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Background. It is generally acknowledged that amphotericin B is the most effective treatment for cryptococcal meningitis. However, administration of this drug is accompanied by substantial adverse effects. This double-blind study, performed before the routine availability of highly active antiretroviral therapy, was designed to compare the efficacy and safety of liposomal amphotericin B to conventional amphotericin deoxycholate in patients with acquired immunodeficiency syndrome (AIDS) and acute cryptococcal meningitis. Methods. Patients were randomized (ratio, 1:1:1) from multiple sites in the United States and Canada to receive either amphotericin B at 0.7 mg/kg/day (n=87), liposomal amphotericin B at 3 mg/kg/day (n=86), or liposomal amphotericin B at 6 mg/kg/day (n=94). Results. Efficacy was similar among all 3 treatment groups. The overall incidence of infusion-related reactions was significantly lower for both the 3 mg/kg/day and 6 mg/kg/day dosages of liposomal amphotericin B, compared with conventional amphotericin B (P<.001). Significantly fewer patients who received the 3 mg/kg/day dosage of liposomal amphotericin B developed nephrotoxicity, indicated by a doubling of the serum creatinine value, compared with recipients of conventional amphotericin B (P=.004). Overall mortality at 10 weeks was 11.6%, with no significant differences among the treatment groups. Conclusions. Liposomal amphotericin B provides an equally efficacious alternative to conventional amphotericin B deoxycholate in patients with AIDS and acute cryptococcal meningitis. Liposomal amphotericin B at a dosage of 3 mg/kg/day is accompanied by significantly fewer adverse effects. [ABSTRACT FROM AUTHOR]

There is an increasing demand from state DOTs to explore alternative ways to provide adequate oversight on construction projects. As one of the innovative contracting techniques encouraged by the Federal Highway Administration, warranties in highway construction hold contractors accountable for potential maintenance for a given period of time after project completion. The warranty practices in many states indicate that such provisions would benefit the state DOTs by improving quality, reducing life-cycle costs and project duration, and encouraging contractor innovation. However, the successful implementation of warranty contracting needs widespread industry acceptance and collaboration. This paper presents the findings of a recent research on the industry acceptance of warranty contracting in the state of Alabama. The paper identifies several major concerns and the needs of the construction industry with respect to the subject matter. More importantly, the paper reports a learning process in using warranties in highway construction. Results shows that factors like leniency in specifications, tort liability, and contractors’ past experience on warranty jobs help achieve a significance level of industry acceptance. The findings presented in this paper would help those state highway agencies that have limited experience in integrating warranties effectively into their contracts. [ABSTRACT FROM AUTHOR]

Purpose. Historical perspective on the use of biotechnology for drug product development, terminology used for biotechnology drug products, potential benefits of biotechnology, applications of biotechnology to drug product development, pharmacy considerations in the use of biopharmaceuticals, and the classification of biotechnology products by the Food and Drug Administration (FDA) are discussed. Summary. Applications of biotechnology to medicine have a long history, and the pace of new applications has accelerated in recent decades. Various terms, including biosimilars, follow-on biologics, and follow-on proteins, have been used to refer to biotechnology products that are highly similar to the reference product, notwithstanding minor differences. New approaches to the production of drug products have been made feasible through biotechnology, facilitating the prevention, cure, and treatment of diseases. Recombinant DNA technology, monoclonal antibodies, and gene therapy are among the applications of biotechnology processes to drug development. Storage, handling, preparation, and administration are among the pharmacy considerations in the use of biopharmaceuticals. The FDA has not defined or developed a pathway for establishing therapeutic equivalence of biosimilar and innovator products. Payers may attempt to make decisions about therapeutic equivalence in order to reduce costs. Conclusion. Considerable confusion surrounds biosimilars. Pharmacists can help resolve the confusion by explaining to lawmakers and health-system decision-makers the terminology and science of biotechnology processes and the implications for use of biotechnology products in the future. [ABSTRACT FROM AUTHOR]

Civil engineering departments in the United States were surveyed to ascertain the range of practices for conducting seminars for graduate students. Two separate internet-based survey instruments were developed and utilized. One survey targeted department heads to determine if the responding program had a seminar for graduate students and, if so, details about the program. In the instance where a program did not have a graduate student seminar, the survey solicited reasons for the program choosing to cancel or not have one. A second survey was disseminated to graduate students. It was intended to gather opinions of students regarding their experience with the graduate student seminar. Forty eight civil engineering department heads and 231 graduate students responded. The consensus among respondents is that a graduate seminar can be a valuable part of the student experience. [ABSTRACT FROM AUTHOR]

