11.1 Kentucky Board-Authorized Protocols

11.1 Kentucky Board-Authorized Protocols

The Commonwealth of Kentucky has long served as a national trailblazer in expanding the clinical scope of pharmacy practice. Through KRS 315.1915 and administrative regulation 201 KAR 2:380, Kentucky established an innovative, evidence-based regulatory framework that empowers licensed pharmacists to independently initiate the dispensing of non-controlled medications and provide targeted clinical services pursuant to Board-Authorized Protocols approved by the Kentucky Board of Pharmacy. Understanding the legal mechanics, approved condition categories, diagnostic mandates, and documentation requirements of these protocols is essential for the Kentucky MPJE.

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1. Statutory & Administrative Framework: KRS 315.1915 & 201 KAR 2:380

Unlike traditional dispensing models that require an individual, patient-specific prescription issued after an in-person medical encounter, the Kentucky protocol model establishes a population-level delegated authority structure:

┌─────────────────────────────────────────────────────────────────────────────┐
│            KENTUCKY BOARD-AUTHORIZED PROTOCOL REGULATORY STRUCTURE           │
├─────────────────────────────────────────────────────────────────────────────┤
│ STATUTORY FOUNDATION: KRS 315.1915 & KRS 315.010                            │
│ • Authorizes the Kentucky Board of Pharmacy to promulgate administrative    │
│   regulations establishing clinical protocols for pharmacist care.          │
│ • Permits pharmacists to initiate non-controlled drug therapy and order     │
│   CLIA-waived diagnostic tests under the direction of an authorized         │
│   practitioner without a prior individual patient-specific prescription.    │
│                                                                             │
│ ADMINISTRATIVE REGULATION: 201 KAR 2:380                                    │
│ • Establishes explicit standards, criteria, and administrative guidelines   │
│   for protocol execution, authorized condition categories, and monitoring. │
│                                                                             │
│ AUTHORIZED PRESCRIBERS (PROTOCOL COLLABORATORS):                           │
│ • Physician (MD or DO) holding an active, unrestricted Kentucky license.    │
│ • Advanced Practice Registered Nurse (APRN) holding an active Kentucky      │
│   license with prescriptive authority.                                      │
│                                                                             │
│ MANDATORY BOARD PROTOCOL REGISTRY SUBMISSION:                               │
│ • Prior to implementation, the pharmacy permit holder / pharmacist must     │
│   submit the fully executed protocol to the Board of Pharmacy's registry.   │
│ • The protocol must strictly mirror the Board-approved clinical guidelines. │
│ • Must be renewed and maintained in active status on the registry.          │
└─────────────────────────────────────────────────────────────────────────────┘

Pharmacist Initiation vs. Prescribing Authority

In Kentucky pharmacy jurisprudence, a critical distinction exists between independent prescribing and protocol-based initiation of dispensing:

1. Initiation of Dispensing: Under 201 KAR 2:380, the pharmacist is initiating therapy pursuant to a protocol signed by an authorized prescriber. The legal authority derives from the overarching agreement and the Board's clinical guidelines, not an open-ended independent prescriptive scope.
2. Non-Controlled Substances Only: Protocol authority is strictly restricted to non-controlled legend drugs, diagnostic devices, and over-the-counter agents. A pharmacist CANNOT initiate, dispense, or modify any controlled substance (Schedule II through V) under a Board-authorized protocol.
3. Voluntary Participation: Individual pharmacists and pharmacies are not legally mandated to offer protocol services; participation is elective but requires strict compliance once undertaken.

