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CSI Pharmacy stories

I’ve been shot!

For this whole pandemic, I’ve had this admittedly distant relationship with this terrible disease. I certainly mourn the more than half a million COVID deaths in this country. I am troubled by the more than 32 million people who have suffered with the disease. And I am concerned for the long-term impact for those, like some of my colleagues, who continue to experience symptoms months after testing positive.

Still all the deaths, the rising and falling cases, the fatigue and heroism of my colleagues in healthcare, even the fear that makes my friends and the patients I write about desperate for a vaccine—none of this has touched me, not directly, not with any real impact. Until yesterday.

For weeks, everyone I know has been getting vaccinated, while I sit and wait for my turn. I’m not old enough, unhealthy enough, or essential enough. That has been my refrain. Being under 65 and safely tucked away at home and healthy, I don’t yet qualify in the prioritization of vaccine distribution. I’m part of phase 2: everybody else. Until yesterday.

Yesterday, my friend Liz, who is a nurse at the university, called me. It’s been far too long since I’ve seen Liz, so I was surprised when her name appeared on my caller ID. She was working at the vaccine clinic and she wanted to let me know my time had come. “We have vaccine available and no one in line,” she said. “If you can get here by 7:30, you can get one.”

It was 6:00. I jumped into the shower and then into the car. As I drove to the shopping center where the clinic was set up, I realized I was excited about this. After months of biding my time and anticipating at least another couple weeks of waiting, I was finally going to get my shot! I would take pictures. I would send them to friends to announce this thrilling experience. This was cause for celebration!

I danced into the cavernous space arrayed with two-dozen vaccinator stations, a long row of check-in stations, and dozens of friendly people to usher me efficiently through this rite of passage. And though no one could tell, because it was covered by my mask, my smile was huge.

I was able to ask for Liz to give me my shot. My friend and I talked and laughed and caught up, and she took my picture. We were having so much fun that I either lost my vaccine card or she forgot to give it to me. So after my 15 minutes of hanging out to see if I would have an allergic reaction, I had to go back and have her make me a new one.

But this morning, as I lay in bed worrying whether the vague headache I feel is a side effect of the Pfizer vaccine or merely my usual need for morning coffee, it occurs to me that now this virus has actually touched me. (At least an mRNA representation of the virus has.)  It is inside my body. And now my amazing body is doing what needs to be done to make sure I can continue to feel untouched by COVID. I’m so grateful!

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Health Information Patient communities

COVID Vaccine and Our Patient Communities

Across the country we are starting to see the light at the end of the tunnel as the rollout of COVID-19 vaccines has begun. For many of our patients with primary immunodeficiency diseases or autoimmune conditions, however, getting vaccinated is not a straightforward decision. They have lots of questions and must weigh carefully a number of considerations.

Immunologist and rheumatologist Dr. Terry Harville has some concerns, too. “There are questions in my mind that haven’t been fully answered,” he says about the new vaccines that have recently been granted emergency use authorization by the Food and Drug Administration (FDA). “And I’m worried that there will be unintended consequences.”

The fact that we have only two months’ worth of safety data from the clinical trials testing these new vaccines from Pfizer/BioNTech and Moderna leaves many medical professionals worried about longer-term effects. Others are unsure about how the vaccines will react in patients with rare autoimmune and primary immunodeficiency diseases, because testing did not include people who live with these conditions.

Despite these concerns, Dr. Harville—along with most other healthcare practitioners—stresses that most people should still get the vaccine. Because when hundreds of thousands of people get COVID and one or two percent of them die, the statistics overwhelmingly support COVID-19 vaccination.

Dr. Harville, who is a professor of medicine at the University of Arkansas for Medical Sciences and an expert in primary immunodeficiency disorders, offers some guidelines for those who are trying to make a decision about the vaccine and might be at greater risk for complications from it.

If you have a primary immunodeficiency (PI) disease, you probably already know that you need to be careful about taking immunizations, especially if they are made with live virus. The COVID-19 vaccines that are currently being administered, however, are not made with live virus. They are created from a man-made part of the virus’s genetic code called mRNA. This means they are safer for those who are unable to take live virus vaccines.

With a few exceptions, Dr. Harville says, “It is the general consensus that we don’t see any reason to not vaccinate those with primary immune deficiency diseases.”

