In January 2020, the United States (US) Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) published Advancing Health through Innovation: New Drug Therapy Approvals 2019. This report provides a summary of a number of approvals and highlights the “game-changers” approved in 2019, solidifying the upward trend in approval volume initially seen in 2017. Compared to 2017 and 2018, in which CDER approved 46 and 59 new drugs, respectively, 48 novel agents were approved in 2019. This number does not include new and expanded uses of already approved drugs, new formulations, new dosage forms, vaccines, blood products, cellular or gene therapy, or the 10 biosimilar approvals. This far exceeds the average of 38 novel approvals per year in the past 10 years. Figure 1 outlines approvals over the past 10 years.

In 2019, the FDA continued its strategic initiatives, with additional approvals of biosimilars and generics (both first-time agents and those off-patent with limited competition), as well as a focus on the expedited approval process, particularly for rare diseases and agents supported by positive patient-reported outcomes. Notably, the FDA hosted a public meeting in April 2019 to receive input on how to tackle barriers associated with the development of treatments for rare diseases, and held another meeting to celebrate “Rare Disease Day” in February 2020. Moreover, this trend is likely to continue, with the FDA releasing several guidances on gene therapy. The new pathway for insulin approval under biologic license applications planned for March 2020 and the launch of internet-based repositories or apps to improve access to information for both providers and patients (e.g., CURE ID in 2019, antiretrovirals in 2020) also highlight strategic initiatives of the FDA.

Last year, all 48 novel drug approvals met their Prescription Drug User Fee Act (PDUFA) goal dates, cementing this as a priority for the Agency. In 2019, 42% were considered first-in-class, and 44% were approved for rare diseases (Orphan Drugs). Priority Review was granted to 58% of novel drugs, 19% received Accelerated Approval (more than doubling the rate of 7% last year), 27% were designated as Breakthrough Therapy, and 35% garnered Fast Track designation. Overall, 60% of all drug approvals in 2019 used expedited development and review methods. In addition, 90% were approved in the first review cycle, and 69% were approved in the US prior to receiving approval in other countries. A breakdown of the types of drugs approved in 2019 is illustrated in Figure 2, with approvals once again dominated by drugs in the expansive oncology spectrum.

Some of the notable 2019 approvals included new advances for the treatment of cystic fibrosis (CF), with the first triple combination therapy and expanded indications of existing CF therapy available to younger patients, and the first new medications in several years for sickle cell disease. Additionally, several approvals targeted rare conditions, such as erythropoietic protoporphyria, neuromyelitis optica spectrum disorder, tenosynovial giant cell tumor, Duchenne muscular dystrophy, and systemic sclerosis-associated interstitial lung disease. Beyond treatments for rare disease and cancer, the FDA also approved agents for more common disorders, including multiple sclerosis, novel treatments for depression, migraine and cluster headaches, epilepsy, several autoimmune conditions, age expansions for diabetes therapy, and a drug-sparing regimen and new prophylaxis option for human immunodeficiency virus-1 (HIV-1). Although down slightly from 2018, the large number of approvals from 2019 represent a continued trend by the FDA to expedite and increase the quantity of annual approvals.

The COVID-19 global pandemic is taking a physical, mental and emotional toll on doctors, nurses, healthcare workers and caregivers. The long work hours and limited resources are causing overwork, exhaustion and in some cases, compassion fatigue. Not to mention balancing your work with the concerns for your own family and loved ones.

What is compassion fatigue?

Compassion fatigue is a state of chronic physical and mental distress and exhaustion. People with this fatigue often describe a negative shift in their world view and a preoccupation with the illness of others. They may experience stress and burnout, affecting their ability to be effective in their jobs and relate to their loved ones and friends.

