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Dispensing LEC > (Prelim) DRUG STANDARDS AND DRUG REGULATIONS > Flashcards

(Prelim) DRUG STANDARDS AND DRUG REGULATIONS Flashcards

1
Q

Pharmakon means

A

drug

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2
Q

Pharmacopeia maens

A

to make drugs

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3
Q

Poien means

A

to make

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4
Q

drug standards book in Bergamo, Italy

A

1580

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5
Q

Many city, state and national pharmacopeias then established

A

The United States Pharmacopeia and the
National Formulary

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6
Q

London, Edinburgh, and Dublin pharmacopeias replaced by British Pharmacopoeia in 1864

A

Great Britain

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7
Q

32-page booklet: 84 internal & 16 external drugs & preparations

A

Lititz Pharmacopeia

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7
Q

1st American pharmacopeia

A

Lititz Pharmacopeia

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8
Q

32-page booklet:

A

84 internal & 16 external drugs &
preparations

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9
Q

Father of the United States of Pharmacopeia

A

Lyman Spalding

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10
Q

only “non-governmental” pharmacopeia in the
world

A

USP-NF

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10
Q

Canada generally uses the ________

A

USP-NF

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11
Q

Used by pharmacists & homeopathists as well as by law enforcement agencies that must ensure the quality of homeopathic drugs

A

HOMEOPATHIC PHARMACOPEIA

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12
Q

a drug that produces symptoms of the illness in healthy persons will also capable of treating those same symptoms and curing the disease

A

Homeopathic drugs

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13
Q

Published by WHO of the UN w/ cooperation of member countries in 1951

A

INTERNATIONAL PHARMACOPEIA

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14
Q

must adhere to the standards approved in their new drug applications

A

Pharmaceutical industry

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15
Q

A recommendation to national pharmacopeial revision committees to modify their pharmacopeias according to international standards

A

INTERNATIONAL PHARMACOPEIA

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16
Q

must also adhere to the USP-NF standards

A

Pharmaceutical industry

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17
Q
  • Purpose is to develop and promote uniform or harmonized international standards
  • ISO 9000 through ISO 9004
  • Quality standards
A

INTERNATIONAL ORGANIZATION FOR
STANDARDIZATION

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18
Q

FDA created to enforce the ________________

A

Federal Food, Drug and Cosmetic Act of 1938

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19
Q

“New drug”

A

Federal Food, Drug, and Cosmetic Act of
1938

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19
Q

Purpose of FDA was to enforce standards (_______, _______, ________) for the pharmaceutical industry

A

strength, purity, & quality

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20
Q

“Grandfathered drugs”

A

Federal Food, Drug, and Cosmetic Act of
1938

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20
Q

“Safety”

A

Federal Food, Drug, and Cosmetic Act of
1938

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21
Q

An Elixir with a solvent diethylene glycol which is a highly toxic agent used in antifreeze solution

A

Sulfanilamide

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21
Q

Prohibits the distribution & use of any new drug or drug product w/o the prior filling of a new-drug application and approval of the FDA

A

Federal Food, Drug, and Cosmetic Act of 1938

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21
Q

Diethylene glycol poisoning

A

Sulfanilamide

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22
Q

Prescription Drug Amendment

A

Durham-Humphrey Amendment of 1952

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23
Q

Durham-Humphrey; Separated drugs into two categories:

A
  • Legend(Prescription drugs)
  • Over the Counter (OTC)
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24
Q

Prescription drugs

A

Legend

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25
Q

OTC

A

Over the Counter

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25
Q

Rx Only

A

Durham-Humphrey Amendment of 1952

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25
Q

Prescription status of drugs

A

Durham-Humphrey Amendment of 1952

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26
Q

OTC drugs vs Rx drugs

A

Durham-Humphrey Amendment of 1952

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27
Q

Federal Law Prohibits Dispensing Without
Prescription

A

Caution of Durham-Humphrey Amendment of 1952

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28
Q

Refill authorization

A

Durham-Humphrey Amendment of 1952

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29
Q

Institute higher safety measures for drugs approved by FDA.

A

Kefauver-Harris Amendments of 1962

30
Q

Manufacturers become responsible for GMP (prove safety and effectiveness of drugs in clinical trials ) before FDA grants permission for marketing and distribution.

