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PubMed1995

Establishment of a community advisory committee at a major teaching hospital.

With the advent of continuous quality improvement and the '90s focus on patient or customer satisfaction, hospitals have started to try to identify what their patients or customers want. Hospitals serve communities of one sort or another, whether local communities or statewide communities for highly specialized procedures. They need to consult at least their local communities as part of a quality improvement process and also to help determine future directions. Austin Hospital in Australia decided to establish a formal advisory committee in order to accomplish this consultation. Although there have been minor deficiencies in the arrangement, the advisory committee has largely fulfilled the promise for which it was created more than seven years ago.

Community Participation↗
PubMed1999

Secretary's advisory committee on genetic testing: its emerging role in public policy deliberation on genetic tests.

The Secretary's Advisory Committee on Genetic Testing (SACGT) was established by the U.S. Secretary of Health and Human Services, Donna E. Shalala, to provide a public forum for the formulation of policy advice in the complex and growing area of genetic testing. After a careful nomination and selection process, the Secretary announced the appointment of thirteen advisors to the SACGT in June 1999. The first meeting of the SACGT was held June 30, 1999. This article describes the purpose, formation, and function of the SACGT. Before addressing these questions about the role of the SACGT, we first will explain what genetic testing is, how it is currently used, and what new uses it may be put to in the future.

Advisory Committees↗
PubMed1999

Lessons learned from a review of the development of selected vaccines. National Vaccine Advisory Committee.

BACKGROUND: Although the vaccine research and development network in the United States remains vibrant, its continued success requires maintaining harmonious interaction among its many components. Changing one component is likely to affect the system overall. An examination of case studies of the development of selected vaccines would allow an examination of the network as a whole. This article presents conclusions drawn from the case study review undertaken. OBJECTIVE: Successful development of vaccines is a time-intensive process requiring years of commitment from a network of scientists and a continuum of regulatory and manufacturing entities. We undertook this work to shed light on how well the vaccine development system in the United States performs. METHOD: The National Vaccine Advisory Committee examined the research and development pathways of several vaccines that reached licensure expeditiously (hepatitis B vaccine, Haemophilus influenzae type b conjugate vaccines); some that became licensed only after considerable delay (oral typhoid Ty21a vaccine, varicella vaccine); some that are at the point of imminent or recent licensure (reassortant Rhesus rotavirus vaccine, which was licensed by the Food and Drug Administration on August 30, 1998) or near submission for licensure (intranasal cold adapted influenza vaccine); and one for which clinical development is slow because of hurdles that must be overcome (respiratory syncytial virus vaccines). RESULTS: Some common themes emerged from the reviews of these vaccine "case histories": the expediting influence of a strong scientific base and rationale; the need for firm quantitation of disease burden and clear identification of target populations; the critical role played by individuals or teams who act as "champions" to overcome the inevitable obstacles; availability of relevant animal models, high-quality reagents and standardized assays to measure immune response; the absolute requirement for well designed, meticulously executed clinical trials of vaccine safety, immunogenicity, and efficacy; postlicensure measurements of the public health impact of the vaccine and a track record of the vaccine's safety and acceptance with large-scale use; and the critical need for international collaborations to evaluate vaccines against diseases of global importance that are rare in the United States (eg, typhoid fever). It was clear that the critical step-up from bench scale to pilot lots and then to large-scale production, which depends on a small group of highly trained individuals, is often a particularly vulnerable point in the development process. CONCLUSIONS: One fundamental lesson learned is that within the varied and comprehensive US vaccine development infrastructure, multiple and rather distinct paths can be followed to reach vaccine licensure. The National Vaccine Advisory Committee review process should be conducted periodically in the future to ascertain that the US vaccine development network, which has been enormously productive heretofore and has played a leadership role globally, is adapting appropriately to ensure that new, safe, and efficacious vaccines become available in a timely manner.

Drug Approval↗
PubMed1983

Report of the Graduate Medical Education National Advisory Committee and health manpower development.

