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https://www.readbyqxmd.com/read/28520709/updated-recommendations-for-use-of-menb-fhbp-serogroup-b-meningococcal-vaccine-advisory-committee-on-immunization-practices-2016
#1
Monica E Patton, David Stephens, Kelly Moore, Jessica R MacNeil
Two serogroup B meningococcal (MenB) vaccines are currently licensed for use in persons aged 10-25 years in the United States. The two vaccines are MenB-FHbp (Trumenba, Pfizer, Inc.) (1) and MenB-4C (Bexsero, GlaxoSmithKline Biologicals, Inc.) (2). In February 2015, the Advisory Committee on Immunization Practices (ACIP) recommended use of MenB vaccines among certain groups of persons aged ≥10 years who are at increased risk for serogroup B meningococcal disease* (Category A) (3), and in June 2015, ACIP recommended that adolescents and young adults aged 16-23 years may be vaccinated with MenB vaccines to provide short-term protection against most strains of serogroup B meningococcal disease (Category B(†)) (4)...
May 19, 2017: MMWR. Morbidity and Mortality Weekly Report
https://www.readbyqxmd.com/read/28515512/a-just-culture-approach-to-managing-medication-errors
#2
Erin Rogers, Emily Griffin, William Carnie, Joseph Melucci, Robert J Weber
Medication errors continue to be a concern of health care providers and the public, in particular how to prevent harm from medication mistakes. Many health care workers are afraid to report errors for fear of retribution including the loss of professional licensure and even imprisonment. Most health care workers are silent, instead of admitting their mistake and discussing it openly with peers. This can result in further patient harm if the system causing the mistake is not identified and fixed; thus self-denial may have a negative impact on patient care outcomes...
April 2017: Hospital Pharmacy
https://www.readbyqxmd.com/read/28507222/meeting-the-goal-of-concurrent-adolescent-and-adult-licensure-of-hiv-prevention-and-treatment-strategies
#3
Michelle Hume, Linda L Lewis, Robert M Nelson
The ability of adolescents to access safe and effective new products for HIV prevention and treatment is optimised by adolescent licensure at the same time these products are approved and marketed for adults. Many adolescent product development programmes for HIV prevention or treatment products may proceed simultaneously with adult phase III development programmes. Appropriately implemented, this strategy is not expected to delay licensure as information regarding product efficacy can often be extrapolated from adults to adolescents, and pharmacokinetic properties of drugs in adolescents are expected to be similar to those in adults...
May 15, 2017: Journal of Medical Ethics
https://www.readbyqxmd.com/read/28502249/psychiatric-mental-health-nursing-advanced-practice-workforce-capacity-to-address-shortages-of-mental-health-professionals
#4
Kathleen R Delaney
There is a recognized shortage of mental health professionals licensed to provide the full scope of mental health services, including assessment, diagnosis, and prescribing. Psychiatric mental health advanced practice nurses (PMH APNs) have the education and licensure to provide these services, address provider shortages and increase access to services. Unfortunately, federal reports and mental health workforce studies inaccurately depict important characteristics of PMH APNs, particularly their scope of practice, a situation that creates misunderstanding and impedes workforce planning...
May 15, 2017: Psychiatric Services: a Journal of the American Psychiatric Association
https://www.readbyqxmd.com/read/28486820/maintenance-of-certification-what-s-to-know
#5
Pat Rich
The Maintenance of Certification (MOC) Program administered by the Royal College of Physicians and Surgeons applies to all Fellows of the Royal College including dermatologists. It is mandatory for those who wish to maintain their fellowship in the Royal College and can be critical for maintaining licensure requirements. Residents can take advantage of the program before becoming Fellows of the Royal College. Fellows and MOC Program participants in the Royal College MOC Program must complete a minimum of 400 credits during a 5-year cycle and a minimum of 40 credits in each year of the cycle...
May 1, 2017: Journal of Cutaneous Medicine and Surgery
https://www.readbyqxmd.com/read/28486773/nonpublication-of-trial-results-for-new-neurological-drugs-a-systematic-review
#6
REVIEW
Amanda K Hakala, Dean Fergusson, Jonathan Kimmelman
OBJECTIVE: To evaluate nonpublication rates among trials of new successful and unsuccessful neurological drugs. METHODS: 'Licensed' drugs consisted of all novel agents receiving FDA licensure 2005 to 2012 inclusive in seven neurological disorders. 'Stalled' drugs included all experimental agents tested in the same domains that had at least one completed phase III trial in the same timeframe but failed to receive FDA approval. Trials of these drugs were included in our sample if their primary outcome collection occurred before October 1, 2010...
