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Essential Elements of Compounded Sterile Preparations

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

Registration and Contact Information:

For more information and to register for this activity

Call 1-844-408-9453 or visit https://education.lp3network.com/live-training/essential-elements-compounded-sterile-preparations 

Activity Offerings

The following dates represent activities offered for this activity in the 2016 calendar year:

May 13th – 15th in Los Angeles, CA
November 4th – 6th in Vancouver, BC
November 18th – 20th in Aventura, FL

 

Activity Description

Home Study

This Knowledge-Based Activity will provide the pharmacist and technician with the necessary comprehension and know-how to meet current standards of practice required for non-hazardous and hazardous drug sterile compounding.

Founded on a unique concept known as System P, participants will learn to appreciate the value of establishing a strong compounding practice infrastructure. System P includes the following divisions; Personnel, Property, Procedure, Process, Preparation, and Patient, as its building blocks. Each component of System P is very much dependent on, and in support of, each other. Personnel are a compounding pharmacy’s most important asset; this section covers personnel roles and responsibilities, competencies, practical testing requirements in the form of health and hygiene, garbing, media-fill challenge testing, fingertip touch testing, aseptic techniques, and hazard communication and medical surveillance programs.

Personnel work in ISO class cleanroom environments and with technology categorized into electromechanical, reusable, disposable, personal protective equipment, safety and emergency equipment, deactivation/decontamination supplies and chemical agents, testing equipment and supplies, and the ingredients used to prepare compounded sterile preparations. The cleanroom and related technology and chemical supplies make up Property.

Procedures are the routine scheduled activities performed in a sterile compounding practice that encompasses the management, maintenance, monitoring, calibration, decontamination and disinfection protocols, and environmental testing requirements that help to ensure chemical safe handling, inventory and storage, technology utilization, waste management, and facility and preparation sterility.

Synonymous with Process Development, Preparations, and Patients are the detailing of the requirements of Process Development worksheets, Master Formulation Records, and Compounding Records. The home study showcases a sample and most comprehensive Master Formulation Record template; a critical and required center piece for any compounding practice that can be utilizes during the process of establishing formulations, well documenting master formulations and completing compounding records upon receipt of a prescription.

Upon concluding this home study, participants will gain a solid foundation and well appreciate the reliance and interdependency between each System P category that is clearly delineated and detailed fulfilling required standards of practice.

Live

This Practice-Based Activity features a series of sixteen workstations. Participants will work in small groups moving from workstation-to-workstation every hour. Live competency assessment reports will be completed by facilitators throughout the duration of this live event providing immediate performance-related feedback to participants.

Prior to the workstation rotations, participants will engage in a live event orientation. This orientation includes a gowning demonstration, followed by a practical orientation that explores a unique quality management system; System P (Personnel, Property, Procedure, Process, Preparation, and Patient). This is followed by a practical skills orientation, i.e., aseptic techniques assessment, assisting facilitators in the grouping of participants in accordance to their respective skill level. Once participants are appropriately assigned to their respective groups, workstation rotations will commence.

Workstations, addressing non-hazardous and hazardous drug compounding, include the preparation of four compounded sterile medications while working in a current USP Chapter <797> compliant clean room environment featuring a garbing room, weighing room, and finishing room, four simulated sterile preparations with a focus on aseptic techniques during the manipulation of a broad range of reusable and disposable technology (includes close system transfer devices for use during hazardous drug compounding), a robust media-fill challenge test, the documentation of a Master Formulation Record template, the creation of a facility design and its related workflow, risk management assessment and process development, verification protocol development, observational auditing, automated compounding device training which features a peristaltic pump, and finally a workstation that features modern technology for today’s compounding pharmacy practice.

At the technology workstation, participants will gain valuable experience with electromechanical equipment, reusable and disposable devices, and testing technologies used for viable surface sampling, non-viable and viable particulate monitoring, preparation sterility and endotoxin testing, wet and dry heat sterilization methods, depyrogenation, disinfection, incubation, and SEC/PEC HEPA filter integrity and airflow dynamics. Positive and negative control technology is also highlighted and incorporates the use of indicators and integrators.

Participants will undergo visual observation and performance assessments throughout the activity as they perfect their aseptic techniques of hand washing, garbing, moving within and between ISO class environments, and technology manipulation which includes end-stage filtration and filter integrity testing. During orientation, cleanroom and simulated sterile preparation workstations, participants will continuously perform disinfection procedures.

Throughout this live event, time allotments have been built into the schedule for participant question and answer periods. The activity concludes with a brief summary and closing remarks presentation.