Tips for preventing compassion fatigue:

• Make self-care a priority. Despite your workload, do your best to practice healthy habits. Focus on making sure you are staying hydrated, sleeping as much as possible, eating nutritious meals and getting exercise when you can. Follow the COVID-19 CDC guidelines on keeping yourself and your family’s risk low.
• Boost your emotional resilience. Deep breathing, meditation, being grateful and allowing yourself some down time are ways to keep your life in balance, so you are better able to handle stress, setbacks and crises.
• Get social support. Reaching out over the phone or through a text message to supportive loved ones, friends and colleagues can be a calming influence and shift your perspective on what you are dealing with every day.
• Be proud of your profession. Your work is important. You are caring for people during the first-ever pandemic caused by a coronavirus and giving them hope and strength.
• Seek professional help. If you are experiencing distress and/or symptoms of burnout, take advantage of your healthcare and employee assistance benefits and meet with a behavioral health professional who can help.

We wholeheartedly thank you for all you are doing to care for others and combat this outbreak.

For more information and tips, visit MagellanHealthcare.com/COVID-19.

When I was a child visiting my grandparent’s Iowa farm, I would often hear stories of how my mom and her eight brothers and sisters lived during the war efforts of the 1940’s. My grandma described a common purpose—that sense of pride that the family rationed and repurposed. Their singular focus was that the good of the individual was less important than the whole of the country, even the world.

Watching the coronavirus make its way across the world and rapidly grow in the United States, I can’t help but think of those stories. As the shelves of Costco and Sam’s Club stores emptied this weekend, and school closures were announced community by community, it made me realize that our time to step up is now. Our singular, collective focus needs to be mitigation and in order to be successful, mitigation efforts need to be embraced and enacted on by us as individuals.

What is Mitigation?

Mitigation is a strategy to reduce the seriousness or impact of a natural disaster, such as a pandemic. The goals of mitigation include minimizing morbidity and associated mortality, avoiding an epidemic peak that overwhelms healthcare services, keeping the effects on the economy within manageable levels, flattening the epidemic curve to wait for vaccine development and manufacturing to reach populations, and actively pursuing the development of antiviral drug therapies. Practically, mitigation relies on social distancing—measures that are taken to restrict when and where people can gather to stop or slow the spread of infectious diseases such as the coronavirus.  Social distancing measures include limiting large group gatherings, closing buildings and canceling events. However, for mitigation to be successful, individuals, even those who are asymptomatic, must be willing to self-isolate.

Self-Isolation Challenges

In a society as mobile as ours, and where high degrees of social contact is the norm, self-isolation is challenging. For instance, if one has become accustomed to eating meals outside the home, the transition to grocery buying and cooking may seem formidable. If one is used to getting together with friends to play cards, go running, have a beer after work, the loss of those types of activities will create holes in one’s social network.

We are fortunate to have an infrastructure in which many people can work from home and education can be delivered virtually. Workers who cannot isolate because the nature of their work cannot be done virtually, must take precautions. While in the workplace, distancing at least six feet, maintaining high levels of handwashing and the use of hand sanitizers is a must.   When returning home, it is best to avoid being in the presence of those most vulnerable to coronavirus—elders and persons with underlying comorbidities. It is also important to acknowledge that one may feel anxious and may not have all the answers that our members or clients are seeking. Maintain lines of communication with co-workers and supervisors. For those who are new to work at home, talk to coworkers for whom this has been the norm to get some advice on structuring the workplace and the day. And don’t forget that you can use technology to connect with friends. Facetime, Skype and other video conference capabilities are a great way foster your relationships during social isolation.

Mitigation is a critically important strategy to quell the spread of the virus. It has been beneficial in China as new cases are now falling. In areas where community spread is mild, targeted isolation of high-risk people, or those who may have come in contact with the virus, can be implemented. Even inside households, those with symptoms should keep distance from the healthy. And, even if you are asymptomatic, but have been in a high-risk area or where there is growing or wide community spread, it is important to maintain social distancing and self-isolation.

Social distancing and isolation are not easy—but I am trying to look at them as the Victory Gardens of my mother’s childhood. I hope that 50 years from now, my grandchildren will hear stories of how the United States and the world beat back the coronavirus, and I hope that my children who are on this journey with me now will reflect and recognize the importance of a global community, productively working together for the common good.

