A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy.

BACKGROUND: Biosimilar medicines are defined as biological products highly similar to an already licensed biological product (RP). The market entry of biosimilars is expected to reduce the costs of biological treatments. OBJECTIVE: This study aims to evaluate the range of differences between the prices of biosimilars and the corresponding RP for biologicals approved in four countries. METHOD: This is a cross-national comparison of pricing of biosimilars in Argentina, Australia, Brazil, and Italy. The study examined online price databases provided by the national authorities of the investigated countries. Biosimilar price difference was calculated by subtracting the unit price of the biosimilar by the unit price of the RP, and then dividing it by the unit price of the RP. The results were presented as percentage. RESULTS: Brazil had the highest median price reduction (- 36.3%) in biosimilars price, followed by Italy (- 20.0%) and Argentina (- 18.6%). All the biosimilars in Italy were priced below the RP presenting a minimum reduction of 6.3%, while in Australia, most of the prices of biosimilars were equal to the RP. In Argentina, one infliximab-biosimilar displayed price above the RP (40.7%) while the lower priced brand had a reduction of 14.4%. Brazil had four biosimilars with prices above the respective RP, including isophane insulin (1), insulin glargine (1) and somatropin (2). CONCLUSION: The study revealed a marked dispersion in the price's differences between biosimilars and RP across the studied countries. Governments should evaluate whether their policies have been successful in improving affordability of biological therapies.

Budget Impact Analysis of Risperidone Use and Adverse Event Monitoring in Autism Spectrum Disorder in Brazil: Assessment of Theoretical Versus Real Data.

BACKGROUND AND AIMS: Risperidone is used in autism spectrum disorder (ASD) to manage aggressive behavior. Budget impact analysis (BIA) assists managers in promoting more sustainable health systems; however, it is unclear whether BIAs underestimate or overestimate the estimates derived from real-world data. This study aimed to compare the estimated BIA values of risperidone use and the monitoring of adverse events in ASD using theoretical and real data. METHODS: Analyses were conducted based on the clinical protocol and the Brazilian therapeutic guidelines for ASD. The perspective adopted was that of the Unified Health System (SUS), considering a time horizon of 5 years. Three possible scenarios were considered based on the maximum daily dose of risperidone. Expenses related to the acquisition of risperidone and the monitoring of adverse events were taken into account using health databases in Brazil. For the calculation based on theoretical data, the prevalence of ASD was estimated using information from the scientific literature and the Brazilian demographic census. The model calculated from real data was obtained by analyzing the linear trend of the number of users assisted in the SUS from 2017 to 2021. RESULTS: The population estimated by the theoretical model compared with the model calculated from the real data was higher. Likewise, the 5-year budgetary impact of the theoretical model versus the model calculated from the real data was higher, with statistical significance in all scenarios (p < 0.001). In the real data model, the most economically advantageous scenarios were Scenario 1 for children (International dollars [I$] 7,630,040.73) and Scenario 3 for adults (I$60,329,288.17). Estimated expenditures for monitoring adverse events ranged from 17 to 74% in children and from 50% to 63% in adults. CONCLUSIONS: The data revealed significant differences in population and cost estimation between theoretical data and real-world data. The expenses associated with monitoring adverse events represented a substantial expenditure estimate for the SUS.

Multisystem inflammatory syndrome drug treatment in countries with different income profiles: a scoping review.

Objective: The purpose of this study was to map and describe the studies that have investigated therapeutic alternatives for the management of paediatric multisystem inflammatory syndrome in children (MIS-C) associated with COVID-19. Considering the origin of the studies performed (low-, middle- and high-income countries), a systematic scoping review was conducted with primary studies that reported the use of medications for the treatment of patients with MIS-C. Sources: The searches were performed in MEDLINE, Embase, Lilacs, Epistemonikos, CINAHL, and CENTRAL, in the grey literature (theses and dissertations from CAPES, ProQuest, and PROSPERO) and in clinical trial databases until May 2022. The selection and extraction of studies were performed independently by two reviewers. Summary of the findings: A total of 173 studies were included, most of which were published as case reports or series. No randomized controlled clinical trials (RCTs) were identified. The investigated drugs were immunoglobulins, glucocorticoids, monoclonal antibodies, anticoagulants, and antiplatelet agents. Conclusion: The dosages, when reported, were heterogeneous among the studies. The ethnicity and comorbidity of the participants were poorly reported. Monoclonal antibodies, drugs with higher costs, were mostly described in studies of high-income countries.

