Product quality of parenteral vancomycin products in the United States.

In response to concerns raised about the quality of parenteral vancomycin products, the U.S. Food and Drug Administration (FDA) is investigating the product quality of all FDA-approved parenteral vancomycin products available in the United States. Product quality was evaluated independently at two FDA Office of Testing and Research (FDA-OTR) sites. In the next phase of the investigation, being done in collaboration with the National Institute of Allergy and Infectious Diseases, the in vivo activity of these products will be evaluated in an appropriate animal model. This paper summarizes results of the FDA investigation completed thus far. One site used a validated ultrahigh-pressure liquid chromatography method (OTR-UPLC), and the second site used the high-performance liquid chromatography (HPLC) method for related substances provided in the British Pharmacopeia (BP) monograph for vancomycin intravenous infusion. Similar results were obtained by the two FDA-OTR laboratories using two different analytical methods. The products tested had 90 to 95% vancomycin B (active component of vancomycin) by the BP-HPLC method and 89 to 94% vancomycin by OTR-UPLC methods. Total impurities were 5 to 10% by BP-HPLC and 6 to 11% by OTR-UPLC methods. No single impurity was >2.0%, and the CDP-1 level was ≤ 2.0% across all products. Some variability in impurity profiles of the various products was observed. No adverse product quality issues were identified with the six U.S. vancomycin parenteral products. The quality parameters of all parenteral vancomycin products tested surpassed the United States Pharmacopeia acceptance criteria. Additional testing will characterize in vivo performance characteristics of these products.

Epidemiology of participation: an Australian community study.

STUDY OBJECTIVE: To determine the levels of participation in social and civic community life in a metropolitan region, and to assess differential levels of participation according to demographic, socioeconomic and health status. To contribute to policy debates on community participation, social capital and health using these empirical data. DESIGN: Cross sectional, postal, self completed survey on health and participation. SETTING: Random sample of the population from the western suburbs of Adelaide, the capital city of South Australia, a population of approximately 210 000. PARTICIPANTS: 2542 respondents from a sample of 4000 people aged 18 years and over who were registered on the electoral roll. MAIN RESULTS: The response rate to the survey was 63.6% (n=2542). Six indices of participation, on range of social and civic activities, with a number of items in each, were created. Levels of participation were highest in the informal social activities index (46.7-83.7% for individual items), and lowest in the index of civic activities of a collective nature (2.4-5.9% for individual items). Low levels of involvement in social and civic activities were reported more frequently by people of low income and low education levels. CONCLUSIONS: Levels of participation in social and civic community life in an urban setting are significantly influenced by individual socioeconomic status, health and other demographic characteristics. An understanding of the pattern of participation is important to inform social and health policy making. Increasing levels of participation will reduce social exclusion and is likely to improve the overall quality of community life.

Presenting the facts about smoking to adolescents: effects of an autonomy-supportive style.

OBJECTIVES: To test the self-determination model of health-related behavior by examining whether the degree to which adolescents experience an appeal to not smoke as autonomy supportive would affect their autonomous motivation for not smoking and, in turn, their behavior of either refraining from smoking or smoking less, and to validate the measures of perceived autonomy support and autonomous motivation for not smoking. DESIGN: Two studies of physicians presenting information about not smoking using 2 message styles, 1 of which was designed to be more autonomy supportive. The preliminary study involved nonrandomized assignment to message style and only immediate assessment of perceptions, motivation, and behavior, while the primary study involved randomized assignment and 4-month longitudinal assessments. SETTING AND PARTICIPANTS: Nearly 400 ninth- through 12th-grade students at 2 suburban high schools in upstate New York. MAIN OUTCOME MEASURES: Adolescents' perceptions of the presentations' autonomy supportiveness of the presenters, as well as adolescents' autonomous motivation for not smoking and their self-reports of smoking. The primary study also assessed change in students' autonomous motivation and change in their self-reported smoking during 4 months. RESULTS: In both studies, the measures were reliable and valid. Students perceived significantly (P = .04 and P<.001, respectively) greater autonomy support in the "It's Your Choice" presentation, after controlling for whether the students were smokers. Perceived autonomy supportiveness of the presentation was positively correlated with autonomous reasons for not smoking in the preliminary study and with increases in autonomous motivation for not smoking in the primary study. Change in autonomous reasons for not smoking significantly (P<.001) predicted reduction in smoking during 4 months. CONCLUSION: When adolescents perceived messages about not smoking as autonomy supportive, they had more autonomous motivation for not smoking, and that, in turn, predicted a decrease in their self-reports of smoking.

School-based health clinics in the mid-1990s.

School-based health clinics have grown in number from one or two in the early 1970s to more than 600 in the 1990s. The main focus of school-based clinics is to provide primary health care and psychosocial counseling to children and adolescents in schools. This article reviews the distribution and availability of school-based clinics in 1994, discussing various models and definitions for school-based health services, the health and educational impact of school-based clinics on adolescents, and the policy issues of concern to school-based health clinics in the current era of health care and health financing reform.