Section 26.2: Full-Scale Case Simulation and CPA Implementation
From Theory to Practice: Navigating a Complex Patient Journey from Code Sepsis to Clinic Follow-Up.
Full-Scale Case Simulation
Applying integrated knowledge in a dynamic, longitudinal patient case.
26.2.1 The “Why”: The Crucible of Practice
You have reviewed the blueprints. Now it is time to build the house. This section is designed to be the ultimate test of your integrated knowledge—a full-scale, dynamic simulation that takes you from the chaos of the Emergency Department to the nuanced management of a longitudinal clinic visit. You will follow a single, complex patient, Mr. Frank Harrison, as he traverses the healthcare system. This is not a series of discrete, academic questions. It is a flowing narrative designed to replicate the pressures, challenges, and triumphs of real-world collaborative practice.
The purpose of this simulation is threefold. First, it will force you to apply your clinical knowledge not in isolated silos, but as an interconnected web. You will see firsthand how a decision about sepsis management in the ICU directly impacts the titration of heart failure medications in your clinic weeks later. Second, it will move you beyond simply making recommendations to taking ownership of the therapeutic plan through the implementation of a Collaborative Practice Agreement. You will be asked to write orders, draft progress notes, and communicate with the team as a privileged provider. Finally, this simulation will serve as a crucible, forging your confidence and competence, ensuring you are not just certified, but truly prepared for the responsibilities and rewards of this advanced practice role.
Pharmacist Analogy: The Flight Simulator
A pilot trains for years, mastering aerodynamics, navigation, meteorology, and engine mechanics. They can pass any written exam on these individual subjects. But before they are allowed to command a real aircraft full of passengers, they must spend countless hours in a full-scale flight simulator.
The simulator is where theory meets reality. It presents the pilot with a series of interconnected challenges in real-time. An engine might fail during a thunderstorm while the pilot is trying to manage a medical emergency in the cabin. Success is not about solving each problem individually; it is about managing all of them simultaneously, prioritizing tasks, communicating clearly with the crew, and flying the plane safely to its destination.
This case is your flight simulator. Mr. Harrison is your aircraft. You will be presented with multiple, simultaneous challenges: sepsis (the thunderstorm), decompensated heart failure (the engine failure), and complex anticoagulation needs (the cabin emergency). Your task is to apply your knowledge, use your protocols (your CPA), communicate with your crew (the medical team), and guide Mr. Harrison safely from the brink of critical illness back to a stable life at home. Fasten your seatbelt.
Part I: The Acute Crisis – ED Arrival and ICU Admission
The simulation begins at the most chaotic and vulnerable point of entry into the hospital: the Emergency Department.
26.2.2 Patient Presentation & Initial Workup
Case Introduction: Mr. Frank Harrison
AGE: 72 Y.O. Male
WEIGHT: 85 kg
ALLERGIES: Penicillin (Rash)
PAST MEDICAL HISTORY:
- Heart Failure with Reduced Ejection Fraction (HFrEF), EF 30%
- Paroxysmal Atrial Fibrillation
- Type 2 Diabetes Mellitus
- Chronic Kidney Disease Stage G3b (Baseline SCr 1.8 mg/dL, eGFR ~35 mL/min)
- Hypertension
- Gout
- Sacubitril/Valsartan 49/51 mg PO BID
- Metoprolol Succinate 150 mg PO daily
- Spironolactone 25 mg PO daily
- Empagliflozin 10 mg PO daily
- Furosemide 40 mg PO BID
- Warfarin 5 mg PO daily (last INR 2 weeks ago was 2.6)
- Metformin 1000 mg PO BID
- Allopurinol 300 mg PO daily
Emergency Department Triage Note (Time: 08:00)
HPI: 72 y.o. male brought in by his daughter with ~3 days of worsening shortness of breath, productive cough with greenish sputum, and subjective fevers. Today, daughter notes he has become increasingly confused and lethargic. He has been taking his medications as prescribed.
VITAL SIGNS: Temp 38.9°C, HR 125 bpm (irregularly irregular), BP 90/55 mmHg, RR 28, SpO₂ 89% on room air.
PHYSICAL EXAM: Appears acutely ill, lethargic but arousable. Rales heard 2/3 up bilaterally. 2+ bilateral lower extremity edema.