A

Kefauver-Harris Amendments of 1962

31
Q

Established definitive procedures for new drug
applications (NDA) and investigational drugs.

A

Kefauver-Harris Amendments of 1962

32
Q

OTC drug which is used as a sedative & tranquilizer

A

Thalidomide Before

33
Q

an arrested development of the limbs of
the affected newborn

A

ADR: Phocomelia

34
Q

Tx fever & painful skin lesions associated with erythema nodosum leprosum in px w/ leprosy

A

Thalidomide now

35
Q

IMPACT ON DRUG REGULATION

A
  • STRICTER REQUIREMENTS
  • REGULATORY REFORMS
  • GLOBAL IMPACT
  • CREATION OF REGULATORY AGENCIES
35
Q

Categorized drugs based on potential for abuse and regulated the record keeping and dispensing of controlled substances.

A

COMPREHENSIVE DRUG ABUSE PREVENTION
AND CONTROL ACT OF 1970

36
Q

High risk of abuse, no accepted medical use.

A

Schedule I

37
Q
A
37
Q
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38
Q
A
39
Q
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40
Q
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41
Q
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42
Q
A
43
Q
A
44
Q
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45
Q
A
45
Q
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45
Q
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46
Q
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47
Q
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48
Q
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49
Q
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50
Q
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51
Q
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52
Q
A
53
Q
A
54
Q
A
55
Q
  • High risk of abuse, accepted medical use with severe restrictions.
  • No refills
A

Schedule II

55
Q
  • Moderate risk of abuse, accepted medical use.
  • 5refills in 6 months
A

Schedule III

55
Q
  • Low risk of abuse, accepted medical use.
  • 5 refills in 6 months
A

Schedule IV

56
Q
  • Lowest risk of abuse, commonly available as over- the-counter medicines.
  • Many Refills
A

Schedule V

56
Q

Includes a risk summary, clinical considerations, and data. It also
mentions pregnancy exposure registries if available.

A

Pregnancy

56
Q

The traditional letter categories (A, B, C, D,
X) have been removed to provide more detailed information.

A

Removal of Pregnancy Categories

56
Q

Provides information on the use of the drug while breastfeeding, including the amount of drug in breast milk and potential effects on the breastfed infant.

A

Lactation

56
Q

ensure that healthcare providers have the
necessary information to assess the benefits and risks of medications for pregnant and
breastfeeding women

A

FDA PREGNANCY AND LACTATION
LABELLING

56
Q

Controlled human studies have demonstrated no fetal risk.

A

Category A

56
Q

No adequate human or animal studies, OR adverse fetal effects in animal studies, but no available human data.

A

Category C

56
Q

Includes information on pregnancy testing, contraception recommendations andinfertility as it relates to drugs.

A

Females and Males of Reproductive Potential

56
Q

Evidence of fetal risk. Risk outweigh any benefits.

A

Category X

57
Q

Animal studies indicate no fetal risk, but no human studies OR adverse effects in animals, but not in well controlled human studies.

A

Category B

57
Q

Evidence of fetal risk, but benefits outweigh risks.

A

Category D

57
Q

Teratogens

A

– Radiation
– Infections
– Maternal and metabolic imbalance
– Drugs and environmental chemicals

57
Q

DURING LACTATION

A
  • Breast Milk Transfer
  • Infant Metabolism
  • Safety Considerations
57
Q

RESOURCES

A
  • Mother to Baby
  • Fact SheetS
57
Q

Birth defect or mental retardation rate is _________

A

3-5% in general population

57
Q

DURING PREGNANCY

A
  • Placental Transfer
  • Teratogenicity
  • Pregnancy Categories
57
Q

There is adverse reaction so serious in proportion to the potential benefit of using the drug

A

BLACK BOX WARNINGS

57
Q

Risk of serious adverse reaction can be prevented in severity by careful use of the drug

A

BLACK BOX WARNINGS

58
Q

Risk of serious adverse reaction can be prevented in severity by careful use of the drug

A

BLACK BOX WARNINGS

59
Q

FDA has approved the drug with restrictions to
prescribing/distribution to ensure its safe use.

A

BLACK BOX WARNINGS

60
Q
A

Dispensing LEC (7 decks)

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