Tag: IVIG therapy

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Advocacy IG Therapy

Peace of Mind with PNS

image of child for illustration purposes

Recently, we received word of a voluntary recall of a particular brand of immune globulin (IG). The manufacturer requested pharmacies to return all units of two specific lot numbers of the product because of reports of allergic-type reactions in patients who had been infused with these specific lots.

The hives, swelling, and skin redness that patients experienced quickly resolved when they were treated with antihistamines (Benadryl, for example), steroids, and Tylenol. Still, the manufacturer wanted to be sure others were not unduly affected by these uncomfortable symptoms caused by their intravenous IG infusions.

While news of a recall may alarm some patients, making them question the safety of their therapy, veteran IG users know that the rare recall of medications is usually not a cause for concern. In fact, the idea that the manufacturer is vigilant enough about their products to take this step voluntarily makes them feel more confident in their treatments.

Product recall or withdrawal is a common practice in industries across the country, including pharmaceuticals and medical devices. A product recall or withdrawal has several different levels; the highest is a Patient Level Recall, which is a request or warning to stop using a product. This directive can come from the Food and Drug Administration (FDA), which oversees drug safety. More often, however, the request comes voluntarily from the manufacturer, usually in response to some safety concern they’ve noticed.

“We get recall notices from both the FDA and manufacturers,” says Jack Lemley, Pharm.D., Chief Pharmacy Officer at CSI Pharmacy. “Any time we receive a recall alert, we review our electronic inventory to determine if we have ever purchased the affected lot numbers. If we have, we then check to see if any of it is still in stock and remove it.”

Still, there are times when a recalled product may be dispensed before pharmacists are aware of the recall. At CSI Pharmacy, if such a product has been shipped to a patient, pharmacists contact the person immediately and advise not to infuse the therapy, if appropriate to the level of the recall. If the patient has already infused the product, pharmacists will evaluate them for any adverse reactions. Patients are urged to notify their healthcare provider(s) of any potential adverse effects for their IG therapy, even if there is no known recall.

As a partner in their own healthcare, we strongly encourage patients to keep their own records. This should include the manufacturer of the product, the lot number (found on the side of the bottle or container), and the way it was administered (IV or subcutaneous). CSI Pharmacy provides patients with an infusion log used to record this information.

Patients can be proactive in finding out about IG product “events,” as recalls and withdrawals are called, by registering for the Patient Notification System (PNS). Through this free, confidential early warning system, patients can be made aware of a recall before they infuse or inject their therapy.

The PNS was developed by producers and distributors of plasma products and is led by the Plasma Protein Therapeutics Association (PPTA) in response to consumer requests. It provides registrants with automatic updates about plasma product withdrawals and recalls from all participating manufacturers.

To access the Patient Notification System, call 1-888-UPDATE-U (1-888-873-2838) or register online at www.patientnotificationsystem.org. You can choose the products with which you would like to receive notifications, as well as the method of notification: via telephone, fax, e-mail, or overnight letter. You will also receive a first-class letter by the US Postal Service when there are notifications.

While pharmacists do everything possible to ensure the safety of patients, there’s always a chance that a product may slip through. The Patient Notification System in one more way you can team up with your pharmacists to ensure your health and peace of mind.

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Advocacy Patient stories

Buyer Beware

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The cost of health insurance had been a struggle for Diane Steele for years. Even the plans offered by her husband’s employer were too expensive when they had children at home. For a while, the family had to go without insurance. When Diane learned about health share programs, she saw this as an affordable way to protect her family.

Health share programs (sometimes called medishare or healthcare sharing ministries) are faith-based programs in which members pay a monthly “share” (notably not called a premium), which is pooled together with other members to pay for approved medical expenses.

While health share programs have been around for decades, because they are significantly less expensive than traditional health insurance, their popularity has increased in recent years as healthcare costs and insurance rates have skyrocketed. Part of the reason they are less expensive is they are not actual health insurance.

Program guidelines for what will be covered are often limited and may be determined by religious beliefs rather than medical need. Some health shares, for example, specifically exclude things like birth control, addiction treatment, or conditions related to smoking or alcohol abuse. Health share programs may even require members to sign a statement of faith, and some require verification of regular church attendance.

