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PubMed2003

[Accreditation of medical laboratories].

In Hungary, the National Accreditation Body was established by government in 1995 as an independent, non-profit organization, and has exclusive rights to accredit, amongst others, medical laboratories. The National Accreditation Body has two Specialist Advisory Committees in the health care sector. One is the Health Care Specialist Advisory Committee that accredits certifying bodies, which deal with certification of hospitals. The other Specialist Advisory Committee for Medical Laboratories is directly involved in accrediting medical laboratory services of health care institutions. The Specialist Advisory Committee for Medical Laboratories is a multidisciplinary peer review group of experts from all disciplines of in vitro diagnostics, i.e. laboratory medicine, microbiology, histopathology and blood banking. At present, the only published International Standard applicable to laboratories is ISO/IEC 17025:1999. Work has been in progress on the official approval of the new ISO 15189 standard, specific to medical laboratories. Until the official approval of the International Standard ISO 15189, as accreditation standard, the Hungarian National Accreditation Body has decided to progress with accreditation by formulating explanatory notes to the ISO/IEC 17025:1999 document, using ISO/FDIS 15189:2000, the European EC4 criteria and CPA (UK) Ltd accreditation standards as guidelines. This harmonized guideline provides 'explanations' that facilitate the application of ISO/IEC 17025:1999 to medical laboratories, and can be used as a checklist for the verification of compliance during the onsite assessment of the laboratory. The harmonized guideline adapted the process model of ISO 9001:2000 to rearrange the main clauses of ISO/IEC 17025:1999. This rearrangement does not only make the guideline compliant with ISO 9001:2000 but also improves understanding for those working in medical laboratories, and facilitates the training and education of laboratory staff. With the official acceptance of ISO 15189 the clauses of this harmonized guideline fulfill the requirements of the new international standard as well. Accreditation of medical laboratories in Hungary may not only facilitate quality improvement of laboratory services, but also the development of a quality-based purchasing and reimbursement policy of the health insurance fund.

Accreditation↗
PubMed1975

The diet, nutrition, and cancer program of the NCI National Cancer Program.

In November 1974, in response to a mandate in the revised National Cancer Act of 1974, a plan was introduced for the formation of a Diet, Nutrition, and Cancer Program. Dr. Frank J. Rauscher, Director of the National Cancer Institute, selected a group of scientists who defined the goals of the program and recommended the appointment of a program director and of an advisory committee. These recommendations were accepted, and an Advisory Committee, reflecting a cross-section of scientific expertise, has been selected. To recommend a well-balanced program, it will be necessary for the Advisory Committee to assess the current state of the art of nutrition in cancer etiology and therapy and to be apprised of current opportunities, needs, and resources. Toward this end, a literature survey project has been initiated and two specialized workshops have been held.

Diet↗
PubMedDate not supplied

The role of ECVAM in promoting the regulatory acceptance of alternative methods in the European Union. European Centre for the Validation of Alternative Methods.

The roles played by the European Centre for the Validation of Alternative Methods (ECVAM) and its advisory committee, the ECVAM Scientific Advisory Committee (ESAC), in the evolution of alternative methods are described. Particular emphasis is given to the process by which ECVAM and the ESAC assess the scientific validities of alternative methods, and, in appropriate cases, initiate the progression of scientifically validated methods toward regulatory acceptance.

Animal Testing Alternatives↗
PubMed2002

Esomeprazole: update and clinical review.

The U.S. Food and Drug Administration's Nonprescription Drugs Advisory Committee and Gastroenterological Drugs Advisory Committee recommended approval of omeprazole as an over-the-counter treatment of heartburn in patients who have at least two episodes of heartburn each week. The consumer studies that have been conducted indicate that the majority of patients understand the proposed labeling and could use the proposed label to determine if the omeprazole therapy was appropriate for them. Esomeprazole is an effective agent in the treatment of gastroesophageal reflux disease (GERD) and erosive esophagitis. Newer studies continue to support its efficacy and safety in the treatment of these conditions. Several of the most recent studies have included comparisons with other proton pump inhibitors. The results of these studies indicate that all the proton pump inhibitors are effective in treating GERD and erosive esophagitis and that some patients would benefit from esomeprazole therapy.

Anti-Ulcer Agents↗
PubMed1987

[Criteria for establishing priorities for research in health].

