CHPOP Certification Review

Certified Hospital Pharmacy Operations Pharmacist (CHPOP) Review

A Review Guide for the Certified Hospital Pharmacy Operations Pharmacist (CHPOP) Exam

Block 1: Foundations & Core Operational Principles

A-C

  • ADC: Automated Dispensing Cabinet.
  • ADR: Adverse Drug Reaction.
  • BCMA: Barcode Medication Administration.
  • BOP: Board of Pharmacy.
  • CADD: Computerized Ambulatory Drug Delivery.
  • CDC: Centers for Disease Control and Prevention.
  • CDM: Charge Description Master.
  • CMS: Centers for Medicare & Medicaid Services.
  • CPOE: Computerized Provider Order Entry.
  • CSP: Compounded Sterile Preparation.

D-H

  • DEA: Drug Enforcement Administration.
  • DUR: Drug Utilization Review.
  • EHR: Electronic Health Record.
  • EMAR: Electronic Medication Administration Record.
  • ER: Emergency Room.
  • FDA: Food and Drug Administration.
  • FMEA: Failure Mode and Effects Analysis.
  • GPO: Group Purchasing Organization.
  • HCAHPS: Hospital Consumer Assessment of Healthcare Providers and Systems.
  • HIPAA: Health Insurance Portability and Accountability Act.

I-N

  • ICU: Intensive Care Unit.
  • IDS: Investigational Drug Service.
  • ISMP: Institute for Safe Medication Practices.
  • IV: Intravenous.
  • JIT: Just-In-Time (Inventory).
  • KPI: Key Performance Indicator.
  • MAR: Medication Administration Record.
  • MUE: Medication Use Evaluation.
  • NDC: National Drug Code.
  • NPSG: National Patient Safety Goals.

O-R

  • OR: Operating Room.
  • OSHA: Occupational Safety and Health Administration.
  • P&T: Pharmacy and Therapeutics (Committee).
  • PACU: Post-Anesthesia Care Unit.
  • PAR: Periodic Automatic Replenishment.
  • PCA: Patient-Controlled Analgesia.
  • PIS: Pharmacy Information System.
  • PO: Per Os (by mouth).
  • PPE: Personal Protective Equipment.
  • RCA: Root Cause Analysis.

S-Z

  • STAT: Statim (immediately).
  • TJC: The Joint Commission.
  • TALLman: Tall Man Lettering.
  • TPN: Total Parenteral Nutrition.
  • UD: Unit Dose.
  • USP: United States Pharmacopeia.
  • VAERS: Vaccine Adverse Event Reporting System.
  • WAC: Wholesale Acquisition Cost.
  • <795>: USP Chapter on Non-Sterile Compounding.
  • <797>: USP Chapter on Sterile Compounding.
  • <800>: USP Chapter on Hazardous Drug Handling.

Transition from Retail to Hospital Pharmacy

  • The hospital environment is fundamentally different from a community pharmacy setting.
  • The focus shifts from dispensing prescriptions to managing the entire medication use system for inpatients.
  • Pharmacists become part of a large, multidisciplinary care team.
  • The scope of practice is often broader, with a greater emphasis on clinical activities and sterile compounding.
  • The patient population is more acute and complex.
  • Reimbursement is based on hospital-level payments (like DRGs) rather than per-prescription fees.
  • The regulatory environment is more complex, with a heavy focus on accreditation standards (e.g., The Joint Commission).
  • A CHPOP must master these differences to operate effectively.

The Mission of the Hospital Pharmacy

  • The primary mission is to ensure the safe and effective use of medications for all patients within the institution.
  • This involves managing the procurement, storage, preparation, distribution, and administration of all medications.
  • The department is responsible for ensuring compliance with all relevant laws, regulations, and standards.
  • It serves as the primary source of drug information for physicians, nurses, and other healthcare professionals.
  • The pharmacy must also be a good steward of financial resources, managing the hospital's multi-million dollar drug budget.
  • A key goal is to integrate pharmacists into direct patient care roles to optimize medication therapy.
  • The CHPOP is responsible for the operational infrastructure that makes this mission possible.

Centralized vs. Decentralized Models

  • Centralized Model: Most pharmacy operations (order verification, compounding, dispensing) occur in a single, central pharmacy.
  • This model is efficient and allows for the consolidation of resources and automation.
  • Decentralized Model: Clinical pharmacists are stationed on patient care units (satellites) to provide services at the point of care.
  • This model improves collaboration with the care team and allows for more direct patient interaction.
  • Most hospitals use a hybrid model, with a central pharmacy for core operations and decentralized pharmacists for clinical services.
  • The CHPOP must manage the complex logistics of supporting these decentralized pharmacists with medications and information.

24/7 Operations

  • Unlike most retail pharmacies, hospital pharmacies operate 24 hours a day, 7 days a week.
  • This is necessary to provide continuous care for inpatients.
  • The CHPOP is responsible for managing the staffing and workflow for all shifts, including nights and weekends.
  • This creates unique challenges for scheduling, supervision, and communication.
  • Many hospitals use remote order verification services to help cover overnight shifts.
  • This involves pharmacists at a remote location verifying orders for the hospital electronically.
  • Ensuring safe and efficient operations around the clock is a core responsibility.

The Role of the Operations Manager

  • The CHPOP is the leader responsible for the day-to-day functioning of the pharmacy.
  • They manage the "engine" of the pharmacy: the people, processes, and technology involved in the medication use system.
  • Key responsibilities include managing staff, overseeing automation, ensuring regulatory compliance, and managing the budget.
  • They must be an expert in workflow design and process improvement.
  • They are the bridge between the clinical goals of the pharmacy and the operational reality of making them happen.
  • This role requires a unique blend of clinical knowledge, business acumen, and leadership skills.

Prescribing & Transcribing (CPOE)

  • The medication use system begins with the prescriber's decision to order a medication.
  • In modern hospitals, this is done via Computerized Provider Order Entry (CPOE).
  • CPOE eliminates the need for handwritten orders, which reduces transcription errors.
  • The system provides clinical decision support to the prescriber at the time of ordering (e.g., allergy alerts, dose range checking).
  • Once the provider signs the order, it is transmitted electronically to the pharmacy for verification.
  • The CHPOP works with the informatics team to ensure the CPOE system is safe and efficient.

Order Verification (The Pharmacist's Role)

  • Order verification is a critical safety check performed by a pharmacist.
  • The pharmacist reviews each new medication order for appropriateness.
  • This includes checking the drug, dose, route, and frequency.
  • They assess the order in the context of the patient's clinical condition, lab results, and other medications.
  • This is a prospective review, designed to catch and correct errors before the first dose is given.
  • If an issue is found, the pharmacist must contact the prescriber to clarify.
  • The CHPOP is responsible for the workflow and staffing of this core process.

Dispensing

  • Once an order is verified, the pharmacy dispenses the medication.
  • For oral medications, this often involves dispensing a 24-hour supply of unit-dose packages.
  • For IV medications, this involves sterile compounding of the final product.
  • Automation, such as robotic dispensing systems and IV compounders, is heavily used in this stage.
  • Barcode scanning is used to verify that the correct drug is being dispensed.
  • The CHPOP is responsible for the accuracy, efficiency, and safety of the entire dispensing process.

Administration (BCMA)

  • The administration stage is when the nurse gives the medication to the patient.
  • This is the last line of defense against a medication error.
  • Barcode Medication Administration (BCMA) is a key technology used at this stage.
  • The nurse scans a barcode on their own ID, the patient's wristband, and the medication package.
  • The system verifies the "five rights": right patient, right drug, right dose, right route, and right time.
  • The CHPOP is responsible for ensuring that all medications dispensed by the pharmacy are barcoded correctly to support BCMA.

Monitoring

  • The final stage of the medication use system is monitoring the patient's response to the therapy.
  • This includes monitoring for both therapeutic effects and adverse effects.
  • This is a collaborative responsibility of the physician, nurse, and clinical pharmacist.
  • The pharmacist uses their expertise to monitor for drug interactions, side effects, and the need for dose adjustments based on lab results.
  • The CHPOP ensures that the operational systems provide the clinical pharmacists with the data they need to perform this monitoring effectively.

The Pharmacy Team (Pharmacists, Technicians)

  • Clinical Pharmacists: Responsible for order verification, clinical monitoring, and providing drug information.
  • Operational/Staff Pharmacists: Oversee the dispensing process and supervise technicians.
  • Pharmacy Technicians: Perform a wide range of technical duties, including filling ADCs, compounding, and managing inventory.
  • Pharmacy Leadership: The Director, Manager (CHPOP), and Supervisors who are responsible for the overall performance of the department.
  • Effective teamwork within the pharmacy is the foundation of all operations.

Nursing Collaboration

  • Nursing is the pharmacy's most important partner.
  • The CHPOP must have a strong, collaborative relationship with nursing leadership.
  • This is essential for resolving issues related to medication availability, ADC management, and BCMA.
  • Regular interdepartmental meetings are crucial for communication and problem-solving.
  • Pharmacists and nurses must work together to ensure the safe and timely administration of medications.
  • This partnership is at the heart of patient safety.

Physician & Provider Collaboration

  • Pharmacists collaborate with physicians and other prescribers on a daily basis.
  • This includes clarifying orders, recommending formulary alternatives, and providing clinical consultations.
  • A key aspect is understanding the different types of providers in a hospital.
  • Attendings: Senior physicians responsible for the patient's overall care.
  • Residents/Interns: Physicians in training who write many of the daily orders.
  • Hospitalists/Internists: Physicians who specialize in the care of hospitalized patients.
  • Medical Group Contractors: Some physicians may be independent contractors, not direct hospital employees.

Ancillary Department Collaboration

  • The pharmacy must collaborate with many other departments.
  • Information Technology (IT): For managing the EHR, PIS, and all automation.
  • Finance: For budgeting, billing, and managing the chargemaster.
  • Environmental Services: For cleaning and waste management, especially in the cleanroom.
  • Facilities/Engineering: For maintaining the HVAC systems that are critical for USP compliance.
  • The CHPOP is the key liaison for many of these relationships.

Patient Transitions (ER, OR, PACU, Floor)

  • Medication management is particularly challenging during patient transitions.
  • When a patient moves from the ER to an inpatient floor, a process of medication reconciliation is required.
  • Orders written in the OR or PACU (Post-Anesthesia Care Unit) must be reviewed and reconciled when the patient is transferred.
  • These transitions are high-risk periods for medication errors.
  • The CHPOP is responsible for designing the operational workflows to support safe medication management during these handoffs.
  • This requires close collaboration with all the involved departments.

The Role of the PIS

  • The Pharmacy Information System is the core software application used by the pharmacy.
  • It manages all aspects of the dispensing process.
  • It contains the drug formulary, inventory records, and patient medication profiles.
  • It is used to process and verify medication orders.
  • It generates labels for IVs and other compounded products.
  • It also manages the purchasing and receiving of medications.
  • The CHPOP must be a super-user and an expert on the functionality of their PIS.

Integration with the EHR

  • In modern hospitals, the PIS is tightly integrated with the main Electronic Health Record (EHR).
  • In some cases, the pharmacy module is part of the same enterprise-wide EHR system (e.g., Epic, Cerner).
  • This integration allows for the seamless flow of information.
  • CPOE orders from the EHR flow directly into the pharmacy's verification queue.
  • When a pharmacist verifies an order, the information flows to the electronic Medication Administration Record (eMAR) for the nurse.
  • This integration is critical for safety and efficiency.
  • The CHPOP works with the IT/informatics team to manage and optimize this integration.

CPOE and Clinical Decision Support (CDS)

  • CPOE is the system that prescribers use to enter orders into the EHR.
  • A key feature of CPOE is Clinical Decision Support (CDS).
  • CDS provides real-time alerts and guidance to the prescriber.
  • This can include allergy alerts, drug interaction checks, and dose range checking.
  • It can also include guidance to promote the use of formulary medications.
  • The CHPOP is involved in the design and maintenance of the pharmacy-related CDS rules.
  • The goal is to create alerts that are helpful but not overwhelming ("alert fatigue").

The Pharmacist Verification Queue

  • All new medication orders flow into the pharmacist's electronic verification queue.
  • This is the primary work queue for the inpatient pharmacist.
  • The system must be designed to prioritize orders based on urgency (e.g., STAT orders appear at the top).
  • The pharmacist reviews the order in the context of the patient's full profile in the EHR.
  • The CHPOP is responsible for the design and efficiency of this workflow.
  • This includes setting standards for the expected turnaround time for order verification.

Label Printing and Dispensing Logic

  • Once an order is verified, the PIS generates the necessary labels and dispensing instructions.
  • For IV admixtures, the label must contain detailed information, including the patient name, all ingredients, and the infusion rate.
  • For oral medications, the system sends a message to the automated dispensing cabinet or robot.
  • The CHPOP is responsible for ensuring that the system's label formats are compliant with all regulatory and safety standards (e.g., ISMP).
  • They must also ensure that the logic for routing dispensing tasks is correct.

The Hospital P&T Committee

  • The P&T Committee is responsible for managing the hospital's formulary.
  • Its primary focus is on clinical efficacy and patient safety.
  • Cost is a secondary, but still important, consideration.
  • The CHPOP is a key member of this committee, providing operational and financial input.
  • They are responsible for implementing the committee's decisions.

Formulary Tiers and Restrictions

  • A hospital formulary may have different levels of restriction.
  • Formulary: Available for use by all prescribers.
  • Restricted: Use is restricted to specific services or physician specialties.
  • Non-Formulary: Not routinely stocked or used; requires a special approval process.
  • The CHPOP is responsible for ensuring these restrictions are built into the CPOE system.

Therapeutic Interchange

  • Therapeutic interchange is the practice of dispensing a drug that is chemically different but therapeutically similar to the one prescribed.
  • This is done according to a P&T-approved protocol.
  • For example, a protocol might allow the pharmacy to automatically switch between two different, but equivalent, statins based on cost and availability.
  • This is a key cost-saving strategy.
  • The CHPOP is responsible for the operational implementation of these protocols.

IV-to-PO Conversion Programs

  • This is a program to switch patients from an intravenous (IV) medication to its oral (PO) equivalent when they are clinically stable.
  • Oral medications are significantly less expensive and safer than IV medications.
  • This is a major cost-saving and patient safety initiative.
  • The P&T committee approves the protocols that define which drugs are eligible and what the clinical criteria are for conversion.
  • The CHPOP helps to operationalize this program within the EHR and pharmacy workflow.

Managing Non-Formulary Requests

  • There must be a clear process for handling requests for non-formulary drugs.
  • This typically involves a pharmacist reviewing the request and discussing it with the prescriber.
  • If a formulary alternative is not appropriate, a formal approval process is followed.
  • The CHPOP analyzes the data on non-formulary requests.
  • A high volume of requests for a specific drug may indicate that it should be considered for addition to the formulary.

Role as Drug Experts

  • Hospital pharmacists are the primary source of drug information for the entire institution.
  • They must be able to answer complex questions from physicians and nurses about dosing, administration, and side effects.
  • The CHPOP ensures that the pharmacy staff have access to the necessary drug information resources.
  • This includes electronic databases (e.g., Lexicomp, Micromedex) and the medical literature.

Clinical Decision Support (CDS)

  • CDS tools are built into the EHR to provide real-time guidance to prescribers.
  • The CHPOP is involved in the policy and operational aspects of designing these tools.
  • This includes dose range checking, duplicate therapy alerts, and drug interaction alerts.
  • The goal is to design alerts that are clinically meaningful and help to prevent errors.
  • A key challenge is preventing "alert fatigue," where users become desensitized to too many alerts.

Clinical Guidelines and Protocols

  • The pharmacy department is a leader in developing evidence-based clinical guidelines for medication use.
  • These guidelines are approved by the P&T committee.
  • Examples include protocols for heparin dosing, vancomycin dosing, and IV-to-PO conversions.
  • The CHPOP is responsible for ensuring these protocols are operationalized within the EHR and pharmacy workflow.
  • This helps to standardize care and improve outcomes.

