Pharmaceutical Flashcards
T or F: The terms pharmaceutical and drug are different .
F
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.
Pharmaceuticals (drugs)
They are called ethical drugs
Prescription drug
also called proprietary drugs
Over-the-counter drugs
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
U.S. Pharmacopeial Convention
Experts from industry, government, and academia are elected every five years to work on the publication of these two voluntary standards.
U.S. Pharmacopeia (USP) and the National Formulary (NF)
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.
Monograph
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.
Drug
are frequently classified as drugs because of claims made on their labels regarding the “intended use” for the product.
Substances
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 ___
Drug
The recent increase in health claims on food packages (a drug derived from food sources) led to a new product grouping called ____
Neutraceuticals
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.
T
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.
F, (every product that is intended for a medical use is drug/medical device)
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.
Prescription drugs
also known as ethical drugs.
Prescriptions drugs
can be purchased for self-medication without the approval of a doctor
Over-the-counter (OTC) drugs
also referred to as proprietary drugs.
Otc drugs
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.
Parenteral drugs
usually refers to injections or infusions.
parenteral
Instruments, apparatuses, implements, machines, contrivances, implants, in vitro reagents, and similar articles, including parts, components, and accessories, are referred to as
Medical devices
In addition, medical devices :
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.
refers to the way that the packaged product is delivered for use.
Presentation
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.
Presentation
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.
Prescription drugs
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.
Otc
OTC products are frequently packaged as
Unit doses
OTC packaging is frequently designed with special convenience features, such as
Automatic dispensing
T or F: Both the drug and the drug package must be approved by the FDA prior to the prouct’s market introduction.
T
T or F: a doctor’s supervision is not necessary for safe and effective use of prescription products.
F
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.
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
T or F: Drugs can usually be supplied in different forms
T
Liquid form of tablets
Solutions
Liquid form of capsules
Suspensions
Liquid form of Caplets
Emulsions
Liquid form of Gel Caps
Elixirs
Liquid form of powder
Tinctures (oil)
Liquid form of suppositories
Spirit
Methods of administering drugs through the gastrointestinal tract:
Orally, Nasogastric (NG) tube (nose), rectally administered medication (suppository).
Methods of administering topical (gina apply) drugs:
Lotions and creams, transdermal patches (salonpas)
Methods of administering drugs through the respiratory system:
Nebulizer, inhalers
Methods of administering drugs injected into the body:
Intravenous(intothevein)
o Intramuscular(intothemuscle)
o Intraspinal(intothespinalcord)
o Intracardial(intotheheart)
o Subcutaneous (under the skin)
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,
T (each drug has its own characteristics of packaging, some are in boxes while other is in the form of laminated capsules)
T or F: Pharmaceutical products are usually more sensitive to atmospheric conditions than medical devices.
T
Many drugs are____, as they attract _____
Hygroscopic, moisture
T or F: Drugs must be protected from moisture in some way.
T
Excess moisture can cause:
Stickiness and caking
o Efflorescence (foaming)
o Inactivation. The drug may degrade or the moisture may simply break down the
structure of tablets.
Many drug products degrade in the presence of ____, causing the drug to lose effectiveness.
Oxygen
T or F: drugs must be protected from oxygen in some way.
T
As with food, ___ can cause or accelerate chemical activity in some drugs, lead- ing to degradation and loss of effectiveness.
Light (Light emits wavelengths that increases the chemical reaction in foods and pharmaceuticals)
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
F, it should be opaque packaging
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.
Heat
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.
T
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.
F, sterility just based on the inside route of the drugs, and isn’t always heavily focused on medical devices
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.
T
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.
Child-Resistant (CR) Packaging
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.” ”
T
What is CPSC
Consumer product safety commission
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.
T
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.
Tamper-Evident (TE) Packaging
In the tylenol poisoning, the bottles were dosed with____
Cyanide
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.
Perforated band (tamper evident closures)
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
Tamper evident closures
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.
Shrink neck band
T or F: consumers are advised to purchase a bottle without an intact neck band
F
________ are applied to the top of a bottle under the
closure, by means of a noncontact heating process called ________
Inner seals, induction heating
The seals are usually made of laminated structure that
includes a layer of ______, but sometimes only _____ is
used.
Aluminum foil, plastic
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.
True, since wala kmn sang gin manufacture and bulong
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.
F, seals are applied so tightly
typically used for the primary package in pharmaceuticals where protection from moisture is needed.
Metal
______ is the most commonly used metal in pharmaceutical packaging.
Aluminum
are favored for many pharmaceutical products because of the excellent barrier provided by the metal and because _____ are
“collapsible”.
Metal tubes
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.
T
____ such as the aluminum caps for parenteral drugs shown in
Metal tubes
the figure, are often made of metal.
Closures
generally made of aluminum, provides a good barrier against oxygen, moisture, and light and is widely used in flexible packaging for pharmaceutical products.
Foil
Blister packs is a good example of this packaging
Laminated structures
used for bulk handling of products, temporary storage, and for transporting from a manufacturing location to the packaging site.
Metal drums and pails
T or F: The choice of a particular plastic depends on the characteristics and protective needs of the product
T
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.
T
used for lotions, creams, and other topical products.
Plastic tubes
have a finish area that is smaller in diameter than the body of the package
Bottles
Are similar to bottles
Jars
is an approximately cylindrical container with a wide- mouth finish that is as large as or larger than the body.
Jar
Also called as phials
Vials
relatively small bottles used to store
medication as liquid, powder, or in other forms, such as tablets and
capsules.
Vials
typically used as secondary packaging for pharmaceuticals.
Paper and papaerboard
piece of paper attached to a container or article. Information about the product is printed on this one.
Label
larger pieces of paper with more information printed on them.
Inserts and outserts
Recall from Chapter 2 that one of the primary components of packaging glass is ____
Na2CO3 / Sodium Carbonate
is also a key element in the process of transport of nutrients across membranesinthebody.
Sodium
T or F: leaching of sodium from glass containers into parenteral pharmaceutical products can have enormous negative consequences.
T
Type 1 glass
Low alkali glass
Type II glass
Conventional container glass with a surface treatment
Type 3 glass
Non-parenteral / General Purpose glass
mostly assembled, packaged, and sterilized in factories by companies that specialize in such products.
Emergency room kits
assembled by companies in a fashion similar to the assembly of kits used in emergency rooms.
Surgical kits
used to gather information about the status of some part of a patient’s body from inside the body
Invasive instruments
Many medical device packages are sterilized by filling them with the gas known as
Ethylene oxide
Ethylene oxide is also referred as
ETO, peroxide
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.
Radiation
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
Heat
physical openings or imperfections in a seal that allow exchanges between the internal environment of the package and the atmosphere.
Leaks
