Opportunities for Pharmacists with Complimentary and Alternative Medicine Practices

1. Opportunities for Pharmacists with Complimentary and Alternative Medicine Practices Angela M. Hill, Pharm.D., BCPP Professor and Chair University of South Florida College of Pharmacy

2. Disclosure Statement • I do not have a vested interest in or affiliation with any corporate organization offering financial support or grant money for this continuing education programs, or any affiliation with an organization whose philosophy could potentially bias my presentation.

3. Learning Objectives • Explain various complimentary and alternative medicine practices. • Describe the regulatory measures for complimentary and alternative medicine practices. • Demonstrate key counseling points that pharmacists can utilize in educating patients about complimentary and alternative practices. • Identify resources that pharmacists can use to enhance their knowledge about herbal and alternative medicine practices. • Discuss strategies for pharmacists to minimize adverse reactions from the combined use of allopathic and herbal medications.

4. What is your Herbal Medicine IQ?

5. What AM I Used For? Black Cohosh Cat’s Claw Devil’s Claw Echinacea Feverfew Fenugreek Feverfew Ginseng Gingko Glucosamine/Chondroitin Huperzine A Kava Kava Milk Thistle Shark’s Cartiledge Saw Palmetto St. John’s wort Melatonin Red Yeast Rice SAMe Valerian Root

6. What is the name of the legislation that regulates herbal medicines?

7. What are common types of herbal medicine practices?

8. What are examples of complimentary alternative medicine practices?

9. Herbal or Botanical Medicine • Used in almost all cultures since primitive times; belief that herbs and plant extracts contain compounds that alter blood chemistry, remove impurities, and strengthen the immune system.

10. Issues surrounding Herbals Regulatory standards Adulteration Poisonings Mislabeling Expiration Dating Allopathic Substitution Manufacturing standards Purity Harvesting Herbal/Allopathic Drug Interactions

11. Which of these are herbal products?

12. Types of Herbals • Traditional Chinese • Ayurveda • Homeopathy

13. Examples of TCM • Dietary Regulation • Plant-based therapies • Acupuncture • Massage therapy

14. Common TCM Herbs • Echinacea • Garlic • Ginger • Black Cohosh • Ginseng • Ginkgo • St John’s wort • Huperzine A

15. Alternative Medical Systems Ayurveda • 5000-year-old system practiced in India, treatments include herbs, massage, breathing exercises and yoga to integrate mind, body and spirit.

16. Common Ayurvedic Practices

17. Common Ayurvedic Products • Gymnemasylvestre (Asclepiasgerminata) • Momordicacharantia (Bitter melon or Bitter gourd) • Trigonellafoenumgraecum L. (Fenugreek)

18. Common Ayurvedic Products Tinosporacordifolia Coleus forskohlii Vincarosea Linn Caesariaesculanta Ocimum sanctum Ficusbengalensis Cyamopsistetragonoloba Bougainvillea spectabilis Phyllanthisniruri Cocciniaindica Eugenia jambolana

19. Homeopathic Products

20. Homeopathy • Using very small, diluted doses of drugs used to produce symptoms of the disease being treated, based on the belief that these substances stimulate the immune system to remove toxins and heal the body.

21. Homeopathic Principles • The Potentized Remedy • Medicinal products are made through serial dilution-succession processes • Potency depends on dilution; Potency with  dilutions X=20 C=100 M=1000 • Succession: process of forcefully striking a homeopathic remedy against a firm surface

22. Potency of Homeopathic Remedies • Low potency: remedies are potentized 3,6,9, or 12 times • Medium potency: remedies potentized 30 times • High potency: remedies potentized 200, 1,000, 10,000, or 100,000 tiems

23. Homeopathic Product Label

24. Critique this Label

25. Critique this Label

26. Homeopathic Preparation Process

27. Patient Counseling Tips on Homeopathic Products • Avoid co-administration with caffeine; the oil may interfere with the therapy • Avoid using an electric blanket; it may change the body’s electromagnetic field • Do not use aromatic aromas; the oil content may interfere with therapy • Avoid other herbals and allopathic therapies

28. How are Herbals Regulated?

29. 1994 Dietary Supplement Health & Education Act (DSHEA):Labels • No therapeutic or health claims may appear on the label. • Must have name & quantity of each ingredient. • Must identify the part(s) of the plant used. • Must have the term “dietary supplement” on the label.

