Chemical products : basic guide on labelling and safety data sheets

Hazardous chemical products have to comply with, amongst others, the provisions of a correct classification of danger, labelling and compilation of the safety data sheets. The aim is to protect people's health and the environment from exposure to hazardous chemicals- especially the health and safety of direct users, professionals or not, and the general public, via environmental exposure. This publication is intended to contribute to the knowledge of the objectives and basic aspects of these legal provisions, and thereby increase their degree of compliance in Andalusia and other european regions. This Guide is directed toward those people who, in the development of their professional activities, are in one way or another in contact with dangerous chemical products.

Long-Term Safety of Canakinumab in Patients with Gouty Arthritis.

Background/Purpose: Gouty arthritis (GA) is a chronic inflammatory disease. Targeting the inflammatory pathway through IL-1_ inhibition with canakinumab (CAN) may provide significant long-term benefits. CAN safety versus triamcinolone acetonide (TA) over initial 24 weeks (blinded study) for patients (pts) with history of frequent attacks (_3 in year before baseline) was reported earlier from core (_-RELIEVED [_-REL] and _-REL-II) and first extension (E1) studies1. Herein we present full 18-month long-term CAN safety data, including open-label second extension (E2) studies. Methods: GA pts completing _-REL E1 and _-REL-II E1 studies1 were enrolled in these 1-year, open-label, E2 studies. All pts entering E2, whether randomized to CAN or TA, received CAN 150 mg sc on demand upon new attack. Data are presented only for pts randomized to CAN, and are reported cumulatively, i.e. including corresponding data from previously reported core and E1 studies. Long-term safety outcomes and safety upon re-treatment are presented as incidence rate per 100 patient-years (pyr) of study participation for AEs and SAEs. Deaths are reported for all pts (randomized to CAN or TA). Selected predefined notable laboratory abnormalities are shown (neutrophils, platelets, liver and renal function tests). Long-term attack rate per year is also provided. Results: In total, 69/115 (60%) and 72/112 (64.3%) of the pts randomized to CAN in the two core studies entered the two E2 studies, of which 68 and 64 pts, respectively completed the E2 studies. The 2 study populations had differing baseline comorbidity and geographic origin. Lab data (not time adjusted) for neutropenia appears worse after retreatment in _-REL E2, and deterioration of creatinine clearance appears worse after retreatment (Table 1). The time-adjusted incidence rates for AEs were 302.4/100 pyr and 360/100 pyr, and for SAEs were 27.9/100 pyr and 13.9/100 pyr in _-REL E2 and _-REL-II E2 respectively (Table 1). The time-adjusted incidence rates of any AEs, infection AEs, any SAEs, and selected SAEs before and after re-treatment are presented in Table 1. Incidence rates for AEs and SAEs declined after re-treatment, with the exception of SAEs in _-REL-II E2, which increased from 2.9/100 pyr to 10.9/100 pyr (no infection SAEs after retreatment in _-REL-II E2, and other SAEs fit no special pattern). In the total safety population (N_454, core and all extensions), there were 4 deaths, 2 in the core studies previously reported1 and 2 during the _-REL E2 study (one patient in the CAN group died from pneumonia; one patient in the TA group who never received CAN died of pneumococcal sepsis). None of the deaths was suspected by investigators to be study drug related. The mean rates of new attacks per year on CAN were 1.21 and 1.18 in _-REL E2 and in _-REL-II E2. Conclusion: The clinical safety profile of CAN upon re-treatment was maintained long-term with no new infection concerns

New technologies and nursing: use and perception of primary healthcare nurses about electronic health record in Catalonia, Spain

