Pharm Module 2

Front 1

What regulated drugs prior to the 20th century?

Back 1

State and local governments

Front 2

What is the Food and Drug Act of 1906?

Back 2

Prohibited marketing of food and drugs that were adulterated. Didn't have anything to do with safety.

Front 3

What did the Federal Food, Drug, Cosmetic Act of 1938 ensure?

Back 3

Safety

Front 4

What is the Durham-Humphrey Amendment of 1951?

Back 4

Required prescription for certain drugs. Prior to that all were OTC.

Front 5

What is the Food Additive Amendment of 1958 and Color Additive Amendment of 1960?

Back 5

No pesticides, no known carcinogens

Front 6

What did the Kefauver-Harris Amendment of 1962 regulate?

Back 6

Effectiveness, not just safety.

Front 7

What is the Dietary Supplement Health and Education Act (DSHEA) of 1994?

Back 7

Act by which the FDA can prove a drug (vitamins, herbs, supps) is unsafe if its safety is in question. But does not ensure safety before marketing.

Front 8

What has to be done to change a prescription drug to OTC?

Back 8

New drug application has to be filed. Classifications based on safety profile, degree of benefit vs risk and pt difficulty in use

Front 9

What are a few problems with the lack of regulation of herbs and supplements?

Back 9

Not required to show bioequivalence, large variances between brands and lots, "standardized" means a spec concentration of a specific component, not the process or other components

Front 10

What must and structure/function claims on herbs/supplements say?

Back 10

"This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease"

Front 11

What is an herb?

Back 11

Any part of a plant used for its medicinal, flavoring, or fragrant property.

Front 12

Do Rx drugs contain herbs?

Back 12

25% of "modern" rx drugs have botanical origins. Ex. Digoxin comes from foxglove and morphine comes from opium

Front 13

What is the difference between herbs used in Western medicine vs Chinese?

Back 13

Western herbalists use "simples" which is just one herb. Chinese use many blended together.

Front 14

What are teas, infusions, dococtions?

Back 14

Made by steeping and soaking herb in water for a few min

Front 15

What are tinctures?

Back 15

Herb is soaked in alcohol, glycerine or alcohol-water combination

Front 16

What are extracts?

Back 16

A filtered or distilled tincture

Front 17

What are tablets and capsules?

Back 17

Drying the herb, powdering it, shaping it into pills

Front 18

What are topicals?

Back 18

Herb added to emollient

Front 19

What is the rule of thumb in terms of botanical safety?

Back 19

Avoid using herbs in infants, children, pregnant women, nursing mothers, pts w/ daisy allergies and pts on mltpl meds

Front 20

What do people use ginseng for?

Back 20

Stress reliever, aphrodisiac, athletic enhancer, energizer, appetite stimulant, immunostimulant

Front 21

Of the things that people use Ginseng for, what are the possible things it is in fact effective for?

Back 21

Improved cognitive function, type 2 DM, and bronchitis

Front 22

Of the things that people use Ginseng for, what is it ineffective for?

Back 22

Enhancing athletic performance

Front 23

What populations should not use Ginseng?

Back 23

Unsafe in newborns. Also unsafe to use > 3 mos because it might alter estrogen levels

Front 24

What are precautions and interactions of Ginseng?

Back 24

May increase BP, overuse can cause HA, insomnia, palpitations, Decreases effect of loop diuretics, Increase bleeding risk if on blood thinners, May induce mania when used w/ antidepressants, May potentiate stimulants (i.e. caffeine)

Front 25

What is Ginkgo biloba used for?

Back 25

Vasodilator. Used to increase periph blood flow and improve intermittent claudication (limp), Used to treat dementia, vertigo and SSRI-induced sexual dysfunction.

Front 26

Of the things Ginkgo biloba is used for, what might it actually be effective for?

Back 26

Treating dementia, improving cognition in norm adults, improving pain free walking distances

Front 27

Of the things Ginkgo biloba is used for what is it ineffective for?

