Free Multistate Pharmacy Jurisprudence Examination (MPJE) Dispensing and Labeling Questions and Answers — Questions and Answers
Question 1: A pharmacist dispenses a new prescription for atorvastatin to a patient in a community pharmacy. According to federal law, when is the pharmacist required to provide a Medication Guide?
- Only when the patient requests it.
- With the initial dispensing and all subsequent refills.
- Only when the prescription is for a controlled substance.
- Each time the drug is dispensed in an outpatient setting. (Correct answer)
Correct answer: Each time the drug is dispensed in an outpatient setting.
Federal regulations (21 CFR 208) require that for certain drugs, like atorvastatin, which are determined by the FDA to pose a serious and significant public health concern, a Medication Guide must be provided to the patient (or their agent) each time the medication is dispensed in an outpatient setting. This applies to both new and refill prescriptions. While a prescriber can request it not be given in specific situations, it must be provided if the patient requests it, but the primary requirement is with every dispensing.
Question 2: A patient presents a valid prescription for sublingual nitroglycerin tablets. According to the Poison Prevention Packaging Act (PPPA) of 1970, which of the following is the most accurate statement regarding the dispensing of this medication?
- The medication must be dispensed in child-resistant packaging unless the patient provides a blanket waiver for all their prescriptions.
- The medication is exempt from child-resistant packaging requirements. (Correct answer)
- The medication can only be dispensed in non-child-resistant packaging if the prescriber explicitly requests it on the prescription.
- The medication must always be dispensed in a container with a safety cap, regardless of patient preference.
Correct answer: The medication is exempt from child-resistant packaging requirements.
The Poison Prevention Packaging Act (PPPA) of 1970 requires child-resistant packaging for most oral prescription drugs. However, there are specific exemptions for medications where rapid access may be critical. Sublingual nitroglycerin is one of the key exemptions to the PPPA, meaning it is not required to be dispensed in child-resistant packaging due to its need for immediate access during an angina attack.
Question 3: Which of the following pieces of information is required by federal law to be on the prescription label for a Schedule III controlled substance dispensed to an outpatient?
- The pharmacy's DEA number.
- The patient's date of birth.
- The name of the practitioner issuing the prescription. (Correct answer)
- The medication's beyond-use date.
Correct answer: The name of the practitioner issuing the prescription.
According to 21 CFR 1306.24, the label for a dispensed Schedule III, IV, or V controlled substance must include the pharmacy name and address, prescription number, date of initial filling, patient's name, practitioner's name, and directions for use, along with any cautionary statements. While a pharmacy's DEA number is required for records and transfers, it is not explicitly required on the patient's label by this federal regulation. Patient's date of birth and beyond-use date may be required by state law but are not federal requirements for the label.
Question 4: A pharmacist is preparing to dispense a non-sterile compounded magic mouthwash. Which term most accurately describes the date that must be placed on the prescription label to indicate the time after which the preparation should not be used?
- Discard Date
- Expiration Date
- Beyond-Use Date (Correct answer)
- Stability Date
Correct answer: Beyond-Use Date
The term 'Expiration Date' is assigned by the manufacturer based on extensive stability testing for a specific product and its packaging. In contrast, a 'Beyond-Use Date' (BUD) is assigned by the dispensing pharmacist for compounded preparations and is based on general guidelines (like USP chapters) or available stability literature for the specific compounded formulation. The BUD is the date after which a compounded preparation should not be used.
Question 5: A patient requests to have their prescription for zolpidem (Schedule IV) with remaining refills transferred from Pharmacy A to Pharmacy B. The two pharmacies do not share a real-time, online database. Under federal law, which of the following actions must the transferring pharmacist at Pharmacy A perform?
- Orally provide the prescription information to a pharmacy technician at Pharmacy B.
- Fax a copy of the original prescription to Pharmacy B.
- Write "VOID" on the face of the original hardcopy prescription. (Correct answer)
- Transfer the prescription only if it has been at least 30 days since the last fill.
Correct answer: Write "VOID" on the face of the original hardcopy prescription.
According to federal law (21 CFR 1306.25), when transferring a Schedule III, IV, or V controlled substance prescription that is not on a shared electronic database, the transferring pharmacist must invalidate the original prescription by writing the word "VOID" on its face. The transfer must also be communicated directly between two licensed pharmacists. The transferring pharmacist must also record the name, address, and DEA number of the receiving pharmacy and the name of the receiving pharmacist on the back of the voided prescription.
Question 6: A pharmacist fills a prescription for a Schedule II medication. In addition to standard prescription label information (pharmacy name/address, patient name, etc.), which specific cautionary statement is federally required to be on the label?
- "May cause drowsiness; do not operate heavy machinery."
- "Take with food to avoid stomach upset."
- "Store in a cool, dry place away from children."
- "CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed." (Correct answer)
Correct answer: "CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed."
Federal law (21 CFR 290.5) requires that the label of any dispensed Schedule II, III, or IV controlled substance must contain the specific cautionary statement: "CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed." The other statements are common and important auxiliary labels but are not explicitly mandated by federal law for all Schedule II drugs.
Free Multistate Pharmacy Jurisprudence Examination (MPJE) Dispensing and Labeling Questions and Answers
A pharmacist dispenses a new prescription for atorvastatin to a patient in a community pharmacy.
According to federal law, when is the pharmacist required to provide a Medication Guide?