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The Orphan Drug Act and the Federal Government's Orphan Products Development Program.

Through the combined efforts of agencies and organizations in the public and private sector, drugs have been made available that would not have been at hand without a specific focus on the orphan drug issue. It is anticipated that these cooperative efforts will continue beyond the first enthusiastic burst engendered by the inception of new and interesting activities.

Drug Industry↗

Can child deaths be prevented? The Arizona Child Fatality Review Program experience.

OBJECTIVE: To determine the causes and preventability of child deaths; to assess the accuracy of death certificate information; and to assess the number of child abuse deaths that are misdiagnosed as deaths attributable to natural or accidental causes. METHODS: Analysis of deaths of children <18 years old that occurred between 1995-1999 using the data collected by the Arizona Child Fatality Review Program (ACFRP). RESULTS: From 1995-1999, local multidisciplinary child fatality review teams (CFRTs) have reviewed 95% of all deaths of children <18 years old in Arizona. Each team has access to the child's death certificate, autopsy report, hospital records, child protective services records, law enforcement reports, and any other relevant documents that provide insight into the cause and preventability of a child's death. After reviewing these documents, the team determines the cause of death, its preventability, and the accuracy of the death certificate. The ACFRP defines a child's death as preventable if an individual or the community could reasonably have done something that would have changed the circumstances that led to the child's death. The ACFRP determined that 29% (1416/4806) of these deaths could have been prevented, and preventability increased with the age of the child. Only 5% (81/1781) of neonatal deaths were considered preventable, whereas the deaths of 38% of all children older than 28 days were considered preventable. By 9 years of age, the majority of child deaths (56%) were considered preventable. Deaths attributable to medical conditions were far less likely to be considered preventable than deaths attributable to unintentional injuries. Although 62% of all deaths in Arizona during the 5-year period were attributable to medical conditions, only 8% (253/2983) of these deaths were considered preventable. In contrast, 91% (852/934) of the deaths attributable to unintentional injuries were considered preventable. Motor vehicle crashes accounted for 634 of the deaths resulting from injuries, and drowning accounted for 187 deaths. Motor vehicle crashes were the leading cause of death for all children in Arizona over 1 year of age. Only 18% of child passengers and 3% of adolescent drivers who died were known to be appropriately restrained. The typical drowning victim was a young child who drowned in the family's backyard pool. Indeed, 70% (131/187) of the drowning victims were <5 years old, and 62% (81/131) of these children died in a backyard pool. Supervision of the child and pool fencing could have prevented 90% of these deaths. Most deaths attributable to medical conditions occurred in the first year of life. Prematurity was the most common medical condition (1036 deaths) followed by congenital anomalies (662 deaths) and infectious diseases (470 deaths). Some of the reasons why CFRTs believed a medical death was preventable included inadequate emergency medical services, poor continuity of care, and delay in seeking care because of lack of health insurance. There were 4 deaths resulting from infections that were vaccine-preventable. There were 263 deaths attributable to sudden infant death syndrome. Only 38 of these infants were found lying on their back; 35 were found lying on their side. The death rate from sudden infant death syndrome decreased from 1.1 per 1000 infants <1 year of age in 1995 to 0.5 in 1999. There were 33 deaths that the CFRTs concluded were attributable to unsafe sleeping arrangements that resulted in unintentional suffocation. From 1995-1999, 317 Arizona children died from gun shot wounds. Most of these deaths were homicides (175) or suicides (109). All suicide deaths occurred in children >9 years old, and 77% of these children were >14 years old. The typical suicide victim was male (83%) and used a gun (70%) to kill himself. After review by the CFRTs, it was determined that 5 of the 67 child abuse deaths were misdiagnosed as attributable to natural or accidental causes on the death certificate. In 3 of these 5 cases, the child was in a persistent vegetative state and died many years after the episode of child abuse. Although inaction or inappropriate action by Child Protective Services (CPS) is often thought to be the cause of child abuse deaths, the ACFRP determined that in 79% of child abuse deaths, there had been no previous CPS involvement with the child's family. Although 61% of child abuse deaths were considered to be preventable, much of the responsibility for preventing these deaths rests with community members (eg, relatives, neighbors) who were aware of the abuse but failed to report the family to CPS. The CFRTs, who had received training in the proper completion of death certificates, reported that the cause of death was incorrect on 13% of all death certificates and in 16 cases, the CFRTs disagreed with the medical examiner on the manner of death (eg, natural, accidental, undetermined). Because CFRTs have access to additional information that may not have been available to the physician who completes a child's death certificate, CFRTs may be able to more accurately determine the cause and manner of death than the physician who completed the death certificate. CONCLUSIONS: Arizona's child death rate is above the national average (82.16/100 000), but the ACFRP determined that many of these deaths could have been prevented by using known prevention strategies (eg, child safety restraints, pool fencing). Most child mortality data are based on death certificate information that often is incorrect and cannot be used to assess preventability. Although most states have child fatality review programs that review suspected child abuse deaths, <3% of all preventable deaths in Arizona were attributable to child abuse. If all child deaths in the United States were reviewed from a prevention/needs assessment perspective, targeted and data-driven recommendations for prevention could be developed for each community, and potentially 38% of all child deaths that occur after the first month of life could be prevented. The ACFRP is an excellent example of a statewide system with a public health focus. To assist other states in developing similar programs, national support is needed. The establishment of a public health focused federally funded national program would provide us with the opportunity to standardize data collection among states and better utilize this data at a national level.

