Three decades of telemedicine in Brazil: Mapping the regulatory framework from 1990 to 2018.

This study characterized the evolution of Brazilian public telemedicine policy in the Brazilian Unified Health System for 30 years from 1988 to 2019 by analyzing its legal framework. We identified 79 telemedicine-related legislations from the federal government (laws, decrees, and ordinances) and 31 regulations of federal councils of health professionals. Three historical phases were established according to the public policy cycle, and material was classified according to the purpose of the normative documents. The content analysis was based on the advocacy coalition framework model. Of the federal legislations, 8.9% were for the Formulation/Decision-Making phase, 43% for the Organization/Implementation phase, and 48.1% for the Expansion/Maturation phase of telemedicine policy in Brazil. The Federal Council of Medicine was the most active in standardizing telemedicine and was responsible for 21 (67.7%) regulations. The first legislations were passed in 2000; however, the coalitions discussed topics related to telemedicine and created their belief systems from the 1990's. The time cycle which included formulation and decision making for Brazilian telemedicine policy, extended until 2007 with the creation of several technical working groups. The expansion and maturation of telemedicine services began in 2011 with the decentralization of telemedicine policy actions across the country. Telemedicine centers which performed telediagnosis influenced the computerization of primary health care units. We conclude that Brazilian telemedicine field has greatly grown and changed in recent years. However, despite the proliferation of legislations and regulations in the period studied, there is still no fully consolidated process for setting up a wholly defined regulatory framework for telemedicine in Brazil.

Hypertension and diabetes treatment affordability and government expenditures following changes in patient cost sharing in the "Farmácia popular" program in Brazil: an interrupted time series study.

BACKGROUND: Increasing medicines availability and affordability is a key goal of Brazilian health policies. "Farmácia Popular" (FP) Program is one of the government's key strategies to achieve this goal. Under FP, antihypertension (HTN) and antiglycemic (DM) medicines have been provided at subsidized prices in private retail settings since 2006, and free of charge since 2011. We aim to assess the impact of sequential changes in FP benefits on patient affordability and government expenditures for HTN and DM treatment under the FP, and examine their implications for public financing mechanisms and program sustainability. METHODS: Longitudinal, retrospective study using interrupted time series to analyze: HTN and DM treatment coverage; total and per capita expenditure; percentage paid by MoH; and patient cost sharing. Analyzes were conducted in the dispensing database of the FP program (from 2006 to 2012). RESULTS: FP has increased its coverage over time; by December 2012 FP covered on average 13% of DM and 11.5% of HTN utilization, a growth of over 600 and 1500%, respectively. The overall cost per treatment to the MoH declined from R$36.43 (R$ = reais, the Brazilian currency) to 18.74 for HTN and from R$33.07to R$15.05 for DM over the period analyzed, representing a reduction in per capita cost greater than 50%. The amount paid by patients for the medicines covered increased over time until 2011, but then declined to zero. We estimate that to treat all patients in need for HTN and DM in 2012 under FP, the Government would need to expend 97% of the total medicines budget. CONCLUSIONS: FP rapidly increased its coverage in terms of both program reach and proportion of cost subsidized during the period analyzed. Costs of individual HTN and DM treatments in FP were reduced after 2011 for both patients (free) and government (better negotiated prices). However, overall FP expenditures by MoH increased due to markedly increased utilization. The FP is sustainable as a complementary policy but cannot feasibly substitute for the distribution of medicines by the SUS.

Factors influencing pharmaceutical pricing - a scoping review of academic literature in health science.

INTRODUCTION: Pharmaceutical pricing has only recently gained space in mainstream health science literature. OBJECTIVES: Bibliometric and content description of health science academic literature and ad hoc analysis of grey literature on factors influencing pharmaceutical pricing on databases commonly accessed by healthcare professionals. METHODS: Scoping study with no time limits performed in Medline, Scopus and Scielo, and relevant sites and databases for grey literature, using search terms with database-appropriate keywords. RESULTS: Two hundred four articles were published in 103 peer-reviewed journals between 1981 and 2016 (last search year). In grey literature 78 documents were retrieved in the final selection. Five key thematic clusters for analysing pharmaceutical pricing emerged: market dynamics, segmented into (i) supply-related, (ii) consumer-related and (iii) product-related; (iv) trading strategies, either buyer's or seller's and (v) regulatory approach. In peer-reviewed literature there is an overall dominance of themes referring to trading strategies and regulatory approaches and a wide thematic cluster scope. Over half of this literature was produced after the year 2010. International agency technical papers make up the most significant contributions of grey literature, with a clear focus on regulatory approaches to pricing and wider consideration of emerging countries. Research lags in the literature on factors affecting pharmaceutical pricing include impacts of financing schemes, market liberalization, internet trading and biosimilars on prices, with insufficient discussion identified for the effects of discounts/rebates, profits and price transparency. CONCLUSIONS: Interest in pharmaceutical pricing literature is increasing. Robust evidence-producing study designs for pricing interventions will be a welcome development.

