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

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.

• 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.

Learning Objectives

What is your Herbal Medicine IQ?

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

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

What are common types of herbal medicine practices?

What are examples of complimentary alternative medicine

practices?

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.

Issues surrounding Herbals

• Regulatory standards

• Adulteration • Poisonings • Mislabeling • Expiration Dating • Allopathic

Substitution

• Manufacturing standards

• Purity • Harvesting • Herbal/Allopathic

Drug Interactions

Which of these are herbal

products?

• Traditional Chinese • Ayurveda • Homeopathy

Types of Herbals

• Dietary Regulation • Plant-based therapies

• Acupuncture

• Massage therapy

Examples of TCM

•Echinacea •Garlic •Ginger • Black Cohosh •Ginseng •Ginkgo •St John’s wort • Huperzine A

Common TCM Herbs

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.

Common Ayurvedic Practices

• Gymnema sylvestre (Asclepias germinata)

• Momordica charantia (Bitter melon or Bitter gourd)

• Trigonella foenum graecum L. (Fenugreek)

Common Ayurvedic Products

Common Ayurvedic Products

• Tinospora cordifolia • Coleus forskohlii • Vinca rosea Linn • Caesaria esculanta • Ocimum sanctum • Ficus bengalensis

• Cyamopsis tetragonoloba

• Bougainvillea spectabilis

• Phyllanthis niruri • Coccinia indica • Eugenia jambolana

Homeopathic Products

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.

• 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

Homeopathic Principles

• 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

Potency of Homeopathic Remedies

Homeopathic Product Label

Critique this Label

Critique this Label

Homeopathic Preparation Process

• 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

Patient Counseling Tips on Homeopathic Products

How are Herbals Regulated?

• 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.

1994 Dietary Supplement Health & Education Act (DSHEA):Labels

• 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

Anatomy of Requirements for Dietary Supplement Labeling

• 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.

What was the benefit of DHSEA?

• 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.

Has DSHEA been revisited?

• 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 Isotretinoin iPLEDGE REMS Mycophenolate REMS Rosiglitazone REMS Transmucosal Immediate-Release Fentanyl (TIRF) Products REMS

– Should REMS be placed on Herbal and homeopathic products?

Risk Evaluation and Mitigation (REMS)

Labeling, Safety, and Issues of Use with Herbal Medicine

• 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

Attempts at Quality Control with Herbal Products

• Feverfew: member of the Asteraceae family

• Chamomile: member of the Asteraceae family

Other members: Ragwood, Yarrow

• Glucosamine/Chondroitin: Shellfish

Herbal Allergy Precautions

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

Top 25 Standardized Extracts

Example

Example

Herbal Products Not Recommended for Human Consumption

• Borage • Calamus • Chaparral • Coltsfoot • Comfrey • Ephedra

• Germander • Licorice • Life Root • Pokeroot • Sassafras

• “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.”

Label Claims for Herbals

Is this label in compliance?

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

• 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

Herbal News

• Should hospitals and other health care organizations have herbal formularies?

A. Yes B. No

Herbal Formularies

• 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

Herbal Formularies- Policies

Ansani 2003 AJHP

• 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

Limitations in Developing an Herbal Formulary

• Melatonin • Lactobacillus • Ginkgo • St. John’s wort • Echinacea

Herbal Products Most Commonly

Found on Herbal Formularies

MedWatch 5600 Fishers Lane

Rockville, Maryland 20852-9787

Fax# 1-800-FDA-0178

Who do you report problems with herbal products to?

• 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).

Concerns About Extinction of Plants

• Structure-function claims • Greek/Latin names • Species names

Misleading Nomenclature

• Pregnancy • Surgery • Bleeders • Sweeteners • Cytochrome influencing herbals • Herbs unfit for human consumption • Kavaism • Herbs affecting Lactation • Dosing • Medications that can chelate with vitamins

Precautions with use of Herbals:

• Popular use • Common side effects • Interactions with allopathic medications

What do I need to know specifically about the herbals?

