The role of acetylcholinesterase and butyrylcholinesterase activity in the development of delirium in acute stroke.

Aim: Our study aimed to test whether plasma acetylcholinesterase and butyrylcholinesterase enzyme activity were related to the presence and intensity of delirium in acute stroke patients. Methods: We carried out a matched (age and gender) case-control study, in a sample of consecutive patients with an acute infarct or intracerebral haemorrhage (≤7 days). We assessed delirium using the DSM-5 criteria and the Delirium Rating Scale, and we measured plasma acetylcholinesterase and butyrylcholinesterase enzyme activity after the patient's admission in the stroke unit and before hospital discharge. Mantel-Haenszel's chi-square was used to test bivariate associations between cases (delirious patients) and controls (non-delirious patients). Results: At admission in the stroke unit, cases and controls did not present significant differences in plasma acetylcholinesterase or butyrylcholinesterase activity. At hospital discharge (18 cases and 21 controls) patients who have had delirium at admission had higher levels of butyrylcholinesterase activity. Butyrylcholinesterase activity may secondarily increase due to the inflammatory process associated with neuronal dysfunction in delirium patients.

Regulação dos medicamentos inovadores em Portugal enquanto exemplo de transparência, accountability e governança pública: nem todas as áreas nascem iguais / Regulation of innovative drugs in Portugal as an example of transparency, accountability and public governance: not all areas are born equal

Objetivo: A regulação como uma área da governança, está patente nas diversas dimensões da administração pública atual. A atividade de regulação das tecnologias da saúde em Portugal é executada pelo INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde), enquanto entidade autónoma administrativa sob a tutela do Ministério da Saúde, exercendo um papel fundamental na avaliação do financiamento dos medicamentos inovadores pelo Estado. Foi criada uma figura designada de Autorização de Utilização Especial (AUE) que permite acesso a medicamentos que estão sob processo de avaliação pelo INFARMED, ainda não comparticipados, o que representa um esforço financeiro extra por parte do Estado. Neste trabalho os autores pretendem analisar as AUEs concedidas num determinado período de tempo com o propósito de identificar áreas prioritárias de estratégia administrativa e de regulação. Métodos: Foram utilizados neste trabalho dados do INFARMED referentes às AUE concedidas no período de 1 de janeiro a 31 de agosto de 2016. A análise encontra-se subdividida por categorias de análise: frequência absoluta de cada área terapêutica e frequência absoluta de cada medicamento. Resultados: Da análise dos dados ressaltam duas realidades, 60% das AUE concedidas são referentes à área terapêutica da oncologia, sendo a segunda área terapêutica mais visada a oftalmologia que corresponde a apenas 15%; e dos 10 fármacos mais requisitados por AUE, 7 são utilizados para tratamento de doenças oncológicas. Conclusões: Desta análise se infere que os esforços das entidades administrativas e reguladoras e as reformas políticas no que toca ao medicamento devem incidir sobretudo na área da patologia oncológica, tendo em conta o actual panorama crescente no que toca às tecnologias de inovação na saúde.

Objective: Regulation as an area of governance becomes evident in the different dimensions of contemporary public administration. The regulatory activity concerning health technologies in Portugal is carried out by INFARMED (National Authority of Medication and Health Products), as an autonomous administrative entity under the Ministry of Health's jurisdiction, playing a fundamental role in the evaluation of the innovative drugs' financing terms by the State. A figure called Special Authorization Use (AUE) was created to allow access to drugs that are under evaluation by INFARMED, which are not yet reimbursable, representing a significant financial effort by the State. In this work the authors analyzed AUEs granted during a determined period of time in order to identify critical areas for administrative and regulatory strategies. Methods: The authors used data from the INFARMED for AUEs granted from January 1st to the 31st of August 2016. This analysis is divided according to category: absolute frequency of each therapeutic area and absolute frequency of each drug. Results: Data analysis highlights two realities: 60% of the AUEs granted refer to the oncology therapeutic area, being the second most frequent the ophthalmologic area corresponding to only 15%; and 7 out of the 10 most required drugs through AUEs are used to treat oncological diseases. Conclusions: From this analysis, it can be inferred that the efforts of the administrative and regulatory authorities and the political reforms regarding drug policies should focus mainly on the area of cancer pathology, considering the current growing panorama regarding the technologies of innovation in health.

Quality of Medicines in Portugal: A Retrospective Review of Medicine Recalls (2000-2015).

INFARMED, the Portuguese national health authority, alerts the general public and health care professionals about quality or safety issues detected in health products. The present study analyses recalls of substandard medicines in Portugal between 2005 and 2015. All 338 alerts for medicine recalls were analysed, which represents a total of 378 drugs withdrawn. Despite the fact that the total number of medicine alerts has increased during the past decade, the number of actual medicine recalls remained relatively constant. The number of batches affected in each recall varies from only one to several batches. In addition, 294 of the alerts are related to voluntary recalls, that is, those initiated by the marketing authorisation holder, whereas only 40 were mandatory recalls. There are marketing authorisation holders that have had several medicine recalls over the period studied. The main cause of product recall was the pharmaceutical dosage form, followed by packaging problems. Forty-two percent of the withdrawn medicines are from solid oral forms, a value slightly higher than that obtained for the injectables group. Finally, substandard medicines have been accessible in the Portuguese market for a period that varied between one month and over four years. The data seem to show that the number of substandard medicines in Portugal has not been increasing. However, this may be due to a variety of causes, that is, better performance of the industry, non-detection of these cases, and so on.LAY ABSTRACT: INFARMED, the Portuguese national health authority, alerts the general public and health care professionals about quality or safety issues detected in health products. The present study analyses market recalls of substandard medicines in Portugal between 2005 and 2015. All 338 alerts for medicine recalls were analysed, which represents a total of 378 drugs withdrawn. Despite the fact that the total number of medicine alerts has increased during the past decade, the number of actual medicine recalls has remained relatively constant. In addition, 294 of the alerts are related to voluntary recalls, that is, initiated by the marketing authorisation holder, whereas only 40 were mandatory recalls. There are marketing authorisation holders that have had several medicine recalls over the period studied. It was also found that substandard medicines have been accessible in the Portuguese market for a period that varied between 1 month and over 4 years. The data seem to show that the number of substandard medicines in Portugal has not been increasing. However, this may be due to a variety of causes, that is, better performance of the industry, non-detection of these cases, and so on.