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Chete Finals > Pharmaceutical > Flashcards

Pharmaceutical Flashcards

1
Q

T or F: The terms pharmaceutical and drug are different .

A

F

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2
Q

products or articles intended for use in dealing with disease or injury, including the treatment, cure, and mitigation of disease and disease prevention in humans and animals.

A

Pharmaceuticals (drugs)

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3
Q

They are called ethical drugs

A

Prescription drug

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4
Q

also called proprietary drugs

A

Over-the-counter drugs

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5
Q

A group consisting of industry and academic personnel, medical practitioners, and government officials who:
o Provide test standards
o Establish classification systems
o Conduct drug research and testing
o Assist medical practitioners in using drugs effectively
o Publish the U.S. Pharmacopeia and the National Formulary

A

U.S. Pharmacopeial Convention

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6
Q

Experts from industry, government, and academia are elected every five years to work on the publication of these two voluntary standards.

A

U.S. Pharmacopeia (USP) and the National Formulary (NF)

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7
Q

a specification (standard) published in the USP for a particular drug product. For example, a drug product labeled “aspirin” must comply with the ___ for aspirin that is printed in the USP.

A

Monograph

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8
Q

It must be intended for use in treatment, mitigation, diagnosis, cure, or prevention of disease in humans or other animals, and It affects the structure or any function of the body of humans or animals and is not food.

A

Drug

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9
Q

are frequently classified as drugs because of claims made on their labels regarding the “intended use” for the product.

A

Substances

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10
Q

If a claim about curing, treating, or preventing a disease is made on the label of a product, including any food product, it can be viewed from a legal perspective as a ___

A

Drug

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11
Q

The recent increase in health claims on food packages (a drug derived from food sources) led to a new product grouping called ____

A

Neutraceuticals

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12
Q

T or F: If a product is intended to be used for a medical purpose, it is by definition a pharmaceutical product or medical device and is subject to regulation by the government.

A

T

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13
Q

T or F: If a product is intended for a medical use, it is not a pharmaceutical or medical device. Even a scalpel, if manufactured and marketed as a wood carving tool, is not intended to be a medical device and is not subject to regulation.

A

F, (every product that is intended for a medical use is drug/medical device)

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14
Q

is a product that can be obtained legally only through a doctor’s (physician’s) written prescription. A doctor’s supervision is deemed necessary for the safety of the patient while he or she is taking the drug.

A

Prescription drugs

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15
Q

also known as ethical drugs.

A

Prescriptions drugs

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16
Q

can be purchased for self-medication without the approval of a doctor

A

Over-the-counter (OTC) drugs

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17
Q

also referred to as proprietary drugs.

A

Otc drugs

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18
Q

The term comes from two Greek words, para (outside) and enteral (intestine), and refers to methods of administering the drug that do not involve the intestines. In other words, the product is not swallowed.

A

Parenteral drugs

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19
Q

usually refers to injections or infusions.

A

parenteral

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20
Q

Instruments, apparatuses, implements, machines, contrivances, implants, in vitro reagents, and similar articles, including parts, components, and accessories, are referred to as

A

Medical devices

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21
Q

In addition, medical devices :

A

It must not depend on being metabolized for the achievement of any of its
principal purposes. In other words, it is not a drug.

The device must be recognized by the USP or National Formulary.

It must be intended for use in the mitigation, cure, treatment, diagnosis, or
prevention of disease in humans or humans.

It must be intended to affect the structure or any function of the body, but not
achieve any of its principal purposes through chemical action within or on the
body.

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22
Q

refers to the way that the packaged product is delivered for use.

A

Presentation

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23
Q

is of heavy concern for medical devices. The package for a medical
device must maintain sterility and still allow the device to be removed quickly and. efficiently for use in an operating room setting.

A

Presentation

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24
Q

include products intended to mitigate (reduce) pain, to cure specific illnesses, or to produce some other specific benefit.

Examples include drugs to reduce the pain of arthritis, regulate heart functions, control blood pressure, reduce serum cholesterol, heal ulcers, control migraine headaches, stop the itching of poison ivy, or reduce the pain of a sprained ankle.

A

Prescription drugs

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25
Q

drugs included only common products, such as headache remedies, cough syrups, various lotions and ointments, and products for cleaning, treating, and bandaging minor cuts and bruises.

Today, the range of products available _____ is much broader, including drugs to grow hair, antidepressants, acid reflux treatments, products to reduce respiratory problems, and tranquilizers.

A

Otc

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26
Q

OTC products are frequently packaged as

A

Unit doses

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27
Q

OTC packaging is frequently designed with special convenience features, such as

A

Automatic dispensing

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28
Q

T or F: Both the drug and the drug package must be approved by the FDA prior to the prouct’s market introduction.

A

T

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29
Q

T or F: a doctor’s supervision is not necessary for safe and effective use of prescription products.

