NUR 521Module 1 Exam Study Guide. University
of Alabama-Graded A
Chapter 1: Issues for the Practitioner in Drug Therapy
1. How do you access packet labeling from drug inserts in order to
identify must know information and black box warnings?
- Dailymed.gov
2. List the four phases of FDA medication trials and be able to explain to a
patient.
- Preclinical: lab and animal studies, computer generated studies to
measure efficacy, toxic effects, and untoward reactions.
- Phase 1: safety study, 20-80 ppl, initial evalutation. Focuses on
ADME of drug. Determines most effective admin routes and
dose rangess.
- Phase 2: safety study with 100-300 ppl, identify side effects and
measure effectiveness in specific targeted population that has the
disease the med is used for
- Phase 3: begins once FDA approves for no adverse reactions and
appropriate dose range. Double blind research used, 1K-3K ppl,
lasts several years. Measures effectiveness and monitors side
effects (usually become evident here). If approved, can be
marketed but ONLY by the company seeking the approval.
- Phase 4: “Postmarketing surveillance” Monitor long term side
effects, compare this drug to others on the market, analyze
cost effectiveness.
3. Identify the scheduled drug classes and make sure you know the
medications associated with the schedules.
- Schedule 1:High potential for abuse, no routine use, not available
for regular use. “Investigational use only” Ex- heroin and LSD
- Schedule 2: Valid medical use but high potential for abuse
(psychological and physiological). Cannot be refilled, can be used in
emergency via telephone.
Ex- amphetamine and barbituates
- Schedule 3: potential for abuse, but lower than 2. Combo of
controlled and non controlled. Can cause low to moderate
dependance. Refilled up to 5 times in 6 months. Ex- certain
narcotics (codeine), nonbarbituate sedatives
- Schedule 4: low potential for abuse, psycho depend but low physio
depend.
Ex- nonnarcotic analgesics and antianxiety Ativan
NUR 521 Module 1 Study Guide
(Chapters 1,2,4,5, and 6)
Page 1 of 11
, - Schedule 5: least potential. Moderate amt of opioids. Mainly
antitussive and antidiarrheal
4. What aspects of the drug must the drug manufacturer supply
evidence of prior to a generic being allowed retail sale?
• - Once brand name patent expires, generic can be made
• FDA must approve to meet specifications for quality, purity,
strength, & potency
• Generic must demonstrate therapeutic equivalence to brand
name
NUR 521 Module 1 Study Guide
(Chapters 1,2,4,5, and 6)
Page 2 of 11
of Alabama-Graded A
Chapter 1: Issues for the Practitioner in Drug Therapy
1. How do you access packet labeling from drug inserts in order to
identify must know information and black box warnings?
- Dailymed.gov
2. List the four phases of FDA medication trials and be able to explain to a
patient.
- Preclinical: lab and animal studies, computer generated studies to
measure efficacy, toxic effects, and untoward reactions.
- Phase 1: safety study, 20-80 ppl, initial evalutation. Focuses on
ADME of drug. Determines most effective admin routes and
dose rangess.
- Phase 2: safety study with 100-300 ppl, identify side effects and
measure effectiveness in specific targeted population that has the
disease the med is used for
- Phase 3: begins once FDA approves for no adverse reactions and
appropriate dose range. Double blind research used, 1K-3K ppl,
lasts several years. Measures effectiveness and monitors side
effects (usually become evident here). If approved, can be
marketed but ONLY by the company seeking the approval.
- Phase 4: “Postmarketing surveillance” Monitor long term side
effects, compare this drug to others on the market, analyze
cost effectiveness.
3. Identify the scheduled drug classes and make sure you know the
medications associated with the schedules.
- Schedule 1:High potential for abuse, no routine use, not available
for regular use. “Investigational use only” Ex- heroin and LSD
- Schedule 2: Valid medical use but high potential for abuse
(psychological and physiological). Cannot be refilled, can be used in
emergency via telephone.
Ex- amphetamine and barbituates
- Schedule 3: potential for abuse, but lower than 2. Combo of
controlled and non controlled. Can cause low to moderate
dependance. Refilled up to 5 times in 6 months. Ex- certain
narcotics (codeine), nonbarbituate sedatives
- Schedule 4: low potential for abuse, psycho depend but low physio
depend.
Ex- nonnarcotic analgesics and antianxiety Ativan
NUR 521 Module 1 Study Guide
(Chapters 1,2,4,5, and 6)
Page 1 of 11
, - Schedule 5: least potential. Moderate amt of opioids. Mainly
antitussive and antidiarrheal
4. What aspects of the drug must the drug manufacturer supply
evidence of prior to a generic being allowed retail sale?
• - Once brand name patent expires, generic can be made
• FDA must approve to meet specifications for quality, purity,
strength, & potency
• Generic must demonstrate therapeutic equivalence to brand
name
NUR 521 Module 1 Study Guide
(Chapters 1,2,4,5, and 6)
Page 2 of 11
