The Regulatory Pathway for Advanced Cell Therapy and Gene Therapy Products in Brazil: A Road to Be Built.

The regulation of cell therapy and gene therapy products is a major challenge for the Brazilian state. From a legal point of view, the legislative apparatus, including constitutional, prohibits the marketing and patent of human substances. From the point of view of the organization of the state bureaucracy, the responsibilities for the regulation of research and application of these technologies in humans may involve up to four different institutions. The National Agency for Health Surveillance (ANVISA) has been the protagonist in structuring the regulation of cell therapy and gene therapy in Brazil, and steps have been taken to ensure quality of these products. However, obstacles such as the commercialization of these therapies and the need to determine whether these products will be regulated following the assumptions adopted in Brazil for drugs and biological products or for human blood and tissues still remain.

Sensitivity of nested-PCR for plasmodium detection in pooled whole blood samples and its usefulness to blood donor screening in endemic areas.

Transfusion-transmitted malaria is a severe disease with high fatality rate. Most Brazilian blood banks in the Amazon region perform malaria screening using microscopic examination (thick smears). Since low parasite concentrations are expected in asymptomatic blood donors a high sensitivity test should be used for donor screening. This study determined the sensitivity of a nested-PCR for plasmodium detection in pooled samples. We performed a one-stage criterion validation study with 21 positive samples pooled with samples from ten negative volunteer until three different concentrations were reached (0.33; 0.25; 0.20 parasites/µL - p/µL). Nested PCR was performed as described by Snounou et al. (1993). Sensitivities (and confidence intervals) were determined by stratum of final parasite concentration on the pooled samples. All samples with parasitemia values of 0.33 and 0.25 p/µL had 100% sensitivity (95%CI=86.3-100). One negative result was obtained from a sample with 0.20 p/µL sensitivity=95.2% (95%CI=76.2-99.9). Compared to parasitemia detectable under ideal conditions of thick smear, this nested-PCR in pooled sample was able to detect 40 times more parasites per microliter. Nested-PCR in pooled samples should be considered as a high sensitive alternative to thick smear for donor screening in blood banks at endemic regions. Local authorities need to assess cost:benefit advantages of this method compared to alternatives.

[Profile of mortality by intoxication with medication in Brazil, 1996-2005: portrait of a decade]. / Perfil da mortalidade por intoxicação com medicamentos no Brasil, 1996-2005: retrato de uma década.

The occurrence of deaths caused by intoxication with medication have been considered a worsening public health problem. The study describes the epidemiological profile of medication-related intoxication in the general Brazilian population from 1996 to 2005. A descriptive study was conducted with mortality data obtained from the Mortality Information System of the Brazilian Ministry of Health. Deaths were selected according to the codes of the International Classification of Diseases (ICD-10). A total of 4,403 deaths were found inn males (53.9%), bachelors (53.7%) and the 20 to 39 year-old age bracket (44%). The majority of deaths were caused by intentional self-intoxication using anticonvulsants, sedatives, antiparkinsonians and psychotropics. The standardized mortality rate was higher in the Midwest region and Potential Life-Years Lost increased by 15.5%. The study showed the characteristics and variations in mortality by intoxication with medication in Brazil, which can be a reflex of the medication consumption patterns of the country, indicating the need for enhancement of sanitary vigilance policies.

[Perceptions on the quality of services relating to women's healthcare]. / Percepções sobre qualidade de serviços que atendem à saúde da mulher.

The scope of this work is to identify the characteristics relating to the quality of women's healthcare services from the perspective of the sanitary vigilance professionals (Visa) and women's healthcare coordinators (CSM) in the municipalities. It is a study with a qualitative approach that was carried out using semi-structured interviews. Three Brazilian state capitals were selected and three individuals in each capital were interviewed, namely a Visa healthcare service chief, as well as a technician, and a CSM coordinator. The content analysis technique was adopted to organize the data and the answers were grouped into the healthcare service evaluation topics based on Donabedian's model, i.e. structure, processes, and outcomes. Visa workers reported aspects related to the structure of health services, such as equipment and qualified human resources more frequently. The Visa chief mentioned aspects related to structure and processes, such as prioritization in attendance. The CWH coordinator examined all three categories, especially processes. Analysis of interviews points to a potential distortion in evaluation by results. The study highlights the need for joint action between the surveillance and assistance sectors to improve the quality of services.