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https://www.readbyqxmd.com/read/28760614/regulatory-considerations-in-development-of-vaccines-to-prevent-disease-caused-by-chikungunya-virus
#1
REVIEW
Sixun Yang, Doran Fink, Andrea Hulse, R Douglas Pratt
Chikungunya virus (CHIKV) is a mosquito-transmitted alphavirus. Chikungunya disease (CHIK) in humans is characterized by sudden onset of high fever, cutaneous rash, myalgia and debilitating polyarthralgia. Until recently the virus was considered endemic to only Africa and Asia, but since 2004 CHIK has spread to previously non-endemic regions, including Europe and the Americas, thereby emerging as a global health threat. Although a variety of CHIKV vaccine candidates have been tested in animals, and a few have advanced to human clinical trials, no licensed vaccine is currently available for prevention of disease...
July 28, 2017: Vaccine
https://www.readbyqxmd.com/read/28739638/undue-inducement-or-unfair-exclusion-considering-a-case-study-of-pregnancy-in-an-hiv-prevention-trial
#2
Bridget G Haire, Morenike Oluwatoyin Folayan
In their recent paper' Undue inducement: a case study in CAPRISA 008', Mngadi et al conclude that a participant in an HIV prevention study who deliberately concealed her pregnancy was not'unduly induced' to participate by the offer of an experimental product. This paper argues that while the authors' conclusion is sound, the framing of this case study is consistent with the preoccupation in research ethics with the concept of undue inducement, coupled with a highly risk-averse attitude to pregnancy (regardless of whether those risks may be willingly assumed by pregnant women themselves)...
July 24, 2017: Journal of Medical Ethics
https://www.readbyqxmd.com/read/28584869/development-of-the-competency-based-medical-curriculum-for-the-new-augsburg-university-medical-school
#3
Anja Härtl, Pascal Berberat, Martin R Fischer, Helmuth Forst, Stefanie Grützner, Thomas Händl, Felix Joachimski, Renate Linné, Bruno Märkl, Markus Naumann, Reinhard Putz, Werner Schneider, Claus Schöler, Markus Wehler, Reinhard Hoffmann
Aim: With the resolution from April 28, 2014, the Bavarian state government in Germany decided to found a new medical school at Augsburg University, thereby requiring the development of a competency-based medical curriculum. Methods: Two interdisciplinary groups developed a spiral curriculum (following Harden) employing the model of Thumser-Dauth & Öchsner. The curriculum focuses on specifically defined competencies: medical expertise, independent scientific reasoning, argumentation and scholarship, as well as communication skills...
2017: GMS Journal for Medical Education
https://www.readbyqxmd.com/read/28562450/considerations-for-residency-programs-regarding-accepting-undocumented-students-who-are-daca-recipients
#4
Sunny Nakae, Denisse Rojas Marquez, Isha Marina Di Bartolo, Raquel Rodriguez
The Deferred Action for Childhood Arrivals (DACA) initiative provides for the temporary deferral of enforcement of immigration laws for certain undocumented individuals brought to the United States before age 16. More than 50 medical schools now consider applicants who are DACA recipients, and medical school graduates with DACA are eligible to continue their training in graduate medical education. In this article, the authors summarize current policy and provide data on DACA recipients in medical school. They then review the implications for considering DACA recipients in graduate medical education, including employment guidelines, employer responsibilities, training at Veterans Affairs facilities, research funding, and professional licensure...
May 30, 2017: Academic Medicine: Journal of the Association of American Medical Colleges
https://www.readbyqxmd.com/read/28507222/meeting-the-goal-of-concurrent-adolescent-and-adult-licensure-of-hiv-prevention-and-treatment-strategies
#5
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/28465097/challenges-in-conducting-post-authorisation-safety-studies-pass-a-vaccine-manufacturer-s-view
#6
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/28447498/regulating-vaccines-at-the-fda-development-and-licensure-of-zika-vaccines
#7
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/28398984/experiences-of-pre-licensure-or-pre-registration-health-professional-students-and-their-educators-in-working-with-intra-professional-teams-a-qualitative-systematic-review
#8
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/28376822/internationally-educated-nurses-in-canada-predictors-of-workforce-integration
#9
Christine L Covell, Marie-Douce Primeau, Kelley Kilpatrick, Isabelle St-Pierre
BACKGROUND: Global trends in migration accompanied with recent changes to the immigrant selection process may have influenced the demographic and human capital characteristics of internationally educated nurses (IENs) in Canada and in turn the assistance required to facilitate their workforce integration. This study aimed to describe the demographic and human capital profile of IENs in Canada, to explore recent changes to the profile, and to identify predictors of IENs' workforce integration...