2. The Ten Board-Approved Protocol Categories & Clinical Guidelines

The Kentucky Board of Pharmacy, in consultation with the Kentucky Board of Medical Licensure and clinical advisory panels, has approved standardized protocols across ten (10) distinct clinical categories under 201 KAR 2:380. Candidates must understand the clinical triggers, diagnostic requirements, approved drug classes, and exclusionary boundaries for each:

1. Influenza Infection

• Diagnostic Standard: Requires CLIA-waived rapid point-of-care influenza diagnostic test (antigen or rapid molecular RT-PCR) performed on site, OR documented positive flu test from an accredited lab, OR presence of characteristic symptoms during a documented community outbreak.
• Temporal Limit: Symptom onset must be within forty-eight (48) hours of presentation for treatment initiation.
• Approved Drug Therapy: Neuraminidase inhibitors including oral oseltamivir (Tamiflu) $75\text{ mg}$ PO BID $\times 5$ days (adjusted for renal function), inhaled zanamivir (Relenza), or cap-dependent endonuclease inhibitor baloxavir marboxil (Xofluza) single oral dose.
• Exclusion Red Flags: Severe respiratory distress, pulse oximetry $< 92%$, hemodynamic instability, altered mental status, pregnancy, severe chronic renal or pulmonary disease, or symptom duration $> 48$ hours (unless protocol specifically permits prophylaxis for high-risk household contacts).

2. Group A Streptococcal Pharyngitis

• Diagnostic Standard: Mandatory on-site CLIA-waived Rapid Strep Antigen Test (RADT) via throat swab.
• Clinical Scoring: Assessment using Centor / McIsaac criteria (fever $> 38^\circ\text{C}$ [$100.4^\circ\text{F}$], tonsillar exudates, tender anterior cervical lymphadenopathy, absence of cough).
• Approved Drug Therapy: Oral Penicillin V ($500\text{ mg}$ PO BID/TID $\times 10$ days) or oral Amoxicillin ($500\text{ mg}$ PO BID or $1,000\text{ mg}$ daily $\times 10$ days). For documented penicillin allergy (non-anaphylactic): oral first-generation cephalosporin (cephalexin $500\text{ mg}$ BID $\times 10$ days) or cefadroxil; for severe IgE-mediated penicillin allergy: azithromycin ($500\text{ mg}$ day 1, then $250\text{ mg}$ daily days 2–5) or clindamycin.
• Exclusion Red Flags: Inability to swallow liquids/saliva (drooling), trismus (difficulty opening mouth), peritonsillar abscess, uvular deviation, muffled "hot potato" voice, age $< 3$ years, or negative rapid strep test.

3. Acute Uncomplicated Urinary Tract Infection (UTI)

• Target Population: Adult non-pregnant females aged 18–64 years presenting with characteristic symptoms of acute lower cystitis (dysuria, urinary frequency, urgency, suprapubic discomfort).
• Diagnostic Standard: Point-of-care urinalysis dipstick (evaluating positive leukocyte esterase and/or positive nitrites) combined with clinical symptom score.
• Approved Drug Therapy:
  1. Nitrofurantoin monohydrate/macrocrystals (Macrobid): $100\text{ mg}$ PO BID $\times 5$ days (preferred first-line; contraindicated if $\text{CrCl} < 30\text{ mL/min}$).
  2. Trimethoprim-Sulfamethoxazole DS (Bactrim DS): 1 tablet ($160/800\text{ mg}$) PO BID $\times 3$ days (if local E. coli resistance $< 20%$ and no sulfa allergy).
  3. Fosfomycin tromethamine (Monurol): $3\text{ g}$ single-dose oral powder sachet dissolved in water.
• Mandatory Exclusion Criteria (Immediate Physician Referral):
  • Male patients (all male UTIs are classified as complicated by definition);
  • Pregnant females (risk of pyelonephritis, preterm labor, teratogenicity);
  • Systemic signs of upper tract infection / pyelonephritis: Fever ($> 38^\circ\text{C}$ / $100.4^\circ\text{F}$), chills, flank pain, costovertebral angle (CVA) tenderness, nausea/vomiting;
  • Recurrent UTIs ($\ge 2$ episodes in 6 months or $\ge 3$ episodes in 12 months);
  • Anatomical urinary abnormalities, catheterization, renal impairment, immunocompromised states (HIV, active chemotherapy), or symptoms persisting $> 7$ days.