The federally chartered Graduate Medical Education National Advisory Committee projected a shortage of approximately 12,000 general and child psychiatrists by 1990. The committee's methods of analysis and recommendations have been criticized on grounds ranging from the accuracy of its data to the appropriateness of federal involvement in free-market issues. Yet the GMENAC report appears to have contributed to a recent reversal of psychiatric recruitment trends, and psychiatrists should be aware of its further implications for clinical and academic psychiatry. We analyzed the GMENAC process as one element among many that will determine future health care personnel development trends.

Child Psychiatry↗
PubMed1999

Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP).

This report updates 1998 recommendations by the Advisory Committee on Immunization Practices (ACIP) on the use of influenza vaccine and antiviral agents (MMWR 1998;47[No. RR-6]:1-26). The principal changes include a) information on the influenza virus strains included in the 1999-2000 trivalent vaccine; b) discussion of the potential expanded use of influenza vaccine; c) new background information on live-attenuated influenza vaccines (LAIVs), neuraminidase-inhibitor drugs, and rapid diagnostic tests; d) new information on the epidemiology of influenza among travelers; and e) the addition of referenced citations. This report and other information on influenza can be accessed at the website for the Influenza Branch, Division of Viral and Rickettsial Diseases, National Center for Infectious Diseases, CDC at .

Adolescent↗
PubMed1995

[The present status and future roles of tuberculosis advisory committees].

We surveyed the present status and future roles of Tuberculosis (TB) Advisory Committees to study the ideal concept of the Committees using questionnaires. After the introduction of the new TB Control Law (which allowed the integration of the Committees), about half of the local governments (prefectures, special cities and special wards in Tokyo) have decreased their committees numbers by a third to two-thirds of the original number of health centers. In order to improve the quality of the Committees, there were additional educational activities suggested by the respondents in the questionnaire. However there were several problems highlighted in the questionnaire, for example a decrease in TB specialists, the aging of Committee members and some Committees with extremely low numbers in reported cases of TB. For the improvement of the Committees both in quality and the range in activities, it is not enough to integrate the Committees. It is recommended that the Committees should be improved in training and education for doctors and staff of the health centers and that they contribute more in comprehensive counter measures against TB in each region. In future the Committees roles should be enlarged and improved in quality, for example, to carry out extra periodic mass screening for TB, and to examine the chest x-rays in mass screenings for lung cancer.

Communicable Disease Control↗
PubMed1993

Statement on pertussis immunization. National Advisory Committee on Immunization.

The following recommendations on pertussis vaccine from the National Advisory Committee on Immunization will appear in the fourth edition of the Canadian Immunization Guide, scheduled for publication in autumn 1993. These revised recommendations represent a major change in vaccine usage and take account of the current understanding of adverse events associated with use of pertussis vaccine. Most adverse events are no longer contraindications to further immunization; only anaphylactic reaction to a previous dose remains an absolute contraindication to pertussis immunization. Other adverse reactions for which there are no sequelae or that have not been proven to be caused by the vaccine are no longer considered valid reasons for withholding immunization. It is hoped that simplification of the contraindications will improve vaccine utilization and achieve higher levels of age-appropriate immunization.

Canada↗
PubMedDate not supplied

Advisory committees: free advice--for a price.

Although it is understood that an advisory committee is "a group of persons outside the educational institution chosen from the community to advise those who are responsible for the planning, implementing, and maintaining of an educational program in radiologic technology that will meet the needs of a community, region, state, or nation," it is advice we buy at a price. No, the price is not in monetary values, but the price of forethought, planning, good organization and effective use of that committee.

Organizations↗
PubMed1998

Hazard analysis and critical control point principles and application guidelines. National Advisory Committee on Microbiological Criteria for Foods.

The HAACP Subcommittee of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) has prepared a revision of the document "Hazard Analysis and Critical Control Point System" that was adopted by the Committee in 1992. The Committee retained the previous seven HACCP principles but made their wording more concise: revised and added definitions such as those for hazard, verification, and validation: included new sections on prerequisite programs, education and training, and implementation and maintenance of the HACCP plan; revised and provided a more detailed explanation of the application of HAACP principles, especially hazard analysis and verification; and added or revised Appendices such as new examples of prerequisite programs and an additional decision tree for identifying critical control points (CCPs).

