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

Segurança do paciente no sistema de medicação: análise de enfermeiros de um hospital de ensino

This study aimed to identify and describe the factors related to Patient Safety in a medication system according to the nurses analysis in a teaching hospital from the photographic analysis method. This was a cross-sectional, descriptive study with mixed approach in a teaching hospital in Rio Grande do Norte. The population consisted of 42 nurses from inpatient units, of which 34 composed the study sample. As eligibility criteria, we defined nurses from public service and nurses who agreed to participate. Ethical determinations were observed, the study was submitted to the Ethics and Research of the University Hospital Onofre Lopes, obtaining the assent with ethical assessment certificate (CAAE 0098.0.051.294-11). For data collection, we used the photographic method (Photographic Analysis Technique) by Patricia Marck (Canada). It was developed in two phases: at first, we randomly captured photos from the medication system, resulting in 282 images; then we selected/processed the photographs, which were reduced to 10 images in Microsoft Excel 2010; in the second phase, the nurses answered the questionnaire divided into socio-professional profile and Digital Photography Scoring Tool (questions a and b ). For analysis of the question a , we used the content analysis technique, and for b , we used the Statistical Package for the Social Sciences 20.0 (temporary license). The socio-professional profile revealed the predominance of females; age group 34-43 years; professionals with specialization; 10-18 years of length of service; and nurses working exclusively in the hospital and who know the Patient Safety. The photographic analysis in relation to Patient Safety resulted in specific categories for each stage of the medication system. Regarding disposal, we identified Proper verification ; Improper verification ; Correct identification ; Disposal in single doses ; and Improper Environment , with predominance of that last category. As for storage: Proper storage ; Improper storage ; Risk of exchange/disappearance ; and Poor hygiene , with special reference to improper storage. In preparation: Risk of exchanging medication/patient ; Inappropriate physical space ; and Inadequate 9 preparation of controlled drugs , highlighting the first category. In drug administration: Lack of Personal Protective Equipment ; Use of Personal Protective Equipment ; Improper administration technique ; Proper administration technique ; Correct drug identification ; Incorrect drug identification ; and Peripheral venous access without identification . From the safety assessment of 10 photographs, by adapting the scores (1-10) to the Likert Scale, we identified three Totally Unsafe (Level 1), three Unsafe (Level 2), three Partially Safe (Level 3), one Safe (Level 4), and no photograph considered Totally Safe. This study identified the prevalence of unsafety in the medication system in the nurses opinion. We were also able to understand that, although nurses identify safety aspects, the most prevalent categories characterize an unsafe assessment. Nursing needs to reflect on its practice, identifying gaps in the medication system in order to achieve a proper and safe care

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

Clima e cultura de segurança do paciente em uma maternidade escola: percepção dos profissionais de enfermagem em terapia intensiva

Since the publication of the report "To Err is Human" by the Institute of Medicine (IOM) , which estimated that between 44.000 to 98.000 Americans die annually as a result of errors in health care, patient safety spent gaining prominence, emerging studies assess the safety culture by measuring the safety climate. In this context, the aim of this study was to identify safety culture perceived by nursing professionals working in the intensive care unit of a maternity school in Natal/RN through the Security Attitudes Questionnaire (SAQ). This was a descriptive study, cross-sectional and quantitative approach undertaken in the Intensive Care Unit Maternal and Neonatal a maternity school in Natal/RN. The project was submitted to and approved by Brazil Platform Zip/UFRN under number 309 540 and CAAE 16489713.7.0000.5537. It was used to collect data two instruments: a questionnaire in order to collect socio-demographic data of the subjects and the Questionário Atitudes de Segurança , a cultural adaptation to Portuguese of the instrument of the World Health Organization titled Safety Attitudes Questionnaire - (SAQ ) Short Form 2006. The collected data were analyzed quantitatively by the organization in electronic databases in Microsoft Excel 2010 spreadsheet and exported to statistical software for free access to be coded, tabulated and analyzed using descriptive statistics. The study included a total of 50 nurses, 31 and 19 of the NICU Maternal ICU, predominantly female, mean age 35 years, median time of 10 years training and working in maternity, mostly, less than 05 anos. As a result, two articles were produced. The first refers to the first two domains of the instrument entitled "climate of teamwork" and "climate security" . The scores of the two areas were slightly higher in Maternal ICU compared to the NICU, but no sector has reached the ideal minimum score of 75: in the first domain Maternal ICU had an average of 74.77, with medians of 75 and 100, while Neonatal ICU reached an average of 69.61 with median also 75 and 100, while the second field means were 69.35 and 66.01 for Maternal and Neonatal ICUs respectively, with a median of 100 in the two sectors. The second article relates to the field "Perception Management Unit and Hospital", which 9 assessed the perception of management units and motherhood by professionals. In general, the items of the domain in question also obtained scores below the ideal minimum: 63.68 to 51.02 and maternal ICU for neonatal, featuring a clear separation between the management and the professionals who work in direct care. These findings indicate a warning sign for the institution and point to the need to implement actions aimed at patient safety