May 9, 2017: Annals of Neurology
https://www.readbyqxmd.com/read/28467558/nursing-students-access-to-test-banks-are-your-tests-secure
#7
Bernadette Madara, Cheryl Resha, Maria D Krol, Kimberly Lacey, Elaine F Martin, Cynthia O'Sullivan, Jan Weingrad Smith
BACKGROUND: Schools of nursing have moved to multiple choice test questions to help prepare students for licensure and practice. However, students can buy test banks to help them "get through" nursing school. Accurate assessment of nursing students' knowledge and judgment comprises access to test banks. METHOD: The purpose of this exploratory study was to gain an understanding about nursing faculty's knowledge concerning test bank security issues, to assess whether publishers were aware of this issue, and vendor's reasons for supplying test banks to students...
May 1, 2017: Journal of Nursing Education
https://www.readbyqxmd.com/read/28465097/challenges-in-conducting-post-authorisation-safety-studies-pass-a-vaccine-manufacturer-s-view
#8
Catherine Cohet, Dominique Rosillon, Corinne Willame, Francois Haguinet, Marie-Noëlle Marenne, Sandrine Fontaine, Hubert Buyse, Vincent Bauchau, Laurence Baril
Post-authorisation safety studies (PASS) of vaccines assess or quantify the risk of adverse events following immunisation that were not identified or could not be estimated pre-licensure. The aim of this perspective paper is to describe the authors' experience in the design and conduct of twelve PASS that contributed to the evaluation of the benefit-risk of vaccines in real-world settings. We describe challenges and learnings from selected PASS of rotavirus, malaria, influenza, human papillomavirus and measles-mumps-rubella-varicella vaccines that assessed or identified potential or theoretical risks, which may lead to changes to risk management plans and/or to label updates...
April 29, 2017: Vaccine
https://www.readbyqxmd.com/read/28456732/packing-polymorphism-of-dapivirine-and-its-impact-on-the-performance-of-a-dapivirine-releasing-silicone-elastomer-vaginal-ring
#9
Clare F McCoy, Diarmaid J Murphy, Peter Boyd, Tiffany Derrick, Patrick Spence, Brid Devlin, R Karl Malcolm
A silicone elastomer vaginal ring providing sustained release over 28 days of the antiretroviral microbicide dapivirine has recently completed Phase III clinical testing and showed moderate protection against HIV acquisition. In support of the product licensure program, we report the impact of dapivirine packing polymorphism on the thermal and solubility characteristics of dapivirine and on the in vitro performance of the 25 mg dapivirine ring product. This is the first time that polymorphism has been reported for a drug-releasing vaginal ring product...
April 26, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28447498/regulating-vaccines-at-the-fda-development-and-licensure-of-zika-vaccines
#10
Marion F Gruber, Philip R Krause
No abstract text is available yet for this article.
May 4, 2017: Expert Review of Vaccines
https://www.readbyqxmd.com/read/28447098/application-of-natural-language-processing-and-network-analysis-techniques-to-post-market-reports-for-the-evaluation-of-dose-related-anti-thymocyte-globulin-safety-patterns
#11
Taxiarchis Botsis, Matthew Foster, Nina Arya, Kory Kreimeyer, Abhishek Pandey, Deepa Arya
OBJECTIVE: To evaluate the feasibility of automated dose and adverse event information retrieval in supporting the identification of safety patterns. METHODS: We extracted all rabbit Anti-Thymocyte Globulin (rATG) reports submitted to the United States Food and Drug Administration Adverse Event Reporting System (FAERS) from the product's initial licensure in April 16, 1984 through February 8, 2016. We processed the narratives using the Medication Extraction (MedEx) and the Event-based Text-mining of Health Electronic Records (ETHER) systems and retrieved the appropriate medication, clinical, and temporal information...
