3. QEM Navigation Home:
Interactions of Herbal and Dietary Supplements with Warfarin
Pre-survey
Introduction
Section 1: HDS classification, regulation, market and usage data
1.1: Herbal and dietary supplements
1.2: Risky communication gap video
1.3: DSHEA survey
1.4: FDA news release
Section 2: New research compiling HDS and warfarin interactions
2.1: HDS-warfarin interactions
2.2: Quantifying the communication gap - phone survey with IHC warfarin patients
2.3: Three resources you can use to identify interactions
2.4: Practice using the three resources
Section 3: Case study, resource practice and a blog
3.1: Case study video and response
3.2: Blog - patient experiences with HDS-drug and HDS-drug interactions
Conclusion and post-survey
4. Introduction
WELCOME VIDEO [Insert video link.]
LEARNING OBJECTIVES:
At the conclusion of this QEM, you will be able to...
• Describe the implications of Dietary Supplement
Health and Education Act (DSHEA) of 1994.
• State the percentage of patients who use HDS.
• Recognize the discrepancy between patient
reported use and HDS use documented in
medical charts. Stamina RX News Release (see Section 1.4): FDA pulled this
HDS because it contained nitroglycerin-like contaminants.
Image credits: www.aragonproducts.com
• Know where to find and how to use three
resources that contain information about HDS.
• Give an example of a risky HDS-drug
combination.
5. Section 1: HDS
classification, regulation,
market and usage data
LEARNING OBJECTIVES
• You will describe the implications of Dietary
Supplement Health and Education Act
(DSHEA) of 1994.
• You will state the percentage of patients who
report HDS use.
Creative commons image source:
http://blog.healia.com/files/images/Vitamins.png
6. Section 1.1: Herbal and dietary supplements
What is an HDS?
We will define herbal and dietary supplements (HDS) as over-the-counter products, often derived from plant, algae, or fungae, which includes vitamins and
minerals. Often, these products are a complex potpourri of many chemical compounds.
Understanding the regulatory laws with regard to HDS
For centuries, botanicals and their derivatives have been utilized for prevention and treatment of disease. Over the past year, 20% of Americans reported using
at least one HDS. In the present day era of patient guided research, selection and self-treatment with supplements, it is imperative that medical providers be
proactive in inquiry about HDS use and provide relevant guidance in efforts to minimize potential adverse events. Growing concern for patient safety has driven
international and national groups in efforts towards regulation of the herbal supplement industry, but with limited success. When combined with prescription
drugs, herbal-drug interactions are of great concern because they may lead to unexpected and serious patient harm.
HDS is the fastest growing sector of the US pharmaceutical market, with reported annual earnings exceeding five billion dollars (2002), and more than 1500
herbal supplements are manufactured for pharmacy shelves. While manufacturers of HDS infer that their products provide “functional support” to the body,
HDS are not considered “drugs”, and are therefore free from the safety and regulatory standards set in place by the FDA. In 1994, the Dietary Supplement
Health and Education Act (DSHEA) was passed and outlines the US regulations set in place for herbal and nonherbal supplements: the manufacturer is to
ensure that the product is safe and labeling must include product ingredients. Period. The manufacturer is not required to produce evidence of safety or efficacy
to the FDA (either pre- or post-marketing), and there are no guidelines for standardization. As a result, one supplement may contain hundreds of ingredients,
product content may vary from lot to lot, and contamination (with prescription drugs and pesticides) has been reported. The quandary with HDS continues to
be that the pharmacologic effects of these products are undefined, unpredictable, and potentially unsafe, yet the well-intended consumer has little knowledge of
this.
Patients with multiple medical comorbidities, fragile end organ function, and those on complicated drug regimens are at the greatest risk. In 2002, the World
Health Organization launched a global strategy with end goals of promoting consumer safety through industry regulation and standardization. Clearly the
unregulated use of HDS is not just a national, but an international concern.
In summary, DSHEA falls short of achieving the regulatory standards established by the FDA for prescription products.
7. Section 1.2: Risky communication gap video
Click on the US map to watch a video which sizes the HDS market
and the percentage of HDS users that communicate their use with
their medical providers
8. Section 1.3: DSHEA Survey
Please click on the link above to confirm your understanding of this material by taking a
short quiz.
9. Section 1.4: FDA Press Release
6-15-2009
Stamina-Rx Dietary Supplement Products
[[http://www.fda.gov/Safety/MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/ucm168017.htm ]]
FDA and Hi-Tech Pharmaceuticals notified patients and healthcare
professionals of a nationwide recall of all product sold under the name
Stamina-Rx. FDA lab analysis found that the product contained the
undeclared ingredient − benzamidenafil − a drug in the same
therapeutic class of active pharmaceutical ingredients that include the
PDE5 inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-
approved for the treatment of erectile dysfunction. Benzamidenafil is
not FDA-approved, and poses a threat to consumers because
benzamidenafil may interact with nitrates found in some prescription
drugs (such as nitroglycerin) and may lower blood pressure to
dangerous levels. Consumers with diabetes, high blood pressure,
high cholesterol, or heart disease often take nitrates and may be most
susceptible to adverse effects from this product. Stamina-Rx is sold
predominantly in health food and drug stores nationwide. Consumers
who have this product in their possession should stop using it
immediately. Stamina RX News Release (see Section 1.4): FDA pulled this
[06/15/2009 - Firm Press Release - Hi-Tech Pharmaceuticals] HDS because it contained nitroglycerin-like contaminants.