One exception is interferonopathies, IDs associated with dysfunction in components of the immune system called interferons. Another exception is CTLA4 deficiency. These are conditions in which patients tend to develop autoimmune disorders. Dr. Harville recommends that individuals with these types of ID should probably not get the currently available COVID vaccines. While there is no data to support this at this time, there is concern among immunologists that vaccination in this group of patients may trigger an overly aggressive immune response that would be harmful. As more data becomes available, better recommendations will be forthcoming.

If you use immune globulin therapy, there appears to be no reason you shouldn’t get the vaccine. In fact, even if you get the disease, you may actually be better off than others.

“What’s interesting is,” Dr. Harville says, “if you look at SARS-CoV-2 infection in patients with antibody deficiencies—whether that’s X-linked agammaglobulinemia (XLA) or common variable immunodeficiency (CVID)—when these patients are receiving appropriate immunoglobulin (IG) replacement therapy, they tend to have milder disease.”

Intravenous immunoglobulin (IVIG) has even been used, in some cases, to treat COVID-19 infection. While clinical trials to prove effectiveness are still ongoing, some physicians believe IVIG does decrease the risk of severe complications. IG manufactured from the plasma of people who have recovered from COVID-19 infection is also being tested as a treatment.

If you have had a severe reaction to immunizations in the past, this may be a reason to opt out of getting the COVID vaccine. This includes those who have a primary immunodeficiency disorder and developed the infection after receiving a vaccine. It also includes autoimmune disease patients who have experienced a severe flare of their symptoms after a vaccination.

In the 1976, there was a rise in cases of the autoimmune condition known as Guillain-Barré syndrome (GBS) that was thought to be triggered by the swine flu vaccine given that year. This was an inactivated virus vaccine, not the type of mRNA vaccine we now have with COVID. Nevertheless, if you’ve had GBS in the past, be sure to let your healthcare provider know this, as it may be a consideration for whether or not you should get the COVID vaccine.

During the COVID vaccine clinical trials, a very small number of participants who received the Pfizer vaccine developed a severe, life-threatening allergic reaction. Since then, others have also had what is called an anaphylactic response soon after getting vaccinated. If you have ever experienced shortness of breath, tightening in the throat, swollen lips or face, or other severe allergic symptoms, you should probably not get this vaccine in particular. (Other vaccines using whole virus are currently in development and will likely be safer.) Anyone who does get a COVID vaccine should be observed for at least 15 minutes and be sure the healthcare personnel administering it have emergency equipment needed to respond to anaphylaxis.

Regardless of your disease, everyone can reduce their own risk. Dr. Harville stresses that, even if you get vaccinated, it’s still important to wear a mask, wash your hands, and maintain physical distance from others.

“Ultimately whether you take or do not take the vaccine is an individual patient decision,” Dr. Harville says. “This should be made after weighing all the risks and benefits and based on a discussion with your physician.”

We highly recommend that you learn more about the risks and benefits of COVID-19 vaccination as it relates to your particular situation. The Centers for Disease Control and Prevention (CDC) offers these guidelines for COVID-19 vaccination for those with underlying medical conditions. In addition, a number of disease organizations offer educational programming about the impact of the virus and the vaccine on specific disease conditions.

Please also see disease-specific statements about COVID-19 vaccines from these patient organizations:

Guillain-Barré syndrome – GBS|CIDP Foundation

Immune Deficiency Foundation

Myasthenia Gravis Foundation of America

The Myositis Association

Myositis Support and Understanding

Platelet Disorder Support Association

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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 CSI Pharmacy stories

Do you have a COVID-19 Preparedness Plan?

(Brandpoint) – 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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Health Information

Get Your Flu Shot Now

For some, getting a flu shot is just part of the fall routine every year. Immunization against the virus that causes influenza prevents millions of people from getting the disease, makes the disease less severe if you do get it, and can prevent death from severe disease and its complications. According to the Centers for Disease Control and Prevention (CDC), influenza causes an estimated 12,000 to 61,000 deaths every year in this country.

This year, because of the COVID-19 pandemic, physicians and public health officials say it’s even more important that everyone over the age of six months get a flu shot. This is especially important if you have an underlying health condition that makes you more at risk for developing complications if you get the flu. While the influenza vaccine will not prevent you from getting COVID-19 (researchers are still working on a vaccine for this different virus), it will help you avoid getting seriously sick with or—heaven forbid—dying from the flu. And the fewer people who get the flu, the more it saves healthcare resources that are still urgently needed for treating COVID-19 patients.

