Nursing - Pharmacology Unit 1 Exam
Questions & Answers 100% Accurate!
Therapeutics - ANSWERSbranch of medicine concerned with the prevention of disease
and treatment of suffering.
Pharmacotherapy or Pharmacotherapeutics - ANSWERSapplication of drugs for the
purpose of disease prevention and treatment of suffering.
After a drug is administered, it is called - ANSWERSa medication
Biologics - ANSWERSagents naturally produced in animal cells, microorganisms, or the
body.
Complementary and alternative medication therapies involve - ANSWERSnatural plant
extracts, herbs, vitamins, minerals, and unconventional techniques.
Over the counter drugs - ANSWERSDrugs that do not require a prescription
prescription drugs - ANSWERSdrugs with a prescription assigned by an authorized
person
Formulary - ANSWERSlist of drugs and drug recipes
Pharmacopoeia - ANSWERSmedical reference summarizing standards of drug purity,
strength, and directions for synthesis
First comprehensive publication of drug standards in the US - ANSWERSU.S.
Pharmacopoeia (1820)
Modern group in the US regarding pharmacopoeia - ANSWERSU.S. Pharmacopoeia-
National Formulary (1975)
Biologics Control Act (1902) - ANSWERSStandardizes the quality of serums and other
blood-relation products
Pure Food and Drug Act (1906) - ANSWERSGave government power to control the
labeling of medicines.
Sherley Amendment (1912) - ANSWERSProhibited the sale of drugs labeled with false
therapeutic claims
, Food, Drugs, and Cosmetic Act (1938) - ANSWERSFirst law preventing the sale of
drugs that had not been thoroughly tested before marketing.
Dietary Supplement Health and Education Act (1994) - ANSWERSAn attempt to control
misleading industry claims.
Food and Drug Administration (FDA) (1988) - ANSWERSAgency of the U.S.
Department of Health and Human Services. Regulates food and drugs.
Controls whether prescription drugs and OTC drugs may be used for therapy -
ANSWERSCenter for Drugs Evaluation and Research (CDER)
Boxed Warnings - ANSWERS(1997) warnings for drugs with "special problems"
Black Box Warnings - ANSWERSOne of the primary alerts for identifying extreme
adverse drug reactions discovered during and after the review process.
CBER - Center for Biologics Evaluation and Research - ANSWERSRegulates the use of
biologics including serums, vaccines, and blood products.
Childhood Vaccine Act - ANSWERS(1986) authorized the FDA to acquire information
about patients taking vaccines.
Center for Food Safety and Applied Nutrition (CFSAN) - ANSWERSOversees
administration of herbal products and dietary supplements
National Center for Complementary and Alternative Medicine (NCCAM) -
ANSWERSFederal Government's lead agency for scientific research and information
about CAM therapies.
Phases of Approval for Therapeutic/Biological Drugs - ANSWERS1. Preclinical
investigation.
2. Clinical investigation.
3. Review of the New Drug Application (NDA).
4. Postmarketing surveillance.
Preclinical Investigation - ANSWERSincludes initial synthesis of drug. Animal testing.
Extensive laboratory research. Averages 18 months
Clinical Investigation - ANSWERSAverages 5 years. Crucial process in approval
process.
NDA Review - ANSWERSAverages 24 months. Requires NDA Submission and NDA
approval. Clinical Phase III trials and further animal testing.
Questions & Answers 100% Accurate!
Therapeutics - ANSWERSbranch of medicine concerned with the prevention of disease
and treatment of suffering.
Pharmacotherapy or Pharmacotherapeutics - ANSWERSapplication of drugs for the
purpose of disease prevention and treatment of suffering.
After a drug is administered, it is called - ANSWERSa medication
Biologics - ANSWERSagents naturally produced in animal cells, microorganisms, or the
body.
Complementary and alternative medication therapies involve - ANSWERSnatural plant
extracts, herbs, vitamins, minerals, and unconventional techniques.
Over the counter drugs - ANSWERSDrugs that do not require a prescription
prescription drugs - ANSWERSdrugs with a prescription assigned by an authorized
person
Formulary - ANSWERSlist of drugs and drug recipes
Pharmacopoeia - ANSWERSmedical reference summarizing standards of drug purity,
strength, and directions for synthesis
First comprehensive publication of drug standards in the US - ANSWERSU.S.
Pharmacopoeia (1820)
Modern group in the US regarding pharmacopoeia - ANSWERSU.S. Pharmacopoeia-
National Formulary (1975)
Biologics Control Act (1902) - ANSWERSStandardizes the quality of serums and other
blood-relation products
Pure Food and Drug Act (1906) - ANSWERSGave government power to control the
labeling of medicines.
Sherley Amendment (1912) - ANSWERSProhibited the sale of drugs labeled with false
therapeutic claims
, Food, Drugs, and Cosmetic Act (1938) - ANSWERSFirst law preventing the sale of
drugs that had not been thoroughly tested before marketing.
Dietary Supplement Health and Education Act (1994) - ANSWERSAn attempt to control
misleading industry claims.
Food and Drug Administration (FDA) (1988) - ANSWERSAgency of the U.S.
Department of Health and Human Services. Regulates food and drugs.
Controls whether prescription drugs and OTC drugs may be used for therapy -
ANSWERSCenter for Drugs Evaluation and Research (CDER)
Boxed Warnings - ANSWERS(1997) warnings for drugs with "special problems"
Black Box Warnings - ANSWERSOne of the primary alerts for identifying extreme
adverse drug reactions discovered during and after the review process.
CBER - Center for Biologics Evaluation and Research - ANSWERSRegulates the use of
biologics including serums, vaccines, and blood products.
Childhood Vaccine Act - ANSWERS(1986) authorized the FDA to acquire information
about patients taking vaccines.
Center for Food Safety and Applied Nutrition (CFSAN) - ANSWERSOversees
administration of herbal products and dietary supplements
National Center for Complementary and Alternative Medicine (NCCAM) -
ANSWERSFederal Government's lead agency for scientific research and information
about CAM therapies.
Phases of Approval for Therapeutic/Biological Drugs - ANSWERS1. Preclinical
investigation.
2. Clinical investigation.
3. Review of the New Drug Application (NDA).
4. Postmarketing surveillance.
Preclinical Investigation - ANSWERSincludes initial synthesis of drug. Animal testing.
Extensive laboratory research. Averages 18 months
Clinical Investigation - ANSWERSAverages 5 years. Crucial process in approval
process.
NDA Review - ANSWERSAverages 24 months. Requires NDA Submission and NDA
approval. Clinical Phase III trials and further animal testing.
