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Pharmaceutics Spring 2016 > Quality Evaluation of Pharmaceuticals > Flashcards

Quality Evaluation of Pharmaceuticals Flashcards

1
Q

What act regulates dietary supplements?

A

Dietary Supplement Health and Education Act of 1994 (DSHEA)

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2
Q

dietary supplement?

A

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

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3
Q

What can a dietary supplement contain? (6)

A
  • vitamin
  • mineral
  • herb
  • amino acid
  • may supplement the diet by increasing the total diet intake
  • a concentrate, metabolite, constituent, extract, or combo
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4
Q

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

A

TRUE

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5
Q

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

A

FALSE: DOES

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6
Q

Who determines the safety of their product?

A

the company seeking to market their product

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7
Q

When does the FDA get involved with DS?

A

When there is a problem with the DS

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8
Q

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

A

Dietary Supplement and Nonprescription Drug Consumer Act (2006)

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9
Q

The label for a DS need to be _____ and ________

A

truthful and not misleading

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10
Q

T/F Manufacturers DO have to prove effectiveness.

A

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

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11
Q

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

A
  • health
  • nutrient
  • structure/function
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12
Q

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

A
  • diagnose
  • mitigate
  • treat
  • cure
  • prevent
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13
Q

CLAIM?

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

A

Health Claim

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14
Q

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

A

TRUE

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15
Q

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

A

Nutrient

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16
Q

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

A

Structure/Function Claim

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17
Q

What claim do most DS fall under?

A

structure/function

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18
Q

TYPE of Claim?

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

A

Health

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19
Q

TYPE of Claim?

♣ Calcium builds strong bones

A

Structure/Function

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20
Q

TYPE of Claim?

♣ Promotes healthy cholesterol level

A

Structure/Function

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21
Q

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

A

Health

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22
Q

TYPE of Claim?

♣ Calcium may reduce the risk of osteoporosis

A

Health

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23
Q

TYPE of Claim?

♣ Helps prevent mild memory loss associated with aging

A

Structure/Function

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24
Q

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

A

NOT ALLOWED

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25
Q

TYPE of Claim?

Protect against heart disease

A

NOT ALLOWED

26
Q

TYPE of Claim?

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

A

NOT ALLOWED

27
Q

When were regulations issued for GMP dietary supplements?

A

June 2007

28
Q

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

A
  • Adulteration

- Contamination

29
Q

addition of impure/inferior substance not normally present

A

adulteration

30
Q

presence of a foreign material that makes the product impure

A

contamination

31
Q

Which selected problem is this?

-¬Removal of a critical substance

A

adulteration

32
Q

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

A

contamination

33
Q

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

A
  • Natural Products Association Tru Label Program
  • Good Housekeeping Institute
  • Consumer Lab
  • USP
  • NSF (National Sanitary Foundation International)
34
Q

Natural Product Association TruLabel Program (3)

A
  • member companies pay for random laboratory tests
  • companies whose products fail are expelled
  • an internal oversight program for companies
35
Q

Good Housekeeping Institute

A

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

36
Q

Consumer Lab (5)

A
  • for profit program
  • verfies content of a DS
  • check for contaminants
  • determines the initial aspect of bioavailability
  • no GMP auditing
37
Q

Which assessment quality programs:

  • include GMP audits of manufacturers facilities
  • started after members of the DS industry approached the organizations
A

USP and NSF (national sanitary foundation international)

38
Q

T/F USP is a voluntary program.

A

TRUE

39
Q

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

A

FALSE: USP

40
Q

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.

A

NSF

41
Q

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

A

USP

42
Q

T/F Dietary supplements are unregulated.

A

FALSE: ARE REGULATED

43
Q

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

A

FALSE:DO NOT REQUIRE

44
Q

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

A

FALSE

45
Q

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

A

TRUE

46
Q

Whose role?

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

A

USP

47
Q

Whose role?

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

A

government

48
Q

Whose role?

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

A

manufacturer

49
Q

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

A

pharmacist

50
Q

Whose role?

-responsibility to purchase their product from an authorized supplier

A

Patient

51
Q

What is Promoting the Quality of Medicines?

A

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

52
Q

TQC?

A

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

53
Q

Which drug recall is the most serious?

A

Class I: involve getting the drug back from the patient

54
Q

T/F USP is a governmental organization

A

FALSE: private non-governmental organization

55
Q

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

A

increase

56
Q

About _____ the people in the US use dietary supplements

A

half

57
Q

WOMEN OR MALE seem to take DS more often

A

WOMEN

58
Q

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

A

to maintain overall health and wellness

59
Q

Why do most elderly patients take DS? (4)

A
  • eye
  • joint
  • bone
  • heart health
60
Q

Where do most people receive information about DS?

A
  • physician (highest)

- pharmacist (lowest)

Pharmaceutics Spring 2016 (20 decks)

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