CPOM Module 15, Section 3: Developing & Maintaining Policies & Procedures
MODULE 15: REGULATORY COMPLIANCE & POLICY MANAGEMENT

Section 3: Developing and Maintaining Policies and Procedures

A masterclass on the art and science of creating effective policies—transforming complex regulations into clear, actionable, and user-friendly guidance.

SECTION 15.3

Developing and Maintaining Policies and Procedures

Crafting Your Pharmacy’s Constitution.

15.3.1 The “Why”: From Binders on a Shelf to Your Operational DNA

In nearly every pharmacy, there exists “The Binder”—a thick, three-ring behemoth sitting on a shelf, filled with densely-worded policies and procedures (P&Ps). For many, this binder is an artifact, created under duress for an inspection and rarely touched again. As a staff pharmacist, you may have been asked to sign a form stating you’ve read it, but your actual day-to-day work was likely learned through on-the-job training and tribal knowledge. This approach is not just inefficient; it is profoundly dangerous and unsustainable.

As a Pharmacy Operations Manager, your first and most critical task is to transform the concept of P&Ps from a static, neglected archive into the living, breathing constitution of your entire operation. Well-crafted P&Ps are not mere rulebooks; they are the single source of truth for your organization. They are the bedrock upon which you build consistency, quality, safety, and efficiency. They are your primary training tool for new employees, your objective standard for performance management, your shield during a regulatory audit, and your primary defense in the event of a lawsuit or adverse event. An operation without clear, accessible, and practical P&Ps is an operation built on sand. This section is a masterclass in pouring the concrete foundation. We will explore the art and science of writing policies that people can actually read, understand, and, most importantly, follow.

Retail Pharmacist Analogy: The Restaurant Cookbook

As a skilled staff pharmacist, you are like a talented chef in a busy restaurant. You have your own “recipes” for handling difficult insurance rejections, managing workflow during a rush, and counseling patients on complex medications. Your methods are effective, learned through years of experience. You can execute them flawlessly. However, if you are sick, on vacation, or a new employee is hired, that institutional knowledge is lost. The quality and consistency of the “dishes” leaving your kitchen become entirely dependent on who is cooking that day.

As the Operations Manager, you are now the Executive Chef and author of the restaurant’s official cookbook (the P&P Manual). Your job is to document the one, official, best-practice recipe for every single task in the kitchen.

  • The recipe for “Handling a Refill Too Soon Rejection” doesn’t just list the ingredients; it provides step-by-step instructions, explains the difference between a vacation override and a lost medication, and shows a picture of the correctly documented note.
  • The recipe for “Accepting a Controlled Substance Delivery” has a clear list of required tools (invoice, pen), a precise sequence of actions (the two-person check-in), and a critical warning about what to do if the count is off.
  • The recipe for “Sterile Compounding” is the most complex, with detailed instructions on handwashing, garbing, aseptic technique, and cleaning, complete with diagrams and references to the health code (USP chapters).

This cookbook ensures that every dish—every prescription—that leaves your pharmacy is prepared with the same level of quality, safety, and care, regardless of which “chef” is on duty. It is the tool you use to train new cooks, the standard you use to judge performance, and the proof you show the health inspector that your kitchen is run with professional excellence.

15.3.2 The Anatomy of an Effective Policy & Procedure

Before you can write an effective P&P, you must understand its fundamental structure. A well-organized, consistent format makes your entire P&P manual easier to navigate, read, and use. Every policy you write, from the simplest to the most complex, should contain these core components. Adopting a standardized template is the first step toward a professional and functional P&P library.

