DDS QUIZ 2 Intro to frugs and pharmacy Flashcards
1
Q
Food, Drug, Cosmetic Act?
A
1938
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
3
Q
Means to slow down the effect
A
Mitigation
4
Q
Diverse action and effects in the body
A
Drugs
5
Q
Selective use in the treatment of a range of common and rare condition involving body organ, tissue, and cell
A
Drug
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
7
Q
Dilate the pupil of the eye?
A
Mydriatic
8
Q
Constrict or diminish pupillary size?
A
Miotics
9
Q
Induces vomiting
A
Emetics
10
Q
Prevents vomiting
A
Antiemetics
11
Q
Increase the flow of urine?
A
Diuretic
12
Q
Increase respiratory tract fluid
A
Expectorant
13
Q
Evacuate the bowel (to defecate)?
A
Cathartics or Laxative
14
Q
To reduce inflammation
A
Anti-inflammatory
15
Q
To reduce fever
A
Antipyretic
16
Q
For pain management
A
Analgesic
17
Q
Attacked a cancerous process?
A
Antineoplastic
18
Q
What are the other use of drugs?
A
Elevate mood, blood pressure
19
Q
Can be used to treat common infections, benign hyperplasia, cancer, Alzheimer’s disease and male impotence
A
Other uses of drugs
20
Q
Can assist smoking cessation or alcohol withdrawal or can modify obsessive or compulsive disorders.
A
Drugs
21
Q
Can prevent pregnancy, assist fertility, and sustain life itself.
A
Drugs
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
23
Q
Plant source such as Lagundi and Sambong?
A
Plant or animal resources
24
Q
Is the original structure of the drug that is chemically synthesized?
A
Through chemical synthesis
25
Is a synthetic copied structure from an original structure to create sa semi-synthetic?
Molecular modification
26
A copied gene from living organism that is reproduced?
Biotechnology
27
What are the examples of biotechnology?
Insulin
28
before are derived from pig and cow's pancreas but now code from living organism is copied?
Insulin
29
Is from moderate and severe pain that is derived from opium poppy?
Morphine
30
After a potential new drug substance is discovered and undergoes definitive?
Chemical and physical characterisation
31
How the drug interact living organism?
The basic pharmacology
32
How the drug works to produce its effect on the body?
Nature and mechanism of action on the biologic system
33
determining the toxicity or harmful effect?
Toxicologic features
34
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
LD50 (Lethal Dose 50)
35
Where and how quickly a drug enters the bloodstream after being taken?
The Drug's site and rate adsorption
36
Refers to the volume of distribution of blood plasma?
Pattern of distribution and concentration within the body
37
Length of time a drug's effects last in the body?
Duration of action
38
How to eliminate the drug out of the body (liver or kidney)
Method and rate of its elimination or excretion
39
how the drug affects a developing fetus or can be transferred through breastfeeding
Effect of drug on the fetus of a pregnant animal or its ability to pass to a nursing baby through breastmilk
40
Guidelines for the dosage recommended for persons for varying?
ages
weights
state of illness
41
Must be suitable to facilitate administration of the drug by the selected route
Appropriate dosage forms
42
Is the only difference between a drug and a poison?
Dose
43
Is the component responsible for its therapeutic effects of the drug?
Active Drug
44
A supplement with no therapeutic effect, it is substance intended to provide the claimed nutritional or health benefit?
Active ingredient
45
An inert ingredient added that does not react with active ingredient
Nonactive ingredient (Inactive ingredient)
46
Does not contribute to the main therapeutic or nutritional effect but is used to help deliver, stabilize, or preserve the product?
Nonactive ingredient (Inactive ingredient)
47
Added in the addition to the active ingredient?
Nonactive ingredient (Inactive ingredient)
48
Using this formulation achieves its unique composition and characteristic physical appearance?
Nonactive ingredient (Inactive ingredient)
49
What are the Non-active ingredient?
Fillers
thickeners
solvents
suspending agents
Tablet coatings
disintegrates
penetration enhancers
stabilizing agents
Antimicrobial preservatives
flavors
colorant
sweeteners
50
Is the medium that carries the active ingredient to its intended site of action in the body?
Vehicle
51
Is a medium that the active ingredient is incorporated
Base
52
The formulation must be such that all components are?
Physically and chemically compatible
53
used to avoid or against decomposition due to chemical degradation
must be preserved
54
protected from microbial contamination and the destructive influences of?
Excessive heat
light
moisture
55
Therapeutic ingredients must be released from the dosage form in the ______ duration of the drug's action are that which are desired
Proper quantity
56
Choosing the right formulation must possess attractive features of? and it enhances the acceptance of the patient
Flavor
odor
color
texture
57
Organized sets of monographs or books of these standards are called?
