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Do you have a COVID-19 Preparedness Plan?

(BPT) – If you’re concerned about getting COVID-19, you have good cause.

According to the latest COVID-19 Data Tracker from the Centers for Disease Control and Prevention (CDC), the U.S. alone has already logged over 16.3 million cases and the overall weekly hospitalization rate is at its highest since the pandemic began.

While it’s critical to stay informed about the spread of the virus and know how to protect yourself and others, many people may not realize how important it is to be prepared with an action plan should an outbreak occur in your community or household.

The better informed you are, the more empowered you can feel about coping with the pandemic.

COVID-19 Preparedness Tips from a Professional Patient Advocate Who was Hospitalized

Professionally, Michelle Vogel works in patient advocacy and provider relations, helping other patients navigate the healthcare system. That experience has taught her that sometimes, patients must be proactive and push to find their best options. Preparing as much as possible in advance is paramount.

Have a testing plan. Know the symptoms and if you have been exposed or experience symptoms, know where to get tested in your area, and know how you’ll isolate or self-quarantine if necessary. Relevant information is listed and regularly updated on the CDC website.

Get to know the hospitals in your area. Look up local and regional hospitals in your area and make a plan for where you would seek treatment if you needed to be hospitalized. If you want access to investigational treatment candidates, websites like www.StopStorm.com can help you find research hospitals in your region as they may be enrolling people in clinical trials.

Ask about treatments and clinical trials. Everyone reacts differently to the coronavirus. As such, there’s no one-size-fits-all approach when it comes to treatment. If you’re hospitalized with COVID-19, ask about treatment options and if you may be eligible to enroll in a clinical trial. Since eligibility criteria can change, it’s important to keep asking your hospital and doctor about clinical trials daily.

Throughout this crisis, the biotech and pharmaceutical industries have worked tirelessly to develop vaccines and therapeutics to help overcome this pandemic. However, with over 4,000 COVID-19 clinical trials listed on www.clinicaltrials.gov and the healthcare system almost overwhelmed, the burden to get access to clinical trials is now often falling to the patient or their families who may need to proactively plan, ask and engage.

Clinical trials are crucial in the development of innovative medicines and participating in a clinical trial helps advance potential treatment options for people in need.

“Typically, hospital researchers will discuss clinical trial options proactively with patients who may be eligible to enroll,” said Vogel. “I think that there is so much research going on right now, patients and their families have to be more vocal and engaged in asking about potential clinical trials than ever before.”

What Happens When the Professional Patient Advocate Becomes the Patient?

The expression, ‘when it rains, it pours,’ doesn’t even begin to capture how torrential Michelle Vogel’s experience was with COVID-19. It was the midst of Florida’s hurricane season, the virus was surging in the state and her mom was just diagnosed with COVID-19 in Boynton Beach, Florida, days prior.

While Michelle, a 53-year-old Jacksonville, Florida, resident, waited to get her COVID-19 test, delayed due to heavy storms, her symptoms were getting worse. After her test came back as positive, she went to the research hospital in her area and was admitted to the Mayo Clinic in Jacksonville. She was diagnosed with pneumonia and was treated with convalescent plasma, remdesivir and steroids. Her condition deteriorated and she developed a hyper-response of the immune system that causes harmful inflammation, known as cytokine storm. The condition affects almost 90% of patients hospitalized with COVID-19 and is a leading cause of COVID-19 progression, use of a ventilator and death.

Vogel asked about clinical trials and learned that the Mayo Clinic was one of the sites enrolling patients in a Phase 3 study evaluating lenzilumab, an investigational treatment candidate designed to combat cytokine storm. She pushed to be enrolled in the clinical trial.

The Unsung Heroes

“Patients participating in clinical trials are too often the unsung heroes in the development of innovative treatments and the pandemic has heightened the importance of patient advocacy in the clinical trial process,” said Cameron Durrant, MD, MBA, chief executive officer of Humanigen, the biopharmaceutical company developing lenzilumab as a potential COVID-19 treatment. “The global biopharmaceutical industry has made tremendous strides to develop viable COVID-19 vaccines, but we need treatment options for all patients while we wait for widespread safe and effective vaccine use and availability.”

