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Dietary Supplements: Encourage or Evict?

November 18th, 2013

by Elizabeth Ledbetter

The Children’s Hospital of Philadelphia (CHOP) declared in early October 2013 that it will ban most dietary supplements from its pharmacy.1 This is because the U.S. Food and Drug Administration (FDA) does not regulate these products in the same way that they regulate prescription drugs. Because the safety and efficacy of dietary supplements have not been clinically tested by the FDA and cannot be guaranteed, CHOP is doing what they call a “clean sweep” in their pharmacy. They will continue to carry only a select few key vitamins, minerals, and amino acids that have been verified by the U.S. Pharmacopeia Convention (USP).1  

It is difficult to argue with the stance that this hospital is taking because their motivation is respectable. They do not want to recommend products to their patients that have not been thoroughly tested for safety and efficacy. Unfortunately, the decision seems to be a bit rash, and I agree with the author when she writes, “…any approach to healing or prevention should be integrative, malleable, and cautiously open-minded.”1 CHOP seems to be taking a closed-minded approach as they essentially eliminate the potential for disease treatment and prevention through supplements.  In my opinion, dietary supplements do not need to be evicted from our pharmacies just because the same prescription drug tests are not being performed on these products.  Adverse events related to dietary supplements are not near as numerous as those related to prescription drugs.  There were 489 adverse events related to dietary supplements reported in the 2012 fiscal year compared with over 300,000 adverse events related to prescription drugs.2,3

I have worked as a technician in a community pharmacy for two years, and I consistently see a large number of customers purchasing dietary supplements.  I will be the first to admit that I do not believe these customers are doing aimless supplement shopping. When I have encountered patients who need help finding a dietary supplement on the shelf they will inquire, “My doctor told me to purchase some ____________. What aisle is it in?” or, “I’ve been doing some research on __________. Do you carry that here?”  Most often, when a customer is purchasing a dietary supplement, he or she is making the final product choice.  I believe that this responsibility motivates customers to do research on dietary supplements and talk to their doctor about potential benefits and risks.

The stance that CHOP has taken on dietary supplements does not change the recommendations I will make in the future.  CHOP’s stance does, however, motivate me to do thorough research on commonly recommended supplements before I am in the position to make a professional recommendation.  I will be happy to make research-grounded recommendations as a pharmacist, yet I will also remind my patients that they need to be cautious when using dietary supplements because the risks and side effects are not known as well as those of prescription drugs.

Although I disagree with the stance that CHOP has taken in banning dietary supplements, there is evidence that supports the thoughts behind their reasoning. In regards to the concern of regulation, admittedly, dietary supplements have no pre-market approval process.4 They may be freely sold until the FDA objects as a result of adverse event reporting.4 The FDA even states on their website, “Generally, manufacturers do not need to register their products with FDA or get FDA approval before producing or selling dietary supplements.”5 In addition, CHOP decided to ban dietary supplements because their safety and efficacy cannot be guaranteed.  One study that examined clinical study reports suggests that the common dietary supplement dehydroepiandrosterone (DHEA) might even be harmful, as it has shown to lead to increased breast cancer risk in postmenopausal women.6 This study reinforces the threat of potential health risks associated with dietary supplements.

I cannot help but agree with the author of this article when she writes, “It baffles me that the same serious [pharmaceutical research] is not given to natural alternatives, which stand not only to help but may also do less harm.”1 Although we still lack the research necessary to recommend dietary supplements with 100% confidence, it is impossible to ignore the potential benefits they could have in preventing disease. So what is the best option: should pharmacies move toward eliminating their dietary supplement sections?

 References

1 Imus D. Is Philadelphia hospital’s ban on supplements a slippery slope? Fox News. October 23, 2013.  Available at: http://www.foxnews.com/health/2013/10/23/is-philadelphia-hospital-ban-on-supplements-slippery-slope/. Accessed October 31, 2013.

2 U.S. Food and Drug Administration. Number of mandatory adverse event reports from the dietary supplement industry entered into CAERS in the month. 2012. Available at: http://www.accessdata.fda.gov/FDATrack/track?program=cfsan&id=

CFSAN-OFDCER-Number-of-mandatory-adverse-event-reports-from-dietary-supplement-industry-entered-into-CAERS. Accessed November 15, 2013.

3 U.S. Food and Drug Administration. FAERS Patient Outcomes by Year. June 30, 2012. Available at: http://www.fda.gov/drugs/guidancecomplianceregulatory
information
/surveillance/adversedrugeffects/ucm070461.htm. Accessed November 15, 2013.

4 Borneman J. The Regulation of Homeopathic Drugs as Complementary and Alternative Medicine Products: The Role of the Homeopathic Pharmacopoeia of the United States. American Journal Of Homeopathic Medicine [serial online]. Winter2007 2007;100(4):258-264. Available from: Alt HealthWatch, Ipswich, MA. Accessed October 29, 2013.

5 U.S. Food and Drug Administration. Dietary Supplements. August 28, 2013. Available at: http://www.fda.gov/Food/DietarySupplements/default.htm. Accessed October 31, 2013.

6 Stoll B. Dietary supplements of dehydroepiandrosterone in relation to breast cancer risk. European Journal Of Clinical Nutrition [serial online]. October 1999;53(10):771-775. Available from: MEDLINE with Full Text, Ipswich, MA. Accessed October 30, 2013.