April 4, 2017: Human Resources for Health
https://www.readbyqxmd.com/read/28350731/new-jersey-pa-regulation-and-the-march-on-trenton
#10
Maryann Ramos, Ellen Mandel
New Jersey was the next to the last state to recognize physician assistants (PAs) and pass legislation allowing them to practice. This first-person account supported by interviews with those who were there details the trail to NJ licensure, including the development of a state society, the growth of support from strong leaders in the medical and academic communities, and the grassroots efforts of many PAs aspiring to work in their home state.
April 2017: JAAPA: Official Journal of the American Academy of Physician Assistants
https://www.readbyqxmd.com/read/28344705/the-influence-of-globalization-on-medical-regulation-a-descriptive-analysis-of-international-medical-graduates-registered-through-alternative-licensure-routes-in-ontario
#11
Wendy Yen, Kathryn Hodwitz, Niels Thakkar, Maria Athina Tina Martimianakis, Dan Faulkner
The increasing globalization of the medical profession has influenced health policy, health human resource planning, and medical regulation in Canada. Since the early 2000s, numerous policy initiatives have been created to facilitate the entry of international medical graduates (IMGs) into the Canadian workforce. In Ontario, the College of Physicians and Surgeons of Ontario (CPSO) developed alternative licensure routes to increase the ability of qualified IMGs to obtain licenses to practice. The current study provides demographic and descriptive information about the IMGs registered through the CPSO's alternative licensure routes between 2000 and 2012...
December 2016: Canadian Medical Education Journal
https://www.readbyqxmd.com/read/28341112/off-label-use-of-vaccines
#12
REVIEW
Pieter Neels, James Southern, Jon Abramson, Philippe Duclos, Joachim Hombach, Melanie Marti, Alanna Fitzgerald-Husek, Jacqueline Fournier-Caruana, Germaine Hanquet
This article reviews the off-label recommendations and use of vaccines, and focuses on the differences between the labelled instructions on how to use the vaccine as approved by the regulatory authorities (or "label"(1)), and the recommendations for use issued by public health advisory bodies at national and international levels. Differences between public health recommendations and the product label regarding the vaccine use can lead to confusion at the level of vaccinators and vaccinees and possibly result in lower compliance with national vaccination schedules...
April 25, 2017: Vaccine
https://www.readbyqxmd.com/read/28333824/committee-opinion-no-697-planned-home-birth
#13
(no author information available yet)
In the United States, approximately 35,000 births (0.9%) per year occur in the home. Approximately one fourth of these births are unplanned or unattended. Although the American College of Obstetricians and Gynecologists believes that hospitals and accredited birth centers are the safest settings for birth, each woman has the right to make a medically informed decision about delivery. Importantly, women should be informed that several factors are critical to reducing perinatal mortality rates and achieving favorable home birth outcomes...
April 2017: Obstetrics and Gynecology
https://www.readbyqxmd.com/read/28333817/committee-opinion-no-697-summary-planned-home-birth
#14
(no author information available yet)
In the United States, approximately 35,000 births (0.9%) per year occur in the home. Approximately one fourth of these births are unplanned or unattended. Although the American College of Obstetricians and Gynecologists believes that hospitals and accredited birth centers are the safest settings for birth, each woman has the right to make a medically informed decision about delivery. Importantly, women should be informed that several factors are critical to reducing perinatal mortality rates and achieving favorable home birth outcomes...
April 2017: Obstetrics and Gynecology
https://www.readbyqxmd.com/read/28273527/the-accuracy-of-state-nclex-rn%C3%A2-passing-standards-for-nursing-programs
#15
Stephen Foreman
BACKGROUND: Nursing education programs in every state must meet specified NCLEX pass rate standards in order to maintain licensure and accreditation. These standards are a source of great anxiety for educators and students. There is wide variety of pass rate standards among the states. In addition, individual nursing program pass rates vary substantially from one year to the next. OBJECTIVES: Pass rate variation suggests the need for scrutiny of the accuracy of applying state pass rates as a standard for evaluating nursing education program...
