News and Updates for Healthcare Professionals

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.

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.

Colchicine may potentially reduce complications accompanying metabolic syndrome.

Adverse Effects of Pharmacological Treatments of Major Depression in Older Adults

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)

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

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…

Study results on long-acting injection formulation now published.

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

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.

Findings may have immediate impact on clinical practice.

(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.

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

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.

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.

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.

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.

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

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.

You might consider “giving the axe” to these 11 drug classes, particularly in older patients, to increase safety and reduce pill burden.

Get resources and guidance on how to implement effective team-based opioid management strategies in primary care by participating in the AHRQ-funded “Six Building Blocks” project. Selected practices will implement the Six Building Blocks toolkit to improve opioid prescribing and collect metrics to monitor progress. An anticipated 15 participating practices will each receive technical assistance and a $2,500 honorarium to offset costs of producing metrics required for program evaluation The estimated start date for practices is January 2019.

Jeff Brady, M.D., M.P.H., director of AHRQ’s Center for Quality Improvement and Patient Safety, and Karen Chaves, M.H.S, Director of AHRQ’s National Healthcare Quality and Disparities Report Program, highlight data in the newly released Chartbook on Patient Safety. The Chartbook, based on AHRQ’s recently released 2017 National Healthcare Quality and Disparities Report, shows that the nation’s efforts to improve the safety of health care resulted in some encouraging overall gains between 2000 and 2016. However, there is much room for improvement, particularly for people of color and people in poor households. The Chartbook findings also identify ongoing safety concerns. Quantifying these challenges provides essential information to inform future quality improvement efforts.

New definition enhances ability to research and treat chronic pain.