What allopathic medications may interact with the following herbals? • 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

• Physician’s Desk Reference for Herbal Medicines

• Lawrence Review of Natural Products • Natural Medicines- Comprehensive

Database • Alternative Health Watch Database • The Complete German Commission E

Monographs

Herbal Resources

Herbal Websites

• http://nccam.nih.gov/

• http://www.naturaldatabase.com/

• www.medscape.com/SCP/DBT/1998/v10.n06/d5131.mull/d5131/mull-01.hml

The Proper Use of Vitamins

Challenges with Use of Vitamins in General

• Megadoses can be problematic.

• Drugs can deplete vitamins.

• Vitamins can interact with medications.

• See handout.

• Do not exceed the recommended daily allowances.

• Incorporate appropriate foods in the diet to supply vitamins.

• Vitamins may be depleted by allopathic medications.

• Vitamins may interact with allopathic medications.

Important Points About Vitamins

Types of Vitamins

• Water soluble – Manufactured by bacteria – Must be obtained on a daily basis – Examples: B Vitamins, Vitamin C

• Fat Soluble – Absorbed through intestinal tract

with the help of lipids – Can cause hypervitaminosis – Examples: Vitamins E,D,K

Multivitamin Label

Case Discussion

• CD is 79 y.o. male patient who is taking Coumadin 2 mg one tablet on Mondays, Wednesdays, and Fridays, and 3mg on the alternate days. This patient is also taking Prozac 10mg one capsule every morning for depression, Nexium 40mg one tablet every morning for reflux, Norvasc 10mg one tablet in the morning for hypertension, and Allegra as needed for allergies.

Case Continued

• Over the past 3 days, he has felt like he was

catching a cold, so he asks you if Claritin-D would be better for his allergies than Allegra, and if he can take Goody powders for headaches. He is also using Airborne, Theragran M, Mucinex, and Echinacea.

Critique This Label

• Calcium: RDA 1000-1200mg/day for adults

• Vitamin D RDA: 400-800 IU/day for adults with

doses up to 50,000 IU/ week

Important Vitamins to Supplement

• The term “herbal medications” may mean traditional Chinese herbs, homeopathic remedies, and/or Ayurvedic medicine.

• There are several different forms of herbal medications.

• Herbal products should be labeled appropriately.

Closing thoughts….

• Some herbal products should be used as standardized extracts.

• Some herbal products should be harvested at a particular time.

• Herbal medications should mentioned to allopathic practitioners.

Closing thoughts….

General Rules for Using Nonprescription Medications:

• Intended for use for < 5-7days.

• Not intended to replace prescription

medications.

• Should not be used to manage chronic disorders.

Closing Comments

Discussion

• What opportunities do you see for our profession with the practice of herbals (including vitamins)?

• If we could send recommendations to the Obama administration to rewrite DSHEA, what you recommend?

Complementary and Alternative Therapies

• Abbreviated CAM

• Complementary – used in conjunction with conventional medical care.

• Alternative – used in place of conventional western medicine.

Today…

• Conventional medical offices are integrating CAM therapies.

• Conventional • Complementary

Safety

• Some CAM therapies are safe and effective. • Some are not.

Holistic Medicine

• Expansion of traditional medicine to include mental, emotional and spiritual well-being.

• Consideration of the entire person when making therapeutic decisions.

• Psychosomatic illness = physical symptoms resulting from what is happening in the mind.