For Michelle Vogel, her condition improved rapidly after participating in the clinical trial. She had read that lenzilumab could help normalize her C-reactive protein and that is what she experienced. Just days later, she was weaned off supplemental oxygen and discharged from the hospital.

“If I hadn’t pushed to see what other options were out there, I don’t know if the lenzilumab trial would’ve been offered,” she said. “Because of my professional experience as a patient advocate, I knew to keep on pushing to see what my options were. But there are many patients who don’t even know that they can ask what their treatment options are.”

Sadly, however, Michelle’s mom passed away from COVID-19 while Michelle was in her own COVID-19 battle. “I tried hard to advocate for the best treatments for my mom but there were no clinical trial options at her hospital and it’s difficult to even think about whether she would have survived if she had access to a clinical trial.”

To learn more and to find a lenzilumab clinical trial site near you, visit www.StopStorm.com.

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Advocacy CSI Pharmacy stories Health Information

Be an Advocate

COVID-19 was the last thing on Michelle Vogel’s mind the day she raced to South Florida to care for her elderly mother who had fallen in her home. Her mom hadn’t been feeling well that week. She thought she had a urinary tract infection again. As it turned out, Judy Vogel had COVID pneumonia. She died a week later in ICU.

Michelle is the head of CSI Pharmacy’s Patient Advocacy team. Since the beginning of the pandemic, she has tirelessly insisted that everyone needs to wear a face mask, wash their hands or use hand sanitizer, and maintain social distancing. And she walks the talk. She knows that the lives of the immune compromised patients she cares for depend on this.

It never occurred to her, however, that she would need to protect herself from her own mother. Judy lived alone. She rarely left the house. And she took precautions. No one knows how she might have contracted this highly contagious condition, but she gave it to her daughter.

Five days after learning of her mom’s diagnosis, Michelle herself tested positive for COVID. As someone who lives with several rare, chronic conditions, she knew her chances of developing severe COVID pneumonia were high, and over the next few days she did become very sick.

“I’ve had migraine headaches, but they’re nothing compared to COVID headaches,” Michelle says. “And I’ve never been so tired. I’ve never had so much pain in my legs that they just give out. The coughing is worse than any bronchitis. And then it’s just odd to lose your smell and taste. My stomach, the diarrhea, the chills and fevers…it just hits every part of you. I even have skin lesions.”

With the support of daily telemedicine checks, Michelle battled the disease at home for a week. Her doctors started her on a corticosteroid (prednisone), which has been shown to reduce lung inflammation in COVID patients. They tried azithromycin (Z-Pak), which has antiviral properties, although it has not been reliably tested in COVID patients.

They also ordered cough suppressant medicine and a portable nebulizer that helped her to breathe in a bigger dose of medication to open her lung passages. From an online supplier, she ordered a pulse oximeter (a medical device that fits over your finger) to be sure her blood oxygen levels stayed adequate. Still, she ended up in the hospital with COVID pneumonia.

“There’s a lot doctors can’t see on a telemedicine call,” she says. “They don’t see you when you’re gasping for air. They can’t listen to your lungs to hear how congested you are. And how do you get a chest x-ray or labs drawn when you’re too exhausted to drag yourself out of the house?”

Michelle is the person many rare disease patients turn to for advice on navigating the maze that is our healthcare system, overcoming health insurance obstacles, and accessing the expensive therapies that keep them alive. She is an expert who loves sorting out these challenges.

So during the week she spent in the hospital, Michelle became her own advocate. She knew, for example, that remdesivir (an antiviral medication) and convalescent plasma (blood serum with antibodies from COVID patients who have recovered from the disease) had shown some positive results, so she requested these. She also asked about other treatments and was offered a clinical trial to test a new biological therapy.

