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At least 217 records · Page 12Linked to original sources
PubMed2004

Debating the Controlled Substances Act.

In the United States, the basis of modern drug regulation is the Controlled Substances Act (CSA) of 1970. The CSA laid out the authority of the federal government and provided a framework within which all existing and new substances could be regulated on their abuse potential, safety, and medical utility. The debates over the CSA centered on several critical issues: where to place the authority to make scheduling designations, the impact of scheduling on drug research, and defining what constituted drug "abuse" for purposes of scheduling. Passage of the CSA was aided by broad language that provided a kind of "big tent" which could accommodate diverse points of view. A retrospective assessment of the CSA shows it to have greatly expanded federal administrative authority over the nation's drug supply, much as its authors intended. Other impacts of the CSA, however, are much less certain. This article concludes by highlighting the issues and questions that should guide future retrospective research on the efficacy of drug control regimes.

Drug and Narcotic Control↗
PubMed1992

[Ethological basis for the evaluation of animal welfare in housing systems for agricultural animals and laboratory animals].

The Swiss Federal Act on Animal Protection (1978) requires the sale of mass-produced housing systems for farm animals to be authorized by the Federal Veterinary Office. Authorization is only granted for housing systems that safeguard the animals' welfare. A concept for the assessment of Animal Welfare has to provide a high forensic value. The capacity of farm animals to adapt to an intensive housing system can be directly examined, whereas the existence and extent of subjective feelings can only be assumed. In our concept the examination focuses on the interaction of individuals with their artificial environment. The main question is whether or not the individuals are able to cope with given nonspecific (e.g. temperature, humidity) and specific (e.g. drinking troughs, behaviour of conspecifics) stimuli in order to reach the immediate (e.g. drinking, make way for) and ultimate (survival, reproduction success) goals. Animals of the same breed are observed in a highly diverse environment in order to determine normal behaviour. Whether behavioural expressions which differ significantly from normal behaviour are adaptive to the restrictive housing conditions is judged by the behaviours' consequences for both, the individuals and the environment. Many studies prove the concept's high forensic value and the authorities prefer conclusions based on this concept to others referring to the animals' motivational and emotional state. However more research has to be done with respect to animal welfare in farm and laboratory animal breeding as well as in the use of laboratory animals for experimental studies.

Animal Husbandry↗
PubMed2001

["Replacement Methods to Animal Testing" as the incentive topic of the German Ministry of Education and Research. Selected results on biological drugs].

Since 1980, BMBF, in co-operation with the appointed project representative BEO (Biology, Energy, Environment), supports research projects with the central goal of the reduction of animal testing. Beginning with the announcement about promoting "Projects in Replacement Methods to Animal Testing" in 1984, a separate incentive topic of research was fostered within the framework of the biotechnological program of the German Federal Government. It is being updated continuously by current reports. The BMBF incentive topic represents the largest and longest running support activity in the field world-wide. During a time-span of 20 years, about 14 million German Marks (approx. 7 millions per annum) were provided, supporting about 230 projects. To date, all applications judged favourably in regard to contributing to potential and substantial savings could also be funded. The incentive topic is being realised in accordance with the 3R principle, following Russel and Burch. Primary attention is given to tests with high levels of stress or involving large numbers of animals. At present, special attention is given to the development and validation of alternatives to animal testing which are required by law. Emphasis is also put on joint projects by testing and regulation authorities together with industrial users in order to broaden the application of these methods and to aid in accelerating the amendment of respective legal regulations. The BMBF continues to adhere to the objectives of the emphasised support and will furnish funding at the present level in the future. Also, together with representatives of testing- and regulating authorities, of industry, science, respective federal authorities and animal protection, the BMBF has developed a new concept to expand funded activities in the future to include animal testing in basic research in a target-fashioned structure. This will be published shortly through a new public announcement. As a complement to the present application procedure ("bottom-up-principle"), new research approaches are being prepared within a limited scope regarding particularly relevant topics (i.e. transgenic animal models) as a "top-down-principle" by means of workshops and accompanying studies. Additionally, reports are appearing concerning the results of selected projects supported by the emphasised support of the BMBF for "Biologica", particularly regarding the realisation of results in the practical reduction of animal testing. The BMBF is supporting a total of 27 projects with respect to "Biologica". Central to the majority of these projects (21) is the test of vaccines, and there in particular, the potency test of particular vaccines. Using four examples, it is being demonstrated that the practical translation of the results of projects always requires the co-operation of the respective partners, and that the complete application of suitable replacement methods usually becomes possible only after the conclusion of a phase of development and testing of several years.

