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1.
Ther Innov Regul Sci ; 58(3): 549-556, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38436905

RESUMO

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.


Assuntos
Medicamentos Biossimilares , Medicamentos Biossimilares/economia , Itália , Argentina , Brasil , Austrália , Humanos , Custos de Medicamentos , Custos e Análise de Custo
2.
Pharmacoecon Open ; 7(6): 951-961, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37707722

RESUMO

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.

3.
Regul Toxicol Pharmacol ; 144: 105485, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37659711

RESUMO

Biosimilars are biological medicines highly similar to a previously licensed reference product and their licensing is expected to improve access to biological therapies. This study aims to present an overview of biosimilars approval by thirteen regulatory authorities (RA). The study is a cross-national comparison of regulatory decisions involving biosimilars in Argentina, Australia, Brazil, Chile, Canada, Colombia, Europe, Hungary, Guatemala, Italy, Mexico, Peru and United States. We examined publicly available documents containing information regarding the approval of biosimilars and investigated the publication of public assessment reports for registration applications, guidelines for biosimilars licensing, and products approved. Data extraction was conducted by a network of researchers and regulatory experts. All the RA had issued guidance documents establishing the requirements for the licensing of biosimilars. However, only three RA had published public assessment reports for registration applications. In total, the investigated jurisdictions had from 19 to 78 biosimilars approved, most of them licensed from 2018 to 2020. In spite of the advance in the number of products in recent years, some challenges still persist. Limited access to information regarding the assessment of biosimilars by RA can affect confidence, which may ultimately impact adoption of these products in practice.

4.
Front Pharmacol ; 14: 1228986, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37680713

RESUMO

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.

7.
BMJ Open ; 13(6): e069114, 2023 06 20.
Artigo em Inglês | MEDLINE | ID: mdl-37339843

RESUMO

INTRODUCTION: Atypical antipsychotics have been studied to treat autism spectrum disorder (ASD). However, like little is known about whether these drugs are effective and safe when compared in controlled and non-controlled settings. This study aims to assess the efficacy and safety of second-generation antipsychotics in ASD in randomised controlled trials (RCT) and observational studies. METHODS AND ANALYSIS: This systematic review will include RCT and prospective cohorts evaluating second-generation antipsychotics in people 5 years and older diagnosed with ASD. Searches will be conducted in Medline, Embase, Cochrane Library, Epistemonikos, Lilacs, CINAHL, PsycINFO, trial registries and grey literature databases without restriction on publication status, year of publication and language. The primary outcomes will be symptoms of aggressive behaviour, quality of life for the individual or their careers, and discontinuation or dropouts/withdrawals of antipsychotics due to adverse events. The secondary outcomes are other not serious adverse events and adherence to pharmacotherapy. Selection, data extraction, and quality assessment will be performed by pairs of reviewers, independently. The Risk of Bias 2 (RoB 2) and Risk of Bias in Non-Randomised Studies of Interventions (ROBINS-I) tools will be used to assess the risk of bias in the included studies. If appropriate, a meta-analysis and network meta-analysis will be conducted to synthesise the results. The overall quality of the evidence for each outcome will be determined by the Recommendation, Assessment, Development and Evaluation approach. ETHICS AND DISSEMINATION: This study will systematically summarise the existing evidence evaluating the use of second-generation antipsychotics for treating ASD, in controlled and uncontrolled studies. The results of this review will be disseminated through peer-reviewed publications and conference presentations. PROSPERO REGISTRATION NUMBER: CRD42022353795.


Assuntos
Antipsicóticos , Transtorno do Espectro Autista , Humanos , Antipsicóticos/efeitos adversos , Transtorno do Espectro Autista/tratamento farmacológico , Viés , Metanálise como Assunto , Estudos Observacionais como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Revisões Sistemáticas como Assunto
8.
Front Pharmacol ; 14: 1131357, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37007033

