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FlashCards for Quizes PRELIMS > DDS QUIZ 2 Intro to frugs and pharmacy > Flashcards

DDS QUIZ 2 Intro to frugs and pharmacy Flashcards

1
Q

Food, Drug, Cosmetic Act?

A

1938

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2
Q

An agent intended for use in the diagnosis, mitigation, treatment, cure, or prevention of diseas in humans or in other animals?

A

Drugs

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3
Q

Means to slow down the effect

A

Mitigation

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4
Q

Diverse action and effects in the body

A

Drugs

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5
Q

Selective use in the treatment of a range of common and rare condition involving body organ, tissue, and cell

A

Drug

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6
Q

What are the important uses of drugs?

A

Reduce pain and fever
Combat infection
Organ transplant rejection
Diagnose diabetes
Replenish a body deficient in antibodies

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7
Q

Dilate the pupil of the eye?

A

Mydriatic

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8
Q

Constrict or diminish pupillary size?

A

Miotics

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9
Q

Induces vomiting

A

Emetics

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10
Q

Prevents vomiting

A

Antiemetics

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11
Q

Increase the flow of urine?

A

Diuretic

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12
Q

Increase respiratory tract fluid

A

Expectorant

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13
Q

Evacuate the bowel (to defecate)?

A

Cathartics or Laxative

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14
Q

To reduce inflammation

A

Anti-inflammatory

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15
Q

To reduce fever

A

Antipyretic

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16
Q

For pain management

A

Analgesic

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17
Q

Attacked a cancerous process?

A

Antineoplastic

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18
Q

What are the other use of drugs?

A

Elevate mood, blood pressure

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19
Q

Can be used to treat common infections, benign hyperplasia, cancer, Alzheimer’s disease and male impotence

A

Other uses of drugs

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20
Q

Can assist smoking cessation or alcohol withdrawal or can modify obsessive or compulsive disorders.

A

Drugs

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21
Q

Can prevent pregnancy, assist fertility, and sustain life itself.

A

Drugs

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22
Q

What are the source of Drugs

A

Derived from plant or animal resources
By products of microbial growth
Through chemical synthesis
Molecular modification
Biotechnology

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23
Q

Plant source such as Lagundi and Sambong?

A

Plant or animal resources

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24
Q

Is the original structure of the drug that is chemically synthesized?

A

Through chemical synthesis

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25
Q

Is a synthetic copied structure from an original structure to create sa semi-synthetic?

A

Molecular modification

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26
Q

A copied gene from living organism that is reproduced?

A

Biotechnology

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27
Q

What are the examples of biotechnology?

A

Insulin

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28
Q

before are derived from pig and cow’s pancreas but now code from living organism is copied?

A

Insulin

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29
Q

Is from moderate and severe pain that is derived from opium poppy?

A

Morphine

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30
Q

After a potential new drug substance is discovered and undergoes definitive?

A

Chemical and physical characterisation

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31
Q

How the drug interact living organism?

A

The basic pharmacology

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32
Q

How the drug works to produce its effect on the body?

A

Nature and mechanism of action on the biologic system

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33
Q

determining the toxicity or harmful effect?

A

Toxicologic features

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34
Q

most used in determining toxicity, it is the amount of substance that will cut off half the population. Animals used are rats, dogs, monkey, and rabbits

A

LD50 (Lethal Dose 50)

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35
Q

Where and how quickly a drug enters the bloodstream after being taken?

A

The Drug’s site and rate adsorption

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36
Q

Refers to the volume of distribution of blood plasma?

A

Pattern of distribution and concentration within the body

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37
Q

Length of time a drug’s effects last in the body?

A

Duration of action

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38
Q

How to eliminate the drug out of the body (liver or kidney)

A

Method and rate of its elimination or excretion

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39
Q

how the drug affects a developing fetus or can be transferred through breastfeeding

A

Effect of drug on the fetus of a pregnant animal or its ability to pass to a nursing baby through breastmilk

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40
Q

Guidelines for the dosage recommended for persons for varying?

A

ages
weights
state of illness

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41
Q

Must be suitable to facilitate administration of the drug by the selected route

A

Appropriate dosage forms

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42
Q

Is the only difference between a drug and a poison?

A

Dose

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43
Q

Is the component responsible for its therapeutic effects of the drug?

A

Active Drug

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44
Q

A supplement with no therapeutic effect, it is substance intended to provide the claimed nutritional or health benefit?

A

Active ingredient

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45
Q

An inert ingredient added that does not react with active ingredient

A

Nonactive ingredient (Inactive ingredient)

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46
Q

Does not contribute to the main therapeutic or nutritional effect but is used to help deliver, stabilize, or preserve the product?

