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Self Care Pharmacy Blog

Posts Tagged ‘herbal’

 

Dietary Supplements: Encourage or Evict?

Monday, 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.

New Study Raises Concern about the Herbal Supplement Industry

Saturday, November 16th, 2013

By Jacob Coleman,  PharmD Student Cedarville University

If you’re a college student like me, you may be wondering what the hype is about vitamins and herbal supplements. These types of products are becoming increasingly popular among American adults, and a college education is just one predictor of dietary supplement use.1 Herbal products alone have grown 15% in the U.S. marketplace in terms of dollars generated in the past year.2 If you’re like me and have even a mild case of physician-phobia, you might prefer to self-treat your ailments before seeking professional help. Most likely you are not like me in having tried to self-treat broken bones before—this is not recommended, as two weeks of Ibuprofen is hardly the cure for dislocated fingers. This tendency towards self-treatment has increased the demand for quality dietary supplements. When the common cold strikes or college stress keeps us awake, one of the most popular solutions is the use of herbal supplements. Unfortunately, the regulation of dietary supplements is a step below the regulation of prescription and non-prescription drugs. Where numerous tests for safety and efficacy are required before drugs can be marketed, the Food and Drug Administration does not require thorough examination of supplements before they are sold. With $60 billion in annual revenues through over 1,000 manufacturers producing more than 29,000 herbal supplements, there is tremendous need for effective products and honest advertising and labeling.3

An article in The New York Times titled Herbal Supplements Are Often Not What They Seem describes the reliability of herbal supplement labeling in U.S. and Canada. The article cites a study from BMC Medicine where researchers examined product labeling to see how well it corresponded with what ingredients were actually in each pill.

The researchers analyzed the contents of 44 bottles of popular herbal supplements from 12 manufacturers, using a technique called “DNA barcoding.” The results revealed that most of the products contained components of plant species not included in the package labeling and only about half actually contained the labeled active ingredient.  One-third even contained other plant species substituted for the labeled active ingredient. For example, one product labeled as black cohosh, a common treatment for menopause symptoms, actually contained a related plant, Actaea asiatica, which can be toxic in humans. In the end, only 2 of the total 12 manufacturers had products that contained the actual label ingredients without contamination. Without mentioning the names of the manufacturers, the results exposed substantial labeling fraud in the herbal supplement market.2,4 The New York Times article discussed the need for regulation of the dietary supplement market while recommending caution to consumers.

The article presented numerous arguments against the herbal supplement industry, citing the lack of integrity in herbal supplement products. I found the article’s argument very compelling and agreed with the need for more FDA involvement in the dietary supplement industry. Aside from the study reference in the article, a variety of other research studies have found similar results, revealing a deficiency in herbal supplement reliability.5,6

file000785313090It is already hard to determine whether or not herbal supplements are effective. Having to find out if herbal products even contain the labeled active ingredient makes self-treatment even more difficult. Countless studies have been done to determine the effectiveness of herbal supplements. If we can’t trust the specific herbal products used in controlled experiments, how can we trust the results of these experiments? The information in this study makes me wonder how accurate my perception of the herbal supplement market is. Where I have been told a particular supplement is ineffective, maybe the manufacturer is the root of the ineffectiveness. Researchers and consumers alike looking to determine the efficacy of particular herbal ingredient should use caution in choosing where they obtain their materials.

There are, however, a few limitations to this study’s approach to determining product quality. DNA barcoding can only determine which ingredients are in a product. It cannot determine the potency of an ingredient or even how much of the available ingredient will even be broken down in the stomach and absorbed into the body. Unfortunately, the names of the manufacturers tested were not included. Because of this, the study invites misleading opinions about the entire herbal supplement without providing helpful information about which product brands to stay away from. Not only is this unhelpful, I don’t think it makes any sense why the researchers would choose to exclude the list of supplements and manufacturers tested. I would very much like to know which product brands in this study were dependable. Without these specifics, the article invites skepticism and can only recommend caution without specific advice concerning which product brands to purchase.

Have you ever taken an herbal supplement? Have you noticed some herbal supplements work better than others depending on the manufacturer?

References

  1. Krinsky, D. L., et. al. (2011) Handbook of Nonprescription Drugs. Washington, DC: American Pharmacists Association.
  2. Newmaster S. G., Grguric M., Dhivya S., et. al. DNA barcoding detects contamination and substitution in North American herbal products. BMC Medicine, 2013, 11:222  doi:10.1186/1741-7015-11-222. Available at http://www.biomedcentral.com/1741-7015/11/222. Accessed November 11, 2013.
  3. Perry, Susan. Herbal supplements often contain substitutes, fillers and contaminants, study finds. MinnPost, November 6, 2013. Available at http://www.minnpost.com/second-opinion/2013/11/herbal-supplements-often-contain-substitutes-fillers-and-contaminants-study-f. Accessed November 11, 2013.
  4. O’Connor, Anahad. Herbal Supplements Are Often Not What They Seem. The New York Times. November 3, 2013. Available at http://www.nytimes.com/2013/11/05/science/herbal-supplements-are-often-not-what-they-seem.html. Accessed November 11, 2013.
  5. Lockwood GB. The quality of commercially available nutraceutical supplements and food sources. Journal of Pharmacy and Pharmacology. 2011;63(1):3-10.
  6. Soller RW. The regulated dietary supplement industry: Myths of an unregulated industry dispelled. HerbalGram. 2012(93):42-57.