News and Updates for Healthcare Professionals

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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Preventing 1 Million Heart Attacks and Strokes: CDC Vital Signs Report

Heart attacks and strokes can be catastrophic, life-changing events that are all too common. Heart disease and stroke are preventable, yet they remain leading causes of death, disability, and healthcare spending in the US. Alarmingly, many of these events happen to adults ages 35-64—over 800,000 in 2016. Million Hearts® is a national initiative with a network of partners focused on preventing one million heart attacks, strokes, and other cardiovascular events by 2022. Coordinated actions by public health and healthcare professionals, communities, and healthcare systems can and will keep people healthy, optimize care, and improve outcomes within priority populations.

Key points:

  • About 16 million heart attacks, strokes, and related heart-threatening events* could happen by 2022.
  • 1 in 3, of these life-changing cardiovascular events happened in adults 35-64 years old in 2016.
  • 80% of premature heart disease and strokes are preventable.
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Opioids Training Modules

The Centers for Disease Control & Prevention (CDC) launched two new opioid trainings that support providers in safer prescribing of opioids for chronic pain. The modules are part of a series of interactive online trainings that feature recommendations from the CDC Guideline for Prescribing Opioids for Chronic Pain, clinical scenarios, tools, and resource libraries to enhance learning. The modules offer free continuing education.

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2019 ADA Standards of Care: changes promote patient-centered approach

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CMS Takes Action to Lower Prescription Drug Costs by Modernizing Medicare

Proposed regulation for Medicare Parts C & D would strengthen negotiations with prescription drug manufacturers to lower costs and increase transparency for patients

Today, the Centers for Medicare & Medicaid Services (CMS) proposed polices for 2020 to strengthen and modernize the Medicare Part C and D programs. The proposal would ensure that Medicare Advantage and Part D plans have more tools to negotiate lower drug prices, and the agency is also considering a policy that would require pharmacy rebates to be passed on to seniors to lower their drug costs at the pharmacy counter.

President Trump is following through on his promise to bring tougher negotiation to Medicare and bring down drug costs for patients, without restricting patient access or choice, said HHS Secretary Alex Azar. By bringing the latest tools from the private sector to Medicare Part D, we can save money for taxpayers and seniors, improve access to expensive drugs many seniors need, and expand their choice of plans. The Part D proposals complement efforts to bring down costs in Medicare Advantage and in Medicare Part B through negotiation, all part of the President’s plan to put American patients first by bringing down prescription-drug prices and out-of-pocket costs.

In the twelve years since the Part D program was launched, many of the tools outlined in today’s proposal have been developed in the commercial health insurance marketplace, and the result has been lower costs for patients. Seniors in Medicare also deserve to benefit from these approaches to reducing costs, so today CMS is proposing to modernize the Medicare Advantage and Part D programs and remove barriers that keep plans from leveraging these tools.

In designing today’s proposal, foremost in the agency’s mind was the impact on patients, and the proposal is yet another action CMS has taken to deliver on President Trump and Secretary Azar’s commitment on drug prices, said CMS Administrator Seema Verma. Today’s changes will provide seniors with more plan options featuring lower costs for prescription drugs, and seniors will remain in the driver’s seat as they can choose the plan that works best for them. The result will be increasing access to the medicines that seniors depend on by lowering their out-of-pocket costs.

Private plan options for receiving Medicare benefits are increasing in popularity, with almost 37 percent of Medicare beneficiaries expected to enroll in Medicare Advantage in 2019, and Part D enrollment increasing year-over-year as well. The programs are driven by market competition; plans compete for beneficiaries’ business, and each enrollee chooses the plan that best meets his or her needs. Consumer choice puts pressure on plans to improve quality and lower costs. Premiums in both Medicare Advantage and Part D are projected to decline next year.

Today’s proposed changes include:

  • Providing Part D plans with greater flexibility to negotiate discounts for drugs in “protected” therapeutic classes, so beneficiaries who need these drugs will see lower costs;
  • Requiring Part D plans to increase transparency and provide enrollees and their doctors with a patient’s out-of-pocket cost obligations for prescription drugs when a prescription is written;
  • Codifying a policy similar to the one implemented for 2019 to allow “step therapy” in Medicare Advantage for Part B drugs, encouraging access to high-value products including biosimilars; and
  • Implementing a statutory requirement, recently signed by President Trump, that prohibits pharmacy gag clauses in Part D.

CMS is also considering for a future plan year, which may be as early as 2020, a policy that would ensure that enrollees pay the lowest cost for the prescription drugs they pick up at a pharmacy, after taking into account back-end payments from pharmacies to plans.

Medicare Advantage and Part D will continue to protect patient access, as both programs are embedded with robust beneficiary protections. These include CMS’s review of Part D plan formularies, an expedited appeals process, and a requirement for plans to cover two drugs in every therapeutic class.

CMS looks forward to receiving comments on these proposals and other policies under consideration.

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NIH statement on World COPD Day 2018

NIH-supported studies aim to reduce the burden of COPD.

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HHS Releases Physical Activity Guidelines for Americans, 2nd edition

Federal physical activity guidance updated for the first time since 2008

(Chicago) – Today, Adm. Brett P. Giroir, M.D., assistant secretary for health, announced the release of the U.S. Department of Health and Human Services’ second edition of the Physical Activity Guidelines for Americans at the American Heart Association’s Scientific Sessions meeting. The second edition provides evidence-based recommendations for youth ages 3 through 17 and adults to safely get the physical activity they need to stay healthy. There are new key guidelines for children ages 3 through 5 and updated guidelines for youth ages 6 through 17, adults, older adults, women during pregnancy and the postpartum period, adults with chronic health conditions, and adults with disabilities.

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