B.Pharm. Bachelor of Pharmacy Bachelor of Pharmacy (B.Pharm.) Pharmaceutical Jurisprudence 5 — Questions and Answers
Question 1: Which FDA program allows patients with serious conditions to access investigational drugs outside of clinical trials?
- Accelerated Approval
- Expanded Access (Compassionate Use) (Correct answer)
- Priority Review
- Breakthrough Therapy Designation
Correct answer: Expanded Access (Compassionate Use)
Expanded Access (also called Compassionate Use) allows patients with serious conditions access to investigational drugs outside of clinical trials when no comparable alternatives exist.
Question 2: A pharmacist who dispenses a medication that was removed from market due to safety concerns may face which type of liability?
- Criminal liability only
- Civil liability only
- Both civil and criminal liability (Correct answer)
- No liability if unaware of recall
Correct answer: Both civil and criminal liability
Dispensing a recalled drug can result in both civil liability for patient harm and criminal liability for violating federal regulations.
Question 3: The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 requires that prescriptions for controlled substances dispensed via the internet must be based on:
- A telephone consultation with a pharmacist
- An in-person medical evaluation by a DEA-registered practitioner (Correct answer)
- A written questionnaire completed by the patient
- Verification of a prior paper prescription
Correct answer: An in-person medical evaluation by a DEA-registered practitioner
The Ryan Haight Act requires that controlled substances dispensed via online pharmacies be based on a valid prescription from a practitioner who has conducted at least one in-person evaluation.
Question 4: Which organization accredits hospital pharmacy programs and sets standards for medication management in healthcare organizations?
- American Pharmacists Association (APhA)
- The Joint Commission (TJC) (Correct answer)
- Board of Pharmacy Specialties (BPS)
- National Association of Boards of Pharmacy (NABP)
Correct answer: The Joint Commission (TJC)
The Joint Commission accredits healthcare organizations and sets medication management standards that hospital pharmacies must meet for accreditation.
Question 5: Under the Poison Prevention Packaging Act, which product is specifically exempt from child-resistant packaging requirements?
- Oral contraceptives in manufacturer's dispenser packages
- Nitroglycerin tablets
- Both A and B (Correct answer)
- Aspirin tablets
Correct answer: Both A and B
Both oral contraceptives in dispenser packages and sublingual nitroglycerin are specifically exempt from child-resistant packaging requirements under the PPPA.
Question 6: A pharmacy sells a controlled substance to a known drug dealer. The pharmacist may be charged under federal law with:
- Drug trafficking and distribution of controlled substances (Correct answer)
- Only prescription fraud
- Only civil RICO violations
- Misbranding under the FD&C Act
Correct answer: Drug trafficking and distribution of controlled substances
Knowingly selling controlled substances to a drug dealer constitutes illegal drug trafficking and distribution, a serious federal criminal offense under the CSA.
Question 7: Which record-keeping requirement applies to Schedule II controlled substances at the pharmacy level?
- Must be maintained for at least 2 years and kept separate from other records (Correct answer)
- Can be combined with Schedule III-V records if clearly marked
- Must be submitted monthly to the state pharmacy board
- Must be maintained for at least 5 years
Correct answer: Must be maintained for at least 2 years and kept separate from other records
Federal regulations require Schedule II records to be maintained for at least 2 years and kept in a separate file from other controlled substance records.
B.Pharm. Bachelor of Pharmacy Bachelor of Pharmacy (B.Pharm.) Pharmaceutical Jurisprudence 5
Which FDA program allows patients with serious conditions to access investigational drugs outside of clinical trials?