This study was aimed to analyze and assess the use and perception of electronic health records (EHRs) by nurses. The study sample included 113 nurses from different shifts of primary health facilities in Catalonia, Spain, devoted to adult as well as pediatric outpatients using EHRs throughout the year 2010. A majority of the sample (87.5%) were women and 12.5% were men. The average age was 44.27 years and the average time working in primary healthcare was 47.15 months. A majority (80.4%) received specific training on the use of the EHR and 19.6% did not. The use of the application required side technical support (mean: 3.42) and it is considered necessary to learn more about the performance of the application (mean: 3.50). The relationship between the average ratings that nurses have about the EHR and age shows that there is no statistically significant linear relationship (r = - 0.002, p-value = 0.984). As to how long they have used the EHRs, there are significant differences (r= -0.304, p-value = 0.00), so the more time the nurse takes using the EHR, the greater degree of satisfaction is shown. In addition, there are significant differences between nurses" perceptions regarding the EHR and gender (t = - 0.421, p-value = 0.675). Nurses assessed as positive the contribution of the EHRs in their nursing care day work (average score: 2.55/5). Considering that the usability of the EHR device is assessed as satisfactory, the results of the perception of nurses show that we must also take into account the training and emphasize the need for a side technical support in the implementation process of the EHR. Doing so, the positive perception that nurses have in regard to information and communication technology in general and with respect to the EHR in particular may be increased.

New technologies and nursing: use and perception of primary healthcare nurses about electronic health record in Catalonia, Spain

This study was aimed to analyze and assess the use and perception of electronic health records (EHRs) by nurses. The study sample included 113 nurses from different shifts of primary health facilities in Catalonia, Spain, devoted to adult as well as pediatric outpatients using EHRs throughout the year 2010. A majority of the sample (87.5%) were women and 12.5% were men. The average age was 44.27 years and the average time working in primary healthcare was 47.15 months. A majority (80.4%) received specific training on the use of the EHR and 19.6% did not. The use of the application required side technical support (mean: 3.42) and it is considered necessary to learn more about the performance of the application (mean: 3.50). The relationship between the average ratings that nurses have about the EHR and age shows that there is no statistically significant linear relationship (r = - 0.002, p-value = 0.984). As to how long they have used the EHRs, there are significant differences (r= -0.304, p-value = 0.00), so the more time the nurse takes using the EHR, the greater degree of satisfaction is shown. In addition, there are significant differences between nurses" perceptions regarding the EHR and gender (t = - 0.421, p-value = 0.675). Nurses assessed as positive the contribution of the EHRs in their nursing care day work (average score: 2.55/5). Considering that the usability of the EHR device is assessed as satisfactory, the results of the perception of nurses show that we must also take into account the training and emphasize the need for a side technical support in the implementation process of the EHR. Doing so, the positive perception that nurses have in regard to information and communication technology in general and with respect to the EHR in particular may be increased.

Probiotic interventions in infancy: Benefit and Safety Assessment of Extended Applications

Immaturity of the gut barrier system in the newborn has been seen to underlie a number of chronic diseases originating in infancy and manifesting later in life. The gut microbiota and breast milk provide the most important maturing signals for the gut-related immune system and reinforcement of the gut mucosal barrier function. Recently, the composition of the gut microbiota has been proposed to be instrumental in control of host body weight and metabolism as well as the inflammatory state characterizing overweight and obesity. On this basis, inflammatory Western lifestyle diseases, including overweight development, may represent a potential target for probiotic interventions beyond the well documented clinical applications. The purpose of the present undertaking was to study the efficacy and safety of perinatal probiotic intervention. The material comprised two ongoing, prospective, double-blind NAMI (Nutrition, Allergy, Mucosal immunology and Intestinal microbiota) probiotic interventions. In the mother-infant nutrition and probiotic study altogether 256 women were randomized at their first trimester of pregnancy into a dietary intervention and a control group. The intervention group received intensive dietary counselling provided by a nutritionist, and were further randomized at baseline, double-blind, to receive probiotics (Lactobacillus rhamnosus GG and Bifidobacterium lactis) or placebo. The intervention period extended from the first trimester of pregnancy to the end of exclusive breastfeeding. In the allergy prevention study altogether 159 women were randomized, double-blind, to receive probiotics (Lactobacillus rhamnosus GG) or placebo 4 weeks before expected delivery, the intervention extending for 6 months postnatally. Additionally, patient data on all premature infants with very low birth weight (VLBW) treated in the Department of Paediatrics, Turku University Hospital, during the years 1997 - 2008 were utilized. The perinatal probiotic intervention reduced the risk of gestational diabetes mellitus (GDM) in the mothers and perinatal dietary counselling reduced that of fetal overgrowth in GDM-affected pregnancies. Early gut microbiota modulation with probiotics modified the growth pattern of the child by restraining excessive weight gain during the first years of life. The colostrum adiponectin concentration was demonstrated to be dependent on maternal diet and nutritional status during pregnancy. It was also higher in the colostrum received by normal-weight compared to overweight children at the age of 10 years. The early perinatal probiotic intervention and the postnatal probiotic intervention in VLBW infants were shown to be safe. To conclude, the findings in this study provided clinical evidence supporting the involvement of the initial microbial and nutritional environment in metabolic programming of the child. The manipulation of early gut microbial communities with probiotics might offer an applicable strategy to impact individual energy homeostasis and thus to prevent excessive body-weight gain. The results add weight to the hypothesis that interventions aiming to prevent obesity and its metabolic consequences later in life should be initiated as early as during the perinatal period.