The author discusses the background for the idea of framing explicit policies on science and technology in the countries. She refers to the work of PAHO's Advisory Committee on Research (formerly Advisory Committee on Medical Research) and to statements made by governments on different occasions to the effect that the countries should establish their own research infrastructure. She mentions the basic elements and components of a national policy on science and technology, enunciates the principles that contribute to the establishment of a set of objectives, and states a number of premises that ensure the attainment of those objectives. She ends with some general observations on the criteria for the setting of priorities in health research.

Health Planning↗
PubMed2006

Direct medical cost of influenza-related hospitalizations in children.

OBJECTIVE: Our goal was to determine the cost of influenza-related hospitalization in children with community-acquired laboratory-confirmed influenza and to identify predictors of high hospitalization costs. PATIENTS AND METHODS: This was a retrospective cohort study of patients 21 years and younger hospitalized at a children's hospital with community-acquired laboratory-confirmed influenza during 4 consecutive influenza seasons (2000-2004). The main outcome measure was the direct medical cost of influenza-related hospitalizations, including the cost of diagnostics, therapeutics, room, and physician services. RESULTS: Electronic billing data were retrievable for 727 (98%) of 745 patients hospitalized for community-acquired laboratory-confirmed influenza during the study period. A total of 478 (66%) children were in a high-risk group for whom the Advisory Committee on Immunization Practices recommended influenza vaccine (patients with Advisory Committee on Immunization Practices-designated chronic medical conditions or aged 6-23 months). The mean total cost of hospitalization for influenza-related illness was 13,159 dollars (39,792 dollars for patients admitted to an ICU; 7030 dollars for patients cared for exclusively on the wards). High-risk patients had higher mean total costs (15,269 dollars) than low-risk patients (9107 dollars). Cardiac, metabolic, and neurologic/neuromuscular diseases and age of 18 to 21 years were independently associated with the highest hospitalization costs (>15th percentile). CONCLUSIONS: The cost of influenza-related hospitalizations in children may be considerably higher than previously estimated. The presence of certain Advisory Committee on Immunization Practices-designated chronic medical conditions is associated with higher influenza-related hospitalization costs. Successfully immunizing patients with these conditions has the potential for significant cost savings.

Adolescent↗
PubMedDate not supplied

Asian workshop recommends injectables.

Injectable contraceptives are now in use in over 65 countries, including 15 developed nations. At the 1st Asian Regional Workshop on Injectable Contraceptives, held in Thailand in May, this fact was underlined and the conclusion reached that it was time that other countries should review the acceptability of and need for injectable contraceptives in the context of their own national family planning programs. Over 50 people from 11 countries, including Bangladesh, India, Indonesia, the Philippines, Sri Lanka, and Thailand, took part. The workshop was also attended by IPPF's deputy medical director, Dr. Pramilla Senanayake. The largest clinical experience in the use of injectable contraceptives is in Asia, and the participants of the workshop were able to meet 10 of the Thai women who had had the injectable, Depo-Provera, continuously for over 10 years. These women had not missed a single injection, and had had no serious side effects, nor any unwanted pregnancies during this time. In a discussion on the recent decision of the U.S. Food and Drug Administration (FDA) to refuse a license for Depo-Provera in the U.S., it was pointed out that on 2 successive occasions Depo-Provera had been recommended for approval to the FDA by its own Obstetric and Gynecological Advisory Committee. (The membership of this advisory committee was made up of U.S. experts in obstetrics and gynecology.) Medical data were considered which showed that the return of fertility with Depo-Provera was comparable to that with oral contraceptives or IUDs, and method failure extremely low. On the evidence now available the workshop agreed that on the grounds of safety, exceptional use-effectiveness, and acceptability, injectable contraceptives had a valuable role to play in family planning. No serious adverse effects had been reported, freedom from metabolic effects was important, and earlier concern about the return of fertility after discontinuation had been dispelled. The current evidence on the safety of injectables did not indicate that this method would be less safe than oral contraceptives or IUDs.

Asia↗
PubMed1996

Disagreement, consensus, and moral integrity.

The Advisory Committee on Human Radiation Experiments experienced some disagreements among its members in the course of its work. An epistemological controversy over the nature and degree of evidence required to draw ethical conclusions pervaded the Committee's deliberations. Other disagreements involved the proper role of a governmental advisory committee and the question of when it is appropriate to notify people that they were unknowing subjects of radiation experiments. In the end, the Committee was able to reach consensus on almost all of its findings and recommendations through a process that preserved the integrity of its members.