Back 27

Memory enhancement, ADHD, depression

Front 28

What is the major concern with Gingko biloba?

Back 28

It antagonizes platelet aggregation. Can result in bleeds. Don't take with blood thinners! Can also cause GI disturbance and CNS symptoms (ex dizziness)

Front 29

What is garlic used for?

Back 29

Improve lipid profiles, antibacterial properties, antithrombotic, hypotensive, anti-inflammatory, anti-cancer activity

Front 30

What is the active ingredient in garlic?

Back 30

Allicin

Front 31

What is the appropriate dosage of garlic?

Back 31

200-400mg tid. Probably safe in usual dose for up to 4 years.

Front 32

What is garlic actually possibly effective for?

Back 32

4-12% decrease in cholesterol levels and BP

Front 33

What are some precautions for taking garlic?

Back 33

May increase the effects of anticoags, inhibit plt aggregation, may inhibit thyroid preparations, may reduce blood glucose.

Front 34

In general, what 3 herbs/supps should be avoided for patients on blood thinners?

Back 34

Supps that start with G! Ginseng, Gingko biloba, Garlic

Front 35

What is Echinacea used for?

Back 35

Prophylaxis and treatment of cold and flu symptoms - stimulates phagocytes, immune system stimulation

Front 36

How long is Echinacea safe for?

Back 36

Likely safe when used short term. Up to 12 weeks.

Front 37

What is Echinacea actually possibly effective for?

Back 37

Decreasing symptoms of cold and flu

Front 38

What is Echinacea likely ineffective for?

Back 38

Preventing URIs if taken year round. If taken every day, immune system already stimulated...won't be any more stimulated when coming down with the flu.

Front 39

What is the appropriate dose of Echinacea?

Back 39

250-500 mg/day

Front 40

What is St. John's Wort (Hypericum) used for?

Back 40

Depression, anxiety, antiviral agent.

# 1 antidepressant in Germany

Front 41

How does St. John's Wort (Hypericum) work?

Back 41

Major action is the inhibition of serotonin, norepi and dopamine reuptake and down regulation of receptors

Front 42

What is the dosage for St John's Wort?

Back 42

daily 900 mg standardized to 0.3% hypericin.
Doses up to 1800 mg tolerated in sever depression

Front 43

What is St John's Wort possibly ineffective for?

Back 43

Antiviral agents - interfere w/ HIV agents and other immunosuppressants

Front 44

What are 4 contraindications for St Johns Wort?

Back 44

Sever depression, suicidal tendencies, severe agitation, hypersensitivity, pregnancy

Front 45

What is one major precaution for using St Johns Wort?

Back 45

Can cause severe photosensitivity

Front 46

What are possible drug interactions associated w/ st johns wort?

Back 46

MAO hibitors - hypersensitivity crisis, SSRIs - serotonin syndrome, transplant drugs

Front 47

What is Saw Palmetto used for?

Back 47

Male genitourinary problems (BPH), prostate cancer

Front 48

What is Saw Palmetto actually effective for?

Back 48

BPH symptoms, possibly effective for adjunctive therapy for prostate cancer.
Likely safe up to 1 year.
Can decrease the size of the prostate.

Front 49

What are precautions and interactions of Saw Palmetto?

Back 49

Due to anti-testosterone action, do not use in pregnancy or children, can cause stomach upset.

Front 50

What is the usual dosing for Saw Palmetto?

Back 50

Lipophilic extract 320 mg daily or whole berries 1-2 gm daily

Front 51

What are cranberries used for?

Back 51

Treatment and prophylaxis of UTI

Front 52

How does cranberry work?

Back 52

Acidifies urine, decreases bacterial adhesion to bladder wall
Likely effective as preventative agent

Front 53

What is the usual dosage of cranberry?

Back 53

360-960 ml daily

Front 54

What is an adverse effect of overuse of cranberry?

