Advanced Sterile Product Preparation Training and Certificate Program ACPE Activity Number(s): 0204-0000-16-725-H04-P & T thru to 0204-0000-16-733-H04-P & T Release Date: November 7, 2016 Expiration Date: November 7, 2019 -based CE Credit Hour(s) (no partial credit): 23.0 hours Accreditation for Pharmacists and Pharmacy Technicians The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Target Audience This program is intended for pharmacists, pharmacy technicians, or other pharmacy personnel who have responsibility for managing and developing competent cleanroom personnel and/or compliant compounding facilities. Activity Overview These modules are designed for participants who have mastered and are proficient in the fundamental skills required for safe and compliant sterile product preparation in a cleanroom environment and are now responsible for managing personnel and facilities associated with these compounding activities. Participants will recognize the many considerations required when developing competent personnel and designing appropriate environments and facilities for compliant sterile product preparation. After completing all of the modules, participants should be proficient in both basic compounding techniques and advanced concepts required for managing safe and compliant sterile product preparation in a cleanroom environment. Learning Objectives and Schedule of Activities 0204-0000-16-725-H04-P 0204-0000-16-725-H04-T CE Hours: 2.0 Title: Beyond the Basics: The Role Management Plays in Ensuring Safe and Compliant Sterile Product Preparation This activity explains the key concepts managers must consider to effectively develop competent personnel and compliant facilities for sterile product preparation. Identify the critical USP chapter 797 elements managers must know in order to manage cleanroom facilities and personnel. Explain the basic personnel competencies required to ensure safe and compliant sterile product preparation. Recognize the key role pharmacy leaders have in creating a culture supporting safe and compliant compounded sterile product preparation. Describe how to implement a continuous learning plan for all staff engaged in sterile product preparation. Page 1
0204-0000-16-726-H04-P 0204-0000-16-726-H04-T CE Hours: 1.75 0204-0000-16-727-H04-P 0204-0000-16-727-H04-T CE Hours: 4.0 0204-0000-16-728-H04-P 0204-0000-16-728-H04-T CE Hours: 2.5 Title: Creating and Maintaining the Right Environment This activity describes the appropriate environment for sterile product preparation and the processes required to maintain it. Restate the environmental requirements for sterile compounding. Explain how environmental conditions are measured and maintained. Discuss how to respond to environmental samples that are out of range. Define and determine how to properly perform surface sampling. Describe the process for how to properly perform volumetric air sampling. Discuss how to build environmental control / monitoring skills into the compounded sterile preparation training program. Title: Facilities and Equipment This activity covers the requirements and maintenance for cleanroom facilities and equipment. Describe primary and secondary engineering controls used in compounding facilities. Identify sterile compounding facility requirements. Discuss essential cleanroom design considerations and compare advantages and disadvantages of available finish materials. Explain selection criteria and appropriate placement of ancillary equipment such as refrigerators, computers, and printers. Recognize automated devices used in compounding sterile products. Describe equipment and cleanroom certification and maintenance requirements. Explain how to develop a plan to accommodate cleanroom or equipment downtime and upgrades. Identify considerations for designing a facility cleaning plan. Title: Developing Personnel for Success in the Cleanroom This activity explains the essential role appropriately trained personnel play in ensuring safe and compliant sterile product preparation. Discuss differences between ISO environments. Describe the purpose of the HEPA Filter Leak Test and Smoke Pattern Testing. Explain the concept of first air and associated hand placement in horizontal and vertical flow hoods. Discuss the differences between appropriate garbing requirements for non-hazardous and hazardous drug preparation. Describe personnel testing and associated outcomes. Explain the processes for low, medium (category 1), and high-risk (category 2) media fill testing. Discuss techniques used for teaching adult learners. Explain how to create an action plan for sub-optimal performance. Identify staff scheduling plan considerations. Page 2
0204-0000-16-729-H04-P 0204-0000-16-729-H04-T CE Hours: 2.75 0204-0000-16-730-H03-P 0204-0000-16-730-H03-T CE Hours: 2.5 Title: Managing the Product from the Beginning to the End This activity describes important considerations associated with effectively managing materials flow from receiving through to the finished product. Describe the materials flow process from receiving to finished product. Explain standards for selection of ingredients and other products used in sterile compounding. List cold-chain requirements for refrigerated products. Discuss material handling requirements for items going into a cleanroom. Recognize storage requirements for all drugs and materials used in sterile compounding. Describe packaging and transport requirements for finished compounded sterile products. Identify considerations in beyond use date (BUD) assignment. Discuss strategies for managing expired and unusable compounded sterile preparations. Title: Legal, Regulatory, and Quality Control This activity covers the regulatory and quality control guidance required to ensure safe and compliant sterile product preparation. Describe the scope and implementation of the Drug Quality and Safety Act (DQSA) with respect to compounding quality. Discuss the guidances issued by the FDA for 503A operations. Explain how section 503B in the Food, Drug, and Cosmetic Act allows for outsourcing facilities. Recognize the guidance documents issued for 503B facilities. Describe the requirements for dispensers under the Drug Supply Chain Security Act. List resources that provide current information on state pharmacy laws, regulations, and accreditation standards. Identify the basic quality control differences between USP chapter 797 and current Good Manufacturing Practices (cgmp). Describe an effective quality assurance / quality control program based on risk assessment. Discuss the criteria and tests employed to evaluate and certify performance of facility and environmental controls used for compounding sterile preparations. Page 3
