This product is an ASHP Learning Center https://elearning.ashp.org/ activity.
Accreditation
The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education with Commendation.
Target Audience
This certificate is intended for pharmacists and pharmacy technicians seeking to expand their knowledge about the medication supply chain and build the skills needed to effectively manage all aspects of pharmacy inventory.
Overview
The curriculum of the Pharmacy Supply Chain & Inventory Management Certificate is intended to be a comprehensive resource for pharmacists and pharmacy technicians currently involved in these functions, or who are preparing for a role in managing medication supply chain processes. The topics addressed in this certificate range from fundamental to advanced and include the following:
- Role of regulatory, accreditation, and standard-setting organizations in the pharmacy supply chain
- Drug Supply Chain Security Act (DSCSA) and other major legislation regulating the drug supply chain
- Basics of the FDA drug approval process and drug manufacturing
- Principles of formulary management and relationship to pharmacy supply chain activities
- Key pharmacy supply chain partners internal and external to health systems including, but not limited to, group purchasing organizations and drug wholesalers
- Pharmacy classes of trade
- Fundamentals of procurement, receiving processes, storage, and inventory optimization
- Controlled substance purchasing; receipt; security; storage; returns, waste, and disposal/destruction; inventories; and best practices for preventing and identifying potential diversion
- Financial management of medication inventory and cost control strategies
- Pharmacy supply chain contracts – types, components, workflow, and considerations
- Vendor management
- Supply chain synergies
- Impact of 340B on inventory management procedures
- Preparing for, and responding to, drug shortages and supply chain crises
- Logistics, distribution, and cold chain management
- Selecting an outsourcing pharmacy
- Use of information technology, data sources, and analytics to support pharmacy supply chain management
- Centralized and consolidated pharmacy service centers
Pharmacy Supply Chain and Inventory Management Certificate Requirement
Once a learner has completed the educational curriculum, they will have the opportunity to complete an online comprehensive exam. Once the learner completes the exam (minimum 80% passing rate; unlimited attempts permitted), they will earn the professional certificate.
Educational Activities
Introduction to the Pharmacy Supply Chain and Inventory Management
ACPE: 0204-0000-26-717-H04-P&T
Application-based
0.75 contact hours
Learning Objectives:
- Compare the historical perspective versus the current state of the pharmacy supply chain.
- Apply knowledge of the pharmacy supply chain organizational structure to effectively coordinate, manage, and optimize pharmacy supply chain operations.
- Identify partners and stakeholders in the pharmacy supply chain and their roles and responsibilities.
Fundamentals of the FDA Approval Process and Drug Manufacturing
ACPE: 0204-0000-26-718-H03-P&T
Application-based
2 contact hours
Learning Objectives:
- Describe the Food and Drug Administration's (FDA) New Drug Application (NDA) 505(b)(1) and 505(b)(2) approval pathways.
- Explain how the pharmacy supply chain intersects with the formulary process for drugs approved via the available pathways, and how drugs recently approved by the FDA are integrated into the pharmacy supply chain.
- Describe the FDA’s Abbreviated New Drug Application (ANDA) approval pathway for generic drugs.
- Describe the FDA's Emergency Use Authorization process.
- Describe the FDA's biologic and biosimilar approval pathways.
- Compare the FDA's approval pathways.
- Explain the creation, formatting, and interpretation of National Drug Codes (NDCs) and their impact on pharmacy technology.
- Explain the key stages as an active pharmaceutical ingredient (API) progresses through the drug manufacturing process.
Regulatory Compliance for Pharmacy Supply Chain Specialists
ACPE: 0204-0000-26-719-H03-P&T
Application-based
2.25 contact hours
Learning Objectives:
- Describe the roles of agencies and organizations that regulate and impact the pharmacy supply chain.
- Explain important legislation and regulations relevant to the pharmacy supply chain.
- Explain compliant practices for purchasing, record keeping, storage and security, and inventorying of controlled substances (CS).
- Discuss the prevention and identification of, and response to, potential and confirmed incidents of CS diversion.
- Describe CS audits including organizations that may survey a healthcare facility's CS processes, as well as strategies for preparing for audits.
- Explain the purpose and requirements of the Drug Supply Chain Security Act (DSCSA).
- Describe the 340B drug pricing program intent and history, eligibility requirements for covered entities and patients, program oversight, compliance, and its effects on drug pricing.
- Explain the impacts of the 340B drug pricing program as they relate to pharmacy procurement and inventory management.
- Explain the role of third-party administrators in covered entities' (CEs) management of their participation in the 340B Drug Pricing Program, and the relationship between 340B CEs and contract pharmacies, including advantages and responsibilities.
Pharmacy Supply Chain Vendor Management and Key External Business Partners
ACPE: 0204-0000-26-720-H04-P&T
Application-based
1.75 contact hours
Learning Objectives:
- Explain vendor management processes and best practices including onboarding, Office of Inspector General (OIG) exclusion reviews, business reviews, and visitation policies.
