Ingredient Disclosures for Prescription Medications (or: A Worthy Cause)

My heart sank when I read a message from my friend Libby that she had discovered that the drug information insert given to her by CVS pharmacy with her food allergic son’s medication was for the brand name drug and not the generic she was being given.  She had made a startling discovery after months and months of anguish and worry for her son’s declining health: the generic version of the drug contained a milk derivative.  The brand name did not.  She had been giving her son a medication that contained an ingredient directly contraindicated by his allergies.  Libby wrote more on her blog, The Allergic Kid.

Think about it this way, if pharmacies are supposed to look at the interplay between one medication you take and another, shouldn’t they also (1) provide accurate ingredient information, (2) consider the act of avoiding an allergen a prescription equal to something actually produced by a company and shipped to the pharmacy, and (3) have to engage in safe practices so that a person obtaining a medication won’t have their pills sorted on the same surface as a medication that would be unsafe for them to ingest?

Like any mama bear would, Libby has sprung into action and I want to help her reach as many people as possible.  If her petition to the White House (remember, President Obama is directly impacted by food allergies in his family) gains enough signatures by July 4, 2014, we can get an official response to her request that FALCPA be updated to include direction that prescription drugs, like the food on our store shelves, take food allergies into account.  This benefits the food allergy community, the celiac community, and the public at large that is owed transparency.

Will you join me in signing this petition?  Thank you!

Update: I am pasting this wonderful comment here so it isn’t missed.  Reader Tiffany writes:

I am a registered pharmacist. Actually I have a Doctorate of Pharmacy–PharmD. I am also the sister of a person within milk protein allergies and the mother of a son with severe food allergies–egg, soy, peanuts, and various tree nuts.

Pharmacists, in general, get no formal training when it comes to food allergies. I must train the technicians at each pharmacy to ask for food allergies in addition to medication allergies. A lot of food allergies can be placed into the pharmacy’s database. However I cannot guarantee that the inactive ingredients are tagged and appropriately flagged—that’s a whole other discussion LOL . Brand and generic medications do not, by law, have to contain the same inactive ingredients. Generic medications are only required by the FDA to show that they compare to the active chemical in terms of efficacy/safety.

I will say that there are numerous medications that contain potential food allergens such as soy, fish, milk, and wheat gluten. For example: Gel caps –soy oil, over the counter vitamins–especially children’s–soy, spectracef (antibiotic) contains milk protein, Androgel–soy, certain vaccines such as flu, MMR–egg, certain diabetes medication–fish/shellfish. I could go on…

Combivent just re formulated this year and no longer contains soy/peanut allergens–hurray!

My top three suggestions would be :

1. Please tell the pharmacist–and stress the importance and severity of the allergy. Make sure that the food allergy is placed into the profile either in the allergy section OR via a patient note. Heck, why not both! As I stated above, pharmacists are somewhat like the general population in terms of food allergy knowledge and most do not even realize that this could be as big an issue as it is. A pharmacist will/should know the difference between lactose intolerance and milk protein allergy. So by discussing the issues–the pharmacist should “get it.” But if the pharmacist/pharmacy staff was never informed then they can’t intervene.

By the way, the doctors are just as clueless. Should you make the doctor aware of food allergies? Yes. Does the doctor weigh this info when prescribing? Probably not.

In my opinion, standard allergy questioning for medical purposes should contain food allergy questions as well.

2. Ask for the package insert (PI) for the NDC THAT YOU ARE RECEIVING. The actual medication that is in your bottle. The NDC is the number that signifies the specific manufacturer, drug, and bottle size from which your prescription was filled. The inactive ingredients are listed there usually. Each bottle comes with a PI–some may have fallen off during shipping. Every pharmacist will know what an NDC is.

As a matter of fact, in most retail settings the pharmacist can order a specific NDC–one that does not contain a specific FA–provided that the product exists and is available. Be patient–it is going to take more than 15 min to track all this information down. It’s worth the wait.

3. Call the manufacturer if unsure. The pharmacist has access to and can provide you with the phone number for the manufacturer of the medication you are receiving.

I have discussed these issues on small scale and I totally agree that medical staff including doctors and pharmacists need better FA knowledge and training as it related to medications and treatment.

Sorry I wrote a book but I hope that will help answer some questions about FA and the pharmacy (FA and the pharmacy that sounds like a good title for a blog—hmmmm LOL)

I think she should certainly start that blog!  Thank you Tiffany for sharing your expertise!