Those who are at high risk for flu complications are also at greater risk for getting COVID-19 and having serious outcomes. If you have an autoimmune condition or immune deficiency disease, such as myositis, myasthenia gravis, pemphigus and pemphigoid, chronic inflammatory demyelinating polyneuropathy (CIDP), and primary immunodeficiency (PI), this means you. You are at a much greater risk for getting sick with the flu and at greater risk for developing complications like pneumonia if you do. If you have heart disease, cancer, or diabetes, getting the flu can also make these conditions worse.

Getting the flu vaccine, however, is not a straightforward decision for some who have these conditions. For example, some people with a history of Guillain-Barré Syndrome (GBS) may have developed this form of muscle paralysis after receiving an influenza immunization. According to the GBS|CIDP Foundation International, the association between GBS and flu vaccines is inconclusive, but they suggest these individuals avoid the vaccine in the future. If you have had GBS, especially if it developed four to six weeks after getting a flu shot, you should talk with your doctor about the risks and benefits of getting the vaccine again.

Another consideration is the aerosol form of the flu vaccine. This is a live attenuated (weakened) influenza vaccine that is given through the nose. While the injected vaccines are made with inactivated virus, the nasal spray is made with live organisms that have been weakened but are still able to activate the body’s immune response against the disease.

The intranasal vaccine is not recommended for those younger than two, older than 50, or those who have a weakened immune system, including some patients who take immune suppressing medications. If you care for or live with someone who is immune compromised, you should also avoid the nasal spray. And if you have an underlying medical condition that puts you at risk for developing severe complications from the flu (such as chronic lung disease, heart disease, kidney disease, liver disorders, neurologic and neuromuscular disorders, blood disorders, and diabetes), it’s important to check with your physician before taking the nasal flu vaccine.

According to the Immune Deficiency Foundation, those with certain forms of immune deficiency (common variable immune deficiency [CVID], severe combined immune deficiency [SCID] or Bruton’s agammaglobulinemia) are unable to develop protective immunity following vaccination. This means their bodies don’t have the infrastructure to develop the immunity needed to keep them from getting sick, so vaccines will not do them any good. In fact, for individuals with these forms of PI, live vaccines—including the influenza nasal spray—may put them in danger of developing severe disease.

The only reason not to get a flu shot is if you have a severe, life-threatening allergy to the vaccine or any of its ingredients. This might include gelatin, certain antibiotics, or other ingredients. If you get hives when you eat eggs, studies have shown that most times you can still get the flu shot. If you have a more serious reaction to eggs or you are worried about this, you should of course talk with your doctor. Egg-free alternative vaccines are available.

The CDC has more information about seasonal influenza and how to prevent it.

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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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Patient communities

Connecting with Patients is the Reward

As a research scientist, immunologist Huub Kreuwel, PhD never really worked with patients. He spent most of his time in an academic lab, trying to understand the basic biology of certain diseases and identifying molecules that could serve as targets for new therapies. He never got to see what happened in the later stages of drug development—that part where patients got better because of the discoveries he’d made.

When he left academia to serve as medical science liaison at Johnson and Johnson, however, he discovered a whole new experience. Now, years later, as Vice President for Scientific and Medical Affairs in the United States for Octapharma, talking to patients and providers about the plasma-based products his company produces is the best part of his job.

“When I came out of academia, I found it was very satisfying to actually talk to a patient who had tried our drug and had good results,” he says. “As an immunologist, it made sense to work on a lot of these rare diseases like primary immune deficiency and dermatomyositis. And it’s gotten more and more interesting over the years.”

Working in the medical affairs department also offers the opportunity to get involved with a wide variety of projects. Huub and his team work with regulatory agencies when the company is seeking approval for new products. They help set up clinical trials to test new therapies and answer physicians’ questions about how those therapies work. Best of all, he meets the people who benefit from Octapharma’s treatments, such as immune globulin (IG) therapies, and helps them enroll as research subjects in the company’s clinical trials.

Recently, the company completed a trial testing intravenous immune globulin (IVIG) therapy in patients with dermatomyositis (DM). While the results have not yet been made public, Huub says the trial did meet its primary endpoints, so it looks very promising that Octagam 10% will eventually become one of the few FDA-approved treatments for this disabling disease that affects the skin and muscles.

Part of what made this trial so successful was the feedback Huub and his team received from patients. In the process of developing the clinical trial, they worked with patient organizations, including The Myositis Association and Myositis Support and Understanding, to understand how patients experienced the disease so they could improve the study protocol and to help recruit participants for the trial.

