Term 1 Pharm - Herbal Medicine Flashcards

1
Q

What type of medicine worldwide do most people have access to?

A

Traditional plant-based medicines are the only treatments available for much of the world

In 2003 WHO reports

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2
Q

Digoxin is made from what plant?

A

Foxglove

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3
Q

Artemisinin

Qinghaosu

A

Effective against all the malaria-causing protozoal organisms

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4
Q

NaturalProducts (“dietary supplements”)

A
  • Herbs (botanicals, phytochemicals)
  • Vitamins and minerals
  • Probiotics
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5
Q

Mind and BodyPractices

A
  • Acupuncture
  • Massage therapy
  • Meditation techniques
    mindfulness meditation, transcendental meditation
  • Movement therapies
    Feldenkrais method, Alexander technique, Pilates, Rolfing Structural Integration, and Trager psychophysical integration.
  • Relaxation techniques
    Breathing exercises, guided imagery, and progressive muscle relaxation
  • Spinal manipulation
  • Tai chi and qi gong; Yoga
  • Healing touch; Hypnotherapy
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6
Q

Herbal medicine makes how much peryear

A

$14.8 billion

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7
Q

Main group of dietary/supplemental use:

A

Rich, white, insured, who exercise & don’t smoke

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8
Q

Why is herbal medicine popular?

A
  • Viewed as “natural”, and therefore relatively safe with few side effects (compared to synthetic drugs)
  • Perceived as validated through traditional usage over generations
  • Considered a lower cost alternative to conventional medicine
  • Avoids the stress/fear/discomfort of visiting a physician or health care professional
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9
Q

Internet resources for herbal medicine

Resources to assess safety & efficacy

A
  • NCCIH – National Center for Complementary & Integrative Health (Within NIH; formerly NCCAM)
  • ODS – Office of Dietary Dietary Supplements (Within NIH)
  • MedlinePlus
  • PubMed
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10
Q

General concerns regarding

most herbal medicines?

A
  • Can directly cause adverse effects
  • Can indirectly interfere with conventional pharmacological treatments through herb-drug interactions
  • Absence of definitive proof of efficacy
  • Limited number/quality of controlled clinical trials

Concerns pertaining to commercial preparation:

  • Are often mixtures containing many compounds
  • May lack standardized active ingredients, or have inconsistent composition or formulation (batch to batch variation)
  • Some commercial products may contain adulterants, impurities or contaminants
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11
Q

Ephedra

A
  • Active components are ephedrine & pseudo ephedrine
  • In combination with caffeine, ephedra appears to facilitate weight loss
  • Adverse effects were observed: high blood pressure, tachycardia, CNS excitation, arrhythmia, myocardial infarction and stroke
  • In 2004, the FDA banned the sale of dietary supplements containing ephedrine in the US…Most evidence around the risks associated with ephedra use is based on higher doses or combination use with caffeine.
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12
Q

Adverse effects may be slow to
manifest themselves.

Aristolochia, or birthwort, has been used for centuries in traditional medicine in China (and ancient Greece before that) to treat arthritis and ease childbirth, among other conditions.

Aristolochic acid, a compound found in birthwort, is linked to what type if disease?

A

Urinary Tract Cancer

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13
Q

Herbal medicines share the same drug metabolizing enzymes and drug transporters with several clinically important drugs, what are some of these?

A
  • cytochrome P450 enzymes (CYPs)
  • UDP-glucuronosyl transferases (UGTs)
  • P-glycoprotein (P-gp)

(Herb-drug interactions can significantly alter pharmacokinetic properties of administered drugs, which occur when absorption, distribution, metabolism, and elimination (ADME) of drugs are altered
Primarily based on inhibition and/or induction of the metabolic enzymes CYPs and UGTs, and drug transporter P-gp)

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14
Q

Cyclosporine interferes with which drug?

A

St. John’s wort

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15
Q

What is the rating system for the safety of supplements?

A

LIKELY SAFE = The product has undergone a rigorous scientific evaluation equivalent to a review by the FDA, Health Canada, or other governmental authority and has been found to be safe when used appropriately. Or reputable references generally agree that the product is safe when used appropriately based on two or more randomized, controlled, clinical trials involving several hundred to several thousand patients and published in refereed journals; or based on large-scale post-marketing surveillance showing a low incidence of significant adverse effects.