Purpose. The Medicare program authority, structure, and current and proposed rules for and rates of pharmaceutical reimbursement; billing issues; proposed expansion of accepted compendia and off-label drug uses; problems with the cost basis for reimbursement; concerns of and need for collaboration among various participants in the health care revenue stream; and implications for pharmacists are described. Summary. Pharmaceutical reimbursement rates have decreased over the past several years as the Centers for Medicare and Medicaid Services (CMS) has striven to maintain neutrality in the federal budget. Now, health systems that fail to report quality indicators can incur financial penalties. Also, smaller payments for cases involving medical errors have been proposed. Efforts by pharmacists to improve the billing process can increase revenue. It is anticipated that rules proposed for 2008 will result in CMS acceptance of a greater number of compendia and off-label uses. Receiving reimbursement for drug handling costs is an important issue for pharmacists. Collaboration among pharmacists and other participants in the health care revenue stream is needed to improve the health care delivery system and ensure that money is wisely spent. Conclusion. An understanding of the complexities of Medicare pharmaceutical reimbursement can help pharmacists improve the financial viability of their institutions. [ABSTRACT FROM AUTHOR]

In 1998 the New Mexico State Highway and Transportation Department (NMSHTD) agreed to pay $60 million for a 20-year pavement warranty on their Route 44 project (NM 44, now US 550). The warranty includes a ceiling clause that caps total expenditures at $110 million. As the first long-term highway warranty in the United States, the transaction set a controversial precedent that parties interested in innovative highway contracting, including other state department of transportations (DOTs), the USDOT, sureties, and contractors, view as a test case for evaluating pricing and cost-effectiveness. An interim audit report published by the State of New Mexico [Abbey (2004). Rep. to the Legislative Finance Committee, State Highway and Transportation Department, Santa Fe, N.M.] provides invaluable fiscal projections and challenges the cost effectiveness of the $60 million expenditure. This paper presents an independent analysis of the effectiveness of the warranty clauses. Based upon NMSHTD data, the analysis contends that $60 million was a fair cost of the 20-year pavement warranty at the time of acceptance if the expenditure ceiling is not considered. Furthermore, this paper argues that the ceiling on expenditure can be valuable. Using the real options approach, the paper evaluates the warranty ceiling clause on NM 44 and some policy suggestions are discussed. [ABSTRACT FROM AUTHOR]

Purpose. The role of patient assistance programs and patient advocacy foundations as a safety net for Americans without health insurance or with inadequate insurance, the financial impact of 14 years of experience promoting enrollment in such programs at a cancer treatment center, and resources and strategies that pharmacists can use to increase patient enrollment and access to needed medications are discussed. Summary. Various patient assistance programs and patient advocacy foundations offer financial and other support for patients who need help obtaining prescription medications because they lack health insurance or their insurance fails to meet their needs. Patients must complete an application and provide personal financial information. Efforts by a pharmacist at a cancer treatment center to enroll patients in such programs produced a marked reduction in write-offs over a 14-year period. Pharmacists can promote patient enrollment in assistance programs by screening for costly drugs and patients who are likely to have difficulty obtaining these drugs. These patients include those who exceed Medicaid coverage or for whom Medicaid coverage is pending, patients without any health insurance, patients without a prescription drug benefit, patients for whom the planned drug therapy is not covered by insurance, and patients enrolled in charity programs. Conclusion. Patient assistance programs and patient advocacy foundations provide a valuable safety net to ensure that Americans without health insurance or with inadequate coverage receive needed prescription medications. [ABSTRACT FROM AUTHOR]

Purpose. Future trends in the Medicare population and drug expenditures, the organizational structure of the Medicare program, and recent changes in Medicare rules and rates for pharmaceutical reimbursement are described. Summary. Large increases in the number of Medicare beneficiaries and drug spending are anticipated in the future. Medicare Part A provides insurance benefits for hospital inpatients, nursing home patients, home health care patients, and hospice care patients. Part B provides benefits for physician services, durable medical equipment, oral chemotherapy, and end-stage renal disease services. For hospitals, Part B rules are followed for ambulatory services, but these services are administered through the Part A Outpatient Prospective Payment System. The average sales price plus 6% is now used for pharmaceutical reimbursement, although physician-owned clinics may participate in a competitive acquisition program under Part B. Payments are the same for generic drugs and brand name products, although they differed in the past. Pharmaceutical reimbursement is available for uses listed in compendia approved by the Centers for Medicare & Medicaid Services and possibly some other authoritative sources. Conclusion. Medicare rules and rates for pharmaceutical reimbursement have undergone substantial changes in recent years and will continue to change in the future, with a potentially large impact on health systems and patients. [ABSTRACT FROM AUTHOR]