Animal Testing Alternatives↗
PubMed1977

Federal constraints: earned or unearned?

The author discusses the evolution of federal constraints on medical, behavioral, and social science research. There has been only one court decision related to behavioral research and none in medical research. The burden of consent procedures can be lightened somewhat by careful consideration of the potential risks and nature of the research; questions are presented that can be used to determine whether constraints apply. The author notes that although there are good reasons for regulations in both behavioral and medical research, the appropriateness of current and proposed constraints is still a matter of debate.

Behavior↗
PubMed1996

Adult immunization priorities in the United States.

Pneumonia and influenza (P&I) are the sixth leading cause of death in the United States. Despite universal coverage under Medicare, one-half to three-quarters of elderly adults fail to get vaccinated against P&I disease. Hepatitis B vaccine is also widely underutilized by adults. Although more than 100 times as many adults as children die from vaccine-preventable disease, the Centers for Disease Control and Prevention (CDC) currently allocates the vast majority of federal immunization funds to childhood programs. Top CDC officials say this is in accordance with the will of the Congress and the President. However, analysis of legislative documents shows that there is no legal bar or restriction to the use of federal funds to support adult immunization. CDC has the authority to use federal immunization funds to enhance adult immunization services, but the agency has yet to make adult immunization a priority. A commentary follows.

Adult↗
PubMed1990

Public policy issues affecting the health care delivery system of adolescents.

Policymakers are at an important crossroad in pursuing viable solutions to the dilemma of preventing and treating adolescent health problems. A variety of coordinated and comprehensive approaches will be needed to resolve these complex and often entrenched problems. In the absence of a national policy for children and youth, it is important that those concerned with these issues join efforts at the community, local, state, and national levels to move the policy agenda forward. As an interim step, it is necessary to work on building and evaluating model programs that will influence the development of new policy directions. Both efforts are needed to address the complex array of problems facing adolescents today. The future of adolescent health will be determined by a variety of factors, including public policy. Of particular importance in shaping public policy are four factors: (1) the American character, including ideas and attitudes that are the basis of politics and policy; (2) the pluralism that characterizes the process, including the relationship between government and the private sector and the dominant role of the private sector; (3) the federal system that distributes authority among various levels of government (federalism); and (4) incrementalism, which is the step-by-step process that characterizes the development of policies. Of particular importance in terms of adolescent health are the ideas and attitudes about adolescence and adolescents; the basic ideas that affect policies broadly; and the concepts of federalism, pluralism, and the role of the private sector in dealing with domestic social issues. Although the field of adolescent health continues to advance, many complex problems that have their origin in biological, behavioral, and sociocultural factors remain. Of particular importance are problems associated with lower socioeconomic status. The problems will not yield to the single-issue, categorical approach of the past but will require comprehensive strategies involving the health, education, income maintenance, job training, employment, and social service sectors. Public policies must support these integrated, coordinated approaches, and health providers concerned with adolescent health can and must play a vital role in this process.

Adolescent↗
PubMed1978

[Surgery of pancreatic endocrine tumours in the German Federal Republic: results of a survey (author's transl)].

Within a ten-year scan (1967-1976) 207 insulinomas, 50 gastrinomas, 8 Verner-Morrison tumors, 5 glucagonomas and 12 endocrine pancreatic tumours with associated MEA syndrome (multiple endocrine adenomatosis) were treated surgically at various university hospitals (information obtained by questionnaire). Half of the insulinomas were treated by enucleation, one third by resection of the tail of the pancreas. Total gastrectomy was the procedure of choice in 80% of patients with gastrinoma, but sometimes pancreatic resection to remove the tumour was added. An new therapeutic concept of using histamine-H2 receptor antagonists for treating patients with Zollinger-Ellison syndrome is discussed. In the eight patients with a Verner-Morrison syndrome removal of the tumour or distal pancreatic resection was the procedure of choice.

