APHA Legal & Regulatory Framework for Pharmacy Immunization 1 — Questions and Answers
Question 1: Under the Public Readiness and Emergency Preparedness (PREP) Act, what protection is provided to pharmacist immunizers?
- Immunity from liability for claims arising from administration of covered countermeasures during a declared emergency (Correct answer)
- Federal licensure to administer any vaccine without a state prescription
- Exemption from VAERS reporting requirements during public health emergencies
- Protection from malpractice suits in all 50 states regardless of emergency declarations
Correct answer: Immunity from liability for claims arising from administration of covered countermeasures during a declared emergency
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?
- FDA Center for Biologics Evaluation and Research (CBER) (Correct answer)
- CDC National Center for Immunization and Respiratory Diseases (NCIRD)
- CMS Center for Medicare and Medicaid Services
- DEA Drug Enforcement Administration
Correct answer: FDA Center for Biologics Evaluation and Research (CBER)
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?
- An FDA-approved document that vaccinators must provide to patients before each vaccine dose under the National Childhood Vaccine Injury Act (Correct answer)
- A CDC publication that patients may optionally request before vaccination
- A state-mandated consent form that pharmacists must have signed before every vaccination
- An insurance billing document required by CMS for vaccine reimbursement
Correct answer: An FDA-approved document that vaccinators must provide to patients before each vaccine dose under the National Childhood Vaccine Injury Act
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?
- It allows pharmacists to vaccinate patients without an individual patient-specific prescription from a prescriber (Correct answer)
- It exempts pharmacists from documenting adverse events in patient records
- It grants pharmacists authority to diagnose contraindications without physician review
- It permits pharmacists to administer vaccines that are not FDA-approved
Correct answer: It allows pharmacists to vaccinate patients without an individual patient-specific prescription from a prescriber
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?
- Sharing with the state immunization registry without specific patient authorization if permitted by law (Correct answer)
- Sharing with the patient's employer without patient consent for workplace health requirements
- Sharing with a family member without patient consent for convenience
- Sharing with a marketing company for vaccine promotion campaigns
Correct answer: Sharing with the state immunization registry without specific patient authorization if permitted by law
HIPAA permits disclosure of immunization records to state registries without individual authorization when state law authorizes or requires such reporting.
Question 6: What does the National Vaccine Injury Compensation Program (VICP) provide?
- A no-fault federal compensation system for individuals who experience serious adverse effects from covered vaccines (Correct answer)
- Criminal liability protection for vaccine manufacturers who produce defective products
- Malpractice insurance for pharmacist immunizers in all 50 states
- Reimbursement to pharmacies for unused vaccines due to cold chain failure
Correct answer: A no-fault federal compensation system for individuals who experience serious adverse effects from covered vaccines
The VICP is a federal no-fault compensation program that allows individuals injured by covered vaccines to file claims for compensation without suing vaccine manufacturers.
APHA Legal & Regulatory Framework for Pharmacy Immunization 1
Under the Public Readiness and Emergency Preparedness (PREP) Act, what protection is provided to pharmacist immunizers?