RESUMO

Background: The social restrictions among coronavirus disease 2019 (COVID-19) pandemic have posed a thoughtful risk to mental health and have implications in the use of drugs, including antidepressants, anxiolytics and other psychotropics. Objective: This study analyzed the sales data of the psychotropics prescribed in Brazil, in order to verify the change in consumption trends of these drugs during the COVID-19 pandemic. Methods: This interrupted time-series analyzed psychotropic sales data, between January 2014 and July 2021, using the National System of Controlled Products Management from The Brazilian Health Regulatory Agency. The monthly mean DDDs per 1,000 inhabitants per day of psychotropic drugs was evaluated by analysis of variance (ANOVA) followed by Dunnett Multiple Comparisons Test. The changes in monthly trends in the use of the psychotropic studied were evaluated by Joinpoint regression. Results: During the period studied, clonazepam, alprazolam, zolpidem and escitalopram were the most sold psychotropic drugs in Brazil. According to Joinpoint regression, an upward trend was observed in sales during the pandemic of pregabalin, escitalopram, lithium, desvenlafaxine, citalopram, buproprion and amitriptyline. An increase in psychotropic consumption was noted throughout the pandemic period, with the maximum consumption (2.61 DDDs) occurring in April 2021, with a downward trend in consumption that accompanied the drop in the number of deaths. Conclusions: The increase in sales, mainly of antidepressants during the COVID-19 pandemic, draws attention to issues related to the mental health of the Brazilian population and on the need for greater monitoring in the dispensing of these drugs.

9.
Epidemiol Serv Saude ; 32(1): e2022556, 2023 03.
Artigo em Inglês, Português | MEDLINE | ID: mdl-36946832

RESUMO

OBJECTIVE: to investigate sociodemographic and clinical characteristics of users of atypical antipsychotics receiving care via the Specialized Component of Pharmaceutical Assistance (Componente Especializado da Assistência Farmacêutica - CEAF), for the treatment of schizophrenia in Brazil, between 2008 and 2017. METHODS: this was a retrospective cohort study using records of the authorizations for high complexity procedures retrieved from the Outpatient Information System of the Brazilian National Health System, from all Brazilian states. RESULTS: of the 759,654 users, 50.5% were female, from the Southeast region (60.2%), diagnosed with paranoid schizophrenia (77.6%); it could be seen a higher prevalence of the use of risperidone (63.3%) among children/adolescents; olanzapine (34.0%) in adults; and quetiapine (47.4%) in older adults; about 40% of children/adolescents were in off-label use of antipsychotics according to age; adherence to CEAF was high (82%), and abandonment within six months was 24%. CONCLUSION: the findings expand knowledge about the sociodemographic and clinical profile of users and highlight the practice of off-label use.


Assuntos
Antipsicóticos , Esquizofrenia , Adolescente , Criança , Feminino , Humanos , Idoso , Masculino , Antipsicóticos/uso terapêutico , Esquizofrenia/tratamento farmacológico , Brasil , Estudos de Coortes , Estudos Retrospectivos
10.
BMJ Open ; 13(2): e070332, 2023 02 06.
Artigo em Inglês | MEDLINE | ID: mdl-36746538

RESUMO

INTRODUCTION: The production of clinical practice guidelines (CPGs) has grown in the past years. Notwithstanding, the quality of these documents and their recommendations for the treatment of schizophrenia in children and adolescents is still unknown. OBJECTIVE: To assess the quality of the guidelines and recommendations for the treatment of schizophrenia in this population. METHODS: CPGs from 2004 to December 2020 were identified through a systematic search on EMBASE, MEDLINE, PsycINFO, PubMed, Epistemonikos, VHL, Global Index Medicus and specific CPG databases. The CPGs' quality was independently assessed by three reviewers using AGREE II and they were considered of high quality if they scored ≥60% in domains 3 and 6. The evidence classification systems were described, the quality of recommendations was assessed in pairs using AGREE-REX and the recommendations were compared. RESULTS: The database search retrieved 3182 results; 2030 were screened and 29 were selected for full-text reading. Four guidelines were selected for extraction. Two CPGs were considered of high quality in the AGREE II assessment. We described the commonly agreed recommendations for each treatment phase. The pharmacological recommendations were described in all treatment phases. Scores of AGREE-REX were lower for psychosocial recommendations. CONCLUSION: There are still few clinical studies and CPGs regarding schizophrenia in children and adolescents. The quality of the documents was overall low, and the quality of the recommendations report has much to improve. There is also a lack of transparency about the quality of the evidence and the strength of the recommendations. PROTOCOL REGISTRATION NUMBER: CRD42020164899.