Segurança do paciente em terapia intensiva neonatal: identificação e análise de eventos adversos

The patient safety is a major concern in health services for its global dimension, as evidenced by the fragility of care processes that predispose an occurrence of adverse events. These events in a neonatal intensive care unit are considered serious and hazardous to lives of newborns. The present study aimed to identify and analyze adverse events in a neonatal intensive care unit based in Trigger Tool. It is an epidemiological, cross-sectional , exploratory, retrospective study with quantitative, descriptive and analytical approach, performed in 2015 at a school hospital. The sample was not probabilistic, involving 116 newborns who met the eligibility criteria. Data collection was performed by retrospective review of medical records, using a specific kind of "trigger" instrument, composed of sentinel events in neonatology, adapted from the American model used by the Vermont-Oxford Network. Data were analyzed using descriptive and inferential statistics. The chi-square test for linear trend was used to assess the associations between the variables of interest. The research received a favorable agreement from Ethics Committee of the Federal University of Rio Grande do Norte, under number 1055533, and Presentation Certificate for Ethics Assessment 43894515.6.0000.5537. The results show among investigated newborns, 110 experienced at least one adverse event during their stay, with a total of 391 medical records analyzed and rate of 3.37 events per patient. Prevailed the preterm newborns with low birth weight, from mother who had hypertensive diseases during pregnancy and urinary tract infection. The average hospitalization time was 25 days, associated with hospital-acquired infections events (p = 0.01). Among the identified adverse events stood out the events related to thermoregulation disorders (39.0%), with prevalence of hypothermia (26.0%), followed by health care-related infections (16.4%) and blood glucose disorders, hypoglycemia (9.00%) and hyperglycemia (6.64%). Most of these incidents were classified in categories E and F, which represents that there was damage small proportion. Due to these damages come from the care practice with newborn, 78% were classified as avoidable. There was statistically significant association between the variable birth weight with infections (p = 0.006) as well as peri/intraventricular bleeding (p = 0.02), hypoglycemia (p = 0.021), hyperglycemia (p = 0.001), hyperthermia (p = 0.39) and death (p=0,02). Gestational age was associated with seizures (p = 0.002), hyperglycemia (p=0.017) e hyperthermia (p=0.027). The security institution culture was reported by the health workers as intermediate, even though the number of adverse events found in only one unit of service indicates that there is much to be done. Thus the high rate of adverse events identified in the neonatal intensive care unit reinforces the necessity to elaborate specific preventive strategies for this risk environment.