4. Allergic Rhinitis

• Clinical Scope: Patients presenting with seasonal or perennial allergic rhinitis symptoms (rhinorrhea, nasal congestion, sneezing, ocular pruritus).
• Approved Drug Therapy:
  • Intranasal Corticosteroids (INCS): Fluticasone propionate, triamcinolone acetonide, budesonide, mometasone nasal sprays;
  • Second-Generation Oral Antihistamines: Cetirizine, loratadine, fexofenadine, levocetirizine;
  • Intranasal Antihistamines: Azelastine, olopatadine nasal sprays;
  • Ophthalmic Antihistamines/Mast Cell Stabilizers: Olopatadine, ketotifen eye drops.
• Exclusion Red Flags: Unilateral nasal polyps, purulent nasal discharge with facial pain/fever (suggestive of bacterial sinusitis), severe epistaxis, age under protocol limits.

5. Fungal Skin Infections (Tinea Pedis, Tinea Cruris, Tinea Corporis)

• Clinical Scope: Localized superficial dermatophyte fungal infections: tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm).
• Approved Drug Therapy: Topical antifungal agents including terbinafine $1%$ cream, clotrimazole $1%$ cream, miconazole $2%$ cream, ketoconazole $2%$ cream, or ciclopirox $0.77%$ cream/gel applied once or twice daily for 2 to 4 weeks.
• Exclusion Red Flags: Onychomycosis (fungal nail infection), tinea capitis (fungal scalp infection), facial involvement, extensive/disseminated lesions, secondary bacterial infection (honey-colored crusting, purulent drainage, cellulitis), diabetic foot ulcers, or immunocompromised status.

6. Tobacco Cessation

• Clinical Scope: Comprehensive assessment of nicotine dependence (Fagerström test), readiness to quit, and initiation of pharmacological and behavioral support.
• Approved Drug Therapy:
  • Nicotine Replacement Therapy (NRT): Nicotine transdermal patches, nicotine polacrilex gum, nicotine lozenges, nicotine oral inhaler, nicotine nasal spray;
  • Varenicline (Chantix): Titration pack ($0.5\text{ mg}$ daily days 1–3, $0.5\text{ mg}$ BID days 4–7, then $1\text{ mg}$ BID for 12 weeks);
  • Bupropion SR (Zyban/Wellbutrin SR): $150\text{ mg}$ daily $\times 3$ days, then $150\text{ mg}$ BID for 7 to 12 weeks.
• Exclusion Red Flags: For bupropion: history of seizure disorder, active eating disorder (anorexia/bulimia), abrupt discontinuation of alcohol/sedatives, or concurrent MAOI use. For varenicline: severe unmanaged psychiatric disorders or end-stage renal disease.

7. HIV Pre-Exposure Prophylaxis (PrEP) & Post-Exposure Prophylaxis (PEP)

• PrEP Scope: Initiation of daily oral prophylaxis for HIV-negative individuals at ongoing substantial risk of HIV acquisition.
  • Mandatory Diagnostics: Documented negative rapid HIV $1/2$ antigen/antibody test within 7 days prior to initiation; baseline estimated creatinine clearance ($\text{CrCl} \ge 60\text{ mL/min}$ for TDF/FTC; $\text{CrCl} \ge 30\text{ mL/min}$ for TAF/FTC); Hepatitis B virus (HBV) surface antigen/antibody screening; pregnancy test; STI screening (syphilis, gonorrhea, chlamydia).
  • Approved Regimens: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF 200/300 mg - Truvada) or Emtricitabine/Tenofovir Alafenamide (FTC/TAF 200/25 mg - Descovy) (note: Descovy not approved for individuals at risk from receptive vaginal sex).
• PEP Scope: Urgent 28-day antiretroviral course initiated within seventy-two (72) hours following potential non-occupational (nPEP) or occupational HIV exposure.
  • Approved Regimens: TDF/FTC ($300/200\text{ mg}$) daily PLUS dolutegravir (Tivicay $50\text{ mg}$ daily) OR raltegravir (Isentress $400\text{ mg}$ BID) $\times 28$ consecutive days.
  • Exclusion Red Flags: Exposure occurring $> 72$ hours prior, known HIV-positive status, baseline reactive HIV test, severe renal failure.

