*This information is for educational use only and is not to be used to treat or manage any condition*
During a surgical procedure, a cortisol deficient patient’s body will require an increase in steroid dosing to replace cortisol. Researchers have reported that in non cortisol deficient patients, HPA axis function during and after surgical procedures causes plasma cortisol levels to increase significantly. In patients without the presence of adrenal insufficiency, cortisol production rates have been shown to increase to 75–150 mg/day after major surgery.
In cortisol deficient patients, the recommendations differ depending on the length and severity of the procedure being performed. Cortisol deficiency patients will always require additional glucocorticoid supplementation during surgical procedures, but there is no uniform standard accepted regimen for glucocorticoid replacement therapy.
It is the best clinical practice to treat the patient instead of following a textbook response. If a patient with cortisol deficiency is declining, the administration of more cortisol should be a first line treatment protocol.
Anytime a cortisol deficient person is going under anesthesia, intravenous cortisol replacement medication must be administered.
If you have cortisol deficiency, be sure you alert your surgical team that you are cortisol dependent before your procedure and have a clear plan for your steroid dosing pre, during and post procedure. Any surgical team who refuses to administer steroids should be reported to medical authorities. Adequate steroid coverage is essential to the well being of cortisol deficient patients.
*DISCLAIMER* There is no universally agreed upon standard dose or duration of exogenous steroids used to treat adrenal insufficiency. Clinicians must be observant of a patient’s vital signs, empirical evidence and quality of life. It is also imperative clinicians be aware of the symptoms of adrenal crisis, which can widely vary in patients. In the event these symptoms should arise, an immediate dose of glucocorticoids should be administered until patient stabilizes.
For Minor Surgery: Double or triple the usual daily dose of glucocorticoid until recovery. Intravenous hydrocortisone 25 mg or equivalent at start of procedure. Usual replacement dose after procedure.
For Dental Procedures: Under local anesthesia, double the daily dose of glucocorticoid on day of procedure. Inject 100mg emergency cortisol injection if patient presents with adrenal crisis symptoms.
For Moderate Surgery: Intravenous hydrocortisone 75 mg/day on day of procedure (25 mg 8-hourly). Intravenous hydrocortisone 25 mg 8-hourly until recovery. Taper over next 1–2 days to usual replacement dose in uncomplicated cases.
For Major Surgery: Intravenous hydrocortisone 150 mg/day (50 mg 8-hourly) Taper over next 2–3 days only once clinical condition stabilizes.
For critical illness/intensive care/major trauma or life-threatening complications: 200 mg/day intravenous hydrocortisone (50 mg 6-hourly, or by continuous infusion)
This information was brought to you by the Adrenal Alternatives Foundation for educational use only and is not meant to provide medical care or advice.
 COLLARD MD, C. D., SAATEE, M.D, S., REIDY, M.D, A. B. AND LIU, M.D, M. M. Perioperative Steroid Management: Approaches Based on Current Evidence: Collard MD, C., Saatee, M.D, S., Reidy, M.D, A. and Liu, M.D, M. (2017). Perioperative Steroid Management: Approaches Based on Current Evidence. [online] Anesthesiology: Trusted Evidence Discovery in Practice. Available at: https://anesthesiology.pubs.asahq.org/article.aspx?articleid=2626031
When most people are diagnosed with adrenal disease, they are told it is a rare disease. Even though over approximately 1,000,000 people in the US and Europe have been diagnosed with cortisol related conditions.
Though it may be true that specific adrenal diseases are rare in occurrence, the incidence of diseases that impact cortisol and require the need for cortisol replacement medications are not as rare as endocrinologist believe. There are many forms of adrenal disease, but the treatment for all cortisol deficient conditions requires steroid replacement medications, leading us to believe that the cortisol deficient population is a large demographic.
The following statistics indicate the prevalence of all cortisol related conditions that require cortisol replacement. All statistics are based on an annual scale in the United States unless otherwise noted. Research references are located in footnotes.
Over 1,000,000 people in the US and Europe have been diagnosed with cortisol related conditions such as:
Adrenal adenoma- According to the American Cancer Society, adrenal adenomas are found in 1 in every 10 people who have an imaging tests of the adrenal gland.
Adrenocortical carcinoma- It is estimated  that diagnosed 600 people are diagnosed in the United States each year.
