Pharmaceutical

Question 1

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

Answer 1

F

Question 2

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.

Answer 2

Pharmaceuticals (drugs)

Question 3

They are called ethical drugs

Answer 3

Prescription drug

Question 4

also called proprietary drugs

Answer 4

Over-the-counter drugs

Question 5

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

Answer 5

U.S. Pharmacopeial Convention

Question 6

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

Answer 6

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

Question 7

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.

Answer 7

Monograph

Question 8

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.

Answer 8

Drug

Question 9

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

Answer 9

Substances

Question 10

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 ___

Answer 10

Drug

Question 11

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

Answer 11

Neutraceuticals

Question 12

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.

Answer 12

T

Question 13

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.

Answer 13

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

Question 14

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.

Answer 14

Prescription drugs

Question 15

also known as ethical drugs.

Answer 15

Prescriptions drugs

Question 16

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

Answer 16

Over-the-counter (OTC) drugs

Question 17

also referred to as proprietary drugs.

Answer 17

Otc drugs

Question 18

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.

Answer 18

Parenteral drugs

Question 19

usually refers to injections or infusions.

Answer 19

parenteral

Question 20

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

Answer 20

Medical devices

Question 21

In addition, medical devices :

Answer 21

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.

Question 22

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

Answer 22

Presentation

Question 23

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.

Answer 23

Presentation

Question 24

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.

Answer 24

Prescription drugs

Question 25

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.

Answer 25

Otc

Question 26

OTC products are frequently packaged as

Answer 26

Unit doses

Question 27

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

Answer 27

Automatic dispensing

Question 28

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

Answer 28

T

Question 29

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

Answer 29

F

Question 30

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.

Answer 30

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

Question 31

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

Answer 31

T

Question 32

Liquid form of tablets

Answer 32

Solutions

Question 33

Liquid form of capsules

Answer 33

Suspensions

Question 34

Liquid form of Caplets

Answer 34

Emulsions

Question 35

Liquid form of Gel Caps

Answer 35

Elixirs

Question 36

Liquid form of powder

Answer 36

Tinctures (oil)

Question 37

Liquid form of suppositories

Answer 37

Spirit

Question 38

Methods of administering drugs through the gastrointestinal tract:

Answer 38

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

Question 39

Methods of administering topical (gina apply) drugs:

Answer 39

Lotions and creams, transdermal patches (salonpas)

Question 40

Methods of administering drugs through the respiratory system:

Answer 40

Nebulizer, inhalers

Question 41

Methods of administering drugs injected into the body:

Answer 41

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

Question 42

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,

Answer 42

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

Question 43

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

Answer 43

T

Question 44

Many drugs are____, as they attract _____

Answer 44

Hygroscopic, moisture

Question 45

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

Answer 45

T

Question 46

Excess moisture can cause:

Answer 46

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

Question 47

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

Answer 47

Oxygen

Question 48

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

Answer 48

T

Question 49

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

Answer 49

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

Question 50

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

Answer 50

F, it should be opaque packaging

Question 51

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.

Answer 51

Heat

Question 52

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.

Answer 52

T

Question 53

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.

Answer 53

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

Question 54

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.

Answer 54

T

Question 55

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.

Answer 55

Child-Resistant (CR) Packaging

Question 56

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.” ”

Answer 56

T

Question 57

What is CPSC

Answer 57

Consumer product safety commission

Question 58

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.

Answer 58

T

Question 59

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.

Answer 59

Tamper-Evident (TE) Packaging

Question 60

In the tylenol poisoning, the bottles were dosed with____

Answer 60

Cyanide

Question 61

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.

Answer 61

Perforated band (tamper evident closures)

Question 62

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

Answer 62

Tamper evident closures

Question 63

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.

Answer 63

Shrink neck band

Question 64

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

Answer 64

F

Question 65

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

Answer 65

Inner seals, induction heating

Question 66

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

Answer 66

Aluminum foil, plastic

Question 67

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.

Answer 67

True, since wala kmn sang gin manufacture and bulong

Question 68

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.

Answer 68

F, seals are applied so tightly

Question 69

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

Answer 69

Metal

Question 70

______ is the most commonly used metal in pharmaceutical packaging.

Answer 70

Aluminum

Question 71

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

Answer 71

Metal tubes

Question 72

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.

Answer 72

T

Question 73

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

Answer 73

Closures

Question 74

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

Answer 74

Foil

Question 75

Blister packs is a good example of this packaging

Answer 75

Laminated structures

Question 76

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

Answer 76

Metal drums and pails

Question 77

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

Answer 77

T

Question 78

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.

Answer 78

T

Question 79

used for lotions, creams, and other topical products.

Answer 79

Plastic tubes

Question 80

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

Answer 80

Bottles

Question 81

Are similar to bottles

Answer 81

Jars

Question 82

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

Answer 82

Jar

Question 83

Also called as phials

Answer 83

Vials

Question 84

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

Answer 84

Vials

Question 85

typically used as secondary packaging for pharmaceuticals.

Answer 85

Paper and papaerboard

Question 86

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

Answer 86

Label

Question 87

larger pieces of paper with more information printed on them.

Answer 87

Inserts and outserts

Question 88

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

Answer 88

Na2CO3 / Sodium Carbonate

Question 89

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

Answer 89

Sodium

Question 90

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

Answer 90

T

Question 91

Type 1 glass

Answer 91

Low alkali glass

Question 92

Type II glass

Answer 92

Conventional container glass with a surface treatment

Question 93

Type 3 glass

Answer 93

Non-parenteral / General Purpose glass

Question 94

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

Answer 94

Emergency room kits

Question 95

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

Answer 95

Surgical kits

Question 96

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

Answer 96

Invasive instruments

Question 97

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

Answer 97

Ethylene oxide

Question 98

Ethylene oxide is also referred as

Answer 98

ETO, peroxide

Question 99

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.

Answer 99

Radiation

Question 100

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

Answer 100

Heat

Question 101

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

Answer 101

Leaks