April 26, 2017: Applied Clinical Informatics
https://www.readbyqxmd.com/read/28446441/long-term-persistence-of-cell-mediated-and-humoral-responses-to-a-h1n1-pdm09-influenza-virus-vaccines-and-the-role-of-the-as03-adjuvant-system-in-adults-during-two-randomized-controlled-trials
#12
Robbert G van der Most, Frédéric Clément, Julie Willekens, Walthère Dewé, Karl Walravens, David W Vaughn, Geert Leroux-Roels
We investigated the role of AS03, an α-tocopherol oil-in-water-emulsion-based Adjuvant System, on the long-term persistence of humoral and cell-mediated immune responses to A(H1N1)pdm09 influenza vaccines. In two studies (NCT00968539/NCT00989287), a total of 261 healthy adults (age ≤60 years) were randomized to receive two doses of AS03-adjuvanted vaccine containing 3.75 μg hemagglutinin, or non-adjuvanted vaccine containing 15 μg hemagglutinin (in Study A) or 3.75 μg hemagglutinin (in Study B), 21 days apart...
April 26, 2017: Clinical and Vaccine Immunology: CVI
https://www.readbyqxmd.com/read/28444323/effectiveness-of-rotavirus-vaccination-a-systematic-review-of-the-first-decade-of-global-post-licensure-data-2006-2016
#13
Christine L Jonesteller, Eleanor Burnett, Catherine Yen, Jacqueline E Tate, Umesh D Parashar
Two rotavirus vaccines, Rotarix (RV1) and RotaTeq (RV5), were licensed for global use in 2006. A systematic review of 48 peer-reviewed articles with post-licensure data from 24 countries showed a median RV1 vaccine effectiveness (VE) of 84%, 75%, and 57% in low, medium, and high child mortality countries, respectively, and RV5 VE of 90% in low and 45% in high child mortality countries. A partial vaccine series provided considerable protection, but not to the same level as a full series. VE tended to decline in the second year of life, particularly in medium and high mortality settings, and tended to be greater against more severe rotavirus disease...
April 21, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/28442230/case-control-vaccine-effectiveness-studies-data-collection-analysis-and-reporting-results
#14
REVIEW
Jennifer R Verani, Abdullah H Baqui, Claire V Broome, Thomas Cherian, Cheryl Cohen, Jennifer L Farrar, Daniel R Feikin, Michelle J Groome, Rana A Hajjeh, Hope L Johnson, Shabir A Madhi, Kim Mulholland, Katherine L O'Brien, Umesh D Parashar, Manish M Patel, Laura C Rodrigues, Mathuram Santosham, J Anthony Scott, Peter G Smith, Halvor Sommerfelt, Jacqueline E Tate, J Chris Victor, Cynthia G Whitney, Anita K Zaidi, Elizabeth R Zell
The case-control methodology is frequently used to evaluate vaccine effectiveness post-licensure. The results of such studies provide important insight into the level of protection afforded by vaccines in a 'real world' context, and are commonly used to guide vaccine policy decisions. However, the potential for bias and confounding are important limitations to this method, and the results of a poorly conducted or incorrectly interpreted case-control study can mislead policies. In 2012, a group of experts met to review recent experience with case-control studies evaluating vaccine effectiveness; we summarize the recommendations of that group regarding best practices for data collection, analysis, and presentation of the results of case-control vaccine effectiveness studies...
June 5, 2017: Vaccine
https://www.readbyqxmd.com/read/28434944/dose-dependent-t-cell-dynamics-and-cytokine-cascade-following-rvsv-zebov-immunization
#15
Christine Dahlke, Rahel Kasonta, Sebastian Lunemann, Verena Krähling, Madeleine E Zinser, Nadine Biedenkopf, Sarah K Fehling, My L Ly, Anne Rechtien, Hans C Stubbe, Flaminia Olearo, Saskia Borregaard, Alen Jambrecina, Felix Stahl, Thomas Strecker, Markus Eickmann, Marc Lütgehetmann, Michael Spohn, Stefan Schmiedel, Ansgar W Lohse, Stephan Becker, Marylyn M Addo
BACKGROUND: The recent West African Ebola epidemic led to accelerated efforts to test Ebola vaccine candidates. As part of the World Health Organisation-led VSV Ebola Consortium (VEBCON), we performed a phase I clinical trial investigating rVSV-ZEBOV (a recombinant vesicular stomatitis virus-vectored Ebola vaccine), which has recently demonstrated protection from Ebola virus disease (EVD) in phase III clinical trials and is currently in advanced stages of licensing. So far, correlates of immune protection are incompletely understood and the role of cell-mediated immune responses has not been comprehensively investigated to date...
