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Health Information Patient communities

Choices: IVIG versus SCIG

Many patients with autoimmune disorders and primary immune deficiency diseases depend on regular infusions of immune globulin (IG) to keep them healthy. For most of the nearly four decades since immune globulin therapies have been available, patients have had only one viable option for how this treatment was given. It was only available as an intravenous (IV) infusion.

Since 2006, however, when the first IG product was approved for subcutaneous (SC) administration, patients have had a choice about how they received their treatments. Both products are considered equivalent in terms of efficacy, but there are lots of other factors that may make one preferable over the other. Providers usually have their own sense about how IG should be administered, but we asked IG users for their thoughts on the pros and cons of each option.

Convenience is the biggest factor in which route patients prefer. Ironically, both IV and SC users think their choice is most convenient.

Rebecca, for example, has been getting IVIG for 12 years after being diagnosed with common variable immunodeficiency (CVID). She speaks for many when she says, “I like that I only sacrifice one day every three weeks for treatment.”

The convenience of once-a-month infusions with IVIG comes at the expense of independence, though. IVIG poses higher risks, because it goes directly into the vein rather than under the skin. So it must be given under a nurse’s supervision, whether that is in the hospital, an infusion center, or at home. This means it also has to take place on a schedule that may not always be convenient.

Those who use SCIG usually take their infusions once a week rather than once every three to four weeks or so. Still they prefer the control they have over when they infuse, because they do it themselves. As Brandina, who has myasthenia gravis, says, “I love that I can administer it myself. The treatment days are flexible, and I can take the medication with me, so I don’t have to plan my vacation around treatments.”

Infusing once a week is also inconvenient for some SCIG users, but for most this is a minor drawback. As Jen, who has specific antibody deficiency, says, “I absolutely love SCIG. There are so many more pros that I could list and only this one con.”

Getting infusions at home, whether it is IV or SC, is also a convenience. This has become especially important since the COVID-19 pandemic has made it less desirable to go to a healthcare clinic. Brynne, whose six-year-old daughter uses IVIG for juvenile dermatomyositis (JDM), was grateful when her overnight hospital infusions were changed to in-home infusions because of coronavirus restrictions.

Making the most of infusion time is something IVIG users have worked into their lives. Sitting in an infusion center or even hanging out at home with a nurse for six to eight hours or more can be a huge inconvenience, but it doesn’t have to be wasted time. Dana, who has dermatomyositis, likes IVIG, because it forces her to take time for herself and relax. And Robin, who has CVID, uses the time to crochet.

Mary, whose husband has myasthenia gravis (MG), prefers to get his IVIG at the hospital infusion center for other self-care reasons. “He loves the heated, vibrating recliner,” she says. “And they provide snacks and lunch.”

Adverse effects can be more of a problem with IVIG. In fact, this is often the reason patients switch to SCIG, which has far fewer reactions. Symptoms can range from fatigue, fever, flushing, chills, and ‘‘flu-like’’ symptoms to more life-threatening reactions like anaphylaxis (severe allergic reaction) and blood clots.

The most frequent side effect is headache, which can last several days and be more severe than a migraine. Some, like Lola, who has Sjögren’s syndrome, even get aseptic meningitis (inflammation of the membrane covering the brain) after infusions. This causes debilitating headaches, dizziness, and other symptoms.

Scar tissue and knots of fluid under the skin from subcutaneous infusions was a drawback for those using SCIG. These knots usually disappear within a few hours, though, and any redness or swelling at the injection site usually decreases over time.

Pain from being stuck with needles is not an insignificant side effect, regardless of whether it’s IV or SC. Whether it’s having to stick oneself multiple times or whether it’s having difficult-to-access veins, nobody likes to feel like a pincushion.

This can be especially challenging for children. Nancy’s nine-year-old daughter has JDM and receives IVIG at a pediatric infusion center. She says having ultrasound to find and insert the IV needle makes a world of difference for her daughter. Being spoiled by the nurses also takes some of the sting out of the whole ordeal.

Fluctuations in therapeutic effect is another reason many people switch to SCIG. An IG dose is mostly metabolized by the body over about 22 days, whether it’s given IV or SC. With IV infusion the dose reaches its peak immediately and dissipates over the next three to four weeks. This means that some patients will feel their symptoms returning as IG levels in the blood go down.

