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Pharmacy Tech Unit 2 Review > Ch 1 Review > Flashcards

Ch 1 Review Flashcards

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

A

Drug Listing Act of 1972

24
Q

NDC

A

National Drug Code

25
Q

How many numbers are in a NDC

A

10 digits (sometimes 11)

26
Q

What does the first segment of the NDC number identify?

A

manufacturer/distributor

27
Q

What does the second segment of a NDC number identify?

A

name/strength/dosage form of the product

28
Q

What does the third segment of the NDC number identify?

A

size/type of packaging

29
Q

NDC numbers with 11 digits contain what?

A

placeholder/leading zero or asterisk

30
Q

Allows manufacturers to submit abbreviated new drug applications for generic medications

A

Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act)

31
Q

ANDA

A

Abbreviated New Drug Application

32
Q

Must prove generic is safe and effective, and performs like the brand-name product

A

Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act)

33
Q

Generic drug can reach the market faster

A

Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act)

34
Q

OBRA

A

Omnibus Reconciliation Act of 1990

35
Q

requires the pharmacist to discuss information about new and refill Rx with patient

A

Omnibus Reconciliation Act of 1990

36
Q

DSHEA

A

Dietary Supplement Health and Education Act of 1994

37
Q

requires dietary supplements to be treated more like drugs than food

A

Dietary Supplement Health and Education Act of 1994

38
Q

What does dietary supplements include

A

vitamins, minerals, and herbals

39
Q

dietary supplements labels can only say the intended effect on the body

A

Dietary Supplement Health and Education Act of 1994

40
Q

cannot say the supplement can treat, prevent, or cure a specific disease or condition

A

Dietary Supplement Health and Education Act of 1994

41
Q

solid, oral dosage forms must have a marking or imprint code on the face of product

A

Imprint Code Legislation

42
Q

help identify individual meds, misfilled orders, and counterfeit drugs

A

Imprint Code Legislation

43
Q

HIPAA

A

Health Insurance Portability and Accountability Act of 1996

44
Q

protects the privacy of patient information

A

HIPAA

45
Q

PHI

A

Private Health Informtion

46
Q

uses and disclose the minimum necessary amount of protected info (give and request the minimum amount of info required

A

HIPAA

47
Q

establish the rights of patient to approve who has access and use of their medication info

A

HIPAA

48
Q

security rule sets standards for ensuring patient info is protected and safe and unauthorized individuals don’t have access

A

HIPAA

49
Q

MedGuides

A

Medication Guide Legislation

50
Q

FDA approved patient education handouts that inform patients about significant risks of using a med

A

Medication Guide Legislation

51
Q

MedGuide is required if one or more of the following exists:

A
  • 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
Q

MedGuide standards

A
  • 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
Q

MedGuide must be dispensed:

A
  • 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
Q

pertain to practice of pharmacy

A

State Laws and Regulations

55
Q

BOP

A

Board of Pharmacy

56
Q

functions to protect the health, safety, and welfare of patients

A

Board of Pharmacy

Pharmacy Tech Unit 2 Review (2 decks)

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