3JC Solutions Blog

3JC Solutions greatly appreciates everyone's interest in the Allergy Free Rx app! We had a great time at the Gluten Free & Allergy Friendly EXPO in San Diego, California last weekend. If you stopped by our booth you know we're eagerly awaiting the iOS app. We're experiencing some technical difficulty uploading the app into the App Store, and are working diligently with Apple to make Allergy Free Rx available as soon as possible. 

At this time, the app continues to be available in the Google Play store, and for those of you using an Apple device, please stay tuned! In the meantime, you can continue to access our program on AllergyFreeRx.com which can be viewed on any mobile device or computer.

Thank you!

From the 3JC Solutions Team 

• Sharing a very well written and informative article on the history and current situation around inactive ingredients and the potential for gluten in medications. Thank you to Jennifer Iscol and the Celiac Community Foundation of Northern California for this excellent information. 
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• The article is: Gluten in Medication: Pressing the FDA to Act Now, posted online January 13, 2016, can be found in it's entity at the following link: 

• An excerpt which covers a timeline of public action and regulatory activity can be found below. 
  
  

* June 2008 – New York resident Michael Weber submitted a citizen petition to the FDA asking that wheat gluten in medication either be banned or labeled.

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• * December 2011 – FDA requested comments and information in a Federal Register announcement on the topic of gluten in medication.
  
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• * April 2012 – The Gluten in Medication Act of 2012 was introduced by Representatives Tim Ryan (D-OH) and Nita Lowey (D-NY).
  
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• * May 2013 – Gluten in Medicine Disclosure Act (H.R. 2003) was introduced by Representatives Tim Ryan (D-OH) and Nita Lowey (D-NY). The bill would have required all drugs to disclose any gluten-containing ingredients.
  
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• * September 2014 – Beyond Celiac (formerly National Foundation for Celiac Awareness) and research collaborators submitted preliminary research results to the FDA, highlighting the need for a large scale study identifying safe thresholds of gluten in medication, its impact on people with celiac disease, and the pervasiveness of gluten in binders and excipients. The research was funded by a 2011 grant the organization received from the FDA.
  
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• * May 12, 2015 – FDA replied to Michael Weber’s citizen petition with a 21-page letter, granting his petition in part and denying it in part.
  
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• * September 29, 2015 – U.S. Representatives Tim Ryan (D-OH) and Nita Lowey (D-NY) introducedGluten in Medicine Disclosure Act of 2015 (H.R.3648).
  
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• * December 2, 2015 – Michael Weber followed up the FDA’s response to his citizen petition with a letter that is publicly available here.
  
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• * December 13, 2015 – Eight board members of the Celiac Support Group in Sacramento, CA, filed a citizen petition as individuals, asking the FDA to require labeling of medications when more than 20 ppm gluten is present.
  
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• * December 31, 2015 – FDA posted the Sacramento group’s citizen petition and opened it for comments. Enter “FDA-2015-P-5081” in the search bar here to access it.

Steve Leuck, PharmD shares his expertise on patient counseling in a Pharmacy Times article: Patient Medication Counseling Tool for Pharmacists

Per Dr. Leuck: I have developed a simple acronym that helps keep me focused while providing a patient medication counseling session. We all need some sort of tool to help us remember to cover all of the important medication counseling aspects of the specific drug. The acronym I use is DRUG, and it goes as follows:

Dosage: I discuss the dose of the medication, how it should be taken, any specific dosage timing issues, and what to do if the patient misses a dose.

Results: What should the patient expect while taking this medication? How is the drug working in the body, and how can the patient tell if the medication is working? It is also important for the patient to understand the consequences of nonadherence.

Underlying Issues: I present potential issues that the patient needs to be aware of when taking the medication, including:

* Does this medication have any Black Box Warnings?

* Is the patient allergic to this medication?

* Is the patient taking any other medications that may interact with this medication?

* Does this medication have any specific alcohol, grapefruit, or sun sensitivity warnings?