Food Analysis↗
PubMed1998

Hazard analysis and critical control point principles and application guidelines. Adopted August 14, 1997. National Advisory Committee on Microbiological Criteria for Foods.

The HACCP Subcommittee of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) has prepared a revision of the document "Hazard Analysis and Critical Control Point System" that was adopted by the Committee in 1992. The Committee retained the previous seven HACCP principles but made their wording more concise; revised and added definitions such as those for hazard, verification, and validation; included new sections on prerequisite programs, education and training, and implementation and maintenance of the HACCP plan; revised and provided a more detailed explanation of the application of HACCP principles, especially hazard analysis and verification; and added or revised Appendices such as new examples of prerequisite programs and an additional decision tree for identifying critical control points (CCPs).

Food Analysis↗
PubMed2005

Nearly queerly: the life and death of a queer health advisory committee.

This paper examines how a group of grassroots activists successfully lobbied for the creation of a lesbian, gay, bisexual and transgender (LGBT) persons' population health advisory committee members balanced the at time conflicting interests of an institutional structure (the public health system) with those communities historically marginal to such institutions. The specific achievements and challenges of the committee and its members during its four-year life span, 1997-2001, are discussed, including their ramifications in other contexts.

Advisory Committees↗
PubMed1992

Debates, divisions, and decisions: recombinant DNA advisory committee (RAC) authorization of the first human gene transfer experiments.

Possibly the most far-reaching, controversial research currently being conducted in the international biological science community involves human gene therapy experimentation. In this paper, I report the dynamics of the political process which ultimately found the Recombinant DNA Advisory Committee (RAC) of the National Institutes of Health approving for the first time protocols of this genre. A full appreciation of the policy-making dialogue shows that significant participants perceived the process from very different vantage points regarding the way in which the American political system works and the way in which it ought to work. I argue that, if we are to understand how the RAC should proceed in orchestrating a human gene therapy policy agenda, then we must flesh out and critically analyze these competing vantage points. To that end, I postulate seven possible "action models" for characterizing how protocol assessments of the type at issue might be developed given the nature of our politics, reaching the conclusion that one of these models holds out the most promise for synthesizing efficaciously the key factors involved. In conclusion, I discuss how the RAC might profitably employ this preferred strategy in these and other cases.

Advisory Committees↗
PubMed2006

Prevention of rotavirus gastroenteritis among infants and children. Recommendations of the Advisory Committee on Immunization Practices (ACIP).

In February 2006, a live, oral, human-bovine reassortant rotavirus vaccine (RotaTeq) was licensed for use among U.S. infants. The Advisory Committee on Immunization Practices recommends routine vaccination of U.S. infants with 3 doses of this rotavirus vaccine administered orally at ages 2, 4, and 6 months. The first dose should be administered between ages 6-12 weeks. Subsequent doses should be administered at 4-10 week intervals, and all 3 doses should be administered by age 32 weeks. Rotavirus vaccine can be co-administered with other childhood vaccines. Rotavirus vaccine is contraindicated for infants with a serious allergic reaction to any vaccine component or to a previous dose of vaccine.

Child, Preschool↗
PubMed2005

A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP) part 1: immunization of infants, children, and adolescents.

This report is the first of a two-part statement from the Advisory Committee on Immunization Practices (ACIP) that updates the strategy to eliminate hepatitis B virus (HBV) transmission in the United States. The report provides updated recommendations to improve prevention of perinatal and early childhood HBV transmission, including implementation of universal infant vaccination beginning at birth, and to increase vaccine coverage among previously unvaccinated children and adolescents. Strategies to enhance implementation of the recommendations include 1) establishing standing orders for administration of hepatitis B vaccination beginning at birth; 2) instituting delivery hospital policies and procedures and case management programs to improve identification of and administration of immunoprophylaxis to infants born to mothers who are hepatitis B surface antigen (HBsAg) positive and to mothers with unknown HBsAg status at the time of delivery; and 3) implementing vaccination record reviews for all children aged 11-12 years and children and adolescents aged <19 years who were born in countries with intermediate and high levels of HBV endemicity, adopting hepatitis B vaccine requirements for school entry, and integrating hepatitis B vaccination services into settings that serve adolescents. The second part of the ACIP statement, which will include updated recommendations and strategies to increase hepatitis B vaccination of adults, will be published separately.

