CCPP Module 4, Section 2: Essential Components and Delegated Functions
Module 4: Collaborative Practice Agreements (CPA) – Core Concepts

Section 4.2: Essential Components and Delegated Functions

Architecting the Agreement: A Clause-by-Clause Masterclass in Defining Your Scope.

SECTION 4.2

The Anatomy of a Collaborative Practice Agreement

A deep dive into the mandatory elements of any CPA, focusing on how to clearly and specifically define the patient population, disease states, and delegated prescriptive authorities.

4.2.1 The “Why”: From Legal Theory to Clinical Reality

In the previous section, we established the foundational concepts of a Collaborative Practice Agreement—what it is, why it’s a game-changer for healthcare, and the three legal pillars that give it authority. We moved from the abstract to the tangible. Now, we take the final and most critical step: we move from the tangible to the practical. This section is designed as a masterclass in architectural drafting, not for a building, but for your professional scope. If Section 4.1 was the law school lecture, this section is the legal workshop where you learn to draft the ironclad contract.

The difference between a successful, safe, and sustainable collaborative practice and one that is fraught with ambiguity, risk, and frustration lies in the details of the written agreement. A vague CPA is not just a poor document; it is a dangerous one. It creates uncertainty for the pharmacist, confusion for the care team, and most importantly, it introduces unacceptable risks for the patient. A well-constructed CPA, on the other hand, is a masterpiece of clinical clarity. It serves as an unambiguous operational playbook, a definitive legal shield, and a catalyst for high-quality, team-based care. It empowers you to act decisively and confidently, knowing that your actions are not only clinically sound but also legally sanctioned.

Our objective in this deep dive is to deconstruct the anatomy of a robust CPA, examining each essential component clause by clause. We will go far beyond simply listing the required elements. We will provide you with the language, the frameworks, and the clinical examples to define each section with the precision of a surgeon. You will learn how to articulate patient populations, how to scope disease state management protocols, and, most critically, how to define your delegated prescriptive authorities in a way that is both expansive in its potential and airtight in its safety. By the end of this section, you will not only understand what goes into a CPA; you will understand how to build one that can serve as the unshakeable foundation for your advanced clinical practice for years to come.

Pharmacist Analogy: The Master Formulation Record

Think of your CPA not as a simple contract, but as the Master Formulation Record for the most complex compound you will ever be responsible for: advanced clinical pharmacy services. You would never dream of making a complex compound without a meticulously detailed Master Formulation Record, and the same principle applies here. Let’s break down the parallel.

  • The Header Information: Your formulation record starts with the basics: Drug Name, Strength, Dosage Form. The CPA starts with its “header”: the names and license numbers of the collaborators, the effective dates, and the practice location. These are the non-negotiable identifiers that make the document legal and valid. Without them, the rest is meaningless.
  • The “For Patient X” and Allergy Warning: The formulation record is specific to a prescription. A CPA is specific to a defined patient population. The “Inclusion Criteria” (e.g., “patients with T2DM”) are the indication. The “Exclusion Criteria” (e.g., “eGFR < 30, pregnant patients") are the critical allergy and contraindication warnings. They tell you exactly who this "compound" is safe for.
  • The Recipe (Ingredients & Instructions): The heart of the formulation record is the list of ingredients and the step-by-step mixing instructions. In a CPA, the “ingredients” are the disease states and medications you can manage. The “mixing instructions” are the clinical protocols and algorithms you must follow. It’s not enough to say “add lisinopril”; the protocol must specify the starting dose, the titration schedule, and the therapeutic target, just as a recipe specifies grams, temperatures, and mixing times.
  • The Authorized Actions (Compounding Steps): Your role in compounding is to perform specific physical actions: weighing, mixing, levigating, packaging. In a CPA, your role is to perform specific clinical actions: initiating, modifying, and monitoring therapy. These are your delegated “compounding steps.”
  • Quality Control & Documentation: After making a compound, you perform quality control checks (e.g., visual inspection, weight verification) and fill out a compounding log. The CPA’s “quality control” is the plan for monitoring and referrals—what to do when the patient’s results are out of spec. The “compounding log” is your documentation plan—the requirement to record every action you take in the patient’s chart with a standardized note.

