárias. Observou-se automedicação significativa não só em adultos jovens, mas também entre idosos. Os preditores de automedicação foram: ser adulto jovem, ter maior nível de escolaridade, não apresentar doenças crônicas, ter pior autopercepção de saúde e não aderir a medicamentos prescritos. Adultos jovens e idosos apresentaram características que os tornaram mais vulneráveis em relação ao uso racional de medicamentos. Conclusão: O estudo pode contribuir para melhorar o cuidado na atenção primária, pois identificou problemas relevantes relacionados à qualidade do uso de medicamentos, especialmente entre adultos jovens e idosos em Minas Gerais. ABSTRACT: Introduction: Inappropriate use and increase of health care spending reinforce the need to extend our knowledge about the quality of medication use. Objectives: To describe and evaluate the profile of medication use in a representative sample of adult users of primary care services in the Unified Health System (SUS) of Minas Gerais. Method: Cross-sectional study, with 1,159 interviewees in 104 municipalities and 253 health care services. Data on sociodemographic characteristics, health conditions and use of medicines were collected, and these variables were stratified by age group. Univariate and multivariate analyses, using logistic regression, were conducted to identify predictors of self-medication. We set a significance level of 5% for all tests. Results: The prevalence of medication use was 81.8%, with an average of 2.67 medicines per user, which increased with age. The most used drugs were losartan, hydrochlorothiazide and simvastatin, which differed between age groups. Significant self-medication was observed not only in young adults but also in the elderly. The predictors of self-medication were: being a young adult, having a higher level of education, not having chronic diseases, having worse self-perception of health and not adhering to prescription drugs. Young and elderly adults showed characteristics that made them more vulnerable in relation to the rational use of medicines. Conclusion: This study can contribute to improving primary care, where it identified problems related to the extent of medication use, especially among young adults and the elderly in Minas Gerais.

Aim: Creation of a single indicator of access to medicines. Methods: Data collection was performed with individuals who obtained their medication from either public and/or private pharmacies. A Likert scale was used to measure the importance and satisfaction in relation to various access dimensions. Results: A total of 580 individuals were interviewed. Overall, participants attributed very similar importance scores to the dimensions of access to medicines. The results of the mean score of each dimension showed a statistically significant difference according to the type of pharmacy that the participant visited. Conclusion: This developed indicator will enable a review of access to medicines, making comparisons possible as well as improving decision making about public policies in the field of Pharmaceutical Services.

To evaluate the persistence of biological drugs used as the first line of biological treatment in patients diagnosed with rheumatoid arthritis. The predictors associated with persistence have also been verified.We evaluated a historical cohort composed of users of the Brazilian National Health System in the period between 2006 January and 2014 December. The endpoint was the medication persistence at 12 months.A population composed of 66,787 individuals started the first line of biological drug. Out of such individuals, 34,595 (51.80%) persisted in the treatment at 12 months. Abatacept was the drug that presented higher persistence, followed by golimumab, tocilizumab, etanercept, and adalimumab and, with lower persistence certolizumab and infliximab. Younger individuals, living in regions with higher social inequality by Gini coefficient, using certolizumab and infliximab in comparison with adalimumab presented a higher risk of non-persistence to treatment. Individuals from the Southeastern region were more persistent than Northeastern, Central-western, Northern and Southern regions.The medication persistence was different between biological drugs. The rigorous follow-up of patients, by a multidisciplinary team, is important to enable the development of strategies for the adequate use of such drugs.

Introduction: Vildagliptin is an inhibitor of the enzyme dipeptidyl peptidase 4, indicated for the treatment of type 2 diabetes mellitus, combined or not with metformin. This study aims to evaluate the cost-effectiveness of vildagliptin in the Brazilian context. Areas covered: Using MEDLINE, Cochrane Library, Lilacs and CRD, six studies were selected for the economic models. This study utilised cost data in the Brazilian health system to provide the context. Expert commentary: Type 2 diabetes mellitus is an epidemic disease and represents a challenge for all health care systems. Although guidelines clearly define first-line treatment, there are several other promising treatments. Vildagliptin is one of them, resulting in a mean lifetime increase of 0.31 years compared to metformin alone and 1.19 more life years compared to other metformin combinations. Considering observational data, life years with dual vildagliptin-containing treatments were 0.37 more compared to other dual treatments. However, its high cost versus generic metformin and its unclear safety profile weakens its subsequent cost-effectiveness. Consequently, the incorporation of vildagliptin or its combination with metformin is currently not recommended for the Brazilian Health Care System. This may change as more data becomes available.

Resumo A fim de esclarecer qual programa de assistência farmacêutica, Rede Farmácia de Minas Gerais RFMG ou Farmácia Popular do Brasil FPB, se apresenta como o mais eficiente sob a perspectiva do financiador público foi realizada uma avaliação econômica. O modelo desenvolvido consiste em um levantamento dos custos incorridos até a dispensação de medicamentos. A análise de Monte Carlo foi utilizada para estimar valores a partir das incertezas. Considerando que a população inicialmente estimada no RFMG fosse atendida em sua totalidade no PFPB, haveria um custo incremental de R$ 139.324.050,19. A análise de Monte Carlo mostrou-se favorável ao RFMG. Foram realizadas 10 mil simulações resultando no valor médio de R$ 114.053.709,99 para RFMG e de R$ 254.106.120,65 para o FPB. O Brasil apresenta uma formulação avançada de políticas públicas na saúde. A Política Nacional de Medicamentos enfatiza a necessidade de fortalecimento da assistência farmacêutica para além da mera aquisição. O modelo público, coerente com princípios e diretrizes do SUS, apresenta-se com condições mais adequadas para garantir assistência integral e universal de qualidade. A avaliação econômica reforça essa afirmativa, pois encontrou maior eficiência na alternativa de aplicação dos recursos diretamente na rede pública.

Aim: Biological disease-modifying antirheumatic drugs (bDMARDs) are used to treat rheumatoid arthritis (RA) with adalimumab and etanercept the most used bDMARDs in Brazil. This open prospective cohort study evaluated their effectiveness and safety among RA patients in the Brazilian Public Health System given their costs. Methods: The Clinical Disease Activity Index was primarily used to assess their effectiveness after 6 and 12 months of follow-up. The Health Assessment Questionnaire and EuroQol-5D were also used. Results : A total of 266 RA patients started treatment with adalimumab or etanercept. Adalimumab was the most widely used bDMARD (70%). In total, 46% achieved remission or low-disease activity at 12 months with no difference in effectiveness between them (p = 0.306). bDMARDs were more effective in patients who had better functionality at treatment onset and had spent longer in education. Conclusion: This real-world study demonstrated that adalimumab and etanercept are equal alternatives for RA treatment and both were well tolerated.

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.