“As I got closer to my next treatment date, I would start to feel the effects of needing my next treatment,” says Karon, who has MG. “After I received it, I could tell I had just received a boost and had more energy.”

Giving IG under the skin makes the blood levels rise more slowly. And because SCIG is given more frequently—usually weekly—IG levels in the bloodstream fluctuate far less, so patients don’t feel that fatigue and other symptoms returning.

Whatever you decide about IG therapy, Lea, who has used IVIG for 22 years to treat CVID, offers this important advice: “You have to listen to your body and watch how it reacts to everything and try things until they work for you.”

For those who would like to learn more about IVIG or SCIG, please contact the CSI Pharmacy advocacy team at advocacy@csipharmacy.com.

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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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Advocacy Patient stories

Profile of a Plasma Donor Hero

Two-and-a-half years ago when she joined a book club through the Wounded Warriors Project (WWP), a nonprofit organization that provides programs and services for wounded veterans, Torey Reese wasn’t thinking about how much she enjoyed reading or needed some motivation to finish a book. She just wanted to find friends.

Like others in this caregiver’s group, Torey had a husband at home who had been injured during active duty as a Marine. She and her family had relocated to San Antonio, Texas a year and a half earlier. Her second child was born shortly after the move with some health problems that required several surgeries. Because of her family’s healthcare needs at the time, she wasn’t working, and she was feeling pretty isolated. The book club was a way for her to get together with others who shared some of the challenges she was dealing with.

“Pretty much immediately I thought I wanted to be friends with Amanda,” Torey says. “We loved similar types of books, and that just kind of sparked the friendship.”

Amanda Martin was there at the book club because she too cares for a former military husband with serious health issues. Since meeting three years ago, the two have found lots of other things they have in common, including children that are around the same age. And except for their current social distancing because of COVID-19, they and their kids have been inseparable.

But Amanda and her 9-year-old daughter Rita live with primary immunodeficiency disorders, which make them vulnerable to recurrent infections. Amanda depends on intravenous immune globulin (IVIG) infusions twice a month to stay healthy. Rita too receives subcutaneous IG weekly.

“Immune globulin helps control our infections,” Amanda says. “Our lives are so much better because of it. It enables my daughter to go to school. It enables me to be out in the community and to advocate for my husband. I wouldn’t be able to function as well as I do without it.”

When Torey found out about Amanda’s and Rita’s disorder and the life-saving therapy they depend on, she had to help. Immune globulin is not a drug that can be mixed up in a laboratory. It is made from donated human plasma, the golden-colored liquid that remains after the red blood cells are removed. It takes 130 plasma donations to treat one immunodeficiency patient for one year. When donations decrease, so do immune globulin supplies. If there is a shortage, as we had last summer, Amanda and Rita risk having to go a longer period of time between their infusions. They may even have to go without.

So once a week or so, Torey goes to one of more than 800 certified plasma donation centers in the country to give a bit of her plasma. She wishes she could donate twice a week, which is the maximum donors are allowed. But in addition to caring for her husband and two boys, Cayden 10 and Caspian 3, Torey now works as an accountant for a small nonprofit organization. Once a week is all she can manage right now. Still, this is a long-term commitment for Torey, who has been donating for nearly a year now.

“It’s something I can directly do to help them stay alive and stay healthy,” says Torey, who has donated plasma in the past. “I never knew anybody before who directly benefited from my donations. So when you have a person you care about, who is a real face and a real name and a real story to you, it’s hard to not want to help them. I mean, it’s a minor inconvenience to me, but it’s a major inconvenience to them.”

“I can’t express my gratitude enough for her doing this,” Amanda says with a catch in her throat. “It’s something my daughter and I talk about when we get our infusions. We’re very, very grateful and just lucky that Torey is healthy and willing to do it. This may not seem like a heroic thing to do, but for the people who benefit from it, it absolutely is.”

