Statistical process control of manufacturing tablets for antiretroviral therapy

Abstract In this study, the manufacturing process of lamivudine (3TC) and zidovudine (AZT) tablets (150+300 mg respectively) was evaluated using statistical process control (SPC) tools. These medicines are manufactured by the Fundação para o Remédio Popular "Chopin Tavares de Lima" (FURP) laboratory, and are distributed free of charge to patients infected with HIV by the Ministry of Health DST/AIDS national program. Data of 529 batches manufactured from 2012 to 2015 were collected. The critical quality attributes of weight variation, uniformity of dosage units, and dissolution were evaluated. Process stability was assessed using control charts, and the capability indices Cp, Cpk, Pp, and Ppk (process capability; process capability adjusted for non-centered distribution; potential or global capability of the process; and potential process capability adjusted for non-centered distribution, respectively) were evaluated. 3TC dissolution data from 2013 revealed a non-centered process and lack of consistency compared to the other years, showing Cpk and Ppk lower than 1.0 and the chance of failure of 2,483 in 1,000,000 tablets. Dissolution data from 2015 showed process improvement, revealed by Cpk and Ppk equal to 2.19 and 1.99, respectively. Overall, the control charts and capability indices showed the variability of the process and special causes. Additionally, it was possible to point out the opportunities for process changes, which are fundamental for understanding and supporting a continuous improvement environment.

Free acquisition of psychotropic drugs by the Brazilian adult population and presence on the National List of Essential Medicines

Abstract The aims of the present study were to estimate the free-of-charge acquisition of psychotropic drugs among Brazilian adults; analyze the distribution of psychotropics according to their presence on the Relação Nacional de Medicamentos Essenciais (RENAME [National List of Essential Medicines]) and acquisition according to the source of funding (free of charge or direct payment); and estimate the proportion of free-of-charge psychotropic drugs according to therapeutic class and presence on the RENAME. This study involved the analysis of data from the 2014 National Survey on the Accessibility, Use and Promotion of the Rational Use of Medicines considering psychotropic drugs used by the adult population (≥20 years; n = 32,348). The prevalence of the acquisition of free-of-charge psychotropic drugs was 53.3% and 64.6% of these drugs were on the RENAME. Among the psychotropic drugs acquired by direct payment, 70.8% were not on the national list. Regarding free-of-charge acquisition according to the therapeutic class and presence on the RENAME, differences were found for antidepressants, anxiolytics and antipsychotics (p <0.05). In conclusion, the most used psychotropic medicines were listed in the RENAME, but free-of-charge acquisition was not provided for all of them

Implantes, componentes e os honorários profissionais: o que agrega mais no custo final da Implantodontia? Análise de custos entre seis marcas comercialmente disponíveis no Brasil / Dental implants, components, and professional fees: what is most signifi cant factor in the overall cost of Brazilian implant dentistry? A cost analysis among six different commercially available brands

Objetivo: sistematizar e organizar o conjunto de informações relacionadas ao planejamento e manejo de custos na área de Implantodontia. Material e métodos: uma reabilitação mandibular (prótese total implantorretida com carregamento imediato e ancorada por cinco implantes) foi utilizada como referência para custos. Para determinação do valor total, foram somados os honorários e os custos do profissional com o consultório, com componentes cirúrgicos e protéticos para execução do caso, além dos custos laboratoriais. O custo total foi acrescido em 20% devido à taxa de risco do tratamento. Seis marcas comerciais foram selecionadas para realização dos orçamentos. Os valores de todos os componentes em moda corrente (Reais) foram expostos baseados em um denominador comum (X). Ainda, as porcentagens de custo de cada componente segundo o tipo de cilindro selecionado também foram descritas. Resultados: o valor do tratamento conforme o sistema de implantes variou entre 64,4 X e 209,6 X. No custo fi nal, a variação ficou entre 243,1 X e 441,4 X. Conclusão: embora este trabalho não tenha englobado no custo as sessões de retorno para acompanhamento e higienização, fratura de pilares protéticos e parafusos, perda de implantes e a fratura de dentes artificiais, a maior variação nos valores do tratamento refere-se aos sistemas de implantes selecionados. Entretanto, o uso de cilindros calcináveis ou de cilindros com base metálica não interferiu significativamente no custo total, o que favorece a postura clínica de utilizar componentes com partes pré-fabricadas para aliviar os problemas biológicos na interface implante/prótese.

Objective: to organize the information related to treatment and cost management for Implant Dentistry. Material and methods: a mandibular restoration (a five implant-retained prosthesis under immediate loading) was used as reference for cost analysis. To determine the overall value, professional, surgical, prosthetic component, and laboratory costs were added. The overall cost was increased in 20% due to the treatment risk. Six different commercial manufacturers were selected to present the costs. The values in the real currency (BRL) were converted to a common denominator (X). Also, the cost percentages associated to each prosthetic cylinder were also described. Results: the overall treatment value according to each implant system ranged from 64.4 X to 209.6 X. For the overall cost, the variation was between 243.1 and 44.1 X. Conclusion: although recall sessions have not been included in this paper (e.g. hygiene maintenance, abutment screw fracture/ loosening, implant loss, and artifi cial tooth fracture events), the great cost variation relates to the choice of the dental implant system. However, the use of pre-fabricated or plastic burnout cylinders did not signifi cantly interfere in the overall cost, which favors the use of pre-fabricated parts to alleviate the biological issues at the implant-prosthesis interface.