Image credits: www.aragonproducts.com
10. Section 2: New research
compiling HDS and
warfarin data
LEARNING OBJECTIVES
• You will identify popular HDS products that
adversely interact with warfarin.
• You will describe the level of risk posed by the
most popular HDS products when taken with
warfarin.
• You will describe the IHC warfarin patient survey
results, particularly the likelihood that the patient
(1) is using HDS, and (2) communicated this with
you. Creative commons image source:
• You will use three online IHC research tools to http://blog.healia.com/files/images/Vitamins.png
investigate the risk posed by a particular HDS.
11. Section 2.1: HDS-warfarin interactions
Let's examine high profile warfarin, a gold standard oral
anticoagulant, and its interaction with the ten top-selling
HDS as a case study of potential patient risk.
Using 2008 HDS sales data, the top ten HDS products are
shown in Figure 2.1. Based on published research, eight of
the ten products have been shown to interact with
warfarin! More than 22 million warfarin prescriptions were
filled in 2008 (http://drugtopics.modernmedicine.cm/
top200gen,) making it the 21st most commonly prescribed
drug in the U.S..
Enormous health care resources are dedicated to the
management of warfarin, yet in spite of efforts to achieve
tight control of the INR, warfarin accounts for more
emergency room visits than any other drug (other than
insulin.) In 2008, the Joint Commission made the
appropriate use of warfarin a National Patient Safety Goal.
As part of this effort, it is crucial to understand the
influence that HDS use may have on INR variability when
taken concomitantly with warfarin.
[insert podcast detailing this research and discussing graphic]
Figure 2.1 Top Ten Selling HDS Products (2008 sales data). Adverse interactions are shown in
blue; no-low risk shown in pink.
12. Section 2.1 continued
CHARACTERIZATION OF "RISKY 8" [details to be added]
• Glucosamine/Chondroitin -
• Essential Fatty Acids -
• Coenzyme Q10 -
• Multi-Herbs -
• Soy -
• Cranberry -
• Melatonin -
• Garlic -
Figure 2.1 Top Ten Selling HDS Products (2008 sales data). Adverse interactions are shown in
blue; no-low risk shown in pink.
13. Section 2.2: Phone survey of IHC
warfarin patients
In April 2010, IHC warfarin patients were phone
surveyed to determine their level of use and
openness about using HDS. The results were
interesting and are summarized in Figure 2.2.
[add survey results as Fig 2.2.... refer to Fig 2.2 from
Creative commons image source:
audio podcast] http://www.freefoto.com/images/9905/05/9905_05_22---Cell-Phone-PDA_web.jpg
14. Section 2.3: Three resources you can use
IHC medical providers can access three resources via http://intermountain.net . Select the CLINICAL tab, then select Clinical
References Home, then you can access three different resources as follows:
A. Micromedex
1. then AltMedDex
B. ClineGuide
1. then Drug Information
2. then Facts and Comparisons
3. then either Herbal Interaction Facts or Review of Natural Products
C. NIH Institutes
1. then National Center for Complementary and Alternative Medicine
2. then A-Z Index of Health Topics
3. then search by herbal name
Click on the link below to access a training video, showing you how to access and use the three IHC resources above:
http://www.screencast.com/users/klmoorma/folders/Jing/media/459f0e83-0e2f-4705-8f86-55b96baa5617
15. Section 2.4: Practice using three resources
Using the three IHC resources, sort the following common HDS into the appropriate LOW RISK or
HIGH RISK boxes:
[create sorting exercise, where user drags HDS name into either the LOW RISK box or the HIGH
RISK box]
ginseng LOW RISK HIGH RISK
fenugreek
St. John's wort
valerian
ginkgo
biloba
shark oil
vitamin E
echinacea
16. Section 3: Case study,
resource practice, and a
blog
LEARNING OBJECTIVES
• You will use the three IHC online resources to
investigate the risk exposure of the patient
described in a case study.
• You will have the opportunity to share HDS case
data with the IHC pharmacy team.
• You will demonstrate mastery of the material
presented in this QEM by taking a short quiz.
Creative commons image source:
http://blog.healia.com/files/images/Vitamins.png
17. Section 3.1: Case study
Watch this video case study describing a patient
HDS and prescription drug use. Use the three
resources presented to you in Section 2.3 to
determine the risk exposure for this patient.
[Insert a video case study which culminates in challenge
for learners to use the three IHC resources presented in
Based on the case data presented, your prior Section 2.2C to determine the risk exposure of the patient.]
knowledge, and your use of the three IHC resources,
describe your concerns for this patient here.
18. Section 3.2: Blog - patient experiences with HDS-drug and HDS-drug interactions
The IHC Pharmacy Team wants to know your experiences with patients whose HDS use has affected
their response to prescribed care. Please use the blog space below to share particular HDS-drug or
HDS-disease combinations which you have personally managed. Thank you for your inputs!
Blog entry
19. Conclusion and post-survey
[Please click on post-survey link.]
The purpose of this QEM was to increase your awareness of the
high likelihood of adverse HDS-drug and HDS-disease
interactions, renew your commitment to discuss and include HDS
use in the medical record, and point you to three excellent IHC
resources for investigating published HDS information. Remember
these three IHC resources can be accessed at http://
intermountain.net under the CLINICAL tab.
The IHC Pharmacy Team appreciates your feedback on this
training, particularly your interest level in learning more about
HDS-drug interactions. Thank you for investing your valuable time
in learning about HDS!
Creative commons image source:
http://blog.healia.com/files/images/Vitamins.png
