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Background Chronic myeloid leukemia (CML) has a low incidence but a high burden of disease, and is treated with high-cost tyrosine kinase inhibitors (TKI). Objective To determine the time from the start of a first-line TKI until it passes to second-line, and to establish the reasons for the change of therapy time. Setting Patients with Philadelphia-positive CML treated with some TKI. Methods Retrospective cohort study, between January 1 2007 and July 31 2015, with information obtained from medical records, the time to change initial drugs to secondline therapy, and the reasons for change, were identified. Kaplan-Meier survival analysis was carried out. Main outcome measure A change in therapy to the secondline TKI and the final reason for the change of therapy. Results A total of 247 patients treated were found in 22 cities in Colombia with a mean age of 53.2 ± 15.2 years. The drug most used as initial therapy was imatinib; 53.8% of cases had to change to another TKI. 50% of patients changed therapy in 42 months, men in 24 and women in 67 months (95% CI 14.314-33.686; p = 0.001). Being male (OR 2.23; 95% CI 1.291-3.854; p = 0.004) and receiving hydroxyurea (OR 3.65; 95% CI 1.601-8.326; p = 0.002) were associated with a higher probability of switching to nilotinib or dasatinib, while receiving a new-generation TKI (OR 0.15; 95% CI 0.071-0.341; p < 0.001) reduced this risk. Conclusions A high proportion of patients needed to change to a second line with nilotinib and dasatinib management. It is necessary to obtain more real world evidence, to improve the effectiveness, adherence and safety of the treatment.

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Latin American countries view biosimilar agents as an effective approach to curtail health-care expenditures while maintaining the safety and efficacy profile of their branded innovator comparators. To understand the complexities of the regulatory landscape and key therapeutic issues for use of biosimilars to treat moderate to severe psoriasis in Latin America, the International Psoriasis Council convened dermatology experts from Argentina, Brazil, Chile, Colombia and Mexico in October 2015 to review the definition, approval, marketing and future of biosimilars in each country and develop a consensus statement. The regulatory framework for marketing approval of biosimilars in Latin America is currently a mosaic of disparate, country-specific, regulatory review processes, rules and standards, with considerable heterogeneity in clarity and specificity. Regulations in Argentina, Brazil, Chile and Mexico have undergone multiple refinements whereas Colombia is finalizing draft guidelines. Verification of the similarity in quality, safety and efficacy of biosimilars to the innovator biologic remains a key challenge for policy makers and regulatory authorities. Other key regulatory challenges include: naming of agents and traceability, pharmacovigilance, extrapolation of indications, and interchangeability and substitution. An urgent need exists for more Latin American countries to establish national psoriasis registries and to integrate their common components into a multinational psoriasis network, thereby enhancing their interpretative power and impact. A Latin American psoriasis network similar to PSONET in Europe would assist health-care providers, pharmaceutical companies, regulators and patients to fully comprehend specific products being prescribed and dispensed and to identify potential regional trends or differences in safety or outcomes.

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This study compared the perception, knowledge, and use of generic drugs by adults in Pelotas, Rio Grande do Sul State, Brazil, using two cross-sectional population-based studies from 2002 and 2012. Study outcomes were: (a) prevalence of use of generics; (b) generics as a proportion of all medication; (c) users' perceptions of prices and quality; (d) users' knowledge of generics; and (e) strategies for acquisition of medicines. Prevalence of generics use increased from 3.6% (95%CI: 3.0-4.3) to 26.1% (95%CI: 24.5-27.7) in the 10-year period. Perceptions of prices and quality of generics remained stable, identification of characteristics that distinguish generics from other drugs improved (p < 0.001), and drug classification errors decreased (p < 0.001). There was a significant increase in acquiring medication by replacing prescribed drugs with generics. Between 2002 and 2012 there was an increase in knowledge and use of generics, while perception of lower prices and equivalent quality remained high.

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Resumo: Este estudo compara a percepção, conhecimento e uso de medicamentos genéricos em adultos de Pelotas, Rio Grande do Sul, Brasil, por meio de dois estudos transversais de base populacional realizados em 2002 e 2012. Os desfechos estudados foram: (a) prevalência de utilização de medicamentos genéricos; (b) proporção de uso de medicamentos genéricos entre os demais medicamentos; (c) percepção dos usuários sobre preço e qualidade dos medicamentos genéricos; (d) conhecimento dos usuários sobre medicamentos genéricos; e (e) estratégias de aquisição de medicamentos. A prevalência de uso de medicamentos genéricos aumentou de 3,6% (IC95%: 3,0-4,3) para 26,1% (IC95%: 24,5-27,7) no período de dez anos. A percepção sobre preço e qualidade dos medicamentos genéricos se manteve estável, a identificação das características que diferenciam os medicamentos genéricos dos demais medicamentos melhorou (p < 0,001) e o erro de classificação de medicamento diminuiu (p < 0,001). Houve um aumento significativo na estratégia de aquisição de medicamentos pela substituição do medicamento prescrito pelo medicamento genérico. Entre 2002 e 2012, aumentou o conhecimento e uso de medicamentos genéricos, enquanto a percepção quanto ao menor preço e qualidade equivalente mantiveram-se elevadas.

Abstract: This study compared the perception, knowledge, and use of generic drugs by adults in Pelotas, Rio Grande do Sul State, Brazil, using two cross-sectional population-based studies from 2002 and 2012. Study outcomes were: (a) prevalence of use of generics; (b) generics as a proportion of all medication; (c) users' perceptions of prices and quality; (d) users' knowledge of generics; and (e) strategies for acquisition of medicines. Prevalence of generics use increased from 3.6% (95%CI: 3.0-4.3) to 26.1% (95%CI: 24.5-27.7) in the 10-year period. Perceptions of prices and quality of generics remained stable, identification of characteristics that distinguish generics from other drugs improved (p < 0.001), and drug classification errors decreased (p < 0.001). There was a significant increase in acquiring medication by replacing prescribed drugs with generics. Between 2002 and 2012 there was an increase in knowledge and use of generics, while perception of lower prices and equivalent quality remained high.

Resumen: Este estudio compara la percepción, conocimiento y uso de medicamentos genéricos en adultos de Pelotas, Río Grande do Sul, Brasil, a través de dos estudios transversales de base poblacional, realizados en 2002 y 2012. Los resultados estudiados fueron: (a) prevalencia de utilización de medicamentos genéricos; (b) proporción de uso de medicamentos genéricos entre los demás medicamentos; (c) percepción de los usuarios sobre el precio y calidad de los medicamentos genéricos; (d) conocimiento de los usuarios sobre medicamentos genéricos y (e) estrategias de adquisición de medicamentos. La prevalencia de uso de medicamentos genéricos aumentó de 3,6% (IC95%: 3,0-4,3) a 26,1% (IC95%: 24,5-27,7) en un período de 10 años. La percepción sobre el precio y calidad de los medicamentos genéricos se mantuvo estable, la identificación de las características que diferencian los medicamentos genéricos de los demás medicamentos mejoró (p < 0,001) y el error de clasificación de medicamentos disminuyó (p < 0,001). Hubo un aumento significativo en la estrategia de adquisición de medicamentos, a través de la sustitución del medicamento prescrito por el medicamento genérico. Entre 2002 y 2012 aumentó el conocimiento y uso de medicamentos genéricos, mientras que la percepción en lo referente al menor precio y calidad equivalente, se mantuvieron elevadas.

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