Viewing your CPA through this lens transforms it from a piece of legal paperwork into a dynamic, operational guide. Just as a detailed formulation record ensures that a compound is made safely, accurately, and consistently every single time, a detailed CPA ensures that your clinical services are delivered with the highest degree of safety, precision, and legal defensibility.

4.2.2 The Anatomy of a CPA: A Clause-by-Clause Masterclass

A robust CPA is constructed from a series of essential, interlocking components. While state regulations will dictate the minimum required elements, a truly effective agreement goes beyond the minimum to create a comprehensive and unambiguous operational blueprint. We will now dissect each of these components in exhaustive detail, providing examples of weak versus strong language and highlighting critical clinical and legal considerations.

1. Identification of Collaborative Parties: The “Who”

This initial section serves as the legal foundation of the agreement, formally identifying every individual who is a party to the collaboration. Absolute precision here is non-negotiable.

Core Requirements:
  • Full Legal Names: Use the full legal name of each pharmacist and provider as it appears on their professional license. Avoid nicknames or abbreviations.
  • Professional License Numbers: Include the license number and state of licensure for every participant. This is a critical identifier for regulatory bodies.
  • Practice Site(s): List the full address of every physical location where the collaborative practice will occur. If telehealth is included, this must be explicitly stated.
  • Contact Information: Provide primary contact information (e.g., office phone number, secure email address) for all parties.
Weak Language (Vague and Risky) Strong Language (Specific and Defensible)
“This agreement is between Dr. Smith’s clinic and the pharmacists at ABC Pharmacy.” “This agreement is entered into by and between the following parties:
Collaborating Physician:
John A. Smith, MD (License #12345, State of Confusion)
The Primary Care Clinic, 123 Main Street, Anytown, USA 12345
Collaborating Pharmacists:
Jane R. Doe, PharmD, RPh (License #P67890, State of Confusion)
William Q. Johnson, RPh (License #P54321, State of Confusion)
ABC Clinical Pharmacy Services, 456 Oak Avenue, Anytown, USA 12345″
“The clinical pharmacists of Anytown General Hospital will collaborate with the hospitalist group.” “This agreement applies to the following provider group: The Anytown General Hospitalist Service. A current list of all participating hospitalist physicians, with names and license numbers, will be maintained in Appendix A and updated quarterly. This agreement applies to the following pharmacist group: The Department of Pharmacy Clinical Specialists. A current list of all participating pharmacists who have met the required competencies, with names and license numbers, will be maintained in Appendix B.”
The Danger of “Floating” Collaborators

Avoid language that refers to generic or rotating roles, such as “the on-call physician” or “the weekend pharmacist.” A CPA must apply to a specific, named group of individuals. If your practice involves rotating providers (like a hospitalist service or a residency clinic), the best practice is to have the CPA signed by the Medical Director of that service, with the agreement explicitly stating it applies to all credentialed physicians practicing within that service. A list of these physicians should be maintained and regularly updated as an appendix to the CPA.

2. Term, Review, and Termination: The “When” and “How Long”

This section defines the lifecycle of the agreement. It ensures the CPA is a living document that is periodically reviewed and can be ended professionally if the collaboration is no longer viable.

Key Clauses:
  • Effective Date: The date on which the agreement becomes active and the pharmacist’s delegated authority begins. No collaborative activities may occur before this date.
  • Term and Expiration Date: Most states require an annual or biennial review. The CPA should have a fixed term (e.g., “This agreement shall be in effect for a period of two years, from January 1, 2025, to December 31, 2026.”). An evergreen clause (“This agreement will automatically renew…”) is generally discouraged by regulatory bodies as it can lead to complacency. A fixed expiration date forces a proactive review process.
  • Review and Renewal Clause: This clause codifies the review process. Example: “The parties agree to jointly review this agreement, including all referenced protocols, on an annual basis, no later than November 1st of each year. The agreement may be renewed upon mutual written consent of all parties.”
  • Termination Clause: This provides a mechanism to dissolve the agreement. Example: “Any party may terminate this agreement, with or without cause, by providing 30 days’ written notice to all other parties. Termination of this agreement immediately revokes all delegated prescriptive authority.” This clause also needs to specify how patient care will be transitioned upon termination.

