APHA Quality Assurance & Compliance 3 — Questions and Answers
Question 1: A pharmacist is audited by the state board and asked for proof of proper vaccine disposal. Which method is considered appropriate for disposing of expired vaccines?
- Returning to the manufacturer or using a licensed medical waste company (Correct answer)
- Flushing down the sink with running water
- Discarding in the regular trash in a sealed bag
- Incinerating in the pharmacy break room
Correct answer: Returning to the manufacturer or using a licensed medical waste company
Expired vaccines must be returned to the manufacturer, reverse distributor, or disposed of as regulated medical waste per EPA and state guidelines.
Question 2: Which of the following is a required element when documenting vaccine administration in an Immunization Information System (IIS)?
- Vaccine lot number (Correct answer)
- Patient's social security number
- Prescriber's DEA number
- Pharmacy's quarterly revenue
Correct answer: Vaccine lot number
The vaccine lot number is a mandated data element in immunization records to support tracking and recall efforts.
Question 3: A state pharmacy law requires pharmacists to participate in the state Immunization Information System. If the state IIS is unavailable, what should the pharmacist do?
- Document by paper and enter data once the system is restored (Correct answer)
- Postpone all vaccinations until the system is online
- Use a neighboring state's IIS as a workaround
- Administer vaccines but skip documentation entirely
Correct answer: Document by paper and enter data once the system is restored
Temporary IIS downtime requires paper backup documentation; data must be entered retroactively when the system is restored.
Question 4: Which protocol should be in place to ensure compliance with epinephrine administration in the event of anaphylaxis during immunization?
- A written emergency protocol with epinephrine available and staff trained in its use (Correct answer)
- Verbal instructions given to the patient upon arrival
- A posted list of nearby hospitals
- An automated external defibrillator (AED) only
Correct answer: A written emergency protocol with epinephrine available and staff trained in its use
APhA standards require a written emergency plan with readily accessible epinephrine and staff trained in recognizing and treating anaphylaxis.
Question 5: How long after vaccine administration should a patient be observed for adverse reactions according to ACIP guidelines?
- 15 minutes (30 minutes for those with a history of allergic reactions) (Correct answer)
- 5 minutes
- 45 minutes
- 60 minutes for all patients
Correct answer: 15 minutes (30 minutes for those with a history of allergic reactions)
ACIP recommends 15-minute post-vaccination observation for most patients and 30 minutes for those with prior allergic reactions.
Question 6: A pharmacy receives a vaccine shipment but the temperature monitor shows an excursion during transit. Who should the pharmacist FIRST contact?
- The vaccine manufacturer or distributor (Correct answer)
- The state department of health
- The patient scheduled for the vaccine
- The FDA MedWatch program
Correct answer: The vaccine manufacturer or distributor
The pharmacist should first contact the manufacturer or distributor to report the excursion and receive guidance on whether the product is still viable.
Question 7: Which standard operating procedure (SOP) component is most critical for ensuring pharmacist compliance with immunization protocols?
- Regular staff training and competency assessments (Correct answer)
- Annual review of pharmacy layout
- Monthly equipment inventory logs
- Patient billing reconciliation records
Correct answer: Regular staff training and competency assessments
Ongoing training and competency assessment ensure all staff adhere to current immunization protocols and recognize protocol changes.
APHA Quality Assurance & Compliance 3
A pharmacist is audited by the state board and asked for proof of proper vaccine disposal.
Which method is considered appropriate for disposing of expired vaccines?