Medication Use Evaluation (MUE)

  • An MUE is a formal, performance improvement-based process.
  • It involves a systematic review of how a specific drug is being used in the hospital.
  • The goal is to determine if the drug is being used according to the approved guidelines.
  • For example, an MUE might look at whether a high-cost antibiotic is being prescribed appropriately.
  • The CHPOP is involved in the operational part of the MUE, such as collecting the data from the PIS.
  • The results are presented to the P&T committee to drive improvements in prescribing.

Educating Staff

  • The pharmacy department is responsible for educating other healthcare professionals about new drugs and policies.
  • This can be done through newsletters, in-services, and email communications.
  • When a new drug is added to the formulary, a formal education plan is needed.
  • The CHPOP is involved in the planning and dissemination of this educational material.
  • This ensures that all members of the care team are up-to-date on the latest medication information.

The Procure-to-Pay Cycle

  • This is the end-to-end process of ordering, receiving, and paying for goods.
  • It starts with identifying a need and creating a purchase order (PO).
  • The PO is sent to the supplier (wholesaler).
  • The supplier delivers the goods and an invoice.
  • The pharmacy receives the goods and performs a "three-way match" between the PO, the packing slip, and the invoice.
  • If everything matches, the invoice is approved for payment.
  • The CHPOP is responsible for the efficiency and accuracy of this entire cycle.

Wholesaler and GPO Relationships

  • Most pharmacies purchase the majority of their drugs from a single, primary wholesaler.
  • This relationship is governed by a Prime Vendor Agreement (PVA).
  • The hospital is also a member of a Group Purchasing Organization (GPO).
  • The GPO negotiates contract pricing with manufacturers on the hospital's behalf.
  • The wholesaler is responsible for loading and honoring these GPO prices.
  • The CHPOP is responsible for managing these key vendor relationships.

Direct Purchasing

  • Some drugs are purchased directly from the manufacturer.
  • This is common for specialty drugs, drugs in short supply, or when a manufacturer offers a better direct price.
  • Managing direct accounts adds complexity to the procurement process.
  • The CHPOP must have a process for creating and managing these direct POs and payments.

Receiving and Put-Away

  • The receiving process is a critical control point.
  • Staff must verify that the correct drug, strength, and quantity were received.
  • They must also inspect for damage and ensure cold chain integrity.
  • Once received, the drugs must be put away in their proper storage location.
  • Stock rotation (FIFO/FEFO) must be performed during this process.
  • The CHPOP must ensure this process is accurate and efficient.

Inventory Valuation

  • The drug inventory is a major asset on the hospital's balance sheet.
  • The value of the inventory is determined by the acquisition cost of the drugs on hand.
  • An accurate perpetual inventory system is essential for accurate valuation.
  • The CHPOP is responsible for the accuracy of the inventory and must be able to report on its value to the finance department.
  • Physical inventories are conducted periodically to verify the valuation.

ISMP Medication Safety Self Assessment®

  • A comprehensive assessment tool developed by the Institute for Safe Medication Practices (ISMP).
  • It allows hospitals to evaluate their medication safety practices against a gold standard of best practices.
  • The assessment is broken down into key elements, many of which are directly related to pharmacy operations.
  • The CHPOP would lead the completion of the sections related to drug storage, distribution, and compounding.
  • The results are used to identify gaps and create a prioritized action plan for improvement.

Failure Mode and Effects Analysis (FMEA)

  • FMEA is a proactive risk assessment tool used to identify potential failures in a process before they happen.
  • A multidisciplinary team maps out a high-risk process (e.g., chemotherapy preparation).
  • They brainstorm potential "failure modes" (what could go wrong) at each step.
  • Each failure mode is rated on its Severity, Probability of Occurrence, and Likelihood of Detection.
  • These scores are multiplied to get a Risk Priority Number (RPN).
  • The team then focuses on designing safeguards to prevent the highest-risk failures.
  • The CHPOP must be skilled in leading FMEAs for pharmacy processes.

Root Cause Analysis (RCA)

  • An RCA is a retrospective tool used to investigate an adverse event after it has occurred.
  • The goal is to find the underlying system-level causes of the error, not to place blame on individuals.
  • A multidisciplinary team is assembled to reconstruct the timeline of the event.
  • They use techniques like the "5 Whys" to dig deep into the contributing factors.
  • The output is a set of strong action items designed to prevent the event from recurring.
  • The CHPOP is a key leader in conducting RCAs for medication-related events.

Lean/Six Sigma Tools

  • These are quality improvement methodologies focused on improving efficiency and reducing waste.
  • Value Stream Mapping: A tool used to visualize all the steps in a process and identify non-value-added steps (waste).
  • 5S: A methodology for workplace organization (Sort, Set in Order, Shine, Standardize, Sustain).
  • Spaghetti Diagram: A tool used to visually track the physical movement of staff or materials to identify wasted motion.
  • A CHPOP uses these tools to analyze and improve the efficiency of pharmacy workflows, such as the IV compounding process.

Productivity Dashboards

  • A dashboard is a visual tool used to monitor Key Performance Indicators (KPIs).
  • For pharmacy operations, this would include metrics like:
  • Doses dispensed per technician FTE.
  • Orders verified per pharmacist FTE.
  • Turnaround time for STAT and routine orders.
  • Inventory turnover rate.
  • The CHPOP uses this dashboard to monitor the daily performance of the department, identify trends, and manage resources.
  • It is a key tool for data-driven operational management.

IV Drip Rate Calculations

  • A fundamental calculation to determine the rate at which an IV medication should be infused.

\( \text{Rate (mL/hr)} = \frac{\text{Total Volume (mL)}}{\text{Total Time (hr)}} \)

Creatinine Clearance (CrCl) - Cockcroft-Gault

  • Used to estimate a patient's renal function, which is critical for dosing many medications.

\( \text{CrCl (mL/min)} = \frac{(140 - \text{Age}) \times \text{Weight (kg)}}{72 \times \text{Serum Cr (mg/dL)}} \times (0.85 \text{ if female}) \)

Body Mass Index (BMI)

  • A measure of body fat based on height and weight, used in some dosing calculations.

\( \text{BMI} = \frac{\text{Weight (kg)}}{[\text{Height (m)}]^2} \)

Inventory Turnover Rate

  • Measures how many times inventory is sold and replaced over a period. A key metric for inventory management efficiency.

\( \text{Inventory Turns} = \frac{\text{Cost of Goods Sold}}{\text{Average Inventory}} \)

Full-Time Equivalent (FTE) Calculation

  • Converts total hours worked by all staff into the equivalent number of full-time employees, essential for budgeting and productivity analysis.

\( \text{FTEs} = \frac{\text{Total Hours Worked per Year}}{2080} \)

Block 2: Medication Order Management & Processing

Receiving Orders via CPOE

  • The process begins when a provider enters a medication order into the Computerized Provider Order Entry (CPOE) system.
  • This order is electronically transmitted to the Pharmacy Information System (PIS).
  • The order appears in the pharmacist's verification queue.
  • The CHPOP ensures this interface between the CPOE and PIS is functioning correctly.
  • The system should be designed to clearly flag new, unverified orders.
  • Orders are prioritized based on their status (e.g., STAT, Routine).
  • The verification queue provides a centralized workload for the pharmacy team.

Systematic Review of Medication Orders

  • Pharmacists must conduct a prospective review of every medication order before the first dose is dispensed.
  • This is a critical patient safety function.
  • The review includes checking for the "five rights": right patient, right drug, right dose, right route, right time.
  • However, the review goes much deeper than just these five elements.
  • It is a comprehensive clinical assessment of the order's appropriateness.
  • The CHPOP is responsible for establishing a standard, consistent process for this review.

Clinical Appropriateness Check

  • The pharmacist evaluates the order in the context of the patient's specific clinical situation.
  • This involves reviewing the patient's diagnosis, comorbidities, allergies, and laboratory results in the EHR.
  • They check for therapeutic duplication (is the patient already on a similar drug?).
  • They assess the dose for appropriateness based on the patient's age, weight, and organ function (especially renal and hepatic).
  • They screen for potential drug-drug, drug-disease, and drug-lab interactions.
  • This clinical review is what differentiates a pharmacist's verification from a simple technical check.

Intervention and Communication

  • If a potential problem is identified with an order, the pharmacist must intervene.
  • This involves contacting the prescriber to discuss the concern and recommend a change.
  • This communication must be clear, concise, and professional.
  • All interventions must be documented in the EHR or PIS.
  • This documentation is essential for legal and quality assurance purposes.
  • The CHPOP ensures that staff are trained in effective communication techniques.
  • A strong, collaborative relationship between pharmacists and prescribers is crucial.

Order Verification Workflow

  • The CHPOP is responsible for designing an efficient and safe verification workflow.
  • This includes setting target turnaround times for different order priorities.
  • It involves managing the workload and assigning pharmacists to the verification queue.
  • In some models, technicians may pre-screen orders to assist the pharmacist.
  • The workflow must ensure that no order is missed or delayed.
  • The use of remote pharmacists for overnight order verification is a common operational strategy.
  • The performance of this workflow is a key metric for the pharmacy department.

Defining Order Priorities

  • Hospitals have a system for prioritizing medication orders.
  • STAT: From the Latin "statim," meaning immediately. These are for life-threatening emergencies and must be dispensed and administered as quickly as possible.
  • ASAP/Now: A high-priority order that is needed quickly but is not a true emergency.
  • Routine: A standard medication order that will be dispensed on the next scheduled delivery run.
  • The CHPOP must ensure these definitions are clear and used consistently throughout the hospital.

STAT Order Workflow

  • The workflow for STAT orders must be designed for maximum speed and safety.
  • The CPOE system should clearly flag STAT orders so they appear at the top of the pharmacist's queue.
  • There should be an audible or visual alert in the pharmacy when a STAT order is received.
  • Once verified, the order must be dispensed immediately. This often bypasses the normal batch-filling process.
  • A clear system for delivering the STAT dose to the nursing unit is essential.
  • This could be via a pneumatic tube system or a dedicated runner.
  • The CHPOP is responsible for designing and stress-testing this critical workflow.

Turnaround Time (TAT) Metrics

  • Turnaround time is a key performance indicator for the pharmacy.
  • It is measured from the time the order is written to the time the medication is available for administration.
  • Hospitals set specific TAT goals for different order priorities.
  • For example, the goal for a STAT order might be a TAT of less than 15 minutes.
  • The CHPOP must have a system to monitor TAT performance.
  • This data is used to identify bottlenecks and drive process improvement.
  • TAT is a major focus of accreditation surveys.

Orders Bypassing Pharmacist Verification

  • In certain true emergencies, policies may allow a nurse to pull a medication from an ADC before a pharmacist has verified the order.
  • This is known as an "override."
  • This is most common in the Emergency Department, ICU, and OR.
  • This practice carries a high risk and must be tightly controlled.
  • The list of medications available for override must be very limited and approved by the P&T committee.
  • The pharmacist must perform a retrospective review of all override orders as soon as possible.
  • The CHPOP is responsible for the policy and monitoring of all ADC overrides.

Coordination with Nursing for STATs

  • Clear communication between pharmacy and nursing is essential for STAT orders.
  • The system should provide feedback to the nurse so they know the status of their order.
  • If there is a delay in verification or dispensing, the pharmacist must proactively communicate this to the nurse.
  • The delivery system (e.g., pneumatic tube) must be reliable.
  • The CHPOP must work closely with nursing leadership to design and troubleshoot this process.
  • Joint meetings to review TAT data and any safety events are a best practice.

Rationale for IV to PO Conversion

  • Switching a patient from an intravenous (IV) to an equivalent oral (PO) medication is a key clinical and financial initiative.
  • IV administration is more invasive and carries a higher risk of infection and complications.
  • IV medications are significantly more expensive than their oral counterparts due to both drug and administration costs.
  • An effective IV-to-PO program can improve patient safety, reduce length of stay, and save the hospital a significant amount of money.
  • A CHPOP must understand the operational components of supporting this clinical program.

Developing P&T-Approved Protocols

  • An IV-to-PO conversion program must be governed by a formal, P&T-approved protocol.
  • The protocol defines which medications are included in the program.
  • It specifies the clinical criteria a patient must meet to be eligible for the switch (e.g., able to tolerate oral intake, afebrile).
  • It also defines the equivalent oral dose for each IV medication.
  • The protocol gives pharmacists the authority to automatically make the switch without contacting the prescriber for each case.
  • The CHPOP helps to ensure these protocols are clear and can be operationalized in the EHR.

Operationalizing the Program

  • The CHPOP is responsible for building the program into the daily workflow.
  • This often involves creating reports from the EHR that identify patients who are on a target IV medication and may be eligible for a switch.
  • Clinical decision support alerts can also be built into the EHR to prompt the pharmacist or prescriber.
  • Pharmacists must be trained on the protocol and how to screen patients.
  • The process for documenting the conversion in the EHR must be clear and standardized.
  • This operational support is key to the program's success.

Therapeutic Interchange

  • Therapeutic interchange is the practice of dispensing a drug that is therapeutically equivalent to, but chemically different from, the drug that was prescribed.
  • This is also done according to a P&T-approved protocol.
  • It is used to drive utilization to the hospital's preferred, formulary agent within a class.
  • For example, a protocol may allow the pharmacy to automatically switch any order for a non-formulary PPI to the hospital's preferred formulary PPI.
  • This is a major tool for formulary compliance and cost control.
  • The CHPOP must manage the operational aspects of these automatic substitution protocols.

Measuring and Reporting Impact

  • The impact of these programs must be measured and reported.
  • For an IV-to-PO program, the key metric is the number of IV days avoided.
  • The associated cost savings should be calculated and reported to the P&T committee and hospital leadership.
  • For therapeutic interchange, the key metric is the formulary compliance rate.
  • The CHPOP is responsible for generating the data and reports to demonstrate the value of these pharmacist-driven programs.
  • This data is essential for justifying the resources allocated to clinical pharmacy services.

The Importance of Organ Function

  • The kidneys and liver are the primary organs responsible for metabolizing and eliminating drugs from the body.
  • Impaired renal or hepatic function can cause drugs to accumulate to toxic levels.
  • Therefore, the doses of many drugs must be adjusted in patients with kidney or liver disease.
  • Failure to do so can lead to serious adverse drug events.
  • Pharmacists play a critical role in screening for and making these necessary dose adjustments.
  • This is a core safety function in the hospital setting.

Renal Dosing Protocols

  • Many hospitals have P&T-approved protocols that allow pharmacists to automatically adjust the doses of specific drugs based on the patient's renal function.
  • Renal function is typically estimated by calculating the creatinine clearance (CrCl).
  • The protocol will specify the appropriate dose for different levels of CrCl.
  • This allows for timely dose adjustments without having to contact the prescriber for each one.
  • The CHPOP is responsible for ensuring these protocols are built into the pharmacy's information systems and workflow.

EHR Integration and Alerts

  • The EHR can be a powerful tool for supporting renal dosing.
  • The system can automatically calculate the patient's CrCl based on their latest serum creatinine level.
  • It can then fire a clinical decision support alert to the pharmacist if a patient is on a renally-cleared drug and their kidney function has declined.
  • These automated alerts help to proactively identify patients who may need a dose adjustment.
  • The CHPOP works with the informatics team to design and maintain these critical safety alerts.

Challenges in Hepatic Dosing

  • Dose adjustment for patients with liver failure is much more complex than for renal failure.
  • There is no single lab test that accurately reflects the liver's drug-metabolizing capacity.
  • The Child-Pugh score is sometimes used, but it is a rough estimate.
  • Dosing recommendations for hepatic impairment are often less precise than for renal impairment.
  • This requires a higher degree of clinical judgment from the pharmacist.
  • The CHPOP ensures that pharmacists have access to the drug information resources they need to make these difficult decisions.

Workflow and Documentation

  • The CHPOP must design a workflow that ensures all patients on high-risk, renally-cleared drugs are monitored.
  • This can involve using daily reports to identify patients whose renal function has changed.
  • All dose adjustments made by a pharmacist must be clearly documented in the EHR.
  • The documentation should include the patient's CrCl and the rationale for the change.
  • This creates a clear record of the pharmacist's intervention.
  • This workflow is a key component of the pharmacy's overall patient safety program.