Initial Labs & Imaging Results (Time: 08:45)
| Lab Test | Result | Reference Range |
|---|---|---|
| WBC | 18.5 x10³/µL | 4.5-11.0 |
| Hemoglobin | 11.2 g/dL | 13.5-17.5 |
| Platelets | 120 x10³/µL | 150-450 |
| Sodium | 132 mEq/L | 136-145 |
| Potassium | 5.6 mEq/L | 3.5-5.0 |
| Bicarbonate | 18 mEq/L | 22-29 |
| BUN | 88 mg/dL | 7-20 |
| Serum Creatinine | 3.1 mg/dL | 0.7-1.3 |
| BNP | 4500 pg/mL | <100 |
| Troponin | 0.08 ng/mL | <0.04 |
| Lactate | 4.2 mmol/L | 0.5-2.2 |
| Prothrombin Time | 35.2 sec | 11-13.5 |
| INR | 3.8 | 2.0-3.0 (Therapeutic) |
Chest X-Ray: Large right lower lobe infiltrate, consistent with pneumonia. Bilateral vascular congestion and pleural effusions noted.
ED Physician’s Initial Assessment & Orders (Time: 09:00)
1. Sepsis secondary to Community-Acquired Pneumonia.
2. Acute Decompensated Heart Failure.
3. Acute on Chronic Kidney Injury.
4. Atrial Fibrillation with RVR.
5. Supratherapeutic INR.
ORDERS (Sepsis Bundle Activated):
1. Blood cultures x 2, Urine culture.
2. Lactated Ringer’s 30 mL/kg IV bolus NOW.
3. Levofloxacin 750 mg IV daily.
4. Furosemide 80 mg IV push NOW.
5. Diltiazem drip, start at 5 mg/hr, titrate for HR < 110 bpm.
6. Hold all home medications.
7. Admit to Medical ICU.
YOUR CHALLENGE: The Pharmacist’s Initial Verification
You are the ED pharmacist responsible for verifying these orders. The clock is ticking. The Surviving Sepsis guidelines demand antibiotics within one hour. However, you are the final safety net. Analyze these orders with the precision of a CCPP. Identify all potential therapeutic problems, including drug selection, dosing, and management of comorbidities. Formulate a comprehensive plan and prepare to communicate it to the ED physician.
What are the Top 5 most critical medication-related problems with this initial plan? How will you resolve them?
26.2.3 Masterclass Response: ED Intervention Strategy
An experienced CCPP would immediately recognize several critical issues that require urgent intervention. The approach must be rapid, logical, and communicated effectively. Here is the breakdown of the thought process and action plan.
Problem #1: Inadequate Empiric Antibiotic Coverage
The Issue: Levofloxacin monotherapy is an inappropriate choice for a septic patient with CAP requiring ICU admission. While it covers typical and atypical pathogens, regional resistance rates for Strep. pneumoniae to fluoroquinolones can be high. More importantly, it does not provide any coverage for Pseudomonas, which is a risk factor in patients with underlying structural lung disease (often comorbid with HF) or from healthcare settings. For a patient this sick, broader coverage is essential.
The Solution: Switch to guideline-recommended, broad-spectrum therapy. The patient has a non-anaphylactic penicillin allergy (rash), so cephalosporins are safe. The ideal regimen is an anti-pseudomonal beta-lactam plus atypical coverage.
- Primary Recommendation: Cefepime + Azithromycin. This covers Strep pneumo, H. flu, atypicals, and Pseudomonas.
- Risk Factor Assessment: Does he need MRSA coverage? He is coming from home, but his multiple comorbidities and recent healthcare exposures could be a risk factor. Given the severity of his illness (septic shock), adding empiric Vancomycin is the safest approach and is consistent with institutional protocols.
Problem #2: Critical Dosing Errors due to AKI
The Issue: The patient has severe AKI on top of his CKD. His creatinine has nearly doubled, and his calculated CrCl is now acutely much lower. $$ \text{CrCl (Cockcroft-Gault)} = \frac{(140 – \text{Age}) \times \text{Weight (kg)}}{(72 \times \text{SCr})} \times 0.85 \text{ (if female)} $$ $$ \text{CrCl} = \frac{(140 – 72) \times 85}{(72 \times 3.1)} = \frac{5780}{223.2} \approx 25.9 \text{ mL/\min} $$ The ordered dose of Levofloxacin 750 mg daily is incorrect for this level of renal function; it should be 750 mg x1, then 750 mg every 48 hours. More importantly, the new recommended regimen (Cefepime + Vancomycin) requires significant dose adjustment.