Pharmacopeias and formularies
58
Comes from the greek word pharmakon?
Drug
59
Meaning of poiein
Make
60
Other standards required to make or prepare a drug?
Recipe or formula
61
What term was pharmacopeia first used?
1580
62
it is published in 1778 at Lititz, Pennsylvania?
Lititz Pharmacopeia
63
Used by Military Hospital of the USA?
Lititz Pharmacopeia
64
It isa a 32 page booklet containing information of 84 internal and 16 external drugs and preparations?
Lititz Pharmacopeia
65
Who is the father of the USP?
Lyman Spalding
66
Submitted a plan to the Medical Society of the County of New York for the creation of national pharmacopeia?
Lyman Spalding
67
When was the creation of a national pharmacopeia?
January 6, 1817
68
What were the 4 districts?
Northern, middle, southern, and western
69
What are the districts that submitted into the national pharmacopeia?
Northern and middle
70
First USP was published, in English and Latin
December 15, 1820
71
It has 272 pages that has a list of 217 drugs?
The First USP
72
cause many drugs and formulas that were accepted and used by the medical profession were not granted admission
Strict selectivity
73
As a type of protest, certain pharmacists, prepared a formulary containing many of the popular drugs and formulas?
The National Formulary of Unofficial Preparations
74
Became one in the year 1906 with President Theodore Roosevelt. What are those Pharmacopeias?
USP and NF
75
What are Presidents Theodore Roosevelt's signing law?
First federal Pure Food and Drug Act
Designating both USP and NF as establishing legal standards for medical and pharmaceutical substances
76
USP-NF is used by?
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
When was pharmakon first used in connection with a local book of drug standards?
1580
78
The first American Pharmacopeia was published?
Lititz Pharmacopeia
79
When was the timeline of Lititz Pharmacopeia?
1778
80
When was masachusetts Medical Society published?
1808
81
When did Lyman Spalding submit a plan to the Medical Society of the Country of New York?
Jan 6,1817
82
When was United States Pharmacopeial Convention assembled?
Jan 1, 1820
83
Where was the the United States Pharmacopeial Convention assembled?
Washington DC
84
When was the first USP published?
Dec 15, 1820
85
Prominent pharmacist were invited to assist in the revision of every 10 years?
1830 & 1840
86
When were the pharmacist awarded full membership?
1850
87
When was the British pharmacopeia published?
1852
88
when was the American Pharmaceutical Association (AphA) organized?
1852
89
Recognized USP as book of standards?
American Pharmaceutical Association
90
what year was USP so nearly in the hands of the pharmacists that vigorous efforts were required to revive interest in it among physicians?
1870
91
When was the synthesis of salicylic acid from phenol inaugurated the synthesis of a group of analgesic compounds including aspirin?
1872
92
When was the first edition of National Formulary of Unofficial Preparations published?
1888
93
When was aspirin introduced into medicine?
1899
94
NFOUP was changed to National Formulary it is also when Roosevelt signed into law the first federal PUREU FOOD AND DRUG ACT
June 30, 1906
95
A specific agent against syphilis
Arsphenamine
96
when was Arsphenamine first introduced to medical science?
1910
97
When it was decided to revise the USP every 5 years instead of 10 years as many?
1940
98
when did USPC, Inc purchased NF, unifying the official compendia
1975
99
When was the spanish edition of the USP-NF introduced?
2006
100
Believes that the body can heal?
Homeopathy
101
Likes cure likes?
Homeopathy
102
Published by the World Health Organization?
International Pharmacopeia
103
First Volume was published in 1951
International Pharmacopeia
104
A non governmental organization that develops and published standards for various industries and fields around the world?
International Pharmacopeia Organization for Standardization
105
It provides guidelines & best practices for companies, organization to follow the aim of improving quality, safety & efficacy?
International Pharmacopeia Organization
106
What series are those various ISO standards used in the pharmaceutical industry?
ISO 9000 - ISO 9004
107
The federal food, drug and cosmetic act
1938
108
Durham-Humphrey Amendment
1951
109
Kefauver Harris amendments
1962
110
Comprehensive Drug Abuse Prevention and Control Act
1970
111
Drug Listing act
1972
112
Orphan Drug Act
1983
113
Drug price Competition and Patent Term Restoration Act
1984
114
Prescription Drug Marketing Act
1987
115
Prescription Drug Amendments
1992
116
Dietary Supplement Health and Education Act of 1994 and the Dietary Supplement and Nonprescription Drug Consumer Protection
Act of 2006
117
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
The federal food, Drug, and cosmetic act of 1938
118
Content is that the drug underwent a drug trial?
NDA
119
Grants or denies permission to manufacture and distribute a new product after reviewing the applicants filled data on the product?