Accuracy of positron emission tomography and positron emission tomography-CT in the detection of differentiated thyroid cancer recurrence with negative (131) I whole-body scan results: A meta-analysis.

BACKGROUND: The purpose of this review was to present a meta-analysis aimed to evaluate the accuracy of positron emission tomography (PET) and PET-CT for detecting recurrence of differentiated thyroid carcinoma (DTC) not identified by (131) I whole-body scintigraphy. METHODS: MEDLINE, EMBASE, LILACS, and Cochrane databases were searched for studies published between January 1985 and March 2012. Systematic methods were used to select and evaluate the quality of studies. Pooled sensitivity and specificity for conventional PET and PET-CT was estimated using random effects model. RESULTS: Twenty studies were included in the systematic review; the data of 18 studies were used in the meta-analysis. The combined sensitivity and specificity for conventional PET were both found to be 84%; for PET-CT, they were 93% and 81%, respectively. The overall accuracies were 91% and 93%, respectively. CONCLUSION: (18) Fluorodeoxyglucose (FDG)-PET and PET-CT are highly accurate diagnostics tools for DTC recurrence in patients who present a negative whole-body scintigraphy and could impact the clinical and therapeutic management of DTC.

[The acquisition of medication to treat Alzheimer's disease in Brazil: an analysis of federal purchases, 2008-2013]. / Aquisição de medicamentos para a Doença de Alzheimer no Brasil: uma análise no sistema federal de compras, 2008 a 2013.

The demographic transition in Brazil has led to substantial aging of the population and an increased prevalence of age-related diseases such as dementia and Alzheimer's Disease (AD). The Brazilian Ministry of Health finances AD medication and, since 2002, a Clinical Protocol and Therapeutic Guidelines (PCDT) for this condition have been made available. This study investigated the acquisition of medication for AD in the Integrated System of Administration of General Services (SIASG) database. A profile of purchases, expenditures and prices from 2008 to 2013 was prepared. All medication and forms of treatment of AD were investigated, including those not contained in the PCDT protocol. Unit prices were deflated to December 2013 by the IPCA (Brazilian Pricing Index). More than 47 million units of medication for AD were acquired and expenditures attained 90.1 million Brazilian reals. The purchase of the various administration routes of rivastigmine were in the forefront. Medication not listed in the protocol represented 3% of expenditures and purchases resulting from health litigation were negligible. Over the period, a reduction of corrected weighted average prices of PCDT and non-PCDT medication was observed.

"Farmácia Popular do Brasil" Program: characterization and evolution between 2004 and 2012.

The "Farmácia Popular do Brasil" Program (PFPB) aims to improve access to medicines, offering subsidized products. It is structured in an arrangement involving public and private sectors. The paper described the organization and expansion of the PFPB and examined the reference price (RP) of the medicines paid by the government, between 2004 and 2012. It is an exploratory study of quantitative and qualitative approach, developed from the literature review and analysis of public documents. Quantitative data were collected from the Ministry of Health and Electronic System of Citizens Information Services. The PFPB is organized in two delivery models: public owned facilities (Rede Própria) and accredited private retail pharmacies (Aqui Tem Farmácia Popular-ATFP). The ATFP has allowed its own expansion, from 2006. Antihypertensives, antidiabetics and antiasthmatics were exempt from copayment, since 2011. The expansion of the ATFP Program was significant, for facilities and covered municipalities, 750% and 528%, respectively. The RP was reduced by 33.6% on average (ranging from 23-52%) for medicines available since the beginning of the ATFP. The expansion was performed with the actions hitherto unprecedented, as copayment and accreditation of private retail pharmacies.

[An analysis of the Ministry of Health of Brazil investments in research and development between 2000-2002: a base line towards future valuations beginning with the implementation of the National Health Research Priority Agenda]. / Análise dos investimentos do Ministério da Saúde em pesquisa e desenvolvimento do período 2000-2002: uma linha de base para avaliações futuras a partir da implementação da agenda nacional de prioridades de pesquisa em saúde.

The aim of this paper is to examine the Ministry of Health of Brazil investments in research and development in health (R&D/H) between the years of 2000-2002, trying to contrast them with the items of the National Health Research Priority Agenda, in order to attempt a base line that makes capable future evaluations on the inductor role. The data was collected by a research carried out with the main goal of measure resources invested in R&D/H in the country on the period, considering only the Ministry of Health investments. The researches were independently categorized by 2 researchers based on 24 subdivisions which compose the Agenda. The amount of the resources invested by the Ministry of Health on the period was of R$ 199.3 millions. Most of the expense was related to researches in transmittable diseases (31.5%), followed by systems and policies in health (16.3%) and communication and information in health (8.6%). Conditions that represent a substantial disease burden (non transmittable diseases, mental health, violence, accidents and traumas, elderly person health) received relative small amount of resource. The work establishes a starting point from which managers of scientific and technological policy may assess the progressive influence of the Agenda and the reduction of the identified imbalances.