“We work on a lot of orphan drugs,” Huub says. “And there aren’t that many patients sometimes, so we need everybody to help us to finish these trials. It worked quite well in the DM trial. Those were very productive relationships.”

The success Octapharma had with this phase III clinical trial with DM will also pave the way for future clinical trials for this indication. When rare diseases have few previous clinical trials, researchers often fumble to find tests that will tell them whether a particular drug is working or not. Octapharma’s trial in DM not only proved that the treatment was effective, it also showed that their measures of effectiveness worked in this patient population.

Huub is now developing protocols to test Octapharma products with other diseases. Among these are pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS for short—a disease in which psychiatric symptoms such as obsessive-compulsive disorder appear suddenly after a strep infection) and secondary immune deficiency (SID—a problem that occurs when immune system deficiencies occur because of something other than genetics, such as HIV or chemotherapy).

As they did with the DM study, he and his team are talking to patients to get input that will improve these studies. One way they do this is by recruiting an advisory board of about a dozen patients who spend the day with company representatives sharing their experiences and suggestions. These open-ended discussions provide insights into all manner of ideas: how to better explain data, ideas for new trials, how patients need to be supported during a trial, and more.

“Those discussions are really good for the company, and usually they’re very productive,” Huub says. “Often patients have ideas for new products or practical solutions that might make our products better. And a lot of times it actually has led to either different products or different marketing material or revamping our website or providing patient education sessions.”

These days the thing that has captured Huub’s interest is COVID-19. Healthcare providers on the front lines of the pandemic are finding success in treating the virus with IG. In fact, recent events have made Octapharma a leader in exploring new therapies for COVID-19.

The company is currently supporting two investigator-initiated projects—one testing IVIG as a treatment for COVID-related respiratory failure, the other using IVIG and steroids to treat COVID-19 patients who are developing heart problems. Octapharma is also conducting their own phase III clinical trial to see if high-dose IVIG can be used to improve severe COVID-19 symptoms. Initial results from the investigator-initiated study with COVID-related respiratory failure are very promising.

“Of course COVID is horrible,” Huub says. “But it also became an opportunity for us to delve deeper into IVIG and how it can potentially work in that disease. It’s very satisfying for me personally and for my team to try and come up with other drugs that could help COVID. So overall, it’s been a very interesting ride.”

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How to Reengage with Less Risk

We’re now four months into a global pandemic, and lots of us are just tired of staying home. Most of the folks in our patient communities, however, have underlying medical conditions that put them at higher risk for developing severe COVID-19 infections. So while others consider reemerging into the world again as states start lifting social distancing restrictions, our patients might be reluctant to take this step.

Still, completely avoiding contact with others for an indefinite period of time is not a viable option either. Human beings need physical and social contact with other human beings, if only to stay sane. The social isolation we’ve been enduring since shutdowns in March has caused serious anxiety and depression for a significant number of people, especially those who live alone.

Fortunately, public health experts say the decision doesn’t have to be either/or. While staying home is still the lowest-risk option for avoiding infection, there are lots of ways to socialize that don’t involve crowded indoor spaces where no one is wearing a face mask (the highest risk option). Weighing the risks of contact with others against the possible benefits to your health can help make the decision-making process easier. Here are some things to think about:

Consider the risk for you and your immediate contacts. If you or someone you live with is especially vulnerable to infection, this is an important factor in weighing how much you want to risk coming in contact with someone who might give you COVID-19.

It’s also important to think about those outside your household with whom you may want to socialize and how much exposure they might have had too. You may want to consider creating a pandemic “pod,” a small cohort of friends or relatives with whom you choose to interact somewhat normally but who agree to stay socially distant outside the pod.

Keep tabs on how the virus is spreading in your community. The number of new cases, hospitalizations, and deaths varies widely in different areas of the country. Check local health department reports or find out here whether these numbers are increasing or decreasing where you live. If they are climbing or remain high, you may want to rethink whether going to a salon for a haircut is a good idea, even if restrictions have been lifted.

Think about how risky the activity is. Most people know the basics of how to stay safe from coronavirus infection. Keep these ideas in mind as you make decisions about venturing out in public. These include:

  • Wearing face covering when out in public significantly reduces transmission, both for the wearer and the ones they are with.
  • Maintaining a distance of at least six feet from others decreases the chances of contact with infected droplets.
  • Large gatherings, especially if they are indoors and especially if others are not wearing face covering, significantly increase the risk that someone will pass on the virus.
  • Encounters in the outdoors are safer than those in close indoor spaces.
  • Limiting the time you spend among others, especially if it is indoors, reduces the chances of encountering the virus.
  • Bringing your own (BYO) food and drink means a lower risk of transmitting the virus through touching a contaminated surface. Bringing your own chairs or picnic blankets also helps you keep your distance from others in an outdoors group.
  • Handwashing with soap and water or using hand sanitizer is still the most effective way to prevent transmission of coronavirus and other disease-causing organisms.