Advisory Committees↗
PubMed2005

[Amendment of tuberculosis prevention law and prospect of tuberculosis control program].

Tuberculosis Control Law, which provides a legal basis for national tuberculosis control, was amended in 2004 and entered into force on April 1, 2005. As it is more than half a century since its initial enactment, the law has been drastically amended based on some of the relatively new important ideas such as up-to-date scientific evidence, recent epidemiological conditions of tuberculosis, decentralization and respect for human rights. Japan has once seen a time when considerable part of producing population were affected with tuberculosis which caused severe infliction on the whole Japanese society including economical damage. With progress in medical technology such as development of chemotherapy and improvement of sanitary conditions, there was a major decline in incidence rate and death rate during the 1960s and 1970s. However, the decrease in TB incidence began to stagnate in the 1980s, partly explained by aging of the overall society and worsening of the urban tuberculosis conditions. Since then, there has been a discussion on review of national tuberculosis control program, and the increase in the number of tuberculosis patients in 1997, which happened for the first time in 38 years, precipitated the process. In 1999, 'Tuberculosis Emergency Declaration' was announced by the Minister of Health, which led to emergency national tuberculosis survey in 2000, and based on the result came forward the Recommendation on Comprehensive Review of National Tuberculosis Plan. Main ideas and spirits of the Recommendation were taken full account of during the process of the amendment of the law and were mostly reflected on the final outcome. Five key elements include; Establishment of National Tuberculosis Fundamental Guideline and Prefectural Tuberculosis Prevention Plan, Review on TB screening, Review on BCG vaccination policy, Promotion of a Japanese version of DOTS, Review on Tuberculosis Advisory Committee 1. Establishment of National Tuberculosis Fundamental Guideline and Prefectural Tuberculosis Prevention Plan With a view to establishing a comprehensive plan in the context of local tuberculosis situation, it was deemed to be necessary for both the central government and local governments to set out a detailed and comprehensive plan that may supplement the newly amended law. Prior to the amendment of Tuberculosis Prevention Law, it was made obligatory in the amended Infectious Diseases Control Law for the central government to establish National Fundamental Guideline and for local governments to establish Prefectural Prevention Plan. 2. Review on TB Screening With a view to promoting early detection of tuberculosis, tuberculosis screening system was totally reviewed to be turned into more effective and efficacious means for the purpose. Previously, all people above 19 years of age were to be screened annually for tuberculosis with chest X-ray. By this means, however, only 1,600 tuberculosis patients were detected out of 20,000,000 people screened which means the detection rate is 0.0067%. Thorough analysis was made to identify who would benefit from regular X-ray screening in terms of detection of tuberculosis patients and was decided to be those who have certain risk factors to develop tuberculosis such as the elderly and socio-economically challenged people and those who, once develops tuberculosis, may easily infect others such as school teachers, healthcare workers and such. Also the procedure of contact trace was reviewed and in highly required cases, compulsory examination implemented by health care officers has become a choice. 3. Review on BCG vaccination policy Previously national BCG policy included BCG vaccination for young children who tested negative on tuberculin skin test before they become 4 years old. However due to low sensitivity of tuberculin skin test and resulting too many of false-positive cases, the estimated number of unnecessary chemoprophylaxis was thought to be more than justifiable. Also, as regards the timing for vaccination, it was'thought of as best to give BCG vaccination before one gets infected, which may happen even before 4 years of age. For reasons above, new national BCG policy include direct BCG vaccination for infants younger than 6 months of age. 4. Promotion of a Japanese version of DOTS DOTS (Directly Observed Treatment, Short-course) is, needless to say, a tuberculosis control policy advocated worldwide by World Health Organization (WHO) since early 1990s. Japan has a long history of supporting tuberculosis patients through various activities by health care workers such as home-visit follow-up, although it is worthwhile to note that in a newly amended law there is a reference to having patients take medicine in the law itself as direction by a doctor or a director of the public health care center. 5. Review on Tuberculosis Advisory Committee The Tuberculosis Advisory Committee is a regional commi- ttee that gives advice on issues such as treatment of tuberculosis and hospitalization order based on the law. The amendment includes review on committee members to select at least one committee member from non-medical staff from the perspective of human rights protection. We acknowledge this time's amendment of the law is a significant step forward in the history of national tuberculosis control and it is our sincere hope that this will eventually lead to great improvement of national tuberculosis condition.

