Herbals, Placebos, OTCs

Question 1

What is the real reason that Naproxen became OTC?

Answer 1

It has a half-life of 12 hours, so it could be used for dysmenorrhea

Question 2

What’s the issue with Cough/Cold Medicines?

Answer 2

Guaifenasin is an expectorant. Dextromethophan is a cough suppressant.
The two are usually formulated together…doesn’t make much sense

Question 3

Why is their now tighter control on pseudoephedrine?

Answer 3

Because it can be extracted from cold medicines to make methamphetamines

Question 4

Why does loperamide (antidiarrheal) cause less sedation

Answer 4

It does not cross the blood brain barrier

Question 5

What are the characteristics of OTCs?

Answer 5

1. Their benefits outweigh their risks
2. The potential for misuse and abuse is low
3. Consumer can use them for self-diagnosed conditions
4. They can be adequately labeled
5. Health professionals are not needed for safe and effective use of the product

Question 6

Grading of OTCs

Answer 6

I: GRASE (generally recognized as safe and effective)
II: Not GRASE, misbranded
III: Available data insufficient to establish GRASE status (needs more studies but it can stay on the market)

Question 7

Why do we need to care about OTCs?

Answer 7

• Misuse may cause complications
• Movement towards OTC status for many Rx drugs
• Ingredients may worsen condition or interact with prescription meds

Question 8

Compare and contrast Prescription and OTCs…

Answer 8

Rx:

• Dispensed by prescription; disease oriented
• Potential for serious adverse complications
• Ads and safety/efficacy are both monitored by FDA

OTCs:

• Sold directly to consumer; symptom oriented
• Low risk of adverse reactions
• Ads regulated by FTC but safety/efficacy regulated by FDA

Question 9

A dietary supplement is defined as what by Congress in 1994?

Answer 9

A product (other than tobacco) that:

• Is intended to supplement the diet
• Contains one or more dietary ingredients or their constituents
• Is intended to be taken by mouth as a pill, capsule, tablet, or liquid
• Is labeled on the front panel as being a dietary supplement

Question 10

True or False: The FDA can get involved with the regulation of herbals and supplements.

Answer 10

FALSE!

Question 11

What are the main concerns about herbals?

Answer 11

• Few clinical trials supporting health claims
• Complex mixtures
• Variability from lot to lot and manufacturer to manufacturer
• Contamination with pesticides

Question 12

What did the 1994 Dietary Supplement Health and Education Act do?

Answer 12

Expanded dietary supplement definition to include vitamins, minerals, herbs, amino acids

Question 13

What are some of the purported uses of garlic?

Answer 13

• Hypolipidemic

- Lowers BP, reduces platelet aggregation, antimicrobial

Question 14

What is Ginkgo supposed to do and what is its alternative?

Answer 14

• Improve memory (used for dementia)

- Donepezil

Question 15

What is St. John’s Wort’s purported use and what are they alternatives?

Answer 15

• Antidepressant

- SSRIs, MAOIs, tricyclics

Question 16

Drug interactions that occur with St. John’s Wort…

Answer 16

Sedation (with SSRIs)

Increased BP and HR (with MAOIs)

Question 17

St. John’s Wort can decrease the levels of which drugs?

Answer 17

• HIV protease inhibitors
• OCPs
• Anti-leukemia drug imatinib mesylate

Question 18

What are some of the adverse effects of the “general cure-all” herbal?

Answer 18

• CNS excitation
• Abnormal menstruation
• Hypoglycemia

-Can also interfere with digoxin assays

Question 19

Your patient comes to you seeking your advice about black cohosh. How do you advise her

Answer 19

She may want to try estrogen therapy

There have been some reported cases of liver toxicity. If she does decide to take it and notices abdominal pain or jaundice, she should stop

Question 20

What is the major use of glucosamine?

Answer 20

Improve the pain and swelling in osteoarthritis

Question 21

Evidence supports a significant decrease in triglycerides in which herbal?

Answer 21

Omega-3 Fatty Acid (Fish Oil)

Question 22

Although Omega-3 can decrease the triglycerides, what can it increase?

Answer 22

LDL “bad cholesterol”

Question 23

What are the adverse reactions associated with Kratom?

Answer 23

Addiction, N/V, Constipation, Confusion

Question 24

Which of the discussed herbals have been looked into by the FDA?

Answer 24

Omega-3 and Kratom

Question 25

Who responds best to placebos?

Answer 25

• Conditions with high levels of stress

- Milder diseases with milder overall symptoms

Question 26

Characteristics of a Placebo

Answer 26

• May be inert or active
• Can be procedures
• Active placebos may be chosen for a response that mimics some aspect of the active drug being compared

Question 27

What is an open placebo??

Answer 27

When the patient knows that they are receiving a placebo treatment

Question 28

Neurobiology of Placebo Effect

Answer 28

Pain causes activation of endogenous anti-nociceptive system, utilizing mu opioid receptors
*Placebo analgesia uses this system but not always the same parts

Question 29

Pharmacology of Placebo Effect

Answer 29

They have time-effect curves, peak, cumulative, and adverse effects similar to those of active metabolites

Question 30

Which conditions respond best to placebos?

Answer 30

• Patient’s conditions must be capable of variable intensity over time
• Asthma, headache, cough/cold/influenza, sexual dysfunction, angina, HTN, UC, gastric ulcers, RA, incontinence