miércoles, 31 de mayo de 2017

Antimicrobial Resistance, Public Health, and ProMED




31 May 2017 
Dear Colleagues,

Resistance to antibiotics is rising worldwide, threatening gains made over the past seventy years in reducing the burden of infectious disease. ProMED has reported news related to antimicrobial resistance (AMR) throughout its 23-year history. In the past month, we've posted several that illustrate the challenges. Here are three I found particularly interesting.
 
In an extended genetic analysis of 1,777 Klebsiella samples taken from patients at the 2,000-bed Houston Methodist hospital system between 2011 and 2015, a strain of antibiotic resistant Klebsiella pneumoniae was found to cause more infections than one that has been well-studied. (See ProMED Archive Number: 20170522.5055025.) Klebsiella pneumoniae causes infections - including outbreaks in health care settings worldwide - that are increasingly difficult to treat because many strains are resistant to multiple antibiotics. The researchers found that the strain that caused the plurality of infections in the hospital patients studied was as virulent as pandemic CG258 strains, leading them to hypothesize the emergence of an especially successful clonal group of antibiotic-resistant K. pneumoniae.
 
Your financial help supports our mission to improve health and combat infectious diseases throughout the world. By sparking connections among health practitioners and researchers around the globe - and reinforcing these critical connections daily - ProMED is a singular force in creating and sharing the vital information you need to prepare for, prevent, manage, and treat infectious disease. We need your help to carry onPlease, help us now. 

Research into the multi-drug resistant fungus Candida auris was detailed in another post. (See ProMED Archive Number: 20170520.5050111.) Since the CDC released a clinical alert about the emerging fungus in June 2016, 77 clinical cases have been reported. Subsequent screening of close contacts of these patients identified an additional 45. Patients' rooms were environmentally tested and C. auris was identified from mattresses, furniture, surfaces, and infusion pumps, indicating environmental contamination; the fungus was not isolated from rooms after thorough cleaning with disinfectant.
 
Support from subscribers like you makes our efforts to improve global health possible. Help from ProMED's friends allowed us to deliver a record number of reports in 2016, touch more people, and extend the reach of ProMED's timely, dependable data to include practitioners in regions that disproportionately bear the burden of infectious diseases. Through the generosity of your peers around the world, ProMED enlarges and enhances the international infectious disease family. Please join them today. 
 
In Kenya, lack of sanitation, poor lab capability, and inadequate disease surveillance are enabling the spread of the H58 strain of Salmonella Typhi, which is multidrug resistant. (See ProMED Archive Number: 20170430.5005152.) The traditional first-line drugs commonly used to treat acute typhoid continue to be prescribed, but since the 1970s, S. Typhi strains have emerged that are resistant to these antimicrobials, leaving costlier second and third generation drugs as the only alternatives. This added expense increases the burden on already strapped health systems.
 
Incomes are expanding in low-resource countries and the accompanying increase in the use of antibiotics is saving lives. But, while it continues to be true that lack of access to these medications kills more people than does antibiotic resistance, the availability of antibiotics is not a responsible substitute for public health.
 
The International Society for Infectious Diseases plays a key role in improving public health by sparking and sustaining critical connections among scientists, practitioners, and the global infectious disease community. ISID supports research and education, advocates for effective infectious disease prevention, management, and treatment, and promotes global disease surveillance through ProMED. But the only way to ensure ProMED remains the most current, reliable source for infectious disease news and the primary vehicle for communication and collaboration with peers in outbreak investigations and prevention efforts is by demonstrating your commitment.  Won't you please join your peers in supporting ProMED today? Please, give what you can afford, but please give!  
 
