R. Douglas Pratt
Food and Drug Administration
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Featured researches published by R. Douglas Pratt.
Pediatrics | 2014
Michael T. Brady; Carrie L. Byington; H. Dele Davies; Kathryn M. Edwards; Mary Anne Jackson; Yvonne Maldonado; Dennis L. Murray; Walter A. Orenstein; Mobeen H. Rathore; Mark H. Sawyer; Gordon E. Schutze; Rodney E. Willoughby; Theoklis E. Zaoutis; Henry H. Bernstein; David W. Kimberlin; Sarah S. Long; H. Cody Meissner; Marc A. Fischer; Bruce G. Gellin; Richard L. Gorman; Lucia H. Lee; R. Douglas Pratt; Jennifer S. Read; Joan Robinson; Marco Aurelio Palazzi Safadi; Jane F. Seward; Jeffrey R. Starke; Geoffrey R. Simon; Tina Q. Tan; Joseph A. Bocchini
Palivizumab was licensed in June 1998 by the Food and Drug Administration for the reduction of serious lower respiratory tract infection caused by respiratory syncytial virus (RSV) in children at increased risk of severe disease. Since that time, the American Academy of Pediatrics has updated its guidance for the use of palivizumab 4 times as additional data became available to provide a better understanding of infants and young children at greatest risk of hospitalization attributable to RSV infection. The updated recommendations in this policy statement reflect new information regarding the seasonality of RSV circulation, palivizumab pharmacokinetics, the changing incidence of bronchiolitis hospitalizations, the effect of gestational age and other risk factors on RSV hospitalization rates, the mortality of children hospitalized with RSV infection, the effect of prophylaxis on wheezing, and palivizumab-resistant RSV isolates. This policy statement updates and replaces the recommendations found in the 2012 Red Book.
Pediatrics | 2012
Richard A. Polin; Susan Denson; Michael T. Brady; Lu Ann Papile; Jill E. Baley; Waldemar A. Carlo; James J. Cummings; Praveen Kumar; Rosemarie C. Tan; Kristi L. Watterberg; Wanda D. Barfield; Ann L Jefferies; George A. Macones; Rosalie O. Mainous; Tonse N.K. Raju; Kasper S. Wang; Jim Couto; Carrie L. Byington; H. Dele Davies; Kathryn M. Edwards; Mary P. Glode; Mary Anne Jackson; Harry L. Keyserling; Yvonne Maldonado; Dennis L. Murray; Walter A. Orenstein; Gordon E. Schutze; Rodney E. Willoughby; Theoklis E. Zaoutis; Marc A. Fischer
Health care−associated infections in the NICU are a major clinical problem resulting in increased morbidity and mortality, prolonged length of hospital stays, and increased medical costs. Neonates are at high risk for health care−associated infections because of impaired host defense mechanisms, limited amounts of protective endogenous flora on skin and mucosal surfaces at time of birth, reduced barrier function of neonatal skin, the use of invasive procedures and devices, and frequent exposure to broad-spectrum antibiotics. This statement will review the epidemiology and diagnosis of health care−associated infections in newborn infants.
Pediatrics | 2009
Helen J. Binns; Joel A. Forman; Catherine J. Karr; Kevin C. Osterhoudt; Jerome A. Paulson; James R. Roberts; Megan Sandel; James M. Seltzer; Robert O. Wright; Elizabeth Blackburn; Mark Anderson; Sharon A. Savage; Walter J. Rogan; N. Beth Ragan; Paul Spire; Joseph A. Bocchini; Henry H. Bernstein; John S. Bradley; Michael T. Brady; Carrie L. Byington; Penelope H. Dennehy; Margaret C. Fisher; Robert W. Frenck; Mary P. Glode; Harry L. Keyserling; David W. Kimberlin; Walter A. Orenstein; Lorry G. Rubin; Robert S. Baltimore; Julia A. McMillan
Drinking water for approximately one sixth of US households is obtained from private wells. These wells can become contaminated by pollutant chemicals or pathogenic organisms, leading to significant illness. Although the US Environmental Protection Agency and all states offer guidance for construction, maintenance, and testing of private wells, there is little regulation, and with few exceptions, well owners are responsible for their own wells. Children may also drink well water at child care or when traveling. Illness resulting from childrens ingestion of contaminated water can be severe. This report reviews relevant aspects of groundwater and wells; describes the common chemical and microbiologic contaminants; gives an algorithm with recommendations for inspection, testing, and remediation for wells providing drinking water for children; reviews the definitions and uses of various bottled waters; provides current estimates of costs for well testing; and provides federal, national, state, and, where appropriate, tribal contacts for more information.