Masterclass Table: The Indispensable Components of a P&P Document

Component Purpose (The “Why”) Manager’s Implementation Details
Document Header Provides essential metadata for version control and organization at a single glance. This is critical for document management.
  • Policy Title: Must be clear, specific, and searchable (e.g., “Controlled Substance Biennial Inventory” not “Drug Counts”).
  • Policy Number: A unique identifier (e.g., OPS-001, HR-015). Use a logical prefix for each department.
  • Version Number: Crucial for tracking revisions (e.g., 1.0, 1.1, 2.0).
  • Effective Date: The date the policy goes into effect.
  • Revision Date: The date of the last review/update.
  • Approved By: The name/title of the person with final approval authority (e.g., you, a compliance committee).
1.0 Purpose / Policy Statement A brief, high-level statement explaining why the policy exists. It sets the context and communicates intent. This section should be 1-3 sentences long. It answers the question: “What are we trying to achieve with this rule?” Example: “The purpose of this policy is to ensure the safe, accurate, and compliant management of all recalled medications to prevent patient harm.”
2.0 Scope / Applies To Clearly defines who is bound by the policy. This eliminates ambiguity about responsibilities. Be specific. “All Pharmacy Staff” may be too broad. Consider: “This policy applies to all Pharmacists, Pharmacy Interns, and certified Pharmacy Technicians involved in the dispensing process. This policy does not apply to delivery drivers.”
3.0 Definitions Clarifies any acronyms, technical terms, or phrases that might be misunderstood. Only include terms that are essential to understanding the policy. Example: “Cold Chain: The system of storing and transporting drugs within the manufacturer-recommended temperature range of 2°C to 8°C.” Do not define common pharmacy terms.
4.0 Procedure This is the heart of the document. It provides clear, sequential, step-by-step instructions on how to perform the task.
  • Use a numbered list for sequential steps.
  • Write in the active voice (e.g., “The Pharmacist will verify…” not “Verification will be done by…”).
  • Start each step with an action verb.
  • Keep sentences short and simple. Use visuals like flowcharts for complex decision trees.
5.0 Responsibilities Explicitly states who is responsible for which part of the procedure. This connects the actions to specific roles. This can be a separate section or integrated into the procedure itself (e.g., “4.1 The Technician will: …”). For complex processes, a separate table or list can clarify roles and prevent finger-pointing later.
6.0 References Lists the specific laws, regulations, accreditation standards, or professional guidelines upon which the policy is based. This is your proof of compliance. It connects your internal rule to the external requirement. Example: “21 CFR § 1304.11 – Inventory Requirements,” “URAC Specialty Pharmacy Standard SP 25.”
7.0 Associated Documents Lists any forms, logs, checklists, or other P&Ps that are related to or required by this policy. Example: “Controlled Substance Biennial Inventory Form (FORM-012),” “P&P: Management of Expired Medications (OPS-007).” This creates an interconnected web of documents.

15.3.3 The P&P Writing Process: From Regulation to Reality

The single biggest mistake in policy writing is simply cutting and pasting the text of a regulation into a document and calling it a policy. A regulation tells you what you must do; a procedure tells your team how they will do it in your specific pharmacy. The process of writing is a process of translation and operationalization. It requires a systematic approach to transform dense legal text into a clear, actionable workflow.

The Manager’s 5-Step P&P Translation Workflow
  1. Step 1: Deconstruct the Source Document.

    Start with the primary source—a new state regulation, a URAC standard, a chapter from the USP. Read it carefully and highlight every single command or requirement, often called a “shall statement.” For example, if reviewing USP <800>, you would pull out statements like “Personnel who handle hazardous drugs (HDs) shall be trained…” and “An initial competency assessment shall be performed…” Each of these becomes a requirement your P&P must address.

  2. Step 2: Map the Real-World Workflow.

    Get out of your office and onto the pharmacy floor. Gather the people who will actually perform the task. Using a whiteboard or large paper, physically map out the process as it currently exists or as it needs to exist to meet the new requirement. Ask questions: Who is the first person to touch this process? What is the trigger? What is the very next step? What decision needs to be made here? This visual map becomes the skeleton of your procedure.

