Tuesday, June 2, 2020

PHARMACISTS CONFIRM THE STUDY OF NMIs (NON-MEDICINAL INGREDIENTS) IN DRUGS IS NOT PART OF CURRICULUM

[Note:  My pharmacist authorized me to summarize our discussion on behalf of corn-allergic patients without revealing his identity or name of the pharmacy.]

May 29, 2020, Discussion with My Pharmacist Re: Corn-Derived Excipients in Drugs:

As posted in corn allergy support group:

“I had a very enlightening discussion with my pharmacist this morning. He was very gracious to spare a few minutes of his time with me.

I first asked him if pharmacists have a drug reference book which lists the "source of inactive ingredients in drugs." After he looked puzzled by my question, I brought up the difficulty of corn-allergic patients to source safe drugs, since the majority of drugs contain corn-derived ingredients as fillers.

I then asked him if a patient is registered in their database as having an allergy to corn, would their database flag drugs containing corn-derived ingredients; thereby contraindicated for corn-allergic patients? He stated that they would have to make that determination through research.

With the utmost respect, I asked him if he knows the difference between dextrose and glucose. After thinking about it for a moment, he stated that these are forms of sugar. I agreed with him, but stated that there is a critical difference between glucose (blood sugar) and dextrose (corn sugar derived from cornstarch per the Code of Federal Regulation 21CFR184.1857), which is why IV fluids containing dextrose are contraindicated for administration to corn-allergic patients on the package insert. I also explained that I am aware that glucose and dextrose are "biochemically identical" per published literature; however, glucose (blood sugar) cannot provoke an allergic reaction; whereas, dextrose (corn sugar) can prove fatal to corn-allergic patients. He confirmed that he was not aware of this difference.

IMPORTANT UPDATE: Apparently, glucose (blood sugar) is NOT biochemically identical to dextrose (corn sugar).  I recently discovered that the molecular formula for dextrose (corn sugar) is C6H14O7.
https://pubchem.ncbi.nlm.nih.gov/compound/66370

I then asked him if he knows what ascorbic acid is, to which he replied "It’s vitamin C." I agreed; however, I pointed out that ascorbic acid is synthetic vitamin C which is usually derived from corn, and could provoke an allergic reaction to anyone with an allergy to corn.

After he revealed that he wasn’t aware of the source of magnesium stearate in response to my question, I then asked him if pharmacists are educated about the source of inactive ingredients in drugs in their colleges of pharmacy. He confirmed that they are not educated about the source of inactive ingredients in college, and thanked me for educating him about corn in drugs.

You may also want to respectfully question your own pharmacists. This is the type of documentation required to add to our FDA citizen's petition requesting that corn be declared an official allergen subject to FDA labeling requirements, since we can’t rely on pharmacists to protect us.”

Testimonies from corn allergy group members reprinted with permission:

[Note that a common complaint by our corn allergy group members is the fact that their physicians are aware of their allergy to corn, but still prescribe drugs containing ingredients derived from corn; and now it has been revealed that pharmacists are not educated about the dangers of NMIs (non-medicinal ingredients) in drugs.  Since the majority of drugs contain corn-derived excipients, many of our members are required to have their medications compounded to exclude corn-derived ingredients.  For these reasons, it is critical that corn allergen warnings be immediately mandated on all drug and biologic products for the safety of corn-allergic patients.

"I’m a pharmacist who works in community practice. Earned my doctorate in 2007. We don’t learn hardly anything about the sources of inactive ingredients in school. I would never have known that so many meds have corn and corn derivatives in them unless my son had been diagnosed with FPIES in 2015. I would venture to say only a handful of other pharmacists nationwide are aware of this particular issue." - Pharmacist

"I basically had to get my entire list of no-nos to my pharmacist so that he could look them up individually as the need arises. He was entirely unaware and even had a difficult time getting answers from the manufacturers about where their ingredients were derived from whenever the source was not stated." - D.D.