A

F

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30
Q

T or F: Prescription drugs may be shipped to the pharmacy in small units for repackaging before distribution or in original pack dispensing (OPD) packages.

Items in OPD packages are repackaged by the pharmacist. They are delivered to the patient in the same package used by the manufacturer. OPD packages are similar to those used for OTC medications.

A

F. Prescriptive drugs are shipped in large units (to save money and lessen the amount of expenses) items in opd (original pack dispensing) are not repackaged by the pharmiscist

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31
Q

T or F: Drugs can usually be supplied in different forms

A

T

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32
Q

Liquid form of tablets

A

Solutions

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33
Q

Liquid form of capsules

A

Suspensions

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34
Q

Liquid form of Caplets

A

Emulsions

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35
Q

Liquid form of Gel Caps

A

Elixirs

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36
Q

Liquid form of powder

A

Tinctures (oil)

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37
Q

Liquid form of suppositories

A

Spirit

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38
Q

Methods of administering drugs through the gastrointestinal tract:

A

Orally, Nasogastric (NG) tube (nose), rectally administered medication (suppository).

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39
Q

Methods of administering topical (gina apply) drugs:

A

Lotions and creams, transdermal patches (salonpas)

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40
Q

Methods of administering drugs through the respiratory system:

A

Nebulizer, inhalers

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41
Q

Methods of administering drugs injected into the body:

A

Intravenous(intothevein)
o Intramuscular(intothemuscle)
o Intraspinal(intothespinalcord)
o Intracardial(intotheheart)
o Subcutaneous (under the skin)

42
Q

T or F: The importance of each characteristic of the packaging is dependent on the type of drug. The manufacturer of a prescription drug may not place the same importance on the communication aspect as the manufacturer of an OTC product,

A

T (each drug has its own characteristics of packaging, some are in boxes while other is in the form of laminated capsules)

43
Q

T or F: Pharmaceutical products are usually more sensitive to atmospheric conditions than medical devices.

A

T

44
Q

Many drugs are____, as they attract _____

A

Hygroscopic, moisture

45
Q

T or F: Drugs must be protected from moisture in some way.

A

T

46
Q

Excess moisture can cause:

A

Stickiness and caking
o Efflorescence (foaming)
o Inactivation. The drug may degrade or the moisture may simply break down the
structure of tablets.

47
Q

Many drug products degrade in the presence of ____, causing the drug to lose effectiveness.

A

Oxygen

48
Q

T or F: drugs must be protected from oxygen in some way.

A

T

49
Q

As with food, ___ can cause or accelerate chemical activity in some drugs, lead- ing to degradation and loss of effectiveness.

A

Light (Light emits wavelengths that increases the chemical reaction in foods and pharmaceuticals)

50
Q

T or F: Light can be excluded by using an neutral packaging material that screens out all visible light, by using colored packaging material that screens out selected portions of the visible light spectrum

A

F, it should be opaque packaging

51
Q

Drugs are chemicals. In general, ____ also increases chemical activity as the temperature rises. As a consequence, chemical interactions can cause some drugs to degrade or even to form toxins if they are subjected to storage temperatures above the optimum.

A

Heat

52
Q

T or F: The importance of sterility depends on the route of administration of the pharmaceutical product as some bodily systems have natural defenses against microbes.

A

T

53
Q

T or F: Sterility is important, but is paramount for medical devices that are to be used externally or drugs that are administered through the digestive tract, topically, or by inhalation.

A

F, sterility just based on the inside route of the drugs, and isn’t always heavily focused on medical devices

54
Q

T or F: sterility is paramount for devices that may be implanted directly into the body and for parenteral drugs that are injected or infused into parts of the body that do not have aggressive and effective defenses against microbes.

A

T

55
Q

A packaging that resulted from the observation that small children were often poisoned by medications intended for adults. Children would sometimes mistake pills and tablets for candy and consume a serious overdose.

A

Child-Resistant (CR) Packaging

56
Q

T or F: the child-resistant feature of a drug package is built into the cap. There are several cap designs available. The basic approach is to require two simultaneous motions to open the cap, such as “push down and turn.” ”

A

T

57
Q

What is CPSC

A

Consumer product safety commission

58
Q

T or F: Research has shown that an average 74-year-old has about the same hand strength as a 4-year-old. Elderly people often had the same difficulty opening a child resistant package as did children.

A

T

59
Q

Federal rules requiring packaging designs for drugs that prevent tampering or provide evidence that tampering has occurred were initially issued after the famous “Tylenol poisoning” case in 1982.

A

Tamper-Evident (TE) Packaging

60
Q

In the tylenol poisoning, the bottles were dosed with____

A

Cyanide

61
Q

The ______ at the bottom of the cap in the figure will break away when the closure is twisted open. The cap can be completely removed, but the plastic (or aluminum) ring drops down and stays on the neck of the bottle.