* Does this medication have an effect on any other disease states that the patient may have?

* Are there any special precautions with the elderly, young, pregnant, or breast feeding patients?

* Are there any other medication specific cautions or precautions that should be discussed?

General information: Assess the patient's understanding of the above information. Discuss how to properly store the medication, what to do about refills, how to dispose of unused meds, and assure that the patient knows who to call for questions. 

The complete article can be found in its entirety at the link below: 

http://www.pharmacytimes.com/contributor/steve-leuck-pharmd/2015/02/patient-medication-counseling-tool-for-pharmacists

An association between olmesartan and sprue-like enteropathy has been observed in several case series and reports. Patients 57 to 81 years of age, irrespective of gender, have experienced weight loss of up to 40 kg while taking this drug. Although the mechanism precipitating this adverse effect remains uncertain, it is essential to consider olmesartan-associated enteropathy in patients with biopsy-proven villous atrophy when no other cause can be found.

Because observational studies do not provide the strongest evidence, further clinical investigation is required to evaluate the specific mechanisms of olmesartan-associated enteropathy.

Although olmesartan has been on the market for more than a decade, cases of olmesartan-induced sprue-like enteropathy have been reported only since 2012. Millions of people have used olmesartan. Careful consideration of patients’ medication regimens is warranted when severe and chronic diarrhea and weight loss are unexplained by other known causes of enteropathy. Greater awareness of olmesartan-induced sprue-like enteropathy, as with other drug-induced diseases, can help to divert expenditures from invasive or high-priced procedures and laboratory testing, to relatively simple and quick trials of drug discontinuation. Accurately identifying olmesartan-induced sprue-like enteropathy is helpful, because drug discontinuation and substitution of another agent or ARB are necessary for treatment.

The full article, can be found here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3956379/

The original article from Dr. Tran H. Tran, P T. 2014 Jan; 39(1): 47–50.  

The American Society of Health-System Pharmacists (ASHP) created a very helpful flyer Pharmacists can use to educate their patients about the inactive ingredients in medications. 

You can download a PDF copy of the flyer from the ASHP website here: http://www.ashp.org/s_ashp/docs/files/PS_Celiac_Flyer.pdf

Celiac disease is an autoimmune digestive disease that damages the villi of the small intestine and interferes with absorption of nutrients from food.  

Roughly one out of every 133 Americans has celiac disease, but 97% remain undiagnosed. This means that almost three million Americans have celiac disease and only about 100,000 know they have it. 

Left untreated, people with celiac disease can develop further complications such as other autoimmune diseases, osteoporosis, thyroid disease, and cancer. Additionally, there are a number of medical problems that are associated with undiagnosed celiac disease including cancer, osteoporosis, diabetes Type 1, thyroid problems and reproductive health issues.

Information for Pharmacists:

Gluten in Medication Gluten is used in many medications as an excipient, so it is important for people with celiac disease to check with the manufacturer to be sure that each medication they take is gluten-free. Some patients may ask their pharmacist’s help in reading the list of ingredients or contacting the manufacturer. It’s also important for pharmacists to be aware that medications may not work as expected in people with undiagnosed celiac disease, due to problems with malabsorption.

3JC Solutions LLC, creators of AllergyFreeRx, would like to comment on a topic of importance to drug product consumers in the United States and also the US Health and Human Services (HHS), Food and Drug Administration (FDA). Read more here.

3JC Solutions is a health care solutions company based out of Dallas, Texas. As pharmacists, we identified a large gap in operations: On a daily basis, patients come to the pharmacy counter concerned about inactive ingredients in their medications.

With growing consumer concern, we realized the need for a better way--which is why we created Allergy Free Rx. With Allergy Free Rx, our goal is to improve the lives and health outcomes of patients with an efficient, accurate, and easily operated system. Allergy Free Rx is the first search-based application to quickly and accurately identify specific active and inactive ingredients contained in prescriptions.