Global health research has typically focused on single diseases, and most economic evaluation research to date has analysed technical health interventions to identify 'best buys'. New approaches in the conduct of economic evaluations are needed to help policymakers in choosing what may be good value (ie, greater health, distribution of health, or financial risk protection) for money (ie, per budget expenditure) investments for health system strengthening (HSS) that tend to be programmatic. We posit that these economic evaluations of HSS interventions will require developing new analytic models of health systems which recognise the dynamic connections between the different components of the health system, characterise the type and interlinks of the system's delivery platforms; and acknowledge the multiple constraints both within and outside the health sector which limit the system's capacity to efficiently attain its objectives. We describe priority health system modelling research areas to conduct economic evaluation of HSS interventions and ultimately identify good value for money investments in HSS., Department of Global Health and Population at the Harvard T.H. Chan School of Public Health

Background Female breast cancer is the most common cancer in Latin American and Caribbean (LAC) countries and is the leading cause of cancer deaths. The high mortality-to-incidence ratio in the regions is associated with mainly the high proportion of advanced stage diagnosis, and also to inadequate access to health care. In this study we aimed to systematically review the proportion of advanced stage (III-IV) at diagnosis (pas) and the five-year stage-specific survival estimates of breast cancer in LAC countries. Methods We searched MEDLINE, Embase, and LILACS (Latin American and Caribbean Health Science Literature) to identify studies, in any language, indexed before Nov 5, 2018. We also conducted manual search by reviewing citations of papers found. pas was summarized by random effects model meta-analysis, and meta-regression analysis to identify sources of variation. Stage-specific survival probabilities were described as provided by study authors, as it was not possible to conduct meta-analysis. PROSPERO CRD42017052493. Results For pas we included 63 studies, 13 of which population-based, from 22 countries comprising 221,255 women diagnosed from 1966 to 2017. The distribution of patients by stage varied greatly in LAC (pas 40.8%, 95%CI 37.0% to 44.6%; I2 = 99%; p

IntroductionIn Brazil, the National Health System (SUS) provides healthcare to the public. The system hasmultiple administrative databases; the major databases record hospital (SIH) and outpatient (SIA)procedures. Epidemiological information is collected for all populations in subsystems, such as mor-tality (SIM), live births (SINASC) and diseases of compulsory declaration (SINAN). Each subsystemhas its own information system, which is able to provide information about consultations, clinicalinformation and medicines dispensed. However, these systems are not linked, thereby preventingindividual-centred analysis. ObjectiveTo describe the methods and results of parameter setting that are needed to execute the probabilisticdeduplication of large administrative and epidemiological databases in Brazil and to create a NationalHealth Database Centred on the individual. MethodsThis paper shows the results of a record linkage model to integrate data from SIH, SIA, SIM, andSINAN, which have different formats and attributes between them and over time. These data consistof 1.3 billion records from 2000-2015. Probabilistic and deterministic record linkages were used todeduplicate these data. The Kappa statistic and clerical review were used to ensure the quality ofthe linkage. The graph algorithm and depth-first search were used to generate the identifiers. ResultsThe deterministic deduplication process resulted in a database with 403,113,527 possible uniqueindividuals. After the probabilistic deduplication process of the former database was performed,159,703,805 unique individuals were identified. This result had an estimated a false positive errorrate of 3.3%, and the false negative error was estimated at 12.3%. ConclusionsThe National Health Database centred on the individual was generated and will allow researchersto use real-world evidence to conduct clinical, epidemiological, economic and other studies. Thisdatabase represents a significant cohort, spanning 15 years of historical data and preserving patientprivacy. The success of the process described will allow repeating and appending the data for futureyears and enable important studies to promote SUS efficiency and provide better treatments forpatients. KeywordsData linkage, record linkage, Brazilian health database, SUS deduplication

Resumo A artrite reumatoide (AR) é uma doença crônica que afeta cerca de 1% da população adulta. No estudo de coorte histórica de pacientes de Minas Gerais, registrados no Sistema de Informações Ambulatoriais (SIA), em 2008-2013, foram identificados 11.573 indivíduos. A perspectiva foi a do financiador público e os valores observados como gastos do Sistema Único de Saúde (SUS) foram ajustados pelo Índice Nacional de Preços ao Consumidor Amplo (IPCA), de dezembro de 2015. O Etanercept foi o tratamento mais caro. A análise múltipla mostrou uma relação negativa entre o aumento das despesas e idade, sexo feminino e diagnóstico de entrada na coorte, e relação positiva para as variáveis Índice de Desenvolvimento Humano Municipal (IDH-M) e o uso de medicamentos bloqueadores do fator de necrose tumoral (ANTI-TNF). Este estudo identificou os fatores que têm impacto sobre o gasto com o tratamento medicamentoso da AR. Também apontou que métodos que permitem extrair dados demográficos e de gastos de sistemas de informação administrativos podem ser ferramentas importantes na construção de estudos econômicos capazes de subsidiar as avaliações econômicas de saúde, especialmente do ponto de vista da gestão. Abstract Rheumatoid arthritis (RA) is a chronic condition that affects about 1% of the adult population. In a historical cohort of Minas Gerais State, 11,573 RA patients registered in the Outpatient Information System (SIA) between 2008 and 2013 were identified. For this study we adopted the public funding body's perspective and the values were adjusted by the national inflation index (IPCA) of December 2015. Etanercept was the most expensive treatment. The mean cohort age was 52 years old and most of the patients were women. Multiple regression analysis indicated a negative association between higher expenditure and age, female sex, and diagnosis at entry in the cohort and positive association between high expenditure and the Human Development Index (HDI) of the municipality and use of tumor necrosis factor agents. This study identified the factors that have an impact on RA drug treatment expenditure. Also, we showed that methods that enable extracting demographic and expenditure data of administrative information systems may represent important tools in the construction of economic studies to subsidize economic health evaluations, especially from the standpoint of the managers.

