Herbs/supplements

Question 1

Regulation that mandates safety of medications

Answer 1

Federal Food, Drug and Cosmetic Act

Question 2

Amendment to FDC act that established prescription vs non-prescription medications

Answer 2

Durham-Humphrey Amendment

Question 3

Amendment to FDC act that mandated efficacy as well as safety and resulted in the OTC drug review process

Answer 3

Kafauver-Harris Amendment

Question 4

Group that is responsible for OTC oversite

Answer 4

FDA and code of federal regulations

Question 5

5 labeling criteria for dietary supplements based on Dietary Supplement Health and Education Act (DSHEA)

Answer 5

1. body structure and function claims
2. cannot make therapeutic claims
3. must state not approved by FDA
4. must have manufacturers name and address
5. not required to have lot #, expiration date, or CIs

Question 6

Amendment to FDC act that requires manufacturers to report serious AEs for OTC drugs and dietary supplements within 15 business days of receipt and have address and phone # on labels

Answer 6

Dietary Supplement and Nonprescription Drug Consumer Act (Adverse Event Reports Bill)

Question 7

Active constituents of Fish oils

Answer 7

EPA and DHA

Question 8

1st FDA approved omega-3 FA containing EPA and DHA that is indicated as adjunct treatment to diet for hypertriglyceridemia

Answer 8

Lovaza

Question 9

FDA approved omega-3 FA that contains only EPA that is indicated as adjunct treatment to diet for hypertriglyceridemia

Answer 9

Vascepa

Question 10

1st omega-3 in free FA form (EPA + DHA) that is marketed as easier to absorb on low fat diet

Answer 10

Epanova

Question 11

Active component of milk thistle

Answer 11

silymarin

Question 12

7 qualities of symptoms to ask about in self-care

Answer 12

location, quality, severity, timing, setting, remitting/exacerbating factors, associated symptoms