30. Anatomy of Requirements for Dietary Supplement Labeling • Statement of Identity • Net quantity of ingredients • Structure-function claim • Directions for use • Supplemental Facts Panel • Other ingredients in descending order of predominance and by common name or proprietary blend • Name and place of manufacturer, packer, or distributor

31. What was the benefit of DHSEA? • DSHEA specifically reaffirmed the status of dietary supplements as a category of food and created a specific definition for dietary supplements. • DSHEA provided FDA with additional enforcement authority, including the ability to remove from the market products the agency deems unsafe through: 1) an “imminent hazard” clause which permits FDA to immediately remove a product it considers to present an immediate safety concern and 2) a “significant or unreasonable risk” clause that allows removal of a product considered to pose an unacceptable risk of illness or injury.

32. Has DSHEA been revisited? • Dietary Supplement and Nonprescription Drug Consumer Protection Act was signed into law by President Bush on December 22, 2006. • The law requires manufacturers to notify the FDA of all serious adverse events associated with an over-the-counter drug or a dietary supplement that they receive.

33. Risk Evaluation and Mitigation (REMS) • In 2007, a new law gave the FDA the authority to require manufacturers to have REMS on certain drug or biological products to ensure the benefits outweigh the risks • Products with REMS: • Buprenorphine Transmuscosal Products for Opioid Dependence (BTOD) REMS  Extended-Release and Long-Acting (ER/LA) Opioid Analgesics REMS  IsotretinoiniPLEDGE REMSMycophenolateREMSRosiglitazone REMS  TransmucosalImmediate-Release Fentanyl (TIRF) Products REMS • Should REMS be placed on Herbal and homeopathic products?

34. Labeling, Safety, and Issues of Use with Herbal Medicine

35. Attempts at Quality Control with Herbal Products • USP has a Dietary Supplementation Verification Program • NSF verifies contents • Consumer Labs puts a seal of approval on products with accurate labeling • NPA verifies labeling and product contents

36. Herbal Allergy Precautions • Feverfew: member of the Asteraceae family • Chamomile: member of the Asteraceae family Other members: Ragwood, Yarrow • Glucosamine/Chondroitin: Shellfish

37. Top 25 Standardized Extracts Bilberry Gugulipid Valerian Black Cohosh Hawthorn Willow bark Boswelia Horse Chestnut Cranberry Horsetail Echinacea Kava Kava Elderberry Licorice Feverfew Milk Thistle Garlic Olive Leaf Ginkgo Saw palmetto Ginseng St. John’s wort Green Tea Turmeric

38. Example

39. Example

40. Herbal Products Not Recommended for Human Consumption Borage Calamus Chaparral Coltsfoot Comfrey Ephedra Germander Licorice Life Root Pokeroot Sassafras

41. Label Claims for Herbals • “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

42. Is this label in compliance?

43. The FDA banned the promotion of products containing >10mg of ephedra.

44. Herbal News • Kava Kava has been removed from the market in Germany • St. John’s wort causes drug interactions and photosensitivity reactions • Ginseng, Ginkgo, and Feverfew can cause bleeding • Glucosamine/Chondroitin should not be used in individuals with allergies to shellfish • Glucosamine/Chondroitin can increase blood sugar and blood pressure

45. Herbal Formularies • Should hospitals and other health care organizations have herbal formularies? • Yes • No

46. Herbal Formularies- Policies • Herbal use not allowed • No written policies • Treat herbal medicines as home medications • Unwritten policy permitting use • Use permitted with specific requirements • 91% required physician write an order • 43% required pharmacy to identify the product (65% did not allow use if pharmacy could not id product) • Only one required IRB approved protocol and patient consent Ansani 2003 AJHP

47. Limitations in Developing an Herbal Formulary • Fear of legal liability • Lack of reputable manufacturers from which to purchase products • Absence of FDA approval, standardization and regulations • Lack of herbal databases • Difficulty identifying product content • Impracticality of reviewing hundreds of products and indications • Physician discomfort with condoning use

48. Herbal Products Most Commonly Found on Herbal Formularies • Melatonin • Lactobacillus • Ginkgo • St. John’s wort • Echinacea

49. Who do you report problems with herbal products to? MedWatch 5600 Fishers Lane Rockville, Maryland 20852-9787 Fax# 1-800-FDA-0178

50. Concerns About Extinction of Plants • On January 18, 2008, the Botanic Gardens Conservation International (representing botanic gardens in 120 countries) stated that "400 medicinal plants are at risk of extinction, from over-collection and deforestation, threatening the discovery of future cures for disease." These included Yew Trees (the bark is used for cancer drugs, paclitaxel); Hoodia(from Namibia, source of weight loss drugs); half of Magnolias (used as Chinese medicine for 5,000 years to fight cancer, dementia and heart disease); and Autumn crocus (for gout).