OBJECTIVE To characterize the availability of tracer medicines in pharmaceutical services in primary health care of the Brazilian Unified Health System (SUS). METHODS This is a cross-sectional and evaluative study, part of the Pesquisa Nacional Sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços, 2015 (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services, 2015). To analyze the availability of medicines, we verified 50 items selected from the Relação Nacional de Medicamentos Essenciais (Rename – National List of Essential Medicines) of 2012. Observation scripts were applied to medicine dispensing services in the primary health care. Interviews were carried out with patients, health care professionals, and public managers, using semi-structured questionnaires. The availability index was presented as the percentage of health units where the medicines were available. For statistical analysis, absolute, relative, and mean frequencies were presented (with 95% confidence intervals). The comparison of groups was carried out by Pearson Chi-square tests or variance analysis, when needed. RESULTS One thousand, one hundred, and seventy-five observation scripts were filled in a national representative sample composed by 273 cities. Statistically significant differences were observed regarding the type of unit, infrastructure, and presence of a pharmacist between regions of Brazil. The average availability of tracer medicines in primary health care was 52.9%, with differences between regions and sampling strata. This index increased to 62.5% when phytotherapic medicines were excluded. We found limited availability of medicines for treatment of chronic and epidemiological diseases, such as tuberculosis and congenital syphilis. CONCLUSIONS The low availability of essential medicines purchased centrally by the Brazilian Ministry of Health indicates deficiencies in supply chain management. The different views on the availability of tracer medicines in SUS confirm the general availability verified in this study. Among patients, about 60% said they obtain medicines in SUS units, data consistent with the lack of medicines reported by medicine dispensers and in line with physicians’ evaluations. RESUMO OBJETIVO Caracterizar a disponibilidade física de medicamentos traçadores nos serviços de assistência farmacêutica na atenção primária do Sistema Único de Saúde. MÉTODOS Estudo transversal de natureza avaliativa, integrante da Pesquisa Nacional Sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços, 2015. Para a análise da disponibilidade física, foram verificados 50 itens selecionados da Relação Nacional de Medicamentos Essenciais 2012. Roteiros de observação foram aplicados nos serviços de dispensação de medicamentos na atenção primária. Foram realizadas entrevistas com usuários, profissionais de saúde e gestores municipais, por meio de questionários semiestruturados. O índice de disponibilidade foi apresentado como o percentual de unidades de saúde onde os medicamentos estavam disponíveis. Para a análise estatística foram apresentadas frequências absolutas, relativas e médias (com intervalos de 95% de confiança). A comparação de grupos foi realizada por meio dos testes Qui-quadrado de Pearson ou análise de variância, quando adequados. RESULTADOS Foram preenchidos 1.175 roteiros de observação em amostra nacional representativa composta por 273 municípios. Observaram-se diferenças estatisticamente significantes em relação ao tipo de unidade, infraestrutura e presença do profissional farmacêutico entre as regiões do Brasil. A disponibilidade média dos medicamentos traçadores na atenção primária foi de 52,9%, com diferenças entre regiões e estratos amostrais. Quando analisados todos os medicamentos, exceto os fitoterápicos, o índice elevou para 62,5%. Verificou-se disponibilidade inadequada de medicamentos para o tratamento de doenças crônicas e para doenças epidemiologicamente importantes, como a tuberculose e a sífilis congênita. CONCLUSÕES A baixa disponibilidade de medicamentos de aquisição centralizada indica possíveis deficiências na gestão da cadeia logística. As diferentes percepções sobre a disponibilidade dos medicamentos traçadores no SUS corroboram com os índices de disponibilidade geral verificados pelo estudo. Dentre os usuários, aproximadamente 60% afirmaram obter os medicamentos que necessitaram nas unidades do SUS, informação coerente com a falta de medicamentos relatada pelos responsáveis pela dispensação de medicamentos e com a avaliação dos médicos.

The Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos –Serviços (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services) aimed to characterize the organization of pharmaceutical services in the Primary Health Care of the Brazilian Unified Health System (SUS). PNAUM – Services is a cross-sectional and evaluative study, with planned sample of 600 cities, held between 2014 and 2015, composed of a remote phase, with telephone interviews with health managers. Of these 600 cities, 300 were selected for a survey on health services. We selected the 27 capitals, the 0.5% largest cities of each region, and the remaining cities were drawn. The estimate of the representative national sample size considered three levels: cities, medicine dispensing services, and patients. The interviews were carried out with a structured questionnaire specific for: municipal secretaries of health, professionals responsible for pharmaceutical services in the city, professionals responsible for the dispensing of medicines, physicians, and patients. The secondary data were obtained in official databases, in the latest update date. PNAUM – Services was the first nationwide research aimed at the assessment and acquisition of national and regional indicators on access to medicines, as well as use and rational use, from the perspective of various social subjects. RESUMO A Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM) – componente Serviços teve por objetivo caracterizar a organização dos serviços de assistência farmacêutica na Atenção Básica do Sistema Único Saúde. A PNAUM – Serviços foi um estudo transversal, avaliativo, com amostra planejada de 600 municípios, realizado entre 2014 e 2015, composto por uma fase remota, com entrevistas telefônicas com gestores. Desses 600 municípios foram selecionados 300 para um inquérito em serviços de saúde. Foram selecionadas as 27 capitais, 0,5% dos maiores municípios de cada região e realizado um sorteio dos demais municípios. O cálculo do tamanho da amostra representativa nacional considerou três níveis: municípios, serviços de dispensação de medicamentos e usuários. As entrevistas foram realizadas com a utilização de um questionário estruturado específico para: secretário municipal de saúde, responsável pela assistência farmacêutica no município, responsável pela entrega de medicamentos, médico e usuário. Os dados secundários foram obtidos em bases oficiais, na data mais recente de atualização. A PNAUM – Serviços foi a primeira pesquisa de âmbito nacional visando a avaliação e obtenção de indicadores nacionais e regionais acerca de acesso a medicamentos, bem como utilização e uso racional, sob a ótica de variados atores sociais.

OBJETIVE To analyze the relationship between access to medicines by the population and the institutionalization of pharmaceutical services in Brazilian primary health care. METHODS This study is part of the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços 2015 (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services 2015), a cross-sectional, exploratory, and evaluative study composed of an information survey in a representative sample of cities, stratified by Brazilian regions. Access was defined based on the acquisition of medicines reported by the patient, ranging between: total, partial, or null. The institutionalization of pharmaceutical services was analyzed based on information provided by pharmaceutical services providers and by those responsible for medicines delivery. Chi-square test and multinomial logistic regression were used in the statistical analysis. RESULTS Full access to medicines was greater when professionals affirmed there were the following aspects of the dimensions: “management tools,” “participation and social control,” “financing,” and “personnel structure,” with significant associations in the bivariate analysis. The “pharmaceutical care” dimension did not achieve such an association. After multinomial logistic regression, full access was more prevalent when those in charge of pharmaceutical services stated that: they always or repeatedly attend meetings of the Municipal Health Council, OR = 3.3 (95%CI 1.5-7.3); there are protocols for medicines delivery, OR = 2.7 (95%CI 1.2-6.1); there is computerized system for managing pharmaceutical services, OR = 3.9 (95%CI 1.9-8.0); those responsible for medicines delivery reported having participated in a course or training for professionals in the past two years, OR = 2.0 (95%CI 1.1-3.5); there is computerized system for pharmaceutical services management, OR = 4.3 (95%CI 2.4-7.5). CONCLUSIONS Aspects related to the institutionalization of pharmaceutical services have been strongly related to access to medicines. Our results indicate the need to prioritize its implementation, contributing to its consolidation in Brazil and to the effectiveness of health services regarding the purposes of pharmaceutical services policies. RESUMO OBJETIVO Analisar as relações entre o acesso a medicamentos pela população e a institucionalização da assistência farmacêutica, na atenção básica. MÉTODOS Este artigo integra a Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços 2015, estudo transversal, exploratório, de natureza avaliativa, composto por um levantamento de informações em amostra representativa de municípios, estratificada pelas regiões do Brasil. O acesso a medicamentos foi definido a partir do referencial de obtenção pelo usuário, variando entre: total, parcial ou nulo. A institucionalização da assistência farmacêutica foi analisada a partir das informações prestadas por responsáveis pela assistência farmacêutica e por responsáveis pela entrega de medicamentos. Na análise estatística foram utilizados o teste Qui-quadrado e regressão logística multinomial. RESULTADOS O acesso total a medicamentos foi maior quando os profissionais afirmaram haver aspectos das dimensões: “ferramentas de gestão”, “participação e controle social”, “financiamento” e “estrutura de pessoal”, constatando-se associações significantes na análise bivariada. A dimensão “atenção farmacêutica” não obteve tal associação. Após regressão logística multinomial, o acesso total foi mais prevalente quando responsáveis pela assistência farmacêutica afirmaram: participar sempre ou repetidamente das reuniões do Conselho Municipal de Saúde, RP= 3,3 (IC95% 1,5–7,3); existir protocolos para a entrega de medicamentos, RP= 2,7 (IC95% 1,2–6,1); existir sistema informatizado para gestão da assistência farmacêutica, RP= 3,9 (IC95% 1,9–8,0); e quando responsáveis pela entrega de medicamentos afirmaram ter participado de curso ou capacitação para profissionais nos últimos dois anos, RP= 2,0 (IC95% 1,1–3,5) e haver sistema informatizado para gestão da assistência farmacêutica, RP= 4,3 (IC95% 2,4–7,5). CONCLUSÕES Aspectos relacionados com a institucionalização da assistência farmacêutica se mostraram fortemente relacionados com o acesso a medicamentos. Os resultados indicam a necessidade de priorizar a sua implementação, contribuindo para sua consolidação no Brasil e efetividade dos serviços de saúde quanto às finalidades das políticas de assistência farmacêutica.