POSSIBLY SAFE = Reputable references agree that the product might be safe when used appropriately, and there are human studies reporting no serious adverse effects.

POSSIBLY UNSAFE = There is some evidence suggesting that use of the product might be unsafe.

LIKELY UNSAFE = Reputable references agree that the product can be harmful, based on human studies or reliable case reports of significant adverse effects.

UNSAFE = The product has undergone a rigorous scientific evaluation or a review by a reliable regulatory agency and found to often cause clinically significant harm to humans. Or large-scale post-marketing surveillance shows a high incidence of significant adverse effects.

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16
Q

(Federal regulations & herbal medicines)

Regulates dietary supplements as foods, and not as drugs. Drugs are required to obtain FDA approval demonstrating safety and efficacy prior to entry into the market; dietary supplements (as foods), do not need FDA approval before they can enter the market.
DSHEA gives FDA the authority to regulate manufacturing of dietary supplements

A

Dietary Supplement Health & Education Act of 1994 (DSHEA)

17
Q

(Federal regulations & herbal medicines)

As of June 2010, dietary supplement production must adhere to GMP, and prepared with “controls that result in a consistent product free of contamination, with accurate labeling.”

A

2007 FDA Final Rule on Good Manufacturing Practices (GMP)

18
Q

(Federal regulations & herbal medicines)

Manufacturers are required to report to the FDA “all serious dietary supplement related adverse events.”

A

Dietary Supplement and Nonprescription Drug Consumer Protection Act (S. 3546)

19
Q

Non-FDA approved substances cannot legally claim therapeutic benefits pertaining to disease

A

(Fact)

20
Q

The levels of herbal medicine claims:

A

Biochemical
substance has activity against a specific protein (e.g., enzyme, receptor) associated with a particular physiological or disease state

Cellular or Tissue
substance demonstrates activity in whole cell preparations (e.g., modulating growth; metabolic activities, etc.) associated with a particular physiological or disease state

Animal (non-primate & non-human primates)
efficacy, safety shown in animal models (some animal models are more relevant than others, depending on the physiological or disease state)

Humans
therapeutic efficacy, safety shown in humans; ideally, large scale, randomized, double-blind clinical trials, with placebo control

21
Q

Most common herbal supplements:

A
Milk thistle
Glucosamine/chondroitin
Black cohosh
Ginkgo
Ginseng
Ginger
Echinacea
St. John’s wort
Saw palmetto
22
Q

Milk thistle

A

General/major therapeutic claim: LIVER DISORDER

(Claimed uses & effectiveness)

  • Possibly effective: allergenic rhinitis; diabetes; dyspepsia; menopausal symptoms; radiation dermatitis
  • Possibly ineffective: Hepatitis B, Hepatitis C

Adverse effects: generally well tolerated, but POSSIBLE ALLERGIC REACTIONS, GI DISTRESS, may lower blood sugar

Drug interactions: moderate rating for drugs metabolized by CYP2C9 (diazepam, warfarin, etc), CYPD6 (haloperidol, chlorpromazine, beta blockers, tamoxifen, codeine, ondansetron, etc), CYP3A4 (cyclosporine, erythromycin, lovastatin, etc)

23
Q

Glucosamine & chondroitin:

note: not botanical products, so not actually “herbal medicines”

A

General/major therapeutic claim: JOINT PAIN (KNEE PAIN)

(Claimed uses & effectiveness)
- Possibly effective: osteoarthritis [chondroitin]

Adverse effects: generally well tolerated

Drug interactions: MAJOR (avoid or use with caution) - glucosamine in a few cases shown to INCREASE ANTICOAGULANT EFFECT OF WARFARIN; moderate - glucosamine might induce resistance to etoposide and doxorubicin; chondroitin might increase anticoagulant effect of warfarin

24
Q

Black cohosh

A

General/major therapeutic claim: MENOPAUSE SYMPTOMS

(Claimed uses & effectiveness)
- Possibly effective: menopause symptoms

Safety: “POSSIBLY UNSAFE” DURING PREGNANCY & LACTATION

Adverse effects: generally well tolerated, but possible GI distress and rashes; potential effects on estrogen-sensitive conditions (e.g., breast cancer, uterine cancer, endometriosis) are unclear

Drug interactions: moderate - atorvastatin; cisplatin; hepatotoxic drugs; drugs metabolized by CYP2D6 (see milk thistle entry)

