News and Updates for Healthcare Professionals

Study funded by NIH supports optimal threshold for diagnosing COPD

Approximately 16 million Americans have COPD.

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NIH-funded trial finds vitamin D does not prevent type 2 diabetes in people at high risk

Study is largest to examine daily supplementation.

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NIH funds clinical trials using genomics to treat chronic diseases

The National Institutes of Health will fund clinical trials to assess the benefits, applicability and efficacy of applying genomic medicine interventions to improve management of diseases such as high blood pressure, depression and chronic pain. The trials are part of the second phase of the Implementing Genomics in Practice (IGNITE) Network with a total investment of $42 million over five years, pending the availability of funds. The trials will begin in 2020.

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FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering

[4-9-2019] The U.S. Food and Drug Administration (FDA) has received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.

While we continue to track this safety concern as part of our ongoing monitoring of risks associated with opioid pain medicines, we are requiring changes to the prescribing information for these medicines that are intended for use in the outpatient setting. These changes will provide expanded guidance to health care professionals on how to safely decrease the dose in patients who are physically dependent on opioid pain medicines when the dose is to be decreased or the medicine is to be discontinued.

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CMS Modernizes Care for Frail, Elderly Individuals Enrolled in PACE

The Centers for Medicare & Medicaid Services (CMS) finalized a rule today to update and modernize requirements for the Programs of All-Inclusive Care for the Elderly (PACE). The PACE program provides comprehensive medical and social services to certain frail, elderly individuals who qualify for nursing home care but, at the time of enrollment, can still live safely in the community. The policies finalized in this rule reflect the latest standards in caring for PACE participants – many of whom are “dually eligible” for both Medicare and Medicaid – and will strengthen patient protections, improve care coordination, and provide administrative flexibilities and regulatory relief for PACE organizations.

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Project to deter opioid tampering wins top Addiction Science Award

NIDA announces awardees at the 2019 Intel International Science and Engineering Fair.

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Food, beverage companies commit to WHO trans fat elimination goal

Trans fat intake is responsible for over 500,000 deaths from coronary heart disease each year globally. WHO welcomes the commitment by the International Food and Beverage Alliance (IFBA) to align with the WHO target to eliminate industrially produced trans fat from the global food supply by 2023.

WHO Director-General Dr Tedros Adhanom Ghebreyesus met with IFBA representatives to discuss actions to take to eliminate industrial trans fats, and reduce salt, sugar and saturated fats in processed foods.

“Eliminating industrially-produced trans fat is one of the simplest and most effective ways to save lives and create a healthier food supply,” said Dr Tedros.

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Patient-Centered Care Is Key to Best Practices in Pain Management

By: Vanila M. Singh , MD, MACM

Summary: Dr. Vanila Singh explains the work of the Pain Management Best Practices Inter-Agency Task Force.

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NIH statement on World Asthma Day 2019

NIH supports increasing knowledge of asthma and better treatment and prevention options

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Guidelines proposed for newly defined Alzheimer’s-like brain disorder

Recommendations for scientists and public emerge from NIH-funded workshop.

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FDA MedWatch – Certain Prescription Insomnia Medicines: New Boxed Warning

A new MedWatch Safety Alert was just added to the FDA MedWatch webpage.

TOPIC: Certain Prescription Insomnia Medicines: New Boxed Warning – Due to Risk of Serious Injuries Caused by Sleepwalking, Sleep Driving and Engaging in Other Activities While Not Fully Awake

AUDIENCE: Patient, Health Professional, Pharmacy

ISSUE: FDA is advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths. These behaviors appear to be more common with Lunesta (eszopiclone), Sonata (zaleplon), Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist (zolpidem) than other prescription medicines used for sleep and we are requiring a Boxed Warning, our most prominent warning, to be added to the prescribing information and the patient Medication Guides for these medicines.

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AHRQ Evidence-Based Practice Update

Telehealth for Acute and Chronic Care Consultations

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Panel highlights need for further innovative research approaches to inform appropriate long-term use of osteoporosis drug therapies

It is projected that by 2025, the total U.S. health care costs attributable to fractures will reach $25 billion annually.

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FDA MedWatch – Opioid Pain Medicines: Drug Safety Communication

MedWatch – The FDA Safety Information and Adverse Event Reporting Program

A new MedWatch Safety Alert was just added to the FDA Drug Safety Communication webpage.

