6.2 Pharmacist Administration & Immunization Protocols

6.2 Pharmacist Administration & Immunization Protocols

Quick Answer: Tennessee pharmacists and pharmacy interns under direct supervision are authorized to administer vaccines under a physician-supervised collaborative practice protocol or statewide standing order (T.C.A. § 63-10-217 and Board Rule 1140-03-.17). To be certified to immunize, a pharmacist must complete an ACPE-accredited immunization certificate course of at least 20 hours, maintain current Basic Life Support (BLS) / CPR certification with hands-on skills verification, and complete at least 2 hours of immunization-related CE every 2-year license renewal cycle. Prior to injection, immunizers must distribute the current federal CDC Vaccine Information Statement (VIS) and screen for contraindications. Pharmacies must maintain an emergency kit with epinephrine and diphenhydramine, call 911 for anaphylaxis, report all administered doses to TennIIS within 30 days, and file adverse events with VAERS.

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1. Legal Authority for Pharmacist & Intern Administration

Under the Tennessee Pharmacy Practice Act of 1996 (T.C.A. § 63-10-204(40) and § 63-10-217), the statutory definition of the "practice of pharmacy" encompasses the administration of prescription drugs, biological products, and immunizations pursuant to a prescription order or collaborative pharmacy practice agreement.

Administrative rules promulgated by the Tennessee Board of Pharmacy under Tenn. Comp. R. & Regs. 1140-03-.17 establish that a licensed pharmacist may administer vaccines, or delegate such administration to a registered pharmacy intern, under the following core legal conditions:

1. Protocol Authority: Administration must occur pursuant to a patient-specific prescription order, a physician-approved Collaborative Pharmacy Practice Agreement, or an authorized statewide standing protocol executed with a licensed Tennessee physician (such as the Chief Medical Officer of the Tennessee Department of Health).
2. Supervised Intern Administration: A registered pharmacy intern who has completed an approved immunization certificate training program and holds active BLS/CPR certification may administer vaccines only under the direct personal supervision of a certified immunizing pharmacist who is physically present on site.
3. Pharmacy Technicians: Under current Tennessee Board of Pharmacy standard regulations, unregistered or non-certified supportive personnel cannot independently administer vaccines unless authorized under specific public health emergency declarations or explicit Board-approved expanded scope pilots; interns and pharmacists remain the primary immunizing personnel.

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2. Immunizing Pharmacist Credentialing Requirements

Before administering a single vaccine, a pharmacist in Tennessee must fulfill three non-negotiable credentialing prerequisites:

┌─────────────────────────────────────────────────────────────────────────────┐
│                 IMMUNIZING PHARMACIST CREDENTIALING TRIAD                   │
├──────────────────────────┬──────────────────────────────────────────────────┤
│ Prerequisite Element     │ Statutory & Regulatory Requirement               │
├──────────────────────────┼──────────────────────────────────────────────────┤
│ 1. ACPE Immunization     │ Minimum 20 hours of instruction (12 hours of     │
│    Certificate Training  │ didactic coursework + 8 hours of live hands-on   │
│                          │ injection technique and emergency simulation).   │
├──────────────────────────┼──────────────────────────────────────────────────┤
│ 2. Active BLS / CPR      │ Current Basic Life Support (BLS) or CPR          │
│    Certification         │ certification through AHA, Red Cross, or ASHI    │
│                          │ featuring an in-person, hands-on skills test.    │
├──────────────────────────┼──────────────────────────────────────────────────┤
│ 3. Continuing Education  │ Minimum of 2 hours of ACPE-approved,             │
│    (CE) Mandate          │ immunization-specific continuing education       │
│                          │ during each biennial (2-year) renewal cycle.     │
└──────────────────────────┴──────────────────────────────────────────────────┘

[!IMPORTANT] The 2 hours of immunization CE are not extra hours above the required 30 biennial CE hours; rather, they must be part of the total 30 hours of Board-approved CE mandated under Tenn. Comp. R. & Regs. 1140-01-.09 for license renewal. An immunizing pharmacist who fails to complete these 2 immunization-specific hours cannot lawfully administer vaccines until the deficiency is remedied.

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3. Administration Protocols, Eligible Vaccines & Age Restrictions

Tennessee law distinguishes between vaccines administered under an individual physician CPPA protocol and those administered under the Statewide Collaborative Practice Agreement / Standing Order issued by the Department of Health.

Eligible ACIP-Recommended Vaccines

Protocols in Tennessee authorize administration of vaccines approved by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC), including:

• Influenza: Inactivated (IIV4), recombinant (RIV4), live attenuated (LAIV4), high-dose, and adjuvanted formulations.
• Pneumococcal: Conjugate (PCV15, PCV20) and polysaccharide (PPSV23) formulations.
• Herpes Zoster: Recombinant zoster vaccine (Shingrix) for indicated adult cohorts.
• COVID-19: Current FDA-approved or authorized mRNA and protein subunit vaccines.
• Tetanus, Diphtheria, Pertussis: Tdap and Td boosters.
• Hepatitis Vaccines: Hepatitis A (HepA), Hepatitis B (HepB), and combination (HepA-HepB).
• Meningococcal: Meningococcal ACWY conjugate and Meningococcal B (MenB).
• Human Papillomavirus: 9-valent HPV vaccine (Gardasil 9).
• Travel & Specialized Immunizations: Varicella, MMR, Yellow Fever, Typhoid, Japanese Encephalitis, and Rabies (where explicitly enumerated in specialized protocols).

