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licensure and regulation

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
Steven J Lemery, M Stacey Ricci, Patricia Keegan, Amy E McKee, Richard Pazdur
The Biosimilar 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"). 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...
December 29, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
(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
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
Holliday Tyson, Karline Wilson-Mitchell
Midwifery educators and regulators in Canada have begun to address diversity, equity, and inclusion in admission processes and program curricula. Populations served by midwives value internationally educated midwives from their countries of origin. The International Midwifery Pre-Registration Program at Ryerson University in Toronto, Ontario, provides assessment, midwifery workplace orientation, and accelerated education for internationally educated midwives on behalf of the regulatory College of Midwives of Ontario...
November 2016: Journal of Midwifery & Women's Health
Denise F Lillvis, Robert J McGrath
State medical boards are increasingly responsible for regulating medical and osteopathic licensure and professional conduct in the United States. Yet, there is great variation in the extent to which such boards take disciplinary action against physicians, indicating that some boards are more zealous regulators than others. We look to the political roots of such variation and seek to answer a simple, yet important, question: are nominally apolitical state medical boards responsive to political preferences? To address this question, we use panel data on disciplinary actions across sixty-four state medical boards from 1993 through 2006 and control for over-time changes in board characteristics (e...
October 11, 2016: Journal of Health Politics, Policy and Law
Corinna Klingler, Georg Marckmann
BACKGROUND: With Germany facing a shortage of doctors, hospitals have been increasingly recruiting physicians from abroad. Studies in other countries have shown that migrant physicians experience various difficulties in their work, which might impact the quality of patient care, physician job satisfaction, and, accordingly, retention. The experiences of migrant doctors in Germany have not been systematically studied so far and will likely differ from experiences migrant physicians make in other contexts...
2016: Human Resources for Health
Binyamin Binyaminy, Eric J Haas
In Israel, only physicians, dentists, and psychologists who complete an accredited licensing process may practice hypnosis. This study examines the characteristics of hypnotherapists compared to nonhypnotherapists in the same discipline. All hypnotherapists in Israel were compared to nonhypnotherapist health professionals. There are more subspecialists among hypnotists, and the most common specialties were psychiatry, pediatric dentistry, and clinical psychology. These findings imply self-sorting of hypnotists as a result of the regulation in Israel...
October 2016: International Journal of Clinical and Experimental Hypnosis
Robert Paul, Maria Athina Tina Martimianakis, Julie Johnstone, Nancy McNaughton, Zubin Austin
The integration of internationally educated health professionals (IEHPs) into the health workforces of their adopted countries is an issue that has challenged policy makers and policy scholars for decades. In this article, the authors explore the implications of the ideological underpinnings of the policy subsystems that IEHPs must navigate in seeking employment in Canada, with a focus on Ontario.Using a policy subsystem approach, in 2015 the authors analyzed a large preexisting data set composed of articles, governmental reports, Web sites, and transcripts of interviews and focus groups conducted in Ontario with IEHPs, health care executives, human resource managers, and job counselors to IEHPs...
August 9, 2016: Academic Medicine: Journal of the Association of American Medical Colleges
Dawn Whiteside
Professionalism in nursing leadership encompasses key elements that include a common body of knowledge, autonomous practice, self-regulation through education and licensure, a set code of ethics, and a commitment to altruism. Perioperative nurse leaders also must embrace collaboration, vision, accountability, and patient and staff member advocacy based on established ethics, values, and standards of care. Nurse leaders who are committed to professional development through pursuit of higher degrees, application of evidence-based practice, collaboration with colleagues, and certification show a strong commitment to their profession and serve as role models for staff members...
August 2016: AORN Journal
(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...
2016: Obstetrics and Gynecology
(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...
August 2016: Obstetrics and Gynecology
Jerry P Weir, Marion F Gruber
Influenza virus vaccines are unique among currently licensed viral vaccines. The vaccines designed to protect against seasonal influenza illness must be updated periodically in an effort to match the vaccine strain with currently circulating viruses, and the vaccine manufacturing timeline includes multiple, overlapping processes with a very limited amount of flexibility. In the United States (U.S.), over 150 million doses of seasonal trivalent and quadrivalent vaccine are produced annually, a mammoth effort, particularly in the context of a vaccine with components that usually change on a yearly basis...