Best regards, 
 
Larry Madoff, MD 
Editor
 
P.S. ProMED is committed to building capacity and connecting you to your peers around the world. To succeed, we need your support and that of your affiliated institutions. Please, help us further by asking your colleagues to help too.
International Society of Infectious Diseases | membership@isid.org |http://www.isid.org
9 Babcock St., Unit 3
Brookline, MA 02446

What's New at HCUP User Support

What's New at HCUP User Support



HCUP Fast Stats Data Update
AHRQ has released new information in HCUP Fast Stats— State Trends in Hospital Use by Payer. This Fast Stats update adds one new State—Ohio—to the inpatient portion of this topic and four new States—Arkansas, Massachusetts, Montana, and Wyoming—to the emergency department (ED) portion of this topic. This update also includes additional 2015-2016 inpatient data and 2013-2015 ED data where available.
More information is available at:  http://www.hcup-us.ahrq.gov/faststats/landing.jsp
The HCUP family of health care databases and related software tools and products is made possible by a Federal-State-Industry partnership sponsored by the Agency for Healthcare Research and Quality (AHRQ). 
Visit the HCUP User Support Web site at: https://www.hcup-us.ahrq.gov 

Register for our upcoming CDER SBIA webinars: REMS (June 15th) and Clinical Pharmacology Information in Prescription Drug Labeling (June 19th)

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)
CDER SBIA Webinars
Register for our upcoming CDER SBIA Webinars!
This LIVE extended webinar format, with Q&A sessions, is intended to provide a deeper look at REMS, focusing on two topics:
  • REMS - Purpose, Process, and Challenges - An overview of FDA-required REMS for certain high-risk drugs - the purpose they serve in ensuring the benefits of certain drugs outweigh their risks, the process of developing REMS programs, and the unique challenges of the requirement for a single, shared system for generics and brand products.
  • REMS in Structured Product Labeling Format: An Introduction - An introduction to the use of structured product labeling as a format for REMS information. FDA will describe the history of the REMS SPL project, provide an introduction to SPL, and describe the role of REMS SPL in standardizing REMS and integrating them into the healthcare delivery system.
This LIVE webinar will feature experts from the Office of Clinical Pharmacology presenting highlights from the FDA guidance, Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format, and key prescription drug labeling regulations. After completion of this activity, the participant will be able to:
  • Understand key regulations that impact clinical pharmacology content in prescription drug labeling (also referred to as prescribing information or package insert (PI)).
  • Describe where clinical pharmacology content is found in prescription drug labeling.
  • Describe the content structure of the Clinical Pharmacology section in prescription drug labeling.
  • Identify alternative methods of communicating complex clinical pharmacology content. 
You will have an opportunity to submit questions during a live Q and A session after the presentations.
These webinars have been pre-approved by RAPS as eligible for up to 3 credits each towards a participant’s RAC recertification upon full completion.
Credit is only available for participation in the live event and not for watching the recording afterwards.
For questions concerning the webinar, please contact CDER SBIA at: (866) 405-5367 | (301) 796-6707

CDRH New Update

FDA Logo

CDRHNew

Date: May 31, 2017

The following new items were added to the CDRH web pages on May 30, 2017. Previous items can be found on the CDRHNew Page.

New Medicare cards offer greater protection to more than 57.7 million Americans

CMS Open Door Forum

Department of Health & Human Services
Centers for Medicare & Medicaid Services
Room 352-G
200 Independence Avenue, SW
Washington, DC  20201 _______________________________________________________________________