3. Patient Population and Consent: The “For Whom”

This is one of the most critical safety components of the entire agreement. It defines the precise cohort of patients for whom the pharmacist has delegated authority. The goal is to create a “fence” around the patient population, clearly defining who is inside and who is outside the pharmacist’s scope.

Drafting Inclusion Criteria: From Broad to Specific

Inclusion criteria should be clear, objective, and easily verifiable in the patient’s record.

Level of Specificity Example Language Critique
Weak (Too Broad) “Patients of the clinic.” This is dangerously vague. Does it include new patients? Pediatric patients? Patients seeing a visiting specialist? It provides no meaningful guardrails.
Better “Patients of the ABC Primary Care Clinic with a diagnosis of hypertension.” This is an improvement, but still lacks detail. What about patients with complex secondary hypertension or those who are pregnant?
Strong (Specific & Safe) “This agreement applies to established patients of the ABC Primary Care Clinic, aged 18 years or older, who have been referred to the Clinical Pharmacy Service by a collaborating provider for management of Essential Hypertension (ICD-10 Code I10).” This is the gold standard. It specifies the clinic, the age, the referral mechanism, and the exact indication, leaving no room for misinterpretation.
Masterclass Table: Crafting Watertight Exclusion Criteria

Exclusion criteria are your primary safety mechanism. You must proactively identify patient populations that are too complex, too high-risk, or fall outside your area of expertise and explicitly exclude them from the CPA. This protects the patient and you.

Category of Exclusion Rationale for Exclusion Example Exclusion Clauses
Specific Populations To exclude patients who require highly specialized care beyond the scope of a general chronic disease management service.
  • Patients under 18 years of age.
  • Patients who are currently pregnant, planning to become pregnant, or breastfeeding.
  • Patients who are incarcerated.
  • Patients with a diagnosis of dementia or cognitive impairment who are unable to participate in their own care planning without a designated healthcare proxy.
Clinical Instability To ensure that acutely ill or unstable patients are managed directly by the physician. The CPA is for managing stable, chronic conditions.
  • Patients presenting with a hypertensive emergency or urgency (e.g., SBP > 180 or DBP > 120 with or without end-organ damage).
  • Patients experiencing diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS).
  • Patients with acute decompensated heart failure.
  • Patients with an active, uncontrolled infection or sepsis.
Severe Comorbidities To exclude patients whose underlying conditions make medication management exceptionally complex or high-risk.
  • Patients with severe renal impairment (e.g., eGFR < 30 mL/min/1.73m² or on dialysis), unless the CPA is specifically for a renal dose adjustment service.
  • Patients with severe hepatic impairment (Child-Pugh Class C).
  • Patients with a known history of substance use disorder that may interfere with safe medication management.
  • Patients with a recent (within 6 months) myocardial infarction, stroke, or major surgery.
Patient Consent

A cornerstone of ethical practice under a CPA is patient transparency. Patients have a right to know who is managing their care. While state laws vary on whether written consent is mandatory, it is always a best practice.

The Patient Consent Script and Documentation

At the initial referral or first visit with the pharmacist, the process should be explained clearly and simply.

The Script: “Hello Mr. Jones, I’m Jane Doe, the clinical pharmacist here at the clinic. Dr. Smith has asked me to work with you to help get your blood pressure to goal. The way I work with Dr. Smith is through a collaborative practice agreement. This means he has given me the authority to make adjustments to your blood pressure medications and to order any necessary lab tests based on the clinic’s approved protocols. Dr. Smith and I work as a team, and he is always updated on your progress and any changes we make. Our goal is to give you more direct access to medication management to get you to your goal faster. Do you have any questions about this process and are you comfortable with us moving forward?”

Documentation: A note should be placed in the patient’s chart documenting this conversation. Example: “Patient was informed of the role of the clinical pharmacist and the collaborative practice agreement with Dr. Smith. Patient verbalized understanding and consented to medication management by the pharmacist for their hypertension.” If written consent is required or desired, a simple form can be created for the patient to sign.