  3. Step 3: Draft the Procedure in Simple, Active Language.

    Now, translate the workflow map into the procedure section of your P&P document. Write for a brand new employee. Avoid jargon where possible. Use short sentences and an active voice.
    Bad (Passive): “The biennial inventory form must be filled out completely.” (By whom? When?)
    Good (Active): “4.1 The Pharmacist-in-Charge will: a) Obtain the official Biennial Inventory Form (FORM-012) on or before the inventory date. b) Complete all header information, including the date and time of the inventory (start or close of business).”

  4. Step 4: Incorporate the “Why” and Define Key Terms.

    Where a step might seem arbitrary or tedious, add a brief, parenthetical explanation. This builds understanding and buy-in. Example: “c) Conduct an exact count of all Schedule II medications (Note: Exact counts are required by the DEA and are critical for diversion detection).” This is also the stage where you fill out the “Purpose” and “Definitions” sections of your template to provide context.

  5. Step 5: Validate with the End-Users.

    This is the most important and often-skipped step. Give your draft procedure to the technicians and pharmacists who will be following it. Ask them to read it and then “dry run” the process. Is anything unclear? Is a step missing? Is the sequence wrong? Is the process you designed actually practical during a busy shift? Incorporate their feedback to create a final version that is both compliant and realistic. A policy written without input from the people doing the work is destined to fail.

15.3.4 Writing for Usability: Avoiding the Pitfalls of Bad Policy Language

An effective policy is one that is used. A policy that is confusing, vague, or impractical will be ignored, rendering it useless. As the author and manager, you must be ruthless in editing your own work and the work of others to eliminate language that creates ambiguity or barriers to understanding. Your goal is absolute clarity. Here are the most common traps to avoid.

The Seven Deadly Sins of P&P Writing
The Sin Example of Bad Writing Why It’s a Problem The Virtuous Solution
1. Vagueness (The Weasel Words) “Refrigerators should be checked periodically.”
“Discrepancies must be reported promptly.”		 These words are meaningless and unenforceable. “Periodically” could mean hourly to one person and yearly to another. An auditor will tear this apart. Be Explicitly Quantitative. “Refrigerator temperatures must be manually logged twice daily.”
“Inventory discrepancies over 3 tablets must be reported to the PIC within one hour of discovery.”
2. Passive Voice “The prescription label is checked for accuracy.” It completely obscures accountability. Who is checking the label? If an error occurs, who is responsible? Use Active Voice with a Clear Subject. “The verifying pharmacist will check the prescription label for accuracy against the original order.”
3. Legal Jargon & “Copy-Paste” Compliance “Pursuant to 21 CFR 1304.04, all records must be maintained…” This is lazy and unhelpful. Your staff are not lawyers. Your job is to translate the law into an operational step, not to quote it. Translate and Reference. “All controlled substance invoices must be filed chronologically and stored in the locked office for two years. (Ref: 21 CFR 1304.04)”
4. The “Perfect World” Procedure “The pharmacist will provide a 15-minute, uninterrupted consultation for every new prescription.” This describes an ideal that is impossible to achieve in a busy pharmacy, setting your staff up for failure and non-compliance from day one. Write for Reality. “The pharmacist will counsel all patients on new prescriptions. For complex therapies like warfarin, the pharmacist will bring the patient to the consultation room to provide detailed education.”
5. The Wall of Text A single, two-page paragraph describing the entire dispensing process without any breaks. It’s intimidating and impossible to scan for specific information. Readers will give up. Use Formatting as a Guide. Break up text with clear headings, subheadings, numbered lists, bullet points, and bold text for emphasis. Use white space generously.
6. Outdated Information A procedure describing how to use a software system that was replaced six months ago. It instantly destroys the credibility of your entire P&P manual and tells staff that these documents are irrelevant. Implement a Mandatory Review Cycle. Policies are not “set and forget.” Every P&P must be reviewed at least annually to ensure it reflects current regulations, technologies, and practices.
7. Forgetting the “Why” “All hazardous drug compounding must be done wearing two pairs of chemo-rated gloves.” The statement is correct, but provides no context, which can lead to staff seeing it as just another tedious rule. Incorporate Purpose. “To protect staff from exposure, all hazardous drug compounding must be done wearing two pairs of chemo-rated gloves, as required by USP <800>.”