April 5, 2017: EBioMedicine
https://www.readbyqxmd.com/read/28430997/global-impact-of-rotavirus-vaccination-on-childhood-hospitalizations-and-mortality-from-diarrhea
#16
Eleanor Burnett, Christine L Jonesteller, Jacqueline E Tate, Catherine Yen, Umesh D Parashar
In 2006, two rotavirus vaccines were licensed. We summarize the impact of rotavirus vaccination on hospitalizations and deaths from rotavirus and all-cause acute gastroenteritis (AGE) during the first 10 years since vaccine licensure, including recent evidence from high child mortality countries. We used standardized guidelines (PRISMA) guidelines to identify observational evaluations of rotavirus vaccine impact among children <5 years of age that presented at least 12 months of pre- and post-vaccine introduction surveillance data...
April 18, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28401577/a-brief-report-on-the-ethical-and-legal-guides-for-technology-use-in-marriage-and-family-therapy
#17
Michael Pennington, Rikki Patton, Amber Ray, Heather Katafiasz
Marriage and family therapists (MFTs) use ethical codes and state licensure laws/rules as guidelines for best clinical practice. It is important that professional codes reflect the potential exponential use of technology in therapy. However, current standards regarding technology use lack clarity. To explore this gap, a summative content analysis was conducted on state licensure laws/rules and professional ethical codes to find themes and subthemes among the many aspects of therapy in which technology can be utilized...
April 12, 2017: Journal of Marital and Family Therapy
https://www.readbyqxmd.com/read/28399824/long-term-impact-of-self-financed-rotavirus-vaccines-on-rotavirus-associated-hospitalizations-and-costs-in-the-valencia-region-spain
#18
Alejandro Orrico-Sanchez, Mónica López-Lacort, Silvia Pérez-Vilar, Javier Díez-Domingo
BACKGROUND: Rotavirus vaccines are available in Spain from 2007. They are recommended by the Spanish Pediatric Association, but not funded by the National Health System (NHS) and its coverage rate reached 40-50%. The hospitalization rate reduction of rotavirus caused gastroenteritis (RVAGE) directly attributable to vaccination remains unclear due to the large differences described in published studies, ranging from 14 to 44.5% in children <5 years of age, even with similar vaccination coverage...
April 11, 2017: BMC Infectious Diseases
https://www.readbyqxmd.com/read/28398984/experiences-of-pre-licensure-or-pre-registration-health-professional-students-and-their-educators-in-working-with-intra-professional-teams-a-qualitative-systematic-review
#19
Diane L Butcher, Karen MacKinnon, Anne Bruce, Carol Gordon, Clare Koning
BACKGROUND: Inter-professional initiatives are prevalent in the healthcare landscape, requiring professionals to collaborate effectively to provide quality patient care. Little attention has been given to intra-professional relationships, where professionals within one disciplinary domain (such as degree and diploma nursing students) collaborate to provide care. New care models are being introduced where baccalaureate and diploma students of a particular discipline (such as nursing, occupational therapy, dentistry or physiotherapy) work closely together in teams to deliver care...
April 2017: JBI Database of Systematic Reviews and Implementation Reports
https://www.readbyqxmd.com/read/28391739/taxonomy-for-education-and-training-in-clinical-neuropsychology-past-present-and-future
#20
Scott A Sperling, Cynthia R Cimino, Nikki H Stricker, Amy K Heffelfinger, Jennifer L Gess, Katie E Osborn, Brad L Roper
OBJECTIVE: Historically, the clinical neuropsychology training community has not clearly or consistently defined education or training opportunities. The lack of consistency has limited students' and trainees' ability to accurately assess and compare the intensity of neuropsychology-specific training provided by programs. To address these issues and produce greater 'truth in advertising' across programs, CNS, with SCN's Education Advisory Committee (EAC), ADECN, AITCN, and APPCN constructed a specialty-specific taxonomy, namely, the Taxonomy for Education and Training in Clinical Neuropsychology...
April 10, 2017: Clinical Neuropsychologist
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