A

Nonactive ingredient (Inactive ingredient)

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47
Q

Added in the addition to the active ingredient?

A

Nonactive ingredient (Inactive ingredient)

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48
Q

Using this formulation achieves its unique composition and characteristic physical appearance?

A

Nonactive ingredient (Inactive ingredient)

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49
Q

What are the Non-active ingredient?

A

Fillers
thickeners
solvents
suspending agents
Tablet coatings
disintegrates
penetration enhancers
stabilizing agents
Antimicrobial preservatives
flavors
colorant
sweeteners

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50
Q

Is the medium that carries the active ingredient to its intended site of action in the body?

A

Vehicle

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51
Q

Is a medium that the active ingredient is incorporated

A

Base

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52
Q

The formulation must be such that all components are?

A

Physically and chemically compatible

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53
Q

used to avoid or against decomposition due to chemical degradation

A

must be preserved

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54
Q

protected from microbial contamination and the destructive influences of?

A

Excessive heat
light
moisture

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55
Q

Therapeutic ingredients must be released from the dosage form in the ______ duration of the drug’s action are that which are desired

A

Proper quantity

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56
Q

Choosing the right formulation must possess attractive features of? and it enhances the acceptance of the patient

A

Flavor
odor
color
texture

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57
Q

Organized sets of monographs or books of these standards are called?

A

Pharmacopeias and formularies

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58
Q

Comes from the greek word pharmakon?

A

Drug

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59
Q

Meaning of poiein

A

Make

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60
Q

Other standards required to make or prepare a drug?

A

Recipe or formula

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61
Q

What term was pharmacopeia first used?

A

1580

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62
Q

it is published in 1778 at Lititz, Pennsylvania?

A

Lititz Pharmacopeia

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63
Q

Used by Military Hospital of the USA?

A

Lititz Pharmacopeia

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64
Q

It isa a 32 page booklet containing information of 84 internal and 16 external drugs and preparations?

A

Lititz Pharmacopeia

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65
Q

Who is the father of the USP?

A

Lyman Spalding

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66
Q

Submitted a plan to the Medical Society of the County of New York for the creation of national pharmacopeia?

A

Lyman Spalding

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67
Q

When was the creation of a national pharmacopeia?

A

January 6, 1817

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68
Q

What were the 4 districts?

A

Northern, middle, southern, and western

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69
Q

What are the districts that submitted into the national pharmacopeia?

A

Northern and middle

70
Q

First USP was published, in English and Latin

A

December 15, 1820

71
Q

It has 272 pages that has a list of 217 drugs?

A

The First USP

72
Q

cause many drugs and formulas that were accepted and used by the medical profession were not granted admission

A

Strict selectivity

73
Q

As a type of protest, certain pharmacists, prepared a formulary containing many of the popular drugs and formulas?

A

The National Formulary of Unofficial Preparations

74
Q

Became one in the year 1906 with President Theodore Roosevelt. What are those Pharmacopeias?

A

USP and NF

75
Q

What are Presidents Theodore Roosevelt’s signing law?

A

First federal Pure Food and Drug Act
Designating both USP and NF as establishing legal standards for medical and pharmaceutical substances

76
Q

USP-NF is used by?

A

Pharmacists, physicians, dentist, veterinarians, nurses
Producers, suppliers of bulk chemicals for drug production
Large and Small manufacturers of pharmaceutical products
Drug procurement officers of various private public health agencies and institutions
Drug regulatory and enforcement agencies

77
Q

When was pharmakon first used in connection with a local book of drug standards?

A

1580

78
Q

The first American Pharmacopeia was published?

A

Lititz Pharmacopeia

79
Q

When was the timeline of Lititz Pharmacopeia?

A

1778

80
Q

When was masachusetts Medical Society published?

A

1808

81
Q

When did Lyman Spalding submit a plan to the Medical Society of the Country of New York?

A

Jan 6,1817

82
Q

When was United States Pharmacopeial Convention assembled?

A

Jan 1, 1820

83
Q

Where was the the United States Pharmacopeial Convention assembled?

A

Washington DC

84
Q

When was the first USP published?

A

Dec 15, 1820

85
Q

Prominent pharmacist were invited to assist in the revision of every 10 years?

A

1830 & 1840

86
Q

When were the pharmacist awarded full membership?

A

1850

87
Q

When was the British pharmacopeia published?

A

1852

88
Q

when was the American Pharmaceutical Association (AphA) organized?

A

1852

89
Q

Recognized USP as book of standards?

A

American Pharmaceutical Association

90
Q

what year was USP so nearly in the hands of the pharmacists that vigorous efforts were required to revive interest in it among physicians?

