Intensive Studies for Recertification: Compounded Sterile Preparations Pharmacy (Cert # L219164)

ACPE Numbers: Various – see listing below
Pre-Sale Date: 07/28/2021
Content Release Date: 08/25/2021
Expiration Date: 08/23/2022
Activity Type: Application-based
CE Credits: 6.0 contact hours (BPS and ACPE)
Activity Fee: $100 (ASHP member); $150 (non-member) 

Accreditation for Pharmacists

 ASHP is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Target Audience

These recertification activities are intended for board-certified pharmacists seeking to update their knowledge and skills in:

  • Compounded Sterile Preparations
  • Managing Cell and Viral Vector Therapies
  • Facility Planning

Activity Overview

The Intensive Study Package is intended for board certified pharmacists in need of recertification credit and is designed based on the content outline developed by the Board of Pharmacy Specialties (BPS). Using a case-based approach, the activities provide high-level, interactive discussions on contemporary and emerging issues in compounding sterile preparations. 

These activities are part of the ASHP professional development program for BCSCP recertification approved by BPS.

Recertification Credit*

Board certified pharmacists are eligible to receive up to 6.0 hours of recertification credit for completing this package. To earn recertification credit, learners must review the activity content and successfully complete the online assessments by the deadline. Only completed assessments will be eligible for credit; no partial or incomplete assessments will be processed. You are allowed only one attempt to successfully complete this assessment.

 

Learning Module

ACPE Number

Credit Hours

*Assessment Pass Point

Complex Compounded Sterile Preparations: Just Because I Can, Does It Mean I Should?

0204-0000-21-630-H07-P

1.75

72%

It's Alive! Managing Cell and Viral Vector Therapies in the Pharmacy

0204-0000-20-321-H04-P

1.25

 

Group 1 Assessment

3.00

 

Sterilization of Compounded Sterile Preparations: Attention to Detail Matters

0204-0000-21-631-H07-P

1.50

72%

Pharmacy Facility Planning Practical Approaches to Building Your New Pharmacy

0204-0000-21-632-H07-P

1.50

 

Group 2 Assessment

3.00

 

Learning Objectives

Complex Compounded Sterile Preparations: Just Because I Can, Does It Mean I Should?
0204-0000-21-630-H07-P

  • Describe the current regulatory landscape for compounding complex or non-sterile to sterile compounded sterile preparations (CSPs).
  • Identify challenges and opportunities associated with preparing complex CSPs (e.g., ophthalmic, intrathecal, and epidural CSPs).
  • Analyze common misconceptions associated with preparing non-sterile to sterile CSPs.
  • Analyze scenarios to determine whether or not an organization should prepare a CSP internally. 

It's Alive! Managing Cell and Viral Vector Therapies in the Pharmacy
0204-0000-20-321-H04-P

  • Recommend processes for safe handling of cell and gene based therapies.
  • Design facilities for storage and preparation of gene and cell therapies that meet applicable standards.
  • Evaluate facility and personnel preparedness for areas of potential occupational hazard when handling cells and live viruses.
  • Based on usage trends for current cell and gene therapies, develop strategies to mitigate operational impact when new therapies become available. 

Sterilization of Compounded Sterile Preparations: Attention to Detail Matters
0204-0000-21-631-H07-P

  • Develop a plan for sterilization of non-sterile to sterile compounded sterile preparations (CSPs) based on applicable USP chapters.
  • Analyze sterilization methods and sterility testing outcomes for extending beyond use dates (BUDs).
  • Determine the feasibility of insourcing terminal sterilization and sterility testing. 

Pharmacy Facility Planning Practical Approaches to Building Your New Pharmacy
0204-0000-21-632-H07-P

  • Summarize best practices in designing an inpatient pharmacy to promote efficient and safe workflows
  • Match the appropriate type and setup of both primary and secondary engineering controls with specific sterile and nonsterile compounding processes
  • Evaluate cleanroom design elements for conditions that may compromise compounded sterile preparations 

Faculty

Full faculty bios 

Matthew Brown, Pharm.D., DPLA, MLS(ASCP)
Pharmacy Manager
Duke Compounding Facility
Chapel Hill, North Carolina 

Johathan Hamer, Pharm.D., M.B.A., BCPS, BCSCP
Chief Operating Officer, The PharmAssist, LLS
Director of Pharmacy Services, AIS Healthcare
Dallas, Texas 