8. Tuberculin Skin Testing (PPD Administration & Reading)

• Clinical Scope: Administration of intradermal Purified Protein Derivative (PPD / Mantoux test) and subsequent clinical interpretation.
• Administration Standard: $0.1\text{ mL}$ of 5 tuberculin units (5 TU) PPD injected intradermally on the volar aspect of the forearm to produce a discrete $6\text{ mm}$ to $10\text{ mm}$ wheal.
• Mandatory Reading Window: The pharmacist must visually inspect and palpate the transverse diameter of induration (not erythema) between forty-eight (48) and seventy-two (72) hours post-administration.
• Interpretation Thresholds: Induration $\ge 5\text{ mm}$ (HIV/immunosuppressed/close contacts); $\ge 10\text{ mm}$ (healthcare workers, high-risk facilities, IV drug users, high-prevalence country immigrants); $\ge 15\text{ mm}$ (general population with no known risk factors). Positive results mandate immediate physician referral for chest radiography and evaluation.

9. COVID-19 Testing & Antiviral Treatment

• Clinical Scope: CLIA-waived rapid SARS-CoV-2 antigen or RT-PCR point-of-care testing and initiation of oral antiviral therapy for mild-to-moderate COVID-19 in high-risk patients.
• Temporal Limit: Initiation within five (5) days of symptom onset.
• Approved Drug Therapy: Nirmatrelvir/ritonavir (Paxlovid) $300\text{ mg}/100\text{ mg}$ PO BID $\times 5$ days (dose-adjusted to $150\text{ mg}/100\text{ mg}$ for moderate renal impairment eGFR $30–59\text{ mL/min}$; contraindicated if eGFR $< 30\text{ mL/min}$), or molnupiravir (Lagevrio) $800\text{ mg}$ PO Q12H $\times 5$ days (contraindicated in pregnancy/lactation).
• Exclusion Red Flags: Severe dyspnea, $\text{SpO}_2 < 94%$, severe drug interactions with ritonavir (e.g., amiodarone, carbamazepine, rivaroxaban), severe hepatic impairment (Child-Pugh Class C), or symptom onset $> 5$ days.

10. Travel Health

• Clinical Scope: Pre-travel health risk assessment, destination-specific prophylaxis, and self-treatment regimens.
• Approved Regimens:
  • Motion Sickness: Transdermal scopolamine $1\text{ mg}$ patch applied behind ear every 72 hours prn, or oral meclizine / dimenhydrinate;
  • Malaria Chemoprophylaxis: Atovaquone/proguanil (Malarone) daily (started 1–2 days pre-travel, continued 7 days post-travel), doxycycline $100\text{ mg}$ daily, or chloroquine/hydroxychloroquine (chloroquine-sensitive regions only);
  • Traveler's Diarrhea Self-Treatment: Azithromycin $1,000\text{ mg}$ single dose (or $500\text{ mg}$ daily $\times 3$ days; preferred for Southeast Asia/dysentery) or ciprofloxacin $750\text{ mg}$ single dose, plus oral rehydration salts and loperamide;
  • Altitude Sickness Prophylaxis: Acetazolamide (Diamox) $125\text{ mg}$ PO BID started 1–2 days prior to ascent.

