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Department Of Health And Human Services (department + of_health_and_human_services)
Kinds of Department Of Health And Human Services Selected AbstractsDeveloping medical countermeasures: from BioShield to BARDADRUG DEVELOPMENT RESEARCH, Issue 4 2009Jonathan B. TuckerArticle first published online: 12 JUN 200 Abstract The U.S. Congress passed the Project BioShield Act in 2004 to create market incentives for the private sector to develop medical countermeasures (MCMs) against high-priority chemical, biological, radiological, and nuclear threats. Two years later, Congress patched recognized gaps in the BioShield legislation by adopting the Pandemic and All-Hazards Preparedness Act of 2006, which established the Biomedical Advanced Research and Development Authority (BARDA) within the Department of Health and Human Services (DHHS). BARDA provides financial and managerial support for companies developing MCMs. This article examines U.S. government efforts in the MCM field and prospects for the future. Drug Dev Res 70:224,233, 2009. © 2009 Wiley-Liss, Inc. [source] Maximizing the use of Project Bioshield contracting opportunitiesDRUG DEVELOPMENT RESEARCH, Issue 4 2009Dana B. Pashkoff Abstract This article explores the often complicated relationship between agency policymakers and the contracting officers that are charged with executing agency procurements. In particular, the article explores the role of the contracting officer in maximizing the use of streamlined contracting practices under the Project BioShield Act of 2004 (Public Law 108,276). Project BioShield, which is implemented through the Biomedical Advanced Research and Development Authority (BARDA) within the Department of Health and Human Services (DHHS), is designed to encourage procurement activity that protects Americans against a chemical, biological, radiological or nuclear attack. To do so, the Act permits the use of special streamlined contracting authorities, many of which are often unused or ignored by the contracting officers engaged in executing and administering Project BioShield procurements. This article argues that these contracting officers are bound to conduct their duties within the confines of overall agency policy, and they cannot use their contracting discretion to circumvent that policy. As a result, DHHS contracting officers are required to use the Project BioShield streamlined contracting methods. In order to assist the agency in encouraging the use of these procedures, this article also recommends techniques that BARDA can apply in order to encourage contracting officers to take advantage of these contracting opportunities and advance agency's policy with respect to Project BioShield. Drug Dev Res 70:234,238, 2009. © 2009 Wiley-Liss, Inc. [source] Accelerating botulism therapeutic product development in the Department of Defense,DRUG DEVELOPMENT RESEARCH, Issue 4 2009Andrea M. Stahl Abstract Coordinated small-molecule drug discovery research efforts for the treatment of botulism by the public sector, especially the U.S. Department of Defense (DoD) and Department of Health and Human Services (DHHS), began in the 1990s and represent a significant resource investment. Organization of an effective botulism therapeutic drug program, however, presents formidable technical and logistical challenges. Seven distinct BoNT serotypes are known, each representing a different target. Moreover, BoNT exerts its action inside peripheral cholinergic neurons, and some serotypes may persist functionally within nerve cells for weeks or months. Clinical botulism occurs infrequently, and the effectiveness of prolonged mechanical ventilation to treat poisoning further limits experimental drug testing. The efficacy of experimental compounds must be extrapolated from disparate cell- or tissue-based or rodent models. Numerous compounds with moderate efficacy in experimental laboratory assays have been reported, but may not possess the necessary safety, efficacy, and pharmacokinetic profile to support therapeutic development. To mitigate these challenges, we propose product development tools to assist in management of the BoNT portfolio and to clearly define the desired therapeutic product. Establishing a target product profile (TPP) is proposed to guide public sector managers toward critical aspects of the desired therapeutic product. Additional product development tools to assist in shaping research portfolios and to inform decisions regarding lead candidates to pursue are also discussed. Product development tools that facilitate the characterization of the ideal therapeutic product, and assist in the maintenance of a robust portfolio, will ameliorate the inherent financial risk in drug development for treating BoNT intoxication. Drug Dev Res 70:303,326, 2009. Published 2009 Wiley-Liss, Inc. [source] Do California Counties With Lower Socioeconomic Levels Have Less Access to Emergency Department Care?ACADEMIC EMERGENCY MEDICINE, Issue 5 2010Deepa Ravikumar Abstract Objectives:, The study objective was to examine the relationship between number of emergency departments (EDs) per capita in California counties and measures of socioeconomic status, to determine whether individuals living in areas with lower socioeconomic levels have decreased access to emergency care. Methods:, The authors linked 2005 data from the American