The article discusses the practice of medication prescription by school health services in the U.S. Despite the dedicated efforts by the school health services team, school nurses, teachers and parents who have medication-dependent children claims that school health services are often inadequate due to insufficient staffing and resources. In addition, children in schools are susceptible to a higher risk of adverse drug effects due to the span of time they spend within the school premises.

In accordance with the Clean Air Act, the U.S. Environmental Protection Agency (EPA) is currently reviewing its National Ambient Air Quality Standards for particulate matter, which are required to provide an adequate margin of safety to populations, including susceptible subgroups. Based on the latest scientific, health, and technical information about particle pollution, EPA staff recommends establishing more protective health-based fine particle standards. Since the last standards review, epidemiologic studies have continued to find associations between short-term and long-term exposure to particulate matter and cardiopulmonary morbidity and mortality at current pollution levels. This study analyzed the spatial and temporal variability of fine particulate (PM2.5) monitoring data for the Northeast and the continental United States to assess the protectiveness of various levels, forms, and combinations of 24-hr and annual health-based standards currently recommended by EPA staff and the Clean Air Scientific Advisory Committee. Recommended standards have the potential for modest or substantial increases in protection in the Northeast, ranging from an additional 13-83% of the population of the region who are living in areas not likely to meet new standards and thereby benefiting from compliance with more protective air pollution controls. Within recommended standard ranges, an optimal 24-hr (98th percentile)/annual standard suite occurs at 30/12 µg/m³, providing short- and long-term health protection for a substantial percentage of both Northeast (84%) and U.S. (78%) populations. In addition, the Northeast region will not benefit as widely as the nation as a whole if less stringent standards are selected. Should the 24-hr (98th percentile) standard be set at 35 µg/m³, Northeast and U.S. populations will receive 16-48% and 7-17% less protection than a 30 µg/m³ standard, respectively, depending on the level of the annual standard. A 30/12 µg/m³ standard suite also provides nearly equivalent 24-hr and annual control of PM2.5 distributions across the United States, thereby ensuring a more uniform and consistent level of protection than unmatched or "controlling" and "backstop" standards. This could occur even within EPA staff's recommended range of standard suites, where 22-43% of the monitors in the country could meet a controlling standard but fail to meet the combined backstop standard, resulting in inconsistent short- and long-term protection across the country. An equivalent standards combination of 30/12 µg/m³ would minimize the wide variation of protectiveness of 24-hr and annual PM2.5 concentrations. Furthermore, given recent associations of subdaily exposures and acute adverse health effects, in the absence of a subdaily averaging metric, a stringent 24-hr standard will more effectively control maximum hourly and multihourly peak concentrations than a weaker standard. [ABSTRACT FROM AUTHOR]

Focuses on several risks resulting from the enactment of the U.S. Commodity Futures Modernization Act in 2000. Purposes for enacting the modernization act; Reasons behind fragmentation in the commodity futures market; Future regulations under the law.

Focuses on the impact of antitrust on exchanges in securities and commodities in the United States. Problem on the acceptability of restrictions imposed in the industry; Adoption of ethical standards restricting freedom of members to compete; Negotiation of minimum commission rates with member firms.

Focuses on the trade of futures in the United States. Dissimilarities between commodities regulation and securities law; Provisions of the Commodity Exchange Act; Advise of lawyers to clients engaged in the futures business.

This articles focuses on science education research information between 1949 and 1950s which was presented during the National Association for Research in Science Teaching in February 1951 annual meeting in Atlantic City, New Jersey. A report on activities and accomplishments may help the Association see how it may improve its plans, increase its accomplishments, and reduce its problems. Immediately after the Association's meeting last year, its plans for gathering and disseminating information concerning science education research were formally presented to the Research and Statistical Service of the Office of Education. This presentation included a description of the plan, a justification for the project, a copy of the proposed form, and a copy of the proposed covering letter. It is interesting to note the extent to which science education leaders responded to the invitation that they report studies.

