HEALTH TECHNOLOGY PERFORMANCE ASSESSMENT: REAL-WORLD EVIDENCE FOR PUBLIC HEALTHCARE SUSTAINABILITY.

OBJECTIVES: Health technology financing is often based on randomized controlled trials (RCTs), which are often the same ones used for licensing. Because they are designed to show the best possible results, typically Phase III studies are conducted under ideal and highly controlled conditions. Consequently, it is not surprising that technologies do not always perform in real life in the same way as controlled conditions. Because financing (and price paid) decisions can be made with overestimated results, health authorities need to ask whether health systems achieve the results they expect when they choose to pay for a technology. The optimal way to answer this question is to assess the performance of financed technologies in real-world settings. Health technology performance assessment (HTpA) refers to the systematic evaluation of the properties, effects, and/or impact of a health intervention or health technology in the real world to provide information for investment/disinvestment decisions and clinical guideline updates. The objective is to describe the development and principal aspects of the Guideline for HTpA commissioned by the Brazilian Ministry of Health. METHODS: Our methods used include extensive literature review, refinement with experts across countries, and public consultation. RESULTS: A comprehensive guideline was developed, which has been adopted by the Brazilian government. CONCLUSION: We believe the guideline, with its particular focus on disinvestment, along with the creation of a specific program for HTpA, will allow the institutionalization and continuous improvement of the scientific methods to use real-world evidence to optimize available resources not only in Brazil but across countries.

Quality of life of patients in renal replacement therapy in Brazil: comparison of treatment modalities.

PURPOSE: This study aimed to analyze and compare the quality of life of renal replacement therapy patients undergoing hemodialysis, peritoneal dialysis and those with renal transplantation in Brazil. In addition, we aimed to verify factors associated with patients' quality of life and the relationship between quality of life and treatment modality, socioeconomic and demographic conditions as well as aspects related to the disease and health services. METHODS: A representative sample of the dialysis units and transplant centers was obtained. Structured questionnaires were used to interview 3,036 patients in one of three treatment modalities: hemodialysis, peritoneal dialysis and renal transplant. Information was collected about socioeconomic and demographic characteristics and quality of life measures. RESULTS: There were significant differences between renal transplants and both forms of dialysis for all dimensions of the SF-36. Hemodialysis patients showed better results in the dimensions of functional capacity, physical aspects and social aspects, compared to peritoneal dialysis patients. Renal transplant patients had the best mean score in the physical component of quality of life. There were no significant differences among treatment groups regarding the mental component of quality of life. The physical and mental components were associated with comorbidities and age; however, older patients had better mental quality of life but worse physical quality of life. Patients in a higher socioeconomic class and patients that were not hospitalized also reported better quality of life. Unmarried and male patients presented better physical quality of life. The dialysis units and transplant centers influenced the patients' quality of life. CONCLUSIONS: Renal transplant patients have the best quality of life of the three treatment modalities. It is necessary to increase access to renal transplants.

Indicator of access to medicines in relation to the multiple dimensions of access.

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.

[Organization of primary health care in cities belonging to project for expansion and consolidation of the family health strategy in Mato Grosso State, Brazil]. / A organização da Atenção Básica em municípios integrantes do projeto de expansão e consolidação do saúde da família em Mato Grosso, Brasil.

This article presents part of the results from the Baseline Study on the PROESF. The objective was to evaluate primary health care in the cities of Cuiabá, Várzea Grande, and Rondonópolis, Mato Grosso State, Brazil, based on the inter-subjectivity in human relations (among health workers, users of health services, and the public at large and within institutionalized levels of social control). A qualitative and quantitative methodology was used, including interviews with key informants; short meetings with managers; focal groups with managers; and interviews with users and health professionals from pre-selected health units. Scores were assigned to all the questions that indicated participatory processes in primary care practices in the various municipalities. Despite the geopolitical identity among the municipalities and their similar access to the same public policies, there was a significant difference in their performance of the functions pertaining to the organization of primary care and the Family Health Program, in terms of portal of entry into the system, longitudinality, comprehensiveness, and coordination. Differences were observed in the type of relations that were established (participatory versus non-participatory), corresponding to the previous difference.

Effectiveness and safety of insulin glargine versus detemir analysis in patients with type 1 diabetes: systematic review and meta-analysis.