15.3.5 Policy Management and Document Control: The System of Record

Writing a good policy is only half the battle. Managing your entire library of P&Ps is a critical operational function. Accrediting bodies like URAC and TJC will audit your document control system just as rigorously as they audit your actual practices. You must have a formal, demonstrable system for how policies are created, approved, distributed, reviewed, and archived. A haphazard collection of Word documents on a shared drive is not a compliant system.

Masterclass Table: Core Components of a Compliant Document Control System

Component What It Is Manager’s Implementation Strategy
1. Centralized Repository A single, designated location that serves as the “source of truth” for all current, approved P&Ps.
  • Good: A locked-down, read-only folder on a network drive.
  • Better: A dedicated SharePoint or intranet site that allows for better search and organization.
  • Best: A commercial P&P management software (e.g., PolicyStat, PowerDMS) that automates many of the functions below.
  • Policy Point: Your P&P on P&Ps must explicitly state that printed copies are uncontrolled and staff must always refer to the electronic repository for the current version.
2. Formal Approval Workflow A defined, documented process for how a P&P moves from a draft to an officially approved document.

Your policy must map this workflow. For example:

  1. Draft created by Subject Matter Expert.
  2. Draft reviewed by the Accreditation Steering Committee.
  3. Committee provides edits; draft is revised.
  4. Final version approved by the PIC and/or Director of Pharmacy.
  5. Approved policy is uploaded to the Centralized Repository, and the previous version is archived.
3. Version Control A systematic way to track the history and revisions of each document. This is managed through the document header (Version Number, Revision Date). Your repository should have a clear file-naming convention, e.g., “OPS-001_Biennial_Inventory_v2.1.pdf”. Never use generic names like “Inventory Policy FINAL final v2.docx”.
4. Mandatory Review Cycle A proactive schedule to ensure every P&P is reviewed and updated on a regular basis.
  • Create a master spreadsheet of all P&Ps with their last review date and next scheduled review date.
  • Your policy must define the review interval (e.g., “All P&Ps will be reviewed at least annually.”).
  • The review must be documented, even if no changes are made (e.g., the reviewer signs and dates a review log).
5. Staff Communication & Attestation A process for notifying staff of new or revised policies and documenting that they have read and understood them.
  • When a critical policy is updated, send out a formal communication explaining the change and the “why” behind it.
  • Use a learning management system or a simple sign-off sheet to collect attestations. An auditor will ask for this. “You updated your HD handling policy in June. Show me the proof that all staff were trained on and acknowledged the new procedure.”
6. Archiving Process A system for removing outdated policies from circulation and storing them securely. Never delete old policies. You may need them to show an auditor or lawyer what your process was at a specific point in time in the past. Create an “Archive” folder in your repository and move outdated versions there. Your P&P must specify the retention period (e.g., “Archived policies will be retained for a minimum of 10 years.”).

15.3.6 Conclusion: Your Policies as a Management Multi-Tool

As a Pharmacy Operations Manager, your Policies and Procedures manual is one of the most powerful tools at your disposal. It is far more than a simple compliance artifact. It is your primary vehicle for standardizing best practices, eliminating ambiguity, and driving a culture of quality and accountability. When you receive a new regulation, your first thought should be, “How do I translate this into a clear procedure?” When you identify an operational inefficiency, your first thought should be, “Can we improve this process and codify it in a P&P?” When a staff member is struggling with a task, your first question should be, “Have you reviewed the P&P for that?”

By embracing the role of author, editor, and librarian of your pharmacy’s operational constitution, you transform abstract rules into tangible daily actions. You create a system that is resilient to staff turnover, prepared for audits, and fundamentally built on a foundation of clarity and safety. This is not merely an administrative task; it is a core leadership function and the hallmark of a truly well-managed pharmacy operation.