A

Perforated band (tamper evident closures)

62
Q

A consumer who sees a bottle with the ring separated can tell that the container has been opened (at least) and that it may have been tampered with in some fashion

A

Tamper evident closures

63
Q

a plastic band that is shrunk around the neck and closure of a bottle. The band breaks and falls off when the bottle is opened. Absence of the band is evidence that the bottle has been opened and may have been tampered with.

A

Shrink neck band

64
Q

T or F: consumers are advised to purchase a bottle without an intact neck band

A

F

65
Q

________ are applied to the top of a bottle under the
closure, by means of a noncontact heating process called ________

A

Inner seals, induction heating

66
Q

The seals are usually made of laminated structure that
includes a layer of ______, but sometimes only _____ is
used.

A

Aluminum foil, plastic

67
Q

T or F: If the seal is not present, the
absence is a proof of evidence that someone has already opened the container. So, it is really difficult for a consumer to know whether
the manufacturer applied a seal when the package was closed. Therefore, seals on Pharmaceutical containers are designed to leave evidence behind when removed.

A

True, since wala kmn sang gin manufacture and bulong

68
Q

T or F: The seals are applied lightly that the seal will come apart when removed, leaving small pieces of fiber, aluminum, or plastic on the bottle as evidence.

A

F, seals are applied so tightly

69
Q

typically used for the primary package in pharmaceuticals where protection from moisture is needed.

A

Metal

70
Q

______ is the most commonly used metal in pharmaceutical packaging.

A

Aluminum

71
Q

are favored for many pharmaceutical products because of the excellent barrier provided by the metal and because _____ are
“collapsible”.

A

Metal tubes

72
Q

T or F: When a tube is squeezed to expel product it remains in the
squeezed form and does not spring back to its original shape.

A

T

73
Q

____ such as the aluminum caps for parenteral drugs shown in
Metal tubes
the figure, are often made of metal.

A

Closures

74
Q

generally made of aluminum, provides a good barrier against oxygen, moisture, and light and is widely used in flexible packaging for pharmaceutical products.

A

Foil

75
Q

Blister packs is a good example of this packaging

A

Laminated structures

76
Q

used for bulk handling of products, temporary storage, and for transporting from a manufacturing location to the packaging site.

A

Metal drums and pails

77
Q

T or F: The choice of a particular plastic depends on the characteristics and protective needs of the product

A

T

78
Q

T or F: Plastic tubes return to their original shape after being squeezed, so they are not suitable for ophthalmological products, burn ointments, and other products where contamination from the atmosphere may be an issue.

A

T

79
Q

used for lotions, creams, and other topical products.

A

Plastic tubes

80
Q

have a finish area that is smaller in diameter than the body of the package

A

Bottles

81
Q

Are similar to bottles

A

Jars

82
Q

is an approximately cylindrical container with a wide- mouth finish that is as large as or larger than the body.

A

Jar

83
Q

Also called as phials

A

Vials

84
Q

relatively small bottles used to store
medication as liquid, powder, or in other forms, such as tablets and
capsules.

A

Vials

85
Q

typically used as secondary packaging for pharmaceuticals.

A

Paper and papaerboard

86
Q

piece of paper attached to a container or article. Information about the product is printed on this one.

A

Label

87
Q

larger pieces of paper with more information printed on them.

A

Inserts and outserts

88
Q

Recall from Chapter 2 that one of the primary components of packaging glass is ____

A

Na2CO3 / Sodium Carbonate

89
Q

is also a key element in the process of transport of nutrients across membranesinthebody.

A

Sodium

90
Q

T or F: leaching of sodium from glass containers into parenteral pharmaceutical products can have enormous negative consequences.

A

T

91
Q

Type 1 glass

A

Low alkali glass

92
Q

Type II glass

A

Conventional container glass with a surface treatment

93
Q

Type 3 glass

A

Non-parenteral / General Purpose glass

94
Q

mostly assembled, packaged, and sterilized in factories by companies that specialize in such products.

A

Emergency room kits

95
Q

assembled by companies in a fashion similar to the assembly of kits used in emergency rooms.

A

Surgical kits

96
Q

used to gather information about the status of some part of a patient’s body from inside the body

A

Invasive instruments

97
Q

Many medical device packages are sterilized by filling them with the gas known as

A

Ethylene oxide

98
Q

Ethylene oxide is also referred as

A

ETO, peroxide

99
Q

The most common technique is to fill and seal the package in a conventional factory. The packages are then moved, usually in pallet load lots, to a chamber where they are irradiated to kill microbes.

A

Radiation

100
Q

Objects that are made of metal, hard plastic, glass, and similar materials can be sterilized by heating the objects to a specified temperature and holding the items at that temperature for a required length of time

A

Heat

101
Q

physical openings or imperfections in a seal that allow exchanges between the internal environment of the package and the atmosphere.

A

Leaks

Chete Finals (2 decks)

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