____

Update: 7/8/14

The petition didn’t gain enough signatures (when I checked last before it went offline I believe it was at about 200) but that doesn’t mean the issue should go quietly into the night.  In other news, Tiffany did get her blog started!

20 thoughts on “Ingredient Disclosures for Prescription Medications (or: A Worthy Cause)

  1. When I discovered this issue myself, I was shocked! Pharmacies need to get educated about food allergies!

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    1. I think that is a huge component, I wonder what is and isn’t included in their training and licensing process…?

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  2. I feel so sorry for this poor mother, how horrible to be inadvertently hurting your child while trying to help him. I am grateful to her for sharing her story because this will help other families.

    The prevailing theory is that generics are no different from name brands, even in non-prescription drugs. I know this isn’t true, because generic “headache reliever” doesn’t work for me, while Excedrin does. They are not interchangeable. I think pharmacies do have a responsibility to be giving out the correct ingredient information, that seems like a pretty basic aspect of the job description to me. Petition signed 🙂

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    1. It is kind of like how people will swear up and down that certain peanut oils can be tolerated by people with peanut allergies but I figure people have a right to know and make that choice for themselves. Same goes for generic vs. name brand. On the one hand, I’m sure the pharmacy will point fingers back at the doctor but in a case like this you have a parent reading ingredients diligently and being presented with the wrong ones – changes the landscape of responsibility a great deal. It takes courage to share that something like this happened, you’re right!

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  3. I am a registered pharmacist. Actually I have a Doctorate of Pharmacy–PharmD. I am also the sister of a person within milk protein allergies and the mother of a son with severe food allergies–egg, soy, peanuts, and various tree nuts.

    Pharmacists, in general, get no formal training when it comes to food allergies. I must train the technicians at each pharmacy to ask for food allergies in addition to medication allergies. A lot of food allergies can be placed into the pharmacy’s database. However I cannot guarantee that the inactive ingredients are tagged and appropriately flagged—that’s a whole other discussion LOL . Brand and generic medications do not, by law, have to contain the same inactive ingredients. Generic medications are only required by the FDA to show that they compare to the active chemical in terms of efficacy/safety.

    I will say that there are numerous medications that contain potential food allergens such as soy, fish, milk, and wheat gluten. For example: Gel caps –soy oil, over the counter vitamins–especially children’s–soy, spectracef (antibiotic) contains milk protein, Androgel–soy, certain vaccines such as flu, MMR–egg, certain diabetes medication–fish/shellfish. I could go on…

    Combivent just re formulated this year and no longer contains soy/peanut allergens–hurray!

    My top three suggestions would be :

    1. Please tell the pharmacist–and stress the importance and severity of the allergy. Make sure that the food allergy is placed into the profile either in the allergy section OR via a patient note. Heck, why not both! As I stated above, pharmacists are somewhat like the general population in terms of food allergy knowledge and most do not even realize that this could be as big an issue as it is. A pharmacist will/should know the difference between lactose intolerance and milk protein allergy. So by discussing the issues–the pharmacist should “get it.” But if the pharmacist/pharmacy staff was never informed then they can’t intervene.

    By the way, the doctors are just as clueless. Should you make the doctor aware of food allergies? Yes. Does the doctor weigh this info when prescribing? Probably not.

    In my opinion, standard allergy questioning for medical purposes should contain food allergy questions as well.

    2. Ask for the package insert (PI) for the NDC THAT YOU ARE RECEIVING. The actual medication that is in your bottle. The NDC is the number that signifies the specific manufacturer, drug, and bottle size from which your prescription was filled. The inactive ingredients are listed there usually. Each bottle comes with a PI–some may have fallen off during shipping. Every pharmacist will know what an NDC is.

    As a matter of fact, in most retail settings the pharmacist can order a specific NDC–one that does not contain a specific FA–provided that the product exists and is available. Be patient–it is going to take more than 15 min to track all this information down. It’s worth the wait.

    3. Call the manufacturer if unsure. The pharmacist has access to and can provide you with the phone number for the manufacturer of the medication you are receiving.

    I have discussed these issues on small scale and I totally agree that medical staff including doctors and pharmacists need better FA knowledge and training as it related to medications and treatment.

