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Theoretical perspectives on public communication preparedness for terrorist attacks.

The experience of federal health authorities in responding to the mailed anthrax attacks in the Fall of 2001 sheds light on the challenges of public information dissemination in emergencies. Lessons learned from the Fall of 2001 have guided more recent efforts related to crisis communication and preparedness goals. This article applies theories and evidence from the field of communication to provide an orientation to how public health communication can best contribute to the preparedness effort. This theoretical orientation provides a framework to systematically assess current recommendations for preparedness communication.

Bioterrorism↗

Direction of the Organ Procurement and Transplantation Network and United Network for Organ Sharing regarding the oversight of live donor transplantation and solicitation for organs.

The Organ Procurement and Transplantation Network (OPTN) operated by United Network for Organ Sharing (UNOS) has taken recent steps to address public solicitation for organ donors and its oversight of live donor transplantation. This report provides the direction of the OPTN regarding deceased donor solicitation. The OPTN has authority under federal law to equitably allocate deceased donor organs within a single national network based upon medical criteria, not upon one's social or economic ability to utilize resources not available to all on the waiting list. The OPTN makes a distinction between solicitations for a live donor organ versus solicitations for directed donation of deceased organs. As to live donor solicitation, the OPTN cannot regulate or restrict ways relationships are developed in our society, nor does it seek to do so. OPTN members have a responsibility of helping protect potential recipients from hazards that can arise from public appeals for live donor organs. Oversight and support of the OPTN for live donor transplantation is now detailed by improving the reporting of live donor follow-up, by providing a mechanism for facilitating anonymous live kidney donation, and by providing information for potential live kidney donors via the UNOS Transplant Living website.

Directed Tissue Donation↗

The new Russian law on psychiatric care.

On July 2, 1992, President Boris Yeltsin signed into effect a law that has the potential for advancing human rights of psychiatric clients in the Russian Federation. The author provides a comparative analysis of the U.S. and Russian psychiatric laws, demonstrating a striking similarity of the laws in terms of substance and scope.

Cross-Cultural Comparison↗

Crisis management during anaesthesia: recovering from a crisis.

Preventing harm to the patient is the priority during a crisis. After a major incident, and especially when a patient has been harmed, there are a number of matters to be addressed: the ongoing care of the patient; documentation of the incident; investigation of the root causes; completion of reports; interviews with the patient and/or the next of kin, together with apologies and expression of regret; updates and ongoing support for friends and relatives; a word of thanks to the staff involved for their assistance; formal debriefing of staff for quality assurance and possibly ongoing support and a separate debriefing for psychological purposes; ensuring that the recommendations of the root cause analysis are carried out; or, failing that, that the issues are logged on a risk register. The extent and depth of the follow up protocol depends on what, if any, harm may have been done. This may constitute completion of an incident report; notification of an equipment failure to a federal regulatory authority; arranging consultations with a mental health professional to manage psychological sequelae (especially following an awareness episode); follow up during weeks of intensive care treatment; or, when a death has occurred, a full medico-legal and/or coronial set of procedures. A precis is appended in an action card format.

Algorithms↗

Safety profile of quinolones.

Tolerability data from reports to Federal Drug Authorities, information from drug companies, medical literature, and personal experience are cited. Tolerability data regarding norfloxacin were derived from more than 31,000 patients in a phase IV study; ofloxacin from more than 14,000 patients in a phase IV study; and ciprofloxacin from more than 8,000 patients during phase II and phase III studies. Adverse experiences occurred in 6.8% of patients treated with norfloxacin, 9.1% with ciprofloxacin, and 9.3% with ofloxacin. The most frequent adverse effects involved the gastrointestinal tract. Untoward effects were generally mild and reversible when therapy was discontinued.

Animals↗

Law & psychiatry: Legal concerns for psychiatrists who maintain Web sites.

