Author: onenine

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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.

Categories
Health Information IG Therapy

When Your IG Therapy Makes You Feel Worse

Infusion treatment at home with CSI Pharmacy

As with most medications, immune globulin (IG) therapy can cause side effects. If your IG infusion leaves you with these uncomfortable symptoms, the good news is most of the time there are things you, your nurse, or the prescriber can do to make side effects less likely and relieve them if they happen.

Infusion reactions are most common if you use intravenous immune globulin (IVIG) rather than the subcutaneous form (SCIG). IG infusion nurses and pharmacists are usually very familiar with the types of reactions that can occur during or after your infusion, and they know how to respond to them. Rest assured that your nurse will be with you throughout your infusion to monitor for any reactions and respond to them.

Premedication can be one way to avoid reactions from occuring. Along with IG infusions, prescribers often prescribe over-the-counter pain medications, such as acetaminophen (Tylenol) or ibuprofen (Advil), and an antihistamine such as diphenhydramine (Benadryl).

Drinking lots of fluids (several liters a day) before, during, and after the infusion will also help. Be sure to hydrate with water not soda, coffee, milk, or other beverages.

Common Symptoms

Headache is one of the most common side effects with IVIG therapy, but usually this is mild. It’s why the nurse will start out running the infusion slowly and increase the rate gradually over the first hour or so. If a headache develops, the nurse will likely run the infusion more slowly to see if this will relieve the pain. Drinking more fluids may also help. If the infusion needs to run so slowly that it will take all day to infuse, it may need to be divided into smaller doses and given over several days.

Other milder symptoms may also occur—with or without a headache—including chills, fever, flushing, dizziness, muscle aches, joint pain, fatigue, nausea and/or vomiting, and rash. If these symptoms are significant, your prescriber may decide to try a different brand of IG. Each brand is slightly different in composition, and some people do better with one brand over another. Your nurse will consult with the pharmacist and/or your prescriber to decide how to best manage your symptoms.

For subcutaneous infusions (SCIG), pain, redness, and swelling at the needle site may also occur. Be sure to let your nurse know if you notice this and if it gets worse during the infusion. One possible solution may be to change or reposition the infusion needle.

If you use SCIG, you may notice lumps under your skin at the infusion site. This is expected and happens because the fluid you are infusing takes some time to be absorbed into your body. If these areas become uncomfortable, you can apply a warm cloth or compress to the area. If they last for more than a day or are painful, call your nurse or pharmacist.

More Serious Adverse Reactions

While headache is a common reaction with IG infusions, it usually goes away during or soon after the infusion, especially if treated with pain medication and hydration.

If your headache continues for days, is especially severe, or you have a stiff neck, drowsiness, high fever, sensitivity to light, eye pain, or severe nausea or vomiting, this is a cause for alarm. These may be signs of a rare reaction called aseptic meningitis (swelling of the brain not caused by infection). You should call your prescriber and the pharmacy and get medical help right away. 

Another rare but serious situation is an allergic reaction (anaphylaxis). This usually happens during the infusion while the nurse is with you. If you get your infusions at home, your shipment from the pharmacy will also include medications the nurse can use to treat this reaction. 

You may notice symptoms of an allergic reaction after the infusion is completed and the nurse has left. Such symptoms may include rash, itching or swelling (especially of the face, tongue, or throat), severe dizziness, or trouble breathing. If these occur, call 911 and get medical attention as fast as possible.

IG may also raise your blood pressure. Your nurse will check this frequently during your infusion. If you have had high blood pressure in the past or are currently being treated for it, please make sure that the prescriber, nurse, and pharmacist are aware. If you check your own pressure, be sure to notify the prescriber if it increases in the days following your infusion.

Other Possible Concerns

IG is made from human blood plasma, so it can rarely cause blood clots. This is more likely in older adults or those who previously have had blood clots, heart problems, or blood circulation problems. Blood clots are also more likely if you have been on bedrest for a long time, are using birth control pills or hormone replacement therapy, or if you have a central intravenous (IV) catheter in place.

Call your prescriber and pharmacist immediately if you have chest pain, trouble breathing, chest tightness, or rapid heartbeats. Other signs of a blood clot can be numbness or weakness, swelling and warmth, or discoloration in an arm or leg.

You should also let your prescriber and pharmacist know right away if you notice that your gums or nose start bleeding, you bruise more easily, it takes a long time to stop a cut from bleeding, you have a fainting spell, you feel like your heart is racing or skipping beats, or you feel unusually tired. These are signs of other cardiovascular problems that may need to be treated.