Assuntos
Esquizofrenia , Humanos , Criança , Adolescente , Esquizofrenia/terapia , Bases de Dados Factuais , Gerenciamento de Dados
13.
Epidemiol. serv. saúde ; 32(1): e2022556, 2023. tab, graf
Artigo em Inglês, Português | LILACS | ID: biblio-1421414

RESUMO

Objective: to investigate sociodemographic and clinical characteristics of users of atypical antipsychotics receiving care via the Specialized Component of Pharmaceutical Assistance (Componente Especializado da Assistência Farmacêutica - CEAF), for the treatment of schizophrenia in Brazil, between 2008 and 2017. Methods: this was a retrospective cohort study using records of the authorizations for high complexity procedures retrieved from the Outpatient Information System of the Brazilian National Health System, from all Brazilian states. Results: of the 759,654 users, 50.5% were female, from the Southeast region (60.2%), diagnosed with paranoid schizophrenia (77.6%); it could be seen a higher prevalence of the use of risperidone (63.3%) among children/adolescents; olanzapine (34.0%) in adults; and quetiapine (47.4%) in older adults; about 40% of children/adolescents were in off-label use of antipsychotics according to age; adherence to CEAF was high (82%), and abandonment within six months was 24%. Conclusion: the findings expand knowledge about the sociodemographic and clinical profile of users and highlight the practice of off-label use.


Objetivo: investigar las características sociodemográficas y clínicas de los usuarios de antipsicóticos atípicos, atendidos por el Componente Especializado de Asistencia Farmacéutica (CEAF) para el tratamiento de la esquizofrenia en Brasil, de 2008 a 2017. Métodos: estudio de cohorte retrospectivo utilizando registros de autorizaciones de trámites de alta complejidad del Sistema de Información Ambulatorio del SUS, de todos los estados brasileños. Resultados: de los 759.654 usuários identificados, el 50,5% era del sexo feminino de la región Sudeste (60,2%), diagnosticadas con esquizofrenia paranoide (77,6%). Hubo una mayor prevalencia de risperidona (63,3%) entre niños y adolescentes; de olanzapina (34,0%) en adultos; y quetiapina (47,4%) en ancianos. Alrededor del 40% de los niños/adolescentes estaba bajo uso no autorizado de antipsicóticos según la edad. La adherencia al CEAF fue alta (82%), y la deserción a los seis meses fue del 24%. Conclusión: los hallazgos amplían el conocimiento sobre el perfil sociodemográfico y clínico de los usuarios y destacan la práctica del uso off-label.


Objetivo: investigar características sociodemográficas e clínicas de usuários de antipsicóticos atípicos assistidos pelo Componente Especializado da Assistência Farmacêutica (CEAF), para tratamento da esquizofrenia no Brasil, de 2008 a 2017. Métodos: estudo de coorte retrospectivo utilizando registros das autorizações de procedimentos de alta complexidade do Sistema de Informações Ambulatoriais do Sistema Único de Saúde, de todos os estados brasileiros. Resultados: dos 759.654 usuários, 50,5% eram do sexo feminino, da região Sudeste (60,2%), diagnosticados com esquizofrenia paranoide (77,6%); observou-se maior prevalência de uso da risperidona (63,3%) entre crianças/adolescentes; de olanzapina (34,0%), em adultos; e quetiapina (47,4%), nos idosos; cerca de 40% das crianças/ adolescentes estavam sob uso off-label de antipsicóticos segundo a idade; a adesão ao CEAF foi alta (82%), e o abandono em seis meses foi de 24%. Conclusão: os achados ampliam o conhecimento sobre perfil sociodemográfico e clínico dos usuários e destacam a prática do uso off-label.