    Sorry I wrote a book but I hope that will help answer some questions about FA and the pharmacy (FA and the pharmacy that sounds like a good title for a blog—hmmmm LOL)

    Liked by 1 person

    1. Tiffany, this is an amazing contribution and I so appreciate you sharing! I had no idea I needed to make a request for the actual ingredient list because of the active/inactive distinction. I think you should certainly write that blog and use your comment as the basis for your first post. I know I would share it far and wide, it is truly helpful. Thank you again!

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  4. Wonderful discussion of an under-recognized issue. I am a board certified allergist/immunologist and I will freely admit that I have absolutely NO idea what medications may contain what ingredients. With so many medications and formulations available, it is impossible for any prescribing provider to know what inactive ingredients may be present inside a particular medication, which also may change over time. This information is also not readily available, making it even more difficult.

    I agree with the idea of listing this in clear language on the medication labeling, to help offer transparency for the patient, prescriber, and also the pharmacist. The fail safe may come at the level of the pharmacy, and help from the pharmacist in determining suitable equivalent alternatives would be critical. Of course, this entails increased awareness and education as pointed out so eloquently above.

    Lastly, it warrants mention and discussion that not every person with food allergies will necessarily be affected by these inactive ingredients. The protein may be altered, broken down, or in such minute quantity so as not to provoke a reaction. This is not a universal rule either way, but something to be considered and discussed with one’s prescribing physician/allergist. It ultimately may come down to a discussion of the benefit of a particular medication versus the risk of possible reaction.

    Great post and great discussion!

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    1. This is great to know, Dr. Stukus, that there is a need here for greater disclosure and transparency. I think as advocates we all want to put our efforts into things that will help the most people. Very good also to point out about the break down of the proteins – I recall Dr. Gupta doing a study that looked at how many people were telling their pediatrician about allergies their children had and the patient communication wasn’t always great. So in theory a general practitioner may not even know when prescribing something that there are these concerns or that the formulation of generic vs. brand name could be so different on the inactive ingredient front. Thank you again!

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  5. I am allergic to soy and my pharmacist told me I had nothing to worry about. Then came the reaction to a prescription drug, and now I always call the manufacturer. Drug companies hide ingredients in so many ways and many use generic ingredient names that are derived from a food.

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    1. I am so sorry you had that experience, Alanna – soy is such a hard allergen to avoid in food already but when you get to even topical medications or sunscreens I know how hard soy derivatives are to avoid. Thank you so much for sharing.

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  6. Thanks to your encouragement and that of friends and family, I have decided to start that blog. I will focus on prescription and OTC medications, lotions, sunscreens, lip balms, chapsticks, etc. As well as any other specific storage and use issues.

    Please visit and follow me at foodallergypharmacist.wordpress.com

    I’m just starting out, so I don’t have much posted yet. I would appreciate any suggestions or areas of interest that I should focus on.

    Thanks again!
    Tiffany

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  7. I searched for this post (I just KNEW you would have something about this issue!) because we had a similar situation occur AT THE ALLERGIST’S OFFICE. I took my son in last week for his annual “pre- school” appointment to get the new prescriptions for his Auvi-Q, etc. While we were there, the allergist recommended switching my son from using Pulmacourt in the nebulizer to a powdered inhaler version of Pulmacourt. She said she had a sample in the office and would like us to try it before we left. After she left the room, I happened to look a poster on the wall describing the various inhaler meds. Listed on the poster was the Pulmacourt powder inhaler the doctor recommended and others like it (Advair, etc.). Included in the information was a listing of each med’s inactive ingredients, and all of the powdered medications listed Lactose as an inactive ingredient. When the nurse returned with the med, I requested to see the Patient Information sheet. Very near the top was a warning that “Patients with milk allergies should not use this product. This product contains lactose (milk sugar proteins) that may cause a severe allergic reaction.” I brought this up to the allergist, and she wanted to try the medication anyway! She said she has never had a problem with the medication with any of her other patients, but my son has an anaphylactic reaction to milk ingestion and a contact allergy to milk resulting in rash. I am still dumbfounded that the allergist would recommend a medication containing milk to a patient with severe milk allergies. Thanks for bringing this issue to everyone’s attention.

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    1. Wow, that is a perfect example of this issue. Like most labeling/disclosure issues I would like to know, as a consumer, and make a decision about risks instead of having what is effectively informed consent given by my physician at the time of the Rx. I understand if her experience indicates no one had an issue but I know when I have an issue with a physician recommendation I switch doctors, I don’t report back to the one with which I am at cross purposes! Thank you for sharing your story, Donna, hope your son has a great year of school ahead.

      Liked by 1 person

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