Popular Alternative Medicine Practices

• Ayurveda • Electro homoeopathy • Unani • Siddha • Naturopathy • Yoga therapy • Acupuncture • Acupressure • Magneto therapy • Shiatsu (finger pressure)

Japanese technique • Herbalism • Meditation • Aroma therapy • Bach flower remedies • Gem therapy

• Chromo therapy • Hydro therapy • Diet therapy • Reiki • Biofeedback • Chiropractic medicine • Hypnosis • Massage • Meditation and relaxation techniques • Moxibustion • Reflexology

Chinese Medicine (Acupuncture)

• Insertion of very thin needles into specific points along the meridians in the body to stimulate and balance the flow of energy. Used to relieve pain, especially headache and back pain, reduce stress-related illnesses, and treat drug-dependency and obesity.

Apitherapy

• Use of beehive products including honey, pollen, propolis, royal jelly, and bee venom.

• TCM practice use to treat arthritis, rheumatism, back pain, skin diseases and in this modern age as an alternative therapy to treat multiple sclerosis, Lyme disease and chronic fatigue syndrome.

Bee Sting Acupuncture

Natural Therapies

Aromatherapy • Therapeutic use of selected fragrances

(concentrated oils from roots, plants and flowers) to alter mood and restore the body, mind and spirit. Used to relieve tense muscles, tension headaches, and lower blood pressure.

Energy-Based Practices

• Practices that are founded on the belief that there are two types of energy fields involved in treating illness. – Veritable energies: use mechanical vibrations

(sound) and electromagnetic forces – Putative energies: based on the idea that

humans are infused with forms of energy; i.e., “Qi” (TCM), “Ki” (Japanese kampo system), “Prana” (Ayurveda)

Qi

• One of the body constituents is Qi (pronounced "chee"), which is the energy that gives us the ability to move, think, feel, and work. Qi circulates along a system of conduits, the principle ones being channels or meridians. There are twelve principle bilateral channels of Qi, each intimately connected with one of the viscera of the body, and each manifesting its own characteristic Qi (e.g. Liver Qi, Gallbladder Qi, etc.). When the flow of Qi becomes unbalanced through physical, emotional, or environmental insults, illness may result.

Types of Energy Therapies

• Acupuncture • Yoga • Polarity Therapy • Therapeutic Touch • Qigong • Reiki • Breema www.minddisorders.com

Acupuncture • In the U.S., visits to acupuncturists tripled, to 17.6

million, between 1997 and 2007, according to a federal report on alternative medicine.

• Effectively used for: – Fibromyalgia – Nausea and Vomiting – Osteoarthritis – Pain management (headaches, migraines, low back

pain) – Smoking Cessation – Cancer

Acupuncture

• Based on belief that Qi runs along life energy pathways which are accessible at approximately 400 different points on the body.

• Practitioners insert fine needles into the points in an attempt to rebalance the body’s energy flow and heal sickness and disease.

Risks of Acupuncture

• Rashes • Bruises/Bleeding • Fainting • Perforation of vital organs • Infection

– Hepatitis B & C – HIV – Acupuncture mycobacteriosis

• 5 percent to 10 percent suffer life-threatening symptoms like organ failure, flesh-eating disease or paralysis

What is Acupressure?

• Acupressure is a science that deals with the human body and the flow of natural energy within the body.

• Acupressure is similar to acupuncture and

uses the same points used called acupoints.

What are acupoints?

An acupressurist works with the same points used in acupuncture - called acupoints - stimulating these healing sites with finger pressure, rather than inserting fine needles. Pressure is applied on different 'pressure points' on the body, stimulating the corresponding glands of the body.

Benefits of Acupressure

• Some of the more common ailments are:

•nausea and vomiting during pregnancy/ morning sickness •motion sickness •nausea after surgery •nausea due to chemotherapy •cancer-related fatigue •headache

Manipulative Methods

Chiropractics • Manipulation of the spine to correct

misalignments that cause pressure on the nerves. Chiropractors may not prescribe drugs, but may recommend nutritional and herbal remedies.

Chiropractic Medicine

• Chiropractic medicine is a health care profession that focuses on disorders of the musculoskeletal system, and the nervous system, and the effects of these disorders on general health.

