martes, 22 de agosto de 2017

Home - American College of Radiology

Home - American College of Radiology

ngc

Coming Soon

New & Updated American College of Radiology (ACR) Appropriateness Criteria Guidelines.

NGC Update Service: August 21, 2017 || American Society for Radiation Oncology

NGC Update Service: August 21, 2017

ngc

American Society for Radiation Oncology

NGC Update Service: August 21, 2017 || American Society of Clinical Oncology

NGC Update Service: August 21, 2017

ngc

American Society of Clinical Oncology

Working to Improve Information on Medication Use during Pregnancy | FDA Voice

Working to Improve Information on Medication Use during Pregnancy | FDA Voice

New FDA Logo Blue



Working to Improve Information on Medication Use during Pregnancy

By: Pamela E. Scott, Ph.D.
When women are pregnant they take care to eat right and refrain from smoking and drinking alcoholic beverages.  But what to do about prescription drugs is a more complicated topic.
Pamela ScottThere are very few prescription medications that have been specifically approved for use during pregnancy. And yet, doctors in clinical practice must prescribe needed medicines to pregnant women to treat a variety of illnesses and conditions such as diabetes, high blood pressure or even something as simple as a dental infection.
Indeed, about half of the 6.3 million women who are pregnant every year take at least one medication, and prescription use is on the rise, up by more than 60 percent from 1976 through 2008.
More information is clearly needed. The 21st Century Cures Act, which was enacted in 2016, established a task force to consider what is being done to identify and address gaps in knowledge and research on safe and effective therapies for pregnant and lactating women. Within 18 months after it is established, the task force will develop a report to Congress with specific recommendations for addressing the issues identified. The Office of Women’s Health (OWH) is leading FDA’s activities for the task force. My colleagues at OWH will be working with FDA’s Centers to promote dialogue and research collaboration. We look forward to hearing from our public and private partners at the Task Force’s two-day public meeting, which begins today.
Meanwhile, we are continuing our work to help ensure that doctors and their patients have better drug information. In 2015 we began implementation of new requirements for the pregnancy and lactation subsections of labeling for prescription products. The new requirements provide a framework for clearly communicating information on the benefits and risks of using a drug during pregnancy and lactation and also remove the decades-old pregnancy category letter system that was often confusing and did not accurately or consistently communicate differences in degrees of fetal risk.
FDA is also collaborating on research to fill in the gaps of our knowledge about medication use by pregnant women. OWH leads pregnancy research initiatives that fund studies and workshops to support FDA decision-making. Some of our research is using predictive modeling to try to anticipate how pregnant women might respond to a drug without having to expose them to the drug during a clinical trial. Other projects address emerging issues like Zika while others have examined ongoing issues like food safety in pregnancy. FDA’s Centers are also conducting research to better understand the safety, efficacy and effects of products used during pregnancy. Their research addresses a wide array of topics including vaccine safety, MRI effects, drug toxicity, and tobacco use and its potential impact in pregnancy.
Through the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP), a multi-site research collaboration between FDA, academia and health insurers, FDA is doing research to learn more about medication effects by linking healthcare records for moms and babies. MEPREP has already conducted a number of projects including an award-winning study of sulfonamide use during pregnancy and the risk of congenital anomalies. MEPREP is currently conducting a 3-year epidemiologic study to evaluate a potential association between neural tube defects and maternal exposure to prescription opioids.
Finally, we are doing what we can to encourage pregnant women to enroll in a pregnancy exposure registry if they take a prescription drug for a medical condition. Enrolling can help improve safety information for medicines used during pregnancy and can be used to update drug labeling. FDA’s pregnancy registry site connects women and health professionals to over 40 registries and provides links to drug information and educational resources on medication use during pregnancy. Studies conducted with the registry data can help to provide information on the effects of prescription drug and vaccine exposures on the health of pregnant women and, after they give birth, of their babies.
Real-World Research and Safety Monitoring
FDA’s pregnancy research assists in the assessment and safety monitoring of the range of products that pregnant women use in their daily lives. Our guidance and policy efforts provide a research framework for industry. And, our pregnancy outreach activities help to raise awareness and disseminate timely safety information. The work that we do with other government and private sector partners leverages existing data and collaborative approaches to address gaps in knowledge about medication use during pregnancy.
Throughout my career at FDA, I have had the chance to collaborate with diverse partners on pregnancy research with MEPREP and later in my role at OWH, and I have seen the positive impact of FDA’s pregnancy initiatives. I look forward to the task force report. But in the interim, I know that OWH will continue to serve as an information source and catalyst for research in support of FDA’s ongoing commitment to providing pregnant women and their healthcare providers with the best possible information to guide their healthcare decisions.
Pamela E. Scott, Ph.D., is Deputy Director and Director of Research and Development, FDA Office of Women’s Health
Recent Related Posts