Kevin Hansen, Pharm.D., M.S., BCPS, BCSCP
Assistant Director, Pharmacy
Moses H. Cone Memorial Hospital
Greensboro, North Carolina 

Ben Lopez, Pharm.D., MHA, BCPS
Director, Pharmacy Operations
The Ohio State University Wexner Medical Center
Columbus, Ohio 

Jim Lund, Pharm.D., M.S., BCSCP
Director of Pharmacy Operations
Massachusetts General Hospital
Boston, Massachusetts 

Ryan Naseman, Pharm.D., BCPS, BCSCP
Senior Director of Acute Care Pharmacy Services
University of Kentucky Healthcare
Lexington, Kentucky 

Lois Parker, BS, R.Ph., FASHP
Clinical Pharmacist
Massachusetts Eye and Ear
Boston, Massachusetts 

Michael Storey, Pharm.D., M.S., BCPS
Medication Use Strategist
Nationwide Children's Hospital
Columbus, Ohio 

Field Testers

Paul Baker, Pharm.D., BCSCP
Rodney Baty, R.Ph.., BCSCP
Dom Bracero, M.B.A., R.Ph., CPh, BCSCP
David Braverman, Pharm.D.,BCSCP
Tara Breuer, R.Ph., BCPS, BCSCP
Kimberly Bruha, Pharm.D., BCPS, BCSCP
Joe Cabaleiro, B.S.Pharm., BCPS
Mikala Conatser, Pharm.D., BCPS, BCSCP
Lacy Crawford, Pharm.D. BCPS BCNSP BCSCP
Martin Farrell, Pharm.D., BCSCP
Anne Ficalora, Pharm.D., BCSCP
Timothy Fine, Pharm.D. BCSCP
Michael Freudiger, Pharm.D., BCPS, BCSCP
Joseph Haynes, R.Ph., M.B.A., BCSCP
Heather Hertema, Pharm.D., BCPS, BCSCP
Jon  Hicks, Pharm.D., BCSCP
Keziah Hubler, R.Ph., MPharm, BCSCP
Kathleen Kane, Pharm.D., BCSCP
Amanda Lang, Pharm.D.,BCPS, BCSCP
Kenneth Lazenby, Pharm.D., BCPS, BCSCP
John Leonard, Pharm.D., BCSCP
Conner Mansfield, Pharm.D.
Jaime Martens, Pharm.D., BCSCP
Ryan Martinez, Pharm.D., BCSCP
Nkiru Mbionwu, Pharm D, BCSCP
Mary McGarry, Pharm.D.
Helen  McKnight, Pharm.D., M.B.A., BCSCP
Kathleen McTernan, Pharm.D., BCSCP, CNSC
Lisa Ohnstad, Pharm.D., M.B.A., BCSCP
Jagwant Rai, BPharm, BCSCP
Rochelle Rogers, Pharm.D..,BCSCP
Stacie Tomkins, Pharm.D., BCSCP
Shunsuke Toyoda, Pharm.D., BCPS, BCSCP, BSNSP, CPHQ
Jennie Ung, Pharm.D BCSCP APh
Maegan Wang, Pharm.D. BCSCP
Philip Wong, Pharm.D., BCSCP
Stacy  Wong, Pharm.D, MSHS, BCSCP
Suha Zein, R.Ph., BCSCP 

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 of his or 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. 

All faculty and planners for ASHP education activities are qualified and selected by ASHP and required to disclose any relevant financial relationships with commercial interests. ASHP identifies and resolves conflicts of interest prior to an individual’s participation in development of content for an educational activity. Anyone who refuses to disclose relevant financial relationships must be disqualified from any involvement with a continuing pharmacy education activity. 

Michael Storey

  • AveXis and Sarepta Therapeutics: advisory board. 

Jonathan A. Hamer

  • AIS HealthCare: director of pharmacy services
  • The PharmAssist, LLS, chief operating officer 

All other persons in control of content do not have any relevant financial relationships with an ineligible company.

As defined by the Standards of Integrity and Independence definition of ineligible company. All relevant financial relationships have been mitigated prior to the CPE activity. 

Methods and CE Requirements

Activities consist of audio/video/PDF files, an attestation statement, and activity evaluation. Learners must review all content and complete the attestation statement and course evaluation 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. 

System Technical Requirements

Learning activities are delivered via your Web browser and Acrobat PDF. For all activities, you should have a basic comfort level using a computer and navigating web sites. 

View the minimum technical and system requirements for learning activities. 

Development

These activities were developed by ASHP.