Addison’s disease– Prevalence estimated to be between 40 and 60 cases per 1 million in the general population.
Antley-Bixler syndrome- (ABS) has been described in more than 100 patients.
Adrenoleukodystrophy– According the Stop ALD Foundation, this condition affects 1 in 18,000 people.
Cortisol Dysregulation– The WHO states that conditions where in which cortisol dysregulation is indicated, form a part of a group of illnesses termed as “noncommunicable diseases” (NCDs) accounts for the majority of deaths with 17.9 million people dying annually. Noncommunicable diseases (NCDs) kill 41 million people each year worldwide, equivalent to 71% of all deaths globally. In the Americas, 5.5 million deaths are by NCDs. Research also highlights the fact that cortisol dysregulation is present in up to 40% of stroke patients.
Cushing’s disease – An estimated 10-15 per million people are diagnosed with this condition in the United States every year.
Congenital adrenal hyperplasia (CAH)– The most common form of CAH, 21 hydroxylase deficiency, affects approximately 1:10,000 to 1:15,000 people in the United States and Europe. Among the Yupik Eskimos, the occurrence of the salt-wasting form of this disorder may be as high as 1 in 282 individuals.
11-Beta hydroxylase deficiency– It is estimated that 11-beta-hydroxylase deficiency occurs in 1 in 100,000 to 200,000 newborns. This condition is prevalent in Moroccan Jews living in Israel and occurs in approximately 1 in 5,000 to 7,000 births.
17a-hydroxylase deficiency– 17a hydroxylase deficiency has an estimated prevalence of 1 in 50,000 to 100,000.
3-Beta-hydroxysteroid dehydrogenase deficiency– Human 3 beta-hydroxysteroid dehydrogenase deficiency (3b-HSD) resulting from HSD3B2 gene mutations has an estimated diagnosis of less than 1/1,000,000.
Congenital lipoid adrenal hyperplasia– Exact statistics for Americans diagnosed with this condition are unknown, however recent studies estimate the rate for this mutation seen in Asian populations to be between 1 in 200 and 1 in 300 people yearly.
PORD (P450 oxidoreductase deficiency) – Estimated annual incidence of 1/100,000-200,000.
Hypopituitarism– Globally, the prevalence is estimated to be 4.2 cases per 100,000 per year, and the prevalence is approximately 45.5 cases per 100 000 people.
Panhypopituitarism– Estimated annual prevalence of 45.5 cases per 100,000 people.
Pheochromocytoma– The prevalence is estimated at 1:2,500 to 1:6,500 patients annually.
Pituitary Adenoma– 9.3 cases per 100,000 population yearly.
Secondary Adrenal Insufficiency– Yearly estimated prevalence is 150–280 per million.
Sheehan’s syndrome– Incidence of Sheehan syndrome is estimated to be 5 patients out of 100,000 births.
Lymphocytic Lypophysitis– The prevalence is approximately 1 in 9 million.
The WHO states that conditions where in which cortisol dysregulation is indicated, form a part of a group of illnesses termed as “noncommunicable diseases” (NCDs) accounts for the majority of deaths with 17.9 million people dying annually. Noncommunicable diseases (NCDs) kill 41 million people each year worldwide, equivalent to 71% of all deaths globally. In the Americas, 5.5 million deaths are by NCDs. Current Research also highlights the fact that cortisol dysregulation is present in up to 40% of stroke patients.
Though cortisol testing is inexpensive and easily performed, in emergency room situations it is not a current standard of care.
This information begs the question, how many unknown causes of death are truly caused by cortisol deficiency?
Another factor in current endocrine diagnostics is that early detection is key to quality of life for those with cortisol deficient diseases. Research shows that cortisol deficient patients diagnosed post adrenal crisis suffer from lowered quality of life and most are declared disabled. Diagnosis prior to adrenal crisis is essential to preventing impairments.
Despite research supported, legal, medical advances, cortisol deficiency patients remain a poorly served demographic with high mortality rates and low quality of life.
Barriers In current cortisol care
Cortisol testing in emergency room situations is not a current standard of care.
There is currently no center in the United States soley dedicated to managing cortisol care. Vital testing to manage cortisol deficiency such as 24-hour cortisol day curve testing is not available. This test evaluates the effectiveness of a patient’s cortisol replacement medication by drawing a cortisol blood lab once an hour for 24 hours and provides insight on a patient’s cortisol metabolism and absorption.