The COVID-19 pandemic has caused a significant reduction in plasma donations in recent months. CSI Pharmacy, in partnership with the Immune Globulin National Society (IGNS) and their #ItsMyTurn campaign, urge those who are eligible to commit to donating plasma to help avoid a shortage of immune globulin and other life-saving plasma-derived products in the months to come. Reminder: It is important to seek out a certified plasma donation center to be sure your donation is used for IG products. (Donations made at blood banks and the Red Cross are not used to create IG products.)

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Advocacy Patient stories

Giving Back One Unit at a Time

Marianne Moyer got a standing ovation recently when she announced to a roomful of rare disease patients at a medical conference that her husband donates plasma every two weeks. Her husband, John, started donating blood and plasma more than 20 years ago, even before Marianne started relying on intravenous immune globulin (IVIG) therapy—a plasma-derived product—to treat myositis. Since then he estimates he has given about 18 gallons of blood and 63 gallons of plasma.

For those like Marianne who depend on immune globulin to help control inflammation in autoimmune and immune deficiency diseases, having enough plasma available to companies that make plasma products is a constant concern. Human plasma is not a drug that can be artificially synthesized. It requires people to donate on a regular basis so therapies such as immunoglobulins, coagulation factors, alpha-1 proteinase inhibitor, and albumin can be produced.

This is an important concern right now because fewer people are donating plasma because of coronavirus restrictions. Many citizens are staying home, which means many are not donating. Donation centers are also taking steps to create social distance within the facility, so they are asking donors to schedule appointments rather than drop in, and they are seating donors farther away from each other. Fewer donations now could mean a shortage of plasma-derived therapies in six to nine months.

Most people are aware of how important donating blood can be, especially when disaster strikes. People also assume that when they give their blood, whatever other blood products are needed can be derived from that donation. The truth is a bit more complicated, though.

Plasma is the golden yellow liquid part of human blood in which red blood cells and proteins are carried throughout the body. Donors can offer their whole blood—red cells and all—on a one-time basis or, like John has done, they can donate every 56 days.

Plasma donors, however, can give more often, because those all-important oxygen-carrying red blood cells are returned to their bloodstream during the donation process. And because plasma is manufactured into lifesaving therapies for many diseases, plasma donors are encouraged to give regularly—as often as twice a week, at a certified plasma donation center.

For the Moyers, volunteering in the community is a way of life. They have been running one of the most successful myositis support groups in southwest Florida for 13 years. Marianne has served on the board of the local Red Cross, and John has been treasurer of their homeowners association and property manager at their church. And they both volunteer with programs at the local public schools. For John, donating plasma is just another way to give back.

“September 11 happened shortly after we moved here to Florida,” John says. “I would donate blood when we lived in Washington, D.C. So when they were calling for blood [after the 9/11 attacks], we both rushed down to the hospital to donate.”

Marianne was heartbroken to find out that, because of her myositis, she was ineligible to donate. But John has been giving about every two weeks ever since. When Marianne was prescribed IVIG in 2003, his donations became even more personal.

Marianne has a form of myositis called necrotizing myopathy, an autoimmune disease of the muscles that makes it difficult for her to do things like climb stairs and lift even small objects. Myositis has also brought interstitial lung disease, which causes scarring in the lungs making it difficult for Marianne to breathe at times. Her IVIG infusions—which she receives in the comfort of her home—control these symptoms well, allowing her to live a fairly normal life.

“All the years when we were working, we didn’t have much time to participate in community affairs or charities,” John says. “Life has been good to us, and now that we are retired, I can afford to spend a couple hours at the donor center. It just makes me feel good to know that I’m helping, not just one person, but many people.”

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Health Information

Concerns about Coronavirus

Those who rely on specialty therapies like IV immune globulin (IVIG) infusions are understandably anxious about the impact of coronavirus containment measures currently being implemented across the country. CSI Pharmacy’s advocacy team have heard from a number of patients, especially those who get their treatments at infusion centers or hospital clinics, who are worried about the possibility of being exposed to the virus in these facilities.

It is extremely important that you get your IVIG treatments, especially during this time when you need your immune system to be as effective as possible. Patients should not postpone or cancel a regularly scheduled infusion.

We urge you to call your infusion site to be sure they are operating as usual. You can also check in with your physician to ask their opinion about coronavirus containment at your facility.

