Smart regulation: will the government's strategy work?
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Canada↗
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Results for “Government Regulation”
Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.
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Removal of obsolete regulations on hemophilia treatment centers and genetic disease testing and counseling programs--HRSA, PHS. Final rule.
This rule removes obsolete regulations governing grants for hemophilia treatment centers and grants for genetic disease testing and counseling programs. These regulations have been replaced by unified regulations governing the maternal and child health project grant program including the hemophilia and genetic programs. This action will eliminate duplicative regulations applicable to the maternal and child health project grant program.
Adult↗
Regulations which govern the availability of therapeutic drugs in Australia.
This article looks at the history and development of drug regulation in Australia, concentrating on the changes that have occurred in the last few years. It touches briefly on the system by which many drugs are subsidized and examines the way in which a de facto "restricted" list became less restricted. It deals with clinical trial approval procedures as these have changed markedly and turns to consider advertising and promotion of drugs. In concluding, it discusses the advantages and some of the shortcomings of the system.
Advertising↗
Suit surfaces questions on status of PSROs.
The federal court ruling that the Washington, DC, Professional Standards Review Organization (PSRO) is a government agency for purposes of the Freedom of Information Act raises interesting questions about the future legal status of PSROs and about government regulation in the health care field. PSROs should be seen as experiments in government regulation--continuously changing, and hopefully improving, mechanisms.
Confidentiality↗
Ethics of psychological research: new policies; continuing issues; new concerns.
The implementation over the past year within Canadian universities of the new Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) ushers in a new era in the oversight of the ethics of psychological research in Canada. Although these new policies apply to all human research, our interest in how they apply to psychology, primarily to deception, undergraduate subject pools, and other continuing concerns. Why have the granting agencies decided that government regulation of research ethics is necessary and what is the relationship between federal regulations and discipline codes? The history of CPA's involvement in protecting psychology's interests in the final revisions to the TCPS is recounted. In spite of what has been achieved, many psychologists feel that the TCPS has created new concerns for the discipline. Although there is the potential for startup problems, it is in our collective and individual best interests to make the policy work, thereby ensuring that escalation of government regulation or legislation will not be pursued.
Advisory Committees↗
Triage in the nation's medicine cabinet: the puzzling scarcity of vaccines and other drugs.
For a variety of reasons, vaccines and other critical pharmaceutical products have become increasingly scarce in the last few years, and persistent shortages involving dozens of essential drugs may imperil the public health. Pressures emanating from regulatory agencies, the courts, and insurers have conspired to make some lines of the pharmaceutical business less than attractive. Although concerns about unpredictable tort liability received most of the blame in the past, two other factors may help to account for the latest round of drug shortages: stringent federal control of manufacturing facilities and aggressive cost-containment efforts that further erode profit margins. Whatever the cause, scarce supplies necessitate efforts at rationing that pose their own difficulties for health care providers. Policymakers could avoid putting physicians to such tough choices regarding patients by focusing on ways to ensure the production of adequate quantities of these highly cost-effective medical technologies. Some commentators have called for greater public sector involvement, but this Article concludes that, in addition to bolstering its emergency stockpiles, the federal government instead needs to take steps designed to encourage private manufacturers to continue supplying critical pharmaceuticals. To this end, the government should adopt more flexible regulations governing manufacturing facilities, provide companies with greater protection from the vagaries of tort liability, and avoid pursuing excessive cost-control strategies. Otherwise, patients may continue to lose access to important therapeutic products.
Cost Control↗
Point-of-care testing: an introduction.
OBJECTIVE: To review available literature and provide perspective on point-of-care testing, focusing on the impact it has on treatment outcomes in patient care, the impact it has on the costs of patient care, and the role it has in the delivery of pharmaceutical care. DATA SOURCES: Information was retrieved from MEDLINE English literature searches using PubMed (1965-August 2003) and included search terms of point-of-care testing, near patient testing, pharmaceutical care, pharmacists, outcomes, and economics. Additionally, references from retrieved articles were reviewed to identify literature not detected by literature searches. STUDY SELECTION AND DATA EXTRACTION: Comparative studies, demonstration project reports, and systematic reviews were selected. Other related resources, such as government documents, relevant legislation, and government regulations, were included. Emphasis was placed on comparative studies and demonstration project reports. In the absence of these data, other resources were included. DATA SYNTHESIS: Point-of-care testing devices and technology are increasingly used in the delivery of care and therapeutic decision making. No studies have evaluated the impact of point-of-care testing, by itself, on patient care and outcomes. All studies have incorporated point-of-care testing with changes in the way patient care is delivered and have shown significant improvements when this approach is taken. The cost of point-of-care testing is greater than traditional laboratory testing, but the increased cost may be offset by improvements in the management of patient care, improvements in patient outcomes, and decreased utilization of the healthcare system. Point-of-care testing has been used successfully by pharmacists in disease management programs. Various government regulations and legislation impact the use of point-of-care testing. CONCLUSIONS: Limited data indicate that point-of-care testing, when combined with changes in healthcare delivery systems, may improve patient outcomes and decrease the overall cost of health care. Pharmacists have used point-of-care testing in programs designed to improve patient care but must carefully consider regulations and laws that govern the use of these devices. There is a great need for additional investigation into the use of point-of-care testing in patient care.