CFSAN Constituent Update: FDA Launches Food Safety Plan Builder to Help Businesses Comply with FSMA Requirements

FDA Logo
Center for Food Safety and Applied Nutrition
Constituent Update

FDA Launches Food Safety Plan Builder to Help Businesses Comply with FSMA Requirements
August 22, 2017
To help businesses meet the requirements of the Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food, the U.S. Food and Drug Administration is releasing a new software tool to help owners and operators of food facilities create a food safety plan specific to their facilities.
The Food Safety Plan Builder (FSPB) is a free software application, developed by FDA,  that businesses can download from the FDA’s website to guide them, step-by-step, through the creation of a food safety plan, as required by  FSMA.
The user is taken through a series of sections (tabs) in the application that prompt the user to answer questions and/or fill in information specific to their business and facility. Once all the  tabs have been completed, the file may be saved or printed, and the firm will have a food safety plan to use in its operations and to provide when the FDA conducts an inspection.
While the Food Safety Plan Builder was primarily designed for use by small manufacturers, which may have limited resources, any size manufacturer can opt to use it. Although manufacturers are not required to use the program, the FDA designed this program to help companies organize their food safety information and minimize the burden of creating their food safety plan.
To assist users, the FDA has also developed an overview video about the application, as well as individual videos that demonstrate how to navigate the various tabs.  These videos are posted on Youtube and may be accessed via the Food Safety Plan Builder webpage. The FDA has also provided a User Guide with individual chapters devoted to each tab. Manufacturers with questions about how to use the tool can access further assistance by contacting the FDA through the email address FoodSafetyPlanBuilder@fda.hhs.gov.   
The program and educational materials are modeled after the successful Food Defense Plan Builder, which was created to assist owners and operators of food facilities with developing personalized food defense plans for their facilities.
Additional Information:

Advances in Patient Safety and Medical Liability | Agency for Healthcare Research & Quality

Advances in Patient Safety and Medical Liability | Agency for Healthcare Research & Quality



A new online publication from AHRQ highlights the results from a number of AHRQ-funded planning and demonstration grants aimed at improving patient safety and malpractice outcomes, as well as the environment in which those outcomes occur. In 2009, AHRQ, the nation’s lead agency on improving patient safety, was asked by the U.S. Department of Health and Human Services to spearhead the Patient Safety and Medical Liability Initiative. Activities and findings from the initiative have laid the groundwork for future patient safety and medical liability projects. Among topics included in the new publication, entitled Advances in Patient Safety and Medical Liability: the role of the patient and family in supporting improved care and patient safety; the harmful impact of institutional silence when patient harm occurs; the use of different types of reporting systems; and implementation of disclosure, apology and offer programs.



AHRQ--Agency for Healthcare Research and Quality: Advancing Excellence in Health Care



In October 2009, AHRQ launched the Patient Safety and Medical Liability (PSML) Initiative to address four goals: (1) putting patient safety first by reducing preventable injuries, (2) fostering better communication between doctors and patients, (3) ensuring fair and timely compensation for medical injuries while reducing malpractice litigation, and (4) reducing liability premiums. Under the PSML initiative, AHRQ funded 13 planning grants and 7 demonstration grants; the goal was to help States and health systems seek comprehensive solutions that improve patient safety and address the underlying causes of the malpractice problem. This publication, Advances in Patient Safety and Medical Liability, presents contributions and findings from the AHRQ-funded projects. In addition to a prologue, the volume includes two commentaries and nine papers, organized into two primary themes: improving communication and improving patient safety.
Editors:
James Battles, PhD
Irim Azam, MPH
Mary Grady, BS
Kathryn Reback, JD, MSN
Agency for Healthcare Research and Quality
Rockville, MD

Contents

Prologue
Kenneth Sands, Alan Woodward, and Melinda Van Niel

Improving Communication

Commentary: Silence
Carole Hemmelgarn
Planning and Implementing the Patient Advocacy Reporting System® in the Sanford Health System
James W. Pichert, Wendell W. Hoffman, David Danielson, Cindy Baldwin, Craig Uthe, Meghan Goldammer, Thomas F. Catron, Sue Garey, Jan Karrass, Peggy Westlake, Rhonda Ketterling, William O. Cooper, and Gerald B. Hickson