4.2.3 The Core of the Agreement: Defining Delegated Functions

This is the engine of the CPA. This section translates legal authority into clinical action. It must detail, with exhaustive clarity, exactly what the pharmacist is authorized to do. We will now build upon the concepts of “initiate, modify, and monitor” by providing masterclass-level detail for two common disease states: Hypertension and Type 2 Diabetes. The level of detail provided here is the standard you should strive for in your own agreements.

Masterclass Example 1: Delegated Functions for Hypertension

This section grants the pharmacist the authority to manage medication therapy for patients with a diagnosis of Essential Hypertension (I10) according to the principles of the most current ACC/AHA Hypertension Guideline and the clinic’s specific, appended Hypertension Protocol.

A. Authority to INITIATE Drug Therapy

The pharmacist may initiate antihypertensive therapy for patients who meet the following criteria: 1) A new diagnosis of hypertension is established by the collaborating provider, or 2) The patient has untreated hypertension confirmed by the pharmacist with at least two elevated readings on separate occasions. The goal of therapy is a BP of < 130/80 mmHg.

Clinical Scenario (Based on Guideline) Pharmacist’s Delegated Authority to INITIATE
Stage 1 HTN (130-139/80-89 mmHg) AND Clinical ASCVD or calculated 10-year ASCVD risk ≥10% Pharmacist shall initiate a single first-line agent. Choice of agent will be based on patient-specific comorbidities and characteristics per the appended protocol:
  • General Population: Initiate ACE-Inhibitor, ARB, Calcium Channel Blocker (CCB), or Thiazide Diuretic at a low starting dose.
  • African American (without HF or CKD): Initiate Thiazide Diuretic or CCB as preferred first-line therapy.
  • CKD (all races): Initiate ACE-Inhibitor or ARB.
  • Diabetes with Albuminuria: Initiate ACE-Inhibitor or ARB.
Stage 2 HTN (≥140/90 mmHg) Pharmacist shall initiate therapy with TWO first-line agents from different classes, either as separate agents or as a single-pill combination.
  • Preferred Combination: ACE-I or ARB + Dihydropyridine CCB (e.g., Amlodipine).
  • Alternative Combination: ACE-I or ARB + Thiazide Diuretic.
  • Do NOT combine: ACE-Inhibitor and ARB.
B. Authority to MODIFY Drug Therapy

The pharmacist may modify antihypertensive regimens for established patients to achieve a BP goal of < 130/80 mmHg. Modifications may include dose titration, addition of agents, or substitution of agents.

Action Specific Protocol for Modification
Dose Titration Pharmacist may titrate doses of existing medications at intervals of no sooner than 2-4 weeks. Standard titration is to double the dose of the current medication until the maximum tolerated dose is reached or the BP goal is achieved.
Adding Agents If BP remains above goal on a single agent at maximum dose, the pharmacist shall add a second agent from a different first-line class. If BP remains above goal on two agents, a third agent may be added. The typical sequence is: 1) ACE-I or ARB, 2) Add CCB, 3) Add Thiazide.
Substitution Pharmacist may substitute one agent for another within the same therapeutic class to manage patient-reported side effects (e.g., substitute an ARB for an ACE-Inhibitor in a patient who develops a cough). Pharmacist may also substitute for formulary reasons after confirming therapeutic equivalence.
C. Authority to MONITOR Drug Therapy

The pharmacist is authorized to order and interpret the following laboratory tests for the purpose of ensuring safe and effective antihypertensive therapy.

Laboratory Test Trigger for Ordering Frequency Critical Value Action Threshold
Basic Metabolic Panel (BMP) Initiation or dose titration of an ACE-Inhibitor, ARB, or Diuretic. Order within 2-4 weeks of change, then annually if stable.
  • Potassium > 5.5 mEq/L: Hold agent, notify provider immediately.
  • SCr increase > 30% from baseline: Hold agent, notify provider.
  • Sodium < 130 mEq/L (for diuretics): Hold agent, notify provider.
Lipid Panel, A1c, TSH At initial assessment for new referrals. One time, to screen for comorbid conditions affecting HTN management. Refer any new, significant abnormalities to the provider.