Delivery of Health Care↗
Tracking genes from seed to supermarket: techniques and trends.
Analytical techniques to track plant genes in the environment and the food chain are essential for environmental risk assessment, government regulation and production and trade of genetically modified (GM) crops. Here, I review laboratory techniques to track plant genes during pre-commercialization research on gene flow and post-commercialization detection, identification and quantification of GM crops from seed to supermarket. At present, DNA- and protein-based assays support both activities but the demand for fast, inexpensive, sensitive methods is increasing. Part of the demand has been generated by stringent food labeling and traceability regulations for GM crops. The increase in GM crops, changes in GM crop design, evolution of government regulations and adoption of risk-assessment frameworks will continue to drive development of analytical techniques.
Enzyme-Linked Immunosorbent Assay↗
Government imposed regulation of prices, revenues and the utilization of services.
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Cost Control↗
Reforming health insurance: realistic options and hard choices.
The persistently high number of people reporting that they have no health insurance has precipitated a number of new comprehensive proposals to extend coverage to most Americans. Such proposals must find solutions to fundamental problems that have thus far eluded policymakers, including the role of government regulation, how much to spend, and who should pay. The experience of the 1990s suggests that an effective policy would offer more choices of health plans through the private market, limit unnecessary government regulation, and provide appropriate subsidies to individuals.
Consensus↗
Proposed regulations to govern private business use of tax-exempt bond financed facilities.
For the most part, owners of tax-exempt hospitals and other health care facilities should welcome the issuance of the proposed regulations because they generally clarify and liberalize former law. As pointed out, however, in certain instances the proposed regulations do impose additional requirements not found in current law. Accordingly, in those instances in which exempt facility owners may elect to apply the proposed regulations prior to their finalization, a careful analysis needs to be made of whether the old or new regime would be most beneficial.
Capital Financing↗
Where is the popular mandate? A reply to conventional wisdom.
Current federal policies include substantial cuts in government expenditures for health programs and for care of the poor, elderly, and handicapped, and the weakening of government regulations in health and medical care. These policies are presented by many political, academic, and medical leaders as responding to a popular mandate both to cut government expenditures in all non-military areas and to diminish government intervention in health care and medicine. Also, it is assumed that the tax revolt that occurred in the late seventies further triggered the need for tax cuts and cuts in all social expenditures, including health and educational expenditures. The evidence of North American people's wants, wishes, and desires--measured by leading polls--leads to opposite conclusions, however. In the period 1977-1982, there has been continuous popular support of government programs for health and education; for care of the elderly, poor, and handicapped; and for strengthening government regulations in health care and medicine. During these years, there has been a popular mandate not to decrease but, rather, to increase such interventions. Thus, the current policies cannot be presented as responding to a popular mandate. In fact, the mandate is for policies precisely opposite to the ones which are being implemented by the Reagan Administration.
Financing, Government↗
Meeting information needs: lessons learned from New Jersey's Individual Health Insurance Reform Program.
At national and state levels, there have been significant changes in the regulations governing individual and small group health insurance markets. Reforms to the individual health insurance market in New Jersey exemplify the challenges of informing consumers about changes in the regulation of insurers, where the changes are intended to simplify and broaden access to health insurance. To best take advantage of expanded access to coverage under new regulations governing the individual health insurance market, individuals need to understand the changed rules under which carriers determine eligibility and premiums. Survey results from New Jersey indicate, however, that a significant proportion of people who purchased policies under the restructured individual health insurance market did not fully understand how the new market operates.
Adult↗
Tobacco harm reduction: what do the experts think?
