Introduction Treatment of hemophilia A in Brazil is offered to all patients at no cost. However, several unmet medical needs exist. Method In this study, we applied the Delphi method to discuss with seven hemophilia A specialists the challenges that patients and the health system face regarding hemophilia A treatment and opportunities for improvement. Results A consensus was obtained regarding the number of weekly infusions and patient adherence to treatment. The bleeding profile, unfavourable pharmacokinetics (PKs), low adherence and high daily activity were patient profiles that would benefit from using the extended half-life (EHL) recombinant factor VIII (rFVIII). The advantages of treatment with the EHL rFVIII were the lower number of infusions per week, which could increase patient adherence and decrease the risk of bleeds, due to a more constant plasma level, a lower value. Additionally, the EHL rFVIII could improve quality of life, especially in patients with high daily activity, such as adolescents and young adults. The panelists mentioned that EHL rFVIII, if available, could be offered first to the priority group (adolescents between 12 and 19 years old), followed by adults (20 to 64 years old) and elderly people (over 65 years old). Conclusion In summary, the EHL rFVIII offers the optimal prophylaxis by decreasing the dose frequency, increasing the treatment adherence and improving the QoL, without compromising safety and efficacy. cost However exist study improvement profile PKs, PKs , (PKs) halflife half life (EHL rFVIII. . (rFVIII) week bleeds level value Additionally available 1 old, old 20 (2 6 over old. summary frequency QoL efficacy (PKs (rFVIII 2 (

Resumo O objetivo deste artigo é avaliar a concordância entre bulas e fontes bibliográficas baseadas em evidências científicas quanto à presença de contraindicação do uso de anticoncepcionais e anti-infecciosos durante a amamentação. Foram selecionados medicamentos anticoncepcionais e anti-infecciosos, segundo a ATC, com registro na ANVISA e presentes nas fontes bibliográficas: Manual Amamentação e Uso de Medicamentos e Outras Substâncias, Medications and Mother’s Milk, LactMed®, Micromedex® e UpToDate®. As informações foram extraídas das seções “Contraindicações” e “Advertências e precauções” das bulas e comparadas com as informações das fontes. Foi avaliada a presença de informação contraindicando o uso do medicamento durante a amamentação. Em cinco (55,5%) dos nove anticoncepcionais foi verificada contraindicação na bula. Entre as fontes bibliográficas, o percentual variou de 0% a 55,5%, dependendo da fonte. Para os anti-infecciosos, o percentual de contraindicação foi de 46,3% na bula, variando de 0% a 12,9% nas fontes. Existe concordância entre as bulas e as fontes bibliográficas com relação aos anticoncepcionais; no caso dos anti-infecciosos, as bulas apresentam contraindicação para o uso durante a amamentação com mais frequência.

Abstract This article aims to evaluate the conformity between drug package inserts (DPIs) and evidence-based bibliographic sources regarding the presence of contraindications to the use of contraceptives and anti-infective agents during breastfeeding. Contraceptive and anti-infectives were selected, according to ATC, with the updated record in the ANVISA and present in the bibliographic sources Breastfeeding and Use of Medicines and Other Substances, Medications and Mother’s Milk, LactMed®, Micromedex® and UpToDate®. Information was extracted from the DPI “Contraindications” and “Warnings and precautions” sections and compared with the information in the bibliographic sources. The contraindication of the drug during breastfeeding was evaluated. Contraindications were found in the DPIs of five (55.5%) of the nine contraceptives. The contraindication percentage ranged from 0 to 55.5% among the bibliographic sources, depending on the source. The percentage was 46.3% in the DPIs, ranging from 0 to 12.9% in the bibliographic sources for anti-infectives. There is an agreement between the DPIs and the bibliographic sources regarding contraceptives; regarding anti-infectives, the DPIs are more often contraindicated for use during breastfeeding.

Resumo O objetivo deste artigo é avaliar a concordância entre bulas e fontes bibliográficas baseadas em evidências científicas quanto à presença de contraindicação do uso de anticoncepcionais e anti-infecciosos durante a amamentação. Foram selecionados medicamentos anticoncepcionais e anti-infecciosos, segundo a ATC, com registro na ANVISA e presentes nas fontes bibliográficas: Manual Amamentação e Uso de Medicamentos e Outras Substâncias, Medications and Mother’s Milk, LactMed®, Micromedex® e UpToDate®. As informações foram extraídas das seções “Contraindicações” e “Advertências e precauções” das bulas e comparadas com as informações das fontes. Foi avaliada a presença de informação contraindicando o uso do medicamento durante a amamentação. Em cinco (55,5%) dos nove anticoncepcionais foi verificada contraindicação na bula. Entre as fontes bibliográficas, o percentual variou de 0% a 55,5%, dependendo da fonte. Para os anti-infecciosos, o percentual de contraindicação foi de 46,3% na bula, variando de 0% a 12,9% nas fontes. Existe concordância entre as bulas e as fontes bibliográficas com relação aos anticoncepcionais; no caso dos anti-infecciosos, as bulas apresentam contraindicação para o uso durante a amamentação com mais frequência.