Intended Audience

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

 

Activity Design

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

 

Overall Learning Objectives of Home Study Activity

Pharmacists

  1. Classify traditional compounding pharmacies and outsourcing facilities in order to understand the parameters of practice for each of these two compounding classifications that fall under the new Drug Quality and Security Act H.R. 3204.
  2. Describe the infrastructure and subdivisions of a quality management system for compounding; System P and its related categories.
  3. Identify the relevance and impact of Unites States Pharmacopeia chapters and their relationship to a non-hazardous and hazardous compounding practice.
  4. Discuss roles and responsibilities, theoretical and practical skills, and performance verification-related testing required for personnel involved in non-hazardous and hazardous compounding.
  5. Discuss engineering and architectural design concepts and requirements for the safe handling and management of non-hazardous and hazardous drugs.
  6. Describe structural, functional, and operational primary and secondary engineering control requirements for the safe handling and management of non-hazardous and hazardous drugs.
  7. Relate principles of air pressure differentials, airflow dynamics, and critical first air to sterile compounding.
  8. Express the relevance of technology used in non-hazardous and hazardous drug compounding; electromechanical, reusable, disposable, personal protective equipment, safety, emergency, testing, and deactivation/decontamination and disinfection equipment and supplies.
  9. Recall procedures involved in the safe handling, maintenance, monitoring, testing and verification of a sterile compounding environment.
  10. Describe protocols for the deactivation/decontamination and disinfection of ISO class environments for non-hazardous and hazardous drug compounding.
  11. Outline the relative significance of Process Development as it applies to the development of a Master Formulation Record.
  12. Relate the functions of excipients to compounded sterile preparations.
  13. Discuss clinical considerations that must be applied to sterile compounding to help to ensure patient safety in a patient-centric practice.
  14. Discuss the components of a Master Formulation Record used for compounded sterile preparations.
  15. Recall pharmaceutical calculations used in a sterile compounding practice.
  16. Repeat a comprehensive series of aseptic techniques related to the compounding of sterile preparations.

Pharmacy Technicians

  1. Identify the differences between traditional compounding pharmacies and outsourcing facilities under the new Drug Quality and Security Act H.R. 3204.
  2. Describe the infrastructure and subdivisions of a quality management system for compounding; System P and its related categories.
  3. List Unites States Pharmacopeia chapters and their relationship to a non-hazardous and hazardous compounding practice.
  4. List roles and responsibilities, theoretical and practical skills, and performance verification-related testing required in maintaining an appropriate level of competency when performing non-hazardous and hazardous compounding.
  5. Recognize engineering and architectural design concepts required for the safe handling and management of non-hazardous and hazardous drugs.
  6. Recognize structural, functional, and operational primary and secondary engineering controls when compounding and handling nonhazardous and hazardous drugs.
  7. Relate principles of air pressure differentials, airflow dynamics, and critical first air to sterile compounding.
  8. Identify relevant technology used in non-hazardous and hazardous drug compounding; electromechanical, reusable, disposable, personal protective equipment, safety, emergency, testing, and deactivation/decontamination and disinfection equipment and supplies.
  9. Recall procedures involved in the safe handling, maintenance, monitoring, testing and verification of a sterile compounding environment.
  10. Relate protocols for the deactivation/decontamination and disinfection of ISO class environments to non-hazardous and hazardous drug compounding activities.
  11. Recognize the importance of Process Development leading to the development of a Master Formulation Record.
  12. Recognize the functions of excipients found in sterile preparation master formulation records.
  13. Recognize clinical considerations a pharmacist-in-charge must consider to ensure patient safety in a patient-centric practice.
  14. Explain how to follow and complete a Master Formulation Record used for documenting compounded sterile preparations.
  15. Recall pharmaceutical calculations used under the supervision of a pharmacist-in-charge in a sterile compounding practice.
  16. Repeat a comprehensive series of aseptic techniques related to the compounding of sterile preparations.

 