Principles of Pharmacokinetics

  • Pharmacokinetics is the study of how the body absorbs, distributes, metabolizes, and eliminates a drug (ADME).
  • For certain drugs with a narrow therapeutic index, pharmacists use PK principles to individualize a patient's dose.
  • This involves using drug serum levels and patient-specific parameters to calculate the optimal dose.
  • The goal is to achieve a drug concentration in the body that is high enough to be effective but low enough to avoid toxicity.
  • Vancomycin and aminoglycosides are the two most common drug classes managed this way.

Pharmacy-to-Dose Protocols

  • Most hospitals have P&T-approved protocols that authorize pharmacists to dose and monitor these drugs.
  • This means that a physician can write an order for "Vancomycin per pharmacy," and the pharmacist is responsible for ordering the drug levels and calculating and adjusting the dose.
  • This is a high-level clinical activity that improves patient safety.
  • The CHPOP is responsible for the operational aspects of this service.
  • This includes ensuring pharmacists are properly trained and have the tools they need.

Vancomycin Dosing and Monitoring

  • Vancomycin is a powerful antibiotic used for serious gram-positive infections like MRSA.
  • It can cause nephrotoxicity (kidney damage) if the levels are too high.
  • The modern approach to dosing is area-under-the-curve (AUC) guided dosing.
  • The goal is to achieve an AUC/MIC ratio of 400-600.
  • This is more accurate than the older method of targeting trough levels.
  • It requires the use of specialized software or Bayesian modeling programs.
  • The CHPOP must ensure their pharmacy has the technology and training to perform AUC-guided dosing.

Aminoglycoside Dosing and Monitoring

  • Aminoglycosides (e.g., gentamicin, tobramycin) are used for serious gram-negative infections.
  • They can cause both nephrotoxicity and ototoxicity (hearing damage).
  • The modern approach is to use high-dose, extended-interval dosing.
  • This involves giving one large dose per day instead of smaller doses every 8 hours.
  • This method is just as effective and is less toxic.
  • Drug levels are drawn at a specific time after the dose to ensure the drug is being eliminated properly.
  • The CHPOP must ensure there is a clear protocol for this dosing and monitoring strategy.

Operational Workflow

  • A successful PK dosing service requires a robust workflow.
  • This includes using reports to identify all patients on these drugs each day.
  • There must be a clear process for pharmacists to order the necessary lab draws for drug levels.
  • The pharmacist must have access to the necessary calculation tools and software.
  • All dosing calculations and recommendations must be documented in the EHR.
  • The CHPOP is responsible for designing and maintaining this critical clinical workflow.
  • It is a key program that demonstrates the value of the pharmacy department.

Block 3: Sterile & Non-Sterile Compounding

Purpose and Scope of USP <797>

  • USP Chapter <797> provides national standards for the process of sterile compounding.
  • Its primary purpose is to prevent patient harm, including death, that could result from microbial contamination, excessive bacterial endotoxins, or other preparation errors.
  • The chapter applies to all pharmacies and facilities where compounded sterile preparations (CSPs) are made.
  • It covers all personnel involved in the compounding process.
  • A CHPOP is responsible for ensuring their sterile compounding operations are fully compliant with these standards.
  • State Boards of Pharmacy enforce USP <797>.

Categories of CSPs (Category 1, 2, and 3)

  • The latest version of USP <797> categorizes CSPs based on the conditions under which they are made.
  • Category 1 CSPs: Made in a Segregated Compounding Area (SCA). These have a shorter Beyond-Use Date (BUD).
  • Category 2 CSPs: Made in a formal cleanroom suite (buffer room and ante-room). These can have a longer BUD.
  • Category 3 CSPs: A new category for CSPs made with enhanced sterility assurance measures, allowing for even longer BUDs.
  • The CHPOP must understand these categories as they determine the required facilities and assigned BUDs.

Beyond-Use Dating (BUD)

  • A BUD is the date or time after which a CSP must not be stored or transported.
  • It is determined by the risk of microbial contamination.
  • The BUDs for Category 1 CSPs are limited to 12 hours at room temperature or 24 hours refrigerated.
  • The BUDs for Category 2 CSPs can be longer, depending on whether a sterility test is performed.
  • The CHPOP is responsible for establishing the pharmacy's policies for assigning BUDs in accordance with USP <797>.
  • Assigning an incorrect BUD is a serious safety risk.

The Role of the Designated Person

  • USP <797> requires the designation of one or more individuals to be responsible and accountable for the compounding program.
  • This "designated person" must have the appropriate training and expertise.
  • The CHPOP often serves in this role.
  • Responsibilities include developing and implementing all compounding procedures, ensuring staff are properly trained, and overseeing the environmental monitoring program.
  • This is the person with ultimate accountability for USP <797> compliance.

Master Formulation and Compounding Records

  • Master Formulation Record: The "recipe" for a specific CSP. It contains all the ingredients, equipment, and step-by-step instructions.
  • Compounding Record: The documentation for a specific batch of a CSP.
  • It documents the lot numbers of all ingredients used, the names of the compounders and checkers, and the assigned BUD.
  • This documentation creates a complete, auditable trail for every CSP made.
  • The CHPOP is responsible for ensuring these records are complete and properly maintained.

Primary Engineering Controls (PECs)

  • The PEC is the device that provides the ISO Class 5 environment where sterile compounding takes place.
  • Laminar Airflow Workbench (LAFW): Provides clean air that moves in a unidirectional (laminar) flow. Can be horizontal or vertical.
  • Biological Safety Cabinet (BSC): Used for hazardous sterile compounding; provides personnel and environmental protection in addition to product protection.
  • Compounding Aseptic Isolator (CAI): A "glovebox" system for non-hazardous compounding.
  • Compounding Aseptic Containment Isolator (CACI): A "glovebox" for hazardous compounding.
  • The CHPOP must ensure the correct PEC is used for each type of compounding.

Secondary Engineering Controls (SECs)

  • The SEC is the room in which the PEC is located.
  • Buffer Room: The main cleanroom where the PECs are located. Must be at least ISO Class 7.
  • Ante-Room: The room adjacent to the buffer room, used for garbing and staging. Must be at least ISO Class 8.
  • The ante-room must have a line of demarcation separating the "clean" and "dirty" sides.
  • The entire cleanroom suite must have specific temperature, humidity, and pressure requirements.
  • The buffer room must be under positive pressure relative to the ante-room to prevent contamination from entering.

Segregated Compounding Area (SCA)

  • An SCA is an alternative space for making Category 1 CSPs.
  • It is a designated space with a visible perimeter, but it does not have to be a full cleanroom.
  • It must contain a PEC (e.g., an isolator).
  • The air in the SCA does not need to meet a specific ISO class, but it should be away from high-traffic areas.
  • This option provides more flexibility for pharmacies that do not have the space or resources for a full cleanroom.
  • However, the BUDs of CSPs made in an SCA are much shorter.

Environmental Monitoring

  • This is the program for sampling and testing the cleanroom environment to ensure it is meeting its required state of control.
  • Viable Air Sampling: Uses an impaction sampler to test the air for microbial contamination. Done every 6 months.
  • Surface Sampling: Uses contact plates to test surfaces (like the inside of the hood) for contamination. Done monthly.
  • The CHPOP is responsible for overseeing this program and for taking corrective action if any results are out of range.
  • This is a critical QA component.

Certification and Cleaning

  • The entire cleanroom suite and all PECs must be certified by a qualified, independent certifier every 6 months.
  • The certifier performs tests to ensure that the airflow, pressures, and HEPA filters are all working correctly.
  • The CHPOP is responsible for coordinating this certification.
  • There must also be a rigorous, daily cleaning and disinfection process for the entire cleanroom.
  • This process must use specific sporicidal and disinfecting agents.
  • The CHPOP must ensure this cleaning is performed and documented correctly every day.

Hand Hygiene and Garbing

  • Proper hand hygiene and garbing are the most critical steps for preventing contamination.
  • The process begins with removing all jewelry and makeup.
  • Hands and forearms are washed vigorously for at least 30 seconds.
  • Garb is donned in order from dirtiest to cleanest: shoe covers, hair cover, face mask, then gown.
  • After entering the cleanroom, sterile gloves are applied.
  • The gloves must be repeatedly sanitized with sterile 70% isopropyl alcohol during compounding.
  • The CHPOP must ensure all staff are trained and competent in this exact procedure.

Aseptic Technique Principles

  • Aseptic technique is a set of practices used to prevent microbial contamination.
  • All critical sites (e.g., vial stoppers, needle hubs) must only be touched by sterile objects.
  • Work must be performed at least 6 inches inside the laminar airflow hood.
  • Nothing should pass between a critical site and the HEPA filter (the "first air").
  • All vial stoppers and injection ports must be disinfected with sterile alcohol before being punctured.
  • The CHPOP must ensure that these principles are understood and practiced by all compounding personnel.

Training and Competency Program

  • All personnel involved in compounding must complete a formal training and competency program.
  • This includes both didactic training on the principles of USP <797> and hands-on skills training.
  • Competency must be demonstrated before an employee is allowed to compound independently.
  • This program must be documented for every employee.
  • The CHPOP is responsible for the design and oversight of this training program.

Gloved Fingertip and Thumb Sampling

  • This is a test used to evaluate an employee's hand hygiene and garbing competency.
  • After garbing, the employee presses their gloved fingertips onto a plate of sterile growth medium.
  • The plate is then incubated to see if any bacteria grow.
  • This test must be passed initially and then re-evaluated periodically (e.g., every 6 months).
  • It provides an objective measure of an individual's aseptic technique.

Media-Fill Testing

  • This is a test used to evaluate an employee's overall aseptic technique.
  • The employee performs a simulation of the most complex compounding procedure they do, but they use a sterile growth medium instead of actual drugs.
  • The final "product" is then incubated to see if it remains sterile.
  • Any sign of microbial growth constitutes a failure.
  • This test must be passed initially and then annually thereafter.
  • It is the ultimate test of an individual's ability to compound safely.

The Compounding Workflow

  • A standardized workflow is essential for safety and efficiency.
  • The process begins with the pharmacist's verification of the order.
  • The system then generates a compounding worksheet and label.
  • A technician gathers all the necessary ingredients and supplies.
  • The ingredients are checked by a pharmacist or by using barcode scanning before they are taken into the hood.
  • The technician compounds the product following aseptic technique.
  • The final product is then brought out for the pharmacist's final check.
  • The CHPOP is responsible for designing this workflow.

The Pharmacist's Final Check

  • The final check by a pharmacist is a critical safety step.
  • The pharmacist verifies that the correct drug and diluent were used.
  • They verify that the correct volume was added.
  • They inspect the final product for any particulates, cloudiness, or other defects.
  • They ensure the final product is labeled correctly.
  • Many pharmacies use IV workflow technology that takes pictures of the process to assist the pharmacist in this final check.

IV Workflow Technology

  • IV workflow management systems are used to enhance the safety of the compounding process.
  • They use barcode scanning to verify that the technician has selected the correct ingredients.
  • They take digital images of the key steps (e.g., the volume drawn up in a syringe).
  • The pharmacist can then review these images remotely from their computer to verify the product.
  • This creates a detailed, electronic record of the entire compounding process.
  • The CHPOP is often involved in the selection and implementation of this technology.

Syringe Pull-Back Method

  • If IV workflow technology is not used, the "syringe pull-back method" is a common way to have a pharmacist verify the volume of an additive.
  • After injecting the drug into the final container, the technician pulls the plunger of the empty syringe back to the volume they injected.
  • They then present the final product, the empty drug vial, and the pulled-back syringe to the pharmacist for the check.
  • While common, this method is prone to error and is considered less safe than systems that use direct image verification.

Batch Compounding

  • Batch compounding is the process of making a large quantity of the same CSP at one time.
  • This is done for commonly used products (e.g., standard antibiotic piggybacks).
  • It is more efficient than making each dose individually.
  • However, it also carries a higher risk, as an error in a batch can affect many patients.
  • Therefore, the QA procedures for batching must be extremely robust.
  • This includes the use of a Master Formulation Record and a detailed Compounding Record for each batch.
  • The CHPOP is responsible for the policies and procedures governing batch compounding.

Scope and Purpose of USP <800>

  • USP Chapter <800> provides standards for the safe handling of hazardous drugs (HDs).
  • Its primary purpose is to protect personnel, patients, and the environment from exposure to HDs.
  • It applies to all healthcare personnel who handle HDs and all entities where they are handled.
  • It covers the entire lifecycle of an HD, from receipt to disposal.
  • A CHPOP must ensure their operations are fully compliant with these standards.

Engineering Controls for HDs

  • USP <800> has very specific requirements for the rooms and hoods used for HD compounding.
  • The sterile HD compounding room must be under negative pressure relative to the adjacent ante-room.
  • This is the opposite of a non-hazardous cleanroom and is designed to contain any airborne contaminants.
  • The Primary Engineering Control must be a containment device, such as a Biological Safety Cabinet (BSC) or a Compounding Aseptic Containment Isolator (CACI).
  • These hoods must be externally vented to the outside.
  • The CHPOP must work with facilities engineering to ensure these complex requirements are met.

Personal Protective Equipment (PPE)

  • Strict PPE is required for handling HDs.
  • This includes two pairs of chemotherapy-tested gloves.
  • A disposable gown that is resistant to chemotherapy is required.
  • Eye protection is required when there is a risk of splashes.
  • For some activities, respiratory protection is also needed.
  • The CHPOP is responsible for selecting the appropriate PPE and for training all staff on how to don and doff it correctly.

Safe Handling Practices

  • USP <800> details safe handling practices for all stages of the lifecycle.
  • This includes procedures for receiving, storing, compounding, dispensing, administering, and disposing of HDs.
  • For example, all HDs must be dispensed in sealed plastic bags with a "Hazardous Drug" warning label.
  • Closed System Drug-Transfer Devices (CSTDs) are required for the administration of chemotherapy and recommended for compounding.
  • The CHPOP is responsible for implementing these safe work practices.

Decontamination, Cleaning, and Disinfection

  • There are specific, multi-step requirements for cleaning all areas where HDs are handled.
  • The process involves four steps: Deactivation, Decontamination, Cleaning, and Disinfection.
  • Specific agents (e.g., sodium hypochlorite for deactivation) must be used.
  • The CHPOP is responsible for developing the SOPs for this process and for ensuring that staff are trained and competent.
  • This is a critical step for preventing the spread of hazardous residue.

Scope and Purpose of USP <795>

  • USP Chapter <795> provides standards for the process of non-sterile compounding.
  • The purpose is to ensure that patients receive non-sterile preparations that are of the appropriate strength, quality, and purity.
  • The chapter applies to all pharmacies that perform non-sterile compounding.
  • Examples include preparing magic mouthwash, topical creams, or oral suspensions from tablets.
  • A CHPOP is responsible for ensuring compliance with these standards.

Facility Requirements

  • Non-sterile compounding must be done in a designated area, separate from the main dispensing and sterile compounding areas.
  • The area must be clean, well-lit, and have adequate ventilation.
  • It must have surfaces that are smooth and easy to clean.
  • A sink with hot and cold running water is required.
  • For hazardous non-sterile compounding, the requirements of USP <800> apply, which includes a containment hood.

Personnel Training and Competency

  • All staff involved in non-sterile compounding must be trained and demonstrate competency.
  • Training should cover the principles of <795>, the proper use of equipment, and the specific procedures used in the pharmacy.
  • Competency should be documented and reassessed on a regular basis.
  • The CHPOP is responsible for this training program.

Beyond-Use Dating (BUD)

  • USP <795> provides specific rules for assigning BUDs to non-sterile preparations.
  • The BUD is based on the type of formulation and whether it contains water.
  • For non-aqueous formulations, the BUD is not later than 6 months.
  • For water-containing oral formulations, the BUD is not later than 14 days when stored at controlled cold temperatures.
  • For water-containing topical formulations, the BUD is not later than 30 days.
  • The CHPOP must ensure these BUDs are calculated and applied correctly.