Approaches to prioritising primary health research: a scoping review.

OBJECTIVE: To systematically identify and describe approaches to prioritise primary research topics in any health-related area. METHODS: We searched Medline and CINAHL databases and Google Scholar. Teams of two reviewers screened studies and extracted data in duplicate and independently. We synthesised the information across the included approaches by developing common categorisation of relevant concepts. RESULTS: Of 44 392 citations, 30 articles reporting on 25 approaches were included, addressing the following fields: health in general (n=9), clinical (n=10), health policy and systems (n=10), public health (n=6) and health service research (n=5) (10 addressed more than 1 field). The approaches proposed the following aspects to be addressed in the prioritisation process: situation analysis/ environmental scan, methods for generation of initial list of topics, use of prioritisation criteria, stakeholder engagement, ranking process/technique, dissemination and implementation, revision and appeal mechanism, and monitoring and evaluation. Twenty-two approaches proposed involving stakeholders in the priority setting process. The most commonly proposed stakeholder category was 'researchers/academia' (n=17, 77%) followed by 'healthcare providers' (n=16, 73%). Fifteen of the approaches proposed a list of criteria for determining research priorities. We developed a common framework of 28 prioritisation criteria clustered into nine domains. The criterion most frequently mentioned by the identified approaches was 'health burden' (n=12, 80%), followed by 'availability of resources' (n=11, 73%). CONCLUSION: We identified and described 25 prioritisation approaches for primary research topics in any health-related area. Findings highlight the need for greater participation of potential users (eg, policy-makers and the general public) and incorporation of equity as part of the prioritisation process. Findings can guide the work of researchers, policy-makers and funders seeking to conduct or fund primary health research. More importantly, the findings should be used to enhance a more coordinated approach to prioritising health research to inform decision making at all levels.

Efficacy and costs of nanocrystalline silver dressings versus 1% silver sulfadiazine dressings to treat burns in adults in the outpatient setting: A randomized clinical trial.

BACKGROUND: Nanocrystalline silver dressings can reduce the number of changes, facilitating burn wound management. However, the evidence regarding their efficacy and cost-consequences compared to well-established treatments, such as 1% silver sulfadiazine, is still scarce. OBJECTIVE: To determine the efficacy, safety, and costs of nanocrystalline silver dressings compared to 1% silver sulfadiazine dressings to treat adult patients with burns. STUDY DESIGN AND SETTING: Randomized, single-center, single-blind trial conducted at a referral hospital in São Paulo, Brazil. METHODS: 100 adult patients were randomized 1:1 to nanocrystalline silver (n = 50) or 1% silver sulfadiazine (n = 50). The primary outcome was the proportion of participants with complete re-epithelization at day 15 after randomization. Secondary outcomes included the number of dressing changes, direct medical costs (in international dollars, I$), pain intensity, the incidence of infections, number of patients undergoing surgery, and adverse events. RESULTS: On day 15, the proportion of patients who reached the primary outcome did not differ significantly between participants treated with nanocrystalline silver dressings (24 [48%]) and those treated with 1% silver sulfadiazine dressings (26 [52%]); risk difference of -4.0 percentage points (95% confidence interval [CI], -17 to 9; P = 0.56). The number of patients undergoing surgical intervention was similar between groups (6% vs. 6%), and no local or serious adverse events were reported. The mean (standard deviation, SD) number of dressing changes in the nanocrystalline silver group was 4.1 (2.3), and the corresponding estimate in the 1% silver sulfadiazine group was 9.6 (6.7); mean difference of -5.56 (95% CI), -7.57 to -3.55, P < 0.001). Treatment with nanocrystalline silver dressing incurred significant cost reductions in medical materials, human resources, and administrative labor. However, the mean total cost with nanocrystalline silver dressing was higher compared to 1% silver sulfadiazine dressings: I$496.37 (445.90) vs. I$274.73 (182.76); mean difference = 221.63 (95% CI, 89.04 to 354.23, P = 0.001). The main driver of higher mean total costs among nanocrystalline silver-treated participants was the purchase cost of the dressings, representing 79.3% of the total cost in the nanocrystalline silver group but only 15.2% in the 1% silver sulfadiazine group. CONCLUSION: We found no evidence of a difference between nanocrystalline silver and 1% silver sulfadiazine dressings regarding efficacy and safety outcomes. Nanocrystalline silver dressings were associated with an increase in the total costs, but they could result in important savings for an institution (less changes of dressings, reducing human resources burden), especially if acquisition costs can be decreased. Additional cost-effectiveness studies are warranted. TRIAL REGISTRATION NUMBER: NCT02108535.