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.

Drug utilization and factors associated with polypharmacy in individuals with diabetes mellitus in Minas Gerais, Brazil. / Uso de medicamentos e fatores associados à polifarmácia em indivíduos com diabetes mellitus em Minas Gerais, Brasil.

The objective of this study was to evaluate the use of drugs and the factors associated with polypharmacy in patients with diabetes mellitus (DM) in Minas Gerais. Descriptive analysis of drugs in use and logistic regression to estimate the association between socio-demographic and clinical characteristics with polypharmacy were performed. Of the 2619 respondents, 56.5% were in polypharmacy. Drugs for DM, agent in renin-angiotensin system, and diuretics are the most frequently used. Factors such as age, comorbidities and increased access to health services were associated with polypharmacy. It was observed high prevalence of polypharmacy, which requires a suitable care and better quality of drug use in this population.

O objetivo deste estudo foi avaliar o uso de medicamentos, a prevalência e os fatores associados à polifarmácia em pacientes com diabetes mellitus (DM) em Minas Gerais. Realizou-se um estudo transversal com descrição dos medicamentos em uso e análise da associação entre características sociodemográficas e clínicas com polifarmácia, por meio de regressão logística. Dos 2619 entrevistados, 56,5% estavam em polifarmácia. Medicamentos para DM, agentes no sistema renina-angiotensina e diuréticos foram os mais usados. Fatores como envelhecimento, presença de comorbidades e maior acesso aos serviços de saúde foram associados à polifarmácia. Observou-se elevada prevalência de polifarmácia, o que requer um cuidado adequado e melhor qualidade do uso de medicamentos para essa população.

Quality of Life of Patients with Type 1 Diabetes Mellitus Using Insulin Analog Glargine Compared with NPH Insulin: A Systematic Review and Policy Implications.

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.

The long-term costs for treating multiple sclerosis in a 16-year retrospective cohort study in Brazil.

BACKGROUND: Multiple Sclerosis (MS) is a disease that appreciably impacts on the quality of life of patients and is associated with high expenditure. MS is a chronic multifactorial disease, characterized by inflammation, demyelination and axonal loss. The Brazilian public health system provides pharmacological treatment as well as hospital and outpatient care for patients with relapsing-remitting and secondary progressive multiple sclerosis. However, we are not aware of any previous publications assessing total direct medical costs in patients with a long follow-up within the Brazilian healthcare system. Consequently, the objective is to analyze public spending on patients with MS to guide stakeholders in future investment and disinvestment decisions. METHODS AND FINDINGS: We retrospectively analyzed public Brazilian spending on patients with MS between 2000 and 2015 using the patient-centered registry of all patients in the public health system (SUS) obtained through deterministic-probabilistic record linkage of the Outpatient Information System, Hospital Information System and Mortality Information Systems in Brazil. Descriptive data analysis and a multiple linear regression model was performed to evaluate the associations between the mean annual cost per patient and the clinical and demographic variables. The suitability of the model was verified from a residue analysis and the level of significance adopted was 5%. RESULTS: 28,401 patients were identified and subsequently 23,082 patients were analyzed. The majority of the patients were female (73.3%), lived in the southeast region (58.9%), had a mean age of 36.8 (± 12.2) years and started treatment using one of the interferons beta (78.9%). The total direct medical cost spending in the sixteen years of the follow-up was US $ 2,308,393,465.60, and the mean annual expenditure per patient was US $ 13,544.40 (± 4,607.05). In the best fit model (p <0.001), approximately 40% of the variability of the mean annual cost per patient was explained by the region of residence; medication used (intention to treat); if the patient was a non-exclusive user of medicines, i.e., used SUS for other procedures other than high-cost medicines; year of treatment start; and presence of events (death; Relapse; change of treatment and/or comorbidity). CONCLUSIONS: In the public health system of Brazil, disease modifying therapies currently represent almost all of the total direct costs of multiple sclerosis treatment. Around the world, new and emerging health technologies to treat of MS impose a challenge to health budgets, highlighting the need for cost-effectiveness studies comparing these technologies to those already available. Our regression model may help in this process, and calls attention to the need to access the real world performance of new therapies available in SUS, with the potential for disinvestment and/ or price reductions if needed.

