MPJE Pharmacist Practice Standards 2 — Questions and Answers
Question 1: A pharmacist receives a prescription for a controlled substance but suspects the prescriber's DEA number is fraudulent. What is the pharmacist's MOST appropriate first action?
- Dispense the prescription and document the concern
- Verify the DEA number using the DEA's online verification tool (Correct answer)
- Refuse to dispense and call the police immediately
- Contact the state board of pharmacy before taking any action
Correct answer: Verify the DEA number using the DEA's online verification tool
Pharmacists have a corresponding responsibility to verify prescriber DEA numbers before dispensing controlled substances when fraud is suspected.
Question 2: Under federal law, which of the following must appear on the label of a dispensed controlled substance in Schedule II?
- The patient's date of birth
- A warning that the drug is a controlled substance and has potential for abuse (Correct answer)
- The prescriber's DEA number
- The quantity originally prescribed
Correct answer: A warning that the drug is a controlled substance and has potential for abuse
Federal regulations require that Schedule II through V labels include a transfer warning and abuse potential notice as specified by the CSA.
Question 3: A pharmacist discovers that a technician has been consistently making errors in calculations. What is the pharmacist's professional obligation?
- Report the technician to the DEA immediately
- Terminate the technician's employment
- Retrain and supervise the technician more closely, documenting actions taken (Correct answer)
- Ignore minor errors if no patient harm has occurred
Correct answer: Retrain and supervise the technician more closely, documenting actions taken
Pharmacists bear supervisory responsibility for pharmacy technicians and must address competency issues through training, supervision, and documentation.
Question 4: When a pharmacist substitutes a generic drug for a brand-name drug without patient or prescriber objection, which regulation governs the substitution?
- Federal OBRA '90 requirements
- State generic substitution laws (Correct answer)
- FDA Orange Book guidelines exclusively
- USP drug standards
Correct answer: State generic substitution laws
Generic drug substitution is governed by individual state laws, which vary in their requirements for therapeutic equivalence and notification.
Question 5: A pharmacist is asked to compound a preparation that is commercially available. Under FDCA Section 503A, which statement BEST describes the applicable standard?
- Compounding commercially available drugs is always prohibited
- Compounding is permitted if it is for an identified individual patient with a valid prescription (Correct answer)
- The pharmacist must obtain FDA approval before compounding any commercially available drug
- Commercial availability has no bearing on compounding decisions under federal law
Correct answer: Compounding is permitted if it is for an identified individual patient with a valid prescription
Under 503A, pharmacists may compound commercially available products for individual patients based on a valid prescription, though routine copying of commercial products is restricted.
Question 6: Which federal act requires pharmacists to offer counseling to Medicaid patients receiving new prescriptions?
- The Drug Price Competition and Patent Term Restoration Act
- OBRA '90 (Omnibus Budget Reconciliation Act of 1990) (Correct answer)
- The Poison Prevention Packaging Act
- The Health Insurance Portability and Accountability Act
Correct answer: OBRA '90 (Omnibus Budget Reconciliation Act of 1990)
OBRA '90 mandates that pharmacists offer prospective drug use review and counseling to Medicaid outpatients receiving new prescriptions.
Question 7: A pharmacist fills a prescription for warfarin and fails to warn the patient about significant drug-food interactions. The patient suffers a serious bleeding event. What legal doctrine most directly applies?
- Respondeat superior
- Negligence per se
- Pharmacy malpractice / professional negligence (Correct answer)
- Strict liability
Correct answer: Pharmacy malpractice / professional negligence
Failure to provide adequate drug interaction counseling constitutes professional negligence (malpractice) because the pharmacist breached the standard of care owed to the patient.
MPJE Pharmacist Practice Standards 2
A pharmacist receives a prescription for a controlled substance but suspects the prescriber's DEA number is fraudulent.
What is the pharmacist's MOST appropriate first action?