A

1870

91
Q

When was the synthesis of salicylic acid from phenol inaugurated the synthesis of a group of analgesic compounds including aspirin?

A

1872

92
Q

When was the first edition of National Formulary of Unofficial Preparations published?

A

1888

93
Q

When was aspirin introduced into medicine?

A

1899

94
Q

NFOUP was changed to National Formulary it is also when Roosevelt signed into law the first federal PUREU FOOD AND DRUG ACT

A

June 30, 1906

95
Q

A specific agent against syphilis

A

Arsphenamine

96
Q

when was Arsphenamine first introduced to medical science?

A

1910

97
Q

When it was decided to revise the USP every 5 years instead of 10 years as many?

A

1940

98
Q

when did USPC, Inc purchased NF, unifying the official compendia

A

1975

99
Q

When was the spanish edition of the USP-NF introduced?

A

2006

100
Q

Believes that the body can heal?

A

Homeopathy

101
Q

Likes cure likes?

A

Homeopathy

102
Q

Published by the World Health Organization?

A

International Pharmacopeia

103
Q

First Volume was published in 1951

A

International Pharmacopeia

104
Q

A non governmental organization that develops and published standards for various industries and fields around the world?

A

International Pharmacopeia Organization for Standardization

105
Q

It provides guidelines & best practices for companies, organization to follow the aim of improving quality, safety & efficacy?

A

International Pharmacopeia Organization

106
Q

What series are those various ISO standards used in the pharmaceutical industry?

A

ISO 9000 - ISO 9004

107
Q

The federal food, drug and cosmetic act

A

1938

108
Q

Durham-Humphrey Amendment

A

1951

109
Q

Kefauver Harris amendments

A

1962

110
Q

Comprehensive Drug Abuse Prevention and Control Act

A

1970

111
Q

Drug Listing act

A

1972

112
Q

Orphan Drug Act

A

1983

113
Q

Drug price Competition and Patent Term Restoration Act

A

1984

114
Q

Prescription Drug Marketing Act

A

1987

115
Q

Prescription Drug Amendments

A

1992

116
Q

Dietary Supplement Health and Education Act of 1994 and the Dietary Supplement and Nonprescription Drug Consumer Protection

A

Act of 2006

117
Q

Prohibits the distribution and use of any new drug or drug products without the prior filing of a New Drug Application (NDA) and the approval of FDA

A

The federal food, Drug, and cosmetic act of 1938

118
Q

Content is that the drug underwent a drug trial?

A

NDA

119
Q

Grants or denies permission to manufacture and distribute a new product after reviewing the applicants filled data on the product?

A

FDA

120
Q

animal tissue, or cell culture and studies including pharmacology and toxicology, and clinical trials on human subjects?

A

Preclinical

121
Q

Study on animals 3-5 years

A

Preclinical studies

122
Q

Study on humans 5-7 or 7-10 years

A

Clinical Trials

123
Q

Drug took effect but doesn’t make the drug effective?

A

Efficacy

124
Q

Measures how well the drug works?

A

Effectiveness

125
Q

To ensure greater degree of safety for approved drugs and manufacturers were now required to prove a drug both safe and effective before it would be granted by the FDA approval for marketing?

A

Kefauver Harris Amendments of 1962

126
Q

The sponsor of Investigational New Drug application with the FDA

A

Kefauver Harris Amendments of 1962

127
Q

Established a legal distinction between prescription and OTC?

A

Durham Humphrey Amendments of 1962

128
Q

Limited to Rx only dispensing?

A

Durham Humphrey Amendments of 1962

129
Q

Prescription for legend drugs may not be refilled without the consent of the prescriber?

A

Durham Humphrey Amendments of 1962

130
Q

To consolidate and codify control authority over drugs of abuse into a single statute?

A

The federal Food, Drug and Cosmetic Act 1938

131
Q

Now referred to as the Controlled Substances Act (CSA)

A

The federal food, Drug and Cosmetic Act of 1938

132
Q

Causes tolerance- the more you take it overtime, you have to take even more

A

Controlled Drugs

133
Q

Schedule I NO ACCEPTED MEDICAL USE

A

Heroin, lysergic acid diethylamide, mescaline, peyote, methaqualone, marijuana

134
Q

With ACCEPTED MEDICAL uses and HIGH POTENTIAL for abuse

A

morphine
cocaine
methamphetamine
amobarbital

135
Q

Drugs with accepted Medical uses and a potential for abuse less than those listed in SCHEDULES I and II

A

Specified quantities of codeine , hydrocodone

136
Q

Drugs with ACCEPTED medical uses and LOW potential for abuse relative to those in SCHEDULE III

A

Specified quantities of difenoxin, diazepam, oxazepam

137
Q

Drugs with ACCEPTED medical uses and LOW potential for abuse relative to those in SCHEDULE IV

A

Specified quantities of dihydrocodeine, diphenoxylate

138
Q

It is the strongest and more potent that morphine?