Hospital Association (AHA) Annual Survey of Hospitals with the Area Resource Files from the United States Department of Health and Human Services and performed Poisson regression analyses of the association between EDs per capita in individual California counties using the Federal Information Processing Standard (FIPS) county codes and three measures of socioeconomic status: median household income, percentage uninsured, and years of education for individuals over 25 years of age. Multivariate analyses using Poisson regression were also performed to determine if any of these measures of socioeconomic status were independently associated with access to EDs. Results:, Median household income is inversely related to the number of EDs per capita (rate ratio = 0.83; 95% confidence interval [CI] = 0.71 to 0.96). Controlling for income in the multivariate analysis demonstrates that there are more EDs per 100,000 population in FIPS codes with more insured residents when compared with areas having less insured residents with the same levels of household income. Similarly, FIPS codes whose residents have more education have more EDs per 100,000 compared with areas with the same income level whose residents have less education. Conclusions:, Counties whose residents are poorer have more EDs per 100,000 residents than those with higher median household incomes. However, for the same income level, counties with more insured and more highly educated residents have a greater number of EDs per capita than those with less insured and less educated residents. These findings warrant in-depth studies on disparities in access to care as they relate to socioeconomic status. ACADEMIC EMERGENCY MEDICINE 2010; 17:508,513 © 2010 by the Society for Academic Emergency Medicine [source] The economics and practicality of t-PA vs tunnel catheter replacement for hemodialysisHEMODIALYSIS INTERNATIONAL, Issue 1 2005Cairoli O. Kaiser Permanente Introduction:,Thrombolytic therapy is an important treatment modality for thrombosis-related catheter occlusion. Central venous access devices (CAVDs) are essential tools for the administration of many therapeutic modalities, especially for patients requiring lifetime therapy like hemodialysis. There are several reasons to salvage the occluded catheter. Catheter replacement results in an interruption of therapy delivery. This interruption may result in complications such as life-threatening metabolic and physiologic states. In addition, the patient's future access sites for CAVDs may be affected. The data released in the 2001 Annual Report , ESRD Clinical Performance Measures Project (Department of Health and Human Services, December 2001) shows 17% of prevalent patients were dialyzed with a chronic catheter continuously for 90 days or longer. In the pediatric population the data shows that 31% were dialyzed with a chronic catheter. The most common reasons for catheter placement included: no fistula or graft created (42%) and fistula and graft were maturing, not ready to cannulate (17%). Five percent of patients were not candidates for fistula or graft placement as all sites had been exhausted. Methods:,A short study was done in our medical center to evaluate the results of t-PA vs. changing the tunnel catheter. On an average a catheter costs about $400.00. If you add the cost of specialty personnel such as an interventional radiologist, radiology technician, radiology nurse, and the ancillaries such as the room, sutures, gauze, and tape, the total could reach $2000.00 easily. CathfloÔ Activase® costs around $60.00 for a single dose. T-PA was reconstituted by pharmacy personnel in single vials containing 2 mg/2 ml. Now with Cathflo, vials are stored in the renal clinic's refrigerator and when the need arises, the RN reconstitutes the medication. The RN, using established protocols, will instill Cathflo in the catheter following the volume requirements of the various tunnel catheters. After the t-PA is placed, the patient is sent home with instructions to return to their dialysis center the next day (arrangements are made by the RN as needed). In seventeen patients (17) with tunnel catheter malfunctions due to inadequate flow, not related to placement, t-PA was used. Of those 17 patients 2 were unable to use their catheter on their next dialysis treatment date, yielding an 88% success rate. This compares with clinical trials in which there is an 83% success rate with a dwell time of 4 hours, or an 89% rate on patients having a 2 hour dwell time (t-PA was repeated a second time if flow was not successfully restored. Results:,15/17 patients in our retrospective study showed that Cathflo worked successfully in restoring blood flow. Two catheters needed to be exchanged. The cost savings were significant when we compared the average cost of an exchange ($2000) versus using t-PA ($170 including nursing time). Conclusion:,Cathflo is not just safe and practical to use but also cost effective. [source] Interview with a Quality Leader,Karen Davis, Executive Director of The Commonwealth FundJOURNAL FOR HEALTHCARE QUALITY, Issue 2 2009Lecia A. Albright Dr. Davis is a nationally recognized economist, with a distinguished career in public policy and research. Before joining the Fund, she served as chairman of the Department of Health Policy and Management at The Johns Hopkins School of Public Health, where she also held an appointment