FDA
120
animal tissue, or cell culture and studies including pharmacology and toxicology, and clinical trials on human subjects?
Preclinical
121
Study on animals 3-5 years
Preclinical studies
122
Study on humans 5-7 or 7-10 years
Clinical Trials
123
Drug took effect but doesn't make the drug effective?
Efficacy
124
Measures how well the drug works?
Effectiveness
125
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?
Kefauver Harris Amendments of 1962
126
The sponsor of Investigational New Drug application with the FDA
Kefauver Harris Amendments of 1962
127
Established a legal distinction between prescription and OTC?
Durham Humphrey Amendments of 1962
128
Limited to Rx only dispensing?
Durham Humphrey Amendments of 1962
129
Prescription for legend drugs may not be refilled without the consent of the prescriber?
Durham Humphrey Amendments of 1962
130
To consolidate and codify control authority over drugs of abuse into a single statute?
The federal Food, Drug and Cosmetic Act 1938
131
Now referred to as the Controlled Substances Act (CSA)
The federal food, Drug and Cosmetic Act of 1938
132
Causes tolerance- the more you take it overtime, you have to take even more
Controlled Drugs
133
Schedule I NO ACCEPTED MEDICAL USE
Heroin, lysergic acid diethylamide, mescaline, peyote, methaqualone, marijuana
134
With ACCEPTED MEDICAL uses and HIGH POTENTIAL for abuse
morphine
cocaine
methamphetamine
amobarbital
135
Drugs with accepted Medical uses and a potential for abuse less than those listed in SCHEDULES I and II
Specified quantities of codeine , hydrocodone
136
Drugs with ACCEPTED medical uses and LOW potential for abuse relative to those in SCHEDULE III
Specified quantities of difenoxin, diazepam, oxazepam
137
Drugs with ACCEPTED medical uses and LOW potential for abuse relative to those in SCHEDULE IV
Specified quantities of dihydrocodeine, diphenoxylate
138
It is the strongest and more potent that morphine?
Fentanyl
139
It is made cheaply in laboratories, sometime they are mixed with other drugs that causes overdose?
Fentanyl
140
In 1979, The United states FD introduced a classification of fetal risks due to pharmaceuticals
The federal food, drug and cosmetic act of 1938
141
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?
Pregnancy Category "X"
142
Adequate and well controlled studies that FAILED to demonstrate a risk to the fetus? What category is this?
Category A
143
What are Example in Category A?
Folic Acid, Levothyroxine, Vitamin B6
144
Prevents skina vivida?
Folic Acid
145
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?
Category B
146
What are examples of Category B?
Acetaminophen, Amoxicillin, Cephalexin
147
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?
Category C
148
What are the examples of Category C?
Fluconazole
Ibuprofen
Phenylephrine
149
There is positive evidence of human fetal risk but POTENTIAL BENEFITS may warrant use despite the risk? what category is this?
Category D
150
Examples of Category D
Lithium
Tetracyclines
Carbamazepine
Valproic Acid
ACE inhibitors
151
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?
Category E
152
Examples of Category E
Thalodomide
Isotretinoin
Warfarin
Misoprostol
Methotrexate
153
Used for pain relief such as opioid analgesic like morphine, codeine, oxymorphone, phentamine?
Narcotics
154
Includes any drug related due to its potential for abuse such as sedative, hypnotics, anti seizures, barbiturate like clonazepam, diazepam
Controlled
155
Drugs intended for the treatment of "rare diseases and conditions"?
Orphan Drugs
156
"rare" diseases are defined as diseases affecting fewer than?
200,000 people
157
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
Orphan Drugs
158
known as alglucosidase alfa
Myozyme
159
Treatment of pompe disease
Myozyme
160
Treatment of narcolepsy
Xyrem
161
Known as sodium oxybate?
Xyrem
162
Ownership, if you discover a drug? what is is called?
Patent
163
Established new safeguards on the integrity of the nations supply of prescription drugs
Prescription drug market act 1987 and prescription drug amendments of 1992
164
Intended to reduce the risk of mislabeled drugs entering the legitimate marketplace through "secondary sources"
Prescription drug market act 1987 and prescription drug amendments of 1992
165
prohibits selling, trading, purchasing, or the offer to sell, trade or purchase explicity fo the use of the institution (e.g. charitable institutions)
Sales restrictions
166
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
Dietary Supplement health and Education Act of 1994 and the
Dietary Supplement and Nonprescription Drug Consumer
Protection Act of 2006
167
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
Drug Product Recall
168
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?
Class I
169
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?
Class II
170
The use of or exposure to a violative product is not
likely to cause adverse health consequences. What class is this?
Class III
