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Prevention of pneumococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP).

This report updates the last recommendations by the Advisory Committee on Immunization Practices (ACIP) concerning pneumococcal polysaccharide vaccine (MMWR 1989;38:64-8, 73-6). ACIP recommends that the vaccine be used more extensively and administered to all persons in the following groups: a) persons aged > or = 65 years, b) immunocompetent persons aged > or = to 2 years who are at increased risk for illness and death associated with pneumococcal disease because of chronic illness, c) persons aged > or = 2 years with functional or anatomic asplenia, d) persons aged > or = 2 years living in environments in which the risk for disease is high, and e) immunocompromised persons aged > or = 2 years who are at high risk for infection. This report contains updated information regarding a) antimicrobial resistance among pneumococci, b) vaccine effectiveness and cost-effectiveness, c) indications for vaccination, d) guidelines for revaccination, e) strategies for improving delivery of vaccine, and f) development of pneumococcal conjugate vaccine.

Adolescent↗

Principles of risk assessment for illness caused by foodborne biological agents. National Advisory Committee on Microbiological Criteria for Foods.

The Risk Assessment Subcommittee of the National Advisory Committee on Microbiological Criteria in Foods has prepared a generic document on the principles of risk assessment as applied to biological agents that can cause human foodborne disease. Typical biological agents include bacteria, viruses, fungi, helminths, protozoa, algae, parasites, and the toxic products that these agents may produce. Basic principles elaborated to characterize food pathogen risks include the four broadly accepted components of risk assessment. The role of surveillance and investigational activities to link biological agents and their food sources to consumer illness is described as is the role of predictive modeling for food pathogens.

Food Microbiology↗

The challenges of new drugs benefits and risks analysis: lessons from the ximelagatran FDA Cardiovascular Advisory Committee.

Ximelagatran is a new oral anticoagulant that acts by direct and reversible inhibition of thrombin and has the potential to replace warfarin. In 2004, the FDA Cardiovascular and Renal drug Advisory Committee (CRAC) reviewed the ximelagatran clinical program. Three indications were proposed: the prevention of venous thromboembolism (VTE) in patients undergoing total knee replacement surgery (TKR), the prevention of stroke and other thromboembolic complications associated with atrial fibrillation (AF), and the long-term secondary prevention of VTE after standard treatment of an episode of acute VTE. The database consisted of a total of 30,698 subjects and included five phase III pivotal studies. During the advisory panel debate, widely divergent analyses of the benefits and risks of ximelagatran were presented. Ximelagatran hepatic toxicity was a key feature leading the CRAC to conclude that the benefit risk ratio of ximelagtran was unfavorable for the three proposed indications. Some design issues also undermined the strength of efficacy data. This paper reviews the benefits and risks of ximelagatran and analyzes the reasons leading to conflicting conclusions among various experts. The aim of this review is to facilitate the interpretation of benefits and risks associated with a new drug product and to improve future clinical drug developments.

Advisory Committees↗

Varicella-zoster immune globulin for the prevention of chickenpox. Recommendations of the Immunization Practices Advisory Committee, Centers for Disease Control.

This is the first statement by the Immunization Practices Advisory Committee on the use of varicella-zoster immune globulin ( VZIG ). Prior recommendations have been made by the manufacturer in cooperation with the Centers for Disease Control and approved by the Office of Biologics, National Center for Drugs and Biologics, U.S. Food and Drug Administration. Because of exceedingly limited supplies, VZIG use has been restricted to proven high-risk individuals--for prophylaxis against chickenpox in immunocompromised children and prevention of postnatal chickenpox following intrauterine exposure. With increasing supplies, some of these restrictions can be lifted. This statement includes use of VZIG for immunocompromised persons of any age, normal adults, pregnant women, and premature and full-term infants. However, because the supply of VZIG is still limited, it continues to be recommended primarily for immunocompromised children and certain neonates exposed in utero. It should not be used indiscriminately.

Adolescent↗

Tuberculosis among foreign-born persons entering the United States. Recommendations of the Advisory Committee for Elimination of Tuberculosis.