Overall Learning Objectives of Live Activity

Pharmacists

  1. Argue in defense of the parameters of a quality management system engaged in sterile compounding for non-hazardous and hazardous drugs.
  2. Support standards of practice and scientific principles applicable to sterile compounding for non-hazardous and hazardous-drugs.
  3. Defend the application of risk management that addresses sterile compounding and the safe handling and management of non-hazardous and hazardous drugs.
  4. Propose verification procedures that satisfy the scientific principles of efficacy, reliability, and validity for numerous operational and functional parameters within a sterile compounding practice.
  5. Defend a functional and operational facility workflow design schematic for a sterile compounding facility in compliance with standards of practice related to the safe handling and management of non-hazardous and hazardous drugs.
  6. Practice gowning, technology transferring, entering, and exiting protocols within ISO class controlled environments.
  7. Practice a series of aseptic techniques in consideration of critical first air, touch- and cross- contamination.
  8. Practice aseptic techniques used to compound sterile preparations in an ISO class environment and in compliance with the United States Pharmacopeia (USP) and related standards of practice.
  9. Practice aseptic techniques specific to hazardous drug compounding utilizing closed system transfer devices.
  10. Defend the use of monitoring- and testing- related technologies used in a sterile compounding practice.
  11. Assess the use and application of indicators and integrators that serve as controls during environmental monitoring, incubation, terminal sterilization, and depyrogenation protocols.
  12. Manage the use of technologies used for microbial air and surface sampling, non-viable particulate monitoring, filter integrity testing, preparation sterility and endotoxin testing, terminal sterilization, depyrogenation, disinfection, incubation, and SEC/C-SEC/PEC/C-PEC HEPA filter integrity and airflow dynamics.
  13. Demonstrate a robust media-fill challenge test in compliance with USP standards of practice.
  14. Manage environmental-, human performance-, and preparation-related audits in compliance with USP and related standards of practice.
  15. Assess regulatory-, preparatory-, and clinical- related risk in a sterile compounding practice.
  16. Demonstrate the use and functional parameters of an Automated Compounding Device (ACD) used in a sterile compounding practice.
  17. Design a Master Formulation Record that consists of pre- and post- qualification requirements related to facility, technology, and personnel, preparation testing, end-stage filtration, terminal sterilization, inspection, beyond-use dating, packaging, labeling, and shipping.

Pharmacy Technicians

  1. Support the parameters of a quality management system employed by a pharmacist-in-charge in a non-hazardous and hazardous drug sterile compounding practice.
  2. Support standards of practice and scientific principles advocated in a sterile compounding practice specialized in non-hazardous and/or hazardous-drug compounding.
  3. Evaluate as a responsibility of all personnel the application of risk management that addresses sterile compounding and the safe handling and management of non-hazardous and hazardous drugs.
  4. Assess verification procedures that are routinely followed and that satisfy the scientific principles of efficacy, reliability, and validity for numerous operational and functional parameters should recommendations for change be warranted.
  5. Assess functional and operational facility workflow design schematics related to the safe handling and management of non-hazardous and hazardous drugs should recommendations for change be warranted.
  6. Practice gowning, technology transferring, entering, and exiting protocols within ISO class controlled environments.
  7. Practice a series of aseptic techniques in consideration of critical first air, touch- and cross- contamination.
  8. Practice aseptic techniques used to compound sterile preparations in an ISO class environment and in compliance with the United States Pharmacopeia (USP) and related standards of practice.
  9. Practice aseptic techniques specific to hazardous drug compounding utilizing closed system transfer devices.
  10. Manage monitoring- and testing- related technologies used in a sterile compounding practice.
  11. Support the routine use of indicators and integrators through their application in environmental monitoring, incubation, terminal sterilization, and depyrogenation protocols.
  12. Support the use of technologies through their application in microbial air and surface sampling, non-viable particulate monitoring, filter integrity testing, preparation sterility and endotoxin testing, terminal sterilization, depyrogenation, disinfection, incubation, and SEC/C-SEC/PEC/C-PEC HEPA filter integrity and airflow dynamics.
  13. Demonstrate a robust media-fill challenge test in compliance with USP standards of practice.
  14. Plan to engage in environmental-, human performance-, and preparation-related audits to demonstrate compliance with USP and related standards of practice.
  15. Demonstrate the use and functional parameters of an Automated Compounding Device (ACD) used in a sterile compounding practice.
  16. Support the use of a Master Formulation Record to demonstrate required compliance with standards of practice that consists of pre- and post- qualification requirements related to facility, technology, and personnel, preparation testing, end-stage filtration, terminal sterilization, inspection, beyond-use dating, packaging, labeling, and shipping.


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 LP3 Network Inc.. assist with the marketing of this activity. LP3 Network Inc. is an independent corporation. LP3 Network Inc. has an established agreement with MEDISCA Inc. ensuring that it has no influence on LP3 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 activity. The activity consists of 30 hours of self-study (3.0 CEUs), 1 hour is designated as law, and 20 hours live participation (2.0 CEUs). The UAN’s for the self-study include 0012-9999-16-008-H04-P and 0012-9999-16-009-H03-P for pharmacists (both knowledge based) and0012-9999-16-008-H04-T and 0012-9999-16-009-H03-T (both knowledge based)  for pharmacy technicians; for the live practice based activity 0012-9999-16-010-L04-P for pharmacists and 0012-9999-16-010-L04-T for pharmacy technicians. The activity accreditation is 01/01/2016-01/01/2019.

 

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 LP3 Network Inc.

 

Cancellation and Refund Policy

A written request must be sent to LP3 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 LP3 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.