Pharmacy Accreditation & Regulatory Compliance Certificate

   
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.

This professional certificate is intended for pharmacists and pharmacy technicians who have an interest in learning more about pharmacy accreditation standards as well as pharmacy regulations and compliance.

Creating a Pharmacy Compliance Model: Accreditation and Compliance Basics
ACPE: 0204-0000-24-764-H04-P&T
CE Hours: 3 contact hours
Activity Type: Application-based

• Identify the federal agency that sets the requirements for hospitals.
• List the accreditation organizations deemed by Medicare to survey hospitals.
• State the pharmaceutical services Hospital Conditions of Participation.
• Recall other sections of the Hospital Conditions of Participation that deal with medications.
• Identify the scope of state board of pharmacy regulations.
• Describe an approach to ensure continuous preparedness.
• Identify federal and related organizations that impact hospital accreditation.
• Differentiate organizations that create and promulgate standards, regulations, and best practices.
• Analyze your organization’s compliance with medication-related CMS Conditions of Participation.
• Rank the compliance of key conditions. 

Medication Use: Systems and Policy
ACPE: 0204-0000-24-765-H04-P&T
CE Hours: 3 contact hours
Activity Type: Application-based

• Identify key elements in the design of safe medication systems.
• Discuss strategies to promote a culture of safety through organizational planning.
• Evaluate the influence of technology on the safety of medication use systems.
• Summarize the role of an institution’s Pharmacy & Therapeutics committee in contributing to safe medication use.
• Apply the principles of drug literature evaluation in the preparation of evidence-based literature reviews.
• Differentiate between policies, procedures, and protocols.
• Evaluate new and existing policies for compliance with regulatory standards.
• Summarize the steps for development and implementation of policy, procedure, and protocol.
• Develop a plan for organizational policy maintenance.
• Summarize the role of pharmacy oversight committees as part of the overall corporate regulatory compliance program in an organization. 

Supply Chain Compliance
ACPE: 0204-0000-24-766-H04-P&T
CE Hours: 3 contact hours
Activity Type: Application-based

• Assess select federal regulatory standards for pharmacy procurement, primarily those related to Drug Enforcement Administration requirements for controlled substances.
• Summarize a brief history of the 340B program, its intended purpose, and basic program requirements for participating covered entities.
• Compare 340B compliant inventory models.
• Interpret key 340B program rules and regulations, primarily those related to group purchasing organization (GPO) prohibition, duplicate discounts, and program diversion.
• Summarize the Drug Supply Chain and Security Act (DSCSA) and its intended purpose.
• Identify basic requirements for health-system pharmacies to ensure compliance with new DSCSA regulations.
• Explain the drug recall classification system as it relates to pharmacy considerations for a recall response.
• Analyze the role regulatory bodies can play in common causes of drug shortages resolution.
• Develop a mitigation strategy to address drug shortages at your institution.
• Describe supply chain compliance oversight considerations for health systems. 

Risk Evaluation and Mitigations Strategy (REMS)
ACPE: 0204-0000-24-767-H04-P&T
CE Hours: 2.75 contact hours
Activity Type: Application-based

• Describe how the FDA REMS program was established.
• Differentiate the types of REMS requirements for patients, providers, and pharmacies / pharmacists.
• Compare retail / community pharmacy and health system management of REMS medications.
• Discuss REMS program infrastructure best practices.
• Explain REMS documentation requirements.
• Apply REMS requirements for audit preparation. 

Diversion Monitoring and Prevention
ACPE: 0204-0000-24-768-H04-P&T
CE Hours: 3.5 contact hours
Activity Type: Application-based

• Define drug diversion.
• Assess the impact drug diversion has on patients, the diverter, and the organization.
• Interpret the DEA CFR as it relates to controlled substances processes.
• Compare the diversion standards from The Joint Commission, Det Norske Veritas, and Centers for Medicare & Medicaid Services.
• Differentiate the key individuals organizations should seek involvement from while building a diversion program.
• Explain the role of the Diversion Response Team.
• Summarize the investigations process.
• Give examples related to internal and external reporting of diversion investigations.
• Identify key internal and external partnerships that can assist in programming/advancement.
• Give example(s) of innovative technology that may assist in diversion investigations.
• Select the tools that may be used during a retail pharmacy diversion investigation. 

Compounding Compliance
ACPE: 0204-0000-24-769-H04-P&T
CE Hours: 4.5 contact hours
Activity Type: Application-based

• Identify the standards of practice that apply to compounding.
• Discuss provisions of the Pharmaceutical Quality, Security and Accountability Act.
• Contrast federal mechanisms that influence sterile compounding practice.
• Differentiate the roles of the Food and Drug Administration and states in sterile compounding regulation.
• Identify other regulations related to workplace safety.
• Describe the rationale of cleanroom design and airflow.
• Discuss the importance of cleanroom behavior to protect compounded sterile preparations.
• Analyze appropriate engineering controls for hazardous drug compounding.
• Identify key elements of personal protective equipment required for hazardous drug compounding.
• Apply standards for documentation to compounding records.
• Define the scope of USP <825>.
• List the personnel training requirements of USP <795>, USP <797>, and USP <800>.
• Choose an appropriate remediation plan after evaluating personnel monitoring data results.
• Explain the rationale of performing environmental monitoring in pharmacy cleanrooms.
• Match microorganisms commonly found in pharmacy cleanrooms to their typical source(s). 

Quality Improvement, Assurance, Tools, and Software
ACPE: 0204-0000-24-770-H04-P&T
CE Hours: 2.75 contact hours
Activity Type: Application-based

• Differentiate between quality improvement and quality assurance.
• Discuss the significance of pharmacy in CMS Quality Assurance and Performance Improvement (QAPI) programs.
• Plan QAPI principles into daily pharmacy practice.
• Explain tools and strategies for comprehensive quality management.
• Develop a continuous quality improvement plan for pharmacy processes using one of the QI tools.
• Analyze compliance for pharmacy regulations and standards.
• Assess scorecards as tools for performance assessment and tracking.
• Create action plans based on scorecard analysis.

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 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 definition of ineligible company. 

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 profile 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 CERTIFICATES℠ 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.