Gluten in Medications: NFCA and the Pharmaceutical Industry
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Celiac disease is a genetic, autoimmune disease that damages the small intestines and interferes with the absorption of nutrients from food. When people with celiac ingest gluten, the protein in wheat, barley and rye, the whole body is affected causing a myriad of symptoms. The only treatment for those with celiac disease is to follow a strict gluten-free diet for life. As gluten is found in medication, pharmacy care is critical in the treatment of this disorder.
The Food Allergen Labeling Consumer Protection Act of 2004, which requires packaged food labels to identify all ingredients containing wheat and other common allergens, was a major landmark for people with celiac disease and food allergies. Yet no similar requirement exists for medication labels.
When developing medications, manufacturers use excipients to bind pills together. Excipients are inactive ingredients that help with the delivery of the medication to the patient. There are several types of excipients that drug companies may use, and some of them may contain gluten. Although few medications actually contain gluten, it is important that the ingredients of each medication are explored to determine the source of excipients – and to verify that the particular drug in question is indeed gluten-free. Complicating matters, a generic form of a medication may use different excipients than the brand name drug. This means that even if the brand name is determined to be gluten-free, the gluten-free status of each generic produced by different manufacturers must also be verified.
The following inactive ingredients indicate the need for additional investigation to determine the gluten-free status of the drug:
Modified starch (source not specified)
Pregelatinized starch (source not specified)
Pregelatinized modified starch (source not specified)
Dextrates (source not specified)
Dextrin (source not specified but usually corn or potato)
Dextrimaltose(when barley malt is used)
Caramel coloring (when barley malt is used)
Gluten-Free is in Demand:
In a perfect gluten-free world, gluten would be banned as excipients. While that is our ultimate objective, we realize that that is a long way off. NFCA has established relationships, partnerships and joined with other organizations to further its goal of readily available medication that is easily identifiable as gluten-free for people with celiac and gluten intolerance:
Consumers are demanding gluten-free products. Packaged Facts reports that the gluten free marketplace will reach $5 billion by 2012! Drug manufacturers, recognizing this trend, will want to promote their gluten-free medications as a marketing tool. NFCA’s GREAT Association is a membership organization in which pharmaceutical manufacturers can register their gluten-free drugs.
In 2008 NFCA conducted a survey of patients with celiac disease in Philadelphia hospitals. 79% of respondants reported that neither the pharmacist nor the physician was able to determine the gluten-free status of needed medication.
New! Audiocast: Celiac Disease and the Pharmacist's Role
In this teleseminar, NFCA Medical Advisory Board member and celiac expert Dr. Dan Leffler discusses the pharmacist's role in educating customers about celiac disease. Dr. Leffler also highlighted the benefits of using point-of-care fingerprick tests, like the Biocard/CeliacSure Test Kit, to improve diagnosis, especially among first and second degree relatives of diagnosed celiacs. Presented by GlutenPro and Pharmacy Business.
What You Can Do:
Pharmacists can play a vital role in protecting celiac and gluten sensitive consumers from accidental gluten ingestion. But to do that, they need to know what to look for.
NFCA offers a free online continuing education program called GREAT Pharmacists. This hour-long course teaches the basics of celiac disease and identifies potential hidden sources of gluten. Current U.S. and international guidelines for labeling gluten in medications are also discussed.
GREAT Pharmacists is co-sponsored by ProCE, Inc., which is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Information and resources for both practictioners and patients can be found in the Resources section of CeliacCentral.org.
NFCA is actively pursuing collaborators in the effort to improve labeling of gluten in medications.
For more information, please contact Kristin Voorhees, Healthcare Relations Manager
Phone: 215-325-1306 x109