If, however, you can’t or don’t want to leave home or your usual infusion site is closed, home infusion may be an option. CSI patient advocates are available to help you sort out these access options, including continuing at your current site. If you decide you’d like to transfer to home infusion, we can also help you navigate this process with your physician and your insurance plan.

Regardless of where you decide to have your infusions, CSI Pharmacy wants to be sure no one goes without the treatments they need during this public health crisis. Please reach out to our advocates at advocacy@csipharmacy.com you have questions or need help accessing care.

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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.”

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CSI Pharmacy stories

CSI: A Special Specialty Pharmacy

“I’d always had a dream of owning a little mom-and-pop pharmacy,” says James Sheets, CEO of CSI Pharmacy. He’d had a number of jobs working in both big box pharmacies and smaller shops in and around his hometown of Texarkana, Texas, and he preferred a small, local business where he and his staff could get to know their customers.

In 2013, James’s dream came true when he and two other pharmacist friends, Barry Buls and Mark McMurry, had the opportunity to partner up and purchase North Heights Pharmacy, a shop that had been in business in Texarkana since 1975.

North Heights was doing some retail sales, but they also provided medications for some local hospice services. They also did compounding, mixing up specialized medications for individualized patient needs. The plan, when James took over as chief pharmacist, was to build on these services, with outstanding customer service as their main goal.

In a previous job, however, James had started a successful home infusion program. The service provided treatments such as intravenous antibiotics, cardiac medications, and intravenous nutrition. It was a way for patients to receive these intensive treatments at home, rather than having to go to the hospital or stay in a nursing home.

He wasn’t really trying to get back into home infusion services at North Heights, but one day James got a call from a local neurologist who had several patients who were desperate for someone to provide intravenous immune globulin (IVIG) therapy in the home. These were people with chronic inflammatory demyelinating polyneuropathy (CIDP) who had been cut off from this service because the big national pharmacy chain that once provided it had decided it wasn’t getting paid enough by the patients’ health insurance.

“These were patients who were stable on IVIG, who had been doing well for years, yet they were losing their home infusion services,” James says. “Naturally we wanted to take care of them. Some of these patients we knew from our previous experience, so we already had a personal relationship with them.”

So James and his partners decided to go all in with home infusions, especially IVIG. They made some infrastructure changes to add the necessary facilities at North Heights, and they hired Tracy Knox, a nurse who specializes in infusion therapies, to work just with these patients. They also hired several other staff members who were experienced with the processes necessary to administer infusions, including pharmacy technician Natalie Edwards, IV technician Jet Richardson, intake coordinator Vanessa Noble, and Abe Cardenas, who serves as warehouse manager.

The pharmacy also needed a new name, one that more accurately reflected this new focus.  Clinical Specialty Infusions was born and immediately became CSI Pharmacy.

“What really sets us apart is that we’ve developed clinical programs around the different types of patients we serve,” James says.

In addition to people with CIDP, CSI also has patient communities for those with myositis and myasthenia gravis, both rare, autoimmune neuromuscular diseases. A new patient community is also developing with people who live with pemphigus and pemphigoid, which are rare autoimmune diseases that affect the skin and/or mucus membranes.

In caring for these patients, James and his team don’t just take an order from a physician and give the customer the medication. CSI hires or contracts with infusion nurses who know how best to administer immune globulin and how to monitor the patient during and after the treatment. More than that, though, they work with the whole CSI team, including physicians, pharmacists, patient advocates, and insurance staff to be sure the patient receives the individualized care they need.

More importantly, because staff spend so much time with patients, both administering the medications and working to get insurance coverage for these expensive treatments, they get to know them as friends not just patients. Staff and patients exchange personal stories, check in with each other, and share the success when the patient’s condition improves.

Infusion nurse Tracy Knox, for example, has been working with James since the beginning. “I can see the difference I’ve made in people’s lives, and I like that,” she says. “I’ve been doing infusions for this one patient for many years now. She used to have to use a wheelchair, but now I see her in Walmart and she’ll say, ‘Look! I can walk with a cane now!’”

Over the past few years, CSI has grown from a small, hometown pharmacy into a thriving nationwide specialty pharmacy with two physical locations and plans for more and a mission to make sure every patient receives the care she or he needs regardless of how much they get paid for it.