Assuntos
Humanos , Masculino , Feminino , Criança , Adolescente , Adulto , Pessoa de Meia-Idade , Idoso , Esquizofrenia/epidemiologia , Esquizofrenia Paranoide/tratamento farmacológico , Antipsicóticos/administração & dosagem , Uso Off-Label , Sistema Único de Saúde , Brasil/epidemiologia , Estudos de Coortes , Risperidona/administração & dosagem , Fumarato de Quetiapina/administração & dosagem , Olanzapina/administração & dosagem , Transtornos Mentais/epidemiologia
14.
Front Microbiol ; 13: 961986, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36262326

RESUMO

Objective: The aim of this study was to estimate the antimicrobial resistance in microorganisms present in periodontal diseases. Methods: A systematic review was conducted according to the PRISMA statement. The MEDLINE (PubMed/Ovid), EMBASE, BVS, CINAHL, and Web of Science databases were searched from January 2011 to December 2021 for observational studies which evaluated the antimicrobial resistance in periodontal diseases in permanent dentition. Studies that allowed the antimicrobial consumption until the time of sample collection, studies that used laboratory acquired strains, studies that only characterized the microbial strain present, assessment of cellular morphological changes, sequencing system validation, and time series were excluded. Six reviewers, working in pairs and independently, selected titles, abstracts, and full texts extracting data from all studies that met the eligibility criteria: characteristics of patients, diagnosis of infection, microbial species assessed, antimicrobial assessed, identification of resistance genes, and virulence factors. "The Joanna Briggs Institute" critical appraisal for case series was adapted to assess the risk of bias in the included studies. Results: Twenty-four studies (N = 2.039 patients) were included. Prevotella and Porphyromonas species were the most cited microorganisms in the included studies, and the virulence factors were related to Staphylococcus aureus. The antimicrobial reported with the highest frequency of resistance in the included studies was ampicillin (39.5%) and ciprofloxacin showed the lowest frequency of resistance (3.4%). The most cited genes were related to macrolides. The quality of the included studies was considered critically low. Conclusion: No evidence was found regarding the profile of antimicrobial resistance in periodontal diseases, requiring further research that should focus on regional population studies to address this issue in the era of increasing antimicrobial resistance. Clinical relevance: The knowledge about the present microorganism in periodontal diseases and their respective antimicrobial resistance profiles should guide dentists in prescribing complementary therapy for these infections. Systematic review registration: [http://dx.doi.org/10.1097/MD.0000000000013158], identifier [CRD42018077810].

15.
Ann Am Thorac Soc ; 19(12): 2077-2086, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36129426

RESUMO

Rationale: Not all individuals with tobacco dependence are ready to give up smoking. Research reveals behavioral differences between adults ready to discontinue tobacco use and those who are not. Thus, the interventions applied to these populations might differ. However, the evidence of using varenicline in individuals who are not ready to discontinue tobacco use is uncertain. Objectives: To determine if, in tobacco-dependent adults who report not being ready to discontinue tobacco use, clinicians should begin treatment with varenicline or wait until subjects are ready to discontinue tobacco use. Methods: We conducted a systematic review to assess the effectiveness and safety of treatment with varenicline in tobacco-dependent adults who are not ready to discontinue tobacco use. We systematically searched the Cumulative Index to Nursing and Allied Health Literature, Embase, MEDLINE, and the Cochrane Central Register of Controlled Trials to identify randomized controlled trials comparing varenicline versus placebo for individuals who were not ready to discontinue tobacco use. Outcomes of interest include point prevalence abstinence during treatment or at six months or longer, smoking reduction, motivation to quit, adverse events, and withdrawal symptoms. Two authors independently extracted data and assessed eligibility and risk of bias using a standardized data collection form. We followed the Grading of Recommendations, Assessment, Development and Evaluations approach to assess the certainty of evidence. Results: Five trials met our inclusion criteria. All 2,616 participants were adults who were not ready to discontinue tobacco use at study entry. For 7-day point prevalence abstinence at six months or longer, high-certainty evidence suggested that varenicline increased abstinence compared with placebo (relative risk, 2.00 [95% confidence interval (CI), 1.70-2.35]; absolute risk reduction, 173 more per 1,000 [95% CI, 121 more to 234 more]). We identified moderate-certainty evidence suggesting that varenicline increased serious adverse events (relative risk, 1.75 [95% CI, 0.98-3.13]; absolute risk reduction, 12 more per 1,000 [95% CI, 0 fewer to 35 more]). For withdrawal, low-certainty evidence suggested that varenicline treatment was associated with a lower symptom score (mean difference, 1.54 points lower; 95% CI, 2.15-0.93 points lower; low certainty) assessed using the Brief Questionnaire of Smoking Urges. Conclusions: In tobacco-dependent adults who are not ready to discontinue tobacco use, initiating varenicline treatment results in a large increase in abstinence and likely results in a slight increase in serious adverse events.


