Walgreens tells pharmacists they should not counsel that any given medication is gluten-free

Walgreens tells pharmacists they should not counsel that any given medication is gluten-free

Where does this leave people with celiac disease and other gluten-related disorders? The handout posted below was provided to Gluten Free Watchdog by a consumer. She received this information when she picked up her prescription. Gluten Free Watchdog is requesting comment on the handout as we contemplate next steps. Please also read the information below the photo. Thank you!

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Gluten in Medicine Disclosure Act of 2021 (originally posted on April 22, 2021)

Note: This act does not appear to have made any headway.

On April 8, 2021, Representative Tim Ryan (D-Ohio) introduced bill H.R.2435 “to amend the Federal Food, Drug, and Cosmetic Act to require the label of a drug that is intended for human use and contains an ingredient that is derived directly or indirectly from a gluten-containing grain to identify each such ingredient, and for other purposes.” Representative Steve Stivers (R-OH) is co-sponsor. This bill is in committee and has not yet been sent to the House. For more information, see https://www.congress.gov/bill/117th-congress/house-bill/2435.

At Gluten Free Watchdog we are fully supportive of transparency and this support extends to ingredients in medicine. Our hope is that passage of this bill will decrease much of the anxiety around medicine and gluten in the celiac disease community.

In the meantime, remember that the FDA has stated they know of no oral drug products currently in the marketplace that contain wheat gluten or wheat flour as an ingredient. The agency has identified a few oral medications that contain wheat starch as an ingredient. (Oral drug products do not typically contain barley or rye). For more information see https://www.fda.gov/drugs/ensuring-safe-use-medicine/medications-and-gluten

It is also important to remember that when wheat starch is used in a medication it is likely to be used in small amounts and contribute very little residual gluten protein to the final product. This is because wheat starch contains only small amounts of residual protein and the weight amount of most medication dosages is low. As a result, the amount of gluten ingested is low. For example if a medication contains 20 ppm of gluten, you would have to ingest one ounce of medication (this is a lot) to take in about ½ milligram of gluten (10 mg of gluten per day is considered a “safe” amount by most experts). What does an ounce of medication look like? Here is one example:

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Comments (12)

  • Shalini Lynch
    Reply

    Reading this handout, it seems that the key issue is that there is a lack of ability for a pharmacist to get an easy and clear-cut answer from manufacturers regarding gluten free status of a product. But since multiple explanations for this lack of a clear-cut status are given, why ask the patient to call the manufacturer? Is a manufacturer more likely to make such a guarantee to a patient than a pharmacist? This comes down to the lack of time for a pharmacist to critically evaluate information provided by the manufacturer and weigh the pros and cons, so this evaluation process is being passed onto the patient. The handout actually does a decent job outlining to patients some potential sources of uncertainty. I feel for busy pharmacists given the inability of manufacturers to provide a clear cut answer, but pushing this responsibility to the patient also sends a mixed message. This whole communication also points to one more reason why FDA needs to mandate the clear status of medicines where gluten is concerned. I also disagree that a gluten allergy should not be documented in the patient’s record. Adverse events such as cough on ACE inhibitors, dizziness on pain meds, etc are commonly documented as allergies when these aren’t even allergies but simply an aspect of the patient’s health record. Gluten allergy is commonly listed in the allergy line in medical records even though celiac disease isn’t truly an allergy. It’s an easy way to capture this information and may be relevant for other aspects of the patient’s care.

    August 19, 2022 at 7:20 pm
  • Donna Thibodeau Reply

    I’m confused. You say there is an act passed saying gluten must be identified in medication. But no medication contains gluten ingredients. We can relax?

    August 19, 2022 at 8:58 pm
    • Tricia Thompson Reply

      The bill has been introduced and has bipartisan support but it appears unlikely to pass. The FDA has stated they know of no oral drug products currently in the marketplace that contain wheat gluten or wheat flour as an ingredient. The agency has identified a few oral medications that contain wheat starch as an ingredient. (Oral drug products do not typically contain barley or rye). It would be very helpful to test medications to determine the ppm level of gluten. Unfortunately, it is very difficult to mail drugs to the lab for testing. We continue to work on this.

      August 22, 2022 at 12:39 pm
  • Beth Meadows Reply

    It can be in the gel-coating of some RX! My kind pharmacist at Publix contacted all of my prescription manufacturers and 2 of them has gluten in the capsule gel! I can’t even take the generic version of Advil!

    August 20, 2022 at 10:35 am
  • Ana A Garcia Reply

    Agree with Shalini Lynch’comment adding that it comes down to the government’s unwillingness to understand the seriousness of this all around. While I understand what an ounce of gluten visually looks like from the photo for pill intake but what about what is being consumed in combination with processed foods? Type 2 diabetics for example aren’t required to go on a diabetic diet and lifestyle which would likely reverse the diabetes in order to prescribe their insulin and meds? While I normally eat only whole foods due to having Celiac Disease not all with Celiac are able to do this as I when I travel.