Strategies to Approach Medicines Litigation: An Action Research Study in Brazil.

Background: In the last decades, litigation has been increasingly used to access medicines in Brazil. This phenomenon has led to the development of diverse strategies to reduce its negative impact on the organization of pharmaceutical services. In spite of that, managers still face difficulties dealing with lawsuits. Objective: This study aims to report the planning and implementation of strategies to approach medicines litigation in a municipality located in the southeast region of Brazil. Methods: Mixed methods were employed through an action research cycle. A network coordination team included researchers from university and municipal managers. The scenario analysis comprised the characterization of pharmaceutical services and the profile of medicines lawsuits. Afterward, strategies were planned to deal with the central problem identified. The action plan involved educational outreach visits and distribution of printed materials for health professionals, evaluated through opinion survey. Group conversations were conducted with the users of the public health system, followed by thematic analysis of reports. Results: The characterization of pharmaceutical services in the municipality revealed that treatments supplied were in accordance with the National Medicines Policy. In addition, a sector was implemented to attend demands for non-incorporated medicines. In spite of the services available, the characterization of lawsuits indicated that the main claimants were users of the public health system, requiring non-incorporated medicines, with therapeutic alternatives available. Thus, educational outreach visits were held in 14 health units (23 physicians in total). Everyone who answered the evaluation declared that they were very satisfied with the approach. Group conversations with the users of the health system reached 227 participants in total. In regard to users' perception about pharmaceutical services, thematic analysis of reports identified three main categories including aspects related to medicines provided, users assisted, and quality of service. Conclusion: The study described the first cycle of an action research project to develop strategies to approach medicines litigation at the municipal level. The application of educational outreach visits for health professionals and group conversations with health system users is a promising approach to improve access to information about pharmaceutical services in Brazil.

Authors of clinical trials seldom reported details when declaring their individual and institutional financial conflicts of interest: a cross-sectional survey.

BACKGROUND: The main objective of this study was to document details of both individual and institutional financial conflicts of interest (FCOIs) reported by the authors of clinical trials. An additional objective was to assess the predictors of having at least one author reporting any FCOI. METHODS: We used a sample of randomized controlled trials from a previous cross-sectional survey and included the trials, which reported at least one FCOI disclosure. We categorized the types of disclosed FCOI as grant, employment income, personal fees, nonmonetary support, drug or equipment supplies, patent, stocks, and other types. We collected data on the characteristics of the included RCTs, of the authors, and of the reported FCOI disclosures. We conducted descriptive analyses and a regression analysis to assess the predictors of having at least one author reporting any FCOI. RESULTS: All 108 included RCTs reported being funded, with 58% reporting funding by a private-for-profit source. Out of 1,687 authors, 814 (48%) reported at least one, and a median of 2, FCOI disclosures. Of the 814 reporting disclosures, far more reported individual FCOIs (99%) than institutional FCOIs (6%). The most commonly reported individual FCOI subtypes were grant (49%), personal fees (48%), and employment income (22%). Of the 99% of disclosures that included the source of FCOI, a private-for-profit entity provided the funds in 85%. Reporting about the relation of the FCOI source's to the product investigated in the trial, the timing of FCOI, and monetary value of FCOI was limited. Reporting of FCOIs proved most strongly associated with author affiliation being an academic institution (OR = 2.981; 95% CI: 2.415-3.680) and trial funding from entity other than a private-for-profit entity (OR = 2.809; 95% CI: 2.274-3.470). CONCLUSION: Approximately half of the trial authors report individual FCOIs, often three or more, but seldom provide details related to source's relation to the trial, or the timing and monetary value of the FCOI.

Administrative Data Linkage in Brazil: Potentials for Health Technology Assessment.