Six years of treatment with the HELP system of a patient with familial hypercholesterolemia

The purpose of the present report is to demonstrate the long-term efficacy and safety of heparin-induced extracorporeal lipoprotein precipitation (HELP) of LDL-c and fibrinogen in the management of familial hypercholesterolemia. From June 1992 to June 1998 a 22-year-old young male patient with familial hypercholesterolemia (double heterozygote for C660X and S305C) resistant to medication and diet and with symptomatic coronary artery disease (angina) was treated weekly with 90-min sessions of the HELP system. The patient had also been previously submitted to right coronary artery angioplasty. The efficacy of the method was evaluated by comparing the reduction of total cholesterol, LDL-c and fibrinogen before and after the sessions and before and after initiation of the study (data are reported as averages for each year). During the study, angina episodes disappeared and there were no detectable adverse effects of the treatment. Total cholesterol (TC), fibrinogen, and LDL-c decreased significantly after each session by 59.6, 66.1 and 64%, respectively. HDL-c showed a nonsignificant reduction of 20.4%. Comparative mean values pre- and post-treatment values in the study showed significant differences: TC (488 vs 188 mg/dl), LDL-c (416.4 vs 145 mg/dl), and fibrinogen (144.2 vs 57.4 mg/dl). There was no significant change in HDL-c level: 29.4 vs 23 mg/dl. These data show that the HELP system, even for a long period of time, is a safe and efficient mode of treatment of familial hypercholesterolemia and is associated with disappearance of angina symptoms.

Development of a Chinese version WHO Self-Assessment Tool for Evaluating Health Promotion in Hospital

[Support Institutions:] Department of Administration of Health, University of Montreal, Canada Public Health School of Fudan University, Shanghai, China

Validity and responsiveness of at-home touch-screen assessments in advanced Parkinson's disease

The aim of this study was to investigate if a telemetry test battery can be used to measure effects of Parkinson’s disease (PD) treatment intervention and disease progression in patients with fluctuations. Sixty-five patients diagnosed with advanced PD were recruited in an open longitudinal 36-month study; 35 treated with levodopa-carbidopa intestinal gel (LCIG) and 30 were candidates for switching from oral PD treatment to LCIG. They utilized a test battery, consisting of self-assessments of symptoms and fine motor tests (tapping and spiral drawings), four times per day in their homes during week-long test periods. The repeated measurements were summarized into an overall test score (OTS) to represent the global condition of the patient during a test period. Clinical assessments included ratings on Unified PD Rating Scale (UPDRS) and 39-item PD Questionnaire (PDQ-39) scales. In LCIG-naïve patients, mean OTS compared to baseline was significantly improved from the first test period on LCIG treatment until month 24. In LCIG-non-naïve patients, there were no significant changes in mean OTS until month 36. The OTS correlated adequately with total UPDRS (rho = 0.59) and total PDQ-39 (0.59). Responsiveness measured as effect size was 0.696 and 0.536 for OTS and UPDRS respectively. The trends of the test scores were similar to the trends of clinical rating scores but dropout rate was high. Correlations between OTS and clinical rating scales were adequate indicating that the test battery contains important elements of the information of well-established scales. The responsiveness and reproducibility were better for OTS than for total UPDRS.

