Hospital Says No More Dietary Supplements in Formulary

Paul A. Offit, MD


October 22, 2013

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Hi. My name is Paul Offit, and I am talking to you today from the Vaccine Education Center here at the Children's Hospital of Philadelphia. Today we are not going to be talking about vaccines. We are going to be talking about dietary supplements.

On July 29 of this year, the Children's Hospital of Philadelphia, to my knowledge, became the first hospital in this country to remove dietary supplements from the formulary. We did that because we were caught between a rock and a hard place. The rock was the Joint Commission of Hospital Accreditation, which asks us to treat these products like drugs. Fair enough. They are drugs. They could have a pharmacologic and physiologic effect that is drug-like, so I think that is a very fair request on their part. On the other hand, the Food and Drug Administration doesn't regulate these products as drugs, so for the 54,000 dietary supplements on the market, there isn't a very good safety profile. Probably fewer than 0.3% of those products have any reasonable safety portfolio. Their efficacy claims are often not true. What is worrisome is that the labeling may not be accurate and that, for example, a selenium product, which is said to contain 200 µg of selenium, may in fact contain 40,800 µg as was recently shown with a couple of products.[1]

The most worrisome thing is that there are drug-drug interactions. For example, St. John's wort, which is metabolized through the liver, can affect immunosuppressant drugs that we are giving to our transplant patients. There have been several reports of patients who rejected their transplants because the child or adult has been taking St. John's wort.[2,3]

Here is the way it works now: When you come to the hospital, we ask parents whether their children are receiving dietary supplements. Many times in the past, we just asked whether they were receiving drugs, and I think that many parents didn't consider supplements to be drugs. So, for the first time, we are really finding out about the level of dietary supplementation, at least in the pediatric population in our hospital.

If they are taking supplements, we strongly discourage their use and give them a pamphlet to explain why it is that these products are not what they claim to be. If they still want to use a dietary supplement and we don't consider it to be potentially harmful like St. John's wort, then we give them a waiver and say that they are using this against medical advice.

I think we are going to learn a lot over the next year or so about dietary supplement use in our hospital, and it will be of benefit to our patients because this is a patient safety initiative. Thank you.


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