While no one expects to come down with COVID—or any other disease, for that matter—Michelle’s experience shows the importance of educating yourself about whatever condition you find yourself burdened with. Know what drugs and therapies are used to treat the disease and ask if they might be right for you (or your loved one). And if you don’t understand what the doctors are saying, ask questions until you do.

“COVID-19 has affected all of us in one way or another,” Michelle says. “I have stayed vigilant in wearing my mask and isolating to stay safe. I never imagined that it would touch my family, take my mother, and leave me battling with COVID pneumonia. Please stay safe so this doesn’t happen to you or someone you love. And if it does, be an advocate for yourself or your loved one.”

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Advocacy CSI Pharmacy stories Health Information

Can’t be Complacent with COVID

Judith Vogel had lovely hands, always perfectly manicured, and beautiful, beautiful eyes with long lashes. She taught fifth grade for most of her life in Montville, New Jersey and saved every letter her daughter Michelle wrote to her from camp as a child.

At 81, she lived alone, but she enjoyed a full social life: playing canasta and mahjong, going to movies, eating out. She had lots of friends. With this year’s pandemic restrictions, though, Judy lost all that. All she could do was sit at home and watch the news and fret. She was afraid she would get sick. And she worried about our country, all the hatred she saw. All the fear.

What she really wanted was to see her grandson get married (his wedding was postponed twice because of the pandemic). And on her birthday, November 3, she wanted to celebrate by voting for Joe Biden. He could turn things around in this country. She was convinced.

Judy will enjoy neither of these dreams. She passed away on August 20. She died, as she feared, of COVID-19.

It was a Thursday morning. Michelle hadn’t been able to get her mom on the phone for two days. She threw some things in the car and drove the 300 miles to South Florida. She made it in record time. On the way, she called her cousin who lived closer and asked her to go check. They found Judy on the floor. She had probably lain there for a full day.

When the paramedics arrived, they decided she was OK. She was conscious. She didn’t have a fever. She wasn’t coughing. They didn’t want to risk taking this elderly lady to the hospital where she might catch COVID.

When Michelle got there, her mom was sitting comfortably in a chair, sipping fluids. She made an appointment for Judy to be seen by her primary care provider the following morning. Judy had a history of urinary tract infections (UTIs). Michelle assumed that’s what was making her confused and fatigued. That and the fact that she’d lain on the floor for the last 24 hours.

Michelle, who serves as CSI Pharmacy’s Vice President of Patient Advocacy and Provider Relations, took her mom to the doctor and got her started on treatment. But that afternoon, when Judy was too weak to stand up from a chair, Michelle knew something more serious was going on.

She had to call 911. It was the only way to get her mom to the emergency room. But she couldn’t go with her; no one is allowed in hospitals these days except the patient. That evening when she called the hospital, she learned that Judy had tested positive for COVID. Judy was in ICU. Soon she would be on a ventilator. Michelle would never see her mom again.

“I was shocked,” Michelle says. “I thought she had a UTI. I didn’t put the symptoms together. I never thought of COVID.”

Looking back, Michelle realizes there were a lot of signs she missed when she talked to her mom every day. She thought, for example, that her mom’s decreased appetite was related to the isolation and depression Judy was feeling. But maybe she wasn’t eating because she couldn’t taste or smell. These are symptoms of COVID.

Judy complained of headaches and muscle aches, but she didn’t have a fever. She just thought she was coming down with a cold. When Michelle talked to her mom’s best friend, though, she said Judy had been coughing for weeks. Maybe she’d been sick for weeks, but no one realized it. Judy didn’t like to bother anyone.

The thought of her mother lying on the floor alone all day and all night before she was finally found will never leave Michelle. But even as she moves through her own grief, Michelle wants her family’s experience to serve as a lesson for others.

“Isolation is hard on everyone,” she says, “but it is especially difficult for our seniors. It affects us both physically and emotionally. It can be really horrible. But as much as people want to be more socially active and get back to their lives, this virus is going to go on for years. And the more complacent we are, the more severe it will be. We can’t assume COVID hasn’t affected anyone in our personal circle. We still need to take precautions. We need to be safe.”