The Solution:
- Cefepime: The standard dose is 2g Q8H. For a CrCl of 25.9 mL/min, the correct dose is 2g Q24H. To optimize PK/PD in this critically ill patient, you should recommend a prolonged infusion of this dose (e.g., infused over 4 hours).
- Vancomycin: A loading dose is essential in sepsis to rapidly achieve therapeutic concentrations. A load of 25-30 mg/kg (actual body weight) is recommended. For this 85 kg patient, this is approximately 2125-2550 mg. You would recommend a 2250 mg loading dose. A maintenance dose would be calculated later based on levels.
Problem #3: Supratherapeutic INR and Acute Bleed Risk
The Issue: The patient has an INR of 3.8. Sepsis itself can cause coagulopathy and thrombocytopenia, increasing bleed risk. He is about to undergo potential procedures in the ICU (e.g., central line placement). Active anticoagulation is dangerous.
The Solution: The warfarin must be held. The INR needs to be corrected. While there is no active, life-threatening bleed, the high INR in this critically ill patient warrants reversal.
- Recommendation: Administer Vitamin K 5 mg IVPB. An oral dose would be too slow and absorption is unreliable. Kcentra (4F-PCC) is not indicated as there is no major hemorrhage.
Problem #4: Unsafe Management of Hyperkalemia and Decompensated HF
The Issue: The patient is hyperkalemic (5.6 mEq/L) in the setting of severe AKI. His home medications include an ARNI (sacubitril/valsartan) and an MRA (spironolactone), both of which cause hyperkalemia. Furthermore, he is in acute decompensated heart failure and is hypotensive. His beta-blocker (metoprolol succinate) and ARNI are contraindicated in this state.
The Solution: While the order to “Hold all home medications” is generally correct, you must ensure this is done with specific intent.
- Confirm Holds: Specifically confirm with the team that the sacubitril/valsartan, spironolactone, and metoprolol are being held due to AKI, hyperkalemia, and hypotension. This ensures these are not accidentally restarted.
- Rate Control Choice: The choice of a diltiazem drip for rate control is reasonable for AFib RVR. However, as a non-dihydropyridine calcium channel blocker, it has negative inotropic effects and can worsen hypotension in a patient with HFrEF and septic shock. An alternative like amiodarone might be safer from a hemodynamic standpoint, though diltiazem is often tried first. Your role is to monitor the blood pressure response closely after the drip is initiated.
Problem #5: Fluid Management in Sepsis vs. Heart Failure
The Issue: This is a classic clinical dilemma. The sepsis protocol demands a large-volume fluid bolus (30 mL/kg = ~2.5 Liters) to restore intravascular volume and perfusion. However, the patient is in a florid heart failure exacerbation with pulmonary edema. A large fluid bolus could worsen his respiratory status significantly.
The Solution: There is no easy answer here, but the immediate threat to life is the distributive shock from sepsis. The hypoperfusion must be treated. The standard of care is to give the fluid, but with extreme caution and preparedness to escalate respiratory support.
- Your Role: You must support the decision to give the fluid bolus as it is guideline-directed for sepsis, but your role is to be the voice of caution and anticipation. You should communicate: “I agree with the fluid bolus for his septic shock. Given his severe CHF, we need to monitor his respiratory status very closely during the infusion and be prepared for a potential increase in oxygen requirements or the need for earlier intubation. We should also be ready to start vasopressors (norepinephrine) immediately if he remains hypotensive after the initial portion of the bolus.” This demonstrates a systems-level understanding of competing pathologies.
The Pharmacist’s SBAR Communication to the ED Physician
You have seconds to convey this complex information. An SBAR format is essential.
- (S)ituation: “Dr. Evans, this is the pharmacist. I’m calling to verify the admission orders for Mr. Harrison, the septic patient in room 3.”
- (B)ackground: “I see the diagnosis of septic shock from CAP and decompensated heart failure. He has severe AKI with a calculated CrCl of about 25 mL/min and an INR of 3.8.”
- (A)ssessment: “I have a few critical recommendations to optimize his therapy and ensure safety. The ordered levofloxacin provides narrow coverage for a patient this sick. His renal failure requires significant dose adjustments. And his high INR needs reversal before any procedures.”
- (R)ecommendation: “I recommend we change his antibiotics to Cefepime 2 grams IV Q24H, infused over 4 hours, plus a one-time Vancomycin 2250 mg loading dose, plus Azithromycin 500 mg IV once. I also recommend we give Vitamin K 5 mg IVPB for his INR. I agree with holding his home meds and the fluid bolus, but we should have norepinephrine ready to go.”