Abstract This article aims to evaluate the conformity between drug package inserts (DPIs) and evidence-based bibliographic sources regarding the presence of contraindications to the use of contraceptives and anti-infective agents during breastfeeding. Contraceptive and anti-infectives were selected, according to ATC, with the updated record in the ANVISA and present in the bibliographic sources Breastfeeding and Use of Medicines and Other Substances, Medications and Mother’s Milk, LactMed®, Micromedex® and UpToDate®. Information was extracted from the DPI “Contraindications” and “Warnings and precautions” sections and compared with the information in the bibliographic sources. The contraindication of the drug during breastfeeding was evaluated. Contraindications were found in the DPIs of five (55.5%) of the nine contraceptives. The contraindication percentage ranged from 0 to 55.5% among the bibliographic sources, depending on the source. The percentage was 46.3% in the DPIs, ranging from 0 to 12.9% in the bibliographic sources for anti-infectives. There is an agreement between the DPIs and the bibliographic sources regarding contraceptives; regarding anti-infectives, the DPIs are more often contraindicated for use during breastfeeding.

Resumo Justificativa e objetivos A previsão do risco de náusea e vômito no pós-operatório é a base para a decisão da profilaxia. O escore de Apfel não define por quanto tempo uma pessoa deve se abster de fumar para ser considerada não fumante, e o uso de opioide espinhal intraoperatório como fator de risco para náusea e vômito também não é abordado. Nosso objetivo foi quantificar o risco de náusea e vômito no pós-operatório por um estado tabagístico ordinal e o uso de opioides intraoperatórios (sistêmicos ou neuraxiais) e desenvolver um novo modelo preditivo. Métodos Pacientes agendados para cirurgia oncológica foram prospectivamente avaliados para náusea e vômito nas primeiras 24 horas após a cirurgia. Resultados De 2.014 pacientes inicialmente incluídos, 185 foram excluídos. A classificação de tabagismo foi associada a taxas de incidência de náusea e vômito no pós-operatório de 14,1%, 18,1%, 24,7%, 29,4% e 33,9% para fumantes, pacientes que pararam de fumar até um mês antes da cirurgia, de um a seis meses antes da cirurgia, mais de seis meses antes da cirurgia ou pacientes que nunca fumaram, respectivamente, o que foi significativo na análise de comparações múltiplas (p = 0,015 ajustado). Os testes de hipóteses foram ajustadas para múltiplas comparações para associação com náusea e vômito no pós-operatório para sexo, idade, náusea e vômito no pós-operatório anterior, náusea induzida por quimioterapia e estado tabagístico ordinal apresentaram valores de p < 0,001. Tipo de cirurgia (p = 0,04), consumo total de fentanil (p = 0,04) e períodos intraoperatório e pós-operatório foram preditivos significativos. Um novo modelo foi desenvolvido e apresentou um poder discriminativo maior do que o escore de Apfel (AUC 67,9% vs. 63,7%, p < 0,001). Conclusão O estado tabagístico mostrou um impacto significativo e linear sobre a incidência de náusea e vômito no pós-operatório e desenvolveu-se um novo modelo que usa preditores não ambíguos de tabagismo e opioides.

Abstract Background and objectives Predicting postoperative nausea and vomiting risk is the cornerstone for deciding prophylaxis. Apfel's score does not define how long a person must be abstinent from smoking to be considered a non-smoker, and the use of intraoperative spinal opioids as a risk factor for predicting postoperative nausea and vomiting is also not addressed. The aim of this study was to quantify predicting postoperative nausea and vomiting risk by an ordinal smoking status and the use of intraoperative opioids (systemic or neuraxial), and to develop a new predictive model. Methods Patients scheduled for cancer surgery were prospectively evaluated for predicting postoperative nausea and vomiting in the first 24 h after surgery. Results Of 2014 initially included patients, 185 participants were excluded. Smoking status classification was associated with predicting postoperative nausea and vomiting incidence rates of 14.1%, 18.1%, 24.7%, 29.4% and 33.9% for smokers, patients who stopped smoking up to 1 month prior to surgery, one to 6 months prior, more than 6 months prior or patients who never smoked, respectively, which was significant in the multiple comparisons analysis (adjusted p = 0.015). The multiple comparisons-adjusted hypothesis tests for association with predicting postoperative nausea and vomiting for sex, age, previous predicting postoperative nausea and vomiting, chemotherapy-induced nausea, and ordinal smoking status had p-values of <0.001. The type of surgery (p = 0.04), total fentanyl consumption (p = 0.04), both intraoperative and postoperative, were significant predictors. A new model was developed and showed higher discriminative power than Apfel's score (AUC 67.9% vs. 63.7%, p < 0.001). Conclusion Smoking status showed a significant and linear impact on predicting postoperative nausea and vomiting incidence, and we developed a new model that uses unambiguous smoking and opioid predictors.