Assuntos
Abandono do Hábito de Fumar , Adulto , Humanos , Vareniclina/uso terapêutico , Agonistas Nicotínicos/efeitos adversos , Abandono do Hábito de Fumar/métodos , Bupropiona/uso terapêutico , Uso de Tabaco
16.
Front Public Health ; 10: 894958, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35979464

RESUMO

Objectives: To identify evidence-based strategies to improve adherence to the preventive measures against the coronavirus disease (COVID-19) at the community level. Method: This is an evidence brief for policy, combining research evidence specific to contextual knowledge from stakeholders. A systematic search was performed in 18 electronic databases, gray literature, and a handle search, including only secondary and tertiary studies that focused on the adherence of the general population to COVID-19 preventive measures in the community. Two reviewers, independently, performed the study selection, data extraction, and assessment of the quality of the studies. Relevant evidence has been synthesized to draft evidence-based strategies to improve adherence. These strategies were circulated for external endorsement by stakeholders and final refinement. Endorsement rates >80%, 60-80% and <60% were considered high, moderate, and low respectively. Results: Eleven studies, with varying methodological qualities were included: high (n = 3), moderate (n = 3), low (n = 1), and critically low (n = 4). Three evidence based strategies were identified: i. Risk communication; ii. Health education to the general public, and iii. Financial support and access to essential supplies and services. The rates of endorsement were: 83% for risk communication, 83% for health education, and 92% for financial support and access to essential supplies and services. The evidence showed that an increase in knowledge, transparent communication, and public awareness about the risks of COVID-19 and the benefits of adopting preventive measures results in changes in people's attitudes and behavior, which can increase adherence. In addition, the guarantee of support and assistance provides conditions for people to adopt and sustain such measures. Conclusions: These strategies can guide future actions and the formulation of public policies to improve adherence to preventive measures in the community during the current COVID-19 pandemic and other epidemics.


Assuntos
COVID-19 , Pandemias , COVID-19/epidemiologia , COVID-19/prevenção & controle , Comunicação , Humanos , Políticas
17.
Syst Rev ; 11(1): 164, 2022 08 10.
Artigo em Inglês | MEDLINE | ID: mdl-35948934

RESUMO

BACKGROUND: The judicialization of health care can be understood as a societal response to pressing healthcare needs, which probably are not being adequately addressed by the current healthcare system. This phenomenon increases the strain on service resources, both in the health sector and in the judiciary system as well, demanding an institutional reorganization to manage judicial actions. It is believed that each institution has developed strategies for coping with the problem in isolation and with little public disclosure. The purpose of this review will be to identify institutional strategies implemented and to investigate their effects in approaching the judicialization of health care. METHODS: Electronic searches will be conducted up to December 2021 on 11 databases, supplemented with gray literature and references lists of secondary studies. The descriptor "judicialization of health" will be the basis for conducting the main research. Studies describing any strategy implemented by public institutions to approach the judicialization of health care will be included. Results related to the quality of services provided by the implemented strategy reported in the studies and those that report accessibility, usability, and potential adverse effects or harms caused by the implemented strategy will be investigated. In addition, it will be explored if there have been changes related to the value or characteristics of health litigation. Two reviewers will independently screen all citations, abstract data, and full-text papers. The risk of bias in each study will be appraised using a tool suggested by Cochrane Effective Practice and Care Organization Group (EPOC). Subsequently, the reviewers will also extract the data of interest and classify the findings of these studies according to their performance at the institutional level. The results obtained will be described as a narrative synthesis. DISCUSSION: This review may provide evidence on the effects of the strategies implemented to approach the judicialization of health care. It will potentially benefit health care and legal professionals, decision-makers, and researchers by identifying the types and characteristics of strategies that have the potential to improve service delivery in the future. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020160608.


