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Pharmacy Tech Unit 2 Review > Ch 1 Review > Flashcards

Ch 1 Review Flashcards

(56 cards)

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1
Q

FDA

A

Food and Drug Administration

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2
Q

governing body over meds sold in US

A

FDA

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3
Q

branch of the U.S. Department of Health and Human Services

A

FDA

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4
Q

Responsible for approval of Rx and OTC meds, drug labeling, and standards for drug manufacturing

A

FDA

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5
Q

CDC

A

Centers for Disease Control and Prevention

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6
Q

provides regulations for infection control

A

CDC

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7
Q

publishes annual vaccination and immunization requirements for children, adolescents, and adults

A

CDC

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8
Q

DEA

A

Drug Enforcement Agency

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9
Q

enforce the laws and regulations surrounding controlled substances and illegal substances

A

DEA

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10
Q

sets requirements for dispensing controlled substances, refills allowed, and product classifications

A

DEA

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11
Q

first law to regulate meds

A

Food and Drug Act of 1906

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12
Q

prohibits misbranding (false labeling)

A

Food and Drug Act of 1906

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13
Q

prohibits adulteration (products contaminated with unknown or unsafe content)

A

Food and Drug Act of 1906

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14
Q

created amendments to Pure Food and Drug Act of 1906

A

Food, Drug, and Cosmetic Act of 1938

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15
Q

Expanded role of FDA

A

Food, Drug, and Cosmetic Act of 1938

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16
Q

created 2 classes of meds

  • prescription (legend)
  • non-prescription (OTC- over-the-counter)
A

Durham-Humphrey Amendment of 1951

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17
Q

authorizes the Consumer Product Safety Commission to create standards for packaging to protect children from taking harmful meds

A

The Poison Prevention Packaging Act of 1970

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18
Q

Created Child resistant containers

A

The Poison Prevention Packaging Act of 1970

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19
Q

Child resistant containers can’t be opened by what percentage of children under the age of 5 years old

A

80%

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20
Q

Child resistant containers can be opened by what percentage of adults

A

90%

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21
Q

Meds that don’t have to be placed in child resistant packaging

A
  • sublingual nitroglycerin
  • oral contraceptives and hormones in memory-aid packaging
  • inhalers
  • drugs dispensed in an inpatient/nursing home setting
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22
Q

If a patient doesn’t want a child resistant packaging for their meds, what must they do?

A

request that the pharmacy not put meds in child resistant packaging and fill out an authorization form for all meds

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23
Q

Requires each new drug to have a national drug code

Study These Flashcards
A

Drug Listing Act of 1972

24
Q

NDC

Study These Flashcards
A

National Drug Code

25
How many numbers are in a NDC
10 digits (sometimes 11)
26
What does the first segment of the NDC number identify?
manufacturer/distributor
27
What does the second segment of a NDC number identify?
name/strength/dosage form of the product
28
What does the third segment of the NDC number identify?
size/type of packaging
29
NDC numbers with 11 digits contain what?
placeholder/leading zero or asterisk
30
Allows manufacturers to submit abbreviated new drug applications for generic medications
Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act)
31
ANDA
Abbreviated New Drug Application
32
Must prove generic is safe and effective, and performs like the brand-name product
Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act)
33
Generic drug can reach the market faster
Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act)
34
OBRA
Omnibus Reconciliation Act of 1990
35
requires the pharmacist to discuss information about new and refill Rx with patient
Omnibus Reconciliation Act of 1990
36
DSHEA
Dietary Supplement Health and Education Act of 1994
37
requires dietary supplements to be treated more like drugs than food
Dietary Supplement Health and Education Act of 1994
38
What does dietary supplements include
vitamins, minerals, and herbals
39
dietary supplements labels can only say the intended effect on the body
Dietary Supplement Health and Education Act of 1994
40
cannot say the supplement can treat, prevent, or cure a specific disease or condition
Dietary Supplement Health and Education Act of 1994
41
solid, oral dosage forms must have a marking or imprint code on the face of product
Imprint Code Legislation
42
help identify individual meds, misfilled orders, and counterfeit drugs
Imprint Code Legislation
43
HIPAA
Health Insurance Portability and Accountability Act of 1996
44
protects the privacy of patient information
HIPAA
45
PHI
Private Health Informtion
46
uses and disclose the minimum necessary amount of protected info (give and request the minimum amount of info required
HIPAA
47
establish the rights of patient to approve who has access and use of their medication info
HIPAA
48
security rule sets standards for ensuring patient info is protected and safe and unauthorized individuals don't have access
HIPAA
49
MedGuides
Medication Guide Legislation
50
FDA approved patient education handouts that inform patients about significant risks of using a med
Medication Guide Legislation
51
MedGuide is required if one or more of the following exists:
- Patient labeling could help prevent serious adverse effects - The drug product has serious risks of which patients should be made aware because info concerning the risks could affect the patient's decision to use, or to continue to use, the product - The drug product is important to health and patient adherence to directions for use is crucial to the drug's effectiveness
52
MedGuide standards
- Contain specific, comprehensive, scientifically accurate info based off of package insert - Be written in non-technical English - Identify that is is a "Medication Guide" with the name and phonetic spelling of the drug - Contains certain headings and clear explanations
53
MedGuide must be dispensed:
- When a patient or patient's caregiver asks for a MedGuide, in both outpatient and inpatient settings - with outpatient Rx, including new and refill orders - When the first dose of a med is dispensed in on an outpatient setting that is to be administered by another health care provider - When the MedGuide is part of the Risk Evaluation and Mitigation Strategies (REMS) program
54
pertain to practice of pharmacy
State Laws and Regulations
55
BOP
Board of Pharmacy
56
functions to protect the health, safety, and welfare of patients
Board of Pharmacy

Pharmacy Tech Unit 2 Review (2 decks)

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