• Chiropractic care is used most often to treat neuromusculoskeletal complaints, including but not limited to back pain, neck pain, pain in the joints of the arms or legs, and headaches

History of Chiropractic Medicine • The actual profession of chiropractic - as a

distinct form of health care -- dates back to 1895.

• Hippocrates believed that a misaligned spine contributed to the health of an individual.

• Herodotus, a contemporary of Hippocrates, gained fame curing diseases by correcting spinal abnormalities through therapeutic exercises. If the patient was too weak to exercise, Herodotus would manipulate the patient's spine.

History of Chiropractic Medicine

• Daniel David (D.D.) Palmer discovered the specific spinal adjustment.

• He was also the one to develop the philosophy of chiropractic which forms the foundation for the profession.

• Discovered the practice from interaction with a deaf janitor

Side Effects of Chiropractic Medicine

• Chiropractic adjustment rarely causes discomfort. • However, patients may sometimes experience mild soreness or

aching following treatment (as with some forms of exercise) that usually resolves within 12 to 48 hours.

• Risks depend on the specific type of chiropractic treatment used.

For example, side effects from chiropractic adjustments can include temporary headaches, tiredness, or discomfort in parts of the body that were treated. The likelihood of serious complications, such as stroke, appears to be extremely low and related to the type of adjustment performed and the part of the body treated.

Manipulative Methods

Massage Therapy • Massage enables the muscles to relax,

promoting better blood circulation, faster healing of injuries, and pain relief. Supplements other forms of therapy. Formal training programs are available.

Massage Therapy

• Massage is the systematic manipulation of the soft body tissues for therapeutic purposes.

• The English word massage is derived from the Arabic word ‘mass’h’, which means to press gently. This itself gives a hint to the long history of massage.

• Massage in its most basic form has been around as long as man; however, today there are many highly specialized forms of massage all derived from these basic techniques.

How Does Massage Therapy Work?

• Might provide stimulation that may help block pain signals sent to the brain (the "gate control theory" of pain reduction).

• Might shift the patient's nervous system away from the sympathetic and toward the parasympathetic.

• Might stimulate the release of certain chemicals in the body, such as serotonin or endorphins.

• Might cause beneficial mechanical changes in the body--for

example, by preventing fibrosis (the formation of scar-like tissue) or increasing the flow of lymph (a fluid that travels through the body's lymphatic system and carries cells that help fight disease).

• Might improve sleep, which has a role in pain and healing.

Massage Therapy

• The first documented descriptions of massage dating back to about 3,000 BC were discovered in China.

• Chinese Taoist priests practiced ‘Qi Gong’ - meditative movement revealing and cultivating the vital life force.

Cultures that Practice Medicine

• Japanese • Greeks • Romans • Native Americans

When Is It Not Safe to get a Massage?

• Deep vein thrombosis • Damaged blood

vessels • Fever • Headaches • Weakened bones • Opened wounds

• Damaged nerves • Tumor • Infection • Acute inflammation • Inflammation from

radiation

Conditions Where Consumers Should be Hesitant About Getting a

Massage? • Pregnancy • Fragile Skin • Cancer • Heart Problems • Dermatomyositis • A history of physical abuse

Side Effects of Massage Therapy

• Bruising • Swelling • Temporary Pain • Allergy to massage oils

Manipulative Methods

Osteopathy • Physicians who receive training

similar to MDs and take same state licensing exam as MDs.

• Added focus on musculoskeletal system, good nutrition and favorable environmental conditions.

Manipulative Methods

Reflexology • Ancient healing art, body divided into 10

equal zones that run from head to toe. Illness or disease causes calcium or acid deposits in the corresponding part of the foot. Pressure applied to specific parts of the foot to direct energy toward affected body part.

Discussion

• What opportunities do you see for our profession with the practice of herbals, alternative and complimentary medicine practices?

Questions?

Angela M. Hill, Pharm.D., BCPP 813.974.2551 Ahill2@health.usf.edu