Segurança do paciente em terapia intensiva neonatal: identificação e análise de eventos adversos

The patient safety is a major concern in health services for its global dimension, as evidenced by the fragility of care processes that predispose an occurrence of adverse events. These events in a neonatal intensive care unit are considered serious and hazardous to lives of newborns. The present study aimed to identify and analyze adverse events in a neonatal intensive care unit based in Trigger Tool. It is an epidemiological, cross-sectional , exploratory, retrospective study with quantitative, descriptive and analytical approach, performed in 2015 at a school hospital. The sample was not probabilistic, involving 116 newborns who met the eligibility criteria. Data collection was performed by retrospective review of medical records, using a specific kind of "trigger" instrument, composed of sentinel events in neonatology, adapted from the American model used by the Vermont-Oxford Network. Data were analyzed using descriptive and inferential statistics. The chi-square test for linear trend was used to assess the associations between the variables of interest. The research received a favorable agreement from Ethics Committee of the Federal University of Rio Grande do Norte, under number 1055533, and Presentation Certificate for Ethics Assessment 43894515.6.0000.5537. The results show among investigated newborns, 110 experienced at least one adverse event during their stay, with a total of 391 medical records analyzed and rate of 3.37 events per patient. Prevailed the preterm newborns with low birth weight, from mother who had hypertensive diseases during pregnancy and urinary tract infection. The average hospitalization time was 25 days, associated with hospital-acquired infections events (p = 0.01). Among the identified adverse events stood out the events related to thermoregulation disorders (39.0%), with prevalence of hypothermia (26.0%), followed by health care-related infections (16.4%) and blood glucose disorders, hypoglycemia (9.00%) and hyperglycemia (6.64%). Most of these incidents were classified in categories E and F, which represents that there was damage small proportion. Due to these damages come from the care practice with newborn, 78% were classified as avoidable. There was statistically significant association between the variable birth weight with infections (p = 0.006) as well as peri/intraventricular bleeding (p = 0.02), hypoglycemia (p = 0.021), hyperglycemia (p = 0.001), hyperthermia (p = 0.39) and death (p=0,02). Gestational age was associated with seizures (p = 0.002), hyperglycemia (p=0.017) e hyperthermia (p=0.027). The security institution culture was reported by the health workers as intermediate, even though the number of adverse events found in only one unit of service indicates that there is much to be done. Thus the high rate of adverse events identified in the neonatal intensive care unit reinforces the necessity to elaborate specific preventive strategies for this risk environment.

Avaliação do cuidado de enfermagem na perspectiva da segurança do paciente em unidades de terapia intensiva: na visão de profissionais, pacientes e familiares

Technological advances combined with healthcare assistance bring increased risks related to patient safety, causing health institutions to be environments susceptible to losses in the provided care. Sectors of high complexity, such as Intensive Care Units have such characteristics highlighted due to being spaces designed for the care of patients in serious medical condition, when the use of advanced technological devices becomes a necessity. Thus, the aim of this study was to assess nursing care from the perspective of patient safety in intensive care units. This is an evaluative research, which combines various forms of data collection and analysis in order to conduct a deepened investigation. Data collection occurred in loco, from April to July 2014 in hospitals equipped with adult intensive care unit services. For this, a checklist instrument and semi-structured interviews conducted with patients, families, professionals were used in order to evaluate the structure-process-outcome triad. The instrument for nursing care assessment regarding Patient Safety included 97 questions related to structure and processes. Interviews provided data for outcome analysis. The selection of interviewees/participants was based on the willingness of potential participants. The following methods were used to collect data resulting from the instrument: statistical analysis of inter-rater reliability measure known as kappa (K); observations from judges resulting from the observation process; and added information obtained from the literature on the thematic. Data analysis from the interviews was carried out with IRAMUTEQ software, which used Descending Hierarchical Classification and Similarity analysis to aid in data interpretation. Research steps followed the ethical principles presented by Resolution No. 466 of December 12, 2012, and the results were presented in three manuscripts: 1) Evaluation of patient safety in Intensive Care Units: a focus on structure; 2) Health evaluation processes: a nursing care perspective on patient safety; 3) Patient safety in intensive care units: perception of nurses, family members and patients. The first article, related to the structure, refers to the use of 24 items of the employed instrument, showing that most of the findings were not aligned with the adequacy standards, which indicates poor conditions in structures offered in health services. The second article provides an analysis of the pillar of Processes, with the use of 73 items of the instrument, showing that 50 items did not meet the required standards for safe handling due to the absence of adequate scientific guidance and effective communication in nursing care process. For the third article, results indicate that intensive care units were safe places, yet urges for changes, especially in the physical structure and availability of materials and communication among professionals, patients and families. Therefore, our findings suggest that the nursing care being provided in the evaluated intensive care units contains troubling shortcomings with regards to patient safety, thereby evidencing an insecure setting for the assistance offered, in addition to a need for urgent measures to remedy the identified inadequacies with appropriate structures and implement protocols and care guidelines in order to consolidate an environment more favorable to patient safety.