The article focuses on a research conducted by the Secondary Education Division of the United States Office of Education. When the U.S. Congress established the Office of Education in 1867, it was said that the purpose of the unit is to collecting statistics and facts that show the progress of education in the several states and territories. But the records do not show much science education research, although many data about science teaching have been collected in studies of the broad aspects of secondary education. The greatest contribution by the Office of Education has been into the field of teaching science by bringing together leaders from different fields and asking them to report the results of their studies. by the Office is the introduction of national surveys of secondary education.

The article discusses the gatekeeper patent damages compromise of S.515, a U.S. Senate patent reform bill in the U.S. Many stakeholders believe that there is no need for legislative action on a reasonable royalty patent damages. Patentees have had a 36% success rate from 1997 to 2010 and median verdict have been constant since 1995. The author says that the U.S. Senate's approval of the gatekeeper compromise is almost certain, even with opposition from lobby groups such as the Coalition for Patent Fairness.

The article discusses the update on pharmaceutical reimbursement and implications for health-system pharmacists of the Centers for Medicare and Medicaid Services (CMS) rules and rates in the U.S. Changes are said to be the result of concerns about the future sustainability of financing to cover a growing population of beneficiaries with increasing health care expenses. Moreover, a Medicare economic index has been proposed, which would limit the growth rate and cost $250 billion to implement.

Reports on drawbacks in epidemiological studies used by the U.S. Environmental Protection Agency (EPA) to evaluate particulate matter (PM) standards. Mortality caused by ambient level of PM; Revelation of the problems in the software used for epidemiological studies by EPA; Challenges to the scientific credibility of existing PM pollution standard.

The article presents several research which explore the history and the factors that contribute in the development of college preparation programs particularly in science education in the educational system in the U.S. In the first study an analysis was made on the historical development of courses of study for the teaching of science in the elementary education. As reflected in the first study, the development of courses of study in science for the elementary school has followed four stages mainly characterized by diverse yet distinct content of courses. Another research which used the survey method, is focused on the role of teachers in the development of courses of study for science education. One major finding in the study, is the varied attitudes of teachers from rural schools and junior high schools on the importance of preparations for the subject-matter.

The authors discuss the impact of oncology drug shortages on clinical care, cost, clinical trials and safety. They argue that the impact on practice is unprecedented and is not adequately documented. The lack of alternative therapies in oncology and the resultant detrimental effect on patient outcomes is highlighted. Other issues involve the growing financial implications of drug shortages, estimated at over 200 million U.S. dollars annually, and concerns over the safety of alternative drugs.

The article presents the author's views on the risk evaluation and mitigation strategies (REMSs) adopted by the U.S. Food and Drug Administration (FDA) to manage drug safety. He opines that proper implementation of REMSs can facilitate integration of all drug providers, patient information and treatment strategies into one process focusing on the overall patient care. According to him, the drug safety considerations should include decision algorithms to manage patients as per their unique needs.

Purpose. Six issues in pharmaceutical reimbursement arising from recent or proposed changes in Medicare rules or rates or the health care environment are described, along with possible strategies for addressing these issues. Summary. Recent reductions in Medicare pharmaceutical reimbursement rates, increases in use of specialty pharmacies, proposed changes in rules for erythropoiesisstimulating agent (ESA) reimbursement, increases in need for patient assistance programs, proposed changes in the clinical trial policy, and possible reductions in reimbursement for cases involving medication errors or other negative events as part of pay-for-performance initiatives are cause for concern. A multidisciplinary team approach to improving reimbursement can reduce institutional financial losses and increase options for Medicare beneficiaries. Health-system pharmacists can address concerns about the use of specialty pharmacies by collaborating with payers and specialty pharmacies on the development of workable models for safely obtaining, handling, and administering medications. Proposed rules for ESA reimbursement contain numerous flaws that could compromise patient outcomes. Pharmacists should provide the Centers for Medicare and Medicaid Services and their fiscal intermediaries with feedback on the potential impact of the proposed rules. The use of patient assistance programs can decrease financial losses associated with providing pharmaceuticals to underinsured or uninsured patients, but these programs can present pharmacists with logistical challenges. The proposed clinical research policy gives priority for research efforts and limited health care dollars to the health issues that are most important to Medicare beneficiaries, but details pertaining to implementation and funding have not yet been worked out. Pharmacists should voice opposition to pay-for-performance models that do not support a nonpunitive culture of openness in reporting quality indicators. Conclusion. An understanding of issues in the current health care environment arising from recent and proposed changes in Medicare rules and rates for pharmaceutical reimbursement can help position pharmacists to manage these issues. [ABSTRACT FROM AUTHOR]