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5 Responses to “Dietary Supplements: Encourage or Evict?”

  1. Anna Smith Says:

    You did a great job presenting the information and your own opinion on the matter. I agree with you that the motivation of the CHOP to do a “clean sweep” of dietary supplements is respectable, although it does seem a bit extreme. Even though the products are not tested by the FDA and do not undergo testing like prescriptions do, there has been research done on most of them after marketing. Unless the products that people want to use are newer without any research done on them, these studies could be used in making informed decisions on what dietary supplements to purchase or recommend. It’s not like there is absolutely no information on these products that can aid in decision-making. I agree that this is very much narrowing the options for treatment within this facility, which is not beneficial to patients where other treatments have not worked. Through taking away those dietary supplements, the possible benefits from them would be eliminated as well.

    I do not think pharmacies should be moving toward eliminating their dietary supplements. There may be some dietary supplements that are deemed as being very harmful through studies that have been done after marketing. It would be logical to take those dietary supplements shown to be very harmful out of the pharmacies. However, there are most likely dietary supplements that have been shown to be more beneficial than harmful. These should not be taken out of pharmacies because some people may need these if no other treatments are working or because they are the best option. If a pharmacist or other healthcare provider is worried about a dietary supplement, they can voice their concerns to the patient and warn them of the risks. I just don’t think that it can be proven for all of the supplements that there is more harm done than help, which is why it is unreasonable to eliminate all dietary supplements from pharmacies. There should be more research and prior planning and discussing done before such drastic measures are taken.

  2. Maria Miller Says:

    This is such an interesting take on how dietary supplements are regulated and how to react to that. I wouldn’t think that an institution as big as a hospital would ban supplements. I feel like that’s a pretty rash decision as you had mentioned. I’m glad they’ve decided to keep the important ones that are known to be helpful, but I think the decision to ban them is going a little too far. If they wanted to take them off the shelf because they don’t like how they aren’t regulated and they think it’ll be more harmful to the patients than beneficial then that would be ok. But the actual act of banning them just doesn’t seem helpful. I’ve heard of pharmacies not carrying an item but are able to order it in per request from a patient, but they wouldn’t be able to do that because of the new policy of banning supplements.

    I can see their reasoning of doing this because supplements aren’t regulated as they ought, they can contain literally anything without having to say what is in the product, and their safety and efficacy is not proven. So I can understand why it might be better not to have them. I think their solution to the problem wasn’t the best choice. They could have kept things behind the counter and that way if a patient asked for one, that would give the pharmacist a chance to counsel and make sure they really need it or know about the possible effects of taking one. Ultimately it is the patient’s choice to buy it. If they really want the product, they will go to another pharmacy where they may not receive the counseling they need that they could have gotten if the hospital pharmacy didn’t have a ban.

    This definitely is a motivator to do research on supplements and make sure you can make good recommendations to patients.

  3. Tirhas Mekonnen Says:

    I also agree with your comment. To completely remove all the dietary supplements is a bit harsh. I think to pick the ones that are causing the most problems would make sense. However, to just wipe out all dietary supplements makes the ones that are helpful useless. I think that some of the dietary supplements are actually beneficial. Some f the dietary supplements have actually some studies done. Although there are some conflicting evidences among studies, that does not necessarily means that all dietary supplements are bad altogether. I think with evidence based good judgment some of the well-known harmful supplements can be avoided.
    The other thing also is that to encourage patients to provide a list of medicines as well as a list of dietary supplements to their health care professional. Some patients may not think that they need to provide this information to their health care professional. Also it is important for health care professionals to ask their patients about what the patients are taking including their dietary supplements before making any decisions.
    Over all I like your presentation and I think the information provided is helpful to other health care providers as well as to patient.

  4. Olumami Amaye Says:

    I completely agree with you that CHOP are doing a clean sweep, but one thing you failed to mention why are doing it, is it because it’ll be beneficial to the patients. Knowing that the potential harmful effects that these supplement cause to patients. However many supplements contain active ingredients that have strong biological effects in the body. Some do cause drug interaction with other medications, if CHOP want to clean it house to avoid law suit from unsafe supplements. From my understanding of supplements, they are not fully safety to use with other drugs. However because they are unregulated, supplement products are often mislabeled and may contain additives and contaminants that are not listed on the label. Some supplements could actually cause allergic reactions, and they might not interact well with conventional drugs, and some are toxic if used improperly or at high doses.

    To your question, I would say “NO” herbal supplements needs further regulation by the Food and Drug Administration to prove their safety and efficacy. If you want to protect your own health and that of others, I recommend doing a bit of research on an herbal supplement before you begin to take it daily. Find out who the manufacturer is and what they’re about. Also, consider the effectiveness of the supplement and if it truly fits your needs. furthermore, you blog is very informative and eye opener on supplements.

  5. Yevgeniy A Solokha Says:

    I think that it might have been appropriate for the hospital to remove the dietary supplements because it usually cares for patients that have severe health problems. With a lack of regulation, it would make sense that the hospital would only keep the vitamins and supplements that have demonstrable efficacy. With regards to pharmacies, I don’t think that it would be appropriate to get rid of the dietary supplements section because the patients that shop there are usually in a better health condition than the ones in the hospital. They should have the option to choose how they want to treat themselves.

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