Part II: The ICU Course – Stabilization and Complications
Mr. Harrison is admitted to the ICU. Your recommendations are accepted and implemented. Despite the fluid bolus and antibiotics, his blood pressure remains low, and his respiratory status worsens. He is intubated for hypoxic respiratory failure.
ICU Progress Note – Hospital Day 1 (Time: 16:00)
OBJECTIVE:
Vitals: T 38.1, HR 115, BP 85/50 (MAP 60) on Norepinephrine 0.15 mcg/kg/min, RR 18 (on AC/VC vent), SpO2 94% on 60% FiO2.
Labs: SCr up to 3.4, K 5.8, Lactate trending down to 3.1.
Meds: Cefepime/Vanc/Azithro onboard. Fentanyl drip for analgesia, Propofol drip for sedation. Diltiazem drip weaned off, amiodarone bolus and drip started for rate control.
ASSESSMENT & PLAN:
1. Septic Shock, Refractory: MAP goal >65 not met on moderate-dose norepinephrine. Lungs sound wet. 2. AKI: Worsening. Making minimal urine. 3. Hyperkalemia: Worsening. 4. Analgesia/Sedation: Appears comfortable, RASS -4.
YOUR CHALLENGE: The ICU Pharmacist’s Next Moves
You are now the ICU satellite pharmacist rounding with the team. The patient is in refractory shock. His sedation may be contributing to the problem. His electrolytes are critical. What are your next set of recommendations to stabilize this patient? Think about hemodynamics, supportive care, and sedation optimization.
Masterclass Response: ICU Optimization Strategy
The CCPP’s role in the ICU is proactive, not reactive. You must anticipate the next steps in the resuscitation and supportive care cascade.
Recommendation #1: Add Second-Line Vasopressor & Stress-Dose Steroids
The Rationale: The patient meets the definition of refractory shock (requiring >0.25 mcg/kg/min of norepinephrine is a common trigger, and he is approaching that). Guideline-directed care calls for two interventions:
- Add Vasopressin: This will work synergistically with norepinephrine via a different mechanism (V1 agonism) and may be catecholamine-sparing. The dose is fixed and not titrated.
- Add Stress-Dose Steroids: To address potential relative adrenal insufficiency.
The Order Recommendation: “I recommend we start a Vasopressin drip at 0.03 units/minute and administer Hydrocortisone 50 mg IV every 6 hours.”
Recommendation #2: Optimize Sedation to Improve Hemodynamics
The Rationale: Propofol is an excellent sedative but is a potent vasodilator and negative inotrope. In a patient with septic shock and cardiogenic shock from HFrEF, it is actively contributing to his hypotension and high vasopressor needs. A switch to a more hemodynamically neutral agent is warranted.
The Order Recommendation: “The propofol is likely worsening his shock state. I recommend we stop the propofol and switch to Dexmedetomidine. We can start the drip at 0.7 mcg/kg/hr and titrate to a RASS goal of -2 to -3. This should allow us to wean his norepinephrine.”
Recommendation #3: Aggressively Manage Hyperkalemia
The Rationale: A potassium of 5.8 mEq/L with worsening AKI is a medical emergency that can lead to fatal arrhythmias. He needs immediate treatment.
The Order Recommendation: “For his critical hyperkalemia, I recommend the following STAT orders: 1 gram Calcium Gluconate IV to stabilize the cardiac membrane, 10 units Regular Insulin IV with 25 grams of D50W to shift potassium intracellularly, and 10 mg of Albuterol nebulized.”
Recommendation #4: Plan for VTE and Stress Ulcer Prophylaxis
The Rationale: The patient is critically ill and immobile, placing him at very high risk for a deep vein thrombosis (DVT). He is also intubated, a primary indication for stress ulcer prophylaxis (SUP).
The Order Recommendation: “His platelets are still low at 120 and he has a coagulopathy from sepsis, so I think pharmacologic VTE prophylaxis should be held for now. I recommend we place sequential compression devices (SCDs) bilaterally. For SUP, let’s start Pantoprazole 40 mg IV daily.”
The CCPP’s Daily ICU Progress Note (Hospital Day 2)
Clear documentation is essential to demonstrate your contribution to the team. Your daily note should follow a system-based approach (e.g., SOAP or APSO format).
S: Pt remains intubated & sedated on Dexmedetomidine, RASS -2.