- Summarize the role of drug wholesalers in the pharmacy supply chain.
- Explain common services provided by drug wholesalers.
- Compare specialty drug distribution versus non-specialty drug distribution.
- Explain how group purchasing organizations provide value to an organization.
- Contrast different types of contracts used by group purchasing organizations.
- Describe common services provided by group purchasing organizations.
- Summarize the characteristics of 503A and 503B pharmacies.
- Describe Current Good Manufacturing Practices (cGMP).
- Identify important considerations for selecting an outsourcing pharmacy.
- Describe the types of data that are generated and available from drug wholesalers, group purchasing organizations, and enterprise resource planning systems; and how the analysis of integrated, multisource data informs pharmacy procurement decision-making and improves performance.
Relationship Between the Pharmacy Supply Chain and Formulary Management
ACPE: 0204-0000-26-721-H04-P&T
Application-based
1.25 contact hours
Learning Objectives:
- Describe common pharmacy and therapeutics committee structures in hospitals and health systems.
- Explain formulary management principles as they relate to the pharmacy supply chain.
- Summarize processes for implementation of approved formulary information.
- Explain therapeutic equivalence and drug substitution.
- Summarize the process for pharmacy supply chain review and implementation of therapeutically equivalent and/or substituted products.
- Explain pharmacy supply chain processes for managing medications with risk evaluation and mitigation strategies (REMS).
- Summarize pharmacoeconomic principles as they relate to formulary decision-making and the pharmacy supply chain.
- Explain the impact of synchronization of formulary and inventory data with technologies used in the medication use system on medication safety, operational efficiency, and regulatory compliance.
- Recommend processes and best practices for, and governance of, initial builds of formulary and inventory information in medication use technology databases, as well as maintenance of these databases.
Pharmacy Supply Chain Contracts
ACPE: 0204-0000-26-722-H04-P&T
Application-based
1 contact hours
Learning Objectives:
- Describe the most common types of pharmacy supply chain contracts, the differences between group purchasing organization (GPO) contracts and contracting directly with manufacturers, and documents such as letters of participation and letters of agreement.
- Explain the key components of pharmacy supply chain contracts.
- Explain the key steps in the pharmacy supply chain contracting workflow.
- Describe standard contract templates and bundled agreements, and their advantages.
- Explain the considerations for evaluating and awarding pharmacy supply chain contracts.
Drug Procurement & Inventory Practices: Optimizing Efficiency and Financial Management
ACPE: 0204-0000-26-723-H04-P&T
Application-based
1.25 contact hours
Learning Objectives:
- Apply Lean principles to pharmacy procurement and inventory management.
- Describe considerations for drug expense budgeting and strategies for decreasing drug expenditures.
- Explain methods for billing and reimbursement of drugs dispensed and administered in various care settings.
- Discuss the financial implications and opportunities associated with annual drug inventory.
- Recommend technologies and innovative practices including automation, data analytics, and artificial intelligence that can optimize medication availability and distribution, as well as efficiency, transparency, and resilience in the pharmacy supply chain.
Drug Procurement and Receiving
ACPE: 0204-0000-26-724-H04-P&T
Application-based
1.25 contact hours
Learning Objectives:
- Recommend strategies for efficient, cost-effective, and compliant procurement of drug products.
- Explain pharmacy classes of trade and their influence on contracting, formulary decisions, and pharmacy supply chain management.
- Explain the procurement processes for medications with special purchasing requirements including limited distribution, investigational, and imported drugs.
- Explain the regulatory and operational considerations for receiving medications.
- Design a safe and compliant process for receiving medications.
- Explain requirements for cold storage and distribution of drug products, including relevant United States Pharmacopeia (USP) standards, and actions to take in response to a cold chain excursion.
Inventory Management
ACPE: 0204-0000-26-725-H04-P&T
Application-based
1.75 contact hours
Learning Objectives:
- Describe the advantages and disadvantages of pharmacy inventory management methods.
- Calculate inventory turns.
- Evaluate procurement and drug utilization data to determine inventory requirements for patient care including identifying patterns to forecast cyclical needs, minimizing drug waste, and mitigating supply disruptions.
- Explain inventory methods and best practices.
- Explain the following approaches to inventory analysis and management: ABC, just-in-time (JIT); and vital, essential, and desirable.
- Describe strategies for optimizing inventory.
- Differentiate among medication storage temperature range requirements.
- Develop a storage assessment plan that incorporates contingency measures for equipment failures, power outages, and other disruptions.
- Analyze key data sources used to track expired medications to reduce medication waste.
- Explain the reverse distribution of drug products including relevant federal and state regulations, and strategies for decreasing expired medications and optimizing return value.
Pharmacy Supply Chain Crisis Response and Contingency Planning
ACPE: 0204-0000-26-726-H04-P&T
Application-based
1.5 contact hours
Learning Objectives:
- Analyze potential risks and vulnerabilities in the pharmacy supply chain to determine points of failure during a crisis.
