ABSTRACT
Molecular target therapy plays an important role in the treatment of malignant tumor.But research and development progress is slow on drugs targeting ovarian cancer.Only bevacizumab and olaparib have been approved for treating ovarian cancer by the FDA or the EMA,and their clinical application is limited.In recent years,there have been more and more reports on molecular tar?get therapy of ovarian cancer.Research advances have been made on novel drugs targeting E3 ubiquitin ligase,VEGF/VEGFR signal?ing pathways,PD-1/PD-L1 signaling pathways,IL-6/IL-6R signaling pathways and macrophage migration-inhibitory factor.This arti?cle briefly summarizes the current progresses in studies of molecular target therapy in ovarian cancer.
ABSTRACT
O objetivo do estudo foi descrever a implantação, estruturação e desenvolvimento da prática de auditoria farmacêutica em uma operadora de planos de saúde de Fortaleza (OPS). Trata-se de um estudo descritivo do tipo estudo de caso, em que a unidade de análise foi uma OPS localizada em Fortaleza, capital do estado do Ceará (Brasil). Foram coletados e analisados dados qualitativos e quantitativos que corresponderam ao período de 2007 a 2010. Para a implantação da área de auditoria farmacêutica foi utilizada como primeira estratégia sua formalização na Diretoria de Recursos Médicos Hospitalares e na estrutura organizacional da OPS em janeiro de 2007. Com o reconhecimento do trabalho desenvolvido pela área, a equipe chegou em 2010 com dois farmacêuticos, dois assistentes de farmácia e cinco estagiários. O desenvolvimento da prática de auditoria farmacêutica resultou na exigência de pareceres técnicos para inclusão de medicamentos em tabela definida pela OPS e de solicitação para medicamentos de alto custo e de reserva terapêutica. A intervenção do farmacêutico, em seis meses de experiência, junto a pacientes em uso de antimicrobianos mostrou uma economia de R$ 279.153,80. A gestão de quimioterápicos resultou em uma economia total de R$ 2.502.278,31 para a OPS em 2009. Embora a auditoria farmacêutica envolva uma discussão recente, é preciso desde já, que aspectos relacionados à sua implantação, estruturação e desenvolvimento sejam apoiados, uma vez que essa prática ajuda na descrição e análise de elementos assistenciais e de gestão que envolve pacientes em tratamento farmacológico.
The purpose of this study was to describe the implantation, organization and development of pharmaceutical audit in a health insurance provider (HIP) in northeast Brazil. This is a descriptive case study in which the unit of analysis was an HIP located n Fortaleza, capital of Ceará State. Qualitative and quantitative data covering the period from 2007 and 2010 were collected and analyzed. In order to create the pharmaceutical auditing team, the first strategy used was to set up a section in the Hospital Medical Resources Directorate and in the managerial structure of the HIP, in January 2007. With the recognition of the work developed by the section, the team was amplified in 2010 with the arrival of two pharmacists, two pharmacy assistants and five trainees. The development of the practical aspects of pharmaceutical auditing revealed a need for technical opinions on the inclusion of medicines in the table defined by the HIP and requests for authorization in the case of high-cost medicines and those used in reserved therapy. The pharmacists intervention, over a six-month period, in the treatment of patients with antibiotics, yielded savings of R$ 279,153.80. The management of chemotherapy resulted in total savings of R$ 2,502,278.31 for the HIP in 2009. Although pharmaceutical auditing has only come out in recent discussions, there is an immediate need to support actions related to its implantation, organization and development, since this practice helps in describing and analyzing the healthcare and management features that involve patients under pharmacological treatment.
Subject(s)
Medical Audit/methods , Hospital Administration , Cost ControlABSTRACT
BACKGROUND/AIMS: To describe the toxicity profile of anti-neoplastic agents from real clinical settings, we analyzed spontaneously reported adverse events (AEs) using data from the adverse drug reaction (ADR) reporting system of the Korean Food and Drug Administration (KFDA). METHODS: Data were extracted from the nationwide spontaneous ADR reporting system of KFDA from July 2009 to December 2010. We extracted and analyzed data related to chemotherapy and identified unlabeled ADR that were not described in the package insert of the products. RESULTS: In total, 5,867 cases of antineoplastic agent-related AE reports were identified after excluding cases for duplication and cases assessed as 'unlikely' and 'unclassifiable', based on expert opinion. Of the patients with AEs, 52.4% were males and the median age was 56 years. In total, 460 AEs (7.8%) from 267 patients were reported as 'serious' AEs. The most common causative anti-cancer drug class was pyrimidine analogs (31.5%), followed by platinum compounds (19.9%), protein kinase inhibitors (10.8%), and taxanes (8.8%). The most common clinical manifestation of AEs was gastrointestinal toxicities (25.5%), followed by skin disorders (25.3%), and generalized reactions (14.3%). In total, 168 cases (2.9%) of unlabeled AEs were identified. Among these, 10 were reported as serious AEs. CONCLUSIONS: The most common causative class of antineoplastic agents was that of pyrimidine analogs. Gastrointestinal and dermatological toxicities were the most common clinical chemotherapy-related adverse events. Further investigation and monitoring to evaluate causality associated with unlabeled AEs identified in this analysis are needed.
Subject(s)
Humans , Male , Antineoplastic Agents , Drug-Related Side Effects and Adverse Reactions , Expert Testimony , Pharmacovigilance , Platinum Compounds , Product Labeling , Protein Kinase Inhibitors , Pyrimidines , Skin , Statistics as Topic , Taxoids , United States Food and Drug AdministrationABSTRACT
BACKGROUND/AIMS: To describe the toxicity profile of anti-neoplastic agents from real clinical settings, we analyzed spontaneously reported adverse events (AEs) using data from the adverse drug reaction (ADR) reporting system of the Korean Food and Drug Administration (KFDA). METHODS: Data were extracted from the nationwide spontaneous ADR reporting system of KFDA from July 2009 to December 2010. We extracted and analyzed data related to chemotherapy and identified unlabeled ADR that were not described in the package insert of the products. RESULTS: In total, 5,867 cases of antineoplastic agent-related AE reports were identified after excluding cases for duplication and cases assessed as 'unlikely' and 'unclassifiable', based on expert opinion. Of the patients with AEs, 52.4% were males and the median age was 56 years. In total, 460 AEs (7.8%) from 267 patients were reported as 'serious' AEs. The most common causative anti-cancer drug class was pyrimidine analogs (31.5%), followed by platinum compounds (19.9%), protein kinase inhibitors (10.8%), and taxanes (8.8%). The most common clinical manifestation of AEs was gastrointestinal toxicities (25.5%), followed by skin disorders (25.3%), and generalized reactions (14.3%). In total, 168 cases (2.9%) of unlabeled AEs were identified. Among these, 10 were reported as serious AEs. CONCLUSIONS: The most common causative class of antineoplastic agents was that of pyrimidine analogs. Gastrointestinal and dermatological toxicities were the most common clinical chemotherapy-related adverse events. Further investigation and monitoring to evaluate causality associated with unlabeled AEs identified in this analysis are needed.