Adolescent↗
PubMed2003

Health and Safety Advisory Committee (HASAC) of the International Embryo Transfer Society (IETS) has managed critical challenges for two decades.

The International Embryo Transfer Society (IETS) was founded in 1974. Early members used the society as a forum for the exchange of scientific and technical information relevant to a newly emerging embryo transfer industry. The impact that embryo transfer could have on the international trade of livestock genetics was clear by 1982, so the IETS commissioned the Import/Export Committee. The initial challenge for this Committee was to deal with concerns about disease transmission via embryo transfer. Many of the early concerns have been dispelled, but at the time they threatened the continued development of a fledgling industry. Over the past two decades, many new critical challenges have been met and managed by this Committee, which was recently renamed the Health and Safety Advisory Committee (HASAC). Assessing risks of animal disease transmission via reproductive technologies and establishing protocols for managing these risks are still major issues for HASAC. However, additional concerns have developed as views of the society changed and as novel applications of biotechnology in farm animals were identified. This paper is intended to chronicle some of the major changes and challenges that were managed by members of the HASAC and its Subcommittees from the early years of embryo transfer to the current millennium with technological advances in molecular biology.

Animals↗
PubMed1999

Rotavirus vaccine for the prevention of rotavirus gastroenteritis among children. Recommendations of the Advisory Committee on Immunization Practices (ACIP).

These recommendations represent the first statement by the Advisory Committee on Immunization Practices (ACIP) on the use of an oral, live rotavirus vaccine licensed by the Food and Drug Administration on August 31, 1998, for use among infants. This report reviews the epidemiology of rotavirus, describes the licensed rotavirus vaccine, and makes recommendations regarding its use for the routine immunization of infants in the United States. These recommendations are based on estimates of the disease burden of rotavirus gastroenteritis among children in the United States and on the results of clinical trials of the vaccine. Rotavirus affects virtually all children during the first 5 years of life in both developed and developing countries, and rotavirus infection is the most common cause of severe gastroenteritis in the United States and worldwide. In the United States, rotavirus is a common cause of hospitalizations, emergency room visits, and outpatient clinic visits, and it is responsible for considerable health-care costs. Because of this large burden of disease, several rotavirus vaccines have been developed. One of these vaccines - an oral, live, tetravalent, rhesus-based rotavirus vaccine (RRV-TV) -- was found to be safe and efficacious in clinical trials among children in North America, South America, and Europe and on the basis of these studies is now licensed for use among infants in the United States. The vaccine is an oral, live preparation that should be administered to infants between the ages of 6 weeks and 1 year. The recommended schedule is a three-dose series, with doses to be administered at ages 2, 4, and 6 months. The first dose may be administered from the ages of 6 weeks to 6 months; subsequent doses should be administered with a minimum interval of 3 weeks between any two doses. The first dose should not be administered to children aged > or =7 months because of an increased rate of febrile reactions after the first dose among older infants. Second and third doses should be administered before the first birthday. Implementation of these recommendations in the United States should prevent most physician visits for rotavirus gastroenteritis and at least two-thirds of hospitalizations and deaths related to rotavirus.

Contraindications↗
PubMed2005

Brief report: Conclusions and recommendations of the Advisory Committee on Poliomyelitis Eradication--Geneva, Switzerland, October 2005.

The second meeting of the Advisory Committee on Poliomyelitis Eradication (ACPE) was convened in Geneva, Switzerland, on October 11-12, 2005, to provide the World Health Organization (WHO) and the Global Polio Eradication Initiative with advice on program policies for 1) interrupting wild poliovirus (WPV) transmission worldwide, 2) limiting the international spread of circulating polioviruses, and 3) refining the program of work for eventual cessation of immunization with oral poliovirus vaccine (OPV). This report summarizes the results of that meeting.

Global Health↗