Estratégias para elaboração de um plano de segurança da água para abastecimento humano do município do Natal/RN

This research study deals with the production and distribution of drinking water with quality and safety in order to meet the needs of the Man. Points out the limitations of the methodology for assessing water quality in use today. Approaches the recommendations of the World Health Organization (WHO) for adoption, by the companies responsible for producing and distributing water, of assessment methodologies and risk management (HACCP), in order to ensure the quality and safety of water drinking. Suggests strategies for implementing the plan for water safety plan. Uses the process of water production, composed by Maxaranguape river basin, the water treatment plant and distribution system, which is part of the Plan for Expansion of the Supply System of Natal, as case study. The results, it was possible to devise strategies for implementation of the Water Safety Plan (WSP), which comprises the following steps: a) a preliminary stage. b) assessment system. c) process monitoring. d) management plan and e) validation and verification of the PSA. At each stage are included actions for its implementation. The implementation of the PSA shows a new type of water production, in which the fountain as a whole (watershed and point of capture), the Water Treatment Plant (WTP) and distribution, shall compose the production process, over which to build quality and safety of the final product (drinking water)

Yield and quality of carrot seeds, cv. Brasilia, as a result of plant population, gibberellic acid and stage of maturity

'Brasilia' is a cultivar of carrot with characteristics suiting cultivation under hot conditions but with problems in seed production, arising from the conflicting requirements of root and seed production. One solution is to select cultivars requiring vernalisation and then to use GA(3) to induce flowering where the climate prevents this. There is, however, little information on plant population, seed maturity and harvesting time on which to base such a procedure. Accordingly this research was carried out to study the physiological quality and production of the seeds in plant populations from 25,000 to 800,000 plants/ha, in the seed-to-seed method of cv. Brasilia in Anapolis, GO, Brazil. In each population, two harvest methods (from first and second orders of umbels, or selected harvest, and remaining orders, or total harvest) and two stages of maturity (brownish, or mature seeds, and yellowish, or immature ones) were also evaluated. Two trials were carried out, with and without gibberellic acid. Seed was evaluated for physical characters, germination, vigour, 1000-seed weight, water content, dry matter and productivity. Seed was produced in both experiments (with or without GA3 spraying). Mature seed showed germination at least 30% greater than immature, and seed from the selected harvest showed germination 16% greater than from the total harvest. In increasing plant population to 200,000 plants/ha, seed quality was not affected, but productivity increased.

Evaluation of Complete Denture Quality and Masticatory Efficiency in Denture Wearers

Purpose: This study aimed to investigate (1) the influence of complete denture quality and years of denture use on masticatory efficiency and (2) the relationship between complete denture quality and years of use. Materials and Methods: A cross-sectional study was conducted with 93 edentulous patients (mean age: 65.6 years) wearing both mandibular and maxillary dentures. Patients were classified into two categories according to years of denture use: <= 2 years and >= 5 years. Masticatory efficiency was evaluated via the colorimetric method with beads as the artificial test food. A reproducible method for objective evaluation of the technical quality of complete dentures was employed. The association between denture quality and years of denture use was analyzed using chi-square and Fisher exact tests. The results of masticatory efficiency testing were analyzed using two-way analysis of variance (with the Tukey post hoc test) in terms of years of denture use <= 2 years, >= 5 years) and denture quality (poor, average, good). Results: A significant relationship was found between denture quality and years of denture use (P < .05). Masticatory efficiency differed significantly (P < .05) between patients with <= 2 years of denture use (0.101 +/- 0.076 absorbance) and >= 5 years of use (0.068 +/- 0.076 absorbance). Masticatory efficiency was not influenced by denture quality. Conclusions: Complete denture quality and masticatory efficiency significantly decreased over time. However, complete denture quality did not influence masticatory efficiency. Int J Prosthodont 2012;25:625-630.