Objetivo: analisar a qualidade de vida relacionada à saúde dos usuários da atenção primária em saúde do Sistema Único de Saúde e fatores a ela associados. Métodos: estudo transversal com dados da Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços, 2015. A coleta de dados foi por meio de questionário que incluiu o instrumento Euroqol 5 Dimensions. Foram entrevistados usuários das cinco regiões do Brasil. Regressão linear múltipla foi utilizada para analisar a qualidade de vida relacionada à saúde e fatores associados. Resultados: do total de 8.590 usuários, as dimensões com maior frequência foram dor/mal-estar (50,7%) e ansiedade/depressão (38,8%). Cerca de 10% dos usuários reportaram problemas extremos nessas dimensões. Os fatores significantemente associados à pior qualidade de vida foram: ser do sexo feminino; ter artrite, artrose ou reumatismo; acidente vascular encefálico; doenças do coração; depressão; relatar autopercepção de saúde ruim/muito ruim; usar bebida alcoólica uma vez ou mais por mês; fazer dietas para perder peso, evitar o consumo de sal e reduzir o consumo de gordura. Foi observada associação significante entre uma melhor qualidade de vida e: residir no Norte e Sudeste; praticar atividades físicas e nível educacional mais alto. Não foi observada associação com fatores relacionados aos serviços de saúde. Conclusões: a qualidade de vida relacionada à saúde dos usuários foi influenciada por fatores demográficos, socioeconômicos, relacionados às condições de saúde e ao estilo de vida, sendo útil para nortear ações específicas de promoção da saúde e cuidado integral à saúde dos usuários do Sistema Único de Saúde. Objective: to analyze the Health-Related Quality of Life (HRQoL) of patients of the primary health care of the Brazilian Unified Health System (SUS) and its associated factors. Methods: this is a cross-sectional study with data from the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços, 2015 (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services, 2015). Data were collected with a questionnaire that included the EuroQol 5 Dimensions (EQ-5D) instrument. Patients from the five regions of Brazil were interviewed. Multiple linear regression was used to analyze their Health-Related Quality of Life and its associated factors. Results: of the total of 8,590 patients, the most frequent dimensions were pain/discomfort (50.7%) and anxiety/depression (38.8%). About 10% of the patients reported extreme problems in these dimensions. The following factors were significantly associated with a worse quality of life: being female; having arthritis, osteoarthritis, or rheumatism; cerebrovascular accident; heart disease; depression; health self-assessment as poor or very poor; drinking alcoholic beverages once or more per month; dieting to lose weight, avoiding salt consumption, and reducing fat intake. Significant association was observed between a better quality of life and: living in the North and Southeast regions of Brazil; practicing physical activities; and having a higher educational level. No association was observed with factors related to the health services. Conclusions: the Health-Related Quality of Life of patients was influenced by demographic and socioeconomic factors that were related to health conditions and lifestyle, being useful to guide specific actions for promoting health and the integral care to patients of the Brazilian Unified Health System.

O Sistema Unico de Saude (SUS) foi instituido em 1990, no conjunto de medidas de reordenamento institucional decorrentes da promulgacao da Constituicao Federal de 1988, com a finalidade de concretizar a Politica de Saude preconizada no texto constitucional. A concretizacao de um sistema de saude com tal amplitude e abrangencia demandou politicas promotoras, preventivas e […]

Aim: Published studies have challenged the cost–effectiveness of insulin glargine versus neutral protamine hagedorn (NPH) insulins in Brazil with limited evidence of increased effectiveness despite considerably higher acquisition costs. However, still a controversy. Consequently, there is a need to address this. Materials & methods: Retrospective cohort study of Type I diabetes patients receiving insulin glargine in Brazil following NPH insulin who met the criteria. Results: 580 patients were enrolled. HbA 1c varied from 8.80 ± 1.98% in NPH insulin users to 8.54 ± 1.88% after insulin glargine for 6 months, which is not clinically significant. Frequency of glycemic control varied from 22.6% with NPH insulin to 26.2% with insulin glargine. No statistically significant difference was observed between controlled and still uncontrolled groups for all analyzed factors including type and frequency of insulin use and carbohydrate counting. Conclusion: Limited differences between NPH insulins and insulin analogs in routine clinical care do not justify an appreciable cost difference.

Resumo Em 2008, o estado de Minas Gerais criou o Programa Rede Farmácia de Minas (RFM), uma estratégia para garantir infraestrutura adequada das farmácias. O objetivo deste artigo é caracterizar a infraestrutura da Assistência Farmacêutica (AF) de Minas Gerais, comparando municípios contemplados ou não pela RFM, no intuito de verificar se os gastos estaduais implicaram em melhoria das AF municipais. Estudo transversal de avaliação da AF de Minas Gerais. Foram realizadas entrevistas presenciais e telefônicas com usuários, médicos, responsáveis pela AF e dispensadores de medicamentos, além de observação das instalações. Foram selecionados 104 municípios, dos quais 41,3% haviam adotado a RFM. Os dados foram coletados de julho de 2014 a maio de 2015. Municípios com RFM apresentaram taxas significativamente maiores de regularização da documentação legal, maior conforto para os usuários e funcionários, melhores condições de armazenamento de medicamento e realização de atividades clínicas. O maior volume de investimentos estadual na AF dos municípios com RFM gerou melhores condições de infraestrutura que foram avaliadas positivamente tanto por profissionais de saúde como pelos usuários do SUS.