25
Q

Ginkgo

A

General/major therapeutic claim: COGNITIVE DISORDERS OR DEFICIENCIES

Claimed uses & effectiveness:

  • Possibly effective: cognitive function (modest improvements in memory, cognitive processing speed); dementia symptoms; glaucoma; diabetic retinopathy
  • Possibly ineffective: age-related memory impairment; antidepressant-induced sexual dysfunction; seasonal affective disorder (SAD); asthma; hypertension
  • LIKELY INEFFECTIVE: cardiovascular disease

(Safety)

  • “Likely Safe” when used orally and appropriately
  • “LIKELY UNSAFE“ when using FRESH GINGKO SEEDS ORALLY
  • “Possibly Unsafe“ in pregnancy

Adverse effects: generally well tolerated, but minor occurrences of headache, nausea, GI complaints; bleeding

Drug interactions: MAJOR (AVOID) - DECREASED EFAVIRENZ (SUSTIVA) CONCENTRATIONS and INCREASED VIRAL LOAD in a few patients taking ginkgo; moderate rating for drugs metabolized by CYP2C9, CYPD6, CYP3A4; fluoxetine (Prozac); ibuprofen

26
Q

Ginseng

A

General/major therapeutic claim: IMPROVE WELL-BEING; IMPROVE IMMUNE FUNCTION

(Claimed uses & effectiveness)

  • Possibly effective: cognitive function; erectile dysfunction; sexual arousal; hypertension; chronic obstructive pulmonary disease (COPD)
  • Possibly INEFFECTIVE: athletic performance

Safety:

  • “Possibly Safe” when used orally, appropriately, and short-term;
  • “Possibly Unsafe” when used long-term; in PREGNANCY
27
Q

Ginger

A

General/major therapeutic claim: NAUSEA, VOMITING, MOTION SICKNESS

Possibly effective: morning sickness; postoperative nausea & vomiting; vertigo; dysmenorrhea; osteoarthritis

Drug interactions: MAJOR (AVOID) - NIFEDIPINE combination SIGNIFICANTLY INHIBITS PLATELET AGGREGATION moderate - warfarin

28
Q

St. John’s Wort

A

General/major therapeutic claim: DEPRESSION, ANXIETY

Safety:
“Possibly Unsafe” in large doses, or pregnancy, lactation

KNOW THESE
Drug interactions: major (avoid) – alprazolam (Xanax); contraceptive drugs; drugs metabolized by CYP2C19 and CYP3A4; digoxin; fenflurimine; imatinib (Gleevec); irinotecan; mephenytoin; NNRTIs (non-nucleoside reverse transcriptase inhibitors); omeprazole (Prilosec); P-glycoprotein substrates (e.g., cyclosporine and numerous others); phenobarbital; phenprocoumon; phenytoin (Dilantin); protease inhibitors; tacrolimus; warfarin

29
Q

Saw palmetto

A

General/major therapeutic claim: BENIGN PROSTATE HYPERPLASIA (BPH)

Possibly effective: transurethral resection of the prostate (TURP)

Drug interactions: moderate for anticoagulants/antiplatelets; contraceptives; estrogens

30
Q

If a patient acknowledges taking supplements, what to do next…

A
  • Ask to see the bottle(s), check the ingredients
  • Consult authoritative information sources; determine if any risks are posed
  • Educate the patient about possible adverse effects
31
Q

The Cheese Reaction

A

Tyramine is a naturally occurring monoamine found in fermented foods such as cheese

Tyramine is metabolized by the enzyme monoamine oxidase (MAO)

Tyramine metabolism is blocked when taking a MAO inhibitor (MAOI), a class of antidepressants
potentiates sympathetic cardiovascular activity by releasing noradrenaline, leading to hypertensive response (in some cases, fatal)

Tyramine-containing foods include:
Avocados, bananas, broad bean (fava bean) pods, chocolate, aged cheese and any dish prepared with aged cheese; sausage (pepperoni and salami); sauerkraut; soy sauce; tap beer; red wine

32
Q

Grapefruit Juice Effect

A

MOST significant food/drug effect

Grapefruit juice can inhibit the intestinal cytochrome P-450 enzyme CYP3A4, which is responsible for the metabolism of many drugs

Inhibition of CYP3A4 leads to increased plasma lifetimes of drugs to dramatically different degrees