Documentation

  • As with sterile compounding, detailed documentation is required.
  • A Master Formulation Record is needed for each unique formulation.
  • A Compounding Record must be completed for each individual preparation.
  • This record must document all ingredients, lot numbers, expiration dates, and the people involved.
  • The CHPOP must ensure these records are maintained and readily retrievable.

Definition of Batching

  • Batching is the process of compounding multiple units of the same preparation in a single process.
  • This is done in anticipation of future orders.
  • It is more efficient than compounding each dose on demand.
  • However, it carries a higher risk because an error in a batch can affect multiple patients.
  • The CHPOP must ensure that there are robust quality controls for all batching processes.

Master Formulation Record

  • A Master Formulation Record is the official "recipe" for a compounded preparation.
  • A separate record is required for each unique formulation.
  • It must contain all the information needed to compound the preparation consistently.
  • This includes the name, strength, and dosage form of the preparation.
  • It lists all ingredients and their quantities.
  • It details the equipment needed and provides step-by-step compounding instructions.
  • It also specifies the quality control procedures, labeling information, and the correct BUD.

The Compounding Record

  • The Compounding Record is the documentation for a specific batch.
  • It must be completed every time a batch is made.
  • It must reference the specific Master Formulation Record that was used.
  • It documents the actual ingredients used, including their manufacturer, lot number, and expiration date.
  • It records the names of the people who prepared and verified the batch.
  • It also documents the date of compounding, the assigned internal control number, and the BUD.
  • This record provides a complete and traceable history of the batch.

Quality Control for Batches

  • Because of the higher risk, batches require additional quality control.
  • This can include in-process checks to ensure steps are being performed correctly.
  • It should also include a final check of the finished products.
  • For sterile batches with a long BUD, USP <797> requires that the batch undergo sterility and endotoxin testing by an independent lab before it is released.
  • The CHPOP is responsible for developing and overseeing this QA program.

Labeling and Storage

  • Each unit in the batch must be labeled correctly.
  • The batch must be stored under the proper conditions to ensure its stability.
  • The perpetual inventory system must be updated to reflect the new batch.
  • When a dose from the batch is dispensed to a specific patient, the system must link the patient to the specific batch control number.
  • This is essential for traceability in the event of a recall.
  • The CHPOP must ensure these logistical processes are in place.

The Role of 503B Outsourcers

  • 503B Outsourcing Facilities were created by the Drug Quality and Security Act (DQSA).
  • They are facilities that can compound large batches of sterile drugs without patient-specific prescriptions.
  • Hospitals often purchase these products to supplement their in-house compounding.
  • This can improve efficiency and provide access to products that are difficult to compound or are on shortage.
  • The CHPOP is responsible for the strategy of when and what to outsource.

Regulation and Oversight

  • 503B facilities are regulated by the FDA.
  • They are required to comply with current Good Manufacturing Practices (cGMPs), which are a higher standard than USP <797>.
  • The FDA inspects these facilities and posts the inspection reports publicly.
  • This provides a level of quality assurance that is not available with traditional 503A compounding pharmacies.

The Vetting and Selection Process

  • A hospital is responsible for performing due diligence before purchasing from a 503B.
  • This is a critical risk management step.
  • The process should include a thorough review of the 503B's FDA registration and inspection history.
  • It should also include a review of their licenses and any disciplinary actions.
  • Many hospitals conduct their own on-site audits of the 503B facility before signing a contract.
  • The CHPOP is a key leader in this vetting and selection process.

Receiving and Managing 503B Products

  • When products are received from a 503B, they must be properly managed.
  • The receiving process should verify the integrity of the shipment.
  • The products must be stored according to their labeling.
  • The hospital must have a system to track the lot numbers of these products.
  • In the event of a recall from the 503B, the hospital must be able to quickly identify and remove all affected products.
  • The CHPOP is responsible for this logistical process.

Strategic Considerations

  • The decision of what to compound in-house versus what to buy from a 503B is a key strategic decision.
  • This is a "make vs. buy" analysis.
  • The analysis must consider cost, quality, risk, and the capacity of the in-house cleanroom.
  • Outsourcing can free up internal staff to focus on more complex, patient-specific preparations.
  • It can also serve as a key part of a drug shortage management strategy.
  • The CHPOP leads this strategic analysis.

The QA Program

  • USP requires every compounding pharmacy to have a formal Quality Assurance program.
  • The QA program is the set of all activities designed to ensure that the compounding processes are under control and that the final products meet their quality specifications.
  • It is a proactive program focused on preventing errors.
  • The CHPOP, as the designated person, is responsible for the overall design and implementation of the QA program.

Environmental Monitoring

  • As discussed, environmental monitoring is a core component of the QA program.
  • This includes the certification of the facilities every six months.
  • It includes the viable air and surface sampling.
  • It also includes the daily monitoring of temperatures and pressures.
  • The QA program must have a clear plan for what to do if any of these results are outside of the acceptable limits.

Personnel Competency

  • The QA program includes the initial and ongoing assessment of staff competency.
  • This includes the documented training program.
  • It also includes the gloved fingertip testing and the media-fill testing.
  • The QA program must have a clear policy for what happens if an employee fails one of these tests (e.g., they must be retrained and re-tested before they can compound again).

End-Product Testing

  • For certain high-risk and batched preparations, the QA program includes testing of the final product.
  • For sterile batches with long BUDs, this includes sending a sample of the batch for sterility and endotoxin testing.
  • The batch must be quarantined and cannot be released until the test results are confirmed as negative.
  • For non-sterile compounds, the QA program may include other types of testing to verify potency.

Continuous Improvement

  • The QA program is not static; it should be part of a continuous quality improvement (CQI) cycle.
  • All the data from the QA program (e.g., environmental monitoring results, staff competency results, error reports) should be regularly reviewed.
  • This data is used to identify trends and opportunities for improvement.
  • The CHPOP is responsible for leading this CQI process.
  • The goal is to constantly refine and improve the safety and quality of the compounding operation.

Types of Compounding Waste

  • The compounding process generates several different types of waste.
  • Sharps Waste: Needles and broken glass.
  • Non-Hazardous Pharmaceutical Waste: Empty vials, syringes, and IV bags that did not contain a hazardous drug.
  • Hazardous Drug Waste: All items contaminated with chemotherapy or other hazardous drugs.
  • RCRA Hazardous Waste: Specific drugs that are defined as hazardous waste by the EPA.
  • Each type of waste must be segregated into a specific, color-coded container.

Sharps Waste

  • All needles and syringes must be disposed of in a puncture-resistant sharps container.
  • The container should be located inside the PEC to allow for immediate disposal.
  • Sharps containers that contain HDs must be managed as hazardous waste.
  • The CHPOP must ensure that these containers are available, not overfilled, and are disposed of correctly.

Non-Hazardous Pharmaceutical Waste

  • This waste stream includes empty vials, IV bags, and other items used in non-hazardous compounding.
  • It should be placed in a designated container (often blue or white).
  • This waste is typically sent for incineration by a medical waste vendor.
  • It should not be mixed with regular trash.
  • The CHPOP must ensure this waste stream is managed correctly.

Hazardous Drug (HD) Waste

  • This is the waste stream for items contaminated with chemotherapy and other HDs as defined by NIOSH.
  • It is often referred to as "trace chemo" waste.
  • All items, including empty vials and used PPE, must be disposed of in a designated container (typically yellow).
  • This waste must be handled by a specialized hazardous waste vendor.
  • The CHPOP is responsible for the pharmacy's compliance with this critical part of USP <800>.

RCRA Hazardous Waste

  • This is the most strictly regulated type of waste.
  • It includes any unused portion of a drug that is on the EPA's P-list or U-list.
  • This waste must be segregated into a black hazardous waste container.
  • It must be managed according to all RCRA regulations, including specific labeling and storage time limits.
  • The CHPOP must work with the hospital's safety officer to ensure full compliance.
  • Improper disposal of RCRA waste can lead to very large fines from the EPA.

Block 4: Medication Distribution, Automation & Technology

Unit Dose Distribution

  • Unit dose is the standard system for distributing oral and injectable medications in hospitals.
  • Each dose of a medication is packaged and labeled separately.
  • The pharmacy typically dispenses a 24-hour supply of each patient's medications in their individual bin.
  • This system significantly reduces the risk of medication errors compared to the old floor stock system.
  • It is a foundational concept in hospital pharmacy operations.
  • The CHPOP is responsible for managing the entire unit dose packaging and distribution workflow.

Automated Dispensing Cabinets (ADCs)

  • ADCs (e.g., Pyxis, Omnicell) are the primary method of medication distribution in most modern hospitals.
  • These secure cabinets are located on the nursing units and store the most commonly used medications.
  • Nurses can access medications for their patients directly from the ADC after a pharmacist has verified the order.
  • This improves the timeliness of medication availability.
  • The CHPOP is responsible for the overall management of the ADC system.
  • This is a major and complex operational responsibility.

Cart Fill Distribution

  • This is a process where the pharmacy fills a 24-hour supply of a patient's scheduled medications into a specific patient bin.
  • These bins are then placed in a large cart and delivered to the nursing unit once a day.
  • This model is used for medications that are not stored in the ADCs.
  • It is often managed using automation that can package and sort the unit doses.
  • The CHPOP must design an efficient and accurate cart fill workflow.

Pneumatic Tube Systems

  • Pneumatic tube systems are used for the rapid transport of medications from the central pharmacy to the nursing units.
  • They are essential for delivering STAT medications and first doses that are not in the ADC.
  • The CHPOP is responsible for the pharmacy's policies regarding the use of the tube system.
  • This includes rules about what can and cannot be sent (e.g., no hazardous drugs, no glass vials).
  • The reliability of the tube system is a critical operational factor.

Technician Delivery (Rounds)

  • Pharmacy technicians often perform scheduled delivery runs or "rounds" throughout the day.
  • They deliver the patient-specific medication carts.
  • They also deliver medications that cannot be tubed, such as large IV bags or refrigerated items.
  • They may also be responsible for stocking medications in the ADCs.
  • The CHPOP must design the schedule and routes for these delivery rounds to be as efficient as possible.

ADC System Management

  • The CHPOP has overall responsibility for the hospital's ADC system.
  • This involves working with the vendor (e.g., Pyxis, Omnicell) to manage the software and hardware.
  • The manager is responsible for the system's configuration.
  • This includes setting up user access, defining security parameters, and building the drug database.
  • It is a complex system that requires specialized technical knowledge.
  • The CHPOP often works with a dedicated pharmacy informatics specialist on this.

Determining PAR Levels

  • The pharmacy team is responsible for setting the inventory levels (PAR levels) for each drug in each ADC.
  • The goal is to set a level that is high enough to prevent stock-outs but low enough to minimize inventory costs.
  • This decision should be data-driven, based on the historical usage of each drug from that specific cabinet.
  • The PAR levels must be reviewed and adjusted on a regular basis.
  • The CHPOP is responsible for the overall strategy and process for managing PAR levels.

The Replenishment Process

  • The ADC system generates replenishment reports that show which medications need to be restocked.
  • Pharmacy technicians are responsible for pulling these medications and refilling the cabinets.
  • This process must be highly accurate to prevent errors.
  • Barcode scanning is used to verify that the correct medication is being placed in the correct pocket of the cabinet.
  • The CHPOP must design an efficient and safe workflow for this daily process.

Discrepancy Resolution

  • A discrepancy occurs when the ADC's electronic count of a medication does not match the actual physical count.
  • All discrepancies must be investigated and resolved in a timely manner.
  • This is especially critical for controlled substances.
  • The investigation involves reviewing all transaction reports to identify the source of the error.
  • The CHPOP is responsible for the policy and procedure for discrepancy resolution.
  • Unresolved discrepancies can be a sign of drug diversion.

Reporting and Analytics

  • ADC systems generate a vast amount of data.
  • The CHPOP uses this data to manage the system and improve safety.
  • Reports on override activity are used to monitor for high-risk practices.
  • Reports on expiring medications help to reduce waste.
  • Reports on controlled substance discrepancies are a key tool for diversion prevention.
  • The ability to analyze and act on this data is a key competency for a CHPOP.
  • This data is also used to optimize inventory levels across the entire hospital.

Purpose and Importance

  • Crash carts and other emergency kits contain a standardized set of life-saving medications.
  • They are strategically located throughout the hospital in patient care areas.
  • They allow for immediate access to critical drugs during a medical emergency, such as a cardiac arrest.
  • The proper management of these carts and kits is a critical patient safety function.
  • The pharmacy department is responsible for ensuring that all carts are properly stocked, sealed, and in-date.

Standardized Contents

  • The specific medications and supplies in a crash cart are determined by the P&T committee.
  • The contents should be standardized throughout the hospital to the greatest extent possible.
  • This ensures that clinicians know what to expect and can find what they need quickly during a stressful code situation.
  • There may be specialized carts for certain areas, such as pediatrics or the OR.
  • The CHPOP is involved in the operational decision-making about the cart's layout and contents.

The Exchange Process

  • When a crash cart is used, the nursing staff brings the used cart or its used tray to the pharmacy.
  • The pharmacy then provides them with a new, fully stocked and sealed cart or tray.
  • This exchange process ensures that a ready-to-use cart is always available on the unit.
  • The CHPOP is responsible for designing this workflow and ensuring there are always enough backup carts ready.

Restocking and Sealing

  • Pharmacy technicians are responsible for restocking the used carts.
  • They must carefully replace all used and missing items according to a standardized checklist.
  • They must also check the expiration date of every single item in the cart.
  • A pharmacist must perform a final check to verify that the cart has been restocked correctly.
  • Once verified, the cart is sealed with a plastic lock.
  • This seal indicates that the cart is complete and ready for use. A broken seal means the cart has been opened and must be exchanged.
  • The CHPOP must ensure this checking process is robust.

Monthly Checks and Documentation

  • In addition to restocking used carts, the pharmacy is also responsible for performing monthly checks of all carts in the hospital.
  • This involves visiting each cart, checking that the seal is intact, and checking for any soon-to-expire medications.
  • Any drugs that are about to expire must be swapped out.
  • These monthly checks must be documented on a log sheet that is kept with the cart.
  • This documentation is a key requirement of The Joint Commission.
  • The CHPOP is responsible for managing this massive logistical task.

The Closed-Loop System

  • Hospitals must maintain a "closed-loop" system of accountability for all controlled substances.
  • This means being able to track every dose from the moment it is received from the wholesaler to the moment it is administered to the patient or wasted.
  • This requires meticulous record-keeping at every step.
  • The goal is to create a complete and auditable trail that can quickly identify any discrepancies.
  • The CHPOP is the primary architect of this closed-loop system.

Distribution to ADCs

  • The vast majority of controlled substances are distributed to the nursing units via ADCs.
  • The process of restocking these ADCs must be highly secure.
  • This often requires a two-person process, with both a technician and a pharmacist involved.
  • The quantities sent from the pharmacy vault must be reconciled with the quantities loaded into the ADC.
  • All of these transactions are electronically documented.
  • The CHPOP must design a secure and efficient workflow for this process.

Waste and Return Handling

  • When a nurse administers a partial dose of a controlled substance, the remaining amount must be properly wasted.
  • This waste must be witnessed by a second nurse, and both must document it in the ADC or EHR.
  • Any controlled substances that are discontinued or refused must be returned to the pharmacy.
  • The CHPOP must have a secure process for managing these returns.
  • Improper handling of waste and returns is a major source of diversion.

Auditing and Surveillance

  • A robust auditing and surveillance program is the cornerstone of diversion prevention.
  • This involves regularly reviewing reports from the ADCs and the EHR.
  • The goal is to identify patterns that may suggest diversion (e.g., a nurse who consistently pulls more narcotics than their peers).
  • Many hospitals now use sophisticated diversion detection software.
  • This software uses machine learning to analyze millions of transactions and flag anomalous behavior.
  • The CHPOP is responsible for managing this surveillance program.