Assuntos
Atenção à Saúde , Setor Público , Instalações de Saúde , Humanos , Revisões Sistemáticas como Assunto
18.
Medicine (Baltimore) ; 101(25): e29499, 2022 Jun 24.
Artigo em Inglês | MEDLINE | ID: mdl-35758388

RESUMO

BACKGROUND: The ABCDE (Awakening and Breathing Coordination of daily sedation and ventilator removal trials, Delirium monitoring and management, and Early mobility and exercise) and ABCDEF (Assessment, prevent and manage pain, Both spontaneous awakening and spontaneous breathing trials, Choice of analgesia and sedation, assess, prevent and manage Delirium, Early mobility and exercise, Family engagement) care bundles consist of small sets of evidence-based interventions and are part of the science behind Intensive Care Unit (ICU) liberation. This review sought to analyse the process of implementation of ABCDE and ABCDEF care bundles in ICUs, identifying barriers, facilitators and changes in perception and attitudes of healthcare professionals; and to estimate care bundle effectiveness and safety. METHODS: We selected qualitative and quantitative studies addressing the implementation of ABCDE and ABCDEF bundles in the ICU, identified on MEDLINE, Embase, CINAHL, The Cochrane Library, Web of Science, Epistemonikos, PsycINFO, Virtual Health Library and Open Grey, without restriction on language or date of publication, up to June 2018. The outcomes measured were ICU and hospital length of stay; mechanical ventilation time; incidence and prevalence of delirium or coma; level of agitation and sedation; early mobilization; mortality in ICU and hospital; change in perception, attitude or behaviour of the stakeholders; and change in knowledge of health professionals. Two reviewers independently selected the studies, performed data extraction, and assessed risk of bias and methodological quality. A meta-analysis of random effects was performed. RESULTS: Twenty studies were included, 13 of which had a predominantly qualitative and 7 a quantitative design (31,604 participants). The implementation strategies were categorized according to the taxonomy developed by the Cochrane Effective Practice and Organization of Care Group and eighty strategies were identified. The meta-analysis results showed that implementation of the bundles may reduce length of ICU stay, mechanical ventilation time, delirium, ICU and hospital mortality, and promoted early mobilization in critically-ill patients. CONCLUSIONS: : This study can contribute to the planning and execution of the implementation process of ABCDE and ABCDEF care bundles in ICUs. However, the effectiveness and safety of these bundles need to be corroborated by further studies with greater methodological rigor. PROTOCOL REGISTRATION: PROSPERO CRD42019121307.


Assuntos
Delírio , Pacotes de Assistência ao Paciente , Cuidados Críticos/métodos , Estado Terminal , Delírio/prevenção & controle , Humanos , Unidades de Terapia Intensiva
19.
Int J Dent ; 2022: 6570812, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35685911

RESUMO

During the COVID-19 pandemic, people worldwide, including the scientific community, were insecure and fearful. The lack of vaccines at the beginning of the pandemic and the high mortality rate led to a search for alternative treatments for COVID-19. Among these proposals, a postulated activity of azithromycin was frequently studied in early treatment. In view of this, many countries saw an increase in the consumption of this antibiotic. Thus, the objective of this study was to evaluate, in Brazil, whether there was an increase in azithromycin prescriptions made by dentists, as they may have been prescribing this antibiotic as a probable treatment for COVID-19. This is an interrupted time series that analyzed antimicrobial prescriptions data between January 2014 and July 2021. The data were taken from the National System of Controlled Products Management, and pre- and postpandemic periods were compared. To assess changes in azithromycin consumption, Joinpoint regression and analysis of variance, followed by Dunnett's test, were used. More than 38 million prescriptions written during the period were analyzed. Amoxicillin (72.3%), azithromycin (18.0%), cephalexin (6.1%), and metronidazole (3.58%) were the most prescribed antibiotics. At the beginning of the pandemic, there was a drop in amoxicillin prescriptions motivated by a decrease in consultations, but conversely, in less than three months, azithromycin prescriptions grew by more than 100%. The exaggerated use of this antibiotic during the pandemic will certainly have consequences in the short and medium term on indicators of bacterial resistance. The use of guidelines and respect for the therapeutic protocols of government agencies should be fundamental for collective and strategic action in the fight against health emergencies.

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