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

The PREP Act grants immunity from tort liability to covered persons administering specified countermeasures during a declared public health emergency.

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

The FDA's Center for Biologics Evaluation and Research (CBER) is responsible for regulating and licensing all vaccines sold in the United States.

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

VIS documents are FDA-approved CDC publications that all vaccine providers are legally required to give patients (or guardians) before each dose of covered vaccines under the NCVIA.

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

A standing order or protocol authorizes pharmacists to screen, select, and administer vaccines to eligible patients without requiring an individual prescriber order for each patient.

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

HIPAA permits disclosure of immunization records to state registries without individual authorization when state law authorizes or requires such reporting.

(APHA) APhA Pharmacy-Based Immunization Certificate Practice Test

(APHA) APhA Pharmacy-Based Immunization Certificate Practice Test

APHA Legal & Regulatory Framework for Pharmacy Immunization