OBJECTIVE: To assess experts' opinions about the future of, and potential to improve individual and public health through "tobacco harm reduction" (THR), the use of novel nicotine containing products purporting to reduce the health risks from cigarette smoking. DESIGN: Semi-structured telephone interviews on nine topic areas, with qualitative content analysis of coded transcripts. PARTICIPANTS: 29 professionals with expertise related to tobacco and interest in THR, including prominent tobacco control advocates (7), pharmaceutical (3) and tobacco industry scientists/officials (5), non-industry scientists (12), and Congressional staff (2). RESULTS: Respondents agreed that harm reduction is at minimum theoretically plausible, that characteristics of "good" and "bad" THR products can be identified, that government regulation is essential but not likely in the foreseeable future, and that additional scientific data are very much needed. However, there was no consensus on specifics, such as preferred regulatory strategies or examples of ideal THR products. Disagreement was seen not only across but also within respondent categories. Mistrust of key stakeholders-for example, tobacco control advocates distrust of tobacco industry scientists and vice versa-was pervasive, and cited frequently as a barrier to regulation and collaboration. CONCLUSIONS: Continued dialogue and debate are essential as we enter a new and uncertain era of products purporting to reduce tobacco produced harm. Experts have concluded that effective government regulation is crucial to minimising the risks associated with THR and maximising potential benefits.
Attitude of Health Personnel↗
Epidemiologists in industry. Past achievements, unexplored opportunities, and future needs.
Epidemiologists in industry have achieved much in the past several years. In addition to conducting important research into known or suspected hazards in the workplace, they have taken the lead in developing a code of ethics for epidemiologists in industry, established guidelines for good epidemiology practices, and have been actively involved in the development of government regulations and the setting of standards. Yet the scope of their activities can be expanded even further. I have discussed some of these, such as environmental health studies, long-term evaluations of health promotion programs, and research into major chronic diseases. But to move into new areas of research and to continue their work in traditional areas, they need to overcome some important obstacles. Among these that I have discussed are: problems involved in getting comprehensive morbidity information into their data bases, restrictions imposed on access to data by privacy protection laws and regulations, and difficulties in publishing and disseminating the results of negative studies. To overcome these obstacles and to enable industry epidemiologists to expand their activities into new areas, they will need additional support from government regulators to ease restrictions on data acquisition, and from company management to provide their epidemiologists with the resources they need. I hope that such support will be forthcoming so that epidemiologic research in industry can achieve its full potential.
Cross-Sectional Studies↗
Policy alternatives for alcohol-impaired driving.
This article summarizes current scientific evidence about the impact of public policy measures on alcohol-related motor vehicle crashes. The public policy measures considered are (1) minimum drinking age laws, (2) taxation of alcoholic beverages, (3) drinking and driving laws, (4) laws and regulations governing the physical availability of alcoholic beverages, and (5) server intervention programs. It is concluded that certain public policy measures reduce alcohol-related crashes. These measures include higher taxes on alcoholic beverages and at least some laws and regulations governing the physical availability of alcohol (as well as the minimum drinking age). The article suggests that strengthening drinking and driving laws without also adopting these other measures may have less than optimum (and possibly disappointing) effects.
Age Factors↗
Opioid availability in Latin America: the Santo Domingo report progress since the Declaration of Florianopolis.
The World Health Organization (WHO) has indicated that opioid analgesics are insufficiently available, particularly in developing countries, due to a variety of reasons, including legislative, educational, and policy issues. In its effort to promote the rational use of medical opioids and the adequate treatment of patients with cancer, WHO has sponsored a meeting of Latin American representatives every 2 years, which includes health professionals and government regulators. During March 24-27, 1996, a group of 86 representatives of cancer pain relief and palliative care programs from nine Latin American countries met in Santo Domingo under the auspices of the WHO Palliative Care Program for Latin America. For the first time since the First Latin American Meeting, government regulators were present to help address the issue of opioid availability from their perspective. During the meeting, issues pertaining to cancer pain, opioid availability, and palliative care were discussed. This report summarizes some of the events and presents a summary of the conclusions of an earlier meeting in 1994, as described in the Declaration of Florianopolis, and presents its follow-up, The Santo Domingo Report, generated following the 1996 meeting.
Analgesics, Opioid↗
Projections of cancer risks attributable to future exposure to asbestos.
To assess the maximum possible impact of further government regulation of asbestos exposure, projections were made of the use of asbestos in nine product categories for the years 1985-2000. A life table risk assessment model was then developed to estimate the excess cases of cancer and lost person-years of life likely to occur among those occupationally and nonoccupationally exposed to the nine asbestos product categories manufactured in 1985-2000. These estimates were made under the assumption that government regulation remains at its 1985 level. Use of asbestos in the nine product categories was predicted to decline in all cases except for friction products. The risk assessment results show that, although the cancer risks from future exposure to asbestos are significantly less than those from past exposures, in the absence of more stringent regulations, a health risk remains.
Actuarial Analysis↗