And finally, here are additional tips from NYC Health to keep yourself and your loved ones safe and healthy as pandemic restrictions start to lift. Be careful out there!

Categories
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

Categories
Advocacy CSI Pharmacy stories

It’s Our Turn

As a member of CSI Pharmacy’s patient advocacy team, it’s my job to create materials for our campaign to increase plasma donations. We’re working to encourage people, especially family members and friends of those who rely on immune globulin therapy, to roll up their sleeves and give back by giving their plasma.

The coronavirus crisis has slowed donations of this life-saving serum from which immune globulin (IG) therapies are made. Together with the Immune Globulin National Society (IgNS), CSI Pharmacy is supporting the #ItsMyTurn campaign, encouraging those of us who are not on the front lines of the battle against COVID-19 to consider this opportunity to be a hero in a different way.

While I sat safely socially isolating in my home, organizing webinars, writing patient stories, and creating social media memes, this voice kept nagging at the back of my head: You could donate, it said.

I could, I thought. But the closest plasma donation center is an hour away from where I live in Central Virginia. But it would take me half the day to donate. But I’d have to do it on a regular basis; a one-time shot won’t work.

Still, I just couldn’t sit here urging others to do this important work if I weren’t willing to get off my “buts” and do my part too. I work remotely all the time anyway, and I could bring my laptop and check social media while I donated. I could commit to donating once a week. So I made an appointment and started donating.

But I’m not the only member of the CSI Pharmacy staff getting out of the workplace to donate plasma. Our leadership is making this a movement by encouraging all employees to become plasma donor heroes. And CSI Pharmacy CEO James Sheets is leading the way to the donation center.

“This is an opportunity for us to give back to our community of patients who depend on this life-saving therapy,” James says. “Our patients are our family, and we can’t let them down. We have to do what we can to be sure they can get the treatments they need.”

For my colleagues who work at the pharmacy headquarters in Wake Village, Texas, there is a certified plasma donation center just three miles away in Texarkana. CSI Pharmacy team members are given time to donate during working hours. Those who donate receive a special #ItsMyTurn t-shirt. James has even created a contest to encourage employees to make donating a routine part of their week.

“Our team members are motivated to this cause, because they’re so connected to our patients and their therapies,” James says. “They know how challenging it can be for folks when IG products are in short supply.”

With seven donations under his belt so far, delivery technician Justin McNeill is leading in donations among the CSI Pharmacy employees. He’s grateful for the time to give, but for him it’s not really about the contest or the modest payment he receives as a donor. 

“If there’s a shortage on our IG products, our patients aren’t going to get the medicine they need,” Justin says. “I figure I’ve got it to give, so I might as well.”

Roxanne Ward, CSI Pharmacy’s Regional Nursing Supervisor in Little Rock, Arkansas got three of her nurses together to make an event of their trip to the plasma donation center. Knowing that plasma donations are down right now is what made her want to take this extra step for her patients.

“I treat so many people who rely on this,” she says. “I felt like donating is the least I can do to help the people I care for.”

Not everyone at CSI Pharmacy will qualify to donate plasma, though. Eligibility guidelines are strict, so those with certain medical conditions, those who take certain medications, or those who may have been exposed certain blood-borne pathogens won’t be able to give. These team members can still participate in our program, however, by recruiting someone else to donate in their place.

“I really wanted to be a plasma donor because it’s so important that we have enough plasma for those who need these therapies,” says VP of Patient Advocacy and Provider Relations Michelle Vogel. “Unfortunately, I’ve used blood products (platelets) in the last year, so I don’t qualify. So I asked my family to help.”

Michelle’s brother-in-law, who was among the four members of her family to volunteer, knows intimately how important IG therapies can be. His mother has myasthenia gravis and has been treated for many years with IVIG.

“We’re really proud of the response from our team members,” James says. “It’s an important effort, and we’d like to invite other businesses and organizations to join this effort to short-circuit an IG shortage by encouraging their employees to donate plasma. Together we can make a difference.”

#ItsMyTurn