O: Vitals: MAP 68 on NE 0.1, Vaso 0.03. T 37.5. Labs: SCr stable 3.5, K 4.5, Lactate 2.1. Cultures: Blood/Urine cx pending. Meds: Cefepime/Vanc/Azithro, Hydrocortisone, Amiodarone, Pantoprazole, Insulin drip for glycemic control.
A/P by System:
1. ID – Sepsis/CAP: Responding to broad-spectrum abx (improving lactate, reduced pressor needs). Continue Cefepime 2g (PI) Q24H, Azithromycin (Day 2/5).
- Vancomycin: Trough level due this AM. Will dose-adjust per protocol based on result. Goal trough 15-20 or AUC/MIC >400.
- Follow cultures for de-escalation at 48-72h.
- VTE Prophylaxis: Platelets stable. Recommend starting Subcutaneous Heparin 5000 units TID.
5. Sedation/Analgesia: Well-controlled on Fentanyl/Dexmedetomidine. Plan for daily sedation interruption to assess neurologic status.
Part III: The Transition – Medical Floor to Discharge
Over the next 5 days, Mr. Harrison improves dramatically. He is extubated, his pressors are weaned off, and he is transferred to the medical floor. His creatinine has improved to 2.2 mg/dL. Urine and blood cultures grew E. coli, sensitive to Cefepime.
YOUR CHALLENGE: The Floor Pharmacist’s Management Plan
You are the pharmacist rounding on the medical floor. It is Hospital Day 7. Your tasks are to optimize his therapy for discharge, focusing on antimicrobial stewardship, restarting chronic medications, and planning for a safe transition of care.
Create a comprehensive pharmaceutical care plan. What is your de-escalation strategy? How will you re-initiate his GDMT for HFrEF? How will you address his long-term anticoagulation?
Masterclass Response: Transitions of Care Plan
Action #1: Antimicrobial De-escalation (Stewardship)
The Rationale: The patient has a clear pathogen with known sensitivities. Continuing triple-antibiotic therapy is unnecessary, costly, and drives resistance.
The Recommendation: “Based on culture results showing Cefepime-sensitive E. coli, I recommend we discontinue the Vancomycin and Azithromycin. We should complete a total 7-day course of Cefepime for his complicated UTI/urosepsis. His last day of therapy will be [Date].”
Action #2: Cautious Re-initiation of Guideline-Directed Medical Therapy (HFrEF)
The Rationale: The patient survived his acute illness, but now he is at high risk for rehospitalization if his chronic HFrEF is not re-optimized. However, restarting his full home regimen is dangerous given his recent hemodynamic instability and kidney injury.
The Recommendation (a step-wise approach):
- Beta-Blocker: “His blood pressure and heart rate are now stable. Let’s restart his Metoprolol Succinate, but at a lower dose. I recommend 50 mg daily. We will monitor for bradycardia and hypotension and titrate up as tolerated.”
- ARNI: “His SCr is still elevated at 2.2. Restarting his sacubitril/valsartan now carries a high risk of worsening his AKI and causing hyperkalemia. I recommend we continue to hold the ARNI for now. We will re-evaluate in the pharmacist-led clinic post-discharge.”
- MRA & SGLT2i: “For the same reason, his spironolactone must remain held. However, SGLT2 inhibitors like empagliflozin have shown renal-protective benefits. Given his stable K+ and BP, I recommend we restart the Empagliflozin 10 mg daily.”
Action #3: Modernize and Plan for Long-Term Anticoagulation
The Rationale: The patient was on warfarin, which is difficult to manage post-hospitalization due to fluctuating nutrition, antibiotics, and acute illness. This is an ideal opportunity to transition to a safer, more effective DOAC. Apixaban is preferred in patients with renal impairment.
The Recommendation:
- The Switch: “Given the difficulty of managing his INR after this critical illness, I recommend we switch his anticoagulation from warfarin to apixaban for his atrial fibrillation.”
- Dosing: “To dose apixaban, we need to apply the 2 of 3 rule: Age ≥80, Weight ≤60kg, SCr ≥1.5. He meets one criteria (SCr). Therefore, the standard dose is appropriate. I recommend Apixaban 5 mg PO BID. We should plan to start this on his last day of Cefepime therapy.”
- Discharge Planning: “I will complete the prior authorization for the apixaban and provide extensive counseling to the patient and his daughter on the importance of adherence and the differences from warfarin.”
Action #4: Create a Cohesive Discharge Plan
The final step is to synthesize all of this into a clear, safe, and actionable plan for the patient, who will be discharging to a Skilled Nursing Facility (SNF) for rehab.