Accidents, Traffic↗

The effect of physician training on treatment of respiratory infections: evidence from rural Egypt.

A three-round survey of child mortality, morbidity and treatment conducted in rural lower Egypt in 1990-91 found relatively poor treatment practices for respiratory infections. Only about 56 per cent of children with a respiratory infection received appropriate treatment. Antibiotics were prescribed for more than half of all mild coughs and colds, but were not prescribed for a quarter or more of serious cases. A training program for government physicians conducted midway through the survey improved treatment practice slightly in government facilities. However, training alone is unlikely to improve treatment much. Better supervision, and information campaigns focused directly on mothers, are suggested as necessary components of a successful project.

Adolescent↗

Advanced technology program: information infrastructure for healthcare focused program.

This paper describes an initiative begun by the Advanced Technology Program in 1994 referred to as the Information Infrastructure for Healthcare (IIH) focused program. The IIH focus program began with an initial exchange of ideas among members of the private and public sectors (industry's submission of "white papers"; workshops conducted by the ATP; meetings held between individuals from both groups) to identify those technologies necessary for the development of a national information infrastructure in healthcare. A discussion of the development of the focus program through a "white paper" process notes differences that existed between what the ATP had hoped to gain through this method and how the private sector responded. A statistical description of the participants as well as a brief discussion of the ATP review and selection process is included.

Biomedical Technology↗

The learning evaluation: a theoretical and empirical exploration.

In this article, the authors theoretically and empirically explore the concept of learning evaluation. They shed light on the positioning of the learning evaluation amid scholarly work on evaluations. Moreover, they describe the learning evaluation in practice in the Netherlands by going into a specific project called the Stimulation Program on Citizen and Environment. The theoretical and empirical quest gives insights into the problems with and possibilities of the learning evaluation. They think that their experiences can help the further development of theory about learning evaluation as well as aid in the practice of such evaluations.

Environment Design↗

Clearing the air: a model for investigating indoor air quality in Texas schools.

This pilot project focused on the assessment of indoor air quality at a local high school in Galveston, Texas, using methods based on guidelines for the U.S. Environmental Protection Agency's Indoor Air Quality Tools for Schools program. Tools for Schools, developed for evaluating and ensuring acceptable air quality for schools, takes a low-cost, minimal-involvement, primarily educational approach. The authors also compared the findings from this approach with the results of an air-sampling program. The overall goal was to determine if use of Tools for Schools was sufficient to identify conditions with the potential to cause adverse health effects. The primary objectives were to 1) establish an indoor air quality committee for the school to implement Tools for Schools assessments and management strategies, 2) collect air quality data in high-risk areas identified within the school by the indoor air quality committee, 3) collect outdoor air quality data at or in close proximity to the school, and 4) develop methods and instruments for assessing environmental risks associated with daily school attendance. Data were gathered on levels of formaldehyde and other volatile organic compounds (VOCs), ozone, particulate matter (PM10), mold, relative humidity, and temperature. Data values for each sampled pollutant were compared with federal standards, recommended values established by the American Conference of Governmental Industrial Hygienists for non-industrial populations, and effects screening levels developed by the Texas Commission on Environmental Quality. Levels of all VOCs except formaldehyde were found to be well within guidelines, as were ozone and particulate-matter levels. Mold, however, was widespread, including both common species and species associated with allergy and asthma, such as Aspergillus and Alternaria. In general, Tools for Schools provides an excellent foundation for a school indoor air quality program, although the authors did find it necessary to streamline data collection and did find that mold with the potential for adverse health effects was present, albeit not visible in some areas.

