Once a drug is approved for use, the FDA assigns it to one of the following categories?
_________ _________ are designated by the federal government as potentially harmful unless their use is supervised by a licensed health care provider, such as a nurse practitioner, physician, or dentist.
The nurse administers the drug and monitors the patient for therapeutic effect and _________ ___________.
Prescription drugs, also called ________ ________, are the largest category of drugs.
Prescription drugs are prescribed by a ?
_____________ ________ are designated by the FDA as safe and can be obtained without a prescription.
over the counter
Drugs that are purchased in a variety of settings, such as a pharmacy, drugstore, or the local supermarket are called ?
Over the counter drugs are known as?
___________ ___________ are the most carefully monitored of all drugs. These drugs have a high potential for abuse and may cause physical or psychological dependency.
___________ ____________ is the habitual use of a drug, in which negative physical withdrawal symptoms result from abrupt discontinuation; it is the body's dependence on repeated administration of a drug.
____________ ____________ act of 1970 established a schedule, or classification system, for drugs with abuse potential.
Controlled Substances Act
This act regulates the manufacture, distribution, and dispensing of these drugs.
The controlled substances act divides drugs into _____ ___________, based on their potential for abuse and physical and psychological dependence.
High abuse potential, lack of accepted safety, not approved for medical use in the United States is what schedule?
Potential for high abuse with severe physical or psychological dependence, approved for medical use in the United States
The schedule approved for opioids such as meperidine, methadone, morphine, oxycodone, amphetamines; and cocaine.
Less abuse potential than schedule 2 drugs, potential for moderate physical or psychological dependence
Examples of this schedule are anabolic steroids, ketamine, hydrocodone/codeine compounded with an nonsteroidal anti-inflammatory drug
Less abuse potential than schedule 3 drugs, limited dependence potential
Examples of this schedule are some sedatives and anxiety agents, non-opioid analgesics, "diet drugs"
Limited abuse potential
Examples of this schedule are small amounts of opiod (codeine) used as antitussives or antidiarrheals, pregabalin (Lyrica)
(What PREGNANCY category?) Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities to the fetus in any trimester of pregnancy.
(What PREGNANCY category?) Animal studies have revealed no evidence of harm to the fetus; however, there are no adequate and well-controlled studies in pregnant women
(What PREGNANCY category?) Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
(What PREGNANCY category?) Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women.
(What PREGNANCY category?) Animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.
Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus.
However, potential benefits may outweigh the risk to the fetus. If needed in a life-threatening situation or a serious disease, the drug may be acceptable if safer drugs cannot be used or are ineffective
Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks.
The use of the product is contraindicated in women who are or may become pregnant.
What are the FDA pregnancy risk categories?
Prescription practices of the primary health care provider for controlled substances are monitored by the ?
In hospitals or other agencies that dispense controlled substances, the scheduled drugs are counted every __ to __ hours to account for each injectable, tablet, or other form of the drug.
Drug development is a long and arduous process that can take from __ to __ years, and sometimes longer.
The ____ has the responsibility for approving new drugs and monitoring drugs currently in use for adverse or toxic reactions.
pre-FDA phase, FDA phase
The development of a new drug is divided into what two phases?
During what phase, does a manufacturer discover a drug that looks promising?
______________ ____________ occurs after the manufacturer places the drug on the market.
FDA by Medwatch
Health care professionals are encouraged to help with this surveillance by reporting adverse effects by reporting to the?
Orphan Drug Act of 1983
What special program was passed to encourage the development and marketing of products used to treat rare diseases?
How many individuals is it considered to be a "rare disease"?
Multiple myeloma, cystic fibrosis, and phenylketonuria are types of what kind of diseases?
What drugs go through these three phases: pharmaceutic phase, pharmacokinetic phase, and pharmacodynamic phase?
the drug dissolves
Drugs must be ________ to be absorbed.
What type of drugs are already dissolved and are absorbed more quickly?
Tablets that have an ________ ________ or time-releasing capsules do not disintegrate until they reach the alkaline environment of the small intestine.