Sometimes IG can harm your kidneys, especially if you have kidney disease or use certain medicines. Signs of kidney problems include swelling, especially in the legs and hands, rapid weight gain, and little or no urination. Call your prescriber and pharmacy right away if you notice any of these symptoms.

Less of a Concern

Because IG is made with donated human plasma, some people worry about getting a disease from it. The risk of getting an infection from your treatment, however, is almost nonexistent. Modern methods used to purify IG destroy bacteria, hepatitis viruses, and other infectious germs. No one can predict every new infection that may develop, though. This is one of the reasons the pharmacy keeps careful records of the specific IG product you receive.

It’s also important that you keep track of when you get your infusions, the brand, product number, lot number, and any reactions you have around the time of the infusion. This will help you determine which products worked best and can help the pharmacist figure out if you are having side effects related to a specific brand.

Please Ask Questions

Never be afraid to ask questions about any symptom or reaction you have during or after your treatment. Your infusion nurse, pharmacist, and prescriber can all help you understand any reactions you may experience and how to treat them.

Please remember: Every patient is unique in the way they respond to any treatment. Do not hesitate to let your nurse or pharmacist know if you start to notice uncomfortable side effects. Lastly, if you ever experience unusual symptoms that cause you concern, be sure to contact your prescriber immediately.   

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Advocacy

Patient Advocates are on Your Side

We know how hard it can be for those who live with chronic or rare diseases to cope with their health challenges. It can be even more overwhelming when you add on all the other questions about specialist care, health insurance coverage, finances, and so much more. A patient advocate can be a lifeline, helping you find the resources to get the care you need, so you can focus on getting well.

A patient advocate is a person who supports your healthcare journey by helping you work with healthcare providers, insurance companies, employers, case managers, lawyers, and others on issues related to your health. These knowledgeable and committed individuals can help resolve issues around access to care, medical billing disputes, and job discrimination related to your medical condition.

Patient advocates can examine your insurance plan and help you understand your coverage. They can also help you choose a new health insurance policy during open enrollment, work with providers to resolve your healthcare needs, and help you apply for disability.

At CSI Pharmacy, we take patient advocacy seriously, going beyond just working with the individuals for whom we provide therapies. We believe advocacy also extends to providing actionable information for patients and their families. One way we do this is by supporting and promoting the wider efforts of disease-based patient support groups throughout the country.

Our nurses, pharmacists, and patient advocates volunteer to speak at patient support groups, national conferences, and webinars. Through these talks, we educate patients and caregivers on issues such as navigating insurance, tailoring therapies to meet your unique needs, infusing specialty therapies in the home, understanding social security disability, and helping patients choose the best health insurance plan for them.

Another way we advocate for patient communities is by providing valuable resources on the CSI Pharmacy news page. We encourage you to subscribe to this page on our website, where you will receive ongoing information about treatments and wellness, patient stories, provider profiles, insurance, policy issues, and much more. You can sign up here.  

Our quarterly email newsletter also provides important news from the pharmacy as well as links to a broader range of news from around the rare disease community and a seasonal recipe too! You don’t need to be a CSI Pharmacy customer to sign up for the newsletter. And please follow CSI Pharmacy on Facebook, Twitter, and LinkedIn where we also post about issues of interest to the rare disease community.

Our patient advocates are always available for you, regardless of whether or not you are a patient of the pharmacy. To schedule a one-on-one consultation, just email us at [email protected].

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Uncategorized

Building a Myositis Team in Texas

A neurology resident Building a Myositis Team in Texas

When Salman Bhai, MD and his wife were looking around for a place to settle into their careers last year, they decided Dallas was where they wanted to be.

“We were looking for a place that would support us,” he says. “Both of our families are here. We’re originally from Dallas, so this has always been home.”

Along with coming home, Dr. Bhai wanted to bring to the area his expertise as a neuromuscular specialist and a myositis researcher. His goal is to build a regional multidisciplinary clinic that specializes in myositis care. Such centers exist in other areas of the country—Baltimore, Boston, Pittsburgh, Kansas City, for example—but they are notably lacking in the South.

In Texas, Dr. Bhai was given the opportunity to create this specialty care clinic and be part of vibrant clinical and scientific communities. He serves as the Director of the Neuromuscular Center at the Institute for Exercise and Environmental Medicine, a joint institute between the University of Texas Southwestern and Texas Health.

“We are developing a myositis center where patients don’t have to travel so far to get the care that they need and deserve,” he says. “It will also be multidisciplinary, so they don’t have to keep coming back and forth to see different specialists. We will have everyone in one place.”