Patient Age Restrictions

Age limitations for pharmacist vaccination depend on the underlying legal instrument:

• Statewide Protocols: Traditionally authorize routine adult vaccinations (ages 18 and older) and establish specific lower age limits for pediatric influenza (e.g., down to 6 months or 3 years of age, depending on the current protocol parameters).
• Federal PREP Act vs. State Transition: During the federal COVID-19 Public Health Emergency, the PREP Act authorized pharmacists and interns nationwide to administer ACIP-recommended routine childhood vaccines to individuals aged 3 through 17. Tennessee's post-emergency regulatory framework incorporates expanded pediatric authority through physician-delegated CPPAs, allowing pharmacies to vaccinate pediatric cohorts if explicitly authorized by the collaborating physician's written protocol.
• Parental / Guardian Consent: For any minor patient (under age 18), informed written or documented verbal consent from a parent or legal guardian is mandatory prior to administration.

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4. Mandatory Pre-Administration Screening & Vaccine Information Statements (VIS)

Federal VIS Mandate

Under the National Childhood Vaccine Injury Act (NCVIA, 42 U.S.C. § 300aa-26), every healthcare provider who administers an ACIP-recommended vaccine—regardless of patient age or setting—must provide a copy of the current CDC Vaccine Information Statement (VIS) to the patient, parent, or legal guardian prior to each administration:

• The VIS must be the most current edition published on the CDC website.
• Providing an outdated or expired VIS is a federal statutory violation.
• For multi-dose series, a new VIS must be provided before each individual dose.
• The pharmacist must record in the patient record: the edition date of the VIS and the date the VIS was provided to the recipient.

Pre-Vaccination Clinical Screening

Immunizing pharmacists must systematically screen every patient for contraindications and precautions using standard CDC/ACIP screening tools:

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5. Anaphylaxis Management & Emergency Action Plans

Under Tenn. Comp. R. & Regs. 1140-03-.17, every pharmacy practice site that administers vaccines must maintain a fully stocked emergency medication kit and an active emergency protocol for managing acute anaphylactic reactions.

┌─────────────────────────────────────────────────────────────────────────────┐
│                     EMERGENCY ANAPHYLAXIS ACTION PLAN                       │
├─────────────────────────────────────────────────────────────────────────────┤
│ 1. Recognize Symptoms Immediately:                                          │
│    Sudden urticaria, angioedema, airway stridor, bronchospasm, hypotension  │
│                                                                             │
│ 2. Administer Intramuscular (IM) Epinephrine into Anterolateral Thigh:      │
│    • Adult (≥30 kg): 0.3 mg IM (1:1,000 / 1 mg/mL formulation)              │
│    • Pediatric (15–30 kg): 0.15 mg IM (1:1,000 / 1 mg/mL formulation)      │
│                                                                             │
│ 3. Activate Emergency Medical Services (Call 911):                          │
│    Direct staff to call 911 immediately and state "anaphylaxis reaction"   │
│                                                                             │
│ 4. Position the Patient Correctly:                                          │
│    Place patient supine with feet elevated; place in recovery position on   │
│    side if vomiting; do NOT allow patient to stand or walk abruptly        │
│                                                                             │
│ 5. Secondary Medications & Repeat Epinephrine:                              │
│    • Repeat Epinephrine every 5–15 minutes if symptoms fail to improve     │
│    • Administer Diphenhydramine (oral or IM: 25–50 mg adult, 1 mg/kg ped)  │
│      ONLY after epinephrine and only if patient is alert and airway intact │
│                                                                             │
│ 6. Document & Monitor Vitals:                                               │
│    Record exact time of epinephrine dose, monitor airway and pulse until EMS│
└─────────────────────────────────────────────────────────────────────────────┘

[!CAUTION] Antihistamines like diphenhydramine are secondary medications that do not relieve bronchospasm, laryngeal edema, or vascular collapse. In anaphylaxis, epinephrine is the primary, first-line medication. Never delay epinephrine administration to administer diphenhydramine.

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6. Mandatory Documentation, TennIIS Registry & VAERS Reporting

Post-administration compliance in Tennessee requires rigorous documentation across three regulatory channels:

A. Pharmacy Practice Site Recordkeeping

Under Board Rule 1140-03-.17, the pharmacist must document the following elements in the patient's permanent pharmacy record:

• Patient full legal name, date of birth, gender, and residential address.
• Date of administration and injection site/route (e.g., left deltoid IM).
• Vaccine manufacturer, product brand name, lot number, and expiration date.
• Name and license number of the administering pharmacist or intern.
• VIS edition date and the date the VIS was delivered to the patient/guardian.
• Prescribing practitioner / standing protocol physician details.
• Retention: Records must be retained for at least ten (10) years (matching CPPA and clinical record retention).

B. Tennessee Immunization Information System (TennIIS)

Under Tennessee Department of Health regulations and protocol terms:

• All vaccinations administered by pharmacists and pharmacy personnel must be reported to the Tennessee Immunization Information System (TennIIS), the state's official electronic immunization registry.
• Reporting Timeframe: Submissions must occur within 30 calendar days of administration (or sooner if specified by the protocol or during an active public health campaign).
• Submissions are typically transmitted via automated HL7 electronic data interfaces from the pharmacy management software.

C. Primary Care Provider (PCP) Notification

• The immunizing pharmacist must provide written or electronic notice of vaccine administration to the patient's designated primary care physician within the timeframe specified in the protocol (commonly within 14 to 30 days of administration).

D. Vaccine Adverse Event Reporting System (VAERS)

• Under federal law, healthcare providers must report to VAERS (vaers.hhs.gov) any adverse event listed in the VAERS Table of Reportable Events, any serious adverse event (death, life-threatening illness, hospitalization, persistent disability), and any clinically significant vaccine administration error.