Patient’s cortisol levels are tested initially at diagnosis but typically are not tested after diagnosis to evaluate effectiveness of their steroid replacement.
Comparative assays of blood, urine and saliva testing to help establish a correct steroid dosing milligram and regiment are not offered in standard endocrinology clinics.
Cortisol deficiency patients are not typically given multiple options to manage their care. The lack of cortisol replacement options is likely due to poor clinician awareness on the latest research showing standard administration of hydrocortisone 2-3x daily is inadequate to replicate the body’s natural cortisol production.
Advances in cortisol replacement medications are available in the United States, but awareness of options such as all steroid medications and alternative cortisol delivery methods such as subcutaneous injections and the cortisol pumping method are not prominent.
There is currently no way to check blood serum cortisol levels outside of a laboratory setting.
Education on the proper management of cortisol deficiency is scarce within the endocrine community, who are mainly educated on diabetes and thyroid conditions. Advances such as circadian rhythm dosing can make massive improvements in quality of life for adrenal patients, yet many endocrinologists are unaware of this advancement.
All EMS personnel are not authorized to administer the life saving cortisol injection in the event of an adrenal crisis.
Solutions to CUrrent Barriers in Cortisol Care:
Early detection and diagnosis prior to experiencing adrenal crisis.
Access to and awareness of all steroid options, which includes oral medications, subcutaneous cortisol injections and the cortisol pumping method.
Access to and awareness of testing that can evaluate cortisol deficient conditions and provide clinicians with insight on better cortisol regimens and replacement methods.
Education on the importance of medication compliance and the need to increase dosing in times of stress, sickness or injury.
Advancements in research to create biotechnology such as a cortisol meter.
How ADrenal Alternatives Foundation intends to solve these problems
Adrenal alternatives foundation is in the process of obtaining the funding to open a cortisol care center to provide appropriate cortisol testing and all possible care options to manage conditions that result in cortisol deficiency or dysregulation. Advances in cortisol care are available, but awareness and access to these options are limited and not widely offered.
Adrenal Alternative’s Cortisol Care Center will be a centralized location for all conditions that result in cortisol deficiency and cortisol dysregulation to have access to all steroid options, which includes oral medications, subcutaneous cortisol injections and the cortisol pumping method. Our center will provide diagnostic testing to screen for cortisol deficiency and dysregulation and also provide comparative lab assays of blood, urine and saliva cortisol levels, testing protocols such as the Cortisol Day Curve and the testing of all adrenal hormones to help patients find better quality of life.
Our goal is to save and improve lives.
We appreciate all contributions which allow us to further our mission, Education, Advocacy and Awareness for all adrenal disease and will help us get closer to our goal of making the cortisol care center a reality.
 Olsson, T. , Marklund, N. , Gustafson, Y. , & Nasman, B. (1992). Abnormalities at different levels of the hypothalamic‐pituitary‐adrenocortical axis early after stroke. American Heart Association Journal: Stroke, 23(11), 1573–1576. [PubMed] [Google Scholar]
 A case of 17 alpha-hydroxylase deficiency. Clin Exp Reprod Med. 2015 Jun; 42(2): 72–76. Published online 2015 Jun 30. doi: 10.5653/cerm.2015.42.2.72 PMCID: PMC4496435. PMID: 26161337 Sung Mee Kim1 and Jeong Ho. Saint Mary’s Women’s Hospital, Daegu, Korea. Department of Obstetrics and Gynecology, Keimyung University College of Medicine, Daegu, Korea. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4496435/
 Human 3 beta-hydroxysteroid dehydrogenase deficiency associated with normal spermatic numeration despite a severe enzyme deficit. Endocr Connect. 2018 Mar; 7(3): 395–402. Published online 2018 Feb 2. doi: 10.1530/EC-17-0306. PMCID: PMC5827574. Available at:
 Cytochrome P450 Oxidoreductase Deficiency. Jan Idkowiak, MD, PhD, Deborah Cragun, MS, CGC, Robert J Hopkin, MD, and Wiebke Arlt, MD, DSc. GeneReviews® Adam MP, Ardinger HH, Pagon RA, Seattle (WA): University of Washington, Seattle; Initial Posting: September 8, 2005; Last Update: August 3, 2017. Available at: https://www.ncbi.nlm.nih.gov/books/NBK1419/
 Panhypopituitarism. Bernard Corenblum, MD, FRCPC Professor of Medicine, Director, Endocrine-Metabolic Testing and Treatment Unit, Ovulation Induction Program, Department of Internal Medicine, Division of Endocrinology, University of Calgary Faculty of Medicine, Canada. Medscape.