Dr. Bhai was fascinated by neurology when he was in medical school. He found the nervous system to be especially interesting because of its complexity, and he knew there was a lot more to be learned about its function and impact on people’s lives. As a neurology resident, he gravitated toward patients with neuromuscular challenges and did clinical fellowships with some of the country’s most renowned myositis experts in Boston.

 “Myositis patients have muscle disease as well as systemic involvement,” he says. “I especially enjoy speaking with patients and trying to understand the issues they have, because we can make a big difference. It requires multimodal care, and it’s a long-term relationship. These patients don’t just need medication. They need a good doctor-patient-caregiver relationship to help them achieve the best outcomes.”

Dr. Bhai is also an Assistant Professor of Neurology at the University of Texas Southwestern Medical Center where he cares for patients with a range of autoimmune neuromuscular conditions, including myasthenia gravis, chronic inflammatory demyelinating polyneuropathy (CIDP), and Guillain-Barré syndrome (GBS).

The myositis center will also be a research institute. Dr. Bhai is collaborating with other researchers at UT Southwestern on projects to better understand all forms of the disease and to develop new therapies to treat them.

Already there is a biobank in place where muscle biopsies and other de-identified patient specimens can be stored for research. The center will also serve as a site for clinical trials—Dr. Bhai currently serves as site investigator for nine clinical trials—where those with myositis can participate in testing of new therapies and diagnostics.

And because exercise is such an important part of the treatment plan for those with myositis, once COVID restrictions are no longer a problem, Dr. Bhai wants to include an exercise program in the mix. His hope is this will be a place where patients can come together not just for an exercise class, but to meet others who have their disease, share their experiences, learn from each other, and serve as a support network.

Raising awareness of myositis among new medical practitioners and trainees is also a priority.

“These patients are rare. You don’t see them every day,” Dr. Bhai says. “My hope is when trainees join me in clinic, they will see more of these cases than they might otherwise. Whether they’re trying to learn how to perform muscle biopsies or exercise testing, or they want to see what myositis looks like in a patient, I want to help support that.”

Dr. Bhai’s own research stems from his personal interest in exercise.

“I think muscle is quite beautiful and complicated, but we treat it too simply,” he says. “We think of it only as something that allows us to move. But in fact, it communicates with the rest of the body. Muscle tissue releases factors that influence your brain, your gut, and other muscles. Because of these factors, we know that exercise improves quality of life, it improves overall muscle health, and it improves mental health. Most people should exercise, even those who have a muscle disease like myositis.”

Dr. Bhai’s current research involves understanding why people with myositis experience exercise intolerance and fatigue, even when their disease is well-controlled. He’s trying to understand the biology of muscles, especially the mitochondria (tiny structures in the cell that generate energy). And he’s exploring genetic markers in the blood to see how these markers released by muscle tissue are different in those with myositis and how that produces the symptoms they feel.

“My goal is to create a partnership with a broad team,” Dr. Bhai says. “Not just with practitioners but also with the patient, the family, the caregivers, their pets, their support team. Everyone. I really want to have a patient-centered approach that brings change to those who live with this disease. That’s when patients get the best care.”

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Uncategorized

Open Enrollment is NOW

working at a computer devoted to work at CSI pharmacy

Do you feel like you are paying too much for healthcare services and prescription drugs under your current health insurance plan? Does your insurer require you to try and fail at less costly therapies before allowing the treatment your doctor has prescribed? Is the medication your doctor prescribed denied by because it isn’t listed on your plan’s formulary?

Now may be the most important time of the year if you are dissatisfied with your health insurance coverage. We are currently in the middle of Open Enrollment season for Medicare and the Affordable Care Act (ACA) Marketplace plans. For those insured under employer plans, the end of the year is also a time when new or updated plans are often offered, allowing employees to make changes to their benefits plans.

The following are important deadlines to keep in mind for applying for or making changes to insurance coverage for 2022:

  • Medicare Open Enrollment ends December 7.
  • ACA Open Enrollment ends January 15 (coverage starts February 1).
    • Deadline for ACA coverage to start on January 1 is December 15.
  • For employer plans, check with your human resources manager.

CSI Pharmacy is here to help you navigate the system. We are experts at understanding the fine print in health insurance policies. We can help you review your options and find the plan that best meets your healthcare needs as well as your budget.

For those who are having trouble paying for healthcare coverage, here are some options that can help:

Medicare Assistance Programs – If you are unable to afford Medicare premiums, several types of State Medicare Savings Programs are available to help you pay your Medicare premiums. In some cases, they may also pay deductibles, coinsurance, copayments, and prescription drug coverage costs. Each of the programs has different eligibility criteria. There are even programs that allow individuals who delayed enrollment into either Medicare Part A or Part B to enroll outside regular enrollment periods. In some cases, qualifying for these programs automatically qualifies you to get Extra Help to pay for Medicare drug coverage.