In 1989, the Department of Health and Human Services Advisory Committee for Elimination of Tuberculosis published a plan for eliminating tuberculosis from the United States by the year 2010. This plan gives a top priority to implementing strategies to prevent tuberculosis in high-incidence groups. Foreign-born persons (as a group) residing in the United States have higher rates of tuberculosis than persons born in the United States. In 1989, the overall U.S. tuberculosis rate was 9.5 per 100,000 population; for foreign-born persons arriving in the United States, the estimated case rate was 124 per 100,000. In the period 1986-1989, 22% (20,316) of all reported cases of tuberculosis occurred in the foreign-born population. A majority of foreign-born persons who develop tuberculosis do so within the first 5 years after they enter the United States. The ACET recommends that all foreign-born persons applying for permanent entry into the United States continue to be screened for disease. Deficiencies in the current screening methods should be corrected. The policy requiring that persons found to have infectious tuberculosis (known or suspected) be prevented from entering the country until treatment has rendered them noninfectious should be continued; however, persons with noninfectious tuberculosis should be permitted to enter the United States. Tuberculin skin testing and preventive therapy programs for foreign-born persons must be expanded both overseas and domestically if the goal of eliminating tuberculosis from the United States by the year 2010 is to be met.

Adolescent↗

Preventing pneumococcal disease among infants and young children. Recommendations of the Advisory Committee on Immunization Practices (ACIP).

In February 2000, a 7-valent pneumococcal polysaccharide-protein conjugate vaccine (Prevnar, marketed by Wyeth Lederle Vaccines) was licensed for use among infants and young children. CDC's Advisory Committee on Immunization Practices (ACIP) recommends that the vaccine be used for all children aged 2-23 months and for children aged 24-59 months who are at increased risk for pneumococcal disease (e.g., children with sickle cell disease, human immunodeficiency virus infection, and other immunocompromising or chronic medical conditions). ACIP also recommends that the vaccine be considered for all other children aged 24-59 months, with priority given to a) children aged 24-35 months, b) children who are of Alaska Native, American Indian, and African-American descent, and c) children who attend group day care centers. This report includes ACIP's recommended vaccination schedule for infants at ages 2, 4, 6, and 12-15 months. This report also includes a pneumococcal vaccination schedule for infants and young children who are beginning their vaccination series at an older age and for those who missed doses. In addition, this report updates earlier recommendations for use of 23-valent pneumococcal polysaccharide vaccine among children aged > or =2 years. Among children aged 24-59 months for whom polysaccharide vaccine is already recommended, ACIP recommends vaccination with the new conjugate vaccine followed, > or =2 months later, by 23-valent polysaccharide vaccine. Conjugate vaccine has not been studied sufficiently among older children or adults to make recommendations for its use among persons aged > or =5 years. Persons aged > or =5 years who are at increased risk for serious pneumococcal disease should continue to receive 23-valent polysaccharide vaccine in accordance with previous ACIP recommendations.

Adult↗

Guidelines on diet, nutrition, and cancer prevention: reducing the risk of cancer with healthy food choices and physical activity. The American Cancer Society 1996 Advisory Committee on Diet, Nutrition, and Cancer Prevention.

The American Cancer Society periodically assembles an expert advisory committee to evaluate recent evidence and update the American Cancer Society's guidelines for diet, nutrition, and cancer prevention. This year's update presents four broad guidelines to reduce cancer risk and provides information on a wide variety of topics concerning nutrition and cancer.

Diet↗

Strengthening the supply of routinely recommended vaccines in the United States: recommendations from the National Vaccine Advisory Committee.

Between late 2000 and the spring of 2003, the United States experienced shortages of vaccines against 8 of 11 preventable diseases in children. In response, the Department of Health and Human Services requested that the National Vaccine Advisory Committee (NVAC) make recommendations on strengthening the supply of routinely recommended vaccines. The NVAC appointed a Working Group to identify potential causes of vaccine supply shortages, develop strategies to alleviate or prevent shortages, and enlist stakeholders to consider the applicability and feasibility of these strategies. The NVAC concluded that supply disruptions are likely to continue to occur. Strategies to be implemented in the immediate future include expansion of vaccine stockpiles, increased support for regulatory agencies, maintenance and strengthening of liability protections, improved communication among stakeholders, increased availability of public information, and a campaign to emphasize the benefits of vaccination. Strategies requiring further study include evaluation of appropriate financial incentives to manufacturers and streamlining the regulatory process without compromising safety or efficacy.