Because these programs have a religious affiliation, they also are not subject to mandates imposed by the Affordable Care Act (ACA), such as coverage for preexisting conditions and no lifetime caps on coverage. Most also specifically exclude drug coverage, especially for long-term treatment of chronic conditions such as diabetes or heart disease. Instead, members are steered to prescription discount cards like GoodRx and NeedyMeds to help pay for insulin and high blood pressure medication.

“We went with the health share because of the cost, and because we liked the idea of helping other people,” Diane says. “The funds go into a universal plan, and as people need it and qualify for it, they cover your costs. The only thing is you have to get approval up front for any kind of major outlay.”

Having to get approval for major healthcare expenses seemed like a small concession for Diane and her family, one that seemed routine when her husband needed major open-heart surgery a few years ago. The health share covered all of the expenses of that hospitalization with little hassle.

When Diane was diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP) in 2017, however, she discovered limitations that were much more of a hassle. CIDP is a rare disease of the nerves and muscles in which inflammation causes disabling numbness, weakness, and pain in the legs and arms. It is a chronic condition that often requires a lifetime of treatment.

“I was so sick,” Diane says. “I couldn’t walk. I couldn’t drive. I was basically in a wheelchair most of the time. And I was gradually getting worse and worse.” 

Among the medications her neurologist prescribed for the condition was Gammagard, a form of intravenous immune globulin therapy (IVIG). This treatment, derived from donated human plasma, is very expensive, but it’s also very effective for a wide variety of autoimmune conditions like Diane’s. IVIG treatments did allow Diane to return to a more normal life, one that no longer includes a wheelchair, but the health share refused to pay for it.

“I worked and worked with the health share,” Diane says. “I talked to all kinds of people over there, and often had to ask for the supervisor’s supervisor. It was so complicated. They didn’t even know what Gammagard was.”

The health share required Diane to have a number of different tests to prove the diagnosis. They also required her to try other, less expensive medications (a process known as step therapy) to show that these treatments didn’t work for her condition. And they wouldn’t approve it just based on the doctor’s prescription. Her neurologist had to send them an extensive written report to justify the scientific basis for using IG for Diane’s disease.

To be fair, Diane’s experience with the health share program was not unique. Even traditional health insurance companies require preapproval for expensive treatments like IG therapy. Many also impose limitations on doses or frequency. There is often a large copay, and some will completely deny coverage for the treatment, especially if it is being prescribed off label (for a treatment that is not approved by the FDA for a particular condition).

But even after jumping through all these hoops, the health share only approved the treatment for forty-five days as a test to see if it would work. And the dose they allowed was also lower than what the doctor prescribed. Even when it did prove to be effective, the health share refused to cover the cost.

After the forty-five-day trial period, Diane worked with her specialty pharmacy to access the life-saving treatments she needed. They helped her apply for a special patient assistance program through the manufacturer that provided the medication for free. The specialty pharmacy then provided the nursing services and supplies at no cost. They also helped her apply for Social Security Disability, which would allow her to enroll in the more comprehensive benefits available through Medicare.

Diane’s story is a cautionary tale that underscores the need to know what you’re buying when you purchase healthcare coverage. All plans have restrictions and limitation. But when a plan is so inexpensive compared to the norm, you have to be especially careful to understand what they will pay for and be sure it covers the care you need.

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Advocacy IG Therapy

Don’t Take No for an Answer

The agency licenses, permits, and oversees pharmacists and pharmacies, as well as the distribution system where there is the sale, delivery, or distribution

Karen has struggled for many years with intense pain and muscle weakness, symptoms of chronic inflammatory demyelinating polyneuropathy (CIDP). This rare nerve disease causes gradually increasing loss of sensation, numbness and tingling, intense pain, and weakness in the extremities. For the last two years, though, Karen has been doing well with monthly infusions of intravenous immune globulin (IVIG) therapy.

Now, however, Karen is terrified that this life-saving treatment will be yanked away from her, not by her doctors, but by her health insurance company.

Karen receives IVIG infusions at home through an independent specialty pharmacy. But after every monthly treatment, she receives a letter from her insurance company’s pharmacy benefits manager (PBM) telling her that her plan requires that she obtain this medication from their preferred specialty pharmacy.

“We’ve just been living with this every month,” Karen’s husband David says. “It’s so nerve racking. We’re always afraid that they will deny coverage and we will get a bill for thousands of dollars.”

