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Priniciples of Pharm

Controlled Substances and FDA Pregnancy Categories

QuestionAnswer
Heroin, marijuana, LSD (lysergic acid diethylamide), peyote C-I
meperidine, methadone, morphine, oxycodone, amphetamines, barbiturates C-II
nonbarbiturate sedatives, nonamphetamine stimulants, limited amounts of certain narcotics C-III
some sedatives; anxiety agents, nonnarcotic analgesics C-IV
small amounts of narcotic (codeine) used as antitussives or antidiarrheals C-V
High abuse potential C-I
Potential for high abuse with severe physical or psychological dependence C-II
Potential for moderate physical or psychological dependence C-III
Limited dependence potential C-IV
Peyote C-1
meperidine C-II
some sedatives and anxiety agents C-IV
oxycodone C-III
nonamphetamine stimulants C-III
lysergic acide diethylamide C-I
a compulsive need to use to avoid mild to severe withdrawal symptoms Physical dependency
a complusion to use a substance to obtain a pleasureable experience Psychological dependency
Who regulates the manufacture, distribution, and dispensing of drugs that have abuse potential? The Controlled Substance Act of 1970
The DEA is within what agency? US Department of Justice
Who enforces the Controlled Substances Act? The Drug Enforcement Adminstration (DEA)
Before the passage of which act, any narcotic could be purchased without a prescription? Harrison Narcotic Act
In 1970 the Harrison Narcotic Act was replaced with what passage? Comprehensive Drug Abuse Prevention and Control Act
Why did Congress pass the Comprehensive Drug Abuse Prevention and Control Act? Because of the growing problem of drug abuse.
What do the Comprehensive Drug Abuse Prevention and Control Act regulate? It regulates the manufacture, distribution, and dispensation of drugs that have the potential for abuse.
Drugs administered to pregnant women, particularly during which time, may cause teratogenic effects? Trimester
Any subtance that causes abnormal development of the fetus leading to a severely deformed fetus is called. Teratogen effects
Controlled studies show no risk to the fetus A
Animal studies show no risk, but there is no well-controlled studies in pregnant women. No evidence of risk in humans. B
Studies in animals and humans have demostrated fetal abnormalities based on investigational or postmarketing reports. X
Positive evidence of risk to the human fetus D
Investigational or postmarketing data show risk to the fetus D
Animal studies have shown adverse effects on the fetus and no well-controlled studies in humans. C
The drug may be used during pregnancy if the potential benefits outweigh its possible risks. C
Example of a medications with teratogen effects Thalidomide, lithium, Ace inhibitors
Created by: Shaddinger
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