Variabilidade de preços de aquisição de medicamentos do grupo 1B do Componente Especializado da Assistência Farmacêutica

Resumo No Sistema Único de Saúde os medicamentos do grupo 1 do Componente Especializado da Assistência Farmacêutica (CEAF) são financiados pela União e adquiridos de forma centralizada (grupo 1A) ou por cada Unidade Federativa (UF) (grupo 1B). Diferentemente de outros países onde se negocia um preço fixo a ser praticado no sistema público, no Brasil as aquisições são realizadas por licitação, o que pode levar a diferentes preços. Para permitir a comparação de preços, foi pactuada a obrigatoriedade de registro das aquisições públicas no Banco de Preços em Saúde (BPS). O estudo teve como objetivo analisar a variabilidade dos preços de medicamentos do grupo 1B adquiridos pelas UF do Brasil em 2021. Foram obtidas as aquisições de medicamentos do grupo 1B realizadas pelas Secretarias de Estado das 27 UF por consulta ao BPS excluindo-se os medicamentos sem preço de ressarcimento estabelecido em dezembro/2021. Foi obtido do Sistema de Informações Ambulatoriais o ressarcimento para cada UF. Verificou-se grande variabilidade dos preços de aquisição para cada medicamento entre as UF e dentro da mesma UF. O estudo demonstrou potencial iniquidade de acesso ao CEAF, privilegiando com menores preços UF mais favorecidas (maior população e riqueza).</jats:p

Mapping the characteristics of network meta-analyses on antithrombotic therapies: an overview and critical appraisal

Objectives: A large number of network meta-analyses (NMAs) in the field of cardiac disease are available, yet the scientific literature lacks an updated straightforward synthesis of this evidence to ground the decision-making process. We aimed to map and critically appraise NMAs on antithrombotic therapies used as treatment or prophylaxis of cardiac diseases and cardiac surgical procedures. Methods: A systematic review of systematic reviews with meta-analysis was conducted following Cochrane Collaboration and Joanna Briggs recommendations (PROSPERO-CRD2020166468). Searches to identify NMAs meeting the eligibility criteria of this study were performed in PubMed and Scopus (Jan-2022). NMAs characteristics including metadata, statistical models’ description, and main pooled results were collected. The methodological quality of NMAs was evaluated using the PRISMA-NMA checklist and AMSTAR-2 tools. Descriptive statistical analyses with categorical variables reported as frequencies and continuous variables as the median and interquartile range (IQR) were performed (SPSS-Statistics v.25.0). Results: Overall, n=88 NMAs published between 2007-2022 were identified. The most evaluated clinical condition was atrial fibrillation (n=57; 64.7%); around one-third of the studies (38.6%) assessed cardiac surgical procedures. Only 28.4% NMAs had a registered study protocol. Fifty NMAs (56.8%) were published by authors from one single country China the most frequently. A median of 14 primary studies (IQR 5-20.75) (mostly randomized clinical trials) were included per NMA. A median of 40 (IQR 24-84.25) indirect meta-analyses per study were found. At least one network diagram for a given outcome was provided by 68 (77.2%) studies, yet only 22 (25.6%) performed treatment ranking analyses. Conflict of interest declarations and study funding were informed by 34 (38.6%) and 38 (43.2%) NMAs, respectively. Conclusions: Although there is a widespread of NMA-type studies assessing different antithrombotic agents for different cardiac conditions, the lack of standardized conduction and reporting of NMAs (poor-moderate methodological quality) may limit their comparison and results implementation into clinical practice.info:eu-repo/semantics/publishedVersio

Publication speed in pharmacy practice journals: A comparative analysis

Background Scholarly publishing system relies on external peer review. However, the duration of publication process is a major concern for authors and funding bodies. Objective To evaluate the duration of the publication process in pharmacy practice journals compared with other biomedical journals indexed in PubMed. Methods All the articles published from 2009 to 2018 by the 33 pharmacy practice journals identified in Mendes et al. study and indexed in PubMed were gathered as study group. A comparison group was created through a random selection of 3000 PubMed PMIDs for each year of study period. Articles with publication dates outside the study period were excluded. Metadata of both groups of articles were imported from PubMed. The duration of editorial process was calculated with three periods: acceptance lag (days between 'submission date' and 'acceptance date'), lead lag (days between 'acceptance date' and 'online publication date'), and indexing lag (days between 'online publication date' and 'Entry date'). Null hypothesis significance tests and effect size measures were used to compare these periods between both groups. Results The 33 pharmacy practice journals published 26,256 articles between 2009 and 2018. Comparison group random selection process resulted in a pool of 23,803 articles published in 5,622 different journals. Acceptance lag was 105 days (IQR 57-173) for pharmacy practice journals and 97 days (IQR 56-155) for the comparison group with a null effect difference (Cohen's d 0.081). Lead lag was 13 (IQR 6-35) and 23 days (IQR 9-45) for pharmacy practice and comparison journals, respectively, which resulted in a small effect. Indexing lag was 5 days (IQR 2-46) and 4 days (IQR 2-12) for pharmacy practice and control journals, which also resulted in a small effect. Slight positive time trend was found in pharmacy practice acceptance lag, while slight negative trends were found for lead and indexing lags for both groups. Conclusions Publication process duration of pharmacy practice journals is similar to a general random sample of articles from all disciplines