Secondly, she wants people to be aware that COVID is a threat that is with us everywhere, and that coronavirus should be at the top of our minds at all times.

“We don’t really understand all the symptoms of COVID-19,” she says. “A lot of patients never present with a fever, but they have all these other symptoms: severe headaches, body pain, diarrhea, rashes, weakness, tingling toes…all kinds of things. We need to understand that there are many more symptoms than just the cough and fever that you always hear about. And if you are feeling bad, you need to get yourself to the doctor.”

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Advocacy

Standards Still Apply

Recently, a patient we will call Angela posted a note on a private Facebook page describing a troubling situation she encountered with her home IVIG infusions. She wrote to the group of fellow immune globulin (IG) patients that her infusion company decided that the nurse no longer needed to stay with her for the duration of her infusion.

Because of coronavirus infection risk, some infusion companies are apparently trying to limit the time the nurse spends in the patient’s home. The nurse is instructed to set up the infusion and stay until it had been increased to the scheduled drip rate, then she is to leave, for the rest of the day. Another patient in the group posted that her nurse didn’t leave, but she spent most of the time of the infusion sitting in her car outside the house.

“My infusions take basically eight hours, and she will be here for two of them,” Angela posted. “She’s going to teach my husband how to draw and administer diphenhydramine [an antihistamine used to counteract an allergic reaction, also known as Benadryl] in case of an emergency. I am nervous for sure. What will we do if air gets in the line? What will we do if something goes wrong?”

Angela’s concerns are not unfounded. According to Michelle Vogel, Vice President of Patient Advocacy and Provider Relations at CSI Pharmacy, leaving the patient during an infusion violates strict standards of care established by the Immune Globulin National Society (IgNS), an organization of Ig therapy professionals.

“Not only is this unacceptable, but it is extremely dangerous,” Michelle says. “The nurse needs to constantly monitor the patient for infusion reactions. This is crucial and cannot be done over the phone or if the nurse is not present.”

“As nurses our duty is to provide safe and effective nursing care,” says Brittany Isaacs, RN, IgCN, Director of Nursing at CSI Pharmacy. “Our nursing judgement should not be clouded by situations that place a patient or their safety in jeopardy. Our duty is to do no harm, so we need to protect both the patient and ourselves during any encounter. Ensuring proper personal protective equipment is doned to keep everyone safe and following the guidelines outlined by the CDC, WHO, IgNS, and the Infusion Nurses Society allows a nurse to continue to provide safe and effective nursing care during home infusions.”

While COVID-19 has caused many changes in healthcare protocols, patient safety should always be the ultimate guiding principle. The following guidelines are drawn from IgNS’s Immune Globulin Standards of Practice and COVID-19 Resource Guide and FAQ.

During the COVID-19 pandemic, patients receiving in-home immune globulin therapy can expect the following from their specialty pharmacy or home infusion company:

  1. Pharmacy personnel will wear personal protective equipment while packing the medications and supplies that are sent to the patient’s home.
  2. The home infusion nurse will be screened by their company for COVID-19 symptoms to ensure they will not carry infection into the patient’s home.
  3. Patients will be screened to ensure they do not have COVID-19 symptoms before being infused.
  4. Nurses will wear personal protective equipment, including masks, gown, gloves, and face protection, while in the home.
  5. Social distancing should be maintained to the extent possible, except when providing direct patient care.
  6. Patients should wear a mask or face covering while the nurse is in the home.
  7. Patients can request that their specialty pharmacy include masks, gloves, and hand sanitizer in their IG shipment.

The following practices are not acceptable, even during COVID-19 restrictions:

  1. Neither the patient nor a family member should be taught to self-infuse IVIG or to remove the IV after the infusion is completed.
  2. The infusion nurse should never leave the home for any reason while the infusion is in process. This includes sitting in her/his car outside of the home during the infusion.
  3. Family members should not be asked to leave the home during the infusion.
  4. Nurses should never refuse to wear personal protective equipment.