Improving Patient Safety

Commentary: Patient Safety Culture and Medical Liability—Recommendations for Measurement, Analysis, and Interpretation
Sallie J. Weaver, Jill A. Marsteller, Albert W. Wu, Mohd Nasir Mohd Ismail, and Peter J. Pronovost
Error Disclosure Training and Organizational Culture
Jason M. Etchegaray, Thomas H. Gallagher, Sigall K. Bell, William M. Sage, and Eric J. Thomas
Applying a Novel Organizational Change Scale in a Multisite Patient Safety Initiative
Douglas M. Brock, Andrew A. White, Lauren Lipira, Patricia I. McCotter, Sarah Shannon, and Thomas H. Gallagher
Implementing Near‑Miss Reporting and Improvement Tracking in Primary Care Practices: Lessons Learned
Steven Crane, Philip D. Sloane, Nancy C. Elder, Lauren W. Cohen, Natascha Laughtenschlager, and Sheryl Zimmerman
Implementing Shared Decision-Making: Barriers and Solutions—An Orthopedic Case Study
Shawn L. Mincer, Michael J. Lee, Richard J. Bransford, Saint Adeogba, Karen L. Posner, Lynne S. Robins, Pornsak Chandanabhumma, Michelle S. Lam, Aaron S. Azose, and Karen B. Domino
Transitional Care Medication Safety: Stakeholders’ Perspectives
Cynthia F. Corbett, Alice E. Dupler, Suzanna Smith, E’lise M. Balogh, and Cory R. Bolkan
Medication Discrepancies and Potential Adverse Drug Events During Transfer of Care from Hospital to Home
Joshua J. Neumiller, Stephen M. Setter, Allison M. White, Cynthia F. Corbett, Douglas L. Weeks, Kenn B. Daratha, and Jeffrey B. Collins
Disclaimer: The opinions presented in this publication are those of the authors and do not necessarily represent the position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
This publication is in the public domain and may be used and reprinted without permission, except for those items identified as protected by copyright. For these items, readers will need to contact the copyright holder for further permission to use and reproduce the materials. Citation as to source will be appreciated.
Suggested citation: Advances in Patient Safety and Medical Liability. Battles J, Azam I, Grady M, and Reback K, Eds. AHRQ Publication No. 17-0017. Rockville, MD: Agency for Healthcare Research and Quality; August 2017.
Editors' Affiliations: James Battles, PhD, Former Project Officer (Retired); Irim Azam, MPH; Kathryn Reback, JD, MSN; Center for Quality Improvement and Patient Safety, Agency for Healthcare Research and Quality (AHRQ). Mary Grady, BS, Office of Communications, AHRQ.
Page last reviewed August 2017
Page originally created August 2017


Internet Citation: Advances in Patient Safety and Medical Liability. Content last reviewed August 2017. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/professionals/quality-patient-safety/patient-safety-resources/resources/liability/advances-in-patient-safety-medical-liability/index.html

SMAIF In Action: Health Models Program in Louisiana Improves HIV Viral Suppression In All Three Participating Clinics | HIV.gov

SMAIF In Action: Health Models Program in Louisiana Improves HIV Viral Suppression In All Three Participating Clinics | HIV.gov

HIV.gov



SMAIF In Action: Health Models Program in Louisiana Improves HIV Viral Suppression In All Three Participating Clinics

August 21, 2017 - HIV.gov Blog

TOPICS: Communities of Color, SMAIF, Viral Supression
It is essential that every person living with HIV be in medical care and receive effective HIV treatment for their entire life (or until a cure is found). This keeps them healthy and reduces the possibility that they would be able to pass on HIV to others. The reality is, however, that keeping up with medical appointments, lab tests, and prescription refills is not always easy.... [READ MORE]

CDER New August 22, 2017

New FDA Logo Blue
What's New on the FDA Drugs Site

August 21, 2017

CDRH New Update

FDA Logo

CDRHNew

Date: August 22, 2017

The following new items were added to the CDRH web pages on August 21, 2017. Previous CDRHNew items can be found on the CDRHNew Page.

Career & Training Opportunities | NIH: National Institute of Allergy and Infectious Diseases

Career & Training Opportunities | NIH: National Institute of Allergy and Infectious Diseases

NIAID Logo

Flag with Flasks

"Flag with Flasks; Credit: NIAID"

Medical Officer (Clinical)

NIAID seeks exceptional and motivated clinicians for medical officer positions within the Division of AIDS. Responsibilities will relate to the development and medical oversight of clinic trials sponsored by the division for the prevention and/or treatment of HIV/AIDS and/or related co-infections such as tuberculosis and hepatitis B. Candidates must be U.S. citizens, have an M.D. or D.O., and have an active medical license. 
The position is now open on www.USAJobs.gov until August 25, 2017. Search vacancy announcement NIH-NIAID-DH-17-1974690 to apply!
Visit NIAID Careers now for additional information.

HHS, NIH, and NIAID are equal opportunity employers.