The novel coronavirus (COVID-19) outbreak in the United States continues to evolve, with more cases and quarantines popping up on news feeds everywhere. The closer it gets to their homes, the more people are worrying. In our last post, “Addressing anxiety about the coronavirus,” we talked about the things people can do to help feel less anxious and more in control. But what about the people on the front lines? Nurses, doctors, healthcare workers and other medical professionals who are testing for and treating patients with COVID-19 are at a higher risk of contracting it than the general public. What can they do to take care of themselves, physically and emotionally?

As Kushal, Gupta and Mehta stated in Study of Stress among Health Care Professionals: A Systemic Review, “Work related stress is a potential cause of concern in healthcare workers and is associated with decreased job satisfaction, days off work, anxiety, depression, sleeplessness , medical errors and near misses.” Long shifts and working with sick people—some of whom are gravely ill—can lead to burnout and anxiety from their normal jobs. These already-struggling healthcare workers are now faced with COVID-19 unknowns and demands, including taking care of people with confirmed cases of the virus.

While some people may feel they are at the whims of the virus, there are things healthcare workers can do to take some control over their work environment and manage their fear or anxiety.

• Know what your organization’s plans are. Read the business continuity plan and know your role. Talk to your team members about cross-training and covering for each other if one of you gets sick. In addition, ensure you are following proper protocols for cleaning and preventing spread. Visit cdc.gov for helpful information. This is particularly important for behavioral health providers who may not always think about universal precautions.
• Surround yourself with green. If your facility permits, bring in a few plants to liven up your surroundings. Being around plants has a calming effect on people. Employees who work in offices with plants tend to feel better about their jobs, worry less and take fewer sick days.¹ If you can’t have plants in your space, take time to look out the window and find some green. You may find that is enough for a quick mental break and perspective.
• Use small tools to create a calming environment. A small water feature, a sand garden or hourglass, stress balls and other items can provide a quick way to refresh your mind. Or just step back, take deep breaths, stretch and/or meditate.
• Find someone to talk to. Some hospitals have on-site or on-call chaplains; take advantage of them. Don’t be afraid to talk to your coworkers about how you are feeling. Chances are, they are feeling the same way and would welcome a discussion. Many medical settings offer a form of rounds that addresses the emotional impact of caring for a particular patient or theme. Similar semi-structured discussion groups with peers can be very helpful in handling stress and preventing the development of PTSD.²
• Get professional help. Be open to contacting your organization’s EAP, if you have one, or reach out to a therapist if you find yourself developing “compassion fatigue,” where your desire to help others erodes.
• Limit exposure to media. Media outlets have a tendency to sensationalize stories, so it’s important to consume news thoughtfully and with a critical eye.

In addition, do all the normal things to take care of yourself: try to eat healthy, well-balanced meals, exercise regularly, get plenty of sleep, and avoid alcohol and drugs. Doing these things can have a positive impact on your mental health and help you manage anxiety.

For more information and tips, visit MagellanHealthcare.com/COVID-19. We wholeheartedly thank you for all you are doing to combat this outbreak.

1: https://www.webmd.com/a-to-z-guides/ss/slideshow-health-benefits-houseplants.

2: See Schwartz rounds.

Disclaimer: The content in this blog article is not a substitute for professional medical advice. For questions regarding any medical condition or if you need medical advice, please contact your healthcare provider.

As the coronavirus disease (COVID-19) continues to evolve with ongoing media coverage, many people are experiencing anxiety due to the uncertainty about how this will impact them. They are worried about the impact to their communities, how they can protect themselves and their families, and how to be prepared if the situation disrupts the normal course of daily life.

It is normal to feel anxious, unsettled, distracted, scared and/or overwhelmed by COVID-19 and the uncertainty surrounding its impact to communities. Some people may be more vulnerable due to pre-existing physical and mental health conditions, including generalized anxiety disorder.

