The quality of research on judicialization and its influence on public policies on access to medicines in Brazil: a systematic review / A qualidade das pesquisas sobre judicialização e sua influência nas políticas públicas de acesso aos medicamentos no Brasil: uma revisão sistemática

Abstract Patients without access to medicines often resort to the judicial system. However, no systematic review has discussed the quality of studies and the factors that may influence the access to medicines from judicialization. This study aimed to characterize the quality of research on access to judicialized medicines and their influence on public policies in Brazil. A search was conducted in the LILACS, PubMed/Medline, Scopus, and Web of Science databases using the terms "judicialization" and "medication". Two reviewers identified articles that met the inclusion criteria. Only studies written in English, Portuguese, or Spanish published from 1990 to 2018 were included. The study selection resulted in a final sample of 45 articles. The retrospective descriptive design was the most common methods, based on reports and lawsuits. A high level of heterogeneity among the studies hindered the comparison and generation of evidence capable of supporting judges' decisions based on technical-scientific criteria. This review showed that studies were heterogeneous and had low methodological quality. Moreover, they did not propose viable solutions for health managers and formulators to face the problem.

Resumo Pacientes sem acesso a medicamentos geralmente recorrem ao sistema judicial. No entanto, nenhuma revisão sistemática discutiu a qualidade dos estudos e os fatores que podem influenciar o acesso aos medicamentos pela judicialização. Este estudo teve como objetivo caracterizar a qualidade da pesquisa sobre acesso a medicamentos judicializados e sua influência nas políticas públicas no Brasil. Foi realizada uma pesquisa nas bases de dados LILACS, PubMed/Medline, Scopus e Web of Science usando os termos "judicialization" e "medication". Dois revisores identificaram artigos que atendiam aos critérios de inclusão. Apenas estudos escritos em inglês, português ou espanhol publicados de 1990 a 2018 foram incluídos. A seleção do estudo resultou em uma amostra final de 45 artigos. O desenho descritivo retrospectivo foi o método mais comum, com base em relatos e ações judiciais. Um alto nível de heterogeneidade entre os estudos impediu a comparação e a geração de evidências capazes de apoiar as decisões dos juízes com base em critérios técnico-científicos. Esta revisão mostrou que os estudos eram heterogêneos e apresentavam baixa qualidade metodológica. Além disso, não propuseram soluções viáveis ​​para gerentes e formuladores de saúde enfrentarem o problema.

Nanostructured transdermal hormone replacement therapy for relieving menopausal symptoms: a confocal Raman spectroscopy study

OBJECTIVE: To determine the safety and efficacy of a transdermal nanostructured formulation of progesterone (10%) combined with estriol (0.1%) + estradiol (0.25%) for relieving postmenopausal symptoms. METHODS: A total of 66 postmenopausal Brazilian women with climacteric symptoms of natural menopause received transdermal nanostructured formulations of progesterone and estrogens in the forearm daily for 60 months to mimic the normal ovarian secretory pattern. Confocal Raman spectroscopy of hormones in skin layers was performed. Clinical parameters, serum concentrations of estradiol and follicle-stimulating hormone, blood pressure, BI-RADS classification from bilateral mammography, and symptomatic relief were compared between baseline and 60 months post-treatment. Clinicaltrials.gov: NCT02033512. RESULTS: An improvement in climacteric symptoms was reported in 92.5% of women evaluated before and after 60 months of treatment. The serum concentrations of estradiol and follicle-stimulating hormone changed significantly (p<0.05) after treatment; the values of serum follicle-stimulating hormone decreased after 60 months from 82.04±4.9 to 57.12±4.1 IU/mL. A bilateral mammography assessment of the breasts revealed normal results in all women. No adverse health-related events were attributed to this hormone replacement therapy protocol. CONCLUSION: The nanostructured formulation is safe and effective in re-establishing optimal serum levels of estradiol and follicle-stimulating hormone and relieving the symptoms of menopause. This transdermal hormone replacement therapy may alleviate climacteric symptoms in postmenopausal women. .