Reports of substandard medicines: a lexicographic analysis of the Brazilian Health Surveillance Report System

Regulatory agencies are responsible for collecting and evaluating spontaneous reports of suspected problems related to medications, including those from substandard medicines (SM). Objectives: The aim was to evaluate the profile of SM reports submitted to the Brazilian Health Surveillance Notification System (Notivisa) and classify these reports objectively by means of lexicographic analysis. Methods: Was extracted all SM reports available in Notivisa during the period 1 January 2007 to 31 December 2017. Descriptive statistics were performed and the reasons for SM reporting were standardized (using OpenRefine and Microsoft Excel). The following analyses were performed using IRAMuTeQ 0.7 alpha2: lexicographic analysis to obtain the frequency of active words; descending hierarchical classification (DHC) to categorize the active words into lexical classes; factorial correspondence analysis (FCA) to obtain graphs of the classes. Approved by the Ethics Committee of the Hospital do Trabalhador/SES/PR CAAE 81873417.3.0000.5225 (protocol number: 2.506.594). Results: A total of 61,775 reports were analyzed, most of them reported by hospitals (46%). The DHC of the reasons for SM produced four classes visualized in the FCA: (i) packaging problems (16%) mainly leakages/opening issues; (ii) inadequate drug identification (22%), such as illegible label information; (iii) stability and contamination issues (11%) such as presence of particles; (iv) damaged tablets/blisters (23%) mainly broken tablets. Most SM (52%) were solutions for parenteral use; sodium chloride (9%), glucose and dipyrone (3%) were the products with most complaints. Conclusions: The reasons for SM reporting can be objectively classified into classes that represent the main problems submitted to Notivisa. This classification could guide the standardization of SM reporting and contribute to improving surveillance reporting systems worldwide

Fecal microbiota transplantation in inflammatory bowel disease patients: A systematic review and meta-analysis

Objectives Current evidence on fecal microbiota transplantation for inflammatory bowel disease is inconclusive. We conducted a systematic review to gather evidence on the efficacy and safety of fecal microbiota transplantation for inflammatory bowel disease. Methods Systematic searches were conducted in PubMed, Scopus, and Web of Science. Clinical remission was considered as the primary endpoint. Pairwise meta-analyses were performed for the randomized controlled studies (Mantel Haenszel, random effects model). Proportion meta-analyses, accounting for weighted pooled rates reported in the interventional studies, were conducted using the mixed effects model. Subgroup analyses considering the type of stool, donor type, and disease subtype were also performed. Cumulative meta-analyses to assess further needs of evidence were conducted. Results Sixty studies were included, from which 36 could be synthesized in the quantitative analyses. Pairwise meta-analyses of six controlled trials showed significant differences in favor of fecal microbiota transplantation compared with placebo (clinical remission: RR 1.70 [95% CI 1.12, 2.56]; clinical response: RR 1.68 [95% CI 1.04, 2.72]). An overall clinical remission of 37%, overall clinical response of 54%, and a prevalence of 29% of adverse events were found for the interventional studies. Frozen fecal material and universal donors were related to better efficacy outcomes. In addition, Crohn's disease patients seemed to benefit more from the procedure. Conclusions The comparative analyses demonstrated that frozen fecal material from universal donors may be related to a higher rate of clinical remission, especially for Crohn's disease

Principles of pharmacoeconomic analysis: the case of pharmacist-led interventions

In the past years, several factors such as evidence-based healthcare culture, quality-linked incentives, and patient-centered actions, associated with an important increase of financial constraints and pressures on healthcare budgets, resulted in a growing interest by policy-makers in enlarging pharmacists' roles in care. Numerous studies have demonstrated positive therapeutic outcomes associated with pharmaceutical services in a wide array of diseases. Yet, the evidence of the economic impact of the pharmacist in decreasing total health expenditures, unnecessary care, and societal costs relies on well-performed, reliable, and transparent economic evaluations, which are scarce. Pharmacoeconomics is a branch of health economics that usually focuses on balancing the costs and benefits of an intervention towards the use of limited resources, aiming at maximizing value to patients, healthcare payers and society through data driven decision making. These decisions can be guide by a health technology assessment (HTA) process that inform governmental players about medical, social, and economic implications of development, diffusion, and use of health technologies including clinical pharmacy interventions. This paper aims to provide an overview of the important concepts in costing in healthcare, including studies classification according to the type of analysis method (e.g. budget-impact analysis, cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis), types of costs (e.g. direct, indirect and intangible costs) and outcomes (e.g. events prevented, quality adjusted life year - QALY, disability adjusted life year - DALY). Other key components of an economic evaluation such as the models' perspective, time horizon, modelling approaches (e.g. decision trees or simulation models as the Markov model) and sensitivity analysis are also briefly covered. Finally, we discuss the methodological issues for the identification, measurement and valuation of costs and benefits of pharmacy services, and suggest some recommendations for future studies, including the use of Value of Assessment Frameworks