Back 54

Diarrhea

Front 55

What is Valerian used for?

Back 55

Valeriana officinalis root extract used to promote sleep

Front 56

How does Valerian work?

Back 56

Increases levels of GABA (neurotransmitter) in the CNS

Front 57

What is the usual dosage of Valerian?

Back 57

400-900 mg extract 2 hour prior to bed

Front 58

What are some adverse effects of Valerian?

Back 58

May potentiate CNS depressants (alcohol, alprazolam). Unsafe for long term use.

Front 59

What was Ma Huang or Ephedra used for?

Back 59

Bronchial asthma, weight loss, athletic performance enhancer.

Front 60

What are some safety issues with Ma Huang or Ephedra?

Back 60

Likely save < 5 days (<24 mg/day), but likely unsafe longer. Associated w/ MI, stroke, seizures and death.
FDA has withdrawn from the market.

Front 61

What was the appropriate dosage for Ma Huang or Ephedra?

Back 61

15-20 mg taken up to QID

Front 62

Why did Ephedra causes problems that made it so unsafe?

Back 62

Syngergistic effect w/ caffeine, decongestants, stimulants.
Pro arrhythmic effects w/ anesthesia and digoxin.
MAO inhibitors potentiate stimulation effects.
Can increase agitation assoc w/ SSRIs
Overdose can be fatal

Front 63

What are some of the Ephedra substitutes? (just as bad as Ephedra)

Back 63

Weight loss products (Hydroxycut, TrimSpa), Guarana - contains caffeine and theophylline like compound - highly arrhythmagenic, green tea extract - contains caffeine and diuretic, Citrus aurantium

Front 64

What is Kava Kava used for?

Back 64

Anxiety, stress and agitation, insomnia

Front 65

How does Kava Kava work?

Back 65

Has central muscle relaxing, anticonvulsive, hypnotic/sedative effects by interaction w/ ion channels and GABA sites

Front 66

What is a possible long term effect of Kava Kava?

Back 66

Liver failure, some reports of coma

Front 67

What are two Kava Kava interactions?

Back 67

Syngergistic w/ alcohol. Increases toxicity.
Potentiates CNS depressants

Front 68

What is Glucosamine used for?

Back 68

Osteoarthritis

Front 69

What is the usual dosage for Glucosamine?

Back 69

1500 mg/day

Front 70

What is glucosamine likely effective for?

Back 70

osteoarthritis symptoms after 4 weeks, comparable to NSAIDs, may prevent further deterioration.

Front 71

What is glucosamine commonly combined with?

Back 71

Chondritin products

Front 72

What is Coenzyme Q10?

Back 72

A naturally occurring, intrinsic, vitamin-like compound found in the nucleus and mitochondria of cells. It is a cofactor in many reactions as an antioxidant.

Front 73

What is Coenzyme Q10 used for?

Back 73

CHF, myopathy (statin induced), mitochondrial disease

Front 74

What is Coenzyme Q10 actually possibly effective for?

Back 74

Mitochondrial encephalomyopathies, possibly effective for CHF especially in combo w/ usual therapy

Front 75

What is the usual dosage for Coenzyme Q10?

Back 75

100-200 mg/day

Front 76

What does Omega 3 Fatty Acids come from?

Back 76

Fish oils (EPA) and (DHA)

Front 77

What is Omega 3 Fatty Acids used for?

Back 77

Hyperlipidemia, CAD, arthritis, weight loss

Front 78

What is the usual dosage of Omega 3 fatty acids?

Back 78

1-4 g/day

Front 79

What are possible drug interactions w/ omega 3 fatty acids?

Back 79

Blood thinners - increases bleeding risk

Front 80

What is the HERBAL mnemonic?

Back 80

H.ear the patient out w/ respect.
E.ducate the patient.
R.ecord and document.
B.eware.
A.gree to discuss.
L.earn about new and popular supplements.