A

Fentanyl

139
Q

It is made cheaply in laboratories, sometime they are mixed with other drugs that causes overdose?

A

Fentanyl

140
Q

In 1979, The United states FD introduced a classification of fetal risks due to pharmaceuticals

A

The federal food, drug and cosmetic act of 1938

141
Q

The strongest and states “if any data exist that a drug may be implicated as a teratogen and the risk versus-benefit ratio does not support the use of the drug then the drug is contradicted during pregnancy?

A

Pregnancy Category “X”

142
Q

Adequate and well controlled studies that FAILED to demonstrate a risk to the fetus? What category is this?

A

Category A

143
Q

What are Example in Category A?

A

Folic Acid, Levothyroxine, Vitamin B6

144
Q

Prevents skina vivida?

A

Folic Acid

145
Q

Animal reproduction studies have FAILED to demonstrate a risk to the fetus. No adequate and well controlled studies in pregnant women? what category is this?

A

Category B

146
Q

What are examples of Category B?

A

Acetaminophen, Amoxicillin, Cephalexin

147
Q

Animal reproduction studies have SHOWN AN ADVERSE EFFECT on the fetus and there are no adequate and well controlled studies in humans? what category is this?

A

Category C

148
Q

What are the examples of Category C?

A

Fluconazole
Ibuprofen
Phenylephrine

149
Q

There is positive evidence of human fetal risk but POTENTIAL BENEFITS may warrant use despite the risk? what category is this?

A

Category D

150
Q

Examples of Category D

A

Lithium
Tetracyclines
Carbamazepine
Valproic Acid
ACE inhibitors

151
Q

Studies in animals or humans have demonstrated fetal abnormalities and/ or there is positive evidence of fetal risk based on adverse reaction? what category is this?

A

Category E

152
Q

Examples of Category E

A

Thalodomide
Isotretinoin
Warfarin
Misoprostol
Methotrexate

153
Q

Used for pain relief such as opioid analgesic like morphine, codeine, oxymorphone, phentamine?

A

Narcotics

154
Q

Includes any drug related due to its potential for abuse such as sedative, hypnotics, anti seizures, barbiturate like clonazepam, diazepam

A

Controlled

155
Q

Drugs intended for the treatment of “rare diseases and conditions”?

A

Orphan Drugs

156
Q

“rare” diseases are defined as diseases affecting fewer than?

A

200,000 people

157
Q

Provides incentives to encourage pharmaceutical companies to develop drugs for rare diseases, including tax credits for clinical research, waved FDA fees, and a period of market for the drug, during which time no other company can sell a similar drug for the same indication

A

Orphan Drugs

158
Q

known as alglucosidase alfa

A

Myozyme

159
Q

Treatment of pompe disease

A

Myozyme

160
Q

Treatment of narcolepsy

A

Xyrem

161
Q

Known as sodium oxybate?

A

Xyrem

162
Q

Ownership, if you discover a drug? what is is called?

A

Patent

163
Q

Established new safeguards on the integrity of the nations supply of prescription drugs

A

Prescription drug market act 1987 and prescription drug amendments of 1992

164
Q

Intended to reduce the risk of mislabeled drugs entering the legitimate marketplace through “secondary sources”

A

Prescription drug market act 1987 and prescription drug amendments of 1992

165
Q

prohibits selling, trading, purchasing, or the offer to sell, trade or purchase explicity fo the use of the institution (e.g. charitable institutions)

A

Sales restrictions

166
Q

Act forbids the manufacturers or distributors of dietary supplements to
make any advertising or labeling claims that indicate that the use of the
product can prevent or cure a specific disease

A

Dietary Supplement health and Education Act of 1994 and the
Dietary Supplement and Nonprescription Drug Consumer
Protection Act of 2006

167
Q

If the FDA or a manufacturer finds that a marketed product presents a
threat or a potential threat to consumer safety, that product may be
recalled or sought for return to the manufacturer

A

Drug Product Recall

168
Q

There is a reasonable probability that the use of or
exposure to a violative product will cause serious
adverse health consequences or death. what class is this?

A

Class I

169
Q

The use of or exposure to a violative product may
cause temporary or medically reversible adverse
health consequences or the probability of serious
adverse health consequences is remote. What class is this?

A

Class II

170
Q

The use of or exposure to a violative product is not
likely to cause adverse health consequences. What class is this?

A

Class III

FlashCards for Quizes PRELIMS (14 decks)

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