Air Pollutants↗

Smallpox Vaccine Injury Compensation Program: administrative implementation. Adoption of interim final rule as final rule with amendments.

This document adopts the Smallpox Vaccine Injury Compensation Program (the Program) Administrative Implementation Interim Final Rule as the Final Rule with amendments, as follows: explains how the term "child" survivor is defined; updates the effective period of the Secretary's Declaration Regarding Administration of Smallpox Countermeasures (the Declaration); corrects an error in Sec. 102.20(d) to clarify that one of the Smallpox (Vaccinia) Vaccine Injury Table requirements to establish a covered Table injury is the first symptom or manifestation of onset of the injury in the Table time period specified; reflects the change in name from the Special Programs Bureau to the Healthcare Systems Bureau; provides the new address of the Bureau's Associate Administrator, and the new address of the Program Office; clarifies that no payments are authorized for fees or costs of personal representatives, including those of attorneys; and corrects a typographical error in Sec. 102.83(c) to make clear that the Secretary determines the timeframe for submission of required documentation.

Compensation and Redress↗

Dietary analysis of meals served in the breakfast and lunch programs of Puerto Rican schools.

BACKGROUND: Nutritional analysis of meals in the Federally-sponsored Breakfast and Lunch Programs in Stateside Schools has recently been completed. However due to ethnic and cultural differences, the findings may not be directly applicable to similar nutrition programs in Puerto Rico. It is our aim to carry out an analysis of meals served in Federal programs in Puerto Rico and to compare results to the stateside study. METHODS: Twenty eight different breakfast meals and 96 different lunch meals being cycled in elementary, middle and secondary schools throughout the entire island of Puerto Rico were analyzed for content using the Minnesota Nutrition Data System 32 and compared with: 1) compliance to meal pattern requirements of federal programs, 2) dietary guidelines for Americans (DG) and 3) recommended dietary allowances (RDA's). RESULTS: Breakfasts and lunches served in Puerto Rican Schools satisfy federal meal pattern requirements however most frequently offered foods different from programs in the mainland, reflecting ethnic and cultural food preferences. In terms of DG's adequate protein was present, cholesterol content was satisfactory but meals had excess percent energy from fat as well as excess energy from saturated fat, high sodium and a lower than recommended level of energy from carbohydrate. In terms of RDA's meals had prescribed levels of vitamin A, vitamin B12, vitamin C, calcium, folacin, magnesium, phosphorus and potassium. Below prescribed levels included vitamin B6, copper, vitamin E, energy, fiber, iron, niacin and zinc. CONCLUSIONS: While differences in food preferences exist between foods available in the Breakfast and Lunch Programs in Puerto Rican and U.S., schools, they have similar strengths and weaknesses when compared to compliance with U.S. Dietary Guidelines and with recommended dietary allowances.

Adolescent↗

Child and Adult Care Food Program: improved targeting of day care home reimbursements--Food and Consumer Service, USDA. Final rule.

This final rule amends the Child and Adult Care Food Program regulations governing reimbursement for meals served in family day care homes by incorporating changes resulting from the Department's review of comments received on a January 7, 1997, interim rule. These changes and clarifications involve: The appropriate use of school and census data for making tier I day care home determinations; documentation requirements for tier I classifications; tier II day care home options for reimbursement, including use of child care vouchers; calculating claiming percentages/blended rates using attendance and enrollment lists; and procedures for verifying household applications of children enrolled in day care homes. This final rule also amends the National School Lunch Program regulations to facilitate tier I day care home determinations by requiring school food authorities to provide elementary school attendance area information to sponsoring organizations. These revisions implement in final form the provisions of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 to target higher CACFP reimbursements to low-income children and providers.

Adult↗

CAM evaluation comes into the mainstream: NIH specialized Centers of research and the University of Maryland Center for Alternative Medicine Research in Arthritis.