To see if you qualify for these programs and to apply, contact your State Medicaid Program or Department of Social Services. You can also call 1-800-MEDICARE (1-800-633-4227) to get the phone number for your state’s Medicaid office.

Extra Help – If you meet certain income and resource limits, you may qualify for Extra Help in paying for your Medicare prescription drug plan premiums, deductibles, and copays. Depending on your income and state of residence, you may pay less or nothing for premiums and deductibles, and copays are capped at an affordable rate.

For additional information and to see if you qualify, see the Extra Help webpage at Medicare.gov. In some cases, you may automatically qualify if you qualify for the Medicare Savings Programs above. If you don’t automatically qualify, there is a link on the Extra Help page where you can apply.

Medicaid is a joint federal/state program that helps with medical costs for those with limited income and resources. Each state has different eligibility requirements and application processes. You can now apply for Medicaid either through the ACA Marketplace or directly with your state Medicaid agency. See this website for more information and to see if you qualify. You can also call 1-800-MEDICARE (1-800-633-4227) to get the phone number for your state’s Medicaid office.

PACE – Program of All-Inclusive Care for the Elderly (PACE) is a comprehensive healthcare program through Medicare and Medicaid that helps individuals remain in the community rather than going to a nursing home or other extended care facility. The program provides a team of healthcare professionals who work with you and your family to coordinate your care. It covers all the services this team decides you need, including drugs, provider visits, transportation, home care, hospital care, and nursing home stays when needed.

You never pay a deductible or copay for any drug or service provided. If you are covered by Medicaid, long-term care is also fully covered. If you have Medicare but not Medicaid, there is a monthly premium for long-term care and Medicare drug coverage (Part D). Enrolling in PACE, however, means you are required to use a PACE-preferred physician and the other providers associated with the plan.

PACE is only available in some states and only in some areas. To qualify, you must:

  • Be 55 or older
  • Live in the service area of a PACE organization
  • Need nursing home-level care (as certified by your state)
  • Be able to live safely in the community with help from PACE

To find out if you qualify and if there is a PACE program in your area, search for PACE plans in your state, or call 1-800-MEDICARE (1-800-633-4227) to get the phone number for your state’s Medicaid office.

Veterans Benefits – If you qualify for health benefits from the Department of Veterans Affairs (VA), you can receive both Medicare and VA benefits, but they don’t work together. Medicare doesn’t pay for any care provided at a VA facility, which is the only place VA benefits are offered. Many veterans use their VA benefits to get services not covered by Medicare, such as prescription drugs. For more about eligibility and benefits, call the VA Health Administration Center at 1-800-733-8387 or 1-877-222-8387.

ACA Marketplace – Uninsured individuals and families who do not qualify for the government-funded programs above can still get coverage, often at a discount, through the ACA Health Insurance Marketplace, also known as the Exchange. ACA plans are offered through private insurers participating in the Exchange. They all provide the same essential health benefits, and you cannot be denied based on pre-existing conditions. You can review plans and apply for coverage at Healthcare.gov. In completing the application, you can also see if you qualify for free or low-cost coverage through Medicaid, or for savings on a Marketplace plan.

Marketplace plans and insurers change every year. This year premium subsidies enacted under the COVID-related American Rescue Plan Act (ARPA) last year are still in effect for 2022. This means many Americans will qualify for lower premiums. The number of insurance companies participating has also increased, so there are more options to choose from. If you currently have a Marketplace plan, you may want to consider exploring these options to see if you can find a more affordable rate rather than allowing you current plan to auto-reenroll.

If you make changes to your health insurance coverage, be sure to notify your healthcare providers and your pharmacist so the transition to the new plan is smooth.

Categories
IG Therapy

Does IG Contain COVID Antibodies?

showing bag for plasma transfusion and donation

Many who depend on immune globulin therapy to treat their autoimmune or primary immune deficiency disease wonder about the presence of antibodies against COVID-19 in the IG products they use. If so, they want to know if it’s possible that these antibodies might protect them against this deadly infection.

To find out, we contacted one of the manufacturers we work with: Octapharma, which produces Octagam, Panzyga, and Cutaquig.

The company ran a study in which they tested their IVIG and SCIG products derived from donated plasm they collected in the United States to see if they contained antibodies to SARS-CoV-2, the virus that causes COVID-19. The testing was done from the end of 2020 through June 2021 and tested to see if these antibodies could react to and neutralize the virus.

