ABSTRACT
From a regulatory perspective,drug quality consistency evaluation must concern different processes used for the same drug.In this study,an assessment strategy based on quality by design(QbD)was developed for population pharmaceutical quality evaluation.A descriptive analysis method based on QbD concept was first established to characterize the process by critical evaluation attributes(CEAs).Then quantitative analysis method based on an improved statistical process control(SPC)method was established to investigate the process indicators(PIs)in the process population,such as mean distri-bution,batch-to-batch difference and abnormal quality probability.After that rules for risk assessment were established based on the SPC limitations and parameters.Both the SPC parameters of the CEAs and the risk of PIs were visualized according to the interaction test results to obtain a better understanding of the population pharmaceutical quality.Finally,an assessment strategy was built and applied to generic drug consistency assessment,process risk assessment and quality trend tracking.The strategy demon-strated in this study could help reveal quality consistency from the perspective of process control and process risk,and further show the recent development status of domestic pharmaceutical production processes.In addition,a process risk assessment and population quality trend tracking provide data-based information for approval.Not only can this information serve as a further basis for decision-making by the regulatory authority regarding early warnings,but it can also reduce some avoidable adverse reactions.With continuous addition of data,dynamic population pharmaceutical quality is meaningful for emergencies and decision-making regarding drug regulation.
ABSTRACT
Resumo A epidemiologia desempenha um papel estratégico neste estágio do ciclo de política, contribuindo para o estabelecimento de metas, alocação de recursos e uso de sistemas de informação. Em 2009, a Secretaria Municipal de Saúde do Rio de Janeiro iniciou uma reforma do modelo de atenção, utilizando como principal influência o conceito de Atenção Primária em Saúde. Este estudo avalia a tendência de indicadores selecionados do "pay-for-performance" que mensuram o processo de cuidado em saúde na APS da cidade. Estudo de painéis repetidos, a partir dos registros administrativos e clínicos dos prontuários eletrônicos no período de 2012 a 2016. Foram escolhidos sete indicadores que analisaram o desempenho longitudinal dentro da meta estabelecida, entre aqueles que representam acesso, longitudinalidade, coordenação do cuidado - atributos da APS, assim como outras características dos serviços como desempenho assistencial e eficiência econômica. Este estudo demonstrou que a descentralização da gestão para níveis mais próximos do usuário é potencialmente exitoso para o registro de dados clínicos, caso seja realizado um adequado monitoramento dos indicadores, auditorias clínicas frequentes e realizado periodicamente um "feedback" aos profissionais de saúde com os dados e indicadores acompanhados.
Abstract Epidemiology plays a strategic role at this stage of the policy cycle, contributing to goal setting, resource allocation and use of information systems. In 2009, the Municipal Health Secretariat of Rio de Janeiro initiated a reform of the health care model under the main influence the Primary Health Care concept. This study evaluates the trend of selected pay-for-performance indicators that measure the health care process in the city's PHC. This a study on repeated panels, from the administrative and clinical records of electronic medical records in the period from 2012 to 2016. We selected seven indicators that analyzed longitudinal performance within the established goal, among those that represent access, longitudinality, coordination of care - APS attributes, as well as other characteristics of the services, such as care performance and economic efficiency. This study demonstrated that management decentralization to levels closer to the user is potentially successful for the recording of clinical data under an adequate monitoring of indicators, regular clinical audits and feedback to health professionals, along with data and indicators monitoring.