Type 1 Diabetes is the disease where the pancreas fails to produce the correct amount of insulin, thus rendering someone insulin dependent.
Adrenal insufficiency is a disease where the adrenal glands fail to produce the proper amounts of steroid hormones and requires lifelong steroid medication for cortisol replacement.
Unlike diabetic patients who have glucometers, adrenal disease sufferers have no meter to check their cortisol levels. They must be constantly vigilant of their own low cortisol symptoms. The excitement from a happy event, the sadness from a death of a loved one or the strain from exercising are examples of things that would cause the body to release more cortisol. In an adrenal insufficient person, this does not happen. They must artificially manage their cortisol, which can differ from day to day. They require an emergency cortisol injection if their levels drop to a critical point.
Hydrocortisone is the standard cortisol replacement medication, which only has a blood serum half-life of 90 minutes and must be taken multiple times a day. This medication must be processed through the stomach and the liver before reaching the blood stream. This causes an abnormal rise and fall of cortisol levels, which results in subpar function, increases mortality rate and decreases quality of life.
However, advances in research have found a solution for adrenal patients. The concept of Cortisol Pumping is the use of solu-cortef (inject-able version of cortisol when mixed with saline) used in an insulin pump programmed to disperse cortisol according to the natural circadian rhythm. This method bypasses the gastric passage and delivers cortisol in a more natural way. With this method, an adrenal insufficient patient can receive cortisol constantly. Side effects due to malabsorption are decreased and patients have been reported to have improved sleep, weight management and experience an overall improvement in their quality of life. This method has also been proven to lessen the prevalence of adrenal crises and lessen hospitalizations due to low cortisol.
Despite the vast amount of research showing the efficacy of this treatment, infusion pumps are not offered to adrenal insufficient patients. Unlike diabetics, they do not have easy access to infusion pumps and supplies.
The Right to Try Act which was passed in 2018, mandated that patients now have legal rights to access life-saving treatments which are not yet FDA approved. Adrenal Alternatives Foundation is a 501c3 organization dedicated to providing adrenal insufficient patients with the resources to safely and legally begin the cortisol pumping method. The nonprofit works to educate physicians on how to manage this protocol. They also assist patients in obtaining insurance approval and their “Pumps for Purpose Program” helps provide pumps and supplies to adrenal patients, with or without insurance coverage. They have also created the resources: Cortisol Pump Guide Book and the Cortisol Pumping website to help guide patients in their pumping journey. Their hope is that one day, there will be disease equality and both adrenal patients and diabetics will both have easy access to infusion pumps.
This information was brought to you by the Adrenal Alternatives Foundation for educational use only and is not meant to provide medical care or legal advice.
Adrenal Alternatives Foundation’s main mission is to provide access and education to “adrenal alternatives” for those who suffer from cortisol deficiency.
For some patients, oral steroid medications are not adequate enough to maintain quality of life, therefore, alternative cortisol replacement methods are a life saving intervention.
Below is an interview with Lauren, a cortisol pumper whose life was saved because of the cortisol pumping method!
Q-Please introduce yourself?
A- Hi, my name is Lauren Michelle and I am 23 years old. I’m a former ballerina turned chemist turned full time chronically ill patient. I am nearly done with my Bachelors of Science in Chemistry, started up at Northern Arizona University, but because of illness I have had to move back home and am finishing the degree at Arizona State University. Currently though I am on medical leave and training my German Shepherd puppy Nova to be my service dog.
Q-What country do you live in?
A- The United States of America. Specifically the state of Arizona.
Q-What form of adrenal disease were you diagnosed with?
A- At the beginning of 2020 I was diagnosed with Adrenal Insufficiency at the hospital after an acute adrenal crisis. I had zero basal cortisol that they could detect, and then the stim test came back as 0.55 cortisol. Later in the year I was diagnosed as Addisons with further testing and more symptoms showing up.
Q-Can you tell us about your pump that helps you manage your adrenal disease?