Health technology assessment (HTA) is the systematic evaluation of the properties and impacts of health technologies and interventions. In this article, we presented a discussion of HTA and its evolution in Brazil, as well as a description of secondary data sources available in Brazil with potential applications to generate evidence for HTA and policy decisions. Furthermore, we highlighted record linkage, ongoing record linkage initiatives in Brazil, and the main linkage tools developed and/or used in Brazilian data. Finally, we discussed the challenges and opportunities of using secondary data for research in the Brazilian context. In conclusion, we emphasized the availability of high quality data and an open, modern attitude toward the use of data for research and policy. This is supported by a rigorous but enabling legal framework that will allow the conduct of large-scale observational studies to evaluate clinical, economical, and social impacts of health technologies and social policies.

Development and validation of a questionnaire for the assessment of the knowledge, management and reporting ADR in paediatrics by healthcare teams (QUESA-P).

OBJECTIVE: We aimed to develop and validate a new instrument called Questionnaire for the assessment of the knowledge, management and reporting ADR in Paediatrics by Healthcare teams (QUESA-P). DESIGN: This is a cross-sectional study. SETTINGS AND PARTICIPANTS: Teams of healthcare professionals (HCP) that lead with pharmacological therapy in Paediatrician's sector (Paediatric-HCP) in seven public hospitals in Brazil. OUTCOME: An assessment of the knowledge and current management of ADR in Paediatric-HCP. METHODS: We developed and validated QUESA-P, using a standardised procedure which included item development and psychometric prevalidation using Cronbach's Alpha, item-total correlation and test-retest validity for internal consistency and reliability. External criterion was used as criterion validation (the instrument was applied to the focus group expert vs focus group team of Paediatric-HCP in hospitals). The focus group of experts who participated in psychometrics was asked to respond to the QUESA-P twice in order to assess test-retest reliability. The content validity of the initial questionnaire was assessed by the Delphi method and pilot test. Subsequently, we made minor revisions and finalized the QUESA-P RESULTS: Selection of domains and facets were based on literature review made in duplicate by authors. Content validity was done by trial of different examiners (panellists, n=16), conducting analysis through Delphi method (three rounds). The QUESA-P was constructed with three domains. The intraclass correlations (0.80) and the Cronbach's alpha coefficient (0.82), indicated adequate test-retest reliability and internal consistency for each domain. The application of the QUESA to 61 Paediatric-HCP in hospital resulted in lower mean score of 42.1 ± 3.4 in all domains when compared with expert teams (n= 46) 48.2 ± 3.7 (p <0.001) indicating that the instrument is valid to discriminate QUESA experts and Paediatric-HCP. CONCLUSION: The selected domains can be used to check weaknesses in the identification, management and reporting of suspected ADR by Paediatric-HCP in Brazil.

Propensity Score Methods in Health Technology Assessment: Principles, Extended Applications, and Recent Advances.

Randomized clinical trials (RCT) are accepted as the gold-standard approaches to measure effects of intervention or treatment on outcomes. They are also the designs of choice for health technology assessment (HTA). Randomization ensures comparability, in both measured and unmeasured pretreatment characteristics, of individuals assigned to treatment and control or comparator. However, even adequately powered RCTs are not always feasible for several reasons such as cost, time, practical and ethical constraints, and limited generalizability. RCTs rely on data collected on selected, homogeneous population under highly controlled conditions; hence, they provide evidence on efficacy of interventions rather than on effectiveness. Alternatively, observational studies can provide evidence on the relative effectiveness or safety of a health technology compared to one or more alternatives when provided under the setting of routine health care practice. In observational studies, however, treatment assignment is a non-random process based on an individual's baseline characteristics; hence, treatment groups may not be comparable in their pretreatment characteristics. As a result, direct comparison of outcomes between treatment groups might lead to biased estimate of the treatment effect. Propensity score approaches have been used to achieve balance or comparability of treatment groups in terms of their measured pretreatment covariates thereby controlling for confounding bias in estimating treatment effects. Despite the popularity of propensity scores methods and recent important methodological advances, misunderstandings on their applications and limitations are all too common. In this article, we present a review of the propensity scores methods, extended applications, recent advances, and their strengths and limitations.

