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Essential Elements of Compounded Sterile Preparations

A University of Florida College of Pharmacy accredited Practice-based Activity


Registration and Contact Information:

For more information and to register for this activity

Call 866.333.7811 or visit http://www.medisca.net/cen/cont_curriculum.aspx.


Activity Description

The Practice-based Activity will provide the pharmacist and technician with current theoretical knowledge, practical skill and measurable competencies necessary to meet the high standard of practice required for a sterile compounding practice and the autonomy to make informed decisions as they relate to a broad range of performance measures. The Activity is comprised of an interactive self-study workbook and a highly dynamic live event staged in a sterile compounding facility. Pharmacists and technicians will be afforded the opportunity to prepare compounded sterile preparations in an ISO class 5 environment. Further, pharmacists and technicians will learn how to conduct all necessary maintenance, control, monitoring and testing procedures to sustain a sterile compounding facility and prepare compounded sterile preparations as they ensure high quality, assess elements of risk and learn how to validate all aspects of sterile compounding practice.

The Practice-based Activity features a series of 16 workstations, each one-hour in duration, and includes four (4) compounded sterile preparations, four (4) simulated sterile preparations, a robust Media-Fill Challenge test, Master Formulation Record design, facility workflow design, risk management assessment development, validation protocol development, observational auditing, automated compounding device training, and a hands-on session related to a series of technologies used in environmental monitoring, measuring, preparation testing, sterilization, sanitization, incubation and validation.

 

Activity Offerings

The following dates represent activities offered for this activity in the 2014 calendar year:

Gainesville, FL

March 7 – 9
October 3 – 5

 

Intended Audience

Pharmacists and Technicians new to sterile compounding or with an existing compounding practice.

 

Activity Design

A two part activity; self-study with learning assessment and live event with competency assessment

 

Overall Learning Objectives of Self-Study Activity

(P DENOTES PHARMACIST; T DENOTES TECHNICIAN)

  • Describe structural and functional primary and secondary engineering controls for an ISO class environment. (P/T)
  • Discuss engineering and architectural design concepts and requirements for an ISO class environment. (P/T)
  • Describe protocols for maintaining, monitoring and testing an ISO class environment. (P/T)
  • Describe a quality assurance management system addressing USP, NIOSH and CETA regulatory guidelines. (P/T)
  • Apply principles of air pressure differentials, airflow dynamics and critical first air to sterile compounding. (P/T)
  • Describe monitoring protocols for non-viable and viable airborne-, surface- and preparation-related particulates. (P/T)
  • Describe protocols for the sanitization and sterilization of ISO class environments. (P/T)
  • Describe a comprehensive series of aseptic techniques related to compounded sterile preparations. (P/T)
  • Discriminate between sterilization by filtration, wet and dry heat sterilization of compounded sterile preparations. (P/T)
  • Incorporate pharmaceutical calculations into preparatory procedures to reduce or eliminate mathematical error. (P/T)
  • Apply methods of prevention and monitoring of secondary

 

Overall Learning Objectives of Live Activity

(P DENOTES PHARMACIST; T DENOTES TECHNICIAN)

  • Apply standards of practice and scientific principles to the practice of sterile compounding. (P/T)
  • Perform a series of aseptic techniques in consideration of critical first air, cross and touch contamination. (P/T)
  • Perform gowning, technology transferring, entering and exiting protocols within an ISO class environment. (P/T)
  • Prepare compounded sterile preparations in an ISO class environment and in compliance with USP and related standards of practice. (P/T)
  • Complete all aspects of Master Formulation Records for a series of compounding sterile preparations; four routes of delivery and four uniquely different delivery systems. (P/T)
  • Conduct environmental- , performance- and preparation- related audits in compliance with USP and related standards of practice. (P/T)
  • Relate regulatory-, preparatory- and clinical- related risk to compounded sterile preparations. (P/T)
  • Perform a robust Media-Fill Challenge test in compliance with USP and related standards of practice. (P/T)
  • Establish an effective workflow design scheme for a sterile compounding facility. (P/T)
  • Develop a risk management-related tool to use in a sterile compounding practice. (P/T)
  • Apply validation processes as they relate to sterile compounding; efficacy, reliability and validity. (P/T)
  • Operate Automated Compounding Devices used in a sterile compounding practice. (P/T)
  • Implement, maintain, operate and validate testing- and monitoring- related technologies used in a sterile compounding practice. (P/T)

Activity Facilitators

Due to the number of highly qualified facilitators involved with this activity, their names, credentials and biographies will be made available upon request.