This scenario is happening more often lately, according to James Sheets, CEO of CSI Pharmacy, a small, independent specialty pharmacy that caters to patients who use IVIG. Between five and ten percent of new referrals to his pharmacy are rejected by the patient’s insurance plan because of preferred pharmacy limitations.

“The thing is, this is not always true,” James says. “Even when the claim is denied, we have to do some investigating to see what the truth really is. Often, we are, in fact, able to provide services to these patients.”

So far, Karen is still able to get her treatments through her pharmacy of choice. But last month the PBM, a middleman in servicing pharmacy benefits for health insurance companies, stepped up the pressure. In a letter she received, they stated that there was a nationwide shortage of IVIG and again stated Karen was required to switch to their preferred pharmacy.

Someone from the preferred pharmacy even followed up with a phone call out of the blue, insisting that her health plan would not pay for the treatment if she didn’t get her medication through their company, a large, nationwide chain that is financially linked to both the insurance company and the PBM.

“IVIG is extremely expensive,” Karen says. “There’s no way we can pay for it ourselves. They’ve been writing these letters and now they’re calling me. I’m terrified! These people have no concern for my diagnosis or my medical care.”

While plasma donations decreased last year as a result of pandemic restrictions and many expect some immune globulin (IG) products to be in short supply, an IG shortage has not yet materialized. In fact, the only agency authorized to make a declaration of a drug shortage is the Food and Drug Administration (FDA), and to date no such declaration has been issued for immune globulin.

“It’s just wrong that there is an IG shortage,” James says. “Even if there were, the pharmacy in question would not be the only place that has availability of IG products. In fact, patients at small pharmacies like CSI Pharmacy would be more likely to be protected than those at a large national chain pharmacy.”

For patients like Karen who might be feeling more pressure to change to a new pharmacy for specialty medications like IVIG, James has a few suggestions. For starters, if you are already receiving services that you are happy with, don’t automatically agree to change.

“Be an advocate for yourself,” James says. “Tell your plan, look, I have been stable with my current pharmacy. I’m happy with the services they provide. I have a good relationship with my infusion nurse. I do not want all that change, and I would like to opt out and continue to use my current provider.”

It’s also a good idea to call your specialty pharmacy’s patient advocate and let them know what’s going on with the insurance company. You have a relationship with the people at your pharmacy, and they can do the necessary investigating to see if anything has changed with your coverage.

As Karen and David found out when they called their specialty pharmacy, the insurer was continuing to cover the cost of Karen’s infusions, despite the threatening letters they were sending to her. And her pharmacy had no intention of billing her for anything more than her copay.

If you have Medicare and your IVIG is covered under the Medicare Part D drug plan, you are protected against this practice. Language in the Medicare legislation specifies that patients can choose to get their medications from “any willing provider.” So by law, insurers are not allowed to force patients to a certain pharmacy.

“I believe that patients deserve to have the power to make their own health care decisions,” James says. “That’s when the best care takes place. I hate to see patients being forced, against their will, to use specific pharmacies simply as a business decision. The problem with that is there’s no incentive for the big chain pharmacies to do a great job, because when patients don’t have a choice, they never have to make patients happy in order to keep their business.”

CSI Pharmacy would like to know if this sort of pressure to change pharmacies is happening to others. If you’ve received communication from your insurance plan or their pharmacy benefits manager urging you to move your care to their preferred specialty pharmacy, please drop us a note at [email protected].

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Advocacy IG Therapy Patient stories

IG Shortage is Coming

Bonnie and Walter Joslin smiling in front of their home door.

Walter “Kip” Caro started noticing tingling, numbness, and pain in his feet back in 2007. Gradually these symptoms progressed up his legs and into his body to the point where he had to be hospitalized because his torso was affected and he couldn’t breathe. It took three years for doctors to diagnose him with chronic inflammatory demyelinating polyneuropathy (CIDP). In that time, Kip suffered permanent nerve damage in his
feet.

For the last 11 years, however, Kip has been treated with intravenous immune globulin (IVIG), which has worked like a charm. He never has to worry about his symptoms, unless he can’t get his treatments every three weeks. If he doesn’t, as happened last June when there was a shortage and his infusion center couldn’t get immune globulin (IG) products from their distributor, his disease starts to relapse.