In September of 1999 the National Institutes of Health (NIH) announced the funding of five Specialized Centers of Research in complementary and alternative medicine (CAM), bringing the total number of centers being supported to nine. The NIH center grant model provides a tremendous boost to the scientific investigation of CAM, nurturing an emerging field through the support of a step-wise research program of clinical and pre-clinical trials and developmental and feasibility studies; the building of infrastructure; and the training of a new cadre of scientific investigators in the field. This article explains the overall objectives of the NIH Specialized Centers program and focuses on one of the oldest CAM research centers in the USA, exploring some of the challenges faced in conducting CAM research while developing a center, and some of the goals and activities of the center.

Academic Medical Centers↗

Health-insurance coverage for adults with diabetes in the U.S. population.

OBJECTIVE: To compare the extent and types of health insurance coverage for adults with diabetes to coverage for those without diabetes in the U.S. population. RESEARCH DESIGN AND METHODS: Nationally representative samples of 2,405 adults with diabetes and 20,131 adults who were not known to have diabetes in the U.S. completed a questionnaire on current health insurance, including coverage through Medicare, private insurance, the military, and Medicaid and other public programs. RESULTS: Among all adults with diabetes, 92.0% have some form of health insurance, including 86.5% of those 18-64 years of age and 98.8% of those > or = 65 years of age. Approximately 41% are covered by more than one health insurance mechanism, but almost 600,000 people with diabetes do not have any form of health-care coverage. Little difference was found by type of diabetes in the proportion who have health insurance. Only small differences exist between people with diabetes and those without diabetes in the percentages covered and the types of health-care coverage. Government-funded programs are responsible for health-care coverage of 57.4% of adults with diabetes, including 26.4% of those 18-64 years of age and 96.0% of those > or = 65 years of age. Private health insurance is held by 69.3% of diabetic people. Lack of private insurance appears to be attributable primarily to lower income. CONCLUSIONS: Almost all patients with diabetes who are > or = 65 years of age have health-care coverage, but 13.5% of those 18-64 years of age have no health insurance. Few differences exist in coverage between individuals with and without diabetes. However, the absence of insurance should have a substantially greater impact on the ability of patients with diabetes to obtain services necessary for care of their disease, compared with those without diabetes. Government-funded insurance mechanisms cover a large proportion of diabetic patients, which indicates a significant societal burden associated with diabetes. Any changes in government reimbursement and coverage policies could have a major impact on health care for patients with diabetes.

Adolescent↗

Nonprofit multihospital systems.

Low cost health care, available to all, is a fundamental goal of our system; a goal which is reflected in our government's programs. We have been successful in providing high quality care to all--so successful that many non-medical social problems are now characterized as medical problems. However, as society's already high expectations of the medical field increase--so do the costs--dramatically. The solution to high costs especially for nonprofit hospitals may lie in the multi-hospital system movement, a management design which concentrates on saving money by uniting hospitals on various levels. This efficient management style may be an alternative to government provided health care.

Hospital Restructuring↗

Lessons learnt from Diarrheal Diseases Control Program and implications for the future.

The national Diarrheal Disease Control Program was launched with the aim of improving the knowledge and practice of appropriate case management among caretakers of young children as well as health care providers. The National Family Health Survey (1992-3) revealed that 42.7% of mothers knew about ORS packets and 25.9% had ever used them. ORS use rates in children who suffered from diarrhea during the previous two weeks varied from 8.3% in Rajasthan to 50.1% in West Bengal. These findings represent substantial accomplishment, and also are a reminder that we still have to reach more than half of the households. Further analysis of the NFHS data showed that exposure to electronic mass media had a significant impact on mothers' awareness about ORS packets (56% in exposed, 32% in unexposed) and ORT use rates (38% in exposed, 25% in unexposed). In this review, future strategies for increasing the impact of the program are discussed. These include involvement of licensed and unlicensed medical practitioners, greater use of the electronic mass media, ORS standardization, greater focus on poorly performing states and resolving residual issues in the case management of diarrhea in malnourished children and infants under 6 months of age.

Dehydration↗

Retention of homeless clients in substance abuse treatment. Findings from the National Institute on Alcohol Abuse and Alcoholism Cooperative Agreement Program.