Investigation and Reporting

  • When a potential diversion is flagged, a formal investigation must be conducted.
  • This is a multidisciplinary process that involves pharmacy, nursing, HR, and security.
  • The investigation must be conducted in a fair and thorough manner.
  • If a theft or significant loss is confirmed, it must be reported to the DEA and the state board of pharmacy.
  • The CHPOP is a key leader in this investigation and reporting process.
  • This is one of the most high-stakes responsibilities of the role.

Definition and Purpose

  • Medication reconciliation is the process of creating the most accurate list possible of all medications a patient is taking.
  • This list is then compared against the physician's admission, transfer, and/or discharge orders.
  • The goal is to identify and resolve any discrepancies.
  • It is a critical patient safety process designed to prevent medication errors at points of transition in care.
  • The Joint Commission has a National Patient Safety Goal dedicated to this process.

Med Rec on Admission

  • This is the most critical step.
  • A best possible medication history (BPMH) is obtained from the patient and/or their outpatient pharmacy.
  • This history is then compared to the medications the physician has ordered upon admission.
  • Any discrepancies (e.g., an omitted home medication) are brought to the prescriber's attention.
  • Pharmacy technicians and pharmacists play a key role in obtaining the BPMH.
  • The CHPOP helps to design the workflow and staffing for this admission process.

Intra-Hospital Transfers

  • Medication reconciliation must also be performed when a patient transfers from one level of care to another within the hospital.
  • For example, when a patient transfers from the ICU to a medical floor.
  • The patient's medication orders must be reviewed and reconciled to ensure that the appropriate therapies are continued, discontinued, or modified.
  • This prevents errors of omission or commission during these internal handoffs.
  • The CHPOP ensures that the pharmacy systems support this process.

Discharge Medication Reconciliation

  • Upon discharge, the patient's inpatient medication list must be reconciled with the medications they will be sent home on.
  • The goal is to provide the patient and their next provider with a clear and accurate list of their discharge medications.
  • This process includes patient counseling on any new medications or changes to their old regimen.
  • It is a key strategy for preventing adverse events after discharge and reducing hospital readmissions.
  • The CHPOP helps to coordinate the pharmacy's role in this important discharge process.

Operational Challenges

  • Implementing a comprehensive medication reconciliation process is a major operational challenge.
  • It requires significant staff time and a high degree of collaboration between pharmacy, nursing, and medicine.
  • The workflow must be carefully designed and integrated into the EHR.
  • The CHPOP is a key leader in designing these workflows and in advocating for the resources needed to do this work well.
  • Despite the challenges, it is considered a non-negotiable standard of care.

Defining Resilience vs. Efficiency

  • Efficiency: Focuses on minimizing costs and inventory through strategies like Just-In-Time (JIT).
  • Resilience: The ability of the supply chain to anticipate, withstand, and recover from disruptions.
  • The COVID-19 pandemic highlighted the fragility of hyper-efficient, lean supply chains.
  • There is a fundamental trade-off; building resilience often requires sacrificing some efficiency (e.g., holding more safety stock).
  • The modern goal is to find the optimal balance between these two competing priorities.
  • A resilient supply chain is characterized by visibility, flexibility, and redundancy.
  • This represents a major strategic shift in hospital pharmacy supply chain management.

Risk Assessment & Vulnerability Analysis

  • The first step in building resilience is to identify potential risks.
  • This includes supply risks (e.g., single-source drug dependency), geopolitical risks, and natural disaster risks.
  • A formal risk assessment should be conducted using a tool like a risk matrix.
  • This matrix evaluates each risk based on its likelihood and potential impact.
  • This allows the hospital to prioritize its mitigation efforts on the most critical vulnerabilities.
  • For example, the risk of a shortage of a life-saving, single-source drug would be a top priority.
  • This analysis should be reviewed and updated at least annually.

Developing a Disaster Plan (The Four S's)

  • Every hospital pharmacy must have a formal Emergency Operations Plan (EOP).
  • The plan should address the "four S's" of emergency preparedness:
  • Space: Where will emergency supplies be stored? Where will emergency operations be conducted?
  • Staff: How will staff be called in? What are their roles and responsibilities during a disaster?
  • Stuff (Supplies): What medications and supplies need to be in the emergency stockpile? How will a surge in demand be managed?
  • Systems: What are the downtime procedures for the EHR and other key information systems?
  • The plan must be practiced through regular drills and exercises.

Managing the Strategic National Stockpile (SNS)

  • In a large-scale public health emergency, the federal government may deploy assets from the SNS.
  • The hospital pharmacy is a key partner in the local plan for receiving, securing, and dispensing these assets.
  • The CHPOP must be familiar with their local jurisdiction's SNS plan.
  • This includes knowing the designated receiving sites and the communication protocols.
  • The pharmacy EOP must include a specific section on how to manage SNS assets.
  • This is a key part of the pharmacy's public health responsibility.

Post-Disaster Recovery & Debriefing

  • After a disaster or drill, a formal debriefing or "hotwash" must be conducted.
  • The goal is to identify what went well and what the opportunities for improvement are.
  • This is a critical part of the continuous improvement cycle.
  • The findings from the debriefing should be used to update the EOP.
  • The recovery phase also involves managing the return to normal operations, including replenishing the emergency stocks.
  • The CHPOP is the leader of this entire disaster planning and response cycle for the pharmacy.

Unit-Dose Packaging Machines

  • These machines automate the process of packaging bulk oral solid medications into single unit-dose packages.
  • This is essential for supporting barcode medication administration (BCMA).
  • The machine packages the tablet or capsule and prints a label with the drug name, strength, and a barcode.
  • The CHPOP is responsible for managing the operation and maintenance of this equipment.
  • Quality control procedures are needed to ensure the correct drug is in the correct package.

Centralized Dispensing Robots

  • These are large robotic systems that automate the storage and retrieval of unit-dose medications in the central pharmacy.
  • When an order is verified, a message is sent to the robot.
  • The robot then picks the correct medication and either dispenses it to be sent to the floor or loads it into a patient-specific cart.
  • These systems improve dispensing accuracy and efficiency.
  • The CHPOP is responsible for managing the inventory within the robot and overseeing its performance.

Carousel Technology

  • Carousels are a semi-automated storage and retrieval system.
  • They consist of a series of rotating shelves that bring the correct medication bin to the operator.
  • They often use "pick-to-light" technology to show the operator which bin to pick from and how many.
  • They improve picking accuracy and save significant space compared to static shelving.
  • The CHPOP manages the inventory and workflow for the carousel system.

IV Compounding Robots

  • These robots automate the process of preparing sterile IV admixtures.
  • They can perform tasks like reconstituting vials, withdrawing the correct volume, and injecting it into an IV bag.
  • They significantly improve the accuracy and sterility of the compounding process.
  • They also reduce staff exposure to hazardous drugs.
  • The CHPOP is involved in the evaluation, implementation, and operational management of this high-cost technology.

Workflow Management Systems

  • These are not robots, but software systems that manage the workflow for manual processes.
  • For IV compounding, these systems use barcode scanning and digital imaging to guide the technician.
  • The system takes a picture of the drug vial and the volume drawn into the syringe.
  • A pharmacist then verifies these images remotely.
  • This enhances the safety of manual compounding and creates a detailed electronic record.
  • The CHPOP manages the implementation and optimization of these workflow systems.

Predictive Analytics for Patient Outcomes

  • Machine learning models can analyze vast amounts of EHR data to predict which patients are at high risk for adverse outcomes.
  • This includes models to predict the risk of readmission, adverse drug events, or developing a specific condition like sepsis.
  • This allows clinical pharmacists to proactively target their interventions to the highest-risk patients.
  • This is a shift from reactive to proactive clinical pharmacy.
  • The CHPOP works with the data science team to implement and validate these models.

AI in Inventory Management & Procurement

  • AI can significantly improve the efficiency of the supply chain.
  • Machine learning algorithms can create much more accurate demand forecasts than traditional methods.
  • This allows for the optimization of inventory levels, reducing both stock-outs and excess inventory.
  • AI can also be used to predict drug shortages by analyzing global supply chain data.
  • This allows the CHPOP to take proactive steps to secure the supply of critical medications.

Machine Learning for Diversion Detection

  • Preventing the diversion of controlled substances is a major operational challenge.
  • Modern diversion surveillance software uses machine learning to analyze millions of transactions from ADCs and the EHR.
  • The algorithms can identify patterns of behavior that are anomalous and may indicate diversion.
  • This is much more powerful than traditional reports that just look for simple outliers.
  • The CHPOP uses these tools to make their diversion prevention program much more effective and efficient.

Natural Language Processing (NLP) in Clinical Review

  • NLP is a type of AI that can understand and interpret human language.
  • It can be used to scan unstructured text, like physician's notes in the EHR.
  • This can help pharmacists to more efficiently identify key clinical information needed for order verification.
  • For example, it could be used to find the indication for an antibiotic to ensure it is appropriate.
  • This technology can help to streamline the clinical review process.

Ethical Considerations & Implementation Challenges

  • The use of AI in healthcare raises important ethical questions.
  • There is a risk that AI models could perpetuate existing biases if they are trained on biased data.
  • There must always be human oversight; AI should be a tool to assist clinicians, not replace their judgment.
  • Implementation challenges include the high cost, the need for specialized data science expertise, and the difficulty of integrating these tools into existing workflows.
  • A CHPOP must be a thoughtful leader in navigating these challenges.

Purpose and Workflow

  • BCMA is a technology-enabled system designed to prevent medication administration errors.
  • It is a key patient safety initiative in hospitals.
  • The workflow involves the nurse scanning three barcodes before administering a medication:
  • The barcode on their own ID badge.
  • The barcode on the patient's wristband.
  • The barcode on the unit-dose medication package.
  • The system then verifies the "five rights" against the electronic medication administration record (eMAR).

The Pharmacy's Role in BCMA

  • The BCMA system is dependent on the pharmacy for its success.
  • The pharmacy is responsible for ensuring that every single dose of medication that leaves the pharmacy has a scannable, accurate barcode.
  • This includes medications that are repackaged or compounded in-house.
  • The CHPOP is responsible for the entire operational workflow that supports BCMA.
  • If barcodes don't scan, the safety benefits of the system are lost.

Managing the Drug Database

  • The BCMA system relies on an accurate drug database that links the NDC barcode to the correct medication entry in the EHR.
  • The CHPOP works with the informatics team to manage this database.
  • When a new drug is added to the formulary, its barcode information must be built into the system.
  • This is a critical step in the new drug onboarding process.
  • A robust process for managing this database is essential.

Troubleshooting Scanning Failures

  • Barcode scanning failures are a common problem.
  • This can be due to a poor quality label, a damaged barcode, or an incorrect entry in the database.
  • The CHPOP is responsible for the process of investigating and resolving these failures.
  • This requires collaboration between pharmacy, nursing, and IT.
  • The goal is to maintain a very high scanning success rate.
  • A high failure rate leads to nurse frustration and the use of risky workarounds.

BCMA and Patient Safety

  • BCMA has been shown to significantly reduce medication administration errors.
  • It is considered a standard of care in modern hospitals.
  • The CHPOP plays a vital, behind-the-scenes role in this critical patient safety system.
  • The operational integrity of the pharmacy's dispensing and barcoding processes is the foundation upon which BCMA is built.
  • It is a key area of focus for The Joint Commission.

Defining Health Equity

  • Health equity means that everyone has a fair and just opportunity to be as healthy as possible.
  • This requires removing obstacles to health, such as poverty and discrimination.
  • Health disparities are the preventable differences in health outcomes experienced by socially disadvantaged populations.
  • The CHPOP must consider how their operational decisions can either improve or worsen health equity.

Role of Social Determinants of Health (SDoH)

  • SDoH are the conditions where people live, work, and play that affect their health.
  • For medication access, key SDoH include income, insurance status, transportation, and health literacy.
  • A patient cannot be adherent if they cannot afford their copay or do not have a ride to the pharmacy.
  • Hospital pharmacy operations must be designed to help patients overcome these barriers, especially at the time of discharge.

"Meds-to-Beds" Programs

  • A "Meds-to-Beds" program is an operational model designed to improve access to medications upon discharge.
  • The hospital's outpatient pharmacy fills the patient's discharge prescriptions and delivers them to the patient's bedside before they leave the hospital.
  • This ensures the patient goes home with their medications in hand.
  • It overcomes potential barriers like transportation or the inability to pay a copay immediately.
  • The CHPOP is responsible for the design and implementation of this high-impact program.

Language & Cultural Competency

  • Health equity requires care that is culturally and linguistically appropriate.
  • For pharmacy operations, this means ensuring that medication labels and instructions are available in the patient's primary language.
  • It requires having access to qualified medical interpreters for patient counseling.
  • Staff should be trained in cultural competency to provide respectful and effective care to a diverse patient population.
  • The CHPOP must ensure their department has the resources to meet these needs.

Technology's Role in Bridging Gaps

  • Technology can be used to help bridge access gaps.
  • Telepharmacy can be used to provide clinical pharmacy services to patients in rural or underserved areas.
  • Mobile apps can provide medication reminders and education in multiple languages.
  • The CHPOP should explore how technology can be leveraged to make medication distribution more equitable.
  • However, they must also be aware of the "digital divide" and ensure that technology does not create new barriers for some patients.

Role in Medication Distribution

  • The pneumatic tube system is a critical piece of infrastructure for medication distribution.
  • It allows for the rapid, point-to-point delivery of medications from the pharmacy to the nursing units.
  • It is the primary method for sending STAT and first-dose medications.
  • An efficient and reliable tube system is essential for meeting turnaround time goals.
  • The CHPOP must have a strong working relationship with the facilities department that maintains the system.

Developing Policies and Procedures

  • The CHPOP is responsible for the pharmacy's policies on the use of the tube system.
  • The policy must clearly define what can and cannot be sent via the tube.
  • Items typically prohibited: Chemotherapy and other hazardous drugs, glass vials or ampules, and controlled substances.
  • The policy should also define the proper procedure for packaging items to be tubed to prevent breakage.
  • All staff must be trained on this policy.

Managing Downtime

  • Pneumatic tube systems can and do go down for maintenance or repair.
  • The CHPOP must have a formal downtime procedure in place.
  • This procedure must outline the alternative method for delivering medications during the downtime.
  • This typically involves using technicians or other staff to perform manual delivery runs.
  • The downtime procedure must be communicated to the nursing staff immediately.
  • This is a critical contingency plan for maintaining operations.

Lost and Misdirected Items

  • Occasionally, items can get lost or sent to the wrong location in the tube system.
  • The CHPOP must have a procedure for investigating these events.
  • This involves working with the facilities department to trace the carrier.
  • If a medication is lost, a replacement dose must be sent to the patient care area immediately to avoid a delay in therapy.
  • Tracking the frequency of these events can help to identify problems with the system.

Safety Considerations

  • The high speed of the tube system can cause breakage of fragile items if they are not packaged correctly.
  • There is also a risk of hemolysis (breakage of red blood cells) if blood products are tubed.
  • The policy restricting certain items is a key safety control.
  • The CHPOP must ensure that these safety policies are followed to prevent patient harm and product waste.
  • Regular audits of items being sent through the tube system can be a useful QA tool.

The Role of Smart Pumps

  • Smart infusion pumps are IV pumps that have a built-in drug library.
  • The drug library contains standardized concentrations and dosing limits for high-risk IV medications.
  • If a nurse tries to program a dose or rate that is outside of these pre-defined limits, the pump will issue an alert.
  • This is a critical safety feature designed to prevent catastrophic IV medication errors.
  • Smart pumps are a standard of care in modern hospitals.

The Drug Library

  • The drug library is the "brain" of the smart pump.
  • It is developed and maintained by a multidisciplinary team, led by the pharmacy.
  • The CHPOP is a key leader on this team.
  • The library must be built with care, using standardized concentrations for all infusions.
  • Hard and soft dosing limits must be set for each drug based on evidence and clinical consensus.
  • A hard limit cannot be overridden by the nurse, while a soft limit can be overridden with a reason.