as professor of economics. She served as deputy assistant secretary for health policy in the Department of Health and Human Services from 1977 to 1980, and was the first woman to head a U.S. Public Health Service agency. Before her government career, Ms. Davis was a senior fellow at the Brookings Institution in Washington, DC; a visiting lecturer at Harvard University; and an assistant professor of economics at Rice University. A native of Oklahoma, she received her PhD in economics from Rice University, which recognized her achievements with a Distinguished Alumna Award in 1991. Ms. Davis is the recipient of the 2000 Baxter-Allegiance Foundation Prize for Health Services Research. In the spring of 2001, Ms. Davis received an honorary doctorate in human letters from John Hopkins University. In 2006, she was selected for the Academy Health Distinguished Investigator Award for significant and lasting contributions to the field of health services research in addition to the Picker Award for Excellence in the Advancement of Patient Centered Care. Ms. Davis has published a number of significant books, monographs, and articles on health and social policy issues, including the landmark books HealthCare Cost Containment, Medicare Policy, National Health Insurance: Benefits, Costs, and Consequences, and Health and the War on Poverty. She serves on the Board of Visitors of Columbia University, School of Nursing, and is on the Board of Directors of the Geisinger Health System. She was elected to the Institute of Medicine (IOM) in 1975; has served two terms on the IOM governing Council (1986,90 and 1997,2000); was a member of the IOM Committee on Redesigning Health Insurance Benefits, Payment and Performance Improvement Programs; and was awarded the Adam Yarmolinsky medal in 2007 for her contributions to the mission of the Institute of Medicine. She is a past president of the Academy Health (formerly AHSRHP) and an Academy Health distinguished fellow, a member of the Kaiser Commission on Medicaid and the Uninsured, and a former member of the Agency for Healthcare Quality and Research National Advisory Committee. She also serves on the Panel of Health Advisors for the Congressional Budget Office. [source] School-based promotion of fruit and vegetable consumption in multiculturally diverse, urban schoolsPSYCHOLOGY IN THE SCHOOLS, Issue 1 2008Jessica Blom-Hoffman Rates of childhood overweight, have reached epidemic proportions (U.S. Department of Health and Human Services, 2001), and schools have been called on to play a role in the prevention of this medical condition. This article describes a multiyear health promotion effort,the Athletes in Service fruit and vegetable (F&V) promotion program,which is based on social learning theory for urban, elementary school children in kindergarten through third grade. Children participate in the program for a period of 3 years. The goals of the program are to increase opportunities for children to be more physically active during the school day and to help students increase their F&V consumption. This article describes the F&V promotion components of the program that were implemented in year 1, including implementation integrity and treatment acceptability data. Year 1 evaluation data demonstrated that the program is acceptable from the perspective of school staff and was implemented by school staff with high levels of integrity. Hallmarks of the program's successful implementation and high acceptability include (a) having a school-based program champion; (b) designing the program to include low-cost, attractive, interactive materials; (c) including many school staff members to facilitate a culture of healthy eating in the school; and (d) spreading out implementation responsibilities among the multiple staff members so that each individual's involvement is time efficient. © 2007 Wiley Periodicals, Inc. [source] The Public Health Nursing Practice Manual: A Tool for Public Health NursesPUBLIC HEALTH NURSING, Issue 2 2004M.S.N./ M.P.H., Sharon D. Sakamoto R.N. Abstract Public health nursing is recognized as an important and critical component of the public health workforce, and today, it makes up the largest single category of public health professionals, according to the U.S. Department of Health and Human Services. Preparation of generalist public health nurses with the knowledge base, skills, and training to effectively respond to public health challenges is essential. The County of Los Angeles Department of Health Services, Public Health Nursing Section, in response to this need, implemented the Public Health Nursing Practice Manual to provide public health nurses with interventions and guidelines to articulate their role and practice as outlined by the framework of the Public Health Nursing Practice Model developed by Los Angeles County. Identification and development of new methods to support the practice of nursing is imperative in facilitating a more sophisticated and expanded level of practice, as well as providing a means of improving, protecting, and enhancing the quality of health for all people. The Public Health Nursing Practice Manual is an effective tool to monitor performance improvement and provide standardization of the generalist public health nurse practicing in Los Angeles County. [source] The Evolution and Direction of OPTN Oversight of Live Organ Donation and Transplantation