Essential Elements of Compounded Sterile Preparations
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.
The Practice-based Activity will provide the pharmacist and technician with the knowledge, skill and measurable competencies necessary to meet the high standard of practice required to compound sterile preparations and the autonomy to make informed decisions as it relates to various performance measures. Comprised of an interactive self-study workbook and a highly dynamic live activity staged in a state-of-the-art regulatory compliant sterile compounding facility, the activity is unique in its design and is complemented by a broad range of training utilities. Pharmacists and technicians will realize how to minimize regulatory, preparatory and clinical-related risk while making up a sterile, appropriately potent and stable compounded preparation thereby reducing the likelihood of untoward or deleterious side effects for patients. The development of competencies in the preparation of low, medium and high risk compounding while working within regulatory compliance guidelines is a central focus to the live event. The participant will conduct all necessary maintenance, control, monitoring and testing procedures to sustain a sterile compounding facility within regulatory compliance guidelines while validating and documenting that process.
The following dates represent activities offered for this activity in the 2014 calendar year:
March 7 – 9
October 3 – 5
Pharmacists and Technicians new to sterile compounding or with an existing compounding practice
A two part activity; self-study with learning assessment and live event with competency assessment
Overall Learning Objectives of Self-Study Activity
- Describe structural and functional primary and secondary engineering controls for an ISO class environment.
- Discuss engineering and architectural design concepts and requirements for an ISO class environment.
- Describe protocols for maintaining, monitoring and testing an ISO class environment.
- Describe a quality assurance management system addressing USP, NIOSH and CETA regulatory guidelines.
- Apply principles of air pressure differentials, airflow dynamics and critical first air to sterile compounding.
- Describe monitoring protocols for non-viable and viable airborne-, surface- and preparation- related particulate.
- Describe protocols for the sanitization and sterilization of ISO class environments.
- Describe a comprehensive series of aseptic techniques related to compounded sterile preparations.
- Discriminate between sterilization by filtration, wet and dry heat sterilization of compounded sterile preparations.
- Incorporate pharmaceutical calculations into preparatory procedures to reduce or eliminate mathematical error.
- Apply methods of prevention and monitoring of secondary side effects related to compounded sterile preparations.
Overall Learning Objectives of Live Activity
- Apply regulatory guidelines, standards of practice and scientific principles to the practice of sterile compounding.
- Perform a series of aseptic techniques in consideration of critical first air, cross and touch contamination.
- Perform gowning, technology transferring, entering and exiting protocols within an ISO class environment.
- Prepare compounded sterile preparations in an ISO class environment and in compliance with USP 797 guidelines.
- Complete all aspects of Master Formulation Records for a series of compounding sterile preparations.
- Conduct environmental- , performance- and preparation- related audits in compliance with USP 797 guidelines.
- Relate regulatory-, preparatory- and clinical- related risk to compounded sterile preparations.
- Perform and design media-fill challenge tests in compliance with USP 797 regulatory guidelines.
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 and 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 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.
The University of Florida College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
The University of Florida College of Pharmacy has allocated 50 hours of continuing education credit (5.0 CEUs) to this practice-based activity; 0012-9950. The activity consists of these four titles: Sterile Elements for Compounded Sterile Preparations, UAN 0012-0000-12-112-H04-P for pharmacists and 0012-0000-12-112-H04-T for pharmacy technicians (6 hours or 0.6 CEU); Aseptic Manipulations and Techniques for Compounded Sterile Preparations, UAN 0012-0000-12-113-H04-P for pharmacists and 0012-0000-12-113-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 0012-0000-12-114-H04-P for pharmacists and 0012-0000-12-114-H04-T for technicians; Essential Elements of Compounded Sterile Preparations-Live Component, UAN 0012-0000-12-115-L04-P for pharmacists and 0012-0000-12-115-L04-T for technicians (20 hours or 2.0 CEUs). The activity accreditation is February 27, 2012; it expires February 27, 2015.