The CCPP’s Discharge Medication Reconciliation Note
This note is not just a list; it’s a narrative that tells the story of the patient’s hospital stay to the next providers of care.
Mr. Harrison was admitted for septic shock from E. coli urosepsis and ADHF. His hospital course was complicated by AKI and respiratory failure. He is now clinically stable for discharge to SNF.
Key Therapeutic Changes During Hospitalization:
1. ANTIBIOTICS: Completed 7-day course of IV Cefepime. No outpatient antibiotics needed.
2. ANTICOAGULATION: Warfarin has been DISCONTINUED. He has been switched to Apixaban 5 mg PO BID for AFib. First dose given this AM.
3. HEART FAILURE MEDS:
- Sacubitril/Valsartan & Spironolactone REMAIN HELD due to AKI. Do not restart without consulting cardiology/nephrology.
- Metoprolol Succinate has been dose-reduced to 50 mg daily.
- Empagliflozin 10 mg daily has been resumed.
- Furosemide dose adjusted to 60 mg PO daily based on current volume status.
ACTION PLAN FOR SNF/FOLLOW-UP:
- Monitor daily weights and signs of fluid overload.
- Monitor BP and HR with metoprolol.
- Check BMP twice weekly to monitor renal function and potassium.
- FOLLOW-UP: Patient has a scheduled appointment in our pharmacist-led Cardiovascular Risk Reduction Clinic in 2 weeks to manage his HF medications, anticoagulation, and diabetes.
Counseling provided to patient’s daughter on all medication changes, with emphasis on the warfarin-to-apixaban switch. She verbalized understanding.
Part IV: CPA Implementation in the Ambulatory Clinic
Two weeks after discharge, Mr. Harrison presents to your pharmacist-led Cardiovascular Risk Reduction Clinic for his follow-up appointment. You operate under a comprehensive CPA with the cardiology service. This is the official document that grants you the authority to perform the following actions.
Full Collaborative Practice Agreement
Pharmacist-Led Cardiovascular Risk Reduction Clinic
I. Parties to the Agreement
This Collaborative Practice Agreement (“Agreement”) is entered into by and between the following parties:
Collaborating Physician Group:
Apex Cardiology Associates, PLLC
123 Health Way, Suite 400
Anytown, USA 12345
Designated Lead Physician:
Jane Doe, MD, FACC
NPI: 1234567890
License: MD98765
Authorized Pharmacist(s):
John Smith, PharmD, BCPS, CCPP
NPI: 0987654321
License: PH56789
II. Term of Agreement
This Agreement shall become effective on October 20, 2025, and will remain in effect for a period of two (2) years, until October 19, 2027. This Agreement will be reviewed annually by all parties and may be renewed by mutual written consent. Either party may terminate this Agreement with sixty (60) days written notice to the other party.
III. Purpose and Goals of Collaboration
The purpose of this Agreement is to improve the health outcomes of patients with complex cardiovascular and metabolic diseases by establishing a formal collaborative practice between the Physician and the Pharmacist. The goals are to:
- Optimize the use of Guideline-Directed Medical Therapy (GDMT) for patients with Heart Failure with Reduced Ejection Fraction (HFrEF).
- Improve glycemic control and reduce cardiovascular risk in patients with Type 2 Diabetes Mellitus (T2DM).
- Ensure the safe and effective use of anticoagulation therapy for stroke prevention in Atrial Fibrillation and for the treatment of Venous Thromboembolism (VTE).
- Enhance patient adherence, education, and self-management skills.
- Reduce hospital readmission rates for cardiovascular-related conditions.
IV. Patient Population
This Agreement applies to any patient who is formally referred by a provider from Apex Cardiology Associates to the Pharmacist-Led Cardiovascular Risk Reduction Clinic and who provides written consent to be managed under this collaborative practice model. Patients must have at least one of the following diagnosed conditions:
- Heart Failure with Reduced Ejection Fraction (HFrEF)
- Type 2 Diabetes Mellitus
- Atrial Fibrillation or Venous Thromboembolism requiring anticoagulation
- Hypertension
- Dyslipidemia
V. Authorized Functions and Protocols for the Pharmacist
The Pharmacist is authorized to perform the following functions for the defined patient population, in accordance with the detailed protocols outlined below.
A. General Patient Care Functions
- Perform patient assessments, including obtaining a medication history, assessing for medication-related problems, evaluating subjective patient reports, and measuring objective data (e.g., blood pressure, heart rate).
- Provide comprehensive patient and family education on disease states, medications, and lifestyle modifications.
