Controle de qualidade físico-químico e biodisponibilidade relativa em ratos de suspensões orais de naproxeno sódico obtidas de farmácias de manipulação na cidade do Natal RN

Compounded medicines have been reported by the ANVISA due to decreased of the therapeutic response or toxicity of these formulations. The aim of this work was to investigate the physicochemical quality control among naproxen sodium oral suspensions 25 mg/mL obtained from six compounding pharmacies (A, B, C, D, E and F) and the manufactured suspension (R). In the quality control test, the tests of pH, content, homogeneity, volume and physical and organoleptic characteristics were performed according to the Brazilian Pharmacopoeia. The analytical method for determination of naproxen in suspensions was validate. This method showed excellent precision, accuracy, linearity and specificity. In the content test the suspensions B, C and E showed lower value and the F suspension showed a high value of the content. The products C and E were disapproved in the description of the physical and organoleptic characteristics test. In the pH test, three suspensions were outside specifications (C, E and F). Only the products R, A and D showed satisfactory results in these tests and therefore they were approved for relative bioavailability test. The R, A and D suspensions were orally administered to Wistar rats and the blood samples were taken at time intervals of 10, 20, 40, 60 min, 3, 4, 6, 24 and 48 h. The plasma samples were immediately stored at 80 ºC until analysis of HPLC. The bioanalytical method validation showed specificity, linearity (R2 0.9987), precision, accuracy, good recovery and stability. The chromatographic conditions were: flow rate of 1.2 mL.min-1 with a mobile phase of acetonitrile : sodium phosphate buffer pH 4.0 (50:50, v/v) at 280 nm, using a C18 column. The confidence interval of 90% for the Cmax and AUCt ratio was within the range of 80 - 125% proposed by the FDA. Only one suspension, obtained from the compounding pharmacy D, was considered bioequivalent to the rate of absorption under the conditions proposed by this study. Thus, the results indicate the need for strict supervision from the relevant authorities to ensure the patient safety and the quality of compounded drugs by pharmacies

Protocolo de avaliação do cuidado de enfermagem e da segurança do paciente em unidades de terapia intensiva

The reports of adverse events date from 1990 up to the present day. Conceptually, these adverse events are unintentional injuries unrelated to the underlying disease, causing measurable lesions in patients, extending the period of hospitalization, or leading to death. These issues require discussions with regard to patient safety, improved quality of service, and preventing medical errors. In the Intensive Care Units, this concern is greater because these are sectors of intensive care to individuals with hemodynamic changes and imminent risk of death. Therefore, it is essential to conduct evaluation processes to investigate aspects of quality of nursing care and patient safety in these spaces. For that reason, we aimed to propose the Evaluation protocol of nursing care and patient safety in Intensive Care Units. For its achievement, we needed to: 1) analyze the evolution of the patient safety concept used in scientific productions, under Rodgers evolutionary concept; 2) identify the necessary items to build the evaluation protocol of nursing care and patient safety in the Intensive Care Unit, from the available evidence in literature; 3) construct an instrument for content validation of the evaluation protocol of nursing care and patient safety in the Intensive Care Unit; and 4) describe and evaluate the appropriateness of the content for an evaluation protocol of nursing care and patient safety in the Intensive Care Unit. This is a methodological study for the content validation of the abovementioned protocol. To meet the first three specific objectives, we used the integrative literature review in Theses Database of the Coordination for the Improvement of Higher Education Personnel and the portal of the Collaborating Centre for Quality of Care and Patient Safety. The fourth specific objective happened through the participation of judges, located from the Lattes curricula, in the content validation process developed in two stages: Delphi 1 and Delphi 2. As instrument, we used the electronic form of Google docs. We present in tables the answers from the evaluation instruments by Delphi consensus and Content Validity Index (CVI) of the entire protocol. We summarized the results in articles entitled Analysis of the patient safety concept: Rodgers evolutionary concept ; Scientific evidence regarding patient safety in the Intensive Care Unit ; Technological device for the content validation process: experience report ; and Evaluation protocol of nursing care and patient safety in Intensive Care Units. The Embodied Opinion of the Research Ethics Committee of the Universidade Federal do Rio Grande do Norte, No. 461,246, under CAAE 19586813.2.0000.5537, approved the study. Thus, we conclude the protocol valid in its content, constituting an important tool for evaluating the quality of nursing care and patient safety in Intensive Care Units