Worked explanations
The paper carries one for every question, at the back. These are the three above.
Q1
A
Ch. 1: Medications
Answer: A - Formulation and sterility differ by route
Because The correct answer is: Formulation and sterility differ by route. See Drug reference ch. 5 (routes of administration). Drug reference ch. 5 (routes of administration)
Where the other options lead
- B.Names potency. The concern is safety rather than only efficacy.
- C.Names labelling. Labelling follows the error rather than causing it.
- D.Names billing. Billing is not the safety issue.
Q2
B
Ch. 3: Patient Safety and Quality Assurance
Answer: B - The next person will make the same mistake
Because The correct answer is: The next person will make the same mistake. See PTCB Knowledge Reference sec. 3. PTCB Knowledge Reference sec. 3
Where the other options lead
- A.Names accountability. The person is already identified.
- C.Names time. Stopping early is faster and useless.
- D.Names records. It can be documented and teaches nothing.
Q3
D
Ch. 1: Medications
Answer: D - One designated interchangeable
Because The correct answer is: One designated interchangeable. See 21 CFR 201.100. 21 CFR 201.100
Where the other options lead
- A.Uses prescriber silence. Silence does not authorise substitution of a biologic.
- B.Assumes all are substitutable. Only an interchangeable designation permits substitution without the prescriber.
- C.Rules it out. Interchangeable biosimilars exist for that purpose.