- Develop contingency strategies and response plans that ensure continuity of medication supply and patient care during disruptions.
- Evaluate the effectiveness of crisis management and recovery strategies through scenario-based simulations and mock drills.
- Describe challenges that drug shortages pose to health systems, including root causes and impacts on health outcomes.
- Recommend strategies for managing drug shortages in hospitals and health systems.
Centralized and Consolidated Pharmacy Service Centers
ACPE: 0204-0000-26-727-H04-P&T
Application-based
1.5 contact hours
Learning Objectives:
- Summarize current trends incentivizing health systems to adopt centralized and consolidated pharmacy service centers (CSCs) and the benefits to health systems realized by CSC implementation.
- Describe the characteristics of an enterprise-wide pharmacy practice structure.
- Explain the services provided by pharmacy CSCs and the advantages of having these functions integrated and consolidated at the enterprise level.
- Explain the regulatory and accreditation requirements for pharmacy CSCs.
- Identify pharmacy CSC opportunities to transform pharmacy services by improving operational efficiency, enhancing financial performance, and supporting high-quality, system-wide patient care.
- Describe the process for planning a CSC including, but not limited to, constructing a governance structure for the project, prioritizing services for implementation, and creating a structure for governing enterprise-wide pharmacy practice.
Faculty Information
Michael Ganio, PharmD, MS, BCPS, BCSCP, FASHP
Senior Director, Pharmacy Practice and Quality
American Society of Health-System Pharmacists
Bethesda, Maryland
Rox Gatia, PharmD, MHSA, BCPS
Vice President, Pharmacy Services
Henry Ford Health
Adjunct Associate Professor
Wayne State University Eugene Applebaum College of Pharmacy & Health Sciences
Detroit, Michigan
Adrian Gonzales, PharmD, APh, BCPS
Chief Executive Officer
Atomic Healthcare Solutions
Roseville, California
Adjunct Professor
University of the Pacific Thomas J. Long School of Pharmacy
Stockton, California
Indrani Kar, PharmD, DPLA, FASHP
System Pharmacy Manager, Formulary and Drug Policy
University Hospitals Health System
Cleveland, Ohio
Annette Karageanes, BSPharm, MS
Director of Pharmacy, System Operations
Henry Ford Health
Detroit, Michigan
Brittany Karas, PharmD, BCPS
Program Manager, Medication-Use Policy
Northwestern Medicine
Chicago, Illinois
Kelly Kline, BS, CPhT-Adv
Inpatient Pharmacy Buyer / Purchasing Agent
Atlantic General Hospital
Berlin, Maryland
Chris Loucks, PharmD, MS
Director of Pharmacy Shared Services
The University of Kansas Health System
Kansas City, Kansas
Matthew McGuire, PharmD, MS, BCPS
Manager, Pharmacy Business Operations
University Hospitals Health System
Cleveland, Ohio
Richard Montgomery, BSPharm, MBA
Director, Pharmacy Contracting and Sourcing
AdventHealth
Orlando, Florida
Chris Odenwelder, PharmD, MBA-HA
Founder and CEO
The Odenwelder Group
Steamboat Springs, Colorado
Josie Quick, CPhT-Adv, CSPT, B.U.S.
Clinical Applications Support Analyst
Sanford Health
Fargo, North Dakota
Samantha Roberts, PharmD, MBA, CPHQ, DPLA, FACHE
Relevant Financial Relationship Disclosure
In accordance with our accreditor’s Standards of Integrity and Independence in Accredited Continuing Education, ASHP requires that all individuals in control of content disclose all financial relationships with ineligible companies. An individual has a relevant financial relationship if they have had a financial relationship with an ineligible company in any dollar amount in the past 24 months and the educational content that the individual controls is related to the business lines or products of the ineligible company.
An ineligible company is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. The presence or absence of relevant financial relationships will be disclosed to the activity audience.
- No one in control of the content of this activity has a relevant financial relationship (RFR) with an ineligible company.
As defined by the Standards of Integrity and Independence in Accredited Continuing Education definition of ineligible company.
Methods and CE Requirements
Each activity consists of audio, video, and/or PDFs and evaluations. Learners must review all content and complete the evaluations to receive continuing pharmacy education credit for each activity.
Follow the prompts to claim, view, or print the statement of credit within 60 days after completing the activity.
Important Note – ACPE 60 Day Deadline:
Per ACPE requirements, CPE credit must be claimed within 60 days of being earned. To verify that you have completed the required steps and to ensure your credits have been reported to CPE Monitor, check your NABP eProfile account to validate that your credits were transferred successfully before the ACPE 60-day deadline. After the 60-day deadline, ASHP will no longer be able to award credit for this activity.
The ASHP Professional CertificatesSM educational product line contains learning activities that are ACPE-accredited knowledge and application-based continuing education. This is not an ACPE Certificate Program. Upon successful completion of the activities, the learner will be able to download an ASHP Professional Certificate.
System Technical Requirements
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