in the United StatesAMERICAN JOURNAL OF TRANSPLANTATION, Issue 1 2009R. S. Brown For more than 20 years, the Organ Procurement and Transplantation Network (OPTN) has developed policies and bylaws relating to equitable allocation of deceased donor organs for transplantation. United Network for Organ Sharing (UNOS) operates the OPTN under contract with the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS). Until recent years, the OPTN had little defined authority regarding living donor organ for transplantation except for the collection of data relating to living donor transplants. Beginning with the implementation of the OPTN Final Rule in 2000, and continuing with more recent announcements, the OPTN's role in living donation has grown. Its responsibilities now include monitoring of living donor outcomes, promoting equity in nondirected living donor transplantation and ensuring that transplant programs have expertise and established protocols to promote the safety of living donors and recipients. The purpose of this article is to describe the evolving mandates for the OPTN in living donation, as well as the network's recent activities and ongoing efforts. [source] Emergency Medicine Public Health Research Funded by Federal Agencies: Progress and PrioritiesACADEMIC EMERGENCY MEDICINE, Issue 11 2009Gail D'Onofrio MD Abstract The emergency department (ED) visit provides an opportunity to impact the health of the public throughout the entire spectrum of care, from prevention to treatment. As the federal government has a vested interest in funding research and providing programmatic opportunities that promote the health of the public, emergency medicine (EM) is prime to develop a research agenda to advance the field. EM researchers need to be aware of federal funding opportunities, which entails an understanding of the organizational structure of the federal agencies that fund medical research, and the rules and regulations governing applications for grants. Additionally, there are numerous funding streams outside of the National Institutes of Health (NIH; the primary federal health research agency). EM researchers should seek funding from agencies according to each agency's mission and aims. Finally, while funds from the Department of Health and Human Services (HHS) are an important source of support for EM research, we need to look beyond traditional sources and appeal to other agencies with a vested interest in promoting public health in EDs. EM requires a broad skill set from a multitude of medical disciplines, and conducting research in the field will require looking for funding opportunities in a variety of traditional and not so traditional places within and without the federal government. The following is the discussion of a moderated session at the 2009 Academic Emergency Medicine consensus conference that included panel discussants from the National Institutes of Mental Health, Drug Abuse, and Alcoholism and Alcohol Abuse and the Centers for Disease Control and Prevention (CDC). Further information is also provided to discuss those agencies and centers not represented. [source] Development of the New Lung Allocation System in the United StatesAMERICAN JOURNAL OF TRANSPLANTATION, Issue 5p2 2006T. M. Egan This article reviews the development of the new U.S. lung allocation system that took effect in spring 2005. In 1998, the Health Resources and Services Administration of the U.S. Department of Health and Human Services published the Organ Procurement and Transplantation Network (OPTN) Final Rule. Under the rule, which became effective in 2000, the OPTN had to demonstrate that existing allocation policies met certain conditions or change the policies to meet a range of criteria, including broader geographic sharing of organs, reducing the use of waiting time as an allocation criterion and creating equitable organ allocation systems using objective medical criteria and medical urgency to allocate donor organs for transplant. This mandate resulted in reviews of all organ allocation policies, and led to the creation of the Lung Allocation Subcommittee of the OPTN Thoracic Organ Transplantation Committee. This paper reviews the deliberations of the Subcommittee in identifying priorities for a new lung allocation system, the analyses undertaken by the OPTN and the Scientific Registry for Transplant Recipients and the evolution of a new lung allocation system that ranks candidates for lungs based on a Lung Allocation Score, incorporating waiting list and posttransplant survival probabilities. [source] Long-term trends in cancer mortality in the United States, 1930,1998,CANCER, Issue S12 2003M.S., Phyllis A. Wingo Ph.D. Abstract BACKGROUND Progress against cancer can be examined by analyzing long-term trends in cancer incidence and mortality. The recent directive from the U.S. Department of Health and Human Services to adopt the 2000 U.S. standard population for the age adjustment of death rates prompted the American Cancer Society to update historical cancer mortality statistics using the new standard. METHODS Mortality data were abstracted by race, gender, year, and age at death for 1930 through 1959 from annual volumes of Vital Statistics of the United States. For 1960 through 1998, these data were obtained from data tapes provided by the National Center for Health Statistics. Two U.S. standard million populations (1970 