Antitubercular Agents↗
PubMed2000

Hyperlipidaemia and primary prevention of coronary heart disease: are the right patients being treated?

BACKGROUND: In 1997, the Standing Medical Advisory Committee report suggested that patients with a coronary heart disease risk of 3% per year or greater should be considered appropriate for lipid-lowering medication. The report stated that cholesterol concentration alone is a poor predictor of absolute risk of coronary heart disease and recommended the Sheffield table as a method of estimating the coronary heart disease risk. OBJECTIVE: To assess the impact of the Standing Medical Advisory Committee report on the management of patients with hyperlipidaemia in the primary prevention of coronary heart disease in primary care. METHOD: A survey questionnaire giving the clinical details of 20 patients with various coronary heart disease risk factors was sent to 200 general practitioners in the West Midlands, UK. RESULTS: Forty-eight percent of the respondents used clinical assessment/perception as the sole means of risk assessment and 26% used the Sheffield table. In patients who did not require treatment, 40.1% of the decisions were inappropriate and, in patients who required treatment, 35.1% of the decisions were inappropriate. Overall, inappropriate decisions were made in 37.9% of the responses. Despite the clear advice in the Standing Medical Advisory Committee report on the importance of incorporating multiple risk factors in estimating absolute coronary heart disease risk, only total cholesterol and triglycerides were significant in influencing treatment decisions. CONCLUSIONS: The Standing Medical Advisory Committee recommendations on the management of hyperlipidaemia in primary prevention of coronary heart disease are not widely used. Large savings could be made by correctly identifying and treating individuals at high risk. We recommend use of the full Framingham risk score in assessment of coronary heart disease risk in primary care.

Adult↗
PubMed2004

Ethics, regulation, and biomedical research.

Controversy has surrounded the institutions that facilitate discussion and regulation of American biomedical research for years. Recent challenges to the legitimacy of the President's Council on Bioethics have been focused on stem cell research. These arguments represent an opportunity to reconsider the legislation under which stem cell research is regulated, as well as to consider preexisting bodies like the Recombinant DNA Advisory Committee and National Bioethics Advisory Commission. This paper proposes a Federal Life Sciences Policy Commission, a novel commission with advisory and regulatory powers that would benefit from the positive and negative lessons learned under the legislation that currently shapes the formation and institutional characteristics of advisory bodies in the United States. The Federal Life Sciences Policy Commission would have institutional independence not present in previous advisory bodies, while maintaining the tradition of broad societal representation and thoughtful discourse that has developed in the United States.

Advisory Committees↗
PubMed1992

Legislating responsible alcohol service: an inside view of the new Liquor Licence Act of Ontario.

The Ontario Government has recently passed a new Liquor Licence Act, based on the recommendations of a special advisory committee. This paper describes how the advisory committee framed the issues and arrived at a lengthy document detailing 73 recommendations on issues such as licence classification, the control of special permit functions, days and hours of operation, legal drinking age, alcohol advertising, the civil liabilities of alcohol providers and server training. The key actors and considerations are discussed, as well as the subsequent Cabinet action on the report and the implementation process currently underway. The paper concludes with an assessment from both an administrative and a public health perspective, with particular attention to the limited role which research played in these policy decisions.

Alcohol Drinking↗
PubMed1994

Palliative medicine education for medical students: a survey of British medical schools, 1992.

The new specialty of palliative medicine is now recognized as making a significant contribution, not only to the practice of cancer medicine, but also to the care of terminal disease. This article reports an enquiry into the current teaching of palliative medicine in undergraduate curricula in Britain. A questionnaire concerning palliative medicine teaching was sent in December 1992 to undergraduate deans of all medical schools, colleges and faculties (hereafter referred to as schools). Replies were received from all and were analysed. Most of the subjects represented by palliative medicine were taught in all schools by palliative medicine specialists or in sessions of other specialisms, or both. Many schools gave opportunity for students to visit local palliative care units or hospices; a few required it as part of the syllabus. The amount of time devoted to this subject in the curricula varied considerably. Eleven per cent of schools regularly asked questions on palliative medicine in final examinations; half occasionally did so, but 30% reported that there was never a question on palliative medicine in finals. In the light of recent publications by the General Medical Council and the Standing Medical Advisory Committee and Standing Nursing and Midwifery Advisory Committee, I urge that increasing attention be paid to teaching the subjects represented by palliative medicine and to examining it. I suggest that the recently published core curriculum will enable this to be carried out more effectively.