Drug Industry↗

Pneumococcal vaccination for cochlear implant candidates and recipients: updated recommendations of the Advisory Committee on Immunization Practices.

In October 2002, CDC recommended that all persons with cochlear implants receive age-appropriate pneumococcal vaccination with 7-valent pneumococcal conjugate vaccine (PCV7) (Prevnar), 23-valent pneumococcal polysaccharide vaccine (PPV23) (Pneumovax), or both according to the Advisory Committee on Immunization Practices (ACIP) schedules for persons at high risk. CDC issued these recommendations on the basis of preliminary data suggesting an increased risk for pneumococcal meningitis in persons with cochlear implants. Findings of a recent investigation by CDC, the Food and Drug Administration (FDA), and state health departments support this recommendation. Children aged <6 years with a cochlear implant had a substantially greater risk for having pneumococcal meningitis, compared with children in the general U.S. population of the same age. Some children who are candidates for cochlear implants have pre-existing anatomic factors that might contribute to an increased risk for meningitis; however, the recent study was not designed to assess this association.

Adolescent↗

THE HOSPITAL MEDICAL ADVISORY COMMITTEE--THE CABINET OF THE MEDICAL STAFF.

Before a hospital medical staff can realistically accept responsibility for the professional practices of its members, a principle initially fostered by the American College of Surgeons and adopted by both the Canadian and American accreditation programs, it must have an effectively functioning medical staff organization. The medical advisory committee is the most important committee of the medical staff organization. A representative composition, adherence to sound administrative principles, and recognition of its prime functions of co-ordination, supervision and jurisdiction will permit this committee-and the total medical staff organization-to discharge adequately the very important responsibilities delegated to them by the governing board of the hospital. Properly structured medical staff bylaws with clearly defined terms of reference assist the smooth functioning of the "cabinet" of the medical staff and safeguard the prerogatives of the individual members of the staff.

Accreditation↗

MyPyramid food intake pattern modeling for the Dietary Guidelines Advisory Committee.

Modeling analyses using the MyPyramid intake patterns were conducted in collaboration with the 2005 Dietary Guidelines Advisory Committee in response to their research questions and to determine likely effects of possible recommendations on overall dietary adequacy. Scenarios modeled included the feasibility of using the food patterns for lacto-ovo-vegetarian diets, of varying fat levels within the patterns, and of increasing dietary flexibility through food group substitutions. Food pattern modeling was a useful tool to identify possible impacts on diet quality of potential Dietary Guidelines recommendations. Modeling analyses can help researchers explore the overall effect of specific dietary recommendations on intake patterns.

Databases, Factual↗

Clinical trial design issues raised during recombinant DNA advisory committee review of gene transfer protocols.

Gene transfer clinical trial protocols are reviewed by the Recombinant DNA Advisory Committee (RAC). Identifying the design concerns and suggestions commonly raised during RAC review may help investigators and sponsors shorten the process of protocol development and improve the quality of gene transfer trials. We therefore examined 53 full public reviews of gene transfer clinical trial protocols performed by the RAC between December 2000 and June 2004 to determine what trial design concerns or suggestions RAC members raised during written review or public discussion or in the formal letter to investigators after the review was completed. We also determined how frequently these concerns were raised. We found that RAC members raised issues regarding selection of subjects in 89% of reviews, dose escalation in 77%, selection of safety end points in 76%, biological activity measures in 66%, and overall design in 60% of reviews. The most common issue raised by RAC reviewers was the need to exclude subjects at increased risk for adverse events. Furthermore, in 89% of reviews, at least one design issue pertaining to safety of participants was raised. In 91% of reviews, at least one design concern was presented as a written RAC recommendation or concern to the investigator after the public review. When submitting protocols for RAC review, investigators and sponsors might devote more attention to issues that RAC reviewers commonly raise. Such attention might help strengthen clinical trial protocols, shorten the protocol development process, and enhance the protection of research participants.

Clinical Protocols↗

Professional advisory committee: a new initiative in governance.

In her article, the author describes the establishment of a professional advisory committee by the board of trustees of the Sisters of Charity of Ottawa Health Service. This new initiative gives the organization's professional disciplines a direct voice on the board and embraces a spirit of openness.

Catholicism↗