Which is one of the main reasons a pharmaceutical company might ...

[daltonest1984]

Which is one of the main reasons a pharmaceutical company might be granted an exclusive period to market and distribute a new drug?
 
  1. It allows the company to recoup the cost of research and development.
  2. It allows consumers to get used to the trade name of the drug.
  3. It allows all the adverse effects to be discovered.
  4. Without competition, consumer savings are significant.

Question 2

Bioavailability can be different between the generic and trade versions of a drug. When is it not appropriate for a generic drug to be substituted for a trade version?
 
  1. The trade version costs the same as the generic.
  2. The time for onset of action is different between the generic and trade versions.
  3. The inert ingredients are different in the generic and trade versions.
  4. The drug is a critical care drug, or one with a narrow safety margin.

[aadams68]

Answer to Question 1

Correct Answer: 1
Rationale 1: Exclusivity allows a pharmaceutical company a period of time to recoup the costs of research and development of a drug.
Rationale 2: The period of exclusivity is not granted so that consumers will become familiar with a trade name.
Rationale 3: Adverse effects are discovered during the clinical drug trials, not during the period of exclusivity.
Rationale 4: Competition between pharmaceutical companies actually results in consumer savings.
Global Rationale: Exclusivity allows a pharmaceutical company a period of time to recoup the costs of research and development of a drug. Exclusivity is not granted so that consumers will become familiar with a trade name. Adverse effects are discovered during the clinical drug trials, not during the period of exclusivity. Competition between pharmaceutical companies actually results in consumer savings.

Answer to Question 2

Correct Answer: 4
Rationale 1: While the cost of the trade version is usually greater than that of the generic version of the same drug, cost does not affect bioavailability.
Rationale 2: The time of onset of action is not always an issue in using the generic over the trade version.
Rationale 3: The difference in inert ingredients is not always an issue in substitution of a generic over the trade version.
Rationale 4: The nurse should not substitute a generic drug for a trade version if the drug is a critical care drug or has a narrow safety margin.
Global Rationale: The nurse should not substitute a generic drug for a trade version if the drug is a critical care drug or has a narrow safety margin. While the cost of the trade version is usually greater than that of the generic version of the same drug, cost does not affect bioavailability. The time of onset of action is not always an issue in using the generic over the trade version. The difference in inert ingredients is not always an issue in substitution of a generic over the trade version.

[daltonest1984]

Thank you!

[aadams68]

Always glad to help...