Retaining clients in treatment who are homeless presents a particular challenge for substance abuse treatment providers. A National Institute on Alcohol Abuse and Alcoholism Cooperative Agreement Program offered the first opportunity to systematically study program retention in a multisite study of interventions for homeless persons with alcohol and other drug problems. This article presents results from analyses conducted across 15 interventions implemented at 8 Cooperative Agreement sites. Both qualitative and quantitative data were collected and analyzed. Key findings were that (a) retention problems with homeless clients are as or more pervasive than in the general addicted population; (b) the provision of housing increases retention, but the increases tend to be nullified when the housing is bundled with high-intensity services; (c) homeless clients leave treatment programs for a multitude of reasons; and (d) midcourse corrections to increase retention are frequently successful. The discussion focuses on service components related to retention, the importance of attending to phase transitions, and the importance of being programmatically responsive when serving this population.

Alcoholism↗

Closer to a compromise on the direction of environmental research.

The Committee for the National Institute for the Environment (CNIE) was created in 1990 "to improve the scientific basis for making decisions on environmental issues," possibly through the establishment of a separate institute devoted to the environmental sciences. But while the goals proposed for the National Institute for the Environment were universally applauded, Congress was averse to adding a new agency to the federal bureaucracy. Recently, a compromise plan has been proposed that could expand the science base without having to create a new agency. On 29 July 1999, the National Science Board approved an interim report recommending an expanded program of environmental research and research planning, education, and scientific assessment with a funding target of an additional $1 billion over five years. The report stresses the importance of environmental research in formulating environmental protection programs and contains 12 recommendations intended to enhance and complement existing research activities in environmental sciences and engineering. If the National Science Foundation implements the recommendations in the report and if Congress appropriates funds for that purpose, the need for additional funding for new science activities identified by the CNIE should be satisfied.

Engineering↗

Data-based organizational change: the use of administrative data to improve child welfare programs and policy.

Administrative databases hold the potential to have a significant impact on the development of effective child welfare programs and policies. This article discusses the strengths and weaknesses of administrative databases, issues with their implementation and data analysis, and effective presentation of their data at different levels in child welfare organizations.

Administrative Personnel↗

Management of HIV-1 infection with a combination of nevirapine, stavudine, and lamivudine: a preliminary report on the Nigerian antiretroviral program.

OBJECTIVE: To evaluate treatment outcome in the first 12 months among HIV-positive patients managed with a combination of nevirapine + stavudine + lamivudine under the current national antiretroviral (ARV) program in Nigeria. DESIGN: This was a prospective observational, cohort study on 50 ARV-naive patients who met the inclusion criteria for the program and had given informed consent. All patients were in stage 2 or stage 3 periods of infection based on World Health Organization clinical classification. The patients were treated with the generic brands of ARVs and treatment consisted of oral nevirapine (Nevimal, Cipla, Mumbai, India), 200 mg daily, lamivudine (Lamivir, Cipla), 150 mg twice daily, and stavudine (Stavir, Cipla), 40 mg twice daily. Prior to initiation of treatment, the clinical history and baseline data for each patient were documented. The levels of plasma HIV-1 RNA, CD4 cell counts, frequency of opportunistic infections, and estimated body mass index were recorded at baseline and subsequently at intervals during treatment. Data obtained at the various sampling times for each parameter were compared against their baseline values. RESULTS: Data on the plasma HIV-1 RNA levels indicated that between baseline and week 24, the median viral load of the patients decreased by 1.79 log(10) copies/mL. Equally between baseline and week 48 the median CD4 cell counts increased by 186 x 10(6) cells/L, the frequency of opportunistic infections decreased by 82%, the median body mass index increased by 4.8 kg/m(2), and 36% experienced side effects, which were minor and transient. The most prevalent side effect recorded was skin rash associated with nevirapine. Good adherence to this triple regimen was recorded in >85% of the patients. CONCLUSIONS: The overall results within the 12-month treatment period indicated an effective suppression of viral replication, the reconstitution of the immune system, and improvement of the physical well-being of the study population. Though there may be differences in global distribution of the infecting HIV-1 subtypes, the clinical and biologic results of this study compared favorably to those documented in cohorts treated with branded and generic ARV drugs in some developed and developing countries. The cumulative data in this study further confirmed that the correct use of generic brands of ARVs is a feasible option in HIV care and support programs in resource-poor countries.

Academies and Institutes↗