They found that their IG products do indeed contain antibodies to SARS-CoV-2, and they do have the ability to neutralize the virus. They also found that concentrations of these antibodies increased over the time of the study, probably as a result of increasing numbers of donors who had been infected or vaccinated before donating their plasma.

According to the company spokesperson, “The increasing levels of SARS-CoV-2 antibodies in Octapharma IVIG and SCIG products indicate that a certain level of protection could be possible against COVID-19 in patients…who are receiving standard IG therapy.”

Given these results, it’s likely that other brands of IG also contain some level of COVID antibodies as well. In fact, a similar study conducted by Takeda evaluated SARS-CoV-2 antibodies in their product, Gammagard Liquid, and found similar results.

Researchers from both studies expect COVID antibodies to continue to increase in the plasma supply as more donors are exposed to or vaccinated against the SARS-CoV-2 virus. They went on to predict that, given the six-month lead time from plasma collection to release of the IG product, IG users can expect a similar level of antibodies as that found in convalescent plasma (that is, plasma donated by individuals who have recently recovered from COVID) by summer 2021.

We want to stress, however, that it is impossible to know at what levels SARS-CoV-2 antibodies may be present in any given dose of IG. It is also unclear exactly how high plasma antibody levels would need to be in order to provide COVID protection to primary immune deficient or autoimmune patients through IG therapy.

Therefore, immune globulin therapy should not be considered a source of protection against COVID infection. According to the CDC, vaccination against SARS-CoV-2 remains the best way to avoid severe disease and hospitalization.

Read the report of Octapharma’s study here.

Read the report of Takeda’s study here.

Categories
Health Information

Wellness is Within Your Control

Walking in the early morning showing health and happiness
Photo by Emma Simpson on Unsplash

Lisa was in her mid-twenties when she suddenly came down with asthma. She had never had allergies or wheezing as a child—the time when this sort of disease usually strikes people. But now she was desperately sick, struggling for breath on a daily basis, often needing to go to the emergency room for intravenous medication that would open her lungs and allow her to breathe again.

Her doctors told her this condition was chronic, that she would have to take medication for the rest of her life, and she’d have to be careful about all the things that could trigger an asthma attack. There may even be things that she would never be able to do again. Dancing, for example.

Like many people who are diagnosed with a chronic medical condition, Lisa was devastated. She became depressed, gained weight, and developed other health problems, all of which left her feeling out of control and helpless. 

One day, however, she learned about a class at the children’s hospital for people newly diagnosed with asthma. She decided to go. Even though it was aimed at kids and their parents, that class changed her life.

She learned what was happening to her body when she was having an asthma attack and what she could do about it. She learned about changes she could make to her home to reduce things like dust and mold and feathers that triggered wheezing. Most importantly, she came away from that session feeling empowered. She wasn’t as helpless as she thought.

That class set Lisa on a path toward wellness. She studied everything she could find about self-care and holistic options for treating chronic conditions. She changed her diet, started exercising more, saw a therapist, started meditating, and spent time in nature. Lisa was determined to prove those doctors wrong.

It took several years and a combination of mainstream medicine and wellness practices, but it happened. Lisa gradually decreased the amount of medication she was taking, and one day she realized that it had been years since she’d had an asthma attack. She could even forget about that inhaler that she always carried with her like a lucky rabbit’s foot “just in case.”

While not everyone who lives with a chronic condition can completely leave it behind in this way, most health problems can be improved by actively taking charge of the things in your life you do have control over. Here are some important areas to address:

Take care of your body

This includes getting enough sleep, eating a healthy diet, and getting enough exercise. In fact, paying attention to these practices puts you way ahead of the curve for all healthy living habits. All three help you think more clearly, lower your stress, improve your mood, and feel less fatigued. They can also help you control your weight, which can reduce your risk from other health conditions, such as diabetes and heart disease. And they all have a positive impact on your immune system and can reduce inflammation.

And while you’re doing good things for your body, don’t forget the things you shouldn’t do that are toxic to your health. Smoking, for example. Quitting is the single most important thing you can do to get your health on sound footing. Taking it easy when it comes to using alcohol and caffeine is also a good idea.

Mind your mental, emotional, and spiritual health

You are more than your physical body. Paying attention to how you are feeling, your mental space, and your spiritual wellbeing can have important influences on your physical health. You may be surprised to see how effective it can be when you take steps to control excessive stress, toxic thoughts, and harmful emotions like anger and anxiety.

There are so many ways to do this: See a therapist or talk to a friend. Start a meditation, mindfulness, or yoga practice. Keep a journal. Pray. Cultivate gratitude and find joy in all that is around you. Take a walk in the woods. Be creative. Cuddle with your furry friends. Make time on a regular basis to do what makes you feel good and helps you connect with the Divine.