Library Maintenance and Updates

  • The drug library is not static; it must be continuously updated.
  • When a new drug is added to the formulary, it must be built into the library.
  • When a dosing guideline changes, the limits in the library must be updated.
  • The process for updating the library is complex and requires careful testing.
  • The updated library must then be wirelessly pushed out to every pump in the hospital.
  • The CHPOP is responsible for the operational management of this update process.

Analyzing Pump Data (CQI)

  • Smart pumps generate a wealth of data that can be used for quality improvement.
  • The data shows which alerts are firing most often.
  • It also shows how often nurses are overriding the soft limits.
  • This data should be regularly reviewed by a multidisciplinary team.
  • A high override rate for a specific drug may indicate that the soft limit is set too low.
  • This Continuous Quality Improvement (CQI) process is essential for optimizing the drug library.
  • The CHPOP leads the analysis of this data.

EHR Integration

  • The most advanced smart pumps can be integrated with the hospital's EHR.
  • This allows the pharmacist-verified order from the EHR to be sent directly to the pump.
  • The pump is then auto-programmed with the correct drug, dose, and rate.
  • The nurse then simply has to verify that the program is correct.
  • This interoperability further reduces the risk of manual programming errors.
  • The CHPOP is a key leader in the complex project of implementing pump-EHR integration.

The Role of an IDS Pharmacy

  • An IDS pharmacy is a specialized pharmacy that manages drugs used in clinical trials.
  • Their role is to ensure that investigational drugs are handled in accordance with the study protocol and all regulations.
  • This is a highly specialized and regulated area of practice.
  • The CHPOP may have operational oversight of the IDS pharmacy.

Procurement and Accountability

  • Investigational drugs are supplied by the trial sponsor, not purchased through the wholesaler.
  • The IDS pharmacy must maintain a strict and separate inventory for each clinical trial.
  • A meticulous drug accountability record must be maintained for every single dose.
  • This record must track the drug from receipt to dispensing, return, or destruction.
  • This level of accountability is far stricter than for commercial drugs and is a major focus of sponsor audits.

Storage and Handling

  • Investigational drugs must be stored in a secure, limited-access area, separate from all other pharmacy stock.
  • Many of these drugs require specific temperature storage and continuous monitoring.
  • The study protocol will specify the exact storage and handling requirements.
  • The CHPOP must ensure the IDS pharmacy has the appropriate facilities and equipment.

Dispensing, Blinding, and Labeling

  • Dispensing is done according to the specific randomization and blinding requirements of the study protocol.
  • Blinding is the process of keeping the patient and/or the investigator unaware of which treatment the patient is receiving (active drug or placebo).
  • The IDS pharmacy plays a key role in maintaining the blind.
  • Labeling for investigational drugs is also highly regulated and must contain specific information.
  • The CHPOP must ensure the operational workflows can support these complex requirements.

Audits and Compliance

  • IDS pharmacies are subject to audit by the study sponsor, the hospital's Institutional Review Board (IRB), and the FDA.
  • These audits are extremely rigorous and focus on drug accountability and documentation.
  • Any discrepancy in the drug accountability records can jeopardize the integrity of the clinical trial.
  • The CHPOP must ensure that the IDS supply chain is designed for maximum compliance and is always audit-ready.

Block 5: Safety, Quality, and Regulatory Compliance

A Systems Approach to Safety

  • The foundation of modern medication safety is the understanding that errors are caused by flawed systems, not bad people.
  • This approach, championed by James Reason's "Swiss Cheese Model," focuses on building multiple layers of defense.
  • Each layer (e.g., CPOE, pharmacist verification, BCMA) has potential holes.
  • An error reaches the patient only when the holes in all the layers line up.
  • The goal of a CHPOP is to design robust systems with as few holes as possible.
  • This requires moving away from a culture of blame towards a "just culture."

Just Culture

  • A "just culture" is a culture of safety that recognizes the difference between human error, at-risk behavior, and reckless behavior.
  • Human Error: An inadvertent slip or mistake. This should be managed by improving the system and coaching the individual.
  • At-Risk Behavior: A choice where the risk is not recognized or is believed to be justified (e.g., taking a shortcut). This is managed by coaching and understanding the incentives for the behavior.
  • Reckless Behavior: A conscious disregard of a substantial and unjustifiable risk. This is the only level that warrants punitive action.
  • A CHPOP must foster a just culture in the pharmacy.

High-Alert Medications

  • These are drugs that have a heightened risk of causing significant patient harm when used in error.
  • The Institute for Safe Medication Practices (ISMP) maintains a formal list of high-alert medications.
  • Examples include insulin, anticoagulants, narcotics, and chemotherapy.
  • Hospitals must have special safeguards in place for these drugs.
  • The CHPOP is responsible for the operational implementation of these safeguards.

Strategies for High-Alert Medications

  • Standardize: Standardize the ordering, storage, preparation, and administration of these drugs.
  • Limit Access: Restrict access to these drugs in ADCs.
  • Use Technology: Use smart pumps with dose error reduction software.
  • Independent Double Checks: Require two clinicians to independently check the drug and dose before administration.
  • Provide Information: Use warning labels and provide clear information to staff.
  • The CHPOP ensures these strategies are built into the pharmacy's workflows.

Look-Alike, Sound-Alike (LASA) Drugs

  • Mix-ups between drugs with similar names are a common source of error.
  • The ISMP maintains a list of commonly confused drug names.
  • Strategies to prevent these errors are a key part of a medication safety program.
  • Tall Man Lettering: Using a mix of upper and lower case letters to highlight the differences in names (e.g., hydrOXYzine vs. hydrALAZINE).
  • Physical Separation: Storing LASA pairs in different locations on the shelf or in ADCs.
  • Barcode scanning is the most effective safeguard.
  • The CHPOP is responsible for implementing these strategies.

The Importance of Reporting

  • A robust medication error reporting system is the foundation of any safety program.
  • The goal is to learn from errors to prevent them from happening again.
  • The system must be non-punitive and confidential to encourage staff to report.
  • Reporting of "near misses" or "close calls" is just as important as reporting errors that reach the patient.
  • Near misses provide valuable insights into system weaknesses before a patient is harmed.
  • The CHPOP is a champion for creating a culture where reporting is seen as a positive contribution to safety.

Types of Medication Errors

  • Errors can be categorized based on the stage of the medication use process where they occur.
  • Prescribing Error: e.g., incorrect drug selection or dose.
  • Transcription Error: e.g., a handwritten order is entered incorrectly.
  • Dispensing Error: e.g., the pharmacy dispenses the wrong drug or strength.
  • Administration Error: e.g., the nurse gives the drug to the wrong patient.
  • The CHPOP's primary focus is on preventing dispensing errors, but they must have a systems view of all error types.

The NCC MERP Index

  • The National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) has developed a categorized index for medication errors.
  • This index classifies an error based on its outcome, from Category A (a circumstance with the capacity to cause error) to Category I (an error that contributed to a patient's death).
  • This provides a standardized way to assess the severity of an error.
  • This is a key tool for prioritizing which events require the most intensive investigation.

Root Cause Analysis (RCA)

  • An RCA is a structured, retrospective investigation of a serious adverse event.
  • The goal is to identify the underlying system failures, not to blame an individual.
  • An RCA team is a multidisciplinary group that maps out the timeline of the event.
  • They use techniques like the "5 Whys" to dig into the contributing factors.
  • The output is a set of strong, system-based action items to prevent recurrence.
  • The CHPOP is a key leader in conducting RCAs for medication-related events.

External Reporting (ISMP, MedWatch)

  • In addition to internal reporting, there is a value in reporting errors to external, national programs.
  • The ISMP operates the National Medication Errors Reporting Program (MERP).
  • This allows ISMP to identify national trends and share lessons learned with all hospitals.
  • The FDA's MedWatch program is used to report serious adverse drug reactions.
  • The CHPOP should have a policy for when and how to report to these external programs.

The PDSA Cycle

  • The Plan-Do-Study-Act (PDSA) cycle is the fundamental model for improvement.
  • Plan: State the objective of the test, make predictions, and develop a plan to test the change.
  • Do: Carry out the test on a small scale and document observations.
  • Study: Analyze the data, compare the results to the predictions, and summarize what was learned.
  • Act: Decide on the next step: adopt the change, adapt it, or abandon it.
  • This iterative cycle allows for rapid, small-scale testing of ideas before a full implementation.
  • The CHPOP uses this model to guide all quality improvement projects.

Lean Principles

  • Lean is a methodology focused on maximizing value and eliminating waste.
  • Waste is any step in a process that does not add value from the customer's (patient's) perspective.
  • The eight wastes are: Defects, Overproduction, Waiting, Non-Utilized Talent, Transportation, Inventory, Motion, and Extra-Processing (DOWNTIME).
  • A key Lean tool is Value Stream Mapping, which is used to visualize all the steps in a process and identify the waste.
  • The CHPOP uses Lean principles to improve the efficiency of pharmacy workflows.

Six Sigma

  • Six Sigma is a data-driven methodology focused on reducing process variation and defects.
  • The goal is to make a process so consistent that its outputs are 99.99966% defect-free.
  • It uses a structured problem-solving methodology called DMAIC (Define, Measure, Analyze, Improve, Control).
  • It is highly reliant on statistical analysis to understand and control process performance.
  • A CHPOP might use Six Sigma to tackle a complex problem like reducing IV compounding errors.

The Model for Improvement

  • This model, from the Institute for Healthcare Improvement (IHI), provides a simple framework for QI projects.
  • It asks three fundamental questions:
  • 1. What are we trying to accomplish? (The Aim)
  • 2. How will we know that a change is an improvement? (The Measures)
  • 3. What changes can we make that will result in improvement? (The Ideas)
  • The PDSA cycle is then used to test the ideas.
  • The CHPOP can use this model to structure any QI project.

Key Quality Tools

  • Flowchart: A visual representation of the steps in a process.
  • Cause-and-Effect Diagram (Fishbone): A tool used to brainstorm the potential causes of a problem.
  • Pareto Chart: A bar chart that shows the frequency of different causes of a problem, ordered from most frequent to least frequent. It helps to identify the "vital few" causes to focus on.
  • Run Chart/Control Chart: A graph that plots data over time, used to see if a process is stable and to track the impact of an improvement.
  • A CHPOP should be familiar with these basic quality tools.

Role of The Joint Commission

  • TJC is the primary accrediting body for hospitals in the United States.
  • Accreditation from TJC is a nationally recognized symbol of quality.
  • It is required for a hospital to receive payment from Medicare and Medicaid (this is known as "deemed status").
  • The CHPOP must be an expert on all TJC standards related to medication management.
  • Compliance is not optional; it is a condition of doing business.

The Medication Management (MM) Chapter

  • The TJC standards are organized into chapters. The MM chapter is the most important one for pharmacy.
  • It covers all aspects of the medication use system, from procurement and storage to prescribing and administration.
  • It includes specific standards on formulary management, order verification, and compounding.
  • It also has standards on medication reconciliation and monitoring.
  • The CHPOP is responsible for ensuring their operations are in full compliance with every standard in the MM chapter.

National Patient Safety Goals (NPSGs)

  • NPSGs are a set of specific goals that TJC establishes to address the most critical patient safety issues.
  • Several NPSGs are directly related to medication safety.
  • These include goals on labeling medications, reducing harm from anticoagulants, and medication reconciliation.
  • Compliance with the NPSGs is a major focus of the TJC survey.
  • The CHPOP must have programs in place to address each of the medication-related NPSGs.

The Survey Process (Tracers)

  • TJC surveys are unannounced and typically last for several days.
  • The primary survey methodology is the "tracer."
  • A surveyor will select a patient and trace their entire experience through the hospital.
  • For medication management, this means they will review the patient's chart, look at their medication orders, and go to the pharmacy to see how the drugs were prepared and dispensed.
  • They will then go to the nursing unit to observe administration.
  • This allows them to see the entire medication use system in action.
  • The CHPOP must be prepared to participate in these tracers at any time.

Continuous Survey Readiness

  • Because surveys are unannounced, the pharmacy must be in a state of continuous readiness.
  • This requires having a robust internal auditing and quality assurance program.
  • Regular "mock tracers" should be conducted to simulate a TJC survey and identify any gaps.
  • All staff must be educated on the key standards and be prepared to speak to a surveyor.
  • The CHPOP is the leader responsible for maintaining this state of constant readiness.
  • The goal is to make the actual survey "just another day."

The Closed System of Distribution

  • The foundation of DEA compliance is the "closed system."
  • This means that all controlled substances must be accounted for at every step, from the manufacturer to the patient.
  • This is achieved through a system of registration, recordkeeping, and security.
  • The CHPOP is responsible for ensuring the integrity of this closed system within the hospital.
  • Any break in the chain of accountability is a potential diversion.

Recordkeeping Requirements

  • The DEA requires meticulous recordkeeping for all controlled substances.
  • Ordering Records: DEA Form 222s and CSOS records.
  • Receiving Records: Invoices, with the date and quantity received documented.
  • Dispensing Records: Prescriptions or medication orders.
  • Inventory Records: A complete and accurate biennial inventory.
  • All records must be kept for at least two years and be readily retrievable.
  • The CHPOP must ensure these records are complete, accurate, and organized.

Biennial Inventory

  • The DEA requires a complete physical inventory of all controlled substances to be taken at least every two years.
  • The inventory must be taken at either the beginning or the close of business on the inventory date.
  • An exact count is required for all Schedule I and II substances.
  • An estimated count is permissible for Schedule III-V substances, unless the container holds more than 1,000 units.
  • This is a major operational undertaking that the CHPOP must plan and oversee.

Theft and Significant Loss Reporting

  • The pharmacy must report any theft or significant loss of controlled substances to the DEA.
  • Initial notification must be made to the local DEA field office within one business day of discovery.
  • A formal report must then be submitted using DEA Form 106.
  • The determination of whether a loss is "significant" is based on a number of factors, including the quantity, the specific drug, and any patterns of loss.
  • The CHPOP is responsible for this critical reporting process.

Diversion Surveillance

  • Beyond the basic DEA requirements, hospitals must have a proactive program to detect and prevent diversion.
  • This involves using technology and data analytics to monitor controlled substance transactions.
  • Reports from ADCs and other systems are analyzed to identify unusual patterns of activity.
  • This surveillance is a key part of a modern controlled substance compliance program.
  • The CHPOP is the leader of this multidisciplinary effort.

Role and Authority

  • Each state has a Board of Pharmacy that is responsible for regulating the practice of pharmacy within that state.
  • Their primary mission is to protect the public.
  • They issue licenses to pharmacies, pharmacists, and technicians.
  • They create and enforce the state's Pharmacy Practice Act and its associated rules.
  • The CHPOP must be an expert on the specific rules of their state BOP.

Licensure Requirements

  • The pharmacy facility itself must have a license from the BOP.
  • All pharmacists practicing in the state must be licensed by the BOP.
  • Most states also have registration or licensure requirements for pharmacy technicians.
  • The CHPOP is responsible for ensuring that all licenses are current for both the facility and all personnel.
  • This includes having a system to track license renewal dates.

Compounding Standards

  • State BOPs are the primary enforcers of USP compounding standards.
  • Many states have incorporated USP <795>, <797>, and <800> directly into their regulations.
  • This means that these chapters are not just best practices; they are the law in those states.
  • BOP inspectors will conduct a detailed review of the compounding facilities and records.
  • The CHPOP must ensure full compliance with these critical standards.

Technician Supervision and Ratios

  • State laws define the scope of practice for pharmacy technicians.
  • They also specify the degree of pharmacist supervision that is required.
  • Many states have laws that set a maximum ratio of technicians to pharmacists (e.g., 3:1).
  • The CHPOP must ensure their staffing and workflow models are compliant with these supervision and ratio rules.
  • Some states are moving towards more flexible, tech-check-tech models, which have their own specific regulations.

Inspections and Audits

  • BOPs conduct routine inspections of all pharmacies in their state.
  • These inspections are often unannounced.
  • The inspector will review all aspects of the pharmacy's operations, with a focus on compounding, recordkeeping, and security.
  • If deficiencies are found, the BOP can issue penalties ranging from a warning letter to a large fine or suspension of the pharmacy's license.
  • The CHPOP is the key person responsible for preparing for and leading the pharmacy through a BOP inspection.

