4.7 Immunizations, Naloxone & Public Health

Why This Topic Is Tested Heavily

Public-health practice is a growing share of the Pharmacist Practice (33%) content area. Pennsylvania has repeatedly expanded pharmacist scope — most recently by conforming Board regulations effective April 11, 2026 (56 Pa.B. 1980) to 8 years for general injectables (and 5 years for flu/COVID), aligning the Code with earlier statutory expansion. The MPJE tests the current age thresholds, supervision rules, and the naloxone standing order. Outdated exam-prep materials citing "6+" or pre-amendment "18+" floors are wrong; use the current Board text — 8+ general / 5+ flu/COVID.

Immunization Authority — 49 Pa. Code § 27.403

General Injectable/Biological Authority

Under 49 Pa. Code § 27.403(a), a pharmacist who has completed the required training and holds a current CPR certificate may administer injectable medications, biologicals, and immunizations to persons 8 years of age or older. Requirements:

• Board authority (initial training and biennial continuing education).
• A standing order or written protocol from a licensed physician, CRNP, or PA, OR practice under the pharmacist's own authority when authorized.
• Current CPR certification (Healthcare Provider level).
• Approved training program (ACPE-accredited immunization course, e.g., APhA Pharmacy-Based Immunization Delivery).

Influenza and COVID-19 — Broader Age Range

Under 49 Pa. Code § 27.403(b), a pharmacist may administer influenza and COVID-19 immunizations (by injection or needle-free device) to persons 5 years of age or older. This is broader than the general 8+ authority because flu and COVID vaccines have a strong pediatric public-health rationale.

Intern Authority

A pharmacist-intern may administer immunizations only under the direct and immediate personal supervision of a pharmacist who has been granted immunization authority. The intern must have completed the same training and CPR certification.

Delegation to Other Professionals

Under 49 Pa. Code § 27.403(c)(1), a pharmacist may delegate the administration of immunizations to:

• Certified Registered Nurse Practitioners (CRNPs),
• Physician Assistants (PAs),
• Registered Nurses (RNs), and
• Licensed Practical Nurses (LPNs).

Under 49 Pa. Code § 27.403(c)(2), a pharmacist may delegate influenza and COVID-19 administration to a registered pharmacy technician for individuals 13 years of age or older, provided:

• The technician is registered with the PA Board (49 Pa. Code §§ 27.701–27.705, effective June 28, 2025).
• The technician has completed Board-approved immunization training and holds current CPR certification.
• The pharmacist provides direct and immediate personal supervision.
• A written protocol is in place.

Immunization Age Reference Table

Competent Authorities for Vaccine Selection

Pharmacists must follow vaccination schedules and medical guidance from recognized competent authorities. PA recognizes:

• CDC / ACIP (Advisory Committee on Immunization Practices) — the primary schedule authority.
• ACOG (American College of Obstetricians and Gynecologists) for pregnancy-related vaccines.
• AAP (American Academy of Pediatrics) and AAFP (American Academy of Family Physicians) for pediatric and family-medicine schedules.
• FDA for COVID-19 product authorization/approval and age indications.

A pharmacist who deviates from these authorities without a documented medical reason risks Board discipline.

Protocol, Training, and CPR

Under 49 Pa. Code § 27.404, a written protocol (standing order) for immunization administration is valid for up to 2 years, at which point it must be renewed in writing. The pharmacist must maintain:

• A copy of the standing order or protocol.
• The pharmacist's immunization training certificate.
• Current CPR card.
• A record of each immunization administered (vaccine, lot, expiration, dose, site, patient, date, administering pharmacist).

Reporting and Pediatric Referral

Every immunization administered must be reported to the PA Department of Health (DOH) immunization registry (SIIS) within 72 hours of administration. For patients under 18, the pharmacist must also notify the parent or caregiver of the recommended well-child visit schedule and refer to a primary-care provider.

Naloxone — Act 139 of 2014 (David's Law)

Standing Order

Under Act 139 of 2014 (David's Law), the Pennsylvania Secretary of Health (and the Physician General) may issue a statewide standing order allowing pharmacists to dispense naloxone (opioid antagonist) without an individual prescription. The current standing order is DOH-001-2025-Amended, effective September 5, 2025, and is tiered to cover both prescription naloxone products and FDA-approved OTC naloxone.

Pharmacist Dispensing Without Individual Rx

A pharmacist may:

• Dispense naloxone to any individual at risk of overdose, a family member, friend, or person in a position to assist, under the standing order.
• Provide patient counseling on how to recognize an overdose, how to administer naloxone (intranasal or intramuscular), and the need to call 911 and provide rescue breathing.
• Document the dispensing under the standing order.
• Bill insurance or Medicaid for naloxone dispensed under the standing order.

Good-Samaritan Protections

Act 139 also provides Good-Samaritan civil immunity to:

• The bystander who administers naloxone in good faith to someone believed to be overdosing.
• The pharmacist who dispenses naloxone under the standing order.
• The physician/Secretary of Health who issues the standing order.

Immunity does not extend to gross negligence or willful misconduct.

Documentation Trap

A pharmacist dispensing naloxone under the standing order does not need an individual prescriber name on the label — the label may identify the Secretary of Health's standing order as the prescriber of record. The dispensing must still be entered in the pharmacy's dispensing system, the PDMP (if dispensed as a prescription product), and the patient record. OTC naloxone sold under the standing order is recorded as a sale under the order, not as a prescription fill.

Public-Health Adjacencies

Pharmacists also engage in broader public-health roles tested lightly on the MPJE:

• Tobacco cessation counseling and OTC nicotine replacement therapy.
• HIV testing (where authorized) and referral.
• Syringe services — PA law is restrictive; pharmacists should not dispense syringes for illicit use but may counsel on safe disposal.
• Pandemic response — pharmacist testing and treatment authority for influenza and COVID-19 under collaborative practice agreements.

Key Numbers to Memorize

• 8+ — general immunization age.
• 5+ — flu and COVID immunization age.
• 13+ — technician delegation age for flu/COVID.
• 2 years — written protocol validity.
• 72 hours — registry reporting deadline.
• DOH-001-2025-Amended — current naloxone standing order (Sept 5, 2025).
• Act 139 of 2014 — David's Law naloxone authority.