There remain enormous gaps in the information available to the public about the effects of their drugs, and in the application of that information to optimizing prescribing and thereby improving the risk/benefit balance from drugs. Centers for Education and Research on Therapeutics (CERTs) offer the opportunity to address many of these deficits, and this proposal goes a long way toward filling that gap. In particular, we propose to: 1. Establish a CERT with a coordinated infrastructure, including: a. Logistical support, including faculty time and core staff; b. Governance, including regular coordination and business meetings; c. Programmatic coordination, including linkage of the pharmacoepidemiology skills of the Center for Clinical Epidemiology and Biostatistics (CCEB) with the pharmacoeconomics skills of the Leonard Davis Institute of Health Economics, the experience in patient -oriented research of the General Clinical Research Center; basic science laboratories interested in evaluating the molecular mechanisms of drug effects; and the social science skills of non-biomedical researchers in other parts of the University; d. Regularly scheduled educational conference series; e. Active participation in the national network of CERTs; and f. A pilot research grant program targeted at the development of R01 quality grants and proposals. 2. Testing and building the capabilities of the current Penn ambulatory drug use evaluation program as a laboratory, expanding it to broader populations; 3. Improve the use of antibiotics locally and nationally, with studies leading to grant funding for larger scale efforts, as well as formal dissemination of evidence-based data both known and to be known. The initial studies will: a. evaluate techniques to reduce the use of antibiotics for acute bronchitis in the outpatient setting b. evaluate the impact of antimicrobial formulary interventions at different hospitals on the resistance patterns of extended-spectrum beta-lactamase- producing Escherichia coli and Klebsiella species; c. simulate data, in order to expand the use of meta-analysis to study rare adverse outcomes from antibiotics; d. study the effects of tetracycline used to treat acne in a dermatology clinic on antibiotic resistance patterns; and e. study the use of the GPRD Database to explore the epidemiology of drug -resistant pneumococcal pneumonia 4. Conduct an extensive education program, including: i) a Masters in Clinical Epidemiology (MSCE) and PhD pharmacoepidemiology fellowship training program; ii) opportunities for MSCE and PhD students in epidemiology and biostatistics to use existing in-house databases to answer new questions, to participate in ongoing research, and to develop new research projects; iii) courses for university physicians housestaff, nurses, and nursing students; iv) courses for pharmacists and pharmacy students; v) courses for medical students; and vi) a degree credit course in pharmacoepidemiology for MSCE students. 5. Organize and formally disseminate the results of our work, consisting of: publications and presentations for the Scientific/Professional community; ii) the FDA, AHCPR, other CERTs, etc.; and iii) the public, building on the dissemination program of the Leonard Davis Institute of Health Economics.
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