Chapter 2- Drug Regulations

Question 1

Phase 1 of Clinical Investigation/Trials

Answer 1

Testing conducted on healthy volunteers to determine proper dosage and assess for adverse effects
- focus is on safety

Question 2

Phase 2 of Clinical Trials

Answer 2

Pts with the dz to be treated are given the drug.

• main focus is on effectiveness
• new drug compared with inert placebo

Question 3

Phase 3 of Clinical Trials

Answer 3

Large numbers of pts with the dz are given the drug to determine patient variability. Potential drug-drug interactions examined. Pts with chronic conditions such as cardiac, renal, or hepatic impairment are given the drug to determine safety in these important populations

Question 4

Scheduled drugs

Answer 4

Drugs that are classified and regulated according to their potential for abuse

• Type 1 = highest potential for abuse,
• Type V = lowest

Question 5

Controlled substances

Answer 5

Drugs whose use is restricted by the Comprehensive Drug Abuse Prevention and Control Act of 1970
- complete records of all quantities purchased and sold

Question 6

When considering various drug therapies, the nurse knows that most drug testing and approval occurs within what population?

Answer 6

Caucasian men, and may not be safe for other populations