APHA Legal & Regulatory Framework for Pharmacy Immunization 2 — Questions and Answers
Question 1: Which reporting system must pharmacists use to report suspected vaccine adverse events in the United States?
- Vaccine Adverse Event Reporting System (VAERS) (Correct answer)
- MedWatch FDA Safety Reporting Portal
- CDC WONDER database
- National Healthcare Safety Network (NHSN)
Correct answer: Vaccine Adverse Event Reporting System (VAERS)
VAERS is the national pharmacovigilance system co-managed by FDA and CDC where healthcare providers are required to report certain adverse events following vaccination.
Question 2: What is the primary role of a state immunization information system (IIS) for pharmacist immunizers?
- To provide a consolidated patient immunization history and record doses administered by the pharmacist (Correct answer)
- To approve or deny vaccine administration requests from pharmacists
- To store vaccine cold chain temperature logs from pharmacy refrigerators
- To issue standing orders authorizing pharmacist immunization activities
Correct answer: To provide a consolidated patient immunization history and record doses administered by the pharmacist
State IIS databases aggregate immunization records from multiple providers, allowing pharmacists to access a patient's complete vaccine history and record new doses administered.
Question 3: Which federal law expanded pharmacist authority to administer vaccines during the COVID-19 pandemic beyond what state law allowed?
- PREP Act Declaration (Correct answer)
- Omnibus Budget Reconciliation Act (OBRA-90)
- Pharmacy Practice Act amendments
- Affordable Care Act Section 1557
Correct answer: PREP Act Declaration
PREP Act declarations during the COVID-19 pandemic preempted state restrictions and authorized pharmacists and pharmacy interns to administer covered vaccines to eligible populations.
Question 4: A pharmacist discovers a patient was previously compensated through VICP for a vaccine injury. What is the implication for future vaccination?
- VICP compensation does not preclude future vaccination; each dose decision is based on current clinical assessment and contraindications (Correct answer)
- The patient is permanently contraindicated from receiving any vaccine covered by VICP
- The patient must obtain written physician approval before receiving any future vaccination
- The pharmacist must file a VAERS report before administering any future vaccine to this patient
Correct answer: VICP compensation does not preclude future vaccination; each dose decision is based on current clinical assessment and contraindications
Past VICP compensation indicates a prior adverse event but does not automatically contraindicate future vaccines; each vaccination decision requires individualized clinical assessment.
Question 5: What minimum documentation is required after administering a vaccine in a pharmacy setting under federal and most state guidelines?
- Date, vaccine name, lot number, manufacturer, site/route, VIS edition date, and administering pharmacist identity (Correct answer)
- Only the vaccine name and lot number in the patient's medication profile
- A signed consent form and photo ID of the patient
- VAERS report number and IIS confirmation code
Correct answer: Date, vaccine name, lot number, manufacturer, site/route, VIS edition date, and administering pharmacist identity
Federal law and ACIP standards require documentation of date, vaccine name, lot number, manufacturer, dose/route/site, VIS date, and the provider's name and address.
Question 6: Which entity sets the recommended immunization schedules that form the clinical standard of care for pharmacist immunizers in the US?
- Advisory Committee on Immunization Practices (ACIP) (Correct answer)
- American Pharmacists Association (APhA)
- FDA Center for Biologics Evaluation and Research (CBER)
- Joint Commission on Pharmacy Practitioners (JCPP)
Correct answer: Advisory Committee on Immunization Practices (ACIP)
ACIP, a federal advisory committee to the CDC, establishes the recommended immunization schedules for children and adults that represent the standard of care in the US.
APHA Legal & Regulatory Framework for Pharmacy Immunization 2
Which reporting system must pharmacists use to report suspected vaccine adverse events in the United States?