0204-0000-16-731-H04-P 0204-0000-16-731-H04-T CE Hours: 3.5 0204-0000-16-732-H04-P 0204-0000-16-732-H04-T CE Hours: 1.0 Title: Hazardous Drugs 101 This activity discusses the appropriate guidelines and procedures required to handle and manage hazardous drugs in a safe and compliant manner. Restate the goals of USP Chapter <800>. Describe the Hazardous Drug Risk Assessment process. List information available on a Safety Data Sheet. Recognize hazardous drug activity and potential opportunities for exposure. List the requirements for hazardous drug receiving, unpacking and storage. Describe appropriate receipt, storage, labeling, packaging, transport, and disposal of hazardous drugs. Explain the gowning and gloving process required for hazardous drug compounding. List and define primary, secondary and supplemental engineering controls. List the steps involved in cleaning a biological safety cabinet (BSC) and compounding aseptic containment isolator (CACI). Discuss the hazardous drug surface wipe sampling process. Describe the hazardous drug spill clean-up process. Discuss OSHA's Hazard Communication Standard. Explain the purpose and elements of the Medical Surveillance Program. Title: Introduction to Nonsterile to Sterile Compounding This activity explains the general requirements and considerations associated with nonsterile to sterile compounding. Explain the requirements under section 503A of the Drug Quality and Safety Act that apply to bulk drug ingredients. Identify the requirements under chapter 797 for nonsterile to sterile compounding. Discuss the facility and environmental requirements for nonsterile to sterile compounding. Restate product release requirements for nonsterile to sterile compounding. List the critical quality attributes for a compounded sterile preparation that must be within limits to guarantee required product quality. Describe the installation and operational validation process for sterilization equipment. Explain chapter 797 guidance on beyond use dating. Recognize the components of quality control. Page 4
0204-0000-16-733-H04-P 0204-0000-16-733-H04-T CE Hours: 3.0 Title: Additional Considerations for the Manager This activity discusses management considerations uniquely associated with preparing compounded sterile products in a safe, efficient, and compliant manner. Describe the key considerations for successful management of sterile compounding operations. Discuss the actions required to appropriately assess current clean room facilities. Explain the key policies and procedures that need to be in place in order to achieve USP chapter 797 and USP chapter 800 compliance. Discuss the value and implications of developing and maintaining a master formulary record. Identify a contingency plan in the event of environmental control downtime or failure. List the key variables and decision points when evaluating outsourcing compounded sterile preparations. Describe the process that must be utilized to evaluate outsourced compounded sterile preparation (CSP) providers. Discuss the implications and challenges of managing CSP operations in a multi-site system. Recognize lean management opportunities in CSP operations. Identify the types of knowledge that c-suite leaders need to have in regard to USP chapter 797 and USP chapter 800. Methods and CE Requirements This online activity consists of a combined total of 9 learning modules. Pharmacists and pharmacy technicians are eligible to receive a total of 23.0 hours of continuing education credit by completing all 9 modules within this certificate program. Participants must participate in the entire activity and complete the evaluation to earn continuing pharmacy education credit. Follow the prompts online at the ASHP elearning portal (http://elearning.ashp.org) to claim credit and view statements of credit within 60 days of completing the activity. Credits will be reported directly to CPE Monitor. Faculty Information Matthew W. Eberts, Pharm.D., M.B.A, FASHP Director of Pharmacy Services Lancaster General Health Lancaster, PA Lisa Ginsberg-Evans, B.S. Pharm Manager, Clean Room and Sterile Products University of Michigan Hospitals and Health System Clinical Instructor University of Michigan College of Pharmacy Ann Arbor, MI Marc Stranz, Pharm.D. Vice President of Compliance Elwyn Pharmacy Group Garnet Valley, PA Page 5
Angela W. Yaniv, B.S.Pharm, Pharm.D. Assistant Director of Pharmacy Cleveland Clinic Cleveland, OH CE Activity Announcement Disclosures In accordance with the Accreditation Council for Continuing Medical Education s Standards for Commercial Support and the Accreditation Council for Pharmacy Education s Standards for Commercial Support, ASHP requires that all individuals involved in the development of activity content disclose their relevant financial relationships. A person has a relevant financial relationship if the individual or his/her spouse/partner has a financial relationship (e.g. employee, consultant, research grant recipient, speakers bureau, or stockholder) in any amount occurring the in the last 12 months with a commercial interest whose products or series may be discussed in the educational activity content over which the individual has control. The existence of these relationships is provided for the information of participants and should not be assumed to have an adverse impact on the content In keeping with this requirement, ASHP asks that all faculty, advisory board members, planning committee members, content development consultants, and staff complete a disclosure form for each program in which they are involved. Anyone who refuses to disclose relevant financial relationships must be disqualified from any involvement with a continuing pharmacy education activity. Faculty, planners, ASHP Staff and consultants report no relevant financial relationships pertinent to this activity. Matthew W. Eberts, Pharm.D., M.B.A., FASHP Lisa Ginsberg-Evans, B.S. Pharm Marc Stranz, Pharm.D. Angela W. Yaniv, B.S.Pharm, Pharm.D. Jill L. Haug, Pharm.D., M.B.A. Alicia M. Ross, B.S. ASHP staff has no relevant financial relationships to disclose. Acknowledgements of Support (if applicable) This activity was planned and developed by The American Society of Health-System Pharmacists. Page 6