Characteristics of funding of clinical trials: cross-sectional survey and proposed guidance.

OBJECTIVES: To provide a detailed and current characterisation of funding of a representative sample clinical trials. We also aimed to develop guidance for standardised reporting of funding information. METHODS: We addressed the extent to which clinical trials published in 2015 in any of the 119 Core Clinical Journals included a statement on the funding source (eg, whether a not-for-profit organisation was supported by a private-for-profit organisation), type of funding, amount and role of funder. We used a stepwise approach to develop a guidance and an instrument for standardised reporting of funding information. RESULTS: Of 200 trials, 178 (89%) included a funding statement, of which 171 (96%) reported being funded. Funding statements in the 171 funded trials indicated the source in 100%, amount in 1% and roles of funders in 50%. The most frequent sources were governmental (58%) and private-for-profit (40%). Of 54 funding statements in which the source was a not-for-profit organisation, we found evidence of undisclosed support of those from private-for-profit organisation(s) in 26 (48%). The most frequently reported roles of funders in the 171 funded trials related to study design (42%) and data analysis, interpretation or management (41%). Of 139 randomised controlled trials (RCTs) addressing pharmacological or surgical interventions, 29 (21%) reported information on the supplier of the medication or device. The proposed guidance addresses both the funding information that RCTs should report and the reporting process. Attached to the guidance is a fillable PDF document for use as an instrument for standardised reporting of funding information. CONCLUSION: Although the majority of RCTs report funding, there is considerable variability in the reporting of funding source, amount and roles of funders. A standardised approach to reporting of funding information would address these limitations. Future research should explore the implications of funding by not-for-profit organisations that are supported by for-profit organisations.

Authors of clinical trials reported individual and financial conflicts of interest more frequently than institutional and nonfinancial ones: a methodological survey.

BACKGROUND AND OBJECTIVE: Conflicts of interest (COIs) are increasingly recognized as important to disclose and manage in health research. The objective of this study was to assess the reporting of both financial and nonfinancial COI by authors of randomized controlled trials published in a representative sample of clinical journals. METHODS: We searched Ovid Medline and included a random sample of 200 randomized controlled trials published in 2015 in one of the 119 Core Clinical Journals. We classified COI using a comprehensive framework that includes the following: individual COIs (financial, professional, scholarly, advocatory, personal) and institutional COIs (financial, professional, scholarly, and advocatory). We conducted descriptive and regression analyses. RESULTS: Of the 200 randomized controlled trials, 188 (94%) reported authors' COI disclosures that were available in the main document (92%) and as International Committee of Medical Journal Editors forms accessible online (12%). Of the 188 trials, 57% had at least one author reporting at least one COI; in all these trials, at least one author reported financial COI. Institutional COIs (11%) and nonfinancial COIs (4%) were less commonly reported. References to COI disclosure statements for editors (1%) and medical writers (0%) were seldom present. Regression analyses showed positive associations between reporting individual financial COI and higher journal impact factor (odds ratio [OR] = 1.06, 95% confidence interval [CI] = 1.02-1.10), larger number of authors (OR = 1.10, 95% CI 1.02-1.20), affiliation with an institution from a high-income country (OR = 16.75, 95% CI 3.38-82.87), and trials reporting on pharmacological interventions (OR = 2.28, 95% CI 1.13-4.62). CONCLUSION: More than half of published randomized controlled trials report that at least one author has a COI. Trial authors report financial COIs more often than nonfinancial COIs and individual COIs more frequently than institutional COIs.

Reporting of financial and non-financial conflicts of interest by authors of systematic reviews: a methodological survey.