CMS NEWS

FOR IMMEDIATE RELEASE
May 30, 2017
Contact: CMS Media Relations
(202) 690-6145 | CMS Media Inquiries
New Medicare cards offer greater protection to more than 57.7 million Americans
New cards will no longer contain Social Security numbers, to combat fraud and illegal use
The Centers for Medicare & Medicaid Services (CMS) is readying a fraud prevention initiative that removes Social Security numbers from Medicare cards to help combat identity theft, and safeguard taxpayer dollars. The new cards will use a unique, randomly-assigned number called a Medicare Beneficiary Identifier (MBI), to replace the Social Security-based Health Insurance Claim Number (HICN) currently used on the Medicare card. CMS will begin mailing new cards in April 2018 and will meet the congressional deadline for replacing all Medicare cards by April 2019. Today, CMS kicks-off a multi-faceted outreach campaign to help providers get ready for the new MBI.
“We’re taking this step to protect our seniors from fraudulent use of Social Security numbers which can lead to identity theft and illegal use of Medicare benefits,” said CMS Administrator Seema Verma. “We want to be sure that Medicare beneficiaries and healthcare providers know about these changes well in advance and have the information they need to make a seamless transition.”  
Providers and beneficiaries will both be able to use secure look up tools that will support quick access to MBIs when they need them. There will also be a 21-month transition period where providers will be able to use either the MBI or the HICN further easing the transition
CMS testified on Tuesday, May 23rd before the U.S. House Committee on Ways & Means Subcommittee on Social Security and U.S. House Committee on Oversight & Government Reform Subcommittee on Information Technology, addressing CMS’s comprehensive plan for the removal of Social Security numbers and transition to MBIs.
Personal identity theft affects a large and growing number of seniors. People age 65 or older are increasingly the victims of this type of crime. Incidents among seniors increased to 2.6 million from 2.1 million between 2012 and 2014, according to the most current statistics from the Department of Justice. Identity theft can take not only an emotional toll on those who experience it, but also a financial one: two-thirds of all identity theft victims reported a direct financial loss. It can also disrupt lives, damage credit ratings and result in inaccuracies in medical records and costly false claims.
Work on this important initiative began many years ago, and was accelerated following passage of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). CMS will assign all Medicare beneficiaries a new, unique MBI number which will contain a combination of numbers and uppercase letters. Beneficiaries will be instructed to safely and securely destroy their current Medicare cards and keep the new MBI confidential. Issuance of the new MBI will not change the benefits a Medicare beneficiary receives.  
CMS is committed to a successful transition to the MBI for people with Medicare and for the health care provider community. CMS has a website dedicated to the Social Security Removal Initiative (SSNRI) where providers can find the latest information and sign-up for newsletters. CMS is also planning regular calls as a way to share updates and answer provider questions before and after new cards are mailed beginning in April 2018.
For more information, please visit: https://www.cms.gov/medicare/ssnri/index.html

CDER New May 31, 2017

New FDA Logo Blue
What's New on the FDA Drugs Site
May 30, 2017

SALUD EQUITATIVA [https://saludequitativa.blogspot.com.ar]: DIRECTORIO DE DOCUMENTOS EDITADOS EN MAYO de 2017 [*] ▲ SALUD EQUITATIVA - GESTIÓN EN SALUD PÚBLICA ► Contenidos Copyright by Cerasale Morteo, Víctor Norberto, 2008 a 2017. SALTA / ARGENTINA. 31 de MAYO de 2017. [13/00064]

SALUD EQUITATIVA [https://saludequitativa.blogspot.com.ar]: DIRECTORIO DE DOCUMENTOS EDITADOS EN MAYO de 2017 [*]  SALUD EQUITATIVA - GESTIÓN EN SALUD PÚBLICA  Contenidos Copyright by Cerasale Morteo, Víctor Norberto, 2008 a 2017. SALTA / ARGENTINA. 31 de MAYO de 2017. [13/00064]

 [https://saludequitativa.blogspot.com.ar]:
SALUD EQUITATIVA [https://saludequitativa.blogspot.com.ar]: DIRECTORIO DE DOCUMENTOS EDITADOS EN MAYO de 2017 [*]  SALUD EQUITATIVA - GESTIÓN EN SALUD PÚBLICA  Contenidos Copyright by Cerasale Morteo, Víctor Norberto, 2008 a 2017. SALTA / ARGENTINA. 

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NUESTRA SEÑORA DE LA MEDALLA MILAGROSA

NUESTRA SEÑORA DE LA MEDALLA MILAGROSA
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