“It was scary,” he says of this experience.

“Over the years, we’ve met people said they could make a change to their treatment schedule, and their symptoms would not be affected,” says Kip’s wife Bonnie Joslin. “But we’ve learned, for Kip, his body just can’t do that.”

Kip feels lucky that Bonnie is such an advocate for him. By the time his infusion center called and told him they weren’t able to get his medication, Bonnie had already been reading about other patients’ experiences
online. She reached out Facebook and was put in touch with CSI Pharmacy, which was able to get Kip hooked up
with home infusions within a week.

“He was already starting to relapse,” Bonnie says. “But CSI pushed it through, and Natalie Edwards in the insurance department worked to get approval. I know it wasn’t easy, but it was like a miracle
happened.”

By early 2021, however, nearly all IG manufacturers expect to see shortages again. This time it’s because pandemic shutdowns earlier in the spring have decreased plasma donations. Plasma is the raw material from which IG and other protein therapies are made. The manufacturing process takes seven to nine months to create IG from donated plasma, so unlike last year’s shortage, this time we know it’s coming and can be prepared.

When IG products are in short supply, rationing does happen. Certain sites of care may stop treating outpatients. If they do treat outpatients, they may limit treatment to primary immune deficiency, Kawasaki disease, and transplant patients.”

That’s because supplies of IG are not universally distributed. Hospitals and infusion centers have contracts with
certain manufacturers or distributors, so they can only get specific brands. Last year, patients like Kip who were served by these sites of care sometimes found their treatments delayed or dropped completely.

Specialty pharmacies like CSI Pharmacy that offer home infusion services, however, have access to more brands
of IVIG as well as subcutaneous immune globulin (SCIG). In 2019, CSI Pharmacy was able to work with patients, their healthcare providers, and their insurance plans to allow them to continue IG treatment in the home.

At times this meant switching to a different brand of IVIG when certain brands were not available. Some patients even switched to subcutaneous (meaning under the skin) infusion after being on the intravenous (IV) form.

While changing to a different product can be scary for patients who have confidence in a brand of IG that is working well for them, please be assured that  a switch can be relatively comfortable if you
work closely with your doctor and pharmacist. The pharmacist can find a brand that is close in formulation to your current brand, for example. If side effects become a problem, the infusion rate can be reduced
and pre-medications prescribed. 

If you depend on IG therapy, now is the time to prepare. We suggest you have a conversation with your provider and current site of care. 

  • Ask your provider what other brands are good options if your brand is in short supply, and ask your care site if they are able to obtain one of these brands if needed.
  • Ask the site of care if they will prioritize patients if there is a shortage. Will it be based on disease, IgG levels, and/or rationing product by the number of grams or frequency?
  • Ask how the site of care handled past shortages.

If it turns out that your site of care does not prioritize patients with your disease or they are unable to obtain your brand of IG, you may want to consider how important is it to you that you continue IG therapy. (Some patients feel comfortable skipping their treatment for a month or two if it means they don’t have to make changes.)

If you’re like Kip, however, and can’t function without regular IG infusions, you’ll need to think about what options are available to enable you to access this treatment. Are you willing to switch brands? Are you willing to move to home infusion? Are you willing to switch to SCIG?

If home infusion becomes your alternative, we urge patients to make that move now. Specialty
pharmacies are more flexible and were less affected during the last shortage, but that may not be the case this time. 

If you are a patient of a specialty pharmacy when this crisis hits, you may be able to get access to IG since they do not ration based on disease and have access to more brands. However, we do not know how the shortage will affect sites of care. 

At CSI, we want to see all patients have access to all brands in their preferred site of care. But we just don’t know what the impact is going to be. We expect this shortage will be across all manufacturers. Patients should understand that this is not going to be a perfect scenario. You may still run into hurdles like access to your preferred brand.

CSI Pharmacy’s patient advocates are available to discuss your options related to IG therapy, regardless of whether or not you are our patient. If we can’t service your needs, we will gladly help you find other resources. No patient should suffer alone.

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Patient communities

Stumbling onto Rare Disease

Susan Foley

Susan Foley used to brag that if she told you she forgot, she was lying. For most of her life, she remembered everything. In the last ten years, however, her mind is more like someone with a traumatic brain injury. She loses her train of thought, and sometimes she can’t get the right words to come out when she talks.