- Order, interpret, and monitor laboratory tests as specified in the disease-state protocols below.
- Formulate and document a patient-specific care plan in the shared Electronic Health Record (EHR).
B. Protocol for Management of HFrEF
The Pharmacist will manage patients with the goal of initiating and titrating all four pillars of GDMT to target doses as tolerated.
| Drug Class | Initiation & Titration Protocol | Safety Monitoring Parameters |
|---|---|---|
| ARNI (Sacubitril/Valsartan) |
|
Hold or Down-Titrate If:
|
| Beta-Blockers (Evidence-Based) (Metoprolol Succinate, Carvedilol, Bisoprolol) |
|
Hold or Down-Titrate If:
|
| MRA (Spironolactone / Eplerenone) |
|
Contraindicated If: K+ > 5.0 or eGFR < 30.
Hold If: K+ > 5.5 mEq/L. Monitor BMP within 1 week of initiation/titration. |
| SGLT2 Inhibitors (Empagliflozin, Dapagliflozin) |
|
Contraindicated If: eGFR below labeled threshold (e.g., <20-25).
Counsel on risk of euglycemic DKA and genital mycotic infections. |
Authorized Labs: Basic Metabolic Panel (BMP), Brain Natriuretic Peptide (BNP).
C. Protocol for Anticoagulation Management
The Pharmacist will manage anticoagulation therapy to ensure safety and efficacy.
Direct Oral Anticoagulants (DOACs)
- Drug Selection: Pharmacist may assist in selecting the most appropriate DOAC based on patient-specific factors (renal function, bleed risk, comorbidities).
- Dose Adjustment: Pharmacist will adjust DOAC doses based on renal function criteria as defined by package labeling. Example for Apixaban: Reduce dose to 2.5 mg BID if patient meets ≥2 of the following: Age ≥80 years, Body Weight ≤60 kg, Serum Creatinine ≥1.5 mg/dL.
- Peri-Procedural Management: Pharmacist will develop and provide written instructions for holding and restarting DOACs for invasive procedures based on established institutional guidelines. Bridging is not to be used routinely.
Warfarin
- Dose Adjustment: Pharmacist will manage warfarin dosing to maintain INR within the goal range specified by the physician (e.g., 2.0-3.0, 2.5-3.5). Adjustments will be made according to a standardized, evidence-based nomogram.
- Management of Supratherapeutic INR:
- INR >3.0 and <5.0, no bleeding: Hold 1-2 doses, decrease maintenance dose by 10-15%.
- INR ≥5.0 and <9.0, no bleeding: Hold warfarin, may consider low-dose oral Vitamin K (1-2.5 mg).
- Any INR with major bleeding: Pharmacist will immediately refer patient to ED and notify the collaborating physician.
Authorized Labs: Prothrombin Time/INR, Complete Blood Count (CBC), Basic Metabolic Panel (BMP).
D. Protocol for Management of Type 2 Diabetes Mellitus
The Pharmacist will manage patients with a primary focus on agents with proven cardiovascular benefit.
- Medication Titration: Pharmacist may initiate and titrate Metformin, SGLT2 Inhibitors, and GLP-1 Receptor Agonists to achieve a goal A1c of <7.0% or a goal specified by the physician.
- Safety Parameters:
- Metformin will not be initiated if eGFR < 30 mL/min.
- SGLT2 Inhibitors will be dosed according to renal function per package labeling.
- Insulin Management: This Agreement does not grant the authority to initiate or titrate insulin. This will require direct consultation with the collaborating physician.
Authorized Labs: Hemoglobin A1c, BMP, Lipid Panel.
VI. Documentation and Communication Plan
- Documentation: The Pharmacist will document every patient encounter in the shared EHR using a standardized SOAP note format within one (1) business day of the visit.
- Routine Communication: All patient care activities will be visible to the Physician through the EHR.
- Required Physician Consultation: The Pharmacist must communicate directly (via secure message or phone call) with the Collaborating Physician under the following circumstances:
- Patient experiences a serious adverse drug event.
- Patient requires hospitalization or an emergency department visit.
- A critical laboratory value is obtained (See Appendix A).
- The desired therapeutic goals are not being met despite protocol-driven titration.
- The patient’s clinical status declines significantly.
VII. Quality Assurance and Outcomes Measurement
- Chart Review: The Physician and Pharmacist will meet monthly to perform a joint review of at least 10% of the active patient charts managed under this Agreement.
