Determining the gluten content of nonprescription drugs: Information for patients with celiac disease
Robert A. Mangione, BSPharm, EdD; Priti N. Patel, PharmD, BCPS; Emy Shin; James Fiebert, PharmD
J Am Pharm Assoc (2003) 2011;51:734-737. doi:10.1331/JAPhA.2011.10137


Objectives  To determine whether the information on the gluten content of nonprescription drugs is readily available from the manufacturer/supplier, to identify how patients are directed on the product labeling to obtain answers to questions that they have about the nonprescription medication, and to determine the time needed to obtain information about the gluten content of the product when contacting manufacturers/suppliers.

Design  Descriptive, exploratory, nonexperimental study.

Setting  United States during July 2010.

Participants  Manufacturers/suppliers of 41 nonprescription drug products.

Intervention  The packaging of the products was reviewed for information on gluten content. The manufacturer/supplier listed on each product's packaging was contacted using the phone number provided and questioned about the gluten content of the product. A uniform script was used for the telephone inquiry. The responses provided and the duration of the phone calls were documented. The manufacturer's websites also were reviewed for pertinent information.

Main outcome measures  Gluten status of products, time spent on phone to determine gluten status, and availability of online information regarding gluten status.

Results  Information concerning the gluten content was not included on any of the products' packaging. The mean time required to receive a response was 6.2 minutes (median 5 minutes). A total of 15 products were reported to be gluten free; 13 products were not tested, but the manufacturer/supplier stated that they did not add gluten to the products; 9 products did not have any gluten added by the manufacturer/supplier, but no guarantee was made that the raw ingredients were gluten free; 2 products contained gluten; and 2 products had no available gluten status information. Gluten information was found on product websites for a total of six products. Four of those six websites indicated gluten status that was different from the information provided via the telephone call with the manufacturer.

Conclusion  Information concerning the gluten content of many nonprescription drugs is relatively easy for patients to obtain if the manufacturer/supplier is contacted. Although the time to obtain a response was quite short for many of the inquiries, it took a substantial amount of time to receive the requested information from some of the companies.

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