A- Before getting on the pump, we tried EVERYTHING to manage my Addisons. The hydrocortisone oral tablets, a liquid formulation specifically compounded for me, and even IV solu cortef. I have malabsorption of my small intestine, and also suffer from MCAS including a lot of idiopathic anaphylaxis. For about 6 months I was in a cycle of anaphylaxis and adrenal crisis due to flare ups because of inconsistent cortisol levels and absorption. Since being on the pump I have been able to stay on maintenance replacement dosing for the first time since being diagnosed. I can micro titrate the amount of hydrocortisone that I need when I feel low, and I don’t have to sit there guessing how much steroid I need with the pills or liquid formulation. Sometimes I only need 1 mg more to get my body back on track, whereas before the pump that was NOT an option.
Q-What made you decide to get on the cortisol pump?
A- I realised I wasn’t absorbing pills when hospitalized for most of the month of June 2020. The doctors helped me to transition to liquid hydrocortisone. This bought me some time before my stomach completely stopped working. I started to have to give more of the liquid to just remain stable and out of crisis. When I heard about the pump I knew I needed to be on it, as I was not stable at all on anything else we had tried.
Q- Was your doctor supportive of your decision to start pumping?
A- I had to see a different endocrinologist than my main one, as she had never done cortisol pumping but was fully supportive of the idea for me. Once I found an endocrinologist who knew how to program and monitor cortisol pumping than the one I was seeing, both endocrinologists and all of my other specialists, specifically my allergist and immunologists, were very supportive of the pump. One of my doctors literally told me they thought I was going to die last year because of how poorly my body was responding to other forms of treatment. I can say with confidence that I felt the same way. I couldn’t stop crying tears of relief and joy once I got on the pump.
Q- Did your insurance cover your pump and supplies?
A- I am one of the fortunate ones where my insurance has covered my Medtronic and supplies. I think this is because I had been hospitalized almost every month in 2020, that or in the ED to treat an adrenal crisis. Literally anything to keep me out of the hospital.
Q- What is something you wish you could tell all adrenal disease patients?
A- Something one of my favorite ED nurses told me when I was first diagnosed was that during her first year of diagnosis (she also has adrenal insufficiency) she thought she was going to die, but once she figured out what worked best for her body she has been fine ever since. I am thankful she told me that. I wish someone had told me that adrenal insufficiency treatment isn’t one size fits all. That you are going to feel overwhelmed. That steroids will make you gain weight. That this will be one of the hardest diseases for you to manage throughout your lifetime. But you WILL be able to manage it. To trust yourself, as the longer you live with the disease (or knowledge that you have the disease), the better you are going to know your own body and what to do to keep it functioning. No one is going to fully understand what you are going through, especially because it is a rare disease. Don’t be afraid to advocate for your health needs, and be sure to keep a log of symptoms and dosing.
Q-How has adrenal disease changed your life?
A- In a very strange way it has brought me so much closer to my family and specifically my mom. We were never the closest growing up but when I was diagnosed she essentially became my caregiver. I treasure this relationship so much. I have faced a lot of life or death situations in the past 4 years leading up to the diagnosis, so my perspective on what is important in life changed drastically. Before, I was so career driven and independent, but now I see that school will always be there and it doesn’t actually matter how long it takes to get through it. I learned quickly that the friends who are true friends and love you will be there for you no matter what, but I have lost a significant amount of friends due to having to deal with my own health. Overall I have been incredibly humbled and grateful since diagnosis, and have so much more empathy for others.
Q-Do you think the cortisol pump has improved your life?
A- 2020 I was so so sick, all of the time. Since getting on the pump I have finally begun healing. My doctors believe that I never had a consistent amount of cortisol in my body until I got on the pump, so I spent last year fighting for my life often because of malabsorption issues. Since starting the pump I finally have a basal cortisol level, making it possible to tackle a lot of my other health issues. If it were not for the pump I do not think I would be here today.
Q-What is a quote that you live by?
34 Therefore do not worry about tomorrow, for tomorrow will worry about itself. Each day has enough trouble of its own. – Matthew 6:34 9 Have I not commanded you? Be strong and courageous. Do not be afraid; do not be discouraged, for the Lord your God will be with you wherever you go. – Joshua 1:9
You can follow Lauren’s journey on her instagram or tiktok at the handle: @cortisol.queen
For more information on cortisol pumping visit the links below.