Avaliação de qualidade da unidade de diálise no Hospital Universitário Onofre Lopes - HUOL

Over the years there has been a broader definition of the term health. At the same time it was found also an evolution of the concept of health care which in turn has led to changes in the approach to delivery of health services and hence in its management. In this regard, currently the nephrology services have been searching for quality technical and social need. In view of these innovations and the quest for quality, it elaborated the general objective: to develop a quality assessment protocol for dialysis service Onofre Lopes University Hospital. It is an intervention project effected through an action research, which consisted of 4 steps. Initially was identified through a literature search in scientific literature, which quality indicators would apply to a dialysis unit being selected as follows: infection rate in hemodialysis access site, microbiological control of water used for hemodialysis and Index User satisfaction. Through critical reflection on the theme researched in the previous step, it was drawn up three data collection instruments, interview form type, applied between the months of October and November 2015. In addition to the information obtained, also made up of the use of information retrieval technique. The results were organized in graphs and tables and analyzed using qualitative and exploratory technical approach. Then a reflective analysis of the data obtained and the diagnosis of reality studied was traced and confronted with the literature was performed. The data produced in this study revealed that the Dialysis Unit of HUOL is much to be desired, considering that some weaknesses have been identified in its structure. Faced with this finding have been proposed, as a contribution and aiming to guide the development of future actions, suggestions for improvement that should be implemented and monitored to be assured overcoming these difficulties, allowing an appropriate organizational restructuring, and resulting in improved service public offered. It was concluded that for hemodialysis treatment results are achieved and positive, it is necessary to have physical structure and adequate infrastructure, multidisciplinary team specialized, trained and in sufficient quantity, well designed processes for professionals to have standards to be followed decreasing the chance to err, and a risk management system to detect and control situations that endanger patient safety.

Avaliação de qualidade da unidade de diálise no Hospital Universitário Onofre Lopes - HUOL

Over the years there has been a broader definition of the term health. At the same time it was found also an evolution of the concept of health care which in turn has led to changes in the approach to delivery of health services and hence in its management. In this regard, currently the nephrology services have been searching for quality technical and social need. In view of these innovations and the quest for quality, it elaborated the general objective: to develop a quality assessment protocol for dialysis service Onofre Lopes University Hospital. It is an intervention project effected through an action research, which consisted of 4 steps. Initially was identified through a literature search in scientific literature, which quality indicators would apply to a dialysis unit being selected as follows: infection rate in hemodialysis access site, microbiological control of water used for hemodialysis and Index User satisfaction. Through critical reflection on the theme researched in the previous step, it was drawn up three data collection instruments, interview form type, applied between the months of October and November 2015. In addition to the information obtained, also made up of the use of information retrieval technique. The results were organized in graphs and tables and analyzed using qualitative and exploratory technical approach. Then a reflective analysis of the data obtained and the diagnosis of reality studied was traced and confronted with the literature was performed. The data produced in this study revealed that the Dialysis Unit of HUOL is much to be desired, considering that some weaknesses have been identified in its structure. Faced with this finding have been proposed, as a contribution and aiming to guide the development of future actions, suggestions for improvement that should be implemented and monitored to be assured overcoming these difficulties, allowing an appropriate organizational restructuring, and resulting in improved service public offered. It was concluded that for hemodialysis treatment results are achieved and positive, it is necessary to have physical structure and adequate infrastructure, multidisciplinary team specialized, trained and in sufficient quantity, well designed processes for professionals to have standards to be followed decreasing the chance to err, and a risk management system to detect and control situations that endanger patient safety.