May 2017: Nurse Education Today
https://www.readbyqxmd.com/read/28242864/financing-of-pediatric-home-health-care
#16
Edwin Simpser, Mark L Hudak
Pediatric home health care is an effective and holistic venue of treatment of children with medical complexity or developmental disabilities who otherwise may experience frequent and/or prolonged hospitalizations or who may enter chronic institutional care. Demand for pediatric home health care is increasing while the provider base is eroding, primarily because of inadequate payment or restrictions on benefits. As a result, home care responsibilities assumed by family caregivers have increased and imposed financial, physical, and psychological burdens on the family...
March 2017: Pediatrics
https://www.readbyqxmd.com/read/28126142/pneumococcal-vaccination-guidance-for-post-acute-and-long-term-care-settings-recommendations-from-amda-s-infection-advisory-committee
#17
David A Nace, Laurie R Archbald-Pannone, Muhammad S Ashraf, Paul J Drinka, Elizabeth Frentzel, Swati Gaur, Dheeraj Mahajan, David R Mehr, William C Mercer, Philip D Sloane, Robin L P Jump
Efforts at preventing pneumococcal disease are a national health priority, particularly in older adults and especially in post-acute and long-term care settings The Advisory Committee on Immunization Practices recommends that all adults ≥65 years of age, as well as adults 18-64 years of age with specific risk factors, receive both the recently introduced polysaccharide-protein conjugate vaccine against 13 pneumococcal serotypes as well as the polysaccharide vaccine against 23 pneumococcal serotypes. Nursing facility licensure regulations require facilities to assess the pneumococcal vaccination status of each resident, provide education regarding pneumococcal vaccination, and administer the appropriate pneumococcal vaccine when indicated...
February 1, 2017: Journal of the American Medical Directors Association
https://www.readbyqxmd.com/read/28034906/fda-s-approach-to-regulating-biosimilars
#18
Steven J Lemery, M Stacey Ricci, Patricia Keegan, Amy E McKee, Richard Pazdur
The Biologics Price Competition and Innovation (BPCI) Act, enacted as part of the Affordable Care Act, created a new licensure pathway for biological products demonstrated to be biosimilar with or interchangeable with an FDA-licensed biological product (the "reference product"). The FDA's approach to the regulation of biosimilars is based on the requirements set forth in the BPCI Act. A biosimilar product is highly similar to the reference product, notwithstanding minor differences in clinically inactive components, and there are no clinically meaningful differences between products in terms of safety, purity, and potency...
April 15, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/27905888/medicare-program-end-stage-renal-disease-prospective-payment-system-coverage-and-payment-for-renal-dialysis-services-furnished-to-individuals-with-acute-kidney-injury-end-stage-renal-disease-quality-incentive-program-durable-medical-equipment-prosthetics-orthotics
#19
(no author information available yet)
This rule updates and makes revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year 2017. It also finalizes policies for coverage and payment for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. This rule also sets forth requirements for the ESRD Quality Incentive Program, including the inclusion of new quality measures beginning with payment year (PY) 2020 and provides updates to programmatic policies for the PY 2018 and PY 2019 ESRD QIP...
November 4, 2016: Federal Register
https://www.readbyqxmd.com/read/27884478/vaccine-provision-delivering-sustained-widespread-use
#20
Scott Preiss, Nathalie Garçon, Anthony L Cunningham, Richard Strugnell, Leonard R Friedland
The administration of a vaccine to a recipient is the final step in a development and production process that may have begun several decades earlier. Here we describe the scale and complexity of the processes that brings a candidate vaccine through clinical development to the recipient. These challenges include ensuring vaccine quality (between 100 and 500 different Quality Control tests are performed during production to continually assess safety, potency and purity); making decisions about optimal vaccine presentation (pre-filled syringes versus multi-dose vials) that affect capacity and supply; and the importance of maintaining the vaccine cold chain (most vaccines have stringent storage temperature requirements necessary to maintain activity and potency)...
December 20, 2016: Vaccine
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