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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
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)

Pharmaceutics Spring 2016 (20 decks)

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