Don’t forget your peeps!

Research shows that a strong social support system is extremely important for staying physically and mentally healthy. Having positive interactions with the people in your life makes you more resilient to stress, decreases the impact of post-traumatic stress disorder (PTSD), reduces the impact of disease, and helps you live longer. Studies also show a positive impact on mental health, immune function, cardiac health, and more. And having the support of friends and family enhances your ability to go along with good health habits, such as eating a nutritious diet, exercising, and smoking cessation.

It’s not just being on the receiving end of support that has an impact. Helping others helps you, too. Lending a hand has been shown to lower stress, disability, and mortality in the giver as well as the receiver.

But beware: poor social support can have a negative impact on health. If interactions with the people in your network cause conflict, criticism, and excessive demands, that’s a cause for concern. You may want to distance yourself, choosing instead to interact with the positive people in your life.

Categories
IG Therapy

FDA Approves First Proven Treatment for Dermatomyositis

CSI Pharmacy Director of Nursing Roxanne Marlar

Until recently, those who live with dermatomyositis (DM), have relied on off-label medications to treat this rare autoimmune disease of the muscles. On July 16, however, the Food and Drug Administration (FDA) approved an intravenous immune globulin (IVIG) therapy called Octagam10% for use by adults with DM.

“This is fantastic news for the myositis community,” says Dr. Rohit Aggarwal. “Octagam is the first proven FDA approved treatment for a myositis indication. We’ve had drugs in the past, but this is the first one that has the kind of scientific evidence—a Phase 3 clinical trial that is randomized, double blind, and placebo controlled—that is required for FDA approval.”

Dr. Aggarwal, an internationally recognized myositis expert, was the principal investigator for the Phase 3 clinical trial called ProDERM that demonstrated that Octagam 10% caused significant improvement in DM skin and muscle symptoms as well as other disease criteria.

Immune globulin is a concentrated solution of antibodies derived from donated human plasma. While immune globulin has been used to treat a variety of autoimmune diseases for more than 30 years, it’s use in myositis has been “off-label.” In fact, with a few grandfathered-in exceptions, all treatments for myositis diseases are used without an FDA labeled indication (approval) for this condition.

For a rare disease like myositis, however, it’s often difficult to convince a pharmaceutical company to invest in the research necessary to attain FDA approval. Fortunately, Octapharma, a privately owned pharma company based in Switzerland, chose to take that leap with Octagam.

“We are very responsive to patient and clinician requests,” says Eric Pluckhorn, US director of sales for Octapharma. “This now gives us an entree into the autoimmune market that up until now we really have not had for the Octagam brand.”

Several years ago when the company started this project, DM represented a huge unmet need. At the time, Dr. Aggarwal and his colleagues had recently developed response criteria that would provide the kind of measurable data needed to clearly demonstrate the drug’s benefit for patients. The success of the trial is good news for both DM patients and the providers who care for them.

For patients, off-label use often makes accessing the medication a challenge. IVIG is very effective, but it’s also very expensive. Health insurance companies, in an effort to cut costs, often don’t want to pay for such costly treatments. So they create roadblocks for patients, such as requiring them to first try a number of other treatments without success before they allow IVIG. This practice is called “step therapy.” If the drug is prescribed off-label, many companies simply refuse to pay for it.

Practitioners are also enthusiastic. “Empirically,we always knew IVIG works,” Dr. Aggarwal says, “but we were hesitant to give it, partly because of not having Phase 3 clinical trial-level of evidence and partly due to the insurance issues. Now we have an approved drug that we can give to the patients, and insurance companies can no longer deny it because it’s off-label.”

Perhaps more importantly, Dr. Aggarwal suggests this approval sets a precedent for future drug development in myositis.

“Once you have a drug approved through the FDA based on a rigorous process and a valid set of criteria, other drug companies will look at that as a pathway for novel drug clinical trials in myositis,” he says. “The ProDERM study sets a precedence for future drug approval in myositis.”

Within the next five to ten years, Dr. Aggarwal predicts there will be a number of novel therapies approved for myositis diseases, including not only dermatomyositis, but also polymyositis and necrotizing myopathy.

To address the other side of the access equation—that is, the expense—Octapharma plans to offer financial assistance to help cover the cost of the treatment. Eligible patients with commercial health insurance will have access to the company’s Copay Assistance Program that will cover out-of-pocket costs, such as coinsurance, copay expenses, and deductibles, up to $2,500 per year. This assistance is provided without regard for ability to pay. (By law in the US, the company is not able to offer this coverage to those who have government plans such as Medicare, Medicaid, or Tricare.) Patients who don’t have insurance or have lost their insurance may also get assistance through a compassionate use program.

