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Flashcards in Quality Evaluation of Pharmaceuticals Deck (60)
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1

What act regulates dietary supplements?

Dietary Supplement Health and Education Act of 1994 (DSHEA)

2

dietary supplement?

a product (other than tobacco) intended to supplement the diet

3

What can a dietary supplement contain? (6)

-vitamin
-mineral
-herb
-amino acid
-may supplement the diet by increasing the total diet intake
-a concentrate, metabolite, constituent, extract, or combo

4

T/F There is NO FDA approval required to the selling of DS

TRUE

5

T/F The company does not have to provide info that the new product "will reasonably expected to be safe"

FALSE: DOES

6

Who determines the safety of their product?

the company seeking to market their product

7

When does the FDA get involved with DS?

When there is a problem with the DS

8

A manufacturer must repot adverse reactions from their product within 15 days....

Dietary Supplement and Nonprescription Drug Consumer Act (2006)

9

The label for a DS need to be _____ and ________

truthful and not misleading

10

T/F Manufacturers DO have to prove effectiveness.

FALSE : DO NOT, this is not a requirement for marketing

11

What are the 3 types of claims that are allowed by a DS?

-health
-nutrient
-structure/function

12

DS may not claim to ....... a specific disease or class of disease(5)

-diagnose
-mitigate
-treat
-cure
-prevent

13

CLAIM?
A link between a food substance/dietary supplement and dose or a health related condition

Health Claim

14

T/F Health Claims must be authorized by FDA before they may be used on label

TRUE

15

CLAIM?
Characterize the level of a nutrient or describe % level of dietary ingredient for which there is NO established Daily Value

Nutrient

16

CLAIM?
The role of a nutrient or dietary ingredient intended to affect normal structure or function in humans
-Could be statements about classical nutrient defiance disease

Structure/Function Claim

17

What claim do most DS fall under?

structure/function

18

TYPE of Claim?
♣ Soluble fiber, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease

Health

19

TYPE of Claim?
♣ Calcium builds strong bones

Structure/Function

20

TYPE of Claim?
♣ Promotes healthy cholesterol level

Structure/Function

21

TYPE of Claim?
♣ Healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord birth defect

Health

22

TYPE of Claim?
♣ Calcium may reduce the risk of osteoporosis

Health

23

TYPE of Claim?
♣ Helps prevent mild memory loss associated with aging

Structure/Function

24

TYPE of Claim?
Chamomille product label states possible benefits include alleviation of insomnia, diverticular disorder, gum disease, and gingivitis

NOT ALLOWED

25

TYPE of Claim?
Protect against heart disease

NOT ALLOWED

26

TYPE of Claim?
Ginseng product label states it possesses a “Powerful Anti-cancer Function” and can prevent diabetes

NOT ALLOWED

27

When were regulations issued for GMP dietary supplements?

June 2007

28

What are the selected problems with dietary supplements? (2)

-Adulteration
-Contamination

29

addition of impure/inferior substance not normally present

adulteration

30

presence of a foreign material that makes the product impure

contamination

31

Which selected problem is this?
-¬Removal of a critical substance

adulteration

32

Which selected problem is this?
¬collection of crude drug substrate
¬debris, pests, stones, sticks, and undesirable plant material
¬current regulations may not be adequate to ensure quality of imported ingredients

contamination

33

What are some companies who assess quality of DS? (5)

-Natural Products Association Tru Label Program
-Good Housekeeping Institute
-Consumer Lab
-USP
-NSF (National Sanitary Foundation International)

34

Natural Product Association TruLabel Program (3)

-member companies pay for random laboratory tests
-companies whose products fail are expelled
-an internal oversight program for companies

35

Good Housekeeping Institute

products that have "sufficient quality" are qualified to advertise in the magazine and to carry good housekeeping seal

36

Consumer Lab (5)

-for profit program
-verfies content of a DS
-check for contaminants
-determines the initial aspect of bioavailability
-no GMP auditing

37

Which assessment quality programs:
-include GMP audits of manufacturers facilities
-started after members of the DS industry approached the organizations

USP and NSF (national sanitary foundation international)

38

T/F USP is a voluntary program.

TRUE

39

T/F NSF is a part of the Dietary Supplement Verification Program. (DSVP)

FALSE: USP

40

NSF vs. USP
¬ verifies products for content and label accuracy, monitors for purity and contaminants, audits the manufacturing process, conducts continued surveillance to ensure compliance
¬ demonstrate manufacturer conformance to currently recommended industry GMPs for dietary supplements.

NSF

41

NSF vs. USP
o specifically indicates that the product has been manufactured in compliance with GMPs
o contains the stated ingredients, in amount and strength, and that the product is pure and meets limits for contaminants
o will break down and release into the body within a specified amount of time
o random tests on products in marketplace

USP

42

T/F Dietary supplements are unregulated.

FALSE: ARE REGULATED

43

T/F All dietary supplements like drugs, require FDA review and approval prior to being sold in the marketplace.

FALSE:DO NOT REQUIRE

44

T/F Efficacy data are needed before dietary supplements are sold.

FALSE

45

T/F There are DS products on the market that may intentionally and or unintentionally contain ingredients that can cause health problems.

TRUE

46

Whose role?
-set standards for quality, purity, identity, strength, labeling, packaging for drug products

USP

47

Whose role?
-to ensure the safety of the patients by enforcing laws (by the FDA) and USP standards

government

48

Whose role?
-make a product of good quality to make money (to be successful)

manufacturer

49

Whose role?
-listen to their patients (be aware of what our patients are telling us) and evaluate if the product they are receiving is a quality product

pharmacist

50

Whose role?
-responsibility to purchase their product from an authorized supplier

Patient

51

What is Promoting the Quality of Medicines?

program that collaborates with developing countries to provide quality medications to their patients living in the country

52

TQC?

Total Quality Control: every person who works for that company has to be trained on what quality is

53

Which drug recall is the most serious?

Class I: involve getting the drug back from the patient

54

T/F USP is a governmental organization

FALSE: private non-governmental organization

55

According to the National Health and Nutrition Examination Survey there is a ______in the use of DS

increase

56

About _____ the people in the US use dietary supplements

half

57

WOMEN OR MALE seem to take DS more often

WOMEN

58

Why do about half of the people taking DS take DS?

to maintain overall health and wellness

59

Why do most elderly patients take DS? (4)

-eye
-joint
-bone
-heart health

60

Where do most people receive information about DS?

-physician (highest)
-pharmacist (lowest)