Susan has Hashimoto’s encephalopathy (HE), a type of autoimmune encephalitis (AE) that causes swelling in the brain. When this happens, patients experience an odd array of symptoms. They can say strange things, act like they have no feelings, and stumble, as Susan says, like a drunken sailor. Too often, family members and even doctors think these people are just behaving badly. So getting an accurate diagnosis for this rare disease can be a challenge.

About a year before she was diagnosed, Susan started having trouble walking up steps, noticed tremors in her hands, suffered debilitating headaches, and couldn’t make her bed in the morning without needing to take a nap. She blamed these symptoms on her stressful job. When she began having absence seizures (a type of epilepsy in which the person blanks out for a few seconds, staring off into space) it scared her. She knew she needed to get help.

“I had so many different symptoms that the doctors had no idea what was going on,” Susan says. “My primary doctor kept telling me it was stress related, but I knew there was something more going on. Finally, I asked her to send me to a neurologist.”

Still, it took almost a year of every imaginable diagnostic test and a trip to see a specialist at a large teaching hospital for the neurologist to put all the pieces together. Among the tests the specialist did was a blood test for thyroid antibodies. The results were off the charts. This was the clue the neurologist needed.

“HE has nothing to do with your thyroid,” Susan says. But doctors have noticed that this form of encephalitis is associated with elevated thyroid antibodies. As in Susan’s case, this is often how physicians identify the disease.

Having a diagnosis is one thing but figuring out what this means for your life is a whole different process. When Susan went to the internet in search of accurate information about HE, all she found was a single article. It took a lot more digging through online forums and support groups to find even one other person who had the disease.

That one other person turned out to be Nicola Nelson, a Chicago attorney who had also been recently diagnosed with HE. The two became good friends and, when Susan told Nicola about her idea to write a book, she wholeheartedly agreed.

“I had big dreams, you know?” Susan says. “I thought, people who are diagnosed with HE have no information. They need to know from other patients what to expect, what that patient has gone through.”

Hashimoto’s Encephalitis: A Guide for Patients, Families, and Caregivers, now in its second edition, is still the only book about HE available. It includes stories of patient experiences along with interviews with prominent physicians who specialize in the disease.

In addition to the book, Susan and Nicola started a nonprofit patient organization to provide ongoing support and information for those affected by HE and other autoimmune encephalopathies. HESA (Hashimoto’s Encephalopathy/SREAT Alliance), provides both scientific and experiential information on living with HE (also known as steroid-responsive encephalopathy associated with thyroiditis [SREAT]; encephalopathy associated with autoimmune thyroid disease [EAATD]; and nonvasculitic autoimmune inflammatory meningoencephalitis [NAIM]).

HESA raises awareness and advocates for the HE community and raises funds to support research that patients hope will one day shed more light on the underlying cause of HE/AE and create new, more effective therapies. Last year, HESA joined together with other AE organizations to host a symposium to educate physicians and other healthcare professionals. (Recordings of these and other presentations are available on the HESA website.)

HESA’s support groups include two private Facebook pages, one specifically for teens. Susan and her medical advisory board also consult with individuals privately on everything from physician referrals to how to get insurance to approve IVIG therapy to sensitive issues such as incontinence.

Despite the fact that Susan’s career in business ended when she became sick, she’s busier now than she’s ever been. HESA is her labor of love.

“I will tell you, when one door closes, another door opens,” she says. “HESA has been a life saver to me. I still feel like I’ve got something to give, and I tell people when they’re feeling sorry for themselves, they need to find a purpose. Do not feel sorry for yourself. Do something. It will give you a reason to get up in the morning.”

One of the most effective therapies for autoimmune encephalopathy is IVIG. CSI Pharmacy is excited to welcome HESA and those with AEs into our family of care.

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Patient communities

Connecting with Patients is the Reward

Huub Kreuwel

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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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.

“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

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Advocacy Health Information

What’s the Difference?

showing bag for plasma transfusion and donation

Plasma donations are down in recent months. Fewer donations now means a possible shortage of plasma products, such as IVIG, within the coming year. Becoming a plasma donor is one way those of us who are not on the front lines of the battle against COVID-19 can bring some good into the world.

