Chapter 02: The Drug Approval Process

Chapter 02: The Drug Approval Process

 

Complete Chapter Questions With Answers

 

Sample Questions Are Posted Below

 

MULTIPLE CHOICE

 

1. The nurse is preparing to administer a schedule II injectable drug and is drawing up half of the contents of a single-use vial. Which nursing action is correct?

a.	Ask another nurse to observe and cosign wasting the remaining drug from the vial.
b.	Keep the remaining amount in the patient’s drawer to give at the next dose.
c.	Record the amount unused in the patient’s medication record.
d.	Dispose of the vial with the remaining drug into a locked collection box.

 

 

ANS:  A

Schedule II drugs are controlled substances, and all must be accounted for. When wasting a portion of a drug, another nurse should observe and cosign that a drug was wasted.

 

DIF:    COGNITIVE LEVEL: Applying (Application)                  REF:   Page 16

TOP:   NURSING PROCESS: Nursing Intervention

MSC:  NCLEX: Physiological Integrity: Pharmacological and Parenteral Therapies

 

2. A patient is prescribed a medication and asks the nurse if the drug is available in a generic form. The nurse understands that a generic medication will have a name that

a.	is a registered trademark.
b.	is always capitalized.
c.	describes the drug’s chemical structure.
d.	is non-proprietary.

 

 

ANS:  D

The generic name is the official, non-proprietary name for a drug. The brand name is the trademark name and is always capitalized. The chemical name describes the chemical structure of the drug.

 

DIF:    COGNITIVE LEVEL: Understanding (Comprehension)    REF:   Page 18

TOP:   NURSING PROCESS: N/A

MSC:  NCLEX: Physiological Integrity: Pharmacological and Parenteral Therapies

 

3. A patient receives a prescription on which the provider has noted that a generic medication may be given. The patient asks the nurse what this means. What will the nurse tell the patient about generic drugs?

a.	They contain the same inert ingredients as brand-name drugs.
b.	They have chemical structures that are identical to proprietary drugs.
c.	They tend to be less expensive than brand-name drugs.
d.	They undergo extensive testing before they are marketed.

 

 

ANS:  C

Generic drugs are approved by the FDA if they are proved to be bioequivalent to the brand-name drug. They tend to be less expensive because manufacturers of these drugs do not have to do the extensive testing required of brand-name drugs before marketing. They are not identical to brand-name drugs and often have different inert ingredients.

 

DIF:    COGNITIVE LEVEL: Applying (Application)                  REF:   Page 18

TOP:   NURSING PROCESS: Nursing Intervention: Patient Teaching

MSC:  NCLEX: Management of Client Care

 

4. The nurse reviews information about a drug and notes the initials “USP” after the drug’s official name. The nurse understands that this designation indicates the drug

a.	is a controlled substance.
b.	is approved by the U.S. Food and Drug Administration (FDA).
c.	is available in generic form.
d.	meets quality and safety standards.

 

 

ANS:  D

The “USP” designation is given to drugs that have met high standards for therapeutic use, patient safety, quality, purity, strength, packaging safety, and dosage form by the United States Pharmacopoeia National Formulary. The FDA classifies controlled substances with Roman numerals from I to V. The USP designation does not indicate FDA approval. The USP designation does not indicate generic availability.

 

DIF:    COGNITIVE LEVEL: Understanding (Comprehension)    REF:   Page 15

TOP:   NURSING PROCESS: N/A

MSC:  NCLEX: Physiological Integrity: Pharmacological and Parenteral Therapies