3. Board-Authorized Protocol Conditions Summary

The following table summarizes the legal and clinical parameters governing all ten Board-authorized protocol categories under 201 KAR 2:380:

4. Operational Requirements, Documentation & Prescriber Notification

To maintain legal validity under 201 KAR 2:380, every pharmacist-initiated encounter must strictly adhere to four administrative pillars:

1. Patient Informed Consent

• The pharmacist must provide a clear explanation of the protocol-based care model to the patient or authorized representative.
• Mandatory Consent: The patient must provide informed consent (verbal or written, as specified in the protocol) confirming their agreement to receive care under the Board-authorized protocol.
• The patient retains the right to decline protocol-based care and request direct referral to their physician.

2. CLIA-Waived Point-of-Care Testing Standards

• Pharmacies conducting diagnostic testing (e.g., flu, strep, COVID-19, HIV, urinalysis) must obtain and maintain an active Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver from CMS and the Kentucky Cabinet for Health and Family Services (CHFS).
• The pharmacy must follow manufacturer package insert instructions, maintain documented quality control (QC) testing logs, and adhere to OSHA bloodborne pathogen disposal standards.

3. Prescriber & Primary Care Provider (PCP) Notification

• Mandatory Notification: Following the initiation of any medication or diagnostic service under a protocol, the pharmacist shall provide written or electronic notice to the collaborating prescriber and the patient's primary care provider (if identified).
• Timeline: Notification must occur within the timeframe specified in the protocol (typically within 24 to 48 hours / 2 business days).
• The notice must include the patient's identity, date of encounter, diagnostic findings/test results, specific drug initiated (name, strength, dosage, quantity, directions), and any referral advice provided.

4. Five-Year Record Retention Mandate (201 KAR 2:171 & 201 KAR 2:380)

• All protocol documentation—including executed protocol agreements, Board registry submission confirmations, signed patient consent forms, diagnostic test results, assessment logs, dispensing records, and prescriber notifications—must be securely retained for a minimum of five (5) years from the date of service.

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5. High-Yield Exam Traps & Key Distinctions

┌─────────────────────────────────────────────────────────────────────────────┐
│                     HIGH-YIELD PROTOCOL EXAM TRAPS                          │
├─────────────────────────────────────────────────────────────────────────────┤
│ 1. Controlled Substances are STRICTLY PROHIBITED:                           │
│    • A pharmacist can NEVER initiate a controlled substance (C-II to C-V)   │
│      under a Board-authorized protocol. Any question suggesting a pharmacist │
│      can initiate codeine cough syrup or tramadol via protocol is FALSE!    │
│                                                                             │
│ 2. Board Registry Submission is a CONDITION PRECEDENT:                      │
│    • Executing a protocol between a physician and pharmacist is NOT enough. │
│    • The protocol MUST be registered with the Board of Pharmacy BEFORE any  │
│      patient services or medications are initiated.                         │
│                                                                             │
│ 3. Male UTIs and Pregnant UTIs are ALWAYS Excluded:                         │
│    • The acute uncomplicated UTI protocol applies ONLY to adult non-pregnant│
│      females. Any male presenting with dysuria MUST be referred to an MD/DO │
│      or APRN; a pharmacist cannot treat male UTIs under the protocol.       │
│                                                                             │
│ 4. Tinea Infections of Nails (Onychomycosis) & Scalp (Capitis) Excluded:    │
│    • Pharmacists can only initiate topical antifungals for localized body,  │
│      groin, or foot infections (tinea corporis/cruris/pedis). Nail and      │
│      scalp fungal infections require systemic therapy and physician referral│
│                                                                             │
│ 5. Temporal Windows for Antivirals & PEP:                                   │
│    • Influenza antivirals: Initiation within <= 48 hours of symptom onset.  │
│    • COVID-19 Paxlovid: Initiation within <= 5 days of symptom onset.       │
│    • HIV PEP: Initiation within <= 72 hours of potential exposure.          │
└─────────────────────────────────────────────────────────────────────────────┘