 

Participant Completion Requirements

Activity participants are required to achieve a 70% passing grade associated with a self-study learning assessment prior to attending the live event. Full attendance and the completion of an activity evaluation and practical skill set competency evaluation are a compulsory requirement to achieve credit for the live event.

 

Declarations and Disclosures

The University of Florida College of Pharmacy believes it is important for the reader to be aware of relevant affiliations and financial relationships regarding the development, design and facilitation of this activity and its financial supporter and the financial supporter’s affiliates.

This activity has been approved by, and is hosted by, the University of Florida College of Pharmacy and is independent of any known bias, prejudice or commercial interest. The University of Florida College of Pharmacy has requested that MEDISCA NETWORK Inc. assist with the marketing of this activity. MEDISCA NETWORK Inc. is an independent corporation. MEDISCA NETWORK Inc. has an established agreement with MEDISCA Inc. ensuring that it has no influence on MEDISCA NETWORK Inc. as it relates to activity offerings.

 

Accreditation

This activity is accredited by the University of Florida College of Pharmacy in accordance with ACPE Standards for Quality and Interpretive Guidelines. The University of Florida College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as providers of continuing pharmacy education. The University of Florida College of Pharmacy has allocated 50 hours of continuing education credit (5.0 CEUs) to this Practicebased activity; 0012-9950. The activity consists of these four titles: Sterile Elements for Compounded Sterile Preparations, UAN 0012-9999-12-112-H04-P for pharmacists and 0012-9999-12-112-H04-T for pharmacy technicians (6 hours or 0.6 CEU); Aseptic Manipulations and Techniques for Compounded Sterile Preparations, UAN 0012-9999-12-113-H04-P for pharmacists and 0012-9999-12-113-H04-T for technicians (6 hours or 0.6 CEU); Essential Elements of Compounded Sterile Preparations-Home Component (18 hours or 1.8 CEUs), UAN 0012-9999-12-114-H04-P for  pharmacists and 0012-9999-12-114-H04-T for technicians; Essential Elements of Compounded Sterile Preparations-Live Component, UAN 0012-9999-13-388-L04-P for pharmacists and   0012-9999-13-388-L04-T for technicians (20 hours or 2.0 CEUs). The activity accreditation for the self-study component is February 27, 2012; it expires February 27, 2015. The activity accreditation for the live event components is February 1, 2014; they expire February 1, 2017.

 

Financial Support

An unrestricted educational grant has been provided by MEDISCA Inc. toward the purchase of electromechanical equipment, reusable and disposable devices, protective and safety supplies, and chemicals specific to compounded medications prepared during laboratory sessions.

 

Food and Beverage

As a matter of activity programming, meals and refreshments during live activities have been provided by MEDISCA NETWORK Inc.

 

Cancellation and Refund Policy

A written request must be sent to MEDISCA NETWORK Inc. requesting a ‘Cancellation without Transfer’ to an alternate live activity event date. If cancellation occurs at greater than or equal to 31 days from the live activity event date, then the registrant will receive a 75% refund; 15-30 days is a 50% refund; and less than or equal to 14 days will result in no refund.

 

Transfer Policy

The transfer policy is only in effect if requested greater than or equal to 14 days prior to original live activity event date. Failure to submit the “Transfer Request” at least 14 days prior to original live activity event date will default to the “Cancellation and Refund Policy”. The transfer policy can only be applied one (1) time. Transfer to a new live activity event date must be within the current calendar year. Failure to attend the new live activity event will result in no refund and will no longer be transferable. Confirmation of the new activity date is subject to approval by MEDISCA NETWORK Inc. based on the number of available seats within the selected live activity event.

 

Hotel Accommodations

Special rates for hotel accommodations have been arranged for activity participants. Payment for hotel accommodations is at the expense of the activity participant.

 


ACPE LogoThe University of Florida College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.