Determining the gluten content of nonprescription drugs: information for patients with celiac disease.

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.

Caring for patients with celiac disease: the role of the pharmacist.

OBJECTIVE: To review the epidemiology, pathophysiology, diagnosis, treatment, and complications of celiac disease, in order to provide guidance to pharmacists. DATA SOURCES: Published articles identified through Medline using search terms such as celiac disease, gluten sensitivity, and gluten enteropathy. Additional resources were identified from personal bibliographies collected by the authors and bibliographies from gathered articles. DATA SYNTHESIS: Celiac disease is an autoimmune disorder that is characterized by intolerance to gluten and affects approximately 3 million Americans. Although the most common manifestations of the disease are gastrointestinal, including diarrhea, steatorrhea, and weight loss, the disease is a multisystem disorder. Malabsorption is common, often leading to vitamin and mineral deficiencies and resulting in anemia and osteoporosis. Diagnosis is initiated through serology testing and confirmed by intestinal biopsy. The only treatment for celiac disease is strict, lifelong adherence to a gluten-free diet, which includes avoidance of foods, prescription and nonprescription pharmaceutical products, and cosmetics containing wheat, barley, and rye. Adherence to the gluten-free diet will promote intestinal healing and symptom relief and usually prevent complications of celiac disease. CONCLUSION: Pharmacists can play an important role by identifying patients who may have celiac disease, providing information for gluten-free foods and pharmaceutical products, and encouraging adherence to the gluten-free diet.

Exploring the Community Pharmacist's Knowledge of Celiac Disease.

Objective. To evaluate pharmacists' knowledge of celiac disease, and identify potential areas where additional continuing education may be needed. Methods. A survey was sent to community pharmacists practicing in a national chain pharmacy in one region of New Jersey and New York. Results. There were 418 pharmacists who responded to the survey with a response rate of 38%. Only 27% of all respondents who reported their understanding of celiac disease to be basic or advanced correctly defined celiac disease as both an autoimmune and a chronic lifelong disease. The majority (60%) of respondents correctly stated there are no federal regulations requiring manufacturers to designate medications as gluten-free. Twenty percent of respondents said they often recommended a change in diet to people suspected to have celiac disease before a confirmed diagnosis. Conclusion. Community pharmacists possess some knowledge of the disease and would benefit from and desire additional education about this disorder.

Making All Medications Gluten Free.

Gluten is found in food containing wheat, rye, and barley, and it may be introduced into medicines through the use of starch or any modified form of starch derived from these grains. The ingestion of gluten poses serious health hazards to people with celiac disease and non-celiac gluten sensitivity, and they must avoid the oral ingestion of gluten. In 2011, the Food and Drug Administration solicited information and public comments on 'gluten in drug products.' However, the 'final rule' that the Agency issued in 2013 involved only the voluntary 'gluten-free' labeling of food, and it did not include drug products. In this commentary, we are proposing that all drug products can and should be made gluten free. This is especially important since there is currently a global trade in medicines, and patients and health care providers do not know whether a product is gluten free or not unless they are labeled as such. All drug products can be made gluten free as there are many alternatives to gluten-containing starch that can be used as excipients during their formulation. Global collaborative efforts of regulatory agencies, pharmaceutical companies, and excipient manufacturers will be needed to implement a gluten-free medication policy and new regulatory guidelines.

Theoretical pharmacokinetic drug alterations in pediatric celiac disease.

INTRODUCTION: The incidence of pediatric celiac disease has risen and many of these children will receive medications at some time in their life. However, the absorption of drugs in pediatric patients with celiac disease has never been studied. The few studies that do exist have only been performed in adults and indicate that drug concentrations can be altered for some drugs. It is also noteworthy that few researchers have conducted studies to determine if the distribution, metabolism, and excretion of drugs are altered in celiac disease. AREAS COVERED: The pharmacokinetics of drugs greatly differ between children and adults. Combined with the pathophysiological changes known to occur with celiac disease, there is compelling evidence to support that drug exposure in pediatric celiac disease may be altered. Relevant characteristics of celiac disease that may affect drug disposition include intestinal atrophy, hypoalbuminemia, reduced CYP3A enzymes, and thyroid dysfunction. EXPERT OPINION: The safety and efficacy of drug dosing in children with celiac disease can be enhanced with additional pharmacokinetic studies of commonly prescribed drugs in this population. Ideally, these studies should include drugs that have high bioavailability, are highly protein bound, undergo extensive CYP3A enzyme metabolism, and/or have a narrow therapeutic range.

Gluten content of barium sulfate suspensions used for barium swallows in patients with celiac disease.

PURPOSE: To determine the availability and accuracy of information provided by hospitals, imaging centers, and manufacturers regarding gluten in barium sulfate suspensions. METHODS: A total of 105 facilities were contacted via telephone to determine the gluten content of the contrast media used in those facilities. Manufacturers were contacted and their Web sites reviewed to determine the gluten content of their barium products. RESULTS: Thirty-nine percent of the hospitals and 52% of the imaging centers were not aware of the gluten content of the contrast media they used. Twenty-nine-and-a-half percent of the respondents provided the correct gluten content. The manufacturers noted that 5 products were tested and confirmed gluten free, 1 product was not tested but described as gluten free, 1 product's gluten content depended upon its flavor, and 1 product was reported to contain gluten. DISCUSSION: Clinicians caring for patients with celiac disease or patients who choose to restrict their gluten consumption must ensure that the barium sulfate suspension ingested is gluten free. CONCLUSION: It can be difficult to determine the gluten content of barium sulfate, as a majority of radiology departments and imaging centers did not know whether the product they use is gluten free. Educating staff members and improving product labeling would benefit the quality of care provided to patients with celiac disease.

Drug absorption in celiac disease.

PURPOSE: Published evidence on established and theorized effects of celiac disease on drug absorption and pharmacokinetics is reviewed. SUMMARY: Patients with celiac disease develop a variety of gastric disorders requiring oral medications, but the impact of damage to intestinal villi and other celiac disease sequelae on drug absorption remains poorly understood. A review of the pertinent literature (English-language articles on research in adults published during the period 1970-August 2012) identified several reports of altered drug absorption mechanisms in patients with celiac disease, including accelerated or delayed gastric emptying, increased permeability of jejunal mucosa, changes in intraluminal pH, decreased intestinal surface area, and reduced intestinal cytochrome P-450 enzymes. A small number of published studies suggest that celiac disease may be associated with altered drug absorption, resulting in higher serum concentrations of propranolol, lower peak concentrations of acetaminophen and practolol, higher dosing requirements with levothyroxine, impaired or delayed absorption of certain antibiotics, and other pharmacokinetic effects with a potential impact on medication efficacy and toxicity. However, these studies involved very small patient samples and were poorly controlled, with some yielding contradictory results. More and larger pharmacokinetic studies in patients with celiac disease-especially studies of drugs that are dosed empirically or are not amenable to dosage adjustment according to vital signs or laboratory values-are needed. CONCLUSION: Given the sometimes conflicting data on drug absorption in the context of celiac disease, cautious medication selection, dosage adjustment, and monitoring for efficacy and potential adverse effects are advised.