geneva briggs, pharm.d., bcps medoutcomes, inc. remedies... · ydigoxin ywarfarin ytheophylline...

© Copyright PharmCon 2008

Geneva Briggs, Pharm.D., BCPSMedOutcomes, Inc.

Herbal Remedies Exposed

PharmCon is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education

This program has been brought to you by PharmCon

http://www.mckesson.com/static_files/McKesson.com/Common_Images/ACPELogo.jpg


Objectives

Discuss the alternative medications that are most dangerous.

Identify the most common drug interactions with alternative medications.

List five sources for unbiased information on alternative medications and supplements.


“Poisons and medicines are oftentimes the same

substances given with different intents”

Peter Mere Latham (1789-1875)


Complementary and Alternative Medicine Practices

~40% of the US population uses dietary supplements often

~ 50% of people have used herbals

~ 4% rely exclusively on alternatives

In Germany over 700 herbs are available and prescribed by 70% of physicians

NEJM 1993;328:246-52.JAMA 1998;279:1548-53.


Complementary and Alternative Medicine Practices

<40% of patients inform someone they are taking alternative medications

Most commonly purchased – echinacea, feverfew, garlic, ginseng, ginkgo, goldenseal, kava, St. John’s wort, saw palmetto, and valerian

“Typical” user – female, 35‐64, white, college graduate, relatively affluent

J Am Diet Assoc 2003;103:1500-5JAMA 1998;280:1569-75

Pharmacotherapy 2000;20:877-91


Pharmaceuticals vs Phytomedicines

Must prove efficacy and safetyMandatory ADE monitoringProduct formulation standardsConsensus for useMarketing more restricted

Safety & efficacy data may be lackingADE monitoring not mandatoryNo product standards mandatedDosing uncertainNo treatment or cure claims on label

Pharmaceuticals Phytomedicines


Concerns with Phytomedicine

Variability of active constituentsMisidentification of the plantSelection of the wrong part of the plantInadequate storageContaminationAdulterationMislabeling of the final product


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

J Clin Pharmacol 1997; 37: 344-50.BMJ 1994; 308: 1162.

N Engl J Med 1998; 339: 847


Which herbals are most likely to cause significant adverse effects?


Top 10 Offenders

Kava [Piper methysticum] ComfreyChaparral [Larrea tridentata] Germander [Teucrium genus]Aristolochic acid Germanium dioxide or lactate citrate

Lobelia [Indian tobacco]Stephania L‐tryptophan Ephedra (ma‐huang)


Beyond the Top 10

Pennyroyal oilSassafrasBorageCalamusColtsfootLife root


Significant Interactions with Alternative Supplements


St John’s Wort [Hypericum perforatum]

DigoxinWarfarinTheophyllineNefazodoneOral contraceptivesAntiretroviralsCyclosporineImatinib (Gleevec)

Irinotecan [Camptosar]SimvastatinAmitriptylineSSRI (fluoxetine, sertraline, etc.)

Lancet 2000;355:1343-8Pharmacotherapy 2004;24:1508-14


Herbal and Supplement Products That Interact with Warfarin

Increased INRGinkgo BilobaDong Quai (Angelica sinesis)Danshen (Salvia miltiorrhiza)Vitamin E

Decreased INRSt. John’s WortCoenzyme Q10American ginseng

Altered PlateletsGarlic [Allium sativum]FeverfewGinsengTurmericMeadowsweetWillow bark

Contain Coumarins*Horse chestnutRed clover

Lancet 2000;355:13438J Clin Pharm Ther 2002;27:391-401


Significant Interactions with Alternative Meds and Supplements

Siberian Ginseng (Eleutherococcus senticocous) ‐ Digoxin

Valerian [Valeriana officinalis] – alcohol, benzodiazepines, anticonvulsants, TCA

Licorice ‐ ACE‐I, ARB, diuretics, digoxin

Lancet 2000;355:13438


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 medicationsHIV/AIDSCancerTransplantTreated with warfarin, digoxin, or other agents prone to drug interactionsUndergoing surgery

Am J Health-Syst Pharm 2004;61:1707-11


Avoid Recommending Herbals

Pregnant and lactating women

Children


Problem Products in Surgery

Ginkgo biloba Saw PalmettoAmerican Ginseng [Panex quinquefolias]KavaSt John’s wortFeverfew


Problem Products in Cancer Treatment

GarlicGinkgoEchinaceaPanax ginsengSt John’s wortKava

J Clin Oncol 2004;22:2489-503


Reasonably Effective Herbals

Aloe Vera (topical)Arnica (topical)Black CohoshChamomile teaEchinaceaEvening primrose oilFeverfew Garlic

GingerGinkgo BilobaHawthornPeppermint teaSaw PalmettoSiberian GinsengSt John’s wortValerian


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.govCenter for Food Safety and Applied Nutrition


Reliable Online Resources

www.uic.edu/pharmacy/research/diet/content/scont_about_evaluations.htm

University of Illinois

www.pharmacist.com/pdf/dietary_supplements.pdf

Healthcare Professional’s Guide to Evaluating Dietary Supplements

www.herbalwatch.com


To Buy Anything and Everything

www.herbalremedies.com

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.


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 atwww.FDA.gov/medwatch/report/hcp.htm

Report by telephone (1‐800‐FDA‐1088)

Download a copy of the form and either fax it to 1‐800‐FDA‐0178 or mail it back using the postage‐paid 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


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

geneva briggs, pharm.d., bcps medoutcomes, inc. remedies... · ydigoxin ywarfarin ytheophylline...

Documents