Courts recognize three types of Web sites: passive, which provide basic information; business, on which business is conducted; and intermediate, which are somewhat interactive but conduct no business. Inviting contact from site visitors may lead to inadvertent doctor-patient relationships, with ensuing legal duties. Statements made may be considered explicit warranties, which are subject to lawsuits when not fulfilled. Providing services to out-of-state clients may amount to practicing without a license. The author reviews Federation of State Medical Boards guidelines for appropriate use of the Internet in medical practice and offers ethical principles to help guide decisions about structure and content of passive sites.

Government Regulation↗

The fixed-dose procedure and the acute-toxic-class method: a mathematical comparison.

The fixed-dose procedure (FDP), proposed by the British Toxicology Society, and the acute-toxic-class (ATC) method, proposed by the German Federal Health Authority, provide alternatives to the LD50 test for classifying substances by their acute oral toxicity. This paper presents a mathematical model that is used to compare the two procedures in terms of their classification properties and the required numbers of animals. It is found that the classification properties of the procedures depend on the dose levels used, the number of animals tested per dose and the criteria that are used to decide whether testing should continue at a higher or lower dose. For substances with steep dose-response curves, the most likely classification is determined chiefly by the choice of the dose levels whilst the number of animals and continuation criteria used are increasingly important for substances with dose-response curves with a smaller slope. The use of toxicity as a possible endpoint as in the FDP and the use of a two-stage testing procedure at each dose as in the ATC method are both found to reduce the expected numbers of animals required with little effect on the classification properties. On the strength of these findings it is indicated that a new procedure combining the dose levels and testing approach of the ATC method with the inclusion of toxicity as an endpoint as in the FDP would be more efficient than either the FDP or the ATC method.

Animal Welfare↗

Food safety: risk assessment methodology and decision-making criteria.

As our scientific technology grows, risk assessment methods become more complex and, therefore, open to greater scientific debate. Risk assessment has always been a part of the regulatory notification and approval process for foods. However, the methodologies applied to risk assessment and decision-making have become diverse, dependent on a number of features, including the areas of the world in which one operates, the need to use cumulative risk assessment for pesticides and other ingredients or alternative risk assessment considerations for evaluating nontraditional or bioengineered foods. Diverse institutional structures within a single federal regulatory authority may tend to lead to diversity in risk outcomes that creates policy decisions that complicate and confuse the risk management process. On top of this challenge, decisions become more complicated by the need to examine beneficial factors of foods rather than the adverse effects of foods and food additives. Foods are a complex mixture of ingredients. Regulatory groups recognize the need to use new approaches for evaluating the safety and risks associated with foods and food additives, and to do so in a timely manner. The United States Food and Drug Administration (US FDA) in its need to ensure standards of "reasonable certainty of no harm" continues to explore alternative means to be responsive to petitioners as well as continue to examine scientifically validated means, e.g., quantitative structure-activity relationship (QSAR), and computer-assisted programs, within the approval process to assist in the evaluation of risks. Another means to improve the risk management process would include the cumulative risk assessment of pesticides that will, no doubt, be the beginning of more intensive efforts to understand cumulative exposures and the inherent risks from multiple pathways of exposure. The passage of the Food Quality Protection Act (FQPA) resulted in developing additional risk assessment methodologies and approaches to assess the potential for multiple exposures and risks. Addressing the international criteria used in decision-making related to foods safety assessment has resulted in acceptable intake values for food ingredients for carcinogens and noncarcinogens that, in general, tend to be more stringent in the United States compared to Europe. Clearly, the need for harmonization of risk assessment criteria and the impact of the decision process on regulatory approvals and safety assessment is a future need for the continued assurances of food safety. The topics presented in this paper are based on a symposium held in November 2002 at the annual meeting of the American College of Toxicology.

Animals↗

Accidental and unspecified deaths among prisoners as disguised suicides.

Analysis of 1987 data from the US Department of Justice for prisoners under the jurisdiction of state and federal correctional authorities indicated that suicide rates were not negatively correlated with accidental or unspecified death rates. These findings do not provide evidence of disguised suicides among prisoners. Possible explanations for high rates of unspecified death among prisoners are presented.