BACKGROUND: Conflicts of interest may bias the findings of systematic reviews. The objective of this methodological survey was to assess the frequency and different types of conflicts of interest that authors of Cochrane and non-Cochrane systematic reviews report. METHODS: We searched for systematic reviews using the Cochrane Database of Systematic Reviews and Ovid MEDLINE (limited to the 119 Core Clinical Journals and the year 2015). We defined a conflict of interest disclosure as the reporting of whether a conflict of interest exists or not, and used a framework to classify conflicts of interest into individual (financial, professional and intellectual) and institutional (financial and advocatory) conflicts of interest. We conducted descriptive and regression analyses. RESULTS: Of the 200 systematic reviews, 194 (97%) reported authors' conflicts of interest disclosures, typically in the main document, and in a few cases either online (2%) or on request (5%). Of the 194 Cochrane and non-Cochrane reviews, 49% and 33%, respectively, had at least one author reporting any type of conflict of interest (p=0.023). Institutional conflicts of interest were less frequently reported than individual conflicts of interest, and Cochrane reviews were more likely to report individual intellectual conflicts of interest compared with non-Cochrane reviews (19% and 5%, respectively, p=0.004). Regression analyses showed a positive association between reporting of conflicts of interest (at least one type of conflict of interest, individual financial conflict of interest, institutional financial conflict of interest) and journal impact factor and between reporting individual financial conflicts of interest and pharmacological versus non-pharmacological intervention. CONCLUSIONS: Although close to half of the published systematic reviews report that authors (typically many) have conflicts of interest, more than half report that they do not. Authors reported individual conflicts of interest more frequently than institutional and non-financial conflicts of interest.

Access to medicines for diabetes treatment in Brazil: evaluation of "health has no price" program.

BACKGROUND: In 2011, private pharmacies associated to the Brazilian Ministry of Health provided patients with two types of insulin (regular human insulin and isophane insulin or NPH) and three oral antidiabetic medications (5 mg glibenclamide and 500 and 850 mg metformin) free of charge. The aim was to evaluate the impact of the "Health Has No Price" Program [Saúde Não Tem Preço (SNTP)] for access to diabetes treatment medicines in Brazil. METHODS: This longitudinal and observational study is based on the number of units of oral hypoglycemic agents, insulin and insulin analogues supplied in 55,000 private pharmacies from February 1, 2010 to January 31, 2012. The number of tablets (oral hypoglycemic agents) and international units (insulins and insulin analogues) supplied in the first 12 months of the SNTP Program were compared with the number of tablets and international units supplied in the 12 months prior to its implementation. RESULTS: The insulins in the SNTP program had the highest percentage change in the number of international units supplied; regular human insulin increased by 97.8 % and isophane insulin (NPH) by 78.0 %. Among the oral hypoglycemic agents, 5 mg glibenclamide increased by 65.9 %, and 500 and 850 mg metformin increased by 46.8 and 39.9 %, respectively, in the number of tablets dispensed in the first year of the SNTP Program. Among the hypoglycemic agents not available in SNTP, 4 mg glimepiride had the highest percentage increase in units supplied (19.2 %) in the same period. Among the insulin analogues, which were not available in the SNTP Program, insulin glulisine showed the greatest increase in units dispensed (34.2 %). CONCLUSIONS: The SNTP Program contributed to increased access to medicines for the treatment of diabetes in Brazil.

[The list of drugs in the Popular Pharmacy Program and the Brazilian National Pharmaceutical Care Policy]. / Elenco de medicamentos do Programa Farmácia Popular do Brasil e a Política de Nacional Assistência Farmacêutica.

This study aimed to analyze the list of drugs in the Popular Pharmacy Program in Brazil (PFPB) in relation to the country's pharmaceutical care policy. The list of drugs in the PFPB was compared to the Brazilian and international reference lists of essential medicines, the components of pharmaceutical care in Brazilian Unified National Health System (SUS), and drug production by the country's government pharmaceutical laboratories. The PFPB list includes 119 drugs, of which 19.3% and 47.1% were not selected on the Brazilian and international reference lists, respectively; 16.8% are not used in primary care, and 40.3% are not produced by the country's government laboratories. A revision of the PFPB list based on the essential medicines concept (World Health Organization), alignment of pharmaceutical care policies, and production by government laboratories are essential to improve quality of health care, management, training of prescribers, and information for the population.