- Outcomes Tracking: The following Key Performance Indicators (KPIs) will be tracked quarterly to assess the effectiveness of the clinic:
- Percentage of HFrEF patients on all four pillars of GDMT.
- Percentage of HFrEF patients at >50% of target beta-blocker and ARNI dose.
- Mean change in Hemoglobin A1c for patients with T2DM.
- Time in Therapeutic Range (TTR) for the warfarin patient cohort.
- 30-day all-cause hospital readmission rate for the clinic population.
VIII. Signatures
By signing below, the parties acknowledge that they have read, understood, and agree to the terms and conditions of this Collaborative Practice Agreement.
Jane Doe, MD, FACC
Lead Collaborating Physician
Date
John Smith, PharmD, BCPS, CCPP
Authorized Pharmacist
Date
YOUR FINAL CHALLENGE: The Clinic Visit
Now, with the full scope of your authority clearly defined by the preceding agreement, you will conduct the clinic visit with Mr. Harrison. Your task is to perform the interview, assessment, and formulate a plan. Your plan must be entirely executed using the authority granted to you by the CPA. Write the orders, make the medication changes, and document your encounter in a formal SOAP note.
Masterclass Response: The Pharmacist-Led Clinic Visit
This is the culmination of your training, where you function as an autonomous provider managing complex chronic disease.
The Patient Interview & Assessment
Mr. Harrison presents for follow-up accompanied by his daughter. Reports his breathing is “much better” than at discharge. No cough or chest pain. Denies orthopnea or PND. Reports mild residual fatigue but is participating in PT at the SNF. Daughter confirms full adherence with the new medication regimen, including the apixaban. No signs of bleeding or bruising reported. Denies polyuria/polydipsia. Glucose logs from SNF show fasting BG in 120-140 range.
OBJECTIVE:
Vitals: BP 118/72, HR 68 bpm.
Weight: 83 kg (down 2 kg from admission weight).
Exam: Lungs clear to auscultation. No JVD. Trace pedal edema.
Point-of-Care Labs Ordered by Pharmacist (per CPA): BMP shows Na 138, K 4.2, BUN 45, SCr 1.9.
The Pharmacist’s SOAP Note & CPA Implementation
CCPP Cardiovascular Risk Reduction Clinic Note
72 y.o. male status-post admission for septic shock, now clinically stable and recovering well. Visit today focused on titration of GDMT and long-term risk reduction, managed per CPA.
1. HFrEF (EF 30%) – Sub-optimally treated: Patient is euvolemic and hemodynamically stable. BP and HR are permissive for titration of GDMT. His SCr and K+ are stable and do not preclude titration.
- Plan (per CPA):
- ACTION: DISCONTINUE Furosemide 60mg daily. Patient is now euvolemic and may not require routine diuretic. Will provide patient with a 40mg PRN prescription for weight gain >3 lbs.
- ACTION: INCREASE Metoprolol Succinate to 100 mg daily. Goal is 200mg daily as tolerated.
- ACTION: INITIATE Sacubitril/Valsartan 24/26 mg PO BID. Restarting his ARNI at the lowest dose is now safe given his improved renal function and stable K+.
2. Atrial Fibrillation – Stable on DOAC: Patient tolerating apixaban 5mg BID well with no signs of bleeding. Adherence confirmed.
- Plan (per CPA):
- ACTION: CONTINUE Apixaban 5 mg PO BID. Counseled again on importance of 100% adherence.
3. Type 2 Diabetes & CKD – Stable: Glucose control appears reasonable. Patient benefitting from empagliflozin for cardiac and renal protection. Metformin remains held appropriately due to renal function.
- Plan (per CPA):
- ACTION: ORDER Hemoglobin A1c test today.
- ACTION: CONTINUE Empagliflozin 10 mg daily.
ORDERS PLACED BY PHARMACIST TODAY (per CPA):
- Metoprolol Succinate 100mg Tablet. Sig: 1 tab PO daily. #30 + 3 refills.
- Sacubitril/Valsartan 24/26mg Tablet. Sig: 1 tab PO BID. #60 + 3 refills.
- Furosemide 40mg Tablet. Sig: 1 tab PO PRN for >3lb weight gain in 24h. #15.
- Lab Order: Hemoglobin A1c.
BILLING: Visit billed as 99214 incident-to Dr. Anderson.
FOLLOW-UP: Return to pharmacist clinic in 4 weeks. Will check BMP prior to visit to assess tolerance to ARNI initiation. Will call patient in 1 week to check on tolerance to new medication regimen.