Global Initiative for Asthma (GINA) strategy 2021 - executive summary and rationale for key changes.

The Global Initiative for Asthma (GINA) Strategy Report provides clinicians with an annually updated evidence-based strategy for asthma management and prevention, which can be adapted for local circumstances (e.g., medication availability). This article summarizes key recommendations from GINA 2021, and the evidence underpinning recent changes. GINA recommends that asthma in adults and adolescents should not be treated solely with short-acting beta2-agonist (SABA), because of the risks of SABA-only treatment and SABA overuse, and evidence for benefit of inhaled corticosteroids (ICS). Large trials show that as-needed combination ICS-formoterol reduces severe exacerbations by ≥60% in mild asthma compared with SABA alone, with similar exacerbation, symptom, lung function and inflammatory outcomes as daily ICS plus as-needed SABA. Key changes in GINA 2021 include division of the treatment figure for adults/adolescents into two tracks. Track 1 (preferred) has low-dose ICS-formoterol as the reliever at all steps: as-needed only in Steps 1-2 (mild asthma), and with daily maintenance ICS formoterol (maintenance-and-reliever therapy, MART) in Steps 3-5. Track 2 (alternative) has as-needed SABA across all steps, plus regular ICS (Step 2) or ICS-long-acting beta2-agonist (LABA) (Steps 3-5). For adults with moderate-to-severe asthma, GINA makes additional recommendations in Step 5 for add-on long-acting muscarinic antagonists and azithromycin, with add-on biologic therapies for severe asthma. For children 6-11 years, new treatment options are added at Steps 3-4. Across all age-groups and levels of severity, regular personalized assessment, treatment of modifiable risk factors, self-management education, skills training, appropriate medication adjustment and review remain essential to optimize asthma outcomes

Global variability in administrative approval prescription criteria for biologic therapy in severe asthma

Background Regulatory bodies have approved five biologics for severe asthma. However, regional differences in accessibility may limit the global potential for personalized medicine. Objective To compare global differences in ease of access to biologics. Methods In April 2021, national prescription criteria for omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab were reviewed by severe asthma experts collaborating in the International Severe Asthma Registry. Outcomes (per country, per biologic) were (1) country-specific prescription criteria and (2) development of the Biologic Accessibility Score (BACS). The BACS composite score incorporates 10 prescription criteria, each with a maximum score of 10 points. Referenced to European Medicines Agency marketing authorization specifications, a higher score reflects easier access. Results Biologic prescription criteria differed substantially across 28 countries from five continents. Blood eosinophil count thresholds (usually ≥300 cells/μL) and exacerbations were key requirements for anti-IgE/anti–IL-5/5R prescriptions in around 80% of licensed countries. Most countries (40% for dupilumab to 54% for mepolizumab) require two or more moderate or severe exacerbations, whereas numbers ranged from none to four. Moreover, 0% (for reslizumab) to 21% (for omalizumab) of countries required long-term oral corticosteroid use. The BACS highlighted marked between-country differences in ease of access. For omalizumab, mepolizumab, benralizumab, and dupilumab, only two, one, four, and seven countries, respectively, scored equal or higher than the European Medicines Agency reference BACS. For reslizumab, all countries scored lower. Conclusions Although some differences were expected in country-specific biologic prescription criteria and ease of access, the substantial differences found in the current study present a challenge to implementing precision medicine across the world

Uso de medicamentos em crianças de zero a seis anos matriculadas em creches de Tubarão, Santa Catarina Drug utilization among children aged zero to six enrolled in day care centers of Tubarão, Santa Catarina, Brazil

