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?
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.