USP <797> Sterile Compounding

  • This chapter is focused on preventing patient harm from contaminated sterile products.
  • Key areas of compliance include facility design (cleanrooms), environmental monitoring, and personnel training and competency.
  • A CHPOP must ensure that their facility and practices meet all the detailed requirements for air quality, pressure differentials, and cleaning.
  • They must oversee the robust documentation required for this chapter.

USP <800> Hazardous Drugs

  • This chapter is focused on protecting healthcare workers from exposure to hazardous drugs.
  • Key areas of compliance include engineering controls (e.g., negative pressure rooms), the use of personal protective equipment (PPE), and safe work practices.
  • It requires the facility to maintain a formal list of all hazardous drugs it handles.
  • The CHPOP must lead a multidisciplinary team to implement and oversee compliance with this complex chapter.

USP <795> Non-Sterile Compounding

  • This chapter provides standards for compounding non-sterile preparations.
  • Key areas of compliance include designating a specific compounding area, personnel training, and assigning appropriate beyond-use dates.
  • It also requires the use of Master Formulation and Compounding Records.
  • While less complex than sterile compounding, the CHPOP must ensure these standards are followed.

The Role of the Designated Person

  • All of the compounding chapters require the formal designation of a person who is responsible and accountable for the compounding program.
  • The CHPOP is often this designated person.
  • This role involves having a deep, expert-level understanding of the chapters.
  • They are responsible for developing all policies and procedures and for ensuring that the QA program is effective.
  • This is a major area of personal and professional accountability.

Integration and Overlap

  • These three chapters are designed to work together.
  • For example, if a pharmacy is compounding a sterile hazardous drug, the requirements of both <797> and <800> apply.
  • This means the compounding must be done in a room that meets the requirements of both chapters (e.g., an ISO 7 buffer room that is also under negative pressure).
  • The CHPOP must be able to understand and integrate the requirements of all applicable chapters.
  • This requires careful planning and design of facilities and workflows.

Causes and Impact of Shortages

  • Drug shortages are a chronic problem in the U.S. healthcare system.
  • Common causes include manufacturing quality problems, discontinuation of older products, and unexpected spikes in demand.
  • Sterile injectable drugs, especially generics, are the most common category of drugs in short supply.
  • Shortages can have a severe impact on patient care, leading to delayed treatment or the use of less effective alternatives.
  • They also create a massive operational burden for the pharmacy.

Proactive Monitoring

  • An effective drug shortage program is proactive.
  • The CHPOP must have a system for monitoring multiple sources to get early warnings of potential shortages.
  • Key sources include the FDA and ASHP drug shortage websites.
  • Wholesalers also provide information on supply disruptions.
  • Early detection allows the pharmacy more time to develop a management plan.

The Drug Shortage Team

  • Managing a critical drug shortage requires a multidisciplinary approach.
  • The CHPOP should lead a drug shortage team that includes clinical pharmacists, physicians from the affected specialty, and nursing representatives.
  • This team is responsible for assessing the clinical impact of the shortage and making decisions about therapeutic alternatives.
  • This collaborative approach ensures that all perspectives are considered.

Management Strategies

  • There are several strategies to manage a shortage.
  • Conservation: Implementing measures to reduce the use of the drug on hand (e.g., using smaller vial sizes to reduce waste).
  • Therapeutic Alternatives: Identifying and switching to an alternative drug based on the P&T committee's guidance.
  • Alternative Suppliers: Trying to source the drug from other wholesalers or directly from the manufacturer.
  • In-house Compounding: For some shortages, the pharmacy may be able to compound the product in-house if it is a sterile injectable.
  • The CHPOP is responsible for coordinating all of these strategies.

Communication

  • Clear and timely communication is essential during a shortage.
  • The CHPOP must have a process for communicating with all prescribers and nurses about the shortage.
  • The communication should explain the situation, the management plan, and the approved therapeutic alternatives.
  • The EHR and CPOE systems must be updated to reflect these changes.
  • This prevents confusion and ensures a smooth transition to the alternative therapy.

Classes of Recalls

  • A medication recall is an action taken to remove a product from the market.
  • The FDA classifies recalls based on the level of hazard involved.
  • Class I: The most serious type. There is a reasonable probability that the use of the product will cause serious adverse health consequences or death.
  • Class II: The use of the product may cause temporary or medically reversible adverse health consequences.
  • Class III: The use of the product is not likely to cause adverse health consequences.
  • The CHPOP must understand these classes to prioritize the response.

The Recall Process

  • The pharmacy receives a recall notification from the manufacturer or wholesaler.
  • The first step is to immediately identify all affected products in the pharmacy's inventory.
  • This requires being able to search the inventory system by the specific NDC and lot number(s) included in the recall.
  • All affected products must be immediately removed from all storage areas and quarantined.
  • This includes the central pharmacy, all ADCs, and any kits or trays.

Identifying Affected Patients

  • For a Class I recall, the pharmacy must also have a system to identify any patients who may have received the recalled drug.
  • This requires being able to run a report from the PIS to find all dispenses of the specific lot number.
  • The pharmacy must then notify the patient's physician so that they can take any necessary clinical action.
  • This "look-back" capability is a critical safety function.
  • The CHPOP must ensure their information systems can support this.

Returning Recalled Products

  • The recall notice will provide instructions on how to return the affected product.
  • The pharmacy must follow these instructions to receive credit for the recalled items.
  • This involves packaging the products and sending them back to the manufacturer or a designated third party.
  • Meticulous documentation of all returned products must be maintained.
  • The CHPOP oversees this logistical process.

Documentation and Policy

  • The pharmacy must have a formal, written policy and procedure for handling medication recalls.
  • The policy should assign responsibility for each step of the process.
  • All actions taken in response to a recall must be documented.
  • This documentation should be maintained and be available for review by a regulator.
  • The CHPOP is responsible for ensuring this policy is in place and is followed every time.

The Concept of Continuous Readiness

  • Because most regulatory and accreditation surveys are unannounced, the pharmacy must operate in a constant state of readiness.
  • This means that policies, procedures, and practices must be compliant every single day.
  • It is a proactive mindset that moves beyond simply "prepping" for a survey.
  • The CHPOP is the leader responsible for instilling and maintaining this culture.
  • It requires robust systems and engaged staff.

Internal Auditing Program

  • A formal internal auditing program is the cornerstone of continuous readiness.
  • The CHPOP should develop an annual audit plan that covers all key operational and regulatory risk areas.
  • This includes areas like sterile compounding, controlled substance management, and ADC operations.
  • These self-audits are used to proactively identify and fix any gaps in compliance.
  • The findings should be tracked and reported to the pharmacy leadership team.

Conducting Mock Surveys/Tracers

  • A mock survey is a simulation of an external audit, such as a TJC survey.
  • This is an excellent tool for assessing readiness and for training staff.
  • The mock survey should use the same methodologies as the real thing, including the use of tracers.
  • It helps to identify areas where staff may be uncomfortable or unfamiliar with the standards.
  • The CHPOP should organize and lead these mock surveys on a regular basis.

Corrective Action Planning

  • When an internal audit or mock survey identifies a deficiency, a formal Corrective Action Plan (CAP) must be developed.
  • The CAP should identify the root cause of the problem and outline specific, time-bound action items to fix it.
  • The CHPOP is responsible for tracking all CAPs to ensure they are completed.
  • This closed-loop process of identifying and fixing problems is the essence of continuous improvement.

Staff Education and Engagement

  • Continuous readiness is a team sport; it cannot be achieved by the manager alone.
  • All staff must be educated on the key regulatory standards that apply to their work.
  • They should be engaged in the quality improvement process.
  • Frontline staff are often the best source of ideas for how to improve a process.
  • The CHPOP must create a culture where every staff member feels a sense of ownership for quality and compliance.

The Future of DSCSA

  • The final phase of the Drug Supply Chain Security Act requires full, unit-level electronic traceability.
  • While the deadline has been stabilized, this requirement is still coming.
  • This will require significant investment in technology and workflow changes for hospital pharmacies.
  • The CHPOP must be the leader in preparing their organization for this major regulatory change.
  • This is the most significant trend in supply chain regulation.

Evolving USP Standards

  • The USP chapters on compounding are not static; they are updated periodically.
  • The recent updates to <795> and <797> included major changes to BUDs and facility requirements.
  • The CHPOP must have a process for staying current on proposed and final changes to these chapters.
  • This requires actively monitoring USP and being prepared to adapt operations to meet new standards.
  • This is a continuous cycle of compliance and improvement.

State-Level Scope of Practice Changes

  • State Boards of Pharmacy are increasingly expanding the scope of practice for pharmacists and technicians.
  • This includes the expansion of collaborative practice agreements.
  • It also includes the creation of "tech-check-tech" programs, where a certified technician can verify the work of another technician for certain tasks.
  • The CHPOP must be aware of these changes in their state.
  • They can leverage these new regulations to design more efficient and innovative workflows.

The Impact of the Inflation Reduction Act (IRA)

  • While focused on reimbursement, the IRA has operational implications for hospitals.
  • The new Medicare drug price negotiation program may change prescribing patterns.
  • The CHPOP must be prepared for the operational impact of these shifts.
  • For example, if a negotiated drug becomes heavily favored, it could have a major impact on inventory levels.

Data Privacy & Cybersecurity

  • With the increasing reliance on technology and integrated data, cybersecurity is a major regulatory focus.
  • A data breach that exposes protected health information (PHI) can have devastating consequences.
  • The CHPOP must work with the IT department to ensure that all pharmacy information systems are secure and compliant with HIPAA.
  • This includes managing access controls and ensuring that all vendor systems are secure.
  • This is an emerging and critical area of operational risk management.

Block 6: Advanced Operations, Clinical Integration & Management

The Drug Budget

  • The drug budget is the largest expense category for the pharmacy and one of the largest for the entire hospital.
  • The CHPOP is a key leader in developing and managing this budget.
  • The process involves forecasting future drug spend based on historical data, volume projections, and expected price inflation.
  • It must account for the impact of new high-cost drugs and patent expirations.
  • The CHPOP must be able to present and defend the budget to senior leadership.

The Labor Budget

  • Labor is the second-largest expense for the pharmacy.
  • The CHPOP is responsible for developing the labor budget based on the approved staffing model.
  • This includes forecasting costs for salaries, benefits, overtime, and on-call pay.
  • Productivity metrics are used to justify the number of FTEs required.
  • The manager must balance the need for safe staffing with the need to control costs.

The Capital Budget

  • The capital budget is for large, one-time investments in equipment and technology.
  • This includes items like new IV robots, ADCs, or cleanroom renovations.
  • The CHPOP is responsible for identifying the need for these investments.
  • They must prepare a formal business case, including a Return on Investment (ROI) analysis, to justify the expenditure.
  • This requires strong financial analysis skills.

Variance Analysis

  • Each month, the CHPOP must perform a variance analysis, comparing the pharmacy's actual spending to the budget.
  • Any significant variance must be investigated and explained.
  • For example, if drug spend is over budget, was it due to higher volume or a price increase?
  • A formal variance report is submitted to the finance department.
  • This is a key process for financial accountability.

Cost-Containment Initiatives

  • A core part of the CHPOP's job is to lead cost-containment initiatives.
  • This includes programs like IV-to-PO conversions and therapeutic interchange.
  • It also involves optimizing inventory to reduce carrying costs and waste.
  • The CHPOP must be able to quantify the savings from these initiatives and report them to leadership.
  • This demonstrates the value that pharmacy operations brings to the organization.

Recruitment and Hiring

  • The CHPOP is the hiring manager for the operational staff.
  • This involves writing accurate job descriptions and working with HR to recruit qualified candidates.
  • The manager must be skilled in behavioral interviewing techniques to select the best candidate.
  • They are responsible for making the final hiring decision and extending an offer.

Onboarding and Training

  • A structured onboarding and training program is essential for new employees.
  • The CHPOP is responsible for designing this program.
  • It should include both general orientation and specific, competency-based training for the employee's role.
  • Effective onboarding is key to employee success and retention.

Performance Management

  • The CHPOP is responsible for the performance of their team.
  • This involves setting clear expectations and providing regular coaching and feedback.
  • Formal performance reviews must be conducted annually.
  • Underperformance must be addressed through coaching and, if necessary, a formal Performance Improvement Plan (PIP).
  • High performers should be recognized and developed for future leadership roles.

Employee Engagement and Retention

  • The CHPOP plays a critical role in creating a positive and engaging work environment.
  • High engagement leads to lower turnover, which is a major cost savings.
  • Key drivers of engagement include open communication, recognition, and opportunities for professional growth.
  • The manager must be an effective leader who can build a cohesive and motivated team.

Labor Laws and Relations

  • The CHPOP must have a working knowledge of key labor laws, such as the FLSA and FMLA.
  • They must ensure that scheduling and pay practices are compliant.
  • In a unionized environment, the manager must understand and manage according to the collective bargaining agreement.
  • They must work constructively with union representatives to resolve issues.

Strategic Planning

  • The CHPOP is a key leader in developing the strategic plan for the pharmacy department.
  • This involves participating in a SWOT analysis (Strengths, Weaknesses, Opportunities, Threats).
  • The plan must be aligned with the overall strategic goals of the hospital.
  • It should include clear, measurable (SMART) goals for the upcoming year.
  • Examples include goals related to cost savings, safety improvements, or the implementation of new technology.

Project Management Fundamentals

  • The CHPOP is often the project manager for major operational initiatives.
  • They must be skilled in the fundamentals of project management.
  • This includes defining the project scope, creating a timeline (Gantt chart), and managing a budget.
  • They must be able to lead a multidisciplinary project team.
  • A structured approach is essential for keeping projects on track.

Leading Change

  • Most projects involve changing a workflow or process.
  • The CHPOP must be an effective change leader.
  • This requires clear communication about the reason for the change.
  • It involves engaging the frontline staff in the design of the new process to build buy-in.
  • It also requires anticipating and managing resistance to change.
  • A structured change management model (e.g., Kotter's 8 steps) can be a useful guide.

Business Case Development

  • To get approval for a new project, especially one that requires a capital investment, a formal business case is needed.
  • The CHPOP is responsible for developing this business case.
  • It should include a description of the problem, the proposed solution, and a detailed financial analysis.
  • The Return on Investment (ROI) is a key part of this analysis.
  • The business case must be persuasive and data-driven.

Performance Monitoring

  • The CHPOP is responsible for monitoring the performance of the entire pharmacy operation.
  • This is done through the use of a dashboard of Key Performance Indicators (KPIs).
  • These KPIs should cover all key areas: safety, quality, service, finance, and people.
  • The manager must review this dashboard regularly to identify trends and opportunities for improvement.
  • This data-driven approach to management is essential.

Program Overview

  • The 340B Drug Pricing Program provides deep discounts to eligible hospitals.
  • The CHPOP must understand the operational requirements of this program.
  • The two key compliance requirements are to prevent diversion to ineligible patients and to prevent duplicate discounts with Medicaid.
  • The financial savings from the program are significant, but the compliance risk is high.

Mixed-Use Inventory Management

  • The biggest operational challenge of 340B is managing the inventory in "mixed-use" settings where both eligible and ineligible patients are treated.
  • The hospital must have a system to track which dispenses are 340B-eligible.
  • This is typically done with a "virtual" inventory managed by specialized software.
  • The CHPOP must have a deep understanding of how this software works.

The GPO Prohibition

  • Certain types of 340B hospitals are prohibited from using a GPO for their outpatient drugs.
  • This requires the CHPOP to manage at least three separate purchasing accounts: inpatient GPO, 340B, and outpatient non-340B (WAC).
  • Ensuring that the purchasing staff order on the correct account is a major compliance responsibility.
  • Accidental purchasing of an outpatient drug on the GPO account is a common audit finding.