____________ refers to activities within the body after a drug is administered.
absorption, distribution, metabolism, excretion
What 4 activites do pharmacokinetics go through?
Another pharmacokinetic component is the ______ ______ of the drug.
is a measure of the rate at which drugs are removed from the body.
__________ follows administration and is the process by which a drug is made available for use in the body.
Which process do the drug particles in the GI tract move into the body fluids?
active transport, passive transport, pinocytosis
What three ways does absorption act in?
cellular energy is used to move the drug from an area of low concentration to one of high concentration
no cellular energy is used as the drug moves from an area of high concentration to an area of low concentration
cells engulf the drug particle (the cell forms a vesicle to transport the drug into the inner cell)
What route are drugs most rapidly absorbed?
(fast or slow) When drugs are absorbed orally, intramuscularly, or sub Q?
first pass effect
the metabolism of orally administered drugs by gastrointestinal and hepatic enzymes, resulting in a significant reduction of the amount of unmetabolized drug reaching the systemic circulation.
protein binding, blood flow, solubilty
Distribution of an absorbed drug in the body depends on __________ _________, _____ _____, and _________.
Drugs bound to protein are pharmacologically _________.
Only ____ _____ can produce a therapeutic effect.
large blood supply
A drug is distributed quickly to areas with a _______ _________ ________, such as the heart, liver, and kidneys.
skin and muscle
Distribution of drugs in these areas occur more slowly.
Metabolism is also called?
the process by which the body changes a drug to a more or less active form that can be excreted
What's the resulting form of metabolism?
an inactive form of the original drug
The elimination of drugs from the body is called _________.
Patients with what type of disease may require a dosage reduction and careful monitoring of kidney function?
_____ ______ refers to the time required for the body to eliminate 50% of the drug.
Drugs with a short half life hours?
Drugs with a long half life hours?
onset of action
time between administration of the drug and onset of its therapeutic effect
peak of concentration
when absorption rate equals the elimination rate (not always the time of peak response)
duration of action
length of time the drug produces a therapeutic effect
_________ is the study of the drug mechanisms that produce biochemical or physiologic changes in the body.
_____________ deals with the drug's action and effect in the body.
The primary effect of a drug is the desired or _________ ___________.
alteration in cellular function, alteration in cellular environment
A drug exerts its action by two main mechanisms:
The function of a cell is altered when a drug interacts with a ________.
receptor-mediated drug action
This occurs when a drug molecule selectively joins with a reactive site---the receptor--- on the surface of a cell.
When a drug binds to and interacts with the receptor, a ___________ response occurs.
a drug that binds with a receptor and stimulates the receptor to produce a therapeutic response.
a drug that joins with receptors but does not stimulate the receptors
What are the two types of antagonists?
competes with the agonists for receptor sites.
bind reversibly with receptor sites, administering larger doses of an agonist can overcome the antagonist effects.
binds with receptor sites and always blocks the effects of the agonists.
Human genome project
was a study to determine the different components of the human genetic code.
is the study of how people's responses to medications are variable due to individual genetic variation.
is the creation of individualized drug therapy that allows for the best choice and dose of drugs.
first trimester (3 months)
Drugs administered to pregnant women, particularly during what trimester, may have teratogenic effects?
any substance that causes abnormal development of the fetus, often leading to severe deformation.
_________ ________ are undesirable drug effects.
to explain mild, common, and nontoxic reactions
to describe more severe and life-threatening reactions
is an immediate hypersensitivity reaction.
A drug allergy occurs because the individual's immune system responds to the drug as a foreign substance called _________.
Lymphocytes respond by forming ________.
protein substances that protect against antigens
Common allergic reactions reactions occur when the individual's immune system responds aggressively to the _________.
__________ _________ released during the allergic reaction produce symptoms ranging from mild to life-threatening.
primary health care provider
Any indication of an allergic reaction is reported to the ________ ______ ___ _____ before the next dose of the drug is given.
Allergic reactions that occur __________ often are the most serious.
_______ ________ is an extremely serious allergic drug reaction that usually occurs shortly after the administration of a drug to which the individual is sensitive.