OBJETIVO: Identificar o padrão de utilização de medicamentos, nos últimos seis meses, em crianças entre zero e seis anos, em quatro creches de Tubarão, Santa Catarina, no ano de 2007. MÉTODOS: Estudo transversal realizado por meio de questionário semi-estruturado, aplicado aos pais ou responsáveis pelas 413 crianças incluídas na pesquisa, após consentimento informado. Foram coletados dados sobre utilização de medicamentos e informações de saúde. A análise estatística foi feita com auxílio do programa Statistical Package for the Social Sciences 15.0. RESULTADOS: A média de idade das crianças foi 3,7±1,3 anos, sendo 195 (47%) meninas e 218 (53%) meninos. Dentre os adultos que responderam ao questionário, 75% eram mães e 43% tinham oito anos de estudo. Diante de situação de doença, 47% forneciam os medicamentos que tinham em casa. Das crianças pesquisadas, 82 (20%) apresentavam doença crônica e 75 (18%) portavam doença aguda no momento da pesquisa. Houve histórico de reações adversas aos medicamentos em 82 (20%) crianças, sendo a mais freqüente a alergia. A classe de medicamentos mais utilizada foi a dos analgésicos e antitérmicos (45%) e o motivo de uso principal foi febre (32%). Nos últimos seis meses, haviam sido utilizados 763 medicamentos, com média de 1,8 medicamentos por criança, sendo 41% com prescrição médica e 59% por automedicação. CONCLUSÕES: A prática freqüente de automedicação em crianças é um fenômeno potencialmente nocivo à saúde. Esse estudo mostrou que a maioria dos pais ou responsáveis segue essa prática, podendo mascarar doenças graves, gerar quadros de reações adversas e desenvolver resistência bacteriana, além de outras complicações.<br>OBJECTIVE: Identify the pattern of drug utilization in a six-month period among children aged zero to six years old, in Tubarão, Santa Catarina, Brazil, during 2007. METHODS: This cross-sectional study was carried out using a semi-structured questionnaire administered to parents or caretakers of 413 children included in the survey. After signing consent, parents were asked about the use of prescribed and over-the-counter medicines and other health information. Statistical Package for the Social Sciences 15.0 was used for statistical analysis. RESULTS: Out of 413 children, 195 (47%) were girls and 218 (53%) boys. Their mean age was 3.7±1.3 years. Most parents who answered the questionnaire were mothers (75%) and 43% had eight years of schooling. When asked about medication use in the event of diseases, 47% reported that they use medicines available at home. Among the children, 82 (20%) had chronic diseases and 75 (18%) presented an acute illness at the time of the study. Adverse drug reactions were reported by 82 (20%) of the caretakers, being allergy the most frequent. Antipyretics and analgesics were the medicines most frequently used (45%) in order to treat fever (32%). During the last six months, the use of 763 drugs was reported, corresponding to 1.8 drugs/child. Of these, 41% were prescribed by a physician and 59% as self medication. CONCLUSIONS: Parental frequent practice of self medication in treating children is potentially harmful to health. This study showed that most caretakers follow this practice which can mask serious diseases, provoke adverse reactions and develop bacterial resistance, among other complications

Determinantes sociais de alterações fonoaudiológicas Social determinants of speech-language disorders

OBJETIVO: Verificar a associação entre fatores sócio-econômicos e alterações fonoaudiológicas auto-referidas. MÉTODOS: Este estudo foi realizado por meio de entrevistas domiciliares com 543 adultos residentes na cidade de Salvador (BA). RESULTADOS: Os resultados mostraram associações positivas e estatisticamente significantes entre escolaridade e queixas de alterações auditivas (RP=1,48 com IC95% 1,22-1,81) e de escolaridade e queixas de linguagem (RP=1,69 com IC95% 1,36-2,11). Também foram encontradas associações entre renda e queixas de alterações de motricidade oral (RP=1,34 com IC95% 1,13-1,60) e renda com queixas vocais (RP=1,24 com IC95% 1,08-1,44). CONCLUSÃO: Conclui-se que condições adversas de vida relacionam-se a alta prevalência de distúrbios fonoaudiológicos em comunidades.<br>PURPOSE: To verify the association between socioeconomic factors and self-referred speech-language disorders. METHODS: This study was carried out through home interviews with 543 adults who lived in the city of Salvador (BA), Brazil. RESULTS: Results showed positive statistically significant associations between level of education and hearing loss complaints (RP=1.48 with IC95% 1.22-1.81), and between level of education and language complaints (RP=1.69 with IC95% 1.36-2.11). Associations between income and oral motricity (RP=1.34 with IC95% 1.13-1.60) and between income and vocal complaints (RP=1.24 with IC95% 1.08-1.44) were also found. CONCLUSION: Adverse life conditions were related to high prevalence of speech-language disorders in communities