The Role of the Wholesaler

  • The wholesaler plays a key role in 340B operations.
  • They are responsible for loading the 340B pricing from the manufacturers.
  • They are also responsible for ensuring that only eligible entities can purchase on a 340B account.
  • The CHPOP must work closely with the wholesaler to resolve any pricing or account setup issues.

Auditing and Compliance

  • 340B hospitals are subject to audit by the Health Resources and Services Administration (HRSA).
  • These audits are very intensive and focus on purchasing records and patient eligibility.
  • The CHPOP is a key leader in preparing for and participating in a HRSA audit.
  • A robust internal auditing program for 340B is a best practice and an expectation of HRSA.

Core Principles of Antimicrobial Stewardship Programs (ASPs)

  • Antimicrobial stewardship is a coordinated program to promote the appropriate use of antimicrobials.
  • The goals are to improve patient outcomes, reduce microbial resistance, and decrease the spread of infections.
  • The CDC has outlined Core Elements for a successful hospital ASP.
  • The pharmacist is a core member and often a co-leader of the ASP team, along with an infectious diseases physician.
  • The CHPOP is responsible for the operational support of the ASP.

Pharmacist-Driven Interventions

  • Pharmacists perform many of the day-to-day interventions of the ASP.
  • Prospective Audit and Feedback: Reviewing new antimicrobial orders to ensure they are appropriate.
  • IV-to-PO Conversion: Switching patients to oral antibiotics as soon as they are clinically stable.
  • Dose Optimization: Adjusting doses based on renal function and pharmacokinetic principles.
  • The CHPOP must design workflows that enable pharmacists to perform these interventions efficiently.

Formulary Management for Antimicrobials

  • The formulary is a key tool for stewardship.
  • Certain broad-spectrum antibiotics may be restricted on the formulary.
  • This means they require pre-approval from a member of the ASP team before they can be dispensed.
  • This ensures that these powerful agents are reserved for situations where they are truly needed.
  • The CHPOP is responsible for the operational implementation of these formulary restrictions in the CPOE and PIS.

Diagnostic Stewardship & Rapid Diagnostics

  • Diagnostic stewardship is about using the right test for the right patient at the right time.
  • The use of rapid diagnostic tests (RDTs) can have a major impact on antibiotic use.
  • For example, a rapid test that can identify a specific pathogen and its resistance profile in hours instead of days allows for much faster de-escalation to a narrow-spectrum antibiotic.
  • The CHPOP works with the microbiology lab to design workflows that leverage these new technologies.

Data Tracking & Reporting (Antibiograms, DOT)

  • The ASP must be data-driven.
  • Antibiogram: An annual summary of the susceptibility patterns of local bacterial isolates. It is a critical tool for guiding empiric antibiotic selection.
  • Days of Therapy (DOT): A key metric for measuring overall antibiotic use in the hospital.
  • The CHPOP is responsible for ensuring the pharmacy systems can accurately track and report this data.
  • This data is used to measure the impact of the ASP and to report to national quality programs.

The Rationale for Health-System Specialty Pharmacies

  • Many health systems have developed their own internal specialty pharmacies.
  • The goal is to provide a more integrated and coordinated model of care for patients with complex conditions.
  • It allows the pharmacy to have direct access to the patient's EHR and the clinical team.
  • It also allows the health system to capture the significant revenue associated with dispensing these high-cost drugs.
  • The CHPOP may have operational oversight of this specialized pharmacy.

Accreditation

  • To be successful, a specialty pharmacy must be accredited.
  • Accreditation from an organization like URAC or ACHC is often required by payers and manufacturers to be in their networks.
  • The accreditation process is rigorous and requires the pharmacy to have extensive policies and procedures.
  • The CHPOP would be a key leader in the effort to achieve and maintain accreditation.

Limited Distribution Drugs (LDDs)

  • A major operational challenge for a health-system specialty pharmacy is gaining access to LDDs.
  • This requires responding to RFPs from manufacturers and demonstrating the pharmacy's capabilities.
  • The CHPOP would be involved in building the operational infrastructure (e.g., data reporting) needed to meet these requirements.
  • Lack of access to LDDs can be a major barrier to providing comprehensive care.

The Patient Journey and Workflow

  • The specialty pharmacy workflow is very different from a traditional pharmacy.
  • It is a "high-touch" model that involves a team of pharmacists, technicians, and patient advocates.
  • The workflow includes benefits investigation, prior authorization, and financial assistance coordination.
  • It also includes extensive patient education and ongoing adherence monitoring.
  • The CHPOP is responsible for designing and managing this complex, service-oriented workflow.

Data and Reporting

  • Specialty pharmacies are required to provide extensive data to manufacturers and payers.
  • This includes data on dispensing, adherence, and sometimes even clinical outcomes.
  • The CHPOP is responsible for the information systems needed to capture and report this data.
  • This data reporting is often a contractual requirement.
  • It is a key part of demonstrating the value of the specialty pharmacy.

Models of Hospital Telepharmacy

  • Telepharmacy uses technology to provide pharmacy services at a distance.
  • Remote Order Verification: The most common model. Pharmacists at a remote location (or at home) access the hospital's EHR to verify orders, often after-hours.
  • Remote Clinical Services: Providing clinical monitoring, such as vancomycin dosing, for multiple hospitals from a central hub.
  • Remote Dispensing: Using technology to allow a pharmacist to supervise a technician at a remote location where drugs are stored and dispensed.

Technology & Infrastructure Requirements

  • A successful telepharmacy program requires a robust and secure IT infrastructure.
  • This includes a secure, high-speed network connection (e.g., a VPN).
  • The remote pharmacist needs secure access to the hospital's EHR and PIS.
  • For remote dispensing, this includes audio-visual technology to allow for real-time supervision.
  • The CHPOP must work closely with the IT department to ensure this infrastructure is reliable and secure.

Regulatory & Licensure Considerations

  • The regulation of telepharmacy is complex and varies by state.
  • The state Board of Pharmacy where the patient is located is the one with jurisdiction.
  • This means a remote pharmacist may need to be licensed in multiple states if they are covering hospitals in different states.
  • The CHPOP must be an expert on the specific telepharmacy rules in their state.
  • These rules govern things like technician supervision and the physical requirements for a remote site.

Quality Assurance & Performance Monitoring

  • Managing a remote workforce requires a strong QA program.
  • The CHPOP must have a system for auditing the work of the remote pharmacists.
  • This includes reviewing their order verifications and clinical interventions.
  • Productivity and turnaround time must be monitored just as they would be for on-site staff.
  • Clear policies, procedures, and performance expectations are essential.
  • Regular communication (e.g., video conferences) is needed to keep the remote team engaged.

Expanding Clinical Services via Telepharmacy

  • Telepharmacy is not just for operational tasks; it can also be used to expand clinical services.
  • This is especially valuable for smaller, rural hospitals that may not have on-site clinical specialists.
  • A central team of specialists (e.g., in infectious diseases or anticoagulation) can provide expert consultations to multiple hospitals via telehealth.
  • This is an efficient way to leverage specialized expertise across a health system.
  • The CHPOP may be involved in the operational design of these innovative clinical service models.

The Importance of Data

  • Modern hospital pharmacy operations are data-driven.
  • The CHPOP must be skilled at using data to make informed decisions.
  • Data is used to monitor performance, identify problems, and justify new resources.
  • The ability to analyze and interpret data is a critical management competency.
  • This requires moving beyond simple reports to true business intelligence.

Key Data Sources

  • Pharmacy Information System (PIS): Data on dispensing, inventory, and purchasing.
  • Automated Dispensing Cabinets (ADCs): Rich data on medication utilization at the unit level.
  • EHR: Clinical data on patients and outcomes.
  • Financial System: Data on drug spend and revenues.
  • The CHPOP must be able to integrate data from these different sources to get a complete picture.

Key Performance Indicators (KPIs)

  • The CHPOP must develop and track a dashboard of KPIs for their department.
  • Financial KPIs: Drug spend per patient day, inventory turns.
  • Operational KPIs: STAT order turnaround time, cart fill accuracy.
  • Quality/Safety KPIs: Dispensing error rate, number of ADC overrides.
  • People KPIs: Staff turnover rate, employee engagement scores.
  • This dashboard is the primary tool for managing the performance of the department.

Business Intelligence (BI) Tools

  • BI tools like Tableau or Power BI are used to create interactive dashboards.
  • These tools allow the manager to easily visualize trends and drill down into the data.
  • They are much more powerful than static spreadsheets or reports.
  • The CHPOP should partner with the hospital's analytics department to develop these tools for the pharmacy.

Data-Driven Decision Making

  • The ultimate goal of all this data is to make better decisions.
  • For example, ADC usage data can be used to optimize the PAR levels in the cabinets.
  • Turnaround time data can be used to identify bottlenecks in the workflow.
  • Financial data can be used to build a business case for new automation.
  • The CHPOP must be able to use data to tell a story and to drive change.

Leading the Pharmacy Team

  • The CHPOP is a key leader in the pharmacy department.
  • This requires creating a clear vision for the operational team.
  • It involves setting high standards for performance and holding people accountable.
  • It also requires coaching, mentoring, and developing the staff.
  • An effective leader creates a culture of safety, quality, and continuous improvement.

Collaboration with Nursing

  • As stated before, the relationship with nursing is the most critical interdepartmental partnership.
  • The CHPOP must build a strong, collaborative relationship with their nursing leadership peers.
  • This involves regular meetings, joint problem-solving, and mutual respect.
  • A positive pharmacy-nursing relationship is essential for patient safety.

Collaboration with Medical Staff

  • The CHPOP must also work effectively with physicians and other prescribers.
  • This involves collaborating on formulary management and medication safety initiatives.
  • The manager must be able to communicate effectively with physicians and be seen as a credible partner.
  • This is key for the success of pharmacist-driven clinical programs.

Collaboration with Ancillary Departments

  • The pharmacy's operations are dependent on many other departments.
  • The CHPOP must have strong working relationships with IT, Finance, Environmental Services, and Facilities.
  • This requires an understanding of their perspectives and priorities.
  • The ability to navigate these interdepartmental relationships is a key political skill for a manager.

Representing the Pharmacy

  • The CHPOP represents the pharmacy on numerous hospital committees.
  • This can include committees on safety, quality, and technology.
  • They must be able to articulate the pharmacy's needs and contributions in these forums.
  • They are an ambassador for the department.
  • This requires strong communication and presentation skills.

The Role of the Pharmacy in Disasters

  • The pharmacy is a critical part of a hospital's response to any internal or external disaster.
  • This includes natural disasters, mass casualty events, and pandemics.
  • The CHPOP is a key leader on the hospital's Emergency Preparedness Committee.
  • They are responsible for developing the pharmacy's specific emergency operations plan.

The Emergency Operations Plan (EOP)

  • The pharmacy's EOP must detail how it will continue to provide services during a disaster.
  • It must address the "four S's": Space, Staff, Stuff (supplies), and Systems.
  • It should include plans for managing a surge in patient volume.
  • It must also have plans for operating with limited staff or resources.
  • The EOP should be practiced through regular drills and exercises.

Managing the Strategic National Stockpile (SNS)

  • In a large-scale public health emergency, the federal government may deploy assets from the SNS.
  • This includes large quantities of medications, such as antibiotics or antivirals.
  • The hospital pharmacy is a key node in the plan for receiving, storing, and dispensing these assets.
  • The CHPOP must be familiar with their role in the local SNS plan.

Downtime Procedures

  • A disaster can often involve the loss of power or computer systems.
  • The CHPOP must have robust downtime procedures for all key pharmacy systems.
  • This includes a paper-based or other manual system for order processing and dispensing.
  • These procedures must be regularly tested through planned downtime drills.
  • The ability to function without technology is a critical part of resilience.

Staff Preparedness

  • All pharmacy staff must be trained on their roles during an emergency.
  • This includes knowing the emergency codes and the pharmacy's EOP.
  • A communication plan is needed to be able to contact staff during a disaster.
  • The CHPOP must also consider the well-being of their staff, who may be working under extremely stressful conditions for long hours.
  • A prepared and well-led staff is the most important asset in any disaster response.

The Concept of a "Green Pharmacy"

  • Sustainability in healthcare is about meeting the needs of the present without compromising the ability of future generations to meet their needs.
  • The healthcare sector has a large environmental footprint.
  • A "green pharmacy" is one that actively seeks to minimize its environmental impact.
  • This is a growing area of focus for socially responsible health systems.
  • The CHPOP can be a key leader in driving sustainability initiatives.

Pharmaceutical Waste Segregation & Reduction

  • As discussed, proper segregation of pharmaceutical waste is a key regulatory requirement.
  • It is also a key part of a sustainability program.
  • Ensuring that only true hazardous waste goes into the black bins reduces the environmental impact and cost of disposal.
  • The CHPOP can also lead initiatives to reduce waste at the source.
  • This can include working with the P&T committee to prefer drugs that come in more environmentally friendly packaging.
  • Optimizing inventory to reduce expired drug waste is another key strategy.

Energy Efficiency in Pharmacy Operations

  • Pharmacy cleanrooms, with their constant airflow and temperature control, are very energy-intensive.
  • The CHPOP can work with the facilities department to explore opportunities for energy efficiency.
  • This can include using more efficient HVAC systems or implementing setbacks during off-hours if allowed.
  • Upgrading to energy-efficient refrigerators and freezers is another opportunity.
  • Even simple things like turning off lights and computers can make a difference.

Sustainable Procurement & Sourcing

  • The CHPOP can incorporate sustainability criteria into the vendor selection process.
  • This can include asking potential suppliers about their own environmental practices.
  • It can also involve prioritizing the purchase of products with minimal or recyclable packaging.
  • Working with the wholesaler to consolidate deliveries can reduce the carbon footprint of transportation.
  • This extends the principle of sustainability to the entire supply chain.

The Pharmacist's Role in Environmental Stewardship

  • Pharmacists have a key role to play in promoting environmental stewardship.
  • This includes educating patients on the proper disposal of unused medications.
  • Many pharmacies now serve as collection points for drug take-back programs.
  • Pharmacists can also play a role in promoting "green chemistry" and the development of more environmentally friendly pharmaceuticals.
  • The CHPOP can be a leader in raising awareness and promoting these practices within their organization and community.

Safety is the First Priority

  • Every operational decision must be viewed through the lens of patient safety.
  • Efficiency and cost-effectiveness are important, but they can never come at the expense of safety.
  • A successful CHPOP builds a powerful and redundant system of safety checks.
  • They foster a non-punitive, "just culture" where staff feel safe to report errors and near misses.
  • The ultimate measure of an operation's success is its safety record.

The System is the Solution

  • A CHPOP is a systems thinker.
  • They understand that sustainable improvement comes from designing better systems, not from asking people to try harder.
  • This means focusing on standardizing workflows, implementing technology, and building robust quality assurance processes.
  • When an error occurs, the first question should be "How did the system allow this to happen?" not "Who made the mistake?"
  • This systems-based approach is the foundation of modern quality improvement.

Data-Driven Management

  • An effective CHPOP manages by data, not by anecdote.
  • They rely on a dashboard of Key Performance Indicators (KPIs) to monitor the health of their operation.
  • They use data to identify problems, measure the impact of changes, and justify resources.
  • They must be skilled at analyzing and interpreting data from a wide range of information systems.
  • The ability to turn this data into actionable intelligence is a critical skill.

Collaboration is Non-Negotiable

  • The pharmacy does not operate in a silo; it is a highly interdependent part of the hospital.
  • Success is impossible without strong, collaborative relationships with other departments.
  • The most important partnership is with nursing.
  • A CHPOP must also build strong relationships with physicians, IT, finance, and other key stakeholders.
  • This requires excellent communication, interpersonal, and political skills.

Continuous Readiness

  • The hospital environment is highly regulated and subject to unannounced inspections.
  • Therefore, the pharmacy must operate in a state of continuous readiness for a survey from The Joint Commission, the DEA, or the State Board of Pharmacy.
  • This requires having a robust internal auditing program.
  • It also requires a culture where every staff member understands the standards and feels a sense of ownership for compliance.
  • The CHPOP is the leader who builds and maintains this culture of excellence and accountability.
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