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35 Cards in this Set

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The Federal Food, Drug, and Cosmetic Act, June 25, 1938
Authorizes the FDA (food and drug administration) of the dept of health and human services to determine the safety of drugs before marketing and to insure labeling specifications and standards in advertising are met.
The Durham-Humphrey amendment of 1952
Tightened control by restricting the refilling of prescriptions.
The Kefauver-Harris amendment of 1962
Provides greater control and surveillance of the distribution and clinical testing of investigational drugs and requires that a product be proven both safe and effective before release for sale.
Controlled Substance Act of 1970
Repelled almost 50 other laws written since 1914 that relate to the control of drugs. The new law is designed to improve the admin and regulation of manufacturing, distributing, and dispensing of drugs that have been found necessary to be controlled. Consists of 5 classifications or Schedules
Schedule I
A high potential for abuse
No currently accepted medical use in the US
A lack of accepted safety for use under medical supervision
Examples: LSD, Marijuana, peyote, STP, heroin, hashish
Schedule I
A high potential for abuse
No currently accepted medical use in the US
A lack of accepted safety for use under medical supervision
Examples: LSD, Marijuana, peyote, STP, heroin, hashish
Schedule II
A high potential for abuse
A currently accepted medical use in the US
An abuse potential that may lead to severe psychologic or physical dependence
Examples: secobarbital, phenobarbital, amphetamines, morphine, methadone, percodan,
Schedule III
A high potential for abuse, but less so than drugs in Schedule I or II
A currently accepted medical use in the US
An abuse potential that may lead to moderate or low physical dependence or high psychologic dependence
Examples: Empirin with codeine, Lortab, Fiorinal, Tylenol with codeine
Schedule IV
A low potential for abuse, compared with those in Schedule III
A currently accepted medical use in the US
An abuse potential that may lead to limited physical or psychologic dependence, compared with drugs in Schedule III
Examples: phenobarbital, Darvon, Chloral hydrate, Valium, temazepam
Schedule V
A low potential for abuse, compared with those in Schedule IV
A currently accepted medical use in the US
An abuse potential of limited physical dependence or psychologic dependence liability as compared to drugs in Schedule IV, since abuse potential is low a prescription may not be required
Examples: Lomotil, Robitussin A-C
DEA
was organized to enforce the Controlled Substance Act
A bureau of the Department of Justice
Reports to the attorney general

An manufacturer, physician , nurse practitioner, PA, dentist, Pharmacy, and hospital that manufactures, prescribes, or dispenses any of the drugs listed in the five schedules must register bi-annually with the DEA
Drug development
Preclinical research and development
Clinical research and development (the testing in humans phase)
New drug application review
Post marketing surveillance
Drugs act in the body:
-Drugs do not create new responses, they alter existing physiologic activity
-Drugs interact with the body in several ways, usually forming a chemical bond with specific receptors
-The intensity of a drug response is related to how well the drug molecule fits into the receptor and to the number of receptor sites that are occupied
pharmacodynamics
The study of interactions between drugs and their receptors and the series of events that result in pharmacologic response
agonists
Drugs that interact with a receptor to stimulate a response
antagonists
Drugs that attach to a receptor but do not stimulate a response
Absorption
the process by which a drug is transferred from its site of entry into the body to the circulating fluids of the body
Distribution
ways in which drugs are transported by the circulating body fluids to the sites of action, metabolism, and excretion
Metabolism
the process by which the body inactivates drugs (enzyme systems of the liver are the primary site for metabolism)
Excretion
elimination of drug metabolites and in some cases the active drug itself from the body (GI tract, evaporation through the skin, exhalation, secretion into saliva and breast milk)
pharmacokinetics
The study of the mathematical relationship among the absorption, distribution, metabolism, and excretion of individual medicines over time
Enteral
administer of a drug directly into the GI tract by oral, rectal, or nasogastric routes
Parenteral
bypass the GI tract by using subcutaneous, intramuscular, or intravenous injection
Percutaneous
inhalation, sublingual, or topical
Pharmacology
the science or study of drugs, including their sources, chemistry, production, use in treating diseases, and side effects
Official sources of drug standards
The United States Pharmacopeia (USP)
Symptoms with drug sensitivity and allergy
a. Skin rash: usually generalized over the body
b. Pruritus: itching of the skin with or without a rash
c. Angioedema: edema due to increased permeability of the blood capillaries
d. Lacrimal tearing: excessive tearing
e. Nausea/vomiting: stimulation of these centers in the brain
f. Wheezing: shortness of breath and wheezing upon inhalation and exhalation due to accumulated fluids and swelling of the respiratory tissues
g. Diarrhea: irritation of the mucosa of the large intestine
Drug Interactions
-Additive effect: two drugs with similar actions are taken for a doubled effect
-Synergistic effect: the combined effect of two drugs is greater than the sum of the effect of each drug alone
-Antagonistic effect: one drug interferes with the action of another
-Displacement: the displacement of the first drug by a second drug increases the activity of the first drug
Interference: the first drug inhibits the metabolism or excretion of the second drug, causing increased activity of the second drug
Incompatibility: the first drug is chemically incompatible with the second drug
desired action/therapeutic action
these words have the same meaning which is the primary effect intended or the reason a drug is prescribed
Side effect
secondary effect of a drug is one that is unintended. Side effects are usually predictable and may be either harmless or potentially harmful.
Adverse effects
– more severe side effects that may justify the discontinuation of a drug
Allergic reactions
an immunologic reaction to a drug. When a client is first exposed to a foreign substance, the body may react by producing antibodies. A client can react to a drug as to an antigen and thus develop symptoms of an allergic reaction.
Idiosyncratic reactions
is unexpected and individual. Underresponse and overresponse to a drug may be idiosyncratic. Also, the drug may have a completely different effect from the normal one or cause unpredictable and unexplainable symptoms in a particular client
Sites and procedures for an intradermal injection:
Sites include vastus lateralis muscle, rectus femoris muscle, gluteal area and deltoid muscle. The bastes lateralis injection site is preferred in infants. In the older, debilitated, or no ambulatory adult, carefully assess the sufficiency of the muscle mass before using this site for injection. The gluteal site must not be used in children under 3 yrs of age because the muscle is not well developed yet.
Sites for subcutaneous injection
Outer aspect of the upper arms and the anterior aspect of the thighs, abdomen, the scapular areas of the upper back, and the upper ventrogluteal and dorsogluteal areas can also be used