Feeling stressed can affect the immune system and increase the risk of getting ill in general. That is why it is important to take steps to manage anxiety and reactions to this evolving situation. The following suggestions can help people manage anxiety and stress for themselves and their families:

1. Seek health information from trusted resources like the U.S. Centers for Disease Control & Prevention (CDC), The World Health Organization and state health department websites.
2. Plan ahead to feel more in control. Make contingency plans for work, childcare or travel if it becomes necessary.
3. Wash hands often, get plenty of rest, exercise, eat well, don’t smoke and limit alcohol consumption.
4. Put things into perspective:
   1. Of the 80,000 confirmed coronavirus cases reported in China, “more than 70% have recovered and been discharged,” according to the World Health Organization (WHO) in a news conference on Monday.¹
   2. Per the CDC, only certain groups, such as older adults and people with serious chronic medical conditions, are at higher risk of getting very sick from COVID-19.²
   3. Public health officials are working to mitigate the virus’ spread.
5. Limit exposure to media. Media outlets have a tendency to sensationalize stories, so it’s important to consume news thoughtfully and with a critical eye.

Magellan Healthcare has resources to help people during crises and difficult times. Our Crisis Communications website provides topical information and connects people with U.S. resources, and our Mind Your Mental Health site addresses many topics related to emotional well-being.

1: https://www.cnn.com/asia/live-news/coronavirus-outbreak-03-09-20-intl-hnk/index.html, “More than 70% of coronavirus cases in China have recovered, WHO says,” posted 3/9/20, 7:25 p.m. EDT, Jacqueline Howard, accessed from site 3/10/20, 12:57 p.m. EDT.

2: https://www.cdc.gov/coronavirus/2019-ncov/specific-groups/high-risk-complications.html#who-is-higher-risk, accessed 3/10/20, 12:34 p.m. EDT.

Disclaimer: The content in this blog article is not a substitute for professional medical advice. For questions regarding any medical condition or if you need medical advice, please contact your healthcare provider.

It’s officially the holiday season—bring on the parties, travel, end-of-year work activities, and squeezing in quality time with loved ones! This year, remember to make time to take care of yourself and start 2020 off with your healthiest, most vibrant YOU. Here are our top three holiday health hacks:

Be mindful of your alcohol intake.

Avoiding triggers can be challenging this time of year. Dr. Caroline Carney, chief medical officer of Magellan Rx, was quoted in a helpful Huffington Post article that offers 14 useful tips for navigating the holidays when you’re not drinking.

Be mindful of your plate.

The celebration over food and eating during the holidays can be tough…but it doesn’t have to be! With a little planning and preparation, you can make healthy choices. Check out these 10 easy tips to for managing your diet this holiday season.

Be mindful.

Close your eyes, take a deep breath through your nose, and exhale slowly through your mouth. It will do wonders when you’re sitting in all that holiday traffic.

Wishing you and yours a happy and healthy holiday!

The following is an excerpt from the 2018 Magellan Community Impact Report.

Standing tall is a tall order. How do  you know what the right thing is? Answers aren’t often cut and dried. Instead, we know by having lived through similar, difficult experiences ourselves and standing beside those we support—standing together as peers on the path to recovery.

Living through the same kinds  of challenges

Magellan’s recovery support navigators represent our best practice approach to tapping the power and potential of peer support. Peer support is an evidence-based practice, and numerous studies continue to validate the effectiveness of these supports. Recovery support navigators are professionals who have lived experiences with some of the same challenges our members face. They have experienced substance use disorders or psychiatric disabilities and may have personally been homeless, had their utilities turned off or experienced food insecurity. They can relate to the members they support, empathize, and then draw on real-world solutions to help them.

Sharing our stories

Every day recovery support navigators show up and not only listen to and support our members, but also share pieces of their own stories to inspire hope and change. Dana Foglesong, director of recovery and resiliency services for Magellan Complete Care of Florida, knows first-hand the transformative power a peer specialist can have. She knows not just because she has been certified as a peer recovery specialist since 2010, but because Dana had the support of a peer support specialist herself.

Dana describes her journey: “In my late teens and early twenties, I bounced from state hospitals to crisis stabilization units. I was desperate to end my life. I had no hope that my former goals could ever be realized. When I started working with a peer specialist, I began to view myself and my future more positively. My peer specialist expected me to recover and connected me to the resources that empowered my recovery process.”