September 2016: Influenza and Other Respiratory Viruses
Meigan K Robb
Pre-licensure baccalaureate nursing programs are facing the demand to retain and graduate students with the skills needed for the complex health care environment. Nursing faculty are challenged to identify the best pedagogical methods for educating the current generation of students. The influence of student-centered approaches is documented in the literature. However, the effective use of these methods requires a collaborative partnership. The cognitive, self-regulated approaches used by millennial nursing students is not well understood...
May 2016: Nursing Education Perspectives
Tegbar Yigzaw, Catherine Carr, Jelle Stekelenburg, Jos van Roosmalen, Hannah Gibson, Mintwab Gelagay, Azeb Admassu
PURPOSE: Realizing aspirations for meeting the global reproductive, maternal, newborn, and child health goals depends not only on increasing the numbers but also on improving the capability of midwifery workforce. We conducted a task analysis study to identify the needs for strengthening the midwifery workforce in Ethiopia. METHODS: We conducted a cross-sectional study of recently qualified midwives in Ethiopia. Purposively selected participants from representative geographic and practice settings completed a self-administered questionnaire, making judgments about the frequency of performance, criticality, competence, and location of training for a list of validated midwifery tasks...
2016: International Journal of Women's Health
Donald M Jensen, Phoebe Sebhatu, Nancy S Reau
The recent development and approval of expensive but highly effective oral agents against hepatitis C has led to restrictions and access limitations in many countries with limited healthcare budgets. Generic formulations of many of these agents are available at a fraction of the retail price in several countries because of generic licensure agreements. The discounted alternatives are only accessible in developing countries and require manufacturing and distribution regulations to ensure the quality and bioequivalence of the new drug formulations...
July 2016: Liver International: Official Journal of the International Association for the Study of the Liver
Tanya Horsley, Jocelyn Lockyer, Elise Cogo, Jeanie Zeiter, Ford Bursey, Craig Campbell
OBJECTIVE: To explore and categorise the state of existing literature for national programmes designed to affirm or establish the continuing competence of physicians. DESIGN: Scoping review. DATA SOURCES: MEDLINE, ERIC, Sociological Abstracts, web/grey literature (2000-2014). SELECTION: Included when a record described a (1) national-level physician validation system, (2) recognised as a system for affirming competence and (3) reported relevant data...
April 15, 2016: BMJ Open
Norman W Baylor
A vaccine is an immunogen, the administration of which is intended to stimulate the immune system to result in the prevention, amelioration, or therapy of any disease or infection (US Food and Drug Administration. Guidance for Industry: content and format of chemistry, manufacturing, and controls information and establishment description information for a vaccine or related product). A vaccine may be a live attenuated preparation of microorganisms, inactivated (killed) whole organisms, living irradiated cells, crude fractions, or purified immunogens, including those derived from recombinant DNA in a host cell, conjugates formed by covalent linkage of components, synthetic antigens, polynucleotides (such as the plasmid DNA vaccines), living vectored cells expressing specific heterologous immunogens, or cells pulsed with immunogen...
2016: Methods in Molecular Biology
R Scott Johnson, J Christopher Fowler, Suni N Jani, Hillary L Eichelberger, John M Oldham, Edward Poa, David P Graham
Few studies examine the effect of interpersonal, regulatory or legal coercion on the treatment of depressive symptoms. This retrospective case-control study compared the recovery rates of 574 adults whose level of coercion was scored on a 0-3 scale from fully voluntary to severe coercion when admitted to the Menninger Clinic between 2009 and 2014. The change in Patient Health Questionnaire-9 (PHQ-9) scores (measuring depression severity) from admission to discharge served as the primary outcome measure. Level of coercion was not associated with a difference in rate of improvement in PHQ-9 score...
March 19, 2016: Psychiatric Quarterly
Cui Tao, Yongqun He, Sivaram Arabandi
The "Vaccine and Drug Ontology Studies" (VDOS) international workshop series focuses on vaccine- and drug-related ontology modeling and applications. Drugs and vaccines have been critical to prevent and treat human and animal diseases. Work in both (drugs and vaccines) areas is closely related - from preclinical research and development to manufacturing, clinical trials, government approval and regulation, and post-licensure usage surveillance and monitoring. Over the last decade, tremendous efforts have been made in the biomedical ontology community to ontologically represent various areas associated with vaccines and drugs - extending existing clinical terminology systems such as SNOMED, RxNorm, NDF-RT, and MedDRA, developing new models such as the Vaccine Ontology (VO) and Ontology of Adverse Events (OAE), vernacular medical terminologies such as the Consumer Health Vocabulary (CHV)...
2016: Journal of Biomedical Semantics
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