ObjectivesOur objectives were unify and deduplicate databases’ of patients registration information coming from Information Systems of SUS in Brazil: Hospital, Outpatient, Births, Notifications and Mortalities, between the years 2008-2015, to get an individualize data and plot patients’ lines of care during the period, enabling pharmacoeconomic and epidemiological studies that parameterize effectiveness and efficiency of public policies and embedded technologies. MethodsSemantic analysis of data was performed to describe and understand different meanings of different fields existing in the studied bases. In addition, there were four main procedures, executed with database operations tools and PLSQL programming language: cleaning and standardization of databases(document’s numbers was checked in the brazilian national people’s database, with a string approximator algorithm to decide if the document’s number belonged or no the register); registration information extraction, deterministic and probabilistic deduplication thereof. The procedures were first performed on each database separately and after the unification of the records, was held again a deterministic deduplication. Except the probabilistic deduplication which was performed only on the final deterministic deduplicated's database. Performed procedures allowed a decision-making to chose fields used in data model for the unified database creation. Nine database's representative fields related to patients were selected: patient's name; patient mother’s name; sex; birth date; state; city; zip code; cpf and cns(brazilian documents). ResultsInitially, the unified registration database resulted in 705.599.785 records, after deterministic deduplication there was a reduction culminating in 198.400.762 records. This reduction is explained because these databases are not fully integrated. Moreover, there is not always agreement between systems’ semantics and in some cases changes occur in the data format over the period within the same system. After probabilistic deduplication, the number of unique records decreased to 124.545.186 which is explained by non-linked pairs by deterministic process. This result is guaranteed with a estimate error of at most 3.3% of false positive and at most 12.3% of false negative pairs. ConclusionThe results show that data deduplication is necessary and should be carried out thoroughly. Where the databases had limited patients’ registration information, the technique enabled to capture, in more complete basis, additional information. Futhermore, it allowed to identify and assist in the understanding of positive and negative aspects within systems and trace clinical condition of patients, enabling pharmacoeconomic and epidemiological studies that define effectiveness and efficiency of public policies and embedded technologies. As future work, is important ensure the univocity of records and link this database with past period.

Introduction and objective: Dengue virus is a serious global health problem with an estimated 3.97 billion people at risk for infection worldwide. In December 2015, the first vaccine (CYD-TDV) for dengue prevention was approved in Brazil, developed by Sanofi Pasteur. However, given that the vaccine will potentially be paid via the public health system, information is need regarding consumers’ willingness to pay for the dengue vaccine in the country as well as discussions related to the possible inclusion of this vaccine into the public health system. This was the objective of this research. Methods: We conducted a cross-sectional study with residents of Greater Belo Horizonte, Minas Gerais, about their willingness to pay for the CYD-TDV vaccine. Results: 507 individuals were interviewed. These were mostly female (62.4%) had completed high school (62.17%), were working (74.4%), had private health insurance (64.5%) and did not have dengue (67.4%). The maximum median value of consumers’ willingness to pay for CYD-TDV vaccine is US$33.61 (120.00BRL) for the complete schedule and US$11.20 (40.00BRL) per dose. At the price determined by the Brazil's regulatory chamber of pharmaceutical products market (CMED) for the commercialization of Dengvaxia® for three doses, only 17% of the population expressed willingness to pay for this vaccine. Conclusion: Brazil is currently one of the largest markets for dengue vaccine and the price established is a key issue. We believe the manufacturer should asses the possibility of lower prices to reach a larger audience among the Brazilian population.

Objetivo: avaliar a satisfação dos usuários com os serviços de assistência farmacêutica na atenção primária. Métodos: estudo transversal, exploratório, de natureza avaliativa, com amostra representativa das cinco regiões geopolíticas do Brasil, oriundas da Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços, 2015. O desfecho foi a satisfação do usuário obtida pelo método de teoria da resposta ao item. Foram testadas associações por meio do teste qui-quadrado de Pearson com variáveis sociodemográficas e de saúde e realizadas análises de regressão logística múltipla. O teste de Hosmer-Lemeshow foi utilizado para verificar a adequação do modelo final. Os resultados da regressão logística foram apresentados por meio de razão de chances. Resultados: o percentual geral de usuários satisfeitos com esses serviços foi de 58,4% (IC95% 54,4–62,3). A dimensão oportunidade/conveniência apresentou menor percentual de satisfação (49,5%; IC95% 46,4–52,6) e o maior percentual foi na dimensão aspectos interpessoais (90,5%; IC95%88,9–91,8), significativamente maior que as demais dimensões. No modelo logístico múltiplo final em relação à satisfação geral, permaneceram associadas as variáveis sexo, faixa etária, limitação por doenças e autopercepção da saúde. Conclusões: a maior parte dos usuários entrevistados mostrou-se satisfeita com os serviços da assistência farmacêutica dos municípios brasileiros e a satisfação com o atendimento apresentou-se como fator relevante na satisfação geral do usuário. Objective: to evaluate patient satisfaction with pharmaceutical services in Brazilian primary health care. Methods: this is a cross-sectional, exploratory, and evaluative study on a representative sample from the five Brazilian geopolitical regions resulting from the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços, 2015 (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services, 2015). The outcome was the patient’s satisfaction, obtained using the item response theory. Associations were tested using Pearson’s Chi-square test with sociodemographic and health variables, and multiple logistic regression analyses were carried out. The Hosmer-Lemeshow test was used to verify the adequacy of the final model. Logistic regression results were presented as odds ratio. Results: the overall percentage of patients satisfied with these services was 58.4% (95%CI 54.4-62.3). The “opportunity/convenience” aspect had the lowest satisfaction percentage (49.5%; 95%CI 46.4-52.6) and “interpersonal aspects,” the highest percentage (90.5%; 95%CI 88.9-91.8), significantly higher than other aspects. Sex, age group, limitations due to disease, and self-perception of health remained associated in the final multiple logistic model regarding general satisfaction. Conclusions: most of the interviewed users were satisfied with pharmaceutical services in Brazilian cities, and the satisfaction with the customer’s service was determinant in the patient’s overall satisfaction.

Greater accessibility to antibiotics has resulted in their excessive use, leading to increasing antimicrobial resistance (AMR) and strains on healthcare systems, with only a limited number of patients in ambulatory care treated according to guidelines. High rates of AMR are now seen across countries and continents, resulting in AMR becoming one of the most critical issues facing healthcare systems. It is estimated that AMR could potentially cause over 10 million deaths per year by 2050 unless addressed, resulting in appreciable economic consequences. There are also concerns with under-treatment especially if patients are forced to fund more expensive antibiotics as a result of AMR to first line antibiotics and do not have available funds. Over-prescribing of antibiotics is not helped by patient pressure even when physicians are aware of the issues. There is also extensive dispensing of antibiotics without a prescription; although this is now being addressed in some countries. Review interventions that have been instigated across continents and countries to reduce inappropriate antibiotic prescribing and dispensing, and associated AMR, to provide future guidance. Narrative case history approach. A number of successful activities have been instigated to reduce inappropriate prescribing and dispensing of antibiotics across sectors. These include the instigation of quality indicators, suggested activities of pharmacists as well as single and multiple interventions among all key stakeholder groups. Multiple inter-linking strategies are typically needed to enhance appropriate antibiotic prescribing and dispensing. The impact of ongoing activities need to be continually analysed to provide future direction if AMR rates, and their impact on subsequent morbidity, mortality and costs, are to be reduced.