Dana not only recovered—she has thrived! She recently completed a master’s degree in social work and leads Magellan’s diverse team of recovery support navigators. She has been awarded for her commitment to providing help and hope to others, including for her work founding the Peer Support Coalition in Florida, which expands leadership, advocacy and employment opportunities for people, like her, with lived experience. Dana describes her life now, saying: “At Magellan, I have the opportunity to do such meaningful, passion-filled work. It keeps me inspired and grateful to be a part of helping our members lead healthy, vibrant lives.”

Leading the way

Magellan was the first managed care company in the United States to recognize and incorporate peer support services into the continuum of care. Since 1999, we have been a leader in increasing access to peer support through partnerships with the recovery community and providers. We have assisted state customers in developing robust certified peer specialist capabilities, driven in large part by our depth and breadth of experience. Magellan continues to create shared learning opportunities for the peer workforce and others to improve and enhance the knowledge, skills, and competencies of the peer workforce.

The following is an excerpt from the 2018 Magellan Community Impact Report.

It is estimated that 130 Americans die every day from an opioid overdose. The opioid epidemic has become a national crisis and is continuing to grow rapidly, affecting families in every city across our nation.

No one is exempt from experiencing the effects of the opioid crisis. Magellan’s own Janet Edwards, RN, senior clinical director of Magellan’s Chronic Pain Management program, describes how close to home the opioid epidemic hit her:
It is estimated that 130 Americans die every day from an opioid overdose. The opioid epidemic has become a national crisis and is continuing to grow rapidly, affecting families in every city across our nation.

“My daughter, Nikki, was 26 when she  died of a Fentanyl overdose. As the mother of a six-year-old and a critical care nurse working in a respected healthcare organization, Nikki was the picture of success. But to handle the pressures of nursing school, a full-time job, and life as a single mother, Nikki sought prescriptions for Adderall and Xanax from multiple physicians. Over time, her addiction to these substances gave way to a new addiction: Fentanyl, which she began to confiscate from the critical care unit where she worked.
Like many others, Nikki didn’t show any signs of addiction. But five years after her son was born, Nikki sat at my kitchen table and admitted that she was addicted to heroin. She was afraid to get help, because she did not want to lose her job or the respect of her peers. She insisted she could recover on her own. Even though I, as a nurse, knew the odds were not good that Nikki could manage her recovery alone, I respected my daughter’s wishes. It’s a decision I will forever regret. Eleven months later, Nikki died of an accidental overdose in front of her son and a friend.”

Following the loss of her daughter, Janet has openly shared Nikki’s story, becoming an advocate for helping prevent opioid addiction. Further, Janet has taken on clinical leadership of Magellan’s Chronic Pain program, which offers alternatives to opioid use.

Meeting opioid users where they are

No matter where or how someone encounters opioids or where they may be in the cycle of use, dependence or addiction, Magellan offers many other ways to address the opioid problem. Our behavioral health products forged from decades of serving the public, our specialty healthcare solutions supported by clinical excellence, and our customized pharmacy programs are ready to answer the call as organizations and individuals look for answers.
Hosting a forum for sharing successes  and discussing solutions

In September 2018, Magellan brought together  national and local leaders in Pennsylvania to  exchange ideas, share successes and  discuss solutions to the opioid  epidemic in our communities.  The free, second-annual  conference featured  keynote addresses and  workshops and highlighted  the proactive efforts of local  organizations. Participants included  national and state officials, county human  services and drug and alcohol leaders, legislative  staff, providers and community stakeholders.

Not staying silent on the silent epidemic

Magellan is actively helping individuals and families on their path to recovery. Further, to educate the public, doctors and other healthcare providers, we offer resources on our Magellan Health OPIOID INSIGHTS microsite. The site includes links to blog posts, videos, resources and published articles.

Hosting a forum for sharing successes and discussing solutions

InSeptember2018, Magellan brought together national and local leaders in Pennsylvania to exchange ideas, share successes and discuss solutions around the challenge we face together in addressing the opioid epidemic in our communities. The second-annual conference featured keynote addresses and workshops and highlighted the proactive efforts of local organizations. Participants at the free one-and-a-half-day conference included national and state officials, county human services and drug and alcohol leaders, legislative staff, providers and community stakeholders.