CE on SUNDAY Jacksonville, FL May 3, 2009

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1 CE on SUNDAY Jacksonville, FL May 3, 2009 Date: Sunday, May 3, 2009 Time: 12:15 PM 1:15 PM Location: Hyatt Regency Jacksonville Riverfront Hotel Title: Speaker(s): Herbal Facts and Fallacies ACPE # L01-P CEU ACPE # L01-T CEU Geneva Briggs, Pharm.D., BCPS, Virginia Commonwealth University Learning Objectives: Upon completion of this activity, participants will be able to: 1. Increase awareness of the use of herbs. 2. Describe the alternative medications that are most dangerous. 3. Identify the most common drug interactions with alternative medications. 4. Identify five sources of unbiased information on alternative medications and supplements. Disclosures: Geneva Briggs, Pharm.D., BCPS, Virginia Commonwealth University declares no conflicts of interest or financial interests in any product or service mentioned in this program, including grants, employment, gifts, stock holdings, or honoraria.

2 ItisthepolicyofPharmContoensurefairbalance,independence,objectivity,scientificrigor,and integrityinalitseducationalactivities.alfacultyparticipatingintheprogram areexpectedto disclosetotheparticipantsanyrelationshipswithcommercialcompanies,thosesupportingthe activity,oranyotherswhoseproductsorservicesmaybediscussed.thefolowinginformationis forparticipantsonly.itisnotassumedthattheserelationshipswilhavenegativeimpactonthe presentations. Dr.Briggshasnoactualorpotentialconflictofinterestinrelationtothisprogram. GenevaClarkBriggs,Pharm.D.,BCPS Dr.GenevaClarkBriggs,aboard-certifiedPharmacotherapySpecialist,receivedherDoctorofPharmacy andbachelorofscienceinpharmacydegreesfrom VirginiaCommonwealthUniversity,MedicalColege ofvirginia.dr.briggsisaclinicalassociatewithmedoutcomes,inc.dr.briggswasthechiefof PharmacotherapyatMcGuireVeteransAfarisMedicalCenterandwasanAssistantClinicalProfessorof PharmacyandPharmaceuticsatVirginiaCommonwealthUniversity,MedicalColegeofVirginia.Priorto becomingchiefofpharmacotherapy,shewasaclinicalpharmacyspecialistingeriatrics.dr.briggshas authorednumerousbookchaptersandarticles.

3 Herbal Facts and Fallacies This program has been brought to you by Geneva Briggs, Pharm.D., BCPS MedOutcomes, Inc. Poisons and medicines are oftentimes the same substances given with different intents PharmCon is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Peter Mere Latham ( ) Herbal Remedies in the US The herbal and pharmaceutical industries in the United States share a common heritage. Most pharmaceutical manufacturers of today were originally herbal extract producers. Many modern herbal manufacturers are becoming pharmaceutical manufacturers Why learn about Herbal Medicine? Your patients are using herbs. Many drugs came from plants. - So, why shouldn t there be potential for efficacy of herbs? Herbs have pharmacological properties including side effects, interactions. Suggestive evidence exists on efficacy Your Patients are Using Herbs! 14% percent of the population takes at least 1 herbal/supplement each week (JAMA Jan 16, 2002) 16% of prescription drug users also use 1+ herbal/supplement $17.8 BILLION on dietary supplements $4.2 Billion for Herbal products (NEJM Dec 19, 2002) YET - only 38% told their doctor

4 Concerns with Phytomedicine REGULATORY: Unmonitored, uncontrolled, non-uniform products No standards of bioequivalence between brands, or between lots Ingredients not required to be completely listed Producers do not need to prove safety or efficacy More Concerns with Phytomedicine Many touted for prevention - hard to evaluate. Placebo effect is strong. Quality of science varies. Much of the research is not in English. Adulteration has commonly been described Herbal Quality Proper identification and plant taxonomy Different lots, genetic variation Time of harvesting, proper part of plant Asian or Chinese patent medicines Of 251 purchased in CA, 24 contained lead, 36 arsenic, 35 mercury 24% of 2,609 samples of Chinese patent medicines contained pharmaceutical adulterants Environmental and soil conditions J Clin Pharmacol 1997; 37: BMJ 1994; 308: N Engl J Med 1998; 339: 847

5 Herbal Standardization Determining active constituents is a biochemical challenge Which herbals are most likely to cause significant adverse effects? Echinacea--caffeic acids, alkylamides, marker compounds, interspecies variation Ginseng--ginsenosides, 30 different types St. John s Wort--hypericin or hyperforin as active ingredient. To which do you standardize? Top 10 Offenders Beyond the Top 10 Kava [Piper methysticum] Comfrey Chaparral [Larrea tridentata] Germander [Teucrium genus] Aristolochic acid Germanium dioxide or lactate citrate Lobelia [Indian tobacco] Stephania L-tryptophan Ephedra (ma-huang) Pennyroyal oil Sassafras Borage Calamus Coltsfoot Life root Significant Interactions with Alternative Supplements St John s Wort [Hypericum perforatum] Digoxin Warfarin Theophylline Nefazodone Oral contraceptives Antiretrovirals Cyclosporine Imatinib (Gleevec) Irinotecan [Camptosar] Simvastatin Amitriptyline SSRI (fluoxetine, sertraline, etc.) Lancet 2000;355: Pharmacotherapy 2004;24:

6 Herbal and Supplement Products That Interact with Warfarin Significant Interactions with Alternative Meds and Supplements Increased INR Ginkgo Biloba Dong Quai (Angelica sinesis) Danshen (Salvia miltiorrhiza) Vitamin E Decreased INR St. John s Wort Coenzyme Q10 American ginseng Altered Platelets Garlic [Allium sativum] Feverfew Ginseng Turmeric Meadowsweet Willow bark Contain Coumarins* Horse chestnut Red clover Siberian Ginseng (Eleutherococcus senticocous) - Digoxin Valerian [Valeriana officinalis] alcohol, benzodiazepines, anticonvulsants, TCA Licorice - ACE-I, ARB, diuretics, digoxin Lancet 2000;355:13438 Lancet 2000;355:13438 J Clin Pharm Ther 2002;27: Copyright Copyright PharmCon PharmCon Significant Interactions with Alternative Meds and Supplements Kava and valerian alcohol, barbiturates, antispychotic drugs, sedatives, benzodiazepines Garlic saquinavir Red rice yeast [Chinese red rice]- statins, gemfibrozil, fenofibrate Patient Groups Most Likely to Have Problems Multiple medications HIV/AIDS Cancer Transplant Treated with warfarin, digoxin, or other agents prone to drug interactions Undergoing surgery Am J Health-Syst Pharm 2004;61: Avoid Recommending Herbals Problem Products in Surgery Pregnant and lactating women Children Ginkgo biloba Saw Palmetto American Ginseng [Panex quinquefolias] Kava St John s wort Feverfew

7 Problem Products in Cancer Treatment Reasonably Effective Herbals Garlic Ginkgo Echinacea Panax ginseng St John s wort Kava Aloe Vera (topical) Arnica (topical) Black Cohosh Chamomile tea Echinacea Evening primrose oil Feverfew Garlic Ginger Ginkgo Biloba Hawthorn Peppermint tea Saw Palmetto Siberian Ginseng St John s wort Valerian J Clin Oncol 2004;22: Reliable Printed Resources Herbal medicine: Expanded Commission E monographs Review of Natural Products Tyler s Herbs of Choice. The Therapeutic Use of Phytomedicinals Tyler s Honest Herbal: A Sensible Guide to the Use of Herbs and Related Products. Facts and Comparisons: The Review of Natural Products Reliable Online Resources consumerlab.com herbalgram.com American Botanical Council nccam.nih.gov NIH s National Center for Complementary and Alternative Medicine vm.cfsan.fda.gov Center for Food Safety and Applied Nutrition Reliable Online Resources _about_evaluations.htm University of Illinois Healthcare Professional s Guide to Evaluating Dietary Supplements To Buy Anything and Everything Blood Circulator Made of medicinal rhubarb, prepared rehmannia root, common peony root, peach seed, bitter apricot seed, licorice root, scute, dun fly, gadfly, leech, June beetle grub, dried lacquer and ground beetle.

8 Patient Counseling Ask every pt about herbs and supplements Address natural must mean safe If it sounds too good to be true, it probably is Avoid preparations with >1 herb Avoid switching brands frequently Buy packaged products with name/address of manufacturer, batch/lot number common and scientific name, standardization when possible dosing guidelines, side effects Patient Counseling Encourage disclosure of ALL medicinal substances Discuss available information about alternative medicines Discuss health risk and self-monitoring Set objective goals to follow progress Steer patients seeking to self-treat serious disorders such as depression to a physician How to Report an Adverse Effect Complete the Medwatch form online at Report by telephone (1-800-FDA-1088) Download a copy of the form and either fax it to FDA-0178 or mail it back using the postagepaid addressed form. Evaluating Products for Quality USP standardization (feverfew, ginger, chamomile, cranberry, ginkgo biloba, St John s wort, saw palmetto, milk thistle, valerian, siberian ginseng, and echinacea) Reputable manufacturer Consumerlab.com evaluations Points to Remember FDA neither establishes nor regularly enforces any standards of quality for herbs Herbs are technically unapproved drugs, in an OTC limbo Best advice: obtain a standardized extract marketed by a reputable firm Conclusion Current regulation of dietary supplements fails to address substantial risk to public health Educate patients to give Full Disclosure Know the problem herbs and most common interacting herbs Report adverse events