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Qem hds warfarin ver 1

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    • 1. HDS-Warfarin Interactions Quarterly Education Module Creative commons image source: http://upload.wikimedia.org/wikipedia/commons/7/78/Arabic_herbal_medicine_guidebook.jpg
    • 2. Pre-Survey Please click on the link above to start this QEM.
    • 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