The Assessment for Disinvestment of Intramuscular Interferon Beta for Relapsing-Remitting Multiple Sclerosis in Brazil.

In Brazil, inclusion and exclusion of health technologies within the Unified Health System (SUS) is the responsibility of the National Committee for Health Technology Incorporation (CONITEC). A recent Cochrane systematic review demonstrated that intramuscular interferon beta 1a (IFN-ß-1a-IM) was inferior to the other beta interferons (IFN-ßs) for multiple sclerosis (MS). As a result, CONITEC commissioned an analysis to review possible disinvestment within SUS. The objective of this paper is to describe the disinvestment process for IFN-ß-1a-IM in Brazil. The first assessment comprised a literature review and mixed treatment comparison meta-analysis. The outcome of interest was the proportion of relapse-free patients in 2 years. This analysis confirmed the inferiority of IFN-ß-1a-IM. Following this, CONITEC recommended disinvestment, with the decision sent for public consultation. More than 3000 contributions were made on CONITEC's webpage, most of them against the preliminary decision. As a result, CONITEC commissioned a study to assess the effectiveness of IFN-ß-1a-IM among Brazilian patients in routine clinical care. The second assessment involved an 11-year follow-up of a non-concurrent cohort of 12,154 MS patients developed by deterministic-probabilistic linkage of SUS administrative databases. The real-world assessment further demonstrated that IFN-ß-1a-IM users had a statistically higher risk of treatment failure, defined as treatment switching or relapse treatment or death, with the assessment showing that IFN-ß-1a-IM was inferior to the other IFN-ßs and to glatiramer acetate in both direct and indirect analysis. In the drug ranking with 40,000 simulations, IFN-ß-1a-IM was the worst option, with a success rate of only 152/40,000. Following this, CONITEC decided to exclude the intramuscular presentation of IFN-ß from the current MS treatment guidelines, giving patients who are currently on this treatment the option of continuing until treatment failure. In conclusion, we believe this is the first example of this new disinvestment process in action, providing an exemplar for other treatments in Brazil as well as other countries.

Consumer Willingness to Pay for Dengue Vaccine (CYD-TDV, Dengvaxia®) in Brazil; Implications for Future Pricing Considerations.

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 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.

The clinical effectiveness of insulin glargine in patients with Type I diabetes in Brazil: findings and implications.

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. HbA1c 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.

Pharmaceutical services in the primary health care of the Brazilian Unified Health System: advances and challenges.

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.

Infrastructure evaluation of Pharmaceutical Services in the National Health System of Minas Gerais. / Avaliação da infraestrutura da Assistência Farmacêutica no Sistema Único de Saúde em Minas Gerais.

OBJECTIVES: To characterize the infrastructure of public pharmacies in Minas Gerais, comparing municipalities that have received the RFM program to the ones that haven't, in order to verify if the State's Economic Incentives implied in improvement of local Pharmaceutical Services (PS). METHODS: A cross-sectional, exploratory, evaluative study in a representative sample of the municipalities of Minas Gerais. Face-to-face interviews were conducted with users, physicians, and drug dispensers, as well as observation of pharmacy facilities and telephone interviews with municipal officials from the PS. 104 municipalities were selected, of which 41.3% had adopted the RFM. Data were collected from July 2014 to May 2015. RESULTS: Municipalities adept to the RFM presented significantly higher rates of legal documentation, more comfort for users and staff, better storage conditions of medicine and competence to conduct clinical activities. CONCLUSION: The higher state investment in the PS organization for municipalities adept to the RFM developed better infrastructure that have been approved by health professionals and the users of the National Health System.

Main characteristics of patients of primary health care services in Brazil.

