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LPN Pharmacology - Final Exams| Questions with 100% verified Answers
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LPN Pharmacology - Final Exams| Questions with 100% verified Answers
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LPN Pharmacology - Final Exams|Questions with 100% verified
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Pure food and drug act states: - ✔ ✔ Pure Food and Drug Act
Prevented the marketing of adulterated drugs; required labeling to eliminate false
or misleading claims
Federal food, Drug and cosmetic Act states: - ✔ ✔ Federal Food, Drug and Cosmetic Act
Mandated tests for drug toxicity and provided means for recall of drugs; established procedures for
introducing new drugs; gave Food and Drug Administration (FDA) the power of enforcement
Durham-Humphrey Amendment states: - ✔ ✔ Durham-Humphrey Amendment
,Tightened control of certain drugs; specified drugs to be labeled "may not be distributed
without a prescription"
Kefauver-Harris Act - ✔ ✔ 1962
Kefauver-Harris Act
Tightened control over the quality of drugs; gave FDA regulatory power over the procedure
of drug investigations; stated that efficacy as well as safety of drugs had to be established
Controlled Substances Act - ✔ ✔ Controlled Substances Act
Defined drug abuse and classified drugs as to their potential for abuse; provided strict controls
over the distribution, storage, and use of these drugs
Orphan Drug Act states: - ✔ ✔ Orphan Drug Act
Provided incentives for the development of orphan drugs for treatment of rare diseases
Food and Drug Administration Pregnancy Categories
, The Food and Drug Administration has established five categories to indicate the potential for a
systemically absorbed drug to cause birth defects. The key differentiation among the categories
rests on the degree (reliability) ) of documentation and the risk-benefit ratio - ✔ ✔ Category A:
Adequate studies in pregnant women have not demonstrated a risk to the fetus in the first
trimester of pregnancy, and there is no evidence of risk in later trimesters.
Category B: Animal studies have not demonstrated a risk to the fetus but there are no
adequate studies in pregnant women, or animal studies have shown an adverse effect, but
adequate studies in pregnant women have not demonstrated a risk to the fetus during the first
trimester of pregnancy, and there is no evidence of risk in later trimesters.
Category C: Animal studies have shown an adverse effect on the fetus but there are no
adequate studies in humans; the benefits from the use of the drug in pregnant women may be
acceptable despite its potential risks, or there are no animal reproduction studies and no
adequate studies in humans.
Category D: There is evidence of human fetal risk, but the potential benefits from the use of
the drug in pregnant women may be acceptable despite its potential risks.
Category X: Studies in animals or humans demonstrate fetal abnormalities or adverse
reaction; reports indicate evidence of fetal risk. The risk of use in a pregnant woman clearly
outweighs any possible benefit.
Regardless of the designated Pregnancy Category or presumed safety, no drug should
be administered during pregnancy unless it is clearly needed
Drug Enforcement Agency Schedules of Controlled Substances
The Controlled Substances Act of 1970 regulates the manufacturing, distribution, and
dispensing of drugs that are known to have abuse potential. The Drug Enforcement Agency
(DEA) is responsible for the enforcement of these regulations. The controlled drugs are divided
into five DEA schedules based on their potential for abuse and physical and psychological
dependence - ✔ ✔ Schedule I (C-I): High abuse potential and no accepted medical use (heroin,
marijuana, LSD)
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