But there are significant differences between donating plasma and donating blood. Most significantly, plasma donated at a blood bank or Red Cross facility will not be used to create immune globulin.

Here is an outline of other differences:

What’s the difference between donating blood vs. plasma?

Plasma Blood
Allowable frequency Twice a week with two days in between Once every 56 days
Donations needed to qualify At least two within a six-month period; prefer regular, ongoing donations One donation qualifies
Time it takes to donate 1 to 2 hours first donation; less than 1 hour for subsequent Less than 1 hour
Uses To produce life-saving therapies such as immune globulins, clotting factors, and albumin Primarily for transfusions in local hospitals
Donations needed to produce IVIG 250 to treat one autoimmune patient for one year NA – Blood and plasma donations at blood banks and hospitals are not used to make IVIG
Where can you donate? IPPQ-Certified plasma donation center specific to your location  https://www.donatingplasma.org/donation/find-a-donor-center Any AABB-accredited blood donation site http://www.aabb.org/tm/donation/Pages/Blood-Bank-Locator.aspx
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Patient stories

Stay Home

When Katherine Holt hears about people who are eager to end pandemic precautions she is outraged. Katherine is among those who are at highest risk from COVID-19 infection, not just because of her age: 76. She has chronic inflammatory demyelinating polyneuropathy (CIDP), an autoimmune disease that makes it hard for her to walk because of damage to the nerves in her legs.

For those like Katherine who live with autoimmune diseases or other chronic illnesses that put them at risk, one of their greatest fears is that people will start to relax coronavirus restrictions like social distancing and gathering in groups. They’re afraid this will increase COVID-19 cases and that vulnerable people like themselves will get sick.

“I just want to jump through the TV when I see people saying we don’t need to stay home,” she says. “It’s not time to lighten up, because it’s just going to make this pandemic longer, and more people will die.”

Katherine knows what she’s talking about. Until she retired, she worked most of her life as a nurse. She also started her career in the US Air Force. Between the two, she still feels a great deal of respect for authority and duty—an authority based on science and a duty to keep people healthy.

So Katherine is sticking to stay-at-home orders. She lives in Jonesboro, Arkansas with her sister Gloria and their four-legged family: four cats and two dogs. Katherine is grateful that her sister is so strict about making sure she is not exposed to coronavirus or other infections.

“In the beginning, my sister and I—she’s 67—looked at each other and we decided between the two of us I was the one at highest risk since I have CIDP,” Katherine says.

Gloria orders ahead and uses drive-through services at the grocery store and pharmacy. Anything that comes into the house sits in the garage for several hours before being brought inside. Then Gloria pulls on gloves and wipes everything down with alcohol or bleach before placing it in the pantry or refrigerator. In a fallback from Katherine’s days as a nurse, they even have a transition area between the outside (dirty) and the inside (clean) where they do the disinfecting.

Katherine had two doctor appointments scheduled during April, one with her PCP, the other with her neurologist. Both were routine checkups, and she was feeling fine, so she canceled them. She will call if she needs medication refills and reschedule when the pandemic precautions are lifted.

One thing she has not canceled is her IVIG therapy. She’s been receiving monthly treatments since 2008 and getting her infusions at home for about four years now. It’s the main thing that keeps her able to walk.

Katherine’s first infusions were done in a hospital. “I had to be there at 7 o’clock in the morning, and I was there all day. I got back home about six or seven at night, because they were giving it to me really slowly and checking all the vital signs and everything very frequently.”

When the hospital canceled her infusions several times in a row, she was getting a little desperate. She happened to have an appointment with her neurologist shortly after a representative from CSI Pharmacy had stopped by, talking about home infusion. The doctor put in the order, and three days later—on a weekend—Katherine was getting her infusion at home. Now with social distancing, home infusion makes even more sense.

“I think home infusion is the way to go,” she says. “It’s everything you could want. They made it all really easy. And I enjoy when they come, because finally I have another nurse to talk to.”

Ever the nurse, however, Katherine wants to educate the public about what it means to people like her for the country to flatten the curve.

“I just wish I could help other people understand how important it is to stay at home,” she says. “I’m praying people will see reason. If they draw on their good conscience, hopefully they’ll be able to say, oh, maybe we shouldn’t go back to business as usual just now.”