Pediatrics | 2011
Michael T. Brady; Henry H. Bernstein; Carrie L. Byington; Kathryn M. Edwards; Margaret C. Fisher; Mary P. Glode; Mary Anne Jackson; Harry L. Keyserling; David W. Kimberlin; Yvonne Maldonado; Walter A. Orenstein; Gordon E. Schutze; Rodney E. Willoughby; Robert Bortolussi; Marc A. Fischer; Bruce G. Gellin; Richard L. Gorman; Lucia Lee; R. Douglas Pratt; Jane F. Seward; Jeffrey R. Starke; Jack Swanson; Tina Q. Tan
The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention and the American Academy of Pediatrics approved updated recommendations for the use of quadravalent (serogroups A, C, W-135, and Y) meningococcal conjugate vaccines (Menactra [Sanofi Pasteur, Swiftwater, PA] and Menveo [Novartis, Basel, Switzerland]) in adolescents and in people at persistent high risk of meningococcal disease. The recommendations supplement previous Advisory Committee on Immunization Practices and American Academy of Pediatrics recommendations for meningococcal vaccinations. Data were reviewed pertaining to immunogenicity in high-risk groups, bactericidal antibody persistence after immunization, current epidemiology of meningococcal disease, meningococcal conjugate vaccine effectiveness, and cost-effectiveness of different strategies for vaccination of adolescents. This review prompted the following recommendations: (1) adolescents should be routinely immunized at 11 through 12 years of age and given a booster dose at 16 years of age; (2) adolescents who received their first dose at age 13 through 15 years should receive a booster at age 16 through 18 years or up to 5 years after their first dose; (3) adolescents who receive their first dose of meningococcal conjugate vaccine at or after 16 years of age do not need a booster dose; (4) a 2-dose primary series should be administered 2 months apart for those who are at increased risk of invasive meningococcal disease because of persistent complement component (eg, C5–C9, properdin, factor H, or factor D) deficiency (9 months through 54 years of age) or functional or anatomic asplenia (2–54 years of age) and for adolescents with HIV infection; and (5) a booster dose should be given 3 years after the primary series if the primary 2-dose series was given from 2 through 6 years of age and every 5 years for persons whose 2-dose primary series or booster dose was given at 7 years of age or older who are at risk of invasive meningococcal disease because of persistent component (eg, C5–C9, properdin, factor H, or factor D) deficiency or functional or anatomic asplenia.
Pediatrics | 2011
Michael T. Brady; Henry H. Bernstein; Carrie L. Byington; Kathryn M. Edwards; Margaret C. Fisher; Mary P. Glode; Mary Anne Jackson; Harry L. Keyserling; David W. Kimberlin; Yvonne Maldonado; Walter A. Orenstein; Gordon E. Schutze; Rodney E. Willoughby; Robert Bortolussi; Marc A. Fischer; Bruce G. Gellin; Richard L. Gorman; Lucia Lee; R. Douglas Pratt; Jennifer S. Read; Jane F. Seward; Jeffrey R. Starke; Jack Swanson; Tina Q. Tan; Carol J. Baker; Sarah S. Long; H. Cody Meissner; Larry K. Pickering; Lorry G. Rubin; Jennifer Frantz
The 2011 recommended childhood and adolescent immunization schedules have been approved by the American Academy of Pediatrics, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, and the American Academy of Family Physicians (schedules have been provided following this article and online as Supplemental Information). These schedules are revised annually to reflect current recommendations for use of vaccines licensed by the US Food and Drug Administration and include the following changes from last year:
Pediatrics | 2009
Joseph A. Bocchini; Henry H. Bernstein; John S. Bradley; Michael T. Brady; Carrie L. Byington; Margaret C. Fisher; Mary P. Glode; Mary Anne Jackson; Harry L. Keyserling; David W. Kimberlin; Walter A. Orenstein; Gordon E. Schutze; Rodney E. Willoughby; Penelope H. Dennehy; Robert W. Frenck; Lorry G. Rubin; Beth P. Bell; Robert Bortolussi; Richard D. Clover; Marc A. Fischer; Bruce G. Gellin; Richard L. Gorman; R. Douglas Pratt; Lucia Lee; Jennifer S. Read; Jeffrey R. Starke; Jack Swanson; Carol J. Baker; Sarah S. Long; Larry K. Pickering
The purpose of this statement is to update current recommendations for routine use of trivalent seasonal influenza vaccine and antiviral medications for the prevention and treatment of influenza in children.