Elenco de medicamentos do Programa Farmácia Popular do Brasil e a Política de Nacional Assistência Farmacêutica / The list of drugs in the Popular Pharmacy Program and the Brazilian National Pharmaceutical Care Policy / Lista de medicamentos del Programa Farmacia Popular de Brasil y la Política Brasileña de Asistencia Farmacéutica

O objetivo deste trabalho foi analisar o elenco de medicamentos do Programa Farmácia Popular do Brasil (PFPB) frente à política de assistência farmacêutica vigente no país. O elenco de medicamentos do PFPB foi comparado com listas de referência de medicamentos essenciais (nacional e internacional), com os componentes da assistência farmacêutica no Sistema Único de Saúde (SUS) e com a produção pública de medicamentos nos Laboratórios Farmacêuticos Oficiais do Brasil (LFOB). O PFPB contém 119 medicamentos, dos quais 19,3% e 47,1% não foram selecionados nas listas de referência nacional e internacional, respectivamente; 16,8% não são utilizados na atenção primária e 40,3% não são produzidos por LFO. A revisão do elenco do PFPB com base na concepção de medicamentos essenciais da Organização Mundial da Saúde, o alinhamento às políticas de assistência farmacêutica e à produção pelos LFO são fundamentais para melhorar a qualidade da atenção à saúde, a gestão, a capacitação dos prescritores e a informação aos cidadãos.

This study aimed to analyze the list of drugs in the Popular Pharmacy Program in Brazil (PFPB) in relation to the country's pharmaceutical care policy. The list of drugs in the PFPB was compared to the Brazilian and international reference lists of essential medicines, the components of pharmaceutical care in Brazilian Unified National Health System (SUS), and drug production by the country's government pharmaceutical laboratories. The PFPB list includes 119 drugs, of which 19.3% and 47.1% were not selected on the Brazilian and international reference lists, respectively; 16.8% are not used in primary care, and 40.3% are not produced by the country's government laboratories. A revision of the PFPB list based on the essential medicines concept (World Health Organization), alignment of pharmaceutical care policies, and production by government laboratories are essential to improve quality of health care, management, training of prescribers, and information for the population.

El objetivo de este estudio fue analizar la lista de medicamentos del Programa Farmacia Popular de Brasil (PFPB), en contraste con la política de la asistencia farmacéutica, en vigor en el país. El catálogo de medicamentos del PFPB se comparó con las listas de referencias de medicamentos esenciales (nacionales e internacionales), así como con la lista de financiación de los componentes de la asistencia farmacéutica del sistema de salud pública, y la producción pública de medicamentos por Laboratorios Oficiales de Farmacéuticos de Brasil (LOFB). El PFPB contiene 119 medicamentos de los que un 19,3% y un 47,1% no fueron seleccionados en las listas de referencias nacionales e internacionales, respectivamente; un 16,8% no se utilizan en la atención primaria y un 40,3% no son producidos por los LOFB. La revisión del catálogo de PFPB, basado en la concepción de medicamentos esenciales de la Organización Mundial de la Salud, el alineamiento político de la asistencia farmacéutica, y la producción por los LOFB es fundamental para mejorar la calidad de la asistencia de salud, la gestión, la formación de los prescriptores y la información a los ciudadanos.

Women's values and preferences for thromboprophylaxis during pregnancy: a comparison of direct-choice and decision analysis using patient specific utilities.

BACKGROUND: Women with a history of venous thromboembolism (VTE) have an increased recurrence risk during pregnancy. Low molecular weight heparin (LMWH) reduces this risk, but is costly, burdensome, and may increase risk of bleeding. The decision to start thromboprophylaxis during pregnancy is sensitive to women's values and preferences. Our objective was to compare women's choices using a holistic approach in which they were presented all of the relevant information (direct-choice) versus a personalized decision analysis in which a mathematical model incorporated their preferences and VTE risk to make a treatment recommendation. METHODS: Multicenter, international study. Structured interviews were on women with a history of VTE who were pregnant, planning, or considering pregnancy. Women indicated their willingness to receive thromboprophylaxis based on scenarios using personalized estimates of VTE recurrence and bleeding risks. We also obtained women's values for health outcomes using a visual analog scale. We performed individualized decision analyses for each participant and compared model recommendations to decisions made when presented with the direct-choice exercise. RESULTS: Of the 123 women in the study, the decision model recommended LMWH for 51 women and recommended against LMWH for 72 women. 12% (6/51) of women for whom the decision model recommended thromboprophylaxis chose not to take LMWH; 72% (52/72) of women for whom the decision model recommended against thromboprophylaxis chose LMWH. CONCLUSIONS: We observed a high degree of discordance between decisions in the direct-choice exercise and decision model recommendations. Although which approach best captures individuals' true values remains uncertain, personalized decision support tools presenting results based on personalized risks and values may improve decision making.