OBJECTIVE To characterize the medicine dispensing services in the primary health care network in Brazil and in its different regions, aiming to promote the access and rational use of medicines. METHODS This is a cross-sectional, quantitative study with data obtained from the Pesquisa Nacional sobre Acesso, Utilização e Uso Racional de Medicamentos (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines), 2015. Observation visits were carried out in 1,175 dispensing units, and interviews were held with 1,139 professionals responsible for the dispensation of medicines in the dispensing units and 495 municipal coordinators of pharmaceutical services. RESULTS More than half (53%) of the units presented a space smaller than 10 m2 for dispensing of medicines; 23.8% had bars or barriers between users and dispenser; 41.7% had computerized system; and 23.7% had counters for individual care. Among those responsible for dispensation, 87.4% said they always or repeatedly inform users how to use the medicines, and 18.1% reported developing some type of clinical activity. Isolated pharmacies presented a more developed physical and personal structure than those belonging to health units, but we found no significant differences regarding the information provided and the development of clinical activities. CONCLUSIONS There are major differences in the organization models of dispensation between cities, with regional differences regarding the physical structure and professionals involved. The centralization of medicine dispensing in pharmacies separated from the health services is associated with better structural and professional conditions, as in the dispensing units of the South, Southeast, and Midwest regions. However, the development of dispensation as health service does not prevail in any pharmacy or region of the Country yet. RESUMO OBJETIVO Caracterizar os serviços de dispensação de medicamentos na rede de atenção básica no Brasil e nas diferentes regiões, com vistas ao acesso e a promoção do uso racional de medicamentos. MÉTODOS Trata-se de estudo transversal, de abordagem quantitativa, a partir de dados obtidos da Pesquisa Nacional sobre Acesso, Utilização e Uso Racional de Medicamentos, 2015. Foram realizadas visitas de observação em 1.175 unidades de dispensação e entrevistas com 1.139 responsáveis pela dispensação dos medicamentos nas unidades dispensadoras e 495 coordenadores da assistência farmacêutica municipal. RESULTADOS Mais da metade (53%) das unidades apresentaram espaço menor que 10 m2 para dispensação de medicamentos, 23,8% apresentavam grades ou barreiras entre usuários e dispensador, 41,7% dispunham de sistema informatizado, 23,7% contavam com guichês para atendimento individual. Entre os responsáveis pela dispensação 87,4% afirmaram informar sobre a forma de uso dos medicamentos sempre ou repetidamente, e 18,1% afirmaram desenvolver algum tipo de atividade clínica. As farmácias isoladas apresentavam estrutura física e pessoal mais desenvolvida que aquelas pertencentes a unidades de saúde, mas não houve diferenças significantes quanto às informações prestadas e o desenvolvimento de atividades clínicas. CONCLUSÕES Há grandes diferenças de modelos de organização da dispensação entre os municípios, com diferenças regionais quanto à estrutura física e a profissionais envolvidos. A centralização da dispensação de medicamentos em farmácias isoladas dos serviços de saúde está associada a melhores condições estruturais e de profissionais, assim como nas unidades dispensadoras das regiões Sul, Sudeste e Centro-Oeste, no entanto o desenvolvimento da dispensação como serviço de saúde ainda não prevalece em qualquer tipo de farmácia ou região do país.

OBJECTIVE To characterize the activities of clinical nature developed by pharmacists in basic health units and their participation in educational activities aiming at health promotion. METHODS This article is part of the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços, 2015 (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services, 2015), a cross-sectional and exploratory study, of evaluative nature, consisting of a survey of information in a representative sample of cities, stratified by the Brazilian regions that constitute domains of study, and a subsample of primary health care services. The interviewed pharmacists (n=285) were responsible for the delivery of medicines and were interviewed in person with the use of a script. The characterization of the activities of clinical nature was based on information from pharmacists who declared to perform them, and on participation in educational activities aiming at health promotion, according to information from all pharmacists. The results are presented in frequency and their 95% confidence intervals. RESULTS From the interviewed subjects, 21.3% said they perform activities of clinical nature. Of these, more than 80% considered them very important; the majority does not dispose of specific places to perform them, which hinders privacy and confidentiality in these activities. The main denominations were “pharmaceutical guidance” and “pharmaceutical care.” The registration of activities is mainly made in the users’ medical records, computerized system, and in a specific document filed at the pharmacy, impairing the circulation of information among professionals. Most pharmacists performed these activities mainly along with physicians and nurses; 24.7% rarely participated in meetings with the health team, and 19.7% have never participated. CONCLUSIONS Activities of clinical nature performed by pharmacists in Brazil are still incipient. The difficulties found point out to the professionals’ improvisation and effort. The small participation in educational activities of health promotion indicates little integration of pharmacists with the health team and of pharmaceutical services with other health actions. RESUMO OBJETIVO Caracterizar as atividades de natureza clínica desenvolvidas pelos farmacêuticos nas unidades básicas de saúde e sua participação em atividades educativas de promoção da saúde. MÉTODOS O artigo integra a Pesquisa Nacional sobre Acesso, Utilização e Uso Racional de Medicamentos – Serviços 2015, estudo transversal, exploratório, de natureza avaliativa, composto por levantamento de informações numa amostra representativa de municípios, estratificada pelas regiões do Brasil que constituem domínios do estudo, e sub-amostra de serviços de atenção básica. Os farmacêuticos entrevistados (n = 285) eram responsáveis pela entrega de medicamentos e foram entrevistados pessoalmente com uso de roteiro. A caracterização das atividades de natureza clínica baseou-se em informações dos farmacêuticos que declararam realizá-las, e a participação em atividades educativas e voltadas à promoção da saúde, em informações de todos os farmacêuticos. Os resultados são apresentados em frequência e respectivos intervalos de confiança de 95%. RESULTADOS Dos entrevistados, 21,3% afirmaram realizar atividades de natureza clínica. Destes, mais de 80% as consideram muito importante; a maioria não dispõe de local específico para realizá-las, prejudicando a privacidade e confidencialidade nessas atividades. As principais denominações foram orientação farmacêutica e atenção farmacêutica. O registro das atividades é feito principalmente em prontuário do usuário, sistema informatizado e documento próprio arquivado na farmácia, o que dificulta a circulação das informações entre os profissionais. A maioria realiza as atividades principalmente em conjunto com médicos e enfermeiros; 24,7% raramente participam de reuniões com a equipe de saúde e 19,7% nunca participou. CONCLUSÕES As atividades de natureza clínica desempenhadas por farmacêuticos no Brasil ainda são incipientes. As dificuldades encontradas apontam improvisação e esforço dos profissionais. A pequena participação em atividades educativas de promoção da saúde indica pouca integração dos farmacêuticos na equipe de saúde e da assistência farmacêutica nas demais ações de saúde.