“The FDA approval of Octagam 10% as a safe, tolerable and efficacious treatment for dermatomyositis in adults is exciting news for patients who previously relied on unapproved treatments,” said Octapharma USA President Flemming Nielsen. “Octapharma is committed to providing life-saving and life-enhancing therapies for patients with rare diseases. We look forward to partnering with patient organizations and the medical community to develop educational and other support programs that will serve dermatomyositis patients.”

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Patient communities

Never Say Die

Vickie Henderson refused to give up on finding the care she needed.

Vickie Henderson is the kind of person you want to have on your team if you want to win. She’s driven. She gives it her all. And she never gives up. But seven years ago, that never-say-die attitude became a liability for her.

Vickie, who is an obstetrician/gynecologist, started noticing her eyes weren’t focusing quite right, especially when she was tired. She told her eye doctor, who kept adjusting her contact lenses, trying to compensate for the blurred vision, but it was never quite right. At home, she would go to bed early, not because she was sleepy, but because she literally could not keep her eyes open.

As it turned out, she had ocular myasthenia gravis (MG), a chronic autoimmune disease that affects the muscles that move the eyes and eyelids. It was a huge surprise, but she refused to see it as a setback. She was training for a five-day, two-hundred-fifty-seven-mile bicycle ride across the state of Missouri, and she was pushing herself. She couldn’t let up now.

“One thing I learned is, if you push MG, it pushes back,” Vickie says. “Of course I pushed it, and six weeks after my diagnosis—just days before the race—it progressed to generalized MG.”

That day of reckoning came at the worst possible time: when she was in the operating room performing a Cesarean section. The muscle weakness of MG started affecting her hands. Still, she kept pushing herself until not only was she unable to hold the instruments properly, but her legs started buckling and she had trouble breathing because her diaphragm was getting weak.

“I was a surgeon in an operating room one minute, and the next I was a patient in a wheelchair on my way to the emergency department,” she says.

Vickie was sent to a larger medical center where she could receive more advanced care. But the neuromuscular specialists at the tertiary care hospital couldn’t figure out what was wrong with her. Even though she already had a diagnosis of ocular MG, she was seronegative. This means that, like 10-20% of myasthenia patients, her bloodwork did not show acetylcholine receptor antibodies. Because this diagnostic test was negative, the doctors didn’t believe her profound muscle weakness was caused by MG.

“They pretty much accused me of faking it,” she says.

She was fifty years old and, thanks to her training for the bike trip, she was in extremely good physical shape. She could do 80 pushups and bike a hundred miles in one day. So when they tested her for strength, she crushed it. But one of the hallmarks of MG is “fatigable” weakness that sets in after you’ve been using the muscle.

“They didn’t test me for fatigable weakness,” she says. “Doctors would come in and they would have me resist, do straight leg raises, do an arm curl. But when they left the room, I couldn’t even get my fork to my mouth. And even if I could, I couldn’t chew my food, because I had weakness in my jaw. So they didn’t take me seriously.”

Talking to support group leaders from the Myasthenia Gravis Foundation of America (MGFA) was one of the things that helped Vickie find her footing again. These were the myasthenia experts she needed, because they too lived with the disease. Not only were they very knowledgeable about how she needed to take care of herself, but they believed her. They reassured her that she was not crazy.

Buoyed by this support, Vickie’s never-say-die attitude became a force in helping her to advocate for herself. She searched both locally and beyond for a doctor who would listen to her and treat her appropriately. She finally found a myasthenia doctor who believed her, but he was 1,000 miles away. This neurologist did electromyography (EMG) studies to measure the electrical activity of her muscles and, backed by the abnormal results, was able to accurately diagnose and treat her.  

Now Vickie speaks out for rare disease patients everywhere, urging them not to give up until they find the care they need. She’s a powerful motivational speaker who uses stories and humor and her own experience to also urge her physician colleagues, even when they don’t understand, to trust their patients and believe their story.

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Health Information

Sleep on It

sleeping peacefully with peace of mind that CSI Pharmacy is doing all they can
Photo by bruce mars on Unsplash

Getting a good night’s sleep does more than just keep you alert during the day. Proper sleep is critical to good mental and physical health. Of course sleep helps you concentrate and think more clearly. But research shows that a good night’s sleep is also associated with other positive health outcomes.