Drug Safety | 2001
C. John Clements; Leslie K. Ball; Robert Ball; R. Douglas Pratt
The mercury-based vaccine preservative thiomersal has come under scrutiny in recent months because of its presence in certain vaccines that provide the foundation of childhood immunisation schedules. Over the past decade new vaccines have been added to the recommended childhood schedule, and the relatively smaller bodyweight of infants has led to concern that the cumulative exposure of mercury from infant vaccines may exceed certain guidelines for the human consumption of mercury. In the US, government agencies and professional societies have recently recommended that thiomersal be removed altogether from vaccines. Some involved in developing vaccine policy feel that the evidence to support these safety concerns has not risen to the level required for such a response. This apparent divergence of opinion has left healthcare professionals and the public with uncertainty about the potential health effects from low level exposure to thiomersal as well as the necessity of removing thiomersal from vaccines. At present, scientific investigation has not found conclusive evidence of harm from thiomersal in vaccines. As a precautionary measure, efforts are under way to remove or replace thiomersal from vaccines and providers should anticipate the availability of more vaccine products that are thiomersal-free over the coming years.
Pediatrics | 2014
Carrie L. Byington; Yvonne Maldonado; Elizabeth D. Barnett; H. Dele Davies; Kathryn M. Edwards; Mary Anne Jackson; Dennis L. Murray; Mobeen H. Rathore; Mark H. Sawyer; Gordon E. Schutze; Rodney E. Willoughby; Theoklis E. Zaoutis; Jennifer Frantz; Doug Campos-Outcalt; Marc A. Fischer; Bruce G. Gellin; Richard L. Gorman; Lucia H. Lee; R. Douglas Pratt; Joan Robinson; Marco Aurelio Palazzi Safadi; Jane F. Seward; Jeffrey R. Starke; Geoffrey R. Simon; Tina Q. Tan
Routine use of the pneumococcal conjugate vaccines (PCV7 and PCV13), beginning in 2000, has resulted in a dramatic reduction in the incidence of invasive pneumococcal disease (IPD) attributable to serotypes of Streptococcus pneumoniae contained in the vaccines. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention and the American Academy of Pediatrics recommend the expanded use of PCV13 in children 6 through 18 years of age with certain conditions that place them at elevated risk of IPD. This statement provides recommendations for the use of PCV13 in children 6 through 18 years. A single dose of PCV13 should be administered to certain children in this age group who are at elevated risk of IPD. Recommendations for the use of PCV13 in healthy children and for pneumococcal polysaccharide vaccine (PPSV23) remain unchanged.
Pediatrics | 2014
Michael T. Brady; Carrie L. Byington; H. Dele Davies; Kathryn M. Edwards; Mary Anne Jackson; Yvonne Maldonado; Dennis L. Murray; Walter A. Orenstein; Mobeen H. Rathore; Mark H. Sawyer; Gordon E. Schutze; Rodney E. Willoughby; Theoklis E. Zaoutis; Henry H. Bernstein; David W. Kimberlin; Sarah S. Long; H. Cody Meissner; Marc A. Fischer; Bruce G. Gellin; Richard L. Gorman; Lucia H. Lee; R. Douglas Pratt; Jennifer S. Read; Joan Robinson; Marco Aurelio Palazzi Safadi; Jane F. Seward; Jeffrey R. Starke; Geoffrey R. Simon; Tina Q. Tan; Jennifer Frantz
Since the last policy statement from the American Academy of Pediatrics (AAP) concerning meningococcal vaccine was published in 2011, 2 meningococcal conjugate vaccines have been licensed for use in infants (Hib-MenCY-TT and MenACWY-CRM). The Centers for Disease Control and Prevention (CDC) has published new recommendations, “Prevention and Control of Meningococcal Disease: Recommendations of the Advisory Committee on Immunization Practices,” which have been endorsed by the AAP. However, the CDC recommendations were published before licensure of MenACWY-CRM for infant use. This policy statement updates the AAP recommendations for use of meningococcal vaccines in children and adolescents. A more comprehensive review of background and technical information can be found in the CDC publication.
Pediatrics | 2001
Leslie K. Ball; Robert Ball; R. Douglas Pratt