Attitudes of mental health professionals towards persons with schizophrenia: a transcultural comparison between Switzerland and Brazil

Background: Stigmatization is an important issue in the treatment and course of schizophrenia. The maintenance of stigmatizing attitudes may be related to socio-cultural factors. Objectives: To compare stigmatizing attitudes of mental health professionals in the culturally diverse countries Brazil and Switzerland. Methods: We analyzed data of two broad stigmatization surveys from Switzerland and Brazil by focusing on the social distance and attitudes of mental health professionals towards the acceptance of side effects of psychopharmacological treatment. Results: Swiss mental health professionals showed significantly higher levels of social distance than their Brazilian counterparts. There was also a weak effect of age as well as an interaction effect between origin and age. With respect to the acceptance of side effects, the effect of origin was rather weak. With the exception of drug dependence, Swiss professionals' acceptance of long-lasting side effects was significantly higher than for their counterparts in Brazil. Discussion: The strong association between origin and social distance may be related to the socio-cultural background of the mental health professionals. In comparison with Switzerland, Brazil is very heterogeneous in terms of ethnicity and socio-economic structure. The distinct acceptance of side effects may additionally be related to the more sophisticated medicaments (i.e. new generation of antipsychotic drugs) commonly used in Switzerland. Hengartner MP, et al. / Rev Psiq Clin. 2012;39(4):115-21

Extent and structure of health insurance expenditures for complementary and alternative medicine in Swiss primary care

BACKGROUND: The study is part of a nationwide evaluation of complementary and alternative medicine (CAM) in primary care in Switzerland. The goal was to evaluate the extent and structure of basic health insurance expenditures for complementary and alternative medicine in Swiss primary care. METHODS: The study was designed as a cross-sectional evaluation of Swiss primary care providers and included 262 certified CAM physicians, 151 noncertified CAM physicians and 172 conventional physicians. The study was based on data from a mailed questionnaire and on reimbursement information obtained from health insurers. It was therefore purely observational, without interference into diagnostic and therapeutic procedures applied or prescribed by physicians. Main outcome measures included average reimbursed costs per patient, structured into consultation- and medication-related costs, and referred costs. RESULTS: Total average reimbursed cost per patient did not differ between CAM physicians and conventional practitioners, but considerable differences were observed in cost structure. The proportions of reimbursed costs for consultation time were 56% for certified CAM, 41% for noncertified CAM physicians and 40% for conventional physicians; medication costs--including expenditures for prescriptions and directly dispensed drugs--respectively accounted for 35%, 18%, and 51% of costs. CONCLUSION: The results indicate no significant difference for overall treatment cost per patient between CAM and COM primary care in Switzerland. However, CAM physicians treat lower numbers of patients and a more cost-favourable patient population than conventional physicians. Differences in cost structure reflect more patient-centred and individualized treatment modalities of CAM physicians.

Implications for Adoption and Implementation of Effective Sexual Health Education Programs

Research on school-based sexual health education programs is at a critical juncture. With the growing number of evidenced-based programs, more focus is needed on how to help schools adopt and implement these programs. The article in this issue titled “Sexual Health Education from the Perspectives of School Staff: Implications for Adoption and Implementation of Effective Programs in Middle School” provides data on individual cognitive factors that may influence adoption and implementation. This commentary explores another framework, Concerns Based Adoption Model, as a tool for examining and supporting change associated with adoption and implementation of sexual health education programs.

Short- and long-term efficacy and mechanism of action of tumescent suction curettage for axillary hyperhidrosis

BACKGROUND Axillary hyperhidrosis is a common and distressing problem interfering with the life of affected individuals. Currently, local surgery is the treatment of choice once conservative treatment has failed. OBJECTIVES To evaluate the clinical efficacy and safety of tumescent suction curettage (TSC) in treating axillary hyperhidrosis and to correlate it with histological markers. METHODS Thirty patients (17 females and 13 males, average age 29.9 years) underwent TSC. After tumescent anaesthesia, a suction cannula was inserted in the axilla on each side through two tiny incisions and subcutaneous tissue was removed by suction. We evaluated the clinical efficacy and complications, and in a subset of patients performed biopsies before surgery, as well as 1 month and 1 year after the operation. RESULTS In comparison with preoperative values, the sweat rate was diminished by 85% after 1 month, 71% after 6 months, 77% after 12 months and 61% after 24 months. The reduced efficacy with time was histologically correlated with an increase in the innervation, whereas the number of sweat glands continued to diminish. The majority of patients were satisfied with the operation but the satisfaction diminished with time. Patients with the highest preoperative sweat rates were the most satisfied after the intervention. CONCLUSION TSC is an effective and safe treatment for axillary hyperhidrosis. The long-term recurrence may be due to reinnervation.