Curriculum↗
PubMed2003

Uncertainties for endocrine disrupters: our view on progress.

The hypothesis that hormonally active compounds in the environment--endocrine disrupters--are having a significant impact on human and ecological health has captured the public's attention like no other toxicity concern since the publication of Rachel Carson's Silent Spring 1962. In the early 1990s, Theo Colborn and others began to synthesize information about the potential impacts of endocrine-mediated toxicity in the scientific literature (Colborn and Clement, 1992) and the popular press (Colborn et al., 1997). Recognizing the possibility of an emerging health threat, the U.S. Environmental Protection Agency (EPA) convened two international workshops in 1995 (Ankley et al., 1997; Kavlock et al., 1996) that identified research needs relative to future risk assessments for endocrine-disrupting chemicals (EDCs). These workshops identified effects on reproductive, neurological, and immunological function, as well as carcinogenesis as the major endpoints of concern and made a number of recommendations for research. Subsequently, the EPA developed a research strategy to begin addressing the recommendations (EPA, 1998a), and the federal government as a whole, working through the White House's Committee on the Environment and Natural Resources, increased funding levels and coordinated research programs to fill the major data gaps (Reiter et al., 1998). In parallel with these research efforts that were attempting to define the scope and nature of the endocrine disruptor hypothesis, the U.S. Congress added provisions to the Food Quality Protection Act (FQPA) and the Safe Drinking Water Act of 1996 to require the testing of food-use pesticides and drinking water contaminants, respectively, for estrogenicity and other hormonal activity. These bills were enacted into law, giving the EPA the mandate to implement them. The EPA, with the help of an external advisory committee, the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), determined that other hormonal activity should include androgens and compounds that affect thyroid function, and expanded the mandate to include all chemicals under EPA's jurisdiction, potentially including the 70,000 chemicals regulated under the Toxic Substances Control Act (Endocrine Disruptor Screening and Testing Advisory Committee [EDSTAC], 1998). EDSTAC recommended an extensive process of prioritization, screening, and testing of chemicals for endocrine-disrupting activity, including a screening battery that involves a combination of at least eight in vitro and in vivo assays spanning a number of taxa (EDSTAC, 1998). What started out as a hypothesis has become one of the biggest testing programs conceived in the history of toxicology and the only one that has ever been based on mechanism of action as its premise. As we pass the 10th anniversary of the emergence of the endocrine disruptor hypothesis, it is useful to look back on the progress that has been made in answering the nine questions posed as data gaps in the EPA's research strategy (EPA, 1998a)--not only to see what we have learned, but also to examine whether the questions are still appropriate for the goal, what gaps remain, and what directions should be emphasized in the future.

Animals↗
PubMed1984

Maryland hospitals get plan for creating ethics committees.

The Maryland Hospital Association's Advisory Committee on Medical Ethics, charged to assist member hospitals in forming ethics committees, focused on four concerns: study and development, physician support, patient/family participation, and potential issues. The committee recommended as a first step in establishing an ethics committee the creation of a study group. It warned hospitals not to expect a fully operational ethics committee immediately. A start-up period, according to the committee, should be used to develop a process for handling ethical questions and for educating the hospital community about the committee's role. To promote the best possible decision making, the hospital ethics committee should function as a support unit, for physicians as well as for patients, families, and hospital personnel. Clearly stated policies will provide a basis for appropriate intervention and help gain physician cooperation, the committee said. Such policies should encourage ethics committees to anticipate problems and to review decisions already made. While recognizing the need to involve patients' families in decision making, the advisory group agreed that the question of their presence at committee meetings should be addressed by each institution. In cases of controversial treatment or disagreement about the course of treatment, patient/family access to the committee should be clearly defined. The advisory committee suggested that each institution prepare its own list of topics that an ethics committee might consider. It also prepared a "model statement" of an ethics committee's purposes, membership, and procedures.

Ethics Committees, Clinical↗