Mompreneur Conversations

One Mom’s Voice:

Please Join the Movement and Let Our Voices Be Heard

I’m speaking out today urging you to participate in the Food & Drug Administration (FDA) Memorandum of Understanding (MOU), a process to protect consumer choice for compounded medications. I recently received a phone call from my son, Jovaan’s, compounding pharmacy, Nutrishare, regarding his medication. My son has been on feeding tube which requires compounding medications called Total Parenteral Nutrition (TPN) for the past 11 years. Every Wednesday, Jovaan receives three big boxes of his medication and supplies which is shipped to us overnight via United Parcel Service (UPS). However, due to the new FDA policy, Nutishare, who is our family pharmacy informed us that they needed to change the delivery date in order to accommodate their consumers due to that policy change.

I didn’t really understand the impact of the policy change until I received our monthly newsletter from Nutrishare and read about dozens of consumers stories on how the new policy would be devesting to the quality of their lives. I read one story of a consumer who had been on TPN, also known as Home Parenteral Nutrition (HPN), for over 52 years. This initiative is important to me because Jovaan relies on this specialized compound medication to keep him alive, along with hundreds of other consumers who depend on compound medication to keep them healthy.

What is TPN & HPN?
Total Parenteral Nutrition (TPN) is one type of compounding medication. It is a special nutritional formulation that comes in an intravenous (IV) bag and is given directly into the bloodstream, which bypasses the gastrointestinal tract.

Home Parenteral Nutrition (HPN) is similar to TPN, however is a highly complex life support therapy performed at home by those who cannot get enough nutrition from food to live. HPN is usually given overnight. For example, Jovaan’s HPN takes 11 hours during the night to complete his IV bag dosage.

According to The American Pharmacists Association (APhA), which is the largest association of pharmacists in the U.S., there are 56,000 community-based pharmacies in the U.S., and about 7,500 pharmacies specialize in compounding services. Out of those 7,500 compounding pharmacies, there are approximately 1,500 that specialize in TPN.¹ However, Nutrishare is the only pharmacy that specializes exclusively in home TPN/HPN Therapy.

What is a compounding?
According to the FDA, drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounding includes the combining of two or more drugs. Compounded drugs are not FDA-approved.²

Why do some patients need compounded drugs?
A drug may be compounded for a patient who cannot be treated with an FDA-approved medication, such as a patient who has an allergy to a certain dye and needs a medication to be made without it, or an elderly patient or a child who cannot swallow a tablet or capsule and needs a medicine in a liquid dosage form. Practitioners in hospitals, clinics, and other health care facilities sometimes provide compounded drugs to patients when an FDA-approved drug is not medically appropriate to treat them.³

Background:
The FDA is seeking to better track the distribution of compounded pharmacological products across state lines. This will help them better identify the source of contaminated medication, should an issue arise. Nutrishare has shipped over one million bags of TPN across state lines for over 500 consumers, and some consumers have been with them for 30 years.⁴ While Nutrishare has never had an issue with contamination or an adverse reaction with their compound medication, Nutrishare and other compounding pharmacies will be caught in this “wide net” approach to the policy.

I believe that the FDA has overstepped their authority which is infringing on consumers rights of choice. This new FDA policy will severely limit the choice of consumers who depend on HPN or any other types of compounded medication. This new policy could also put many compounding pharmacies out of business because compounding pharmacies will be limited to shipping no more than 5% of their compounded medications across state lines. This means that the current operations like Nutrishare-or any other compounding pharmacy that does business across state lines – will be severely impacted.⁶

I recently submitted an E-Letter to my State Board of Pharmacy to sign the FDA’s MOU! If you are a consumer, caregiver, family or friend, I’m urging you to join the movement and let your voice be heard by submitting an E-Letter asking your State Board of Pharmacy to sign the FDA’s MOU. This will allow compounding pharmacies to continue to ship their products across state lines. Also, please consider sharing the link with family and friends to submit a letter too.

Here is the link to submit your e-Letter:
https://www.protectcompounding.org/consumer

This is a copy of my e-Letter I wrote to the State Board of Pharmacy:

Nutrishare has been our compounding pharmacy of choice for 10 years because they are the only nationwide HPN pharmacy to specialize exclusively in-home TPN. Prior to Nutrishare, I was assigned to another compounding pharmacy when my son was first released from the hospital. Unfortunately, I had a couple of bad experiences with that compounding pharmacy because they didn’t understand my son’s needs.

When Nutrishare came into our life, it changed for the better. Due to my son’s complex illness, I get a phone call from my assigned pharmacist at Nutrishare about three to four times a month to discuss his health care needs. My son’s quality of life is dependent on Nutrishare’s impeccable service that they have provided for me and my son for the past 10 years. Nutrishare is part of our family and they have listened to my needs, my wants, and my concerns when it comes to my son’s healthcare challenges. I have peace of mind and confidence knowing that Nutrishare is always there for us.

However, I am appalled by the FDA’s decisions to restrict interstate options to access the best health care for my son and other consumers who depend on TPN as their lifeline. For nearly 30 years, Nutrishare has provided TPN to over 500 consumers who have an ongoing need for continuing highly specialized nutrition support. Since 1991, Nutrishare has shipped over one million bags of TPN to customers across state lines without a single incident of contamination or a single adverse effect to their consumers.

If you do not sign the FDA’s MOU, there will be a hard cap of 5% total allowable compounded medications to be shipped across state lines. That means Nutrishare would not be able to continue to operate in its current capacity in any state that does not sign the MOU. This would be a detriment to my son’s health and the health care needs of hundreds of consumers nationwide.

I urge you to sign the MOU in order to protect consumer choice in compounding pharmacies. In closing, I leave you with this quote by Julio Frenk, “Health care is not a commodity or privilege, but a human right.”

Please Take Action Now!
One Mom’s Voice: Please Join the Movement and Let Our Voices Be Heard

Here is the link to submit your e-Letter:
https://www.protectcompounding.org/consumer

^[1] The American Pharmacists Association, “Frequently Asked Questions About Pharmaceutical Compounding”, https://www.pharmacist.com/frequently-asked-questions-about-pharmaceutical-compounding

^[2] U.S. Food & Drug Administration (FDA), “Compounding and the FDA: Questions and Answers”https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers

^[3] U.S. Food & Drug Administration (FDA), “Compounding and the FDA: Questions and Answers”https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers

^[4] Nutrishare, “FDA MOU Fact Sheet”

^[4] Nutrishare, “FDA MOU Fact Sheet”

^[6] Nutrishare, “FDA MOU Fact Sheet”