and 2000) were used to calculate age-adjusted rates. Average annual percent change was estimated for each decade by site, gender, and age, and the statistical significance of the change was assessed at p < 0.05. RESULTS After long-term increases or mostly level trends that date from the 1930s for some sites, death rates for cancers of the lung (in males), prostate, female breast, colon-rectum, pancreas, leukemia, and ovary were decreasing in the 1990s. Liver cancer death rates were increasing in the 1990s. Throughout the study period, death rates for female lung cancer increased, while death rates for stomach and uterine cancers declined. CONCLUSIONS The trends of decreasing cancer death rates for the leading cancer sites in the 1990s are encouraging. However, surveillance researchers must continue to monitor these declines to assess whether the progress seen in this decade persists. Efforts also must be made to study the sites with increasing trends and identify potential underlying causes. Cancer 2003;97(12 Suppl):3133,3275. Published 2003 by the American Cancer Society. DOI 10.1002/cncr.11380 [source] U.S. Federal Regulations for Emergency Research: A Practical Guide and CommentaryACADEMIC EMERGENCY MEDICINE, Issue 1 2008Andrew McRae MD Abstract Emergency medicine research requires the enrollment of subjects with varying decision-making capacities, including capable adults, adults incapacitated by illness or injury, and children. These different categories of subjects are protected by multiple federal regulations. These include the federal Common Rule, the Department of Health and Human Services (DHHS) regulations for pediatric research, and the Food and Drug Administration's (FDA) Final Rule for the Exception from the Requirements of Informed Consent in Emergency Situations. Investigators should be familiar with the relevant federal research regulations to optimally protect vulnerable research subjects, and to facilitate the institutional review board (IRB) review process. IRB members face particular challenges in reviewing emergency research. No regulations exist for research enrolling incapacitated subjects using proxy consent. The wording of the Final Rule may not optimally protect vulnerable subjects. It is also difficult to apply conflicting regulations to a single study that enrolls subjects with differing decision-making capacities. This article is intended as a guide for emergency researchers and IRB members who review emergency research. It reviews the elements of Federal Regulations that apply to consent, subject selection, privacy protection, and the analysis of risks and benefits in all emergency research. It explores the challenges for IRB review listed above, and offers potential solutions to these problems. [source] Emergency Department Operational Changes in Response to Pay-for-performance and Antibiotic Timing in PneumoniaACADEMIC EMERGENCY MEDICINE, Issue 6 2007Jesse M. Pines MD Background:The percentage of adult patients admitted with pneumonia who receive antibiotics within four hours of hospital arrival is publicly reported as a quality and pay-for-performance measure by the Department of Health and Human Services and is called PN-5b. Objectives:To determine attitudes among physician leaders at emergency medicine training programs toward using PN-5b as a quality measure for pay for performance, and to determine what operational changes academic emergency departments (EDs) have made to ensure early antibiotic administration for patients with pneumonia. Methods:The authors administered an online questionnaire to 129 chairpersons and medical directors of 135 academic ED training programs in the United States on attitudes toward performance measurement in pneumonia and changes that academic EDs have made in response to PN-5b; one response was sought from each institution. Respondents were identified through the Society for Academic Emergency Medicine Web site and e-mailed five times to maximize survey participation. Results:Ninety chairpersons and medical directors (70%) completed the survey; 47% were medical directors, 51% were chairpersons, and 2% were medical directors and chairpersons. Forty-five (50%) did not agree that PN-5b was an accurate quality measure, and 61 (69%) did not agree that pay for performance targeting this measure would lead to improved pneumonia care. The most common strategy to address PN-5b was to provide information to providers on the importance of early treatment with antibiotics (n = 63; 70%). For patients with suspected pneumonia, 46 (51%) automate chest radiograph (CXR) ordering at triage, 37 (41%) prioritize patients with suspected pneumonia, and 33 (37%) administer antibiotics before obtaining CXR results. Overall ED changes include improved turnaround time for CXR (n= 33; 37%), prioritized CXRs over other radiographs (n= 13; 14%), and improved inpatient bed availability (n= 12; 13%). Of 13 strategies identified to improve PN-5b, the median number that programs have implemented is five (interquartile range, 5,7). All sites reported engaging in at least three operational changes to address PN-5b. Conclusions:All EDs in this study have addressed early antibiotic administration with multiple operational changes despite mixed sentiment that these changes will improve care. Future research is needed to measure the impact of pay-for-performance initiatives. [source] | ||||||||||