" I have had a 20 year relationship with my compounding pharmacists and I have had to educate them over the years. They haven't any idea which inactive ingredients are corn derived, so whenever they look up drugs in their pharmaceutical book, or check packaging for me, I get them to read out the ingredients and I tell them which inactive ingredients are likely derived from corn. It is a shame they are not taught the sources of inactive ingredients. My pharmacist also told me that inactive ingredients are purchased in huge vats for pharmaceutical companies, usually from China, and even they don't know the origins of the inactive ingredients they buy."  - S.P.

“The day that I offered the list of newly diagnosed food allergies to my daughters pharmacist, he essentially told me he didn’t need a list of food allergies because he couldn’t cross check them anyway. I then verified this with a few of the pharmacists and pharmacy techs that I work with and they verified for me that this is true. My daughter is required by her health insurance plan to get medications either from this pharmacy or their mail order pharmacy which would mean I would not even have a person to discuss this with. We now keep her at the bare minimum of medications for this reason.” – B.M.

My personal testimony related to compounded doxycycline:
Due to my life-threatening 7-week allergic reactions to most antibiotics (QT interval prolongation, and an 8-week acute reaction to the blue dye in doxycycline for which I was prescribed an Epi-Pen®), I was required to have doxycycline compounded to exclude all excipients. The compounding pharmacist asked me to provide him with the documentation for all of my allergens in the event the FDA requires proof for the need to have this drug compounded.  Even after I presented the pharmacist with my 16-page summary of each of my allergens with the corresponding derivatives, he asked me if I would like flavorings or sweeteners added – which I declined; since they are included in the list of corn-derived ingredients I have to avoid due to my allergy to corn. It was clear that my compounding pharmacist was not familiar with the dangers of NMIs (non-medicinal ingredients) in drugs.

    
Additional Published Corn Allergy Testimonies:

The Truth About Corn Allergy, MomLifeTV, LLC




Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
Twitter:  @CornAllergy911

References:

PETITION: DRUG PRODUCTS W/DEXTROSE MUST BE UNIFORMLY CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS

DEXTROSE (CORN SUGAR), CODE OF FEDERAL REGULATION 21CFR184.1857

LACTATED RINGER’S IN 5% DEXTROSE CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS

Vitamin K1 Injection Contains Corn-Derived Dextrose [NO CONTRAINDICATION WARNING]

ACD-A Anticoagulant Citrate Dextrose Solution, Solution A [NO CONTRAINDICATION WARNING]

My April 20, 2020, Email to the Children’s Hospital of Philadelphia Re: Corn Allergies and Vaccines

My May 11, 2020, Email to the FDA Re: Corn-Derived Excipients in Vaccines

My March 5, 2020, Email to the FDA Re: Dextrose (Corn Sugar), Code of Federal Regulation 21CFR184.1857, vs. Glucose (Blood Sugar)

"Probable anaphylactic reaction to corn-derived dextrose solution."

BCPharmacists, "Warning: corn-related allergens . . ."

Corn Allergy: A Potentially Life-Threatening Diagnosis

Corn Allergy References, Surveys, Studies, Statistics, & Petitions
(Includes my submission to The Joint Commission, Congress, FDA, & U.S. Dept. of Health requesting emergency mandate that hospitals stock corn-free foods, liquids, & drugs.)

Published Corn Allergy Studies/Statistics  (“. . . Maize major allergen . . .”)

United States Hospitals/Health Systems Contacted Re: Protocol for Treating Corn-Allergic Patients

Colleges of Medicine Contacted Re: Protocol for Treating Corn-Allergic Patients

Colleges of Pharmacy Contacted Re: Protocol for Treating Corn-Allergic Patients

Pharmaceutical Companies Contacted Re: Protocol for Treating Corn-Allergic Patients

STRICT AVOIDANCE OF ALLERGENS IS ALWAYS ADVISED
https://cornallergyadvocacyresources.blogspot.com/2020/05/strict-avoidance-of-allergens-is-always.html

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