Chapter 8 Over-the-Counter Drugs and Herabl and Dietary Supplements

Question 1

Criteria for Over-the-Counter Status

Indication for Use

Answer 1

Consumer must be able to easily:
*diagnose condition
*monitor effectiveness
Benefits of correct usage must outweigh risks

Question 2

Safety Profile

Drug should have:

Answer 2

• Favorable adverse event profile
• Limited interaction with other drugs
• Low potential for abuse
• High therapeutic index

Question 3

Practicality for Over-the-Counter Use

Drugs should be:

Answer 3

• Easy to use

* Easy to monitor

Question 4

Use of OTCs/Herbal Products

Answer 4

• May postpone effective treatment of more chronic disease states
• May delay treatment of serious and/or life threatening disorders
• May relieve symptoms of a disorder but not the cause

Question 5

Dietary Supplement and Health Education Act (DSHEA) of 1994

Answer 5

• Herbal products are considered “dietary supplements”
• No proof of efficacy or safety required
• No standards for quality control
• May claim effect but cannot promise a specific cure

Question 6

Dietary Supplement and Health Education Act

continued

Answer 6

• Supplement manufacturer does not have to provide the FDA with evidence on which it relies to substantiate the safety or effectiveness of a product before or after it markets the product
• Other countries (UK, Canada, France, Germany) require manufacturers to meet quality and safety standards

Question 7

Commonly Used Herbal Products

Answer 7

• Aloe
• Feverfew
• Ginkgo
• Goldenseal
• St. John’s wort
• Valerian
• Kava
• Echinacea
• Garlic
• Ginseng
• Hawthorn
• Saw palmetto
• Melatonin