The cortisol pumping method is a relatively unknown alternative treatment for adrenal insufficiency. Most doctors have never heard of it, but that does not mean it is not available. The use of infusion pumps to deliver medication is a common practice, mainly in the management of diabetes. However, the use of cortisol in infusion pumps is considered “off label” use. Cortisol pumping is available wherever infusion pumps are available. All you need is a doctor willing to manage your care, which involves he or she writing a prescription for an infusion pump, supplies and solu-cortef. Adrenal Alternatives Foundation works with patients internationally with cortisol pumping advocacy and we educate healthcare professionals all over the world on how to safely and effectively start the cortisol pumping method. We also work alongside other organizations to repurpose pumps and supplies to adrenal patients with our Pumps for Purpose program. Cortisol pumping is available internationally, wherever infusion pumps are available.
Myth #2 “It isn’t safe.”
Research has shown that cortisol pumping is an effective alternative treatment to oral steroids for the management of cortisol deficiency. We have compiled a comprehensive list of evidence showing that this method is safe.
A recent poll done by Adrenal Alternatives Foundation revealed that 97% of the patients surveyed stated that cortisol pumping improved their quality of life.
Adrenal insufficiency requires adequate cortisol replacement in the form of steroid medications. With the cortisol pumping method, patients can bypass the gastric pathway and absorb their life-sustaining medication better. This treatment is revolutionary for hypermetabolizers and for those with gastro-intestinal problems or malabsorption issues. The cortisol pumping method truly puts adrenal patients in control of their cortisol distribution in a way that steroid pills cannot. In situations of physical or emotional stress where “updosing” is needed, the pump can immediately administer a bolus, which is extra cortisol administered through the pump canula at the amount you select. Instead of having to wait for pills to metabolize, the cortisol can be absorbed faster and can help prevent adrenal crisis. Cortisol pumping is not a cure for adrenal insufficiency and is not a treatment that is right for everyone. If you are well managed on steroid replacement pills, being on the pump method may not be necessary to achieve quality of life.
Myth #3 “My insurance won’t cover it”
What your insurance will cover is completely dependent on your specific coverage plan and insurance company. If you are denied, you can always file an appeal. Visit this link to download the example appeal letter you can fill out with your information to appeal your insurance company’s denial.
Our foundation team also assists patients file insurance appeals has successfully battled countless insurance companies across the nation and can assist you in your fight for coverage.
It is also an option to cash purchase a pump and supplies specifically from companies such as Omnipod and Medtronic if you have a prescription from your overseeing physician.
Adrenal Alternatives Foundation has also aligned with the organization CR3 to help adrenal patients acquire pumps in a safe and legal manner. Visit this link to apply for pump assistance.
Myth #4 “My doctor said no.”
Finding a healthcare professional willing to work with this relatively unknown treatment option can be a challenge. You may have to “query” multiple physicians before you find one willing to manage your care on the cortisol pumping method.
In order to achieve this, it is best to prepare a compelling case and provide it to the physician before your appointment. Send research on the cortisol pumping method and your health records to the physician before your appointment so they are aware of your intentions before hand. We have created a pump proposal letter you can fill out with your information, explaining your diagnosis, failed treatments and desire to be on the pump. The doctor may or may not be receptive to your request and alerting them of your intentions beforehand may save you time, money and effort. Again, you may have to contact multiple physicians before finding one who is willing to manage the cortisol pumping method.
Our clinical team is also willing to speak with your current physician and provide them with guidelines on how to safely start the pumping method. If you would like our assistance, fill out our contact form and request a cortisol pumping consult.
Myth #5 “It isn’t legal.”
FDA approval is not necessary to safely and legally begin cortisol pumping under the care of a licensed physician. Use of the infusion pump for adrenal insufficiency is considered an “off label” treatment. Infusion pumps have long been approved for the administration of medications.
According to the Department of Health and Human Services Centers for Medicare and Medicaid Services Medicare Coverage Issues Manual Section 60-14 A: “6. Other uses of external infusion pumps are covered if the contractor’s medical staff verifies the appropriateness of the therapy and of the prescribed pump for the individual patient.”
In addition, according to the recently passed Right to Try Act, patients have legal rights to access to life-saving treatments which are not yet FDA approved.