Accidents↗

Medicaid and state health care reform: process, programs, and policy options.

Health care reform is a continuously evolving process. The States and the Federal Government have struggled with policy issues to combat escalating Medicaid expenditures while ensuring access and quality of care to an ever-expanding population. In the absence of national health care reform, States are increasingly relying on Federal waivers to develop innovative approaches to address a myriad of issues associated with the present health care delivery system. This article provides a summary of State health care reform efforts that have been initiated under Federal waiver authority.

Evaluation Studies as Topic↗

Exemption of certain research and demonstration projects from regulations for protection of human research subjects--Office of the Secretary, HHS. Final rule.

The Department of Health and Human Services (the Department or HHS) is including among the types of research specifically exempt from the application of the regulatory requirements of 45 CFR Part 46 (protection of human research subjects) research and demonstration projects conducted under the Social Security Act and other federal statutory authority and designed to study certain public benefit or service programs, the procedures for obtaining benefits or services under those programs, and possible changes or alternatives to those programs or procedures, including changes in methods or levels of payment. These demonstration and service projects are already subject to procedures which provide for extensive review by high level officials in various program administration offices. Review by an Institutional Review Board (IRB), as required under Part 46, would be duplicative and burdensome to state and local agencies and to other entities participating in demonstration projects. Removal of this unnecessary layer of review will not only reduce the cost of the projects but help to avoid unnecessary delays in project implementation. However, in order to ensure the continued protection of human subjects participating in such research activity, the Department is adding a specific requirement of written, informed consent in any instance, not reviewed by an IRB, in which the Secretary determines that the research activity presents a danger to the physical, mental or emotional well-being of a participant.

Human Experimentation↗

Perceived preparedness for a mass casualty disaster in the United States: a survey.

INTRODUCTION: A mass casualty disaster (MCD) never has occurred in the United States, but such an event remains a fearful possibility. The purpose of this study was to establish baseline information concerning the perceptions relative to the capabilities of the United States to respond to a MCD of persons most likely to involved in the responses to such an event when it does occur. METHODS: A survey was constructed in 1995 to query the perceptions of persons in authority in federal, state, and local agencies who would participate in the medical responses to a MCD. Participants were asked to select the most likely scenario, a hurricane or earthquake, that could generate 30,000 casualties within their respective region. The survey requested respondent's perceptions as to the timing of the federal responses and the quality and sufficiency of these responses. The survey also sought information about the availability of plans to meet such a catastrophe in the region, and the frequency with which such plans have been exercised. Responses were grouped by phase of the responses and whether the respondents were employed by federal, state, or local agencies. Descriptive statistics were used to summarize the data. When appropriate, a one-tailed t-test was used to compare the responses of the groups. A p-value = 0.05 was considered statistically significant. RESULTS: A total of 104 surveys were distributed of which 88 were completed and returned (85%). Both the federal and state respondents had considerable experienced in this area. Overall, the federal respondents were more optimistic about the availability, utility, and timely arrival of federal resources to assist regions in meeting the medical needs. In each of the three phases of MCD responses evaluated (medical response, patient evacuation, and definitive care), there was concern that there were insufficient resources to meet the requirements. States and local respondents perceived that initially, they will be on their own for field rescue, life-supporting first-aid, and casualty evacuation. Respondents acknowledged that a combination of local, state, federal, and private resources eventually would be needed to meet the huge demand. Only 31% federal and 26% state/local respondents believed that there will be sufficient combined local, state, federal, and private resources to meet the requirements for the evacuation of casualties to definitive care facilities outside of the region, and another 50% acknowledged the resources would only partially meet these requirements. Sixty-eight percent of state/local respondents believed that there would be insufficient local, state, federal, and private definitive care resources to meet the requirements for definitive care. CONCLUSIONS: While three years have elapsed since the survey was conducted and there have been some improvements in preparedness and responses, concerns center around the perceived lack of resource capability or lack of ability to get the resources to the MCD scene in time to meet requirements. Such perceptions by experienced professionals warrant further review by those at all levels of government responsible for planning and responding to mass casualty disasters.