TOPIC: Opioid Pain Medicines: Drug Safety Communication – Harm to Patient Reported From Sudden Discontinuation of Opioid Pain Medicine

AUDIENCE: Patient, Health Professional, Pain Management, Pharmacy

ISSUE: FDA has received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.

Rapid discontinuation can result in uncontrolled pain or withdrawal symptoms. In turn, these symptoms can lead patients to seek other sources of opioid pain medicines, which may be confused with drug-seeking for abuse. Patients may attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.

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Women outlive men: where and why

Women outlive men everywhere in the world – particularly in wealthy countries. The World Health Statistics 2019 – disaggregated by sex for the first time – explains why. Our task is to use these data to make evidence-based policy decisions that move us closer to a healthier, safer, fairer world for everyone.

“Breaking down data by age, sex and income group is vital for understanding who is being left behind and why. Behind every number in the World Health Statistics is a person, a family, a community or a nation,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.

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Gout treatment may help prevent obesity-related type 2 diabetes, suggests small NIH study

Colchicine may potentially reduce complications accompanying metabolic syndrome.

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AHRQ Evidence-Based Practice Update

Adverse Effects of Pharmacological Treatments of Major Depression in Older Adults

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MedWatch – The FDA Safety Information and Adverse Event Reporting Program

An Update to Three Recent MedWatch Safety Alert Recalls: on Angiotensin II Receptor Blocker Including Valsartan and Losartan.

  • Losartan Potassium Tablets and Losartan Potassium/Hydrochlorothiazide Tablets by Torrent Pharmaceuticals Limited: Recall – Due to the Detection of Trace Amounts of N-Methylnitrosobutyric Acid Found in an Active Pharmaceutical Ingredient (API) (03/01/19)
  • Amlodipine Valsartan Tablets and Valsartan Tablets by AurobindoPharma USA: Recall – Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity (03/01/19)
  • Losartan Potassium Tablets by Camber Pharmaceuticals: Recall – Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino Butyric Acid (NMBA) Impurity Found in the API (02/28/19)
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NIH study of brain energy patterns provides new insights into alcohol effects

Study could help understanding of how the brain uses energy in health and disease.

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Long periods of sedentary behavior may increase cardiovascular risk in older women

new study has found that the longer older women sit or lay down during the course of a day—and the longer the individual periods of uninterrupted sitting—the greater their risk of cardiovascular diseases such as heart disease and stroke. But…

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Monthly buprenorphine injections effective for opioid use disorders

Study results on long-acting injection formulation now published.

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Two decades of data reveal overall increase in pain, opioid use among U.S. adults

Researchers measured pain’s impact on normal work activities, people’s health status, and health care use.

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Study helps solve mystery of how sleep protects against heart disease

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Addressing Social Isolation To Improve the Health of Older Adults: A Rapid Review

Purpose of Review

To rapidly evaluate the effect of interventions targeting social isolation/loneliness in community-dwelling older adults (60 years and older) on outcomes of social isolation/loneliness, health and health care utilization.

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NIH study provides answer to long-held debate on blood sugar control after stroke

Findings may have immediate impact on clinical practice.

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Nearly half of US adults have cardiovascular disease, study says

(CNN) – Nearly half of all adults in the United States have some type of cardiovascular disease, according to the American Heart Association, defining the condition as coronary heart disease, heart failure, stroke or high blood pressure.

And after decades of declines, deaths from cardiovascular disease are on the rise again, with 840,678 deaths recorded in 2016, up from 836,546 in 2015, according to the association’s annual report Heart and Stroke Statistics,, published Thursday in the medical journal Circulation.

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American Diabetes Association 2019 Guidelines for Type 2 Diabetes

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What’s New at AHRQ

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Daily low-dose aspirin found to have no effect on healthy life span in older people

Large NIH-funded study examined outcomes in United States and Australia

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Announcement

New AHRQ Study To Explore Models for Making Evidence More Accessible and Usable

A new study initiated by AHRQ will help identify new models for disseminating and accessing evidence-based clinical practice guidelines. The 12-month project is intended to build on AHRQ’s previous support for the National Guideline Clearinghouse. The study will explore innovative approaches to make evidence readily discoverable, accessible and usable to support improved patient outcomes. Viable models will be defined by commitment to core elements such as free public access, advertising-free content, upholding of copyright permissions and adherence to trustworthiness standards established by the Institute of Medicine. The study will also identify organizations with the potential to satisfy those standards.

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