Description of network meta-analysis geometry: A metrics design study

© 2019 Tonin et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Background The conduction and report of network meta-analysis (NMA), including the presentation of the network-plot, should be transparent. We aimed to propose metrics adapted from graph theory and social network-analysis literature to numerically describe NMA geometry. Methods A previous systematic review of NMAs of pharmacological interventions was performed. Data on the graph’s presentation were collected. Network-plots were reproduced using Gephi 0.9.1. Eleven geometric metrics were tested. The Spearman test for non-parametric correlation analyses and the Bland-Altman and Lin’s Concordance tests were performed (IBM SPSS Statistics 24.0). Results From the 477 identified NMAs only 167 graphs could be reproduced because they provided enough information on the plot characteristics. The median nodes and edges were 8 (IQR 6–11) and 10 (IQR 6–16), respectively, with 22 included studies (IQR 13–35). Metrics such as density (median 0.39, ranged 0.07–1.00), median thickness (2.0, IQR 1.0–3.0), percentages of common comparators (median 68%), and strong edges (median 53%) were found to contribute to the description of NMA geometry. Mean thickness, average weighted degree and average path length produced similar results than other metrics, but they can lead to misleading conclusions. Conclusions We suggest the incorporation of seven simple metrics to report NMA geometry. Editors and peer-reviews should ensure that guidelines for NMA report are strictly followed before publication

Pharmacovigilance: an evaluation on the practice of pharmacists acting in pharmacies and drugstores

Pharmacists acting in pharmacies and drugstores stores are some of the most accessible healthcare providers and the last to intervene before the patient takes their medicine. This puts the pharmacist in a position of authority that should be harnessed for the benefit of health. Thus, this professional is strategic for performing pharmacovigilance. Our objective of this study was to interrogate the practice of pharmacists in relation to pharmacovigilance activities, and to identify difficulties and possible stimuli for the improvement these activities in pharmacies and drugstores. The information was collected through an online questionnaire via Survey Monkey®. The data were analyzed statistically using SPSS software. Responses were received from 5174 pharmacists: mostly young women within five years of graduation and experience in pharmaceutical retail. 81% of them reported having identified suspected substandard medicines, but only 16% used the Brazilian notification system Notivisa. More than 85% of pharmacists agreed with the importance of pharmacovigilance and the recognition of reporting services as part of pharmacist duties and pharmaceutical care. The main barriers to making notifications were the lack of access and knowledge about Notivisa. Pharmacists agreed that simplifying the system would be a stimulus for notifications, and requested more feedback from notifications, as well as material and courses to understand the notification process. Pharmacists have important data to feed into pharmacovigilance systems, recognize their responsibilities and are willing to contribute, but still demonstrate low compliance. Simplification of the system and training on it are likely to increase notifications

Lag times in the publication of network meta-analyses: A survey

Objective We assessed the extent of lag times in the publication and indexing of network meta-analyses (NMAs). Study design This was a survey of published NMAs on drug interventions. Setting NMAs indexed in PubMed (searches updated in May 2020). Primary and secondary outcome measures Lag times were measured as the time between the last systematic search and the article submission, acceptance, online publication, indexing and Medical Subject Headings (MeSH) allocation dates. Time-to-event analyses were performed considering independent variables (geographical origin, Journal Impact Factor, Scopus CiteScore, open access status) (SPSS V.24, R/RStudio). Results We included 1245 NMAs. The median time from last search to article submission was 6.8 months (204 days (IQR 95-381)), and to publication was 11.6 months. Only 5% of authors updated their search after first submission. There is a very slightly decreasing historical trend of acceptance (rho=-0.087; p=0.010), online publication (rho=-0.080; p=0.008) and indexing (rho=-0.080; p=0.007) lag times. Journal Impact Factor influenced the MeSH allocation process, but not the other lag times. The comparison between open access versus subscription journals confirmed meaningless differences in acceptance, online publication and indexing lag times. Conclusion Efforts by authors to update their search before submission are needed to reduce evidence production time. Peer reviewers and editors should ensure authors' compliance with NMA standards. The accuracy of these findings depends on the accuracy of the metadata used; as we evaluated only NMA on drug interventions, results may not be generalisable to all types of studies