Acute Kidney Injury↗
PubMed1979

[The conservative treatment of acute pancreatitis in the Federal Republic of Germany in 1977 (author's transl)].

A questionnaire on the conservative treatment of acute pancreatitis was answered by 312 surgical [n = 139] and medical [n = 173] departments from all over Western Germany and from West-Berlin. Nearly total positive agreement was found about routine administration of parenteral fluids and on the prohibition of oral food and fluids. The application of glucocorticoids, glucagon, heparin in small doses and of a carboanhydrase inhibitor [Diamox] is rejected by most of the departments. Renal failure is treated in 63% by hemodialysis and in 37% by peritoneal dialysis. There is great disagreement between the answers about the administration of atropine, antacids and aprotinin [Trasylol]. Antibiotics are applied routinely by 63% of the surgical and 70% of the medical departments.

Acute Disease↗
PubMed1977

[Phage-typing and tetracycline resistance in Salmonella panama strains of animal origin in the Federal Republic of Germany (1969-1975) (author's transl)].

505 out of 1369 S. panama strains isolated mainly from animals, foods, and feedstuffs from 1969 to 1975 were phage-typed. 41% (= 207) of the S. panama isolates examined originated from swine, 26% from cattle and calves, 15% from dogs, and 13% were from other animal species and materials. 465 strains (=92%) showed typical reactions. 23% were specified as phage-type A, 24% as phage-type B and 36% as phage-type G. Phage-types D, E, and F did not occur. In swine, being the most frequent carriers of S. panama, phage-types A, B, and G had nearly the same shares. In dogs, phage-type G predominated to which nearly one half of the examined S. panama isolates from this species belonged. 205 (=41%) out of 505 strains examined for their resistance to antibiotics proved to be tetracycline-resistant. All 123 strains of phage-type B were tetracycline-resistant, all 35 strains of phage-type C were tetracycline-sensitive. 5 strains of phage-type A exhibited transferable tetracycline-resistance determinants.

Animals↗
PubMed2003

HIPAA privacy rules and compliance with federal and state employment laws: the participant authorization form.

Although HIPAA privacy rules do not apply directly to employers or to employment records, they do apply indirectly to employers because employer-sponsored group health plans and all health care providers are covered. HIPAA privacy regulations overlap with federal and state employment laws, and liabilities for breach of confidentiality can be substantial. Employers can use a participant's authorization form to comply with employment laws and company policies. Sample authorization forms are provided at the end of this article.

Confidentiality↗
PubMed1993

[Data protection and data access (II): Physician's responsibility for confidentiality, federal statistics law and data collection by authorization with reference to implementing occupational medicine epidemiologic studies in Germany].

The additional legal rulings governing access to personal data for epidemiological research are the medical professional secrecy regulators and the federal statistics law. These permit access to personal data only if the individual has given his or her informed constant. Beyond this, both laws contain clauses governing the transfer of anonymous data for research and science. Thus anonymized data may be transferred on request to authorized persons or institutions, such as a physician or the regional statistics office. Finally, a custodian model is presented which provides further possibilities for research in occupational medicine and epidemiology within this very restrictive legal framework.

Cause of Death↗
PubMed2002

Engaging community members in health policy processes: a Mississippi example.

Legislation, such as the federal Personal Responsibility and Work Opportunity Reconciliation Act (1996), the Balanced Budget Act of 1997, and the authorization of federally-funded health insurance coverage for children (State Children's Health Insurance or SCHIP) continues the shift of assigning increased power and responsibility for health and human services "safety net" programs from the federal level to the state level. Known as "devolution," this complex shifting of responsibility and accountability continues to evolve with increasing transference of authority, control, and administration of social programs to local governments. Such changes require an informed citizenry and, hence, demand grassroots capacity building activities around public policy issues. This article describes a project designed to build the capacity of community-based organizations in several cities in Mississippi to become involved in health care policy activities. The primary purpose of this project was to inform and organize community members around improving health policies for low-income children and families.

Child↗