Improved brain function is the most obvious benefit of getting enough sleep. In addition to helping you focus better and think more clearly, studies show that those who sleep well are more productive and perform better on mental tasks. Memory improves with adequate sleep, which helps you learn better, improves problem-solving, and allows you to form new insights better.

Healthy sleep patterns, especially during middle age, may also help you avoid dementia as you get older. Mental health issues, such as depression and even thoughts of suicide, are associated with poor sleep quality and sleep disorders, such as sleep apnea and insomnia.

The benefits of bedtime are not limited to the brain, though. Studies show that those who sleep well perform better on physical activities as well as mental ones. Athletic performance, for example, was shown to improve with more sleep. In contrast, functional limitations, such as walking, grip strength, and ability to perform independent activities, was worse for older women who slept less well.

Good quality sleep is essential for other factors associated with chronic illness, too. For example, not getting enough sleep is one of the strongest risk factors for obesity. Adequate sleep helps regulate hormones and other factors that affect appetite and blood sugar (an important factor for those with diabetes), which helps you maintain better weight control.

Getting enough sleep also improves immune function and decreases inflammation. So sleep may be an important part of your therapy if you have an autoimmune disease like myositis, CIDP, myasthenia, and others. Better sleep may also lower your risk for developing serious conditions like heart disease and stroke.

So how do you get a good night’s sleep? Good sleep hygiene is all about putting yourself in the best position to fall asleep easily and sleep well throughout the night. Here are some tips for making that happen:

  • Stick to a consistent sleep schedule. Go to bed at the same time every night, and wake up at the same time every morning, even on weekends. Make sure this schedule allows for 7-9 hours of shuteye.
  • Unwind with a relaxing bedtime routine. Give yourself 30-60 minutes before tucking yourself in to leave behind the busyness of your day. Take a warm bath, meditate, write in your journal, read…anything that helps you de-stress and feel drowsy. Anything, that is, except activities that involve a blue light-emitting screen.
  • Make your bed a device-free zone. Phones, computers, and e-reader devices emit a blue light that reduces melatonin levels in your body, making it more difficult to fall asleep. When you use them before bedtime, they can keep your brain more alert, which also makes it harder to fall asleep. Your phone’s dings, pings, and rings and the light that pops on when notifications come through are also disturbing to your sleep. Best to turn the phone off at night.
  • Exercise every day. Thirty minutes of exercise a day not only improves your health and physical functioning, but it can improve sleep quality as well. Being active outside, where you are exposed to natural light, can also help to regulate your sleep cycle. It’s best, however, to avoid vigorous exercise within an hour or two of bedtime.  
  • Limit caffeine late in the day. Caffeine’s effects can last up to seven hours after your last cup of coffee, making it more difficult to fall asleep.
  • Make your sleep space cool, comfy, dark, and quiet. Bedroom temperatures are better when they’re lower than the rest of the house (between 60°F and 67°F). A comfortable mattress, pillows, and bed linens also go a long way in helping you fall asleep and stay asleep. And keep the room dark and quiet (use earplugs if you must) to keep you from waking up.
  • Manage your stress before you go to bed. Try not to bring your worries to bed with you. Write down what’s bothering you or make a to-do list for tomorrow so these concerns don’t keep you up at night. Meditation or other relaxation techniques can also calm your mind.
  • Save your bed for sleep and sex only. It’s best to avoid working, talking on the phone, watching TV, or other activities when you’re in bed. That way your brain is conditioned to expect to fall asleep when you climb under the covers. Even reading can keep your brain on alert, so it’s better to read in another comfy spot before slipping into bed.
  • Avoid tossing and turning. If you have trouble falling asleep, especially if you wake up in the middle of the night, don’t just lie there. If it takes more than 20 minutes to fall asleep, try getting up and doing something relaxing—drink a cup of herbal tea, read a book (on the couch, not in bed), meditate—until you feel tired.
  • Limit daytime naps. Napping during the day can make it harder to fall asleep and stay asleep during the night, especially for older people. If you must nap, don’t do it late in the day, and limit it to 30 minutes or less.
  • Prioritize sleep. While it’s tempting to work, study, socialize, or exercise late into the night, burning the midnight oil is not a good idea. It’s important to treat sleep as a priority in the same way you do eating three healthy meals every day.
  • Avoid these things: consuming alcohol in large quantities, eating a large meal late in the day, or smoking at any time. All of these activities cause sleep disruption.

Falling asleep and staying asleep can be a problem for some, especially when you’re taking certain medications, such as prednisone. If you’ve tried these tips but sleep continues to be a problem, discuss this with your doctor. He or she can help you figure out whether an underlying medical condition is causing your sleep issue and work with you to solve it.