APHA Legal & Regulatory Framework for Pharmacy Immunization

Question 1

Under the Public Readiness and Emergency Preparedness (PREP) Act, what protection is provided to pharmacist immunizers?

Accepted Answer

Immunity from liability for claims arising from administration of covered countermeasures during a declared emergency

Answer

Federal licensure to administer any vaccine without a state prescription

Answer

Exemption from VAERS reporting requirements during public health emergencies

Answer

Protection from malpractice suits in all 50 states regardless of emergency declarations

Question 2

Which federal agency is responsible for licensing vaccines in the United States?

Accepted Answer

FDA Center for Biologics Evaluation and Research (CBER)

Answer

CDC National Center for Immunization and Respiratory Diseases (NCIRD)

Answer

CMS Center for Medicare and Medicaid Services

Answer

DEA Drug Enforcement Administration

Question 3

What is the Vaccine Information Statement (VIS) and who is required to provide it?

Accepted Answer

An FDA-approved document that vaccinators must provide to patients before each vaccine dose under the National Childhood Vaccine Injury Act

Answer

A CDC publication that patients may optionally request before vaccination

Answer

A state-mandated consent form that pharmacists must have signed before every vaccination

Answer

An insurance billing document required by CMS for vaccine reimbursement

Question 4

A pharmacist administers a vaccine in a state that requires a standing order or protocol. What does this legal mechanism allow?

Accepted Answer

It allows pharmacists to vaccinate patients without an individual patient-specific prescription from a prescriber

Answer

It exempts pharmacists from documenting adverse events in patient records

Answer

It grants pharmacists authority to diagnose contraindications without physician review

Answer

It permits pharmacists to administer vaccines that are not FDA-approved

Question 5

Under HIPAA, which of the following is permissible when a pharmacist shares a patient's immunization record?

Accepted Answer

Sharing with the state immunization registry without specific patient authorization if permitted by law

Answer

Sharing with the patient's employer without patient consent for workplace health requirements

Answer

Sharing with a family member without patient consent for convenience

Answer

Sharing with a marketing company for vaccine promotion campaigns

Question 6

What does the National Vaccine Injury Compensation Program (VICP) provide?

Accepted Answer

A no-fault federal compensation system for individuals who experience serious adverse effects from covered vaccines

Answer

Criminal liability protection for vaccine manufacturers who produce defective products

Answer

Malpractice insurance for pharmacist immunizers in all 50 states

Answer

Reimbursement to pharmacies for unused vaccines due to cold chain failure