OBJECTIVE To identify limiting factors in the management of pharmaceutical services in the primary health care provided by the Brazilian Unified Health System (SUS). METHODS This study was based on the data from the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos no Brasil (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines), and it was conducted by interviews with professionals responsible for pharmaceutical services in Brazilian cities, in 2015. To identify the management limiting factors, we considered the organizational, operational, and sustainability indicators of the management. For the analyses, we included the weights and structure of analysis plan for complex samples. The results were expressed by frequencies and measures of central tendency with 95% confidence interval, considering the Brazilian geographic regions. RESULTS We identified the following limiting factors: lack of pharmaceutical services in the Municipal Health Secretariat organization chart (24%) and in the health plan (18%); lack of participation of managers in the Health Board and the absence of reference to this topic in the agenda of meetings (58.4%); lack of financial autonomy (61.5%) and lack of knowledge on the available values (81.7%); lack of adoption of operational procedures (about 50%) for selection, scheduling, and acquisition; and the fact that most professionals evaluate the organization of pharmaceutical services as good and great (58.8%), despite the worrisome indicators. CONCLUSIONS Pharmaceutical services management is currently supported by a legal and political framework that should guide and contribute to improve the pharmaceutical services in the Brazilian Unified Health System primary health care. However, there is a mismatch between the goals established by these guidelines and what is actually happening. RESUMO OBJETIVO Identificar fatores condicionantes da gestão da assistência farmacêutica na atenção primária no âmbito do Sistema Único de Saúde. MÉTODOS Estudo com dados obtidos da Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos no Brasil (PNAUM) – Serviços, realizada por meio de entrevistas com responsáveis pela assistência farmacêutica em municípios, em 2015. Para identificar os fatores condicionantes da gestão foram considerados indicadores organizacionais, operacionais e de sustentabilidade da gestão. Para as análises consideraram-se os pesos amostrais e a estrutura do plano de análise para amostras complexas. Os resultados foram expressos por meio de frequências e medidas de tendência central com intervalo de confiança de 95%, por regiões geográficas do Brasil. RESULTADOS Foram identificados os fatores condicionantes: a ausência da assistência farmacêutica no organograma da secretaria (24%) e no plano de saúde (18%), a não participação dos gestores no conselho de saúde e a não referência desse tema na pauta das reuniões (58,4%), falta de autonomia financeira (61,5%) e conhecimento dos valores disponíveis (81,7%), falta de adoção de procedimentos operacionais em cerca de 50% para seleção, programação e aquisição e o fato da maioria avaliar a organização da assistência farmacêutica como boa e ótima (58,8%), apesar dos indicadores preocupantes apontados. CONCLUSÕES A gestão da assistência farmacêutica encontra-se respaldada em um arcabouço legal e político, que deveria nortear e contribuir para melhoria da assistência farmacêutica na atenção primária no Sistema Único de Saúde. No entanto, há um descompasso entre os objetivos fixados por essas normativas e o que se observa na realidade.

OBJECTIVE To identify and discuss the conceptions of pharmaceutical services in Brazilian Primary Health Care, according to different subjects. METHODS This study is part of the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços, 2015 (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services, 2015), which is composed of an information survey in a representative sample of cities, stratified according to Brazilian regions, and a subsample of primary health care services. Municipal secretaries of health, those responsible for pharmaceutical services, and those responsible for medicine delivery in pharmacies/dispensing units of the selected services were interviewed. The questionnaires included one question about the understanding of the interviewee regarding pharmaceutical services. The content analysis technique was used to apprehend, in the statements, the meanings attributed to pharmaceutical services, which were subsequently classified into categories according to their main conceptions. RESULTS Among the wide diversity of conceptions on pharmaceutical services (PS), we highlight the ones focused on 1) logistic control of medicines with activities concerning guidance or information on their use and 2) guidance or information to users on the use of medicine. The findings reveal a shifting tendency from a medicine-focused conception to one that considers the users and their needs as the final recipient of these actions. However, the lack of references to conceptions regarding care management and integrality point out the slowness of this change; after all, this is a social and historical process that comprises the production of meanings that transcend legal, logistic, and technical arrangements in pharmaceutical services. CONCLUSIONS The diversity of conceptions expresses the several meanings attributed to pharmaceutical services; we also identified, in their reorientation process, a movement that reflects a gradual shift in the technical paradigm, from the focus on medicine logistics to a user-oriented approach of health services. RESUMO OBJETIVO Identificar e discutir as concepções de assistência farmacêutica segundo distintos atores, na Atenção Primária à Saúde, no Brasil. MÉTODOS Estudo integrante da Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços, 2015, composta por levantamento de informações numa amostra representativa de municípios, estratificada pelas regiões do Brasil, e sub-amostra de serviços de atenção básica. Entrevistaram-se os secretários municipais de saúde, os responsáveis pela assistência farmacêutica e os responsáveis pela entrega de medicamentos nas farmácias/unidades de dispensação dos serviços selecionados. Os questionários incluíram uma pergunta acerca do entendimento dos entrevistados sobre assistência farmacêutica. Utilizou-se a técnica de análise de conteúdo, buscando-se apreender nos enunciados os sentidos atribuídos à assistência farmacêutica, que posteriormente foram classificados em categorias com as principais concepções. RESULTADOS Entre a grande diversidade de entendimentos sobre AF destacaram-se as concepções centradas 1) no controle logístico dos medicamentos com atividades de orientação ou informação sobre o uso e 2) na orientação ou informação ao usuário sobre o uso do medicamento. Os achados revelam tendência de deslocamento de uma centralidade no medicamento para uma concepção mais ampliada que inclui o usuário e suas necessidades como o destinatário final dessas ações. Entretanto, a pouca referência a concepções relacionadas à gestão e integralidade da atenção apontam a lentidão da mudança; afinal trata-se de um processo social e histórico que envolve a produção de sentidos que transcendem os arranjos legais, logísticos e técnicos na organização da assistência farmacêutica. CONCLUSÕES A diversidade de concepções expressa os muitos sentidos atribuídos à assistência farmacêutica; identificando-se também, no processo de sua reorientação, um movimento que reflete uma mudança gradual do paradigma técnico, centrado na logística de medicamentos, para uma abordagem orientada ao usuário dos serviços de saúde.