OBJECTIVE: To characterize patients of primary health care services according to demographic and socioeconomic aspects, habits and lifestyle, health condition, and demand for health services and medicines. METHODS: This study is part of 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), a cross-sectional study carried out between 2014 and 2015. Interviews were conducted with patients over the age of 17 years, with a standardized questionnaire, in primary health care services of a representative sample of cities, stratified by regions of Brazil. The analysis was performed for complex samples and weighted according to the population size of each region. RESULTS: A total of 8,676 patients were interviewed, being 75.8% women, most of them aged from 18 to 39 years; 24.2% men, most of them aged from 40 to 59 years; 53.7% with elementary school; 50.5% reported to be of mixed race ethnicity, 39.7%, white, and 7.8%, black. Half of patients were classified as class C and 24.8% received the Bolsa Familia benefit. Only 9.8% had health insurance, with higher proportion in the South and lower in the North and Midwest. The proportion of men who consumed alcohol was higher than among women, as well as smokers. The self-assessment of health showed that 57% believed it to be very good or good, with lower proportion in the Northeast. The prevalence of chronic diseases/conditions, such as hypertension (38.6%), dyslipidemia (22.7%), arthritis/rheumatism (19.4%), depression (18.5%), diabetes (13.6%), and others are higher in these patients them among the general population. Medicines were predominantly sought in the health care service or in pharmacies of the Brazilian Unified Health System. CONCLUSIONS: It was possible to characterize the profile of patients of Primary Health Care, but the originality of the research and its national scope hinders the comparison of results with official data or other articles.

Pharmaceutical care in Brazil's primary health care.

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.

Workforce in the pharmaceutical services of the primary health care of SUS, Brazil.

OBJECTIVE: To characterize the workforce in the pharmaceutical services in the primary care of the Brazilian Unified Health System (SUS). METHODS This is a cross-sectional and quantitative 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). For the analysis, we considered the data stratification into geographical regions. We analyzed the data on workers in the municipal pharmaceutical services management and in the medicine dispensing units, according to the country's regions. For the statistical association analysis, we carried out a Pearson correlation test for the categorical variables. RESULTS: We analyzed 1,175 pharmacies/dispensing units, 507 phone interviews (495 pharmaceutical services coordinators), and 1,139 professionals responsible for medicine delivery. The workforce in pharmaceutical services was mostly constituted by women, aged from 18 to 39 years, with higher education (90.7% in coordination and 45.5% in dispensing units), having permanent employment bonds (public tender), being for more than one year in the position or duty, and with weekly work hours above 30h, working both in municipal management and in medicine dispensing units. We observed regional differences in the workforce composition in dispensing units, with higher percentage of pharmacists in the Southeast and Midwest regions. CONCLUSIONS: The professionalization of municipal management posts in primary health care is an achievement in the organization of the workforce in pharmaceutical services. However, significant deficiencies exist in the workforce composition in medicine dispensing units, which may compromise the medicine use quality and its results in population health.

Medicine dispensing service in primary health care of SUS.

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.

Infrastructure of pharmacies of the primary health care in the Brazilian Unified Health System: Analysis of PNAUM - Services data.

OBJECTIVE: To characterize the infrastructure of the primary health care pharmacies of the Brazilian Unified Health System, aiming at humanizing the offered services. METHODS: This is a cross-sectional study, of quantitative approach, from data obtained in the Pesquisa Nacional de 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). Information on 1,175 pharmacies/dispensing units were gathered from direct observation and assessment of dispensing units installations conducted by trained researchers who used a standardized form. The analyzed variables refer to the physical structure of pharmacies or medicine dispensing units of the health units under research. RESULTS: The pharmacy area was greater than 14 m2 in 40.3% of the sampled units, highlighting those from Midwest (56.9%) and Southeast (56.2%) regions and those of Northeast, with only 23.3%. About 80.2% units had waiting rooms with chairs for patients, 31.8% of them had dispensing areas inferior to 5m2, while in 46.2% these areas were superior to 10m2. Bars were found in service counters in 23.8% of health units, thus separating the patient from the professional; 44.1% had internet access. In most units, the area of medicine storage had no refrigerator or freezer for their exclusive storage and 13.7% had a specific room for pharmaceutical consultation. CONCLUSION: Aiming at achieving care humanization and improving working conditions for professionals, the structuring of the environment of pharmacy services is necessary. This would contribute to the better qualification of pharmacy services, comprising more than medicine delivery. Data on the Northeast region indicated less favorable conditions to the development of adequate dispensing services. Based on the panorama pointed out, we suggest the expansion of stimulus concerning the physical structure of pharmaceutical services, considering regional specificities.

Indicators related to the rational use of medicines and its associated factors.

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.

Patient satisfaction with pharmaceutical services in Brazilian primary health care.

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.