Disaster Planning↗

[Doping and sports].

Doping is widely known as the use of banned substances and practices by athletes in an attempt to improve sporting performances. The term doping likely derives from "dope", an ancient expression referred to a primitive alcoholic drink that was used as a stimulant in South African ceremonial dances; gradually, the term was extended and finally adopted his current significance. There are at least two essential reasons to support the fight against doping: the potential harmful effects on athletes and the depth corruption of the fair competition. An exhaustive list of banned substances and methods has been drawn by the International Olympic Committee and further accepted by other International Sport Authorities and Federations. This list, regularly updated, is basically divided into doping substances (stimulants, narcotic analgesics, anabolic agents, diuretics, peptide and glycoprotein hormones and analogues), doping methods (blood doping, pharmacological, chemical and physical manipulation) and drugs subjected to certain restrictions (alcohol, marijuana, local anesthetics, corticosteroids and beta-blockers). Although there might be some medical conditions, which could legitimate the need of these substances or methods, there is no place for their use in sport. Thus, an athlete's consume of any of these substances or methods will result in disqualification. Aim of the present review is to provide a synthetic description of both the desirable effects and the potentially harmful consequences of the use of some of the major doping substances and methods.

Adult↗

[Standard legal regulation and creation of a law code as the most important stage of public health reformation].

The significance of a law-making process is substantially increasing under the conditions of intensified expansion of the scope of standard legal regulation in the field of human health care in the Russian Federation. The authors state that any law-making process should begin with the definition of the subject-matter of a future law, its role and value in medical law creation and also indicate that the choice of the subject-matter of a future law is of priority and the most important stage of its preparation from the points of both contents-rich and standard legal views. Moreover, the paper presents main groups of issues that can determine the subjects of sociomedical laws and states the basic rules how reflect systemic relations in legislation. The paper shows it important to create a code of laws in the field of health protection for legal assurance of health public reforms.

Health Care Reform↗

[Molecular genetic characteristics of HIV-1 in Russia].

The paper presents data on the variants of human immunodefficiency virus type 1 (HIV-1) currently circulating in Russia. The subtype A HIV-1 variant dominating is shown to be most widespread among drug-injected users in the most regions under study. By using the results of an analysis of 1,464 blood samples taken in the past 4 years in 69 subjects of the Russian Federation, the authors have estimated that this HIV-1 variant is responsible for 93% of all HIV-infection cases in the country. The greatest regional genetic diversity was observed in Moscow and its mean (2.35(1.59) was found to be comparable to that (2.41(1.85) in the whole country. Penetration of the subtype A IV-1 variant early detectable among drug-users into other risk groups was noted.

HIV Infections↗

Effects of suspended residual spraying and of imported malaria on malaria control in the USA.

The activities of the National Malaria Eradication Programme, a co-operative campaign inaugurated in July 1947 by the United States Public Health Service and certain State and local health agencies, are outlined. Control operations reached their maximal level in 1948, when 1,364,950 dwellings in 13 "malarious" States were sprayed with residual DDT, and the percentage of mosquito control achieved was 83.2.In 1950, only 2,227 cases of malaria were reported, as compared with 16,203 in 1947 and 9,797 in 1948. But the return of infected servicemen from Korea caused a temporary increase in the incidence in 1951 and 1952, when the totals were 5,600 and 7,023, respectively. In 1953, however, only 559 civilian cases were reported; of the cases appraised, 28 were of local origin, and, of these, at least 24 are known to have been infected in 1952.The Public Health Service ceased active participation in the Programme in 1951, but continued to give technical advice. At the same time, State authorities received Federal support in activating malaria surveillance-and-prevention programmes. More-selective anti-anopheline activities have replaced residual insecticide spraying, which is now carried out in only a few isolated areas. It is believed that these measures have prevented imported malaria from increasing the diminishing incidence of primary indigenous cases in the USA.

Biomedical Research↗