Trata-se de uma síntese dos principais resultados da Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos, componente de Avaliação dos Serviços de Assistência Farmacêutica Básica. Com base em narrativa crítica dos elementos das políticas farmacêuticas no Brasil, discutem-se aspectos relacionados à estrutura dos serviços farmacêuticos, situação sanitária dos medicamentos, recursos humanos, acesso a medicamentos, uso racional e gestão. Apesar dos avanços que refletem o empenho do conjunto de atores implicados, os resultados da Pesquisa apontam desafios, como o acesso equitativo dos medicamentos, a estruturação dos serviços farmacêuticos, o aprimoramento da logística e da gestão e a implantação de ações voltadas ao cuidado farmacêutico nas unidades de saúde. This study is a synthesis of the main results of the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines), Evaluation Component of the Basic Pharmaceutical Services. Based on the critical narrative of the elements of Brazil’s pharmaceutical policies, we discuss aspects related to the structure of the pharmaceutical services, the medicines’ sanitary state, human resources, access to medicines, rational use and management. Despite the advances that reflect the commitment of the group of actors involved, the results of the Survey indicate challenges, such as equitable access to medicines, the structuring of pharmaceutical services, the improvement of logistics and administration, and the implementation of actions directed to pharmaceutical care in the health units.

Background: Infection with the Hepatitis C Virus (HCV) is a widespread transmittable disease with a diagnosed prevalence of 2.0%. Fortunately, it is now curable in most patients. Sales of medicines to treat HCV infection grew 2.7% per year between 2004 and 2011, enhanced by the launch of the protease inhibitors (PIs) boceprevir (BCV) and telaprevir (TVR) in addition to ribavirin and pegylated interferon (pegIFN). Costs will continue to rise with new treatments including sofosbuvir, which now include interferon free regimens. Objective: Assess the uptake of BCV and TVR across Europe from a health authority perspective to offer future guidance on dealing with new high cost medicines. Methods: Cross-sectional descriptive study of medicines to treat HCV (pegIFN, ribavirin, BCV and TVR) among European countries from 2008 to 2013. Utilization measured in defined daily doses (DDDs)/1000 patients/quarter (DIQs) and expenditure in Euros/DDD. Health authority activities to influence treatments categorized using the 4E methodology (Education, Engineering, Economics and Enforcement). Results: Similar uptake of BCV and TVR among European countries and regions, ranging from 0.5 DIQ in Denmark, Netherlands and Slovenia to 1.5 DIQ in Tayside and Catalonia in 2013. However, different utilization of the new PIs vs. ribavirin indicates differences in dual vs. triple therapy, which is down to factors including physician preference and genotypes. Reimbursed prices for BCV and TVR were comparable across countries. Conclusion: There was reasonable consistency in the utilization of BCV and TVR among European countries in comparison with other high priced medicines. This may reflect the social demand to limit the transmission of HCV. However, the situation is changing with new curative medicines for HCV genotype 1 (GT1) with potentially an appreciable budget impact. These concerns have resulted in different prices across countries, with their impact on budgets and patient outcomes monitored in the future to provide additional guidance, peer-reviewed

Objective: The Brazilian National Health System provides high cost medicines through the Specialized Component of Pharmaceutical Assistance in accordance with adherence to agreed Clinical Guidelines. However, physician compliance to these Guidelines, as well as the barriers and facilitators related to them and the influence on the subsequent quality of care provided is unknown. Consequently, the objectives of this paper are to undertake a review of international experiences and scientific publications of a strategy to disseminate and communicate guidelines to physicians through Academic Detailing. Subsequently use the findings to develop and conduct a pilot Academic Detailing Program in Brazil targeting specialists who prescribe medicines for patients with Alzheimer’s disease, which are part of the Specialized Component of Pharmaceutical Assistance. Methods: Review international experiences and scientific publications relating to academic detailing based on a thorough review of available literature including publications known to the co-authors. Develop and monitor physician acceptance of academic detailing for patients with Alzheimer’s Disease and the impact on future prescribing. Key findings: Based on the lessons learnt from the international experience and review, coupled with the initial experiences in Brazil, we conclude that conducting academic detailing to enhance the implementation and dissemination of clinical protocols and therapeutic guidelines in Brazil is worthwhile. We will be closely monitoring the outcome of the pilot academic detailing programme as a basis for developing future programmes to further improve the quality of prescribing in Brazil. Conclusion: Findings from the experiences are encouraging. This will be further explored to provide a basis for this approach in the future.

Objetivo: avaliar indicadores relacionados ao uso racional de medicamentos e seus fatores associados em unidades básicas de saúde. Métodos: estudo transversal realizado em amostra representativa de municípios do Brasil incluídos na Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços, 2015. Os dados foram coletados por meio de entrevista com usuários, profissionais dispensadores de medicamentos e prescritores; e descritos por meio de indicadores de prescrição, dispensação e de serviços de saúde. Realizou-se análise da associação entre características dos recursos humanos dos serviços farmacêuticos e indicadores de dispensação. Resultados: em nível nacional, o número médio de medicamentos prescritos foi de 2,4. A proporção de usuários com prescrição de antibiótico foi de 5,8%, 74,8% dos usuários receberam orientações sobre medicamentos na farmácia e para 45,1% usuários todos os medicamentos prescritos eram da relação nacional de medicamentos essenciais. Todos os indicadores apresentaram variações estatisticamente significantes entre as regiões do Brasil. Os dispensadores que relataram a presença de farmacêutico na unidade com carga horária igual ou superior a 40 horas semanais apresentaram 1,82 mais chance de transmitir orientações sobre o modo de usar dos medicamentos no processo de dispensação. Conclusões: a análise de indicadores de prescrição, dispensação e de serviços de saúde nas unidades básicas de saúde mostrou proporção insatisfatória de prescrição de medicamentos essenciais e limitações na identificação correta do medicamento, orientação aos pacientes sobre medicamentos e de disponibilidade de protocolos terapêuticos nos serviços de saúde. Objective: to evaluate indicators related to the rational use of medicines and its associated factors in Basic Health Units. Method: this is a cross-sectional study carried out in a representative sample of Brazilian cities included in the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços, 2015 (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services, 2015). The data were collected by interviews with users, medicine dispensing professionals, and prescribers; and described by prescription, dispensing, and health services indicators. We analyzed the association between human resources characteristics of pharmaceutical services and dispensing indicators. Results: at national level, the average number of medicines prescribed was 2.4. Among the users, 5.8% had antibiotic prescription, 74.8% received guidance on how to use the medicines at the pharmacy and, for 45.1% of users, all prescribed medicines were from the national list of essential medicines. All the indicators presented statistically significant differences between the regions of Brazil. The dispensing professionals that reported the presence of a pharmacist in the unit with a working load of 40 hours or more per week presented 1.82 more chance of transmitting information on the way of using the medicines in the dispensing process. Conclusion: the analysis of prescription, dispensing, and health services indicators in the basic health units showed an unsatisfactory proportion of essential medicines prescription and limitations in the correct identification of the medicine, orientation to the patients on medicines, and availability of therapeutic protocols in the health services.