If you are uncomfortable or do not feel safe with your infusion company’s changes in protocol, please do not stop treatment! Staying on therapy is vital. If your company is unwilling to adhere to these standards of care, you may want to consider changing companies. If you need help with this, CSI Pharmacy’s patient advocates can help, even if you are not our patient.

Additional resources can be found here:

Infusion therapy standards of practice. Journal of Infusion Nursing

Immune Globulin National Society – Standards and guides

The role of an IG infusion nurse. IG Living Magazine. August/September 2013

National Home Infusion Association

IDF guide for nurses: Immunoglobulin therapy for primary immunodeficiency diseases Immune Deficiency Foundation

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CSI Pharmacy stories

Caring for and about Patients

When Michelle Vogel joined CSI Pharmacy as Vice President for Advocacy and Provider Relations in 2016, one of the first things she did was take owner James Sheets to a support group for myositis patients.

From the very beginning, CSI had been committed to caring for patients, not just filling prescriptions. But until this point, the only interactions the pharmacists, nurses, and staff had with patients was when they provided their infusions.

“He didn’t really know about working with patient communities, so I took him to participate in The Myositis Association support group in Houston,” Michelle says. “That’s when James became dedicated to helping patient communities.”

“I went there to talk about IVIG ,” James says. “I went in there thinking this will be great. I can really help this community learn a lot. But when I heard some of what patients were experiencing, I realized I had so much more to learn. That’s really where my passion for building relationships with the rare disease community came from.”

James and Michelle and some other staff started making a habit of attending support group meetings, not just for myositis, but for myasthenia gravis and other rare diseases that are part of CSI’s patient community.

These support groups are a place where people who live with a rare disease can get together with others who have the same disease. At the meetings, patients and caregivers share their experiences of dealing with the challenges of things like symptoms, treatments, and living with chronic or disabling conditions. When they participate in these gatherings, the CSI staff gain valuable insight into what their patients deal with on a daily basis. It makes a difference in how the pharmacy works with patients.

Knowing more about myositis as a disease, for example, and the sorts of challenges patients face in dealing with it gives CSI much more ammunition in helping them access treatments, most of which are used “off label” and can be very expensive.

“When we’re working to get approvals from insurance companies,” Michelle says, “we’re able to ensure that the patient meets the diagnostic criteria of their individual health insurance plan. There is no reason why these lifesaving therapies should be denied when we can submit it to insurance appropriately.”

Having an advocacy program also supports the physicians who prescribe treatments like immune globulin therapy, infused and injected immune suppressants, and cutting-edge biologic treatments.

In addition to advocating for patient access with insurance providers, Michelle can also help people find copay assistance programs to help cover the expenses insurance doesn’t. There are also some financial assistance programs that can help patients with extraordinary medical expenses. And if a person’s insurance is too restrictive, she can help them choose a plan that works more to their advantage.

And then there are the times when CSI just needs to bend over backwards to get the patient their treatments. Michelle tells a story, for example, of an uninsured patient who had been diagnosed with myasthenia gravis. She had applied for social security disability and was waiting for approval, so she would be eligible for Medicare, but it would be three or four months before her hearing with a judge. Meanwhile, she needed IVIG treatment to live.

Michelle was sure the judge would approve the patient for social security disability, making her eligible for Medicare. She also knew Medicare would cover the treatment retroactively. So, CSI agreed to provide all the patient’s medications while she awaited approval. Michelle even contacted the patient’s physicians to ask if they would waive their fees during that waiting period. (They could always bill Medicare later.) Three months later, the patient was approved, and the physicians and the pharmacy all got paid.

“We had to pay for everything in advance, but in the end it all worked out,” Michelle says. “I don’t know of any other specialty pharmacy that would do that. There’s that trust, that extra step for patients. That’s really what you need, because if you do things right, it all comes back tenfold.”