    August 20, 2022 at 12:49 pm
    • Tricia Thompson Reply

      The total daily intake of gluten is what matters. It is important to put into context the amount of gluten taken in at a given ppm level and this depends on the weight amount of product consumed (remember ppm is a proportion). For example if a bread and a spice and a medication all contain a level of gluten of 20 ppm, you would take in far more gluten from the bread than the spice or the medication simply because a higher weight amount of bread is typically consumed. For more visuals, please see https://www.glutenfreewatchdog.org/news/video-putting-gluten-contamination-levels-into-context/. But again, at Gluten Free Watchdog we are fully supportive of transparency and this support extends to ingredients in medicine.

      August 22, 2022 at 12:35 pm
  • Sarah Reply

    I understand the hesitancy by the government to call out gluten specifically. As stated in the article, the amount of gluten potentially in a pill is very small and would most certainly be from wheat, not other gluten containing grains. That small of an amount would be unlikely to affect someone with celiac unless they are taking an extremely high dosage.

    What I don’t understand is the lack of labeling on prescriptions in terms of the top 8 allergens. People with celiac are a very small subset of the population, but when you combine everyone with the top 8 allergies, it’s a large portion. Being that barley and rye aren’t used in prescriptions, labeling for the top 8 allergens would resolve the issue for folks with celiacs. For people like me with a wheat allergy, it would be potentially lifesaving. I have a small panic attack every time I have to take something new because most manufacturers don’t respond to the pharmacy in a timely manner. Generally speaking, a person can’t wait days or potentially weeks to get an answer before starting a new med.

    Additionally, oral drugs aren’t the only ones we need to be concerned about. Anyone going into surgery, hospitalization or emergency care is likely to receive a variety of medications via injection or IV. I would love to see those labeled with the top 8 allergens as well. I recently learned that the dye used to detect scratches on the cornea contains gluten and will cause a reaction for those with allergy or celiacs.

    August 22, 2022 at 7:18 pm
  • Patty Reply

    I have always had to fight like hell to get my pharmacy to use a particular generic for one of my medicines (I take four tablets daily). The manufacturer they prefer is based in another country and I have tried numerous times to contact them regarding gluten content in their drug. I have never heard back. It may very well be safe but it’s just a risk I can’t afford to take. My pharmacy is not helpful in this regard, as they don’t like to dispense the other brand. They didn’t do any of the heavy lifting, I’m the one who calls and researches and advocates for myself. I always ask for the drug package insert and call the manufacturer to check for gluten in all my prescriptions. It’s a huge pain but I can’t trust anyone else to do it. In my opinion the Walgreens counseling paragraph at the beginning is useless. Just advise us to call and check, don’t give us the usual boilerplate response about not being able to guarantee anything – you know that’s completely a CYA statement thrown together by their legal team.

    August 23, 2022 at 4:04 am
  • Kelsey B. Reply

    If small town pharmacies and even places like Sam’s Club are willing and able to accommodate, then why can’t one of the nation’s largest pharmacy chains? To word is as if the patient has a choice to take their medications or not was really the icing on the cake for me… I don’t have a thyroid. If I go long enough without my thyroid meds, I die. I also shouldn’t have to choose between playing it safe and not taking my antidepressants bc my pharmacy refuses to see the severity of my celiac, and being suicidal, depressed, and anxious. Times are changing. This isn’t magically going away, and with most of the celiac population still remaining undiagnosed, it could be way more of an issue down the road than we even have a grasp on. This could set a dangerous precedent for other pharmacies, and doesn’t demand any accountability from the manufacturer or the FDA. To some of us, our diet isn’t merely a preference but a requirement if we want to have any sort of quality of life, and there shouldn’t be the option for our PHARMACY to refuse to accommodate us. It seems a bit medically prejudicial, especially since Walgreen’s will not respond to me inquiring about their other allergy protocols(peanut, shellfish, egg, etc) as I’d like to side-by-side compare them to how they handle gluten.

    August 23, 2022 at 9:00 pm
  • Rochelle Reply

    This is so wrong it’s hard believe we still have a “buyer be ware” attitude about prescribed medication. If most or all meds are gluten free according to the FDA then what is the problem with regulating and requiring labeling? I just don’t understand.

    August 30, 2022 at 8:41 pm
    • Anna Reply

      The scary part is that Walgreens is admitting they don’t know with 100% certainty what is in their medications. I appreciate the honesty but I see a serious problem with that, not just for Celiacs.

      September 2, 2022 at 7:33 am

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